Zero-exchange workflow for cryoballoon ablation in pulmonary vein isolation using a direct over-the-needle transseptal access with the FlexCath sheath: A multicenter observational study.

IF 3.7 3区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Kardiologia polska Pub Date : 2025-04-03 DOI:10.33963/v.phj.105344

Piotr Denysiuk, Marcin Szczasny, Milena Stachyra, Joanna Popiolek-Kalisz, Magdalena Stadnik, Jarosław Wojcik, Piotr Blaszczak, Andrzej Glowniak

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引用次数: 0

Abstract

Background: Transseptal puncture (TSP) is a crucial step during cryoballoon ablation (CBA) allowing for left atrium access. During the procedure an over-the-wire sheath exchange is required, which brings concerns about the exchange-related complications. An alternative option is performing the TSP through a steerable sheath and thus avoiding the exchange.

Aims: We aimed to evaluate the feasibility, efficacy and safety of a simplified zero-exchange workflow for CBA procedure.

Methods: Patients undergoing CBA (with Arctic Front Advance Pro, Medtronic) at 3 centers in Poland were prospectively enrolled and assigned to the standard approach (N=62) or the no-exchange group (N=62). The TSP in the standard approach group was performed through a fixed-curve sheath that was exchanged for a 15F steerable sheath (FlexCath Advance, Medtronic). In the no-exchange group the puncture was performed through the steerable sheath.

Results: TSP was successfully performed in all patients. In the no-exchange group compared to the standard approach group the median (IQR) procedure time and left atrium dwell time were significantly shorter (75.0 (60.0 - 90.0) min vs 80.5 (70.0 - 100.0) min; P = 0.02 and 47 (40.0 - 56.0) min vs 51.5 (43.25 - 64.5) min, P = 0.04 , respectively) with comparable median (IQR) fluoroscopy time (14.0 (8.5 - 20.4) min vs 12.25 (10.0 - 17.6) min, P = 0.74). Only one potentially TSP-related complication has occurred in each group.

Conclusion: A direct TSP with the FlexCath Advance sheath is a feasible, safe and efficient alternative to the standard approach.

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背景：经房间穿刺（TSP）是冷冻球囊消融术（CBA）中进入左心房的关键步骤。在手术过程中，需要进行线外鞘管交换，这带来了交换相关并发症的担忧。目的：我们旨在评估 CBA 手术零交换简化工作流程的可行性、有效性和安全性：在波兰的 3 个中心接受 CBA（使用 Arctic Front Advance Pro，美敦力公司）手术的患者均为前瞻性入组，并被分配到标准方法组（62 人）或无交换组（62 人）。标准方法组的 TSP 是通过固定曲线鞘进行的，该鞘被换成了 15F 可转向鞘（FlexCath Advance，美敦力公司）。结果：结果：所有患者都成功进行了 TSP 穿刺。与标准方法组相比，无交换组的中位（IQR）手术时间和左心房停留时间明显缩短（75.0（60.0 - 90.0）分钟 vs 80.5（70.0 - 100.0）分钟；P = 0.02；47（40.0 - 56.0）分钟 vs 51.5（43.25 - 64.5）分钟，P = 0.04），透视时间中位数（IQR）相当（14.0（8.5 - 20.4）分钟 vs 12.25（10.0 - 17.6）分钟，P = 0.74）。两组患者均只发生了一起可能与 TSP 相关的并发症：结论：使用 FlexCath Advance 鞘直接进行 TSP 是一种可行、安全且高效的标准方法替代方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Kardiologia polska 医学-心血管系统

CiteScore

3.00

自引率

24.20%

发文量

431

审稿时长

3-6 weeks

期刊介绍： Kardiologia Polska (Kardiol Pol, Polish Heart Journal) is the official peer-reviewed journal of the Polish Cardiac Society (PTK, Polskie Towarzystwo Kardiologiczne) published monthly since 1957. It aims to provide a platform for sharing knowledge in cardiology, from basic science to translational and clinical research on cardiovascular diseases.