Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Left Radial Complete Cerebral Protection during Transcatheter Aortic Valve Replacement – Results from the PROTEMBO C Trial
T. Schmidt1, C. Frerker1, D. Jagielak2, R. Targonski3, M. Abdel-Wahab4, J. Wilde4, M. Lauterbach5, I. Eitel1, J. Leick5, M. Grygier6, M. Misterski6, A. Erglis7, I. Narbute7, A. R. Witkowski8, D. Frank9, M. Adam10, F. Gatto11, N. Werner5, für die Studiengruppe: PROTEMBO-C
1Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Lübeck; 2Uniwersyteckie Centrum Kliniczne, Gdansk, PT; 3Uniwersyteckie Centrum Kliniczne, Gdansk, PL; 4Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 5Innere Medizin III, Krankenhaus der Barmherzigen Brüder Trier, Trier; 6Poznan University of Medical Sciences, Poznan, PL; 7Pauls Stradins Clinical University Hospital, Latvian Centre of Cardiology, Riga, LV; 8Kardiologie, National Institute of Cardiology, Warschau, PL; 9Klinik für Innere Medizin III, Kardiologie, Angiologie und Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Kiel; 10Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 11Medizinische Klinik I, Kardiologie und Angiologie, HerzZentrum Saar - SHG-Kliniken Völklingen, Völklingen;

Background:

Stroke and other brain injury remain a feared and harmful complications during transcatheter aortic valve implantation  (TAVI) procedures. The ProtEmbo Cerebral Protection System is indicated for use as a temporary intra-aortic filter device to deflect embolic material in patients undergoing TAVI. The objective of the PROTEMBO C Trial was to evaluate the safety and performance of the ProtEmbo.

Methods:

The primary safety endpoint was the rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined by VARC-2 criteria. The primary performance endpoint was defined as the rate of technical success. The performance goals were established based upon data from randomized controlled trials of similar embolic protection devices. The secondary objective was to assess the efficacy of the device by comparing the new diffusion-weighted magnetic resonance imaging (DW-MRI) lesion volume in the brain and the rate of death or all strokes to historical data.

Results: 
Both primary safety and performance endpoints were met early in this study. The MACCE rate at 30 days was 8.1% (upper limit of the 95% confidence interval equal 21.3%; 3.7% below the predefined performance goal of 25%; p=0.0088); 3 MACCE events in 37 patients in the intention-to-treat (ITT) cohort. Performance success was achieved in 94.6% of patients (lower limit of the 95% confidence interval equal 82.3%; 7.3% above the predefined performance goal of 75%; p=0.0030); 35 successful procedures in 37 patients. Major vascular complications in the access vessel occurred in 2.7% of cases; 1 event in 37 patients in the ITT cohort. The volume of new DW-MRI lesions after use of the ProtEmbo was low (median total new lesion volume of 210 mm3). There were no large single lesions above 410 mm3 as assessed be DW-MRI and there were no deaths or strokes in the per protocol cohort of the study. 

Conclusion: 
The primary safety and performance endpoints of the PROTEMBO C Trial were met. The device was easy to use and fits into the work flow of TAVI procedures. Use of the ProtEmbo was associated with a reduction in the volume of new DW-MRI lesions and rate of death and stroke in comparison to historical data.
https://dgk.org/kongress_programme/jt2022/aV1020.html