麻豆传媒

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SAN DIEGO -- Cerebral embolic protection during transcatheter aortic valve replacement (TAVR) got a boost from several studies presented here.

The first study showed that of 984 consecutive patients who got TAVR, those who had protection with the Claret Sentinel fared better on neurological follow-up at 72 hours, demonstrating reduced risks of mortality or stroke (1.5% versus 4.4%, P<0.01) and disabling stroke (0.6% versus 3.2%, P<0.01) compared with peers who got the procedure without embolic protection.

Baseline characteristics were similar between groups that did and did not get cerebral embolic protection, reported Julia Seeger, MD, of the University of Ulm in Germany, at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

However, the Sentinel was more often used in patients who received predilatation and larger valves due to more frequent use of self-expandable valves, she noted.

Her results were echoed in a meta-analysis pooling the SENTINEL, CLEAN-TAVI, and SENTINEL-ULM studies (n=1,306), which altogether suggested that embolic protection recipients had fewer strokes (1.88% versus 5.44%, OR 0.35, 95% CI 0.17-0.72) and the combination of mortality or strokes in 72 hours (2.06% versus 6.00%, OR 0.34, 95% CI 0.17-0.68) in comparison with controls.

"By multivariable analysis, the use of [the] double filter embolic protection device was the only significant predictor for patients being stroke-free," according to Seeger.

Furthermore, it was the disabling strokes that were reduced, not non-disabling ones. It appeared also that recipients of balloon-expandable valves in particular tended to get better stroke protection from the filter.

These analyses together won Seeger the TCT "Best Oral Abstract" award.

For the meta-analysis, her group used propensity score matching to adjust for factors such as non-general anesthesia being more likely in the group without protection (84.9% versus 77.4%, P=0.002). Included in the final analysis were 533 patients each in both protection and non-protection groups.

The stroke-reduction benefits of embolic protection were also suggested in a separate TCT study of transfemoral TAVR at two tertiary care institutions in the Netherlands.

Consecutive TAVR patients there showed higher unadjusted rates of neurological events 72 hours after undergoing the procedure without the Sentinel filter (5.4% versus 1.4%, P<0.01), a disadvantage that persisted out to 30 days (7.6% versus 2.7%, P<0.01).

The difference was driven by a reduction in disabling strokes among those who got embolic protection, reported Herbert Kroon, MD, of Erasmus University Medical Center in the Netherlands.

Stroke prevention associated with embolic protection was most apparent in patients ages ≥75.

Between those who did (n=485) and did not (n=589) get protection during TAVR, the former was a group of slightly younger, lower-risk patients who were more likely to get non-CoreValve valves. The main findings of the study didn't budge upon propensity-score matching to adjust for these differences.

However, additional matching by year of TAVR saw the reduction in neurological events maintained in Sentinel recipients at 72 hours and 30 days, but the disabling stroke rates were no longer different between groups.

Notably, 40% of ischemic events still came from "protected" areas, according to Kroon.

"This is not going to be perfect but it will reduce the impact of stroke. The bigger thing for me is there is no way for me, as an operator, to predict who is going to have a stroke," said Ashish Pershad, MD, of Banner-University Medicine Heart Institute in Phoenix.

He told 麻豆传媒 that neither operator nor center experience has been shown to prevent neurological complications after TAVR. "It's a random event and therefore it behooves us that we use [embolic protection] in all patients, all things being equal."

The current studies are "very topical" because of the fact that Oct. 1, 2018 is when the new technology add-on payment for embolic protection will be approved by Centers for Medicare & Medicaid Services, Pershad said. Without reimbursement, hospitals have been reluctant to embrace this technology.

"Once this is approved, I plan on protecting all patients that can be protected with this device," he said. "The signal is getting more and more obvious that this device is safe and effective, and when reimbursed, I don't see how this cannot be the standard of care for people undergoing TAVR."