Cerebral ischemic events after transcatheter aortic valve replacement (TAVR) have been identified as independent predictors of morbidity and mortality. New-generation devices have managed to partially reduce the rate of cerebral events, but it still is around 5.5% at 30 days for patients undergoing TAVR through transfemoral access.

First data on cerebral protection devices had only shown a reduction in the number and volume of new lesions detected by magnetic resonance imaging (MRI) in reduced populations.

The SENTINEL study presented a 3.6% absolute reduction of stroke at 30 days, which correlated with a 42% reduction of new lesions detected in MRIs.

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This prospective, “all-comer” work assessed the positive impact of the Claret Sentinel cerebral protection device (Claret Medical Inc., Santa Rosa, California) in patients undergoing TAVR through transfemoral access, and carried out a comparison with patients treated without cerebral protection.

A total of 802 consecutive patients were enrolled; among them, 280 received the device (34.9%). All remaining patients underwent the exact same procedure, but without cerebral protection.

Neurological follow-up was done within 7 days post-procedure, and the primary endpoint was a composite of all-cause mortality and all-stroke. The population was propensity-matched in order to avoid potentially confounding variables.

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Both filters forming the device were successfully positioned in 280 or 305 patients (91.8%) in whom the procedure was attempted. With use of cerebral protection, the rate of all-stroke (whether disabling or nondisabling) was significantly reduced from 4.6% to 1.4% (odds ratio [OR]: 0.29; 95% confidence interval [CI]: 0.10 to 0.93) in the propensity-matched population (n = 560).

The primary endpoint occurred in 2.1% (n = 6 of 280) of the protected group compared with 6.8% (n = 19 of 280) of the unprotected group (p = 0.01).

In a multivariable analysis, the Society of Thoracic Surgeons (STS) score and TAVR without protection were event predictors.

Conclusion

In patients undergoing TAVR through a transfemoral access, the use of a cerebral protection device during the procedure reduced significantly the risk for stroke.

Editorial

Within the PARTNER 1 trial, the rate of stroke was 5.5% at 30 days compared with 2.4% for surgery. A lack of improvement in these indicators would limit TAVR in younger and lower-risk populations.

For the PARTNER 2 trial, which used a better profile valve, the rate of stroke was reduced to 3.2% for TAVR vs. 4.3% for surgery in medium-risk patients. This rate could still be improved.

This work defined its primary endpoint at 7 days, instead of the 30 days proposed by the SENTINEL trial. A much earlier endpoint offers the advantage of covering immediate peri-procedural events and those related with filter positioning, while leaving out posterior events that may be related to atrial fibrillation and dilute the difference.

Despite the use of cerebral protection, there still were stroke events, which may be related to two factors. On the one hand, the whole left vertebral artery is unprotected. On the other, the filter comes in a single measure; in consequence, it might not adapt properly to all anatomic variations.

Original title: Cerebral Embolic Protection During Transfemoral Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures.

Reference: Julia Seeger et al. J Am Coll Cardiol Intv 2017, Article in press.

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