A systematic review and meta-analysis was conducted to identify the overall incidence and patient-specific predictors of worsening TR after ICD or PPM implantation.

Researchers searched the CENTRAL, Medline, and Scopus databases from inception through January 2023. Eligible studies were randomized controlled trials and cohort studies that reported patients who received PPM or ICD implantation and had a follow-up echocardiogram to determine whether there was worsening TR by 1 degree or more (mild to moderate, or moderate to severe TR).

Log odds ratio was used to summarize group differences, and statistical significance of the between-group differences was determined with use of meta-analysis with a random-effect model.

The analysis included 29 studies (8 prospective, 21 retrospective) with 66,590 participants (60% men; mean age, 68 years).

In 2 studies (59,613 participants) that compared patients who had a device implantation with control groups, patients with device implantation (n=1008) were significantly more likely to have worsening TR vs control individuals (n=58,605) (odds ratio [OR], 3.18; 95% CI, 1.58-6.39; P <.01). In analysis of 28 studies with 7777 patients, the pooled incidence of 1 degree or more worsening of TR post-implantation was 23%.

Worsening TR after device implantation significantly increased mortality (hazard ratio, 1.42; 95% CI, 1.05-1.92; P =.02). In addition, greater right atrial area (OR, 1.11; 95% CI, 1.06-1.17; P <.01) was significantly associated with an increased risk of worsening TR postimplantation, and men (OR, 0.74; 95% CI, 0.61-0.91; P <.01) were less likely to have this complication vs women.

No statistically significant difference was observed between the ICD and PPM groups for TR (OR, 1.12; 95% CI, 0.57-2.18; P =.71).

Right ventricular dysfunction (OR, 0.99; 95% CI, 0.98-1.01; P =.47), baseline pulmonary hypertension (OR, 1.03; 95% CI, 0.99-1.07; P =.12), baseline mitral regurgitation (OR, 1.75; 95% CI, 0.74-4.1; P =.20), left ventricular ejection fraction (OR, 0.99; 95% CI, 0.94-1.04; P =.69), baseline atrial fibrillation (OR, 1.94; 95% CI, 0.67-5.66; P =.22), and increasing age (OR, 1.0; 95% CI, 0.98-1.01; P =.75) were not associated with worsening TR after device implantation.

Among several study limitations, TR after device implantation has an uncertain etiology and significant heterogeneity was observed. In addition, individual patient-level data are not available, most participants are from single-center and retrospective studies, and the etiology of mortality was not specified in the included studies.

“Our analysis demonstrates that patients undergoing PPM or ICD implantation are at an increased risk of worsening TR,” the researchers wrote. “Most important, this complication significantly increases mortality.”

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This study recruited patients (N=198) with multivessel STEMI and non-culprit stenosis of 35% to 75% from the Hospital of Lithuanian University of Health Sciences between 2020 and 2021. The patients were randomly assigned to receive QFR-guided PCI (n=98) or visual estimation-only-guided PCI (n=100) treatment for non-culprit lesions. The primary outcome was mortality, which was evaluated by telephone call or mailed letter at 12 months.

The study population included patients with a mean age of 65.0 (SD, 10.60) years, 70.7% were men, 52.5% had an inferior myocardial infarction (MI), 15.7% had a history of PCI, 8.1% had a history of MI, and 3.0% had in-hospital mortality. All in-hospital mortality events occurred among the angiography-guided group (P =.046).

At follow-up, 42.4% of patients had minimal, 47.5% had mild, and 4.0% had moderate physical limitations per the Seattle Angina Score Questionnaire.

The QFR recipients had a greater change in left ventricular ejection fraction at 6 months (mean difference, 3.97% vs -0.06%; P =.041) and fewer received additional non-culprit artery revascularization at 12 months (1.0% vs 6.0%; P =.047) compared with the angiography cohort.

The mortality rate during the 12-month follow-up was lower for the QFR group (2.04%) compared with the angiography group (12%). These values indicated that QFR-guided PCI was associated with decreased risk of mortality (odds ratio [OR], 6.23; 95% CI, 2.20-17.87; P =.006).

The limitations of this study include the small sample size and the significant differences between groups at baseline.

“The QFR is a noninvasive coronary physiology evaluation method that is accurate for STEMI patients and can be performed by any qualified team member,” the study authors wrote. “The use of QFR for patients with ST-elevation myocardial infarction significantly reduced the mortality rate and revascularization at the 12-month follow-up.”

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The retrospective, cross-sectional study assessed the association between carotid plaque parameters detected on carotid ultrasound and contrast-enhanced ultrasound, as well as coronary artery plaque progression in nonculprit lesions.

Participants aged 18 to 80 years who had previously received PCI were enrolled in the study from September 2020 to April 2022. All patients were receiving moderate-intensity statins. A total of 173 patients were categorized into 2 groups based on coronary angiography results at baseline and follow-up: the progression group (n=55) and the nonprogression group (n=118).

Binary logistic regression multivariate analysis was used to assess the association between carotid plaque parameters detected on ultrasound and contrast-enhanced ultrasound and nonculprit coronary lesions plaque progression.

The participants had a mean age of 60.36±8.42 years, and 80.35% were men. Nonculprit coronary lesion plaque progression was observed in 31.79% of patients and 143 patients had carotid plaques.

No statistically significant difference was observed in intima–media thickness between the 2 groups (t=1.436; P =.162), and the difference in plaque echogenicity also was not statistically significant (χ² = 0.084, P =.772). Plaque thickness, plaque length, and IPN score in the progressive group were significantly increased compared with those in the nonprogressive group (P <.01).

Multivariate analysis demonstrated that a history of previous PCI (odds ratio [OR], 3.995; 95% CI, 1.241-12.865), plaque length (OR, 3.418, 95% CI, 1.101-10.610), and IPN score (OR, 7.395; 95% CI, 3.154-17.342) were strongly associated with plaque progression in nonculprit coronary lesions. A history of previous PCI, plaque length, and IPN score remained independent predictors for plaque progression in nonculprit coronary lesions after adjustment for age, high-density lipoprotein cholesterol, C-reactive protein, serum creatinine, and plaque thickness (P <.05).

The logistic regression model’s specificity, negative predictive value, accuracy, positive predictive value, and sensitivity for predicting nonculprit coronary lesion progression were 90.53%, 82.69%, 81.12%, 76.92%, and 62.50%, respectively, with an area under the receiver operating characteristic curve of 0.882 (95% CI, 0.826-0.939).

Plaque thickness, length, and IPN score were significantly (P <.01) greater in the progressive group vs the nonprogressive group within 1 year and longer than 3 years. The difference in plaque thickness was not statistically significant (P >.05) in the 2 groups between 12 and 36 months, and the differences between plaque length and IPN score were statistically significant (P < .05).

Limitations of the study include the single-center, retrospective, cross-sectional, observational design and small sample size. Although all patients received statins, the investigators did not obtain the length of time or whether participants had received other lipid-lowering medications. In addition, the relationship between statin therapy and carotid plaque parameters was not evaluated, and the researchers did not assess the association between carotid plaque parameters and cardiovascular events separately.

“This present study demonstrates that carotid plaque length and IPN score measured by ultrasound and contrast-enhanced ultrasound were strongly correlated with the plaque progression of nontarget coronary lesions,” the investigators wrote. “The combination of plaque length, IPN score, and the history of previous PCI has good predictive value in predicting the plaque progression of nontarget coronary lesions.”

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Data for this post-hoc subgroup analysis were sourced from the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) and STOPDAPT-2 for Patients With Acute Coronary Syndrome (ACS) trials which were prospective, multicenter, open-label trials conducted in 2015 to 2017 and 2018 to 2020, respectively. In this analysis, the effects of treatment with 1-month DAPT with clopidogrel plus aspirin followed by 11 months of clopidogrel monotherapy compared with 12 months of DAPT after receiving a cobalt-chromium everolimus-eluting stent were evaluated. Cardiovascular and bleeding outcomes were compared between patients with (n=2030) and without (n=3967) diabetes.

The diabetic and nondiabetic cohorts included patients with a mean age of 68.3 (SD, 10.6) and 67.5 (SD, 11.7) years (P =.01), who were 79.0% and 78.1% men (P =.47), with BMIs of 24.7 (SD, 3.7) and 24.0 (SD, 3.5; P <.001), of whom 60.5% and 73.3% presented with acute coronary syndrome (P <.001), and of whom 23.0% and 14.3% received a prior PCI (P <.001), respectively.

During the PCI procedure, significant group differences were observed on the basis of diabetes status for approach, staged procedure, number of procedures, number of target lesions, number of vessels treated, use of intravascular imaging, number of implanted stents, stent diameter, and stent length.

The cumulative 1-year incidence for the composite outcome (cardiovascular-associated death, myocardial infarction, definite stent thrombosis, stroke, and thrombolysis in myocardial infarction bleeding events) occurred among 3.85% of the diabetes and 2.48% of the nondiabetes groups (hazard ratio [HR], 1.56; 95% CI, 1.16-2.10; P =.004). Stratified by composite cardiovascular and bleeding outcomes, the composite risk for cardiovascular events was higher among the cohort with diabetes (HR, 1.87; 95% CI, 1.33-2.65; P <.001) but the composite risk for bleeding events did not differ between groups (HR, 0.98; 95% CI, 0.56-1.72; P =.94).

Among the diabetic cohort, risk for the composite primary endpoint did not differ between clopidogrel and DAPT groups (HR, 0.87; 95% CI, 0.56-1.37; P =.55). Similar trends were observed in the nondiabetic cohort (HR, 0.99; 95% CI, 0.67-1.48; P =.97).

Conversely, clopidogrel receipt decreased risk for the composite bleeding outcome among patients with diabetes (HR, 0.20; 95% CI, 0.06-0.68; P =.01) but not among those without diabetes (HR, 0.51; 95% CI, 0.25-1.01; P =.054).

Results of the exploratory subgroup analysis that stratified by insulin use status were consistent with the main analysis.

This study may be underpowered, as it is a post-hoc analysis and the results should be considered as exploratory.

“Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT with aspirin and clopidogrel reduced major bleeding events without an increase in cardiovascular events regardless of diabetes,” the study authors wrote. “However, the results of this post hoc subgroup analysis should be considered hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Recognizing that adherence to GDMTs is critical for the secondary prevention of cardiovascular disease, researchers sought to evaluate the association between depression and 12-month adherence to GDMTs (antiplatelet agents, beta-blockers, renin-angiotensin-aldosterone system (RAAS) inhibitors, and statins) in patients receiving PCI.

All study participants received PCI between January 1, 2014, and December 31, 2019. All data for the analysis were obtained from a large US health claims database and reviewed from February 2022 to August 2022. A diagnosis of depression was identified as that occurring during the 12 months of enrollment prior to PCI or within 6 months after PCI.

Medication adherence was evaluated using proportion of days covered (PDC), which was calculated as the ratio of the number of days a medication is available and the number of follow-up observation days. Medication discontinuation per PDC is defined by a period of 60 days or longer without available medication. 

Twelve-month adherence was categorized as adequate (PDC ≥80% to <90%) or optimal (PDC ≥90%). The investigators theorized that patients with depression would exhibit a lower likelihood of either adequate or optimal adherence to medications that are essential for GDMT.

A total of 124,443 individuals who received PCI were included in the analysis. Overall, 33.3% of the participants were women, 10.1% were Black, 9.9% were Hispanic, and 3.0% were Asian. The mean patient age was 69.3 (SD, 10.6) years. In all, 72.2% of the patients received Medicare. The median number of GDMT classes of medication used was 3 (range, 3 to 4).

Results of the study showed that 16.6% of the participants had a diagnosis of depression. Individuals with depression were significantly less likely to obtain adequate 12-month adherence to antiplatelet agents (odds ratio [OR], 0.80; 95% CI, 0.77-0.85), beta-blockers (OR, 0.84; 95% CI, 0.80-0.88), and statins (OR, 0.88; 95% CI, 0.85-0.93) than were participants without depression. No association was reported between depression and adherence to RAAS inhibitors (OR, 0.93; 95% CI, 0.85-1.00).

Additionally, individuals with depression had a similarly decreased likelihood of optimal 12-month adherence to antiplatelet agents, beta-blockers, and statins, as well as to RAAS inhibitors (OR, 0.87; 95% CI, 0.82-0.94).

There are several limitations of the study. As only individuals with insurance were included in the analysis, the results may not be generalizable to those without insurance. Further, the possibility of misclassification of depression status exists because of the reliance of the claims data on ICD coding. Since adherence was established based on records of prescription fills, it is not reflective of patients’ daily use of medications.

“Further studies are needed to determine whether treatment of depression may improve medication adherence as well as how such treatment improves secondary prevention of cardiovascular disease,” the researchers wrote.

Disclosure: One of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the author’s disclosures.

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Stephen P. Messier, Ph.D., from Wake Forest University in Winston-Salem, North Carolina, and colleagues conducted a randomized clinical trial among patients aged 50 years or older with knee osteoarthritis and overweight or obesity. A total of 823 patients were enrolled and randomly assigned to a diet and exercise intervention or an attention control group (414 and 409 participants, respectively) for 18 months.

The researchers found the adjusted mean Western Ontario and McMaster Universities Osteoarthritis Index pain score was 5.0 and 5.5 in the diet and exercise and attention control groups, respectively at 18-month follow-up (adjusted difference, −0.6). Five of seven secondary outcomes were significantly better in the intervention group versus the control group. The mean change in unadjusted 18-month body weight was −7.7 and −1.7 kg (8 and 2 percent) in the diet and exercise and attention control groups, respectively. Overall, there were 169 serious adverse events, none of which were definitely related to the study.

“The 7.7-kg (8 percent) weight loss combined with a 9-cm reduction in waist circumference in the diet and exercise group has the potential for health benefits for older adults with knee osteoarthritis,” the authors write.

One author disclosed financial ties to the biopharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

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Investigators retrospectively compared the probability of delayed intra-abdominal hemorrhage in patients with concomitant blunt abdominal trauma and BTAI between those with and without TEVAR from January 2015 to December 2019. Participants had concomitant blunt abdominal trauma and severe blunt chest trauma (chest Abbreviated Injury Scale score ≥3).

An adjusted multivariate logistic regression model was developed to assess whether each patient’s need for TEVAR independently affected delayed intra-abdominal hemorrhage. Covariables that could clinically affect delayed intra-abdominal hemorrhage were considered in propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) and adjusted for in the multivariate logistic regression model.

Outcome measurements included the probability of delayed intra-abdominal hemorrhage and delay in blood transfusion.

A total of 341 patients with blunt trauma with concomitant severe chest trauma and abdominal trauma that could be managed conservatively were evaluated, 26 patients had concomitant BTAI and blunt abdominal trauma, of whom 7 did not have TEVAR (mean age, 45.3 [SD, 22.2]; 100% men). Of the participants who had TEVAR (mean age, 42.6 [SD, 15.1] years; 89.5% men), 21.1% had delayed intra-abdominal hemorrhage and required hemostatic interventions, but none of those without TEVAR had delayed intra-abdominal hemorrhage. The difference was nonsignificant (P =.306). However, participants who had TEVAR had a significantly greater delayed need for blood transfusions vs those who did not have TEVAR (1118.4 mL vs 857.1 mL; P =.010).

The researchers then used the same selection criteria to identify 322 patients without TEVAR. The 2 groups had significantly different demographics and injury severities before matching. With use of PSM, 38 patients were identified for a balanced group. After matching, participants with TEVAR were more likely to require a blood transfusion 24 hours after presenting to the emergency department (1118.4±2241.9 mL vs 422.4±968.3 mL, P <.001) and were more likely to have delayed intra-abdominal hemorrhage (21.1% vs 5.3%, P <.001) vs those without TEVAR.

When IPTW was applied, patients with blunt abdominal trauma and TEVAR for BTAI were more likely to have a delayed need for a blood transfusion (977.5±1235.7 mL vs 713.8±544.8 mL, P =.010) and were more likely to have intra-abdominal hemorrhage (14.8% vs 5.9%, P =.009) compared with patients who did not have TEVAR.

Among all 341 patients in the multivariate logistic regression analysis, TEVAR for BTAI was an independent risk factor for delayed intra-abdominal hemorrhage (odds ratio, 10.534; 95% CI, 2.599-42.688; P <.001) after adjustment for other covariables.

The researchers noted that their findings were retrospectively based on a single institution with a small number of patients and without more detailed information available regarding patient care. In addition, participants with BTAI frequently are polytraumatized, no patients received nonheparinized TEVAR, and the control group included patients without BTAI.

“More attention should be given in patients with high-grade aortic injuries and concomitant abdominal trauma,” the study authors wrote.

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Drew J. Braet, M.D., from the University of Michigan in Ann Arbor, and colleagues queried a large statewide registry from 2014 to 2021 to assess the association between cannabis use and postoperative outcomes after lower-extremity bypass. Data were included for 11,013 patients who underwent lower-extremity bypass procedures.

The researchers found that 91.0 and 9.0 percent of patients reported no cannabis use and cannabis use in the past month, respectively. Patients using cannabis had higher opioid use at discharge (odds ratio, 1.56), reduced bypass patency at 30 days and one year (odds ratios, 0.52 and 0.64, respectively), and an increased rate of amputation at one year after lower-extremity bypass (odds ratio, 1.25) compared with noncannabis users.

“Our results serve as an important framework for physicians and vascular surgeons to use when counseling patients who use cannabis about the risks of lower extremity bypass,” the authors write. “Patients should be screened for cannabis use and counseled appropriately when considering vascular procedures.”

Abstract/Full Text (subscription or payment may be required)

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Investigators sought to study practice variation, temporal trends, and associated outcomes with the use of IVUS during peripheral arterial intervention. The primary outcome was major adverse limb events, defined as a composite of acute limb ischemia or major lower extremity amputation.

The investigators conducted an observational analysis of all Medicare beneficiaries greater than 65 years of age who underwent peripheral arterial interventions from 2016 through 2019 patients (N=479,756) and used IVUS (n=63,372). Temporal trends in IVUS were stratified based on physician specialty and whether the procedure was done in an inpatient, outpatient, or ambulatory surgery center/office-based laboratory settings.

Use of IVUS during peripheral arterial intervention was greater in ambulatory surgery center/office-based laboratory settings (26.8%) compared with outpatient (5.2%) or inpatient (4.0%) settings, and was performed by interventional radiologists (17.4%), surgeons (11.5%), cardiologists (10.3%), or other physician specialties (10.4%).

The investigators found significant growth in IVUS use in the ambulatory surgery center/office-based laboratory setting (2016 to 2019 growth, 23.6%) and noted significant variation in use. Among the 12,844 operators included in the study, the mean use of IVUS during peripheral arterial intervention was 6.5% (median, 0.0%; IQR, 0%-5%). Among operators who used IVUS at least once during the study period (N=3822), mean use was 13.4% (median 5.4%; IQR 2.2%-15.0%).

The investigators observed that use of IVUS during peripheral arterial intervention was associated with a 28% reduction in the hazard ratio (HR) for developing major adverse limb events through a median of 514 days (adjusted HR, 0.73; 95% CI, 0.70-0.75; P <.0001). Similar reductions were found in the composite outcomes, acute limb ischemia (adjusted HR, 0.82; 95% CI, 0.78-0.87; P <.0001) and major amputation (adjusted HR, 0.69; 95% CI, 0.66-0.71); P <.0001). Similar findings were noted with stratification by severity of peripheral artery disease, and by anatomic location of peripheral arterial intervention.

Analysis limitations include ambiguity of claim codes, claim codes that do not explain how IVUS was incorporated into procedures resulting in possible misclassification, observational study design, lack of detailed procedural and clinical information, exclusion of patients who underwent unsuccessful endovascular revascularization, and the possibility of residual and unmeasured confounding.

Investigators concluded “IVUS use during PVI [peripheral arterial intervention] has increased since 2016, driven by growth in the ASC/OBL [ambulatory surgery center/office-based laboratory] setting.” They reiterated the substantial variation in operator practice and added “When used during PVI [peripheral arterial intervention], IVUS was associated with a lower risk of short- and long-term MALE [major adverse limb events].”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Patients (N=70) with type 2 diabetes mellitus who were referred for catheter ablation of AF to the Hyogo College of Medicine in Japan between 2017 and 2020 were recruited for this prospective, single-center, open-label, randomized controlled trial. The rate of AF suppression following catheter ablation was evaluated among patients randomly assigned to receive 20 mg tofogliflozin once daily (n=38) or 100 mg anagliptin twice daily (n=32) for 2 to 6 weeks prior to catheter ablation and during the 1-year follow-up.

