Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation
Autor: | Martin B. Leon, Sorin V. Pislaru, Dale Fowler, Konstantinos Koulogiannis, Prashanthi Vandrangi, Michael J. Mack, Robert Kipperman, Akhil Narang, Robert L. Smith, Katie M Hawthorne, Ted Feldman, Paul A. Grayburn, Shekhar H Deo, Susheel Kodali, D. Scott Lim, Mackram F. Eleid, Florian Deuschl, William A. Gray, Clasp Tr Efs Investigators, Abdellaziz Dahou, Rebecca T. Hahn, Charles J. Davidson |
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Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty Regurgitation (circulation) 030204 cardiovascular system & hematology Cardiac Valve Annuloplasty 03 medical and health sciences 0302 clinical medicine Tricuspid Valve Insufficiency Quality of life Internal medicine medicine Humans 030212 general & internal medicine Prospective Studies Adverse effect Aged Aged 80 and over Clinical events business.industry Endovascular Procedures Atrial fibrillation medicine.disease Treatment Outcome Echocardiography Cardiology Feasibility Studies Functional status Female Tricuspid Valve Core laboratory Cardiology and Cardiovascular Medicine business |
Zdroj: | Journal of the American College of Cardiology. 77(4) |
ISSN: | 1558-3597 |
Popis: | Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options.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.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.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).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). |
Databáze: | OpenAIRE |
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