Researchers conducted a systematic review to assess the literature on cerebrovascular hemodynamics in patients with ACS and their effect on cognitive functioning.¹

A search was performed in the MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases through May 2022 for prospective case-control studies that included adults aged 18 years or older with unilateral or bilateral ACS, a control group, and a validated, objective measure of global cognitive function or 1 or more domains of cognitive function separately.

The review included 5 studies with 782 patients and 407 control individuals. Among the studies, 4 were cross-sectional and 1 provided longitudinal data for 3 years of follow-up.

All included studies used the breath-holding index to evaluate cerebrovascular reactivity, and substantial heterogeneity was observed in the use of neuropsychologic assessments to assess cognitive performance.

All 5 studies found a significant association between unilateral and/or bilateral ACS and cognitive impairment, and 4 studies reported a significant association between a reduction in cerebrovascular reserve and impaired cognitive function in patients with unilateral ACS. The participants with ACS and reduced cerebrovascular reserve had significantly decreased global and domain-specific cognitive performance, and the lowest cognitive scores occurred in patients with bilateral stenosis and cerebrovascular reserve reduction.

In the 1 longitudinal study, Balestrini et al² evaluated progressive cognitive decline in patients with unilateral ACS vs control individuals during a 3-year period. Cognitive deterioration, based on a 3-point reduction in Mini-Mental State Examination scores, occurred in 24.8% of patients with ACS (unilateral stenosis, 70%-99%) compared with 7% of age-matched control individuals. The study authors found a significant association between impaired ipsilateral cerebrovascular reserve and progressive global cognitive decline in patients with ACS vs those with preserved ipsilateral cerebrovascular reserve (P <.05).

Limitations include the small number and size of the studies, which did not allow a quantitative analysis to be performed. Also, significant heterogeneity occurred regarding the neuropsychologic tests used, and most studies did not include a standard protocol for baseline or follow-up neuroimaging evaluation. Furthermore, most of the participants were men, and most studies were cross-sectional.

“This review provides support for the use of comprehensive neurocognitive assessments and CVR [cerebrovascular reserve] assessment, in addition to longitudinal ultrasound evaluations of carotid plaque progression and/or phenotype, to facilitate risk stratification of patients with ACS,” wrote the researchers. “Clinicians may be prompted to consider cognitive impairment as a critical factor in risk stratification of ACS patients for consideration of carotid interventions.”

Disclosure: One of the study authors declared affiliations with a medical technology company. Please see the original reference for a full list of authors’ disclosures.

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Thyroid eye disease (TED) affects the ocular surface and orbital tissues. The clinical activity score (CAS) measures disease activity and guides treatment. In previous studies, optical coherence tomography angiography (OCT-A) has been used to detect deterioration in radial peripapillary capillary (RPC) density in glaucoma or ischemia and parapapillary deep vessel density in glaucomatous optic neuropathy. However, parapapillary deep vessel density has not been studied in TED. Therefore, researchers aimed to evaluate peripapillary microvascular change in the choroid of patients with TED using automated image processing. 

The study participants were divided into 3 groups: group 1 included the controls (n=40), group 2 included inactive TED (ITED, n=22), and group 3 included active TED (ATED, n=19). The mean age of the control group was 43.9, and the TED group was 45.0. Among these, 24 of the 40 in the control group and 21 of the 41 in the TED group were women. 

Annular and hemifield RPC density was significantly lower in the ATED group compared with participants in the control and ITED groups, while parapapillary retinal nerve fiber layer (pRNFL) thickness was significantly higher in the ATED group than controls. There was a notable rise in the density of parapapillary choroid microvasculature (PPCMv) in the ATED group for the entire ring area. 

In the DON subgroup, there was a significant reduction in RPC density, but no changes were observed in pRNFL thickness and PPCMv density. PPCMv density was correlated with pRNFL thickness (r=0.334; P =.002). The RPC density was correlated with the thyroid-stimulating hormone receptor antibody (TSHr AB) level (r<-0.396; P <.001). CAS was positively correlated with parapapillary choroid microvasculature density (r=0.349; P =.001) and pRNFL thickness (r=0.293; P =.008), and negatively correlated with RPC density (r=-0.321; P =.004).

“These results suggest that altered peripapillary microvascular perfusion may contribute to DON,” the researchers explain. “As the level of clinical activity increases, so does the change in the peripapillary parameters.”

Study limitations include the small number of non-DON and DON subgroups. Additionally, no longitudinal RPC density and PPCMv density data were available. Smoking may have affected the results of OCT-A.

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Researchers evaluated adverse events associated with PJP prophylaxis and assessed PJP incidence among patients receiving treatment for AAV.

Data were taken from the TriNetX electronic health records database, comprised of information from 72 healthcare organizations. Patients with diagnostic-confirmed AAV who received at least one administration of rituximab or cyclophosphamide were included in the analysis. Incidence of PJP within 6 months of treatment initiation was the primary endpoint. Adverse events occurring within the 6-month period following treatment initiation were evaluated.

A total of 1461 patients with AAV were included in the analysis. Mean patient age was 56.2 years, 59.8% of patients were women, and 73.0% were White. Rituximab was most commonly used for induction therapy (69.7%).

Overall, 37.1% of patients received PJP prophylaxis within the first 30 days of induction therapy, with trimethoprim-sulfamethoxazole (30.7%) being most commonly used.

During the 6 months following treatment initiation, 10 cases of PJP occurred, corresponding to an incidence rate (IR) of 15.0 cases/1000 patient-years. No deaths occurred during this period.

A total of 709 patients were included in a subset analysis investigating rituximab maintenance therapy. An additional 5 cases of PJP were identified during this period, corresponding to an IR of 2.11 cases/1000 patient-years. One patient died while hospitalized with PJP.

Patients receiving vs not receiving prophylaxis were at greater risk for rash (hazard ratio [HR], 1.9; 95% CI, 1.0-3.6), nephropathy (HR, 2.6; 95% CI, 1.3-5.1), and leukopenia (HR, 3.1; 95% CI, 1.1-8.6), according to adjusted analyses.

Study limitations included potential missed diagnoses of PJP and under/miscoding of PJP and adverse events. Additionally, data on prophylaxis medication adherence was unknown. 

The study authors stated, “This study identified a lower incidence of PJP than previously observed.”

“Taken together, our study and similar recent real-world evaluations suggest that PJP may be less common among patients with AAV than previously assumed,” they concluded.  

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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Researchers conducted a systematic review and meta-analysis to evaluate the effect of MDT management on outcomes in patients with infective endocarditis. Studies included in the analysis comprised hospitalized patients with infective endocarditis and were designed to examine short- or long-term mortality, morbidity complications, length of hospitalization, treatment adherence, patient satisfaction, and surgical outcomes. Restricted maximum likelihood random-effects models were used to calculate unadjusted risk ratios (RRs) and 95% CIs.

The final analysis included 18 studies, representing a total of 3993 episodes of IE. Among the studies, sample sizes ranged between 6 and 645 patients, the mean age was 41.1 years, and 29.7% of the population were women. All studies had a single-center design, 44% were retrospective, and most (83%) were conducted at either tertiary care facilities or reference centers for infective endocarditis.

In regard to MDT composition, all teams included cardiac surgery and most included cardiology and infectious diseases; other common specialties included neurology, echocardiography/radiology, and microbiology.

In the meta-analysis, data captured from 15 studies showed reduced risk for in-hospital mortality among patients who did vs did not receive care from dedicated MDT (RR, 0.61; 95% CI, 0.47-0.78). Multivariate analyses performed in 8 studies indicated an independent associated between dedicated care via MDT and reduced mortality. This association was preserved in 3 studies in which results were adjusted by calendar year and in 2 that included propensity score matching.

In 11 studies with data available on outcomes following MDT implementation, length of hospitalization was increased in 6 (55%) and reduced in 5 (45%), though results from only 4 studies were significant. Reductions in time to surgery and increased rates of surgery were also reported following MDT implementation.

Limitations of this analysis include potential residual confounding and selection bias as most studies had single-center observational designs. Other limitations include moderate heterogeneity, the small number of women, and a lack of generalizability as most studies were conducted in high-income countries.

According to the researchers, “Publishing guidance on a standardized framework for MDT management could be helpful, especially if such guidelines were to include meaningful outcome definitions to be used in future observational, quasi-experimental, and randomized studies.”

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Investigators sought to evaluate patients with CLTI treated for occluded femoro-popliteal stents with bypass vs endovascular treatment for a comparison of early- and medium-term outcomes.

They conducted an observational retrospective study using the OUT-STEPP2 multicentric registry to include 161 consecutive patients who received treatment for symptomatic occlusion of femoro-popliteal artery stents between January 2016 and December 2021 at 14 vascular surgery centers in Italy. Patients who were excluded had either lack of follow-up, hybrid revascularization, primary major amputation, acute limb ischemia, or popliteal artery aneurysm as indication for first treatment.

Among the included patients, 46 (mean age, 71.8 years; 30.4% >80 years of age; 71.7% men) received open bypass surgery (Group OPEN) and 115 (mean age, 73.7 years; 31.3% >80 years of age; 62.6% men) received endovascular treatment (Group ENDO). Primary risk factors were similar between Group OPEN vs Group ENDO, with current smokers (47.8% vs 50.4%), hypertension (97.8% vs 93.9%), hypercholesterolemia (93.5% vs 82.6%), and diabetes (65.2% vs 59.1%). Body mass index of greater than 30 was significantly different between groups (34.8% vs 13.9%). Preoperative pharmacological therapy in the OPEN vs ENDO groups included aspirin (73.9% vs 72.2%), clopidogrel (23.9% vs 41.7%), and statin (71.7% vs 74.8%).

There were no between-group differences at 30 days post-procedure for major amputations, reinterventions, acute kidney injury, major adverse cardiovascular events (MACE), or all-cause mortality.

Patients in Group OPEN had greater mean (SD) length of hospital stays (9.7 [5.8] vs 3.3 [1.4] days), mean length of intensive care unit (ICU) stays (0.3 [0.9] vs 0 days), and need for blood transfusions (36.9% vs 11.3%; all P <.001).

Overall, median follow-up duration was 33.1 (IQR, 14-49.5) months. The investigators found no between-group differences at 5 years for limb salvage (77.2% vs 90.4%; P =.17), absence of target lesion restenosis (56.8% vs 62.7%; P =.42), primary patency (56.3% vs 67.8%; P =.39), secondary patency (59.1% vs 77.8%; P =.24), or survival (68.7% vs 68.8%; P =.27).

Study limitations include the observational retrospective design, heterogeneity, and unaccounted-for confounders.

“Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in CLTI patients,” the investigators wrote. They noted open surgery was associated with increased use of blood transfusions, and longer stays in the hospital and ICU. “At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.”

Disclosure: One study author 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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Despite advantages of economics, radiation protection, and no need for nephrotoxic contrast, the practice of duplex ultrasound for AVF angioplasties is underutilized, perhaps due to insufficient documentation of efficacy and safety.

Investigators aimed to show no significant differences exist between observed rates and DA of AVF in the recommended thresholds of clinical success, postintervention patencies, and minor and major complications (the main outcomes of AVF angioplasty).

They conducted a single-center retrospective study using the medical database of the Vichy District Hospital, France, and included all 141 patients (298 DAs performed) with chronic kidney disease and upper limb AVF treated by DA from January 2015 through December 2019. The investigators collected ultrasound parameters up to 30 days before DA, at the end of angioplasty, and 30 days postprocedure (some echographic data missing after insertion of covered stent). They excluded declotting of acute thrombosis procedures or recanalization of chronic occlusion, as well as proximal venous, x-ray-guided, or arterial angioplasty.

Of the patients, 74% (mean [SD] age, 69.7 [12.4] years; 66% men) had AVF dialysis access before intervention, 14% were not yet on dialysis, 12% had central venous catheters, and 96% had native type AVF. Overall, 64% of patients had received previous angioplasty. AVF localization was split between forearm (42%), wrist (30%), and elbow (28%), and mean (SD) time between ultrasound examination and procedure was 7.1 (10) days. Among the 298 DAs, almost half (49%) involved 1 stenotic lesion, 42% had 2 lesions, and 9% had 3 to 4 lesions. Stenosis was located in inflow (42%), outflow (39%), and both inflow and outflow (19%).

Clinical success occurred in 95.3% of DAs, hemodynamic success occurred in 95.0% of DAs, and anatomical success occurred in 47.7% of DAs. Minor complications that required no adjunctive treatment were found in 52.7% of DAs, much higher than expected rates (balloons, 54% vs 8%, P <.001; stents, 36% vs 7%, P <.001).

Major complications were higher than expected rates but not significantly (balloons, 2.6% vs 2%, P =.55; stents, 5% vs 1.5%, P =.28). Major complications requiring specific therapy occurred in 8 patients (2.7%).

Overall postintervention primary patency (PP) was 34.0% at 12 months and 23.2% at 24 months. Primary assisted patency (PAP) was 87.4% and secondary patency (SP) was 92.5% at 12 months, and 78.4% and 90.5% at 24 months, respectively. No significant between-group differences of patency rates were noted (with or without minor complications [P-value for PP =.08; P-value for PAP =.08; P-value for SP =.23] or residual stenosis [P-value for PP=.82; P-value for PAP=.46; P-value for SP=.63]). Further improvement was noted at day 30 postangioplasty in duplex parameters.

Study limitations include the retrospective monocentric design, the confounding effect of multiple stenotic lesions, and some stenosis may not have been treated.

“Duplex-guided hemodialysis vascular access angioplasty is safe and efficient,” the investigators wrote “It presents postintervention patency and complications rates within the recommended threshold and provides duplex ultrasound parameters that could facilitate the definition of new efficiency criteria in the future.”

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Only a small proportion of patients with subsegmental pulmonary embolism (PE) may be eligible for structured surveillance without anticoagulation as recommended by the American College of Chest Physicians (CHEST) guidelines, and despite the CHEST guideline on structured surveillance in these patients, it is rarely used in the community setting, according to research published in JAMA Network Open.

“[The 2016 CHEST guideline and expert panel report authors] suggested structured surveillance without anticoagulation for ambulatory patients with stable subsegmental PE without active cancer, [deep vein thrombosis (DVT)] (requiring bilateral compression ultrasonography regardless of DVT signs and symptoms), impaired cardiopulmonary reserve, marked symptoms, and increased risk of recurrent [venous thromboembolism (VTE)],” explained the researchers. “This cautious recommendation was reiterated in the subsequent 2021 CHEST guideline and expert panel report.”

The researchers conducted a retrospective cohort study across 21 US community hospitals to assess the prevalence of surveillance among outpatients with acute subsegmental PE and to estimate the proportion of outpatients in community practice eligible for structured surveillance using the modified CHEST criteria (excluding patients with higher-risk characteristics or right ventricular dysfunction) and a stricter set of criteria requiring an age <65 years and no more than 1 embolus.

