Ischemic Stroke With Cerebral Protection System During Transcatheter Aortic Valve Replacement

doi:10.1016/j.jcin.2020.05.039

JACC: Cardiovascular Interventions

Volume 13, Issue 18, 28 September 2020, Pages 2149-2155

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Abstract

Objectives

The objective of this study was to evaluate in-hospital outcomes with use of the Sentinel cerebral protection system (CPS) in transcatheter aortic valve replacement (TAVR).

Background

The role of the Sentinel CPS in preventing clinical ischemic stroke has been controversial.

Methods

The Nationwide Inpatient Sample database from the last three quarters of 2017, after the approval of the Sentinel CPS device, was queried to identify hospitalizations for TAVR. A 1:2 propensity score–matched analysis to compare in-hospital outcomes with versus without use of the CPS. The primary outcome was the occurrence of ischemic strokes.

Results

A total of 36,220 weighted discharges of patients who underwent TAVR (525 with the CPS and 35,695 without) were identified. The overall percentages of ischemic and hemorrhagic strokes were 2.4% and 0.2%, respectively. After propensity score matching (525 CPS, 1,050 no CPS), the risk for ischemic stroke was lower with use of the CPS (1 % vs. 3.8%, odd ratio [OR]: 0.243 (95% confidence interval: 0.095 to 0.619); p = 0.003). The cost of the index hospitalization was higher with use of the CPS ($47,783 vs. $44,578; p = 0.002). In multivariate regression analysis, use of the CPS was independently associated with a lower risk for ischemic stroke (OR: 0.380; 95% confidence interval: 0.157 to 0.992; p = 0.032).

Conclusions

Use of the Sentinel CPS in patients undergoing TAVR is associated with a lower incidence of ischemic stroke and in-hospital mortality, without an increased risk for procedural complications but with an increased cost of the index hospitalization.

Central Illustration

Key Words

cerebral embolic protection device

cerebral protection system

Sentinel

transcatheter aortic valve replacement

Abbreviations and Acronyms

CPS

cerebral protection system

ICD-10

International Classification of Diseases-10th Revision

NIS

Nationwide Inpatient Sample

propensity score

TAVR

transcatheter aortic valve replacement

TIA

transient ischemic attack

Cited by (0)

: Dr. Sorajja has received consulting and speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific; and holds equity in and has received consulting fees from Pipeline Technologies and Admedus. Dr. Cavalcante has received consulting fees from Abbott Vascular, Boston Scientific, Medtronic, 4Tech, and Edwards Lifesciences; has received grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and Circle Cardiovascular Imaging; and has received speaker honoraria from Siemens Healthineers and Medtronic. Dr. Garcia is a consultant for Surmodics, Osprey Medical, Medtronic, Edwards Lifesciences, and Abbott Vascular; has received institutional grant support from Edwards Lifesciences, Abbott Vascular, and BSCI; and has received honoraria from the American College of Cardiology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

: The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.