Purpose: Atrial fibrillation (AF) is the most common postoperative complication following coronary artery bypass graft (CABG). Since postoperative hemodynamics involve constriction of pericardium, we therefore hypothesize that placing a piece of Cormatrix ECM (porcine-derived extracellular matrix implant) may allow reduction of postoperative AF.
Methods: This is a prospective, multi-center, single blinded, randomized control study. The computerized randomized sequence was applied to randomize the patients into two arms. Primary end point for this study is postoperative AF, both during the hospital stay and at 3-month follow up. Secondary end points for this study are length of hospital stay (LOS) and stroke/TIA. Patients more than 18 years old undergoing CABG, CABG with valvular surgery, or valvular surgery alone were eligible for this study. Any patient with repeat CABG or pre-op AF was excluded from the study. It was planned to include 200 patients in this study. Interim analysis was not planned for this study with adjustment of type I error. Th us, this presentation is solely made to do the trend analysis of the recruited patients.
Results: A total of 38 patients (17: Cormatrix and 21: Control) with age (63.9 ± 11.6) were recruited in this clinical trial to date. Incidence of postoperative AF in hospital was found to be 6 (35.3%) in the Cormatrix group and 8 (38.1%) in the control group, providing an 11% less risk of postoperative AF in hospital in the Cormatrix group. All the considered cofactors were found to be equally distributed between the groups except diabetes mellitus (DM).
Conclusions: It seems there is a beneficial trend in the incidence of postoperative AF in hospital stay in the Cormatrix group. Length of stay seems to be unaffected by the intervention in this group of patients. Due to imbalance in DM status at baseline, the results may need to be adjusted according to DM status in future.
Source: STS.
