The retrospective, propensity-matched cohort study analyzed the effects of SGLT2 inhibitors on AF recurrence in patients with type 2 DM who have received ablation for AF with use of data from the TriNetX Analytics Network database. Participants were aged 18 years or older with a history of type 2 DM and ablation for AF from April 1, 2014, to November 30, 2021.

The main composite outcome was the need for cardioversion, new class I or III antiarrhythmic drug (AAD) therapy, or re-do AF ablation after a 3-month blanking period following the index AF ablation. Participants were stratified into 2 cohorts according to their use of SGLT2 inhibitors at index ablation.

Of the participants with a history of type 2 DM who had received AF ablation, 10,974 were not receiving an SGLT2 inhibitor and 2366 were receiving an SGLT2 inhibitor. After propensity score matching, 2225 patients were in each group (mean age, 65±9 years; 82% White). In the non-SGLT2 inhibitor group, 26% of participants were women vs 25% in the SGLT2 inhibitor group.

The main composite outcome after the index AF ablation occurred in 619 patients in the SGLT2 inhibitor group vs 802 patients in the non-SGLT2 inhibitor group (adjusted odds ratio OR [aOR], 0.68; 95% CI, 0.602-0.776) after the 3-month blanking period. The likelihood of event-free survival at 12 months (66% vs 61%; P = .003; hazard ratio, 0.85; 95% CI, 0.77-0.95) was increased for the SGLT2 inhibitor group.

Patients in the SGLT2 inhibitor cohort had lower rates of cardioversion (aOR, 0.62; 95% CI, 0.49-0.80; P <.0001), new class I or III AAD use (aOR, 0.72; 95% CI, 0.63-0.82; P <.0001), and re-do ablations for AF (aOR, 0.71; 95% CI, 0.53-0.95; P =.022) 3 months after the index ablation. HF exacerbations (aOR, 0.81; 95% CI, 0.71-0.91; P =.001) and all-cause hospitalizations (aOR, 0.78; 95% CI, 0.68-0.91; P =.001) also were lower among patients who received SGLT2 inhibitors.

Patients on SGLT2 inhibitors had a lower all-cause mortality (aOR, 0.62; 95% CI, 0.41-0.93; P =.019).

Limitations of the study include residual unmeasured confounding in the observational study with use of retrospective data. In addition, an accurate incidence of recurrent AF after ablation may not have been obtained, because patients may have had recurrent AF after ablation but were not treated with cardioversion, AAD, or re-do ablation. Furthermore, social determinants of health and other unmeasurable confounding factors may have affected outcomes.

“…this retrospective analysis suggests that the use of SGLT2-Is [inhibitors] in patients with type 2 DM undergoing AF ablation is associated with a lower risk of needing subsequent cardioversion, new AAD therapy, and re-do AF ablation,” wrote the investigators. “This suggests that SGLT2-Is may increase the likelihood of maintaining sinus rhythm after AF ablation in patients with type 2 DM and AF.”

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.

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Ambiguity as to whether older patients with AF living with frailty should be switched from VKA to NOAC led the researchers to conduct a superiority trial to determine the more efficacious treatment approach. The primary endpoint was a major or clinically relevant nonmajor (CRNM) bleeding complication, accounting for death as a competing risk. An intention-to-treat analysis was conducted. Thrombotic events were included as secondary endpoints.

The researchers conducted a pragmatic, open-label, multicenter, randomized controlled trial (FRAIL-AF) in the Netherlands from January 2018 through June 2022. This included 1323 patients randomly assigned to either switch from a VKA to a NOAC (n=662) or continue with a VKA (n=661). Included patients were older, living with frailty (age ≥75 years plus a Groningen Frailty Indicator (GFI) score ≥3) and had AF. Patients with valvular AF or with a glomerular filtration rate of less than 30 mL/min/1.73m² were excluded.

All patients were followed-up through 12 months (mean follow-up duration, 344 days), and 90 patients died during follow-up (31 cardiovascular deaths [12 intervention arm; 19 control arm]; 10 bleeding deaths [5 in each arm]). The researchers defined a major bleeding event as bleeding in a critical area or organ, bleeding leading to a decrease in hemoglobin level of at least 2 g/dL, bleeding leading to a transfusion of 2 or more units, or a fatal bleeding. A CRNM bleeding complication was defined as not major bleeding but leading to face-to-face consultation, health care professional medical intervention, or hospitalization.

Among all patients (mean age, 83 years; median GFI, 4), 163 primary endpoint events occurred (101 in the switch arm; 62 in the continue arm), and as per prespecified analysis protocol, the trial was stopped for futility.

The researchers noted the primary endpoint hazard ratio (HR) was 1.69 (95% CI, 1.23-2.32; P =.00112). The thromboembolic events HR was 1.26 (95% CI, 0.60-2.61). Numerically, the intervention arm vs control arm had more urogenital (20 vs 11) and gastrointestinal (17 vs 4) bleedings. HR for the first 100 days was 1.17 (95% CI, 0.70-1.96) in sensitivity analysis and 2.10 (95% CI, 1.40-3.16) for days 100 to 365.

Study limitations include a patient population tolerant to VKA treatment, the choice of NOAC at the discretion of treating physicians, and the underpowered sample size.

“In this pragmatic randomized trial in older patients with atrial fibrillation, living with frailty, more major and/or clinically relevant non-major bleeding complications were observed when switching from vitamin K antagonist treatment to a non-VKA oral anticoagulant, compared to continuing VKA treatment,” the researchers wrote. “This higher bleeding risk with NOACs was not off-set by a reduction in thromboembolic events, albeit the risk of thrombo-embolic events was low in both treatment arms.”

Disclosure: This research was supported by Boehringer-Ingelheim, BMS-Pfizer, Bayer, and Daiichi-Sankyo. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Investigators aimed to compare efficacy and safety of standard-dose rivaroxaban (15 mg/d) vs non-recommended reduced-dose rivaroxaban (10 mg/d) in patients with NVAF and preserved renal function who are aged at least 65 years.

The investigators conducted a subanalysis of the EXPAND study (ClinicalTrials.gov Identifier: NCT02147444) and assessed the efficacy and safety of rivaroxaban regarding stroke and systemic embolism. EXPAND was a noninterventional observational study from 684 centers across Japan. Rivaroxaban dosage of 15 mg/d or 10 mg/d was at the physician’s discretion.

In the subanalysis, only patients from EXPAND who were aged at least 65 years with a creatinine clearance (CrCl) of 50 mL/min or more were included (ALL cohort; N=3982). This cohort was stratified into the early elderly (ELD) subcohort (65-74 years of age; n=2386) and the late ELD subcohort (at least 75 years of age; n=1444). Subcohorts were further divided into patients who received reduced-dose and patients who received standard-dose groups. Patients in the subanalysis were predominantly men with hypertension. More than 40% had hyperlipidemia and one-quarter had diabetes.

Previous EXPAND subanalysis showed reduced-dose rivaroxaban was associated with lower risk for any bleeding vs standard dose rivaroxaban in a comparison of propensity score-matched dose groups in a population with preserved renal function (CrCl ≥50 mL/min).

There was no difference between dosages in the ALL cohort, early ELD subcohort, or late ELD subcohort in the adjusted hazard ratio (aHR) for incidence of major bleeding. They found no significant between-cohort differences in the occurrence of stroke, systemic embolism, myocardial infarction (MI), and cardiovascular (CV) death or in the occurrence of stroke and systemic embolism.

There were significantly higher occurrence rates for MI/unstable angina, interventional/CV surgery, and CV death with reduced-dose rivaroxaban vs standard-dose rivaroxaban in the ALL cohort (aHR, 1.56; 95% CI, 1.02-2.37; P =.039) and the late ELD subcohort (aHR, 1.86; 95% CI, 1.01-3.42; P =.045) but not in the early ELD subcohort (aHR, 1.20; 95% CI, 0.65-2.23; P =.565).

Limitations of the study include overestimation of the risk for incidence or worsening of coronary artery disease and the underpowered sample size leading to conclusion of no clear benefit of standard-dose rivaroxaban.

“Reduced-dose rivaroxaban in older patients with preserved renal function reduces overall bleeding events, but the benefit gained in terms of major bleeding prevention was not significant…reduced-dose rivaroxaban increased the risk of coronary artery events compared with standard-dose rivaroxaban,” the study authors wrote. “Compared with standard-dose rivaroxaban, reduced-dose rivaroxaban may not adequately prevent CV events or avoid major bleeding in patients with NVAF aged 75 years [or older].”

Disclosure: This research (EXPAND study) was supported by Bayer Yakuhin, Ltd. 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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The findings are based on a systematic review and meta-analysis that evaluated the epidemiology of AF in patients with CS.

Researchers performed a literature search in the Web of Science, Scopus, and PubMed/Medline databases from inception to April 26, 2023. They estimated the prevalence and incidence of AF in patients with CS with use of an inverse-variance weighted random-effects meta-analysis.

Overall, 16 studies and 1523 participants with an established diagnosis of CS were included. The studies were published from 2012 to 2022, and 43.8% were conducted in the United States. Participants had a mean age of 55.6±10.7 years, and 43% were men.

The prevalence of AF was assessed in 8 studies with 978 participants, with a pooled rate of 23% (95% CI, 13%-34%). Regarding AF subtypes based on 5 studies, paroxysmal AF was the most common with a prevalence of 83% (95% CI, 77%-90%), followed by persistent AF with a prevalence of 17% (95% CI, 10%-23%).

Based on 9 studies with 545 patients in which incidence rates could be inferred, the overall pooled estimate for AF incidence was 10.6% (95% CI, 4.9%-17.8%). The pooled estimate for AF incidence in patients with less than 2-year follow-up was 5% (95% CI, 1.6%-11.3%), compared with 13.1% (95% CI, 4.4%-25%) in those with 2 to 4 years of follow-up, and 8.9% (95% CI, 1.1%-21.4%) in those with more than 4 years of follow-up.

Multivariate logistic regression models in the primary studies showed that maximum left atrial volume (hazard ratio, 1.05; 95% CI, 1.02-1.09), left atrial enlargement (relative risk, 6.12; 95% CI, 2.19-17.11), and left atrial diameter (odds ratio, 1.08; 95% CI, 1.01-1.16) were significantly associated with atrial arrhythmias. Atrial ¹⁸F-fluorodeoxyglucose (FDG) uptake was significantly associated with atrial arrhythmias in 2 studies.

Limitations of the study include the absence of randomized controlled trials, and a limited number of studies reported on predictors and outcomes, which resulted in inadequate power to analyze the prognostic implications of atrial arrhythmias among patients with CS. In addition, the varying methods of detecting arrhythmias may have affected outcomes, and it is unclear how the observed heterogeneity and different diagnostic criteria for CS may have affected the findings.

“The AF burden in CS is high and emphasizes the need for close follow-up,” the study authors wrote. “Increased left atrial size and atrial ¹⁸F-FDG uptake are strong independent predictors for the development of atrial arrhythmia. The role of screening for AF and related arrhythmias in this population needs further study as is the predictive accuracy of traditional risk-stratification tools in a relatively younger population.”

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While right ventricular pacing is accepted as the gold standard pacing method, it can be detrimental to mechanical and electrical dyssynchrony, possibly leading to increased heart failure hospitalization (HFH), atrial fibrillation (AF), and pacing induced cardiomyopathy. LBBAP is a viable alternative to achieve conduction system pacing, however the effects of LBBAP compared with right ventricular pacing have not been examined in a large study. Therefore, investigators sought to compare the efficacy and safety of LBBAP vs right ventricular pacing in patients with bradyarrhythmia and conduction system disorders. All-cause mortality, HFH, and AF were the primary outcomes.

The investigators conducted this systematic review and meta-analysis by searching the EMBASE, MEDLINE, and PubMed databases from inception until November 2022 for randomized controlled trials (RCTs) and observational studies. These studies compared LBBAP with right ventricular pacing in bradycardia or conduction system disorders in adult patients at least 18 years of age. They included 25 trials (N=4250 patients; 4 RCTs, 21 observational studies) in which a total of 2127 patients received LBBAP.

Across all studies, pacing indications were either atrioventricular block, sinus node dysfunction, or AF with a slow ventricular rate. Mean follow-up duration was 11.2 months (range, 0-29 months) with no between-group differences. Participants (mean age, 70.4 years; mean left ventricular ejection fraction, 60.58%) who received LBBAP had a mean procedural success rate of 93.6% and those who received right ventricular pacing had a mean success rate very near 100% (not all studies reported success rates).

Compared with right ventricular pacing, LBBAP was associated with lower risk for all-cause mortality (risk ratio [RR], 0.52; 95% CI, 0.34-0.80; P =.003; assessed in 3 studies, n=849 patients), HFH (RR, 0.33; 95% CI, 0.21-0.50; P <.001; assessed in 8 studies, n=1966 patients), and occurrence of AF (RR, 0.43; 95% CI, 0.27-0.68; P <.001; assessed in 2 studies, n=593 patients). There were no significant between-group differences in lead-related complications (P =.780; assessed in 20 studies).

LBBAP vs right ventricular pacing achieved better intraventricular mechanical synchrony (standard mean difference [MD], -1.77; 95% CI, -2.45 to -1.09; P <.001; I²=90%) and at follow-up, QRS duration was shorter in the LBBAP group vs right ventricular pacing group (weighted MD, -32.20 msec; 95% CI, -40.70 to -23.71; P <.001; I²=92%).

Pacing thresholds were similar between groups (P =.860), and the LBBAP group vs right ventricular pacing group had higher R wave amplitudes (P =.009).

Limitations of the analysis include the observational design of most included studies and the 4 RCTs are not sufficiently powered for all outcomes. Additionally, many studies have short follow-ups and there is very high heterogeneity in some of the outcomes.

“LBBAP is associated with significantly lower HFH, all-cause mortality, AF occurrence rates, and similar lead-related complication rates in comparison to RVP [right ventricular pacing] in patients with bradycardia and conduction system disorders,” the investigators wrote. “It achieves better electromechanical ventricular synchrony, low, and stable pacing thresholds, and high R-waves.”

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

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Investigators sought to compare the cost-effectiveness of first-line cryoablation with first-line AADs for treating symptomatic PAF from a US Medicare payer perspective.

They conducted an analysis incorporating individual patient-level data from 703 participants enrolled into Cryo-FIRST (ClinicalTrials.gov Identifier: NCT01803438), STOP AF First (ClinicalTrials.gov Identifier: NCT03118518), and EARLY-AF (ClinicalTrials.gov Identifier: NCT02825979) to derive parameters for a cost-effectiveness model. Quality-adjusted life years (QALYs) were used to express health benefits.

The investigators used a 1-year time horizon hybrid decision tree and a 40-year time horizon Markov model. Costs and benefits were discounted 3% per year.

They incorporated AF recurrence and resolution, rate of AF-related hospitalization, rate of emergency department visits, rate of pharmaceutical and electrical cardioversion, rate of outpatient appointments, rate of repeat ablation, and EQ-5D-3L utility values (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) into the analysis.

Cryoablation was estimated to yield higher costs (+$4274/patient; 95% credible intervals [CrI], $391-$8126) over a 40-year time horizon and higher QALYs (+0.17; 95% CrI, 0.04-0.36) than AADs. Analysis authors stated this produced an average incremental cost-effectiveness ratio of $24,637/QALY gained (95% CrI, $4910-$132,703). Individual patients were expected to receive approximately 1.2 ablations over a lifetime, independent of initial treatment.

Compared with patients treated with AADs, those initially treated with cryoablation had a 45% relative reduction in time spent in AF health states.

