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The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR
Amos Levi1, Matthias Linder2, Moritz Seiffert2
1Rabin Medical Center, Petah-Tikva, Israel; Tel Aviv University, Tel-Aviv Israel.
Insights
Cerebral embolic protection devices (CEPD) did not significantly reduce the risk or severity of acute ischemic stroke complicating transcatheter aortic valve replacement (TAVR). Outcomes like disability and mortality remained similar between protected and unprotected TAVR procedures.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Acute ischemic stroke is a significant risk following transcatheter aortic valve replacement (TAVR).
- Cerebral embolic protection devices (CEPD) were developed to prevent strokes during TAVR.
- Current evidence on CEPD efficacy in preventing TAVR-related strokes is inconclusive.
Purpose of the Study:
- To compare the characteristics and outcomes of patients who underwent TAVR with and without CEPD, specifically those who experienced an acute ischemic stroke complicating TAVR (AISCT).
Main Methods:
- Analysis of an international multicenter registry of AISCT cases within 72 hours of TAVR.
- Assessment of stroke severity using the National Institutes of Health Stroke Scale (NIHSS).
- Evaluation of primary outcomes including 30-day modified Rankin Score and 6-month all-cause mortality, using propensity score matching.
Main Results:
- Out of 18,725 TAVR procedures, 416 (2.2%) resulted in AISCT.
- No significant difference in stroke severity (NIHSS ≥15) or disabling stroke rates (modified Rankin Score >1) between CEPD-protected and unprotected groups.
- Similar 6-month all-cause mortality rates between the CEPD-protected (23.3%) and unprotected (31.3%) groups, with no significant difference after propensity score matching.
Conclusions:
- In patients experiencing AISCT after TAVR, the use of CEPD showed minimal impact on stroke distribution, severity, and patient outcomes.
- Further research may be needed to identify patient subgroups who could benefit from CEPD or to refine device technology.
Background:
Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention.
Objectives:
In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+).
Methods:
Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups.
Results:
In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively.
Conclusions:
In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.
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