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

84 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.
@article{1a23bb0f0d1747c2a051ff2f6633114a,
title = "True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device: Impact of learning curve on vascular complications",
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.",
keywords = "closure device, percutaneous approach, Prostar device, transcatheter aortic valve implantation, vascular complications",
author = "Kentaro Hayashida and Thierry Lefvre and Bernard Chevalier and Thomas Hovasse and Mauro Romano and Philippe Garot and Darren Mylotte and Jhonathan Uribe and Arnaud Farge and Patrick Donzeau-Gouge and Erik Bouvier and Bertrand Cormier and Morice, {Marie Claude}",
year = "2012",
month = "2",
doi = "10.1016/j.jcin.2011.09.020",
language = "English",
volume = "5",
pages = "207--214",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - True percutaneous approach for transfemoral aortic valve implantation using the prostar XL device

T2 - Impact of learning curve on vascular complications

AU - Hayashida, Kentaro

AU - Lefvre, Thierry

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

PY - 2012/2

Y1 - 2012/2

N2 - 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.

AB - 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.

KW - closure device

KW - percutaneous approach

KW - Prostar device

KW - transcatheter aortic valve implantation

KW - vascular complications

UR - http://www.scopus.com/inward/record.url?scp=84857552892&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84857552892&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2011.09.020

DO - 10.1016/j.jcin.2011.09.020

M3 - Article

C2 - 22361606

AN - SCOPUS:84857552892

VL - 5

SP - 207

EP - 214

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 2

ER -