Real-world data for tricuspid edge-to-edge repair

M. Wild (Bad Krozingen)¹, L. Stolz (München)², S. Rosch (Mainz)³, F. Rudolph (Bad Oeynhausen)⁴, B. Goebel (Bad Berka)⁵, B. Köll (Hamburg)⁶, P. von Stein (Köln)⁷, W. Rottbauer (Ulm)⁸, T. Rassaf (Essen)⁹, H. Beucher (Siegburg)¹⁰, M. Kraus (Heidelberg)¹¹, M. Kassar (Bern)¹², T. Geisler (Tübingen)¹³, A. Rück (Stockholm)¹⁴, J. Ferreira (Nancy)¹⁵, S. Toggweiler (Luzern)¹⁶, P. Sagmeister (Leipzig)¹⁷, D. Westermann (Freiburg im Breisgau)¹⁸, T. Stocker (München)², L. Weckbach (München)², M. Näbauer (München)², S. Dawkins (Oxford)¹⁹, T. Kister (Leipzig)¹⁷, F. Praz (Bern)¹², M. M. Vorpahl (Siegburg)²⁰, M. Konstandin (Heidelberg)¹¹, P. Lüdike (Osnabrück)²¹, M. Keßler (Ulm)⁸, C. Iliadis (Köln)⁷, D. Kalbacher (Hamburg)²², P. Lauten (Bad Berka)⁵, M. Gercek (Bad Oeynhausen)⁴, C. Besler (Bad Krozingen)²³, P. Lurz (Mainz)³, J. Hausleiter (München)^2
1Universitäts-Herzzentrum Freiburg / Bad Krozingen Klinik für Kardiologie und Angiologie II Bad Krozingen, Deutschland; ²LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; ³Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; ⁴Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; ⁵Zentralklinik Bad Berka GmbH Klinik für Kardiologie und Internistische Intensivmedizin Bad Berka, Deutschland; ⁶Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; ⁷Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ⁸Universitätsklinikum Ulm Klinik für Innere Medizin II Ulm, Deutschland; ⁹Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland; ¹⁰HELIOS Klinikum Siegburg Siegburg, Deutschland; ¹¹Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; ¹²Inselspital - Universitätsspital Bern Universitätsklinik für Kardiologie Bern, Schweiz; ¹³Universitätsklinikum Tübingen Innere Medizin III, Kardiologie und Kreislauferkrankungen Tübingen, Deutschland; ¹⁴Karolinska University Hospital Cardiology Stockholm, Schweden; ¹⁵Centre Hospitalier Universitaire de Nancy Nancy, Frankreich; ¹⁶Luzerner Kantonsspital Heart Center Lucerne Luzern, Schweiz; ¹⁷Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ¹⁸Universitäts-Herzzentrum Freiburg - Bad Krozingen Innere Medizin III, Kardiologie und Angiologie Freiburg im Breisgau, Deutschland; ¹⁹University of Oxford John Radcliffe Hospital/Dept. of Cardiovasc. Medicine Oxford, Großbritannien; ²⁰HELIOS Klinikum Siegburg Herzzentrum Siegburg, Klinik für Kardiologie, Angiologie Siegburg, Deutschland; ²¹Marienhospital Osnabrück Klinik für Innere Medizin / Kardiologie und Intensivmedizin Osnabrück, Deutschland; ²²Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland; ²³Universitäts-Herzzentrum Freiburg / Bad Krozingen Klinik für Kardiologie und Angiologie Bad Krozingen, Deutschland

Background: Tricuspid valve transcatheter edge-to-edge repair (T-TEER) has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR).

Objectives: The study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in an all-comers, real-world patient population.

Methods: The PASTE (PASCAL for Tricuspid Regurgitation – a European registry) study is an investigator-initiated, multicenter, retro- and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from 02/2019 to 11/2023 without application of exclusion or inclusion  criteria. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were all subjected to centralized analysis.

Results: The study included 1059 high-risk patients (mean age 79±9 years, 53% female, TRI-SCORE risk 23±18%) with a high burden of comorbidities and symptoms (87% NYHA III/IV, 61% previously hospitalized for heart failure within 12 months). Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium (TVARC) criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. A post-procedural residual TR of >moderate was linked to worse clinical outcome. Independent predictors for more than moderate residual TR were coaptation gaps ≥8 mm (OR 1.67, 95%CI 1.03-2.72, p=0.038), tenting height ≥10mm (OR 2.18, CI 1.30-3.65, p=0.003), the presence of a transvalvular lead (OR 1.91, CI 1.19-3.05, p=0.007), right ventricular dilatation >42mm (OR 3.35, CI 1.37-9.1, p=0.009) and massive/torrential TR at baseline (OR 4.59, CI 2.35-8.96 p<0.001). TR reduction was sustained at 1-year with 83% of patients showing ≤moderate TR. Significant clinical improvements included enhanced NYHA class (66% class I/II vs. 17% at baseline, p<0.001) as well as improved functional status (follow-up: 293±114 m, ∆ improvement 40±86 m, p<0.001 [367 patients]) and quality of life (MLHFQ follow-up: 28±19 points, ∆ improvement -9±20 pts, p<0.001 [188 patients]) in a subset of patients. Patients treated with the 1^st generation PASCAL system (570 patients) and with the new PASCAL Precision system (489 patients) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63 vs. 49%, p<0.001), shorter procedure times (median 93 min [IQR 69-130] vs. 120 min [82-165], p<0.001), and higher clinical success rates according to TVARC at 30 days and 1 year (87 vs. 81% [p=0.021] and 56 vs. 50% [p=0.044], respectively). Higher center experience (≥20 patients/year) resulted in higher intraprocedural and clinical success.

Conclusions: The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up.