VIP BOLT interim analysis: VA-ECMO vs off-pump bilateral lung transplantation

Interim results from the prospective, randomized, multicenter VIP BOLT trial (NCT05547698), comparing intraoperative venoarterial extracorporeal membrane oxygenation (VA-ECMO; n = 44) with an off-pump approach (n = 31) in adults without severe pulmonary hypertension who received bilateral lung transplantation, were published in The Journal of Thoracic and Cardiovascular Surgery by Villavicencio et al. The primary endpoint was Grade 3 primary graft dysfunction (PGD) at 48–72 hours. 

Key data: Grade 3 PGD at 48–72 hours occurred in 13.6% in the VA-ECMO group vs 19.4% in the off-pump group (p = 0.506). Secondary endpoints showed no significant differences: 90-day or in-hospital mortality (2.3% vs 6.5%; p = 0.363), composite Grade 3 PGD / death (13.6% vs 25.8%; p = 0.183), Grade 3 PGD at 0–24 hours (15.9% vs 29.0%; p = 0.172), pneumonia (15.9% vs 35.5%; p = 0.051), or any serious adverse event (SAE; 77.3% vs 87.1%; p = 0.282). VA-ECMO required significantly more fresh-frozen plasma and platelet transfusion. 

Key learning: Both intraoperative VA-ECMO and off-pump bilateral lung transplantation demonstrated comparable early efficacy and safety in patients without severe pulmonary hypertension. Continued enrollment toward the 228-participant target is needed to adequately power the trial.