Transcatheter innovations in tricuspid regurgitation: FORMA device.
Prog Cardiovasc Dis
; 62(6): 496-499, 2019.
Article
em En
| MEDLINE
| ID: mdl-31801698
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 II >8 in both cohorts). Implantation success was achieved in 16 (89%) and 27 (93%) of patients, respectively. In the US EFS trial, results at 30â¯days showed improvements in New York Heart Association (NYHA) functional class (NYHA classâ¯≥â¯III in 28% vs 84% at baseline, pâ¯=0.0002), 6-minute walking test (increase by 21â¯m, pâ¯=0.012) and in the Kansas City Cardiomyopathy Questionnaire (increase by 29 points, pâ¯<â¯0001). In addition, the Core Lab evaluation at 30â¯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 classâ¯≥â¯III was reduced from 93% to 34% (pâ¯<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. 0.77â¯cm2; pâ¯= 0.516). In conclusion, this first experience with the FORMA device showed the feasibility of the procedure. Despite the magnitude of TR reduction was moderate at long-term, significant improvements in heart failure symptoms and quality of life were achieved.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Valva Tricúspide
/
Insuficiência da Valva Tricúspide
/
Próteses Valvulares Cardíacas
/
Implante de Prótese de Valva Cardíaca
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article