Limitations of the analysis include the health state parameters being derived from electrocardiogram monitoring data, which may incorrectly estimate the rate of AF recurrence (leading to incorrectly estimating re-treatment costs), and the application of publicly available costs based on Medicare Part D drugs.

“Initial rhythm control with first-line cryoballoon ablation is highly cost-effective compared to first-line AADs from a US Medicare payer perspective,” analysis authors wrote. Specifically, they noted, “Cryoablation is estimated to be more costly than AADs whilst yielding higher QALYs over a patient’s lifetime, resulting in an average incremental cost-effectiveness ratio of $24,637 per QALY gained.”

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

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Investigators aimed to assess the occurrence of cardioembolic ischemic events (according to Acute Ischemic Stroke Treatment [TOAST] classification) in patients with ACM and distinguish imaging and clinical predictors of cardioembolic ischemic events. Incidence of atrial arrhythmias, risk for stroke in patients with atrial arrhythmias, and possible utility of CHA₂DS₂-VASc score to identify patients at high risk were secondary points.

The investigators conducted a retrospective, prospective observational, cohort study that enrolled 111 consecutive patients (at least 18 years of age) with ACM at the Città della Salute e della Scienza Hospital, Turin, Italy, from 1982 to October 2022. Atrial arrhythmias were detected with electrocardiography (ECG), Holter monitoring, or implantable cardiac devices. Patient mean age at event was 42±9 years. The investigators excluded patients with ACM family history without phenotypic expression and ACM mimics.

Echocardiographic signs of left ventricular involvement at diagnosis were seen in 39 patients and left atrial dilation in 31 patients. Right ventricular (RV) dilation was found in 69 patients, RV outflow tract dilation in 43 patients, and right atrial dilation in 46 patients. T-wave inversion was the most common ECG finding, occurring in 60 patients.

Across 12.9-year median follow-up, investigators found cardioembolic ischemic events in 11 (10%) patients (hazard ratio, 4.12; incidence rate, 7.9 events/1000 patient-years vs general population incidence rate, 1.9 events/1000 patient-years). Cardioembolic ischemic events were associated with T-wave inversion (P =.03), right ventricular outflow tract dilation (P =.006), female sex (P =.03), and decreased left ventricular ejection fraction (P =.006). Transient ischemic attack accounted for 4 cardioembolic ischemic events and ischemic stroke accounted for 7.

Among 23 patients with atrial arrhythmias (15 atrial fibrillation; 8 atrial flutter), 5 patients experienced cardioembolic ischemic events. CHA₂DS₂-VASc was not helpful for identifying patients at higher risk for cardioembolic ischemic events (P =.098). Patients (specifically women) with stroke had a pre-event score between 0 and 1.

Study limitations include the underpowered sample size and the follow-up was performed at the physician’s discretion.

“In ACM patients, cardioembolic cerebral events are much more common than in [the] general population and present a high burden even at a relatively young age; AAs [atrial arrhythmias] relate to less than half of these events,” the study authors wrote. “In AAs patients, the CHA2DS2-VASc score may not help stratify those requiring oral anticoagulation.”

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Investigators sought to characterize AF symptoms pre- and post- de novo catheter ablation and identify clinical and patient characteristics associated with post-ablation symptom resolution.

They conducted a retrospective cohort study using electronic health records (EHRs; ICD-9 and ICD-10 codes) from an academic medical center in New York City, New York, United States, from January 2010 through December 2020. They identified 1293 patients aged at least 18 years with AF who received catheter ablation. Included patients had a mean (SD) age of 65.5 (12.6) years, 35.2% were women, and 58.0% were White. Almost a quarter of these patients lived in a socially deprived neighborhood, almost half had comorbid heart failure, almost half were prescribed antiarrhythmic drugs, and three-quarters were prescribed rate control medication pre-ablation.

Almost all patients had documented symptoms of AF pre-ablation, and the remaining 4% were asymptomatic. The most common documented symptoms pre-ablation were fatigue (49%), palpitations (57%), edema (62%), and dyspnea (64%). Documented symptoms continued in 91% to 95% of patients post-ablation at each time point. The number of patients with anxiety decreased significantly from 6-months post-ablation to 12-months post-ablation (41% to 36%). The number of patients with weakness increased significantly from pre-ablation to all timepoints post-ablation (15% to 20-22%).

The investigators found that at 12-months post-ablation (in adjusted models), patients with heart failure vs those without heart failure had higher odds of palpitations resolution (odds ratio [OR], 1.90; 95% CI, 1.25-2.89), but significantly lower odds of fatigue resolution (OR, 0.54; 95% CI, 0.34-0.85), dyspnea resolution (OR, 0.38; 95% CI, 0.25-0.57), and edema resolution (OR, 0.37; 95% CI, 0.25-0.56).

Lower odds of specific symptom resolution at 6 and 12 months occurred in women, Black or African American patients, patients with heart failure, patients with smoking history, patients aged 65 years or older, and patients receiving antiarrhythmic drugs. Patients aged 65 years and older vs patients younger than 65 years had significantly lower odds of palpitations resolution at 6 months post-ablation.

Women vs men had significantly lower odds of anxiety resolution, dizziness resolution, and palpitations resolution. Asian patients vs White patients had significantly higher odds of anxiety resolution. Black or African American patients vs White patients had significantly lower odds of malaise resolution. Patients living in socially deprived neighborhoods vs those not in socially deprived neighborhoods had significantly higher odds of chest pain resolution.

Study limitations include the single site design, which lacked a control group, and potential age and documentation bias.

“This analysis…suggests that symptom resolution post-ablation varies by specific symptoms and specific patient characteristics,” the study authors wrote. “…patients with comorbid heart failure, age 65 and older, female sex, Black or African American race, with smoking history, and anti-arrhythmic use may be less likely to experience resolution of specific symptoms 6- and 12-months post-ablation.”

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 sought to compare the effect of DOACs and warfarin on the risk for dementia in patients with atrial fibrillation (AF). They analyzed 342,624 patients from 10 different studies to compare the incidence of dementia between patients treated with DOACs compared with warfarin for AF. The incidence of dementia was determined by reviewing the incidence of new disease codes for a dementia diagnosis after initiating an anticoagulant at hospital admission. Prospective or retrospective studies that compared the outcome of dementia incidence between patients treated with a DOAC for AF and patients treated with warfarin were included in the meta-analysis. The researchers excluded case reports, case series, reviews, and conference abstracts. The hazard ratio (HR) was pooled to analyze the risk for dementia across all the studies, including propensity score-matched studies. Heterogeneity was measured and subgroup analyses were performed to stratify outcomes for patients aged 75 years and older and patients aged 65 and 75 years.¹

Compared with warfarin, patients treated with DOACs had a significantly lower risk of developing dementia (in 9 of the 10 studies; HR, 0.88; 95% CI, 0.80-0.98; P =.017), but the finding had high heterogeneity (I² =75%). After the patients were stratified by region, Asian patients treated with DOACs were found to have a significantly lower risk of developing dementia compared with Asian patients treated with warfarin (in 4 of the 10 studies; HR, 0.81; 95% CI, 0.68-0.86). The benefits of DOACs in relation to dementia was insignificant in European patients (in 4 of the 10 studies; HR, 0.96; 95% CI, 0.81-1.14).¹  

For the subgroup analyses, researchers found a lower risk of dementia in patients aged 65 to 75 years who were treated with DOACs, compared to those treated with warfarin (HR, 0.80; 95% CI, 0.70-0.91; P <.001; I²=0%). Patients 75 years and older did not significantly benefit from DOACs in relation to dementia risk (HR, 0.94; 95% CI, 0.87-1.02; P =.140; I² =23%). The researchers also found that a lower mean age corresponded to a lower HR favoring DOACs over warfarin (β =.023; 95% CI, 0.002-0.043; P =.03), however this finding had high heterogeneity (I²=70%).¹   

Notably, 6 of the 10 studies were propensity score-matched while the remaining 4 were unmatched. In the subgroups of propensity score-matched studies, patients treated with DOACs had a significantly lower risk of developing dementia than those treated with warfarin (HR, 0.81; 95% CI, 0.73-0.89; P <.001; I² =44%).¹

Study limitations include that most of the studies are not randomized and the incidence of dementia was only recorded using the disease code assigned at hospital admission.¹

Vern Hsen Tan, MBBS and senior consultant in the department of cardiology at Changi General Hospital concludes that, “We would highly recommend DOACs for Asian patients, in particular, as they saw the most benefit of dementia reduction. Nevertheless, the data suggestion of a reversal of this benefit with increasing age warrants further study.”²

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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Min Jun, PhD, MScMed, of The George Institute for Global Health in Sydney, Australia and colleagues conducted a retrospective study of 55,568 adults with atrial fibrillation from Australia and Canada, including 27,784 rivaroxaban users propensity-score matched to 27,784 warfarin users. The mean age of the matched cohort was 74 years. Of the cohort, 33.5% had an estimated glomerular filtration (eGFR; in mL/min/1.73m²) less than 60, including 2.4% overall with an eGFR less than 30 (most with eGFR 15-29).

Compared with warfarin use, rivaroxaban use was associated with a 28%, 22%, 30%, and 22% decreased risk of the composite endpoint of death, stroke, and transient ischemic attack within 1 year among patients with an eGFR of 60 or more, 45-59, 30-44, and less than 30, respectively. All results were significant except for the eGFR 45-59 group.

The risk for major bleeding requiring hospitalization did not differ between rivaroxaban and warfarin users across eGFR categories less than 60. Patients with an eGFR of 60 or more who used rivaroxaban, however, had a significant 25% decreased risk for major bleeding.

Still, the investigators urged caution.

“There remains insufficient evidence to establish benefits or harms of DOACs or warfarin in patients with advanced CKD, who have been largely excluded from randomized trials.”

In an accompanying editorial, Marisa Battistella, HBSc, BScPhm, Pharm D, of the University Health Network in Toronto, Ontario, Canada, and colleagues pointed out that only 2.4% of the cohort had an eGFR less than 30, which may indicate a prescribing bias against DOACs in this patient group. DOACs, such as rivaroxaban, are partially renally cleared and may accumulate, they reiterated. Dr Battistella and collaborators pointed out that guidelines differ markedly in their guidance for patients with an eGFR less than 30, especially those on dialysis. Dosing remains a crucial decision for both efficacy and safety. Adding to the known bleeding risk associated with CKD remains a major concern.

“Considering the existing evidence on anticoagulant use in those with advanced CKD, it is clear that 1 agent is not the magic potion above all others,” the editorialists’ wrote. “Still, Ha et al were able to add to a limited body of real-world evidence showing effectiveness and safety of rivaroxaban in those with eGFR <30 mL/min/1.73m². More robust studies are needed to demystify the role of DOACs across the spectrum of kidney function.”

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 sought to investigate the association between psychosocial risk factors and AF in postmenopausal women. They performed a retrospective study with 83,736 patients (mean age, 63.9 years; White, 88.1%; Hispanic or Latino, 2.9%; Black, 7.2%) from the Women’s Health Initiative randomized controlled trials and observational study.

Patients completed baseline questionnaires requesting data for demographics, health habits, and medical history. Patients also had baseline vital sign measurements and laboratory testing. The baseline questionnaires also measured 8 psychosocial risk factors, which were optimism, social support, social strain, stressful life events, cynical hostility, emotional expressiveness, insomnia, and symptoms of depression. Patients who had AF at baseline, never enrolled in fee-for-service Medicare part A/B, or missing covariate data were excluded from the study.

A hierarchical cluster analysis tool was used to identify homogeneous clustering patterns of the 8 psychosocial risk factors and created 2 distinct clusters. Stressful life events, symptoms of depression, and insomnia were grouped into the stress cluster. Optimism, social support, social strain, cynical hostility, and emotional expressiveness were grouped into the strain cluster. The stress and strain clusters were further divided into 4 quartiles. Cox proportional hazard models were used to find the association between the clusters and AF. Researcher adjusted for covariates in 3 distinct models:

• Model 1 was adjusted for age, ethnicity, race, and education
• Model 2 was adjusted for waist-hip ratio, physical activity, smoking, alcohol, and Model 1 covariates
• Model 3 included adjustments for hypertension, diabetes, history of heart failure, history of myocardial infarction, and Model 2 covariates

The risk for AF within 5 years was calculated using the CHARGE-AF risk score and was included in the adjustments. Patient follow-up was performed at approximately 10.5 years.

The researchers discovered that 28.6% of postmenopausal women had an incidence of AF. After adjusting for the other 7 psychosocial risk factors and Model 3 covariates, they found that stressful life events (hazard ratio [HR], 1.02; 95% CI, 1.01-1.04; P <.001), insomnia (HR, 1.04; 95% CI, 1.03-1.06; P <.001), and social strain (HR, 1.02; 95% CI, 1.00-1.03; P =.02) were each significantly associated with AF. Depressive symptoms (P =.85), optimism (P =.56), social support (P =.16), cynical hostility (P =.71), and emotional expressiveness (P =.99) were each not significantly associated with the incidence of AF after the previous adjustments.

Compared with the strain cluster (HR, 1.03; 95% CI, 1.00-1.05; P =.02), the stress cluster (HR, 1.07; 95% CI, 1.05-1.09; P <.001) had a significantly higher incidence of AF after adjusting for Model 3 covariates. Postmenopausal women who were adjusted for Model 3 covariates in the highest quartile of the stress cluster had a higher incidence rate of AF compared with those in the reference baseline quartile (HR, 1.14; 95% CI, 1.10-1.19; P <.001). A similar trend was observed in the strain cluster, denoting an association between the incidence of AF and the 8 psychosocial risk factors.

A key limitation of this study is that sleep apnea and other sleep disorders can confound the association between insomnia and AF, but was not included. The study was also conducted primarily with postmenopausal White women, denoting that generalizability to other racial and ethnic groups is limited. Other limitations include that the psychometric questionnaires were only administered once at study entry and causal associations cannot be inferred because of other potential confounders not measured.

“Both the Stress Cluster (SLE [stressful life event], depressive symptoms, and insomnia) and the Strain Cluster (optimism, cynical hostility, emotional expressiveness, social support, and social strain) were significantly associated with incident AF after controlling for traditional AF risk factors,” the researchers wrote.

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The observational, prospective, nonrandomized study was conducted at a hospital in Italy and included patients with NVAF at high bleeding risk who initiated a DOAC or had successful LAAO from July 2009 to December 2016.

High bleeding risk was defined based on a HAS-BLED score 3 or higher. The high bleeding risk patients were prospectively followed up to 2021.

The primary effectiveness endpoint included thromboembolic events, and the primary safety endpoint was major bleeding per the International Society of Thrombosis and Hemostasis (ISTH) classification.

The cohort included 940 participants with NVAF, of whom 382 patients had a HAS-BLED risk score of 3 or higher and represented the high bleeding risk study population (193 patients in the LAAO group [mean age, 74.2±7.7 years; 32.6% women] and 189 patients in the DOAC group [mean age, 77.7±6.9 years; 30.7% women]). Participants who had percutaneous LAAO had more comorbidities such as diabetes and an increased HAS-BLED score (4.2 for the LAAO group vs 3.3 for the DOAC group, P <.001). Patients who used DOACs had a greater ischemic risk according to CHA₂DS₂-VASc score (4.8 vs 4.3, P =.005).

The median follow-up in the 2 unmatched high bleeding risk groups was 5.1 years (IQR, 2.6-6.7). The combined safety and effectiveness endpoint was significantly increased in the LAAO group (P =.042), primarily due to a significantly greater number of thromboembolic events (P =.047). The 2 groups had a comparable rate of ISTH-major bleeding events (P =.221). The all-cause death rate was significantly greater in the LAAO group (35.8% vs 26.6%; P =.028) compared with the DOAC group. In addition, the LAAO group had a higher cardiac death rate (13.3% vs 6.8%; P =.016).