The study participants were had a mean age of 70.3±8.2 years, 69% were men, average body mass index (BMI) was 25.4 (SD, 4.5), 57% had nonparoxysmal AF, they had AF for 38.5 (SD, 47.7) months, 64% had hypertension, 64% dyslipidemia, and 31% were receiving antidiabetic drugs. No significant group differences were observed at baseline.

After exposure to interventional drugs, the tofogliflozin recipients had greater improvements in waist circumference, BMI, systolic and diastolic blood pressure, urinary excretion of sodium and potassium, total serum ketones, and b-hydroxybutyrate acid at 12 months compared with baseline.

All patients had successful pulmonary vein isolation (PVI) and most (74%) received radiofrequency PVI. An additional cavotricuspid isthmus ablation was performed among 71% of patients and an additional superior vena cava isolation was performed among 17% of patients. Sinus rhythm was achieved among all patients following intervention.

The AF recurrence ratio was higher among the anagliptin recipients (47%) than tofogliflozin recipients (24%; P =.0417). Freedom from AF recurrence favored tofogliflozin in the intention-to-treat (P =.0377) and per-protocol (P =.0415) analyses.

No thromboembolic events were observed during the follow-up.

Stratified by recurrence (n=24) and no recurrence (n=46), predictors for recurrence included the following:

• Presence of nonparoxysmal AF (92% vs 39%; P <.0001)
• Left ventricular ejection fraction (mean, 52.6% vs 63.7%; P =.0007)
• Brain natriuretic peptide levels (mean, 304.9 vs 144.2 pg/mL; P =.0025)
• Left atrial diameter (mean, 48.4 vs 43.6 mm; P =.0026)
• E wave length (mean, 87.4 vs 74.5 cm/s; P =.0091)
• Urinary microalbumin levels (mean, 182.6 vs 50.8 mg/mL; P =.0123)
• Use of cryoballoon PVI (8% vs 35%; P =.0207)
• Urinary albumin-creatinine ratio (mean, 195.9 vs 73.7; P =.0395)
• Use of sodium-glucose cotransporter 2 inhibitors (SGLT2i; 37% vs 63%; P =.0417)
• Use of dipeptidyl peptidase-4 inhibitors (63% vs 37%; P =.0417)

The major limitation of this study is that a multivariate analysis cannot be performed due to the small sample size.

“A comparison of the effects of tofogliflozin and anagliptin on the suppression of recurrence of AF after CA [catheter ablation] in patients with type 2 DM [diabetes mellitus] revealed that tofogliflozin, and SGLT2i, was associated with a significantly lower risk of recurrent AF,” the study authors wrote.

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The TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) study was a randomized, placebo-controlled trial conducted at 187 sites in 11 countries. Patients (N=7038) receiving PCI with 1 or more drug-eluting stents who were at high risk for ischemic or bleeding events received 3 months of open-label 90 mg ticagrelor twice daily and 81 to 100 mg aspirin once daily. The patients who tolerated the dual antiplatelet therapy (DAPT) regimen were randomly assigned in a 1:1 ratio to receive open-label ticagrelor plus aspirin or placebo for 12 months. The primary endpoint was Bleeding Academic Research Consortium (BARC) events.

The patient population comprised 23.8% women, 30.5% were not White, their mean age was 63.9 (SD, 10.2) years, 42.3% had a previous PCI, and 64.6% had a PCI indication of acute coronary syndrome. Stratified by normal (BMI, 18.5-24.99; 25.7%), overweight (BMI 25-29.99; 41.6%), and obese (BMI, ³30; 32.7%) status, all baseline characteristics differed significantly between groups (all P £.017) except for the rates of peripheral artery disease, previous myocardial infarction, and previous major bleeding.

During PCI, 72.8% had radial artery access, the average number of vessels treated was 1.3 (SD, 0.5), the number of lesions treated was 1.5 (SD, 0.7), the total stent length was 39.8 (SD, 24.1) mm, minimum stent diameter was 2.8 (SD, 0.5) mm, and 32.7% had a complex PCI. Stratified by BMI, the patients with normal BMI had more lesions treated, a larger total stent length and minimum stent diameter, and more had complex PCI compared with overweight or obese groups (all P £.016).

At 1 year, the rate of BARC 2, 3, or 5 bleeding events was 5.7% for the normal and overweight cohorts and 5.3% for the obese group (P =.830). The composite outcome of death, myocardial infarction, or stroke occurred among 3.8% of the normal, 3.7% of the overweight, and 4.2% of the obese groups (P =.680).

Stratified by BMI and treatment, monotherapy was preferred for reducing BARC events among all patients (hazard ratio [HR] range, 0.48-0.63) and among obese patients for reducing BARC 3 or 5 events (HR, 0.25), Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries moderate or severe events (HR, 0.41), and International Society on Thrombosis and Hemostasis major events (HR, 0.29) compared with DAPT. No significant treatment-by-BMI interactions were observed. No treatment was preferred for reducing ischemic events stratified by BMI.

Net adverse clinical events were lower among the obese monotherapy recipients (HR, 0.67) compared with obese DAPT recipients.

This study is a subgroup analysis, and may be underpowered to detect significant differences.

“Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories,” the study authors wrote.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Researchers conducted a retrospective multicenter analysis of patients receiving mitral valve TEER with the MitraClip system (Abbott Vascular) from December 2009 to February 2021 at 13 European centers. All participants had a complete echocardiographic evaluation at baseline and short-term follow-up (30 to 180 days) and received a successful mitral valve TEER procedure (defined as residual mitral regurgitation [MR] ≤2+ at discharge).

The participants were stratified based on changes in TAPSE/PASP between baseline and the echocardiographic reassessment in 2 groups: those with improved TAPSE/PASP (responders) and those with unchanged or worsened TAPSE/PASP (nonresponders).

Short-term follow-up was the time from mitral valve TEER to echocardiographic reassessment, and long-term follow-up was the time from that reassessment to the end of follow-up. All-cause mortality was assessed at long-term follow-up.

A total of 501 patients were included, 331 responders (mean age, 72.1 [SD, 10.1] years; 74% men) and 170 nonresponders (mean age, 73.2 [SD, 9.5] years; 62% men). The median time from baseline to short-term echocardiographic reassessment was 89 days (IQR, 43-159 days).

Of the nonresponders, 55% had no right ventricular (RV) dysfunction (TAPSE >15 mm), and 45% had a TAPSE/PASP of more than 0.36 mm/mm Hg at the short-term follow-up.

Responders were younger, more likely to be men, and less likely to have a history of cardiac procedure vs nonresponders. Responders also had larger left ventricular and left atrial dimensions, higher PASP, and lower TAPSE and TAPSE/PASP compared with nonresponders. No prior cardiac surgery, low baseline TAPSE, high baseline PASP, tricuspid regurgitation of 2+ or greater at baseline, and low postprocedural mitral mean gradient were independently associated with TAPSE/ PASP improvement after mitral valve TEER.

The baseline PASP, TAPSE, and degree of tricuspid regurgitation were the only independent predictors of TAPSE/PASP changes after patients with previous cardiac procedures were excluded.

The median follow-up for clinical outcomes was 584 days (IQR, 191-1243 days). All-cause mortality was lower in cumulative incidence among responders vs nonresponders (31.5% vs 44.9%, respectively; P =.002). An increase in TAPSE/PASP was associated with a reduced mortality risk on a continuous level (hazard ratio [HR], 0.34 per unit [95% CI, 0.18-0.65]; P =.001).

Multivariable analysis demonstrated that changes in TAPSE/PASP (responders vs nonresponders) were significantly associated with mortality (HR, 0.65 [95% CI, 0.42-0.92], P =.017), and changes in TAPSE or PASP alone were not.

Study limitations include the retrospective, observational, single-arm design, and unknown biases may affect the findings. In addition, a core laboratory for assessing echocardiographic images is not used, and a complete echocardiographic evaluation of RV function is not available for a majority of patients. Another potential limitation is selection bias owing to the exclusion of patients who died before the short-term echocardiographic reassessment or who are without complete echocardiographic data at baseline and follow-up.

“Changes in RV-PA coupling after M-TEER [mitral valve TEER] might have a strong impact on clinical outcome and seem to be affected by several clinical and procedural variables,” the study authors wrote. “Further larger and randomized studies are needed to confirm our results and identify patients who may obtain RV reverse remodeling after SMR correction.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Data for this retrospective analysis were sourced from University Hospital Bonn and University Hospital Düsseldorf in Germany. Patients (N=268) who received tricuspid TEER with the MitraClip/TriClip or PASCAL systems between 2015 and 2021 were evaluated for 1-year outcomes on the basis of AKI.

The study population comprised patients with a mean age of 79.0 [SD, 6.8] years, 43.3% were men, BMI was 25.8 [SD, 5.0], estimated glomerular filtration rate (eGFR) was 50.4 [SD, 23.1] mL/min/1.73 m², 82.8% had hypertension, and 25.0% had diabetes. A total of 42 patients developed AKI. Patients with AKI were more male (P =.003), had higher European System for Cardiac Operative Risk Evaluation II score (P =.003), and were older (P =.012) compared with the patients who did not have AKI.

Overall, 88.4% of patients had procedural success and 94.4% technical success. Fewer patients who developed AKI had procedural (78.6% vs 90.3%; P =.038) and technical (85.7% vs 96.0%; P =.008) success compared with the non-AKI cohort, respectively. No other procedural data differed on the basis of AKI.

The in-hospital mortality rate was 2.2% and was significantly higher among the AKI cohort (9.5%) compared with the non-AKI group (0.9%; P =.006). The AKI group was also associated with higher rates of major or life-threatening bleeds (9.5% vs 2.2%; P =.037) and longer hospital stays (median, 8 vs 7 days; P =.041) compared with the non-AKI group, respectively. Rates of the composite outcome of all-cause mortality and hospitalization for heart failure were higher for patients with AKI at 30 days (P =.004) and 1 year (P <.001).

Risk for AKI was associated with male gender (odds ratio [OR], 3.12; 95% CI, 1.53-6.40; P =.002), eGFR below 60 mL/min/1.73 m² (OR, 2.75; 95% CI, 1.06-7.14; P=.037), lack of procedural success (OR, 2.54; 95% CI, 1.01-6.38; P =.046), and age (OR, 1.07; 95% CI, 1.00-1.14; P =.036).

Risk for all-cause mortality and heart failure hospitalization was associated with AKI (hazard ratio [HR], 2.39; 95% CI, 1.45-3.94; P =.001), chronic obstructive pulmonary disease (HR, 1.67; 95% CI, 1.02-2.74; P =.041), and left ventricular ejection fraction per 10% (HR, 0.69; 95% CI, 0.56-0.85; P <.001).

In a subgroup analysis, no significant interactions were observed for the relationship between AKI and the composite outcome of all-cause mortality and hospitalization for heart failure.

The results may not be generalizable to patients with advanced tricuspid regurgitation and right ventricular dysfunction, as the majority of patients in this study have preserved right ventricular function.

“Postprocedural AKI was associated with a higher incidence of the composite outcome, consisting of all-cause mortality and rehospitalization for worsening heart failure, within 1 year after the procedure,” the study authors wrote. “Our findings highlight the clinical impact of AKI following TEER for TR and should assist in identifying patients at high risk for AKI.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Researchers sought to evaluate the association between county-level racial segregation and rates of AS diagnosis and subsequent TAVI.

They conducted a review and analysis of 29,264,075 Black and White Medicare fee-for-service beneficiaries between 2016 and 2019 living in metropolitan areas. ICD-10 codes were used to calculate population-level rates of AS diagnosis and TAVI. Segregation in each beneficiary’s county of residence was determined using the American Community Survey’s residential segregation index (SI) that measures Black and White resident relative geographic distribution on a scale of 0 (complete integration) to 100 (complete segregation).

The researchers observed increased rates of AS diagnosis were associated with living in a high-segregation county (SI>60) for the total population (adjusted odds ratio, 1.03; 95% CI, 1.02-1.03) and no difference in TAVI rates. They found high county-level segregation was associated with decreased rates of AS diagnosis and decreased rates of TAVI among Black beneficiaries. They noted the same was not true of White beneficiaries who saw increased rates of AS diagnosis and increased rates of TAVI associated with living in counties with high-level segregation.

The researchers found the interaction between Black race and segregation, and lower TAVI rates continued among those with an AS diagnosis (interaction P =.003). They found no independent association for 30-day mortality with race or segregation.

Study limitations include the lack of long-term follow-up.

 “Living in a high-segregation county is independently associated with decreased population-level rates of AS diagnosis and receipt of TAVI for Black, but not White, individuals,” the study authors wrote. “Among Black people living in high-segregation counties, disparities in TAVI rates are associated with decreased AS diagnosis and access to TAVI.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Investigators from Thomas Jefferson University Hospital and John H Stroger Jr Hospital of Cook County in the United States sourced data for this study from the National Readmission Database. Patients (N=223,238) who received off-label-TAVI or GD-TAVI between 2015 and 2019 were evaluated for outcomes using a propensity-matching approach.

The study population comprised 55% men and 18.5% received off-label-TAVI.

In general, both off-label-TAVI and GD-TAVI use increased between 2015 and 2019 (P =.026).

Among the propensity-matched cohort, off-label-TAVI was associated with increased risk for mortality (adjusted odds ratio [aOR], 2.94; 95% CI, 2.66-3.24), net adverse cardiac events (aOR, 1.83; 95% CI, 1.73-1.95), major bleeding (aOR, 1.49; 95% CI, 1.36-1.63), and stroke (aOR, 1.20; 95% CI, 1.07-1.34) during index hospitalization compared with GD-TAVI. At 30 days (aOR, 1.54; 95% CI, 1.23-1.92) and 180 days (aOR, 1.30; 95% CI, 1.03-1.65) off-label-TAVI associated with increased major bleeding risk compared with GD-TAVI.

Stratified by TAVI indication, off-label-TAVI was associated with increased readmission rates among patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy compared with GD-TAVI. Patients with a bicuspid aortic valve, leukopenia, and peptic ulcer disease had similar outcomes following off-label- or GD-TAVI.

The trends observed in this study should be confirmed in a large safety study.

“OL [Off-label]-TAVI utilization has increased significantly over the 4-year study period,” the study authors wrote. “Patients undergoing OL-TAVI have a higher likelihood of mortality, stroke, and bleeding compared with those undergoing GD-TAVI during the index hospitalization.”

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Researchers sought to explore racial and ethnic disparities in rates of PVI utilization. They used data from the Healthcare Cost and Utilization Project National Inpatient Sample to identify all patients aged 65 years or older diagnosed with peripheral artery disease (PAD) who had received infrailiac PVI between 2010 and 2017. Comparisons were made regarding demographic and socioeconomic data, pre-existing disorders, and outcomes among non-Hispanic White, Black, and Hispanic participants.

A total of 9,637,980 hospital admissions involving a PAD diagnosis and 436,278 PVIs were identified. Non-Hispanic White patients, Black patients, and Hispanic patients were aged 76±7, 74±7, and 75±7 years; 44.2%, 53.3%, and 44.9% were women; and 91.4%, 89.3%, and 83.2% paid with Medicare, respectively. Results of the study showed that Black and Hispanic patients who receive PVI experience more comorbidities (dyslipidemia, hypertension, diabetes, congestive heart failure, chronic kidney disease, and chronic obstructive pulmonary disease) and have a lower socioeconomic status compared with non-Hispanic White patients.

PVI is utilized less among Hispanic and Black patients compared with non-Hispanic White patients. When the percentage of PVIs is adjusted for the total number of hospitalizations, however, findings show that Black and Hispanic patients receive more PVIs and amputations, and have higher odds of experiencing periprocedural complications. 

Although rates of amputation downtrended for all patients during the study period, Hispanic and Black patients still were shown to have significantly higher rates of amputation (P <.001), which suggests suggesting that Hispanic and Black individuals present at later stages of PAD.

The researchers concluded that “Black and Hispanic patients who undergo PVI have a higher likelihood of experiencing complications during their admission.”

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Patients with moderate to severe COPD have been associated with poorer outcomes following TAVR compared with the general TAVR population. It remains unclear, however, whether the subset of patients who required home oxygen support may be associated with poorer clinical outcomes than the patients with COPD not requiring home oxygen.

Investigators from Hartford Hospital in the United States evaluated data from a cohort of patients (N=2463) with COPD who received TAVR. In-hospital and 1-year outcomes were evaluated on the basis of home oxygen support. Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ12) instrument.

The home oxygen cohort (n=150) was younger (mean, 78.9 vs 81.5 years; P <.001), had greater Society of Thoracic Surgeons risk score (mean, 15.50 vs 9.29; P <.001), more had diabetes (43% vs 33%; P =.020) and carotid artery disease (36% vs 27%; P <.034). They had lower forced expiratory volume in 1 second predicted (mean, 50.3% vs 75.0%; P <.001) and diffusion capacity (mean, 48.6 vs 74.6; P <.001), and had worse KCCQ12 score (mean, 32.5 vs 49.1; P <.001) at baseline compared with the no home oxygen cohort (n=2313).

During hospitalization for TAVR implantation, the rates of procedural cardiac arrest (4.7% vs 1.0%; P <.001), postoperative atrial fibrillation (4.0% vs 1.5%; P =.013), and mortality (5.3% vs 1.6%; P =.001) were higher among the home oxygen group compared with no home oxygen, respectively. Similar rates of stroke (P =.388), major vascular complications (P =.411), and need for a permanent pacemaker (P =.678) were observed between groups.

At 1 year, the home oxygen cohort was associated with a higher mortality rate (14% vs 4.3%; P <.001) and lower KCCQ12 scores (mean, 69.5 vs 82.1; P <.001) compared with no home oxygen, respectively.

The data from this study indicate that, among patients with COPD receiving TAVR, the subset with more severe disease requiring home oxygen support are more likely to experience poorer outcomes in-hospital and at 1 year, in addition to having worse quality of life.

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Jung-Min Ahn, M.D., from the University of Ulsan College of Medicine in Seoul, South Korea, and colleagues conducted a prospective, randomized controlled trial at 27 international heart centers. The trial was designed for 1,776 patients with angiographic multivessel coronary artery disease who were randomly assigned to PCI with everolimus-eluting stent or CABG. The trial was terminated early after inclusion of 880 patients (438 and 442 in the PCI and CABG groups, respectively) due to slow enrollment.

The researchers found that the primary end point — the composite of death from any cause, myocardial infarction, or target-vessel revascularization — occurred in 34.5 percent of patients in the PCI group and 30.3 percent of patients in the CABG group during a median follow-up of 11.8 years. The occurrence of a safety composite of death, myocardial infarction, or stroke did not differ significantly between the groups, nor did occurrence of death from any cause. However, spontaneous myocardial infarction and any repeat revascularization occurred significantly more frequently after PCI than CABG (7.1 versus 3.8 percent and 22.6 versus 12.7 percent, respectively).

“The extended follow-up of the BEST trial provides important long-term insights that could aid in decision-making for the optimal revascularization strategy in patients with multivessel coronary artery disease,” the authors write.

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Recognizing that scant data are available on clinical outcomes among patients who receive high-risk PCI using the heart pump Impella^® [Abiomed], investigators sought to analyze patients from the PROTECT III Study who received Impella-supported high-risk PCI. The study participants were stratified into 3 groups, according to kidney function. These groups were normal kidney function, CKD without dialysis, and CKD with dialysis. The researchers compared the composite incidence of MACCE, defined as all-cause death, myocardial infarction (MI), stroke/transient ischemic attack, and repeat revascularization, at 30 days and 90 days.

A total of 1223 patients were included in the study. On average patients were aged 71±11 years and 73% of the patients were men. Overall, 68% of the participants had normal kidney function (serum creatinine, 1.1 mg/dL [IQR, 0.9-1.2 mg/dL]), 23% had had CKD without dialysis (serum creatinine, 1.7 mg/dL [IQR, 1.3-1.9 mg/dL), and 9% were receiving dialysis.

