Standard donor lung procurement with normothermic ex vivo lung perfusion: A prospective randomized clinical trial.
BACKGROUND
Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx).


METHODS
This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP.


RESULTS
From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p < 0.001; second side, 437 minutes vs 370 minutes, p = 0.001); median duration of surgery showed no differences (277 minutes vs 275 minutes). Median oxygen partial pressure/fraction of inspired oxygen ratio at 24 hours after Tx was 516 (range, 280-557) in the EVLP group and 491 (range, 352-575) in the control group (p = 0.63). Incidence of primary graft dysfunction >1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients remained intubated (1.6 days vs 1.6 days, p = 0.67), in the intensive care unit (6 days vs 6 days, p = 0.76), and in the hospital (23 days vs 19 days, p = 0.42) for a comparable period of time. The 30-day survival was 97.1% vs 100% (p = 0.46).


CONCLUSIONS
This study provides evidence that EVLP can safely be used in standard donor lungs. Functional results and perioperative outcome are comparable to those achieved with standard donor lung preservation techniques. As an evaluation tool, EVLP allows clinicians to identify and to possibly exclude lungs with functional impairment. Finally, EVLP can safely extend total preservation time.
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Department of Thoracic Surgery and Surgical Endoscopy, Ruhrlandklinik-University Clinic Essen, Essen, Germany.
Alexis
A
Slama
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Lukas
L
Schillab
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Maximilian
M
Barta
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Aris
A
Benedek
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Andreas
A
Mitterbauer
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Konrad
K
Hoetzenecker
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Shahrokh
S
Taghavi
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Department of Thoracic Surgery, Semmelweis University, National Institute of Oncology, Budapest, Hungary.
Gyoergy
G
Lang
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Jose
J
Matilla
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Hendrik
H
Ankersmit
Department of Anaesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.
Helmut
H
Hager
Department of Anaesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.
Georg
G
Roth
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Walter
W
Klepetko
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Department of Thoracic Surgery and Surgical Endoscopy, Ruhrlandklinik-University Clinic Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.
Clemens
C
Aigner
D000293:Adolescent; D000328:Adult; D000368:Aged; D005112:Extracorporeal Circulation; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000503:physiopathology / Q000601:surgery*; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D009926:Organ Preservation / Q000379:methods*; D010477:Perfusion / Q000379:methods*; D011446:Prospective Studies; D009927:Tissue and Organ Procurement / Q000379:methods*; D055815:Young Adult
donor organ preservation; ex vivo lung perfusion; lung transplantation; preservation time; standard donor lungs