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经导管主动脉瓣植入术后经皮瓣周漏封堵:国际 PLUGinTAVI 注册研究。

Percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international PLUGinTAVI Registry.

机构信息

Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network (UHN), Toronto, ON, Canada.

Department of Cardiology, Royal Papworth Hospital, Cambridge, UK.

出版信息

EuroIntervention. 2023 Aug 7;19(5):e442-e449. doi: 10.4244/EIJ-D-22-01110.

DOI:10.4244/EIJ-D-22-01110
PMID:37128805
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10397666/
Abstract

BACKGROUND

Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce.

AIMS

This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure.

METHODS

All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included.

RESULTS

Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%).

CONCLUSIONS

Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.

摘要

背景

经导管主动脉瓣置换术(TAVI)后经皮瓣周漏(PVL)封堵的安全性和长期有效性数据稀缺。

目的

本研究旨在介绍欧洲和北美的 14 家医院进行的经皮 TAVI 后 PVL 封堵的大型多中心国际经验。

方法

研究纳入了 2018 年 1 月至 2022 年 10 月期间在这 14 家医院接受经皮 TAVI 后 PVL 封堵的所有患者。

结果

共有 45 名患者(64%为男性)入组。中位年龄为 80 岁(75-84 岁)。其中,67%和 33%的患者分别接受了自膨式和球囊扩张式瓣膜植入。基线 TAVI 后 PVL 严重程度为 67%,中度为 33%。从 TAVI 到 PVL 封堵术的时间为 16.1(8.7-34.8)个月。大多数患者在手术前处于纽约心脏协会(NYHA)心功能 III 级和 IV 级(73%),40%的患者在 TAVI 和 PVL 封堵术之间因心力衰竭住院。94%的患者成功封堵了 PVL,91%的患者反流减少至≤轻度,其余患者减少至中度。Amplatzer 瓣周漏封堵器 III 型是最常使用的装置(27 例),其次是 Amplatzer 瓣周漏封堵器 4 型。严重不良事件发生率为 11%。无患者在住院期间死亡。在长期随访(21.7±16.2 个月)中,全因死亡率为 14%,患者的功能状态得到改善,心力衰竭住院率显著降低(从 40%降至 6%)。

结论

经皮 PVL 封堵术是治疗 TAVI 后瓣周漏的一种可行且安全的选择。成功将 PVL 减少至轻度或更低程度可能与急性和长期临床结局的改善相关。

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Eur Heart J. 2023 Apr 17;44(15):1331-1339. doi: 10.1093/eurheartj/ehad146.
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Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.经导管瓣周漏封堵术后临床成功的预测因素:一项国际前瞻性多中心注册研究。
Circ Cardiovasc Interv. 2022 Oct;15(10):e012193. doi: 10.1161/CIRCINTERVENTIONS.122.012193. Epub 2022 Oct 18.
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Paravalvular Leakages after Surgical Aortic-Valve Replacement and after Transcatheter Aortic-Valve Implantation: Strategies to Increase the Success Rate of Percutaneous Closure.外科主动脉瓣置换术后及经导管主动脉瓣植入术后的瓣周漏:提高经皮封堵成功率的策略
J Clin Med. 2022 May 25;11(11):2989. doi: 10.3390/jcm11112989.
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J Clin Med. 2022 Apr 1;11(7):1978. doi: 10.3390/jcm11071978.
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