Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

Autor:	Jagielak D; Department of Cardiac & Vascular Surgery, Uniwersyteckie Centrum Kliniczne, Gdansk, Poland., Targonski R; Department of Cardiac & Vascular Surgery, Uniwersyteckie Centrum Kliniczne, Gdansk, Poland., Frerker C; Universitätsklinikum Lübeck, Lübeck, Germany., Abdel-Wahab M; Heart Center Leipzig, University of Leipzig, Leipzig, Germany., Wilde J; Heart Center Leipzig, University of Leipzig, Leipzig, Germany., Werner N; Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany., Lauterbach M; Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany., Leick J; Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany., Grygier M; 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland., Misterski M; 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland., Erglis A; Pauls Stradiņš Clinical University Hospital, University of Latvia, Riga, Latvia., Narbute I; Pauls Stradiņš Clinical University Hospital, University of Latvia, Riga, Latvia., Witkowski AR; National Institute of Cardiology, Warsaw, Poland., Adam M; University Hospital Cologne, Cologne, Germany., Frank D; UKSH University Medical Center Schleswig-Holstein, Kiel, Germany.; DZHK Partner Site Hamburg/Kiel/Lübeck, Germany., Gatto F; HerzZentrum Saar, Völklingen, Germany., Schmidt T; Universitätsklinikum Lübeck, Lübeck, Germany., Lansky AJ; Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA.
Jazyk:	angličtina
Zdroj:	EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology [EuroIntervention] 2022 Sep 20; Vol. 18 (7), pp. 590-597.
DOI:	10.4244/EIJ-D-22-00238
Abstrakt:	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).
Databáze:	MEDLINE
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