RESULTS OF MAITRE (ARGUMENTS TO APPLY EPINEPHRYNE FOR POCKET HEMATOMA REDUCTION) STUDY

N. Ilov, A. Nechepurenko, A. Abdulkadyurov, D. Paskeev, E. Damrina, E. Kulikova, O. Palnikova, M. Terent'eva, D. Stompel, D. Tarasov

Federal Center of Cardiovascular Surgery, Astrakhan, Russian Federation

Abstract

Introduction: Pocket hematoma is a frequent early complication after pacemaker implantation. Searching for new ways to prevent this complication is actual.
Methods: We conducted a single-center, double-blind, placebo-controlled randomized clinical trial in two compared groups of patients with implanted single and dual chambered pacemakers in order to present safety of epinephrine using as a component of local anesthesia during pacemaker implantation procedure and to evaluate its effects for pocket hematoma reduction. The primary endpoint was the presence of pocket hematoma. Secondary endpoints included death from any cause, procedure-related complications, drainage insertion.
Results: We randomized 133 patients who met the inclusion criteria. Primary endpoint occurred in 6 of 73 patients in the epinephrine group: 4 of them applying warfarin and 2 patients without any hemostasis-related drugs. Pocket hematoma occurred statistically rare in placebo group (1 of 57 patients, p=0,002).
Conclusions: We presented a safety of performing pacemaker surgery with the use of epinephrine. However, 86% of hematomas referred to epinephrine group. We suppose that local vasopressor effects of epinephrine hide the true extent of bleeding dissuading the surgeon from active tactics.