Transcatheter cerebral embolic protection (TCEP) during transcatheter aortic valve replacement (TAVR) is safe, but does not reduce new brain lesion volume, study results indicate.1

Susheel Kodali, MD, of Columbia University Medical Center in New York City and colleagues presented findings from the SENTINEL trial (Clinical Trials ID: NCT02214277) at the 2016 Transcatheter Cardiovascular Therapeutics meeting in Washington, DC. Their accompanying paper was simultaneously published by the Journal of the American College of Cardiology.

“Stroke is still a significant complication of TAVR,” Dr Kodali told Cardiology Advisor. According to Dr Kodali, some studies reported low stroke rates with TAVR, but others found that stroke rates were 6% or higher. “Beyond stroke itself, 70% of patients have evidence of new silent brain infarction on imaging. The question is: what are the long-term consequences?”2,3


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Small exploratory studies have suggested that TCEP during TAVR is effective at preventing cerebral embolic events.1,2 Dr Kodali and colleagues evaluated the safety and efficacy of TCEP during TAVR using the Sentinel TCEP device (Claret Medical, Inc.).

A total of 363 patients were randomized 1:1:1 to safety (TCEP only), device imaging (TCEP only), and control imaging (no TCEP). The primary safety and efficacy outcomes were major adverse cardiac and cerebrovascular events (MACCE) at 30 days and reduction in new lesion volume in protected brain territories on MRI at 2-7 days, respectively.

MACCE was 7.3% among patients treated with TCEP, which was non-inferior to the performance goal of 18.3% (P <.001) and similar to MACCE among control patients (9.9%; P =.405).

New lesion volume in protected brain territories was 42% lower in TCEP patients than in control patients, but this difference did not reach statistical significance (102.8 mm3 vs 178.0 mm3; P =.33).

Although the primary efficacy end point was not met, a post hoc analysis showed that after adjusting for baseline MRI T2/FLAIR lesion volume (marker of prior brain injury) and valve type, TCEP significantly reduced new lesion volume in protected and all brain territories compared with no TCEP (P =.025 for protected and P =.050 for all territories).

A total of 99% of TCEP patients had histopathologic debris in their filters, frequently derived from valve tissue, calcification, artery wall, and foreign material.

“We found that TCEP during TAVR reduced new brain lesion volume to a similar extent as prior randomized trials, CLEAN-TAVI and MISTRAL-C,” Dr Kodali said. “In contrast to those studies, SENTINEL involved multiple operators, institutions, and valve types, which introduced a wide range of variability, which may be one of the reasons why the study didn’t reach statistical significance.”

Dr Kodali also noted that the trial may not have met its primary end point because the study was underpowered. “I think one important thing to do going forward is to pool the data from SENTINEL and 2 other similar studies that used the same MRI core lab. We may be able to show a benefit with TCEP during TAVR with greater statistical power,” he suggested.

“The key findings from this trial are that the Sentinel device is safe and captured debris in 99% of patients,” Dr Kodali concluded. “Whether [or not] TCEP reduces new brain lesion volume [will need] to be evaluated in future device studies.”

Disclosures: The SENTINEL trial was funded by Claret Medical, Inc.


Drs Kodali, Makkar, Jilaihawi, Anwaruddin, Thourani, Nazif, Nakamura, McCabe, and Zajarias have reported financial relationships with Edwards Lifesciences. Drs Mehran and Zivadinov, as well as Ms. Alu, Ms. White, and Ms. Kraemer, have reported financial relationships with Claret Medical, Inc. Dr Parhizgar is an employee of Claret Medical, Inc.

References

  1. Kapadia SR, Kodali S, Makkar R, et al. Cerebral embolic protection during transcatheter aortic valve replacement. J Am Coll Cardiol. 2016. doi:10.1016/j.jacc.10.023 [Epub ahead of print].
  2. Latib A, Pagnesi M. Cerebral embolic protection during transcatheter aortic valve replacement: a disconnect between logic and data? J Am Coll Cardiol. 2016.  doi:10.1016/j.jacc.2016.10.036 [Epub ahead of print].
  3. Pagnesi M, Martino EA, Chiarito M, et al. Silent cerebral injury after transcatheter aortic valve implantation and the preventive role of embolic protection devices: a systematic review and meta-analysis. Int J Cardiol. 2016;221:97-106.