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Breathing New Life Into Lung Transplants

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NEW YORK, NY (Ivanhoe Newswire) - We breathe 17,000 times a day, but for more than 1,600 people waiting for a lung transplant, each breath is a struggle. Now, there's new hope for patients waiting to inhale easier.

Nancy Block travels far and wide to find the perfect paintings. But a few years ago her world was closing in on her. She was diagnosed with a rare lung disease, fibroelastosis.

"I started on two liters oxygen," Nancy told Ivanhoe. "By the time I was in the hospital I was on eight, which is an inhuman amount."

The tissues of her lungs were stiffening. Soon they would stop working. A transplant was her only option. Nancy was called in for a transplant seven times, but each time, the organ was either not a perfect match or was not working properly, but doctors at New York-Presbyterian offered her a new option.

"The ex-vivo is an opportunity to test lungs we would be turning down otherwise," Frank D'Ovidio, M.D., Ph.D., an associate surgical director of the lung transplant program director of the ex vivo lung perfusion program at New York-Presbyterian/Columbia, said.

In ex vivo, lungs that would not pass the test for transplant are hooked up to a perfusion and ventilator system outside the body.

"Over four hours we can have a more throughout understanding of how that lung is really ventilating and performing," Dr. D'Ovidio

The lungs are re-warmed, fluid is forced through them and a special solution re-nourishes them. So far, seven lungs have been tested, four were turned down, but three were successfully transplanted. Nancy has one of them.

"I was breathing right away without oxygen," Nancy said. "I'm walking. I'm driving."

And she's looking forward to flying to Europe to find her next work of art.

Because the lungs are perfused, doctors believe they'll be reconditioned and make a better organ for transplantation with lower risk of failure. Right now there's discussion about the possibility of ex-vivo becoming the standard procedure for all lung transplants.

RESEARCH SUMMARY

BACKGROUND: There are more than 1,600 people waiting for a lung transplant today. The wait for suitable donor organs to become available may be a year or longer. The average waiting time on the list is 18 months. Unfortunately, many patients who would benefit from a lung transplant sadly die before suitable donor lungs become available. The shortage of organ donors is made even more dramatic for those waiting for lung transplant as donor lungs are particularly delicate and are easily damaged by events that happen before their removal from the donor. This means that only 1 in 5 of the potential donor lungs available, currently used in lung transplants. (Source: http://www.hta.ac.uk/project/2554.asp)

THE TRANSPLANT: There are four main types of lung transplants. The first three depend on finding the right donor who has just died but has a healthy lung. The fourth type depends upon finding two healthy living donors. Your doctors will determine which type of lung transplant is best for you and your condition.

Single lung transplantation: Although you have two lungs, certain patients can live a normal, healthy, and active life with just one good lung. When a single lung transplant is done, one of your bad lungs is removed and a new healthy lung is put in its place.

Double lung transplantation: This operation involves taking both lungs out and replacing them with new lungs. Both lungs are replaced at the same time with two good lungs usually coming from the same organ donor.

Heart-lung transplantation: This operation involves taking out the heart and both lungs at the same time and putting in a new heart and two new lungs—all from the same donor. This is the rarest form of lung transplantation.

Living donor lobar transplantation: In this operation, two healthy living donors each give you one lobe (out of five normally present). Typically, both of your lungs are taken out and replaced with a right lower lobe from one donor, and a left lower lobe from the other donor. This operation is usually done on patients who are either in rapid decline, or are so ill that they will not be able to get through a successful transplant from a deceased donor. (Source: American Society of Transplantation)

NEW TECHNOLOGY: A new technology attempts to make the transplant process easier and to make sure the lungs are in good condition before transplant. The "ex vivo" or outside-the-body approach involved removing lungs from a deceased donor, then enclosing them inside a transparent dome and connecting them to a cardiopulmonary pump and a ventilator. For four hours, the lungs were infused with nutrients and antibiotics. They were gradually warmed to body temperature, ventilated and oxygenated — a process that resembles breathing, with the lungs inflating and deflating. Once determined to be viable, the lungs were immediately transplanted into the patients. Currently, fewer than 30 percent of donor lungs are acceptable for transplantation, but physicians say ex vivo has the potential to double this figure as the reconditioning process is refined and improved.

The recent transplants at NewYork-Presbyterian/Columbia are part of an ongoing FDA investigational multicenter clinical research trial designed to compare outcomes from lung transplants using the ex vivo technique with those using the traditional method. This investigational trial, currently taking place in the United States, is coordinated and funded by Vitrolife, makers of the ex vivo perfusion system. (Source: New York Presbyterian/Columbia)

INTERVIEW

Frank D'Ovidio, MD, PhD, Associate Surgical Director of the Lung Transplant Program, Director of the Ex Vivo Lung Perfusion Program at New York-Presbyterian/Columbia, talks about breathing new life into lung transplants.

How many lung transplants do you do?

Dr. D'Ovidio: Our center is averaging anywhere between fifty five to sixty a year.

How hard is it to receive an organ after you make it into the transplant list?

Dr. D'Ovidio: The goal is to satisfy as many transplant candidates as we can. The problem is donors are few and only about fifteen to twenty percent of donors end up being lung donors. Many times our procurement team is sent to assess lungs and in the meantime we'll bring the patients in hoping that their run will be successful, but unfortunately many times the lungs are turned down and the candidates are then informed that the lungs are not good and they go back home. Some patients have been called in eight, nine times.

What has to go right for a lung to be considered good for a transplant?

