当前位置： SCI文献检索 > JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY期刊下所有文献 > Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

Abstract：

BACKGROUND:Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES:This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS:Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS:Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS:In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

journal_name

J Am Coll Cardiol

journal_title

Journal of the American College of Cardiology

authors

Kodali S,Hahn RT,Eleid MF,Kipperman R,Smith R,Lim DS,Gray WA,Narang A,Pislaru SV,Koulogiannis K,Grayburn P,Fowler D,Hawthorne K,Dahou A,Deo SH,Vandrangi P,Deuschl F,Mack MJ,Leon MB,Feldman T,Davidson CJ,CLASP TR

doi

10.1016/j.jacc.2020.11.047

subject

Has Abstract

pub_date

2021-02-02 00:00:00

pages

345-356

issue

eissn

0735-1097

issn

1558-3597

pii

S0735-1097(20)37916-X

journal_volume

pub_type

杂志文章

在线工具

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.