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 SentinelTM 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.
Highlights
Newer-generation transcatheter heart valve devices and increased operator experience have reduced the incidence of cerebrovascular events during transcatheter aortic valve replacement (TAVR) [1,2], stroke remains one of the most feared procedural complications
From April 2019 to April 2020, 231 patients were submitted to a transfemoral TAVR procedure, 165 (71.5%) of them under cerebral embolic protection
Almost 50% of all early post-TAVR strokes are directly procedure-related and occur within the first 24 h [3,19,23]. This post-TAVR stroke incidence peak is consistent with what has been observed in carotid stenting procedures, suggesting that stroke occurrence is related to hostile aortic arch and anatomical features of supra-aortic vessels [24]
Summary
Newer-generation transcatheter heart valve devices and increased operator experience have reduced the incidence of cerebrovascular events during transcatheter aortic valve replacement (TAVR) [1,2], stroke remains one of the most feared procedural complications. In the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, after propensity-weighted analysis, significant reduction in in-hospital stroke [relative risk (RR) 0.82; 95% confidence interval (CI) 0.69-0.97], in-hospital death or stroke (RR 0.84; 95% CI 0.73-0.98), 30-day stroke (RR 0.85; 95% CI 0.73-0.99), and 30-day mortality rate (RR 0.78; 95% CI 0.64-0.95) was observed in patients submitted to a protected TAVR [9] Corroborating these findings, another propensity-weighted analysis from the National Inpatient Sample showed that Sentinel use was associated with lower risk of in-hospital ischemic stroke [odds ratio (OR) 0.24; 95% CI 0.09-0.62] and in-hospital death (0 vs 1%; p = 0.036) [10]. Bovine arch is a recognized anatomic risk factor for carotid stenting, increasing the procedural difficulty level [13], and thoracic aortic disease development [14] In this respect, in younger patients with this anatomical configuration, TAVR may represent a valid option considering that they could, in time, require an open aortic valve repair. This is the first study evaluating a cohort of patients with bovine aortic arch anatomy submitted to TAVR under cerebral protection
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