Original Research

DOI: 10.4244/EIJ-D-23-01033

Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads

Björn Goebel1, MD; Philipp Lurz2, MD, PhD; Thomas Schmitz3, MD; Raffi Bekeredjian4, MD; Georg Nickenig5, MD; Helge Mollmann6, MD; Ralph Stephan von Bardeleben7, MD; Alexander Schmeisser8, MD; Megan Heitkemper9, PhD; Iskandar Atmowihardjo10, MD; Rodrigo Estévez-Loureiro11, MD; Erwan Donal12, MD

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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Volume 21 Number 5
Mar 3, 2025
Volume 21 Number 5
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