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Cerebral embolic protection beneficial in TAVR, but one size does not fit all
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SAN DIEGO — Cerebral embolic protection to reduce stroke risk in transcatheter aortic valve replacement has clear benefits, but it may not be appropriate in all anatomic situations or for all institutional budgets.
According to randomized trials, registry data and meta-analyses, the stroke rate in TAVR is about 2.5%. Although it has decreased over time and remains lower than with surgical AVR, the rate is still unacceptably high, Samir Kapadia, MD, professor of medicine, section head of interventional cardiology and director of cardiac catheterization laboratories at Cleveland Clinic, said during a debate at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Protection for all patients
Cerebral protection is one solution to getting the stroke rate down. Not only have data shown that the Sentinel cerebral protection system (Claret Medical) is safe, but they also show that the device can capture most emboli, according to Kapadia, who was tasked with arguing for use of cerebral embolic protection in all patients.
For example, in the SENTINEL trial — for which Kapadia was a co-primary investigator — the device captured 99% of emboli. Additionally, the 30-day MACCE rate was lower in patients treated with the device vs. the control group (7.3% vs. 9.9%) in the intention-to-treat analysis, and the procedural clinical stroke rate was also about 63% lower with the device vs. the control group. Several other studies, including real-world experiences, also show that the RR reduction in stroke is nearly 80%, he said.
These data are important, according to Kapadia, because physicians cannot yet pinpoint which patients undergoing TAVR will experience stroke.
“If you use the device, patients will benefit 80% of the time,” he said, noting that the data suggest that many patients with a higher risk for stroke are likely undergoing TAVR anyway. “If everybody is likely to have a stroke, how can you be selective?”
At the Cleveland Clinic, Kapadia and colleagues currently use the Sentinel device in all patients with appropriate anatomy — about 95%, he said. However, a lack of reimbursement for the device may present a significant problem for some institutions.
More selective use
During his rebuttal, Steven J. Yakubov, MD, FACC, FSCAI, John H. McConnell Chair of Advanced Structural Heart Disease; system chief of OhioHealth Structural Heart Disease; and medical director of OhioHealth Research Institute, also said the stroke rates in TAVR remain high despite newer-generation devices and greater facility with the procedure on the part of operators. Research has shown that neither surgical risk nor Society of Thoracic Surgeons score adequately predicts who will have a stroke in TAVR or surgical AVR.
“There are some issues that are clearly undeniable,” Yakubov said. “The debris arises from many places, including the aorta, the myocardium or things that we don’t really predict.”
The Sentinel device, he noted, is “excellent” at capturing this debris and likely results in some reduction in stroke risk, but it does not fit all anatomy and does not cover the left vertebral artery distribution. Furthermore, the SENTINEL trial did not meet its primary efficacy endpoint, Yakubov said.
Additionally, not only does cerebral embolic protection add some time to the TAVR procedure, it removes the possibility for use of the right radial approach, Yakubov said, adding that there is a small learning curve.
“At the Cleveland Clinic, they’re excellent at using the device and can move quickly, but it is not comprehensive, does not protect all of the cerebral circulation, does not apply to everyone’s anatomy and, most importantly, the device is not free,” Yakubov said.
In a smaller institution with fewer resources or in more rural hospitals, this lack of reimbursement remains the major barrier to more expanded use of cerebral embolic protection and, therefore, routine use may not be suitable in all situations, he said. – by Melissa Foster
Reference:
Dvir D, et al. TAVR Academy III: Unresolved Issues and Future Directions. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; April 25-28, 2018; San Diego.
Disclosures: Kapadia reports he is a co-primary investigator for the SENTINEL trial sponsored by Claret Medical. Yakubov reports he serves on the medical advisory board for Abbott Vascular, Boston Scientific and Medtronic; he is a steering committee member/proctor for Medtronic; he serves on the advisory board and has equity interest in BioStar Ventures; and he is a consultant for Foldax and SentreHeart.