Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation

Davidson, Charles J.; Lim, D. Scott; Smith, Robert L.; Kodali, Susheel; Kipperman, Robert; Eleid, Mackram F.; Reisman, Mark; Whisenant, Brian; Puthumana, Jyothy; Abramson, Sandra; Fowler, Dale; Grayburn, Paul A.; Hahn, Rebecca T.; Koulogiannis, Konstantinos; Pislaru, Sorin; Zwink, Todd; Minder, Michael; Dahou, Abdellaziz; Deo, Shekhar H.; Vandrangi, Prashanthi; Deuschl, Florian; Feldman, Ted; Gray, William A.

doi:10.1016/j.jcin.2020.10.017

Cited by 71 publications

(22 citation statements)

References 26 publications

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“…A total of 17 studies 12 , 13 , 18 , 22 – 26 , 28 – 36 were included in the analysis of procedural outcomes ( Table 2 and Supplementary Table 6 ). The pooled technical and procedural success rates were 93.9% (95% confidence interval (CI): 90.7%–96.4%) and 82.1% (95% CI: 74.0%–89.0%), respectively.…”

Section: Resultsmentioning

confidence: 99%

Periprocedural, short-term, and long-term outcomes following transcatheter tricuspid valve repair: a systemic review and meta-analysis

Zhu

Kaisaier

et al. 2023

Therapeutic Advances in Chronic Disease

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Background: There has been an increasing use of transcatheter tricuspid valve repair (TTVR) recently. However, the periprocedural, short-term, and long-term outcomes of TTVR remain unclear. Objectives: To determine the clinical outcomes in patients with significant tricuspid regurgitation undergoing TTVR. Design: Systematic review and meta-analysis. Data Source and Methods: The systematic review and meta-analysis is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed and EMBASE were searched for clinical trials and observational studies until March 2022. Studies reporting the incidence of clinical outcomes after TTVR were included. The clinical outcomes included periprocedural, short-term (in-hospital or within 30 days), and long-term (>6-month follow-up) outcomes. The primary outcome was all-cause mortality whereas the secondary outcomes included technical success, procedural success, cardiovascular mortality, rehospitalization for heart failure (HHF), major bleeding, and single leaflet device attachment. The incidence of these outcomes across studies was pooled by a random-effects model. Results: A total of 21 studies with 896 patients were included. A total of 729 (81.4%) patients underwent isolated TTVR while only 167 (18.6%) patients underwent combined mitral and tricuspid valve repair. Over 80% of the patients used coaptation devices while approximately 20% used annuloplasty devices. The median follow-up duration was 365 days. Technical and procedural success was high at 93.9% and 82.1%, respectively. The pooled perioperative, short-term, and long-term all-cause mortality for patients undergoing TTVR was 1.0%, 3.3%, and 14.1%, respectively. The long-term cardiovascular mortality rate was 5.3% while the HHF rate was 21.5%. Major bleeding and single leaflet device attachment were two major complications, accounting for 14.3% and 6.4%, respectively, during long-term follow-up. Conclusion: TTVR is associated with high procedural success and low procedural and short-term mortality. However, all-cause mortality, cardiovascular mortality, and HHF rates remain high during long-term follow-up. Registration: PROSPERO (CRD42022310020).

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Section: Resultsmentioning

confidence: 99%

Periprocedural, short-term, and long-term outcomes following transcatheter tricuspid valve repair: a systemic review and meta-analysis

Zhu

Kaisaier

et al. 2023

Therapeutic Advances in Chronic Disease

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“…Data from both the TRI-REPAIR ( 20 ) and the U.S. early feasibility study ( 21 ), with a total of 30 patients included in each of them, along with the TriBAND study ( 22 ) ( n = 61) are currently available ( Table 3 ). Besides, real-world data for this device has been recently published ( 27 ).…”

Section: Devices With Clinical Data: Transcatheter Tricuspid Valve Re...mentioning

confidence: 99%

Transcatheter tricuspid valve interventions: Current status and future perspectives

Alperi

Almendárez

Álvarez

et al. 2022

Front. Cardiovasc. Med.