The study included 666 adult outpatients with acute subsegmental PE between January 1, 2017, and December 31, 2021. Of those, 229 (34.4%) had lower-risk characteristics. These patients had median age of 58 years (interquartile range, 42-68 years). This lower-risk cohort was 52.4% men and 55.9% self-identified as non-Hispanic White.

Among the lower-risk cohort, the researchers found that 6 patients (2.6%) were not treated initially with anticoagulants and only 1 patient (0.4%) underwent structured surveillance.

The analysis revealed that 15.3% and 6.6% of the lower-risk cohort and 5.3% and 2.3% of the full cohort were eligible for structured surveillance using the modified CHEST criteria and the stricter criteria, respectively.

“These findings suggest that there was almost no effect on surveillance practices attributable to the CHEST guideline in this large US health care system—a system that is conducive to structured surveillance, with ready access to VTE imaging, specialty consultation, and timely primary care follow-up,” stated the study authors. “Although trials are ongoing to define which patients with subsegmental PE can safely undergo surveillance, widespread uptake of any new surveillance practice will require more than passive diffusion.”

Limitations of the study included the retrospective design, a 5-year study period, potential bias of unblinded physician abstractors, incomplete case ascertainment, and inclusion of only northern California residents.

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Investigators assessed whether patients with AAV are at increased risk for CVD during the months preceding their diagnosis.

A retrospective, nested case-control study was conducted, including patients with AAV

registered in the Danish National Patient Registry as having granulomatosis with polyangiitis or microscopic polyangiitis. Each patient with AAV was age- and sex-matched with 3 patients free of disease (control group). Patients with AAV and their matched counterparts were given the same index date, defined as the first hospital or clinic visit with a diagnosis of AAV.

The primary study outcome was a composite of all cardiovascular outcomes, defined having a “cardiovascular history” according to medical records.

The risk for major adverse cardiovascular events (MACE) including stroke, acute myocardial infarction or revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery was also assessed.

A total of 2371 patients with AAV and 7113 members of the control group were included in the analysis. The median patient age among both groups was 63 years and nearly 54% were men.

The prevalence of any cardiovascular outcome was 10.3% among patients with AAV compared with 3.8% among the control group (hazard ratio [HR], 3.05; 95% CI, 2.48-3.75) within the 12 months prior to the index date.

The prevalence of MACE was 2.4% among patients with AAV compared with 1.3% among the control group (HR, 1.98; 95% CI, 1.39-2.82) within the 12 months prior to the index date.

The risks for any cardiovascular outcome and MACE increased temporally, as the time until index date and subsequent AAV diagnosis decreased. These risks peaked 1 month prior to index date for any cardiovascular outcome (HR, 10.73; 95% CI, 7.05-16.32) and MACE (HR, 5.78; 95% CI, 2.67-12.52).

When individual cardiovascular outcomes were considered separately, patients with AAV were found to be at greater risk for all outcomes, with the exception of ventricular arrhythmias/implantable cardioverter-defibrillator-implantation/cardiac arrest.

Study limitations included potential AAV diagnostic delay and residual confounding due to the inability to account for patients’ lifestyle factors that may increase their risk of developing CVD. 

The study authors concluded, “Based on these findings, the initial period preceding AAV diagnosis should be considered as a “high-risk window” for developing cardiovascular disease and thus the importance of early clinical vigilance toward cardiovascular disease.”

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The retrospective study reviewed all EVARs performed at a Veterans Administration Hospital between January 2010 and December 2021.

The researchers obtained data regarding patient demographics, anticoagulation or antiplatelet medication use at the time of the EVAR procedure, pre-existing medical comorbidities contributing to vascular disease, and mental health disorder status.

The primary outcomes were follow-up rates, postoperative complications, and mortality. Postoperative complications included infection, acute kidney injury, bleeding, return to the operating room, hemodynamic instability, respiratory failure requiring ventilatory support, urinary tract infection, myocardial infarction, and stroke.

A total of 241 patients (mean age, 71.5±6.9 years; 99.2% men) had infrarenal EVARs during the study period, of whom 58.1% were diagnosed with a mental health disorder and 41.9% had no previous diagnosis of a mental health disorder.

Among the patients who were previously diagnosed with a mental health disorder, 92 (43%) had a history of substance abuse disorder, 54 (25%) had depression, 41 (19%) had post-traumatic stress disorder (PTSD), and 27 (13%) had anxiety. In addition, 5 (3.6%) patients were diagnosed with a major psychiatric disorder, 3 with bipolar disorder, 2 with schizophrenia, and 23.7% had more than 1 mental health disorder diagnosis. More than half of the patients with a mental health disorder were receiving active treatment at the institution.

The mean follow-up was 1931.8 days (5.3 years), and the median follow-up was 1979.0 days (5.4 years). No statistically significant differences in demographics or medical comorbidities were observed in the patients with and without a mental health disorder. The 2 groups also had a similar preoperative albumin level, body mass index, and smoking status, as well as antiplatelet or anticoagulation use. A statistically significant difference was found between anesthesia type used in the 2 groups, with a higher percentage of epidurals used in patients without a mental health disorder diagnosis (9.9%) vs those with a mental health disorder (1.4%; P =.007).

Patients with a mental health disorder had a statistically significantly lower composite postoperative complication rate (28.6% vs 32.7%; P =.05). No statistically significant differences occurred for readmission rate or 30-day mortality. A significantly reduced percentage of patients with a mental health disorder were lost to follow-up compared with those without a mental health disorder (8.6% vs 15.8%; P =.05).

In binary logistic regression analysis, no statistically significant differences were found in the primary outcomes of postoperative complications, readmission rates, loss to follow-up, and 1-year mortality in stratification according to mental health disorder type. Cox proportional hazards modeling yielded a hazard ratio of 0.56 (95% CI, 0.29-0.107) for patients with a mental health disorder, although it was not statistically significant (P =.08).

In the analysis according to mental health disorder subtype, no statistical significance was found in cumulative survival hazard ratios in patients with a diagnosis of PTSD (1.59; 95% CI, 0.88- 2.88; P =.13), anxiety (1.25; 95% CI, 0.65-2.43; P =.50), substance abuse disorder (0.84; 95% CI, 0.49-1.46; P =.55), and depression (0.69; 95% CI, 0.42-1.16; P =.17).

Limitations of the study include the retrospective design being limited to EVARs performed at a single institution. Also, the cohort is primarily men, and the analysis did not stratify between treated and untreated mental health disorder, which could have affected outcomes.

“Veterans Health Administration resources and multidisciplinary support of patients with mental illness diagnoses may improve adherence and follow-up rates, mitigating postoperative complications in patients undergoing EVARs,” wrote the study authors.

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Researchers sought to assess the association between fluoroquinolone therapy, compared with other antibiotics, and hospitalization for aortic aneurysm or dissection. They pooled 2 separate UK patient primary care records—Aurum and GOLD—to separately conduct a cohort and case-crossover study in patients aged 18 years and older who were hospitalized and received treatment for an aortic aneurysm or dissection between April 1997 and December 2019.

In the cohort study, researchers pooled 1,077,584 patients prescribed fluoroquinolones (mean age, 52.7 years; women, 47.6%) and 2,056,537 patients prescribed cephalosporins (mean age, 52.2 years; women, 70.8%) from Aurum and 160,636 patients prescribed fluoroquinolones (mean age, 54.5 years; women, 49.5%) and 291,450 patients prescribed cephalosporins (mean age, 53.7 years; women, 71.0%) from GOLD.  The hazard ratio (HR) was estimated using the Cox regression model to assess the association between fluoroquinolone prescriptions and cephalosporin prescriptions relative to hospitalization with aortic aneurysm or dissection within 60 days of receiving the prescription. The researchers also adjusted for covariates such as demographics and lifestyle variables, prior comorbidities, risk factors for hospitalization with aortic aneurysm or dissection, and risk factors for tendon rupture. They used tendon rupture as a positive control outcome for patients that were prescribed fluoroquinolones.

In the case-crossover study, the researchers pooled 84,841 patients from Aurum and 10,357 patients from GOLD, who were hospitalized with aortic aneurysm or dissection. Patient characteristics such as age, sex, index date, and antibiotic use were matched 1:3 to control individuals. The odds ratio was used to estimate the association between fluoroquinolone use, the use of 3 comparator antibiotics (cephalosporin, co-amoxiclav [amoxicillin-clavulanate], and trimethoprim), and nonantibiotic use relative to the patient’s first hospitalization with aortic aneurysm or dissection.

Fluoroquinolone therapy significantly increased risk for aortic aneurysm or dissection hospitalization, compared with cephalosporin therapy (pooled HR, 1.28; 95% CI, 1.13-1.44; P <.001). After adjustment for covariates, the pooled adjusted HR (aHR) was 1.03 (95% CI, 0.91-1.17; P =.65), denoting an insignificant association. Patients who were prescribed fluoroquinolones also had a high risk for tendon rupture (pooled aHR, 1.98; 95% CI, 1.56-2.50; P <.001), confirming the primary control outcome. 

Compared with nonuse, fluoroquinolone therapy increased the odds of hospitalization with aortic aneurysm or dissection (pooled OR, 1.58; 95% CI, 1.37-1.83; P <.001). However, when compared to cephalosporin use (pooled OR, 1.05; 95% CI, 0.87-1.27; P =.59), trimethoprim use (pooled OR, 0.89; 95% CI, 0.75-1.06; P =.20), and co-amoxiclav use (pooled OR, 0.98; 95% CI, 0.82-1.18; P =.85); fluoroquinolones did not significantly increase the odds of hospitalization with aortic aneurysm or dissection.

A key study limitation is the potential for misclassification of antibiotic exposure, since medication adherence was not recorded. Ciprofloxacin accounted for the majority of fluoroquinolone prescriptions, which potentially limited the generalizability of findings to other antibiotics in the same drug class. Also, deaths from ruptured aneurysms and dissections before hospitalization were not identified.

“…infection itself may increase the risk of aortic aneurysm or dissection,” the researchers wrote. “Further research on the mechanism of increased risk could usefully inform patient care and infectious disease control and prevention.”

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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Among 647 patients with diagnosed aortic stenosis (peak aortic jet velocity [Vmax] of 2.5 m/s or more and a left ventricular ejection fraction of at least 50%), 261 patients (40%) had CKD. Over 2.9 years, the aortic valve area (AVA) significantly and progressively narrowed by -0.07, -0.08, -0.09, -0.10, and -0.10 cm²/year in patients with an eGFR of more than 60, 45-59, 30-44, 15-29, and less than 15, respectively, as assessed by echocardiography, Christophe Tribouilloy, MD, PhD, of Jules Verne University of Picardie in Amiens, France, and colleagues reported in Nephrology Dialysis and Transplantation.

An eGFR less than 45 was significantly associated with rapid progression of aortic stenosis as well as aortic valve placement or death compared with an eGFR greater than 60. Rapid progression of aortic stenosis (an aortic value area change above the median of -.07 cm²/year) in patients with an eGFR less than 45 was significantly associated with all-cause and cardiovascular mortality.

“Patients with kidney dysfunction should be closely monitored and those with rapid progression seriously considered for aortic valve replacement decision making,” according to Dr Tribouilloy’s team. “It is, therefore, important to include a nephrologist as an integral component of the heart–kidney team in the management, even for patients with mild to moderate CKD.”

Data on risk factors such as CKD-mineral and bone disorders, albuminuria, low-grade inflammation, and the etiology and duration of CKD were lacking, preventing further analyses.

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Investigators examined how the presence of IA mineralization, detected using computerized tomography (CT) scans, relates to the development of knee pain over time.

A longitudinal analysis of the Multicenter Osteoarthritis (MOST) study (ClinicalTrials.gov Identifier: NCT03033238) was conducted. Researchers categorized knee pain based on frequency and severity: frequent knee pain (FKP), intermittent or constant knee pain worsening, and pain severity worsening.

Knee imaging was conducted at baseline visit and pain assessments were completed every 8 months for a total of 2 years.

A total of 2093 patients (4168 knees) were included in the analysis. More than half of the study participants were women (57%) and mean patient age was 61 years.

Computerized tomography-detected mineralization was present among 13.3% of patients, anywhere in the joint. A total of 10.2% of knees had some form of IA mineralization (found in cartilage, meniscus, and/or capsule) on CT scans, while the prevalence on radiographs was 6%. 

The presence of IA mineralization in the joint was strongly associated with likelihood of developing FKP (odds ratio [OR], 1.71; 95% CI, 1.25-2.35), but no other types of pain.

In particular, mineralization in the cartilage increased the likelihood of experiencing FKP by 96% and frequent intermittent/constant pain by 83%, compared against patients with no cartilage mineralization. However, IA mineralization in the cartilage itself did not have a significant impact on the severity of pain (β, 0.17; 95% CI, -0.05 to 0.40).

Greater IA mineralization within any part of the knee was associated with increased odds for all pain outcomes (ORs ranged from 2.14-2.2).

The investigators noted it was unclear whether the location of IA mineralization among specific tissue types, (eg, cartilage, meniscus, capsule) was clinically relevant to the development of pain, though slight variations in the level of risk associated with each type of tissue were present.

Limitations of this study included reduced generalizability among patient cohorts. Additionally, fluctuations in pain occurring between study visits and subsequent development of mineralization were unable to be studied. Finally, specific crystal types were not assessed.

The study authors concluded, “These findings implicate calcium crystal deposition in changing pain patterns over time in knee OA. These insights also raise the potential for developing and testing therapies directed towards crystal deposition and downstream mediators to improve knee OA symptoms.”

Disclosure: One or more 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 sought to assess the association between race and ethnicity and clinical outcomes in patients who have had carotid endarterectomy, transfemoral carotid artery stenting, and transcarotid artery revascularization before and after accounting for socioeconomic status using the Area Deprivation Index (ADI).

Participants received carotid revascularization from January 2003 to February 2022. Data were from the Society for Vascular Surgery Vascular Quality Initiative carotid endarterectomy and carotid artery stenting databases. Patients who were Hispanic or a race other than Black or White were excluded.

The main study exposures were patient race and ADI, and the primary outcomes were in-hospital and long-term composite stroke or death.

Among 201,395 patients, 5.1% (mean age, 68.6±0.10 years; 51% women) were non-Hispanic Black patients and 94.9% (mean age, 70.9 ± 0.02 years; 38.2% women) were non-Hispanic White patients. They had a mean follow-up time of 3.4±0.01 years.

Compared with their White counterparts, a disproportionately increased percentage of Black patients were living in the most socioeconomically deprived neighborhoods (ADI-4, 38.5% vs 20.3%; P <.001). A comparison of crude in-hospital outcomes by race showed a significantly increased frequency of in-hospital stroke, death, and combined stroke and death occurring in Black patients vs White patients (all, P <.001).

