True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device: Impact of learning curve on vascular complications

Kentaro Hayashida, Thierry Lefvre, Bernard Chevalier, Thomas Hovasse, Mauro Romano, Philippe Garot, Darren Mylotte, Jhonathan Uribe, Arnaud Farge, Patrick Donzeau-Gouge, Erik Bouvier, Bertrand Cormier, Marie Claude Morice

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Abstract

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.

Original languageEnglish
Pages (from-to)207-214
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume5
Issue number2
DOIs
Publication statusPublished - 2012 Feb 1

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Keywords

  • Prostar device
  • closure device
  • percutaneous approach
  • transcatheter aortic valve implantation
  • vascular complications

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Hayashida, K., Lefvre, T., Chevalier, B., Hovasse, T., Romano, M., Garot, P., Mylotte, D., Uribe, J., Farge, A., Donzeau-Gouge, P., Bouvier, E., Cormier, B., & Morice, M. C. (2012). True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device: Impact of learning curve on vascular complications. JACC: Cardiovascular Interventions, 5(2), 207-214. https://doi.org/10.1016/j.jcin.2011.09.020