Lung in a Box

Each year around 1,400 lung transplants are performed in the U.S. The traditional way to transport lungs for surgery involved putting them in a cooler with ice. Now there's a better way to preserve these organs.
Fernando Padilla takes pride in his cars and his family.
But a year and a half ago, he couldn't keep up with either. Pulmonary fibrosis destroyed his lungs.
"I was getting tired. I was coughing a lot and I was spitting up a lot." Padilla told Ivanhoe.
Lupe Padilla, Fernando's wife, could sense he was suffering. "I was seeing how bad he was getting day by day." She said.
Padilla needed a transplant. When donor lungs became available, doctors used an experimental technology to transport them. It's called "Lung in a Box".
Abbas Ardehali, MD, FACS, Director of UCLA Heart, Lung and Heart-Lung Transplant Programs at David Geffen School of Medicine at UCLA, is a proponent of the "Lung in a Box"
"This technology has the promise to improve the outcome of lung transplantation." Dr. Ardehali told Ivanhoe, "We have noted that the patients who received their organ, their lungs that were kept in the box do better."
Instead of putting the organ on ice, doctors kept Padilla's lungs in a warm, breathing state. A machine circulated blood and oxygen through them. Padilla was the first patient in the U.S. to have his lungs stored this way. Since then, doctors have studied more than 300.
Lungs on ice cannot survive for more than eight hours. With the "box" doctors have transplanted lungs after 12 hours.
Today, Padilla is healthy and back to doing what he loves most.
The "Lung in a Box" technology will soon be tested in another clinical trial to see if it can improve the condition of lungs that are considered unusable. The idea is to expand the donor pool so more patients can receive life-saving transplants.

BACKGROUND:  About 140,000 Americans have been diagnosed with pulmonary fibrosis.  It usually affects people between the ages of 50 to 75.  Pulmonary fibrosis is a disease marked by scarring in the lungs.  Tissue deep in the lungs becomes thick, scarred, and stiff.  That scarring is called fibrosis.  In certain cases, the cause of pulmonary fibrosis can be found, but most are unknown.  It can develop quickly or slowly and there is not a cure.  Most people with the disease only live about three to five years after diagnosis.  It can lead to other medical problems, including collapsed lung infections, blood clots in the lung, and lung cancer.  As the disease worsens, it can lead to respiratory failure, heart failure, and pulmonary hypertension.  (Source: www.lung.org)

CAUSES:  In most cases, the cause is unknown. However there are certain things that increase the risk of developing the disease.  They include:
"    Certain viral infections
"    Cigarette smoking
"    Gastroesophageal reflux disease (GERD). Some people who have GERD may breathe in tiny drops of acid from their stomach, which can injure the lungs.  (Source: www.lung.org)

TREATMENT:  Many doctors label pulmonary fibrosis as an untreatable disease, but there are a few treatments that can be done to help suppress its effects.  Unfortunately, there is no standard method of treatment approved by the FDA. Lung transplantation can be a viable treatment option for those dealing with pulmonary fibrosis.  In 2013, pulmonary fibrosis accounted for nearly half of all lung transplants done in the United States. Medical improvements and new technology is allowing for easier lung transplants to be performed. (Source: www.pulmonaryfibrosis.org)

NEW TECHNOLOGY:  A lung transplant team at the Ronald Raegan UCLA Medical hospital has successfully transplanted the nation's first "breathing lung" into a 57 year old suffering from pulmonary fibrosis. These new "breathing" lungs come from a device known as the Organ Care System (OCS), which can keep a lung in a living, breathing state while it is outside the body. The OCS does this by continuously circulating blood and oxygen through the lung. Previously, lungs had to be put on ice to be preserved during a transplant, but if placed in an OCS box, a lung can remain in a warm breathing state for 12 hours or more. This technology not only improves the natural function of the lungs but is also allowing transplant teams to better assess donor lungs, since the device keeps the lungs in an active state for a longer period of time. The OCS is also creating a possibility for expanding the donor pool by allowing for longer transports of donor lungs. This device comes after the success of the "heart in a box" technology which worked in a similar manner for donor hearts. The lung and heart transplant program at UCLA is the largest lung transplant program on the West Coast. (Source: www.newsroom.ucla.edu/releases/ucla-performs-first-breathing-241056)

FOR MORE INFORMATION, PLEASE CONTACT:

Abbas Ardehali, MD, FACS
Director, UCLA Heart, Lung and Heart-Lung Transplant Programs
David Geffen School of Medicine at UCLA

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting
Marjorie Bekaert Thomas at mthomas@ivanhoe.com
 
Abbas Ardehali, MD, FACS, Director, UCLA Heart, Lung and Heart-Lung Transplant Programs at David Geffen School of Medicine at UCLA talks about a new way to preserve transplant lungs.

