Hu Feng, Xu Bin, Qiao Zhiqing, Cheng Fuyu, Zhou Zien, Zou Zhiguo, Zang Minhua, Ding Song, Hong Jun, Xie Yuquan, Zhou Yong, Huang JianFeng, Pu Jun
Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, 160# PuJian Road, Shanghai 200127, China.
Department of Cardiology, Ningbo Hangzhou Bay Hospital, Ningbo, Zhejiang, China.
Europace. 2023 Dec 6;25(12). doi: 10.1093/europace/euad349.
This study was performed to compare the usability, efficiency, and safety of a modified angioplasty guidewire-assisted transseptal puncture (TSP) technique vs. the conventional approach in facilitating access into the left atrium during left atrial appendage occlusion (LAAO) procedures for the treatment of atrial fibrillation.
The ADVANCE-LAAO trial (Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion) was an investigator-initiated, prospective, multicentre, randomized controlled trial (NCT05125159). Patients with atrial fibrillation who underwent LAAO were prospectively enrolled from four centres and randomly assigned to an angioplasty guidewire-assisted TSP group (n = 131) or to a conventional Brockenbrough needle TSP group (n = 132). The primary endpoint was the one-time success rate of TSP. We also analysed the TSP procedure time, failure rate of the assigned TSP type, radiation dose, contrast dose, and procedural complications in both groups. All patients in the guidewire-assisted group underwent successful TSP, whereas five in the standard conventional group switched to the guidewire-assisted approach. The guidewire-assisted puncture improved the one-time success rate (92.4 vs. 77.3%, P = 0.001), shortened the TSP procedure time (109.2 ± 48.2 vs. 120.5 ± 57.6 s, P = 0.023), and tended to have a higher rate of good coaxial orientation of the sheath with the left atrial appendage during the LAAO procedure (66.4 vs. 54.5%, P = 0.059). No TSP-related complications occurred in the guidewire-assisted TSP group, whereas two complications occurred in the conventional TSP group. There was no significant difference in the failure rate of the assigned TSP type, the total procedure time, the total radiation dose, the rate of successful LAAO implantation, or the procedural complication rate between the two groups (all P > 0.05).
This study confirmed that angioplasty guidewire-assisted puncture can effectively improve the success rate of TSP during LAAO procedures. This novel technique has high potential for application in interventional therapies requiring TSP.
本研究旨在比较改良血管成形术导丝辅助经房间隔穿刺（TSP）技术与传统方法在房颤治疗的左心耳封堵（LAAO）手术中进入左心房的易用性、效率和安全性。
ADVANCE-LAAO试验（血管成形术导丝辅助与传统经房间隔穿刺用于左心耳封堵）是一项由研究者发起的前瞻性、多中心、随机对照试验（NCT05125159）。接受LAAO的房颤患者从四个中心前瞻性纳入，并随机分配到血管成形术导丝辅助TSP组（n = 131）或传统Brockenbrough针TSP组（n = 132）。主要终点是TSP的一次性成功率。我们还分析了两组的TSP手术时间、指定TSP类型的失败率、辐射剂量、造影剂剂量和手术并发症。导丝辅助组的所有患者均成功进行了TSP，而标准传统组中有5例改为导丝辅助方法。导丝辅助穿刺提高了一次性成功率（92.4%对77.3%，P = 0.001），缩短了TSP手术时间（109.2±48.2秒对120.5±57.6秒，P = 0.023），并且在LAAO手术期间鞘管与左心耳的良好同轴定位率有升高趋势（66.4%对54.5%，P = 0.059）。导丝辅助TSP组未发生与TSP相关的并发症，而传统TSP组发生了2例并发症。两组在指定TSP类型的失败率、总手术时间、总辐射剂量、LAAO植入成功率或手术并发症发生率方面无显著差异（所有P>0.05）。
本研究证实血管成形术导丝辅助穿刺可有效提高LAAO手术期间TSP的成功率。这种新技术在需要TSP的介入治疗中具有很高的应用潜力。
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