The patients on dialysis were younger and had more comorbidities, including diabetes, heart failure, anemia, prior stroke, and peripheral vascular disease, than those not receiving dialysis. High-risk PCI status (urgent vs elective), proportion of patients experiencing acute MI, and mean SYNTAX scores were similar in the 3 groups of participants.

No significant differences in MACCE were demonstrated among the groups at 30 days and 90 days. Per Cox proportional hazards analysis, participants with normal renal function had comparable risks for 30-day and 90-day MACCE compared with patients with CKD not receiving dialysis. Further, patients with normal renal function had a significantly lower risk for 90-day MACCE compared with patients with CKD who were receiving dialysis (P =.03). Of note, participants receiving and those not receiving dialysis had a similar 90-day risk for MACCE. Further, patients with CKD who were not receiving dialysis had a higher risk for MI at 90 days.

“Patients with CKD and dialysis undergoing HRPCI [high-risk PCI] exhibit higher risk for 90-day MACCE compared to patients with normal kidney function,” the study authors wrote. “CKD patients without dialysis also had higher risk of MI at 90 days. Further research is needed.”

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Preprocedural anxiety is common among patients receiving cardiac catheterization. To evaluate whether a VR intervention may reduce anxiety levels, patients (N=179) scheduled to receive left heart catheterization, coronary angiography, or both at Spectrum Health in the United States were randomly assigned to receive VR plus standard education (n=89) or standard education alone (n=90). The interventions were delivered less than 1 week prior to the procedures. Standard education was delivered both in-person and over the phone. The VR intervention was delivered using a headset and smartphone and included a true-to-life simulation of the hospital lobby, waiting room, preprocedural nursing area, and procedure room. Anxiety was measured using the State-Trait Anxiety Inventory state score (STAI-S) before randomization and following the intervention.

The study population comprised 63.7% men and was aged mean 63±8 years.

Prior to randomization, average STAI-S scores were 40±12 points among the VR group and 39±11 points among the education group (P =.48). Prior to the procedure, anxiety levels did not differ between the VR (mean, 38) and education only (mean, 38; P =.66) cohorts.

Patients who used the VR device reported disorientation (8.0%), altered vision (5.7%), headache (3.4%), and nausea (3.4%).

The results of this study may not be generalizable to other study populations or for anxiety related with other procedures.

“In the first randomized study to evaluate the impact of VR on preprocedural anxiety, VR did not reduce preprocedural anxiety compared with standard education alone,” the study authors noted. “Future studies are needed to determine if novel applications of VR can enhance patient experience in the catheterization laboratory.”

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Patients (N=30) who had been experiencing trigeminal neuralgia for more than 6 months were recruited in Brazil for this sham-controlled, double-blind, randomized trial. Patients underwent either thermal radiofrequency ablation of the trigeminal nerve delivered inside Meckel’s cave using a coaxial approach at 75°C for 60 seconds (n=15) or sham treatment (n=15). Changes in scores on the numeric rating scale for pain and the 36-Item Short-Form Health Survey questionnaire (SF-36) were evaluated up to 1 year after the procedure.

The intervention and control arms consisted of 80% and 66.7% women with a mean age of 66.9 (standard deviation [SD], 10.7) and 62.5 (SD, 10.50) years, 28.5% and 40% had both V2 and V3 trigeminal branch involvement, 57.1% and 60.0% reported suicidal ideation, and numeric rating sale for pain scores were 9.6 (SD, 0.7) and 9.8 (SD, 0.4) points, respectively.

Recipients of the active intervention experienced a significant reduction in pain scores (from 9.2 to 0.7 points) compared with those receiving the sham intervention (8.9 to 5.8 points). This decrease in pain scores was observed as early as 1 day following treatment. The change in pain scores was maintained throughout the 12-month follow-up. At 1 month, the patients assigned to the sham treatment were allowed to switch to active treatment. After the patients switched treatments, the reductions in pain scores were similar between groups.

Initially, recipients of radiofrequency ablation experienced greater improvements in all SF-36 scales, except for general health perception.

At 1 month following treatment, participants in the ablation cohort decreased consumption of carbamazepine or oxcarbazepine by 84.75% compared with a decrease of 16.46% among participants in the sham group.

Adverse events included numbness (40%), paresthesia (13.3%), and labial herpes reactivation (n=6).

Study authors concluded that percutaneous trigeminal radiofrequency ablation caused a clinically significant reduction in pain compared with sham treatment among patients with trigeminal neuralgia. Although additional study is needed to compare outcomes of this treatment with surgical decompression, the authors conclude that “[t]hese results support using radiofrequency nerve ablation as a treatment for refractory trigeminal neuralgia.”

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Samir R. Kapadia, M.D., from the Cleveland Clinic Foundation, and colleagues randomly assigned patients with aortic stenosis to undergo transfemoral TAVR with CEP or without CEP (control; 1,501 and 1,499 patients, respectively). A CEP device was successfully deployed in 94.4 percent of the patients in whom an attempt was made.

The researchers observed no significant difference between the groups in the incidence of stroke within 72 hours after TAVR or before discharge (2.3 versus 2.9 percent; difference). Disabling stroke occurred in 0.5 and 1.3 percent of the CEP and control groups, respectively. There were no substantial differences seen between the groups in terms of the percentage of patients who died; had a stroke, transient ischemic attack, or delirium; or had acute kidney injury.

“Although the trial did not definitively identify a role for CEP in all patients undergoing TAVR, the CEP device was safe and may be a reasonable choice for some patients and physicians,” the authors write.

Several authors disclosed financial ties to pharmaceutical, medical device, and biomedical companies, including Boston Scientific, which funded the study.

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Typically, mental health is overlooked among patients hospitalized for cardiovascular-related complications. However, mental health status has the potential to contribute to outcomes and use of health care resources.

In order to evaluate whether mental health status contributes to health care utilization, investigators from Wayne State University and Detroit Medical Center reviewed data from the National Inpatient Sample. Patient outcomes were evaluated following PCI on the basis of whether or not the patient had diagnosed schizophrenia.

The schizophrenia (n=8345) and control (n=1,681,275) cohorts comprised 24.0% and 9.7% Black individuals (P <.05), 25.0% and 9.3% were covered by Medicaid insurance (P <.05), and 46.0% and 30.0% had lower socioeconomic status (P <.05), respectively.

Patients with schizophrenia experienced a 1.52 day longer hospital stay (P <.05) and a $12,185.41 greater cost of hospitalization (P <.05) compared with control patients.

Among the subset of patients who had PCI following acute myocardial infarction, schizophrenia was associated with a similar 1.57 day longer hospital stay (P <.05) and $14,736.98 greater health care cost (P <.05) compared with control patients.

Schizophrenia did not associate with increased mortality risk among the entire study group (odds ratio [OR], 1.13; P =.437) or among the subset of patients who had acute myocardial infarction (OR, 1.10; P =.58).

“History of mental health disorders such as schizophrenia is associated with increased resource use after PCI,” the study authors wrote. “Multiple socioeconomic factors play into this association. Involvement of a behavioral health team during the inpatient course for PCI patients with concurrent diagnoses on the schizophrenia spectrum may lessen hospital resource and care team burden while improving patient outcomes.”

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Elliott R. Haut, M.D., Ph.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a cluster-randomized trial in which all adult non-intensive care units (10 medical and six surgical) from an academic hospital were randomly assigned to a real-time, electronic alert-triggered, patient-centered education bundle intervention or nurse feedback intervention to examine their effectiveness for reducing nonadministration of prophylaxis for venous thromboembolism. Outcomes were compared preintervention versus postintervention in each cohort.

The researchers found that the overall dose nonadministration declined significantly after the interventions among 11,098 patient visits (13.4 to 9.2 percent). In both arms, nonadministration decreased significantly (12.2 to 7.4 percent for the patient-centered education bundle; 14.7 to 11.2 percent for nurse feedback). In both arms, patient refusal decreased significantly (7.3 to 3.7 percent and 9.5 to 7.1 percent for the patient-centered education bundle and nurse feedback, respectively). Compared with nurse feedback, the patient-centered education bundle was significantly more effective in reducing all nonadministered and refused doses.

“Our study provides clear evidence that supports the use of information technology strategies combined with targeted patient-centered education to bolster best practices of VTE prophylaxis medication administration,” the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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Researchers conducted a systematic review and meta-analysis of studies comparing outcomes among patients with and without CKD who received LAAO device implantation. They searched PubMed and Google Scholar databases for relevant studies and analyzed outcome data with use of a random effects model.

A total of 11 studies with 78,257 patients were included in the final analysis. No difference was found regarding the risk for ischemic transient event or stroke (odds ratio [OR], 1.24; 95% CI, 0.87-1.77; P =.23) during the follow-up. Patients with CKD had an increased risk for bleeding (OR, 1.55; 95% CI, 1.41-1.70; P <.01) and in-hospital mortality (OR, 1.63; 95% CI, 1.11-2.40; P =.01) with LAAO device implantation.

No difference was observed for risk for significant pericardial effusion (OR, 1.17; 95% CI, 0.86-1.57; P =.32), vascular complications (OR, 1.18; 95% CI, 0.92-1.51; P =.18), or device-related thrombus (OR, 1.13; 95% CI, 0.53-2.40; P =.75) between the 2 groups.

“Due to a delicate balance between increased risks of thrombotic and bleeding events in this population, future studies comparing outcomes with LAAO and anticoagulation are warranted in CKD patients,” the study authors wrote.

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Vascular access life may be prolonged by treating vascular access stenosis with covered stents at cannulation sites according to review findings published in the Journal of Endovascular Therapy.

Researchers evaluated the results of covered stent placement at cannulation sites to salvage failing vascular access. They conducted a retrospective review that included 11 of 856 patients from a prospectively maintained database in a single-center cohort study with chronic renal dysfunction requiring hemodialysis. Patients were treated between November 2004 and December 2021.

Among the 11 patients who received covered stent placement at cannulation sites for salvaging failing vascular access between 2018 and 2021 (median age at stent placement, 63.0 years; 7 women), there were 4 procedures in patients with brachiocephalic arteriovenous fistulae, 5 in patients with an arteriovenous graft, and 2 in patients with a basilic vein transposition. There were 8 patients who received a covered stent due to recurrent stenosis, 2 due to an acute occlusion, and in 1 case the repair of a damaged polytetrafluoroethylene arteriovenous graft was accomplished with a covered stent.

The researchers found that at 6 months the primary patency after stent placement was 40.9%, at 12 months primary-assisted patency was 79.5%, and at 24 months secondary patency was 80%. They noted the intervention rate per patient-year was not statistically different before (3.8 [IQR=9.5] interventions per year) or after (2.5 [IQR=3.0] interventions per year; P =.280) covered stent placement. They reported no significant problems observed during dialysis sessions following stent placement.

Review limitations include the underpowered sample size and the retrospective study design.

“Based on our results, treating vascular access stenosis at cannulation sites with covered stents should be considered to prolong vascular access life with similar intervention rates and acceptable patency rates in these fragile hemodialysis patients,” the study authors wrote.

Reference

Drouven JW, Bruin C, van Roon AM, et al. Use of covered stents in cannulation sites as a last option to salvage failing vascular access. J Endovasc Ther. Published online August 16, 2022. doi:10.1177/15266028221116745

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HealthDay News — An intervention, including clinical decision support with audit and feedback, reduces the likelihood of acute kidney injury (AKI) among patients undergoing coronary angiography, according to a study published in the Sept. 6 issue of the Journal of the American Medical Association.

Matthew T. James, M.D., Ph.D., from the University of Calgary in Alberta, Canada, and colleagues examined whether a multifaceted intervention is effective for the prevention of AKI after coronary angiography or percutaneous coronary intervention (PCI) in a cluster randomized clinical trial conducted in Canada, which included invasive cardiologists at three cardiac catheterization laboratories. Cardiologists received educational outreach, computerized clinical decision support on contrast volume and hemodynamic-guided intravenous fluid targets, and audit and feedback during the intervention period. The intervention group included 31 physicians who performed 4,327 procedures among 4,032 patients undergoing nonemergency coronary angiography, PCI, or both, while the control group (preintervention period) included 34 physicians who performed 3,493 procedures among 3,251 patients.

The researchers found that the incidence of AKI was 7.2 and 8.6 percent during the intervention and control periods, respectively (odds ratio, 0.72). Of the 12 prespecified secondary outcomes, no significant differences were seen in eight outcomes. Reductions from the control to intervention period were seen in the proportion of procedures in which excessive contrast volumes were used (51.7 to 38.1 percent) and in the proportion of procedures in eligible patients in whom insufficient intravenous fluid was given (75.1 to 60.8 percent).

“Whether this intervention would show efficacy outside this study setting requires further investigation,” the authors write.

Several authors disclosed financial ties to the pharmaceutical and health care industries.

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Implantable cardioverter-defibrillators (ICDs) are equally effective at reducing all-cause and cardiac mortality in men and women, and cardiac resynchronization therapy with defibrillators (CRT-D) may lower all-cause and cardiac mortality in women more than in men according to a study in Heart Rhythm.

Researchers evaluated sex-based differences regarding the mode of death and device efficacy of ICD and CRT-D in the MADIT-II, MADIT-CRT, and MADIT-RIT trials.

The overall population included 3038 men and 1000 women with ischemic cardiomyopathy (ICM) or nonischemic cardiomyopathy (NICM) who received an ICD or CRT-D. The women with ICM (n=375) had a mean age at death of 66.9±9.6 years vs 71.0±8.7 years for men with ICM (n=2135). The women with NICM (n=625) had a mean age at death of 69.2±14.1 years vs 61.0±14.2 years for men with NICM (n=903).

The most frequent type of death in men was nonarrhythmic cardiac death (41%), followed by noncardiac death (34%) and arrhythmic cardiac death (17%). For women, noncardiac death was most common (33%), followed by nonarrhythmic cardiac death (29%) and arrhythmic cardiac death (20%).

A total of 295 men and 66 women died (9.7% vs 6.6%; P =.003) during a median follow-up of 26 months. Men had a significantly higher cumulative probability of all-cause death compared with women, with an annual mortality rate of 4% per year for men and 2.5% per year for women (P =.004).

Men had a nonsignificant difference in all-cause mortality compared with women for ischemic heart disease (5% vs 3.3% per year; P =.222), and no difference occurred for nonischemic heart disease (2.3% vs 2.3% per year; P =.889).

The mortality risk for men was substantially increased (41%) but not statistically significant compared with women with ischemic heart disease (hazard ratio [HR], 1.41; 95% CI, 0.98-2.04; P =.063) after controlling for relevant clinical covariates. A similar risk was observed between men and women with nonischemic heart disease (HR, 1.05; P =.524) according to Cox proportional hazards regression analysis.

A trend toward an approximate 2-fold increase was observed in the risk of nonarrhythmic cardiac death in men vs women with ischemic heart disease (HR, 1.88; P =.057), and no difference was found in those with nonischemic disease, per Cox proportional regression analysis.

Noncardiac death was 2-fold higher in men and women with ICM compared with patients with NICM. After adjustment, no difference was found in noncardiac death by sex with ischemic (HR, 1.20; P =.538) or nonischemic heart disease (HR, 1.30; P =.524).

All-cause mortality was increased significantly in men who qualified for but did not receive an ICD (19.4%-27.2%) vs men who received an ICD (10.3%) or CRT-D (9.1%). Women had a similarly lower rate of all-cause mortality for those who received an ICD (10%) or CRT-D (3.9%) vs historical cohorts (21.9%-22.6%). The lower rate of all-cause mortality was mainly accounted for by a lower rate of arrhythmic and nonarrhythmic cardiac death in men and women with an ICD or CRT-D vs patients without a defibrillator.

Some study limitations are that cohorts from 3 trials are used in the analysis, and enrollment criteria are not identical and could introduce selection bias. Also, the 3 trials were conducted over 14 years, and this study does not include recent advances in medical therapies.

“Our findings provide important clinical implications when assessing mortality risk in male and female patients with an implanted ICD or CRT-D,” the investigators wrote. “Women are generally thought to be at a lower risk of all-cause mortality and nonarrhythmic cardiac death than men, but our data suggest that this may not be the case in those with nonischemic cardiomyopathy.”

Disclosure: The original MADIT studies were supported by research grants from Boston Scientific. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Tompkins CM, Zareba W, Greenberg H, et al. Differences in mode of death between men and women receiving implantable cardioverter defibrillators or cardiac resynchronization therapy in the MADIT trials. Heart Rhythm. Published online August 21, 2022. doi: 10.1016/j.hrthm.2022.08.018

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Supraventricular arrhythmia may be diagnosed in patients with use of systematic cardiac loop recording within at least 28 days following patent foramen ovale (PFO) closure. These findings were published in JACC: Cardiovascular Interventions.

Investigators sought to determine the incidence and timing of atrial fibrillation (AF), using systematic 28-day or longer electrocardiography monitoring with implantable loop recorders (ILR) or external loop recorders and their determinants and impact in patients who had PFO closure.

All participants received PFO percutaneous closure at a hospital in Paris, France, and were proposed to be monitored with ILR in case of high-risk features.

The ILR devices were implanted before hospital discharge, with patients being rhythmically monitored for up to 3 years. Patients with an ILR implanted before the PFO closure for ruling out AF were also included. Participants without postprocedural arrhythmia or high-risk features were monitored for 4 weeks with external loop recorders, initiated before discharge.

The primary endpoint was the incidence of new onset AF, supraventricular tachycardia, or flutter lasting 30 seconds or longer, according to the European Society of Cardiology guidelines, within 28 days of the procedure.

A total of 225 patients (median age, 52.2 years; 57.3% men) were included from June 2018 to October 2021. Of these patients, 97.3% had PFO percutaneous closure for secondary prevention of embolic events, including a cerebrovascular event in 215 cases.

The overall incidence of the primary endpoint at 28 days was 20.9% (95% CI, 16.1-26.7). Postdischarge, 36.9% patients were monitored with an ILR, of which 7 (8.4%) were implanted preprocedure as part of ruling out AF. The percentage of patients monitored with an external loop recorder was 58.7%, with a median duration of analyzable data of 22.3 (21-26) days.

The incidence of new-onset supraventricular arrhythmia from hospital discharge to 28 days postprocedure was 9.9% (95% CI, 5.9-16.1) and 28.9% (95% CI, 20.3-39.4) among external loop recorder-monitored and ILR-monitored patients, respectively. The median follow-up in ILR-monitored patients was 428 (211-752) days.

At 1 year, the cumulative incidence of supraventricular arrhythmia in ILR-monitored patients was 32.7% (95% CI, 23.7-44.0), and the median delay to the first sustained supraventricular arrhythmia episode was 14.0 (6.5-19.0) days. A total of 26 of 51 patients had 1 episode of arrhythmia.

Independent determinants of the primary endpoint were age at procedure (per 10-year increase) (adjusted odds ratio [aOR], 1.67; 95% CI, 1.18-2.36; P =.004), device left disc diameter 25 mm or wider (aOR, 2.67; 95% CI, 1.19-5.98; P =.017), and male sex (aOR, 4.78; 95% CI, 1.96-11.66; P =.0006), in stepwise multivariate logistics regression.

Clinical symptoms related to arrhythmia occurred in 28 (54.9%) patients and resulted in an unplanned medical visit in 9 cases and unplanned hospital admission in 4 additional cases.

The researchers noted that using ILR and external loop recorders devices may limit the information obtained on the timing of AF episodes in lower-risk patients and may have resulted in an unbalanced comparison between the 2 groups. In addition, the incidence of arrhythmia reported in the external loop recorder-monitored groups may be underestimated, and data regarding the type and duration of cardiac monitoring performed before the PFO closure are not available.

“Our study provides a precise timing of when these events occur, which were recorded rapidly after PFO closure, with a median of 2 weeks after the procedure,” wrote the investigators. “Few patients appear to have recurrences beyond 1 month.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Guedeney P, Laredo M, Zeitouni M, et al. Supraventricular arrhythmia following patent foramen ovale percutaneous closure. JACC Cardiovasc Interv. Published online August 22, 2022. doi: 10.1016/j.jcin.2022.07.044

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Hemodynamically supported high-risk percutaneous coronary intervention (HRPCI) is associated with significant improvement in 90-day left ventricular ejection fraction (LVEF), according to a study published in the Journal of the Society for Cardiovascular Angiography & Interventions.

