Division of Vascular Surgery, University of Vermont College of Medicine, Burlington, Vt.
J Vasc Surg. 2013 Dec;58(6):1518-1524.e1. doi: 10.1016/j.jvs.2013.06.064. Epub 2013 Sep 5.
The goal of this study was to evaluate whether protamine usage after carotid endarterectomy (CEA) increased within the Vascular Study Group of New England (VSGNE) in response to studies indicating that protamine reduces bleeding complications associated with CEA without increasing the risk of stroke.
We reviewed 10,059 CEAs, excluding concomitant coronary bypass, performed within the VSGNE from January 2003 to July 2012. Protamine use and reoperation for bleeding were evaluated monthly using statistical process control. Twelve centers and 77 surgeons entering the VSGNE between 2003 and 2008 were classified as original participants, and 14 centers and 60 surgeons joining after May 2009 were considered new. Protamine use for surgeons was categorized as rare (<10%), selective (10%-80%), or routine (>80%). Outcome measures were in-hospital reoperation for bleeding, postoperative myocardial infarction (POMI), and stroke or death.
Two significant increases occurred in protamine use for all VSGNE centers over time. From 2003 to 2007, the protamine rate remained stable at 43%. In 2008, protamine usage increased to 52% (P < .01), coincident with new centers joining the VSGNE. Protamine usage then increased to 62% in 2010 (P < .01), shortly after the presentations of the data showing a benefit of protamine. This effect was due to 10 surgeons in the original VSGNE centers who increased their usage of protamine: six surgeons from rare use to selective use and four surgeons to routine use. Reoperation for bleeding was reduced by 0.84% (relative risk reduction, 57.2%) in patients who received protamine (0.6% vs 1.44%; P < .001). There were no differences in POMI (1.1% vs 1.09%) or stroke or death (1.1% vs 1.03%) between protamine treated and untreated patients, respectively. Reoperation for bleeding was decreased for surgeons who used protamine routinely (0.5%; P < .001) compared with selective (1.4%) and rare users (1.5%) of protamine. There were no differences in POMI (0.9%, 1.2%, 1.1%; P = .720) and stroke or death rates (1.0%, 1.2%, 1.0%; P = .656) for rare, selective, and routine users of protamine.
Protamine use increased over time by VSGNE surgeons, most significantly after the presentations of VSGNE-derived data showing the benefit of protamine, and was associated with a decrease in reoperation for bleeding. Improvements in processes of care and outcomes can be achieved in regional quality groups by sharing safety and efficacy data.
本研究旨在评估在新英格兰血管研究小组(VSGNE)中,颈动脉内膜切除术(CEA)后使用鱼精蛋白是否有所增加,因为有研究表明鱼精蛋白可减少与 CEA 相关的出血并发症,而不会增加中风风险。
我们回顾了 2003 年 1 月至 2012 年 7 月 VSGNE 进行的 10059 例 CEA,不包括同时进行的冠状动脉旁路移植术。使用统计过程控制每月评估鱼精蛋白的使用情况和因出血再次手术的情况。2003 年至 2008 年期间加入 VSGNE 的 12 个中心和 77 名外科医生被归类为原始参与者,2009 年 5 月后加入的 14 个中心和 60 名外科医生被视为新参与者。将外科医生使用鱼精蛋白的情况分为罕见(<10%)、选择性(10%-80%)或常规(>80%)。主要结局指标为术后因出血而再次手术、术后心肌梗死(POMI)以及中风或死亡。
随着时间的推移,所有 VSGNE 中心使用鱼精蛋白的情况均有两次明显增加。2003 年至 2007 年,鱼精蛋白的使用率保持在 43%的稳定水平。2008 年,鱼精蛋白的使用率上升至 52%(P<0.01),这与新中心加入 VSGNE 同时发生。2010 年,鱼精蛋白的使用率进一步上升至 62%(P<0.01),这是在表明鱼精蛋白有益的数据发布后不久。这种效果归因于 10 名来自原始 VSGNE 中心的外科医生增加了他们使用鱼精蛋白的频率:6 名外科医生从罕见使用变为选择性使用,4 名外科医生变为常规使用。接受鱼精蛋白治疗的患者再次出血手术的比例降低了 0.84%(相对风险降低 57.2%)(0.6%比 1.44%;P<0.001)。接受鱼精蛋白治疗和未接受鱼精蛋白治疗的患者之间,心肌梗死(1.1%比 1.09%)或中风或死亡(1.1%比 1.03%)的发生率无差异。常规使用鱼精蛋白的外科医生再次出血手术的比例降低(0.5%;P<0.001),而选择性(1.4%)和罕见(1.5%)使用鱼精蛋白的外科医生则无差异。鱼精蛋白的罕见、选择性和常规使用者之间的心肌梗死(0.9%、1.2%、1.1%;P=0.720)和中风或死亡率(1.0%、1.2%、1.0%;P=0.656)无差异。
VSGNE 外科医生随着时间的推移增加了鱼精蛋白的使用,在发布表明鱼精蛋白有益的 VSGNE 数据后,使用量显著增加,并且与减少因出血而再次手术相关。通过分享安全和疗效数据,区域质量小组可以在改善护理流程和结果方面取得进展。