On April 11-12, the world’s largest software user community for organ, tissue and eye donation will come together to collaborate on innovations that will increase, expedite and improve the donation process. The results? Better quality, faster decisions, improved efficiency and more lives saved and healed through the miracles of organ, tissue and eye donation and transplantation.

Established in 1984, LifePoint serves 62 hospitals throughout the state. Operating a fully-staffed, 24/7 donor referral center, LifePoint provides comprehensive organ, tissue and ocular donor screening, recovery and allocation/distribution for transplant to those in need. In addition, LifePoint provides a full range of services in hospital development, community education and donor family services and aftercare.

For several years prior, LifePoint had previously operated an in-house software system to manage its donor cases and track performance. The switch to the iTransplant System was made after careful consideration of all options and vendors and related due diligence. According to Anna Barra, LifePoint’s IT Director, “Transplant Connect’s iTransplant Enterprise Software far outpaced other options available in terms of comprehensiveness, proven capabilities, reliability and ease-of-use. This made our choice of systems a clear one.”

Marking the successful teamwork between LifePoint and Transplant Connect, the two teams worked effectively to configure and launch the iTransplant Enterprise System in less than five months from execution of the agreement, including software validation in compliance with 21CFR11, 21CFR1271. This is a significant accomplishment in that the iTransplant System deployed is utilized by LifePoint’s 132 unique users and contains extensive functionality, including:

• 24/7 Call Center, Donor Referral and Screening
• Organ Donor Recovery and Organ Offers / UNOS uploads (DonorNet, DNR, DDR)
• Tissue Recovery and Offers/Processor Allocation
• Comprehensive Eye Banking, from Recovery through Inventory, Processing and Distribution
• Hospital Development, Family Services, Case Note Logs, Quality Assurance, Staff Scheduling
• Reporting and Management Dashboards
• Automated Notifications and Communication Features
• Audit Log, Case Lock and Other Quality Assurance Features

Ms. Barra further commented, “By implementing the Best Practices iTransplant Enterprise System with minimal initial customization, LifePoint projects we will improve efficiency and data reliability, while realizing operational cost savings. This results from cost efficiencies inherent in the iTransplant software platform and the expertise and effectiveness of the Transplant Connect project and support teams”.

Founded in 2004, Transplant Connect is an innovative medical software firm based in Santa Monica, California and is a certified Public Benefit “B” Corporation. The company’s mission is to help improve, increase and expedite organ, tissue and eye donation and transplantation through advanced software and related technologies. Transplant Connect is the most-widely adopted provider of organ, tissue and eye donation-transplant software in the world.

Learn more about Transplant Connect.

OPOs are charged with the important and mission-critical social obligation of interfacing with hospitals and donor families to carry out the time-sensitive organ and tissue recovery process. Facing severe logistical and other challenges, OPOs make possible the wishes of individual donors and their families, so that human lives can be saved and healed through the miracles of organ and tissue transplantation.

Designed, developed and provided by socially-conscious medical software firm, Transplant Connect, the iTransplant System is the most-heavily adopted software of its kind for organ, tissue and eye donation and transplantation in the world. More than 3,000 individuals at over 40 donor-transplant agencies rely on Transplant Connect for their day-to-day mission critical activities in electronic medical records, communications, reporting and overall enterprise management.

From June to September 2011 alone, three (3) different federally-designated organ procurement organizations in the United States have partnered with Transplant Connect for the implementation of the iTransplant Organ and Tissue Donor Enterprise Management System. These OPOs, listed below, had previously utilized other systems and chose Transplant Connect after evaluating other options.

LifeShare Oklahoma is the federally-designated OPO for the State of Oklahoma, serving 3.7 million population and providing for the recovery and transplant of organs and tissue.

Intermountain Donor Services is the federally-designated OPO serving a 2.7 million population spanning across Utah, Southeastern Idaho and Western Wyoming and providing for the recovery and transplant of organs and tissue.

LifePoint is the federally-designated OPO serving nearly all of the counties in the State of South Carolina – approximately 4.5 million people – and providing for the recovery of organs and tissue as well as corneas for those in need

LifeShare Oklahoma, mentioned above, is noteworthy in that the total elapsed time from the June contract signing to the September launch of the system was approximately 3 months, demonstrating the collaborative working relationship between the LifeShare and Transplant Connect project teams and the efficiency and streamlined configuration, quality assurance, training and deployment processes developed by Transplant Connect for launching new partner systems.

After having successfully launched his team’s real-time utilization of the iTransplant System, LifeShare Oklahoma’s Interim Chief Operating Officer, Phil Van Stavern, remarked: “Since everything we do in organ and tissue recovery is data-driven, LifeShare needed an electronic medical records system that is user friendly, has excellent report generation capabilities, and a responsive staff, available at a moment’s notice when we have problems. After evaluating our options, that’s what we found in Transplant Connect’s iTransplant software. By adopting the configurable Best Practices iTransplant System, LifeShare was up and running with our organ and tissue cases on iTransplant in a short 3 month period, and we’re very pleased with the efficiencies and operational transparency we’ve gained thus far.”

Founded in 2004, Transplant Connect is based in Santa Monica, California and is a certified Public Benefit “B” Corporation dedicated to helping improve, increase and expedite organ, tissue and eye donation and transplantation through advanced software and related technolgies.

Growth in the number of registered donors is vital because the need for transplants continues to rise. More than 112,000 people are currently waiting for lifesaving organ transplants. Thousands more await tissue transplants to resume their normal lives. Last year, more than 28,000 people received organ transplants, more than 40,000 received corneal transplants and hundreds of thousands received tissue transplants, yet 6,590 died awaiting organ transplants. A surge in the number of donors is necessary to save more lives. Therefore, as the donation and transplant community celebrates the accomplishment of registering 100 million people, work has already begun to reach the new national goal of registering 20 million new donors by the end of 2012. Twenty million additional donors would result in saving thousands more lives each year. The public is encouraged to register by visiting www.donatelife.net.

“At a time when we as a nation have difficulty finding common ground on many important issues, 100 million people have agreed on their desire to save lives by registering as donors. They are hope for all of the men, women and children in need of lifesaving transplants today. For that, we say thank you,” says David Fleming, President and CEO, Donate Life America. “While this achievement speaks volumes about the generosity of human beings, more work needs to be done to motivate Americans to register and save the lives of those in need.”

In 2006, DLA launched the Donor Designation Collaborative (DDC) as a nationwide effort to improve organ, eye and tissue donation rates. A main tactic for achieving the DDC’s goals is ensuring that each state has an effective system for allowing individuals to legally designate themselves as donors. Since the DDC’s launch, there has been a 45 percent increase in the number of designated donors in the United States.

On average, nearly 8 million people join a state donor registry each year; a majority (97 percent) joins through state departments of motor vehicles (DMV’s). Therefore, DLA builds strong relationships with many DMV officials throughout the nation to encourage education and training of their staff to help them better advocate for organ, eye and tissue donation.

“I am proud to witness meeting such a milestone in organ and tissue donor history,” says Jesse White, the Illinois Secretary of State. “Our ultimate goal is to see that all Americans become registered organ and tissue donors.”
As the DDC works to increase the number of donors, the high percentage of registrations through DMV’s poses a new challenge to overcome. The majority of state donor registries were created nearly a decade ago. Once a registry goes through its first driver’s license/ID card renewal cycle (ranging from every 4 to every 12 years depending on the state), new designated donors come from only three sources – first-time drivers, new residents, and current residents who previously elected not to register. This maturity factor decreases the ability to sustain high donation rates through DMV efforts alone– a fact that necessitates new strategies to promote registrations.

“As we lay the foundation to register an additional 20 million people by the end of 2012, we are developing strategies to overcome the obstacles presented by maturing registries. We are not deterred by the challenges ahead,” says Donate Life America Chairperson, Helen W. Bottenfield. “Our primary goal is to preserve human life and improve the quality of life for those in need of organ, corneal and tissue transplants. We will remain focused and find creative ways to reach, educate and motivate those who have not yet registered as donors.”

As of June 30, 2011, data reported by Donate Life America state teams revealed 42 percent of U.S. adults (age 18 and older) are registered as organ, eye and tissue donors. States with the highest percentage included: Alaska and Montana (78 percent each) and Washington (74 percent).

The public is encouraged to join the 100 million individuals already registered as organ, eye and tissue donors by visiting www.donatelife.net and registering today.

The talk will outlilne key considerations for tissue banks in moving from the older paradigm of fragmented paper systems, homegrown databases and redundant data entry into the world of real-time, professionally-developed and managed, web-based electronic medical records. Regulatory considerations and operational challenges will be discussed, and Alan Taylor will share the experiences, challenges and benefits experienced by the Donor Network of Arizona in adopting electronic medical records.

Last week, a Boston hospital released a photo of Charla Nash, the Connecticut woman mauled by a chimpanzee. She had a face transplant in May. Other people who had face transplants are able to walk the streets without people knowing they have someone else’s face.

Eighteen such transplants have been done worldwide. The first was in November 2005 on a French woman mauled by her dog. The first in the U.S. was in December 2008 in Cleveland. A Pittsburgh hospital hopes to offer them soon. The U.S. Department of Defense is funding more in hopes of helping disfigured soldiers.

“Some of those the doctors would be able to repair over his childhood through different surgeries,” she said. “He had several different things and he had a heart valve that was wasn’t working right.
“The doctors thought they could eventually repair everything, but because he was born prematurely, they didn’t think they could fix it all because the valve was so small.” That is why he qualified for a heart transplant.
He was already at Children’s Hospital in St. Louis, Lindsay said, because he had been rushed there when he was born and was still there.
With his new heart, “from a cardiac standpoint, he has been doing really well,” she said. “It functions really well.”
In his follow-up treatment he takes medications for his immune system so his body won’t reject his heart, Lindsay reported. The medication “causes him to be prone to infections” and can catch things “easier than other kids.
“He goes for checkups and blood work and heart testing and heart cauterizations,” Lindsay said. “At some point he might need another transplant, but that is an unknown thing and something we will have to deal with as he gets older.
“One of the interesting things” about his heart transplant, she said, is that “the heart he received is a different blood type and he was able to receive the transplant so young because all the antibodies weren’t formed yet. That helped him to receive a heart more quickly.”
The Uhlmeyer family includes a daughter, Chayse, who will be 3 in September. “We are expecting a third child – a son – around the first of December,” Lindsay reported. “Both this baby and Chayse underwent some testing while I was pregnant, so they could check for heart defects, but luckily they seem to be healthy.”
Jesse is principal of Canton High School, where Lindsay teaches English, serves as basketball coach and sponsors some organizations.
Both of Avery’s parents encourage people to participate in the Heart Walk or make donations to the AHA. She said donations help the AHA “to perform all the research necessary in order to help kids like Avery, so doctors can help to treat those conditions and learn about different ways to repair other heart defects that children can be born with or develop.”
Jesse noted that the Heart Walk is important “because events like the Heart Walk raise awareness about how these things affect us locally. Even in a small town, we can help people become aware of the different problems.”

“Donor hearts are a limited resource,” says John V. Conte, M.D ., a professor of surgery at the Johns Hopkins University School of Medicine and the senior author of the study. “Now, we have a simple-to-use tool that is highly predictive of survival after a heart transplant, and can help guide organ allocation decisions.”

Conte and his colleagues, writing in the September issue of Annals of Thoracic Surgery, pulled together a series of risk factors already associated with poor outcomes, such as age, race, gender, the cause of a patient’s heart failure and whether he or she was on dialysis, and then assigned a number of points to each factor. The sum of those points created a score. The higher the score, the higher the risk of death one year after transplant.

