Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report.
Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did not reduce mortality, but was associated with a lowered rate of stroke at 30 days, according to the report.
The decline was mainly driven by registry data and was not confirmed by randomized controlled trials, Medscape specified.
Stroke was reported in 4.8% of patients treated with embolic protection devices, and at 6% in those without. At 30 days, mortality was similar between both groups with stroke rates significantly lower for patients treated with embolic protection.
Data indicated an 80% rate of new silent ischemic cerebral lesions, with no differences between patients treated with embolic protection devices and those without, according to the report.
“The available literature does not support the routine use of cerebral protection in patients undergoing TAVR. It should be considered in selected patients who are at high risk of embolization from the aortic valve, root and arch,” study author Dr. Luca Testa of Milan, Italy’s IRCCS Policlinico San Donato said, according to Medscape.
A separate substudy, from Claret Medical‘s Sentinel trial, showed a trend towards stroke reduction with the use of embolic protection across all anatomic subsets.
The substudy examined 347 of the Sentinel trial’s 363 patients, examining only those with complete anatomic data at baseline. A total of 16 patients in the subset had a stroke three days after TAVR procedures.
Patients with a type 1 aortic arch comprised more than 80% of the patients in the study, according to Medscape, and showed a “clear and significant reduction in stroke events,” according to study author Dr. Hasan Jilaihawi of New York University Langone Health.
Patients with the lowest range of aortic calcium received the most benefit from embolic protection, according to Medscape.
Dr. Testa suggested that future randomized trial would need to be undertaken to further understand who will benefit most from embolic protection during TAVR procedures, including enrolling younger patients and putting in extra effort to detect differences in a clinical endpoint of stroke, rather than a surrogate endpoint based off MRI results.
