Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid RegurgitationInsights From the First-in-Human Experience
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Author + information
- Lluis Asmarats, MDa,∗,
- Gidon Perlman, MDb,c,∗,
- Fabien Praz, MDd,
- Mark Hensey, MB, BCh, BAOb,
- Michael P. Chrissoheris, MDe,
- Francois Philippon, MDa,
- Hadass Ofek, MDb,
- Jian Ye, MDb,
- Rishi Puri, MBBS, PhDa,f,g,
- Philippe Pibarot, DVM, PhDa,
- Adrian Attinger, MDb,
- Robert Moss, MDb,
- Elisabeth Bédard, MDa,
- Aris Moschovitis, MDd,
- David Reineke, MDd,
- Sandra Lauck, PhDb,
- Philipp Blanke, MDb,
- Jonathon Leipsic, MDb,
- Konstantinos Spargias, MDe,
- Stephan Windecker, MDd,
- John G. Webb, MDb and
- Josep Rodés-Cabau, MDa,∗ (josep.rodes{at}criucpq.ulaval.ca), @IUCPQ
- aDepartment of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada
- bDepartment of Cardiology, St. Paul’s Hospital, Vancouver, Canada
- cDepartment of Cardiology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel
- dDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- eDepartment of Cardiology, Hygeia Hospital, Athens, Greece
- fDepartment of Medicine, University of Adelaide, Adelaide, Australia
- gDepartment of Cardiology, Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, Quebec G1V 4GS, Canada.
Central Illustration
Abstract
Objectives To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California).
Background Scarce data exist on long-term outcomes following TTVr.
Methods This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter.
Results Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline.
Conclusions TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.
Footnotes
↵∗ Drs. Asmarats and Perlman contributed equally to this work.
Dr. Asmarats has been supported by a grant from the Fundación Alfonso Martin Escudero. Dr. Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. Drs. Perlman, Praz, and Lauck have served as consultants for Edwards Lifesciences. Dr. Chrissoheris has served as a proctor for Edwards Lifesciences and Abbott Vascular. Dr. Ye has served as a consultant for and received a consultation fee from Edwards Lifesciences. Dr. Pibarot has served as a consultant for Edwards Lifesciences and Medtronic. Dr. Moss has served as a consultant and is on the advisory board for Edwards Lifesciences. Dr. Blanke has served as a consultant for Edwards Lifesciences, Circle Cardiovascular Imaging, Neovasc, Gore, and Tendyne Holdings. Dr. Windecker has received institutional research grants from Abbott, Amgen, Bayer, Bristol-Myers Squibb, Boston Scientific, Biotronik, CSL Behring, Edwards, Medtronic, Polares, and Sinomed. Dr. Webb has served as a consultant for and has received research grants from Edwards Lifesciences. Dr. Leipsic has received institutional core lab support from Edwards Lifesciences, Medtronic, Abbott Vascular, and Neovasc; and has served as a consultant for Circle Cardiovascular Imaging, Edwards Lifesciences, and Heartflow; and owns stock options in Circle Cardiovascular Imaging and Heartflow. Dr. Rodés-Cabau has served as a consultant for and has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 25, 2019.
- Revision received April 23, 2019.
- Accepted April 26, 2019.
- 2019 American College of Cardiology Foundation
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