Kidney Transporter Update

[okarol]

Lifeline Scientific: LifePort(R) Kidney Transporter Update

Edited Press Release
10-02-07

LONDON -(Dow Jones)- Lifeline Scientific said Tuesday that results of a clinical trial presented for the first time yesterday at the European Society of Transplantation (ESOT) show that preserving a deceased donor kidney with the LifePort(R) Kidney Transporter increases the likelihood of it functioning immediately post transplantation compared with the current standard practice of static storage using ice in a cool box.

When cases of delayed graft function (DGF) did occur, the impact was significantly reduced when LifePort was used.

A patient who receives a kidney that is affected by DGF will be required to receive post-transplant dialysis treatment. DGF is also associated with an increased risk of organ rejection and greater costs to the healthcare system.

The Machine Preservation Trial compared outcomes in 338 pairs of kidneys, one preserved with machine preservation on the LifePort and the other by static ice box storage.

The statistically significant results showed that DGF occurred in 20.8% of kidneys preserved with LifePort compared with 26.5% in kidneys preserved with static storage, and lasted for just 8 days with machine preservation compared with 13 days for static storage.

The trial also shows that machine preservation protects against graft loss. Only 76% of DGF kidneys preserved by static storage survived six months, compared with 87% of DGF kidneys preserved with machine preservation, a statistically significant improvement.

In all patients, graft survival at six months after transplantation is significantly improved with machine preservation compared to static storage. Patients will continue to be monitored and further data will be extracted from the study.

The study data is being submitted for peer reviewed publication.

"The results of this trial demonstrate the clear benefits of machine preservation from donor to recipient using the LifePort Kidney Transporter compared with traditional static ice box storage." said David Kravitz, Chief Executive of Lifeline Scientific, Inc.

"It is our hope that LifePort may significantly raise the quality and quantity of kidneys available for transplant as well as improve clinical outcomes for recipients."

http://www.nasdaq.com/aspxcontent/NewsStory.aspx?cpath=20071002%5cACQDJON200710021040DOWJONESDJONLINE000356.htm&

[okarol]

New machine improves donor kidneys

1 day ago

Donor kidneys function better and are less likely to fail if they are stored and transported in a specially designed machine instead of being packed in ice, a study has shown.

European researchers found using a LifePort Kidney Transporter machine reduced the likelihood of failure within a year by 48%. Transplant patients given machine-transported kidneys were 43% less likely to suffer a delay before their new organ started working than those receiving ice-stored kidneys, scientists reported in the New England Journal of Medicine.

The traditional method of preserving transplant kidneys removed from dead donors is "static cold storage". The organ is chilled with a cold preservative solution and placed in an ice box.

Using the LifePort Kidney Transporter, a different method known as "hypothermic machine perfusion" is employed. Instead of being packed in ice, the organ has preservative solution continuously pumped through it at temperatures of between 1C and 10C. Interest in machine-storage of kidneys has grown as a result of a general deterioration of organ quality, which has increased the failure rate of transplants.

Donors today are generally older than they were several decades ago, and kidneys are now more likely to be taken from people who have died from heart or artery disease. Between 15% and 50% of donor kidneys do not work immediately after transplantation, so many recipient patients have to undergo a period of dialysis treatment after surgery.

These kidneys have an increased risk of rejection and their survival may be shortened, placing more pressure on transplant waiting lists. The new study was carried out by researchers in the Netherlands, Belgium and Germany and involved 336 pairs of donor kidneys. One kidney from each pair was randomly assigned to machine preservation and the other to cold storage. The kidneys were then transplanted into 672 patients whose progress was followed for one year.

Machine preservation significantly reduced the risk of delayed organ function, the scientists reported in the New England Journal of Medicine. Seventy of the 336 kidney recipients in the machine group experienced a delay in transplant organ function compared with 89 in the ice storage group. After a year, 10% of the cold storage kidneys and 6% of the machine-preserved kidneys had failed.

Professor Rutger Ploeg, from the University of Groningen in the Netherlands, co-ordinating principal investigator for the trial, said: "This is a truly important finding for the thousands of people on transplant waiting lists around the world. The ongoing challenges we face today are a global shortage of organs for transplantation and that a growing number of the organs available for transplantation are often from older donors or from people with more complex medical conditions.

"Evidence tells us that these kidneys may not work as well immediately post transplantation and as a result may not last as long. This trial shows us that, regardless of the type of donor, by using machine preservation we can ensure that there will be more kidneys available for transplantation and that they will be in better health."

