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

Research output: Contribution to journalArticle

82 Citations (Scopus)

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
Externally publishedYes

Fingerprint

Learning Curve
Aortic Valve
Blood Vessels
Equipment and Supplies
Confidence Intervals
Incidence
Thigh
Hemostasis
Transcatheter Aortic Valve Replacement
Databases
Safety

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device : Impact of learning curve on vascular complications. / Hayashida, Kentaro; Lefvre, Thierry; Chevalier, Bernard; Hovasse, Thomas; Romano, Mauro; Garot, Philippe; Mylotte, Darren; Uribe, Jhonathan; Farge, Arnaud; Donzeau-Gouge, Patrick; Bouvier, Erik; Cormier, Bertrand; Morice, Marie Claude.

In: JACC: Cardiovascular Interventions, Vol. 5, No. 2, 02.2012, p. 207-214.

Research output: Contribution to journalArticle

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, MC 2012, 'True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device: Impact of learning curve on vascular complications', JACC: Cardiovascular Interventions, vol. 5, no. 2, pp. 207-214. https://doi.org/10.1016/j.jcin.2011.09.020
Hayashida, Kentaro ; Lefvre, Thierry ; Chevalier, Bernard ; Hovasse, Thomas ; Romano, Mauro ; Garot, Philippe ; Mylotte, Darren ; Uribe, Jhonathan ; Farge, Arnaud ; Donzeau-Gouge, Patrick ; Bouvier, Erik ; Cormier, Bertrand ; Morice, Marie Claude. / True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device : Impact of learning curve on vascular complications. In: JACC: Cardiovascular Interventions. 2012 ; Vol. 5, No. 2. pp. 207-214.
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AU - Chevalier, Bernard

AU - Hovasse, Thomas

AU - Romano, Mauro

AU - Garot, Philippe

AU - Mylotte, Darren

AU - Uribe, Jhonathan

AU - Farge, Arnaud

AU - Donzeau-Gouge, Patrick

AU - Bouvier, Erik

AU - Cormier, Bertrand

AU - Morice, Marie Claude

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