Loyola Medicine Testing EVLP Which Could Increase Supply of Usable Donor Lungs

MAYWOOD, IL – As many as 80% of lungs from organ donors are not used, either because they are not in good enough condition to transplant, or there are doubts about their quality and there is no way to verify their condition.

“Because transplant physicians do not want to risk using lungs that won’t work well, they tend to be very conservative in what donor lungs they will accept for transplant," said Daniel Dilling, MD, Loyola Medicine's medical director of lung transplantation.

An investigational technology called ex vivo lung perfusion (EVLP) potentially could increase the organ supply by providing a more informed evaluation of lungs that otherwise would be deemed ineligible for transplant.

Loyola Medicine recently performed its first transplant using a lung that was assessed with the EVLP system.

"Everything feels fine," said the patient, Bob Falat, of Lockport, Illinois. "All of the doctors, nurses and staff genuinely care, and they all did everything they could to make sure my transplant worked. Loyola is a special type of hospital."

Mr. Falat's transplant was performed by Mamdouh Bakhos, MD, one of the nation's most experienced lung transplant surgeons, and Syed Ali, MD.

Mr. Falat's transplant was performed as part of a multi-center clinical trial sponsored by Lung Bioengineering Inc. In the trial, if a donor's lungs appear to need further evaluation, they are flown to Lung Bioengineering’s lung assessment center in Silver Spring, MD. After spending three to six hours functioning on the EVLP machine, the lungs are tested and examined. If they are found suitable for transplant, the lungs are flown to a participating center.

Mr. Falat received the donor's right lung, while the left lung went to a patient at another center.

The clinical trial is comparing 66 lung transplant patients such as Mr. Falat who receive EVLP lungs with 66 patients who receive standard lungs that qualified for transplant without undergoing EVLP. Loyola is the only Illinois center participating in the study.

Most donor lungs are not suitable for transplant because the organs are compromised by trauma (such as car and motorcycle accidents); pre-existing lung diseases; medical treatments such as extended mechanical ventilation; pneumonia; or the dying process. Depending on the injury, donor lungs can become bruised, swollen or waterlogged.

Ex vivo lung perfusion is performed after lungs are removed from the donor (ex vivo means outside the body). The lungs are inflated with a ventilator and the blood vessels are perfused with a solution of proteins and nutrients. The perfusion is done at body temperature to mimic normal physiological conditions. The condition of the lungs is monitored with tests such as X-rays, bronchoscopies and oxygen level analyses. Donor blood remaining in the lungs, including medications, is diluted and filtered away. Also removed are blood clots. Antibiotics and anti-inflammatory drugs are administered as a precaution.

During the EVLP process involving Mr. Falat's lung, Loyola's lung transplantation team remained in close communication with the EVLP center. After reviewing test results, they determined that the lung – which would not have been deemed usable based on normally available information – was suitable for transplant based on the additional evaluation provided by the EVLP process.

“The lung is working very well, and Mr. Falat's prognosis is excellent, thanks to the life-giving generosity of his donor,” Dr. Dilling said.

For years prior to his transplant, Mr. Falat suffered from a progressive lung condition called chronic obstructive pulmonary disease (COPD). By the time of his transplant, he was breathing supplemental oxygen 24/7, and even minor exertions such as tying his shoes left him winded.

“Unless you have the disease, you can't understand what it does to your life,” he said. “If you can't breathe, you can't do anything.”

Before he got sick, Mr. Falat, 72, was quite active. And now that he has the chance to breathe more normally again, he hopes to resume activities such as golfing, doing household repairs and taking his grandchildren fishing.

“I am forever grateful to Loyola, Dr. Dilling and all the staff who took care of me,” Mr. Falat said.

For 30 years, Loyola has operated the largest and most successful lung transplant program in Illinois. Loyola has performed more than 900 transplants – more than all other Illinois centers combined. Loyola's multidisciplinary team regularly evaluates and successfully performs transplants in patients who have been turned down by other centers in Illinois and surrounding states. Despite taking on more challenging cases, Loyola consistently records outstanding outcomes.

The clinical trial Mr. Falat is participating in is titled: “Phase 2, Multicenter, Open-label Study to Measure the Safety of Extending Preservation and Assessment Time of Donor Lungs Using Normothermic Ex Vivo Lung Perfusion and Ventilation (EVLP) as Administered by the SPONSOR Using the Toronto EVLP System™.”