Some factors were weighted more heavily than others, such as female gender (three points); African-American race (three points), and the need for dialysis in the time between being put on the transplant waiting list and getting a transplant (five points).

Patients with the lowest scores — between zero and two — had a 92.5 percent chance of being alive 12 months after surgery.

Patients with so-called IMPACT scores — the acronym the researchers came up with for the Index for Mortality Prediction After Cardiac Transplantation — above 20 points had a less than 50 percent chance of survival one year after surgery. Every point on the scale increased the chance of death within one year by 14 percent.

To develop and test the validity of IMPACT, Conte and his team analyzed data provided by the United Network of Organ Sharing comprising information from all heart transplants — 21,378 of them — conducted in the United States between 1987 and 2010.

More research is needed to learn what role is played by factors other than the recipient’s risks, Conte says. Resuslts of their study suggest, for example, that an organ coming from a donor over the age of 50 or one that has been outside the body for more than four hours also increases the risk of death in the recipient, he says.

More than 3,000 people are on the waiting list for a heart transplant in the United States, and many will die before they can get a new heart. Only about 2,000 heart transplants are performed in the U.S. annually. Currently, determining who gets an available heart takes into account how long a patient has been on the list and how sick they are. There is no standardized consideration of other factors that may predict patients’ outcomes, as is the case in determining which patients receive available lungs for transplant. Incorporating the IMPACT score would add another dimension to the conversation about who gets a heart transplant, says Conte, surgical director of heart transplantation at Johns Hopkins.

“As clinicians, we make an educated risk of what the risk is going to be,” he says. “This tool provides a quantitative way to assess the risk.”

Doctors will be told to look out for those who are on the donation register, who can be kept alive on ventilators until relatives arrive then allowed to die naturally while specialist doctors are put in place to retrieve their organs.

Until recently scarcely any organs were taken from patients who died in A&E even if they were registered donors, meaning that many of those on waiting lists for new kidneys or hearts missed out.

But over the past few years the number of donors has doubled to reach 75 following work by health experts, and is set to rise still further with the imminent publication of new guidelines by the College of Emergency Medicine and the British Transplantation Society.

The NHS’s “transplant tsar”, Chris Rudge, told The Daily Telegraph: “The numbers are still small but it has increased very, very markedly over the last year or two.

Transplant Connect is working with one of the world’s leading eye banks, SightLife, to fight corneal blindness in India. These photos were taken between meetings and conferences during our week long visit in January 2011. We hope you, too, are moved by India.

Now, Herrick has passed away.

The 79-year-old died Monday at the Augusta Rehabilitation Center in Maine. His wife, Cynthia, said his health deteriorated after undergoing heart surgery in October.

Herrick donated a kidney to his twin brother, Richard, at what is now Brigham and Women’s Hospital in Boston. Because they were identical twins, there was no problem with rejection. The United Network for Organ Sharing says it was the first successful organ transplant.

The operation on Dec. 23, 1954, kept Herrick’s brother alive for eight years. Lead surgeon Dr. Joseph Murray went on to win a Nobel Prize.

The 37-year-old native of San Antonio – an endurance runner, avid cyclist, general fitness enthusiast and executive director of a nonprofit agency- was the one with the big heart.

Actually, it’s her second.

The first, her original, failed. At age 17, viral cardiomyopathy, a vicious virus, attacked it, eventually putting her on a transplant list. In 1992, at age 21, a new heart was made possible by a family that turned their tragedy into triumph.

As a living, breathing organ recipient and major proponent of organ donation, Lundy-Kwan is glad to wave, smile and ride on a parade float on almost any day. But the Donate Life Rose Parade Float has a deeper purpose beyond celebrating a new year or a football game. It seeks to raise awareness about the urgent need for organ, eye and tissue donation.

“The registry just hit 100,000 people needing a transplant,” Lundy-Kwan said. “Two years ago, it was 92,000.”

How many organs are available for transplant in the U.S.?

“It’s not 100,000,” said

Lundy-Kwan, who runs Transplants for Children, a nonprofit agency serving children awaiting transplants and those who’ve already received them.

The need for more organ, tissue and eye donors is a major issue for the 60 organizations behind this float, including tissue banks, state donor registries and transplant centers.

The Donate Life float featured “floragraphs” – portraits created with flowers and floral materials – of organ donors, including one of someone especially important to Lundy-Kwan: Shay Ledbetter. Ledbetter was the young woman who died in 1992 and whose heart beats inside of her.

The transplant required a painstaking 22-hour operation to stitch most of a dead woman’s face onto a recipient so horribly disfigured she was willing to undergo the risky surgery in the hopes of being able to smile, smell, eat and breathe normally again — and go out in public without frightening children.

The 30-member Cleveland Clinic team replaced about 80 percent of the patient’s face — essentially recreating the entire middle of her face including her lower eyelids, nose, cheeks, and upper jaw, along with supporting the bones, muscles, nerves and arteries.

The operation, transferring everything except the upper eyelids, forehead, lower lip and chin, marks the first time the controversial procedure has been performed in North America and the most extensive face transplant yet.

“I’m very proud and emotional today to share with you what we finally did,” said Maria Siemionow, the reconstructive surgeon who led the team. “The patient is doing well . . . I must tell you how happy she was when with both her hands she could go over her face and feel that she has a nose, feel that she has a jaw.”

To protect the privacy of the donor and the recipient, no details about either were released, other than a statement from the recipient’s family.

“We never thought for a moment that our sister would ever have a chance at a normal life again, after the trauma she endured,” the statement said. “There are tears of joy, and tears of pain that it took one to pass for one to have a life.”

Other experts praised the operation, saying it was a prelude to many other similar surgeries to help thousands of patients mutilated by accidents, tumors and other trauma.

“This is wonderful advance,” said L. Scott Levin of the American Society of Reconstructive Transplantation, noting that hospitals in North Carolina, Massachusetts and Tennessee were already planning similar surgeries. “The entire North American reconstructive surgery community is on the precipice of jumping into this in a big way.”

Several surgeons and bioethicists said many of their early reservations about the procedure have eased since the first one in France three years ago. But a host of thorny questions remain, and some continued to question the operations, saying it remains far from clear how long the graft will last and whether the benefits outweigh the risks.

“A graft loss would leave the patient with an open wound across most of the face,” said Carson Strong, a professor of human values and ethics at the University of Tennessee College of Medicine. “The patient clearly would be worse off than before the attempted face transplant.”

The researchers acknowledged the procedure poses concerns for society, including fears it would become used for purely cosmetic purposes or even to steal someone’s identity.

“We will do everything in our power to prevent the misuse of this important advance,” said Eric Kodish, a bioethicist who was on the team.

When the first partial face transplant was performed in France on a woman who had been mauled by her dog, the news set off an international firestorm. Another face transplant was subsequently performed on a Chinese farmer who had been attacked by a bear, and then another in France on a man disfigured by a genetic condition.

The transplants are controversial because they are aimed at improving a patient’s quality of life rather than saving it, raising questions about whether the procedures are worth the risks, which include potentially life-threatening side effects from powerful immune-suppressing drugs patients need for the rest of their life.

But despite a difficult recovery, the first recipient, Isabelle Dinoire, gradually regained normal skin sensation and control of her facial muscles and has reported that the operation transformed her life.

“I’ve become convinced a competent team could manage this,” said Arthur Caplan, a University of Pennsylvania bioethicist. “I think the microsurgery, the cosmetic surgery, the management of the immunosuppression has gotten to the point where trying this, given the desperation of the patients, makes sense.”

Others said they were reassured that the transplanted tissue does not resemble the donor, as had been feared.

“When we think of face transplants we think it’s going to be someone else’s face on another person — a Frankensteinian kind of thing,” said Jeffrey Kahn, a University of Minnesota bioethicist. “In fact, that’s not what happens. It’s the underlying structure of the recipient that really determines what it’s going to look like.”

Others, however, remain uncomfortable.

“For a patient who needs a heart transplant, not receiving the transplant is going to be fatal. That isn’t the case for a patient who needs a face transplant,” Strong said.

Siemionow and her colleagues defended the procedure, saying it was based on more than 20 years of research, including practice on animals and cadavers. Dozens of candidates were carefully screened, subjecting them to intensive psychiatric testing before selecting the first patient. The woman finally selected had undergone several reconstructive procedures but remained unable to eat, speak or breathe normally.

The procedure began at 5:30 p.m. sometime in the past two weeks after the donor’s family agreed. After confirming the two women’s tissues were a good match, surgeons carefully began to remove the donor’s face at about 8 p.m., working for more than nine hours.

In an adjacent room, a second team prepared the recipient. The facial tissue was transferred to her operating room just past 5 a.m. the next morning. For nearly three more hours, surgeons connected the patient’s blood vessels to the facial graft vessels to restore circulation. When the tissue turned pink, they knew they had succeeded. The multidisciplinary team of surgeons then continued to work in shifts to allow some to rest, sleep and confer, completing the operation at 4:30 p.m.

“I think it’s the most complex surgical procedure ever performed,” said Frank Pupay, who was part of the team.

“It’s very exciting,” said Bohdan Pomahac, who is planning a face transplant at Brigham & Women’s Hospital in Boston. “It’s great for the field.”

Doctors stressed that the patient has a long, potentially treacherous road ahead. They are carefully monitoring her for any signs of rejection. Assuming no complications occur, doctors expect that the swelling will subside after a couple of months and that feeling will return to her face within about six months. With intensive physical therapy, function should return within about a year. Eventually, the woman’s destroyed right eye will be replaced by a prosthetic device. If the graft fails, doctors said it would be replaced with a skin graft from different parts of her body.

“If it did fail and the face was rejected, it would be an almost unimaginable situation,” Caplan said. “Your face would be sloughing off. You can’t eat. You can’t breathe.”

Others said the transplantation of a face could cause people to reevaluate how they perceive their own identity and those of others.

“People have a lot of very deep-seated psychological anxieties related to receiving the face of another,” said Carla Bluhm of Allegheny College, who co-authored an upcoming book exploring the issues, titled “Somone Else’s Face in the Mirror.” “How deeply can it disrupt your sense of who you are? And what are those consequences? We simply don’t know yet.”

Another issue is whether people who sign organ donor cards should be advised that in addition to their heart, kidney and other organs, their faces might also be used for transplants.

“When I signed my organ donor card I wasn’t thinking about someone taking my face,” Caplan said. “I doubt most Americans do. Do you also have to have the family consent? They bear the emotional consequences of seeing their loved one’s face on someone else. Even if it looks different it will remind them of you.”

But Siemionow said she hoped the operation would eventually help many others.

“There are so many patients . . . who are hiding from society because they are afraid to go to the grocery store, they are afraid to go to the street because they are called names and they are humiliated,” Siemionow said. “You need a face to face the world.”

Size may be at least part of the explanation. Men’s hearts are bigger than women’s and have greater pumping capacity, and men who get men’s hearts fare better. But doctors believe differences in hormones or immune systems between the sexes may also have an impact.

The federally-funded study was led by Dr. Eric Weiss, a cardiac surgery researcher at Johns Hopkins University. He presented his findings Wednesday at an American Heart Association conference.

Daschle accepted the offer, according to two Democratic sources close to Daschle and with intimate knowledge of the decision. Daschle had been a longtime adviser on Obama’s campaign and served as a frequent surrogate on the campaign trail and in media interviews.

As Health and Human Services chief, Daschle will be responsible for helping set health care policy. He supports a government-funded insurance program for the nation’s uninsured.  Daschle has also been the head of the health care working group in the Obama transition team. Democratic officials shied away from a term some are throwing around — “health care czar” — but say Daschle “is likely to play a leading role in the passage of health care reform and the strategy to implement it.”