Black race was associated with greater odds of in-hospital combined stroke and death after carotid artery revascularization compared with White race (adjusted odds ratio [aOR], 1.24; 95% CI, 1.10-1.40), after adjustment for standard demographic, comorbidity, and disease characteristics. This association was mostly similar after additional adjustment for ADI (Black vs White; aOR, 1.23; 95% CI, 1.09-1.39).

Black patients had an estimated 3-year risk for combined stroke and death of 12.0% (95% CI, 11.2-12.8) compared with 9.85% (95% CI, 9.69-10.0) for White patients (P <.001). Black race was significantly associated with an increased risk for combined stroke and death after carotid artery revascularization compared with White race after adjustment for standard demographic, comorbidity, and disease characteristics (adjusted hazard ratio [aHR], 1.13; 95% CI, 1.04-1.23). After additional adjustment for ADI, Black race continued to be associated with a greater risk for long-term combined stroke and death (aHR, 1.12; 95% CI, 1.03-1.21).

Participants who lived in more socioeconomically deprived neighborhoods (ADI-3 and ADI-4) had a significantly increased risk for long-term combined stroke and death vs patients who lived in the least socioeconomically deprived neighborhoods (both, P <.05).

Among several limitations, the Vascular Quality Initiative database is limited to centers that electively participate and thus may not be representative of general United States health care trends. In addition, the data are manually entered by physicians and subject to self-reporting bias, error, and limited to categorical variables in the dataset. Furthermore, ADI is the only composite measure of socioeconomic status, and the researchers were only able to analyze outcomes for Black and White patients.

“…we must recognize the possibility that gaps in our care and systems may prevent Black patients from experiencing equitable outcomes following carotid artery revascularization,” wrote the study authors. “In addition, Black patients undergoing carotid artery revascularization more frequently live in areas of higher socioeconomic deprivation compared to White patients.”

The post Worse Outcomes Following Carotid Revascularization in Black Patients appeared first on The Cardiology Advisor.

Investigators assessed differences, similarities, and the likelihood for specific clinical features among patients with UV vs CSU.

An international, prospective, investigator-initiated observational multicenter study was performed, including adult patients with skin biopsy-confirmed UV or CSU. The study participants completed a questionnaire on the clinical features, disease course, and response to treatment for their respective diseases.

A total of 106 patients with UV and 126 patients with CSU were included in the analysis. The majority of patients were women (82.1% vs 77.2%), and more than 60% of patients among the UV and CSU groups reported stress as the most common trigger factor, respectively. 

A total of 63.1% of patients with UV reported wheals lasting 24 hours or more compared with 20.8% of patients with CSU (P <.001).

Wheals of greater than 48 hours duration were reported by 30.1% of patients with UV, but only 8.8% of patients with CSU (P <.001).

Post-inflammatory hyperpigmentation at sites of whealing occurred in 72.6% of patients with UV vs 20.6% of patients with CSU (P <.001) and was more commonly associated with pruritis (67.0 % vs 19.8%), skin pain (41.5% vs 9.50%), long wheal duration (50.0% vs 7.90%), and systemic symptoms (54.7% vs 12.7%) among patients with UV vs CSU, respectively.

Among patients with UV, 72.6% experienced systemic signs and symptoms, while only 52.4% of patients with CSU had such symptoms.

Study findings are limited, as not all patients with CSU underwent a skin biopsy and complement levels were not available for all patients with UV. Additionally, skin biopsies were not examined according to recently published criteria. Finally, the analysis did not assess ethnicity and laboratory findings.

The study authors concluded, “A longer diagnostic delay for normocomplementemic UV indicates an unmet need for raising disease awareness among medical specialists to improve UV diagnosis and reduce the time from diagnosis to appropriate treatment of patients with UV.”

The post Differentiating Between Urticarial Vasculitis and Chronic Spontaneous Urticaria appeared first on The Cardiology Advisor.

In this cross-sectional study, which was published in the journal International Ophthalmology, ophthalmic exams were conducted among 56 children with transfusion-dependent thalassemia (TDT), 14 children with thalassemia who were not transfusion dependent (NTDT), and 63 children without thalassemia.

OCTA was used to evaluate vessel density (VD) of the superficial capillary plexus, deep capillary plexus, radial peripapillary capillary network, choriocapillaris, and the foveal avascular zone area (FAZ).

Patients with NTDT demonstrated the lowest macula VD of superficial capillary plexus (P =.001) and peripapillary VD (P <.001), whereas patients with TDT demonstrated the highest.

Retinal thickness was lowest among patients with TDT, including for the macular (P =.013), fovea (P =.002), and parafoveal areas (P =.012), compared with patients with NTDT and children without thalassemia. The choroidal thickness was also thinner in the TDT group compared with the NTDT and control groups for the temporal (P <.001), foveal (P <.001), and nasal (P <.001) regions. The peripapillary retinal nerve fiber thickness was not significantly different between the groups.

Among patients with TDT, peripapillary VD (P =.010) and the peripapillary inferior hemisphere VD (P =.007) were significantly thinner after a blood transfusion compared with before. Retinal thickness of the fovea (P =.011) increased and the peripapillary retinal nerve fiber thickness decreased (P =.039) after a transfusion.

“Changes in retinal and choroidal microvascular structure can be observed in children with beta-thalassemia before visual loss or ophthalmological examination findings,” the authors concluded in their report.

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In recent decades, there’s been a sea change in the understanding of pulmonary arterial hypertension (PAH), which in turn has affected the patient journey in this disease. The prognosis of PAH has evolved from impending death with few treatment options to a chronic condition notable for improved survival.¹

Improved patient survival has been realized due to the development of effective therapies and the expansion of risk-stratification scores, which aid clinicians in clinical decision-making. Although PAH can now be better controlled — with improved quality of life and clinical course for patients — patients still face barriers to care. The treatment burden is cumbersome and hinders quality of life, and many with the condition initially present with advanced or end-stage disease.¹

Changes and Challenges in Disease Diagnosis

A focus on early disease detection and new clinical outcomes findings have changed the definitions of PH and PAH.^2-4 According the 2022 ESC/ERS Guidelines for Pulmonary Hypertension, patients with a mean pulmonary artery pressure of more than 20 mmHg measured by right heart catheterization are now considered to have PH. A pulmonary vascular resistance or more than 2.0 Wood units and pulmonary arterial wedge pressure of at least 15 mm Hg further implies the existence of PAH.^3,4  

“These lowered thresholds aim to identify patients early in the disease course, which is important because delay to diagnosis of PH is common and linked to elevated morbidity and shortened lifespan,” according to the author of a review published in the Journal of the American Heart Association.²

Although the 2022 ESC/ERS Guidelines for Pulmonary Hypertension cover the whole spectrum of PH, these updated guidelines include “an emphasis on diagnosing and treating pulmonary arterial hypertension.”⁴

Within the 2022 guidelines, the principal diagnostic algorithm for PH has been streamlined to a 3-step approach³ that includes:

1. suspicion by first-line physicians;
2. detection by echocardiography; and
3. confirmation via right-heart catheterization at PH specialty centers.

In an exclusive interview, Jean Elwing, MD, FCCP, Chair of the Pulmonary Vascular and Cardiovascular Network with the American College of Chest Physicians, provided guidance on how to best recognize PH in patients, and to then identify PAH.

“Pulmonary hypertension can present with multiple nonspecific symptoms and can be very challenging to diagnose,” she said. “When patients have progressive dyspnea, exercise limitation, and exertional chest discomfort, we have to think about potential causes that are both pulmonary and cardiac. When we are thinking of cardiac causes, one of the best tools to use is an echocardiogram. The echocardiogram will give us insight into the likelihood of pulmonary hypertension.”

She advised that PH should be a differential diagnosis in anyone with unexplained dyspnea/exercise limitation or other nonspecific symptoms such as intermittent chest discomfort with exertion, dizziness, lightheadedness, fatigue, and swelling. The index of suspicion should be high in patients with a higher risk of developing the disease, and their clinical trajectory should be followed closely.

For instance, if a patient with HIV, liver disease with portal hypertension, or connective tissue disease develops shortness of breath, an echocardiogram should be performed followed by right-heart catheterization, if needed, to rule out PH. 

Socioeconomic Factors Affecting PAH

Dr. Elwing also remarked on the impact of socioeconomic factors in the recognition of PH. “Social challenges and socioeconomic status can play a significant negative role in pulmonary hypertension diagnosis and lead to delays in care. This is an area where we need to be very mindful and consider all patients equally when assessing symptoms and pursuing further work-up of pulmonary hypertension,” she stated.

For instance, women and men present with PH and PAH in a similar fashion, but due to a lower prevalence of the disease in men, symptoms could be overlooked.

As for race and ethnicity, she said, “We believe that different races/ethnicities present with similar symptoms of pulmonary hypertension but the etiologies of pulmonary hypertension in these populations may differ. Hispanic patients are more at risk for congenital heart disease-associated pulmonary arterial hypertension and have an increased risk of viral hepatitis increasing their risk of portal hypertension and portopulmonary hypertension. Connective tissue disease-associated pulmonary hypertension has been shown to be more common in Black patients in available registry data.”

The Evolution of PAH Treatment

Over the past 3 decades, much has been clarified regarding pulmonary hypertension treatment; 30 years ago, the only treatment available involved high dosages of calcium-channel antagonists, which improved survival only in a handful of those with pulmonary arterial hypertension.⁵

Approved medical treatments for PAH (along with their routes of administration) include the following²:

• prostacyclin derivatives (inhaled iloprost, intravenous [IV] epoprostenol, IV/subcutaneous or inhaled or oral treprostinil);
• selective prostacylin (intraperitoneal injection) receptor agonist (oral selexipeg)
• endothelin receptor antagonists (oral bosentan, oral ambrisentan, oral macitentan)
• PDE5 inhibitors (oral/IV sildenafil, oral tadalafil)
• soluble guanylyl cyclase stimulator (oral riociguat)

In the aggregate, these agents help improve outcomes such as exercise tolerance and capacity, as well as mitigating clinical deterioration.²

In addition to pharmacologic therapies, there are also nonpharmacologic interventions that may improve patient well-being. These revolve around diet, sleep, and exercise, said Dr. Elwing. 

“A balanced diet with monitoring of salt and fluid intake can have a major impact on right heart-failure management and other comorbidities. Exercise can improve dyspnea and tolerance of many health conditions. This is important for exercise tolerance as well as overall well-being,” she said.

“Sleep is imperative for mood and resilience. Good sleep hygiene and assessment of sleep disorders is critical for patients to feel well and have the reserve to care for themselves with this complex medical condition,” she added.

The Patient Journey in PAH

Helping patients with PAH through the rigors of diagnosis and treatment requires empathetic conversations by specialists. Unfortunately, due to time constraints, it is hard for clinicians to make patients comfortable enough to open up about their goals and to revisit these goals over time. Instead, expedient visits pinpoint clinical factors, therapy, and medication adherence/tolerability.¹

Outside of clinicians, there are a few options patients and their caregivers may be encouraged pursue for further information and support, including Living with PAH, an online support and discussion community, and the American Lung Association Patient & Caregiver Network.

Dr. Elwing recommends that specialists take time to partner with patients to improve care.

“Knowledge is power, especially in complex diseases like pulmonary hypertension. Taking the time to educate patients will pay off for the patient and the provider in multiple ways,” she stressed. “Successful treatment and best outcomes can be achieved with joint efforts of the care provider as well as the patient. In order to achieve this, patients need to be educated on the disease and made aware of the importance of medication adherence, close follow-up, testing, and potential for medication changes.”

 She added, “Once patients understand the disease itself and the medications/therapies, the next step really would be to help them understand risk assessment and goals of low-risk status. Calculating a risk score in PAH is not just a number. Using a risk assessment tool helps guide medical therapy and provides some insight in terms of prognosis for that individual.”

On a final note, Dr. Elwing exhorted providers to take time to consider the patient in a holistic sense.

“We need to understand their level of medical literacy, ability to communicate, social support, and the severity of the illness. We assess patients’ risk status and design a treatment approach based on that. We choose the type of medications and the delivery system based on what the patient is able to tolerate and use safely,” Dr Elwing noted.

“We should closely monitor every PAH patient and provide opportunities to use our most aggressive therapies but may have to tailor medications based on that individual patient’s needs for the patient’s safety and ability for them to use medications consistently,” she added.

The post PAH: Changing Approaches to Diagnosis, Treatment, and the Patient Journey appeared first on The Cardiology Advisor.

Investigators sought to compare risks for macrovascular disease development among patients with T2D with and without microvascular disease. They also compared matched patients with diabetic retinopathy vs diabetic neuropathy, diabetic kidney disease vs diabetic neuropathy, and diabetic kidney disease vs diabetic retinopathy for the same risks. Primary outcomes were development of heart failure, stroke, coronary artery disease, and cardiovascular death.

They conducted a retrospective nationwide cohort study using the National Health Insurance Research Database in Taiwan to identify newly diagnosed T2D patients from January 2008, through December 2019, using ICD-9 and ICD-10 codes. Patients were propensity score matched for diabetic neuropathy, diabetic retinopathy, and diabetic kidney disease.

Patients were between the ages of 18 and 80 years. Risk of outcomes between patients with and without microvascular disease were measured using multivariable-adjusted Cox proportional-hazard models.

Among patients with T2D, there were 718,059 without microvascular disease; 46,634 with diabetic kidney disease; 51,887 with diabetic neuropathy; 15,778 with diabetic retinopathy; 36,850 with diabetic kidney disease and neuropathy; 11,763 with diabetic kidney disease and retinopathy; 10,917 with diabetic retinopathy and neuropathy; and 8934 with diabetic kidney disease, retinopathy, and neuropathy (mean follow-up, 5.55 years).

Patients with T2D and microvascular disease vs those without microvascular disease had a significantly higher risk for cardiovascular morbidities and mortality. Patients with diabetic retinopathy vs those with diabetic kidney disease had significantly higher risk for stroke (adjusted hazard ratio [aHR], 1.11; 95% CI, 1.03-1.20) among the matched pairs. Patients with diabetic retinopathy vs those with diabetic kidney disease had a significantly higher risk for incident heart failure (aHR, 1.43; 95% CI, 1.30-1.57).

Patients with diabetic neuropathy vs those with diabetic kidney disease had a significantly higher risk for stroke (aHR, 1.17; 95% CI, 1.10-1.25) as did patients with diabetic neuropathy vs those with diabetic retinopathy (aHR, 1.12; 95% CI, 1.03-1.21).

Patients with diabetic neuropathy vs those with diabetic retinopathy had a significantly lower risk for incident heart failure (aHR, 0.79; 95% CI, 0.71-0.87).

