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First-in-man assessment of a dedicated guidewire for transcatheter aortic valve implantation.

AIMS
The aim of this study was to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire.


METHODS AND RESULTS
From May 2011 to August 2012, 39 consecutive patients referred for TAVI were prospectively enrolled in a first-in-man, open label, non-randomised feasibility study to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire in our institution (mean age 80.4±5.1 years, mean logistic EuroSCORE 26.8±11.7%, n=29 CoreValve transfemoral, n=8 CoreValve direct aortic, n=1 Edwards SAPIEN valve direct aortic, n=1 CoreValve subclavian). The primary safety endpoint was reached successfully with the dedicated TAVI guidewire in all 39 cases with no cases of guidewire displacement from the left ventricle during the procedure. In three cases the wire was repositioned to optimise loop position using a pigtail catheter prior to valve implantation. There were no cases of guidewire-related procedural complications. The mean delivery system tracking time using the guidewire was 1.4±0.6 minutes and the mean deployment time for TAVI was 13.8±7.8 minutes.


CONCLUSIONS
This represents the first recorded use of a dedicated TAVI guidewire to treat patients with a transcatheter aortic valve. The wire is easy to place, safe to adjust within the ventricle, and the stiffness of the wire facilitates valve tracking through tortuous anatomy. In this study there were no pericardial complications with the use of this dedicated TAVI guidewire.