TY - JOUR
T1 - 1-Year Outcomes After Edge-to-Edge Valve Repair for Symptomatic Tricuspid Regurgitation
T2 - Results From the TriValve Registry
AU - Mehr, Michael
AU - Taramasso, Maurizio
AU - Besler, Christian
AU - Ruf, Tobias
AU - Connelly, K. A.
AU - Weber, Marcel
AU - Yzeiraj, Ermela
AU - Schiavi, Davide
AU - Mangieri, Antonio
AU - Vaskelyte, L.
AU - Alessandrini, Hannes
AU - Deuschl, Florian
AU - Brugger, Nicolas
AU - Ahmad, H.
AU - Biasco, L.
AU - Orban, Mathias
AU - Deseive, S.
AU - Braun, Daniel
AU - Rommel, Karl Philipp
AU - Pozzoli, Alberto
AU - Frerker, Christian
AU - Näbauer, Michael
AU - Massberg, Steffen
AU - Pedrazzini, Giovanni
AU - Tang, Gilbert H.L.
AU - Windecker, Stephan
AU - Schäfer, Ulrich
AU - Kuck, Karl Heinz
AU - Sievert, H.
AU - Denti, P.
AU - Latib, A.
AU - Schofer, Joachim
AU - Nickenig, G.
AU - Fam, Neil
AU - von Bardeleben, Stephan
AU - Lurz, Philipp
AU - Maisano, Francesco
AU - Hausleiter, Jörg
N1 - Funding Information:
Dr. Mehr has received travel grants from Bristol-Myers Squibb. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Connelly has received honoraria from Abbott; and is supported by a New Investigator award from the Canadian Institutes of Health Research and an Early Researcher award from the Ontario Ministry of Research. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; has received speaker honoraria from Abbott; and has received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Windecker has received research contracts to the institution from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo. Dr. Schäfer has received lecture fees, study honoraria, and travel expenses from Abbott Vascular, and is a member of an advisory board for Abbott Vascular. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Biosense Webster, Boston Scientific, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Prof. Sievert has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr. Denti has served as a consultant for Abbott Vascular, 4tech, Neovasc, and InnovHeart; and has received honoraria from Abbott. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; is on the Speakers Bureau for Abbott Vascular; is on the scientific advisory board for Millipede; and serves as a consultant for 4tech, Mitralign, and Millipede. Dr. Lurz has received speaker fees from Abbott. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; and is cofounder of 4tech. Dr. Hausleiter has received research support and speaking honoraria from Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
Dr. Mehr has received travel grants from Bristol-Myers Squibb. Dr. Taramasso is a consultant for Abbott Vascular, Boston Scientific, 4tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Connelly has received honoraria from Abbott; and is supported by a New Investigator award from the Canadian Institutes of Health Research and an Early Researcher award from the Ontario Ministry of Research. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; has received speaker honoraria from Abbott; and has received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Windecker has received research contracts to the institution from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, St. Jude, and Terumo. Dr. Schäfer has received lecture fees, study honoraria, and travel expenses from Abbott Vascular, and is a member of an advisory board for Abbott Vascular. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Biosense Webster, Boston Scientific, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Prof. Sievert has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr. Denti has served as a consultant for Abbott Vascular, 4tech, Neovasc, and InnovHeart; and has received honoraria from Abbott. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; is on the Speakers Bureau for Abbott Vascular; is on the scientific advisory board for Millipede; and serves as a consultant for 4tech, Mitralign, and Millipede. Dr. Lurz has received speaker fees from Abbott. Dr. Maisano has served as a consultant for Abbott Vascular, Edwards Lifesciences, Cardiovalve, Valtech, and Medtronic; and is cofounder of 4tech. Dr. Hausleiter has received research support and speaking honoraria from Abbott Vascular and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/8/12
Y1 - 2019/8/12
N2 - Objectives: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair. Background: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse. Methods: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed. Results: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm. Conclusions: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.
AB - Objectives: The purpose of this study was to evaluate procedural and 1-year clinical and echocardiographic outcomes of patients treated with tricuspid edge-to-edge repair. Background: Transcatheter edge-to-edge repair has been successfully performed in selected patients with symptomatic tricuspid regurgitation (TR) and high risk for surgery, but outcome data are sparse. Methods: This analysis of the multicenter international TriValve (Transcatheter Tricuspid Valve Therapies) registry included 249 patients with severe TR treated with edge-to-edge repair in compassionate and/or off-label use. Clinical and echocardiographic outcomes were prospectively collected and retrospectively analyzed. Results: In 249 patients (mean age 77 ± 9 years; European System for Cardiac Operative Risk Evaluation II score 6.4% [interquartile range: 3.9% to 13.9%]), a successful procedure with TR reduction to grade ≤2+ was achieved in 77% by placement of 2 ± 1 tricuspid clips. Concomitant treatment of severe TR and mitral regurgitation was performed in 52% of patients. At 1-year follow-up, significant and durable improvements in TR severity (TR ≤2+ in 72% of patients) and New York Heart Association functional class (≤II in 69% of patients) were observed. All-cause mortality was 20%, and the combined rate of mortality and unplanned hospitalization for heart failure was 35%. Predictors of procedural failure included effective regurgitant orifice area, tricuspid coaptation gap, tricuspid tenting area, and absence of central or anteroseptal TR jet location. Predictors of 1-year mortality were procedural failure, worsening kidney function, and absence of sinus rhythm. Conclusions: Transcatheter tricuspid edge-to-edge repair can achieve TR reduction at 1 year, resulting in significant clinical improvement. Predictors of procedural failure and 1-year mortality identified here may help select patients who will benefit most from this therapy.
KW - TR
KW - edge-to-edge repair
KW - heart failure
KW - structural heart disease
KW - tricuspid valve interventional repair
UR - http://www.scopus.com/inward/record.url?scp=85069820960&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069820960&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2019.04.019
DO - 10.1016/j.jcin.2019.04.019
M3 - Article
C2 - 31395215
AN - SCOPUS:85069820960
SN - 1936-8798
VL - 12
SP - 1451
EP - 1461
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 15
ER -