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三尖瓣经导管缘对缘修复的真实世界经验:西班牙注册研究中的经导管三尖瓣修复术

Real-World Experience in Tricuspid Transcatheter Edge-to-Edge Repair: Transcatheter Tricuspid Valve Repair in Spain Registry.

作者信息

Sisinni Antonio, Barreiro-Perez Manuel, Freixa Xavier, Arzamendi Dabit, Moñivas Vanessa, Carrasco-Chinchilla Fernando, Pan Manuel, Nombela-Franco Luis, Pascual Isaac, Benito-González Tomás, Perez Ruth, Gómez-Blázquez Iván, Amat-Santos Ignacio J, Cruz-González Ignacio, Sánchez-Recalde Ángel, Alvarez Ana Belén Cid, Sanchis Laura, Caneiro-Queija Berenice, Li Chi Hion, Del Trigo Maria, Martínez-Carmona Jose David, Mesa Dolores, Pozo Eduardo, Avanzas Pablo, Cepas-Guillén Pedro, Estévez-Loureiro Rodrigo

机构信息

Department of Cardiology University Hospital Alvaro Cunqueiro Vigo Spain.

Department of Cardiology IRCCS Policlinico San Donato, San Donato Milanese Milan Italy.

出版信息

J Am Heart Assoc. 2025 Jan 21;14(2):e037070. doi: 10.1161/JAHA.124.037070. Epub 2025 Jan 17.

Abstract

BACKGROUND

Significant tricuspid regurgitation (TR) is associated with increased morbidity and mortality. The development of transcatheter valve repair therapies has opened a wide range of opportunities for treatment of patients with high surgical risk. Real-world data might improve patient selection and outcome. The authors sought to investigate acute and short-term cardiovascular outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with dedicated devices in a real-world setting.

METHODS AND RESULTS

This is a retrospective, single-arm, multicenter registry conducted at 15 sites in Spain. The primary end point was a composite of all-cause death, rehospitalization for heart failure, and tricuspid valve re-intervention. Patients included (n=283) were older (76±9 years, 70% female), and showed significant comorbidities. Massive or torrential TR was present in 55% of subjects, with secondary cause being the main mechanism of regurgitation in ≈80% of individuals. Intraprocedural success was achieved in 79% of patients. At 1-year follow-up, significant improvements in TR grade (≥3+, 100% to 25%, <0.001) and New York Heart Association functional class (I/II, 33%-86%, <0.001) were observed. Lead-induced cause and single leaflet device attachment emerged as independent predictors of at least severe predischarge residual TR. In-hospital mortality occurred in 4 (1.4%) patients, whereas the Kaplan-Meier estimated 1-year primary end point occurrence rate was 21%. Intraprocedural success (hazard ratio, 0.353 [95% CI, 0.156-0.798]; =0.012), was found to be an independent predictor of primary end point.

CONCLUSIONS

In a real-world contemporary setting, tricuspid transcatheter edge-to-edge repair with dedicated devices emerged as effective therapeutic option for patients with severe TR.

摘要

背景

严重三尖瓣反流(TR)与发病率和死亡率增加相关。经导管瓣膜修复治疗的发展为高手术风险患者的治疗提供了广泛机会。真实世界的数据可能会改善患者的选择和预后。作者旨在研究在真实世界中使用专用设备进行三尖瓣经导管缘对缘修复(T-TEER)的急性和短期心血管结局。

方法和结果

这是一项在西班牙15个地点进行的回顾性、单臂、多中心注册研究。主要终点是全因死亡、因心力衰竭再次住院和三尖瓣再次干预的综合指标。纳入的患者(n = 283)年龄较大(76±9岁,70%为女性),且有明显的合并症。55%的受试者存在大量或重度TR,约80%的个体反流的主要机制为继发性原因。79%的患者手术成功。在1年随访时,观察到TR分级(≥3+,从100%降至25%,P<0.001)和纽约心脏协会功能分级(I/II级,从33%升至86%,P<0.001)有显著改善。导线导致的原因和单叶瓣装置附着是至少严重出院前残余TR的独立预测因素。4例(1.4%)患者发生院内死亡,而Kaplan-Meier估计的1年主要终点发生率为21%。手术成功(风险比,0.353[95%CI,0.156 - 0.798];P = 0.012)被发现是主要终点的独立预测因素。

结论

在真实世界的当代环境中,使用专用设备进行三尖瓣经导管缘对缘修复成为严重TR患者的有效治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037d/12054511/33660e4e82ee/JAH3-14-e037070-g001.jpg

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