September 16, 2014

By Walter Alexander

WASHINGTON D.C. -- September 16, 2014 -- Use of a dual-filter cerebral protection system reduces the number and volume of cerebral lesions in patients with severe aortic stenosis undergoing transaortic valve replacement (TAVR), according to prospective research presented at the 2014 Transcatheter Cardiovascular Therapeutics meeting (TCT).

“In patients with severe aortic stenosis who are at increased surgical risk, the use of [a] dual-filter cerebral protection system during TAVR significantly reduces the number and volume of cerebral lesions as determined by DW-MRI [diffusion-weighted magnetic resonance imaging] subtraction at 2 and 7 days after TAVR,” explained presenter Axel Linke, MD, University of Leipzig Heart Center, Leipzig, Germany, speaking here at a plenary session on September 13.

“Although results with TAVR have improved considerably over the last decade, stroke remains a major issue, and increases mortality by threefold,” Dr. Linke noted. He said also that neuro-imaging studies are revealing ischaemic brain lesions in more than two-thirds of these patients. “We know that those lesions are associated with a poorer neurocognitive outcome,” he added.

The purpose of cerebral-protection devices is to capture and remove embolic debris released during TAVR procedures, thereby reducing stroke risk. Dr. Linke and colleagues undertook the CLaret Embolic Protection ANd TAVI (CLEAN-TAVI) study as the first TAVR trial to examine the impact of a cerebral-protection device for preventing MRI-detected brain lesions. The primary endpoint was the number of lesions at 2 days post-TAVR in the protected brain region as determined by DW-MRI subtraction.

The hypothesis of the double-blind single centre study was that the filter device would reduce the number of emboli by 50% at 2 days post-TAVR relative to baseline. All 100 subjects underwent transfemoral TAVR; half had their TAVR procedures with the filter and half without.

The median number of total lesions in protected regions of the brain was reduced by 60% at 2 days with the filter (10 vs 4, P = .009), and by 57% at 7 days (7 vs 3, P = .0032). In all regions, the total number of lesions was reduced by 50% with the filter at 2 days (P = .0023), and by 50%, as well, at 7 days (10 vs 5, P = .0123).

Similarly, median lesion volume was reduced in protected regions with the filter (53% at 2 days from 527 mm3 to 246 mm3, P = .0023; 65% at 7 days from 292 mm3 to 101 mm3, P = .002) and in all regions with the filter (41% at 2 days from 800 mm3 to 471 mm3, P = .0243; 53% at 7 days from 472 mm3 to 220 mm3, P = .0127).

In a per-protocol analysis at 2 days post-TAVR, the ataxia rate was significantly lower (24% vs 9%) in the filter group.

“That supports the notion that the filter has the potential to improve neurological outcome,” Dr. Linke stated.
[Presentation title: CLEAN-TAVI: A Prospective, Randomized Trial of Cerebral Embolic Protection in High-Risk Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.]

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