True Percutaneous Approach for Transfemoral Aortic Valve Implantation Using the Prostar XL Device: Impact of Learning Curve on Vascular Complications

doi:10.1016/j.jcin.2011.09.020

JACC: Cardiovascular Interventions

Volume 5, Issue 2, February 2012, Pages 207-214

https://doi.org/10.1016/j.jcin.2011.09.020 Get rights and content

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Objectives

The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a “true percutaneous approach” in transfemoral transcatheter aortic valve implantation (TAVI).

Background

Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort.

Methods

Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience.

Results

Patients were 83.0 ± 7.2 years old and with a EuroSCORE of 24.0 ± 11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. 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 = 0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p = 0.012). Major vascular complications (2.9% vs. 14.3%, p = 0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p = 0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p = 0.044) predicted Prostar failure by univariate analysis.

Conclusions

Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.

Key Words

closure device

percutaneous approach

Prostar device

transcatheter aortic valve implantation

vascular complications

Abbreviations and Acronyms

ACT

activated clotting time

aortic stenosis

BMI

body mass index

confidence interval

hazard ratio

MLD

minimal lumen diameter

MSCT

multislice computed tomography

SFAR

sheath to femoral artery ratio

TAVI

transcatheter aortic valve implantation

VARC

Valve Academic Research Consortium

Cited by (0)

: Dr. Hayashida is supported by a grant from Banyu Life Science Foundation International, Tokyo Japan. Dr. Lefèvre is proctor for transfemoral-TAVI for Edwards Lifesciences and is a consultant for Simetys and Directflow. Dr. Chevalier is a consultant for Abbott Vascular. Dr. Romano is proctor for transapical-TAVI for Edwards Lifesciences. Dr. Mylotte is supported by an educational bursary from Merck Sharp & Dohme. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.