North American first: Successful bridge to lung transplant with external, artificial lung for patient at Toronto General Hospital

“…This artificial lung – the Novalung - provides the hope that we can ‘bridge’ or keep a patient alive until a life-saving lung transplant is possible.”

(Toronto, February 14, 2007) – In a North American first, the lung transplant team at Toronto General Hospital (TGH), University Health Network used the Novalung, an external, artificial lung to keep a patient alive, until a set of donor organs became available for transplantation. The artificial lung functions like normal lungs, while avoiding or reducing lung injuries linked to the use of a breathing machine or ventilator.

The procedure was performed because there were no other options for the patient, and the team raced again time to save the patient’s life. Subsequent procedures will be part of a clinical trial at TGH testing the artificial lung as a bridge-to-transplant for end-stage lung disease patients who are waiting for a lung transplant. The device has been used in the Balad Theatre Hospital in Iraq on soldiers who have been critically wounded and needed life-saving measures.

The three-hour procedure at TGH was performed on December 2, 2006 by a 20-member team headed by Dr. Shaf Keshavjee, Director of the Lung Transplant Program at Toronto General Hospital, Director of the Latner Thoracic Surgery Research Laboratories, and Professor and Chair, Division of Thoracic Surgery, at the University of Toronto. The patient was on the artificial lung for one day until a pair of lungs and a heart became available for her on December 3, 2006. She remained on the artificial lung for one more day after the operation, allowing her newly transplanted lungs to recover from the procedure. Other key members of the team included: Drs. Tom Waddell, Marc De Perrot, Andrew Pierre, Stefan Fischer, Terry Yau, Stuart Reynolds, and cardiac perfusion manager Stephen Harwood, along with a team of OR and intensive care nurses, anesthesiologists, and other health-care professionals.

“Without the artificial lung, our young patient would not be alive today to be a beloved daughter, wife and mother for her three children,” said Dr. Keshavjee. “This young woman came to TGH and was found to be so ill that she was admitted to our intensive care unit on the same day. She needed to have a lung transplant urgently and the wait for donor lungs can be between three to five months,” he said. The TGH lung transplant program performs between 80 to 90 transplants a year, making it one of the largest transplant centres in the world.

Yen Tran, 21, is the mother of 4-year old fraternal twins and a 14-month-year-old son. She had rarely been sick in her life, had played soccer in high school, but began to have difficulty breathing after she had her third child. At first, she thought she was “just out of shape,” but grew alarmed when she eventually could not walk up and down the stairs in her home, and her lips and nails turned a dark blue.

Yen was admitted to TGH with a condition known as primary or unexplained pulmonary hypertension, a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels putting a strain on the heart. Yen began to realize how ill she was and wondered if she would survive.

“I hoped that I could get a pair of lungs, but I was not sure if I could wait that long,” she said, adding that after the transplant, she feels she was “brought back to life and given a second chance. I’m so grateful that I was able to benefit from the artificial lung and a generous donor for real ones. I’m so glad to be alive, and I’m so glad that I can go home to my children.”

One of the most terrifying fears which patients waiting for a lung transplant face daily is that they may die before they are able to get a set of donor lungs, explains Dr. Keshavjee, adding that about 20% of patients on the waiting list die before getting a transplant. “Until now, there have been few options for these desperately ill patients, and this device provides hope that we can ‘bridge’ or keep a patient alive long enough to receive a life-saving lung transplant.”

The Novalung or Interventional Lung Assist Device is about the size of a CD case and essentially does the work of the lungs. The blood leaving the device has the same amount of oxygen and carbon dioxide that exits the normal lung because the patient’s blood passes through a type of special filtering membrane in the device. A unique feature of this device is that it does not require a pump to run it, thereby reducing damage to blood cells. It is attached to a patient via tubes through the femoral (thigh) blood vessels and is powered by the patient’s own heartbeat.

The German company NovaLung GmbH is funding the clinical trial.

Toronto General Hospital is a partner in the University Health Network, along with the Toronto Western Hospital and the Princess Margaret Hospital. These teaching hospitals are affiliated with the University of Toronto. Toronto General Hospital is a national and international source for research, education and patient care, and is recognized internationally for its innovations in transplantation, surgical innovation, infectious diseases, diabetes and genomic medicine. The lung transplant program is renowned worldwide for its innovation and comprehensiveness in treating patients with severe and complex lung diseases. A pioneer in research on how best to preserve fragile lungs, the program is currently developing new molecular diagnostic and treatment strategies to repair and improve the quality of donor lungs, which could increase the number of transplants performed and survival after transplant.