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TriClip 系统行缘对缘经导管三尖瓣修复术。西班牙多中心研究。

The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study.

机构信息

Departamento de Cardiología, Hospital Clínic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

出版信息

Rev Esp Cardiol (Engl Ed). 2022 Oct;75(10):797-804. doi: 10.1016/j.rec.2022.01.007. Epub 2022 Mar 11.

Abstract

INTRODUCTION AND OBJECTIVES

In patients with tricuspid regurgitation (TR), edge-to-edge transcatheter tricuspid valve repair (TTVR) is the strategy with the highest penetration worldwide. A dedicated edge-to-edge TTVR system has recently become available in Europe. The present study describes the initial experience with the system in Spain.

METHODS

This multicenter study collected individual data from the centers accepted for the use of the novel system within an initial limited release. Between June 2020 and March 2021, all patients undergoing an edge-to-edge TTVR using the TriClip system in Spain were included in the study. The primary endpoint was the achievement of a TR reduction of at least 1 grade at discharge.

RESULTS

We included 34 patients. Most of them reported a previous history of atrial fibrillation (91%) and only 1 had a pacemaker lead. The primary endpoint (TR reduction of at least 1 grade at discharge) was met in all patients. Most of the patients required 1 (47%) or 2 clips (44%) with a clear predominance of XT (87%) over NT (13%). The location of the first clip was anteroseptal in >90% of the patients. Only 1 patient had a partial detachment, which was stabilized with additional clips in the same procedure. At discharge, TR severity was≤2 in 91% of patients. At 3 months, mortality was nil. Overall, 88% of patients were in New York Heart Association functional class≤2 and 80% had residual TR≤2.

CONCLUSIONS

Edge-to-edge TTVR seemed to be effective and safe with a sustained TR reduction at 3 months. Further studies will be needed to confirm our findings.

摘要

简介和目的

在三尖瓣反流(TR)患者中,边缘对边缘经导管三尖瓣修复(TTVR)是全球应用最广泛的策略。一种专门的边缘对边缘 TTVR 系统最近在欧洲上市。本研究描述了该系统在西班牙的初步经验。

方法

这项多中心研究从最初有限发布中获准使用新型系统的中心收集了个体数据。2020 年 6 月至 2021 年 3 月期间,西班牙所有接受 TriClip 系统边缘对边缘 TTVR 的患者均纳入本研究。主要终点是出院时 TR 至少降低 1 级。

结果

我们纳入了 34 名患者。他们大多有房颤(91%)病史,只有 1 人有起搏器导线。所有患者均达到主要终点(出院时 TR 至少降低 1 级)。大多数患者需要 1 个(47%)或 2 个夹子(44%),其中 XT(87%)明显多于 NT(13%)。第一个夹子的位置在前间隔超过 90%的患者中。只有 1 名患者发生部分脱开,在同一次手术中用额外的夹子稳定。出院时,91%的患者 TR 严重程度≤2。3 个月时无死亡。总体而言,88%的患者纽约心脏协会功能分级≤2,80%的患者残余 TR≤2。

结论

边缘对边缘 TTVR 似乎是有效且安全的,可在 3 个月时持续降低 TR。需要进一步的研究来证实我们的发现。

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