57 year-old Fernando Padilla, the first American participant in the INSPIRE lung transplant trial, is doing well after his November 2012 surgery.
Transplant patients can breathe easy. A new organ preservation device called the Organ Care System™, or OCS, is now being tested at medical centers in the U.S. and Europe, with the prospect of increasing the number of donated organs that survive to be transplanted.
Fernando Padilla had pulmonary fibrosis, a condition that causes scarring of the lungs, making it difficult to breathe and hard to get enough oxygen into his blood. Now, four months after receiving his new “breathing lungs,” he is able to walk several miles a day and enjoy life with his family again.
The OSC LUNG machine offers a promising alternative to traditional organ preservation. For the past 30 years, the standard method has been to preserve organs in an icebox. The problem is that once the lungs are removed from the donor’s body, the tissue can quickly die.
With OCS, donated lungs are transported in a near lifelike state outside the body. The OSC machine simulates breathing and infuses the lungs with oxygen and red blood cells immediately after harvest from the donor.
Dr. Abbas Ardehali is the director of the heart, lung, and heart-lung transplantation programs at Ronald Reagan UCLA Medical Center, and leads the U.S. arm of the INSPIRE study to evaluate the effectiveness of OCS.
He says OCS may expand the window of time in which a donated organ can be used, improve patient health outcomes, and help more patients who are on waiting lists secure an organ.
Ardehali stresses the importance of the time factor. “Lungs preserved on ice can be subject to significant injury,” he says. “We are working against the clock. Once we’re beyond eight hours, the organ is often no longer viable.”
OCS may expand that window of time to as much as 18 to 24 hours. This will allow organs to be transported across greater distances, and will give transplant teams more time to clean and treat the lungs prior to surgery, which may improve patient outcomes.
“Patients with chronic lung disease now die on the waiting list because there are not enough useable organs available,” Ardehali says. “The most exciting prospect of this technology is that it may expand the number of useable organs and help us save more lives.”
An estimated 1,500 lung transplants are performed in the U.S. each year. According to the U.S. Department of Health and Human Services, more than 105,500 people were waiting for an organ in 2009—enough to fill two large football stadiums.
The University of California Los Angeles (UCLA) medical team has performed more than 450 lung transplants, and UCLA is one of the leading transplant centers in the U.S. in terms of patient outcomes and program size.
The INSPIRE study will evaluate the success of lung preservation using the Organ Care System™ developed by TransMedics. Based in the U.S., TransMedics is a medical device company focused on developing more effective transplant technologies and meeting a vital unmet need.
According to TransMedics spokesperson Neal Beswick, the goal of the INSPIRE trial is to enroll 264 randomized patients from eight countries, including Germany, the U.S., Canada, France, the U.K., Spain, Italy, and Australia.
The trial launched in November 2011, and 101 patients have been tested thus far. Interim results of the study will be presented at a meeting of the International Society for Heart and Lung Transplantation on April 25, 2013.
Lung transplant patients waiting for an organ face enormous challenges. This new preservation technology may help to improve those odds.
More information about the study is available at www.clinicatrials.gov using identifier: NCT01630434.