After 1:1 propensity-score matching, data from 192 patients (96 in the DOAC group and 96 in the LAAO group) were adjusted for variables in the CHADs-VASc and HAS-BLED scores. No significant difference in thromboembolic events was found between the 2 matched groups, although an absolute higher number of thromboembolic events occurred in the LAAO group vs the DOAC group (13.3% vs 9.5%, P =.357). Both groups had a major bleeding rate of 7.5 (P =.918).

The DOAC group had a significantly increased overall bleeding rate (25.0% vs 13.7%, P =.048). All-cause and cardiac mortality were significantly increased for the LAAO group vs the DOAC group (P =.020 and .021, respectively).

Multivariable Cox regression analysis showed that significant independent predictors of all-cause death were age (hazard ratio [HR], 1.1; 95% CI, 1.05-1.15; P <.001), heart failure (HR, 2.3; 95% CI, 1.3-4.0; P =.003), and LAAO indication (HR, 1.9; 95% CI, 0.9-10.4; P =.033).

Limitations of the study include the observational design, and some potential confounders are not directly measured or included in the database. In addition, the mortality rate, which is particularly high in the LAAO group, could have affected the rates of thromboembolic and bleeding events. Also, the sample size is relatively small, and discharge antithrombotic therapies in the LAAO group are not standardized.

“This single-center, real-world, 1:1 propensity-matched study confirmed that LAAO was as effective as DOACs in preventing ischemic events at 5-year follow-up,” wrote the investigators. “On the other hand, DOACs were extremely safe with no excess of major bleeding. Thus, both treatments can be considered valuable at-long term follow-up in patients at high bleeding risk.”

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The findings are based on an analysis of the home BP subcohort study of the All Nippon AF in the Elderly (ANAFIE) registry that sought to determine the incidence of clinical outcomes in elderly Japanese patients with NVAF who received oral anticoagulant (OAC) therapy (warfarin or direct oral anticoagulants [DOACs]) stratified by home BP level.

Participants were aged 75 years or older with a definitive NVAF diagnosis who could attend hospital visits and consented to measure their home BP using an oscillometric device with an arm cuff.

The study endpoints were net cardiovascular outcome (a composite of stroke/systemic embolic events [SEE] and major bleeding), stroke/SEE, major bleeding, intracranial hemorrhage (ICH), and all-cause death.

Home BP measurements were taken 4 times a day for 1 week within 60 days of enrollment. The home systolic BP (SBP) categories were: lower than 125 mm Hg, 125 to 134 mm Hg, 135 to 144 mm Hg, and 145 mm Hg or higher.

A total of 4933 patients were included, with a mean follow-up of 1.88 years. In the home SBP subgroups, 2030 participants had lower than 125 mm Hg, 1585 had 125 to 134 mm Hg, 878 had 135 to 144 mm Hg, and 440 had 145 mm Hg or higher.

The cohort’s mean age was 81.4 years and 56.2% of patients were men. Most of the participants (93%) were receiving anticoagulants, of whom 70.8% received DOACs and 22.1% received warfarin. No differences occurred in the distribution of OACs among the H-SBP groups.

For the warfarin group, the incidence rates for patients with a home SBP lower than 125 mm Hg and for patients with a home SBP of 145 mm Hg or higher were 1.91 and 5.89, respectively, for net cardiovascular outcome, 1.31 and 3.39 for stroke/SEE, 0.59 and 3.91 for major bleeding, 0.59 and 3.43 for ICH, and 4.01 and 6.24 for all-cause death. The incidence rates of net cardiovascular outcome, stroke/SEE, major bleeding, and ICH were increased significantly for patients with a home SBP of 145 mm Hg or higher vs less than 125 mm Hg (P <.05).

For the DOAC group, in patients with a home SBP of lower than 125 mm Hg and in patients with a home SBP of 145 mm Hg or higher, the incidence rates were 1.64 and 2.65, respectively, for net cardiovascular outcome, 1.00 and 1.88 for stroke/SEE, 0.78 and 1.69 for major bleeding, 0.55 and 1.31 for ICH, and 3.43 and 3.51 for all-cause death. The incidence rates of these events tended to increase with a home SBP of 145 mm Hg or higher, although no significant difference in the event rates was observed between home SBP of lower than 125 mm Hg and home SBP of 145 mm Hg or higher in the DOAC group.

The incidence rate of net cardiovascular outcome was significantly decreased in the DOAC group at a home SBP of 145 mm Hg or higher (P <.05) compared with the warfarin group.

The investigators noted that data on DOAC and warfarin use and home BP were collected at baseline only, and changes in OACs and antihypertensive drugs in the observation period were not assessed.

“Among elderly NVAF patients treated with warfarin, the incidence rates of net cardiovascular outcome, stroke/SEE, major bleeding, and ICH were significantly increased at H-SBP [home SBP] 145 mm Hg or higher vs lower than 125 mm Hg, but not in those treated with DOACs,” wrote the researchers. “Among elderly patients 75 years of age or older with NVAF who are receiving either anticoagulation with DOACs or warfarin, strict BP control guided by H-BP [home BP] may be required.”

Disclosure: This study was supported by Daiichi Sankyo Co., Ltd. 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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While traditional ablation procedures require the completion of the time-consuming task of changing out different catheters to find the proper fit, cryoablation is a procedure where an adjustable balloon catheter delivers cryotherapy to the pulmonary vein and freezes the problematic tissue. This creates scarring that blocks irregular electrical signals. The POLARx cryoablation system allows physicians to adjust and expand the POLARx FIT balloon—sized at 28 mm and expandable to 31 mm—to personally fit the patient’s heart anatomy during an ablation procedure. This feature increases the range of different pulmonary vein anatomies that the physician can treat. The system also allows physicians to create scarring in optimal positions to better treat the tissue of origin in the heart that is causing atrial fibrillation.¹

The approval of this system is supported by results from a global, prospective, non-randomized, single-arm, 12-month long study (FROZEN-AF IDE; ClinicalTrials.gov Identifier: NCT04133168) presented at Heart Rhythm 2023.¹ Researchers enrolled 385 patients with paroxysmal atrial fibrillation to find the safety and efficacy of the POLARx cryoablation system. The primary safety endpoint of a composite of acute and chronic primary safety events was achieved throughout the length of the trial (12 months) with an event-free rate of 96.3%.² The primary efficacy endpoint of the rate of freedom from postprocedure treatment failure was 79.9% at the end of the trial. There were also no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas experienced postprocedure.

Fifty of the patients were treated with at least 1 application of the 31 mm cryoballoon and are included in an extension arm substudy for the FIT balloon catheter, which will be followed for 12 months. The substudy has passed the 6 month mark of follow-up and the event-free rate is 100%, with a rate of freedom from postprocedure treatment failure of 88.0%.²

“…the combination of maneuverability and variable balloon sizes makes this system particularly useful in addressing longstanding challenges with varying cardiac anatomies and brings to the table occlusion capabilities physicians aren’t used to seeing with traditional systems,”¹ the study authors wrote. The ability of this device to adapt to a patient’s individual anatomy shows promise in the successful treatment of paroxysmal atrial fibrillation.

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The products that are approved to be used in a zero fluoroscopy workflow include the THERMOCOOL SMARTTOUCH SF catheter, THERMOCOOL SMARTTOUCH Catheter, CARTO^® VIZIGO^® Bi-Directional Guiding Sheath, PENTARAY^® NAV ECO High Density Mapping Catheter, DECANAV^® Mapping Catheters, and Webster^® CS Catheter.

Fluoroscopy is a type of medical imaging that displays a continuous x-ray image on a monitor and is used in many examinations and procedures, including cardiac ablation to treat patients with atrial fibrillation. This procedure commonly requires fluoroscopy to guide the insertion and positioning of intracardiac catheters. However, fluoroscopy can result in high radiation exposure, especially for complex procedures that require fluoroscopy to be given for a long period of time. The patient, operator, and medical support staff suffer from an increased long-term risk for cancer from the radiation and musculoskeletal pain from wearing heavy personal protective equipment during the procedure. Biosense Webster’s integrated medical device ecosystem anchored by the CARTO^® 3 mapping and navigation system, enables these newly FDA-approved diagnostic and treatment catheters to conduct cardiac ablation procedures without fluoroscopy, which improves safety and efficiency of the procedure. 

The approval of these medical devices is supported by data collected from the REAL AF Registry (an observational, prospective, and multicenter registry) that assesses real-world catheter ablation clinical outcomes—procedural efficiency, safety, and long-term effectiveness—in patients with paraoxysmal atrial fibrillation who have received ablation with radiofrequency technologies, which do not use fluoroscopy.  

Jose Osorio, MD, FHRS and President of Heart Rhythm Clinical and Research Solutions said in a press release,¹ “Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab.” Overall, catheter ablation without fluoroscopy is a safe, effective, and reduces radiation exposure for all persons involved in the procedure.

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The retrospective, observational study presented results of all AF ablation cases performed at a single ambulatory outpatient laboratory from December 1, 2016, to March 22, 2023.

Patient data were obtained from medical records and included demographics, AF history, echocardiographic data, intraprocedural and postprocedural data, complications, discharge characteristics, and emergency department (ED) records and hospitalization data in the month after the procedure.

A total of 476 patients were included. They had a mean age of 57.5±9.3 years, body mass index of 32.9±7.0, and CHA₂DS₂-Vasc score of 1.7±1.3. Of the cohort, 55% had paroxysmal AF and 45% had persistent or longstanding persistent AF. The patients received pulmonary vein isolation, and most received additional ablation beyond the pulmonary veins.

The primary outcome of a major perioperative safety event occurred in 7 patients. In addition, 4 patients had tamponade that required percutaneous drainage and 3 patients were transferred for computed tomography imaging owing to suspected bleeding. All patients were stabilized in the catheter laboratory and were transferred in stable condition to the hospital for overnight observation, and none needed surgical intervention.

The secondary safety outcome, ED incidence or use of hospital services before discharge, occurred in 7 patients. Prolonged groin care was needed in 2 patients, and 2 patients were slow to awaken after anesthesia and needed to be admitted to the ED or hospital for slow vasopressor wean.

Use of the ED postdischarge within 24 hours of the procedure was required in 7 patients for a variety of reasons, including shortness of breath (managed with fluids), groin bleeding (managed with pressure), visual changes (contact lens left in after procedure), chest pain (2 patients with no specific diagnosis, 1 treated for pericarditis), and bradycardia (spontaneously resolved). ED use from 24 hours to 7 days following ablation occurred in 34 patients, and ED use late postprocedure from 1 week to 1 month was needed in 24 patients.

Limitations of the study include the single-center, retrospective, observational design without a direct comparison with hospital-based ablation in a similar cohort. Also, the age of patients was relatively young, and they were only offered ambulatory ablation if they satisfied the physician’s judgment for safety.

“…we observed a comparable rate of complications to published hospital-based cohorts, all of which were promptly stabilized on-site,” stated the investigators. “We hope the lessons learned from this cohort guide patient safety efforts by physician groups who pursue ablation in a similar setting. We also hope to spurn a conversation between professional societies and the Centers for Medicare & Medicaid Services to expand electrophysiologic care of Medicare patients to facilities outside of hospital walls.”

Disclosure: This study was funded by an investigator-initiated grant from Medtronic, Inc. Please see the original reference for a full list of disclosures.

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Investigators sought to determine the predictors and incidence of sustained VTAs in patients with HCM. They conducted an observational retrospective study that included 207 patients that had a cardioverter-defibrillator (ICD) among 1328 patients with HCM. Data were from a registry at 2 tertiary medical centers (Chaim Sheba Medical Center in Tel HaShomer, Israel, and Complexo Hospitalario Universitario A Coruña, Spain). HCM was defined as unexplained LV wall thickness of 15 mm or thicker or 13 mm or thicker if the patient had a first-degree family member with HCM.

Patients with ICDs were propensity score matched to 562 patients without ICDs, though significant between-group differences remained for beta-blocker use, larger LV end-systolic diameter (LVESD), and higher proportion of patients with history of non-sustained ventricular tachycardia.

Among the 207 patients with ICDs (30% women; mean [SD] age, 33 [16] years) followed over a mean (SD) of 10 (6) years, sustained VTAs developed in 37 patients. These VTAs were associated with a personal history of VTA (with VTAs, 27% vs without, 6%; P =.001) and family history of sudden cardiac death (with VTAs, 54% vs without 34%; P =.036). Among the patients who developed VTAs, 70% had sustained monomorphic VT with or without ventricular fibrillation (VF; VT±VF group) and 30% had only VF. Compared with the VF only group, the VT±VF group had decreased LVEF and increased LV end-diastolic diameter and increased LVESD.

There were 326 VT events in 26 patients in the VT±VF group (median event rate, 2/patient; 5 patients presented with VT storm).

Overall, among the 326 VT events, 79% were successfully terminated with antitachycardia pacing (ATP). The investigators noted comparable mortality rates between patients with vs without ICDs (16% vs 20%; P =.367) and between patients with vs without VTAs (17% vs 15%; P =.270).

Across follow-up, cumulative all-cause mortality rates were similar among matched pairs (with ICD, 16%; without, 20%; P =.367).

In univariate analysis, events of VT were associated with decreasing LVEF and increasing LV dimensions (both LV end-diastolic diameter and LVESD). In multivariate analysis, LVEF and LVESD remained independently associated with VT.

Study limitations include the participants being higher risk than the general population, which reduces generalizability. The sample size is also underpowered in some analyses. Additionally, there are significant between-ICD-group characteristic differences.

“VT rather than VF is the most common arrhythmia in patients with HCM; it is amenable to ATP and is associated with lower LV ejection fraction and higher LV diameters,” the investigators wrote. “HCM patients with LVEF [of less than] 60% are more likely to present with VT, with or without VF, and therefore a transvenous ICD with ATP abilities should be considered for these patients.”

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Using a prospective AF registry, researchers evaluated AF ablation outcomes and QOL benefits in young adults who had received catheter ablation. Patients who had received ablation at a single center from 2013 to 2016 with either radiofrequency (RF) or cryoablation targeting isolation of the pulmonary veins were included in the study.

An automated remote follow-up system was created for PRO data collection and QOL measures in the patients, mainly with the AF severity score (AFSS). The PRO system automatically sent an email invitation to patients to complete a survey 10 days before the scheduled ablation procedure, as well as at 3 and 6 months following the procedure and every 6 months after for a duration of 5 years.

A total of 241 patients aged 16 to 50 years received AF ablation. They had a mean age of 43.1±7.3 years and 83% were men. Ablation was performed for paroxysmal AF in 59.3% of patients and 40.3% had ablation for persistent AF.

In 1 year of follow-up, 77.2% of patients were arrhythmia-free. Among those without structural heart disease, 80% remained arrhythmia-free at 1 year and 66% of those with structural heart disease were arrhythmia-free after 1 year. For patients who had paroxysmal AF, 78.3% remained arrhythmia-free at 1-year follow-up vs 75.3% of patients with persistent AF.

The participants answered an average of 3.34 surveys and significant QOL improvement occurred following ablation. The median AFSS was 14 (7-22) at baseline and decreased to 4 or less for all time points during follow-up (P <.0001).

The participants with RF ablation also had a baseline median AFSS of 14 (7-22), which was lowered to 4 or less at all time points (P <.0001), and those who had cryoablation had a median AFSS of 9 (9-9) at baseline with a decreased score of 6 or less at all time points.

