TY - JOUR
T1 - 1-Year Outcomes of Transcatheter Tricuspid Valve Repair
AU - Kodali, Susheel K.
AU - Hahn, Rebecca T.
AU - Davidson, Charles J.
AU - Narang, Akhil
AU - Greenbaum, Adam
AU - Gleason, Patrick
AU - Kapadia, Samir
AU - Miyasaka, Rhonda
AU - Zahr, Firas
AU - Chadderdon, Scott
AU - Smith, Robert L.
AU - Grayburn, Paul
AU - Kipperman, Robert M.
AU - Marcoff, Leo
AU - Whisenant, Brian
AU - Gonzales, Mike
AU - Makkar, Raj
AU - Makar, Moody
AU - O'Neill, William
AU - Wang, Dee Dee
AU - Gray, William A.
AU - Abramson, Sandra
AU - Hermiller, James
AU - Mitchel, Lucas
AU - Lim, D. Scott
AU - Fowler, Dale
AU - Williams, Mathew
AU - Pislaru, Sorin V.
AU - Dahou, Abdellaziz
AU - Mack, Michael J.
AU - Leon, Martin B.
AU - Eleid, Mackram F.
N1 - Funding Information:
The authors thank the staff and patients of the study centers who participated in the CLASP TR study. In addition, they thank Edwards Lifesciences TMTT members for their support of this publication: Ted Feldman, MD, Suzanne Y. Gilmore, MPIA, Ann Krzmarzick, MBC, Jeff Kim, PhD, Shekhar H. Deo, MBBS, PhD, Kirk Livingston, Mei Li, PhD, and Lan Xu, PhD.
Publisher Copyright:
© 2023
PY - 2023/5/9
Y1 - 2023/5/9
N2 - Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.
AB - Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.
KW - PASCAL
KW - transcatheter tricuspid valve repair
KW - tricuspid regurgitation
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U2 - 10.1016/j.jacc.2023.02.049
DO - 10.1016/j.jacc.2023.02.049
M3 - Article
C2 - 37137586
AN - SCOPUS:85153088659
SN - 0735-1097
VL - 81
SP - 1766
EP - 1776
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 18
ER -