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 - 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 -