Other sources lay out substantial work being done by the incoming administration to enable health care reform, all of which indicates Obama does intend to move on this issue in spite of the monumental difficulties, including financial obstacles.

The former South Dakota senator led the Senate Democrats from 1994 until he lost his re-election bid in 2004. He was minority leader for most of that time, serving as majority leader from May 2001 until January 2003, when Democrats returned to the minority after losing seats in the November 2002 midterm elections.

Claudia Castillo, 30, suffered from tuberculosis for years.

“This technique has great promise,” said Dr. Eric Genden, who did a similar transplant in 2005 at Mount Sinai Hospital in New York. That operation used both donor and recipient tissue. Only a handful of windpipe, or trachea, transplants have ever been done.

If successful, the procedure could become a new standard of treatment, said Genden, who was not involved in the research.

The results were published online Wednesday in the medical journal, The Lancet.

The transplant was given to Claudia Castillo, a 30-year-old Colombian mother of two living in Barcelona, who suffered from tuberculosis for years. After a severe collapse of her left lung in March, Castillo needed regular hospital visits to clear her airways and was unable to take care of her children.

Doctors initially thought the only solution was to remove the entire left lung. But Dr. Paolo Macchiarini, head of thoracic surgery at Barcelona’s Hospital Clinic, proposed a windpipe transplant instead.

Once doctors had a donor windpipe, scientists at Italy’s University of Padua stripped off all its cells, leaving only a tube of connective tissue.

Meanwhile, doctors at the University of Bristol took a sample of Castillo’s bone marrow from her hip. They used the bone marrow’s stem cells to create millions of cartilage and tissue cells to cover and line the windpipe.

Experts at the University of Milan then used a device to put the new cartilage and tissue onto the windpipe. The new windpipe was transplanted into Castillo in June.

“They have created a functional, biological structure that can’t be rejected,” said Dr. Allan Kirk of the American Society of Transplantation. “It’s an important advance, but constructing an entire organ is still a long way off.”

So far, Castillo has shown no signs of rejection and is not taking any immune-suppressing drugs, which can cause side effects like high blood pressure, kidney failure and cancer.

“I was scared at the beginning,” Castillo said in a press statement. “I am now enjoying life and am very happy that my illness has been cured.”

Her doctors say she is now able to take care of her children, and can walk reasonable distances without becoming out of breath. Castillo even reported dancing all night at a club in Barcelona recently.

Genden said that Castillo’s progress needed to be closely monitored. “Time will tell if this lasts,” he said. Genden added that it can take up to three years to know if the windpipe’s cartilage structure is solid and won’t fall apart.

People who might benefit include children born with defective airways, people with scars or tumors in their windpipes, and those with collapsed windpipes.

The technique might even be adapted to other organs like the bowel, bladder, or reproductive tract, Birchall said.

“Patients engineering their own tissues is the key way forward,” said Dr. Patrick Warnke, a surgeon at the University of Kiel in Germany. Warnke is also growing patients’ tissues from stem cells for transplants.

Warnke predicted that doctors might one day be able to produce organs in the laboratory from patients’ own stem cells. “That is still years away, but we need pioneering approaches like this to solve the problem,” he said.

But the experts quickly warned that the treatment is not feasible for most AIDS patients or HIV carriers because for one thing donors with the genetic mutation that may be responsible for the miraculous cure are rare.  Only one in every 1,000 Europeans and Americans may carry the desirable mutation.

Other obstacles to successfully receiving the procedure are high risk of dying from the procedures itself.  Studies showed 20 to 30 percent of patients die from bone marrow transplant because the sick bone marrow needs to be killed by high doses of radiation and or medications.

Even if some people can find a HIV-resistant donor and be able to survive the procedure, bone marrow transplant is too costly for millions of HIV carriers and AIDS patients who live in Africa where the disease is most commonly seen.

The 42-year-old man suffered both leukemia and HIV.  Ever since he received the transplant at Berlin’s Charite clinic two years ago, he had been free of HIV virus as tests on the man’s bone marrow, blood and other organ tissues had been all clear.

Scientists believe the mutated gene of concern, called Delta 32, prevents HIV from attaching itself to cells by blocking a receptor called CCR5.

But doctors are not so sure if the man was cured because of the genetic mutation in the donated bone marrow.  But theoretically, knocking out the receptor by a gene therapy may be a future treatment for AIDS, Professor Andrew Sewell, University of Cardiff, was cited by BBC as saying.

This German case is an exceptional, said a health observer. Previous reports showed that bone marrow transplantation could be more likely to spread HIV than cure AIDS.

He was 19 when the hand he relied on to write his name, throw a ball and do hundreds of daily tasks was mangled in a metal-stamping machine, and doctors had to amputate. That was 37 years ago.

Then, almost two years ago, Savage became the third American to get a hand transplant from a cadaver donor. Today, the 56-year-old Michigan man says he wakes up every morning happy to realize that he has two hands again.

“It’s like you’re waking up from a bad dream,” he says. “You’ve had this dream all night long, you know, like you’re falling or whatever. And you wake up and you’re just laying in bed. It’s that kind of feeling.”

Savage’s new hand is still gaining strength, but he can swing a hammer with it, and he can throw a football or baseball. “I couldn’t do that with a hook,” he says. He can now turn doorknobs and do “the everyday things in life.”

Savage’s story is remarkable enough, but he’s also teaching scientists remarkable new things about the adaptability of the human brain.

When a limb is amputated, the parts of the brain that control it and register feeling — hot and cold, pressure and pain — go blank. It’s almost like deleting a computer program. Gradually, the brain uses that empty real estate for other things. Animal studies suggest the part of the brain that registers sensation in the face often expands to the area devoted to a missing limb.

Experts have long assumed that this brain reorganization is irreversible, especially years after an amputation. But Savage is proving them wrong.

Neuroscientist Scott Frey of the University of Oregon is using magnetic resonance scanning to study Savage’s brain. The first results are in the Oct. 14 issue of the journal Current Biology.

Frey says shortly after Savage’s hand transplant, his brain began remapping itself — again. The brain area responsible for sensation in his original right hand is performing the same function for the new hand.

“What was remarkable is really that after 35 years of complete deprivation, this sensory map of the hand could be that reversible in a mere four months after a hand transplant,” Frey says.

Savage is only one patient, and many more studies will be needed to confirm the results, but researchers think the fact that Savage’s middle-aged brain could rewire itself this way has big implications. Frey says it could point the way toward better artificial limbs.

“We’re entering a really exciting era right now where the ability to marry technology to the human brain is becoming a very real thing,” Frey says.

Frey thinks the brain’s newfound adaptability might lead to prostheses that function more naturally, and maybe even have a sense of touch.

Dr. Warren Breidenbach, the surgeon at Jewish Hospital in Louisville, Ky., who did Savage’s hand transplant — as well as the other three done so far in the U.S. since 1999 — sees other implications in Savage’s brain scans.

“It means that a stroke victim who has lost the ability to function could possibly recapture it, as long as the brain was not scarred or actually dead tissue,” he says.

Scientists don’t know yet why Savage’s brain has responded to the hand transplant, while other patients with either brain or limb injuries have not responded as well to rehabilitation. Frey thinks it may have something to do with the intensive, long-lasting physical therapy that hand-transplant patients get.

“There’s a real revolution taking place right now in the way we think about the capacity of a fully developed brain to reorganize itself,” Frey says. “Those insights are starting to penetrate the world of rehabilitation.”

Breidenbach thinks the brain’s ability to adapt might one day open a door for people born without a hand, a relatively common congenital defect.

“Here’s the question: If someone is born without a hand and I put a new hand on, will they be able to feel?” he says. “The first step of answering that question will be doing patients like Mr. Savage.”

Researchers may soon have more patients like Savage to study. So far, 44 hands have been transplanted around the world, almost all with good results. Breidenbach says other U.S. centers are gearing up to do more.

One reason may be the growing number of military amputees — it’s no accident that much of this research is funded by the Department of Defense.

A recent successful transplant at India’s Army’s Research and Referral Hospital in New Delhi was hailed as an unique effort, and former President A P J Abdul Kalam on Wednesday said it was a major breakthrough in the history of medicine in India.

“It is an unique in-situ organ transplant under which life was given to two patients from a single donor and it is a major breakthrough in the medical history of the country,” Kalam said, inaugurating the Organ Transplant and Continuing Nursing Education program at the hospital here.

The former President also recalled a situation where one of his close friends had to undergo a liver transplant years ago and had to go all the way to the United Kingdom to get the transplant performed.

“With the Army Hospital achieving a breakthrough in the field, it would be easier for Indians and also affordable”, he added.  Appreciating the achievement, he said the feat would inspire others to wilfully donate organs to give the gift of life to others.

The 10-day program for medical and nursing officers in India will provide hands-on training to those who already have experience in various other organ transplantation methods.

Determined Steve Deakin, aged 46 swam, the distance in 14 hours 15 minutes to raise awareness about the opportunities available to people who have undergone transplant operations.

The dad-of-three children and two step-children, of Ealing Road, Great Sankey, battled with difficult weather conditions during the swim on August 30.

Three of the six swimmers who took part – all of whom have had transplants – suffered from sea sickness in the choppy weather.

The British citizen, who has undergone two kidney transplants, said: “We wanted to show that there’s life after the transplant. We raised awareness through local papers.�

Steve is currently waiting to find out if he has qualified for next August’s World Transplant Games in Australia.

Last month he came away from Sheffield’s Transplant Games with five medals for swimming, canoeing and squash.

This operation was managed by the Clinic for Plastic Surgery and Hand Surgery (Director Prof. Hans-Günther Machens). The operation, with a team of 40 people participating, was headed by PD Dr. Christoph Höhnke (Head of the transplant team, Senior Physician of the Clinic for Plastic Surgery and Hand Surgery) and Prof. Edgar Biemer (long-standing ex-board member of the plastic surgery division).

Case history

Six years ago, the 54 year old farmer lost both his arms at upper arm level during an accident. Thus the man had to heavily rely on help – a condition which he wanted to change as quickly as possible. After two attempts with various artificial limbs had proven unsuccessful, his desire for arms consisting of live tissue became ever bigger. He approached the Clinic for Plastic Surgery and Surgery at the “Klinikum rechts der Isarâ€? for help.

The physicians of the Clinic for Plastic Surgery had to initially clarify whether the future patient was physically and psychologically suitable for the difficult surgical procedure. The man was examined from head to foot, for in order to be prepared for the suppression of the immune defence system required after transplantation, he had to be perfectly healthy. One also had to ensure that he had a stable personality and a stable social environment. The last phase of operative preparation was represented by an explorative operation on the upper arm stump, during which the physicians tested to see where and how they would be able to seal off nerves and vessels during transplant. During this procedure they ascertained that the main artery in the left shoulder was occluded; this would thus require several bypasses.

Now it was solely a matter of waiting for a suitable donor, matching the host in sex, age, skin colour, size and blood group and would have no injuries to the upper extremities.

The Operation

It all happened on the evening of the 25th July, around 10 p.m.: five teams started simultaneously in two operating theatres – one group each on the left and right side of the donor and host and an additional team removing a leg artery from the donor. First they had to expose each of the muscle ends, nerves and the vessels and prepare them for connection. Before the donor’s bones were severed, the blood vessels in the arms were filled with cooled preservation solution (perfusion). Both arms were then removed in such a way, that they accurately corresponded to the patient’s arm length.

