Early results using an ePTFE membrane for pericardial closure following coronary bypass grafting.

A prospective randomized trial was conducted to evaluate the early efficacy and safety of the Gortex surgical membrane. Three hundred two patients (265 males, 37 females) undergoing isolated coronary bypass surgery were randomized to receive a Gortex membrane (GM = 138) or have the pericardium left open (complication [C] = 164). The groups did not differ in age, gender, urgency of procedure, length of procedure, or use of arterial grafts. Two deaths occurred in each group giving an overall mortality of 1.3%. Fifty-three (17%) patients experienced some complication (C = 34, 21%), GM = 19 (14%). Although the combined complication rate was higher in the control group, this was not statistically significant (chi2 = 2.51, p = 0.11). Postoperative ischemic events (C = 8, GM = 4) observed between the groups were not significant (chi2 = 0.05, p = 0.8), and no statistically significant difference was observed between the incidences of infections (C = 7, GM = 5) or mediastinal complications (C = 3, GM = 3). The Gortex surgical membrane can be used safely without increasing the risk of infection or mediastinal complications. The incidence of recurrent myocardial ischemia, a possible indicator of graft compression, was not higher following membrane implantation. Efficacy at injury prevention will need to be determined by a longitudinal follow-up study presently underway.

RCT Entities:   Population Interventions Outcomes