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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.
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Background: Pulmonary vein isolation (PVI) is a common therapeutic approach for symptomatic atrial fibrillation (AF). Among various techniques, cryo-balloon (CB) PVI is widely adopted, but, to date, established CB systems have had fixed balloon sizes. A novel size-adjustable CB, allowing balloon size adjustments during ablation, lacks sufficient data on optimal utilization in patient care. This study aims to systematically investigate this feature with a tailored ablation protocol. Methods: Our single-center prospective study included patients with paroxysmal or persistent atrial fibrillation undergoing first-time PVI with the size-adjustable CB from July 2023 to February 2024. Ablation was performed using the balloon size that provided better occlusion. The ablation protocol involved an initial occlusion test with the small balloon size (28 mm). If optimal occlusion (occlusion level 4) could not be achieved, an attempt with the larger balloon (31 mm) was initiated. Ablation was conducted using the balloon configuration that provided better occlusion of the pulmonary vein ostium. Results: Our prospective study includes 50 patients (median age [interquartile range, IQR]: 72 [65; 79] years, 24 [48.0%] females, and 35 [70.0%] patients with paroxysmal AF). The median procedure duration (IQR) was 77 (65; 96) minutes, and the median fluoroscopy time (IQR) was 17.7 (12.5; 22.0) min. PVI was successfully accomplished in each treated pulmonary vein (PV), with 87.4% of PVs isolated during the first freeze. The large balloon configuration was used to isolate 16.8% of PVs. Conclusions: The utilization of the size-adjustable CB, combined with the presented tailored ablation workflow, appears to facilitate effective and efficient pulmonary vein isolation. The use of a larger balloon configuration appears beneficial in isolating a significant proportion of the PVs.
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Background/Objectives: Single-shot devices are important tools for efficient pulmonary vein isolation (PVI) in atrial fibrillation (AF). In addition to the standard cryo-balloon (CB) catheter, a novel multi-electrode radiofrequency balloon-catheter (RFB, Heliostar, Biosense Webster, Irvine, CA, USA) with 3D-mapping-integration is available. Currently, there is no evidence allowing for a direct comparison between RFB-PVI and CB-PVI in a matched population. The study aimed to assess the procedural data, safety profiles, and outcomes of RFB-PVI versus CB-PVI. Methods: In this prospective registry study, symptomatic AF patients undergoing first-time PVI from January 2019 to April 2023, using RFB or CB, were included, with patients matched in a 1:2 ratio to reduce potential confounders. Results: The results from 171 consecutive RFB patients and 342 matched CB patients showed comparable recurrence-free survival after 12 months (81.3% RFB vs. 76.8% CB, p = 0.359). The RFB group had a longer procedure duration (88 vs. 73 min, p < 0.001) and longer fluoroscopy time (18.9 vs. 14.5 min, p < 0.001). Conclusions: In conclusion, the novel RFB system enables efficient and safe PVI, which is broadly comparable to the established CB system. However, the 3D-mapping integration in RFB did not reduce fluoroscopy time compared to CB.
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Pulmonary vein isolation (PVI), as the cornerstone of atrial fibrillation (AF) ablation, has emerged a widely used therapy for patients suffering from AF. To improve PVI efficiency, single-shot catheters (SSCs) have been developed. Regrettably, SSCs are not integrated into 3D-mapping technology. In that regard, a novel radiofrequency balloon catheter (RFBC, Heliostar, Biosense Webster) with full integration into 3D-mapping technology has been developed. The aim of this study was to assess operative and follow-up outcomes of the RFBC in AF patients. In this monocentric prospective registry, patients with a first-time PVI using the RFBC were included. Follow-up visits were scheduled 3, 6, 12 and 24 months after ablation and in case of symptoms. A total of 171 patients (36.8% female) were included, with a mean age of 68.5 ± 10.2 years. Among them, 63 patients (36.8%) presented with persistent AF. Notably, no major periprocedural complications were observed. The mean follow-up period was 287 ± 157 days. In the Kaplan-Meier analysis, the estimated recurrence-free survival after 12 months was 81.8%. Based on our data, PVI with the fully 3D-mapping-integrated RFBC seems to be safe and effective and to have a favorable 12-month outcome in patients with paroxysmal and persistent AF.
