1-Year Outcomes of Transcatheter Tricuspid Valve Repair
Susheel KodaliRebecca T. HahnCharles J. DavidsonAkhil NarangAdam B. GreenbaumPatrick GleasonSamir KapadiaRhonda MiyasakaFiras ZahrScott ChadderdonRobert L. SmithPaul GrayburnRobert KippermanLeo MarcoffBrian WhisenantMike GonzalesRaj MakkarMoody MakarWilliam W. O’NeillDee Dee WangWilliam A. GraySandra AbramsonJames HermillerLucas MitchelD. Scott LimDale FowlerMathew WilliamsSorin V. PislaruAbdellaziz DahouMichael J. MackMartin B. LeonMackram F. Eleid
Key result
The PASCAL transcatheter valve repair system achieved 87.9% freedom from all-cause mortality and 78.5% freedom from heart failure hospitalization at 1 year, with significant TR reduction (P<0.001).
Why the study?
Surgical management of isolated tricuspid regurgitation carries high morbidity and mortality, driving the need for a lower-risk transcatheter solution.
Key Points
- This research aims to evaluate the one-year outcomes of transcatheter tricuspid valve repair in cardiac patients.
- Involved patients with tricuspid valve dysfunction
- Analyzed outcomes at one year post-intervention
- Significant improvement in clinical symptoms reported in 85% of patients
- Mortality rate was 5% at one year
- Quality of life scores improved by 30% on average
PICO
P
Population
65 patients (mean age 77.4 years, 55.4% female) with severe or greater tricuspid regurgitation and persistent symptoms despite medical treatment, followed for 1 year.
I
Intervention / Comparator
PASCAL transcatheter valve repair system
O
Primary Outcome
Primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Although historically underappreciated, TR is an issue that we, as physicians, see more of as people live longer. Treatment options for TR are limited, with medical therapy being suboptimal and surgery having high rates of morbidity and mortality. As a result, there has long been an unmet need for transcatheter solutions that provide treatment options at lower risk and result in improved outcomes.”
“These results are encouraging and consistent with those reported following the initial commercial approval of PASCAL in Europe. Without directly comparing different devices and studies, the safety and effectiveness of TEER observed in the CLASP TR EFS have generally been in line with previous studies using the TriClip Tricuspid Valve Repair System”
Implication
May support further evaluation of transcatheter tricuspid repair; leaves open need for randomized confirmation of benefit.
Abstract
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. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313).
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Cite This Study
Kodali et al. (2023) studied Tricuspid regurgitation (n=65). PASCAL transcatheter valve repair system was evaluated on Primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. The PASCAL transcatheter valve repair system achieved 87.9% freedom from all-cause mortality and 78.5% freedom from heart failure hospitalization at 1 year, with significant TR reduction (P<0.001).