Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation.

OBJECTIVES

This study sought to evaluate the technical success and clinical outcomes of an adjunctive crossover balloon occlusion technique (CBOT) combined with the 10-F Prostar percutaneous closure device (PCD) on the incidence of vascular and bleeding complications in patients after transfemoral transcatheter aortic valve implantation (TAVI).

BACKGROUND

Vascular closure following large-vessel access has most commonly been performed using a surgical cut-down and repair procedure.

METHODS

Between November 2008 and September 2010, 58 consecutive patients with severe aortic stenosis underwent TAVI via a retrograde femoral artery approach using the Edwards-SAPIEN transcatheter valve. Among these patients, 56 were treated with a CBOT using the "pre-close" technique and the 10-F Prostar system. The technical success of this new CBOT and the 30-day frequency of clinical events, including all-cause mortality, major vascular complications, and major bleeding (defined according to a modified version of the Valve Academic Research Consortium criteria), were assessed.

RESULTS

Successful closure was obtained in all but 3 patients (94.6%). The 30-day frequencies of mortality, major vascular complications, and major bleeding were 7.1%, 14.3%, and 5.4% respectively. No deaths were directly related to access site complications. Fourteen patients (25%) received at least 1 transfusion during the index hospitalization, of which 8 (57.1%) were not related to vascular complications. The mean and median hospital lengths of stay were 7.8 and 6.0 days.

CONCLUSIONS

This new percutaneous adjunctive CBOT combined with the Prostar PCD resulted in controlled, safe, and successful percutaneous closure in most patients after TAVI.