Edwards' Forma Transcatheter Coaptation System 1-Year Results Evaluated for Severe Tricuspid Regurgitation
October 9, 2017—The 1-year clinical and echocardiographic results using the transcatheter Forma system (Edwards Lifesciences) for severe tricuspid regurgitation were published by Gidon Perlman, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:1994–2003).
The investigators prospectively evaluated baseline characteristics, procedural, 30-day, and 1-year outcomes using multimodality imaging and hemodynamic and clinical assessments. The study was composed of 18 patients who underwent device implantation at three centers in Canada and Switzerland.
As summarized in JACC: Cardiovascular Interventions, 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 one device at 4 months and there was one 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 < .001), the average 6-minute walk test increased by 84 meters (P = .03), and the Kansas City Cardiomyopathy questionnaire heart failure score improved by 18 points (P = .02) compared with baseline.
Echocardiography showed a reduction of tricuspid regurgitation 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 = .001), and in six of 13 patients (46%) by 1 year (P = .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 = .004; 54 ± 5.3 mm to 49.9 ± 4.3 mm; P = .02; respectively).
The investigators concluded that implantation of the Forma system in high-risk patients with severe tricuspid regurgitation shows feasibility with a good midterm safety profile. At 1 year, despite variable success in reducing echocardiographic tricuspid regurgitation grade, there were significant clinical improvements and reductions in right ventricular dimensions, noted the investigators in JACC: Cardiovascular Interventions.