Overall, about 75.0% of the patients reported marked improvement in AF symptoms after ablation, 11.5% reported moderate improvement after ablation, 6.6% reported mild improvement after ablation, and 7.0% reported no improvement after ablation (P <.0001). At 12 months, 73.8% (n=59) of patients reported marked improvement, 18.8% (n=15) reported mild-to-moderate improvement, and 7.5% (n=6) reported worse or no change in symptoms after ablation. Health care use, including emergency department visits and hospitalizations, also significantly decreased postablation.

The investigators noted some limitations, including the observational nature of the study, and that asymptomatic recurrences could be missed with PROs. In addition, the participants were part of a single-referral center that mostly performed RF ablation and may not be representative of community practice. Furthermore, the population was predominantly obese, White, non-Hispanic male patients, and the PRO survey may have led to selection bias with more satisfied patients completing the survey than those less satisfied.

“AF ablation remains a durable tool for rhythm-control strategies in young adults with AF,” wrote the researchers. “In addition to typical outcomes of arrhythmia-free survival, young adults also experience significant improvement in QOL, symptoms, and AF-related healthcare utilization.”

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

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Investigators sought to determine whether the incidence of NOAF among patients with critical illness could be affected by treatment with dexmedetomidine. Occurrence of NOAF within 7 days of intensive care unit (ICU) admission was the primary outcome. Hospital length of stay, ICU length of stay, and in-hospital mortality were secondary outcomes.

Using medical records from the Medical Information Mart for Intensive Care-IV database of patients admitted to the Beth Israel Deaconess Medical Center in Boston from 2008 through 2019, the investigators conducted a retrospective propensity score-matched cohort study. They included 8015 critically ill patients (age, 61.0 [SD, 17.1] years; 65.4% men) who were then propensity score-matched 1:3, with 2106 patients in the dexmedetomidine group treated with dexmedetomidine within 48 hours of ICU admission and 5909 patients in the no dexmedetomidine group who were never treated with dexmedetomidine. Included patients were hospitalized in the ICU and at least 18 years of age. The investigators used multivariate imputation for imputing missing data prior to propensity score matching.

Among all eligible patients before propensity score matching (N=22,237), the dexmedetomidine group vs no dexmedetomidine group had higher mean sequential organ failure assessment scores, greater frequency of sepsis, lower Charlson Comorbidity Index scores (mean 4.86 [SD, 2.83] vs 5.80 [SD, 2.95]), and they were younger (60.61 [SD,16.02] years vs 66.44 [SD,16.66] years). The groups were comparable for age, sex, race/ethnicity, sepsis, and mean sequential organ failure assessment scores.

There was a decreased risk for NOAF associated with dexmedetomidine treatment (17.6% of patients in the dexmedetomidine group vs 22.4% of patients in the no dexmedetomidine group; hazard ratio [HR], 0.80; 95% CI, 0.71-0.90). This association was sustained through sensitivity analyses. Patients in the dexmedetomidine group vs no dexmedetomidine group had a significantly longer time from ICU admission to AF onset (median 2.1 days [IQR, 1.5-2.9] vs median 1.3 days [IQR, 0.2-2.2]; P <.001). There were no significant differences in medication use for electrical cardioversion, rhythm control, or rate control concerning treatment for AF.

There was a longer hospital length of stay among patients in the dexmedetomidine group vs the no dexmedetomidine group (median 10 days [IQR, 6.6-16.3] vs 8.8 days [IQR, 5.9-14.0]; P <.001). There was a longer ICU length of stay among patients in the dexmedetomidine group vs the no dexmedetomidine group (median 4.0 days [IQR, 2.7-6.9] vs 3.5 days [IRQ, 2.5-5.9]; P <.001).

The investigators found an association between treatment with dexmedetomidine and decreased risk of in-hospital mortality (6.3% deaths in the dexmedetomidine group vs 12.8% deaths in the no dexmedetomidine group; HR, 0.43; 95% CI, 0.36-0.52). These associations were sustained through sensitivity analyses.

Study limitations include the retrospective design and the unmeasured confounders that may have influenced results.

“This cohort study found that dexmedetomidine was associated with decreased risk of NOAF in 2 different propensity score-matched ICU cohorts, supporting generalizability of the results,” the investigators wrote.  “These findings suggest that use of dexmedetomidine may be associated with a protective outcome against NOAF in patients with critical illness.”

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Kathryn A. Wood, Ph.D., from Emory University in Atlanta, and colleagues examined sex differences between AF and neuropsychological tests and cognitive disease progression using data from 43,630 participants in the National Alzheimer’s Coordinating Center.

The researchers found that AF is associated with increased odds of dementia and MCI in women versus men (odds ratios, 3.00 and 3.43, respectively). Compared to men with AF or men and women without AF, women with AF and normal baseline cognition had a higher risk of disease progression from normal to MCI (hazard ratio, 1.26) and from MCI to vascular dementia (hazard ratio, 3.27).

“The analyses indicate stronger associations between atrial fibrillation and declining cognitive function in women compared with men,” Wood said in a statement. “Establishing ways to identify atrial fibrillation patients at the highest risk of cognitive decline and stroke will inform future interventions to prevent or slow the progression to cognitive impairment and dementia.”

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Investigators compared the risk for dementia between users and nonusers of statins in patients with NVAF receiving OAC from the Korean National Health Insurance Service database from January 2013 to December 2017.

Diagnoses were based on the International Classification of Diseases, 10th Revision, Clinical Modification, and eligible participants had a CHA₂DS₂-VASc score of 2 or higher.

The primary endpoint was the occurrence of dementia. The risk for events was assessed with use of Cox proportional hazards analysis, and cumulative incidences of clinical endpoints were developed as Kaplan–Meier estimates based on therapy used and were compared with the log-rank test.

The cohort included 91,018 patients with NVAF, 17,700 patients in the statin therapy group and 73,318 patients in the nonstatin therapy group. The statin therapy group was older (mean age, 69.3 vs 67.9 years, P <.001) and had a lower percentage of women (45.6% vs 47.1%, P <.001).

Patients in the statin group had a higher CHA₂DS₂-VASc score (4.3±1.5) compared with the nonstatin group (4.1±1.3). The statin group also had a higher prevalence of hypertension, diabetes mellitus, dyslipidemia, myocardial infarction, and peripheral artery disease, compared with the nonstatin group. The median follow-up was similar in the statin therapy group (2.14 years) and the nonstatin therapy group (2.10 years; P =.132).

Warfarin or non-vitamin K antagonist oral anticoagulant therapy alone was associated with a significantly reduced risk for dementia vs non-OAC therapy (hazard ratio [HR], 0.74; 95% CI, 0.62-0.85; and HR, 0.62; 95% CI, 0.51-0.73, respectively) in patients with NVAF. Risk for dementia was significantly lower in the statin group (HR, 0.77; 95% CI, 0.64-0.90). Low-, moderate-, and high-intensity statin use was associated with a decreased risk for dementia vs nonstatin therapy (HR, 0.81; 95% CI, 0.69-0.94; HR, 0.74; 95% CI, 0.61-0.88; and HR, 0.67; 95% CI, 0.55-0.80, respectively; P for trend =.001).

Dementia incidence in the nonstatin group was significantly higher vs the statin group in patients who had CHA₂DS₂-VASc scores of 2 or 3 and 4 or higher (log-rank P <.001 for both).

Limitations of the study include the nonrandomized, retrospective, observational design. Additionally, the drug adherence rate was not measured owing to the inherent limitations of the claims data, and the investigators could not assess the effects of the different types of statins and off-label, underdosed, or different types of direct-acting oral anticoagulants.

“Statin therapy was associated with a dose-dependent reduction in dementia in these patients,” wrote the study authors. “Prospective randomized trials with an adequate follow-up period are warranted to explore whether this relationship is causal.”

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Patients with TIA are at elevated risk for future stroke, as are patients with AF. This study was designed to evaluate whether anticoagulation therapy may mitigate some of the risk for recurrence of neurovascular events among patients with AF and TIA.

This study was a planned secondary analysis of patients (N=1286) with AF who presented with TIA to 1 of 13 EDs in Canada between 2006 and 2018. The primary outcome was a composite of ischemic or hemorrhagic stroke, TIA recurrence, or mortality at 90 days.

The patients had a mean age of 77.3 (SD, 11.1) years, 52.4% were men, 73.5% had hypertension, 44.2% had history of stroke or TIA, 54.4% (n=699) were already on anticoagulation therapy, and 6.9% (n=89) started anticoagulation therapy at the ED.

At 90 days, the cumulative incidence of subsequent TIA was 6.5%, subsequent ischemic stroke was 4.0%, mortality was 2.6%, and intracerebral hemorrhage was 0.4%.

Stratified by anticoagulant usage, the patients who received anticoagulation therapy at the ED had higher rates of stroke at 90 days (10.1%) than those who were already taking anticoagulants (3.3%) or were not taking anticoagulants (4.0%). Similar trends were observed for TIA recurrence (7.9% vs 6.7% vs 5.8%, respectively) and mortality (16.9% vs 10.2% vs 12.8%, respectively).

Increased risk for the composite outcome at 90 days was associated with medium Canadian TIA Score compared with a low score (odds ratio [OR], 3.18; 95% CI, 1.47-6.85).

The final model predicting the composite outcome at 90 days (area under the curve [AUC], 0.64; 95% CI, 0.59-0.68; P =.004) found that anticoagulation therapy prescribed in the ED tended to increase risk (OR, 1.37; 95% CI, 0.74-2.52) whereas already taking anticoagulation therapy tended to decrease risk (OR, 0.74; 95% CI, 0.44-1.24).

A major limitation of this study is the small sample size of patients who received anticoagulation therapy at the ED.

These data did not find that ED-prescribed anticoagulation therapy post-TIA decreases risk for recurrence or mortality at 90 days among patients with AF. The study authors wrote, “The role and timing of ED-prescribed anticoagulation in patients with atrial fibrillation and a new TIA who are not already on anticoagulation need further investigation.”

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.

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Individuals with heart failure (HF) frequently have atrial fibrillation (AF) as a comorbidity, which increases risk for adverse events and complicates treatment. SGLT2 inhibitors are a promising first line treatment for HF; however, their risk reduction for AF is not yet conclusive. Researchers aimed to conduct a meta-analysis to examine conflicting results regarding the effect SGLT2 inhibitors on AF in HF patients with reduced or preserved ejection fraction (HFrEF and HFpEF).

The meta-analysis was conducted using PubMed and ClinicalTrials.gov. The researchers used key search words including SGLT2 inhibitor-related terms, “heart failure,” and “atrial fibrillation.” Studies selected included randomized controlled trials (RCTs), participants with a confirmed diagnosis of HFrEF or HFpEF, SGLT2 inhibitor and placebo use as the intervention, and data on adverse outcomes that include AF. Studies using other drug interventions besides SGLT2 inhibitors and incomplete RCTs were excluded from the study.

The primary outcome was incidence of AF, defined as AF reported as a serious adverse event or other adverse events.

A total of 10 eligible studies that compared use of SGLT2 inhibitors and placebo in a total of 16,579 patients were included in the study. Of these studies, 5 used dapagliflozin and 5 used empagliflozin. Mean age ranged from 61.3 to 73.5 years and mean follow-up time was from 12 to 26.2 weeks.

Of the patients treated with an SGLT2 inhibitor (n=8292), 348 experienced AF, while 379 AF events occurred in the participants in the placebo group (n=8287). SGLT2 inhibitor use did not significantly affect risk for AF when compared to placebo (risk ratio (RR), 0.92; 95% CI, 0.80-1.06; P =.23).

Subgroup analysis found that neither dapagliflozin or empagliflozin therapy reduced risk for AF (RR, 0.97; 95% CI, 0.73-1.28; P =.82; RR, 0.90; 95% CI, 0.76-1.06; P =.20, respectively).

Subgroup analysis was conducted using follow-up times, as they varied between studies. No significance was found in the subgroups, regardless of duration of follow-up (≤1 year: RR, 1.23; 95% CI, 0.48-3.16; P =.66; >1 year: RR, 0.85; 95% CI, 0.66-1.11; P =.24).

No significant heterogeneity was found across trials when adjusting for type of HF (HFpEF: P =.56; I²=0%; HFrEF: P =.51; I²=0%) and there was no difference in AF observed in any type of HF (HFpEF: RR, 0.99; 95% CI, 0.83-1.17; P =.87; HFrEF: RR, 0.80; 95% CI, 0.63-1.02; P =.07).

Limitations of the study include using trial studies which did not include AF as a primary endpoint, which may lead to inconsistent results. Additionally, trials could not be grouped according to comorbidities as patient-level data is not available.

“…this analysis suggests that SGLT2i [inhibitors] may not prevent the occurrence of AF in patients with HF,” the study authors wrote. “Therefore, more studies should be conducted in patients with HF to demonstrate the effects of SGLT2i on AF.”

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Using data from the US Renal Data System, United Network for Organ Sharing, and Medicare parts A and B, Leonardo Pozo Garcia, MD, of Baylor College of Medicine in Houston, Texas, and colleagues studied 43,621 adult patients receiving their first kidney transplant who did not have previously diagnosed atrial fibrillation. Prior to transplantation, 37,034 patients used hemodialysis and 6587 used peritoneal dialysis. Patients had a mean age of 51 years.

Patients previously on hemodialysis had a significant 18% increased risk for atrial fibrillation compared with those previously on peritoneal dialysis, after adjusting for multiple variables, Dr Pozo Garcia reported. Graft failure was significantly associated with a 2.8-fold increased risk for atrial fibrillation.

In addition, longer dialysis vintage was significantly associated with a 5% increased risk per year for atrial fibrillation.

Transplant factors also affected atrial fibrillation risk. Receiving a kidney from a female vs male donor was significantly associated with a 1.1-fold increased risk for atrial fibrillation, respectively, whereas receiving a kidney from a living donor was significantly associated with a 25% decreased risk.

“In our study, we found that patients on hemodialysis prior to transplantation were at increased risk of developing new-onset post-kidney transplant atrial fibrillation as compared to patients who were on peritoneal dialysis,” Dr Pozo Garcia told Renal & Urology News. He noted that factors associated with hemodialysis such as higher rates of heart failure, left atrium enlargement, impaired left ventricle contractility and ejection fraction, and hemodynamic changes related to dialysis access might contribute to the discrepancy between dialysis modalities.

“Both classic atrial fibrillation and transplant-related risk factors play a role in the development of post-transplant atrial fibrillation. As our understanding of transplant-specific risk factors for atrial fibrillation increases, we may be able to better risk-stratify the kidney transplant population and develop monitoring and management strategies that can improve outcomes.”

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Individuals with PKP2-ACM have been known to experience life-threatening ventricular arrhythmias, cardiac structural abnormalities, and sudden cardiac death. RP-A601 is an adeno-associated virus (AAV.rh74)-based gene therapy that is being investigated as a one-time curative treatment for these patients. The FDA’s designations are supported by preclinical studies indicating that the gene therapy candidate has the potential to decrease arrhythmias and increase survival.

An upcoming phase 1 dose escalation trial will evaluate the safety and efficacy of RP-A601 in at least 6 high-risk adult patients with PKP2-ACM (ClinicalTrials.gov Identifier: NCT05885412). According to Rocket Pharmaceuticals, the study will assess the impact of the gene therapy on PKP2 myocardial protein expression, cardiac biomarkers, clinical predictors of life-threatening ventricular arrhythmias, and sudden cardiac death.

Approximately 50,000 adults and children in the US and Europe are affected by PKP2-ACM. The current standard of care includes medical therapy, implantable cardioverter defibrillators, and ablation procedures.

