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
N1 - Funding Information:
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.
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 - Prostar device
KW - closure device
KW - percutaneous approach
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
SN - 1936-8798
VL - 5
SP - 207
EP - 214
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 2
ER -