Objectives: This study aimed to evaluate the safety of low-dose protamine administration to facilitate earlier vascular sheath removal.
Background: Vascular access complications are the most common cause of postprocedural morbidity in patients undergoing peripheral endovascular intervention (PEI). Prolonged manual compression and closure devices do not eliminate these complications.
Methods: A consecutive series of 166 patients who underwent PEI were retrospectively compared to an all-comers control group of 136 patients who did not receive protamine. The study population received an intravenous dose of protamine based upon the dose of heparin received and the length of the procedure. The arterial sheath was removed when activated clotting time was less than 220 seconds. Primary end-points included bleeding complications, comprised of groin hematomas and retroperitoneal bleeding, and vascular complications, comprised of pseudoaneurysms, access vessel thrombosis, and arteriovenous fistula formation.
Results: The study population on average was older than the control group (71 vs. 67 years) and had a higher incidence of hypercholesterolemia (89.8% vs. 76.5%, P = 0.002). The average dose of protamine was 1.9 ± 0.83 mg, with a total dose of heparin of 5371 ± 1327 units. The time until sheath removal was 8.9 ± 8.6 minutes in the protamine group versus 188 ± 118 minutes in the control group (P < 0.001). There were no episodes of protamine anaphylaxis or adverse reactions. The access site complication rate between the 2 groups was statistically insignificant.
Conclusions: This strategy offers an inexpensive, safe, and reliable method to achieve hemostasis and facilitate earlier sheath removal in patients undergoing PEI. (J Interven Cardiol 2011;24:278–284)