Transfemoral Aortic Valve Implantation of Edwards SAPIEN XT Without Predilatation Is Feasible

Background Transcatheter aortic valve implantation (TAVI) without predilatation has fewer procedural steps and thereby potentially fewer complications. This has been demonstrated for the antegrade transapical access; however, whether TAVI can be safely performed without predilatation using the retrograde transfemoral route is unknown. Hypothesis We postulated that TAVI is feasible with a balloon-expandable device without predilatation using the retrograde transfemoral route. Methods Twenty-six consecutive patients with stenosis of the native aortic valve (AV) undergoing transfemoral TAVI with the Edwards SAPIEN XT prosthesis without predilatation were enrolled in this retrospective study and compared with 30 patients treated previously with predilatation. Results The procedure was successfully performed in all 26 patients, irrespective of the AV area and the extent of AV calcification. At baseline mean AV area, mean AV gradient, and median left ventricular ejection fraction were 0.70.2cm(2), 36.0 +/- 17.3mm Hg, and 55.0% (interquartile range [IQR], 35.0-60.0], respectively; prior to discharge these values were 1.7 +/- 0.3 (P<0.001), 9.8 +/- 6.1mm Hg (P<0.001), and 57.5% (IQR, 38.7-60.0) (P=not significant). Postdilatation was required in 3 patients due to aortic regurgitation >2 degrees; this was reduced by the procedure to <2 degrees in all cases. Radiation dose and amount of contrast dye were significantly reduced in comparison with the predilatation group. No periprocedural neurological adverse events occurred. Mortality at 30 days was 0%. Conclusions TAVI without predilatation using the transfemoral Edwards SAPIEN XT valve is feasible and safe. Larger studies are required to further evaluate this approach.