Now both surgical teams connected the new body parts to the body of the host on both sides in a step-by-step procedure. First they joined the bones together with an 8 hole plate. They then connected the arteries and veins in order to recreate circulation of the transplanted arms as quickly as possible. The left side had already been prepared with three venous bypasses. Before completion of the anastomoses, the arms were rinsed with a special liquid to remove the preservation solution. Then the blood was released at intervals of 20 minutes; because from an anaesthetic point of view it must be ensured that the patient does not suffer acute damage from the blood flowing back from the transplants. The arms quickly took on their rosy colour. There was no significant swelling – proof for a well-functioning circulation and a short ischemia period (lack of tissue circulation). The surgeons then sewed the muscle and tendon strands back together and finally reconnected all the nerves (nervus musculocutaneus, nervus radialis, nervus ulnaris and nervus medianus). Now the skin could be sewn back together. Finally, a cross-joint fixateur externe was attached with pins to the lower and upper arm. This allows the arms to be suspended to avoid pressure marks. The operation was successfully concluded after 15 hours.

Current situation and further care

Not only the operation itself but also the first days thereafter continued optimally for the patient. His condition is very good under the circumstances. Now it is a matter of avoiding future wound healing disorders, infections, strong side effects caused by the drugs and, in particular, any rejective reaction (see below). Quite a number of measures were taken to this effect: close monitoring, antibiotic prophylaxis, drug monitoring and immuno-monitoring. To avoid degeneration of the muscles, these are regularly stimulated with physiotherapy, among others. The patient is also given psychological support.

Worldwide, not many hands and lower arms have been transplanted to date. The transplantation, performed in Munich, represents an even greater challenge: it also encompassed the elbow joint as well as the upper arm, signifying significantly larger regeneration areas and a more difficult immunological situation.

Allogenic upper arm transplant: an immunological challenge

In contrast to the transplant of solid organs (liver, kidney, pancreas, etc.), an extremity histologically represents heterogeneous tissue, consisting of various components with varying immunogeneity. From an immunological point of view, the focus is on the skin, containing cells with high immunogeneity bone marrow, which is also transferred within the scope of an upper arm transplant The highly immogeneous cells of the skin lead to a strong immuno-reaction in the host. During an upper arm transplant, approximately 20% of the body’s entire skin surface is transplanted. At least initially, this requires a strong immunosuppressive therapy with all the possible side effects (e.g. infections Furthermore, the skin lacks a simple lab-chemical parameter (such as creatinine during a kidney transplant) to enable the recognition of an immunological reaction in the host. The diagnosis of an immunological defence reaction is thus based on the clinical assessment of the skin, regular skin biopsies and different immunological tests. This type of monitoring is far more complex than after transplantation of solid organs.

The hollow bones in the upper arm contain large volumes of bone marrow (in contrast to a hand transplant, during which hardly any bone marrow is transplanted). Bone marrow consists of immuno-competent cells, which could trigger a so-called graft-versus-host-reaction (GvHD). This means, that these cells are able to attack the host. Such an attack denotes a life-threatening situation for the host. The extent of the risk after an upper arm transplant is difficult to assess, as it has been shown that preclinical data cannot be directly transferred to the human situation. This also requires different immunological examinations in order to recognise and treat the occurrence of such a reaction at an early stage.

In principle, upper arm transplantation combines the immunological problems of bone marrow transplantation with those of solid organ transplantation. In the long run, this is joined by possible side effect caused by immuno-depressors. From a transplantation surgeon’s point of view, upper arm transplantation thus represents an interesting challenge, which also offers the opportunity of making a contribution to understanding immunological processes after transplantation.

Both little battlers are in training for the Australian Transplant Games.

They are alive, happy and as well as can be expected because of the medical wonder of organ transplants. Both will need another transplant, although no one can say when.

When that time does come everyone who knows and loves them will be hoping for a miracle to pull them through. Their lives will depend on compatible organs being available.

So far this year, only seven West Australians have donated their organs.

AJ is a little boy with a wicked sense of humour — he will show off the scars across his stomach and tell people that “a Great White Shark did it”. He had a liver transplant at age three.

His mother, Jane Myers, said he woke up one day in July 2004 with yellow eyes and skin. He was in liver failure and was virtually flown straight to Westmead children’s Hospital in Sydney where he went to the top of the list for a transplant.

With the rare O negative blood type, AJ was fortunate that a liver became available and he underwent 8 hours of life-saving surgery.

“It was the longest wait,” Jane said.

“He was in an induced coma for a week because of the pain and after a week he woke up and that was the best day of my life and he said “mummy”. There was no sound, it was just his mouth, but he said it.”

Four months later, AJ made it home to Perth just in time for Christmas.

“It was wonderful. I was so happy when he came back normal — to the AJ that we knew before he got sick.”

AJ and his brother Matthew, 4, are looking forward to competing at the Transplant Games and have been brushing up on their chess, track and field, long jump, athletics, swimming and ten-pin bowling.

Despite the nine medications he takes morning and night and the weekly trip to PMH, AJ’s life is fairly normal — although not many children can produce a jar of 45 staples which held their chest together after such a harrowing operation.

Recently he has had a few setbacks with his health, such as a bad reaction to a new medication and confirmation that he will need another transplant at some stage.

Jane cannot speak more highly of donors and urges everyone to register as a donor: “They are the most wonderful, selfless people to give a stranger the second chance at life. There is no better gift.”

Of the donor’s family that Jane feels indebted to she said: “I feel for the family and I would like to thank them and I have sent cards but we haven’t heard from the other side.

“It would be nice to say thank you in person and if they saw AJ it would be wonderful to see what they had done.”

While AJ’s need for a transplant arrived suddenly, Joshua, who was born in Melbourne and now lives in Stirling, struggled from before his birth in 2001 when it was revealed that his kidneys were not developing.

He was born with 1 per cent kidney function and in his first week parents Jennifer and Neil were told to “take him home to die”.

He made it through that first week and has been a fighter ever since.

Since birth he has been unable to eat like everyone else and is still fed through a tube at night, although Jennifer packs him a school lunch every day.

From the start Joshua needed a kidney transplant, but he needed to grow to a size that would fit an adult kidney.

Joshua’s four grandparents volunteered to give him the life saving kidney and Jennifer’s father Ross Leddin, from Perth, was selected as a match.

Two months after his second birthday in May 2003 he required peritineal dialysis, which was administered each night, along with the feeding tube and by October 2003, he was ready for the transplant.

He suffered a heart attack while undergoing minor surgery four days before the operation so the transplant was cancelled, despite Ross having caught the train to Melbourne from Perth.

In March 2004, Ross’s 62-year-old kidney was transplanted into Joshua who was just three years old.

Life changed dramatically for the better for little Joshua, who needs to stay fit to keep up with his three-year-old twin siblings Noah and Georgia. He has been running up and down his front lawn while dad Neil times him in preparation for the 50m event at the Transplant Games.

He will also compete in the long jump, swimming and ten-pin bowling.

He was bitterly disappointed last year when a septic hip stopped him from going to Bangkok to compete in the World Transplant Games.

“He participated in the Geelong games so he is really excited,” Jennifer said.

She said it is critical to children like Joshua that people donate their organs: “There are a lot of children that just need donations.”

It is likely that Joshua will need a new kidney every 15 years. He shares a special bond with his Pop and the family moved to Perth from Melbourne last year so the family could be closer.

The Australian Transplant Games are held bi-annually to celebrate the proof that organ donation works.

Through this partnership, Transplant Connect and Microsoft will work together to bring the latest technologies to bear on the challenges of the mission-critical organ, tissue and eye transplant field.

As an innovator and leader in the mission-critical environment of transplant software, Transplant Connect develops robust and scalable Electronic Medical Records solutions built on advanced Web 2.0 technologies.  Through the Microsoft Partner Program, Transplant Connect is able to capitalize on the major advances delivered by Microsoft across many areas of software and technology.

Transplant Connect’s Chief Executive Officer, John Piano says “by partnering with Microsoft, Transplant Connect will continue to bring unprecedented resouces and powerful, advanced technology to the organ, tissue and eye transplant field.”

Mr. Piano further states “we are now positioned to build, deploy and support even greater and more advanced solutions to support our partners.  We believe this partnership will deliver powerful impact and gains in efficiency and bottom-line results (of more lives saved and improved) to many transplant agencies in the United States and worldwide.”

The Transplant Connect team of professional developers leverage the latest enhancements in the Microsoft .NET framework, MS SQL Server, Web Services, and AJAX to provide industry-leading solutions on the company’s proven iTransplant software platform.

The company’s goal is simple: to help the heroes of the transplant field save and improve more lives with the most advanced and most reliable software and systems available.  With Microsoft at its side, Transplant Connect stands in a powerful position to do just that.

Richard Baker, MD, Renal Unit, St. James University Hospital, Leeds, United Kingdom, and colleagues analysed data on kidney transplant recipients treated with a steroid avoidance (January 2004 to October 2006) and a control group who received kidney transplants before the introduction of the steroid-avoidance regimen (2001 through 2003).

The study enrolled 258 low- to medium-risk adult patients who received kidney transplants treated with steroid avoidance and 216 patients who were not treated with steroid avoidance.

Baseline demographics were similar in the 2 groups except for higher proportions of “donation-after cardiac-death” (DCD) and living donors in the later cohort.

The researchers found that the rate of acute rejection was significantly higher in the steroid-avoidance group (19.8% vs 12.5%, P = .045). Furthermore, in those patients who experienced a rejection episode, the 1-year graft survival was significantly lower in the steroid avoidance group than in the control patients (80.3% vs 100% respectively, P = .045).

All the patients who remained on steroids after a rejection episode had a preserved graft at 1 year compared with 27.7% of the 36 patients who did not start steroid therapy after a rejection episode.

Based on these findings, Dr. Baker suggested that transplant physicians using steroid avoidance in their patients should look for early signs of rejection and reintroduce steroids if they notice any such signs.

“Any clinician looking after transplant patients who have steroid avoidance should be very vigilant for signs of rejection, and once detected, we would advocate continuing oral steroid treatment for at least 6 months,” he said. “The question to address in the future is whether steroid-avoidance patients should undergo protocol biopsies to look for early subclinical rejection, and whether this deterioration in function can be rectified by continuing oral steroid therapy,” Dr. Baker added.

Often, people who need of a corneal transplant elect the conventional Penetrating Keratoplasty (PKP) procedure. In his procedure, the surgeon removes part of the patient’s unhealthy, clouded cornea (what should be the clear film that lies over the iris) and replaces it with a cadaver’s donated tissue. This is basically done by cutting out a “window” and sewing in the new piece. Those stitches are not removed for at least six months. Even then they may only be taken out over the course of several visits.

“PKP, or a total corneal transplant, is the gold standard for those who have corneas which are scarred or damaged,” said Dr. M. Bowes Hamill, an ophthalmologist/corneal specialist at the Baylor College of Medicine’s Cullen Eye Institute.

According to Hamil, there are issues to consider, as with all major surgeries, especially those which use donor tissue/organs. In the case of PKP, more often than not the surgery leaves the patient with a serious stigmatism that must be corrected with hard contact lenses. But they will see 20/20 with this addition.

The other major risk, according to Hamill, is that because the tissue never really regains its strength, there is always the chance of a rupture. If the patient is older, has arthritis or other dexterity problems, putting in the contact lenses might prove to be a big problem.

In Orange County, California, a new procedure has been developed that apparently works better and requires shorter recovery time.  That procedure is known as Descemet’s Stripping Endothelial Keratoplasty, or DSE.

Hamill feels that this new method should be considered if the patient fits the criteria (transplant is needed due to disease and not injury) and the patient doesn’t mind giving up 20/20 vision for about 20/30 to 20/40. The patient will not need to wear contact lenses and the risk of a rupture is no longer a consideration.

While the technology has been around for several years, the procedure itself has been honed with phenomenal results only during the last few years.

Dr. John Hovanesian of Harvard Eye Associates, which has offices in Laguna Hills and San Clemente, answered some questions about this innovative surgery. Hovanesian is a corneal specialist and the first surgeon in Southern California to perform DSEK.

