Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice

• Published in: Journal of the American College of Cardiology 2023-07, Vol.82 (4), p.281-291
• Main Authors: Lurz, Philipp, Besler, Christian, Schmitz, Thomas, Bekeredjian, Raffi, Nickenig, Georg, Möllmann, Helge, von Bardeleben, Ralph Stephan, Schmeisser, Alexander, Atmowihardjo, Iskandar, Estevez-Loureiro, Rodrigo, Lubos, Edith, Heitkemper, Megan, Huang, Dina, Lapp, Harald, Donal, Erwan, Adamo, Marianna, Golino, Paolo, Melica, Bruno, Rudolph, Volker, Corti, Roberto, Freixa, Xavier, Arzamendi, Dabit, Praz, Fabien, Castriota, Fausto, Veien, Karsten, Kowalski, Marek, Rensing, Bernard, Schofer, Niklas, Zirlik, Andreas, Rottbauer, Wolfgang
• Format: Article
• Language: English
• Subjects: Aged; Cardiac Catheterization - adverse effects; Heart Valve Prosthesis Implantation - adverse effects; Humans; leaflet repair; Prospective Studies; Severity of Illness Index; Treatment Outcome; TriClip; tricuspid regurgitation; tricuspid repair; Tricuspid Valve Insufficiency - diagnosis; Tricuspid Valve Insufficiency - surgery
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2023.05.008

Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089) [Display omitted]