TY - JOUR
T1 - Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation
AU - CLASP TR EFS Investigators
AU - Kodali, Susheel
AU - Hahn, Rebecca T.
AU - Eleid, Mackram F.
AU - Kipperman, Robert
AU - Smith, Robert
AU - Lim, D. Scott
AU - Gray, William A.
AU - Narang, Akhil
AU - Pislaru, Sorin V.
AU - Koulogiannis, Konstantinos
AU - Grayburn, Paul
AU - Fowler, Dale
AU - Hawthorne, Katie
AU - Dahou, Abdellaziz
AU - Deo, Shekhar H.
AU - Vandrangi, Prashanthi
AU - Deuschl, Florian
AU - Mack, Michael J.
AU - Leon, Martin B.
AU - Feldman, Ted
AU - Davidson, Charles J.
N1 - Funding Information:
This study was funded by Edwards Lifesciences. Dr. Kodali has received grant support from Edwards Lifesciences. Drs. Davidson, Gray, Lim, Smith, Grayburn, Mack, and Leon have received grant support/consulting fees from Edwards Lifesciences. Dr. Hahn has served as a speaker and consultant for Edwards Lifesciences; and has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she has received no direct industry compensation. Drs. Deo, Vandrangi, Deuschl, and Feldman are employees of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2021/2/2
Y1 - 2021/2/2
N2 - 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)
AB - 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)
KW - echocardiography
KW - leaflet repair
KW - PASCAL
KW - tricuspid valve insufficiency
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U2 - 10.1016/j.jacc.2020.11.047
DO - 10.1016/j.jacc.2020.11.047
M3 - Article
C2 - 33509390
AN - SCOPUS:85099623681
VL - 77
SP - 345
EP - 356
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 4
ER -