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Ischemic Stroke With Cerebral Protection System During TAVR
Quick Takes
- The use of the cerebral protection system (CPS) during TAVR was independently associated with a lower risk for ischemic stroke and in-hospital mortality.
- Larger randomized trials are indicated to confirm these findings.
- Understanding of the mechanistic causes of ischemic strokes despite use of the CPS is needed to help develop better protection devices or refinements in procedural techniques.
Study Questions:
What are in-hospital outcomes with use of the Sentinel cerebral protection system (CPS) in transcatheter aortic valve replacement (TAVR)?
Methods:
The investigators queried the Nationwide Inpatient Sample database from the last three quarters of 2017, after the approval of the Sentinel CPS device to identify hospitalizations for TAVR. A 1:2 propensity score–matched analysis was used to compare in-hospital outcomes with versus without use of the CPS. The primary outcome was the occurrence of ischemic strokes. Outcomes in the matched groups are reported as odds ratios (ORs) with 95% confidence intervals (CIs).
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%, OR, 0.243; 95% CI, 0.095-0.619; 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% CI, 0.157-0.992; p = 0.032).
Conclusions:
The authors concluded that use of the Sentinel CPS in patients undergoing TAVR is associated with a lower incidence of ischemic stroke and in-hospital mortality.
Perspective:
This real-world sample of commercial TAVR procedures performed after approval of the Sentinel CPS device in the United States reports that use of the CPS was independently associated with a lower risk for ischemic stroke and in-hospital mortality, a similar risk for complications, but a higher cost of the index hospitalization. Given the recent analysis was observational and retrospective and has the inherent limitations of selection bias and coding errors, larger randomized trials are indicated to confirm these findings. In addition, understanding of the mechanistic causes of ischemic strokes occurring despite use of the CPS is needed to help develop better protection devices or refinements in procedural techniques.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Brain Ischemia, Cerebral Hemorrhage, Heart Valve Diseases, Hospital Mortality, Inpatients, Patient Discharge, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement, Treatment Outcome, Vascular Diseases
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