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Background: Pulsed field ablation (PFA) and very high-power short-duration (vHPSD) radiofrequency ablation are the most recently introduced technologies for atrial fibrillation (AF) ablation. The procedural performance, safety, and effectiveness of PFA vs vHPSD are currently unknown., Objective: The study aimed to compare PFA with vHPSD for the treatment of paroxysmal or persistent AF., Methods: We conducted an observational, multicenter study enrolling 534 consecutive patients (63 ± 9 years; 36% female) with paroxysmal (n = 368 [69%]) or persistent (n = 166 [31%]) AF undergoing ablation by either PFA (Farapulse; n = 192) or vHPSD (90 W/4 seconds; QDOT Micro; n = 342) between 2020 and 2023. Atrial tachyarrhythmia recurrence after a 1-month blanking period was the primary efficacy end point and was assessed both overall and in propensity score-matched patients. The primary safety end point was a composite of procedure-related complications., Results: Successful pulmonary vein isolation was achieved in all patients, with shorter procedure duration (PFA,70 minutes; vHPSD, 100 minutes; P < .001) but longer fluoroscopy time (PFA, 15 minutes; vHPSD, 7 minutes; P < .001) in the PFA group. PFA was associated with more frequent use of general anesthesia (P < .001). Primary safety outcome events occurred in 19 patients (3.5%), with similar prevalence in both groups (PFA, 4%; vHPSD, 3%; P = .745). After a median follow-up of 12 (9-12) months, survival free from recurrent atrial tachyarrhythmia was similar between the PFA and vHPSD groups, both overall (12-month estimate: PFA, 75%; vHPSD, 76%; log-rank P = .73) and in propensity score-matched patients (n = 342; 12-month estimate: PFA, 75%; vHPSD, 77%; log-rank P = .980)., Conclusion: In a large, multicenter experience, PFA was associated with more common use of general anesthesia, shorter procedural times, and longer fluoroscopy exposure compared with vHPSD ablation, with both techniques displaying superimposable safety and efficacy., Competing Interests: Disclosures A.D.R. is a consultant for Abbott Medical. M.A. is a consultant for Biosense Webster and Boston Scientific, is a clinical proctor for Medtronic, and has received educational grants from Abbott. M.C. has received speaker honoraria from Biosense Webster. All other authors declare no conflicts of interest., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study., Methods: Observational studies assessing failure-free estimates of transvenous ICD leads with KM method, were identified through a systematic search up to November 2021., Results: Forty-four studies were eligible that included 41,870 (63.1%) non-recalled leads and 24,493 (36.9%) recalled leads. The 8-year cumulative failure-free rate was 94.1% (CI, 93.6% - 94.6%) for contemporary non-recalled leads and 81.2% (80.3% - 82.0%) for recalled leads (hazard ratio [HR], 3.15 [2.85-3.47], p < 0.001). Failure-free rate was lower in single-center studies in both the non-recalled (HR, 0.28 [0.15-0.51], p < 0.001) and recalled (HR, 0.54 [0.33-0.88], p = 0.014) group compared with multicenter studies. Similarly, estimates were significantly lower in small (i.e. extracted KM curve with <312 leads) versus large studies (HR non-recalled group, 0.54 [CI, 0.33-0.89], p = 0.015; HR recalled group, 0.62 [CI, 0.43-0.89], p = 0.009)., Conclusions: In this meta-analysis including >66,000 leads, we provide pooled survival curves that may play a role in generating evidence-based standards for assessing clinically acceptable failure rates for ICD leads. Lead performance was underestimated with single-center and small-sized studies; multicenter studies remain the main tool to reliably conduct post-market surveillance of ICD leads., Competing Interests: Declaration of Competing Interest D.G. and A.G. are employees of BIOTRONIK Italia. All the remaining authors have no conflicts of interest to disclose., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). "Single-shot" ablation devices have been recently engineered., Objectives: We report on the safety and efficacy of a novel ablation catheter for PV isolation in patients with AF., Methods: One hundred eighty consecutive patients (58 ± 10 years, 125 male, 31% with structural heart disease) referred for paroxysmal (140) or persistent (40) AF underwent PV isolation by an open-irrigated mapping and radiofrequency (RF) decapolar ablation catheter in 7 centers. Ablation was guided by electroanatomic mapping, allowing RF energy delivery in the antral region of PVs from 10 irrigated electrodes simultaneously., Results: Mean overall procedure time was 113 ± 53 minutes with a mean fluoroscopy time of 13.1 ± 8.4 minutes. The use of a preablation PV imaging related to a significant reduction in fluoroscopy time (from 14.7 ± 9.7 to 8.7 ± 6.6, P < .001). Mean ablation time was 12.5 ± 5.1 minutes, and 98% of the targeted veins were isolated with a mean of 23.4 ± 6.3 RF pulses per patient. In only 4 patients (2.2%) a single-point ablation strategy was required to achieve PV isolation. One groin hematoma and 1 PV stenosis were reported. During a mean follow-up of 13.9 ± 8.2 months 38 of 140 patients (27%) with paroxysmal AF and 12 of 40 patients (30%) with persistent AF had an atrial arrhythmia relapse (P = .671)., Conclusions: In this multicenter registry, irrigated multielectrode RF ablation proved feasible, achieving a high rate of isolated PVs. Procedural and fluoroscopy times and success rates were comparable with other techniques, with a low complication rate., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)