Large calibre arterial access device closure for percutaneous aortic valve interventions: use of the Prostar system in 118 cases.

BACKGROUND: Percutaneous aortic valve treatments, balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI), are effective ways to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Large bore vascular access is required, and successful management of this arterial access is key to overall procedural success. We report outcomes and complications using the Prostar vascular closure device following BAV and TAVI.

METHODS: During the period under consideration, 54 patients underwent BAV and 64 patients underwent TAVI (n = 118). Procedural data and outcomes were collected prospectively on a dedicated database.

RESULTS: Patients were aged 80 ± 6.9 years (BAV) and 80.8 ± 6.1 years (TAVI) and 46.2% (BAV) and 46.8% (TAVI) were male, respectively. Primary success (hemostasis achieved immediately after deployment of the Prostar system on the table and persisting for a minimum of 24 hr in the absence of major or minor bleeding complications) was achieved in 94.4% (n = 54) of the patients undergoing BAV and 92.2% (n = 64) of the patients undergoing TAVI, respectively. The combined success rate was 93.3%. Major bleeding (see definitions section) was seen in 1.9% of cases in the BAV group and 4.7% of cases in the TAVI group. Minor bleeding (see definitions section) was seen in 3.7% of cases in the BAV group and 3.1% of cases in the TAVI group.

CONCLUSIONS: Use of the Prostar vascular closure system to achieve hemostasis following percutaneous aortic valve interventions is associated with a high primary success rate and acceptable level of bleeding complications.