Do not use STEEN SolutionTM if the solution is not
clear, the bottle is damaged, the flip-tear seal has been tampered
with, or if the “use by” date has expired. Transplant Suitability
Post-Ex Vivo Lung Perfusion (EVLP) The responsibility for
correct clinical use and interpretation of the lung function
evaluations during EVLP in determining transplant suitability resides
exclusively with the transplant surgeon.
Like in any other clinical decision, all available data should be
taken into consideration when determining the suitability of an organ
for transplantation; that is, the transplant surgeon is clinically
satisfied with the lung evaluation. This criterion should take
priority, since the transplant surgeon is the ultimate responsible
person for safely transplanting EVLP lungs. The use of the EVLP lung
physiologic evaluations in determining transplantability (e.g., EVLP
transplantability criteria) has been evaluated in the clinical
studies, including the NOVEL trial (see summary of NOVEL study below).
Validation has not occurred as to whether the parameters are adequate
as surrogates for in vivo performance.
The use of ex-vivo perfusion/ventilation discrete parameters on their
own to determine transplant suitability according to the two sets of
transplantability criteria used in the NOVEL and NOVEL EXTENSION
respectively have not been validated. Clinicians should exercise
discretion when using these criteria as the main decision-making tool
for transplantability and instead utilize the perfusion/ventilation
trends coupled with EVLP x-rays and bronchoscopies and their clinical
expertise to make decisions on transplant suitability. Two different
transplant suitability criteria (NOVEL: 2 consecutive delta PaO2s ≥
350 vs NOVEL Extension: 2 non-consecutive delta PaO2s ≥ 350 OR 1
absolute PaO2 > 400) have been used in the NOVEL and NOVEL
EXTENSION respectively, and neither of these criteria have been
validated. The transplant suitability criteria between the NOVEL and
NOVEL Extension studies have shown no difference in survival and/or
incidence of Primary Graft Dysfunction (PGD).