Study limitations include a lack of information on neurological, biochemical, blood glucose, proteinuria, renal function, imaging, and pathology findings. There is also missing information on alcohol consumption, family history, exercise, and dietary habits.

“Our study shows that microvascular diseases early in the diagnosis of type 2 diabetes are closely associated with the development of coronary artery disease, stroke, heart failure, and cardiovascular death,” the study authors wrote. “Furthermore, people with one, two or three microvascular diseases signify an even higher risk of cardiovascular morbidity and mortality than those without microvascular disease.”

The post Type 2 Diabetes With Microvascular Disease Increases Risk of Cardiovascular Death appeared first on The Cardiology Advisor.

Researchers evaluated predictors of 90-day home time using data from the Quality Improvement and Clinical Research registry in Alberta, Canada, in patients with MeVO vs LVO who received EVT. The data were limited to 1 center that provided EVT to patients in southern Alberta from July 1, 2015, to November 30, 2020.

Patient imaging was reviewed by 2 independent readers who were blinded to clinical data. All participants had baseline computed tomography (CT) and CT angiography, conventional angiography, and follow-up CT or magnetic resonance imaging. The primary outcome was 90-day home time.

Of the 663 patients who had EVT, 139 had MeVO on baseline CT angiography and 524 had LVO. Among the participants, 58.3% had proximal M2 occlusion, 24.5% had distal M2 occlusion, 14.4% had M3/M4 occlusion, and 2.9% had A2–anterior cerebral artery occlusion. Patients with MeVO had a median age of 71 years (50.4% women) compared with patients with LVO (median age, 74 years; 48.3% women).

Successful reperfusion occurred in 86.7% of patients in the MeVO group vs 85.3% in the LVO group (P =.72). In-hospital and 90-day mortality were comparable in the 2 groups.

Data regarding home time were available for all patients. The 90-day home time was increased, but not significantly, in the MeVO group compared with the LVO group in the unadjusted analyses (median, 37 [0-82] vs 32 [0-84]; P =.804). In random forests regression that included MeVO, atrial fibrillation, collateral grade, diabetes, heart failure, hypertension, occlusion site, sex, tandem occlusion, intravenous thrombolysis use, and onset to arterial access time as features and subsequent partial dependence estimates, mean predicted home times were similar in the MeVO (43.5 days) and LVO (43.9 days) groups.

With use of partial dependence estimates, premorbid diabetes (-8.7 days), hypertension (-6.6 days), and atrial fibrillation (-3.4 days) predicted worse 90-day home time. Home time had a constant relationship with age until about age 70 years, when it decreased with increasing age. Home time generally decreased with increasing time from onset to arterial access. No meaningful differences were observed in predicted 90-day home time based on sex, collateral grade, tandem lesion, and thrombolysis use.

Limitations of the study include use of nonrandomized data from a provincial registry, and 90-day home time is not a routine outcome in large clinical trials, which limits direct comparability of the findings. A limitation of home time is that it does not consider the level of assistance required by patients at home or quality of life at home. Also, only patients with primary MeVO who received EVT were included, and the number of patients treated for MeVO in the registry was relatively small.

“Our study demonstrates that patients with disabling strokes due to MeVO who are selected for EVT with similar demographic and clinical profiles to patients with LVO can achieve similar 90-day home time outcomes to patients with LVO,” the study authors wrote.

Disclosure: One 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.

The post 90-Day Home Times Following Endovascular Thrombectomy for Medium-Vessel Occlusion appeared first on The Cardiology Advisor.

Researchers evaluated national trends in completion imaging use following lower extremity bypasses (LEBs) and the relationship between routine completion imaging and 1-year MALE and loss of primary patency with use of the Vascular Quality Initiative (VQI). Participants received LEB between 2003 and 2020.

The cohort was classified according to the surgeons’ completion imaging strategy at time of LEB: routine (≥80% of cases/year), selective (<80% of cases/year), or never. Participants were further stratified by surgeon volume category into 3 groups based on the number of cases performed by each surgeon per year: low (<25th percentile per year), medium (25th-75th percentile per year), or high (>75th percentile per year).

The primary outcomes were 1-year MALE-free survival and 1-year loss of primary patency-free survival.

The analysis included 37,919 patients, of whom 22.7% were treated by surgeons who never performed completion imaging, 58.4% by surgeons who performed completion imaging selectively, and 18.8% by surgeons who routinely performed completion imaging. The patients in all 3 groups had a mean age of 68.11 years, and 68% were men.

A statistically significant steady decrease in completion imaging use occurred from 77.2% in 2003 to 32.0% in 2020 (P <.001). Among patients with grafts that had more distal infrageniculate targets (tibioperoneal trunk, anterior tibial, posterior tibial, peroneal) a similar trend was observed (86.0% in 2003 vs 36.9% in 2020; P <.001). During the same time period, 1-year MALE rates increased from 44.4% in 2003 to 50.4% in 2020 (P <.001).

In multivariate Cox regression, the surgeons’ use of completion imaging or their completion imaging strategy did not affect the risk for 1-year MALE or loss of primary patency. Grafts with tibial outflows were associated with an increased risk for 1-year MALE (hazard ratio [HR], 2.09; 95% CI, 1.46-3.01; P <.001) and loss of primary patency (HR, 2.05; 95% CI, 1.26-3.32; P <.001). Procedures by high-volume surgeons were associated with a lower risk for 1-year MALE (HR, 0.84; 95% CI, 0.75-0.95; P =.006) and loss of primary patency (HR, 0.83; 95% CI, 0.71-0.97; P <.001) vs low-volume surgeons.

In analyses stratified by surgeon volume category to assess the effects of completion imaging, no association was found between completion imaging use or surgeons’ completion imaging strategy and the primary outcomes in any of the subgroups.

Limitations of the study include the use of retrospective analysis, and completion imaging findings were not reported in the VQI. Also, the findings may not reflect practice patterns among all surgeons, and errors in data collection and missing information likely occurred. Furthermore, selection bias is possible and no causality can be determined.

“Our data indicate that CI [completion imaging] use has decreased over time while 1-year MALE rates and LPP [loss of primary patency] have increased,” wrote the study authors. “A significant drop in the use of intraoperative angiography is noted. At 1 year, CI use was not associated with improved MALE-free or LPP-free survival. All CI strategies, whether routine, selective, or never performing CI, were found to have no effect on outcomes independent of surgeon volume.”

The post Use of Completion Imaging After Lower Extremity Bypass Decreasing appeared first on The Cardiology Advisor.

Since previously communicating about the potential safety signal back in 2019, the Agency has been working to gather additional analyses to get a better understanding of the risk for late mortality. Randomized controlled trials included in an updated meta-analysis followed patients from 2 to 5 years. Findings showed no increased risk of late mortality with paclitaxel-coated devices.

Data from the SWEDEPAD trial (Clinicaltrials.gov Identifier: NCT02051088), the VOYAGER PAD study (Clinicaltrials.gov Identifier: NCT02504216), the German BARMER Health Insurance study, the US Veterans Health Administration study, and the Medicare SAFE-PAD study (ClinicalTrials.gov Identifier: NCT04496544) were also reviewed. None of these studies, in which patients were followed from 1.7 to 3.5 years, showed an increased risk of long-term mortality with paclitaxel-coated devices.

Based on these findings, the FDA recommends that health care providers discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices with patients. Patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents should continue to be routinely monitored. Long-term follow-up is ongoing in several of the aforementioned studies. The Agency plans on working with device manufacturers to update the product labeling based on the new information.

Adverse events related to paclitaxel-coated devices should be reported to the FDA’s MedWatch program.

The post FDA Issues Updated Information Related to Paclitaxel-Coated Devices for PAD appeared first on The Cardiology Advisor.

Ylva Östlund, MD, of Sahlgrenska University Hospital in Göteborg, Sweden, and colleagues studied 91 patients diagnosed with AAV with renal involvement from March 1, 2002 to October 30, 2018 at a single center. Of these, 52 (57%) were diagnosed with proteinase 3 (PR3)-ANCA and 39 (43%) with myeloperoxidase (MPO)-ANCA. Both groups received comparable induction therapy, but a significantly higher proportion of patients with PR3-ANCA than MPO-ANCA received plasma exchange therapy (44% vs 21%).

The overall 1- and 5-year renal survival rates were 91% and 69%, respectively, with no significant differences between the PR3-ANCA and MPO-ANCA groups, the investigators reported in a poster presentation. The overall 1- and 5-year patient survival rates were 92% and 77%, respectively. The mean survival time was 11.5 years overall.

Treatment with plasma exchange had no effect on 1-year renal and patient survival among patients with an estimated glomerular filtration rate below 15 mL/min/1.73 m², according to the investigators.

Cox regression analysis revealed that older age significantly predicted a higher mortality risk and MPO-ANCA subtype significantly predicted a lower mortality risk, Dr Östlund’s team reported.

The post ANCA-Associated Vasculitis With Renal Involvement Characterized appeared first on The Cardiology Advisor.

Previous research has indicated that PAC may be a sensitive indicator of vascular remodeling and may provide prognostic information not offered by PVR, a standardly used PH prognostic indicator. Investigators therefore sought to identify the association between PAC levels and PH survival and to determine the levels of PAC that had a protective effect on patients with PH. 

The researchers’ primary analysis (ie, the discovery cohort) used data from inpatients and outpatients in the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA-CART) program from October 1, 2006, to September 30, 2018, who had right heart catheterization (RHC). The analysis focused primarily on patients with pulmonary artery pressure (mPAP) that was mildly elevated (19-24 mmHg).

The study also included a validation cohort using de-identified data from Vanderbilt University in Nashville, Tennessee, of patients with RHC between September 24, 1998, and December 20, 2013, who were followed up for at least 1 year.

A total of 21 distinct patient subgroups were identified and characterized by variable clinical profiles. Across the 21 subgroups, all-cause mortality ranged from 15.9% to 61.2% and all-cause hospitalization ranged from 14.0% to 54.2%.

In the discovery cohort, 37,744 patients (median age, 67.2 [interquartile range {IQR}, 61.7-73.8] years; 96.7% male) with mPAP of at least 19 mmHg were available for analysis, including 10,421 (27.6%) with mPAP 19 to 24 mmHg and 27,323 with mPAP of 25 mmHg or greater.

With use of a PAC value of 3.0 mL/mmHg as a reference point, a semi-parabolic relationship between PAC and adjusted all-cause mortality was observed that was maintained after limiting mPAP to 19 to 24 mmHg. In addition, a PAC of 3.0 mL/mmHg or greater was associated with an adjusted all-cause mortality hazard ratio of less than 1.0, which reduced progressively up to a PAC of approximately 7 mL/mmHg.

A PAC of 3.0 mL/mmHg or greater was protective compared with the corresponding reference group in all subgroup analyses. The protective association with increased PAC continued with increased pulmonary vascular resistance (hazard ratio 0.74; 95% CI, 0.70-0.78; P <.001).

The discovery cohort had a median follow-up of 1236 (591-2160) days. The estimated 1-year mortality was 22.2% in patients with a PAC of less than 3.0 mL/mmHg and 9.1% in those with a PAC of 3.0 mL/mmHg or greater.

In the validation cohort (median age, 60.2 [IQR, 49.2-69.1] years; 48% male), the median follow-up was 2485 (IQR, 671-3580) days. The findings in the validation cohort confirmed a protective association with increased PAC when referenced to 3 mL/mmHg. Adjusted hazard ratios for all-cause mortality across various hemodynamic subgroups and raw estimates of 1-year and 5-year mortality were similar in the primary and validation cohorts.

Among several limitations, information on renal function and cause of death was not available, and differences in observation periods between the discovery and validation cohorts may have confounded the results regarding therapeutic advances for PH.

“Elevated PAC ³3.0 mL/mmHg was protective against all-cause mortality in a large national referral PH cohort, which was maintained in various subgroup analyses and validated in a second sex-balanced cohort,” the concluded study authors, stressing that use of PAC could provide an additional prognostic measure for PH, rather than a replacement of the current standard measure of PVR. [O]pportunity exists to refine the prognostic significance of specific hemodynamic measures and their ranges possibly by including PAC into this framework,” the researchers noted.

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 disclosures.

The post Increased PAC Has Protective Effect on Survival in Pulmonary Hypertension appeared first on The Cardiology Advisor.

This multicenter study was a noninferiority trial evaluating the use or withholding of prophylactic platelet transfusion prior to CVC placement in patients with severe thrombocytopenia, which was defined as having a platelet count between 10,000/mm³ and 50,000/mm³. Patients were randomly assigned 1:1 to receipt or withholding of prophylactic platelet transfusion, which involved administration of 1 unit of platelet concentrate.

The study had a primary outcome of catheter-related bleeding events of grade 2 to 4 within 24 hours following CVC placement. A key secondary outcome was bleeding events of grade 3 or 4, with additional outcomes also evaluated.

The per-protocol primary analysis of this study included 338 patients, among whom there were 373 CVC placement events. The median age was 58 years in the 188 patients of the group receiving prophylactic transfusions (transfusion group), and it was 59 years in the group of 185 patients not receiving transfusions. The median platelet counts were 30,000 mm³ (interquartile range [IQR], 20,000-38,000) in the transfusion group and 30,000 mm³ (IQR, 20,000-37,000) in the group not receiving transfusions.

The transfusion group had a rate of catheter-related bleeding of grade 2 to 4 of 4.8%, compared with 11.9% in the group not receiving transfusions (relative risk [RR], 2.45; 90% CI, 1.27-4.70).

Rates of catheter-related bleeding events of grades 3 or 4 were 2.1% for the group receiving transfusions and 4.9% for those not receiving transfusions (RR, 2.43). There were serious adverse events reported in 13 patients overall, which were all catheter-related bleeding events. These occurred in 4 patients of the transfusion group and in 9 patients of the group not receiving transfusions.

The net cost savings associated with withholding prophylactic platelet transfusions was also calculated. This was estimated to amount to $410 per catheter placement.

“In patients with severe thrombocytopenia, we found that withholding prophylactic platelet transfusion before CVC placement in those with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for noninferiority and resulted in more CVC-related bleeding than prophylactic platelet transfusion,” the study investigators wrote in their report.

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

The post Withholding Transfusions Before Central Venous Catheter Placement Linked to Worse Outcomes in Severe Thrombocytopenia appeared first on The Cardiology Advisor.

Investigators sought to explore factor Xa inhibitor initiation following PVI trends over time and identify patient and procedural characteristics related to factor Xa inhibitor use. They conducted a retrospective cross-sectional study using de-identified data from the Vascular Quality Initiative PVI registry. Data were from January 2018 through June 2022. Predictors of factor Xa inhibitor initiation following PVI were determined using multivariate logistic regression. Patients on preoperative anticoagulation therapy, with history of stroke, or with end-stage renal disease requiring dialysis were excluded from the study, as were patients who were aged younger than 50 years.