The observational, multicenter RESTORE EF (ClinicalTrials.gov Identifier: NCT04648306) study assessed the 90-day change in LVEF and clinical symptoms of heart failure and angina in patients who received standard of care, percutaneous ventricular assist device-supported, elective or urgent PCI performed at US centers with expertise in HRPCI. All participants underwent HRPCI supported with the Impella microaxial rotary pump (Abiomed).

The primary endpoint was LVEF at 90 days after PCI (60- to 180-day window), and secondary endpoints included change in heart failure and angina symptoms at follow-up and completeness of revascularization.

A total of 406 patients were enrolled at 22 US sites between August 2019 and May 2021. The participants had a mean age of 70.2±11.4 years, 106 (26.1%) were women, and the mean baseline LVEF was 37±16%.

Among 251 patients with baseline and 90-day follow-up LVEF measurements available, baseline LVEF improved from 35±15% to 45±14% at 90 days (P <.0001).

Participants with a baseline LVEF of 20% or less had the greatest improvement in LVEF. In subset analyses, all baseline quartiles of LVEF were associated with significant improvement at 90 days, except for patients with baseline LVEF over 45%, who had significant improvement in New York Heart Association (NYHA) class III/IV heart failure symptoms and Canadian Cardiovascular Society (CCS) class III/IV anginal symptoms at follow-up.

LVEF improvement at 90 days was significantly higher in patients with residual SYNTAX score I of 0 (10% LVEF improvement vs 5% improvement in those with residual SYNTAX Score I >0; P =.007).

Of the 274 patients with baseline and follow-up NYHA heart failure classification, 62% were NYHA class III or IV at baseline (32% class IV, 30% class III). The percentage of patients who were NYHA class III/IV decreased to 15% at the last follow-up (P <.0001), with 1% class IV and 14% class III.

For the 260 patients who had baseline and follow-up CCS angina classification, 72% were CCS class III or IV at baseline (44% class IV, 28% class III), which declined to 2% at the last follow-up (P <.0001), with 0% class IV and 2% class III.

The main study limitations are the observational, nonrandomized design and absence of a comparator. In addition, the data are investigator-reported, and the final study population included only patients who survived at 90 days, with no intervening cardiac procedures. Furthermore, the study was conducted primarily during the COVID-19 pandemic, and the role of optimal heart failure medical therapy in augmenting LV function cannot be reliably determined.

“This observational study suggests that hemodynamically supported HRPCI may afford a significant improvement in LVEF at 90 days, along with significant relief of angina and heart failure symptoms, in an ideal patient population with successful HRPCI and without the need for subsequent procedures,” the researchers wrote. “In this setting, complete revascularization was associated with a more significant improvement in LVEF.”

Disclosure: This study was funded by Abiomed, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Wollmuth J, Patel MP, Dahle T, et al. Ejection fraction improvement following contemporary high-risk percutaneous coronary intervention: RESTORE EF study results. J Soc Cardiovasc Angiogr Interv. Published online August 12, 2022. doi.org/10.1016/j.jscai.2022.100350

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Use of a strategy that involves additional superior vena cava isolation at repeat pulmonary vein isolation (PVI) ablation for recurrent atrial fibrillation (AF)/atrial tachycardia does not improve patient outcomes compared with use of a PVI-only approach, according to the results of a study published in the Journal of Interventional Cardiac Electrophysiology.

The researchers sought to evaluate the role played by an empirical strategy of superior vena cava isolation in addition to pulmonary vein (PV) re-isolation during a repeat procedure in patients who experience AF recurrence following index PVI. They performed a nonrandomized, registry-based, dual center study.

Consecutive patients with documented AF recurrence with a duration of longer than 30 seconds after index PVI, who received a repeat ablation at 1 of 2 centers between 2010 and 2017, were analyzed retrospectively. Although only a re-isolation of the pulmonary vein was intended in individuals with reconnections of 2 or more pulmonary veins (PVI group), an additional superior vena cava isolation was planned for those patients with fewer than 2 isolated pulmonary veins in addition to the re-isolation of the pulmonary vein (PVI+ group). The analyses were performed in an as-treated and per-protocol basis. 

A total of 344 participants were enrolled in the study. PVI only was performed in 269 patients, and PVI plus superior vena cava isolation was performed in 75 patients (as-treated). Overall, 73% of the participants were men and 66% had paroxysmal AF. The mean patient age was 60±10 years.

Median follow-up after a repeat PVI was 320 days, and no statistically significant difference was reported between the 2 groups (PVI group: 265±113 days [median, 313 days] vs PVI+ group: 273±112 days [median, 350 days]; P =.822).

Freedom from AF/atrial tachycardia following repeat PVI was 80% in the PVI group compared with 73% in the PVI+ group (P =.151). Per multivariable Cox regression analysis, the presence of persistent AF (hazard ratio [HR], 2.067; 95% CI, 1.389-3.078; P <.001) and hypertension (HR, 1.905; 95% CI, 1.218-2.980; P =.005) were recognized as the only statistically significant predictors of AF/atrial tachycardia  recurrence. Results of the per-protocol analysis did not differ from these findings.

Some limitations of the study are that a relatively small number of patients with superior vena cava isolation are included. Further, the ablation strategy used (additional superior vena cava isolation in participants with ≤1 reconnected pulmonary vein and PVI in participants with ≥2 reconnected pulmonary veins) is not performed in all of the patients, because the decision regarding the strategy used was ultimately made at the discretion of the physician.

“A strategy of an empirical additional [superior vena cava isolation] at repeat PVI ablation for recurrence of AF/[atrial tachycardia] does not improve outcomes compared to a PVI only approach,” the study authors noted. “This holds true for the as-treated and per-protocol analysis as well for patients with paroxysmal AF. The only independent predictors of recurrence after repeat PVI were the presence of hypertension and persistent AF type.”

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Knecht S, Zeljkovic I, Badertscher P, et al. Role of empirical isolation of the superior vena cava in patients with recurrence of atrial fibrillation after pulmonary vein isolation-a multi-center analysis. J Interv Card Electrophysiol. Published online August 18, 2022. doi:10.1007/s10840-022-01314-w

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A position paper regarding increased exposure to x-rays experienced by clinicians performing fluoroscopically guided procedures was published in Catheterization & Cardiovascular Interventions on behalf of members of the Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory.

The advent of fluoroscopically guided procedures some 30 years ago has resulted in increased exposure to x-rays which predisposes clinicians performing these procedures to definite occupational health hazards. In addition to the well-established risk for radiation exposure in recent years other consequences, such as physical stress and predilection to orthopedic injuries, have become clearer.

The burdensome personal protective equipment and the poor ergonomic design of fluoroscopic equipment and procedure rooms have been associated with increased risk for orthopedic injury, particularly related with the spine. A survey in 2004 by the Society of Cardiac Angiography and Interventions found that nearly half of respondents reported spine problems, which was much higher than the general population in the United States (27.4%).

In addition, despite improvements to both equipment and awareness, a busy interventionalist can frequently approach or exceed radiation limits that were previously believed as acceptable.

Recent reports reaffirmed the Linear-No-Threshold model for solid cancer risk and radiation exposure, indicating that risk rises linearly with increasing dose. During fluoroscopically guided procedures, the brain is the least protected organ. Recent anecdotal reports of the rate of brain and hematologic cancers among clinicians in the field have been found to be alarming by the authors.

Due to the long-understood potential harm from radiation exposure, the As Low As Reasonably Achievable (ALARA) policy was established. The position authors posed the question: What do “low” or “reasonably achievable” mean in practice? The National Council on Radiation Protection and Measurements established the maximum permissible doses by setting numerical values equal to risks for “safe,” non-radiological occupations. To that end, most radiation protection programs alert an individual when their badge readings exceed 10% and 30% maximum permissible doses.

The position authors closed out their statement with a call to action. They stated that additional research about the occupational hazards for clinicians performing fluoroscopically guided procedures is needed. These studies should address the incidence rates of orthopedic injury and radiation-associated harms, the aspects of the working environment that contribute to orthopedic problems, which radiation-induced diseases clinicians be aware of, and the clinician- or workplace-specific aspects that contribute to increased risk.

With regard to governing agencies, professional societies, and workplaces, the authors ask why there has been little improvement in workplace safety over the last 30 years. The authors stated that it is unclear what entity should be responsible for improving workplace safety and if laboratory equipment can be improved, who should cover the cost?

 “Our profession has numerous members who retired early or became seriously ill as a direct consequence of the interventional laboratory environment in which we work,” the study authors wrote. “It is time that the interventional community began working with industry to take a fresh look at laboratory design, leaving no innovation unconsidered, and that this endeavor be undertaken at the highest levels.”

Disclosure: An author declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Klein LW, Miller DL, Balter S, et al. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. Published online January 4, 2018. doi:10.1002/ccd.21772

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Among the many products comprising the booming dietary supplement industry, a growing number of individuals are turning to supplements and drinks containing caffeine and other compounds purported to increase energy. According to some reports, the energy drink market in the United States reached more than $9.7 billion in sales in 2015.¹ While many use these supplements with the aim of reducing fatigue and improving mental focus, people often seek to improve athletic performance by consuming such products.

However, experts have cautioned that, despite their popularity, caffeine-based products and other types of energy-boosting supplements could have adverse effects, especially on cardiovascular health. Because of these risks, the World Health Organization has cited consumption of energy drinks as a significant public health issue.²

While most of these risks are associated with the high levels of caffeine contained in these products, other common ingredients intended to increase energy include taurine, guarana, ginseng, glucuronolactone, and bitter orange.³ In a 2022 position statement, the European Association of Preventive Cardiology notedthat consumption of a formulation containing caffeine, taurine, and glucuronolactone “may increase arterial blood pressure, act as a platelet aggregation enhancing factor and compromise endothelial function in healthy individuals.”³

The authors point to a range of cardiovascular side effects linked to consumption of energy drinks, including coronary disease, heart failure, cardiac arrhythmias, ventricular tachycardia, and aortic dissection, among numerous other potential cardiovascular consequences.³

In addition, in a randomized, double-blind, placebo-controlled trial published in 2019, Shah et al examined the effects of 2 different energy drinks on cardiovascular parameters compared to placebo.⁴ The results showed that that consumption of the energy drinks significantly prolonged participants’ QTc interval (maximum change from baseline in Bazett’s corrected QT interval: +17.9±13.9 ms for drink A, +19.6±15.8 ms for drink B, and +11.9±11.1 ms with placebo; P =.005 for ANOVA; P =.04 and P <.01, respectively, compared to placebo).

Significant increases in peripheral and central systolic and diastolic blood pressure were also observed with the energy drinks compared to placebo (all P <.001).

These risks may be especially elevated among individuals with underlying heart conditions. A 2017 study found that the risk of cardiac arrest increased by 20% in individuals with familial long QT syndrome after drinking 2 cans of an energy drink.³

Along with the cardiovascular hazards associated with these drinks and other energy supplements in general, consuming them before exercise can further compound the risks as cardiovascular demands increase with physical activity. For example, some findings suggest that intake of 200-300 mg of caffeine 1 hour prior to aerobic exercise decreased endothelial cell function in healthy individuals, as indicated by reductions in myocardial blood flow.⁵

To gauge clinician views on the potential cardiovascular risks of consuming caffeine and other energy supplements before exercise, Cardiology Advisor checked in with Gregory M Marcus, MD, MAS, professor of medicine in residence and associate chief of cardiology for research at the University of California, San Francisco, School of Medicine, and  Jeffrey J. Hsu, MD, PhD, assistant clinical professor of medicine in the division of cardiology at the University of California, Los Angeles, School of Medicine.

What is known thus far about the cardiovascular effects of supplements such as energy drinks containing caffeine or other substances before exercising? 

Dr Marcus: The great majority of research in this area has been conducted in artificial environments using small numbers of research participants and usually examining 1 brief moment in time rather than repeated assessments.⁶ Although the data there are conflicting, there is some evidence that caffeine may help bolster athletic performance. However, these studies have generally not been designed to assess the safety of this practice nor longer-term consequences beyond mainly a single workout.

It’s important to emphasize that the possible health benefits of caffeine that have been recently highlighted in the medical literature and lay press stem from large observational studies of predominately regular coffee drinkers rather than the use of high doses of caffeine or caffeine supplements specifically before exercise.⁷

Dr Hsu: Caffeine is a common ingredient in most energy drinks, including those taken prior to exercise. While caffeine in moderate amounts – the equivalent of 2 to 4 cups of coffee – may help to improve endurance, the concern is that higher doses of caffeine may increase the risk of adverse cardiovascular effects, including arrhythmias and severe hypertension, particularly when combined with high-intensity exercise. 

Have you observed any effects related to these drinks or supplements in your own patients?

Dr Hsu: Yes, it is increasingly common for athletes – both at the recreational and elite levels – to use caffeinated “pre-workout” supplements during their training, and I have seen young athletes present with symptoms related to arrhythmias or ectopy. These often improve or completely resolve with cessation of these supplements. 

How should clinicians advise patients regarding the use of these supplements in the context of exercise?

Dr Marcus: While clinicians should, of course, encourage regular exercise, they should likely caution their patients against using supplements or energy drinks to facilitate workouts. There is no strong evidence of clinical benefit and some observational data to demonstrate harm.

These energy drinks may include other constituents, including sugar, that are overall detrimental to health. I generally recommend avoiding supplements, as the concentrations of molecules tends to exceed those in natural foods that our bodies have evolved to consume.

In general, large randomized trials of supplements tend to show either no benefit or harm to health, often with unintended adverse consequences.⁷ For example, while observational studies suggest that caffeine as can be found in commonly consumed beverages like coffee does not have a meaningful negative effect on heart rhythm disturbances and may even protect against some common heart rhythm problems, there are many case reports of young, otherwise healthy individuals experiencing clinically significant heart rhythm disturbances in the context of consuming energy drinks with high levels of caffeine.⁸

Dr Hsu: Clinicians who care for athletes should inquire about supplement use during clinic visits. Clinicians should counsel their patients that there is no “magic bullet” for optimizing their cardiovascular fitness or athletic performance, and athletes should carefully review the components of any exercise supplement they plan to consume. Those who have a history of cardiovascular disease such as arrhythmias, hypertension, or cardiomyopathy should take extra caution and review supplements with their physician prior to use. 

What are the most pressing remaining research needs regarding this topic?

Dr Marcus: Long-term investigations examining actual health-related outcomes beyond simply immediate physical performance are needed to inform clinicians and, in turn, help us to provide the most beneficial guidance to our patients.

Dr Hsu: In my opinion, with the widespread use and marketing of these exercise supplements, we need a better understanding of whether we are clearly seeing adverse cardiovascular effects in people who use these supplements. My concern is that there is little regulation of how these supplements are marketed, and combining high doses of caffeine or other stimulants with vigorous exercise may carry undue cardiovascular risk. 

References

1. Al-Shaar L, Vercammen K, Lu C, Richardson S, Tamez M, Mattei J. Health effects and public health concerns of energy drink consumption in the United States: a mini-review. Front Public Health. 2017;5:225. doi:10.3389/fpubh.2017.00225
2. Breda JJ, Whiting SH, Encarnação R, et al. Energy drink consumption in Europe: a review of the risks, adverse health effects, and policy options to respond. Front Public Health. Published online October 14, 2014. doi:10.3389/fpubh.2014.00134
3. Adami PE, Koutlianos N, Baggish A, et al. Cardiovascular effects of doping substances, commonly prescribed medications and ergogenic aids in relation to sports: a position statement of the sport cardiology and exercise nucleus of the European Association of Preventive Cardiology. Eur J Prev Cardiol. Published online January 27, 2022. doi:10.1093/eurjpc/zwab198
4. Shah SA, Szeto AH, Farewell R, et al. Impact of high volume energy drink consumption on electrocardiographic and blood pressure parameters: a randomized trial. J Am Heart Assoc. Published online May 29, 2019. doi:10.1161/JAHA.118.011318
5. Planning Committee for a Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements; Food and Nutrition Board; Board on Health Sciences Policy; Institute of Medicine. Caffeine in food and dietary supplements: examining safety: workshop summary. Washington (DC): National Academies Press (US). 2014(5): Caffeine Effects on the Cardiovascular System. 
6. Cameron M, Camic CL, Doberstein S, Erickson JL, Jagim AR. The acute effects of a multi-ingredient pre-workout supplement on resting energy expenditure and exercise performance in recreationally active females. J Int Soc Sports Nutr. 2018;15:1. doi:10.1186/s12970-017-0206-7
7. Poole R, Kennedy OJ, Roderick P, Fallowfield JA, Hayes PC, Parkes J. Coffee consumption and health: umbrella review of meta-analyses of multiple health outcomes. BMJ. Published online November 21, 2017. doi:10.1136/bmj.j5024
8. Mandilaras G, Li P, Dalla-Pozza R, Haas NA, Oberhoffer FS. Energy drinks and their acute effects on heart rhythm and electrocardiographic time intervals in healthy children and teenagers: a randomized trial. Cells. 2022;11(3):498. doi:10.3390/cells11030498

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When the United States (US) Supreme Court overturned the Roe v Wade decision in June 2022, proponents of reproductive choice warned of the wide range of adverse consequences that may result from the decision to end federal protection of abortion access. In addition to the anticipated impact of abortion restrictions on the general population, many medical experts and patient advocacy groups have emphasized the potential dire effects of such restrictions on certain patient populations including those with chronic diseases and disabilities.^1,2

Certain cardiovascular diseases (CVDs), for example, are associated with increased risk for morbidity and mortality in pregnancy.³ Recent findings from the US Centers for Disease Control and Prevention show that cardiac conditions represent the leading cause of maternal mortality, accounting for more than one-third of pregnancy-related deaths.⁴ Thus, it is important that individuals with these conditions retain the option to terminate a pregnancy if it poses risks to the patient.

“Patients with heart disease, including congenital heart disease (CHD), often face increased risks to their health during pregnancy,” said Dr Joseph M Truglio, MD, MPH, assistant professor of medicine, pediatrics, and medical education at the Icahn School of Medicine at Mount Sinai in New York City. “For some, a pregnancy may be life-threatening, while others may be at high risk for complex fetal heart conditions.”

Dr Ali N. Zaidi, MD, associate professor of medicine and pediatrics and director of the Adult Congenital Heart Disease Center at Mount Sinai, noted that an estimated 1% of all live newborns have CHD, and more than 90% of these individuals now reach adulthood.⁵ “This leads to a considerable number of women of childbearing age who have CHD, including those with moderate and severely complex CHD.” An earlier population-based study based in Quebec, Canada, found that the prevalence of severe CHD among adults increased between 1985 and 2000, with a predominance of such cases observed among women.⁶

“As physicians, our primary job remains to the welfare and safety of all our patients, including women with CHD who are already at high risk of adverse maternal outcomes during pregnancy,” Dr Zaidi said. The overturning of Roe v Wade “makes it much harder to safeguard a pregnant woman’s health, especially those with complex CHD.”

The Supreme Court’s ruling “represents a catastrophic barrier to evidence-based care for patients with CHD and other cardiovascular diseases – particularly those from marginalized groups and racialized communities, who already experience marked maternal-fetal health inequities,” Dr Truglio stated. He emphasized that clinicians must continue to heed their ethical obligations to patients and advises that clinicians stay abreast of abortion laws in each state as well as resources for locating abortion providers. He points to resources such as the Abortion Finder and the Planned Parenthood abortion access tool.

For additional discussion regarding the implications of increasing abortion restrictions on these patient groups, we interviewed Dr Monica V. Dragoman, MD, MPH, assistant professor and system director of the complex family planning division in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai; and Dr Linda Cassar, DNP, RNC-OB, CNE, clinical associate professor and program director of the Accelerated BSN program at the George Washington University School of Nursing in Washington, DC.

Regarding the recent Supreme Court decision to overturn Roe v Wade, what are the potential effects of lack of abortion access on patients with CHD and other cardiovascular diseases?

