Ischemic Stroke With Cerebral Protection System During Transcatheter Aortic Valve Replacement
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Published on: June 3, 2018
Michael Megaly1, Paul Sorajja2, João L Cavalcante2
1Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota; Division of Cardiovascular Medicine, Hennepin Healthcare, Minneapolis, Minnesota.
Insights
The Sentinel cerebral protection system (CPS) significantly reduces ischemic stroke risk during transcatheter aortic valve replacement (TAVR). While associated with higher hospitalization costs, CPS use lowers stroke incidence and in-hospital mortality.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- The clinical effectiveness of the Sentinel cerebral protection system (CPS) in preventing strokes during transcatheter aortic valve replacement (TAVR) remains a subject of debate.
- Evaluating in-hospital outcomes associated with CPS use in TAVR is crucial for understanding its clinical utility.
Purpose of the Study:
- To assess the impact of the Sentinel CPS on in-hospital outcomes in patients undergoing TAVR.
- To determine the efficacy of the Sentinel CPS in mitigating the risk of clinical ischemic stroke post-TAVR.
Main Methods:
- A retrospective analysis of the Nationwide Inpatient Sample database (2017) was performed.
- Hospitalizations for TAVR were identified, and a 1:2 propensity score-matched analysis compared outcomes between patients with and without CPS use.
- The primary endpoint was the occurrence of ischemic strokes.
Main Results:
- The study identified 36,220 TAVR hospitalizations (525 with CPS, 35,695 without).
- After propensity score matching, CPS use was associated with a significantly lower risk of ischemic stroke (1% vs. 3.8%, OR: 0.243, p=0.003).
- CPS use was linked to increased hospitalization costs ($47,783 vs. $44,578, p=0.002) but independently associated with reduced ischemic stroke risk (OR: 0.380, p=0.032).
Conclusions:
- The Sentinel CPS is associated with a reduced incidence of ischemic stroke and in-hospital mortality in TAVR patients.
- Its use did not increase procedural complication risks but did elevate index hospitalization costs.
- The findings support the use of Sentinel CPS for stroke prevention in TAVR procedures, balancing efficacy with cost considerations.
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.
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