Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results

TY - JOUR

T1 - Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results

AU - Baldus, Stephan

AU - Schofer, Niklas

AU - Hausleiter, Jörg

AU - Friedrichs, Kai

AU - Lurz, P

AU - Luedike, Philipp

AU - Frerker, Christian

AU - Nickenig, G

AU - Lubos, Edith

AU - Pfister, Roman

AU - Körber, M I

AU - Kalbacher, Daniel

AU - Näbauer, Michael

AU - Besler, C

AU - Mahabadi, Amir Abbas

AU - Weber, Marcel

AU - Zdanyte, M

AU - Ren, C B

AU - Geisler, Tobias

N1 - © 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

PY - 2022/12/15

Y1 - 2022/12/15

N2 - BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated.RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001).CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

AB - BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated.RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001).CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

KW - Humans

KW - Female

KW - Aged, 80 and over

KW - Male

KW - Tricuspid Valve Insufficiency/diagnostic imaging

KW - Heart Valve Prosthesis Implantation

KW - Cardiac Catheterization

KW - Follow-Up Studies

KW - Prospective Studies

KW - Treatment Outcome

KW - Severity of Illness Index

U2 - 10.1002/ccd.30450

DO - 10.1002/ccd.30450

M3 - SCORING: Journal article

C2 - 36378678

VL - 100

SP - 1291

EP - 1299

JO - CATHETER CARDIO INTE

JF - CATHETER CARDIO INTE

SN - 1522-1946

IS - 7

ER -