Oriented to Thoracic Transplant Recipients -- August 1999


Some salient points from:

The Registry of the International Society for Heart and Lung Transplantation: Sixteenth Official Report- 1999

By Hosenpud et al

  • Over the past 12 months The Registry added a total of 3673 additional thoracic organ recipients - the smallest number in the past 5 years.
  • In total, the current report represents data on 48,541 cardiac transplants; 2,510 hem-lung transplants; with 5,347 single lungs and 3,751 double lung transplants.
Heart Transplantation
  • The 2,961 heart transplants recorded in 1998 represents a 16% decline over the 3,534 in 1997, and perhaps more importantly, is the lowest year on record since 2737 in 1988.
  • Taken over the past 15 years, the overall l-year survival rate for heart recipients is 79%.
  • The patient _ life (time to 50% survival) at transplant is 8.8 years, but after surviving the first year the _ life increases to 11.5 years.
  • The reason for transplant is still about 46% coronary artery disease and 46% cardiomyopathy, with 8% other, including re-transplants.
  • The 3-year actuarial survival curve of those recipients transplanted from 1980 to 1985 is significantly lower than those done from 1985 to 1991 and forward, which really means nothing more than the procedure has gotten more successful as time passes.
  • After year I and through year 15 the morbidity of heart transplant recipients is nearly a straight-line drop representing a constant mortality rate of 4% per year.
  • While the great majority of patients are using cyclosporine, an increasing number are being treated with tacrolimus or mycophenolate.
  • Over 70% of patients are still on corticosteroids at four years post transplantation. []
  • At the end of 4 years, 8.5% of patients will have been diagnosed with some form of malignancy of which 55% will be skin cancer.
  • At the end of 5 years, the two major causes of death are cancer (20% est.) and transplant coronary artery disease (25% est.) followed by infection.
Heart-lung Transplantation
  • The number of heart-lung procedures peaked in 1989 and has declined thereafter. There were 241 such procedures in 1989, yet only 103 in 1998.
  • Over a 12-year period the 1-year survival rate for heart-lung transplant is 61%, while the 12 year survival is 21%. The survival _ life for the 12-year curve is 2.8 years due to the high first year mortality. Adjusted to the period after the first year, the _ life converts to 8.6 years.
  • While heart-lung transplantation has declined overall, it still accounts for approximately 1/3 of the total in the Eastern Hemisphere but only 10% of the total procedures in the Western Hemisphere.
  • Lung Transplantation
  • Although lung transplantation had enjoyed continued growth through 1993, based on the past 3 years' data, this growth has clearly ceased, again despite the use of increasingly older donors.
  • The age distribution for lung transplantation is younger than for heart or heart-lung transplant recipients primarily due to its use in the cystic fibrosis population.
  • The indications for adult single lung transplantation continue to be dominated principally by chronic obstructive pulmonary disease, while cystic fibrosis is the most common indication for double/bilateral lung transplantation.
  • For pediatric lung transplant the primary indications are congenital heart disease, cystic fibrosis, and primary pulmonary hypertension.
  • Pediatric lung transplants are retransplanted much more frequently than adults.
  • The 8 year actuarial survival for all lung transplantation (adult and pediatric is approximately 30%.
  • Even after 4 years, about 30% of all lung transplants require repeat hospitalization.
  • There is a larger proportion of patients on tacrolimus following lung transplantation compared to heart transplantation both at I year (26% vs. 10.5%) and 4 years (36.4% vs. 8.7%) post-transplantation.
  • As with heart-lung transplant recipients, bronchiolitis and infection persist as being the major causes of mortality.
J. of Heart and Lung Transplantation, Vol. 18, No. 7

Trials in A German Hospital Make It Good to Be Home

By Diether H. Haenicke, Kalamazoo Gazette 8/4/99

One thing has always puzzled me. When I tell physician friends that I have to check into a hospital, they sometimes advise: "Be very careful!" What am I to make of that? Should I stay awake during surgery and make sure no instruments are left in my abdomen? Should I clean my own room to reduce the risk of infection?

I certainly had occasion to exercise some caution recently when I checked into a German hospital. Things there were startlingly different. Once admitted, I found my self in a room with two other patients, both women and very much my seniors. This situation revitalized my lifelong quest for privacy, particularly in medical settings. Three persons in any hospital room are two too many, especially if room occupancy is unisex Even the usual American configuration of semiprivate rooms is uncomfortable for me. I believe there is no such thing as a semi-private room as much as there is no semi-pregnant woman. You either are or you aren't.

Hospital gowns are the same in Germany as in the United States: back wide open. The unisex setting created distinct visual challenges since one of my roommates frequently walked by my bed to exercise her legs. The other woman, a recent refugee from Serbia, turned hostile when she realized that I was an American.

One of her relatives had been "collaterally damaged" (the war in Yugoslavia being at its peak at the time), and she repeatedly stopped by to berate the great American Satan. My pleas to leave me alone in my struggle to recover from a heart attack went unheeded.

I considered this an environment not conducive to proper convalescence and focused my energy on obtaining a private room. I succeeded. After two days during which my eyes and ears suffered collateral damage inflicted by my roommates, I was transferred to the only single room available: the one set aside for kidney transplant patients.