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Investigators sought to assess clinical outcomes, management, and incidence of esophageal fistula following catheter ablation for treatment of atrial tachycardia (AT) or AF. The primary endpoint was esophageal fistula occurrence following catheter ablation for AT or AF treatment. Diagnosis and management of esophageal fistula and mortality were secondary endpoints.

They conducted the retrospective POTTER-AF (Prognosis Following Oesophageal Fistula Formation in Patients Undergoing Catheter Ablation for AF; ClinicalTrials.gov Identifier: NCT05273645) study at the Department of Rhythmology at the Lübeck University Heart Center, University Hospital Schleswig-Holstein, Germany. The investigators included data from 553,729 deidentified catheter ablation procedures (62.9% radiofrequency; 36.2% cryoballoon; 0.9% other modalities) worldwide between 1996 and 2022. Procedures were performed in 35 countries at 214 centers, during which 138 patients (0.025%) in 78 centers were diagnosed with esophageal fistula (0.038% radiofrequency; 0.0015% cryoballoon; P <.0001). The study had no exclusion criteria.

There were 118 patients with available periprocedural data (mean age, 62.0±11.4 years; 47% women; 8% history of esogastric pathology; 23% preprocedural proton pump inhibitor therapy). The energy source was radiofrequency in 96.6% of patients.

Median time to diagnosis following catheter ablation was 21 days (IQR, 15.0-29.5; range, 2.0-63.0). Median time to symptoms following catheter ablation was 18 days (IQR, 7.75-25.00; range, 0.00-60.00). From symptom onset to esophageal fistula diagnosis (80.2% established by chest computed tomography), median time was 3 days (IQR, 1.0-9.0; range 0.0-42.0). Fever and neurological symptoms were reported by all early diagnosed patients.

Fever was the most common initial symptom (59.3%), followed by chest pain or pain when swallowing (54.2%), and stroke or seizures (44.1%). Additional symptoms occurred in 62.3% of patients, with 1 patient reporting no symptoms. Delayed complications that presented during the clinical course included septic shock (57.9%), coma (46.7%), cerebral hemorrhages (23.4%), cardiac arrest (18.7%), gastrointestinal bleeding (16.8%), and cardiac tamponade (11.2%). There were 29% of patients who experienced additional complications, and no complications were reported by 4.7% of patients.

There were 32.8% of patients who received conservative management, 19.8% who received endoscopic treatment only, and 47.4% who received esophageal surgery. In patients who received conservative management, median time from procedure to earliest symptom onset was 20.5 days (IQR, 10.0-29.0) and median time from procedure to esophageal fistula diagnosis was 26.5 days (IQR, 19.0-32.0). In patients who received endoscopic treatment only, median time from procedure to earliest symptom onset was 10.0 days (IQR, 6.0-15.0) and median time from procedure to esophageal fistula diagnosis was 18.0 days (IQR, 10.0-25.0). In patients who received esophageal surgery, median time from procedure to earliest symptom onset was 18.0 days (IQR, 11.0-22.5) and median time from procedure to esophageal fistula diagnosis was 21.0 days (IQR, 15.0-29.0).

Mortality was high following isolated endoscopic treatment (56.5%) or esophageal surgery (51.9%), and was even higher in the conservative treatment group (89.5%; odds ratio, 7.463; 95% CI, 2.414-23.072; P <.001). Intravenous antibiotic therapy was given to all patients.

Study limitations include possible selection bias, patients that were lost to follow-up, and potential lack of generalizability.

“Esophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy,” the investigators wrote. “Mortality without surgical or endoscopic intervention is exceedingly high.”

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The population-based study used prospective data from several nationwide registers in Denmark, Sweden, and Finland to evaluate whether preterm birth, being small for gestational age (SGA), or being LGA are associated with AF risk in childhood and adulthood.

All live singleton births were identified in Denmark from 1978 through 2016 (n=2,332,882) and in Sweden from 1973 through 2014 (n=4,171,006). Additionally, there was a random sample of 90% live singletons in Finland from 1987 through 2014 (n=1,636,116). The analysis included 8,012,433 births after the exclusion of births with missing or implausible gestational age, birth weight, or sex.

AF was the outcome and was defined as AF or atrial flutter. Follow-up was initiated at birth and ended at the first AF diagnosis, emigration, death, or the latest date with available data, whichever came first.

Among the cohort, 378,917 participants were born preterm (4.7%), 800,959 were SGA (10.0%), and 802,759 were LGA (10.0%). Participants’ maximum age at the end of follow-up was 49 years (median, 21 years; IQR, 11.7-30.7 years). In the 174.4 million person-years of follow-up, 11,464 individuals had AF (0.14%), with a median age at diagnosis of 29.3 years (IQR, 22.3-36.4 years).

An inverse, mostly linear association was observed between gestational age and the risk for AF. Preterm birth was associated with an increased risk for AF, with adjusted hazard ratios (HRs) of 1.30 (95% CI, 1.18-1.42) in the population analysis and 1.29 (95% CI, 1.08-1.55) in the sibling analysis.

The risk for AF increased significantly according to birth weight for gestational age from the 50th percentile. Individuals who were born SGA had a lower AF risk (adjusted HR, 0.93; 95% CI, 0.88-0.99) and those born LGA had an increased AF risk (adjusted HR, 1.55; 95% CI, 1.46-1.63), compared with individuals born appropriate for gestational age (AGA). Only being LGA was associated with AF risk in the sibling analysis. For the population and sibling analyses, AF risk was higher for severe LGA vs moderate LGA.

Being SGA was associated with a higher risk for AF in the first 18 years of follow-up (adjusted HR, 1.27; 95% CI, 1.07-1.50) and with a lower risk afterward (adjusted HR, 0.90; 95% CI, 0.84-0.96). The association between LGA and risk for AF was similar in both periods.

Compared with term AGA births, the risk for AF was increased by 71% among preterm LGA births, 55% for term LGA births, 31% in preterm AGA births, and 25% in preterm SGA births. AF risk was 9% lower for term SGA vs term AGA births. The HRs were generally higher during the first 18 years of follow-up compared with later in these analyses.

In sensitivity analyses, the associations of preterm birth, being SGA, and being LGA with AF risk were not different based on the child’s sex or country of birth.

Among several limitations, some asymptomatic, paroxysmal, or mild cases of AF could have been missed, and residual confounding is possible. Furthermore, the findings apply only to children and young adults, and the population was predominantly White with universal free health care systems.

“Further studies with longer follow-up and that may elucidate the underlying mechanisms for the observed associations are warranted,” wrote the study authors. “As the prevalence of LGA births is reported to increase over time, the possible long-term health effects of being born LGA may become increasingly important.”

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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Recruitment for the long-term study took place between 2000 and 2002. The study examined 6670 participants aged 45 to 84 years. Participants were enrolled at 6 sites in the United States. Participants did not have clinical cardiovascular disease when the study began.

Participants were assessed for ECG-LAA, which the authors defined as P-wave terminal force in V1 greater than 5000 μV × ms. They were also assessed for albuminuria, which the authors defined as a urine albumin-creatinine ratio (UACR) of 30 mg/g or greater.

Over the course of the study, the investigators tracked incident AF using a combination of follow-up study ECGs and telephone interviews to identify hospital admissions and medical diagnoses. In addition, the researchers used hospital discharge records of diagnosis of AF, as well as AF-related inpatient, outpatient, and physician claims data for participants enrolled in fee-for-service Medicare.

All participants were followed from recruitment until 2015.

The data were analyzed using the Cox proportional hazard model to assess multiple associations with AF. Patients were stratified into the following groups:

• Patients without albuminuria and ECG-LAA (reference)
• Patients with albuminuria only (isolated albuminuria)
• Patients with ECG-LAA only (isolated ECG-LAA)
• Patients with albuminuria and ECG-LAA

Additional data modeling was performed to adjust for age, sex, race, socioeconomic factors, and certain health indicators.

At baseline, the researchers found that ECG-LAA was higher among patients who had albuminuria than in those without albuminuria (12.9% vs 6.2%, respectively; P <.01). The prevalence of ECG-LAA was 11.4% (n=212) among Black participants vs 5.2% (n=132) among White participants. The prevalence of albuminuria was 11.5% among Black participants vs 5.8% among White participants.

The researchers recorded 979 cases of AF during the study. Rates of AF were highest among participants with concomitant albuminuria and ECG-LAA (40.1 per 1000 person-years). Lower rates were reported in participants who displayed albuminuria alone (23.3 per 1000 person-years) or ECG-LAA alone (19.9 per 1000 person-years).

Comparative analysis by race showed a 4-fold greater AF risk for Black participants who had both albuminuria and ECG-LAA (hazard ratio [HR], 4.37; 95% CI, 2.38-8.01). There was no statistically significant risk increase in White participants (HR, 0.60; 95% CI, 0.19-1.92).

Study limitations include a lack of data on social determinants of health among participants. The study did not address longitudinal changes and their impact on health outcomes.

“Concomitant presence of ECG-LAA and albuminuria confers a higher risk for AF compared to either one in isolation with a stronger association in Black [patient]s than White [patient]s,” the study authors wrote. They also urged further study on the matter, noting the implications on other health outcomes for Black individuals.

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 in Canada sought to compare prevention of recurrent atrial tachycardia, atrial flutter, or AF following double WACA vs standard single WACA in patients with paroxysmal AF. The primary endpoint was recurrence of atrial arrhythmia 91 to 365 days postablation. Need for repeated catheter ablation, along with procedural and safety variables, represented secondary endpoints. The hypothesis was that the chance of durable pulmonary vein isolation (PVI) would be increased by the wider area of atrial ablation resulting in atrial arrhythmia reduction.

The researchers conducted the prospective, multicenter, randomized, blinded AWARE trial (ClinicalTrials.gov Identifier: NCT02150902) in Canada at 10 university-affiliated centers. Patients aged at least 18 years with symptomatic paroxysmal AF were enrolled from March 2015 to May 2017. The researchers included 398 patients who received radiofrequency catheter ablation for PVI after being randomly assigned in a 1:1 ratio for either the double WACA experimental arm (n=203; mean age, 61.5±9.3 years; 32.5% women; 40.9% hypertension) or the single WACA control arm (n=195; mean age, 60.6±9.3 years; 33.3% women; 42.1% hypertension).

Prior to ablation, antiarrhythmic drug use was discontinued. Following ablation, patients received 6 weeks of ambulatory monitoring with electrocardiography, and no antiarrhythmic drugs were used during the 90-day blanking period. No patients received antiarrhythmic drugs during the 91- to 365-day period following ablation. Intention-to-treat analyses occurred between January and April 2022.

Following catheter ablation in the control arm, 52 patients (26.8%) experienced dormant pulmonary vein conduction requiring additional ablation. In all patients, electrophysiologic testing was used to confirm bidirectional conduction block across all pulmonary veins.

There were 50 patients (24.6%) in the experimental arm and 52 patients (26.7%) in the control arm that experienced recurrent atrial arrhythmia at 1 year (relative risk [RR], 0.92; 95% CI, 0.66-1.29; P =.64). There were 15 patients (7.4%) in the experimental arm and 20 patients (10.3%) in the control arm who received repeated catheter ablation (RR, 0.72; 95% CI, 0.38-1.36). There were 14 patients (6.9%) in the experimental arm and 13 patients (6.7%) in the control arm with adjudicated serious adverse events. There was no difference between study arms regarding atrial arrhythmia-related emergency department visits or hospitalizations and no significant difference between arms in patient satisfaction scores or quality of life.

There was no influence on trial results with prespecified subgroup analyses. There was no difference in any primary outcome between patients who received high-power ablation (radiofrequency energy ≥45W) vs patients who received standard radiofrequency energy settings. Comparing the University of Ottawa site vs all other centers combined showed no difference in primary outcomes.

Significant study limitations include the insufficient sample size and lack of generalizability.

“In patients with paroxysmal AF, an ablation strategy using routine delivery of a second circumferential line of ablation did not show any additional benefit in preventing AA [atrial arrhythmia] recurrence at 1 year,” the researchers wrote. “This is consistent with prior research in catheter ablation in patients with persistent AF, where empirical adjunctive ablation strategies failed to reduce AA recurrence.”

Disclosure: This research was supported by Biosense Webster, part of the Johnson & Johnson Family of Companies. 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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Wayne A. Ray, Ph.D., from the Vanderbilt University School of Medicine in Nashville, Tennessee, and colleagues compared risk for bleeding-related hospitalizations during treatment with amiodarone versus flecainide or sotalol in a retrospective cohort study. Data were included for 91,590 patients aged 65 years or older with atrial fibrillation who initiated use of anticoagulants and antiarrhythmic drugs: 54,977 with amiodarone and 36,613 with flecainide or sotalol.

The researchers observed an increase in the risk for bleeding-related hospitalizations with use of amiodarone (rate difference, 17.5 events per 1,000 person-years; hazard ratio, 1.44). No increase was seen in the incidence of ischemic stroke or systemic embolism. The risk of death with recent evidence of bleeding was higher than that seen for other deaths (risk difference, 9.1 versus 5.6 events per 1,000 person-years; hazard ratio, 1.66 versus 1.15). The increased incidence of bleeding-related hospitalizations was higher for rivaroxaban than for apixaban (risk difference, 28.0 versus 9.1 events per 1,000 person-years).

“These findings, consistent with pharmacokinetic data and case reports, suggest that bleeding risk should be considered in the management of rhythm control medications,” the authors write.

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

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Investigators sought to explore changes over time in incidence rates of AF, treatment approaches, and AF hospital readmission (primary or secondary diagnosis for in-patient or emergency room visit following primary AF visit) rates in patients aged younger than 65 years.

They conducted a retrospective cohort study using Danish nationwide registries and data from 2000 through 2018 to identify 60,917 patients aged between 18 and 65 years with a first AF diagnosis. Patients were categorized according to the following calendar periods:

• 2000 to 2002; n=8150 (13.4%)
• 2003 to 2006; n=11,898 (19.5%)
• 2007 to 2010; n=13,560 (22.3%)
• 2011 to 2014; n=14,167 (23.3%)
• 2015 to 2018; n=13,142 (21.5%)

There was similar burden of comorbidities, age, and sex distribution in all 5 calendar periods.  Across calendar periods, 73.2% of patients were admitted with AF as primary diagnosis and 26.8% of patients were admitted with AF as a secondary diagnosis.

Patients with previous AF diagnosis; those that had filled prescriptions of OAC in the 6 months prior to AF diagnosis; those that had prescriptions of dronedarone, amiodarone, digoxin, or flecainide prior to the AF diagnosis; those with prior catheter ablation for AF; and those with congenital heart disease or mitral valve stenosis were excluded.

There was a stepwise increase in the crude incidence rate of AF across the following calendar periods:

• 2000 to 2002 (78.7 per 100,000 person years; 95% CI, 77.0-80.4)
• 2003 to 2006 (86.3 per 100,000 person years; 95% CI, 84.7-87.8)
• 2007 to 2010 (97.9 per 100,000 person years; 95% CI, 96.3-99.6)
• 2011 to 2014 (102.3 per 100,000 person years; 95% CI, 100.7-104.0)

The increase was not observed in 2015 to 2018 (93.6 per 100,000 person years; 95% CI, 92.0-95.2).

There was a stepwise increase in cumulative incidence of OAC treatment within 3 months after AF diagnosis from 2000 to 2002 (28.5%) through 2015 to 2018 (47.8%; P_{for trend} ≤.0001). Among patients treated with OAC, 44.8% had a CHA2DS2-VASc score of 0, 20.2% had a score of 1, and 35.0% had a score of more than 1.

Incidence of OAC treatment within 3 months before and after ablation increased from 2000 to 2002 (54.3%) through 2015 to 2018 (95.5%; P_{for trend}≤.0001).

