MHH Press Release: Transport system for donor lungs approved in the USA following MHH study
Author
MHH Press and Public Relations
Stefan Zorn, Director
Transport system for donor lungs approved in the USA following MHH study; study on organ care system for the lungs successful / American Food and Drug Administration (FDA) grants approval / publication in Lancet Respiratory Medicine
A large international research team led by physicians from Hannover Medical School (MHH) has demonstrated in the INSPIRE clinical trial that transporting and storing donor lungs in the Transmedics Organ Care System (OCS) is safe and effective compared to the current standard procedure of storing them at four degrees Celsius. Another clinical advantage: Patients who received an organ from the OCS experienced primary graft dysfunction less frequently, a common complication of refrigerated storage, which usually occurs within the first 72 hours. “This could mean that patients can be ventilated for a shorter time and discharged sooner,” says Professor Dr. Gregor Warnecke, senior consultant at the MHH Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery (HTTG) and principal investigator of the study. Twenty-one transplant centers participated in the international study, with MHH treating the largest group of patients. The physicians published their findings in the journal “Lancet Respiratory Medicine.”.
Based on the results of the study, the United States Food and Drug Administration (FDA) already granted approval for the OCS for storing lungs for transplantation at the end of March.
Advantages of the Organ Care System
The OCS is a mobile device for ex vivo lung perfusion. Inside the device, the organ is transported at body temperature, perfused with a blood-like solution, and supplied with nutrients. The lungs are ventilated within the OCS, allowing them to oxygenate themselves. The device gives physicians up to twelve hours to transport the donor organ, assess lung function, and improve it: for example, by drying out fluid retention and suctioning mucus. "This way, the organ reaches the recipient in a significantly better condition than with the previously standard cold storage," says Professor Warnecke. "And the operations can also be planned more effectively – ultimately benefiting patient safety!" Professor Dr. Axel Haverich, Director of the MHH Clinic for Cardiac, Thoracic, Transplant, and Vascular Surgery, adds: "The number of organ donations in Germany is steadily declining. The OCS enables us to implant donor organs from more distant European countries here in Hanover – something that was previously impossible."“
The current standard method for transporting transplants at four degrees Celsius only gives transplant surgeons up to ten hours. During this time, the organ deteriorates continuously due to a lack of blood and nutrient supply, resulting in primary transplant dysfunction in up to 30 percent of patients after transplantation. This dysfunction leads to a decline in lung function and can ultimately be fatal.
Various aspects of the research and development of ex vivo lung perfusion were supported by the three major transplantation research consortia of the MHH: the Cluster of Excellence REBIRTH (From Regenerative Biology to Reconstructive Therapy), the German Center for Lung Research (DZL) and the Integrated Research and Treatment Center for Transplantation (IFB-Tx).
Further information can be obtained from the MHH press office, telephone (0511) 532-6772.
A photo is attached. It shows Professor Dr. Axel Haverich, Director of the MHH Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, next to an OCS. You may use it free of charge in connection with this press release, provided you cite “MHH/Kaiser” as the source and send us a copy.
MHH Press and Public Relations
Stefan Zorn, Head
Telephone: 0511 532-6772, Fax: 0511 532-3852, pressestelle@mh-hannover.de, Carl-Neuberg-Straße 1, 30625 Hannover. Further information from the MHH can be obtained at [website address missing]. www.mh-hannover.de
