Larzon T, Roos H, Gruber G, Henrikson O, Magnuson A, Falkenberg M, Lönn L, Norgren L
Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Vascular Surgery, Örebro, Sweden.
Department of Vascular Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
Eur J Vasc Endovasc Surg. 2015 Feb;49(2):166-73. doi: 10.1016/j.ejvs.2014.10.021. Epub 2014 Dec 27.
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.
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.
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).
In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique.
旨在研究在接受血管腔内主动脉修复术的患者中，与Prostar技术相比，筋膜缝合技术（FST）是否能缩短穿刺口闭合时间并降低手术成本，并评估两种技术的短期和中期疗效。
在这项双中心试验中，2006年6月至2009年12月期间，100例患者被随机分为采用FST或Prostar进行穿刺口闭合。主要终点是穿刺口闭合时间。次要结局指标包括与穿刺口相关的成本以及短期和中期并发症的评估。在围手术期、术后、出院时、30天和6个月随访时进行评估。
FST的中位穿刺口闭合时间为12.4分钟，Prostar为19.9分钟（p <.001）。根据回归分析，Prostar所需的手术时间比FST长54%，平均比值为1.54（95%CI 1.25 - 1.90，p <.001）。经操作者经验调整后，平均比值为1.30（95%CI 1.09 - 1.55，p =.005），经患者体重指数调整后为1.59（95%CI 1.28 - 1.96，p <.001）。熟练水平的操作者技术失败率为5%（2/40），而基础水平的操作者为28%（17/59）（p =.003）。熟练水平组中，FST的技术失败率为4%（1/26），Prostar为7%（1/14），p = 1.00；而基础水平组中，FST的相应失败率为27%（6/22），Prostar为30%（11/37）（p =.84）。成本方面存在显著差异，FST更具优势，中位差异为800欧元（95%CI 710 - 927，p <.001）。
在主动脉腔内修复术中，FST是一种比Prostar技术更快且更便宜的技术。