There was a stepwise increase in cumulative incidence of electrical cardioversion from 2000 to 2002 (2.0%) through 2015 to 2018 (8.7%; P <.0001). There was also a stepwise increase in cumulative incidence of catheter ablation within 1 year of AF diagnosis from 2000 to 2002 (1.2%) through 2015 to 2018 (7.6%; P <.0001). Among all patients receiving catheter ablation (n=2562), 15.1% had a heart failure (HF) diagnosis within 2 years prior to catheter ablation. Incidence of 1-year AF readmission showed no differences across time.

Study limitations include a lack of data on critical clinical factors and AF type and duration.

“In a nationwide cohort from 2000 to 2018 examining patients under 65 years of age, we found an increment in the incidence of AF over calendar time,” the study authors wrote. “The use of catheter ablation, electrical cardioversion, and OAC treatment increased throughout the study period.”

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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Individuals with AF have an elevated risk of developing dementia. It has been posited that varying mechanisms, including hypoperfusion, systemic inflammation, cerebral ischemia, and microbleeds, perform in a synergistic way and contribute to the cognitive decline observed among individuals with AF.

Even though AF has been linked mainly to vascular dementia, recent brain imaging studies have reported increased amyloid deposition in patients with AF, thus implying that degenerative subtypes of dementia, such as AD, are associated with AF as well.

For the study, researchers explored the relationship between dementia subtype and risk for adverse outcomes among individuals with AF via use of the TriNetX global federated database of electronic medical records (EMRs).

The researchers used the TriNetX research network to examine the inclusion of patients with AF between ages 18 and 80.

Participants with AF were classified into 1 of 2 groups, based on the occurrence of AD or vascular dementia, with the groups balanced via the use of propensity score matching (PSM). The dates selected in the study permitted 4 years of follow-up within the participating HCOs. Outcome measures were as follows:

• ICH
• Composite of ischemic stroke/transient ischemic attack (TIA)
• Hospitalizations
• All-cause mortality

A total of 2,377 individuals with AF and a dementia diagnosis were identified, with 1,225 patients (mean age, 66.0±6.4; 37.3% women) diagnosed with vascular dementia and 1,152 patients (mean age, 67.9±6.1 years; 43.7% women) diagnosed with AD.

The researchers found that patients who had AF and AD were significantly older
(P <.001), primarily of non-Hispanic White ethnicity, and presented with a lower cardiovascular (CV) risk profile (ie, lower prevalence of hypertension, heart failure, ischemic heart disease, and diabetes) compared with those with AF and vascular dementia (P <.05 for all).

After the application of PSM, a total of 615 patients were included in each of the 2 cohorts. Incident ICH was reported among 3.6% (22 of 615) of patients with AF and vascular dementia vs 8.9% (55 of 615) of those with AF and AD during the 4 years of follow-up. The risk for ICH was greater among patients with AF and AD than among those with AF and vascular dementia (hazard ratio [HR], 2.22; 95% CI, 1.33-3.70; log-rank P =.002).

Over the 4-year follow-up period, 38.5% (237 of 615) of participants with vascular dementia and AF vs 31.4% (193 of 615) of those with AD and AF experienced an ischemic stroke/TIA. The risk for ischemic stroke/TIA was 1.32-fold higher among those with vascular dementia and AF compared with those with AD and AF (HR, 1.32; 95% CI, 1.09-1.59; log-rank P = .003).

Over 4 years, 66.0% (406 of 615) of patients with AF and vascular dementia vs 62.1% (382 of 615) of those with AF and AD were hospitalized. The risk for being hospitalized was 1.14-fold higher among participants with vascular dementia and AF than among those with AD and AF (HR, 1.14; 95% CI, 1.01-1.31; log-rank P = .048). Additionally, mortality was higher among individuals with AF and vascular dementia compared with those with AF and AD (HR, 1.25; 95% CI, 1.01-1.58; log-rank P = .049).

“Considering our results, there is a need for a more holistic or integrated care approach to patients with AF, which has been associated with an improved clinical prognosis,” the researchers noted. “Such an integrated management should also consider dementia risk, as it not only impacts on cognitive decline and quality of life but also on the risk of other subsequent worse clinical outcomes.”

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

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Xiaowei Xue, from Fudan University in Shanghai, and colleagues conducted a nationwide, case-crossover study in China between 2015 and 2021 to examine the association between exposure to air pollution and onset of acute symptomatic arrhythmia. Data on hourly concentrations of six air pollutants — fine particles (PM_2.5), coarse particles (PM_2.5-10), nitrogen dioxide (NO₂), sulfur dioxide (SO₂), carbon monoxide (CO), and ozone — were included. For each of 190,115 patients with acute onset of symptomatic arrhythmia, the case period was matched to three or four control periods during the same hour, day of week, month, and year.

The researchers found air pollution to be associated with an increased risk for symptomatic arrhythmia onset within the first few hours of exposure; after 24 hours, this risk was substantially attenuated. In the first 24 hours after exposure, an interquartile range increase in PM_2.5, NO₂, SO₂, and CO was associated with significantly higher odds of atrial fibrillation (1.7 to 3.4 percent), atrial flutter (8.1 to 11.4 percent), and supraventricular tachycardia (3.4 to 8.9 percent). Exposure to PM_2.5-10 was associated with elevated odds of atrial flutter and supraventricular tachycardia (8.7 and 5.4 percent, respectively), while exposure to ozone correlated with elevated odds of supraventricular tachycardia (3.4 percent).

“Our study adds to evidence of adverse cardiovascular effects of air pollution, highlighting the importance of further reducing exposure to air pollution and of prompt protection of susceptible populations worldwide,” the authors write.

Abstract/Full Text

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A meta-analysis compared the efficacy and safety of minimally invasive surgical off-pump ablation, including the thoracoscopic and transdiaphragmatic or subxiphoid approaches to CA.

Researchers conducted a search of multiple databases up to March 2022. Eligible studies were 2-armed studies published in English that compared minimally invasive surgical off-pump ablation, including the hybrid approach, and CA alone, and reported restoration to sinus rhythm (SR) as the primary outcome. The systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

The primary endpoint was freedom from AF based on reconstructed IPD.

A total of 21 studies with 2234 patients were included in the analysis. Of these patients there were 1070 in the minimally invasive surgical off-pump ablation group (mean age, 58.8±5.1 years; 78.6% men) and 1164 in the CA group (mean age, 59.3±5.0 years; 74% men). The studies were published from 2011 to 2021, 9 were randomized controlled trials, 4 were propensity-matched studies, and 8 were observational studies. The pooled mean follow-up was 16.8±7.5 months.

The minimally invasive surgical off-pump ablation and CA groups had similar outcomes for postoperative cerebrovascular accident (CVA) incidence (odds ratio [OR], 2.00; 95% CI, 0.91-4.40; P =.084), postoperative permanent pacemaker (PPM) implant (OR, 1.55; 95% CI, 0.61-3.95; P =.358), and 30-day mortality (OR, 1.96; 95% CI, 0.90-4.22; P =.087). The total number of postoperative adverse events was greater in the minimally invasive surgical off-pump ablation group vs the CA group (OR, 4.44; 95% CI, 2.38-8.27; P <.001).

Survival freedom from AF was analyzed in 19 studies, with 1021 patients in the CA group and 892 in the minimally invasive surgical off-pump ablation group. Freedom from AF at 4 years was 29.1%±3.5% in the CA group vs 52.1%±3.2% in the minimally invasive surgical off-pump ablation group (log-rank P <.001).

Significant improvement in survival freedom from AF was observed in the minimally invasive surgical off-pump ablation group vs the CA group after 5 months of follow-up in the landmark analysis (2 months from the blanking period; log-rank P-value =.044). Minimally invasive surgical off-pump ablation was a protective factor for AF in univariable weighted estimation Cox regression (hazard ratio, 0.60; 95% CI, 0.50-0.72; P <.001).

In the thoracoscopic subgroup, freedom from AF at 3 years was 48.4%±3.0% vs 66.9%±2.5% for CA and minimally invasive surgical off-pump ablation, respectively (log-rank P <.0001). For the transdiaphragmatic subgroup, freedom from AF at 3 years was 34.5%±4.2% vs 54.1%±4.2% for CA and minimally invasive surgical off-pump ablation, respectively (log-rank P =.00062).

Among several limitations, nonrandomized trials were included in the analysis, and the 2 patient groups significantly differ in the proportion of patients who had a history of a previous ablation and type of AF. In addition, most of the data are from centers that are highly experienced in performing minimally invasive surgical off-pump ablation, and the rhythm follow-up of the included studies was limited with few exceptions.

“Despite the superiority of the surgical approach for the primary endpoint, MISOA [minimally invasive surgical off-pump ablation] is associated [with] higher postoperative complications compared to CA,” stated the investigators. “However, postoperative CVA and PPM implantation did not significantly differ between the 2 groups.”

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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Investigators from the Chongqing Traditional Chinese Medicine University searched publication databases through December 2021 for randomized controlled trials evaluating post-surgical POAF prevention strategies.

A total of 27 articles were included in this analysis. The studies were conducted primarily in the European Union, North America, and Asia and the most recent study was published in 2016.

The pooled study population comprised 14,442 patients who had received CABG or valvular surgeries. The active interventions included dexamethasone, methylprednisolone, and hydrocortisone.

Risk for POAF was decreased more with glucocorticoid therapy (relative risk [RR], 0.80; 95% CI, 0.71-0.92; P =.001) compared with the control group.

In a subgroup analysis, low-dose (<100 mg) dexamethasone significantly reduced POAF risk (RR, 0.81; 95% CI, 0.71-0.92; I², 59.3%; P =.001) whereas high-dose (³100 mg) dexamethasone did not (RR, 0.81; 95% CI, 0.56-1.19; I², 69.8%; P =.286). Glucocorticoid therapy reduced POAF risk in patients who received CABG only (RR, 0.71; 95% CI, 0.58-0.87; I², 26.3%; P =.001).

Glucocorticoid use was not associated with infection risk (RR, 0.85; 95% CI, 0.68-1.06; I², 38.3%; P =.158) or gastrointestinal injury (RR, 1.12; 95% CI, 0.83-1.50; I², 0.0%; P =.450).

The limitations of this analysis include the pooling of corticosteroid treatments, the observed heterogeneity, and the lack of recent large studies.

“The results of this study showed that glucocorticoids were beneficial in reducing the effect of POAF, and low-dose glucocorticoids could reduce the incidence of POAF,” the study authors wrote. “However, heterogeneity of overall study and subgroup analysis was high, so we held a cautious recommendation. Our study also did not find that glucocorticoids use increased the risk of infection and gastrointestinal injury.”

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Data for this study were sourced from the Clinical Practice Research Datalink (CPRD) database that has been collecting patient information from over 700 general practices in the United Kingdom since 1987. For this study, patients (N=142,227) aged older than 50 years with incident atrial fibrillation (AF) diagnosed between 1988 and 2017 were evaluated for dementia risk through 2019.

The study population comprised individuals with a mean age of 74.9 (SD, 10.0) years, 47.5% were women, 24.1% were obese, 67.0% had hypertension, and 20.4% were taking 12 or more classes of medications.

Within the first 3 months after AF diagnosis, 59,226 individuals used OACs and 83,001 did not.

Among the OAC users, there were 4354 dementia events during a 380,947 person-year follow-up and for the non-users, 3669 dementia events during a 281,719 person-year follow-up. Overall, after adjusting for 54 covariates, risk for dementia was decreased among OAC users compared with non-users (adjusted hazard ratio [aHR], 0.88; 95% CI, 0.84-0.92). Dementia risk tended to decrease with duration of use from 2 or fewer (aHR, 0.90; 95% CI, 0.84-0.95) to more than 5 (aHR, 0.88; 95% CI, 0.81-0.95) years of OAC use.

In subgroup analyses, risk for dementia was decreased for OAC users who had ischemic stroke or transient ischemic attack (aHR, 0.82), were aged 75 years or older (aHR, 0.84), did not have chronic kidney disease (aHR, 0.87), had a CHA₂DS₂-VASc score of 2 to 9 (aHR, 0.87), had a CHADS₂ score of 0 to 1 (aHR, 0.88), and were men (aHR, 0.90) compared with their non-OAC user counterparts.

Stratified by type of dementia, OAC use was associated with lower risk for Alzheimer disease (HR, 0.90; 95% CI, 0.82-0.99) and unspecified dementia (HR, 0.77; 95% CI, 0.71-0.83) but not for other dementia subtypes.

Similar findings that OAC therapy decreased risk for dementia were observed in a sensitivity analysis with antiplatelet use as an active comparator (aHR, 0.87; 95% CI, 0.83-0.92) and in a propensity-matched analysis (aHR, 0.85; 95% CI, 0.81-0.89).

The results of this study may be limited as no data about treatment compliance are available.

“…when balancing the risks and benefits of OAC use in these patients, the potential benefit of OACs in preventing dementia is an important consideration for the management of NVAF,” the study authors wrote.

The post Oral Anticoagulant Therapy for Atrial Fibrillation Decreases Dementia Risk appeared first on The Cardiology Advisor.

Cardiovascular research findings have consistently demonstrated a range of disparities in cardiovascular disease (CVD) risk factors, outcomes, and quality of care among women compared with men.¹ Among the ongoing gaps in this area, numerous studies have highlighted various sex-based differences in patients with atrial fibrillation (AF).

In a 2022 retrospective cohort study of 327 patients who presented to the emergency department with AF¸ results showed several differences between women and men in terms of baseline characteristics, treatment strategies, and outcomes. Women were significantly older than men (mean age, 69.30±11.9 [27–91] vs 57.79±14.8 [21–87], respectively; P <.001) and had higher rates of thyroid dysfunction (18.3% vs 1.8%; P <.001) and several other comorbidities including valvular heart disease, hypertension, and diabetes.²

After adjusting for age and comorbidities, women showed higher rates of heart failure hospitalization (odds ratio [OR], 2.73; 95% CI, 1.04–5.89; P <.001) and recurrent AF (OR, 3.86; P =.02) compared with men.²

In terms of treatment differences, antiarrhythmic medications were used less often in women vs men (24.0% vs 42.8%; P <.001), rate control medications were used more often than antiarrhythmic medications in women (P <.001), and catheter ablation was performed at higher rates in men (63.6%) vs women (36.4%).²

For the overall sample, thyroid dysfunction (OR, 5.95; 95% CI, 3.15-9.73; P <.001) and lack of antiarrhythmic therapies (OR 3.42; 95% CI, 1.81-6.46; P <.001) were associated with an increased risk for AF.² 

These results align with those of numerous other studies demonstrating greater morbidity and treatment disparities in women with AF, including less frequent use of cardioversion and catheter ablation and worse outcomes with stroke prevention measures.^3,4 In addition, researchers have observed a higher risk for stroke (and more severe strokes) and death, as well as worse symptoms and quality of life, in women vs men with AF.^3,5 

Factors Linked to Sex-Based AF Disparities

“There might be biological differences in terms of the effect of AF on the heart—for example, it may cause more heart failure in women because of the combined risk of AF and heart failure associated with hypertension,” said Louise Pilote, MD, MPH, PhD, FRCPC, professor of medicine at McGill University in Montreal, deputy director of the Research Institute of the McGill University Health Centre, and co-author of a 2022 study regarding sex-based disparities in AF research and guidelines.⁴

Hormonal mechanisms, specifically the impact of changing estrogen levels throughout the reproductive lifespan, have also been implicated in sex-based AF disparities. In a 2022 population-based cohort study of 235,191 women without AF at baseline, the risk for new-onset AF was higher in those with a history of irregular menstrual cycle, early or late menarche, early or delayed menopause, no live births, and 7 or more live births, after adjustment for multiple confounding variables.⁶

“These results underscored the importance of taking into account the reproductive history of women when developing tailored screening strategies for AF prevention in women,” wrote the study authors.⁶

Dr Pilote added, “Gender-related factors such as caregiving responsibility also affect women more than men and prevent them from seeking the care they need or adhering to medications for AF.”