Dr Dragoman: The prevalence of cardiac disease is on the rise among reproductive-age women.⁷ Increasing rates of acquired disease can be linked to increasing rates of obesity, diabetes, and increasing maternal age, while increasing rates of maternal CHD can be attributed to advancements in treatment – allowing women to live longer and start families. 

All women face challenges avoiding unintended pregnancy and planning their families if and when they choose. The stakes can certainly be higher for women living with CVD, especially for those in whom pregnancy can present potentially life-threatening health risks. Restricting access to abortion, an essential health care intervention, is bad for all women’s health. Restricting access to abortion in the context of caring for a person with CVD amplifies impacts in the general population; it exacerbates jeopardy to their life and health, the life and health of their pregnancy, as well as their current or potential future families.

Dr Cassar: Physiologic changes during pregnancy cause significant stress on the heart. Blood volume will increase by approximately 1,500 mL by the end of pregnancy, heart rate will increase by 25%, and cardiac output increases by 30 to 50%, peaking at about 25 weeks of gestation.⁸ Women without cardiac disease, and even some with lower risk cardiac diseases, can compensate for these changes and have relatively healthy pregnancies with positive outcomes.

For those with certain congenital cardiac complications or those with severely limiting acquired cardiac conditions, pregnancy should be avoided, as the risk of maternal morbidity and mortality can be significant. The World Health Organization (WHO) has classified cardiac disorders into 4 risk classifications.⁹ Risk Class 1 patients have no detectable increase in the risk of complications from their cardiac conditions, and the risk increases with each class up to Risk Class 4.

These are patients for whom pregnancy is contraindicated and termination of pregnancy is recommended due to the increased likelihood of severe maternal morbidity and high probability of maternal mortality. According to the CDC, from 2016 to 2018, cardiac conditions (cardiomyopathy, hypertensive disorders, and other cardiovascular complications) accounted for 35.5% of all maternal deaths.⁴

What are the implications specific to your institution, and how is your facility planning to prepare for and address these issues?

Dr Dragoman: We are privileged to live in a state that values bodily autonomy and honors that health care decisions are best made in partnership between patients and their doctors. New York is currently positioned to offer sanctuary for those who have the means to receive care in our state during this evolving medical crisis. 

Unfortunately, we are already dealing with a national epidemic of maternal mortality that disproportionately affects communities of color. According to the Kaiser Family Foundation, 43% of women ages 18-49 living in states where abortion has been banned or likely will be banned are women of color.¹⁰ These women will face higher barriers to accessing abortion care in other states due to less access to financial resources for services, travel, and other logistical needs, exacerbating disparities in maternal morbidity and mortality. People of color also carry a disproportionate burden of CVD. These harmful bans will hurt a lot of people who are unable to access essential reproductive health care services, including abortion.

Mount Sinai’s OB/GYN department is home to world-class experts in complex family planning who work with patients with complex medical conditions to create individualized contraceptive management plans. Some goals include reducing the likelihood of unintended pregnancy and helping patients time any pregnancies to when their conditions are stable or optimized.

For patients who decide not to continue a pregnancy and for whom pregnancy presents an unacceptable health risk in the context of their condition, we offer pregnancy termination. Patients also work with maternal-fetal medicine specialists who provide care during high-risk pregnancies to support the best health outcomes for moms and babies.

How might the ruling on Roe v Wade affect medical education and future generations of clinicians?

Dr Cassar: In higher education, abortion restrictions will impact the way that the curriculum is developed and presented in health education programs, including medical schools, nursing schools, physician assistant programs, and surgical tech training, just to name a few. In states where abortion is not permitted, appropriate training will not be provided to practitioners who would traditionally be providing this type of care.

These clinicians will move into practice unprepared to care for patients who need an abortion or may be suffering from the complications of one performed incorrectly. This does not just impact practitioners in an OB/GYN setting. It will have a ripple effect to emergency rooms, operating rooms, intensive care units, and primary care settings. 

What are your recommendations for other clinicians in terms of providing optimal care and support to these patients in the context of tightened abortion restrictions?

Dr Dragoman: As a first step, it is important for clinicians caring for patients living with CVD to find out if they have a local complex family planning specialist to confer with regarding contraceptive management, pregnancy planning, and pregnancy termination. Complex Family Planning was just recognized by the American Board of Obstetrics and Gynecology as an official subspecialty in 2020, but fellowship training to cultivate physicians with this expertise has existed since the mid-1990s.  

In addition, there are evidence-based guidelines produced by the US Centers for Disease Control and Prevention, the Medical Eligibility Criteria for Contraceptive Use, that offer recommendations on which contraceptive methods a given patient may be eligible to use safely.¹¹ It is important that patients, especially those living with CVD and other medical conditions, are aware of the full range of effective contraceptive options available to best support decision-making and pregnancy planning.

If you live in a state with restrictions on abortion, make sure you are also clear on the limits of the law and whether or not there are health exceptions to accessing the procedure. Support your institution to provide safe and legal services to the full extent possible in your context. Be aware of resources available to connect patients to out-of-state services when necessary. In addition to the Abortion Finder, there is a national network of abortion funds that can assist patients with financial and logistical support, especially with out-of-state care seeking.

Dr Cassar: All patients, but especially those with preexisting cardiac conditions, should receive preconception counseling to ensure an optimal state of health and assess the risks of pregnancy before moving ahead with any plans to conceive. For patients with lower risk cardiac conditions, there will likely be limited, if any restrictions on pregnancy, and their counseling may be as simple as ensuring optimal management of their disease prior to pregnancy and having more frequent doctor visits during the pregnancy to assess the health of the patient and fetus.

Patients with certain congenital cardiac anomalies or higher risk acquired cardiac disease will likely be counseled not to become pregnant, and reliable birth control methods should be discussed. In case of unintended pregnancy for these higher risk patients, a plan should be in place for how to proceed with the option that is safest for the patient and does not violate any laws for their state of residence.

What broader measures are needed to protect patients with CVD and other disabilities in light of the new restrictions? 

Dr Dragoman: Abortion is essential health care. Patients don’t come to us with a political agenda when they are facing a pregnancy crisis – they need help. All clinicians involved in caring for reproductive-age people capable of pregnancy have a stake in reversing these harmful policies restricting comprehensive reproductive health care. Physicians and other clinicians have an important role to play in advocating for necessary policy change.

Dr Cassar: The easiest option here is to amend the laws and allow practitioners to provide abortions to women who are medically in need of them – this would be the most ethical thing for states to do. Unfortunately, this may be a long and arduous uphill battle. In the absence of changes in the laws to allow this, networking between providers will be critical to optimize maternal health and outcomes. Developing networks of resources and practitioners to supplement the care that is allowed to be provided in states with severe restrictions or bans on abortion will be essential to having good outcomes for mothers with preexisting cardiac or other chronic conditions.

References

1. Harris LH. Navigating loss of abortion services – a large academic medical center prepares for the overturn of Roe v. Wade. N Engl J Med. Published online June 2, 2022. doi:10.1056/NEJMp2206246
2. Adams C. Disability rights groups say it’s time to abolish the ableism that dominates abortion activism. NBC News. Published July 21, 2022. Accessed August 14, 2022.
3. Neale T. As US abortion protections are lost, cardiologists brace for impact. TCTMD. Published online June 24, 2022. Accessed August 14, 2022.
4. US Centers for Disease Control and Prevention. Pregnancy mortality surveillance system. Accessed August 14, 2022.
5. Müller MJ, Norozi K, Caroline J, et al. Morbidity and mortality in adults with congenital heart defects in the third and fourth life decade. Clin Res Cardiol. Published online March 1, 2022. doi:10.1007/s00392-022-01989-1
6. Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. Published online January 8, 2007. doi:10.1161/CIRCULATIONAHA.106.627224
7. Lindley KJ, Bairey Merz CN, Davis MB, Madden T, Park K, Bello NA; American College of Cardiology Cardiovascular Disease in Women Committee and the Cardio-Obstetrics Work Group. Contraception and reproductive planning for women with cardiovascular disease: JACC Focus Seminar 5/5. J Am Coll Cardiol. Published online April 5, 2021. doi:10.1016/j.jacc.2021.02.025
8. Ricci SS. Essentials of maternity, newborn, and women’s health nursing. 5^th edition. LWW; 2020.
9. American College of Obstetricians and Gynecologists’ Presidential Task Force on Pregnancy and Heart Disease and Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 212: pregnancy and heart disease. Obstet Gynecol. 2019;133(5):e320-e356. doi:10.1097/AOG.0000000000003243
10. Artiga S, Hill L, Ranii U, Gomez I. What are the implications of the overturning of Roe v. Wade for racial disparities? Published July 15, 2022. Accessed August 14, 2022.
11. US Centers for Disease Control and Prevention. US medical eligibility criteria (US MEC) for contraceptive use, 2016. Accessed August 14, 2022.

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In patients who are receiving an endovascular interventional procedure and general anesthesia, the use of a dexmedetomidine infusion has been shown to mitigate the occurrence of emergence coughing. These findings were published in the European Journal of Pharmaceutical Sciences.

A randomized, double-blinded, prospective, dose-finding study was conducted at the Renmin Hospital of Wuhan University (Wuhan, China) and the Yulin No. 2 Hospital (Yulin, China). Researchers sought to determine the optimal dose of dexmedetomidine infusion for the prophylaxis of emergence coughing from the induction of anesthesia until the conclusion of the procedure in patients who were scheduled for an endovascular interventional procedure.

The primary study outcomes include cough grade and frequency. Secondary study outcomes include hemodynamic parameters; extubation respiratory rate; extubation sedation score; extubation time; postanesthesia care unit discharge time; sleep quality score on the first night following surgery; postoperative length of hospital stay; and incidence of agitation, dizziness, postoperative nausea and vomiting (PONV), shivering, and poor sleep quality.

During emergence, cough grade was evaluated using the following 4-point scale:

• 0 = no cough
• 1 (mild) = single cough
• 2 (moderate) = 1 or more nonsustained cough episode lasting for less than 5 seconds
• 3 (severe) = sustained, repetitive cough with head lift, lasting for longer than 5 seconds

Shivering score was evaluated similarly, with the following 4-point scale:

• 0 = no shivering
• 1 (mild) = facial and neck muscle fasciculations
• 2 (moderate) = more than 1 muscle group tremor
• 3 (severe) = whole-body tremor

Sedation score, agitation, PONV, and sleep quality were all assessed as well.

A total of 351 participants were randomly assigned to 1 of 5 groups. All patients’ dexmedetomidine infusion rates were set to 10 mL·h^-1, with the total dexmedetomidine dosage (μg) as follows:

• group C (saline control with no dexmedetomidine dosage; n=68)
• group D 0.3 μg (1.5 x weight [kg]; n=70)
• group D 0.4 μg (2 x weight [kg]; n=70)
• group D 0.5 μg (2.5 x weight [kg]; n=73)
• group D 0.6 μg (3 x weight [kg]; n=70)

Results of the study show that for cough, the respective incidences in groups D 0.3, D 0.4, D 0.5, and D 0.6 vs group C are 78.6%, 68.6%, 53.4%, and 42.9% vs 89.7% (P =.002, P <.001, and P <.001 among groups D 0.4, D 0.5, and D 0.6 vs group C, respectively). For agitation, the respective rates are 30.0%, 27.1%, 20.5%, and 15.7% vs 44.1% (P=.04, P =.003, and P <.001 among groups D 0.4, D 0.5, and D 0.6 vs group C, respectively).

For shivering, the respective incidences in groups D 0.3, D 0.4, D 0.5, and D 0.6 vs group C are 8.6%, 7.1%, 6.8%, and 5.7% vs 22.1% (P =.027, P =.013, P =.01, and P =.01 among groups D 0.3, D 0.4, D 0.5, and D 0.6 vs group C, respectively). For poor sleep quality, the respective rates are 52.9%, 57.1%, 42.5%, 44.3% vs 61.8% (P =.02 and P =.04 between groups D 0.5 and D 0.6 vs group C, respectively).

Groups D 0.4, D 0.5, and D 0.6 show lower mean arterial pressure (MAP), as well as MAP during extubation, compared with group C. Further, patients in groups D 0.5 and D 0.6 exhibit a slight delay in extubation (3.1 minutes and 3.3 minutes longer than group C; P =.002 and P <.001, respectively).

Based on patients’ hemodynamic changes, limitations of the study include the fact that the attending anesthesiologist who evaluated the cough grade may have been blinded to a participant’s group assignment. Further, since a presurgical sleep assessment was not performed, the possible deviation introduced by inconsistent baseline sleep quality could not be prevented.

Both the 0.5 and 0.6 μg·kg^-1·h^-1 dexmedetomidine infusion rates were effective in decreasing cough grade, as well as the occurrences of sleep disturbances and moderate to severe cough, but prolonged extubation time. “0.6 μg·kg-1·h-1 [dexmedetomidine] infusion rates were identified as most effective to control cough overall prevalence, agitation, sleep disturbance, shivering, and hemodynamic stability,” the study authors wrote.

Reference

Wang W, Huo P, Wang E, et al. Dexmedetomidine infusion for emergence coughing prevention in patients undergoing an endovascular interventional procedure: a randomized dose-finding trial. Eur J Pharm Sci. Published online July 8, 2022. doi:10.1016/j.ejps.2022.106230

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A high rate of pulmonary vein isolation (PVI) durability is maintained in most patients receiving PVI with diffuse posterior wall isolation, according to results of a study published in the Journal of Cardiovascular Electrophysiology.

This was a retrospective analysis of prospectively collected data between 2017 and 2019 among patients receiving atrial fibrillation (AF) ablation at Vanderbilt University Medical Center. All patients (N=137) had diffuse posterior wall ablation in addition to PVI and received AF ablation using a 3.5-mm THERMOCOOL SMART-TOUCH contact force-sensing ablation catheter. Clinical outcomes through 2020 were evaluated.

The patients are aged mean 67±9 years, 65.0% are men, 96.4% are White, 79.6% have persistent AF, CHA₂DS₂-VASc score is 3.1±1.7, 78.1% have hypertension, 34.3% have left ventricular ejection fraction of less than 50%, and 41.6% have an additional cavotricuspid isthmus ablation.

Posterior wall isolation that achieved elimination of all posterior wall electrograms was highly successful (97.8%). The 3 incomplete procedures are due to esophageal temperature rise and a procedure-related tamponade event. No stroke, transient ischemic accident, phrenic nerve injury, odynophagia, or atrio-esophageal fistula events were observed.

Following PVI with diffuse posterior wall isolation, 3-month or longer of follow-up data is available for 126 patients. Over a median follow-up of 14 months, 30.2% of patients have an AF (n=22) or atrial flutter (AFL; n=13) recurrence. The recurrence events occur more often among older patients (P =.001), with higher CHA₂DS₂-VASc scores (P =.04), and those using antiarrhythmic drugs (P =.034).

The patients who require repeat ablation following PVI with diffuse posterior wall isolation (n=18) are more likely to have congestive heart failure (50.0% vs 8.9%; P <.001), fewer have pulmonary vein reconnection (11.1% vs 77.8%; P<.001), they have larger left atrial diameters (median, 46 vs 38 mm; P =.001), more have atrial tachycardia/AFL recurrence (72.2% vs 28.9%; P =.002), fewer have AF recurrence (44.4% vs 88.9%; P =.002), and more have persistent AF at index procedure (72.2% vs 42.2%; P =.05) compared with patients who require repeat ablation following PVI alone (n=45), respectively.

Among 18 patients who received repeat ablation following PVI with diffuse posterior wall isolation, 7 have complete durable posterior wall isolation and the remaining 11 have regional posterior wall electrical recovery. For the patients without durable posterior wall isolation, 9 have no electrical conduction.

The patients with durable isolation and electrical recovery differed significantly in left atrial diameter (median, 41 vs 51 mm; P =.02).

This study may have included selection bias, as the decision to perform PVI with diffuse posterior wall isolation was left to the physician’s discretion.

“Diffuse posterior wall ablation with a low‐flow, medium‐power, short‐duration protocol is safe, feasible, and efficacious with a favorable rate of maintaining sinus rhythm after ablation,” the study authors wrote. “Among patients undergoing repeat ablation, durable pulmonary vein isolation persisted in nearly 90% of patients after PVI plus [posterior wall isolation].”

Reference

Li DL, El-Harasis M, Montgomery JA, et al. Durable pulmonary vein isolation with diffuse posterior left atrial ablation using low‐flow, median power, short‐duration strategy. J Cardiovasc Electrophysiol. Published online May 22, 2022. doi:10.1111/jce.15550

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A study published in Catheterization & Cardiovascular Interventions found that Proglide preclosure technique is a safe approach following removal of large bore venous access sheaths among patients receiving transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR).

Patients (N=354) at a single center who received TEER with MitraClip (n=287) or TMVR with Edwards Sapien Valves (n=67) between 2012 and 2019 were evaluated in this study. Investigators used a Perclose ProglideÔ device during the procedures. Clinical outcomes, 30-day mortality rates, and vascular access complications were evaluated up to 1 year postprocedure.

The patient population is aged mean 78±10.28 years, 55% are women, average BMI is 27.5±6.67, 93% of patients have hypertension, 69% have atrial fibrillation, 48% have coronary artery disease, 30% have a history of myocardial infarction, and 69% use aspirin.

Patients were hospitalized for an average of 6 days and a median of 3 days.

Among the TEER and TMVR cohorts, transfusion not related with vascular access (3.5% vs 10.4%, respectively), transfusion related with vascular access (1.05% vs 3.0%), small (<6 to >2 cm) hematoma (1.05% vs 4.5%), deep vein thrombosis (0.7% vs 0%), large (>6 cm) hematoma (0.35% vs 1.5%), and retroperitoneal hemorrhage (0.35% vs 0%) complications occurred.

The major bleeding event that occurred in the TEER group was spontaneous and likely related with thrombocytopenia. The other major bleed is in the TMVR group and was an arterial bleed that required stenting.

No infections, surgical repair of the access site, pseudoaneurysms, or arteriovenous malformation events occurred.

This study is limited by not having a comparator cohort and by the fact that routine vascular imaging follow-up was not performed. Subclinical complications could have been underreported.

“Randomized trials are needed to compare suture‐mediated versus other modalities of hemostasis,” the study authors wrote.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Mohammed M, Nona P, Asala EA, et al. Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair. Catheter Cardiovasc Interv. Published online May 14, 2022. doi:10.1002/ccd.30229

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Mavacamten reduces the need for septal reduction therapy at 16 weeks among symptomatic patients with obstructive hypertrophic cardiomyopathy (oHCM), according to a study published in the Journal of the American College of Cardiology.

Investigators sought to assess whether the addition of mavacamten to maximally tolerated medical therapy would allow patients with severely symptomatic oHCM to improve enough so that they no longer met guideline criteria for septal reduction therapy or could choose not to receive septal reduction therapy.

The Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy (VALOR-HCM; ClinicalTrials.gov Identifier: NCT04349072) trial is a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial conducted at 19 sites in the United States.

Study participants were treated with maximally tolerated medical therapy and referred for consideration of septal reduction therapy, either surgical myectomy or alcohol septal ablation, within 12 months. Patients had to meet 2011 American College of Cardiology/American Heart Association guideline criteria for septal reduction therapy. The patients were aged 18 years or older, with severe dyspnea or chest pain despite maximally tolerated medical therapy and New York Heart Association (NYHA) functional class III/IV or class II with exertional syncope or near syncope.

The participants were randomly assigned in a 1:1 ratio to mavacamten 5 mg/day or placebo once daily by mouth. Randomization was stratified according to type of septal reduction therapy recommended and NYHA functional class.

The primary endpoint is the composite of eligibility for septal reduction therapy according to the 2011 guidelines or the patient’s decision to have septal reduction therapy after 16 weeks of treatment.

A total of 112 highly symptomatic oHCM patients (mean age, 60±12 years; 51% men; 93% ≥NYHA functional class III) were enrolled from July 2020 to October 2021. Of these patients, 56 received mavacamten (mean age, 59.8±14.2 years; 51.8% men; 85.7% White), and 56 received placebo (mean age, 60.9±10.5 years; 50.0% men; 92.9% White).