Q.What makes DSEK different from PKP?

A.The main difference is that DSEK uses special instruments to go through the front of the cornea. The back portion (Descemet’s membrane) is then painlessly stripped and replaced with a healthy graft from a cadaver donor. Because no stitches are used, the patient recovers much quicker and there is much less of astigmatism, providing the patient with much better vision.

Q.Who are the best candidates for this surgery?

A.Patients who have only one form of eye disease tend to have the best results. While age is truly not a factor, the younger patient does tend to heal faster. But I have personally done the procedure on someone in their 90s and had terrific results.

Q. What kind of “down time” can someone expect to go through?

A.The down time is minimal compared to PKP. The patient does have to lie as flat as possible for the first 24 hours. This is due to the fact that an air bubble is put in to “set” the transplant. The air bubble dissolves after that and the graft is permanently set. The patient may not do any lifting or exercise for one week.

Naturally, it’s best to stay away from areas that would have a lot of dust and dirt to avoid the possibility of infection during the first couple of weeks following the procedure. We also don’t want the eye (s) to come in contact with chlorinated water.

Q.Is this similar to other transplants where anti-rejection drugs will have to be taken for the rest of their lives?

A.As with any transplant, rejection is always a possibility. However, unlike other organs, access to the eyes is quite simple. If something must be done, eye drops are used. There is no need to take any pills. The drops used are steroid in nature, but it doesn’t have to go through the blood stream for the patient to get the most benefit from it.

Q.What is the most important thing a patient should do when they find out they need a corneal transplant and would like to have DSEK done?

A.It would be very important to first talk to an ophthalmologist who has enhanced their training with further studies dealing with corneal diseases, treatments and of course, surgical procedures.

The term Organ transplant tourism is itself disputed. In an article by Prof. Leigh Turner in the June 2008 edition of the British Medical Journal, he objects to the use of the term in both the media and academic circles. But semantics and style apart, Shimazono, in 2007, gives the following definition of the term: “‘Transplant tourism’ involves not only the purchase and sales of organs, but also other elements relating to the commercialization of organ transplantation.”

The Declaration of Istanbul (2008) proposed in April-May 2008 the following definition, “Travel for transplantation becomes transplant tourism if it involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals, and transplant centres) devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population.” (see the Declaration itself for a fuller description).

There is a difference between organ transplant tourism and health service providers outsourcing medical services abroad. For example, the British NHS has a programme to outsource certain medical procedures in the rest of Europe. And in the abstract of a paid for paper, Dr K. A Bramstedt et al (Pubmed), in Ethics Corner American Journal of Transplantation (July 2007), write about the various insurance programmes in the US who encourage policy holders to travel abroad. The organ transplant tourism that is repugnant and objectionable is the one that exploits living donors directly, and in many cases the patients. The circumstances of obtaining organs from live donors and the consequences of organ transplant tourism are the main concerns of international health organisations, such as the WHO, governments, NGOs and professional groups. Live organ donors are usually people from countries without a regulatory framework to protect donors from, as Shimazono describes the situation, coercion, exploitation and physical harm.

Danovitch writes, “Potential living donors who may be educationally, socially or economically vulnerable…” And a Lancet commentary describes live donors as possibly being: illiterate and impoverished individuals, undocumented immigrants, prisoners, and political or economic refugees. But what does this really mean?. Shimazono, refers to a study were 71% of the Indian donors were below the poverty line. What is more revealing about this study is that from the 305 donors, 71% were female and 96% of all the donors sold a kidney to “pay off” debt. Ironically, if exploiting live organ donors seems bad, the consequences of organ transplant tourism are much worse. For donors, the list of consequences is nearly endless, the money they might have made from selling an organ would soon disappear. In a study of Egyptian donors, 78% of the group spent their money within five months (Shimazono). But the more serious consequences for donors, are deterioration of health, psychological effects, discrimination, inability to do labour intensive jobs, and lack of follow up health care. Recipients (organ transplant tourists) of organs from live donors are themselves not immune from consequences of the transplant. Like donors, organ transplant tourists can be the victims of fraud and more seriously sometimes die from the procedure. Dr Michael D. Horowitz et al, writes in Medscape Journal of Medicine, that transplant tourists may also find it difficult to “identify well trained physicians and modern hospitals.” After an operation abroad, who does the recipient consult should a problem develop?

In a Canadian study, Dr Leigh Turner, writing in Canadian Family Physician, 2007, says that family doctors back home might have to deal with the problems. As for the success rate of the procedure Shimazono says that some studies show that results are considerably lower than international standards, while other studies show results “comparable with local results.” Giving specific examples, Shimazono says that there is a, “heightened frequency of medical complications, including the transmission of HIV and the hepatitis B and C viruses”

Organ transplant tourism would not be a global medical issue if it did not involve some serious ethical problems. Maybe the most relevant of these problems is the implication organ transplant tourism has on the medical profession itself. Danovitch describes how the Declaration of Helskinki (1964) can be applied in the context of the Declaration of Istanbul. For example, responsibility for human subjects should always rest with the medically qualified person even if consent is given by the patient, “consent does not free the physicians from responsibility…”

The Lancet commentary is more forceful, “The success of transplantation as a life-saving treatment does not require-nor justify-victimising the world’s poor people as the source of organs for the rich.” It is not surprising, therefore, that Organ transplant tourism, is a serious concern for the medical profession. Coercion, commercialisation of organs and lack of follow up treatment does not exactly meet the criteria of what an honest medical health carer ought to be associated with. That organ transplant tourists can just pay their way to the front of the queue only confounds the ethical issues. It would be rather odd to write an article on the theme of tourism, even if we have to stretch the meaning of the word here, and not mention money and countries. For practical reasons, the money aspect is not that relevant because this changes with time. But how does one calculate a market value for an industry that can easily be described as murky?

Horowitz, gives some figures, for example, some studies suggest annual revenues from global medical tourism (and not just organ transplantation tourism) to be US$60 billion, but other studies dispute this and project a figure of US$40 billion by 2010. Shimazono calculates renal “transplant packages” to range between US$70, 000 to US$160, 000. Given that Organ Transplantation Tourism depends on poor people giving up their organs it is not difficult to imagine the origin and destination of this trade. David Spurgeon (quoting Professor Daar, Canada: BMJ) identifies the Philippines, Iraq, China, India, South Africa, Turkey and Eastern Europe as destinations for transplant tourists. However, the Lancet commentary reports that the representatives of the Declaration of Istanbul have “played major roles in the promulgation” of laws and regulations affecting transplantation tourism in China, Pakistan and the Philippines. Although the Australian website abc.net.au on 12 August 2008, had a story with the headlines: Australia urged to ban China’s ’transplant tourism’. Shimazono quoting an Organs Watch report, identifies the following major countries as “organ importing countries” (origin of tourists): Australia, Canada, Israel, Japan, Oman, Saudi Arabia and the USA. The Declaration of Istanbul is a major step forward in curbing organ transplant tourism by apply pressure on the relevant authorities and governments. Some advocate going the commercial route and let market forces decide. Of course, market forces with the right sort of regulations and safeguards.

The Iran model is often quoted as an example of a successful organ transplantation programme for a country where the donor is paid from an official fund. Donors and recipients are managed by this programme with the result that there were no waiting lists. This model is supposed to maintain the equitable nature of organ transplantation and still reward the family of the deceased. Details of the model are described by Ahad J. Ghods et al, in a paper, Iranian Model of Paid and Regulated Living-Unrelated Kidney Donation, published in 2006, in the Clinical Journal American Society of Nephrology. The Committee on Environment, Public Health and Food Safety of the European Parliament, (March 2008) have urged the Commission to introduce an European donor cards and regulations to fight organ transplant tourism.

Another solution aimed at addressing the shortage of organs is to modify genetically animals to provide the necessary organs. However, Prof. Robert Winston, Imperial College, in 2007 failed to persuade the Department for Environment, Food and Rural Affairs (UK) to start research on modifying pigs. In the same article, the Guardian.co.uk (UK) reported that Prof. Winston moved his research to the USA. Prof Winston was also reported as saying that it was ethical to eat pigs as food, but not ethical to provide us with life saving organs.

No doubt organ transplant tourism is a serious ethical and philosophical issue in bioethics. It is also an issue that cannot be solved by a single lobby or group with vested interests. Nor is organ transplant tourism a problem for the medical profession alone to solve or politicians to fudge. What is clear, however, is that this is a twenty first century problem. But despite the various efforts to deal with this problem the situation is still, to use Shimazono words, “provisional and tentative.”

“To my knowledge, this is the first time this has been done with a transplanted heart,” Dr. Lawrence S. C. Czer, medical director of the center’s heart transplant program, told Reuters. “Even with other organs, repeat transplantation is very rare.”

The second patient was a 45-year-old man with noncompaction syndrome, a rare cardiac condition in which the heart assumes a sponge-like appearance. The man’s heart became more and more disabled despite the best medical therapy. According to Czer, the patient first went on the waiting list for a heart transplant in 2002 but he improved and came off the list for several years.

About a year ago, his condition worsened and again he was placed on the list. Finding a suitable donor heart was complicated by the fact that the patient was a “very large man.”

As Czer noted, “You can transplant a large heart into a smaller recipient, but not a small heart into a larger recipient.”

Two months ago, the patient received a call from the transplant coordinator saying that a heart had become available. As it turned out, this organ had already been transplanted into one recipient who had died a week after the procedure from unrelated causes. There are a number of potential issues that arise with re-transplantation – for one thing, the risk of rejection is heightened because the organ has now been exposed to tissue and antibodies from two different individuals. In addition, the operation is more complex since the cardiac vessels have already been grafted previously. Furthermore, having two periods without blood-flow while the heart is removed prior to each transplantation may damage the heart muscle further.

Czer said that the short time the heart spent in the first recipient may have been critical to the success of the re-transplantation. With longer periods, there may have been more significant immune issues. The new recipient is now several weeks out from the transplantation and thus far seems to be doing well with no sign of rejection or other complications.

The cold preservation method, which has been in practice for more than 25 years, delivers the organ in a non-functioning state immersed in a cold solution for preservation during transport. The time during transport in this method is referred to as cold ischemic time (CIT), more specifically the interval beginning when an organ is removed from the donor and is cooled with the solution, to the time when the organ is implanted.

Conversely, the Organ Care System (OCS) is based on warm blood perfusion technology, which it uses to maintain organs in a warm, functioning state. This state mimics the environment of the human body during transport from organ donor to recipient. Nutrient rich, oxygenated blood is continuously pumped through the heart in order to maintain the organ in a living, beating, state. Preserving an organ with this method reduces CIT and allows for evaluation of organ function during transport.

New data presented during a late afternoon session on Wednesday, Concurrent Session 2 Cardiac Ischemic Time: Warm, Cold, or Pump?, highlighted the benefits of reducing or eliminating CIT, such as increased availability of donor organs, improved transplant outcomes, and reduced costs associated with end stage organ failure. Presentations during the session outlined research results demonstrating that reducing CIT will increase survivorship, and further how the OCS may eliminate CIT almost entirely.

Gero Tenderich, M.D., Clinic for Thoracic and Cardiovascular Medicine, Bad Oeynhausen, Germany, provided results from the PROTECT I clinical trial, Prospective Multi-Center European Trial To Evaluate the Safety and Performance of the Organ Care System for Heart Transplants, during the Wednesday session (Abstract 10). The PROTECT I trial, which was performed in Europe, studied the efficacy of the OCS in regards to survivorship. The results demonstrate the use of the OCS in maintaining and transporting donated hearts for transplant surgery. Results showed 100 percent survival of patients 30 days post surgery. Results also revealed that using the OCS allowed for patients to spend less time on the ventilator and experience a quicker recovery in the hospital. The ability of the OCS to assess organ function was also discussed. The trial sites participating in the PROTECT I study included the Clinic for Thoracic and Cardiovascular Medicine, Bad Oeynhausen and the German Heart Institute in Berlin, Germany, as well as Papworth Hospital and Harefield Hospitals, NHS Trusts in Cambridge and Middlesex, United Kingdom, respectively.

