Stroke continues to be a feared complication of transcatheter aortic valve replacement (TAVR), affecting about 2% of patients1. This has led to the development of numerous embolic stroke protection devices, the most widely used device being the Sentinel cerebral embolic protection (CEP) device (Boston Scientific). The SENTINEL trial, which led to FDA approval of the device, randomized 363 patients undergoing TAVR and showed that debris was captured in 99% of cases and had numerically fewer strokes but did not reach statistical significance for change in neurocognitive function or reduction in new stroke lesion volume on brain MRI2. Several small subsequent studies suggested possible benefit with CEP. This led to calls for a larger clinical trial in the form of PROTECTED TAVR.
PROTECTED TAVR was a large multi-center trial enrolling 3,000 patients undergoing TAVR that were randomized to CEP with the Sentinel device vs. control3. There was no significant difference between groups in the primary endpoint of clinical stroke within 72 hours of TAVR (2.3% with CEP vs. 2.9% for control; p=0.30). There was a reduction in disabling strokes, 0.5% with CEP vs. 1.3% in the control group; however, the study was not powered for this endpoint and the number needed to treat to prevent one disabling stroke would be 125.
With PROTECTED TAVR missing its primary endpoint, debate continues about the role of CEP in TAVR. Sub-group analyses failed to provide guidance on which patient subset may derive the most benefit from CEP. Future studies, including BHF PROTECT-TAVI, which will be larger than PROTECTED TAVR, and a prospectively planned meta-analysis of the two studies will no doubt shed light on this vexing problem.
1Huded, BP, Tuzcu, EM, Krishnaswamy, A, et al. Association Between Transcatheter Aortic Valve Replacement and Early Postprocedural Stroke. JAMA 2019
2Kapadia, SR, Kodali, S, Makkar, R et al. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. JACC 2017.
3Kapadia, SR, Makkar, R, Leon, M et al. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. NEJM 2022.
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