Claret Medical™ is touting a newly presented study that supports the use of its cerebral protection device during Transcatheter Aortic Valve Implantation (TAVI) procedures.
Background
Although the clinical outcomes of TAVI have improved considerably during the last decade, stroke, which is associated with a 3-fold increase in mortality following the procedure, remains an important concern. Furthermore it is observed that ischemic lesions are found in as many as 80 percent of TAVI patients. Numerous devices have been developed to protect the brain from injury caused by embolic debris during TAVI, although clear evidence of the efficacy of any embolic protection device in TAVI is still missing. Now though, a study appearing in the August 9 issue of JAMA suggests that among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the number and volume of brain lesions. The device in question is Claret Medical’s Sentinel™ Cerebral Protection device, covered previously on our pages, most recently in October 2015 when an oral presentation at the annual Transcatheter Therapeutics event came to similar conclusions.
Axel Linke, M.D., of the University of Leipzig*, Germany, and colleagues randomly assigned 100 higher-risk patients with severe aortic stenosis to undergo TAVI with a cerebral protection device (n = 50; filter group) or without a cerebral protection device (n = 50; control group). Brain magnetic resonance imaging (MRI) was performed at study entry, 2 days, and 7 days after TAVI. The researchers found that the number of new brain lesions 2 days after TAVI was lower in the filter group (4) than in the control group (10). New lesion volume after TAVI was lower in the filter group (242 mm3) vs in the control group (527 mm3).
Regarding adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy (surgical incision into the chest wall).
Investigator comments
“Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions,” the authors write.
Physician comments
The results from this trial demonstrates 2 important points, write Steven R. Messe, M.D., of the University of Pennsylvania, Philadelphia, and Michael J. Mack, M.D., of the Heart Hospital Baylor Plano, Plano, Texas, in an editorial to accompany the study.
“First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with TAVI. In this trial, acute lesions on MRI were present in virtually all patients enrolled, although the vast majority of these lesions were quite small. Second, use of an embolic protection device can successfully reduce cerebral infarct number and volume. Whether that reduction translates to a meaningful improvement in clinical outcomes will require more study, but the findings represent a compelling and encouraging start.”
*The Leipzig Heart Center received a grant from Claret Medical and Medtronic.
published: August 18, 2016 in: Cardio, Clinical Studies/Trials, Medtronic, Neuro