The participants had severe dynamic left ventricular outflow tract (LVOT) obstruction with a mean resting gradient of 49±30.9 mm Hg, a Valsalva gradient of 76±30.2 mm Hg, and a post-exercise LVOT gradient of 84±35.8 mm Hg on maximally tolerated medical therapy. Thirty-two percent of patients received combination therapy (including disopyramide).

After 16 weeks of treatment, 76.8% of patients who received placebo continued to meet guideline criteria for septal reduction therapy or chose to have the procedure vs 17.9% of patients who received mavacamten (treatment difference, 58.9%; 95% CI, 44.0%-73.9%; P <.001).

Statistically significant differences favoring mavacamten are found in hierarchical testing of all prespecified secondary outcomes comparing mavacamten with placebo (all P <.001), including the following:

• Post-exercise LVOT gradient (mean difference, -37.2 mm Hg; 95% CI, -48.1 to -26.2 mm Hg)
• The proportion of participants who have 1 class or higher of NYHA functional class improvement (41.1%; 95% CI, 24.5%-57.7%)
• The change in patient-reported Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score (9.4 points; 95% CI, 4.9-14.0 points)
• Geometric mean ratios for change in N-terminal pro–B-type natriuretic peptide (0.33; 95% CI, 0.26-0.42)
• Cardiac troponin I levels (0.53; 95% CI, 0.41-0.70)

Mavacamten is well-tolerated, with 3.6% patients having left ventricular ejection fraction of less than 50% that led to temporary drug discontinuation in the mavacamten group and none in the placebo group.

Among several study limitations, the primary endpoint is driven solely by a decrease in guideline eligibility for septal reduction therapy and not by the decision of patients not to have septal reduction therapy. In addition, participants are randomized for 16 weeks of treatment, and the long-term safety of mavacamten has not been determined in this patient group. Furthermore, the study includes predominantly White patients from high-volume HCM centers with established septal reduction therapy.

“In highly symptomatic obstructive HCM patients meeting guideline criteria for [septal reduction therapy], the addition of mavacamten to maximally tolerated background medical therapy significantly reduced guideline eligibility for [septal reduction therapy] after 16 weeks of treatment,” wrote the investigators. “The study also demonstrated significant reduction in LVOT gradients in mavacamten-treated patients, improvements in NYHA functional classification, and quality-of-life measures. The safety of mavacamten and effect on outcomes during long-term administration remain to be determined.”

Disclosure: The VALOR-HCM study was funded by MyoKardia, Inc, a wholly owned subsidiary of Bristol Myers Squibb. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 

Reference

Desai MY, Owens A, Geske JB, et al. Myosin inhibition in patients with obstructive hypertrophic cardiomyopathy referred for septal reduction therapy. J Am Coll Cardiol. Published online July 4, 2022. doi: 10.1016/j.jacc.2022.04.048

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A study published in JACC: Cardiovascular Interventions found that differing redo transcatheter aortic valve replacement (TAVR) combinations do not result in equivalent future coronary access.

Geometric characteristics of transcatheter heart valve (THV) design combinations following Sapien XT, Sapien 3, CoreValve Evolut R, ACURATE neo, or Portico TAVR and redo TAVR were compared.

For index TAVR, valves were sized 23, 26, or 29 mm except the ACURATE THV, which were sized small, medium, and large. For the smallest valves, neoskirt heights ranged from 7.2 mm (Sapien XT) to 13.6 mm (Evolut R) and for the largest valves, heights ranged from 10.9 mm (Portico) to 15.5 mm (ACURATE).

The area of lowest accessible cell is smallest for the Evolut R system (range, 15.7-19.6 mm²) and largest for the ACURATE system (range, 489.0-610.0 mm²). Similar trends are observed for the largest fitting circle diameter.

For cell width, the sizes range from 4.3 mm (Evolut R 23 or 29 mm) to 22.4 mm (ACURATE large) and cell height from 6.4 mm (Evolut R 26 mm) to 39.9 mm (ACURATE large).

At redo TAVR, neoskirt height is higher compared with index configuration.

For failed Sapien XT implants, neoskirt heights range between 15.2 to 23.2 mm. The lowest value is observed from 25 mm Portico implanted at -4 mm into a 23 mm Sapien XT compared with the highest which is from 29 mm Evolut R implanted at +4 mm into a 26 mm Sapien XT.

For failed Evolut R, the lowest neoskirt height (22.4 mm) is from a 23 mm Evolut Pro implanted at 0 mm into a 23 mm Evolut R and the highest (31.6 mm) is from a 26 mm Evolut Pro implanted at +4 mm into a 26 mm Evolut R.

Overall, the area of lowest accessible cell is 4.8 mm² observed for a 26 mm Evolut R implanted in a 26 mm Evolut R at +4 mm, which is also associated with the smallest fitting circle diameter (1.9 mm).

Cell misalignment reduces accessibility even further but without effecting the neoskirt height. As an example, the lowest accessible cell dimension for a 26 mm Evolut Pro in Evolut R combination was 15.7 mm² for index, 8.3 mm² for aligned redo, and 5.5 mm² for misaligned redo.

This study is limited, as not all THV designs and combinations could be evaluated.

“This study suggests that most THV designs, and implantation depths result in geometrical interaction that would allow potential selective catheterization following redo TAVR,” the study authors wrote. “However, some of these interactions might significantly impact cell size, and certain THV designs, or implantation positions may be more desirable than others when performing redo TAVR. Finally, cell misalignment can further compromise future coronary access in the context of Evolut in Evolut redo TAVR.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Meier D, Akodad M, Landes U, et al. Coronary access following redo TAVR: impact of THV design, implant technique and cell misalignment. JACC Cardiovasc Interv. Published online July 13, 2022. doi:10.1016/j.jcin.2022.05.005

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The health of Americans has improved significantly over the past 50 years, as evidenced by an increased lifespan and lower infant and adult mortality rates. However, Black Americans and other racial/ethnic minority groups are still at greater risk for early mortality and morbidity from a range of chronic health conditions such as diabetes, hypertension, obesity, asthma, and heart disease compared with White Americans.^1,2 Evidence suggests that these health disparities stem from structural racism, as well as provider implicit bias or unconscious bias, that factors into judgments and influences clinical decision-making.¹

Moreover, these health disparities cannot be accounted for by socioeconomic factors alone. The COVID-19 pandemic further underscored these health disparities, as minority populations were disproportionately affected by the illness in the first 2 years of the pandemic.¹

Health Disparity: Part of American History

Prior to the Civil War, physicians, scientists, and slave owners perpetuated beliefs in the physical dissimilarities between Black and White populations as a way to justify slavery.³ These beliefs are still held today. A 2016 survey found that almost 50% of White medical students and residents admitted to false beliefs regarding biologic variances between White and Black patients.⁴

It is crucial to understand racial inequalities in medical treatment. The term “racism” refers to a system based on a discriminative mentality that classifies and ranks the human population in stereotypical ways and allocates societal resources accordingly (Table 1).^5,6 At the individual level, this may or may not be accompanied by bias, whether conscious or unconscious. These untrue opinions may influence medical decisions and contribute to racial disparities in health-related outcomes.^3-4

Table 1. Definitions^5,6

Distrust of the medical profession by Black patients can be traced back to when Black individuals were used for experimental procedures, surgeries, and dissections. For example, in the 1800s, James Marion Sims, MD, known as the “father of modern gynecology,” performed gynecologic surgical procedures on unanesthetized Black women.⁵ More recently, the Tuskegee Syphilis Study has contributed to fear and mistrust among patients and vestiges of the belief that Black people are less than human, which is still rooted in America today.⁷

Distrust of medical professionals, false beliefs, social disadvantages, clinician bias, and a discriminative health care system all contribute to ethnic and racial disparities. According to Fiscella and Sanders, “Separate and unequal systems of health care between states, between health care systems, and between clinicians constrain the resources that are available to meet the needs of disadvantaged groups, contribute to unequal outcomes, and reinforce implicit bias.”⁸

To counter implicit and unconscious bias, initiatives beyond diversity and cultural competency training are needed. PAs and nurse practitioners (NPs) can positively impact disparities by building trust and respect while promoting equity and justice in the health care system. Medical students, including PA and nursing students, should be offered courses that promote cultural awareness in patient care and help to develop vital communication and clinical skills related to reducing negative associations, which can affect judgment and behavior.⁹

Health Disparities Related to Implicit Bias

Implicit bias refers to an individual’s unconscious or conscious perceptions, stereotypes, and beliefs of others. Subconscious beliefs can cause one to speak or act in ways contrary to their conscious principles. These biases can be positive or negative and may raise serious concerns in health care. The implicit bias of health care providers can adversely affect their medical decision-making, severely impacting an already underprivileged population.¹⁰

Maina et al found that 8 of 14 studies (57%) that explored the relationship between implicit bias and health care outcomes using clinical scenarios or simulated patients found no statistically significant relationship between implicit bias and patient care.¹⁰ However, 6 studies found that higher implicit bias was correlated with disparities in treatment recommendations, expectations of therapeutic bonds, pain management, and empathy. Half of the studies examined the impact of implicit provider bias on real-world, patient-provider interaction and found that providers with more pronounced implicit bias demonstrated poorer patient-provider communication.¹⁰

A provider’s ability to empathize with a patient can enhance their ability to deliver high-quality and competent care. A positive interaction between clinicians and patients can influence the likelihood of a patient adhering to medical treatments. It also helps these patients understand and participate in their care. However, Roberts et al found that patients with low socioeconomic status rated their clinicians’ empathy scores as lower than those reported by patients not of low socioeconomic status (mean difference, -0.87 [95% CI, -1.72 to -0.02]).¹¹

Moreover, race or ethnicity is also factored into some of the strategies and calculations applied by practitioners when administering treatment and medications. As a result of this implicit bias, Black patients may be less likely to receive specific medicines, transplants, and specialist referrals. For example, study findings show that minorities are less likely to be prescribed pain relief medications by doctors. Specifically, an analysis of data from 350 emergency departments in the US found that non-White patients were 22% to 30% less likely to receive analgesic medication and 17% to 30% less likely to receive opioids compared to their White counterparts.¹²

Another trickle-down effect of implicit bias is that a health care provider might not issue a referral for an uninsured patient to a specialty clinic if there is no system of care for uninsured patients in the local community. In addition, a patient may not visit a specialist if the clinic is too far away from their home or if the out-of-pocket costs are too high. Also, minority populations often have limited access to health care, particularly preventative care, early intervention, and effective management of chronic illness, which play a fundamental role in optimal health-related outcomes. As a result, disparities in the quality and quantity of treatment among different racial and ethnic groups contribute to racial health disparities.

Even among minority patients who do have access to health care, the quality of that care is decreased compared with that among White patients. The 2021 National Healthcare Quality and Disparities Report found worse quality of care among Black vs White patients for 11 out of 29 (38%) patient safety measures, 18 out of 43 (42%) effectiveness of care measures, and 32 out of 72 (44%) healthy living measures (Table 2).¹³

Table 2. Measures With Worse Outcomes for Black Patients

An illustration of health disparity is the disproportionate effects of the COVID-19 pandemic on racial and ethnic minority communities during the early stages of the pandemic when the death rate for Black Americans was almost 2-fold higher than that for White Americans (Figure).^14,15 The death rate among Latino populations was also higher than that for White individuals. The pandemic also showed the effects that concerted outreach efforts can have on balancing out health disparities as this statistic has changed and White Americans now have a 14% higher COVID-19 death rate compared with Black Americans and a 72% higher rate than that among Latino Americas, according to the latest data from the Centers for Disease Control and Prevention. Among the successful outreach efforts were those that lead to an increase in vaccination rates over the 18 months.

Another recent correction of implicit bias in health care is the removal of race from the calculation of estimated glomerular filtration rate (eGFR) recommended by the National Kidney Foundation (NKF)–American Society of Nephrology (ASN) Task Force in 2021.¹⁶ The inclusion of race in eGFR estimations has been linked to disparities in care such as delays in kidney disease diagnosis and the eligibility for kidney transplantation.¹⁷

Thus, negative biases toward marginalized groups give rise to social disadvantages and imbalances and, in some cases, poor health outcomes. Health care disparities signify the failure of this system at many levels. However, change can be made.

What Can Providers Do?

With the knowledge that unconscious bias exists, measuring and mitigating its effect is a new area of focus that is needed for health care professionals.¹⁸ Amazon, Microsoft, and Zillow have announced plans and initiatives to increase Black representation in their boardrooms and CEO positions.¹⁹ In health care, more than “just” diversity training and cultural competency training is needed — organizations like DNPs of Color are calling for more people of color in the C-suites of hospitals and health care systems. Similar to Fortune 500 companies, health care providers need to modernize their approach to understanding cultures that they are not familiar with. Individual strategies of reflection, mentorship, and sponsorship initiatives as well as a commitment to cultural awareness and humility are some of the proposed calls to action.²⁰ In medicine, it is so easy to link a specific behavior or disease pattern to a specific racial/ethnic group and this may lead to negative attitudes toward certain minority populations. Clinicians must commit to the normalcy of treating all patients equally.

Research suggests that biased behaviors increase during medical education in part because of biases shown by professors that are picked up by medical/nursing students.²¹ Medical education is also missing the mark in terms of representation of diverse patients in core medical courses. The Mayo Clinic has targeted bias in medical education by studying the environment and training provided in 49 medical schools in the US and the change in student attitudes and values over time.²² As noted previously, positive interaction with health care providers can improve patients’ attitudes surrounding their medical care and improve communication, trust, and knowledge. Learning to connect with patients by understanding their perspectives begins in the classroom. Through the development of practical and tangible clinical skills and learning exercises, students can practice vital communication skills before using these skills in clinical settings with patients.²³ This type of training may be provided annually instead of as a one-time workshop. In addition to promoting clinicians’ awareness of implicit biases, training also can offer strategies to reduce associations and even control the influence of such associations on judgment and behavior.

For practicing clinicians, the American Medical Association (AMA) and the American Academy of Family Practice (AAFP) have developed strategies for clinicians to address possible bias. These include debiasing techniques through training, taking the perspective of others, emotional expression, counter stereotypical exemplars, and intergroup contact.^24,25

Conclusion

Despite significant advances in the diagnosis and treatment of medical conditions, Black Americans and other minority groups, on average, tend to receive lower-quality health care and have greater morbidity and mortality rates compared with White Americans. This is primarily because of the long-term effects of racism regardless of one’s socioeconomic status. Health disparities can be reversed; however, it will require authentic commitment to remove racial bias and improve training from medical/nursing school through practice.

Recently, the attitudes and biases of health care professionals toward disadvantaged groups have become the focus of research. As the United States becomes more diverse, racial bias and discrimination may increase as well; thus, continued research on implicit bias is required. All providers should be aware of their bias when providing care to patients as this can affect patient outcomes. Mitigating personal bias and improving clinician perceptions are self-directed pursuits and require reflection and commitment to counter stereotypes.

Resources

Leah D. Moss, PA-C, DMSc, MSPAS, is a Navy physician assistant.

References

1. Racism and health. Centers for Disease Control and Prevention. Updated November 24, 2021. Accessed June 15, 2022. https://www.cdc.gov/healthequity/racism-disparities/index.html
2. Kochanek KD, Anderson RN, Arias E. Leading causes of death contributing to decrease in life expectancy gap between black and white populations: United States, 1999-2013. NCHS Data Brief. 2015;(218):1-8.
3. American medicine was built on the backs of slaves. and it still affects how doctors treat patients today. The Washington Post. June 4, 2021. Accessed June 15, 2021. https://www.washingtonpost.com/news/made-by-history/wp/2018/06/04/american-medicine-was-built-on-the-backs-of-slaves-and-it-still-affects-how-doctors-treat-patients-today/
4. (old 4) Hoffman KM, Trawalter S, Axt JR, Oliver MN. Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proc Natl Acad Sci U S A. 2016;113(16):4296-301. doi:10.1073/pnas.1516047113
5. Merriam-Webster’s Collegiate Dictionary. 11th ed. Merriam-Webster Inc; 2003. [continuously updated] https://merriam-webster.com
6. Social justice guide. Howard University School of Law. Accessed June 21, 2022. https://library.law.howard.edu/socialjustice/disparity
7. Thomas SB, Casper E. The burdens of race and history on black people’s health 400 years after Jamestown. Am J Public Health. 2019;109(10):1346-1347. doi:10.2105/AJPH.2019.305290
8. Fiscella K, Sanders MR. Racial and ethnic disparities in the quality of health care. Annu Rev Public Health. 2016;37:375–394. doi:10.1146/annurev-publhealth-032315-021439
9. Dehon E, Weiss N, Jones J, Faulconer W, Hinton E, Sterling S. A systematic review of the impact of physician implicit racial bias on clinical decision making. Acad Emerg Med. 2017;24(8):895-904. doi:10.1111/acem.13214
10. Maina IW, Belton TD, Ginzberg S, Singh A, Johnson TJ. A decade of studying implicit racial/ethnic bias in healthcare providers using the implicit association test. Soc Sci Med. 2018;199:219-229. doi:10.1016/j.socscimed.2017.05.009
11. Roberts BW, Puri NK, Trzeciak CJ, Mazzarelli AJ, Trzeciak S. Socioeconomic, racial and ethnic differences in patient experience of clinician empathy: Results of a systematic review and meta-analysis. PLoS One. 2021;16(3):e0247259. doi:10.1371/journal.pone.0247259
12. Shah AA, Zogg CK, Zafar SN, et al. Analgesic access for acute abdominal pain in the emergency department among racial/ethnic minority patients: a nationwide examination. Med Care. 2015;53(12):1000-1009. doi:10.1097/MLR.0000000000000444
13. 2021 National Healthcare Quality and Disparities Report. Agency for Healthcare Research and Quality. Updated January 2022. Accessed June 21, 2022. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr21/index.html
14. COVID-19 weekly cases and deaths per 100,000 population by age, race/ethnicity, and sex. Centers for Disease Control and Prevention. Accessed June 13, 2022. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
15. Leonhardt D. Covid and race. New York Times. June 9, 2022. Accessed June 13, 2022. https://www.nytimes.com/2022/06/09/briefing/covid-race-deaths-america.html
16. Delgado C, Baweja M, Crews DC, et al. A unifying approach for GFR estimation: recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. Am J Kidney Dis. 2022;79(2):268-288.e1. doi:10.1053/j.ajkd.2021.08.003
17. Eneanya ND, Yang W, Reese PP. Reconsidering the consequences of using race to estimate kidney function. JAMA. 2019;322(2):113-114. doi:10.1001/jama.2019.5774
18. Blair IV, Steiner JF, Havranek EP. Unconscious (implicit) bias and health disparities: where do we go from here? Perm J. 2011 Spring;15(2):71-78.
19. Amazon, Microsoft, and Zillow are backing an initiative to increase black representation on corporate boards. CNN. October 7, 2021. Accessed June 15, 2021. https://edition.cnn.com/2021/06/03/investing/corporate-diversity-black-boardroom-initiative/index.html
20. Kerner J, McCoy B, Gilbo N, Colavita M, Kim M, Zaval L, Rotter M. Racial disparity in the clinical risk assessment. Community Ment Health J. 2020;56(4):586-591. doi:10.1007/s10597-019-00516-3
21. Nolen L. How medical education is missing the bull’s-eye. N Engl J Med. 2020 25;382(26):2489-2491. doi:10.1056/NEJMp1915891
22. Targeting unconscious bias in health care. Mayo Clinic News Network. April 21, 2015. Accessed June 15, 2022. https://newsnetwork.mayoclinic.org/discussion/targeting-unconscious-bias-in-health-care/
23. Zestcott CA, Blair IV, Stone J. Examining the presence, consequences, and reduction of implicit bias in health care: a narrative review. Group Process Intergroup Relat. 2016;19(4):528-542. doi:10.1177/1368430216642029
24. Implicit bias. American Academy of Family Physicians. Accessed June 6, 2022. https://www.aafp.org/about/policies/all/implicit-bias.html
25. Health equity education center. American Medical Association. Accessed June 6, 2022. https://edhub.ama-assn.org/health-equity-ed-center

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Percutaneous right-sided greater splanchnic nerve (GSN) ablation in patients with heart failure with preserved ejection fraction (HFpEF) improves 12-month outcomes according to study findings published in the Journal of the American College of Cardiology: Heart Failure.