The investigators found that 51.0% of the 179,494 included PVI procedures had patients that were eligible for factor Xa inhibitor therapy postprocedure. Among those eligible following PVI, initiation of factor Xa inhibitors increased from 3.5% in 2018 to 9.1% in 2022 (P <.0001). After adjusting for confounding variables, this increase remained significant.

Patients who were prescribed factor Xa inhibitor therapy following PVI had the following characteristics:

• mean age, 68.4±9.9 years
• 40.5% were women
• 77.0% were White
• 16.2% were Black
• 43.1% were current smokers
• 84.5% had hypertension
• 35.3% had coronary artery disease
• 58.3% had elective PVI
• 33.4% had nonelective PVI
• 8.3% had emergent PVI

Emergent PVI and nonelective PVI were the strongest positive predictors of factor Xa inhibitor initiation following PVI (odds ratio [OR], 8.20 [95% CI, 7.14-9.41]; and OR, 4.36 [95% CI, 4.06-4.68], respectively; all P <.0001). Additional positive predictors included female gender (OR, 1.10; 95% CI, 1.03-1.18) and being a current smoker (OR, 1.24; 95% CI, 1.12-1.38).

The strongest negative predictor for factor Xa inhibitor initiation was postoperative dual antiplatelet therapy (OR, 0.20; 95% CI, 0.17-0.23; P <.0001). Additional negative predictors included preoperative statin use (OR, 0.93; 95% CI, 0.86-1.00) and being age 70 to 76 years (OR, 0.86; 95% CI, 0.77-0.95) and 77 years or older (OR, 0.77; 95% CI, 0.69-0.86).

Study limitations include the unavailability of data for history of major bleeding, which may have influenced providers’ choice to initiate factor Xa inhibitors, and lack of information on use of low or high-dose treatment with factor Xa inhibitor.

“Factor Xa inhibitor initiation after PVI has increased in recent years, although the absolute rate remains low, and the vast majority of eligible patient are not prescribed this treatment,” the study authors wrote. “This study highlights the limited translation of VOYAGER PAD findings into clinical practice.”

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Yeneabeba Tilahun Sima, Ph.D., from the University of Bergen in Norway, and colleagues assessed long-term CVD mortality by offspring birth weight patterns among women with spontaneous and iatrogenic term deliveries in Norway (1967 to 2020).

The researchers found that changes in offspring birth weight quartiles were associated with long-term maternal CVD mortality. Women with a first offspring in quartile 2/3 (Q2/Q3) and a second in quartile 1 had higher mortality risk (hazard ratio [HR], 1.33; 95 percent confidence interval [CI], 1.18 to 1.50), compared with women who had two term infants in Q2/Q3. Risk of CVD mortality was lower if the second offspring was in quartile 4 (HR, 0.78; 95 percent CI, 0.67 to 0.91). Having a second offspring in quartile 4 offset the risk associated with having a first infant in quartile 1 (HR, 0.99; 95 percent CI, 0.75 to 1.31). These patterns were similar regardless of iatrogenic or spontaneous deliveries.

“Our findings highlight the importance of including information from women’s subsequent births for identification of high-risk subgroups for specific follow-up,” the authors write.

Abstract/Full Text

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For this retrospective study, investigators used deidentified data from the Vascular Quality Initiative PVI dataset from 2010 to 2021. Patients aged 18 years and older with advanced chronic kidney disease (CKD) were who receiving PVI for peripheral artery disease (PAD) were included in the study. Advanced CKD was defined as having an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73 m². Patients were excluded if they had any of the following characteristics:

• History of renal transplantation
• On dialysis
• History of bypass surgery
• Missing data for CO₂ angiography, PC-AKI, or preoperative creatinine

The primary outcomes measured by the investigators were PC-AKI, defined by RENALCOMP as a creatinine increase greater than or equal to 0.5 mg/dL from baseline, or if the patient had a new dialysis requirement and cardiac complications, defined as any dysrhythmia, myocardial infarction, congestive heart failure, or other clinically significant cardiac complication observed during the PVI or following the procedure but before discharge from the hospital. Secondary outcomes included failure of the PVI to cross the lesion, amputation, thromboembolism, bleeding complications, and 30-day mortality.

The investigators found 157,317 PVIs performed between 2014 and 2021. Of these, 4.7% utilized CO₂ angiography during the procedure. Before matching the cohorts for specific characteristics, there were no significant differences in outcomes. However, after matching the cohorts, investigators discovered that the use of CO₂ angiography was associated with a significant reduction in PC-AKI from 4.8% to 3.9% (P =.03) and a significant reduction in cardiac complications from 2.9% to 2.1% (P =.03). There were no significant differences in the rates of procedural failure, thromboembolic complications, or amputation rates between the 2 matched cohorts.

The investigators noted a few limitations of the study. The main limitation is that it is retrospective and the investigators were unable to control for selection bias in the original set of data. According to the researchers, other limitations stem from the fact that certain complications of PVI were not tracked and could have impacted the decision to use or not to use CO₂ angiography in certain patients, and the type of contrast used in every patient is also unknown. Last, they note that their study demonstrates association but cannot prove causation.

They conclude, “The major finding of this paper is that the use of CO₂ angiography is associated with a decreased risk of PC-AKI and post-operative cardiac complications when patients with advanced CKD (eGFR<45) undergo PVI for PAD.” They note that “CO₂ angiography is currently under-utilized (22% of advanced CKD patients) and should be considered to reduce the risk of PC-AKI and cardiac complications in this vulnerable population.” According to the investigators, the significant reductions in both PC-AKI and cardiac complications equate to greatly reduced morbidity and mortality, considering the large number of patients struggling with advanced CKD at any point in time.

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Lovedeep S. Dhingra, M.B.B.S., from the Yale School of Medicine in New Haven, Connecticut, and colleagues assessed the sociodemographic patterns of use of wearable devices among U.S. adults with or at risk for CVD. The analysis included 9,303 participants in the Health Information National Trends Survey.

The researchers found that an estimated 3.6 million U.S. adults with CVD (18 percent) and 34.5 million at risk for CVD (26 percent) used wearable devices versus an estimated 29 percent of the overall U.S. adult population. Older age (odds ratio, 0.35), lower educational attainment (odds ratio, 0.35), and lower household income (odds ratio, 0.42) were independently associated with lower use of wearable devices in U.S. adults at risk for CVD when adjusting for other sociodemographic characteristics and cardiovascular risk factor profile. Most wearable device users (83 percent with CVD and 81 percent at risk for CVD) favored sharing wearable device data with their clinicians to improve care.

“These findings suggest that as wearable devices emerge as tools that can improve cardiovascular health, their current use patterns could exacerbate disparities unless there are strategies to ensure equitable adoption,” the authors write.

Several authors disclosed ties to the medical technology industry.

Abstract/Full Text

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Fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) is often used to detect large-vessel vasculitis (LVV) among patients with PMR and GCA, as well as those with fever of unknown origin (FUO).

Researchers investigated whether the use of statins could reduce vascular inflammation among patients with PMR, GCA, and FUO, as evaluated by FDG-PET/CT.

Patient data from January 2009 to April 2016 were included in the analysis. Vascular uptake was assessed with a visual score and volumetric regions of interest (VOIs) on CT scans. FDG arterial uptake was calculated using mean standardized uptake values (SUVs) within VOIs. Arterial uptake was quantified on a 4-point scale, with the summation for each patient comprising their total vascular score (TVS).

A total of 129 patients (67.4% women) were included in the analysis; 96 patients were diagnosed with PMR, 16 with GCA, 13 with PMR-associated GCA, and 4 with FUO. The LVV was visualized in 58.1% of patients using PET/CT scan and was present in 50% of patients with PMR, 75% of those with GCA, 84% of those with both PMR and GCA, and 100% of patients with FUO. A total of 15.5% of patients used statins.

Median TVS was significantly lower among patients who used vs did not use statins (P =.02). When TVS was stratified according to specific arterial sites, total score was significantly lower at the aortic arch (P =.023), ascending aorta (P =.017), and both right (P =.023) and left (P =.027) femoral arteries among patients who received vs did not receive statins. Among patients who used statins, differences in arterial uptake were more pronounced in the aortas of patients with LVV (P =.07) and femoral arteries (P =.05) of patients without LVV.

When multiple regression analysis was performed to assess the effects of statin use on clinical and laboratory values, fever was present more often in patients who used vs did not use statins (P =.03).

This study was limited by its retrospective and observational design. In addition, it may have been possible that the use of statins was underreported by patients, accounting for a low value overall. Finally, the makeup of the study population was not well-balanced.

Researchers concluded, “The results of our clinical study indicate that statins may play some potential anti-inflammatory role and support the view that further studies should be performed to test this hypothesis. These observations are in line with the known pharmacological properties of statins, in particular with the literature data reporting their use in inflammatory conditions, such as atherosclerotic plaques and rheumatoid arthritis.”

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Investigators conducted a randomized controlled trial to evaluate an 8-week exercise-based rehabilitation program for patients with persistent dyspnea following pulmonary embolism. Outcomes of interest included exercise capacity, dyspnea, and quality of life.

Participants were identified from the thrombosis registry (TROLL) at a hospital in Norway. To be eligible, the patients (aged 18 to 75 years) had to have: (1) PE greater than isolated subsegmental emboli on computed tomography pulmonary angiography 6 to 72 months before inclusion; and (2) persistent, self-reported dyspnea of at least grade 1 as measured by the modified Medical Research Council dyspnea scale, with onset or exacerbation at PE diagnosis. The participants were enrolled from January 1, 2018, to June 1, 2022.

A total of 211 patients were randomly assigned to an intervention group (n=108) or control arm (n=103). Their overall median age was 57 (49-67) years, 56% were male, and their median time from diagnosis to inclusion was 10.3 (7.2-21.0) months. The intervention group engaged in a supervised outpatient exercise program for 1 hour twice a week for 8 weeks. They also had a home-based exercise program once or twice weekly. Patients in the control arm received usual care based on guidelines. The primary endpoint was the difference in Incremental Shuttle Walk Test (ISWT) in the 2 groups at follow-up. The median walking distance at baseline for the ISWT was 695 (530-940) meters.

Follow-up and primary outcome data were available for 89 participants from the rehabilitation group and 87 participants from the control group. The researchers found that participants in the rehabilitation group performed better on the ISWT compared with those in the control group, with a mean difference between groups of 53.0 meters (95% CI, 17.7-88.3; P = .0035). No adverse events occurred.

In comparing participants based on time since diagnosis, researchers found that the difference in ISWT between the rehabilitation and control group consistently favored the rehabilitation group; the difference for those who were 6 to 12 months post-diagnosis was 63.8 meters (95% CI, 12.4-115.2; P =.015) and 47.4 meters for those who were 12.1 to 27 months post diagnosis (95% CI, 2.0-92.9; P =.041).

No difference was found regarding the EuroQol-5 Dimension index score or Shortness of Breath Questionnaire sum score between the 2 groups. The rehabilitation group had a better Pulmonary Embolism Quality of Life questionnaire total score vs the control group (difference -0.04 [-4%]; 95% CI, -0.09 to 0.00; P =.041).

The researchers noted that the primary endpoint was subject to a considerable ceiling effect, which may have affected the findings. In addition, a number of different physiotherapists participated in the completion of the intervention owing to the COVID pandemic, which may have resulted in some heterogeneity in the rehabilitation. Furthermore, a majority of participants had mild symptoms, which may have limited the potential benefits of the program.

“Rehabilitation should be considered in patients with persistent dyspnea following PE, though further research is needed to assess the optimal patient selection, timing, mode, and duration of rehabilitation,” the investigators commented.

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 disclosures.

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Researchers evaluated the efficacy and safety of sotatercept in adult patients with symptomatic pulmonary arterial hypertension in the phase 3, multicenter, double-blind, randomized, placebo-controlled STELLAR trial (ClinicalTrials.gov Identifier: NCT04576988). The study’s primary endpoint was the change from baseline to week 24 in 6-minute walk distance. Researchers also evaluated a number of secondary endpoints, including change in pulmonary vascular resistance, change in N-terminal

pro-B-type natriuretic peptide level, improvement in WHO functional class, and time to death or clinical worsening.

Eligible patients were stratified based on World Health Organization (WHO) functional class (II vs III) and background therapy for pulmonary arterial hypertension (monotherapy or double therapy vs triple therapy) and were randomly assigned 1:1 to receive sotatercept or placebo combined with stable background therapy. Sotatercept was initiated at a dose of 0.3 mg per kilogram at visit 1 and then escalated to the target dose of 0.7 mg per kilogram at visit 2 (day 21, ±3 days).

A total of 163 patients received sotatercept and 160 received placebo, with all receiving stable background therapy. The participants had a mean (SD) age of 47.9 [14.8] years and a mean length of time since diagnosis of 8.8 years.

The sotatercept group had a mean change at week 24 in 6-minute walk distance of 40.1 meters (95% CI, 29.9-50.2) compared with -1.4 meters (95% CI, −13.2 to 10.3) in the placebo group. The median change from baseline in 6-minute walk distance was 34.4 meters (95% CI, 33.0-35.5) for participants who received sotatercept and 1.0 m (95% CI, -0.3 to 3.5) for those who received placebo. The post hoc analysis of 6-minute walk distance showed comparable findings with those of the prespecified analysis.

With respect to secondary study outcomes, improvement in a multicomponent measure that included 6-minute walk distance, N-terminal pro–B-type natriuretic peptide level, and WHO functional class was seen in 39% of those in the sotatercept group vs 10% of those in the placebo group. Significant improvements from baseline to week 24 were observed with sotatercept vs placebo in pulmonary vascular resistance, NT-proBNP levels, and WHO functional class. A significant difference was also observed in the distribution of time to first occurrence of death or nonfatal clinical worsening event between the sotatercept vs placebo groups.

Serious adverse events were reported in 23 patients (14.1%) in the sotatercept group compared with 36 patients (22.5%) in the placebo group; notably, investigators indicated that there were likely only 2 patients (1.2%) in each group whose adverse events were related to either sotatercept or placebo. The most common adverse events were bleeding events (35 patients [21.5%] in the sotatercept group vs 20 [12.5%] in the placebo group).

Study limitations include the enrollment of only WHO functional class II or III patients with certain forms of pulmonary arterial hypertension. In addition, there is potential unblinding owing to side effects such as telangiectasia or hematologic changes. Furthermore, the median treatment of 7.5 months precluded the ability to establish the long-term durability of the treatment response.