Dr. D'Ovidio: We have preliminary information on the characteristics of the organ from the organ procurement organization. We screen donors on the basis of that. Then we send out our team to do a final assessment which we call visualization. That's a visual inspection of the lung also performing bronchoscopies and we get further blood gases directly from the lung. We make an overall judgment and see if the lung satisfies the criteria that we usually follow to go ahead with the transplant. At that moment we finalize whether the lungs are going to be used or not. In the meantime the potential candidate is brought in to the hospital and is set up to go to the operating room and is in a holding area near the operating room facility waiting for the final go. That's when we disclose whether the transplant will be performed or not.

What was Nancy like when you first met her, what was her health like?

Dr. D'Ovidio: She probably was one of the sickest we had at that moment. She had a very high lung allocation score, it's called the LAS score. Probably one of the highest at ninety four, in fact the score goes up to a hundred. She was hospitalized for a few weeks if not more because of an exacerbation of her disease and she was in extreme need for a transplant. Her interaction wasn't normal she was a patient that was at the end of the road and basically dying in the hospital.

How were her lungs?

Dr. D'Ovidio: The lungs had a scarring process that provoked the restriction of its function.

She was just at the end of her line, why was the Ex-vivo a good fit for her?

Dr. D'Ovidio: The Ex-vivo offers the opportunity to test lungs that we would be turning down otherwise. The implementation of the Ex-vivo is meant to assess lungs that we don't totally understand why they're not performing and satisfying our criteria. We have the opportunity to bring them back to our center, hook them up to a perfusion and a ventilator system, which ultimately allows a four hour detailed assessment of the lungs, and also resuscitation and reconditioning of the lung. In her case they were actually very good and we went forward and transplanted them.

What are the reasons some lungs don't work?

Dr. D'Ovidio: Some may be because the arterial blood gasses are low in other words the oxygenation provided is poor, although the lungs look good upon our inspection. We don't understand why there is this discrepancy. Or the other way around, the gasses are good but the lungs feel heavy, boggy. There seems to be some inflammatory process going on that we need to further understand. This is the opportunity to really test them and monitor parameters that we can't monitor at the donor site just because the instruments are not available. With the ex vivo system we have an objective assessment of how the lungs inflate and deflate which is called compliance. We can monitor over time the pulmonary artery pressures, the pulmonary vein pressures. Repeat blood gasses get chest x-rays. So over four hours we can have a more thorough understanding of how that lung is really ventilating and performing. That's the advantage of the Ex-vivo system in lungs that we don't truly understand.

What percentage would you guess that you turn down lungs that might not hit it on the scale but would be okay?

Dr. D'Ovidio: It's hard to say what the percentage is because we don't still know what the limits are of the ex vivo assessment. We are in the phase of a FDA trial trying to prove safety of the device and also prove the concept of reconditioning. Our expectation is that we'll increase the numbers and if it's just an increment of ten percent that's already great. If we are doing fifty five or sixty in average then we'll be doing sixty five, seventy transplants, which is already a great improvement. There's potential for even further increments as we get more understanding of what the limit of the assessments are.


How many patients do you have on the list right now?

Dr. D'Ovidio: In our center we have forty to forty five patients listed. I don't know the exact number nationwide.

Why is it so hard to get people to donate their lungs?

Dr. D'Ovidio: It's not how to get them to donate lungs; it's how to get people, the society in general to donate. Many do not understand what organ donation is all about and there are also cultural barriers. There's an educational process that needs to take place to teach about donation and also educate on the need and the social utility of organ donation.

Can you explain to me how Ex-vivo works?

Dr. D'Ovidio: The Ex-vivo perfusion or Ex-vivo is meant to test lungs outside of the body at a normal temperature. We rewarm the lungs; we use a ventilator to ventilate the lungs and the perfusion pump to flow a special solution through the vessels of the lung. The solution is called the Steen solution by the surgeon that developed it in Sweden. The solution is rich in glucose and albumin and electrolytes and it has the opportunity to re-nourish and revamp the biologic activity within the lung. That's where the concept of potentially re-conditioning the lung after a period of non-nutrition in a cold environment that is our current preservation method. It's a cold preservation that we currently implement once we procure the organ from the donor. Then we go on with a normal temperature perfusion and nutrition, basically cultivating the organ, and testing it throughout this phase of reconditioning and re-nourishment.

What's a clean lung?

Dr. D'Ovidio: The concept behind the clean lung is that when we procure an organ we do flush the donor's blood out using a special preservation solution that has been used for the last decade, which allows us to preserve the organ in a cold, static preservation. With that flush we hope to eliminate as much blood from the donor as possible. Having said that there is always some left behind and the Ex-vivo perfusion allows us to really wash out the lung for four hours. After the first hour the entire batch of perfusion solution gets exchanged with a fresh batch and we do see the difference. The first batch is usually pinkish after an hour of perfusion while the second batch remains a straw yellow colored as it should be. The intention is to wash out all of the blood cells from the donor and therefore eliminate potentially the inflammatory molecules that are present within the donor's blood consequent to the cause of the death as well as the impact of the overall donation process.

Is there less risk of rejection with cleaning it out?

Dr. D'Ovidio: Potentially, but we're not sure of that. The ex vivo system provides us with the opportunity to research if this is true or not. Conceptually we think it is a beneficial aspect. In fact there is data that is being reported at the international meetings to suggest that there potentially is a lesser incidence of acute lung dysfunction after transplantation in organs that have been reconditioned on the Ex-vivo system. This is yet to be confirmed by the ongoing research.

FOR MORE INFORMATION, PLEASE CONTACT:

Jaya Tiwari
New York Presbyterian/Columbia
(212) 342-1518

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