Editor's choice: A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair

TY - JOUR

T1 - Editor's choice

T2 - A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair

AU - Larzon, T

AU - Roos, H

AU - Gruber, G

AU - Henrikson, O

AU - Magnuson, A

AU - Falkenberg, M

AU - Lönn, L

AU - Norgren, L

N1 - Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

PY - 2015/2/1

Y1 - 2015/2/1

N2 - Objectives The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. Methods In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications. Evaluation was performed peri- and post-operatively, at discharge, at 30 days and at 6 months follow up. Results The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar (p <.001). Prostar required a 54% greater procedure time than FST, mean ratio 1.54 (95% CI 1.25-1.90, p <.001) according to regression analysis. Adjusted for operator experience the mean ratio was 1.30 (95% CI 1.09-1.55, p =.005) and for patient body mass index 1.59 (95% CI 1.28-1.96, p <.001). The technical failure rate for operators at proficiency level was 5% (2/40) compared with 28% (17/59) for those at the basic level (p =.003). The proficiency level group had a technical failure rate of 4% (1/26) for FST and 7% (1/14) for Prostar, p = 1.00, while corresponding rates for the basic level group were 27% (6/22) for FST and 30% (11/37) for Prostar (p =.84). There was a significant difference in cost in favor of FST, with a median difference of €800 (95% CI 710-927, p <.001). Conclusions In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique.

AB - Objectives The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. Methods In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications. Evaluation was performed peri- and post-operatively, at discharge, at 30 days and at 6 months follow up. Results The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar (p <.001). Prostar required a 54% greater procedure time than FST, mean ratio 1.54 (95% CI 1.25-1.90, p <.001) according to regression analysis. Adjusted for operator experience the mean ratio was 1.30 (95% CI 1.09-1.55, p =.005) and for patient body mass index 1.59 (95% CI 1.28-1.96, p <.001). The technical failure rate for operators at proficiency level was 5% (2/40) compared with 28% (17/59) for those at the basic level (p =.003). The proficiency level group had a technical failure rate of 4% (1/26) for FST and 7% (1/14) for Prostar, p = 1.00, while corresponding rates for the basic level group were 27% (6/22) for FST and 30% (11/37) for Prostar (p =.84). There was a significant difference in cost in favor of FST, with a median difference of €800 (95% CI 710-927, p <.001). Conclusions In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Aneurysm, Abdominal

KW - Catheterization, Peripheral

KW - Clinical Competence

KW - Cost Savings

KW - Cost-Benefit Analysis

KW - Endovascular Procedures

KW - Equipment Design

KW - Fascia

KW - Female

KW - Femoral Artery

KW - Health Care Costs

KW - Humans

KW - Male

KW - Operative Time

KW - Punctures

KW - Suture Techniques

KW - Sweden

KW - Time Factors

KW - Treatment Outcome

KW - Vascular Closure Devices

U2 - 10.1016/j.ejvs.2014.10.021

DO - 10.1016/j.ejvs.2014.10.021

M3 - Journal article

C2 - 25549577

SN - 1078-5884

VL - 49

SP - 166

EP - 173

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

IS - 2

ER -