“In this trial, treatment with sotatercept improved exercise capacity as determined by the 6-minute walk distance and showed clinical benefit across multiple efficacy end points,” concluded study authors. “Sotatercept had a favorable benefit-risk ratio, findings that confirm and extend the results of previous studies,” they added.

Disclosure: This research was supported by Acceleron Pharma, a subsidiary of MSD. 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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The most common cause of ischemic stroke worldwide is intracranial artery stenosis. The higher prevalence of ischemic stroke amongst people of East Asian descent suggests that environmental and genetic factors may play a role. Recent research has found the p.R4810K variant of the RNF213 gene present in 20%-50% of the East Asian population with intracranial artery stenosis, which is only present in 1%-2% of the general population.

For the study, researchers assessed this genetic variant and its role in the progression and prognosis of intracranial artery stenosis in patients in a 15-year follow up survey.

The researchers collected data on patients with intracranial artery stenosis who were >1 month after stroke onset. Patients were enrolled in 1 of 2 collected registries (NCVC Genome Registry and Osaka Clinical Research Network for Stroke) between September 1, 2006 and October 31, 2021. Inclusion criteria consisted of patients aged >20 years who consented to genetic testing and who have had periodic magnetic resonance imaging (MRI) follow up >5 years. Those who had intellectual disability or who participated in other clinical trials were excluded from the study.

A validated grading scale of 1-4 was used to classify the degree of stenosis. Inclusion of stenosis was defined as a diameter of 30%-99% (grades 2-3). Progression was defined as an increase of stenosis by at least 1 grade. Blood samples were obtained from all patients for RNF213 p.R4810K genotyping to define patients as homozygous, heterozygous, or noncarriers.

A total of 52 eligible patients were enrolled in the study, of which 22 (42%) were carriers of the RNF213 p.R4810K variant. No patients were homozygous for the genotype. Patients were followed up for a median of 10.3 years and an average of 10 MRI scans were performed per patient.

Intracranial artery stenosis progression was evidenced in 14 (64%) of variant carriers and 8 (27%) of noncarriers (OR, 4.81; 95% CI, 1.47–15.77; P = 0.011). Progression of stenosis was found in 8 (36%) carriers and 3 (10%) noncarriers (OR, 5.14; 95% CI, 1.18–22.49; P = 0.037).

A significant association was found with time to progression of intracranial artery stenosis and time to marked progression in those with the RNF213 p.R4810K variant (Log-rank P = 0.004 and log-rank P = 0.0025, respectively).

Cox regression analysis found carriers of the RNF213 p.R4810K variant were significantly associated with intracranial artery stenosis (HR, 3.31; 95% CI, 1.38–7.90; P = 0.007).

Compared with patients who did not use statins, those who did experienced a reduced progression of intracranial stenosis. Carriers of the RNF213 p.R4810K variant who had statin treatment were found to have a significant risk reduction (HR, 0.20; 95% CI 0.06–0.63; P = 0.006) but not in noncarriers (HR, 0.65; 95% CI, 0.16–2.63; P = 0.55).

The researchers found 45% of carriers had a symptomatic stroke and/or transient ischemic attack (TIA), compared with 13% of noncarriers (OR, 5.52; 95% CI, 1.41–20.82; P = 0.013).

Study limitations included the exclusion of those with moyamoya disease, in which 80%-90% of patients have the genetic variant. This could underestimate the risk of the RNF213 p.R4810K variant.

The researchers concluded, “Our results indicate the importance of genetic testing for RNF213 in patients with intracranial stenosis for predicting prognosis. Targeted prevention and management strategies, including aggressive lipid lowering therapy, are warranted for RNF213 p.R4810K variant carriers with intracranial artery stenosis.”

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The GVGs were published in 2019 and defined bypass-preferred patients as having Wound, Ischemia, and Foot Infection (WIfI) stages 3 to 4 and Global Anatomic Staging System (GLASS) stage III. This study was designed to evaluate outcomes of patients with chronic limb-threatening ischemia (CLTI) who were defined as bypass preferred.

Data for this study were sourced from Kyushu University, Matsuyama Red Cross Hospital, and Saiseikai Yahata General Hospital in Japan. Bypass-preferred patients (N=715) who received EVT (n=183) or a bypass (n=156) procedure between 2015 and 2020 were evaluated for outcomes. To balance for cohort differences, a propensity score-matching approach was used for a final sample size of 84 patients in each treatment group.

Before propensity matching, the EVT and bypass cohorts had mean ages of 78.0 (SD, 10.2) and 73.0 (SD, 10.7) years, 55.2% and 62.2% were men, and they had body mass indices of 20.7 (SD, 3.7) and 22.3 (SD, 4.1), respectively.

The EVT and bypass cohorts were categorized as stages 3 (45.4% vs 38.5%) and 4 (54.6% vs 61.5%) according to the WIfI classification (P =.23), stages 3 (26.2% vs 9.0%) and 4 (37.2% vs 52.6%) according to the GLASS femoropopliteal classification (P <.01), stages 3 (12.6% vs 12.8%) and 4 (73.8% vs 62.8%) according to the GLASS infrapopliteal classification (P =.10), and P1 (73.2% vs 63.5%) and P2 (12.0% vs 7.1%) according to the GLASS inframalleolar classification (P <.01).

Among the propensity-matched cohorts, bypass procedures were associated with increased rates of limb salvage (P <.01), wound healing (P <.01), freedom from major adverse limb events (P <.01), and freedom from reintervention (P <.01) at 730 days compared with EVT.

In the multivariate analyses, major amputation was associated with EVT (hazard ratio [HR], 3.72; P <.01), serum albumin level decrease (HR, 2.61; P <.01), and WIfI classification increase (HR, 1.56; P =.04).

Among the EVT group, major amputation was associated with congestive heart failure (HR, 2.83; P <.01), serum albumin level decrease (HR, 2.35; P <.01), GLASS inframalleolar classification increase (HR, 1.86; P =.04), and WIfI classification increase (HR, 1.65; P =.03).

Decreased likelihood of wound healing was associated with EVT (HR, 0.56; P <.01), serum albumin level decrease (HR, 0.60; P <.01), WIfI classification increase (HR, 0.68; P <.01), GLASS inframalleolar classification increase (HR, 0.73; P =.01), and GLASS infrapopliteal classification increase (HR, 0.89; P =.02).

Study limitations include the study design and potential for selection bias. Social determinants of health are also not examined by the investigators.

“Bypass surgery provides better limb salvage and wound healing in patients with WIfI Stage 3 to 4 and GLASS Stage III, which is classified as bypass-preferred category by the GVG,” the study authors wrote.

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The Arteriovenous Stent Graft in the Treatment of Venous Outflow Stenosis in AV Fistula Access Circuits (AVeNEW) study examined outcomes from 280 patients with AVF stenosis of 50% or more and circuit dysfunction. Investigators randomly assigned 142 patients to covered stent placement after surgery and 138 patients to percutaneous transluminal angioplasty alone.

Target lesion primary patency was maintained by a significantly higher proportion of the stent than no stent group at 6 months (78.7% vs 47.9%) and 12 months (55.8% vs 21.2%), Bart Dolmatch, MD, of Mountain View Interventional Radiology in California, and colleagues reported in Kidney International. At 24 months, the covered-stent group had a higher rate of target lesion primary patency (40.0% vs 11.6%), fewer target-lesion reinterventions (1.6 vs 2.8), and a longer mean interval between target-lesion reinterventions (380.4 vs 217.6 days).

Access circuit primary patency was comparable between groups at 6 months. Within 2 years, 195 new lesions occurred in the covered-stent group, 146 new lesions occurred in the surgery-only group, and 16 new thromboses occurred in each group. A third of patients had a nontarget stenosis that required treatment at study enrollment.

The primary safety outcome was 30-day freedom from an adverse event involving the access circuit that required reintervention or surgery, led to hospitalization or longer length-of-stay, or resulted in death. The primary safety outcome occurred in 95.0% of the covered stent group and 96.4% of the surgery-only group, meeting the noninferiority criterion for safety.

Compression of the covered stent occurred in 2 cases and were treated with a repeat angioplasty. A total of 59 patients died prior to study completion.

“Given the high morbidity and mortality for patients with renal failure on hemodialysis (approximately 21% mortality during our 24-month study), if a covered stent can improve the care and lives of these patients by even a modest reduction in the number of interventions, their use seems to have little downside,” Dr Dolmatch’s team wrote. The investigators acknowledged that a future trial is needed to compare covered stents and drug-coated balloons for stenosis.

Disclosure: This research was supported by C. R. Bard/Becton, Dickinson and Company. Please see the original reference for a full list of disclosures.

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The systematic review and meta-analysis assessed the efficacy and safety of DOACs vs VKA therapy in patients with NVAF and PAD, focusing on mortality, MALE, major adverse cardiovascular events, and major bleeding.

A comprehensive literature search was conducted in Medline, EMBASE, Scopus, Web of Science, and CENTRAL databases in September 2021. A total of 12 articles (3 post hoc analyses from randomized controlled trials and 9 observational cohorts) published from 2013 to 2020 were included.

The primary point of interest was lower-limb events, which were reported as a composite outcome of MALE. The analysis included 3 studies with 13,561 total patients with PAD who received anticoagulation therapy for concomitant NVAF. Patients in the DOAC group were significantly less likely to have a MALE compared with those in the VKA group, with moderate heterogeneity (hazard ratio [HR], 0.58; 95% CI, 0.39-0.86; P <.01; I² =32%).

Analysis of patients with PAD without AF was based on 4 studies, in which the need for reoperation was a separate outcome. Among 2323 patients, no significant difference was observed between the 2 treatment groups, without any evidence of heterogeneity (odds ratio [OR], 1.49; 95% CI, 0.79-2.79; P =.14; I² =6%).

Regarding efficacy outcomes in patients with PAD and AF, compared with VKAs, the use of DOACs was associated with a significantly decreased risk for stroke/systemic embolism (HR, 0.76; 95% CI, 0.61-0.95; P <.01; I² =64%) and all-cause mortality (HR, 0.78; 95% CI, 0.66-0.92; P <.01; I² =86%), with substantial heterogeneity. No statistically significant difference occurred between the DOAC and VKA groups for the incidence of myocardial infarction (HR, 0.81; 95% CI, 0.59-1.11; P =.21; I² =18%) and cardiovascular mortality (HR, 0.77; 95% CI, 0.58-1.02; P =.07; I² =.17).

Major bleeding was reported in most of the studies in patients with PAD and AF. Similar risks (HR, 0.91; 95% CI, 0.74-1.12; P <.01; I² =91%) were found for major bleeding episodes in DOACs vs VKAs. These results were analyzed separately owing to the considerable heterogeneity. Rivaroxaban at higher doses significantly increased the risk for bleeding (HR, 1.16; 95% CI, 1.07-1.25; P <.01; I² =12%). A significantly lower risk for major bleeding was observed in the composite group of other DOAC drugs at conventional dosages and rivaroxaban administered at a reduced dose (HR, 0.71; 95% CI, 0.63-0.79; P <.01; I² =35%).

Study limitations include the residual confounding results are related to unmeasured factors, and misclassification or miscoding of baseline comorbidities is possible. Also, there was significant overlap between the meanings of coronary artery disease, lower-extremity artery disease, and PAD. In addition, the researchers were unable to conduct a subgroup analysis by age, comorbidities, or medication.

“Using DOACs in patients undergoing lower-extremity arterial procedures may play a more significant role in the future, but further investigations are needed for definitive results and safe decision-making,” the investigators stated.

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Chloé A. Powell, M.D., from the University of Michigan in Ann Arbor, and colleagues evaluated the potential pathway through which race and socioeconomic status affect outcomes following lower-extremity bypass CLTI, a marker for delayed presentation. The analysis included 7,077 patients who underwent a lower-extremity bypass procedure.

The researchers found that Black patients had a higher prevalence of CLTI (80.6 versus 66.4 percent). There were significant indirect effects identified where Black patients were more likely to present with CLTI and thus had increased odds of 30-day amputation (odds ratio [OR], 1.11), one-year amputation (OR, 1.08), and surgical site infection (OR, 1.05). Similarly, there were significant indirect effects observed, with patients in the fifth quintile for social deprivation index more likely to present with CLTI and thus have increased odds of 30-day amputation (OR, 1.06) and surgical site infection (OR, 1.03), as well as one-year amputation (OR, 1.07) and surgical site infection (OR, 1.03).

“Health care providers need to recognize the vulnerability of certain subgroups to adverse outcomes and be on alert for early signs and symptoms of PAD to manage patients accordingly,” Powell said in a statement.

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

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Induced by cold or emotional stress, Raynaud phenomenon is associated with functional abnormalities, such as small vessel contraction, vascular wall fibrosis, and calcification. Treatments for Raynaud phenomenon include avoiding cold temperatures, use of vasodilators, and surgical interventions. As Raynaud phenomenon is induced by sympathetic vasoconstriction, botulinum toxin may have clinical applications in Raynaud phenomenon.

Researchers conducted a systematic review and meta-analysis to explore the safety and efficacy of botulinum toxin therapy for Raynaud phenomenon. For the analysis, researchers searched publication databases through August 2022 for relevant studies.

A total of 13 studies of retrospective (n=5), prospective (n=4), and randomized trial (n=4) designs were included in the analysis. The studies were conducted in the United States (n=4), Spain (n=2), the United Kingdom (n=2), Japan (n=2), Iran (n=2), and China (n=1) and were published between 2009 and 2022. Most studies used botulinum toxin A (n=11). The average follow-up durations ranged between 1 to 4 weeks and 3 years.

The pooled sample size comprised 286 patients, of whom 269 received botulinum toxin. The patients were diagnosed with primary or secondary Raynaud phenomenon, Raynaud phenomenon secondary to systemic sclerosis, or Raynaud phenomenon secondary to scleroderma.

Data from 125 patients indicated that botulinum toxin treatment decreased visual analog scale (VAS) pain scores (standardized mean difference [SMD], -3.82; 95% CI, -6.62 to -1.02 points). Similarly, data from 76 patients indicated the botulinum toxin associated with a significant reduction in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score (SMD, -0.83; 95% CI, -1.47 to -0.19 points).

Study limitations include small sample sizes, a lack of control groups, and less than a year of follow-up among the selected studies for the meta-analysis.

“The results of this single-arm meta-analysis revealed that Btx [botulinum toxin] injections for the treatment of RP [Raynaud phenomenon] resulted in lower VAS pain and QuickDASH scores,” the study authors wrote. “However, the evidence might not be strong enough in light of the inconsistent patient population, injection techniques, and outcome parameters in published works. Future research with larger sample sizes and comparison groups is warranted.”