The U.S. Food and Drug Administration has recently granted IDE approval to initiate the pilot phase of the PROCEED multi-center clinical trial in the U.S. to evaluate the safety and performance of the OCS for heart transplants. The PROCEED trials will take place at five centers, including University of Pittsburgh Medical Center in Pittsburgh; Heart, Lung, and Esophageal Surgery Institute in Pittsburgh; UCLA Medical Center in Los Angeles; The Cleveland Clinic Heart and Vascular Institute in Cleveland, The University of Chicago Hospitals Cardiac Center in Chicago and Brigham & Women’s Hospital in Boston.

“The PROTECT trial results establish validity of the Organ Care System. Given its relatively recent introduction to the transplant world, we are excited about the results and look forward to seeing what further tests will demonstrate about this innovative system,� said Bruce Rosengard, M.D., Director of Cardiac Transplantation at Massachusetts General Hospital and former ISHLT board member.

Analysis of data from studies conducted in the United Kingdom and Australia were presented by Julian Gooi, M.D., Alfred Hospital, Melbourne, Australia, The Potential Impact of Reducing Cold Ischaemic Time on Cardiac Transplant Survival (Abstract during the same Concurrent Session. The analysis concluded that a CIT of less than one hour would result in longer-term survival or an increase in life-years gained (LYG). Overall, the research showed that there were 2.2 LYG per donor heart for the United Kingdom transplant program, and 2.1 LYG per donor heart for the Australian transplant program. Dr. Gooi’s presentation demonstrated how reworking the means of transport and developing central procurement and transplant centers could be beneficial to the transplant community.

“These results should alert the transplant community of issues that need immediate attention in order to increase survivorship in transplant patients. The amount of life years gained through better efficiency within the organ transport system is astonishing,� continued Dr. Rosengard.-International Society for Heart and Lung Transplantation

Last week, that changed.

A renowned infertility expert in suburban St. Louis transplanted a whole ovary from Lagos’ sister into Lagos, a step that could enable her to have children.

Dr. Sherman Silber completed the whole ovary transplant Feb. 5 in Missouri after performing the same procedure between twins last month.

The surgery could restore normal hormone function for women going through early menopause. It also could mean that one day a woman with cancer could freeze an ovary, undergo chemotherapy and radiation, and have her own ovary returned later to restore her fertility.

When Lagos, now 30, was diagnosed with non-Hodgkins lymphoma in 2004, her older sister Maeapple Chaney, now 31, donated bone marrow. Lagos was cured of cancer, but the treatment disabled her ovaries and she went into early menopause.

“I was devastated,” Lagos recalled, her voice still breaking as she tried to talk about it Monday. Now married, Lagos wasn’t with a partner at the time, so wasn’t able to freeze any embryos, she said.

“I think it sounds selfish, but I just wanted to feel like a woman again,” she said.

Yes, she wanted to have children of her own, but the menopause also induced osteoporosis, ended her monthly cycle, diminished her sex drive, and interfered with the natural “ebb and flow” of her emotions, she said.

Chaney was willing to donate eggs so Lagos and her new husband, Rodrigo Lagos, could have a baby through in vitro fertilization, but then Rodrigo Lagos saw a television report about Silber.

In 2004, Silber placed strips of ovarian tissue from a fertile twin into her prematurely menopausal sister. That woman, Stephanie Yarber, now has two children following the surgery. He has since done similar surgeries on six other sets of twins.

All of the twins who have had the ovarian tissue transplants are ovulating and menstruating normally, Silber said.

But the women may get only a few years of ovarian function using the strips of tissue, he said.

Silber, who directs the Infertility Center of St. Louis at St. Luke’s Hospital in Chesterfield, Mo., hopes that a whole ovary with its own blood supply will last decades.

Last week, Silber removed one of Chaney’s ovaries and gave it to Lagos, a form of microsurgery that requires sewing the tiny ovarian artery of the donor to the ovarian artery of the recipient.

“It’s maybe the size of a tiny piece of white thread you might use to sew on a button,” Silber said of the vessel.

Dr. Pasquale Patrizio, director of the fertility center at Yale University, said he’s paying attention to Silber’s work because he is working on freezing and thawing ovaries to help cancer patients preserve their fertility.

“It’ll tell us in the field if the entire organ can be successfully retransplanted,” Patrizio said.

Surgeons at China’s Zhejiang Medical Science University reported a successful whole ovary transplant between sisters earlier this decade; however, Silber and Patrizio said they have not seen any published medical literature or peer review related to that case.

Doctors also still have concerns about transplants that would require immune-suppressing drugs because of possible health effects for the mothers and their babies. “If they’re not a close match, we’re not ready to tackle that yet,” Silber said.

Because of the bone marrow transplant and the close match to Chaney, Lagos is able to tolerate her sister’s tissue and didn’t have to use the drugs.

The Lagoses said the surgery cost about $15,000, which is being paid for with the couple’s resources and donations. Chaney, who lives on Vandenberg Air Force Base in Lompoc, Calif., said it’s possible she could go into menopause a few years earlier than she otherwise would have because of the ovary donation, but doesn’t regret the bone marrow and ovary she has given her sister.

“It’s a great opportunity, both for my sister and for fertility treatment in general,” Chaney said.

Q: Why should you consider becoming an organ and/or tissue donor?

A: The major problem is obtaining enough organs for the growing number of Americans needing them.

Advances in medical science have made transplant surgery increasingly successful.

Transplantation is no longer considered a short-term experimental solution, but rather a long-term desirable treatment option to a deadly medical disease.

There are more than 90,000 Americans waiting for organs to become available.

Approximately every 12 minutes a new name is added to the waiting list. Each day, 17-18 people die waiting for a lifesaving transplant.

In contrast to the large number of people awaiting transplant, there are approximately 10,000 organ donors in the United States each year. Most donors contribute multiple organs however; there are still a great number of people waiting for transplant.

Q: What can you as an individual do?

A: Discuss your wishes with your family. In certain states, your legal next-of-kin must give permission for donation to occur. In most cases, the family will honor their loved one’s wish to donate. However, in many situations the family is unsure what to do since their loved one never brought up the topic of donation.

Sign a donor card.

Sign your driver’s license.

Sign up on your state’s online donor registry.

Tell others.

Q: Who can become a donor?

A: Consider yourself a potential organ and tissue donor. Your medical condition at the time of death will determine what organs and tissues can be donated.

Anyone over 18 can indicate their desire to be an organ donor by signing a donor card or expressing their wishes to family members.

Relatives can also donate a deceased family member’s organs and tissues. In certain states, the legal next-of-kin must always give consent for organ donation to occur.

Contrary to poplar belief, age makes little difference in determining if you can donate. In one case, an 84-year-old Mississippi man’s family donated his organs. His liver went to a 17- year-old boy who lived in New York. Even further evidence that age is not a factor: The oldest documented organ donor in the United States was 96.

Q: Why don’t more people donate?

The perception that a donor card carries a “death wish.” Some people admit they are afraid to carry a signed donor card. They fear it might influence hospital staff to withhold lifesaving medical treatment in order to recover organs.

Some people think organ and tissue donation is against their religious beliefs.

Many fear that the body will be mutilated. They think donation hinders funeral arrangements.

Lack of education and awareness of the current status of organ transplantation and the dire need for lifesaving organs.

An overall distrust of medical professionals.

Many times the subject is over looked. Families don’t about donation while they’re in a state of grief. Hospital staff mistakenly think that they are “sparing the family from more grief” by over looking the subject.

Q: Can you choose to donate if you are under eighteen years of age?

A: Yes, but only with the consent of an adult who is legally responsible, such as a parent or legal guardian. The adult or adults should encourage you to sign a donor card.

Q: Can you donate an organ while you are still alive?

Certain kinds of transplants can be done using living donors.

Almost 50 percent of all kidney transplants are performed with living donors.

The donor is often related to the person in need of the transplant.

Both donor and recipient can live a normal life with just one healthy kidney.

There are new methods of transplanting a portion of a living adult’s liver to a child needing a liver transplant.

A portion of lung or pancreas can also be transplanted from a living donor.

Q: What organs and tissues can I donate?

A: Needed organs include the heart, kidney, pancreas, lungs, liver and intestines.

Tissues that can be donated to help others includes the eyes, skin, bone, heart valves and tendons.

Q: Will my decision to become an organ and tissue donor affect the quality of my medical care?

A: No. Organ and tissue recovery takes place only after all efforts to save your life have been exhausted and death has been legally declared. The doctors working to save your life are entirely separate from the medical team that would be involved in recovering your organs and tissues.

Q: Are there costs to my family for donation?

A: Donation costs nothing to the donor’s family or estate.

The donor’s family is responsible for hospital charges not involved with the donation, and the donor’s funeral arrangements.

Q: What will happen to my donated organs and tissues?

A: When your legal-next-of-kin gives permission for donation to occur, they can give consent for any needed organs and tissues; or they make specific requests.

The wishes of the family are always honored and only the organs and/or tissues for which the family signs consent are recovered for transplantation.

The patients who receive the organs and tissues for transplant will be chosen based upon many factors, such as blood type, body size and medical matching.

A national system is in place to ensure the fair distribution of organs in the United States. The buying and selling of organs is against the law.

Assisted reproductive therapy, while widely used, is of little value to a woman without a functioning uterus and note that this study suggests that it is possible to retrieve the organs from brain-dead donors.

Caution that a uterine transplant using these techniques has not yet been performed and shown to be able to produce a healthy pregnancy.
Although the prospect of a uterus transplant raises ethical issues, it is technically feasible by current transplant protocols and local organ donor networks, says Giuseppe Del Priore, M.D., of New York Downtown Hospital.

Dr. Del Priore and colleagues took part in an organ donor network retrieval team for more than six months and successfully retrieved the uterus in eight of nine cases, they reported in the January issue of Obstetrics & Gynecology.

“Our hope is to eventually restore reproductive function through transplantation of a human uterus,” Dr. Del Priore and colleagues said, and creating techniques to retrieve the organ is a key first step.

For the study, about 1,800 eligible organ donors were identified and multi-organ procurement surgery took place in about 150, the researchers reported. There was specific consent from the families to retrieve the uterus in nine cases.

However, one donor did not have retrieval surgery because her clinical status deteriorated before a full retrieval team could be gathered, the researchers said.

The causes of death included stroke, cardiac arrest during electrophysiologic testing, and traumatic brain injury. All donors had previously given birth, with between one and three deliveries of healthy children, and were 30 to 45 years old.

The procedure added 10 to 30 minutes of operating time, Dr. Del Priore and colleagues reported, but by the fourth patient, the average time needed for the entire uterine dissection was down to about 15 minutes.

The organs appeared to remain viable, with no histologic changes when they were kept for 12 hours in cold conditions without a blood supply.

Before the development of current assisted reproductive therapy, the researchers noted, scientists had been studying reproductive organ transplant in animals with a view to transferring the techniques to humans.

Current reproductive therapy has helped many people. Dr. Del Priore and colleagues noted, but there is little that can be done for women without a functioning uterus.

Potential mothers who wish to receive a uterus would have to take the risk of short-term immunosuppression – one or two years for one successful pregnancy, Dr. Del Priore said.

On the other hand, the situation for the fetus appears to be relatively reassuring, the researchers said, because many women who have had other forms of transplants have had successful pregnancies.

