Cerebral embolic protection device may lower stroke risk, severity after TAVR
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Adults who underwent transcatheter aortic valve replacement with a cerebral protection system experienced fewer disabling strokes compared with patients who did not receive the device, data show.
“Cerebral embolic protection should be considered in patients undergoing TAVR to prevent disabling strokes,” Samir Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic, told Healio. “These findings are hypothesis-generating, because our data included a retrospective control group from a single center, which may not address all confounding variables. However, this is a large number of patients with very detailed data collection.”
Kapadia and colleagues analyzed data from 2,839 adults who underwent transfemoral TAVR at Cleveland Clinic from 2013 to 2020. The mean age of patients was 79 years; 41.5% were women. Researchers stratified patients as cerebral embolic protection device users (Sentinel, Boston Scientific; n = 1,802) and nonusers (n = 1,037). A neurologist masked to device use or nonuse assessed neuroimaging data and made a final diagnosis of a cerebrovascular event.
Researchers compared the incidence and severity of stroke, assessed by the NIH Stroke Scale (NIHSS), through 72 hours after TAVR or discharge between the two groups. The 72-hour period was consistent with the ongoing randomized PROTECTED TAVR trial, which is assessing incidence of periprocedural stroke among 3,000 patients undergoing TAVR with and without the cerebral embolic protection device.
The findings were published in Catheterization and Cardiovascular Interventions.
After adjustment for patient characteristics, researchers found the rate of overall stroke was numerically lower in cerebral embolic protection device users compared with nonusers; however, the difference did not reach statistical significance (0.49% vs. 1.18%; P = .064).
Device users experienced a lower rate of moderate to severe stroke (NIHSS score 6; 0.11% vs. 0.69%; P = .013) and severe stroke (NIHSS 15; 0 vs. 0.29%; P = .046) compared with nonusers. Additionally, stroke after device use (n = 8) compared with stroke after nonuse (n = 15) tended to carry a lower NIHSS score (median score, 4 vs. 7; P = .087). Four of 15 patients with stroke after device nonuse died within 30 days; there were no deaths after stroke in the device group.
“The risk reduction for moderate or severe stroke by cerebral embolic protection (–0.58%) was comparable to that for overall stroke (–0.69%), possibly suggesting that the stroke risk reduction by cerebral embolic protection is mainly from prevention of moderate or severe stroke,” the researchers wrote. “The present study also found that the NIHSS (albeit not statistically significant) tended to be lower in stoke following TAVR with than without cerebral embolic protection. These findings suggest that cerebral embolic protection may reduce the neurological severity of stroke following TAVR, possibly indicating an important role of cerebral embolic protection in the management and prognosis of stroke following TAVR.”
For more information:
Samir Kapadia, MD, can be reached at kapadis@ccf.org; Twitter: @tavrkapadia.