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Multicenter Study
. 2024 Mar 11;17(5):666-677.
doi: 10.1016/j.jcin.2023.12.033.

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR

Amos Levi  1 , Matthias Linder  2 , Moritz Seiffert  2 , Guy Witberg  3 , Thomas Pilgrim  4 , Daijiro Tomii  4 , Yeela Tamlor Barkan  3 , Nicolas M Van Mieghem  5 , Rik Adrichem  5 , Pablo Codner  3 , David Hildick-Smith  6 , Sandeep Arunothayaraj  6 , Leor Perl  3 , Ariel Finkelstein  7 , Itamar Loewenstein  7 , Ole De Backer  8 , Rani Barnea  3 , Giuseppe Tarantini  9 , Luca Nai Fovino  9 , Hana Vaknin-Assa  3 , Darren Mylotte  10 , Max Wagener  10 , John G Webb  11 , Mariama Akodad  11 , Antonio Colombo  12 , Antonio Mangieri  12 , Azeem Latib  13 , Faraj Kargoli  13 , Francesco Giannini  14 , Alfonso Ielasi  15 , Lars Søndergaard  16 , Itay Aviram  3 , Tsahi T Lerman  3 , Mark Kheifets  3 , Eitan Auriel  3 , Ran Kornowski  3 ; ASTRO-TAVI Study Group
Affiliations
Free article
Multicenter Study

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR

Amos Levi et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention.

Objectives: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+).

Methods: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups.

Results: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively.

Conclusions: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

Keywords: SENTINEL; cerebral embolic protection device; complications; registry; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Seiffert has received speaker or advisory fees from Abbott Vascular, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Daiichi-Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers; and a research grant from Boston Scientific—all unrelated to the submitted work. Dr Pilgrim has received institutional research grants from Edwards Lifesciences, Boston Scientific, and Biotronik; and personal fees from Biotronik, Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, and AstraZeneca, and advisory/consultancy/speaker fees from JenaValve, Anteris, Siemens, Pie Medical, Materialise, Amgen, Abbott Vascular, Boston Scientific, Medtronic, Daiichi-Sankyo, Teleflex, and PulseCath BV. Dr Perl is a consultant for Edwards Lifesciences. Dr De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr Wagener has received educational support from Medtronic. Dr Webb has been a consultant to, and has received research funding from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie; and is a consultant for Medtronic and Edwards Lifesciences. Dr Mangieri has received an institutional research grant from Boston Scientific; and has served on a medical advisory board for Boston Scientific. Dr Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. Dr Søndergaard is chief medical officer at Abbott Structural Heart; and has received consultant fees and/or institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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