Regarding the stroke findings in particular, disparities likely stem from multiple factors. “Since women are older when they get AF, they tend to have more comorbidities such as hypertension, diabetes, and heart failure, which increases their risk for strokes,” explained Annabelle Santos Volgman, MD, FACC, FAHA, theMcMullan-Eybel Endowed Chair of Excellence in Clinical Cardiology and professor of medicine at the Rush University Medical College in Chicago, and medical director of the Rush Heart Center for Women.

Women are also not receiving anticoagulation therapy as often as men “for various reasons such as physicians not prescribing anticoagulants,⁴ perhaps due to fear of an increased bleeding risk,” she said in an interview with Cardiology Advisor.

Closing the Gap

An overarching factor driving some of the ongoing sex-based disparities in AF is the relative lack of research focused on women with AF. As Dr Pilote and colleagues noted in their study, women are significantly underrepresented in AF studies, especially randomized controlled trials, and thus the evidence that shapes clinical practice guidelines on AF management are insufficient to inform sex-specific recommendations.⁴ 

On a related note, Michos et al recently found that women are also underrepresented in clinical AF trial leadership, and they stated that increasing such representation could ultimately increase the number of women enrolled in these trials as well.⁷ 

There is a clear need to increase participation of women in AF research, Dr Pilote told Cardiology Advisor: “We need to enroll sufficient numbers of women in AF trials to know that results apply to women. For example, do women require a different dose of anticoagulants than men?”

On the clinical level, physicians should “explain the importance of using anticoagulants to decrease the risk of strokes, and they should refer patients to cardiac specialists who can keep them in a normal rhythm instead of letting them stay AF,” Dr Volgman advised. “Additionally, women need to be informed of the importance of measures to prevent AF, such as controlling their blood pressure, being on the right medications for heart failure, and having awareness of potential AF triggers such as alcohol and poor blood pressure control.”

Physician Q&A: Salvatore Savona, MD

To gain further insights into sex-based disparities in AF, we interviewed Salvatore Savona, MD, clinical assistant professor in cardiac electrophysiology at The Ohio State University Wexner Medical Center in Columbus.

What does the available evidence suggest about differences in AF in women compared with men?

AF is the most commonly encountered arrhythmia and can affect men and women differently. Prior studies have shown that women with valve disease may be more likely to develop AF, whereas coronary disease may be more prevalent in men.² The previously published Women’s Health Study has also shown an increased risk of developing AF with the number of pregnancies.⁸ Prior large studies including the Euro Heart Study on Atrial Fibrillation and the ORBIT-AF Registries have found that women present with AF later in life, with worse quality of life, and may have less typical symptoms.^9,10

Women in these and other studies were also less likely to have received a rhythm control strategy. In regards to stroke prevention, women had lower rates—up to 33% lower—of prescribed anticoagulation in the PINNACLE National Cardiovascular Data Registry.¹¹ Additionally, women prescribed warfarin have higher rates of stroke compared to men, though the rates are similar with direct oral anticoagulation therapy. Regarding catheter ablation, early studies showed a higher rate of complications with procedures, though this seems to have improved with the use of ultrasound-guided access and transeptal puncture.⁴

What are some of the proposed mechanisms driving these differences?  

There are many proposed mechanisms to explain the differences in AF between men and women. Prior MRI studies have shown that there is a high fibrotic burden in women compared to men.¹² Additionally, there are QT differences in men and women at baseline, and studies have also shown QT differences on ECG based on hormone changes, such as during menopause. This may result in less utilization of anti-arrhythmic therapy.¹³

Additionally, women have been underrepresented in cardiology trials, therefore they may present later in the time course of their disease, with more advanced disease. Regarding higher stroke risk while on warfarin, it is theorized this may be related to less time being therapeutically anticoagulated. Additionally, women appear to have more nonpulmonary vein triggers for AF, which may result in more complicated procedures.¹²

What are implications for cardiologists in terms of special screening and treatment considerations for women with AF?  

The most feared complication from AF is a stroke, and patients should be thoroughly assessed for stroke risk at the time of AF diagnosis. This should be guided by the CHA₂DS₂-VASc score as outlined in the current AF guidelines.¹⁴ Additionally, there should be an early assessment of symptoms, especially more atypical symptoms such as fatigue and shortness of breath. This may allow for early intervention to prevent adverse remodeling from persistent AF. More data is suggesting that an early rhythm control strategy is helpful to prevent progression to persistent and permanent AF, highlighting the importance of early intervention.

What additional measures are needed to improve the care of women with AF? 

As ablation strategies evolve and new energy delivery techniques—such as pulsed field ablation, for example—become utilized, it will be paramount to ensure women are represented in trials and post-approval studies to ensure procedural risks are mitigated.¹⁵ More patient education is also necessary so that patients do not dismiss symptoms that may be related to AF. Additionally, ongoing research into the drivers and mechanisms for AF and fibrosis will continue to be important to understand previously reported sex differences in patients with AF.

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Patients were recruited from 27 hospitals in Thailand between 2014 and 2020 into the COOL-AF Thailand (Cohort of Antithrombotic Use and Optimal International Normalized Ratio Level in Patients with Nonvalvular Atrial Fibrillation in Thailand) registry, a multicenter, prospective cohort of patients with nonvalvular AF.

A total of 3461 patients with AF were recruited into the COOL-AF Thailand registry. Of the individuals eligible for study inclusion, 2340 patients were taking warfarin and 228 were taking NOACs. The average participant age was 68.8±10.7 years. Overall, 72.5% of the patients had hypertension and 54.2% had renal disease.

Results of the study showed that, among the participants, 13.0% of those taking warfarin and 9.2% of those taking NOACs met the efficacy outcome. Additionally, 6.6% of those taking warfarin and 4.8% of those taking NOACs met the safety outcome.

Following adjustment for confounders, overall, warfarin-treated participants reported significantly more secondary outcomes compared with NOAC-treated participants (11.4% vs 7.5%, respectively; adjusted hazard ratio, 1.74; 95% CI, 1.10-2.99; P =.045), regardless of SAMe-TT₂R₂  score.

The most notable limitation of this study is the fact that a low event rate is reported for CV death in the warfarin group, whereas no CV death is reported in the NOAC group. Thus, a much larger study population might be needed to examine CV death more accurately as an outcome variable. Additionally, the results may not be generalizable.

“AF patients taking warfarin had a significantly higher rate of CV death or IS/TIA/SE or major bleeding compared to those taking NOACs regardless of SAMe-TT2R2 score,” the study authors wrote.

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Researchers evaluated the perceptions and approaches of physicians who are typically involved in the decision-making process of LAAO. They randomly identified 500 physicians for each of the following specialty areas: general cardiologists, interventional cardiologists, electrophysiologists, and vascular neurologists.

Surveys were mailed to participants as many as 3 times between November 9, 2021, and January 14, 2022. The survey included 28 questions regarding experiences, perceptions, approaches, and a patient vignette. The physicians were randomly assigned to 1 of 4 versions to assess potential disparities in decision-making: White man, White woman, Black man, and Black woman.

Among 122 responders, 59.8% considered “procedural risks and complications” as reasons to limit their recommendations for LAAO, and 42.6% considered “limiting efficacy data comparing LAAO to non-vitamin K oral anti-coagulants (NOACs)” as a reason to limit their recommendations. Nearly all responders (97.5%) considered evidence from randomized controlled trials (RCTs) as extremely or very useful, and 29.5% believed this for observational studies.

The 3 leading reasons for considering LAAO were a history of intracranial bleeding (94.3%), a history of major extracranial bleeding (91.8%), and gastrointestinal lesions (59.0%). The 3 main reasons for withholding LAAO were other indications for long-term oral anticoagulation (87.7%), low bleeding risk (77.0%), and low stroke risk (65.6%).

No difference in decision-making according to patients’ race (P =.73), sex (P =.12), or combination of race and sex (P =.30) was observed according to the patient vignette, which indicated no unconscious bias against women or minority groups. Of the responders who performed LAAO, 83.8% would consider NOACs after the device was implanted.

“In the first US national physician survey, we found considerable variations in perceptions and approaches related to the practice of LAAO,” the researchers conclude. “Future RCTs are needed to close the evidence gaps and establish consistent best practices for this important device therapy.”

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.

The post Physician Perceptions Vary Regarding Left Atrial Appendage Occlusion for AF appeared first on The Cardiology Advisor.

Researchers assessed the relationship between gendered social determinants of health and adverse outcomes among patients with AF with use of data from the European Society of Cardiology–European Heart Rhythm Association EURObservational Research Programme in AF General Long-Term Registry. Social determinants of health included factors such as education, living alone, smoking, alcohol use, gender inequality index (GII), physical activity, and quality of life measures.

The outcome measure was a composite of major adverse cardiovascular events and all-cause death.

The analysis included 11,096 patients (mean [SD] age, 69.2 [11.4] years; 40.7% women), with a median CHA₂DS₂-VASc score of 3 (IQR, 2-4). A majority of participants had secondary education, did not live alone, did not smoke or use alcohol, were physically inactive, had a moderate quality of life score, and lived in countries with gender equity.

After adjustment, multivariate analysis showed that higher education (odds ratio [OR], 0.80; 95% CI, 0.66-0.97), not living alone (OR, 0.82; 95% CI, 0.70-0.97), and having at least moderate weekly physical activity (OR, 0.71; 95% CI, 0.60-0.85) were associated with a reduced risk of adverse outcomes.

An increased GII reflecting greater gender inequity was associated with poorer outcomes (OR, 1.18; 95% CI, 1.07-1.30) for each increment of 0.1 in GII. Female patients had a reduced risk (OR, 0.85; 95% CI, 0.73-0.98), although this effect was reversed in countries that had a higher GII (OR, 1.14; 95% CI, 1.00-1.30; P_interaction = .049).

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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Investigators sought to assess when patients with TOF should receive PVR and PVR’s impact on the development of subsequent ventricular tachycardias.

They conducted a meta-analysis that included 12 studies (N=1740) with patients with concomitant TOF and the development of ventricular arrhythmias following initial repair. The investigators aimed to compare patients with TOF who received late PVR after initial repair vs patients with no further intervention. The effect of age and time to PVR on incidence of ventricular arrhythmias was assessed with meta-regression analysis.

The investigators found almost 60% lower cumulative incidence of ventricular arrhythmias in patients with late PVR vs patients without PVR (odds ratio, 0.40; 95% CI, 0.22-0.73; P <.003) among patients with TOF. There were similar results in random and fixed effect models.

There was a significant reduction in difference in means of right ventricular end-diastolic volume (RV-EDV) after PVR (random-effects model: -1.44; standard error, 0.188; P <.0001). Following late PVR, patients with a reduction in RV-EDV experienced significant reduction in ventricular arrhythmia frequency.

Using metaregression, the investigators noted statistically significant coefficients for changes relative to preoperative RV-EDV in postoperative RV ejection fraction and postoperative quality rating system (QRS) but not for ventricular tachycardia. They noted relative to preoperative QRS, statistically significant coefficients for changes in postoperative RV-EDV and postoperative RV ejection fraction, but not for incidence of ventricular tachycardia.

“For patients with TOF and survival after repair, there was a markedly higher rate of ventricular arrhythmias in patients who never received PVR compared to patients who had late PVR,” the investigators wrote.

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The success of an ablation procedure depends, in part, on diagnosis-to-ablation time and is an important predictor for freedom from AF. Despite this relationship, it remains unclear what the relationship is between diagnosis-to-ablation time and postablation AF recurrence.

To better understand this relationship, investigators from Thomas Jefferson University in the United States and Dow Medical College in Pakistan searched publication databases through August 2022 for studies evaluating the effect of diagnosis-to-ablation time on AF recurrence at 1 and 3 years.

A total of 8 studies comprising 16,093 patients were included in the analysis. All studies were of observational design and were published between 2013 and 2022.

Among the 7 individual studies that compared outcomes for diagnosis-to-ablation time of 1 or fewer years with outcomes for longer than 1 year, 5 significantly favored shorter diagnosis-to-ablation time (risk ratio [RR] range, 0.61-0.86). In the pooled meta-analysis, diagnosis-to-ablation time at 1 or fewer years was associated with decreased risk for postablation AF recurrence (RR, 0.76; 95% CI, 0.66-0.86; I², 82%; P <.0001).

In the 3 studies that compared outcomes after diagnosis-to-ablation time at 3 or fewer years with outcomes for longer than 3 years, all 3 favored shorter diagnosis-to-ablation time (RR range, 0.75-0.82). Similarly, in the meta-analysis, the shorter diagnosis-to-ablation time was associated with a lower risk for AF recurrence (RR, 0.77; 95% CI, 0.72-0.83; I², 0%; P <.00001).

Limitations of this study include the few available studies and the lack of any randomized controlled trials evaluating the relationship between diagnosis-to-ablation timing and AF recurrence.

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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CABANA (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation; ClinicalTrials.gov Identifier: NCT00911508), a randomized controlled trial to determine if ablation-based therapy for AF is more effective than drug-based therapy in relation to cardiac arrest, serious bleeding, disabling stroke, or death, revealed these major clinical outcomes were similar by sex. CABANA included 2204 patients (819 women) at 126 international clinical sites with new-onset or undertreated symptomatic AF who were enrolled between 2009 and 2016. All patients were either at least 65 years of age and younger with at least 1 risk factor for stroke.

Investigators sought to describe the effects of ablation vs drug therapy on QOL outcomes stratified by sex in the CABANA trial. There were 413 women and 695 men in the ablation group and 406 women and 690 men in the drug therapy group. The investigators used the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score to periodically evaluate symptoms over 60 months, and they used the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary and component scores to evaluate QOL. Overall, women were older (mean age, 69 years vs 67 years) and more symptomatic at baseline (42% vs 32% in New York Heart Association class II or III; 48% vs 39% in Canadian Cardiovascular Society class 3 or 4) than men.

Baseline QOL scores were lower for women vs men (mean AFEQT, 55.9 vs 65.6). Patients with ablation improved more than patients with drug therapy with similar treatment effect by sex. Mean AFEQT summary score for women was 81.5 for ablation vs 75.3 for drug therapy. Mean AFEQT summary score for men was 89.3 for ablation vs 84.1 for drug therapy (12-month mean adjusted AFEQT treatment difference: women 6.1 points [95% CI, 3.5-8.6]; men 4.9 points [95% CI, 3.0-6.9]).

Roughly 75% of women and 51% of men had severe AF symptoms at enrollment, with baseline AFEQT summary scores of less than 70. Overall, the greatest QOL improvement was seen in patients with baseline AFEQT scores of less than 70 (12-month mean treatment difference: women 7.6 points; 95% CI, 4.3-10.9; men 6.4 points; 95% CI, 3.3-9.4). The MAFSI frequency score between patients randomly assigned to ablation vs drug therapy also showed a difference by sex (12-month mean adjusted difference: women -2.5 [95% CI, -3.4 to -1.6]; men -1.3 [95% CI, -2.0 to -0.6]).

Report limitations include potential patient response bias and clinician procedural bias. There are also a large number of potential outcome comparisons of QOL assessment and no standard for identifying QOL.

