Learning Curve With True Percutaneous TAVI Shows Reduced Vascular Complications Using Prostar XL Access Device

February 15, 2012—A study has been completed that sought to evaluate the impact of a learning curve on vascular complications using a “true percutaneous approach” for transcatheter aortic valve implantation (TAVI) while employing the Prostar XL percutaneous vascular surgical system (Abbott Vascular, Santa Clara, CA), which is designed for use in femoral artery access sites. Kentaro Hayashida, MD, et al published their findings in the Journal of the American College of Cardiology: Cardiovascular Interventions (2012;5:207–214).

The investigators found that experience reduced major vascular complications when using a true percutaneous approach for transfemoral TAVI and concluded that further application of this less-invasive strategy is feasible, and may be beneficial, in this high-risk patient cohort.

The background of the study is that the safety and efficacy of a true percutaneous approach for transfemoral TAVI has not been described in a large prospective cohort.

In a prospective, 264-patient TAVI database (October 2006–December 2010), transfemoral TAVI was performed in 170 patients. A true percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar XL was defined as adequate hemostasis without device-related vascular complications. The investigators compared the incidence of vascular complications in their early and late experience.

As detailed in the Journal of the American College of Cardiology: Cardiovascular Interventions, patients were 83 ± 7.2 years of age on average, with an average EuroSCORE of 24% ± 11.6%.

The Edwards Sapien valve (Edwards Lifesciences Corporation, Irvine, CA) (18–24 F) was used in 109 cases, and the CoreValve (Medtronic, Inc., Minneapolis, MN) (18 F) was used in 31 cases. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96 ± 0.14. Successful closure was achieved in 90.7% and was significantly increased (95.7% vs 85.7%; P = .047) in the late experience group. Crossover to surgery was required in 3.6% of cases.

Vascular complications occurred in 20% of cases and were significantly lower in the late experience group (11.4% vs 28.6%; P = .012). Major vascular complications (2.9% vs 14.3%; P = .018) were decreased in the late experience group. Early experience (HR, 3.66; 95% CI, 1.04–13.89; P = .047) and SFAR (HR, 110.80; 95% CI, 1.15–10,710.73; P = .044) predicted device failure by univariate analysis, reported the investigators in the Journal of the American College of Cardiology: Cardiovascular Interventions.