Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results
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Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results. / Baldus, Stephan; Schofer, Niklas; Hausleiter, Jörg; Friedrichs, Kai; Lurz, P; Luedike, Philipp; Frerker, Christian; Nickenig, G; Lubos, Edith; Pfister, Roman; Körber, M I; Kalbacher, Daniel; Näbauer, Michael; Besler, C; Mahabadi, Amir Abbas; Weber, Marcel; Zdanyte, M; Ren, C B; Geisler, Tobias.
in: CATHETER CARDIO INTE, Jahrgang 100, Nr. 7, 15.12.2022, S. 1291-1299.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -