Background:
Transcatheter aortic valve replacement (TAVR) has become
the dominant treatment for aortic valve disease. While TAVR safety has improved
over time, concern remains over the occurrence of cerebrovascular accidents (CVA)
secondary to device placement, which is associated with increased morbidity and
mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce
the risk of embolic strokes associated with debris produced during TAVR. Studies
evaluating Sentinel CPS efficacy have produced conflicting results, and there is
little understanding of which patients are selected for device placement in
“real-world” settings. With no existing guidelines on device use, the purpose
of this study was to describe and compare the characteristics of patients who
receive CPS with those who do not in a “real-world” setting of consecutive TAVR
patients and evaluate its impact on postoperative complications, namely stroke.
Methods:
This was a single-center, retrospective study of all patients
undergoing TAVR between July 1, 2019, and December 31, 2020. Patient
demographics, baseline, and perioperative characteristics were collected
prospectively using the Society of Thoracic Surgeons (STS)/American College of
Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution’s
TAVR database for analysis. Postoperative outcomes were assessed using primary
endpoints of in-hospital/30-day stroke and the composite of death, stroke, and
bleeding/vascular events at one-year. To adjust for baseline differences, a
propensity score was developed including all factors that were different between
groups, and Multivariate Cox Regression analysis was used to control for these
differences. Patient follow-up was 97% complete at 12 months with 100%
echocardiographic follow-up.
Results:
A total of 242 consecutive
patients (57.9% male) were analyzed, with a mean age of 79.9
9 years. Of
these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not.
Sentinel CPS patients were more likely to be male, not on dialysis, without prior
CVA or pacemaker, had less severe chronic lung
disease, and were lower operative risk compared to concurrent non-CPS patients.
CPS patients were also found to have higher hemoglobin and albumin levels, lower
creatinine, and were less likely to be on immunosuppressant therapy. The
incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and
non-CPS patients (0.0% vs. 1.9%;
p
= 0.198). Unadjusted analyses at
one-year showed a lower occurrence of the composite endpoint in CPS patients
compared non-CPS patients (8.3% vs. 17.0%;
p
= 0.034). After
adjustment, the hazard ratio (Adj HR) for the CPS group was no longer
significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI
0.244–1.523;
p
= 0.289). Both unadjusted (
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