Universität zu Köln

Jagielak, Dariusz, Targonski, Radoslaw, Frerker, Christian, Abdel-Wahab, Mohamed, Wilde, Johannes, Werner, Nikos, Lauterbach, Michael, Leick, Juergen, Grygier, Marek, Misterski, Marcin, Erglis, Andrejs ORCID: 0000-0002-3999-0182, Narbute, Inga, Witkowski, Adam Ryszard, Adam, Matti, Frank, Derk, Gatto, Fernando, Schmidt, Tobias and Lansky, Alexandra J. (2022). Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention, 18 (7). S. 590 - 613. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213

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Abstract

Background: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. Aims: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. Methods: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. Results: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm(3). There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. Conclusions: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Jagielak, Dariusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Targonski, Radoslaw UNSPECIFIED UNSPECIFIED UNSPECIFIED Frerker, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Abdel-Wahab, Mohamed UNSPECIFIED UNSPECIFIED UNSPECIFIED Wilde, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Werner, Nikos UNSPECIFIED UNSPECIFIED UNSPECIFIED Lauterbach, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Leick, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Grygier, Marek UNSPECIFIED UNSPECIFIED UNSPECIFIED Misterski, Marcin UNSPECIFIED UNSPECIFIED UNSPECIFIED Erglis, Andrejs UNSPECIFIED orcid.org/0000-0002-3999-0182 UNSPECIFIED Narbute, Inga UNSPECIFIED UNSPECIFIED UNSPECIFIED Witkowski, Adam Ryszard UNSPECIFIED UNSPECIFIED UNSPECIFIED Adam, Matti UNSPECIFIED UNSPECIFIED UNSPECIFIED Frank, Derk UNSPECIFIED UNSPECIFIED UNSPECIFIED Gatto, Fernando UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Lansky, Alexandra J. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-692657
DOI:	10.4244/EIJ-D-22-00238
Journal or Publication Title:	EuroIntervention
Volume:	18
Number:	7
Page Range:	S. 590 - 613
Date:	2022
Publisher:	EUROPA EDITION
Place of Publication:	TOULOUSE CEDEX 6
ISSN:	1969-6213
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DIFFUSION-WEIGHTED MRI; REPLACEMENT; RISK Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69265