Efficacy of transcatheter edge-to-edge repair for cardiac implantable electronic device-associated tricuspid regurgitation: insights from the TRI-SPA registry
Andrea Ruberti , Pedro Cepas-Guillén , Julio Echarte-Morales , Dabit Arzamendi , Vanessa Moñivas , Fernando Carrasco-Chinchilla , Manuel Pan , Luis Nombela-Franco , Isaac Pascual , Claudio E. Guerreiro , Tomás Benito-González , Ruth Pérez , Iván Gómez-Blázquez , Ignacio J. Amat-Santos , Eduardo Flores-Umanzor , Ignacio Cruz-González , Ángel Sánchez-Recalde , Ana Belén Cid Álvarez , Manuel Barreiro-Pérez , Laura Sanchis , Xavier Freixa
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引用次数: 0
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 (≤ 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.
前言和目的:本研究旨在评估三尖瓣经导管边缘到边缘修复(T-TEER)在心脏植入式电子装置(cied)患者中的有效性和临床结果。方法:对西班牙经导管三尖瓣修复(TRI-SPA)登记的亚分析纳入了2020年6月至2023年5月在西班牙接受T-TEER治疗的至少严重三尖瓣反流(TR)患者。没有或轻度三尖瓣铅-小叶相互作用的cied患者与没有cied的患者进行比较。主要综合终点为全因死亡率、心力衰竭相关住院和12个月时三尖瓣再干预。结果:在接受T-TEER治疗的310例明显TR患者(平均年龄75.5±9.1岁,70%为女性)中,35例(11%)发生cied。两组植入术成功率均较高(CIED组为97.1%,非CIED组为96.4%,P = 0.81),残余TR≤2+的比例相似(CIED组为84.9%,非CIED组为91.0%,P = 0.26)。cied患者的主要综合终点率与非cied组相当(分别为23.8%和19.1%,HR为1.40;95%置信区间,0.60 - -3.31;P = 0.44),持续成功的TR降低(≤2+,55.0% vs 73.8%, P = 0.07)和功能改善(NYHA I/II级81.8% vs 79.9%, P = 0.79)。结论:在现实环境中,T-TEER似乎是中度以上TR和cied患者的有效治疗选择,没有或轻微的铅叶相互作用,与没有铅叶的患者相比,提供了相当的心血管结局和临床改善。然而,cied的存在可能是TR复发的独立危险因素。