Clinical research in cardiology : official journal of the German Cardiac Society · 2025
Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Wrobel Jan M, Kirchner Johannes, Friedrichs Kai, Gietzen Thorsten, Althoff Jan, Hasse Caroline, von Stein Philipp, Wörmann Jonas, von Stein Jennifer, Curio Jonathan, Rudolph Felix, Ivannikova Maria, Iliadis Christos, Steven Daniel, Baldus Stephan, Rudolph Volker, Pfister Roman, Gerçek Muhammed, Koerber Maria I
Аннотация
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.
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.