Universität zu Köln

Mauri, Victor, Besler, Christian, Riebisch, Matthias, Al-Hammadi, Osamah, Ruf, Tobias, Gercek, Muhammed, Horn, Patrick, Grothusen, Christina, Mehr, Michael, Becher, Marc Ulrich, Mues, Christoph, Boeder, Niklas, Kreidel, Felix, Friedrichs, Kai, Westenfeld, Ralf, Braun, Daniel, Oeztuerk, Can, Baldus, Stephan, Rassaf, Tienush, Thiele, Holger, Nickenig, Georg, Hausleiter, Joerg, Moellmann, Helge, Kelm, Malte, Rudolph, Volker, von Bardeleben, Ralph-Stephan, Nef, Holger M., Luedike, Peter, Lurz, Philipp and Pfister, Roman (2020). German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral Regurgitation. JACC-Cardiovasc. Interv., 13 (23). S. 2769 - 2779. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1876-7605

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Abstract

OBJECTIVES The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system. BACKGROUND The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture. METHODS Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). RESULTS Among the 309 patients (mean age 77 +/- 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 +/- 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was <= 2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class <= II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%). CONCLUSIONS Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status. (C) 2020 by the American College of Cardiology Foundation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mauri, Victor UNSPECIFIED UNSPECIFIED UNSPECIFIED Besler, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Riebisch, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Al-Hammadi, Osamah UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruf, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Gercek, Muhammed UNSPECIFIED UNSPECIFIED UNSPECIFIED Horn, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Grothusen, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Mehr, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Becher, Marc Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Mues, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Boeder, Niklas UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreidel, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedrichs, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Westenfeld, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Braun, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Oeztuerk, Can UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Rassaf, Tienush UNSPECIFIED UNSPECIFIED UNSPECIFIED Thiele, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausleiter, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Moellmann, Helge UNSPECIFIED UNSPECIFIED UNSPECIFIED Kelm, Malte UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED von Bardeleben, Ralph-Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Nef, Holger M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Luedike, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Lurz, Philipp UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfister, Roman UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-308127
DOI:	10.1016/j.jcin.2020.08.025
Journal or Publication Title:	JACC-Cardiovasc. Interv.
Volume:	13
Number:	23
Page Range:	S. 2769 - 2779
Date:	2020
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1876-7605
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/30812