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.

Asmarats, Lluis; Perlman, Gidon; Praz, Fabien; Hensey, Mark; Chrissoheris, Michael P; Philippon, Francois; Ofek, Hadass; Ye, Jian; Puri, Rishi; Pibarot, Philippe; Attinger, Adrian; Moss, Robert; Bédard, Elisabeth; Moschovitis, Aris; Reineke, David; Lauck, Sandra; Blanke, Philipp; Leipsic, Jonathon; Spargias, Konstantinos; Windecker, Stephan; ... (2019). 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. Cardiovascular Interventions, 12(15), pp. 1438-1447. Elsevier 10.1016/j.jcin.2019.04.038

[img] Text
Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (945kB) | Request a copy

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Praz, Fabien and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1876-7605

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

11 Feb 2020 07:11

Last Modified:

11 Feb 2020 07:11

Publisher DOI:

10.1016/j.jcin.2019.04.038

PubMed ID:

31395213

Uncontrolled Keywords:

transcatheter coaptation system transcatheter tricuspid valve intervention tricuspid regurgitation

BORIS DOI:

10.7892/boris.139128

URI:

https://boris.unibe.ch/id/eprint/139128

Actions (login required)

Edit item Edit item
Provide Feedback