51. Transcatheter innovations in tricuspid regurgitation: FORMA device
- Author
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Josep Rodés-Cabau, François Philippon, David del Val, Guillem Muntané-Carol, and Elisabeth Bédard
- Subjects
medicine.medical_specialty ,Cardiac Catheterization ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,Balloon ,Severity of Illness Index ,New york heart association ,Time-to-Treatment ,03 medical and health sciences ,0302 clinical medicine ,Euroscore ii ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Registries ,Heart Valve Prosthesis Implantation ,Tricuspid valve ,Walking test ,business.industry ,Patient Selection ,Equipment Design ,Alternative treatment ,Tricuspid Valve Insufficiency ,medicine.anatomical_structure ,Treatment Outcome ,Heart Valve Prosthesis ,cardiovascular system ,Cardiology ,Tricuspid Valve ,Cardiology and Cardiovascular Medicine ,business ,Surgical patients - Abstract
Transcatheter tricuspid valve interventions (TTVIs) have arisen in recent years as an alternative treatment of tricuspid regurgitation (TR) in high risk patients. TTVIs can be classified as annuloplasty devices, caval valve implantation (CAVI), tricuspid valve replacement and coaptation devices. The FORMA repair system (Edwards Lifesciences, Irvine, CA, USA) aims to improve the coaptation of tricuspid leaflets by occupying the regurgitant orifice with a balloon spacer, which reduces the regurgitant orifice area. After the first-in-human reported case back in 2015, data from 18 patients treated under compassionate clinical use conditions and from 29 patients under the US early feasibility (EFS) trial have been published. The two studies included very high-risk surgical patients (Euroscore II8 in both cohorts). Implantation success was achieved in 16 (89%) and 27 (93%) of patients, respectively. In the US EFS trial, results at 30 days showed improvements in New York Heart Association (NYHA) functional class (NYHA class ≥ III in 28% vs 84% at baseline, p =0.0002), 6-minute walking test (increase by 21 m, p =0.012) and in the Kansas City Cardiomyopathy Questionnaire (increase by 29 points, p 0001). In addition, the Core Lab evaluation at 30 days showed statistically significant reductions in TR severity grading in the 25 available patients. Regarding the compassionate cohort, 15 patients had available data at long-term follow-up (≥ 2 years). NYHA functional class ≥ III was reduced from 93% to 34% (p 0.001). However, two-thirds of the patients remained with significant TR at last available follow-up, and there were no significant changes in EROA (0.92 vs. 0.77 cm
- Published
- 2019