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
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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. / Larzon, T; Roos, H; Gruber, G; Henrikson, O; Magnuson, A; Falkenberg, M; Lönn, L; Norgren, L.
In: European Journal of Vascular and Endovascular Surgery, Vol. 49, No. 2, 02.2015, p. 166-73.Research output: Contribution to journal › Journal article › Research › peer-review
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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
Y1 - 2015/2
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
VL - 49
SP - 166
EP - 173
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
SN - 1078-5884
IS - 2
ER -
ID: 162694338