Researchers sought to investigate the first in-human use of splanchnic ablation for volume management for right-sided GSN denervation. They initiated a single-arm, open-label prospective trial (ClinicalTrials.gov Identifier: NCT04287946) of right-sided GSN ablation in patients with HFpEF between January 2020 and March 2020 at the Tbilisi Heart and Vascular Clinic (Tbilisi, Republic of Georgia). They included 11 patients with HFpEF (aged 70±8 years; 8 women), an ejection fraction of 50% or more, elevated pulmonary capillary wedge pressure, and functional class II or III symptoms. Follow-up for splanchnic ablation for volume management included echocardiography, Kansas City Cardiomyopathy Questionnaire, and 6-minute walk test at 1, 3, 6, and 12 months.

Clinical improvements are seen at 1 month and are sustained through 12 months. The 6-minute walk test results improve from baseline (292±82 m) to 1 month (341±88 m) to 12 months (359±75m) (P <.05). The Kansas City Cardiomyopathy Questionnaire scores improve from baseline median (48, IQR 35-52) to 1 month (65, IQR 58-77) to 12 months (80, IQR 77-88) (P <.05), although these are not considered clinically significant gains. The N-terminal pro-brain natriuretic peptide decreases from baseline mean (1292±1186 pg/mL) to 1 month (1202±797 pg/mL; P =.585) to 12 months (379±165 pg/mL; P =.039).

Trial limitations include the lack of a control group and blinding. There is also no minimum time from trial enrollment to procedure, which may have resulted in compliance bias. Additionally, change in splanchnic vascular capacitance is not directly evaluated.

“In this open-label, single-arm feasibility study, right-sided GSN ablation was safe and improved mostly subjective clinical metrics in patients with HFpEF over 12 months,” the study authors wrote.

Disclosure: This research was supported by Axon Therapies. Please see the original reference for a full list of disclosures. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Fudim M, Zirakashvili T, Shaburishvili N, et al. Transvenous right greater splanchnic nerve ablation in heart failure and preserved ejection fraction. JACC Heart Fail. Published online July 6, 2022. doi:10.1016/j.jchf.2022.05.009

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Absolute coronary flow and microvascular resistance measurements can be successfully automated, according to results of a study published in Catheterization & Cardiovascular Interventions.

Patients (N=19) receiving physiological assessment of coronary circulation were recruited for this study at 2 centers in Europe. Conventional and automated resting and hyperemic Q and R measurements during resting flow (Q_rest, R_rest) and hyperemic flow (Q_hyp, R_hyp) were performed sequentially in the same vessel while maintaining the position of the intracoronary infusion microcatheter constant. The order to conventional or automated assessments was randomly assigned. The automated assessment was obtained by programming the automatic infusion pump to infuse saline at 10 ml/min for 2 minutes then to switch to 20 ml/min for 1.5 minutes and to switch back to 10 ml/min for 1 minute.

The mean age of the patients is 63.47±11.52 years, 84.2% of them are men, 31.6% are current smokers, 57.9% have hypertension, 47.4% have dyslipidemia, 73.7% have a class 1 Canadian Cardiovascular Society grading of angina, and left ventricular ejection fraction was 64.38%±14.25%.

Procedure time is significantly reduced from 5 minutes and 25 seconds to 4 minutes and 36 seconds (P =.013) with automation.

The automated and conventional evaluations of Q_rest (median, 83.00 vs 89.49 ml/min; P =.493), Q_hyp (median, 210.80 vs 209.55 ml/min; P =.680), R_rest (median, 949.1 vs 941.6 WU; P =.321), R_hyp (median, 380.3 vs 393.7 WU; P =.327), fractional flow reserve (FFR; median, 0.83 vs 0.81; P =.170), coronary flow reserve (CFR; median, 2.52 vs 2.57; P =.902), and microvascular resistance reserve (MRR; median, 3.06 vs 3.02; P =.729) do not differ significantly, respectively.

Significant correlations are observed between automated and conventional assessments for Q_rest (R, 0.89; P <.001), Q_hyp (R, 0.88; P <.001), R_rest (R, 0.90; P <.001), R_hyp (R, 0.92; P <.001), FFR (R, 0.89; P <.001), CFR (R, 0.88; P <.001), and MRR (R, 0.89; P <.001). The intraclass correlations of the measurements ranged from 0.84 (MRR) to 0.93 (Q_hyp).

The major limitation of this study was the small sample size.

”The present data indicate that continuous thermodilution‐derived FFR, CFR, and MRR measurements can be performed with a programmed pump setting and a single wire pullback without vessel rewiring,” the study authors wrote. “The measurement is short (approximately 4.5 min) and virtually automated.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Candreva A, Gallinoro E, Peregrina EF, et al. Automation of intracoronary continuous thermodilution for absolute coronary flow and microvascular resistance measurements. Catheter Cardiovasc Interv. Published online June 20, 2022. doi:10.1002/ccd.30244

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Despite an overall reduction in the incidence of myocardial infarction (MI) and associated mortality in the general population, a growing body of research suggests increasing MI rates and worsening outcomes among individuals younger than 55 years.^1,2 To elucidate these trends, numerous studies have focused specifically on the reported sex-based disparities in MI risk factors and outcomes in this patient population. 

“Myocardial infarction rates are going up in young women, and cardiovascular mortality is no longer improving in young people in the United States,” Viola Vaccarino, MD, PhD, said in an interview with Cardiology Advisor. Dr Vaccarino is the Wilton Looney Professor of Cardiovascular Research in the Rollins School of Public Health at Emory University in Atlanta and professor in the division of cardiology at the Emory University School of Medicine. She published a paper on the increasing acute MI (AMI) rates among young women in a 2019 issue of Circulation.³ 

Study Highlights

A 2019 study analyzed data from the Atherosclerosis Risk in Communities (ARIC) Surveillance study and observed an increase in the annual incidence of AMI hospitalizations among young women (aged 35-54 years) from 1995 to 2014, while AMI incidence decreased among young men.²

Adjusted analyses further demonstrated that young women are less likely than young men to receive coronary revascularization (relative risk [RR], 0.79; 95% CI, 0.71–0.87), nonaspirin antiplatelets (RR, 0.83; 95% CI, 0.75–0.91), lipid-lowering therapies (RR, 0.87; 95% CI, 0.80–0.94), coronary angiography (RR, 0.93; 95% CI, 0.86–0.99), and beta blockers (RR, 0.96; 95% CI, 0.91–0.99).

While this study found comparable rates of 1-year all-cause mortality in women and men (hazard ratio [HR], 1.10; 95% CI, 0.83–1.45), a 2022 study⁴ described in the Journal of Clinical Medicine found an 84.3% higher 3-year all-cause mortality rate in young women (<65 years) vs young men (<55 years) after AMI (adjusted HR [aHR], 1.843; 95% CI, 1.098–3.095). Conversely, elderly women show a 20.4% lower mortality rate compared to elderly men (aHR, 0.796; 95% CI, 0.682–0.929).

Research published in 2020 in the European Heart Journal reported similar disparities in invasive procedures and guideline-based treatment approaches provided to young (<50 years) women vs men. While there was no significant difference in cardiovascular mortality between women and men following discharge, women demonstrate greater all-cause mortality (aHR, 1.63; P =.01) after a median follow-up period of 11.2 years.⁵

In a multicenter prospective study reported in August 2021 in Frontiers in Cardiovascular Medicine, investigators observed a longer duration of time from symptom onset to hospital admission among young (≤45 years) women compared to young men.⁶ Additionally, the risk for in-hospital adverse events is higher for young women vs men (adjusted odds ratio [aOR] for death, 5.767; 95% CI, 1.580–21.049; P =.0080; aOR, for the composite of death, re-infarction, and stroke, 3.981; 95% CI, 1.150–13.784; P =.0292). Among patients who are discharged, the 2-year cumulative incidence of death is higher for women vs men (3.8 vs 1.4%; P =.0412).

Risk Factors

In a matched case-control study published in May 2022 in JAMA Network Open, researchers examined sex-specific risk factors for MI in a sample of 2,264 adults aged younger than 55 years who experienced a first acute MI compared with 2,264 matched control participants.⁷

Most of the factors that collectively contributed to roughly 85% of the total AMI risk showed stronger associations for young women, including:

• diabetes (OR, 3.59; 95% CI, 2.72-4.74 in women vs OR, 1.76; 95% CI,1.19-2.60 in men)
• depression (OR, 3.09; 95% CI, 2.37-4.04 in women vs OR, 1.77; 95% CI, 1.15-2.73 in men)
• hypertension (OR, 2.87; 95% CI, 2.31-3.57 in women vs OR, 2.19; 95% CI, 1.65-2.90 in men)
• currently smoking (OR, 3.28; 95% CI, 2.65-4.07 in women vs OR, 3.28; 95% CI, 2.65-4.07 in men)
• family history of premature MI (OR, 1.48; 95% CI, 1.17-1.88 in women vs OR, 2.42; 95% CI, 1.71-3.41 in men)

Hypercholesterolemia shows a stronger association in young men (OR, 1.02; 95% CI, 0.81-1.29 in women vs OR, 2.16; 95% CI, 1.49-3.15 in men). Low household income represents an additional risk factor in both groups (OR, 1.02; 95% CI, 0.81-1.29 in women vs OR, 2.16; 95% CI, 1.49-3.15 in men).

As many of these risk factors are potentially modifiable, the results point to the need for sex-specific strategies to modify these risk factors to prevent AMI in young adults, according to the authors.

The disparities in MI rates and outcomes are “especially marked in rural communities, suggesting that economic deprivation may be affecting cardiovascular health, especially among young women,” Dr Vaccarino noted.⁸ Related factors may include reduced access to prevention services and affordable health care in general, environmental factors such as lack of access to fresh food and safe places to walk, and psychosocial stress due to the multiple family demands that women often fill.

“Clinicians should offer prevention services to women beginning at a younger age and offer resources that can provide them the support they need to stay healthy or recover if they already developed a myocardial infarction,” she said. “These services are especially needed in low resource settings.”

Expert Q&A

Cardiology Advisor interviewed the lead authors of 2 of the recent studies^7,5 on MI in young women to learn more about the concerning trends observed in this population: Yuan Lu, ScD, researcher and assistant professor in the section of cardiovascular medicine at Yale School of Medicine in New Haven, Connecticut; and Ersilia M. DeFilippis, MD, a specialist in advanced heart failure and transplant cardiology and assistant professor of medicine at Columbia University Irving Medical Center in New York.

What are your thoughts about findings of disparities in MI risk factors and outcomes in young women, and do they align with your observations in practice?

Dr Lu: Our study identified sex differences in AMI risk factors as well as the strength of associations between these risk factors and AMI among young adults. Traditional cardiovascular risk factors such as hypertension and diabetes had stronger associations in women vs men, with significant interactions by sex. This observation is consistent with prior studies, including the INTERHEART study⁹ of older populations, and we provided an independent validation of these findings in young adults.

Moreover, we showed that current smoking and gender-related characteristics including low income and depression were linked to greater risk in women compared to men. These findings align with our observations in practice. In clinical practice, we noticed that young women admitted for AMI are more likely to have depression, which partially contributes to the higher mortality and poorer health status after AMI in young women.

Dr DeFilippis: Unfortunately, sex disparities in outcomes have been demonstrated across a variety of cardiovascular conditions, so while our findings were disappointing, they were not surprising. Although the most common presentation of MI in women is chest pain, they also may have atypical presentations (including shortness of breath, palpitations, and fatigue) that could lead to delayed diagnosis.⁵ I know women who have been told they were having an anxiety attack when in fact they were having manifestations of ischemic heart disease or heart failure.

What are the possible mechanisms driving these disparities?

Dr Lu: We found that socioeconomic and psychological factors have an important role in the development of AMI in young women. Although the mechanisms by which low socioeconomic status and low social support negatively affect patient outcomes remain unclear, numerous psychological, behavioral, and physiological theories have been proposed. These range from poor self-care and negative health behaviors to increased financial strain and elevated stress responses.

Indeed, we found that patients with low socioeconomic status had a higher prevalence of all cardiovascular factors and more financial instability than patients with moderate or high socioeconomic status. Depression also plays an intimate role in the development of AMI in young women, and depression was strongly associated with poorer functional status and mental health status after AMI.

Dr DeFilippis: We do understand that certain traditional cardiovascular risk factors may have a greater risk for future CV events in women than in men. Additionally, the mechanisms underlying ischemic heart disease may be different in women, including microvascular disease, coronary spasm, and spontaneous coronary artery dissection in addition to classic plaque rupture. These may require further testing or imaging modalities. 

Despite this, we know that few women with abnormal stress tests get referred for diagnostic angiography or have a change in medication therapies. Therefore, underdiagnosis and undertreatment likely also result from implicit bias on the part of health care providers.

Additionally, we know that awareness of heart disease as the leading cause of death among women declined from 2009 to 2019, highlighting a need for increased education of women so they can recognize their symptoms and advocate for themselves.¹⁰

What are the relevant recommendations for clinicians?  

Dr Lu: As a first step, clinicians need to be aware of the sex difference in risk factors for AMI in young women and pay attention to screening these risk factors when providing care for young women. Then they can refer the patient to targeted interventions to address these risk factors if indicated.

Dr DeFilippis: To paraphrase William Osler, “Listen to the patient; she is telling you the diagnosis.” Since women may have atypical presentations, it is important to have a high index of suspicion. Additionally, all physicians should take an obstetric and gynecologic history on their female patients. We know that sex-specific risk factors for CVD include a history of pre-eclampsia or premature ovarian failure among others. This can help to risk-stratify women in addition to traditional cardiovascular risk factors. 

What other measures may be needed to reduce these disparities?

Dr Lu: Raising awareness about cardiovascular disease risk in young women is the first necessary step to address these disparities. Then, screening risk factors including family history and psychological factors are needed to further identify high-risk patients for AMI. Documentation of family history and social determinants of health in the electronic health records will help clinicians to better understand and risk-stratify their patients. Finally, the development of more individualized risk prediction will enable more effective application of preventive therapies in young women.

Dr DeFilippis: Needed measures include targeting social determinants of health and development of sex-specific guidelines and sex-specific risk calculators.¹¹

Increased education of women regarding heart disease as the leading cause of death is also needed. Unfortunately, many women with the lowest awareness rates are those with lesser education and low income, and those who are racial and ethnic minorities. Therefore, this education must include partnership with local communities, including in local gyms, schools, and faith-based organizations.

There is also a need to improve the diversity of women in clinical trials of ischemic heart disease. We know that increased diversity of clinical trial leadership is associated with increased recruitment of women into cardiovascular trials, so this represents an additional need.

References

1. Wu WY, Berman AN, Biery DW, Blankstein R. Recent trends in acute myocardial infarction among the young. Curr Opin Cardiol. 2020;35(5):524-530. doi:10.1097/HCO.0000000000000781
2. Arora S, Stouffer GA, Kucharska-Newton AM, et al. Twenty year trends and sex differences in young adults hospitalized with acute myocardial infarction. Circulation. Published online November 11, 2019. doi:10.1161/CIRCULATIONAHA.118.037137
3. Vaccarino V. Myocardial infarction in young women. Circulation. Published online February 19, 2019. doi:10.1161/CIRCULATIONAHA.118.039298
4. Song PS, Kim MJ, Seong SW, et al; Kamir-Nih Investigators. Gender differences in all-cause mortality after acute myocardial infarction: evidence for a gender-age interaction. J Clin Med. 2022;11(3):541. doi:10.3390/jcm11030541
5. DeFilippis EM, Collins BL, Singh A, et al. Women who experience a myocardial infarction at a young age have worse outcomes compared with men: the Mass General Brigham YOUNG-MI registry. Eur Heart J. Published online October 13, 2020. doi:10.1093/eurheartj/ehaa662
6. Lv J, Ni L, Liu K, et al. Clinical characteristics, prognosis, and gender disparities in young patients with acute myocardial infarction. Front Cardiovasc Med. Published online August 22, 2021. doi:10.3389/fcvm.2021.720378
7. Lu Y, Li SX, Liu Y, et al. Sex-specific risk factors associated with first acute myocardial infarction in young adults. JAMA Netw Open. Published online May 3, 2022. doi:10.1001/jamanetworkopen.2022.9953
8. Tran P, Tran L. Influence of rurality on the awareness of myocardial infarction symptoms in the US. Ther Adv Cardiovasc Dis. Published online December 4, 2019. doi:10.1177/1753944719891691
9. Anand SS, Islam S, Rosengren A, et al; INTERHEART Investigators. Risk factors for myocardial infarction in women and men: insights from the INTERHEART study. Eur Heart J. Published online March 10, 2008. doi:10.1093/eurheartj/ehn018
10. Cushman M, Shay CM, Howard VJ, et al; American Heart Association. Ten-year differences in women’s awareness related to coronary heart disease: Results of the 2019 American Heart Association National Survey: A Special Report From the American Heart Association. Circulation. Published online September 19, 2021. doi:10.1161/CIR.0000000000000907
11. DeFilippis EM, Van Spall HGC. Is it time for sex-specific guidelines for cardiovascular disease? J Am Coll Cardiol. Published online July 5, 2021. doi:10.1016/j.jacc.2021.05.012

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Percutaneous coronary intervention (PCI) with the revived directional coronary atherectomy (DCA) catheter is safe and has low complication rates in patients with stable coronary artery disease or unstable angina, according to a study published in Catheterization & Cardiovascular Interventions.

Researchers sought to assess differences in baseline characteristics of and in‐hospital outcomes for patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA based on data from a Japanese nationwide coronary intervention registry.

A total of 188,324 patients from 1112 Japanese hospitals were included from January to December 2018. The participants are categorized into 2 groups, the DCA group (n=1696; mean age, 68.0±11.2 years; 14.2% women) and the non-DCA group (n=186,628; mean age, 71.3±10.6 years; 23.3% women).

The DCA group patients are younger, more frequently men, and have a lower rate of comorbidities, including hypertension, diabetes mellitus, and chronic kidney disease, compared with patients in the non‐DCA group. Patients in the DCA group also are less likely to have unstable angina and have emergency PCI vs patients in the non‐DCA group.

Drug‐eluting stents (DES) are used less frequently among DCA group participants (45.9%) vs the non‐DCA group (82.5%), and drug‐coated balloons (DCB) are used more frequently in the DCA group (63.4%) vs the non-DCA group (20.0%). Stentless PCI is more common in the DCA group (53.7%) vs the non‐DCA group (17.3%). Within the DCA group, 50% of patients have stentless PCI using DCA with additional DCB angioplasty, followed by 32% who have DCA plus a stent.

The DCA group have a 99.8% procedural success rate vs 98.3% for the non-DCA group. Also, the DCA group have a 1.8% rate of overall complications and a 0.2% rate of in-hospital mortality, compared with a 1.7% rate of overall complications and 0.3% in-hospital mortality rate in the non-DCA group.

Fluoroscopy time (47.5±23.4 minutes) is longer and the total contrast volume (168.4±77.2 mL) is higher in the DCA group compared with the non‐DCA group (30.2±28.4 minutes and 126.1±67.4 mL, respectively).

Study limitations include the observational design and use of data from an ongoing, prospective, nationwide registry. In addition, long‐term follow‐up data are not available for clinical outcomes after PCI with or without DCA, and the definition of bleeding complications differed from the standard criteria. Furthermore, the registry did not include precise procedural data regarding the size of sheaths and catheters and other clinical factors of PCI using DCA.

“This Japanese nationwide registry‐based study showed that the novel DCA catheter is safely used in patients with stable coronary artery disease or unstable angina with low complication rates, even when comparing in‐hospital outcomes with those in the non‐DCA group undergoing PCI, mainly with new‐generation DES,” the investigators wrote.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Numasawa Y, Inohara T, Ishii H, et al. Overview of in‐hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy. Catheter Cardiovasc Interv. Published online May 20, 2022. doi: 10.1002/ccd.30233

The post PCI With Directional Coronary Atherectomy in Stable CAD or Unstable Angina appeared first on The Cardiology Advisor.

Young age and V1 tortuosity are associated with an increase in in‐stent restenosis (ISR) rates after vertebral V1 segment stenting, according to a study published in Catheterization & Cardiovascular Interventions.