“When controlled for other factors, pregnancy outcomes appear acceptable,” the researchers said. “Fortunately, long-term safety data are available because generations have now become pregnant after organ transplants.”

The procedure appears likely to have many takers, Dr. Del Priore said. He and colleagues have more than one hundred candidates in the preparation process.

“There were times when I loved her to death,” says Hehr, now 26, “and there were times I had to remind myself I loved her to death.”

Hehr was the last person to see his mother alive. Two years ago, on her way home from her job as a music promoter, she stopped at his house to bring him orange juice because he wasn’t feeling well.

After she left, she was hit by a drunk driver going more than 100 miles per hour. The other driver was uninjured. She was rushed to a hospital in Houston.

“It was like 4:15 in the morning,” when the hospital called, said De Rossi’s mother, Dorothy Hyde. “You know it’s bad news.”

De Rossi’s mother, sister and son gathered around her bedside to say their goodbyes. She never regained consciousness. The family knew she wanted to be an organ donor.

“When a spirit and soul dies, and all that’s left is the body,” explained De Rossi’s mom, “it’s a crime to waste all the body that’s left. The donor doesn’t need it anymore.”

To date, that decision to donate organs and tissue has changed the lives of 35 people, including NFL quarterback Carson Palmer, whose knee was rebuilt using De Rossi’s Achilles tendon more two years after her death.

Watch a full report on Julie De Rossi’s organ and tissue donation gift Sunday on “World News.”

De Rossi’s family knows she would have approved. Her mom was confident. “She was probably up there watching and saying, ‘OK, go for it.”

De Rossi’s organs were immediately harvested. That’s when Paul Ehlinger, 59, got the call.

“Paul picked up the phone,” said Vivian, his wife of 38 years. “We think we have a liver for you, and you need to be at the hospital within an hour,” the caller said.

Ehlinger quickly gathered his things. He had been on and off the transplant waiting list for a donated liver for years after suffering from hepatitis and liver cancer. This was his last chance at survival.

“It was unfortunate someone else’s life ended to give me a new liver,” Ehlinger said. “I’m more than grateful for that.”

Ehlinger is a father and a grandfather, and his wife is thrilled “he’ll be here to see his grandchildren, which otherwise would not have been possible.”

Unlike organs, which must be used immediately after death, some tissue can be taken and frozen.

“Organ donation is a great thing: It saves people’s lives,” said Mike Nickel with Lifegift, an organ donation center. “But the other side, though, is tissue. Most people don’t realize they can donate the bones in their bodies. … Everyone is potentially a tissue donor.”

Almost two years after De Rossi died, Palmer was in a playoff game for the Cincinnati Bengals against the Pittsburgh Steelers. During his first pass of the game, he was tackled to the ground and tore his knee’s two main ligaments.

“People said it was a career-ending injury,” Palmer says. “People said I wasn’t gonna be the same. I took all the naysayers and the doubters inside, and I used that as my fuel to get through it.”

This weekend, Palmer takes the field at the Bengals season opener. His amazing recovery would not have been possible without the help of De Rossi and her achilles tendon.

Palmer admits, “It’s a very eerie feeling to think that someone else’s body part can be used to reconstruct one of your body parts.”

De Rossi’s family thinks it’s only appropriate that their daredevil, adventure-loving Julie lives on in the spirit of a football player.

“I’m looking forward to seeing her in the Super Bowl,” jokes De Rossi’s sister, Karen Abercrombie.

They admit De Rossi would not have known who Carson Palmer was if she bumped into him on the street. But now they’ve become big Bengals fans and are very protective of Palmer and his knee.

“We feel like we know who he is,” said Abercrombie. “We have a great respect for him and are glad he’s back on his feet. We’re going to be cheering him on. He’s got some good support there, some good stalk.”

De Rossi’s family believes her legacy — the lives she has saved — makes her death easier to bear.

“Just the fact she was a donor is a keystone to how she lived her life.” said De Rossi’s son, Aaron Hehr, choking back the tears. “I hope to be half the person she was.”

“Certainly, her organs were absolutely lifesaving,” Nickel said. “But I would argue … a tissue transplant is also lifesaving. Carson’s life is football. This surgery that he got with her [De Rossi's] Achilles heel gave him his life back.”

Palmer knows he has a second chance at football because of Julie De Rossi’s gift.

“It’s not something you think about,” Palmer said, “until you’re actually affected by it or something within your family around you is affected by it.”

It’s a gift he hopes to pass on one day, because he, too, now has become an organ donor.

The new rules were co-authored by Stuart Russell, a cardiologist at Johns Hopkins Hospital, and issued by the International Society for Heart and Lung Transplantation (ISHLT).

The guidelines were last updated in 1997, when they restricted access to cancer patients who were tumor-free for less than five years, and who were presumed to have treatment-weakened immune systems that would prevent them from taking anti-rejection drugs.

But the new guidelines allow some people with slow-growing, less-treated cancers to get on the list, and the age cap was raised from 65 to 70 after research found that transplant recipients over age 65 have a 90 percent survival rate one year post-transplant and 50 percent survival at 10 years.

Russell estimated that the inclusions could result in up to 400 more patients in the United States per year qualifying for heart transplants. Since the United Network for Organ Sharing estimates that the demand for transplant organs will probably never be fully met, ISHLT has called for more resources to slow the progression of heart failure and prevent the need for transplant surgery in the first place.

Russell said new drugs, implantable defibrillators and pacemakers, and smaller heart pumps could assist weakened hearts for longer periods, or until a donor organ becomes available.

The new guidelines are posted at http://www.ishlt.org.

Denise Egielski went public today with her new transplanted jaw which she received five weeks ago. A cystic deformity in childhood caused her jaw to be removed and left her with a misshapen lower face and difficulty with food, drink and sleep most of her life.

Dr. Alex Greenberg, Mt. Sinai Medical Center: “More recently … her tongue would fall back into her throat.”

Today, Denise, her husband and her doctors told about the remarkable transplant surgery.

Denise: “I can sleep now and I can concentrate…”

Denise’s jaw area is swollen still, but the implanted jaw, which came from a cadaver donor — a 15-year-old boy — has given her a new life.

Dr. Eric Genden, Mt. Sinai Medical Center: “Now she can have implants placed so that she can actually bite and chew food, which she wasn’t able to do prior to the surgery.”

But the two surgeries were not easy for this wife, mother and children’s book illustrator.

First, the donated jaw had to be implanted with Denise’s own bone marrow and allowed to become live bone. Wrapped in one of her muscles, doctors surgically placed it under Denise’s shoulder, where it stayed for eight months.

Dr. Genden: “Essentially, what makes this transplant unique is that it’s not just donor bone … it’s a combination of donor bone with Denise’s own bone marrow.”

The new bone in her jaw, which is fed by her own bone marrow, should get beyond immune system rejection.

And implants on her new lower jaw will finish a perfect plan.

Denise: “When I get implants, I can’t ask for anything more.”

The findings come from the same study that previously found that inhaled cyclosporine improved survival and extended periods of chronic rejection-free survival in lung transplant patients. Those results were published in The New England Journal of Medicine in January 2006.

“Many lung transplant patients develop chronic rejection of the new lung — it is the Achilles heel of the transplant process,” said lead researcher Aldo Iacono, MD, Medical Director of Lung Transplantation at the University of Maryland in Baltimore. “Typically, patients experience a progressive, inexorable decline in lung function, most likely because of this chronic rejection and infections. This finding that aerosolized cyclosporine preserves lung function bolsters our previous findings that the drug reduces chronic rejection of the lung.”

The new study looked at 58 lung transplant patients, who were randomly assigned to inhale either 300 mg of aerosol cyclosporine or aerosol placebo three days a week for the first two years after their transplant. Both groups received oral anti-rejection medicines.

Patients who received the placebo experienced a decline in lung function that was four times as great as those who inhaled the cyclosporine. There was no difference in the rate of acute rejection of the lung (rejection occurring in the first few weeks after surgery) between the two groups.

“Since the early 1990s we have been studying inhaled cyclosporine in lung transplant patients after they experience chronic rejection, but this is the first trial in which inhaled cyclosporine was used soon after the lung transplant occurred, before chronic rejection sets in,” Dr. Iacono said.

About 1,700 lung transplants are done at 150 centers around the world each year, but they are among the riskiest types of transplant surgery. Almost half of recipients die within three years, and the long-term survival rate has not changed much in the last 20 years.

Dr. Iacono said that the data on the drug’s impact on survival and chronic rejection were presented to the U.S. Food and Drug Administration in June 2005, and that the FDA requested further studies. “I am hoping that the lung transplant community can work together to organize a multi-center trial,” he said. “If we find promising results from a new, bigger, trial, and the drug becomes readily available, it could make a big difference for lung transplant patients.”

In June that year, the Diet had passed the Organ Transplant Law, which enabled doctors to transplant organs donated by patients who had suffered brain death.

The objective of my trip to the United States before the law took effect in October was to see the state of affairs on transplanting body parts in a nation lauded as one of the world’s most advanced in organ implants.

My assignment covered a group called the United Network for Organ Sharing and a Japanese surgeon performing organ transplants at the University of Pittsburgh. But my most striking memory was of Tamio Kihara, then 23, from Fukuoka, who was hospitalized at StanfordUniversity and waiting for a liver transplant.

“Has it already been nine years? Time really flies,” Kihara’s mother, Hiroko, 69, said to me on the telephone recently. Suffering from chronic liver failure, Tamio had been told his days were numbered. There was no way for him to receive an organ transplant in Japan so his family flew to the United States, using donations collected through fund-raising.

Kihara was in serious condition in an intensive care unit when I visited him. With tears in his eyes, his father, Tatsufumi, comforted him. It was obvious, even to a layman like me, that he was near death. I did not know what to say to them.

Then, out of the blue, a liver donor was found and Tamio received a transplant. He was back on his feet two days after the operation, walking in the hospital corridor for exercise. I was stunned to see his dramatic recovery.

I also was immensely touched by his parents’ comments. “We hope we are the last ones to go through such an ordeal,” they told me.

A bill to revise the Organ Transplant Law was submitted recently to the Diet. But the legislation has not been given high priority and it is unclear whether deliberations on the bill will even start before the current Diet session ends.

The key point of the debate, once it starts, is essentially whether organs can be donated with just the consent of family members. Politicians are divided over the matter and two versions of proposals to add changes to the bills also are muddying the waters. One proposal calls for requiring the consent of the patient himself to be an organ donor while easing age and other qualifications needed to be a donor.

Some observers have called for debates over the revisions not to be done hastily. I also am aware that others espouse improving medical treatment to prevent people from becoming brain dead in the first place, rather than using them for organ transplants after the fact.

But I do not feel comfortable with the notion of stalling on debates over the transplant issue.

First of all, no law will please every single person. According to the rules of our society, Diet members–representatives of the people–are tasked with deciding how Japan should deal with organ transplants from brain-dead patients.

Hiroko Kihara said the days waiting for a donor to replace her son’s ailing liver were “hellish.” On the other hand, less fortunate families are lamenting the deaths of loved ones, unable to receive lifesaving treatment, who became brain dead before passing away.

Politicians must listen to such stories and take them into account before coming up with a comprehensive decision.

In the Diet, the ruling coalition has freed its members from their obligation to vote along party policy lines when it comes to revising the Organ Transplant Law, saying that bills dealing with matters of life and death should be left to each Diet member’s conscience.

The notion that the coalition can ram the bill through the Diet using its overwhelming majority is not true in the case of this legislation.

Some lawmakers admit they do not know the finer details of the transplant law because they have not thoroughly studied it. Such excuses are open invitations to tag Diet members as lazy: As elected lawmakers, they are obligated to properly study such matters, no matter how busy they are.

