PARIS – The most appropriate stroke prevention strategy in patients undergoing transcatheter aortic valve replacement is routine use of a cerebroembolic protection device for all, because no identifiable high-risk anatomic subsets exist, Hasan Jilaihawi, MD, said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.SENTINEL trial. The new analysis couldn’t identify any high-risk anatomic features that would safely permit selective use of cerebroembolic protection in transcatheter aortic valve replacement (TAVR) patients.
“We looked at the anatomy in great detail. I’d hoped to find a strata that was truly high risk, but there is no clear strata that is truly higher risk. So stroke remains an unpredictable event in TAVR, and in the ideal world we would use cerebroembolic protection in everyone,” said Dr. Jilaihawi, codirector of transcatheter valve therapy at New York University.
“I put it to you that, as in carotid stenting, where we routinely use cerebroembolic protection, perhaps we need to consider the same in TAVR,” the cardiologist added.
The SENTINEL trial randomized 363 patients undergoing TAVR 2:1 to the use of the Sentinel intraluminal filter device or no neuroprotection during the procedure. The use of the cerebroembolic protection device was associated with a statistically significant 63% reduction in the incidence of neurologist-adjudicated stroke within 72 hours, from 8.2% to 3.0% (J Am Coll Cardiol. 2017 Jan 31;69:367-77). The device was cleared for marketing by the Food and Drug Administration in 2017 and approved by European authorities several years earlier.
A wealth of evidence shows that the average stroke rate associated with contemporary TAVR is 4.4%, although this figure is probably on the low side because most of the data come from nonrandomized registries, which typically underreport neurologic outcomes. The stroke rate is independent of operator experience and volume, surgical risk score, and institutional TAVR volume. Moreover, in the SENTINEL trial, embolic debris was captured in 99% of patients fitted with the cerebroembolic protection device.
“A huge variety of material was captured, including thrombus, valve tissue, calcified material, and – alarmingly – foreign material in 35% of cases,” Dr. Jilaihawi noted.
Nonetheless, the issue of routine versus selective use of cardioembolic protection remains controversial at a time when interventionalists are trying to make TAVR a simpler, briefer procedure, even though the approved Sentinel device is successfully deployed in a median of only 4 minutes. This was the impetus for Dr. Jilaihawi to examine baseline anatomy as a potential predictor of stroke.
He looked at four key anatomic features: aortic arch type, aortic root angulation, aortic arch calcium, and aortic valve calcification. The bottom line: The benefit of cerebroembolic protection with the Sentinel device was consistent across all anatomic subgroups. For example, in patients with an aortic root angulation angle of less than 50 degrees, the incidence of stroke within 3 days post TAVR was 3.2% with and 5.9% without cerebroembolic protection, while in those with an angle of 50 degrees or more the stroke rate was 2.6% with and 9.1% without the Sentinel device. With a total of only 16 strokes by day 3 in the study, those stroke rates in the absence of cerebroembolic protection aren’t significantly different.