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.<BlockQuote> <FormalPara RenderingStyle="Style1"> 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. </FormalPara> <FormalPara RenderingStyle="Style1"> What the study adds? <UnorderedList Mark="Bullet"> <ItemContent> Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. </ItemContent> <ItemContent> Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. </ItemContent> <ItemContent> Postinterventional CIED interrogations did not show critical technical issues. </ItemContent> </UnorderedList> </FormalPara> </BlockQuote> Graphical abstract Intraprocedural success and TR reduction following TTVA in CIED- and non-CIED-carriers. Blue arrows indicate CIED lead trajectory through tricuspid valve. BL Baseline, FU = 30-day Follow Up, LTR-A Lead-associated Tricuspid Regurgitation, type A, LTR-B Lead-associated Tricuspid Regurgitation, type B, TR Tricuspid Regurgitation, TTVA Transcatheter Tricuspid Valve Annuloplasty

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

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2025年3月10日

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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

摘要

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.

Graphical abstract

Intraprocedural success and TR reduction following TTVA in CIED- and non-CIED-carriers. Blue arrows indicate CIED lead trajectory through tricuspid valve.

BL Baseline, FU = 30-day Follow Up, LTR-A Lead-associated Tricuspid Regurgitation, type A, LTR-B Lead-associated Tricuspid Regurgitation, type B, TR Tricuspid Regurgitation, TTVA Transcatheter Tricuspid Valve Annuloplasty