Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights

Jan M Wrobel; Johannes Kirchner; Kai Friedrichs; Thorsten Gietzen; Jan Althoff; Caroline Hasse; Philipp von Stein; Jonas Wörmann; Jennifer von Stein; Jonathan Curio; Felix Rudolph; Maria Ivannikova; Christos Iliadis; Daniel Steven; Stephan Baldus; Volker Rudolph; Roman Pfister; Muhammed Gerçek; Maria I Koerber

doi:10.1007/s00392-025-02616-5

Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights

Clin Res Cardiol. 2025 Mar 10. doi: 10.1007/s00392-025-02616-5. Online ahead of print.

Authors

Jan M Wrobel¹, Johannes Kirchner², Kai Friedrichs², Thorsten Gietzen¹, Jan Althoff¹, Caroline Hasse¹, Philipp von Stein¹, Jonas Wörmann¹, Jennifer von Stein¹, Jonathan Curio¹, Felix Rudolph², Maria Ivannikova², Christos Iliadis¹, Daniel Steven¹, Stephan Baldus¹, Volker Rudolph², Roman Pfister¹, Muhammed Gerçek², Maria I Koerber³

Affiliations

¹ Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
² Clinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
³ Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany. maria.koerber@uk-koeln.de.

PMID: 40063122
DOI: 10.1007/s00392-025-02616-5

Abstract

Background: Transtricuspid cardiac implantable electronic devices (CIEDs) complicate the management of tricuspid regurgitation (TR). Transcatheter tricuspid valve annuloplasty (TTVA) offers a promising approach due to minimal interaction with leaflets and transvalvular CIEDs, though real-world evidence is limited.

Methods: This bi-center, retrospective study includes 204 consecutive patients who underwent TTVA with the Cardioband (Edwards Lifesciences) for severe symptomatic TR. Patients were divided into CIED carriers and non-CIED carriers. CIED carriers were further classified into those with lead-associated TR (LTR-A) and those with TR unrelated to CIED leads (LTR-B).

Results: Among the 204 patients, 41 (20%) were CIED carriers. Of these, 24% had mixed TR etiology (functional and LTR-A), while 76% had predominantly functional TR (LTR-B). Compared to non-CIED-carriers, CIED carriers were more symptomatic (NYHA-FC > II; 93% vs. 89%; p = 0.026) with comparable TR severity at baseline. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.

Conclusions: TTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. WHAT THE STUDY ADDS?: Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. Postinterventional CIED interrogations did not show critical technical issues.

Keywords: Cardiac implantable electronic devices; Efficacy; Safety; TVARC; Transcatheter tricuspid valve annuloplasty; Tricuspid regurgitation.