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Updated: Jun 10, 2025

Transcatheter Pulmonary Valve Replacement from Autologous Pericardium with a Self-Expandable Nitinol Stent in an Adult Sheep Model
Published on: June 8, 2022
Real-World Patient Eligibility and Feasibility of Transcatheter Edge-to-Edge Repair or Replacement Interventions for
Abdelrahman Abushouk1, Habib Layoun1, Serge C Harb1
1Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Abstract:
Novel transcatheter therapies for tricuspid regurgitation (TR) appear promising, yet their applicability to an all-comer TR population remains unclear. We aimed to assess the feasibility of emerging transcatheter tricuspid therapies in a real-world population with greater than or equal to moderate symptomatic TR. A total of 178 patients were referred to our center between January 2019 and December 2021 for greater than or equal to moderate symptomatic TR and were classified into 4 groups: Investigative (patients eligible for enrollment in the Triluminate, Clasp TR, and TRISCEND trials), off-label clipping, surgery, and medical treatment. A total of 10.7% of the population were deemed eligible for investigative therapies, 20.2% and 19.7% of patients were offered off-label clipping and surgery, respectively, and 49.4% received medical treatment. Common reasons for investigative therapy-related ineligibility were unsuitable anatomy (large tricuspid annulus or wide leaflet coaptation gap) and the presence of significant comorbidities. Compared with the other groups, the investigative group was less likely to harbor concomitant ≥moderate mitral regurgitation, greater than or equal to moderate right ventricular dysfunction or severe pulmonary hypertension (P < .05). At 1 year, there remained a significant reduction in TR severity in the investigative group (P < .001) in comparison with the medical treatment group. However, the results were comparable to off-label clipping (P = .60) and inferior to surgery (P =.04). Exploratory analyses failed to show evidence of differences in the rates of all-cause mortality (P =.40) and heart failure hospitalizations (P = .94) between all groups. Current real-world eligibility of TR patients for emerging transcatheter therapies remains limited, underscoring the need for continued innovative efforts to offer device therapies to a broader TR cohort.
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