Background No adequately powered prospective studies have compared the safety and efficacy of rectilinear biphasic waveform (RBW) shocks and biphasic truncated exponential (BTE) shocks for direct current cardioversion of atrial fibrillation. The study objective was to compare the efficacy of first shock direct current cardioversion from atrial fibrillation to normal sinus rhythm using a full‐output 200J RBW synchronized shock or a full‐output 360J BTE synchronized shock. Methods This investigator‐initiated, open‐label, unblinded, randomized controlled trial was performed at 3 hospitals in the Inova Health System between July 2023 and July 2024. Adult patients with symptomatic atrial fibrillation were randomized 1:1 to full‐output shock using a 200J RBW or 360J BTE shock waveform defibrillator. ECGs were performed before and 1 minute after each shock and adjudicated by a board‐certified electrophysiologist blinded to treatment assignment. Skin pads were positioned in an anterolateral placement in all patients. Successful direct current cardioversion was defined as normal sinus rhythm on 12‐lead ECG obtained ≥1 minute after shock delivery. Results A total of 546 unique patients were eligible for randomization, 270 patients were randomized to a 200J RBW shock and 276 patients to a 360J BTE shock. Normal sinus rhythm ≥1 minute after first shock delivery occurred in 223/270 (82.6%) patients randomized to 200J RBW shock and in 233/276 (84.4%) patients randomized to 360J BTE shock ( P =0.565). Overall, there were no significant differences in the frequency of attaining normal sinus rhythm after multiple direct current cardioversion shocks or safety events between patients randomized to 200J RBW or 360J BTE shocks. Conclusions We observed no difference in safety or efficacy between full‐output RBW or BTE shocks for atrial fibrillation cardioversion. Registration URL: https://clinicaltrials.gov ; Unique Identifier: NCT05992623.
BACKGROUND:New technologies may affect efficacy, safety, efficiency, or cost of pulmonary vein isolation (PVI) ablation for atrial fibrillation (AF). OBJECTIVE:This study aimed to compare efficiencies and costs of radiofrequency (RF), over-the-wire (OTW) pulsed field ablation (PFA), and lattice tip dual energy (DE) ablation (RF/PFA) platforms in a real-world United States (US) clinical setting. METHODS:Patients aged ≥18 years undergoing PVI in 3 US hospitals between January 1, 2024, and November 14, 2025, were included. Univariable and multivariable linear regression analyses were performed to compare procedure time and costs across procedure platforms. RESULTS:Among 3173 PVI procedures, 2986 met inclusion and exclusion criteria. The unadjusted procedure time (minutes) was shorter with lattice DE 118 (interquartile range [IQR] 101-138) compared with RF 137 (117-163) or OTW PFA 135 (IQR 112-163), (P < .001 for both comparisons). There was no difference in median procedure time for OTW PFA compared with RF (P = .12). In multivariable analysis, lattice DE (-31 (IQR -33 to -28) minutes/case) and OTW PFA (-9 [IQR -12 to -5] minutes/case) were associated with a reduction in median procedure time compared with RF (P < .001 for both comparisons). OTW PFA ($3600 (IQR $3413-$3884) per case) and lattice DE ($4469 (IQR $4327-$4611) per case) were independently associated with increased cost per case compared with RF, (P < .001 for comparison.) CONCLUSION: Use of a lattice DE is associated with AF ablation efficiency improvements sufficient to perform additional procedure volume that partially offsets increased technology costs. OTW PFA was associated with increased cost and insufficient efficiency improvements to allow for increased procedure volume.
Atrial fibrillation (AF) is increasing in incidence, prevalence, and lifetime risk, and contributes to substantially greater health care costs and increased risks of stroke, heart failure, and mortality. Improving adherence to evidence-based recommendations equitably in AF is critical to advancing clinical care, patient outcomes, and public health. The writing committee developed a comprehensive set of 5 performance measures, which are appropriate for public reporting or pay-for-performance programs, and 16 quality measures, which are useful to clinicians and health care organizations for quality improvement. The writing committee selected the measures from the strongest recommendations (Class 1 or 3) in the “2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation.” The purpose of the writing committee’s performance measures is meant to ensure that patients with newly diagnosed AF receive a basic clinical evaluation, with an emphasis on secondary prevention for patients at all stages of AF, documenting stroke risk, and, if indicated, providing appropriate anticoagulation. AF quality measures cover a variety of topics including measuring and addressing health inequities, optimizing antiarrhythmic or anticoagulant treatment, engaging in shared decision-making for rate- versus rhythm-control strategies, and, in appropriate patients, offering catheter ablation for those with heart failure with reduced ejection fraction. The performance and quality measures are intended to advance the quality and equity of AF care across all patient populations with AF.
