麻豆传媒

The Sentinel embolic prevention device was approved earlier this year. Click here to read our original report on the approval. In this follow-up article, we look at what has transpired since.

Since the Sentinel device was approved by the FDA for embolic protection during transcatheter aortic valve replacement (TAVR) in June, it has gained routine use in a growing number of cath labs, although limited by uncertainty over efficacy in stroke prevention.

The SENTINEL trial, conducted in 17 centers in the U.S. and two in Germany, revealed at the Transcatheter Cardiovascular Therapeutics meeting in 2016 that the dual-filter device did not reduce new lesion volume overall or stroke rates after TAVR. With an advisory panel recommendation based on little harm associated with the Sentinel, the FDA cleared it anyway.

The $3,000 device has yet to be covered by Centers for Medicare & Medicaid Services, though.

But that hasn't stopped 19 centers from joining the original trial sites in adopting the device for use in catching debris during TAVR, bringing the number of institutions using the Sentinel in the U.S.

"Our initial plan was to launch into high volume Centers of Excellence that participated in the U.S. SENTINEL IDE trial. What we saw was great interest from a broader group of centers, in addition to adoption by those Centers of Excellence. As a result, we more than doubled our forecast and continue to expand the rollout of Sentinel proportionally as we scale-up manufacturing," according to James Hallums, Chief Commercial Officer of Sentinel maker Claret Medical.

The University of California San Francisco Medical Center was one site that came on board after Sentinel's FDA approval.

"Sentinel adoption in our TAVR program started off cautiously but now we are more enthusiastic," said Vaikom Mahadevan, MD, their Director of Structural and Adult Congenital Interventions. "We are using Sentinel in approximately 50% of our TAVR patients."

Hallums estimated that the 36 Sentinel centers use the device about 70% of the time during TAVR.

Seattle's University of Washington Medical Center was one of the participating sites in the SENTINEL trial. There, the embolic protection device is now routinely used in most TAVR cases.

"I do see that the use of cerebral protection devices during TAVR is growing," Danny Dvir, MD, an interventional cardiologist there, told 麻豆传媒. "I admit that the data supporting neuroprotection devices in TAVR is not strong. However, there is a concern of stroke, and this strategy is commonly easily performed, quick and most important safe."

As for the device's efficacy, things may be looking up: A propensity-matched analysis suggested that strokes were statistically less likely when TAVR recipients got embolic protection with the Sentinel.

Still, continued uncertainty regarding whether it can truly prevent strokes has hampered many centers from taking up the Sentinel. North Shore University Hospital in Manhasset, N.Y., is one.

"Our multidisciplinary Heart Teams across the system have met and meticulously reviewed the existing data regarding the potential risks and benefits of adopting routine cerebral embolic protection for our TAVR (and other structural) procedures," Bruce Rutkin, MD, Interventional Director of Transcatheter Valve Therapies Assistant Professor of Medicine, Hofstra North Shore-LIJ School of Medicine, told 麻豆传媒.

"In short, we have not yet reached a consensus opinion regarding its use -- i.e., if it will be routinely used in cases (when anatomically suitable) or at the discretion of the operating team when they agree there may be a particular benefit in that patient," he said.

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