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Balazs Odler, MD, PhD, of the University of Cambridge in the UK and the Medical University of Graz in Austria, and colleagues analyzed data from 197 patients in the RAVE (Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis) clinical trial. Of 22 severe infections that developed during the trial, 18 (82%) occurred within 6 months of study entry and 15 (68%) were respiratory tract infections, the investigators reported in the Annals of the Rheumatic Diseases. A higher CD19+ B cell number at study endtry and TMP-SMX prophylaxis against Pneumocystis jirovecii pneumonia (PJP) were associated with a reduced risk for severe infections. TMP/SMX prophylaxis was significantly associated with a nearly 77% lower risk for severe infections compared with no TMP/SMX prophylaxis.

Dr Odler and colleagues concluded that their study demonstrates that use of TMP/SMX prophylaxis against PJP “is significantly associated with reduced risk of severe infections in patients with [ANCA-associated vasculitis], independent of the choice of therapy used to induce remission. These data further suggest that certain B cell subpopulations may serve as a useful tool to determine general immunocompetence of [ANCA-associated vasculitis] patients, and to identify individuals at higher risk of infectious complications.”

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Researchers sought to compare long-term clinical outcomes of patients with a high prevalence of acute coronary syndrome treated with an ultrathin-strut stent vs a thick-strut stent.

They conducted the BIODEGRADE (BioMatrix and Orsiro Drug-Eluting Stents in Angiographic Result in Patients with Coronary Artery Disease; ClinicalTrials.gov Identifier: NCT02299011) trial, a prospective, randomized, open-label, multicenter study comparing revascularization in patients with thick-strut stents and patients with ultrathin-strut stents between July 2014 and September 2017. The primary outcome was target lesion failure.

Patients (N=2341) were randomly assigned in a 1:1 ratio to receive treatment with an ultrathin-strut stent (n=1175; 1526 lesions) or a thick-strut stent (n=1166; 1512 lesions). There was no significant difference in lesion characteristics or treatment procedures between the 2 treatment groups other than maximal pressure, which was significantly lower in the thick-strut stent group. After withdrawals, missed exclusions, and loss to follow-up, the analysis included 1167 patients with 1516 lesions in the ultrathin-strut stent group and 1160 patients with 1506 lesions in the thick-strut stent group. Exclusion criteria included cardiogenic shock, symptomatic heart failure, and noncardiac comorbid conditions resulting in life expectancy of less than 1 year.

Overall, patients had a mean age of 63.5±10.9 years and 28.1% were women. Common comorbidities included arterial hypertension (59.8%), dyslipidemia (53%), and diabetes (33.4%). There were 27% current smokers and 12% had previous percutaneous coronary intervention. There were 27.6% with stable angina and 36.5% with unstable angina. There was 1 target lesion per patient in 73.4% of the patients and 2 lesions in 20.5%. At discharge, patients were on clopidogrel (82.6%), renin-angiotensin system inhibitors (63.5%), and beta-blockers (63%). All of these patient characteristics were well-matched between treatment groups.

For the ultrathin-strut stent group, the 3-year incidence rate of target lesion failure was 3.2%. For thick-strut stent group, the 3-year incidence rate of target lesion failure was 5.1% (P =.023). The researchers noted that this primary difference was most likely due to differences in ischemia-driven target lesion revascularization (ultrathin-strut stent, 1.5%; thick-strut stent, 2.8%; P =.035) between groups.

Subgroup analysis showed consistency for target lesion failure outcomes except for diabetes. Target lesion failure occurred less frequently in the ultrathin-strut stent group in patients without diabetes than in the thick-strut stent group (hazard ratio, 0.33; 95% CI, 0.18-0.62; P =.001, P for interaction =.004).

Study limitations include the limited statistical power for comparisons of selected end points and selection bias. Additionally, 1 of the stents was replaced with a newer version by the manufacturer.

“In patients with a high prevalence of acute coronary syndrome, the thin-strut BP-SES [biodegradable polymer sirolimus-eluting stent] with sustained drug release system showed superior outcomes compared to the thick-strut BP-BES [biodegradable polymer biolimus-eluting stent] with the standard drug release system with respect to clinical outcomes (TLF [target lesion failure]) at prespecified 3-year follow-ups,” the researchers wrote. “This is a remarkable finding, showing that the substantial differences in strut thickness and stent design may be contributing factors to the long-term clinical outcomes of stents.”

Disclosure: This research was supported by BIOTRONIKS KOREA (Seoul, Republic of Korea) and DIO KOREA (Seoul, Korea). Please see the original reference for a full list of disclosures.

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A team led by Adrian Schreiber, MD, of Charité-Universitätsmedizin in Berlin, Germany, used flow cytometry to quantify T cell subsets in blood and urine specimens from 95 patients with ANCA-associated vasculitis and 8 healthy patients serving as a control arm.

Patients with active renal ANCA-associated vasculitis had significantly higher urinary T cell counts compared with patients in remission, those with extrarenal manifestations, and the control arm, the investigators reported in Kidney International Reports.

Urinary T cells demonstrated robust discrimination of disease activity with superior performance compared with monocyte chemoattractant protein-1 (MCP-1) and soluble CD163 (sCD163), which have shown promise as urinary biomarkers of renal disease in ANCA-associated vasculitis, according to the investigators. Patients with kidney biopsies classified as “crescentic” according to Berden classification showed higher urinary T cell counts. Further, patterns of urinary regulatory T cells and T helper cells were associated with clinical response and risk for renal relapse.

“In summary,” the authors wrote, “urinary T cells directly reflect the renal inflammatory milieu and show reliable biomarker characteristics, outperforming soluble markers.”

If confirmed by future studies, urinary T cells would represent the first noninvasive biomarker to assess disease activity, enable prognosis of clinical response, and identify patients who could benefit from tailored treatment strategies, Dr Schreiber and colleagues concluded.

“These characteristics could make urinary T cells a perfect tool for a personalized treatment of ANCA-associated glomerulonephritis,” they added.

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The finding is from a subgroup analysis of patients in the phase 3 ADVOCATE trial who had an estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²) of 20 or less. The trial included 330 patients with ANCA-associated vasculitis (of whom 81% had renal involvement) randomly assigned to receive avacopan (166 patients) or prednisone (164 patients). In the original trial, eGFR increased on average by 7.3 in the avacopan group compared with 4.1 in the prednisone group.

The subgroup analysis included 50 patients who had an eGFR of 20 or less (27 in the avacopan group (16%) and 23 in the prednisone arm (14%). The groups had a mean eGFR at baseline of 17.6 and 17.5, respectively.

At week 52, eGFR increased an average of 16.1 in the avacopan recipients compared with 7.7 in the prednisone recipients, a significant difference between the groups, Frank B. Cortazar, MD, of the New York Nephrology Vasculitis and Glomerular Center at Saint Peter’s Hospital-Albany in Albany, New York, and colleagues reported in Kidney International Reports.

The last eGFR value obtained during the 52-week treatment period was at least 2-fold higher compared with baseline in 41% and 13% of the avacopan and prednisone arms, respectively, also a significant difference.

Serious adverse events occurred in 13 avacopan recipients (48%) and 16 prednisone recipients (70%).

Study findings raise the question of whether avacopan could benefit patients presenting with an eGFR below 15, according to the investigators. “These patients have the highest risk for end-stage kidney disease and mortality, and are in need of effective therapies that reduce these risks and their downstream consequences,” Dr Cortazar’s team wrote. “The data presented here further support the need to study this more severe subgroup who may have much to gain from avacopan.”

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Previous studies have suggested that rates of dementia in the United States may be declining. However, these temporal trends have not been sufficiently assessed.

Researchers from Rush Alzheimer’s Disease Center in the United States sourced data for this study from the Religious Orders Study and the Rush Memory and Aging Project, which were established in 1994 and 1997 in the US, respectively. In this study, participants (N=1554) were stratified by birth year and trends in Alzheimer disease (AD) pathology, neurodegenerative neuropathology, cerebrovascular pathology, and cognitive outcomes were evaluated.

A total of 374 individuals (65%-71% were women; 97%-99% were White) were born in 1905-1914, 360 in 1915-1919, 466 in 1920-1924, and 354 in 1925-1930. The median age at death decreased over time from 93 years for those born in 1905-1914 to 87 years for those born in 1925-1930. These individuals completed an average of 16.1-16.5 years of education and they had 1.9-2.2 comorbidities.

The age-standardized prevalence of AD was similar for the first 3-birth cohorts (range, 68%-69%) but decreased to 64% for those born in 1925-1930 (P =.76). Age-standardized Alzheimer dementia slightly decreased from 46% for those born in 1905-1914 to 44% for 1915-1919, 42% for 1920-1924, and 41% for 1925-1930 (P =.18).

A significant trend was observed across birth cohorts for the level of amyloid beta (Ab; P <.001), in which those born in 1915-1919 (mean, 1.72) and 1920-1914 (mean, 1.65) had higher levels than those born in 1905-1914 (mean, 1.36) and 1925-1930 (mean, 1.41) as well as a significant increase in tau tangle density over time (P =.01).

For cerebrovascular pathologies, significant decreases in moderate or severe atherosclerosis from 54% to 22% (P <.001) and arteriosclerosis from 44% to 28% (P <.001) were observed, whereas the rate of chronic microinfarcts increased with time from 27% to 40% (P =.007).

These trends may have had effects on cognitive outcomes, as levels of cognition tended to increase over time from -1.07 standard units for those born in 1905-1914 to -0.93 standard units for 1915-1919, -0.93 standard units for 1920-1924, and -0.89 standard units for 1925-1930 (P =.05).

The major limitation of this study was the lack of diversity among the study population.

These data indicated that although no significant change in the rates of AD or Alzheimer dementia were observed, rates of cerebrovascular pathologies were decreasing over time, which led the researchers to conclude, “This indicates that any improvements over time in clinical dementia are likely associated with improved resilience to pathology over time.”

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Investigators sought to evaluate risk factors and assess evidence-based prevention strategies for early death after surgery in patients with ATAAD.

They conducted a systematic search of the Cochrane Library, Web of Science, Scopus, Ovid, and PubMed databases from inception to May 2021. They identified 23 articles that included 5510 patients and met the following inclusion criteria:

• Patients were at least 19 years of age
• Patients were diagnosed with Stanford type A or DeBakey type I or type II aortic dissection
• Patients had less than 15 days from initial symptom onset to diagnosis
• Patients died within 30 days after receiving a procedure
• Studies were cross-sectional/cohort/retrospective studies involving a case group and a control group and reporting between-group comparisons
• Study outcomes included risk factors for early death after receiving a procedure

Exclusion criteria included experimental studies, case reports or reviews, lack of original data or unable to transfer or combine data, and no clear phase of the perioperative period.

Patients’ mean age after receiving a procedure ranged from 42.7 years to 70.0 years, the percentage of patients who were men ranged from 49.74% to 87.5%, and study sizes ranged from 56 to 609 patients. Mortality after surgery ranged from 6.12% to 35.00%. There were 5 studies that defined early death after surgery as death within 30 days. Of the included studies, 10 were conducted in China, 3 in Japan, and 4 were conducted in European countries.

The investigators found the preoperative risk factors for early death after receiving a procedure in patients with ATAAD were cardiac tamponade (odds ratio [OR], 3.89; 95% CI, 1.17-12.98; P =.027), malperfusion (OR, 3.45; 95% CI, 2.24-5.31; P <.001), shock (OR, 1.91; 95% CI, 1.06-3.45; P =.032), male sex (OR, 1.43; 95% CI, 1.06-1.92; P =.020), and age (OR, 1.03; 95% CI, 1.01-1.06; P =.005). They found no evidence to suggest that creatinine level and time from symptom onset to operation effected the increased risk for early mortality.

Sensitivity analysis revealed that excluding 1 of the studies changed the conclusions for cardiac tamponade, malperfusion, shock, and male sex, but not for age. The investigators found no evidence suggesting that cardiopulmonary bypass time (CPB) (7 studies), cross-clamping time (4 studies), and operation time (3 studies) affected increased risk for early mortality after receiving a procedure in patients with ATAAD. Sensitivity analysis showed that if certain studies were excluded, CPB time was affected, as was operation time conclusions. Cross-clamping time conclusions were not changed by study exclusion.

Study limitations include using pooled effect sizes from retrospective studies only and the limited number of studies involving every risk factor.

“Patients of an older age, of male sex, and with shock, malperfusion and cardiac tamponade have a higher risk for early death after surgery,” the study authors wrote. “However, significant heterogeneity was found for some of the factors, and many intraoperative and postoperative risk factors were not included in this meta-analysis because of the limited number of included studies.”

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Jeremy R. Van’t Hof, M.D., from the University of Minnesota Medical School in Minneapolis, and colleagues examined whether use of smokeless tobacco is associated with the risk for developing peripheral artery disease. From 1987 to 1995, smokeless tobacco use was assessed three times; peripheral artery disease events were examined from 1987 to 2018. Data were included for 14,344 participants.

The researchers identified 635 incident peripheral artery disease events during a median follow-up of 27.6 years. The incidence rate of peripheral artery disease was 4.44 versus 1.74 per 1,000 person-years for those who used smokeless tobacco versus those who did not. After adjustment for sociodemographic characteristics and cigarette smoking, the hazard ratio for current versus never smokeless tobacco use was 1.94. Among those currently using smokeless tobacco, the incidence rate for peripheral artery disease was similar to that of current cigarette smokers (3.39 per 1,000 person-years).

“While smokeless tobacco products may not expose people to the noxious effects of combustion, our study shows that they nonetheless have an adverse impact on vascular health,” Van’t Hof said in a statement. It is important for clinicians to understand these health implications, screen patients for all forms of tobacco and nicotine use, and counsel accordingly.”

One author disclosed financial ties to Fukuda Denshi.

Abstract/Full Text

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Because of the risk for complications associated with aortitis, including aneurysm and dissection, the use of CTA imaging has been recommended for GCA diagnosis. Currently, the main aortic imaging modalities used include ¹⁸fluorine FDG (¹⁸FDG)-PET/CT scans and magnetic resonance angiography.

Researchers sought to compare the risk for relapse among individuals with GCA-related aortitis, as observed on FDG-PET/CT scans and CTA.

Patients diagnosed retrospectively from 2008 to 2020 at 13 tertiary care centers in the French Study Group for Large Vessel Vasculitis were included in the analysis. Eligible patients had GCA with at least 3 of the 5 American College of Rheumatology (ACR) diagnostic criteria or were aged older than 50 years, along with a C-reactive protein (CRP) levels of at least 10 mg/L and large-vessel vasculitis (LVV).

Aortitis was defined as a circumferential wall thickening 2.2 mm or greater away from atheroma on CTA or on PET/CT, with a grade 2 or 3 aortic wall ¹⁸FDG-uptake. Relapses of GCA were defined by “a combination of recurrence of clinical manifestations, inflammatory syndrome (CRP ≥10 mg/dL) and/or radiologic evidence of LVV progression.” Relapse was considered to be positive if participants presented with at least 2 of the 3 features concomitantly during the follow-up period.

