一种用于心房心律失常消融的新型聚焦晶格尖端导管，可在脉冲场能量和射频之间切换：来自真实世界多中心注册研究的结果。

A novel focal lattice-tip catheter toggling between pulsed field energy and radiofrequency for atrial arrhythmia ablation: Results from a real-world, multicenter registry.

作者信息

Vetta Giampaolo, Della Rocca Domenico G, Sarkozy Andrea, Menè Roberto, Pannone Luigi, Almorad Alexandre, Sorgente Antonio, Betancur Andres, Marcon Lorenzo, Mouram Sahar, Stroker Erwin, Doundoulakis Ioannis, Eltsov Ivan, Kariki Ourania, Del Monte Alvise, Overeinder Ingrid, Audiat Charles, Nakasone Kazutaka, Sousonis Vasileios, Zaher Wael, Bala Gezim, Letsas Kostantinos P, Combes Stephane, Sieira Juan, Efremidis Michael, Boveda Serge, de Asmundis Carlo, Chierchia Gian-Battista

机构信息

Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, Brussels, Belgium.

出版信息

Heart Rhythm. 2025 Jul;22(7):e13-e22. doi: 10.1016/j.hrthm.2024.12.021. Epub 2024 Dec 16.

DOI:10.1016/j.hrthm.2024.12.021

PMID:39694305

Abstract

BACKGROUND

A novel focal lattice-tip catheter allowing the delivery of either pulsed field (PF) or radiofrequency (RF) energy has recently received regulatory approval. The technology features a proprietary 3-dimensional electroanatomic mapping system.

OBJECTIVE

We describe the first real-world and multicenter experience.

METHODS

Consecutive AF patients undergoing first-time or redo atrial tachyarrhythmia ablation with the Affera system were prospectively enrolled at 3 different centers. PF was the only energy source allowed when ablating the posterior left atrium; anterior applications were performed with either RF (PF/RF strategy) or PF (PF/PF strategy) on the basis of the operator's preference. The primary efficacy end point included acute electrical isolation of pulmonary veins and posterior wall or bidirectional block in case of linear lesions.

RESULTS

The study included 130 patients (mean age, 67 ± 10 years; 63.8% [n = 83] male; 61.5% [n = 80] nonparoxysmal AF; 55.4% first-time AF ablation). First-time pulmonary vein isolation was performed in 72 patients: RF/PF in 13 (18.1%) patients and PF/PF in the remaining 59 (81.9%); first-pass isolation for pulmonary vein and posterior wall was achieved in 100% of cases. A total of 289 ablation lines were performed (roof line, 91 patients; inferior line, 83 patients; anterior mitral line, 32 patients; posterior mitral line, 45 patients; cavotricuspid isthmus line, 38 patients). First-pass isolation and primary efficacy end point were 96.2% (roof line, 100%; inferior line, 100%; anterior mitral line, 96.9%; posterior mitral line, 84.4%; cavotricuspid isthmus, 92.1%) and 100%, respectively. We had 2 (1.5%) major complications: 1 ST-segment elevation at the inferolateral leads requiring intracoronary administration of nitrate and 1 complete atrioventricular block.

CONCLUSION

Catheter ablation with a novel 9-mm lattice-tip catheter confirmed high efficacy and safety in a real-world scenario.

摘要

背景

一种新型的聚焦点阵式导管最近获得了监管批准，该导管可用于输送脉冲场（PF）或射频（RF）能量。该技术具有专有的三维电解剖标测系统。

目的

我们描述了首次真实世界多中心的应用经验。

方法

在3个不同中心前瞻性纳入连续接受首次或再次心房快速心律失常消融治疗的房颤患者，使用Affera系统。消融左心房后壁时，PF是唯一允许使用的能量源；根据术者偏好，前壁消融可使用RF（PF/RF策略）或PF（PF/PF策略）。主要疗效终点包括肺静脉急性电隔离以及在线性消融时后壁双向阻滞。

结果

该研究纳入了130例患者（平均年龄67±10岁；男性63.8%[n = 83]；非阵发性房颤61.5%[n = 80]；首次房颤消融55.4%）。72例患者进行了首次肺静脉隔离：13例（18.1%）患者采用RF/PF策略，其余59例（81.9%）采用PF/PF策略；100%的病例实现了肺静脉和后壁的首次隔离。共进行了289条消融线（房顶线，91例患者；下腔线，83例患者；二尖瓣前壁线，32例患者；二尖瓣后壁线，45例患者；腔静脉峡部线，38例患者）。首次隔离和主要疗效终点分别为96.2%（房顶线，100%；下腔线，100%；二尖瓣前壁线，96.9%；二尖瓣后壁线，84.4%；腔静脉峡部，92.1%）和100%。我们有2例（1.5%）主要并发症：1例下侧壁导联ST段抬高，需要冠状动脉内注射硝酸酯类药物；1例完全性房室传导阻滞。