Outcomes of Tricuspid Transcatheter Edge-to-edge Repair in Subjects with Endocardial Leads

Overview

Journal EuroIntervention

Specialties Cardiology & Vascular Diseases
Pharmacology

Date 2025 Mar 3

PMID 40028727

Authors

Bjorn Goebel

Philipp Lurz

Thomas Schmitz

Raffi Bekeredjian

Georg Nickenig

Helge Mollmann

Ralph Stephan von Bardeleben

Alexander Schmeisser

Megan Heitkemper

Iskandar Atmowihardjo

Rodrigo Estevez-Loureiro

Erwan Donal

Affiliations

Soon will be listed here.

Abstract

Background: Transcatheter edge-to-edge repair (TEER) using the TriClip tricuspid valve repair system has emerged as a therapy for tricuspid regurgitation (TR). Patients with TR undergoing TEER commonly present with an endocardial lead across the tricuspid valve (TV).

Aims: We sought to examine the effectiveness and safety of tricuspid TEER (T-TEER) in subjects with endocardial leads in the bRIGHT EU Post-Approval Study (PAS).

Methods: The bRIGHT EU PAS is a prospective, single-arm, open-label, multicentre, post-market registry conducted at 26 sites in Europe. Echocardiographic assessments of endocardial lead placement, interaction, and TR grade were performed at a core laboratory.

Results: Of the 511 enrolled subjects, a total of 110 had an endocardial lead, and in 80.7% of these subjects, TR was at least partially related to the lead. At 30 days, 71% of subjects with endocardial leads had TR of moderate or less. The percentage of subjects with endocardial leads categorised as New York Heart Association Functional Class I-II increased from 17% at baseline to 75% at 30 days (p<0.0001), and quality of life with the Kansas City Cardiomyopathy Questionnaire showed a mean improvement of 20±24 points from baseline to 30 days (p<0.0001). T-TEER was safe in subjects with endocardial leads, with similar rates of events, including TV reintervention/reoperation and TV surgery, to those in subjects without leads. No reports of lead malfunction were reported.

Conclusions: In the bRIGHT EU PAS, T-TEER using the TriClip system was safe and effective in severe TR subjects with an endocardial lead across the TV.

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