Venoarterial extracorporeal membrane oxygenation versus off-pump lung transplantation: Interim analysis of a prospective, randomized clinical trial.

Abstract

Primary graft dysfunction (PGD) after lung transplantation (LTx) is associated with increased mortality. Retrospective studies have reported an inconsistent incidence of PGD when comparing intraoperative venoarterial extracorporeal membrane oxygenation (VA ECMO) with off-pump LTx. To address this, we initiated a prospective, randomized trial comparing intraoperative support techniques in LTx. This trial compares intraoperative VA ECMO and off-pump LTx outcomes at 90 days. Six centers are currently enrolling. Inclusion criteria include age ≥18 years and bilateral LTx with mean pulmonary artery pressure ≤35 mm Hg. Exclusion criteria include multiorgan transplant, donation after circulatory death, retransplantation, planned postoperative ECMO, previous lung surgery or pleurodesis, and preoperative ECMO or mechanical ventilation. Patients were randomized 1:1 to VA ECMO or off-pump with an intention-to-treat analysis. The primary end point was PGD grade 3 at 48 to 72 hours, and 15 secondary end points were studied. Sample size estimation was determined to be 228 patients to detect a 15% absolute risk reduction in PGD grade 3 at 48 to 72 hours. The interim analysis includes 75 patients. Of these, 44 (58.6%) were randomized to VA ECMO and 31 (41.3%) to off-pump LTx. Four patients (12.9%) crossed over from off-pump to VA ECMO. There was no significant difference between groups in PGD grade 3 at 48 to 72 hours, VA ECMO 6 (13.6%) versus off-pump 6 (19.4%), P = .506. No significant differences were observed in the safety profile and secondary end points. There was significantly more fresh-frozen plasma and platelet transfusion in the VA ECMO group. In this interim analysis of the Veno-arterIal ECMO Versus Off-Pump Bilateral Orthotopic Lung Transplantation trial, no significant primary end-point difference was noted between VA ECMO and off-pump LTx. Continued enrollment is needed to ensure the study is adequately powered.