Date of Award

January 2014

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Alexandra J. Lansky

Subject Area(s)

Medicine, Health sciences

Abstract

Utilization of a cerebral protection device during transcatheter aortic valve replacement (TAVR) will reduce the rate of periprocedural stroke as well as the occurrence and volume of new lesions on diffusion weighted magnetic resonance imaging (DW-MRI), which may serve as a potential surrogate endpoint for clinical studies. The DEFLECT I study is a prospective, multi-center, single arm study that aims to demonstrate the safety and performance of the TriGardTM Embolic Deflection Device (EDD) (Keystone Heart, Caesarea Business Park, Israel), among patients undergoing TAVR. Primary endpoints were device performance and in-hospital device-related safety. A powered secondary endpoint was the number and volume of new DW-MRI brain lesions. Of the 20 consecutive patients enrolled, the device performed as intended with complete vessel coverage until completion of the valve implant in 80% of cases. The hierarchical composite in-hospital procedure-related major adverse cardiac and cerebrovascular (MACCE) event rates was 10% due to 2/20 major disabling strokes, which occurred the day after the procedure following urgent surgery for a failed TAVR implant and a cardiac arrest due to loss of pacer capture. Compared with historical controls, the number of new ischemic brain lesions detected on DW-MRI were similar (70% vs. 76%); however, patients undergoing TAVR with the TriGardTM EDD device demonstrated a 94% reduction in the maximum lesion volume, a 94% reduction in maximum total lesion volume, and a 65% reduction in mean lesion volume compared with historical controls. An angiographic sub-study demonstrated that the only clinical factor associated with the maintenance of device coverage throughout the procedure was anchorage of the upper stabilizer in the innominate artery. The DEFLECT I study established proof of concept of the TriGardTM device and justifies further evaluation in a planned randomized clinical trial.

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