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

DOI: 10.4244/EIJ-D-22-00238

Dariusz Jagielak
Dariusz Jagielak1, MD, PhD; Radoslaw Targonski1, MD, PhD; Christian Frerker2, MD, PhD; Mohamed Abdel-Wahab3, MD, PhD; Johannes Wilde3, MD, PhD; Nikos Werner4, MD, PhD; Michael Lauterbach4, MD, PhD; Juergen Leick4, MD, PhD; Marek Grygier5, MD, PhD; Marcin Misterski5, MD, PhD; Andrejs Erglis6, MD, PhD; Inga Narbute6, MD, PhD; Adam Ryszard Witkowski7, MD, PhD; Matti Adam8, MD, PhD; Derk Frank9,10, MD, PhD; Fernando Gatto11, MD, PhD; Tobias Schmidt2, MD, PhD; Alexandra J. Lansky12, MD
1. Department of Cardiac & Vascular Surgery, Uniwersyteckie Centrum Kliniczne, Gdansk, Poland; 2. Universitätsklinikum Lübeck, Lübeck, Germany; 3. Heart Center Leipzig, University of Leipzig, Leipzig, Germany; 4. Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany; 5. 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland; 6. Pauls Stradiņš Clinical University Hospital, University of Latvia, Riga, Latvia; 7. National Institute of Cardiology, Warsaw, Poland; 8. University Hospital Cologne, Cologne, Germany; 9. UKSH University Medical Center Schleswig-Holstein, Kiel, Germany; 10. DZHK Partner Site Hamburg/Kiel/Lübeck, Germany; 11. HerzZentrum Saar, Völklingen, Germany; 12. Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA

Background: Stroke remains a feared complication associated with 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 mm3. 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).

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