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Cerebral protection devices for TAVR may help in TEVAR
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HOLLYWOOD, Fla. — Data indicate that cerebral protection devices may reduce risk for clinical stroke and cerebral lesions during or after transcatheter aortic valve replacement, and may also apply to thoracic endovascular aortic repair, an expert said at the International Symposium on Endovascular Therapy (ISET).
“Stroke is a clinically important complication of TAVR and TEVAR procedures,” Robert Bersin, MD, MPH, a Bellevue, Washington-based interventional cardiologist and emeritus medical director of structural heart and endovascular services at Swedish Medical Center, Seattle, said during a presentation. “For cerebral embolic protection, we have a wealth of data in the TAVR world, like we usually do in cardiac research, but we have very little in TEVAR.”
A meta-analysis of recent TAVR trials determined a weighted average of 4.5% risk for clinical stroke at 30 days, with more than half of events occurring at 24 hours and as many as three-quarters occurring at 48 hours, he said.
“The lion’s share of this problem is procedural, as you might expect,” Bersin said.
In addition, registry data indicate that stroke incidence does not improve with increased TAVR volume, he said.
TAVR also confers increased risk for silent cerebral ischemic events, Bersin said, noting that 75% of patients undergoing TAVR have new cerebral ischemic lesions as detected by diffusion-weighted MRI.
Unfortunately, “there is a correlation between cerebral lesion volume and neurocognitive decline,” he said.
There are fewer data in TEVAR. In one study, 63% of patients had new cerebral ischemic lesions as detected by diffusion-weighted MRI after TEVAR, Bersin said.
“The problem appears to be about the same magnitude [in TAVR and TEVAR] for overt clinical strokes and subclinical emboli,” he said. “In TEVAR, when you are working on the arch, the risk for stroke is significant, and if you go around the arch and get into Zones 1 and 0, it becomes a very significant issue.”
Three embolic protection devices — Embrella (Edwards Lifesciences), Sentinel (Claret Medical) and Triguard (Keystone Heart) — have been tested in the TAVR population. “The one most relevant to TEVAR is the Sentinel,” which has a “double-filter” technology, he said.
Meta-analyses showed that the devices reduce the number of lesions and total lesion volume following TAVR, but the SENTINEL pivotal trial of the Sentinel device did not show a statistically significant relationship, he said.
“This was surprising, because the periprocedural stroke was reduced very significantly by two thirds in the early perioperative phase, but at 30 days, that difference disappeared statistically,” Bersin said.
Fortunately, a propensity-matched, nonrandomized study found use of the Sentinel device predicted freedom from stroke at 7 days after TAVR, he said.
Two very small studies of cerebral protection devices in TEVAR showed the filters collect debris, including thrombus and foreign material. “We need a lot more data when it comes to TEVAR as to whether this is of benefit,” he said.
“We need more data to determine whether or not cerebral protection devices reduce total volume of cerebral emboli and clinical stroke,” Bersin concluded. – by Erik Swain
References:
Bersin R. Session 6: Future of Aortic Therapies. Presented at: the International Symposium on Endovascular Therapy (ISET); Feb. 3-7, 2018; Hollywood, Fla.
Grover G. Session VII: EVAR State of the Art. Presented at: the International Symposium on Endovascular Therapy (ISET); Feb. 6-10, 2016; Hollywood, Fla.
Kapadia SR, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.10.023.
Muralidharan A, et al. Am J Cardiol. 2016;doi: 10.1016/j.amjcard.2016.07.011.
Disclosure: Bersin reports he is a consultant for Abbott Vascular, Boston Scientific, Cardinal Health, Cook Medical, Endologix, Medtronic, Spectranetics and W.L. Gore and Associates; a speaker for Abbott Vascular, Boston Scientific, Cook Medical, Endologix, Medtronic and Spectranetics; and a major stock shareholder of Ablative Solutions, Boston Scientific, Med Alliance SA, Omeros Corp., QT Vascular and Transverse Medical.