A total of 82 patients were enrolled in the study, with mean age of participants being 67±8 years; 77% were women.

Study results showed that 78% of the participants had CTA and PET/CT scans that were positive for aortitis (Ao-CTA+/PET+ group). In addition, 21% of the participants had a positive PET/CT scan for aortitis and a negative CTA for aortitis (Ao-CTA-/PET+ group). One study participant had a positive CTA and no evidence of aortitis on the PET/CT scan.

All participants received initial treatment with glucocorticoids. A total of 94% in the Ao-CTA+/PET+ group vs 76% in the Ao-CTA-/PET+ group underwent CTA imaging before glucocorticoid use (P =.06), and 80% vs 76%, respectively, underwent PET/CT before glucocorticoid onset (P =.75).

During follow-up, 63% of the participants experienced a relapse — 70% of those in Ao-CTA+/PET+ group and 29% in the Ao-CTA-/PET+ group (P =.004). Overall, 44% of participants in the Ao-CTA+/PET+ group and 12% of participants in the Ao-CTA/PET+ group experienced a single relapse (P =.02), whereas 27% and 18%, respectively, experienced multiple relapses (P= .54). Relapse-free survival was significantly lower in the Ao-CTA+/PET+ group compared with the Ao-CTA-/PET+ group (log-rank test, P =.019).

According to multivariate analysis, aortitis on CTA was the only independent risk factor significantly associated with an elevated risk for relapse (hazard ratio, 2.90; 95% CI, 1.11-7.63; P =.03).

Study limitations included the retrospective design; the enrollment of patients who underwent both the imaging procedures at GCA diagnosis, which may have introduced a selection bias; and that treatment and follow-up therapeutic modalities were not standardized at the various centers.

“In this study, aortic wall thickening was associated with an increased risk of relapse,” the researchers indicated. However, “Further studies are needed to define the appropriate therapeutic approach for these patients,” they concluded.

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Joshua A. Jacobs, Pharm.D., from the Spencer Fox Eccles School of Medicine at the University of Utah in Salt Lake City, and colleagues examined the prevalence of primary prevention statin use by race and ethnicity according to 10-year ASCVD risk using data from the National Health and Nutrition Examination Survey from 2013 to March 2020. Data were included for 3,417 participants, representing 39.4 million U.S. adults, aged 40 to 75 years.

The researchers found that statin use was lower in Black and Hispanic versus White participants and was comparable among Asians in the overall cohort (25.5, 20.0, 15.4, and 27.9 percent for Asian, Black, Hispanic, and White participants, respectively) and within ASCVD risk strata. A graded increase in statin use was observed across increasing ASCVD risk strata within race and ethnicity groups. In the highest risk stratum overall, statin use was low, with significantly lower rates of use seen for Black and Hispanic versus White participants (prevalence ratios, 0.90 and 0.90, respectively). In Black, Hispanic, and White adults, factors such as routine health care access and health insurance were significantly associated with higher statin use. Over time, there was no meaningful change observed in the prevalence of statin use by race and ethnicity or by ASCVD risk stratum.

“The significant differences in prevalence of statin use observed in this study, despite high ASCVD risk, highlight the importance of identifying intervenable factors to reduce cardiovascular health inequities,” the authors write.

Several authors disclosed financial ties to the biopharmaceutical industry.

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

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Researchers at the University of Copenhagen collected data from population registers in Denmark to study the effects of preeclampsia in pregnancy on cardiovascular disease (CVD) risk.

Women who had a live birth or stillbirth after 20 weeks or more of pregnancy in Denmark between 1978 and 2017 were evaluated for ischemic event risk based on their diagnosis of preeclampsia during pregnancy.

Preeclampsia was defined as a notation in the National Patient Register of preeclampsia, eclampsia, or hemolysis, elevated liver enzymes, and low platelets (HELP). Early preterm preeclampsia was defined as delivery at less than 34 weeks; late preterm preeclampsia was defined as delivery at 34 to 36 weeks; and term preeclampsia was defined as delivery at more than 37 weeks.

The study population included 1,111,846 women without preeclampsia, 3270 with early preterm preeclampsia, 5405 with late preterm preeclampsia, and 37,145 with term preeclampsia. The majority of study participants (36.9%-40.4%) were aged between 25 and 29 years during pregnancy, with 0.2% to 4.0% of pregnancies resulting in a stillbirth; 0.5% to 5.4% of women developed gestational diabetes.

Compared with women without a preeclampsia, those with a first pregnancy and a preeclampsia diagnosis had a higher cumulative incidence rate of ischemic events within the first 7 to 8 years after delivery.

Among women aged less than 35 years at their first delivery, the cumulative incidence rates of all ischemic events at 20 years were 1.84% for women with preeclampsia and 0.96% for those without preeclampsia. Among women aged greater than 35 years at delivery, the rates were 4.13% and 2.13%, respectively.

Stratified by event, women with and without preeclampsia in their first pregnancy had a 20-year cumulative incidence of AMI of 0.90% and 0.34% among those who delivered aged less than 35 years and 2.03% and 0.74% among those who delivered aged more than 35 years, respectively.

The rates of ischemic stroke were 1.05% and 0.57% among those who delivered aged less than 35 years and 2.02% and 1.10% among those who delivered aged more than 35 years, respectively.

Overall, AMI was associated with recurrent preeclampsia (adjusted hazard ratio [aHR], 3.05), preeclampsia in a second (aHR, 2.10), and in a first pregnancy (aHR, 1.58).

Stratified by time, risk for AMI remained elevated among women with recurrent preeclampsia (aHR, 3.19) and preeclampsia in a second (aHR, 2.70) and first (aHR, 1.66) pregnancy at less than 20 years after delivery. Risk for AMI also remained higher among women with recurrent preeclampsia (aHR, 2.90) and preeclampsia in a second (aHR, 1.50) and first (aHR, 1.47) pregnancy at more than 20 years after delivery. Similar trends were observed for ischemic stroke.

Criteria for preeclampsia changed during the study period, which may have limited study findings.

The study authors concluded, “Our findings suggest that a history of [preeclampsia] should focus attention on a group of women at potentially high risk of CVD, with the aim of improving risk assessment and disease prevention in this vulnerable group.”

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Maddalena Ardissino, M.B.B.S., from Imperial College London, and colleagues examined the causal role of reproductive factors on cardiovascular disease in women using Mendelian randomization. Uncorrelated, genome-wide significant single-nucleotide polymorphisms were extracted from sex-specific genome-wide association studies.

The researchers found that earlier genetically predicted age at first birth increased the risk for coronary artery disease, heart failure, and stroke (odds ratios per year, 1.49, 1.27, and 1.25, respectively); partial mediators included body mass index, type 2 diabetes, blood pressure, and cholesterol traits. The risks for atrial fibrillation, heart failure, ischemic stroke, and stroke were increased with a higher genetically predicted number of live births (fewer than two versus two versus more than two: odds ratios, 2.91, 1.90, 1.86, and 2.07, respectively). Increased risks for coronary artery disease and heart failure were seen with earlier genetically predicted age at menarche (odds ratios per year, 1.10 and 1.12), with both associations partially mediated by body mass index.

“The findings support the emerging research focus on female-specific risk factors for CVD, by demonstrating that earlier first birth, higher number of live births, and earlier menarche are all associated with increased CVD in women,” the authors write. “We stress the importance of routine evaluation of reproductive history in clinical risk stratification and consideration of targeted prevention strategies for women.”

Abstract/Full Text

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Raynaud Diary was developed as a symptom diary with a 24-hour recall period. Completed daily over the course of a week, the diary captured the number and duration of symptomatic Raynaud attacks; patient-reported worst pain, numbness, and tingling in fingers; and overall disease burden, according to the Raynaud’s Condition Score.

The Raynaud Diary was tested in 2 sets of participants: the first set completed the diary on an electronic tablet and the second set used a smartphone application. Before using the diary, all participants underwent structured qualitative interviews to describe their experiences with Raynaud attacks. Symptoms as described during patients’ interviews were compared with those data collected in the diaries.

A total of 39 patients (mean age, 55.1 years; 87% women) were enrolled in the study.

The most common symptoms as described in the interviews were color change (100%), numbness (90%), tingling (82%), pain (77%), and discomfort (72%). The reported frequency of attacks ranged from several per hour to once per day. Most patients (72%) reported experiencing more attacks during winter. Many patients indicated that Raynaud phenomenon affected their ability to spend time outdoors and hold or grip things.

All participants rated the Raynaud Diary as “easy” or “very easy” to use. The majority of participants noted that they would be able to complete the diary daily for an extended period of time. Data collected during the interviews supported the content validity of the diary regarding attack frequency, severity, and symptoms. No major feasibility issues were identified.

While initial results support its usability, further study of the Raynaud Diary in a larger cohort is necessary.

“The next steps in its development will be to measure its psychometric performance using data from phase 2 and phase 3 trials,” the study authors wrote. “Definitive conclusions about possible applications of the Raynaud Diary will depend on the results of this psychometric evaluation.”

Disclosure: This research was supported by Eicos Sciences, Inc. Please see the original reference for a full list of authors’ disclosures.

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Previous studies have correlated vascular risk factors such as hypertension, dyslipidemia, and impaired fasting glucose levels with a heightened risk for cognitive decline, but very few studies have analyzed the effect of modifying vascular risk factors on functional status.

To determine if a polypill could reduce cognitive and functional decline in people with vascular risk factors, researchers in 86 centers across 8 countries conducted a randomized clinical trial, International Polycap Study 3 (TIPS-3), between June 30, 2012 and September 30, 2020. Out of 5713 study participants, 2389 (42%) were aged 65 years and older with an intermediate risk for cardiovascular disease.

The researchers randomly assigned these participants into 4 different treatment groups: a polypill plus aspirin group, a polypill plus placebo group, an aspirin plus placebo group, and a double placebo group. The polypill treatment consisted of a daily combination of 100 mg of atenolol, 10 mg of ramipril, 25 mg of hydrochlorothiazide, and 40 mg of simvastatin. The aspirin treatment consisted of 75 mg of aspirin daily.

Of the 2389 individuals aged 65 years and older, 2098 (88%; 60% women; mean age, 70.1 years) completed both a baseline and at least 1 follow-up assessment, including:

• the Montreal Cognitive Assessment (MoCA) to evaluate for mild cognitive impairment,
• the Digit Symbol Substitution Test (DSST) to assess attention, psychomotor speed, and executive function,
• the Trail Making Test Part B (TMT-B) to assess attention, and
• the Standard Assessment of Global Everyday Activities (SAGEA) to assess functional status.

The researchers combined all these outcome measure scores into a composite score, indicating both cognitive and functional decline.

After an average follow-up of 5 years, the researchers did not observe any significant difference in terms of composite cognitive and functional decline when comparing the 3 treatment groups to the double placebo group.

Approximately 356 individuals in the polypill only group experienced substantial decline at a rate of 6.52 per 100 patient-years, whereas 328 individuals in the double placebo group experienced substantial decline at a rate of 6.34 per 100 patient-years (hazard ratio [HR], 1.05; 95% CI, 0.90-1.21; P =.55). They found comparable results when assessing the aspirin only and aspirin plus polypill treatment groups to the double placebo group.

In contrast, when just looking at functional status alone, participants in the polypill only and polypill plus aspirin treatment groups both demonstrated reduced functional decline compared with the double placebo group (mean country-standardized adjusted follow-up SAGEA scores, 0.06 vs 0.15; P =.01 and 0.01 vs 0.14; P =.01)

Overall, the findings suggest vascular risk factor modification could potentially slow functional decline, but not cognitive decline, in older adults.

The researchers do emphasize that “Larger studies with longer follow-up may be warranted to detect small changes in cognition that may still be relevant at a population level. Use of functional assessments may be a more sensitive outcome measure in international studies.”

Study limitations included lack of study power to detect small changes in cognition and function, potential responder bias, lack of proper measurement of decline in cognitive status, potential lack of generalizability of Western outcome measures to global populations, and the effects of physical decline on functional status.

Disclosures: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see original source for full list of disclosures.

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It is known that GCA is the most common primary systemic vasculitis among adults aged 50 years and older.

Researchers from Universidade Federal de São Paulo in Brazil conducted a study to evaluate whether the halo sign of the temporal arteries detected by CDU was an accurate diagnostic tool.

Researchers searched publication databases, including PubMed, Embase, CENTRAL, and ClinicalTrials.gov, through December 2022 for studies using CDU to diagnose suspected GCA.

A total of 22 studies including 2893 patients were identified for the analysis.

The pooled sensitivity of the halo sign in temporal arteries observed by CDU for GCA diagnosis was 0.76 (95% CI, 0.69-0.81; I²=88.7%), the specificity was 0.93 (95% CI, 0.89-0.95; I²=82.9%), the positive likelihood ratio was 10.15 (95% CI, 6.42-16.31), the negative likelihood ratio was 0.26 (95% CI, 0.20-0.35), and the area under the curve (AUC) was 0.91.

These data indicated that in a hypothetical population of 1000 individuals, 857 would have been accurately diagnosed by CDU and receive appropriate treatment, 103 would have a false-negative result, and 40 would have a false-positive result.

In a subset of studies that included a CDU device with a frequency of at least 15 MHz, the sensitivity and specificity for diagnosing GCA were 0.84 (95% CI, 0.75-0.89) and 0.93 (95% CI, 0.85-0.97), respectively.

A subset of studies used additional or alternative CDU markers for diagnosing GCA. Four studies evaluated the halo sign in both the temporal and axillary arteries, which had a sensitivity of 0.86 (95% CI, 0.78-0.91; I²=69.6%), specificity of 0.95 (95% CI, 0.89-0.98; I²=65.7%), and an AUC of 0.94. Five studies used the compression sign in temporal arteries, which had a sensitivity of 0.84 (95% CI, 0.72-0.92; I²=87.7%), specificity of 0.95 (95% CI, 0.88-0.98; I²=86.3%), and an AUC of 0.97. Four studies used both the halo sign and flow abnormalities in the temporal arteries, which had a sensitivity of 0.71 (95% CI, 0.56-0.82; I²=84.9%), specificity of 0.89 (95% CI, 0.82-0.94; I²=75.5%), and an AUC of 0.92.

A major limitation of the analysis was the high heterogeneity observed between studies.

The study authors concluded, “This systematic review and meta-analysis showed that the halo sign detected by the CDU of the temporal arteries has a good diagnosis performance for GCA.”

In general, accuracy of GCA diagnosis can be improved by using the compression sign and by evaluating the halo sign of axillary arteries. Incorporating blood flow abnormalities did not contribute to better GCA diagnostic accuracy.

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