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经 Evolut 自膨式瓣膜行经导管主动脉瓣置换术中多次重新定位的临床影响。

Clinical impact of multiple resheathing during transcatheter aortic valve implantation with Evolut self-expanding valves.

机构信息

Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Department of Cardiovascular and Pulmonary Sciences, Università Cattolica del Sacro Cuore, Rome, Italy.

出版信息

Int J Cardiol. 2024 Sep 1;410:132218. doi: 10.1016/j.ijcard.2024.132218. Epub 2024 May 28.

Abstract

BACKGROUND

The possibility to resheath some transcatheter heart valves (THV) facilitates the optimization of self-expandable devices implantation. However, resheating manoeuvres (expecially when repeated) increase the interaction between the transcatheter prosthesis and the patient's tissues potentially causing side-effects.

AIMS

To assess the clinical outcomes of resheathing at midterm follow-up with a focus on the safety of multiple resheathing.

METHODS

This retrospective observational study included all consecutive patients who underwent TAVI with a self-expandable supra-annular THV between December 2018 and December 2022. Primary endpoint was a composite of cardiovascular (CV) mortality, neurological events, non-fatal acute myocardial infarction and CV rehospitalizations. All clinical endpoints were assessed according to VARC-3 criteria.

RESULTS

469 TAVI procedures with self-expandable supra-annular THV were included in the study. The attempt to resheath and the resheath manoeuvres number was prospectively recorded into an electronic database. Resheating was attempted in 253 (53.9%) cases; 1, 2 and ≥ 3 resheathing were performed in respectively 122 (26.0%), 63 (13.4%) and 68 (14.5%) procedures. At a median follow-up of 640 days (interquartile range 340-1033 days), the incidence of the primary endpoint did not differ between 0 vs. ≥1 (22.7 vs. 26.1%, LogRank p = 0.584) and < 3 vs. ≥3 resheathing groups (24.2 vs. 26.5% LogRank p = 0.963). Furthermore, no significant differences in the primary endpoint were observed between 0, 1-2 and ≥ 3 resheathing (p = 0.84).

CONCLUSIONS

Our study found that resheathing of self-expandable THVs during TAVI did not result in worse clinical outcomes compared with no resheathing at mid-term follow-up. These results are independent from the number of resheathing, underling the safety of multiple resheathing in terms of peri-procedural and mid-term outcome.

CONDENSED ABSTRACT

In this retrospective observational study of 469 patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe aortic stenosis with self-expanding valves, we investigated the influence of resheathing on mid-term clinical outcomes. Specifically, we focused on the safety of multiple resheathing procedures. Our findings revealed no significant impact of resheathing on medium-term outcomes. The primary endpoint, a composite of cardiovascular mortality, neurological events, non-fatal acute myocardial infarction, and cardiovascular rehospitalizations, did not show statistically significant differences between no resheathing, single resheathing and multiple resheathing groups. Our study suggests that resheathing, even when performed multiple times, does not appear to significantly affect clinical outcomes at mid-term follow-up.

摘要

背景

一些经导管心脏瓣膜(THV)能够重新护套,这使得自扩张装置的植入能够得到优化。然而,重新护套的操作(尤其是重复进行时)增加了经导管假体与患者组织之间的相互作用,可能会导致副作用。

目的

评估在中期随访中重新护套的临床结果,重点关注多次重新护套的安全性。

方法

本回顾性观察性研究纳入了 2018 年 12 月至 2022 年 12 月期间接受自扩张瓣上 THV 经导管主动脉瓣置换术(TAVI)的所有连续患者。主要终点是心血管(CV)死亡率、神经事件、非致死性急性心肌梗死和 CV 再入院的复合终点。所有临床终点均根据 VARC-3 标准进行评估。

结果

研究共纳入 469 例接受自扩张瓣上 THV 的 TAVI 手术。尝试重新护套和重新护套操作的次数被前瞻性地记录在电子数据库中。253 例(53.9%)尝试重新护套;1、2 和≥3 次重新护套分别在 122 例(26.0%)、63 例(13.4%)和 68 例(14.5%)患者中进行。在中位随访 640 天(四分位距 340-1033 天)期间,0 次与≥1 次(22.7%与 26.1%,LogRank p=0.584)和<3 次与≥3 次重新护套组(24.2%与 26.5%,LogRank p=0.963)的主要终点发生率无差异。此外,0、1-2 次和≥3 次重新护套组之间的主要终点也无显著差异(p=0.84)。

结论

我们的研究发现,与中期无重新护套相比,TAVI 期间重新护套自扩张 THV 并未导致更差的临床结果。这些结果与重新护套的次数无关,表明多次重新护套在围手术期和中期结局方面是安全的。

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