Guillem Muntané-Carol1, Maurizio Taramasso2, Mizuki Miura2, Mara Gavazzoni2, Alberto Pozzoli2, Hannes Alessandrini3, Azeem Latib4, Adrian Attinger-Toller5, Luigi Biasco6, Daniel Braun7, Eric Brochet8, Kim A Connelly9, Sabine de Bruijn10, Paolo Denti11, Florian Deuschl12, Edith Lubos12, Sebastian Ludwig12, Daniel Kalbacher12, Rodrigo Estevez-Loureiro13, Neil Fam9, Christian Frerker3, Edwin Ho4,9, Jean-Michel Juliard8, Ryan Kaple14, Susheel Kodali15, Felix Kreidel16, Claudia Harr3, Alexander Lauten17, Julia Lurz18, Vanessa Monivas13, Michael Mehr7, Tamin Nazif15, Georg Nickening19, Giovanni Pedrazzini6, François Philippon1, Fabien Praz20, Rishi Puri1, Ulrich Schäfer12, Joachim Schofer21, Horst Sievert10, Gilbert H L Tang22, Ahmed A Khattab2,23,24, Martin Andreas25, Marco Russo25, Holger Thiele18, Matthias Unterhuber18, Dominique Himbert8, Marina Urena8, Ralph Stephan von Bardeleben16, John G Webb5, Marcel Weber19, Stephan Windecker20, Mirjam Winkel20, Michel Zuber2, Jörg Hausleiter7, Philipp Lurz18, Francesco Maisano2, Martin B Leon15, Rebecca T Hahn15, Josep Rodés-Cabau1. 1. Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (G.M.-C., F. Philippon, R.P., J.R.-C.). 2. Cardiology Department, University Hospital of Zurich, University of Zurich, Switzerland (M.T., M. Miura, M.G., A.P., A.A.K., M.Z., F.M.). 3. Cardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany (H.A., C.F., C.H.). 4. Cardiology Department, Montefiore Medical Center, New York, NY (A. Latib, E.H.). 5. Cardiology Department, St. Paul Hospital, Vancouver, Canada (A.A.-T., J.G.W.). 6. Cardiology Department, Cardiocentro, Lugano, Switzerland (L.B., G.P.). 7. Cardiology Department, Klinikum der Universität München, Germany (D.B., M. Mehr, J.H.). 8. Cardiology Department, Hôpital Bichat, Université Paris VI, Paris, France (E.B., J.-M.J., D.H., M.U.). 9. Cardiology Department, Toronto Heart Center, St. Michael's Hospital, Canada (K.A.C., N.F., E.H.). 10. Cardiology Department, CardioVascular Center Frankfurt, Frankfurt am Main, Germany (S.d.B., H.S.). 11. Cardiac Surgery Department, San Raffaele University Hospital, Milan, Italy (P.D.). 12. Cardiology Department, University Heart and Vascular Center Hamburg, Germany (F.D., E.L., S.L., D.K., U.S.). 13. Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain (R.E.-L., V.M.). 14. Cardiology Department, Westchester Medical Center, Valhalla, NY (R.K.). 15. Cardiology Department, New York-Presbyterian/Columbia University Medical Center, New York, NY (S.K., T.N., M.B.N., R.T.H.). 16. Cardiology Department, Department of Cardiology, University Medical Center Mainz, Germany (F.K., R.S.V.B.). 17. Cardiology Department, Charité University Hospital, Berlin, Germany (A. Lauten). 18. Cardiology Department, Heart Center Leipzig, University Hospital Leipzig, Germany (J.L., H.T., M.U., P.L.). 19. Cardiology Department, Universitatsklinikum Bonn, Germany (G.N., M. Weber). 20. Cardiology Department, Inselspital, Bern University Hospital (F. Praz, S.W., M. Winkel), University of Bern, Switzerland. 21. Cardiology Department, Albertinen Heart Center, Hamburg, Germany (J.S.). 22. Cardiac Surgery Department, Mount Sinai Hospital, New York, NY (G.H.L.T.). 23. Cardiology Department (A.A.K.), University of Bern, Switzerland. 24. Cardiology Department, Cardiance Clinic, Pfäffikon, Switzerland (A.A.K.). 25. Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna (M.A., M.R.).
Abstract
BACKGROUND: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. METHODS: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. RESULTS: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). CONCLUSIONS: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.
BACKGROUND: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients. METHODS: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg. RESULTS: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, P<0.001). CONCLUSIONS: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patientsdied after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.