Universität zu Köln

Baldus, Stephan, Schofer, Niklas, Hausleiter, Joerg, Friedrichs, Kai, Lurz, P., Luedike, Philipp, Frerker, Christian, Nickenig, G., Lubos, Edith, Pfister, Roman, Koerber, M., I, Kalbacher, Daniel, Naebauer, Michael, Besler, C., Mahabadi, Amir Abbas, Weber, Marcel, Zdanyte, M., Ren, C. B. and Geisler, Tobias (2022). Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results. Catheter. Cardiovasc. Interv., 100 (7). S. 1291 - 1300. HOBOKEN: WILEY. ISSN 1522-726X

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Abstract

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 as NCT04614402. The current analysis is an interim report.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Schofer, Niklas UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausleiter, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedrichs, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Lurz, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Luedike, Philipp UNSPECIFIED UNSPECIFIED UNSPECIFIED Frerker, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickenig, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lubos, Edith UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfister, Roman UNSPECIFIED UNSPECIFIED UNSPECIFIED Koerber, M., I UNSPECIFIED UNSPECIFIED UNSPECIFIED Kalbacher, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Naebauer, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Besler, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahabadi, Amir Abbas UNSPECIFIED UNSPECIFIED UNSPECIFIED Weber, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Zdanyte, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ren, C. B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Geisler, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-692624
DOI:	10.1002/ccd.30450
Journal or Publication Title:	Catheter. Cardiovasc. Interv.
Volume:	100
Number:	7
Page Range:	S. 1291 - 1300
Date:	2022
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1522-726X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ASSOCIATION; DISEASE Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69262