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经导管缘对缘修复治疗心脏植入式电子设备相关三尖瓣反流的疗效:来自TRI-SPA注册研究的见解

Efficacy of transcatheter edge-to-edge repair for cardiac implantable electronic device-associated tricuspid regurgitation: insights from the TRI-SPA registry.

作者信息

Ruberti Andrea, Cepas-Guillén Pedro, Echarte-Morales Julio, Arzamendi Dabit, Moñivas Vanessa, Carrasco-Chinchilla Fernando, Pan Manuel, Nombela-Franco Luis, Pascual Isaac, Guerreiro Claudio E, Benito-González Tomás, Pérez Ruth, Gómez-Blázquez Iván, Amat-Santos Ignacio J, Flores-Umanzor Eduardo, Cruz-González Ignacio, Sánchez-Recalde Ángel, Álvarez Ana Belén Cid, Barreiro-Pérez Manuel, Sanchis Laura, Li Chi-Hion, Caneiro-Queija Berenice, Trigo María Del, David Martínez-Carmona José, Mesa Dolores, Quevedo Pilar Jiménez, Avanzas Pablo, Estévez-Loureiro Rodrigo, Freixa Xavier

机构信息

Servicio de Cardiología, Hospital Clínic Barcelona, Barcelona, España; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, España. Electronic address: https://x.com/@a_rubi_5.

Servicio de Cardiología, Hospital Clínic Barcelona, Barcelona, España; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, España. Electronic address: https://x.com/@pedro_cepas.

出版信息

Rev Esp Cardiol (Engl Ed). 2025 Jan 31. doi: 10.1016/j.rec.2025.01.010.

Abstract

INTRODUCTION AND OBJECTIVES

This study aimed to assess the effectiveness and clinical outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with cardiac implantable electronic devices (CIEDs).

METHODS

This subanalysis of the Transcatheter Tricuspid Valve Repair in Spain (TRI-SPA) registry included patients with at least severe tricuspid regurgitation (TR) who were treated with T-TEER between June 2020 and May 2023 in Spain. Patients with CIEDs and no or mild tricuspid lead-leaflet interaction were compared with those without CIEDs. The primary composite endpoint was all-cause mortality, heart failure-related hospitalization, and tricuspid valve reintervention at 12 months.

RESULTS

Among 310 patients (mean age 75.5±9.1 years, 70% female) with significant TR treated with T-TEER, 35 (11%) had CIEDs. Device implantation success was high in both groups (97.1% in the CIED group vs 96.4% in the non-CIED group, P=.81), with a similar rate of ≤2+ residual TR (84.9% in the CIED group vs 91.0% in the non-CIED group, P=.26). Patients with CIEDs experienced comparable rates of the primary composite endpoint to the non-CIED group (23.8% vs 19.1%, respectively, HR, 1.40; 95%CI, 0.60-3.31; P=.44), sustained successful TR reduction (δ 2+ in 55.0% vs 73.8%, P=.07), and functional improvement (NYHA class I/II 81.8% vs 79.9%, P=.79).

CONCLUSIONS

In a real-world setting, T-TEER seems to be an effective therapeutic option for selected patients with more than moderate TR and CIEDs with no or mild lead-leaflet interaction, offering comparable cardiovascular outcomes and clinical improvement to those without leads. However, the presence of CIEDs may represent an independent risk factor for TR recurrence.

摘要

引言与目的

本研究旨在评估经导管三尖瓣缘对缘修复术(T-TEER)在植入心脏植入式电子设备(CIED)患者中的有效性和临床结局。

方法

西班牙经导管三尖瓣修复术(TRI-SPA)注册研究的这项亚分析纳入了2020年6月至2023年5月在西班牙接受T-TEER治疗的至少患有重度三尖瓣反流(TR)的患者。将患有CIED且无或仅有轻度三尖瓣导联与瓣叶相互作用的患者与未患有CIED的患者进行比较。主要复合终点是12个月时的全因死亡率、心力衰竭相关住院和三尖瓣再次干预。

结果

在310例接受T-TEER治疗的重度TR患者中(平均年龄75.5±9.1岁,70%为女性),35例(11%)患有CIED。两组的设备植入成功率均较高(CIED组为97.1%,非CIED组为96.4%,P = 0.81),≤2+残余TR的发生率相似(CIED组为84.9%,非CIED组为91.0%,P = 0.26)。患有CIED的患者的主要复合终点发生率与非CIED组相当(分别为23.8%和19.1%,HR为1.40;95%CI为0.60 - 3.31;P = 0.44),持续成功降低TR(δ 2+分别为55.0%和73.8%,P = 0.07),以及功能改善(纽约心脏协会I/II级分别为81.8%和79.9%,P = 0.79)。

结论

在现实世界中,对于选定的中度以上TR且CIED无或仅有轻度导联与瓣叶相互作用的患者,T-TEER似乎是一种有效的治疗选择,其心血管结局和临床改善与无导联患者相当。然而,CIED的存在可能是TR复发的独立危险因素。

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