Author + information
- Received April 26, 2017
- Revision received June 11, 2017
- Accepted June 12, 2017
- Published online October 2, 2017.
- Gidon Perlman, MDa,b,
- Fabien Praz, MDc,
- Rishi Puri, MBBS, PhDd,e,f,
- Hadass Ofek, MDa,
- Jian Ye, MDa,
- Francois Philippon, MDd,
- Thierry Carrel, MDc,
- Philippe Pibarot, DVM, PhDd,
- Adrian Attinger, MDa,
- Nay Min Htun, MBBS, PhDa,
- Danny Dvir, MDa,
- Robert Moss, MDa,
- Francisco Campelo-Parada, MDd,
- Elisabeth Bédard, MDd,
- David Reineke, MDc,
- Aris Moschovitis, MDc,
- Sandra Lauck, PhDa,
- Philipp Blanke, MDa,
- Jonathon Leipsic, MDa,
- Stephan Windecker, MDc,
- Josep Rodés-Cabau, MDd and
- John Webb, MDa,∗ ()
- aSt. Paul’s Hospital, Vancouver, British Columbia, Canada
- bHadassah-Hebrew University Medical Center, Jerusalem, Israel
- cBern University Hospital, Bern, Switzerland
- dQuébec Heart & Lung Institute, Québec City, Quebec, Canada
- eDepartment of Medicine, University of Adelaide, Adelaide, Australia
- fCleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio
- ↵∗Address for correspondence:
Dr. John Webb, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Objectives This study sought to describe the 1-year experience with the transcatheter FORMA system for severe tricuspid regurgitation (TR).
Background Severe TR is associated with significant morbidity and mortality. Novel transcatheter therapies have been recently developed.
Methods Eighteen patients underwent device implantation at 3 centers in Canada and Switzerland. Baseline characteristics, procedural, 30-day, and 1-year outcomes were prospectively evaluated using multimodality imaging and hemodynamic and clinical assessments.
Results Procedural success was achieved in 16 (89%) patients. Unsuccessful procedures were because of right ventricular perforation requiring open surgery and device dislocation. At 1 year there were no deaths, significant arrhythmias, device infections, or dislocations. Thrombus was observed on 1 device at 4 months and there was 1 rehospitalization for heart failure. Among the 14 patients with successful device implantation and 1-year follow-up, 79% were in New York Heart Association functional class I/II (p < 0.001), the average 6-min walk test increased by 84 m (p = 0.03), and the Kansas City Cardiomyopathy Questionnaire heart failure score improved by 18 points (p = 0.02) compared with baseline. Echocardiography showed a reduction of TR from severe in 17 of 18 (94%) patients at baseline to moderate-severe or less in 11 of 16 patients (69%) by 30 days (p = 0.001) and 6 of 13 patients (46%) by 1 year (p = 0.01). The diameters of the tricuspid annulus and the right ventricle were reduced at 1 year (45.7 ± 4.8 mm to 42.1 ± 4.4 mm, p = 0.004; 54 ± 5.3 mm to 49.9 ± 4.3 mm, p = 0.02, respectively).
Conclusions Implantation of the FORMA system in high-risk patients with severe TR shows feasibility with a good mid-term safety profile. At 1 year, despite variable success in reducing echocardiographic TR grade, there were significant clinical improvements and reductions in right ventricular dimensions.
Drs. Perlman, Dvir, and Leipsic are consultants for Edwards Lifesciences. Dr. Praz is a consultant for Edwards Lifesciences. Dr. Ye is a consultant for and has received a consultation fee from Edwards Lifesciences. Dr. Pibarot is a consultant for Edwards Lifesciences and Medtronic. Dr. Blanke is a consultant for Edwards Lifesciences, Circle Cardiovascular Imaging, Neovasc, and Tendyne Holdings. Dr. Windecker has received institutional research grants from Bracco, Boston Scientific, and Terumo. Dr. Rodés-Cabau is a consultant for and has received research grants from Edwards Lifesciences. Dr. Webb is 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. Drs. Perlman and Praz contributed equally to this work.
- Received April 26, 2017.
- Revision received June 11, 2017.
- Accepted June 12, 2017.
- 2017 American College of Cardiology Foundation