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BACKGROUND: Ablation strategies for patients with symptomatic atrial fibrillation and isolated pulmonary veins vary and their effects on arrhythmia recurrence remain unclear. A prospective randomized German multicenter trial sought to compare 2 ablation strategies in this patient cohort. METHODS: Patients with atrial fibrillation despite durable pulmonary vein isolation were randomly assigned at 7 centers to undergo low-voltage area ablation using 3-dimensional mapping and irrigated radiofrequency current ablation (group A) or empirical left atrial appendage isolation (LAAI) using the cryoballoon followed by staged interventional left atrial appendage closure (group B). The primary end point was freedom from atrial tachyarrhythmias between 91 and 365 days after index ablation. The study was powered for superiority of LAAI compared with low-voltage area. RESULTS: Patients (40% women; mean age, 68.8±8 years) with paroxysmal (32%) or persistent atrial fibrillation (68%) were randomized to undergo low-voltage area ablation (n=79) or cryoballoon-guided LAAI (n=82). After a planned interim analysis, enrollment was halted for futility on January 10, 2023. In the LAAI group, 77 of 82 left atrial appendages were successfully isolated with subsequent left atrial appendage closure in 57 patients. Procedure-related complications occurred in 4 (5%) and 11 (13.5%) patients in group A and B, respectively (P=0.10). The median follow-up was 367 days (interquartile range, 359-378). The Kaplan-Meier point estimate for freedom from atrial tachyarrhythmias was 51.7% (CI, 40.9%-65.4%) for group A and 55.5% (CI, 44.4%-69.2%; P=0.8069) for group B. CONCLUSIONS: The current study did not detect superiority of cryoballoon-guided LAAI over low-voltage area ablation in patients with atrial fibrillation despite durable PVI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04056390.
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Background: Pulmonary vein isolation (PVI) is the standard of care for the treatment of symptomatic atrial fibrillation (AF). Novel techniques for PVI are the thermal size-adjustable cryo-balloon (CB) system and non-thermal pulsed field ablation (PFA) system. There are currently no data available for a direct comparison between these two systems. Furthermore, with new techniques, it is important to ensure a high level of efficiency and safety during treatment right from initial use. Therefore, the aim of this study was to directly compare the procedural data and safety of these two new PVI techniques in first-time users. Methods: We conducted a single-center prospective study involving 100 consecutive patients with symptomatic atrial fibrillation who underwent first-time PVI using either size-adjustable CB PVI or PFA PVI from July 2023 to March 2024. Results: Acute PVI was achieved in 100% of patients in both groups. First-pass isolation (FPI) was more frequently achieved in the PFA group compared to the size-adjustable CB group. The mean procedural duration and fluoroscopy dose were significantly shorter in the PFA cohort (p < 0.001). Furthermore, a significant reduction in fluoroscopy time was observed during the learning curve within the PFA group (p = 0.023). There were no major complications in both groups. Conclusions: Both systems demonstrate good effectiveness and safety during PVI performed by first-time users. However, the PFA group exhibited a significantly shorter procedural duration.
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Background: Complex arrhythmias often arise from the left side of the heart, necessitating established electrophysiological (EP) procedures like 3D-mapping-assisted radiofrequency (RF) ablations or pulmonary vein isolation (PVI). These procedures typically require transseptal access, emphasizing the critical role of achieving an optimal catheter position through a precise transseptal puncture (TSP). Commonly employed imaging methods for TSP guidance include fluoroscopy and interventional echocardiography. Despite their routine use, there is limited evidence on which imaging modality offers superior catheter positioning for EP procedures, and safety concerns regarding transseptal punctures with imaging remain underexplored. This study aims to systematically evaluate the feasibility, safety, and accuracy of echo-guided TSP compared to fluoroscopy-guided TSP. Methods: In this prospective study, 150 consecutive patients undergoing left atrial EP procedures were enrolled between October 2023 and February 2024 at the Ulm University Heart Center. Following optimal fluoroscopy-guided transseptal needle positioning at the interatrial septum, the catheter placement was further verified using transesophageal echocardiography (TEE). Adjustments were made in cases of suboptimal needle positioning observed in TEE. The fluoroscopically achieved septal positions were categorized based on TEE images as optimal, suboptimal, poor, or dangerous. Results: Among the 150 patients included (58.0% male), fluoroscopy achieved optimal, suboptimal, and poor/dangerous positions in 32.7%, 43.3%, and 24.0%, respectively. After TEE-guided adjustments, optimal and suboptimal positions were achieved in 59.3% and 40.7% of patients, respectively. No instances of poor or dangerous transseptal needle positions were observed under TEE guidance. Conclusions: TEE-guided TSP emerges as a feasible, more accurate, and safer imaging method for transseptal punctures in EP procedures.