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

doi:10.3390/jcm9124118

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

J Clin Med. 2020 Dec 20;9(12):4118. doi: 10.3390/jcm9124118.

Authors

Ana Paula Tagliari^{1

2}, Enrico Ferrari^{1

3}, Philipp K Haager^{1

4}, Martin Oliver Schmiady¹, Luca Vicentini¹, Mara Gavazzoni¹, Marco Gennari^{1

5}, Lucas Jörg^{1

4}, Ahmed Aziz Khattab^{6

7}, Stefan Blöchlinger⁸, Francesco Maisano¹, Maurizio Taramasso¹

Affiliations

¹ Cardiac Surgery Department, University Hospital of Zurich, University of Zurich, 8091 Zurich, Switzerland.
² Postgraduate Program in Health Sciences: Cardiology and Cardiovascular Sciences-Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre 90035003, Brazil.
³ Cardiac Surgery Department, Cardiocentro Ticino, 6900 Lugano, Switzerland.
⁴ Cardiology Department, Kantonsspital St. Gallen, 9007 St. Gallen, Switzerland.
⁵ Cardiac Surgery Department, IRCCS Centro Cardiologico Monzino, 20138 Milan, Italy.
⁶ Cardiology Department, University Hospital of Zurich, University of Zurich, 8091 Zurich, Switzerland.
⁷ Cardiology Department, Cardiance Clinic, 8808 Pfäffikon, Switzerland.
⁸ Cardiology Department, Kantonsspital Winterthur KSW, 8400 Winterthur, Switzerland.

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^TM 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; p = 0.002), and debris was captured in 95% (94% non-BAA vs. 95% BAA; p = 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.

Keywords: bovine aortic arch; cerebral protection device; cerebrovascular events; stroke; transcatheter aortic valve replacement.