Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience

JACC Cardiovasc Interv. 2019 Aug 12;12(15):1438-1447. doi: 10.1016/j.jcin.2019.04.038.


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.

Keywords: transcatheter coaptation system; transcatheter tricuspid valve intervention; tricuspid regurgitation.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Canada
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / mortality
  • Compassionate Use Trials
  • Europe
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Hemodynamics*
  • Humans
  • Male
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Prosthesis Design
  • Recovery of Function
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tricuspid Valve / diagnostic imaging
  • Tricuspid Valve / physiopathology
  • Tricuspid Valve / surgery*
  • Tricuspid Valve Insufficiency / diagnostic imaging
  • Tricuspid Valve Insufficiency / mortality
  • Tricuspid Valve Insufficiency / physiopathology
  • Tricuspid Valve Insufficiency / surgery*