INTRODUCTION:Changes in tricuspid regurgitation (TR), mitral regurgitation (MR), and left ventricular ejection fraction (LVEF) are frequently noted after right ventricular apical (RVA) pacemaker implantation but prior studies evaluating whether left bundle branch area (LBBA), deep septal (DS), or leadless pacemaker implantation modify risk for those changes are limited. This study aims to compare changes in TR, MR, and LVEF after implantation of RVA, LBBA, DS, and leadless pacemakers. METHODS:Patients were included if they underwent de novo pacemaker implantation for sinus node dysfunction or atrioventricular block and received pre- and post-implant echocardiography. Change in TR, MR, and LVEF were analyzed using post-hoc adjusted Kruskal-Wallis and Chi-squared testing, and multivariable ordinal logistic regression. RESULTS:Among 386 consecutive patients (RV, n = 185; LBBA, n = 122; DS, n = 43, leadless, n = 36) the change in TR grade differed between pacemaker types (median [interquartile range] grade change: RVA 0[0,1], leadless 0[0,1], DS 0[0,1], LBBA 0[0,0]; p = 0.01). In multivariable ordinal logistic regression, leadless (OR 2.41, p = 0.01) and DS pacemakers (OR 2.44, p < 0.01) predicted TR worsening compared to LBBA. The change in MR grade also differed between pacemaker types (grade change: RVA 0[0,1], leadless 0[0,1], DS 0[0,0], LBBA 0[-1,0]; p = 0.03). The change in LVEF differed between pacemaker types (LVEF change: RVA -3[-9,3]%, leadless -5[-14,1]%, DS -3[-11,0]%, LBBA -1[-5,5]%; p < 0.01). CONCLUSION:The change in TR and MR grade and LVEF following pacemaker implant varied by pacemaker type. Compared to implantation with RVA, leadless, and DS pacemakers, LBBA pacemaker implantation was associated with more favorable changes in valvular and ventricular function.
Background Catheter ablation (CA) for atrial fibrillation (AF) is a widely used treatment strategy in patients with and without heart failure (HF). Objective To evaluate patient characteristics, ablation strategies, and complications of CA for AF by HF status. Methods We conducted a retrospective analysis of patients undergoing CA between 2016 and 2022 from the National Cardiovascular Data Registry. Patients were grouped by: HF with reduced ejection fraction (HFrEF), HF with preserved EF (HFpEF), and no HF. Multivariable logistic regression was used to assess complication risk. Results Among 75,527 patients, 51,285 had no HF, 13,625 had HFrEF, and 10,617 had HFpEF. HF groups had a higher prevalence of hypertension, diabetes, and coronary disease. Patients with HFrEF received more adjunctive ablation than patients HFpEF or no HF, including linear (32%, 29.3%, and 23.4%, respectively) and cavotricuspid isthmus ablation (33.1%, 30.2%, and 30.1%, respectively) (P < .0001). Complication rates were higher in HFrEF (4%) and HFpEF (3.8%) vs no HF (2%), with adjusted odds ratios (HFrEF: OR, 1.80; P < .0001; HFpEF: OR, 1.42; P < .0001). Complication rates declined from 2016 to 2022 across all groups (HFrEF: 5.2% to 2.9%, P = .0002; HFpEF: 5.9% to 3.0%, P < .0001; no HF: 2.8% to 1.6%, P < .0001). Ablation volume increased from 2018 to 2022 by 138% (HFrEF), 191% (HFpEF), and 113% (no HF). Conclusion Patients with HFrEF and HFpEF have more comorbidities, undergo more adjunctive ablation, and experience higher complication rates. Despite this, ablation volumes rose and complications declined across all groups over time.
BACKGROUND:Leadless pacemakers have transformed pacing by reducing risk for infection and lead-related complications. The feasibility of achieving leadless Bachmann's bundle area pacing (BBAP) for atrial resynchronization is not known. FIRST-IN-HUMAN SUMMARY:A 49-year-old woman with sinus node dysfunction and interatrial conduction delay underwent leadless atrial pacemaker targeting Bachmann's bundle (BB). Using intracardiac echocardiography and electrographic mapping, the pacemaker was positioned at the BB region. Reduced right atrium-to-lateral left atrium conduction time and paced P wave duration were confirmed. DISCUSSION:Right atrial appendage pacing may exacerbate interatrial conduction delay and promote atrial fibrillation. BBAP using a leadless atrial pacemaker, in contrast, has been shown to enhance atrial synchrony. NOVELTY:This case demonstrates the first-in-human permanent implantation of a leadless pacemaker in the BB area, providing a strategy for leadless atrial resynchronization. TAKE-HOME MESSAGE:Leadless BBAP may offer a physiological approach to atrial conduction system pacing by improving atrioventricular dromotropy and reducing subsequent risk for atrial fibrillation.
Heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF) have emerged as major age-related epidemics within cardiology. Both conditions carry overlapping symptomatology, and delineating between AF and HFpEF from a diagnostic standpoint is challenging as echocardiographic and biomarker assessments used to diagnose HFpEF may be impacted by AF. Indeed, these two conditions are commonly found in the same individual, so much so that AF has been used in proposed diagnostic criteria for HFpEF. The frequent concomitant presence of these two conditions is associated with poorer quality of life, exertional capacity, as well as increased risk for decompensated heart failure and all-cause mortality. Though these deleterious effects of AF in HFpEF patients are well described, we currently have only a superficial understanding of the complex interplay between these two conditions. Preliminary studies on intervening in AF in HFpEF are very small, with mixed data on whether modifying the natural history of AF can lead to improvement in heart failure (HF) outcomes in HFpEF. In this review, we will describe the clinical implications of carrying both cardiovascular conditions, address recent advances in HFpEF and AF, and highlight preliminary studies targeted at reduction of effects associated with AF burden in HFpEF.