Normothermic perfusion of donor lungs for preservation and assessment with the Organ Care System Lung before bilateral transplantation: a pilot study of 12 patients.
BACKGROUND
Cold flush and static cold storage is the standard preservation technique for donor lungs before transplantations. Several research groups have assessed normothermic perfusion of donor lungs but all devices investigated were non-portable. We report first-in-man experience of the portable Organ Care System (OCS) Lung device for concomitant preservation, assessment, and transport of donor lungs.


METHODS
Between Feb 18, and July 1, 2011, 12 patients were transplanted at two academic lung transplantation centres in Hanover, Germany and Madrid, Spain. Lungs were perfused with low-potassium dextran solution, explanted, immediately connected to the OCS Lung, perfused with Steen's solution supplemented with two red-cell concentrates. We assessed donor and recipient characteristics and monitored extended criteria donor lung scores; primary graft dysfunction scores at 0, 24, 48, and 72 h; time on mechanical ventilation after surgery; length of stays in hospital and the intensive-care unit after surgery; blood gases; and survival of grafts and patients.


RESULTS
Eight donors were female and four were male (mean age 44·5 years, range 14-72). Seven recipients were female and five were male (mean age 50·0 years, range 31-59). The preharvest donor ratio of partial pressure of oxyen (PaO(2)) to fractional concentration of oxygen in inspired air (F(I)O(2)) was 463·9 (SD 91·4). The final ratio of PaO(2) to F(I)O(2) measured with the OCS Lung was 471·58 (127·9). The difference between these ratios was not significant (p=0·72). All grafts and patients survived to 30 days; all recipients recovered and were discharged from hospital.


CONCLUSIONS
Lungs can be safely preserved with the OCS Lung, resulting in complete organ use and successful transplantation in our series of high-risk recipients. In November, 2011, we began recruitment for a prospective, randomised, multicentre trial (INSPIRE) to compare preservation with OCS Lung with standard cold storage.


BACKGROUND
TransMedics and German Federal Ministry of Education and Research.
Division of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hanover Medical School, Hanover, Germany. warnecke.gregor@mh-hannover.de
Gregor
G
Warnecke
Javier
J
Moradiellos
Igor
I
Tudorache
Christian
C
Kühn
Murat
M
Avsar
Bettina
B
Wiegmann
Wiebke
W
Sommer
Fabio
F
Ius
Claudia
C
Kunze
Jens
J
Gottlieb
Andres
A
Varela
Axel
A
Haverich
D000293:Adolescent; D000328:Adult; D000368:Aged; D003911:Dextrans / Q000008:administration & dosage; D004867:Equipment Design; D005260:Female; D006801:Humans; D016040:Lung Transplantation / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D009926:Organ Preservation / Q000295:instrumentation* / Q000379:methods; D019188:Organ Preservation Solutions / Q000008:administration & dosage; D010865:Pilot Projects; D016019:Survival Analysis; D013696:Temperature; D014019:Tissue Donors; D055815:Young Adult
D003911:Dextrans; D019188:Organ Preservation Solutions