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The development of transcatheter therapies to treat valvular heart diseases has changed the rules of the game, particularly in the case of aortic stenosis and mitral regurgitation. In the last years, the tricuspid valve has also been the focus of these percutaneous techniques for several reasons: (1) tricuspid regurgitation is a frequent disease associated with poor clinical outcomes in spite of medical treatment, leading to end-stage right ventricular heart failure, (2) surgical tricuspid valve repair or replacement has been the treatment of choice for patients with tricuspid valve disease, but high mortality rates for isolated surgical tricuspid valve intervention have been reported in the literature, and (3) most patients with tricuspid pathology are ultimately denied cardiac surgery because of their comorbidity burden. Thus, in this context the development of less invasive catheter-based therapies would be of high clinical relevance. The present review provides an overview regarding the framework of chronic tricuspid regurgitation transcatheter therapeutic options, summarizes the transcatheter systems under clinical use or clinical evaluation with their technical features, and describes the updated current evidence in this challenging and evolving field.

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“…Nach Cardioband-Implantation im Bereich der Trikuspidalklappe wird eine ASS-Therapie für 1 Monat bzw. eine Fortsetzung der OAC bei bestehender Indikation empfohlen [5,31,32,33]. Ähnliches gilt für interventionelle Valve-in-Valve-sowie Valve-in-Ring-Prozeduren in Mitralposition: Abhängig von der Studienpopulation werden VKA für mindestens 3 Monate (Dauer abhängig von der Evaluation mit-tels transösophagealer Echokardiografie nach 3 Monaten) sowie ASS dauerhaft eingesetzt, aber auch eine duale antithrombozytäre Therapie oder eine antithrombozytäre Monotherapie [28,34].…”

Section: Patienten Ohne Indikation Zur Oralen Antikoagulation Nach In...unclassified

Orale Antikoagulation nach Klappeneingriffen – Was ist der Standard?

Stark

Maßberg

2022

Aktuelle Kardiologie

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ZusammenfassungNach interventionellen Eingriffen an der Aortenklappe oder den atrioventrikulären (AV) Klappen (u. a. TAVI, M-TEER, T-TEER) wird prinzipiell eine antithrombotische Therapie empfohlen. Dabei muss differenziert werden zwischen Patienten, für die unabhängig vom Klappeneingriff eine Indikation zur oralen Antikoagulation (OAC) besteht, meist aufgrund von Vorhofflimmern (AF), und Patienten ohne OAC-Indikation. Mehrere randomisierte Studien konnten zeigen, dass bei AF-Patienten, die eine TAVI erhalten, eine Fortführung der OAC (Vitamin-K-Antagonisten oder NOAC) als Monotherapie einer dualen Therapie, bestehend aus OAC plus zusätzliche Thrombozyteninhibition, überlegen ist. Andererseits ist bei TAVI-Patienten ohne vorbestehende OAC-Indikation eine ASS-Monotherapie als postinterventionelle antithrombotische Therapie zu empfehlen. Nach segelbasierter (Edge-to-Edge) Rekonstruktion der Mitral- und Trikuspidalklappe wird bei bestehender OAC-Indikation eine Fortsetzung der Antikoagulation empfohlen, ansonsten ASS dauerhaft mit Clopidogrel für 1–3 Monate. Die optimale antithrombotische Therapie im Kontext interventioneller Eingriffe an den AV-Klappen ist jedoch bislang nicht in größeren randomisierten Studien untersucht.

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Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation

Cited by 71 publications

References 26 publications

Periprocedural, short-term, and long-term outcomes following transcatheter tricuspid valve repair: a systemic review and meta-analysis

Periprocedural, short-term, and long-term outcomes following transcatheter tricuspid valve repair: a systemic review and meta-analysis

Transcatheter tricuspid valve interventions: Current status and future perspectives

Orale Antikoagulation nach Klappeneingriffen – Was ist der Standard?

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