Neurological complications during transcatheter aortic valve replacement (TAVR) may be reduced with cerebral protection devices; this study was designed to explore that hypothesis.

The study enrolled 363 patients undergoing TAVR in 19 sites and divided them in three arms:

• a safety arm (n = 123),
• a device imaging arm (n = 121),
• and a non-device imaging arm (n = 119).

The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events at 30 days The primary efficacy endpoint was reduction in new cerebral lesion volume and in brain territories protected by the device as assessed through nuclear magnetic resonance imaging scans at 2 and 7 days. All patients underwent a cognitive assessment, and all debris captured by the device was analyzed.

The rate of cardiac and cerebrovascular events for those who received the device was 7.3%, which was not statistically different from that of the control group, with 9.9% (p = 0.41).

New lesion volume on magnetic resonance scans was 179 mm³ in the control group and 102.8 mm³ in those who received the cerebral protection device, which was not statistically significant either.

A post hoc multivariable analysis found that the pre-existing lesion volume and the valve type were predictors of new lesions.

Strokes at 30 days were 9.1% in the control arm and 5.6% in the device arm (p = 0.25).

Neurocognitive function was similar in control subjects and subjects who received the device; when the whole population was analyzed, a correlation between lesion volume and neurocognitive decline was found (p = 0.0022).

Debris found within filters in 99% of patients included thrombus, calcification, native valve tissue, artery wall, and foreign material, such as gauze.

Conclusion

The SENTINEL cerebral protection device designed for use during transcatheter aortic valve replacements captured debris in 99% of patients. However, it did not improve cognitive function when compared to the control group. Reduction in new lesion volume as assessed through magnetic resonance scans was not statistically significant either.

Original title: Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement.

Reference: Samir R. Kapadia et al. J Am Coll Cardiol 2017;69:367–77.

We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.