About 40 organ transplants have been conducted in Japan since the law went into force in 1997. During the same period, a number of people have died while waiting for a donor or have gone abroad to have transplants. The reality remains that Japanese patients often have to go to the United States to receive organ transplants, just as they did nine years ago.

Prospects for amending the transplant law are unclear. The Diet might decide that suddenly expanding the scope of transplants from brain-dead patients cannot be done in one step. Such a decision might anger some people and cause others despair. But once the Diet reaches that decision, we have no choice but to accept it.

But I could not bear Japan becoming a country of indifference, a country of people who refuse to even think about organ transplants from brain-dead people, a country of people hesitant to express whether they want to offer their organs should they become brain dead, or a country that fails to squarely face up to reality.

As I see the Diet is barely interested in even taking up this important legislation, I feel drained of energy. It makes me wonder just when Japan became a nation full of cowards.

Sato is a deputy science news editor of The Yomiuri Shimbun.

Cristina was the fourth to undergo a multi-organ transplant at the hospital, but the first to recover enough to go home. The other three patients survived the surgery but ultimately developed infections that killed them, the hospital said. In the 11-hour operation on Cristina, doctors replaced her liver, pancreas, small intestine, large intestine, stomach and spleen. All the organs came from the same donor.

“It is a transplant of maximum complexity from every point of view,” Manuel Lopez Santamaria, the doctor who coordinated the surgical team, told reporters Wednesday. The big danger for the baby now is infection and the risk of organ rejection, and she will undergo treatment for years. She was born with an abdominal cancer and suffered multiple organ problems after a key artery was damaged in surgery aimed at removing the tumor.

At the age of 15 months, she weighed just 6.5 kilograms (14 pounds) and was fed intravenously. “It is awful to see your child slowly waste away and move toward death,” the baby’s mother Maria Jose Garcia said.

She thanked the parents of the donor baby and said she understood their pain, but added: “Donation can be the first step toward saving another life.”

In a 14-hour operation, the 30-year-old hunter received a new cheek, upper lip and nose from a single donor. The man, identified as Li Guoxing from the southwestern province ofYunnan, was reported to be in good condition, BBC News reported.

Last November, a 38-year-old French woman became the first person in the world to receive a face transplant. Isabelle Dinoire received new lips, chin and nose. Her face was disfigured when she was mauled by her dog.

DOWNLOAD THE PDF

September 2003

EXECUTIVE SUMMARY
Introduction
One of the Nation’s most pressing public health issues is the widening gap between the supply and demand for organs and tissues. To raise awareness about the vital importance of organ and tissue donation to the Nation’s health and to increase donation rates, U.S. Secretary of Health and Human Services (HHS) Tommy G. Thompson initiated the Gift of Life Donation Initiative in April 2001. The “Organ Donation Breakthrough Collaborative” is the most recent component of Secretary Thompson’s initiative. Its purpose is to generate significant, measurable increases in organ donation by helping the national community of organ procurement organizations (OPOs) and hospitals to quickly identify, learn, adapt, replicate, and celebrate “breakthrough” practices that are associated with higher donation rates. Further,
it is designed to enhance the understanding of existing knowledge as well as contribute new and vital information about increasing organ donation rates. In particular, its goals are to:

• Increase the average conversion rate of eligible donors from the current average of 43 percent to 75 percent in the Nation’s largest 200 hospitals;
• Increase donations by up to 1,900 donors per year;
• Increase transplantations by 6,000 per year; and
• Help save lives of thousands of people each year and prevent up to 17 deaths per day.

The first phase of the Organ Donation Breakthrough Collaborative consists of the identification of breakthrough or “best” practices. Subsequent phases include learning these practices, replicating the practices, and celebrating successes. This general approach is intended to be consistent with contemporary collaborative models of identifying and spreading improvements in health care systems. This report presents a set of overarching principles and best practices associated with higher rates of organ donation that were identified based on site visits, in-depth face-to-face discussions, and other data collection involving selected OPOs and hospitals across the country.Best Practices

The 15 best practices described in this report refer to actions of OPOs and hospitals that appear to be associated with higher organ donation performance and are capable of being replicated in other OPOs and hospitals. More than one best practice may support or enhance the individual overarching principles cited above. For each best practice, the body of this report provides several specific strategies or examples used to achieve or implement it, along with other supporting evidence. The best practices are as follows.

1. Orient organizational mission and goals toward increasing organ donation.

OPOs and hospitals demonstrate goal-focused leadership and management toward improving organ donation performance, including orienting operations toward measurable outcomes and making organ donation an expected, routine process of the organization.

2. Do not be satisfied with the status quo; innovate and experiment continuously.

None of the OPOs and hospitals reported being satisfied with their current level of performance. In fact, some noted that maintaining the status quo is regressive. These entities regularly implement new, innovative strategies.

3. Strive to recruit and retain highly motivated and skilled staff.

Both OPOs and hospitals attributed their higher than average performance to their skilled, motivated, and tenured staff. Given high turnover in the industry, they are highly attentive to staff recruitment and retention.

4. Appoint members to OPO board who can help achieve organ donation goals.

In most of the sites, OPOs organized their boards or advisory structures to advance all of the interests of the OPO, including donation, procurement, and placement of organs. Boards are comprised to promote collaboration and mitigate conflicts via professionally diverse composition and balanced representation of organ donation and transplantation interests.

5. Specialize roles to maximize performance.

Various key roles in organ donation are assumed by different actors. At least 3 critical roles are: family support, clinical coordination, and hospital relations. OPO and hospital staff are assigned particular roles according to their professional strengths, experience, and performance.

6. Tailor or adapt the organ donation process to complementary strengths of OPO and individual hospitals.

High performing OPOs and hospitals do not approach organ donation in the same way in all settings. With experience, and over time, they tailor their approaches based on their respective strengths, experience, performance, and the broader needs and context of their institutions and communities.

7. Be there: integrate OPO staff into the fabric of high potential hospitals.

Among the sample of higher than average OPO and hospital performers, there is a high level of ongoing, routine interaction between OPO and hospital staff. OPO staff do not simply arrive on the scene at the time of a potential donation; they are well recognized in the settings of their affiliated hospitals.

8. Identify and support organ donation champions at various hospital levels; include leaders who are willing to be called upon to overcome barriers to organ donation in real time.

Hospital champions advocate organ donation, link the hospital to the OPO, facilitate the process of organ donation in hospitals, and break down institutional and other barriers to donation. OPOs endeavor to identify, support, and maintain relationships with these champions.

9. All aboard: secure and maintain buy-in at all levels of hospital staff and across departments/functions that affect organ donation.

OPO and hospital personnel do not rely on champions alone to achieve high levels of performance. They articulate the importance of “top-down, bottom-up and sideways buy-in,” that is, identification with and commitment to organ donation. OPOs use diverse and creative strategies for securing and maintaining buy-in.

10. Educate constantly; tailor and accommodate to staff needs, requests, and constraints.

Hospital staff in particular attributed higher than average performance, in part, to the repeated education they receive and provide to others in organ donation. Educational interactions address topics such as brain death criteria; donor identification, referral, consent and recovery processes; mechanisms for matching organs to recipients; transplantation processes; recipient care; bereavement care; and criteria for donation after cardiac death.

11. Design, implement, and monitor public education and outreach efforts to achieve informed consent and other donation goals.

OPO and hospital staff expressed differences of opinion on the impact of public education and outreach efforts on organ donation consent and conversion rates. Hospital respondents tended to give greater weight to the role of public education campaigns; OPO leaders more often found little or no causal relationship between such efforts and organ donation performance. Most hospital and OPO staff would concur that this type of education is a best practice when it has a specific purpose and continuing or improving it is linked to measurable outcomes.

12. Referral: anticipate, don’t hesitate, call early even when in doubt.

One of the most important messages that OPOs convey in education sessions and via regular contacts with hospital staff is to call as early as possible to facilitate consent and organ recovery. Among the hospitals visited, there is a common interest and willingness to make early referrals to the OPO and to consult its experts regarding potential donations. OPO personnel have cultivated this inclination by teaching the early signs of brain death and emphasizing the importance of not waiting until brain death declaration to place a call to the OPO.

13. Draw on respective OPO and hospital strengths to establish an integrated consent process. One size does not fit all, but getting to an informed “yes” is paramount.

Obtaining consent can be an intricate process that is highly dependent on the cooperation, skills, and responsiveness of OPO staff and hospital-based physicians, nurses, pastoral care staff, and social workers. The roles in the consent process are largely consistent across high performing sites; however, they can be carried out by different combinations of OPO and hospital staff. Interacting with a potential donor family to achieve informed consent to donate usually entails a sequence of time-sensitive events and carefully conveyed communications, all within a context of trust.

14. Use data to drive decision-making.

All of the OPOs and most of the hospitals cited the importance of data-driven decision-making to improve organ donation and focus their resources appropriately. Using data to inform and document decisions helps OPOs and hospitals to maximize referrals, consents, and donors and improve continuously. In particular, conducting regular death record reviews in all hospitals helps to determine those with the highest donor potential and ways to increase donations.

15. Follow up in a timely and systematic manner. Don’t let any issues fester.

OPO staff, physicians, and nurses affirmed that timely and systematic feedback is crucial to increasing awareness and improving organ donation processes at hospitals, thereby maximizing the number of early referrals and actual donors at hospitals. Immediate problem solving is another contributor to success. OPO and hospital staff emphasized that, when the organ donation process breaks down or when an aspect of the process has been poorly handled, it must be resolved as soon as possible so as not to adversely affect future events. OPOs conduct follow-up both formally and informally, using a variety of techniques.

Conclusions

Site visits with 6 OPOs and 16 hospitals, revealed 7 overarching principles and 15 best practices and accompanying strategies that appear to be associated with high organ donation performance. Many of these principles and best practices are interrelated, and many of the strategies and examples gleaned from the OPOs and hospitals support more than one principle or best practice. A noteworthy example is the OPO practice of providing letters of thanks to hospital staff following a donation, which is consistent with principles and best practices concerning recognizing and celebrating success, providing timely and systematic feedback, maintaining buy-in, and maintaining a network of interpersonal relationships.

Best practices can be viewed in the context of a systems approach to organ donation. Some OPOs and hospitals explicitly manage organ donation using a systems approach. Others implement various of its components. In this systems approach to organ donation, goals are set by OPOs and their governing bodies, and discussed with and adopted by the hospitals in their service areas. These goals are set with the intention of maximizing organ donation performance and improving organ donation processes and protocols.

To be successful, organ donation processes and protocols are implemented both within and outside of the hospital setting by champions from among OPO staff, hospital staff, and others, such as medical examiners, EMS staff, and donor families. These processes and protocols span hospital development activities, family support and bereavement care, clinical support of potential donors, and follow-up.

Hospital development focuses on building and strengthening the relationships between OPO and hospital staff. Family support and bereavement care are continuous, and focused on helping families by offering them emotional support, information, and resources needed to deal with these tragic situations. Processes and protocols related to the clinical support of potential donors include identification of potential donors, donor referrals, determination of medical suitability, obtaining consent, stabilization of donors, locating recipients, organ recovery and preservation, and, finally, transplantation. Follow-up processes include those related to OPO-hospital staff case debriefs, OPO follow-up with hospital staff regarding transplant recipients, and OPO and hospital follow-up with donor families.

Finally, OPOs and hospitals generate outcome data as a result of the implementation of these processes. Data are monitored and analyzed within the OPO and hospital settings to determine how well processes were implemented and whether goals were achieved. Results of data analysis continuously inform the organ donation process so that improvements can be made over time and organ donation goals can be modified accordingly.