The Sentinel cerebral protection system (CPS) was associated with a lower incidence of ischemic stroke and in-hospital mortality in patients undergoing transcatheter aortic valve replacement (TAVR), according to a study published in JACC: Cardiovascular Interventions.
The investigators searched the Nationwide Inpatient Sample database to identify hospitalizations for TAVR performed during the last 3 quarters of 2017, following the approval of the Sentinel CPS device (Boston Scientific, Marlborough, MA) by the US Food and Drug Administration earlier that year. The study’s primary outcome was the occurrence of ischemic stroke.
A total of 36,220 weighted discharges of patients (median age, 81 years; interquartile range, 75 to 86 years; 46.2% women) who had TAVR (n=525 performed with CPS; n=35,695 performed without CPS) were recorded. The data of 1575 patients (n=525 with CPS; n=1050 without CPS) were examined after propensity score matching.
Overall, the percentage of ischemic strokes was 2.4% and the percentage of hemorrhagic strokes was 0.2%. After propensity score matching, the risk for ischemic stroke was lower in TAVR preformed with vs without the use of the CPS device (1% vs 3.8%, respectively; odds ratio [OR], 0.243; 95% CI, 0.095-0.619); P =.003). The cost of the index hospitalization was higher with vs without the use of the CPS device ($47,783 vs $44,578, respectively; P =.002). In addition, the use of the CPS device was independently associated with a lower risk for ischemic stroke (OR, 0.380; 95% CI, 0.157-0.992; P =.032).
Factors that were independently associated with post-TAVR ischemic stroke included a history of carotid artery disease, peripheral artery disease, atrial fibrillation or flutter, older age, bicuspid aortic valve, and female sex.
Study limitations include its observational and retrospective design, and the fact that long-term outcomes were not examined.
“Investigating the incidence of causes of ischemic strokes occurring with use of the CPS is also warranted to understand the limitations of the device better and promote further developments to increase its safety and efficacy,” noted the researchers.
Disclosures: Some of the authors declared affiliations with medical device companies. Please see the original reference for a full list of disclosures.
Megaly M, Sorajja P, Cavalcante JL, et al. Ischemic stroke with cerebral protection system during transcatheter aortic valve replacement. J Am Coll Cardiol Intv. 2020;13(18):2149-2155.