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.

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

transcatheter coaptation system transcatheter tricuspid valve intervention tricuspid regurgitation

Journal

JACC. Cardiovascular interventions

ISSN: 1876-7605

Titre abrégé: JACC Cardiovasc Interv

Pays: United States

ID NLM: 101467004

Informations de publication

Date de publication:
12 08 2019

Historique:

received: 25 02 2019

revised: 23 04 2019

accepted: 26 04 2019

entrez: 10 8 2019

pubmed: 10 8 2019

medline: 29 7 2020

Statut: ppublish

Résumé

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). Scarce data exist on long-term outcomes following TTVr. 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. 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. 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.

Sections du résumé

OBJECTIVES

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.

Identifiants

DOI: 10.1016/j.jcin.2019.04.038 PMID: 31395213

pubmed: 31395213

pii: S1936-8798(19)31018-0

doi: 10.1016/j.jcin.2019.04.038

pii:

doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

1438-1447

Commentaires et corrections

Type : CommentIn