TY - JOUR
T1 - Transcatheter Tricuspid Valve Intervention in Patients with Right Ventricular Dysfunction or Pulmonary Hypertension
T2 - Insights from the TriValve Registry
AU - Muntané-Carol, Guillem
AU - Taramasso, Maurizio
AU - Miura, Mizuki
AU - Gavazzoni, Mara
AU - Pozzoli, Alberto
AU - Alessandrini, Hannes
AU - Latib, Azeem
AU - Attinger-Toller, Adrian
AU - Biasco, Luigi
AU - Braun, Daniel
AU - Brochet, Eric
AU - Connelly, Kim A.
AU - De Bruijn, Sabine
AU - Denti, Paolo
AU - Deuschl, Florian
AU - Lubos, Edith
AU - Ludwig, Sebastian
AU - Kalbacher, Daniel
AU - Estevez-Loureiro, Rodrigo
AU - Fam, Neil
AU - Frerker, Christian
AU - Ho, Edwin
AU - Juliard, Jean Michel
AU - Kaple, Ryan
AU - Kodali, Susheel
AU - Kreidel, Felix
AU - Harr, Claudia
AU - Lauten, Alexander
AU - Lurz, Julia
AU - Monivas, Vanessa
AU - Mehr, Michael
AU - Nazif, Tamin
AU - Nickening, Georg
AU - Pedrazzini, Giovanni
AU - Philippon, François
AU - Praz, Fabien
AU - Puri, Rishi
AU - Schäfer, Ulrich
AU - Schofer, Joachim
AU - Sievert, Horst
AU - Tang, Gilbert H.L.
AU - Andreas, Martin
AU - Russo, Marco
AU - Thiele, Holger
AU - Unterhuber, Matthias
AU - Himbert, Dominique
AU - Urena, Marina
AU - Von Bardeleben, Ralph Stephan
AU - Webb, John G.
AU - Weber, Marcel
AU - Windecker, Stephan
AU - Winkel, Mirjam
AU - Zuber, Michel
AU - Hausleiter, Jörg
AU - Lurz, Philipp
AU - Maisano, Francesco
AU - Leon, Martin B.
AU - Hahn, Rebecca T.
AU - Rodés-Cabau, Josep
N1 - Funding Information:
Relationship with industry: Dr Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic and received speaker honoraria from Edwards Lifesciences. Dr Gavazzoni has served as a consultant for Biotronik. Dr Latib has served on the advisory board for Medtronic and Abbott Vascular; on the Speakers Bureau for Abbott Vascular; on the scientific advisory board for Millipede; and as a consultant for 4Tech, Mitralign, and Millipede. Dr Braun has received speaker honoraria and travel support from Abbott Vascular. Dr Brochet has received speaker fees from Abbott Vascular. Dr Connelly has received honoraria from Abbott Industries. Dr Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart and received honoraria from Abbott and Edwards. Dr Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; received speaker honoraria from Abbott; and received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr Kodali has served on the scientific advisory board for Microin-terventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, and Supira. Dr Kreidel has received speaker honoraria and consulting fees from Abbott and Edwards Lifesciences. Dr Lauten has received research support from Abbott and Edwards Lifesciences; and has been a consultant to Abbott, Edwards Life-sciences, and TricValve. Dr Lurz has received speaker fees from Abbott. Dr Nazif has served as a consultant for and received consulting honoraria from Edwards Lifesciences, Boston Scientific, Medtronic, and Biotrace Medical. Dr Praz has been a consultant to Edwards Lifesciences. Dr Schäfer has received lecture fees, study honoraria, travel expenses from, and has been a member of an advisory board for Abbott. Dr Sievert has received study honoraria, travel expenses, and consult- ing fees from 4TECH Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Viva-sure Medical. Dr Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr Webb has received research support from Edwards Lifesciences; and served as a consultant for Abbott Vascular, Edwards Lifesciences, and St. Jude Medical. Dr Windecker has received institutional research grants from Abbott, Amgen, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, St Jude, and Terumo. Dr Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Maisano has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; is cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT (New Valve Technology), and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (functional mitral regurgitation surgical annuloplasty); and is a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Leon has served as a nonpaid member of the scientific advisory board of Edwards Life-sciences; and has been a consultant to Abbott Vascular and Boston Scientific. Dr Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3men-sio. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr von Bardeleben has served as a unpaid advisory board member to Abbott Vascular, Boston Scientific, Edwards Lifesciences and Philips Healthcare, Speaker for Abbott Structural, Bioventrix, Cardiac Dimensions, Edwards Lifesciences and Philips Healthcare, no stock options or shares to any device company. Dr Zuber has served as a consultant for Abbott Vascular, Edwards Life-sciences, Cardiovalve, Vortex, CoreMedics, Cardiovalve and that received speaker fees from Pfizer and Canon. Dr Himbert has served as a proctor for Edwards Lifesciences and Abbott. Dr Ludwig received travel compensation from Edwards Lifesciences. Dr Andreas served as proctor/consultant (Edwards/ Abbott) and advisor (Medtronic). Dr Kalbacher has received travel compensation and lecture fees from Abbott, and proctor fees and travel compensation from Edwards. The other authors report no conflicts.
Funding Information:
Dr Muntané-Carol is supported by a research grant from the Fundación Alfonso Martín Escudero (Madrid, Spain). Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions.
Publisher Copyright:
© 2021 Wolters Kluwer Health. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - blood pressure
KW - hypertension, pulmonary
KW - mortality
KW - pulmonary artery
KW - tricuspid valve
UR - http://www.scopus.com/inward/record.url?scp=85102211536&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85102211536&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.120.009685
DO - 10.1161/CIRCINTERVENTIONS.120.009685
M3 - Article
C2 - 33541097
AN - SCOPUS:85102211536
SP - 184
EP - 192
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
SN - 1941-7640
ER -