Posterior wall ablation (PWA) is frequently performed during pulsed field ablation (PFA) of persistent atrial fibrillation (pe-AF), despite unclear evidence. We aim to study the safety and efficacy of PWA, compared to pulmonary vein isolation (PVI) alone, in this population. In this multi-center study, we included all patients with pe-AF who underwent PFA from April to November, 2024. Clinical records were retrospectively reviewed for demographics, procedural details, and clinical outcomes. During the study period, 387 patients with pe-AF underwent PFA (mean age 68.7 years, 32.0
Background Use of implantable cardioverter defibrillator (ICD) leads for left bundle branch area pacing (LBBAP) has relied on adaptation of conventional leads not designed for conduction system pacing (CSP). Objective This study aimed to evaluate the safety and effectiveness of a purpose-built CSP ICD lead designed for implantation within the LBBA. Methods The ASCEND CSP Investigational Device Exemption (IDE) trial is a prospective, multicenter, global, single arm, pivotal trial evaluating the UltiSynq CSP ICD lead (Model LDA1122Q) in patients undergoing de novo ICD or cardiac resynchronization therapy defibrillator (CRT-D) implantation. The primary safety end point was freedom from lead-related serious adverse device effects through 3 months, compared with a pre-specified performance goal of 88%. The primary effectiveness end point was the 3-month composite success rate of acceptable pacing capture threshold and R-wave sensing amplitude, with a performance goal of 80%. Defibrillation testing success was assessed in a pre-specified cohort. Results Among 205 implant attempts, 202 patients (98.5%), had successful lead implantation, with LBBAP criteria met in 99.0%. Among these, LBBP or likely LBBP capture criteria were met in 86.0%. The 3-month major complication-free rate was 97.5% and the primary effectiveness end point was achieved in 94.6%, exceeding both safety and effectiveness performance goals. Defibrillation testing was successful in 100%, with 92.5% defibrillated with a single 20 J shock. Lead electrical performance remained stable through 3 months. Conclusion In this pivotal IDE trial, a dedicated bipolar CSP ICD lead demonstrated high implant success, stable electrical performance, reliable defibrillation efficacy, and favorable short-term safety. Longer-term follow-up is warranted to confirm durability and sustained clinical benefit.
INTRODUCTION:The AVEIR DR pacemaker (Abbott) is a dual-chamber leadless pacemaker (LP) system that includes right atrial and right ventricular helix-fixation LPs (ALP, VLP), with atrioventricular synchrony maintained via wireless communication between the two devices. The initial, multi-center commercial implant experience of the AVEIR DR dual-chamber LP system has yet to be evaluated. METHODS:Patients indicated for dual-chamber pacing after US commercial release were consecutively included. Implant procedural characteristics were evaluated, and electrical parameters were measured during pre-fixation mapping, post-fixation tether mode, after LP release, and before patient discharge. Any acute procedure- or device-related complications within 30 days were noted. RESULTS:Patients were implanted with AVEIR DR per standard practice (N = 175 at 8 centers; 72 ± 11 years; 60% male; 62% sinus node dysfunction, 37% AV block; 83% de novo implants). ALPs were implanted predominantly in the base of the right atrial appendage (82%), VLPs in the mid-to-apical right ventricular septum (94%). Pre-fixation mapping allowed repositioning to be avoided in 95% of ALPs and VLPs. The total procedure duration was 64 ± 33 min, from initial incision to final suture, with a cumulative fluoroscopy duration of 13 ± 8 min. In both LPs, capture thresholds and sensed amplitudes improved significantly before patient discharge (ALP 1.2 ± 1.0 V, 2.1 ± 1.1 mV; VLP 0.8 ± 0.6 V, 9.5 ± 3.8 mV). At 30 days post-implant, 99% of patients were complication-free. CONCLUSION:The initial commercial experience of the helix-fixation, dual-chamber LP system demonstrated safe and efficient implantation with clinically acceptable electrical metrics and minimal acute complications.