The findings are based on a meta‐analysis and systematic review that sought to identify risk factors for ISR after V1 segment stenting.

Investigators searched the PubMed, Embase, and Cochrane Library databases from inception to September 2021. Eligible studies were retrospective and prospective English-language original articles on vertebral artery stenting for V1 segment (“ostium” or “origin”) that provided complete data for 1 or more suspected risk factors of analysis between ISR and non‐ISR groups. Pooled analyses were conducted when data of the same suspected risk factor were available for 2 or more studies.

A total of 11 studies with 1356 patients were included in the analysis, which consisted of 10 observational studies and 1 randomized controlled trial (RCT). The overall ISR rate was 19.6% (305 of 1554 arteries).

In analysis of age as a potential risk factor, 5 studies with 784 patients were used to compare patients’ age between the ISR group (n=163) and the non‐ISR group (n=621). Pooled analysis demonstrated that patients in the ISR group were significantly younger compared with those in the non‐ISR group (weighted mean difference, -1.958; 95% CI, -3.453 to -0.463; P =.01).

For V1 tortuosity, data were provided in 2 studies with 120 participants (25 ISR, 95 non‐ISR). The ISR group had more patients with V1 tortuosity (odds ratio, 4.145; 95% CI, 1.56-11.012; P =.004) vs the non-ISR group, according to the pooled analysis.

Other suspected risk factors, including bare-metal stent (BMS), stent diameter, stent length, diabetes mellitus, coronary artery disease, and smoking, were not associated with a significant increase in ISR rates. Regarding postoperative antiplatelet strategies in the included studies, the most frequently used initial regimen was dual antiplatelet therapy, which was received for 1 to 12 months.

No significant publication bias was observed in each pooled analysis.

Among several limitations, the included studies were published from 2008 to 2021, and 1 study was a RCT, which limits the quality grade of the findings. Also, analysis of more detailed stent types was not possible, and only 2 studies provided data about V1 tortuosity and drug-eluting stent diameter for pooled analysis. The overall analysis is based on limited current data, and the results could change as more data become available, the researchers noted.

“A meta‐analysis based on current data shows that younger age and V1 tortuosity are risk factors for ISR after vertebral V1 segment stenting,” wrote the study authors. “With limited data and a lack of RCTs, more detailed studies are still required.

Reference

Guo J, Ning Y, Wu S, et al. Risk factors for in‐stent restenosis after vertebral artery stenting of V1 segment: a systematic review and meta‐analysis. Catheter Cardiovasc Interv. Published online June 22, 2022. doi: 10.1002/ccd.30296

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HealthDay News — Addressing the social determinants of health may improve diabetes outcomes, according to a review published in the July issue of Health Affairs.

Leonard E. Egede, M.D., from the Medical College of Wisconsin in Milwaukee, and colleagues conducted a systematic literature review to identify studies evaluating nonmedical interventions (e.g., those targeting social determinants of health) to reduce risk and improve clinical outcomes for type 2 diabetes.

The researchers found that interventions with targeted, multicomponent designs that combine both medical and nonmedical approaches can reduce risk and improve clinical outcomes for type 2 diabetes. Food supplementation with referral and diabetes support; financial incentives with education and skills training; housing relocation with counseling support; and the integration of nonmedical interventions into medical care using the electronic medical record all were associated with significant improvement in hemoglobin A1C.

“Actionable strategies outlined in this article may be used as a guide to build that empirical foundation to improve clinical outcomes for adults with type 2 diabetes,” write the authors. “Multiple policy opportunities also exist that have the potential to target structural inequalities in health as pathways to decrease social risk and improve health outcomes for this segment of the U.S. population.”

Abstract/Full Text (subscription or payment may be required)

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Among certain patients with left ventricular assist devices (LVAD) outflow graft obstruction, percutaneous intervention is an acceptable alternative and less invasive than surgical pump replacement, and the use of a catheter-based cerebral protection system may lower the occurrence of associated embolism. These findings were published in Catheterization & Cardiovascular Interventions.

Researchers sought to investigate the efficacy of the Sentinel cerebral protection system (CPS) among patients with LVAD outflow graft obstruction receiving percutaneous intervention. To accomplish this, they conducted a retrospective case-series analysis of 6 patients (median aged 56.5 years at implantation from 2013 through 2018; 33% women; 100% Black) with LVAD outflow graft obstruction selected from among 501 LVAD patients with implants from a single institute. Four of these patients had a HeartMate-III LVAD, 1 patient had HeartMate-II LVAD, and 1 patient had HeartWare (HVAD).  

Median time from LVAD implantation to LVAD outflow obstruction was 1343 days, and 934 days for the 4 LVAD HeartMate-III implants. Thrombus or debris was removed in all patients with the use of the Sentinel CPS. Among these patients, 1 with suspected thrombosis of LVAD developed a recurrence of LVAD outflow graft stenosis.

Study limitations include stenting of the outflow graft was accomplished with no cerebral protection and the rate of periprocedural stroke during such stenting is unknown. Also, the concomitant use of thrombolytics associated with intracranial hemorrhage.

The researchers wrote, “Percutaneous intervention of LVAD outflow graft obstruction is less invasive than surgical pump exchange and an acceptable alternative in properly selected patients.” Researchers added that their experience suggests that using a catheter-based CPS may help lower the occurrence of embolism before, during, or after percutaneous intervention.

Reference

Joury A, Patel RAG, Wever-Pinzon J, et al. Cerebral protection during percutaneous intervention for left ventricular assist device outflow graft obstruction. Catheter Cardiovasc Interv. Published online May 25, 2022. doi:10.1002/ccd.30241

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The FDA on April 8 posted to its website a draft document proposing recommendations to increase the cybersecurity of medical devices. The document is titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.

“With the increasing integration of wireless, Internet- and network- connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device related health information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important,” the document reads.

Effective cybersecurity relies upon security being “built-in” to a device, and not “bolted-on” after the device is designed because cybersecurity threats to the health care sector have become more frequent and severe, according to the FDA.

Cybersecurity incidents have rendered medical devices and hospital networks inoperable and have disrupted patient care across healthcare facilities in the United States and elsewhere.

In the draft document, which contains nonbinding recommendations, the FDA noted that “the safety and security risks of each device should be assessed within the context of the larger system in which the device operates. In the context of cybersecurity, security risk management processes are critical because, given the evolving nature of cybersecurity threats and risks, no device is, or can be, completely secure.”

The FDA listed the following security objectives: authenticity (including integrity), authorization, availability, confidentiality, and secure and timely updatability and patchability. The agency advises that premarket submissions should include information describing how these security objectives are addressed by an integrated into device design.

“Because exploitation of known vulnerabilities or weak cybersecurity controls should be considered reasonably foreseeable failure modes for systems, these factors should be addressed in the device design,” the FDA wrote.

Michael K. Hamilton, Chief Information Security Officer for Critical Insight, a cybersecurity company in Bremerton, Washington, said the Biden Administration has taken significant steps toward helping to bridge the gap between the public harm done by cyberattacks against the health sector and the private responsibility for security. “Creating security standards for medical device security is another facet of this strategy, and while a bit late to the game, very welcomed as it provides the opportunity to transfer the responsibility for device security to manufacturers rather than continuing to expect that the health sector will provide the resources to do so,” Hamilton said.

“Cyberspace is continuously evolving, and with the growing number of cybercriminals, it is always a cat and mouse game,” said Mohiuddin Ahmed, PhD, a cybersecurity and data analytics expert at Edith Cowan University’s School of Science in Perth, Australia. “I appreciate the new FDA guidance, but it could have been imposed earlier.”

Although cybersecurity has improved significantly in the past few years, there is no room for complacency, Dr Ahmed said. “Cybercrime is a trillion-dollar business. Unless we go back to non-Internet days, there will always be cyber incidents, especially in health care, as the cybercriminals know the pressure points,” he said.

Hamilton said the FDA’s recommendations make sense and have to potential to improve the cybersecurity of medical devices. “Knowing that these devices are confirmed secure when delivered, and with strategies to maintain security through routine vulnerability detection and updates, provides a bit of breathing room for overtaxed technology security professionals working in the health sector.”

Lynne Coventry, PhD, Professor of Human Cybersecurity at Northumbria University in Newcastle upon Tyne, UK, who has studied the fundamental tension between privacy/security goals and the traditional medical goals of utility and safety, said health care systems may be more vulnerable now because of the COVID-19 pandemic, which has increased the workload and contributed to fatigued health care personnel, she noted. The result could be less vigilance regarding cybersecurity as personnel focus their reserves on patient care.

Throughout history, medical professionals have protected public health and responded to health threats. Their ability to do that is being threatened by risks associated with connecting medical devices to computer networks, Prof Coventry said. “Cybersecurity is not just a technical problem to solve. It is a complicated sociotechnical problem. Reducing cybersecurity risks also requires addressing interconnected social, business and legal aspects,” she said.

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Transgender individuals face numerous health disparities compared to the general population, including elevated rates of HIV, mental illness, and substance use disorder.¹ Additionally, various research findings have demonstrated an increased risk for cardiovascular disease (CVD) among transgender patients, although results have been mixed across studies.

In a retrospective single-center study published in September 2021 in the American Journal of Preventive Cardiology, Mahowald et al examined CVD prevalence rates and associated comorbidities in transgender women referred to a women’s heart clinic for management of CVD or cardiac risk factors or for preoperative risk assessment in preparation for gender-affirming surgery.² Of the 52 patients (aged mean, 57±10 years) comprising the sample, 92% were receiving gender-affirming hormone therapy.

The pooled cohort equation demonstrated that the 10-year risk for atherosclerotic CVD was 9.4±7.7% when using a risk calculation for cisgender men, compared with 5.2±5.1% when using a risk calculation for cisgender women (P <.001).

“Older transgender women may have an underestimated prevalence of CVD and its risk factors,” the authors wrote.² “More research is needed to identify cardiovascular health profiles, improve practice consistency, and establish normative values for transgender patients.”

In a 2019 study using data from the Behavioral Risk Factor Surveillance System (BRFSS), Caseres et al found higher rates of any CVD condition (adjusted odd ratio [AOR], 2.98; 95% CI, 1.65-3.06) as well as diabetes (AOR, 1.45; 95% CI, 1.05-1.99), angina and coronary heart disease (AOR, 1.90; 95% CI, 1.34-2.68), stroke (AOR, 1.88; 95% CI, 1.16-3.03), and myocardial infarction (AOR, 2.98; 95% CI, 2.14-4.17) among transgender women compared with cisgender women.³

The results further showed higher rates of myocardial infarction among gender nonconforming individuals compared to cisgender women (AOR, 2.68; 95% CI, 1.14-6.30). Comparisons between transgender women and transgender men yielded no differences in CVD rates.³

In another 2019 study that used BRFSS data, the rate of myocardial infarction was substantially higher in transgender men compared with cisgender men (OR, 2.53; 95% CI, 1.14–5.63; P =.02) and cisgender women (OR, 4.90; 95% CI, 2.21–10.90; P <.01), after adjustment for CVD risk factors such as age, presence of hypertension, exercise, and smoking.⁴ Among transgender women, the rate of myocardial infarction was higher compared to cisgender women (OR, 2.56; 95% CI, 1.78–3.68; P <.01) but not in comparison to cisgender men.⁴

Research published in August 2021 in Transgender Health also used data from the BRFSS to investigate the odds of CVD among transgender individuals compared with cisgender individuals.⁵ Analyses revealed that the odds of CVD were 2.66 times greater (95% CI, 1.60–4.41) among participants assigned female at birth (AFAB) who identify as transgender vs cisgender, while no significant difference in the odds of CVD was noted between transgender vs cisgender participants among those assigned male at birth (AMAB).

In a comparison between gender nonconforming and cisgender participants, the odds of CVD were 2.21 times higher (95% CI, 1.04–4.70) among the gender nonconforming individuals.⁵

Noting a possible link between estrogen-based hormone therapy and CVD in transgender individuals, Getahun et al explored this association in a 2018 cohort study based on electronic medical records of 2,842 transgender women and 2,118 transgender men matched to 48,686 cisgender men and 48,775 cisgender women, respectively.⁶ The results showed a higher incidence of venous thromboembolism (VTE) among transgender women, with more pronounced differences found among those who initiated hormone therapy during the follow-up period.

The differences in VTE risk at 2 and 8 years were 4.1 (95% CI, 1.6-6.7) and 16.7 (95% CI, 6.4-27.5) per 1000 persons compared with cisgender men, and 3.4 (95% CI, 1.1-5.6) and 13.7 (95% CI, 4.1-22.7) compared with cisgender women. There was insufficient evidence to draw conclusions regarding comparative VTE risk among transgender men.⁶

A systematic review published in 2021 in the Journal of Sex Medicine reported a greater incidence of VTE in AMAB patients compared with AFAB patients (42.8 vs 10.8 VTE per 10,000 patient years; P =.02) and a “similar or higher” incidence in AMAB patients compared with cisgender women on hormone replacement therapy.⁷

The key question regarding these findings is, “How important is the impact of exogenous estrogen on VTE risk?” according to study co-author Dr Joshua D. Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, and co-author of the 2018 study and other articles on the topic.^6,1,8 “It may be that standard approaches to otherwise high-risk patients – like deep vein thrombosis prophylaxis in surgery – essentially erase the very modest increased risk of VTE suggested in cross-sectional studies.”

The higher body weight and lower frequency of exercise observed in transgender populations may further contribute to an elevated CVD risk, he noted.⁹ Such factors may be attributable to the discomfort these individuals experience in a hostile environment such as the typical fitness center. “It may be that the stigma and discrimination experienced by transgender people are the greatest concerns for CV health, contributing to decreased exercise, more obesity, and delayed medical care,” Dr Safer said.

In addition, psychosocial stressors related to other forms of structural violence including reduced access to affordable housing and health care may contribute to excess CVD and associated mortality in this population, as described in a scientific statement published in 2021 by the American Heart Association.⁹

“At the population level, the largest benefit for transgender people may be to remove stigma in order to better integrate them in exercise programs and athletics and appropriate health care,” Dr Safer stated. On the clinician level, “Physician and medical staff education is important to create safe spaces for transgender people to receive timely care.” These efforts may include the use of medical forms with inclusive language such as questions about the patient’s current gender identity as well as their gender assigned at birth if this information is needed, and use of the term “relationship status” rather than “marital status,” for example.¹⁰

For clinicians who are unsure of how to address the increased CV risk observed among transgender patients, “A major point is not to rush to overemphasize the likely small – if any – contribution from exogenous hormone treatment and to approach transgender people like anyone else,” Dr Safer advises.

References

1. Safer JD, Coleman E, Feldman J, et al. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes. 2016;23(2):168-71. doi:10.1097/MED.0000000000000227
2. Mahowald MK, Maheshwari AK, Lara-Breitinger KM, et al. Characteristics of transgender women referred to women’s heart clinic. Am J Prev Cardiol. Published online July 10, 2021. doi: 10.1016/j.ajpc.2021.100223.
3. Caceres BA, Jackman KB, Edmondson D, Bockting WO. Assessing gender identity differences in cardiovascular disease in US adults: an analysis of data from the 2014-2017 BRFSS. J Behav Med. 2020;43(2):329-338. doi:10.1007/s10865-019-00102-8
4. Alzahrani T, Nguyen T, Ryan A, et al. Cardiovascular disease risk factors and myocardial infarction in the transgender population. Circ Cardiovasc Qual Outcomes. Published online April 5, 2019. doi:10.1161/CIRCOUTCOMES.119.005597
5. Howerton I, Harris JK. Transgender identity and cardiovascular disease. Transgender Health. Published online 19, 2021. doi:10.1089/trgh.2020.0188
6. Getahun D, Nash R, Flanders WD, et al. Cross-sex hormones and acute cardiovascular events in transgender persons: A cohort study. Ann Intern Med. Published online August 21, 2018. doi:10.7326/M17-2785
7. Kotamarti VS, Greige N, Heiman AJ, Patel A, Ricci JA. Risk for venous thromboembolism in transgender patients undergoing cross-sex hormone treatment: A systematic review. J Sex Med. Published online June 14, 2021. doi:10.1016/j.jsxm.2021.04.006
8. Slack DJ, Safer JD. Cardiovascular health maintenance in aging individuals: The implications for transgender men and women on hormone therapy. Endocr Pract. Published online December 12, 2021. doi:10.1016/j.eprac.2020.11.001
9. Streed CG Jr, Beach LB, Caceres BA, et al; American Heart Association Council on Peripheral Vascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Stroke Council. Assessing and addressing cardiovascular health in people who are transgender and gender diverse: A Scientific statement from the American Heart Association Circulation. Published online July 8, 2021. doi:10.1161/CIR.0000000000001003
10. Schultz G. Making medical forms and doctor visits more inclusive: Creating safe appointments for transgender, nonbinary, and gender diverse individuals. INvisible Project. Accessed online July 1, 2022.

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Most patients who experience a peridevice leak (PDL) at early imaging follow-up after left atrial appendage occlusion (LAAO) with implantation of Amplatzer devices continue to demonstrate PDL at 12 months’ follow-up, according to the results of a study published in the journal Catheterization & Cardiovascular Interventions.

A single-center, observational study of consecutive patients receiving LAAO with the Amplatzer Cardiac Plus or Amulet (Abbott) devices at Aarhus University hospital in Aarhus, Denmark, was conducted between 2010 and 2017. The researchers sought to examine changes in PDL from 2 until 12 months following LAAO via use of cardiac computed tomography (CT), as well as to evaluate the possible association between persistent PDL and clinical outcomes among study participants.

Per institutional practice, all patients in whom an Amplatzer device was implanted were scheduled for a 2-month post-LAAO follow-up, which included transesophageal echocardiography (TEE) and cardiac CT scan. A total of 206 patients who had received LAAO from 2010 to 2017 were scheduled for repeat TEE and cardiac CT scan at their 12-month follow-up. In these individuals, cardiac CT scan was not performed in those individuals with a glomerular filtration rate of less than 30 mL/min, thus leaving a total of 153 participants in the current study.

All of the CT images were analyzed blindly. PDL was determined by the frequency and size of the device disc, lobe, and LAA contrast patency. All of the participants were followed for the composite outcome of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death. The median follow-up from LAAO was 3.1 years (range, 2.3-4.3 years).

Contrast patency was observed in 66% of the participants at 2 months and in 47% of the participants at 12 months (P <.001). PDL was identified at the disc in 67% of the participants at 2 months, compared with 61% of the participants at 12 months (P =.08). Additionally, PDL was detected at the lobe in 19% of the participants at both 2 months and 12 months.

The median PDL area at the disc did not change significantly over time (Δ area, -8.95 mm; 95% CI, -18.9 to 1.01; P =.08). Further, the mean PDL width at the disc did not change significantly over time (Δ width, -0.03 mm; 95% CI, -0.35 to 0.28; P= .84). The PDL length was 12.2±10.5 mm at 2 months vs 11.5±10.8 mm at 12 months (Δ length, -0.75 mm; 95% CI, -1.82 to 0.32; P =.17).

Participants with persistent PDL (CT Grade 2-3) at the 12-month follow-up were more likely to have permanent atrial fibrillation (AF); a higher CHA₂DS₂-VASc risk score; and larger LAA diameters, as well as to have received a larger device implant.

Per multivariable analysis, only permanent AF was significantly associated with persistent PDL in cardiac CT scan at 12 months (P =.04). Persistent PDL vs no PDL was associated with a 62% worse clinical outcome, which was not statistically significant (HR, 1.62; 95% CI, 0.9-2.93; P =.11).

Limitations of the current study include its single-center, observational design, which has such inherent drawbacks as potential selection bias and lack of generalizability to other practice settings that use other LAAO platforms. The restricted sample size of this study is another drawback.

“Persistent PDL was associated with worse clinical outcomes, however, not statistically significant,” the study authors wrote. “The study data questions the need for repeated imaging after LAAO, however, the clinical consequence of PDL requires confirmation in larger studies.”

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference  

Korsholm K, Jensen JM, Nørgaard BL, Nielsen-Kudsk JE. Temporal changes and clinical significance of peridevice leak following left atrial appendage occlusion with Amplatzer devices. Catheter Cardiovasc Interv. Published online May 18, 2022.

doi:10.1002/ccd.30178

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