PMID- 31801698
OWN - NLM
STAT- MEDLINE
DCOM- 20200309
LR  - 20200309
IS  - 1873-1740 (Electronic)
IS  - 0033-0620 (Linking)
VI  - 62
IP  - 6
DP  - 2019 Nov-Dec
TI  - Transcatheter innovations in tricuspid regurgitation: FORMA device.
PG  - 496-499
LID - S0033-0620(19)30158-6 [pii]
LID - 10.1016/j.pcad.2019.11.017 [doi]
AB  - 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 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(2); 
      p = 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.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Muntane-Carol, Guillem
AU  - Muntane-Carol G
AD  - Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
FAU - Del Val, David
AU  - Del Val D
AD  - Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
FAU - Bedard, Elisabeth
AU  - Bedard E
AD  - Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
FAU - Philippon, Francois
AU  - Philippon F
AD  - Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
FAU - Rodes-Cabau, Josep
AU  - Rodes-Cabau J
AD  - Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada. 
      Electronic address: josep.rodes@criucpq.ulaval.ca.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20191202
PL  - United States
TA  - Prog Cardiovasc Dis
JT  - Progress in cardiovascular diseases
JID - 0376442
SB  - IM
MH  - Cardiac Catheterization/methods
MH  - Equipment Design
MH  - *Heart Valve Prosthesis
MH  - *Heart Valve Prosthesis Implantation/adverse effects/instrumentation/methods
MH  - Humans
MH  - Patient Selection
MH  - Registries/statistics & numerical data
MH  - Severity of Illness Index
MH  - Time-to-Treatment
MH  - Treatment Outcome
MH  - *Tricuspid Valve/diagnostic imaging/pathology/surgery
MH  - *Tricuspid Valve Insufficiency/diagnosis/physiopathology/surgery
OTO - NOTNLM
OT  - Transcatheter tricuspid valve interventions
OT  - Tricuspid regurgitation
EDAT- 2019/12/06 06:00
MHDA- 2020/03/10 06:00
CRDT- 2019/12/06 06:00
PHST- 2019/11/27 00:00 [received]
PHST- 2019/11/27 00:00 [accepted]
PHST- 2019/12/06 06:00 [pubmed]
PHST- 2020/03/10 06:00 [medline]
PHST- 2019/12/06 06:00 [entrez]
AID - S0033-0620(19)30158-6 [pii]
AID - 10.1016/j.pcad.2019.11.017 [doi]
PST - ppublish
SO  - Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):496-499. doi: 10.1016/j.pcad.2019.11.017. 
      Epub 2019 Dec 2.