Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England

Abstract

Objective 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. Methods 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. Results 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. Conclusions 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.

Dual antiplatelet therapy reduces stroke but increases bleeding at the time of carotid endarterectomy

“…Interestingly, our current study also confirmed that the use of protamine to reverse heparin during CEA has a powerful protective effect against reoperation for bleeding, a finding consistent with previously published studies by Patel et al 18 and Stone et al 19 In our current study, the administration of protamine to reverse heparin in patients taking dual therapy was associated with observed reoperation for bleeding rates of <1%. These findings further highlight that the optimal perioperative management of patients undergoing CEA calls for continued dual antiplatelet therapy in combination with intraoperative protamine administration.…”

Carotid Endarterectomy in the Southern California Vascular Outcomes Improvement Collaborative

“…One example of a regional quality group achieving this goal is from the Vascular Study Group of New England (VSGNE), which demonstrated that a focus on protamine use during CEA in their region resulted in an increase in protamine use from 46% before 2009 to 61% after 2009. 21 Corresponding to the increase in protamine use, there was a decrease in the incidence of reoperation for bleeding from 1.2% to 0.6%, with no change in the incidence of postoperative neurologic events.…”

Regional variation in patient selection and treatment for lower extremity vascular disease in the Vascular Quality Initiative

“…We believe this internally driven, self-monitored approach has high buy-in from participating centers and early efforts have shown it to be effective in changing practice, as reported for bovine patch use and protamine administration in the Vascular Study Group of New England. [36, 37] Future analyses focused on adherence rates to new guidelines will need to factor in the confounding effect of the addition of new hospitals to the VQI.…”