BACKGROUND:Racial and ethnic disparities in catheter ablation (CA) utilization for atrial fibrillation have been reported, but inconsistent estimates complicate comparisons and understanding of root causes of disparity. OBJECTIVES:The purpose of this study was to quantify CA disparities by race/ethnicity, explore sources of heterogeneity, and offer recommendations for standardized definitions and methods to improve research. METHODS:We systematically searched MEDLINE, Embase, Web of Science, and Cochrane's CENTRAL from inception to January 15, 2024, for U.S.-based studies. Data were extracted on equity standards, cohort characteristics, methods, and risk of bias by 2 reviewers. We metaanalyzed cross-sectional and survival data separately using random effects models. We evaluated heterogeneity through qualitative synthesis, meta-regression, and sensitivity analyses. RESULTS:Eighteen studies were included. None explicitly defined disparity or the source of race/ethnicity data. The most common analytic approach estimated disparity as the residual direct effect of race/ethnicity after adjusting for confounders, but key confounders were missing. Only one study evaluated mediators of disparity through sensitivity analysis. Compared to non-Hispanic White patients, non-Hispanic Black (OR: 0.65; 95% CI: 0.58-0.74), Hispanic/LatinX (OR: 0.78; 95% CI: 0.73-0.83), and Asian (OR: 0.74; 95% CI: 0.54-1.0) patients were less likely to receive CA. There was a high degree of between-study heterogeneity, likely from differences in source population, methods, and risk adjustment. CONCLUSIONS:While evidence confirms racial and ethnic disparities in CA utilization for atrial fibrillation, significant heterogeneity exists across studies. Standardized disparity definitions and consistent covariate adjustment may help confirm the scale of disparities and identify underlying mechanisms to inform interventions.
BACKGROUND:Racial and sex disparities in catheter ablation (CA) utilization for atrial fibrillation (AF) have been documented. Less is known about race and sex differences in comorbidity burden and quality of care outcomes after CA. OBJECTIVES:We sought to characterize racial and sex differences in patient and procedural characteristics and their impact on prolonged length of stay (LOS) after CA for AF. METHODS:A retrospective cohort of patients that received CA for AF between 2018 and 2024 was developed from our single center NCDR registry. The analysis was restricted to non-Hispanic White (NHW) and non-Hispanic Black (NHB) patients due to small sample sizes for other groups. The association between race, sex, and prolonged LOS was evaluated using a multivariable stepwise regression model. A sensitivity analysis was performed with the composite outcome of complications given its sparsity. Causal mediation analysis was performed to assess whether race differences in prolonged LOS were mediated by complications. RESULTS:Between 2018 and 2024, 3345 patients were included in the cohort. NHB patients were younger and more likely to have Medicaid insurance, higher BMI, higher comorbidity burden, history of atrial flutter, prolonged LOS, and complications after ablation. They were less likely to have prior CA. Female patients were older, less likely to have private insurance and prior CA, and more likely to have paroxysmal AF, transient ischemic attack, and chronic lung disease. NHB race [aOR 1.90 (95% CI: 1.24-2.88), p = 0.003] and a composite outcome of procedural complications [aOR 156 (95% CI: 72.5-377), p < 0.001], but not sex, were independently associated with prolonged LOS. The effect of race on prolonged LOS was partially mediated by higher comorbidity burden and obesity among NHB, but not by complications, Medicaid status, or AF type. CONCLUSION:Prolonged LOS was more frequent among NHB patients undergoing CA. The higher odds of prolonged LOS among NHB patients was not mediated by a higher incidence of complications, suggesting that other factors like comorbidity burden and social determinants of health (SDOH) are more significant contributors. Policies focused on improving comorbidity management and addressing sociocultural disparities may reduce prolonged hospitalizations after CA for AF.
Cardiac physiologic pacing (CPP) after atrioventricular node (AVN) ablation for persistent atrial fibrillation (AF) has improved outcomes in patients with heart failure with reduced and preserved ejection fraction (HFpEF). Emerging evidence suggests patients with HFpEF benefit from higher heart rates, yet the optimal pacing rate after AVN ablation remains unknown. Optimal Pacing Rate for cardiac resynchronization therapy after atrioventricular node ablation in persistent Atrial Fibrillation and heart failure (OPT-RATE AF) is a prospective, randomized crossover study of patients with HFpEF after AVN ablation for persistent AF (NCT06445439). Approximately 60 patients with AF and AVN ablation, CPP, and HF with left ventricular ejection fraction ≥50% will be enrolled. Participants will be randomly assigned 1:1 to a pacing lower rate limit of 60 beats/min for 3 months and then switched to a rate of 80 beats/min for 3 months and vice versa. The primary end point is the change in exercise capacity assessed using the 6-minute walk test. Notable secondary outcomes will include changes in the Kansas City Quality of Life Questionnaire (KCCQ-12), creatinine and natriuretic peptide, and clinical events. Patient mortality and HF hospitalizations will be recorded at each phase. Electrocardiogram, echocardiogram, pacemaker interrogation, and primary and secondary outcomes will be recorded at baseline, 3 months, and 6 months. Study enrollment is ongoing and estimated to be completed by 2026. OPT-RATE AF is a randomized clinical trial that will determine the effect of a higher pacing rate in patients with persistent AF and HFpEF after AVN ablation and/or CPP. Study findings will provide insight on the role of chronotropy in improving quality of life and other important cardiovascular outcomes.