ISHLT and One-Year Outcomes from the NOVEL trial
Thank you for visiting our booth at ISHLT in San Diego!
We hope that you found the scientific program of interest and that you enjoyed your stay. Ex vivo Lung Perfusion (EVLP) at this year´s ISHLT congress in San Diego set a new record! This year well over 40 abstracts on EVLP were presented including the results from the NOVEL trial. We had great interest in the new version of the XPS and look forward to the introduction in Europe!
The NOVEL Lung Trial One-Year Outcomes presented at ISHLT in San Diego
The NOVEL trial is the first prospective and multicenter clinical trial (six U.S. centers) designed to evaluate the safety of ex vivo lung perfusion (EVLP) as a method to screen and identify good quality grafts from lungs that have been unused or rejected for transplantation. EVLP was considered if the donor PaO2/FiO2 ≤ 300mmHg; or when the PaO2/FiO2 > 300mm Hg and the donor had any of the following risk factors: multiple blood transfusions, pulmonary edema, donation after cardiac death (DCD) or the investigator deemed the donor lung quality as poor.
Controls included contemporary transplants using standard criteria lungs. Results to date on 42 EVLP lungs and 42 controls indicate that early and midterm results between patients that received EVLP or standard criteria lungs are equivalent, despite the fact that all EVLP lungs were initially rejected (up to 39 times) as unsuitable for transplantation.
As indicated below, there were no significant outcome differences between the two groups: the incidence of PGD grade III at 72hrs (a major predictor for mortality) e.g. was 5% in the EVLP (formerly rejected) group vs 3% in the SOC control group and there was no significant difference in 30-day or 1 year survival. Prior to EVLP, major differences in key parameters were evident: average pre-EVLP PaO2 in the EVLP group was ca 347 mm Hg compared with 429 mm Hg in the control group and chest X-ray infiltrates were seen in 63% of the rejects group subjected to EVLP compared with 36% of the SOC controls.
The authors conclude that EVLP is a safe diagnostic tool to increase the percentage of tx lungs by screening the unused donor pool.