How many lung transplants do you do in a week?
Dr. Ardehali: UCLA is one of the busiest lung transplant programs in the country. We perform about 80 lung transplants a year. UCLA is in the top four or five programs in the country in terms of the volume.
How long have you been doing lung transplants?
Dr. Ardehali: I have been involved in the UCLA lung transplant program for nearly 14 years.
I read a quote from you that lungs should never be put on ice.
Dr. Ardehali: My belief is that a human organ was never meant to be on ice. I don't think that lungs are exceptions to that rule and the human organs, be it the heart, the lungs, the kidney or the liver were never meant to be taken out of the human body and be placed on ice for transportation, even for a brief period of time.
But that was how it was done for years, right?
Dr. Ardehali: For the past 30-40 years that we've been doing lung transplants, we've always sent a team out to where the donor is to procure the organ. The team stops the organ, specifically the lung, and puts the lung on ice. We bring the organ on ice in a cooler to UCLA where the transplant is performed. During that time we are fighting against the clock because we need to minimize the period that the organ is kept out of the human body and on ice.
What's the time you try to get it in?
Dr. Ardehali: We invariably like to keep it less than six hours and once it goes beyond eight hours, most transplant centers consider the organ non-usable. The reason is that there is a continued time-dependent injury to the organ as it's kept on ice. This is the way we have been doing it for the past 30-40 years. It makes intuitive sense that, if you can somehow continue to breathe the organ and continue to have blood circulating through it, then that organ would be a better organ at the time of transplant.
And now there's a way to do that right?
Dr. Ardehali: Now we have a technology for the first time in human history that can keep a human organ alive outside of the human body for hours.
So just tell me, what is the organ care system?
Dr. Ardehali: It is a platform to transport human organs while keeping them in a near physiologic state, nearly alive. Then after a few hours, transplant those same organs and allow them the opportunity to resume the vital function of another human being.
You had eight hours traditionally; does this buy you more time?
Dr. Ardehali: We believe it does. We believe that this has the potential to expand the duration potentially up to 12 maybe even 24 hours, but we do not know that at this point. We are in the stages of investigating this technology. This is an FDA trial which compares the old way of transporting organs on ice and comparing it with the new way, which is in a warm, breathing near-physiologic state. The study is a multi-center, international study and we plan to enroll over 300 patients. Once the study is complete, we will see if this technology is superior to the current method of organ preservation.
And how do you know immediately if the organ works?
Dr. Ardehali: One of the parameters that we follow is how well the new lungs transfer oxygen after being implanted. We believe that with the lungs being kept in a breathing warm perfused state, the organs that are transplanted are actually better organs.
What happens to the lungs when it is kept on ice, do they perform not as well?
Dr. Ardehali: There is an ongoing and time dependent injury to the organs on ice. That is why we have to fight against the clock during those six to eight hours to make sure that the transplant is done during that period of time. We believe that this technology decreases the severity of injury and preserves the organ in a better shape for transplantation. We believe that we may transplant better organs into patients.
If the organ is better, what does that mean to the patient? What were the drawbacks before?
Dr. Ardehali: If the organs are better, we believe that the patients will do better. They will be able to have less complications and may stay in the hospital a shorter period of time and resume their normal lifestyle sooner.
Okay, can you tell me how the box works?
Dr. Ardehali: The box is a self-contained platform that has a pump, a tank of oxygen and a lot of other machines and devices that circulate blood through the new lungs. We also have a way of treating potential infections in the donor lung, we can add antibiotics. We also have a way that we go to the airway of the new lungs and clear out secretions or mucus or other secretions that are there. We have an opportunity to actually improve the quality of the organs that will ultimately be transplanted.
Is there any downside to this? It sounds like there would be no downside.
Dr. Ardehali: It's interesting that you mention that because when you talk to most people they say it makes intuitive sense and why didn't we come up with this twenty years ago. The reality is that a lot of people have put a lot of efforts into it over the past several decades. But the technology was not there to have a self-contained platform to maintain the organ in a near physiologic state. Now we are at a point where this box is able to maintain that human organ in a near normal state. As far as that organ is concerned it still feels like it's in a human body. It's still breathing, there's still blood going through it. That is the fascinating aspect of this technology, which is to maintain a human organ in a near live state for several hours outside of the human body and then transplanting it into a recipient.
It's being done in hearts already, right?
Dr. Ardehali: It has been done in hearts and we are still completing the study. We have not completed the study and UCLA was amongst the leaders in the heart study. We expect that within the next several months we will be completing the heart study.
Anything else?
Dr. Ardehali: I think from a scientific standpoint the potential benefits of this technology are several folds. I think we touched upon one of the areas that you mentioned which is we believe this technology delivers a better organ for transplantation. Ultimately, the patients will do better. I think that the real promise of this technology is that if can potentially expand the donor pool. There are about 70-80 percent of the donor lungs that we are not currently using, because of a variety of factors such as pneumonia and damage to the lungs. We also have a lot of patients that are dying on the waiting list because there are not enough organs. I think the real promise of this technology is that if it can allow us to improve the quality of the donor lungs that we're not currently using to make them usable organs, it could potentially change the game. You actually will be expanding the donor pool and will be offering this life-saving therapy to more patients and potentially save many lives in the process. It is one thing to improve the quality of the organs that we are currently using, but I think the greatest promise is expanding the donor pool and converting the organs that we are not currently using to usable organs.
Now the patients were going to talk to tomorrow, the only patient right?
Dr. Ardehali: Yes, we've done 11 or 12 patients.
Do you know the name?
Dr. Ardehali: Mr. Padilla.
He's your patient?
Dr. Ardehali: Yes.
How's he doing?
Dr. Ardehali: He's doing well. He actually had a big operation and within a couple weeks he was home and was able be back with his family for the holidays. He's progressing very nicely from a lung standpoint.
Good. What was he like when you first saw him?
Dr. Ardehali: He was quite limited. He had a condition called pulmonary fibrosis which is a life-threatening condition. As you may know, there are no effective therapies available for patients with end stage pulmonary fibrosis. Lung transplantation is the only option. Mr. Padilla has noted significant improvements in his quality of life and we are optimistic that he will lead a very healthy and long life ahead of him.
So now there's a way to keep this alive?
Dr. Ardehali: This technology, for the first time, is able to keep a human organ alive outside of the human body for hours, and possibly improve the quality of that donor organ for transplantation.

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