Lead author Dr Cyril Moers, also from the University of Groningen, said: "The results of the study clearly show the advantages of machine preservation over the traditional box of ice. Although machine preservation has been around for quite some decades, a large randomised clinical trial investigating its merits had never been conducted. Our international study for the first time demonstrates that any deceased donor kidney will benefit from this preservation method."

http://www.google.com/hostednews/ukpress/article/ALeqM5h2lMgadMuMVQGdUO1ob06m05Lbtw

[okarol]

A Better Method of Kidney Storage

By Ed Edelson
HealthDay Reporter
Wednesday, December 31, 2008; 12:00 AM

WEDNESDAY, Dec. 31 (HealthDay News) -- Pumping a solution continuously through a donated kidney raised the chances of a successful transplant when compared to simple cold storage of the organ, European researchers report.

The study, published in the Jan. 1 issue of the New England Journal of Medicine, got generally favorable reviews from American transplant experts.

It was hailed as "a landmark study" by Dr. Jonathan Bromberg, chairman of the Mount Sinai Medical Center Transplant Institute in New York.

"Machine perfusion has been performed for upwards of 20 years, and there has been a general perception among people in the field that it might do several important things -- better preservation of the kidney, clearing away toxins, giving data on whether the kidney is any good," Bromberg said. "But all the data until this have come from small, single-center retrospective studies. This is the largest and far away best to be done."

The European study, led by Dutch physicians, compared results of 336 transplants in which the donated kidney was subjected to hyperthermic machine perfusion to the same number in which the organs were kept in cold storage. Overall, the perfused kidneys did better once transplanted.

Delayed function of the transplanted kidney that required dialysis was seen in 70 cases where the organ was perfused, compared to 89 cases in the cold-storage group. Lower serum creatinine levels, a measure of better kidney function, was more common in the perfused organs. The one-year success rate for perfused organs was 94 percent, compared to 90 percent for the cold-storage group.

"This is clearly the best paper around," Bromberg said. "But you really have to look at the details and analysis of subsets of patients, and also at the economics. The study was not large enough to enable a subset analysis, and there was no economic or financial analysis at all."

Dr. John Fung, director of transplant services at the Cleveland Clinic, did his own financial analysis, which was not favorable for perfusion.

"To pump a kidney costs about $1,000 to $1,500," Fung said. "Is that added cost going to be offset by the benefits? If you look at the data, the reduced cost of dialysis and better survival at one year, they didn't answer that question."

The study will not change the Cleveland Clinic's use of perfusion, which is limited, Fung said. "We use cold storage for most kidneys," he said. "We use the pump for those kidneys we are not so sure about -- from older donors, those where the kidney function may not be as good, for example. We're selective about it."

And the study will not change the practice at Mount Sinai, which is governed by the rules of the New York Organ Donor Network, Bromberg said. "The overwhelming majority of kidneys transplanted in New York have been on the machine," he said. "Every now and then, we don't use it."

Still, the study does not provide definitive evidence about whether perfusion is necessary for all donated kidneys, Bromberg said.

The practice in New England is to use perfusion for "extended-criteria" kidneys, such as those from older donors or donors whose heart stopped beating before the kidney was removed, said Dr. Stefan G. Tullius, chief of transplant surgery at Brigham and Women's Hospital in Boston, who wrote an editorial accompanying the journal report.

"We will continue to do that," Tullius said. "But there will be greater emphasis on using perfusion with the report of this clinical trial."

The study showed "a significant reduction of delayed organ function, which is certainly a very unique finding, and this is the first trial showing it," Tullius said.

More information

The basics of kidney transplantation are described by the U.S. National Library of Medicine.

SOURCES: Jonathan Bromberg, M.D., chairman, Mount Sinai Medical Center Transplant Institute, New York City; John Fung, M.D., director, transplant services, Cleveland Clinic; Stefan G. Tullius, M.D., chief, transplant surgery, Brigham and Women's Hospital, Boston; Jan. 1, 2009, New England Journal of Medicine

http://www.washingtonpost.com/wp-dyn/content/article/2008/12/31/AR2008123102536_pf.html

[Chris]

Going to have to read this one when I am fresh, lots of information to read.

[2_DallasCowboys]

Thanks, Carol!

I am sure many of us (LIKE ME!) who personally
do not have a live offered match for t hemselves or
a loved one will find this very interesting

Anne