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Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy

Ana Paula Tagliari, Enrico Ferrari, Philipp K. Haager, Martin Oliver Schmiady, Luca Vicentini, Mara Gavazzoni, Marco Gennari, Lucas Jörg, Ahmed Aziz Khattab, Stefan Blöchlinger, Francesco Maisano & Maurizio Taramasso

abstract

BACKGROUND
Cerebral embolic protection devices (CEPDs) have emerged as a mechanical barrier to prevent debris from reaching the cerebral vasculature, potentially reducing stroke incidence. Bovine aortic arch (BAA) is the most common arch variant and represents challenge anatomy for CEPD insertion during transcatheter aortic valve replacement (TAVR).

METHODS
Cohort study reporting the Sentinel Cerebral Protection System insertion's feasibility and safety in 165 adult patients submitted to a transfemoral TAVR procedure from April 2019 to April 2020. Patients were divided into 2 groups: (1) BAA; (2) non-BAA.

RESULTS
Median age, EuroScore II, and STS score were 79 years (74-84), 2.9% (1.7-6.2), and 2.2% (1.6-3.2), respectively. BAA was present in 12% of cases. Successful two-filter insertion was 86.6% (89% non-BAA vs. 65% BAA; = 0.002), and debris was captured in 95% (94% non-BAA vs. 95% BAA; = 0.594). No procedural or vascular complications associated with Sentinel insertion and no intraprocedural strokes were reported. There were two postprocedural non-disabling strokes, both in non-BAA.

CONCLUSION
This study demonstrated Sentinel insertion feasibility and safety in BAA. No procedural and access complications related to Sentinel deployment were reported. Being aware of the bovine arch prevalence and having the techniques to navigate through it allows operators to successfully use CEPDs in this anatomy.
   
citation Tagliari A P, Ferrari E, Haager P K, Schmiady M O, Vicentini L, Gavazzoni M, Gennari M, Jörg L, Khattab A A, Blöchlinger S, Maisano F, Taramasso M. Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy. J Clin Med 2020; 9:.
   
type journal paper/review (English)
date of publishing 20-12-2020
journal title J Clin Med (9/12)
ISSN print 2077-0383
PubMed 33419286
DOI 10.3390/jcm9124118