Jun.09.2017 / 11:36 AM ET
A lot has changed in medicine since the first human organ a kidney was successfully transplanted into another human in 1954. But one part of the transplant process that hasn't changed much since then is how the organ is delivered from donor to recipient. Basically, organs still travel via cooler.
An organ first gets taken out of the donor and flushed with a cold salt solution (that includes preservatives to help keep the organ viable for transplant). Its then put on ice and sent to a hospital where the recipient is waiting, explains Dr. David Klassen, chief medical officer of the United Network for Organ Sharing, the private non-profit that manages the organ transplant system in the United States.
The technology thats currently widely in use has really been in place for close to 50 years now, Klassen says.
But that standard is about to change. New devices now make it possible to keep donor organs in a functioning state at body temperature while theyre being transported to the recipient.
The new technology makes it possible to monitor an organs health more closely before its transplanted, which means doctors can better predict whether an organ will function properly in the new body. And the new technique called ex vivo warm perfusion makes it possible to keep donated organs outside of a human body for longer periods of time, so they can be sent farther distances to waiting recipients.
The time constraints imposed by organ preservation are a fundamental limitation in the current organ allocation system, Klassen says.
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Organs start to deteriorate as soon as theyre removed from the donor and put on ice so when theyre shipped cold, after a certain amount of time they are no longer viable to be put into a waiting recipient. Kidneys can last up to 36 hours on ice, so they can be shipped widely via car, helicopter, or plane. But hearts and lungs can only be kept out of the body for about four to six hours.
You typically cannot send a heart from Los Angeles to New York, Klassen says.
This technology will allow for significantly more donated organs to be delivered in time for a transplant, he explains. The system will be more successful, fair, and efficient.
The new warm storage devices are already being used in Europe, Canada, Australia, and elsewhere for kidney, heart, lung, and liver transplants. And the Organ Care System for lung transplants the first device of this kind is currently up for FDA approval in the U.S.
New devices like TransMedics' Organ Care System the so-called beating heart in a box work by pumping a donor organ with warm, oxygenated, and nutrient-enriched blood. The Organ Care System is about waist-height and is made out of carbon fiber. The whole thing sits on a four-wheeled cart for easy transport. Its equipped with an oxygen tank, a supply of blood, batteries, and special electric and mechanical equipment to monitor the organ, as well as a transparent, sterile plastic box (specific to each organ type) that houses the donor organ during delivery, keeping it at the right temperature and humidity levels.
The organ believes that its still in the body, says Dr. Waleed Hassanein, president and CEO of TransMedics, the Andover, Mass.-based medical device company thats developing the Organ Care System. The heart is beating, he says. The lung is breathing. The liver is making bile. The kidneys are making urine.
Because the organs are functioning during transport, doctors can monitor the organs and in some cases improve their health, Hassanein adds. Antibiotics can be delivered to an organ to prevent or treat an infection. Clinicians can inflate sections of a donor lung that have collapsed to optimize lung capacity.
In the future it may be possible to apply new fields of research gene therapy or regenerative medicine to actually improve organs before a transplant, Hassanein says. It opens up a huge area of scientific and clinical innovation.
Currently, TransMedics perfusion devices for heart, lung, and liver transplants have been approved for use in Europe, Canada, and Australia. The company is sponsoring five U.S. clinical trials for its devices and it currently has a perfusion device for kidney transplants in development. More than 815 successful human organ transplants have been performed using TransMedics perfusion devices so far.
The heart is beating. The lung is breathing. The liver is making bile. The kidneys are making urine.
Several other companies, including OrganOx, XVIVO Perfusion, and Organ Assist are making warm organ storage devices abroad. Here in the U.S., Lung Bioengineering in Silver Spring, Md. is developing similar devices. And Revai, a New Haven, Conn.- based company founded by scientists from Yale Universitys School of Medicine and School of Engineering and Applied Sciences, is using the technology to develop a warm organ transport device for small intestine transplants.
Were seeing this technology transform the entire field as we speak, Hassanein says. Theres not enough data yet to quantify exactly how many more organs this technology will help be transplanted in the near future, but Hassanein suspects it could as much as double or triple the number of successful procedures.
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UNOS is currently strategizing how to incorporate the new technology into its organ allocation systems, Klassen says. The machines are expensive and it will take some time for these systems to be rolled out, but Klassen expects these devices to be used extensively within the next few years. Its the patients on organ transplant waiting lists that will benefit in big and noticeable ways, he adds
The new devices will allow more organs to be transplanted into recipients who currently often wait many years before receiving a transplant (and some who never do), Klassen says. And its going to allow [transplanted organs] to function better and for longer periods of time.
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