Protamine Sulfate Use During Tibial Bypass Does Not Increase Thrombotic Events or Affect Short Term Graft Patency
John Phair, MD, John Futchko, MD, Charles DeCarlo, MD, Eric Trestman, MD, Issam Koleilat, MD, Evan Lipsitz, MD.
Montefiore Medical Center, Bronx, NY, USA.
OBJECTIVES:
While the use of protamine sulfate as a heparin reversal agent has been extensively reviewed in patients undergoing carotid endarterectomy and coronary artery bypass grafting, there is a lack of literature on protamine's effects during lower extremity bypass. The purpose of this study was to determine the risk of thrombotic or bleeding events, including early bypass failure, of protamine sulfate dosing after tibial bypass.
METHODS:
We performed a retrospective review of our institutional database for patients undergoing tibial bypass from January 2009 through December 2015. Primary endpoints were 30 day major adverse cardiac events (MACE) including myocardial infarction and stroke, 30 day major adverse limb events (MALE) including graft occlusion, reintervention or amputation, post-operative bleeding and transfusion, and perioperative death. A stepwise multivariate logistic regression was performed to identify predictors of the primary outcomes.
RESULTS:
A total of 261 tibial bypasses in 217 patients with critical limb ischemia were recorded. 146 (56.3%) patients received protamine sulfate intraoperatively and 114 (43.7%) did not. Protamine use had no effect on the rates of 30 day MACE (5.5% vs 3.5%, P=0.659), or perioperative mortality (3.4% vs 3.5%, P=1.0). There was no significant difference in post-operative bleeding events (5.5% vs 4.4%, P=0.64) or need for blood transfusion (13.1% v 15.8%, P=0.632) between both groups; however patients who received protamine did have significantly higher recorded operative blood loss (324cc v 261cc, P=0.019) and procedure lengths (275min vs 245min, P=0.031). Protamine use was not associated with any significant difference in the composite outcome of 30 day MALE (15.0% vs 12.3%, P=0.658). Kaplan-Meier estimation did not demonstrate a long-term difference in one-year patency (41.2% vs 50.2%, P=0.18) or one-year amputation-free survival (64.9% vs 66.0%, P=0.73).
CONCLUSIONS:
Heparin reversal with protamine sulfate after tibial bypass grafting is not associated with higher MACE, MALE, or mortality. In addition, there was no difference in post-operative bleeding complications between both groups. Protamine sulfate is safe for intraoperative use without increased risk of thrombotic complications or early graft failure.
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