“On average, women with AF in CABANA consistently reported moderate-to severe AF-related baseline impairments in QOL with lower baseline scores than those reported on average by men,” the study authors wrote. “Despite clinically effective ablation, however, women averaged persistently lower QOL scores than men despite a similar relative benefit from ablation and a similar distribution of symptoms.”

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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Previous studies have found that febuxostat increases AF risk among older adults with gout. However, the effects of ULTs on AF risk in gout are not well known among Asian populations.

Researchers of a retrospective cohort study aimed to study the incidence of AF after administering ULTs to Asian patients with gout.

Patients who received a gout diagnosis between January 2013, and December 2020 with a documented baseline serum uric acid level but no previous AF diagnosis were included in the study.

The outcome of interest was the development of incident AF during the follow-up period.

Of 713 patients with gout, 63 received allopurinol, 220 received benzbromarone, and 430 received febuxostat for more than 2 months.

Researchers did not observe a difference in risk for incident AF with all 3 ULTs. Follow-up (mean, 49.4±26.6 months) assessment revealed that 6% (n=43/713) of patients developed incident AF. Febuxostat and benzbromarone was not significantly correlated with an increased adjusted hazard ratio (HR) for incident AF (HR, 1.20; 95% CI, 0.43-3.34 and HR, 0.68; 95% CI, 0.22-2.08, respectively).

Patients who received febuxostat vs the other ULTs had an increased risk for stroke (P <.001) and a higher prevalence of chronic kidney disease (P <.001), diabetes mellitus (P <.001), and heart failure (P <.05).

The study authors noted several limitations, including the potential bias attributed to confounding variables; the lack of a control group; the lack of electrocardiographic data; the potential for gout misdiagnoses in some participants; the inability to determine accurate drug adherence; and possible selection bias due to the use of hospital records.

Researchers concluded, “There was no difference in the risk of incident AF among Asian patients with gout who received febuxostat, allopurinol, or benzbromarone.” However, they noted, “Further studies are needed to evaluate long-term cardiovascular outcomes in patients receiving different ULT drugs.”

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Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently. The Company believes that by avoiding cytochrome P450-mediated interactions, tecarfarin may potentially have an improved safety profile over warfarin.

The investigational treatment has been evaluated in 11 human clinical trials in over 1000 patients, including a phase 2/3 trial (EmbraceAC; ClinicalTrials.gov Identifier: NCT00691470), which included 607 patients with indications for chronic anticoagulation. Patients were randomly assigned to receive either tecarfarin or warfarin, with dose adjusted based on international normalized ratio (INR). Findings showed that the time in therapeutic range was similar between the tecarfarin and warfarin groups. Thrombotic and major bleeding events occurred in 11 patients treated with warfarin and 5 patients treated with tecarfarin.

Tecarfarin was also compared with warfarin in a phase 1 study that enrolled 23 patients with chronic kidney disease (CKD). Findings from this trial demonstrated that among CKD patients, the metabolism of warfarin was inhibited, while with tecarfarin, it was not.

The Company is expected to begin a randomized, double-blind, placebo-controlled phase 3 trial of tecarfarin (ACTOR-AF) in the second half of 2023. The study will include patients with both ESRD and AFib who are not currently on chronic oral anticoagulants.

“Patients with ESRD and AFib have not been well represented in clinical trials evaluating stroke prevention,” said Dr Sean Pokorney, an electrophysiologist, Assistant Professor of Medicine at Duke University, and Primary Investigator for the ACTOR-AF Tecarfarin versus placebo phase 3 Trial. “The development of tecarfarin is an exciting opportunity to collect randomized clinical trial data on stroke prevention in patients with ESRD and AFib, and tecarfarin provides a unique opportunity to optimize stroke prevention in patients with ESRD and AFib.”

The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.

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The investigators sought to evaluate the efficacy and safety of etripamil nasal spray when self-administered in patients with symptomatic, sustained PSVT. Intranasal etripamil is an investigational, fast-acting, nondihydropyridine, L-type calcium channel blocker that has been designed for unsupervised self-administration, in order to terminate atrioventricular nodal–dependent PSVT.

They conducted the phase 3, multicenter, double-blind, placebo-controlled NODE-301 study (ClinicalTrials.gov Identifier: NCT03464019). In the study, following a medically supervised etripamil test dose that was administered to individuals while they were in sinus rhythm, participants were randomly assigned in a 2:1 ratio to treatment with etripamil 70 mg or placebo. When symptoms of PSVT developed, participants applied a cardiac monitor and attempted the use of a vagal maneuver. If their symptoms continued, they self-administered a blinded treatment of either etripamil or placebo. Continuous electrocardiogram (ECG) readings were reviewed by an independent adjudication committee.

The primary efficacy endpoint of the study was termination of PSVT within 5 hours of administration of the study drug. The study population comprised individuals aged 18 years or older with ECG documentation of prior PSVT and a history of episodes that typically lasted for approximately 20 minutes or longer.

There were a total of 156 positive PSVT events that were treated with etripamil (n=107) or placebo (n=49). Results of the study showed that the hazard ratio (HR) for the primary outcome of time-to-conversion to sinus rhythm during the 5-hour observation period was 1.086 (95% CI, 0.726-1.623; P =.12).

Based on predefined sensitivity analyses, the effects of etripamil, compared with  placebo, occurred at 3, 5, 10, 20, and 30 minutes (P <.05). Despite not meeting the primary efficacy endpoint, evidence of an early treatment effect was demonstrated, which persisted through 30 minutes to approximately 60 minutes, compared with placebo. At 30 minutes, there was 53.7% of SVT conversion in the etripamil group, compared with 34.7% in the placebo group (HR, 1.87; 95% CI, 1.09-3.22; P =.02).

Treatment with etripamil was shown to be well tolerated, with a majority of adverse events limited to the administration site, and considered mild and transient. Adverse events that were reported in the etripamil and placebo treatment arms included nasal discomfort, nasal congestion, and oropharyngeal pain.

Some limitations of the study include the broad range of participant ages in the study, which likely reflects the known difficulties involved in recruiting participants for the 18- to 30-year-old age-group. Further, the lack of a specific time when the study drug should be taken after PSVT initiation might influence the conversion rate and the time to conversion in each group.

The authors wrote, “These findings support the ongoing clinical development of etripamil nasal spray for patient-actuated, on-demand, acute treatment of PSVT outside a health care environment.”

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

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Researchers sought to explore the prevalence of silent AF and associated risk factors in patients evaluated for OSA or those with known OSA. The current analysis was conducted in 2 sites — Zealand University Hospital in Denmark and 1 private ear, nose, and throat clinic in Slagelse, Denmark. Patients were assessed for OSA with the use of a type-3 portable sleep monitoring device. Heart rhythm was monitored at home for 7 days with use of an event-triggered loop recorder. All participants were divided into groups of mild, moderate, and severe OSA, according to the Apnea-Hypopnea Index (AHI).

The researchers found that in a cohort of 303 individuals, 78.5% (238 of 303) of them were diagnosed with moderate or severe OSA and 21.5% (65 of 303) of them with no or mild OSA, with the latter individuals comprising the control group. Among the 238 participants with moderate or severe OSA, AF was detected in 8.8% (21 of 238) of them, compared with 1.5% (1 of 65) of participants with mild OSA (P =.045).

Candidates for anticoagulation treatment were referred for additional CV therapy. The majority of patients had known hypertension (66%) and dyslipidemia (77.6%). In those individuals with moderate or severe OSA, (ie, AHI ≥15), hypertension was significantly more dysregulated (P =.005) and more patients had prediabetes (P <.001).

Limitations of the study include the lack of use of a polysomnography for evaluation of OSA. Additionally, the researchers did not utilize Holter monitoring.

“We believe our study supports the alignment of the systematic screening and management of potential comorbidities associated with OSA, especially silent AF, prediabetes and diabetes, hypertension and hyperlipidaemia, to the benefit of OSA patients in the future,” the researchers acknowledged.

They concluded, “We propose that long-period home-monitoring in these patients is useful for identifying candidates for preventive anticoagulation, cardiovascular treatment and possibly prevent future ischemic stroke.”

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AAs are increasingly common in advancing age among patients with TOF. Catheter ablation is generally more effective compared with antiarrhythmic drugs for the treatment of atrial flutter and intra-atrial reentrant tachycardia. Initial rhythm control management is preferred vs a rate control strategy for moderate and complex congenital heart disease (CHD), including TOF.

Among patients with TOF, catheter ablation can reduce AA frequency, improve symptoms, and be an effective treatment option when conducted by specialists in TOF anatomy. Surgical AA ablation during pulmonary valve replacement (PVR) may reduce the risk for future arrhythmia and could be considered in individual scenarios with a multidisciplinary heart team.

Key recommendations for evaluating and managing patients with TOF and bradyarrhythmia include treating reversible causes of bradyarrhythmia, using ambulatory monitors to correlate symptoms, using atrial pacemakers for symptomatic sinus node dysfunction, and using dual-chamber pacemakers for complete or advanced atrioventricular block.

VAs can occur in adults with TOF throughout their life span, with monomorphic ventricular tachycardia (VT) the predominant form of VA. The main mechanism of arrhythmia is macro-reentry, and for patients with repaired TOF, reentry occurs with a critical circuit traversing well-defined anatomic isthmuses.

Sudden cardiac death (SCD) is a leading cause of death for adults with TOF, although the annual risk of SCD in adults with repaired TOF is too low to justify invasive risk stratification or implantable cardioverter defibrillator (ICD) implantation for all patients, according to the researchers. Studies have been inconsistent regarding which noninvasive risk factors are associated with SCD.

Univariate analyses have shown that older patient age, older age at initial repair, and older age at PVR are associated with an increased VA risk. In addition, the surgical era effect has been suggested as a potential risk factor for VA and SCD. The mechanisms may be associated with prolonged cyanosis or extensive right ventriculostomy, which has been associated with an increased risk of VA.

Other research has shown that a QRS duration of 180 milliseconds or longer was strongly associated with VT and SCD and that fragmentation of the QRS complex is more common in patients with right ventricular dysfunction, fibrosis, or dyssynchrony and therefore may help identify patients with a risk for VA.

Patients who have VA, especially polymorphic VT that is not responsive to catheter ablation, may benefit from β-blockade. ICDs can effectively terminate VA but do not prevent it and are associated with complications such as high rates of ICD shocks, lead dysfunction, and infection. Radiofrequency catheter ablation may help control recurrent monomorphic VT and prevent ICD shocks.

The combination of valve replacement with surgical ablation guided by intraoperative VT mapping has resulted in a significant decrease in the rate of spontaneous monomorphic VT postsurgery. An empirical surgical ablation line that connects the boundaries of the isthmus at the time of PVR may be an alternative to mapping-guided ablation.

Nonfatal but symptomatic and sustained VT may occur despite effective surgery and excellent functional status. For this group of patients, ablation may be an alternative to medical treatment and ICD therapy if procedural endpoints have been achieved.

“Preventing sudden death remains one of the largest challenges in the care of adults with CHD,” the researchers wrote. “Although there has been progress in noninvasive and invasive risk stratification, there remains no widely accepted algorithm to identify patients who are at greatest risk of arrhythmia and warrant more aggressive treatment.”

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.

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Investigators from the Athens General Hospital in Greece searched publication databases through May 2022 for studies of PA among women with the outcome of AF risk. A total of 15 studies were included in this analysis.

The studies were conducted in the United States (n=7), South Korea (n=3), Norway (n=2), Sweden (n=1), the Netherlands (n=1), and the United Kingdom (n=1).

The studies evaluated PA using self-assessment (n=13) or a wearable device (n=2) and the studies defined AF by diagnosis (n=6), electrocardiogram (n=6), via medical records (n=2), or use of flecainide or sotalol (n=1).

The study population comprised 1,821,422 women and sample sizes ranged from 2675 to 1,023,895. The women had a median age of 36.8 to 78.2 years; however, 7 studies did not report age. Overall, the incidence rate of AF was 3.7% during follow-ups ranging from 3.5 to 20 years.

The relationship between PA and AF risk was nonlinear (P <.0001). The nonlinear relationship between PA and AF risk was still observed when low-quality studies were removed (P <.0001), when only studies that used METs to quantify PA were included (P <.0001), or when MET hours were subtracted or added to PA categories (P <.0001). All comparisons had low to moderate heterogeneity (I² range, 13.7%-45.1%).

In the final analysis, the J-shaped dose response curve indicated that risk for incident AF increased when PA levels reached 70 to 80 MET-h/w (P <.0001; I², 78.5%), indicating that a PA level of 50 MET-h/w can likely be safely recommended for women to reduce their future AF risk.

The major limitation of this analysis is that most studies quantified PA by self-reported questionnaires and not by objective measures.

“In this systematic review and meta-analysis we demonstrated that weekly PA is inversely associated with the risk for future AF in the female general population,” the study authors wrote. “This relationship is far from being a straightforward linear dose-response effect; even low levels of regular exercise can provide comparable benefit to that seen in highly active individuals.”

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The DELIVER (Dapagliflozin Evaluation to Improve Lives of Patients with Preserved Ejection Fraction Heart Failure; ClinicalTrials.gov Identifier: NCT03619213) trial is an event-driven, randomized, double-blind, controlled. Recognizing that the presence of atrial fibrillation (AF) is common among individuals with heart failure (HF) and is associated with worse outcomes compared with sinus rhythm, investigators sought to explore the effects of dapagliflozin based on the presence or absence of AF.

Patients were aged 40 years or older, had a diagnosis of HF for 6 weeks or longer and at least intermittent use of a diuretic agent, were New York Heart Association functional class II to IV, had left ventricular ejection fraction of more than 40%, had evidence of structural heart disease, and had a N-terminal pro-B-type natriuretic peptide concentration of 300 pg/mL or more. Both hospitalized and ambulatory patients were eligible for study enrollment.

A total of 6261 patients with HF who fulfilled all study criteria were randomly assigned to dapagliflozin or placebo. The primary study endpoint was a composite of cardiovascular (CV) death or worsening HF. The effects of dapagliflozin and clinical outcomes, based on an individual’s AF status, were evaluated.

Of the participants, 56.7% of them reported having AF at study initiation.

Results of the study showed that the risk for the primary endpoint was higher among participants with AF, in particular, among those with paroxysmal AF, which was driven by a higher rate of hospitalization for HF. In patients without AF the HF hospitalization rate per 100 person-years was 4.5 (95% CI, 4.0-5.1). In patients with paroxysmal AF the HF hospitalization rate per 100 person-years was 7.5 (95% CI, 6.4-8.7). In patients with persistent/permanent AF the HF hospitalization rate per 100 person-years was 6.4 (95% CI, 5.7-7.1; P <.001).

Findings showed that the benefit of dapagliflozin on the primary study outcome was consistent across all types of AF. In patients without AF the hazard ratio [HR] was 0.89 (95% CI, 0.74-1.08). In patients with paroxysmal AF the HR was 0.75 (95% CI, 0.58-0.97). In patients with persistent/permanent AF the HR was 0.79 (95% CI, 0.79; 95% CI, 0.66-0.95; P_interaction =.49).

Consistent effects were reported for CV death, all-cause mortality, hospitalization for HF, and improvement in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score.

Limitations of the study include that the evaluation of secondary and exploratory outcomes by AF status was conducted post hoc. Additionally, the prespecified inclusion and exclusion criteria in DELIVER prevents the enrollment of very high-risk patients, possibly impacting the generalizability of the study results.

“…the beneficial effects of dapagliflozin, compared with placebo, on clinical events and symptoms were not modified by AF at baseline, irrespective of definition or type of AF,” the study authors wrote. “These findings provide further evidence for dapagliflozin as a new treatment option for patients with HFmrEF/HFpEF.”

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

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