Patients in this particular hospital didn't wear wristbands or any other form of identification. Given my room assignment, this practice induced slight panic in me especially during the nights. My wife assured me, though; that survival with one kidney is possible should there be a case of mistaken identity.

Still, privacy was achieved, and my peace of mind returned due to the unusual hospital food. Although labeled "low fat" my tray always contained real strong coffee (to stimulate my heart?), cream for my coffee (10 percent fat), a generous portion of butter (82 percent fat) or margarine (40 percent fat) plus Camembert cheese (30 percent fat) with slices of very tasty bread. One of my doctors advised me that even beer was available to patients who could persuade their doctors that sudden removal of alcohol from their daily diet would have an unsettling effect on them. I passed on the beer.

Two days later a single room in cardiology became available. Would I want it? I jumped at the chance to leave nephrology and triumphantly moved into a private room complete with WC/ shower. Almost immediately a representative from admissions entered asking me if I wanted to use the private bathroom. I replied: Not right now. But I had misunderstood. She meant: Did I want to acquire the right to use the private bathroom for an additional charge of 50 Deutsche Marks per day? I inquired about other choices. The answer was:

Down the hall. I agreed to pay but decided to ask my doctor for an additional diuretic to get my money's worth out of that unusual fee.

When scheduled for an ultrasound, I waited patiently in my room for an orderly to put me in a wheelchair and transport me to the lab. When she showed up she told me to follow her on foot because she already had another wheelchair patient and could handle only one. I did my best. But on one of the long corridors she outpaced me and entered an elevator that closed just seconds before I reached it. A sign read: "Hospital personnel only. Access card needed." I wandered around on my own and finally found the lab. After the test was completed the attendant told me: "Since you found your way down here on foot, I'm sure you'll have no trouble getting back to your room without help." Thus I experienced a new approach to physical therapy.

I must admit, though, that I received fine medical care and made it back to Kalamazoo safely. However, when sick, one really prefers familiar settings.

Being home again is a good feeling. Now, when I can't sleep at night, I don't count sheep. I count my blessings.

Diether H. Haenicke is president emeritus of Western Michigan University in Kalamazoo, MI.
Contributed by: Dr. Don Marshall

Dr. Warren Breidenbach: His Careful Preparation Helped Him Make Medical History

By Amy Reynolds, Investor's Business Daily

Dr. Warren Breidenbach knew the protocol. Surgeons always waited until the scrubs were off to tell the public they'd completed a breakthrough operation.

Then the critics always would raise a ruckus, asking long questions and challenging the procedure. But by then it was too late to take their criticisms into account.

Breidenbach decided he'd beat the media to the punch. In fact, he decided to use challenges from the media and the public to prepare for a risky hand transplant he'd gotten approval to do.

So in October of last year, Breidenbach - a partner at Kleinert, Kutz & Associates Hand Care Center in Louisville, Ky. - announced he'd perform the first hand transplant in the US He didn't even have a patient.

Time magazine said Breidenbach was going out on a limb. Dr. Andrew Palmer, president of the American Society for Surgery of the Hand, said the statement was "driven by marketing."

A gutsy step? You bet. Naysayers? Lots. But Breidenbach, a Berkeley Calif. Native knew that his announcement would bring him exactly what he wanted - feedback.

"I had to listen to the criticism and embrace what was worth embracing and reject what was not, and I had to be willing to take criticism that was inevitable and feel calm," Breidenbach, 53, said.

The tactic worked, and Breidenbach was confident when he walked into the operating room at Jewish Hospital in Louisville on Jan. 25. Patient Matthew Scott had lost his left hand in a fireworks accident. The 15-hour surgery went smoothly.

Eleven weeks later, Scott threw the ceremonial first pitch at the Philadelphia Phillies' opening day game with his new left hand.

Today, Scott has returned to work in his hometown of Absecon, N.J. He is starting to sense heat and cold in the hand.

The operation, the third ever attempted, has been deemed a success. The first attempt, in South America in 1964 failed when the new hand was rejected within two weeks. The second try, in Lyon, France, in September last year, has been successful so far.

Breidenbach won't rest on his accomplishment.

"You need to be very careful about what success is," he said. "I think it would be presumptuous at this point to claim we have ultimate success here, because, we don't.

"A hand surviving for six months is not enough," he went on. "We need to get out and extend things further"

Breidenbach always carefully analyzes both sides of any issue, his colleagues say. It helps him prepare for complex operations and any controversy.

"I knew that just because I felt strongly I was right, that was going to be insufficient," He said.

I had to build the strongest ethical argument around this hand transplant that had ever been built around a surgical procedure in the history of medicine," he said. '"' I went out and read the ethics of how you proceed with an innovative procedure, and then upped the ante.'"'

When Breidenbach announced his intention and people denounced giving a patient dangerous anti-rejection drugs just to replace a hand, Breidenbach hung on their every word. When they said he'd only end up taking off the rejected donor hand two weeks later, he asked them to explain their views.

"I thought it was important to listen to arguments of why it wouldn't work, so I could examine them," he said. "What I also did then was to try and test the people who said it wouldn't work with arguments of why I thought it would work."

To remind himself not to get too attached to old ways of thinking Breidenbach keeps some words from Ralph Waldo Emerson's essay "Self Reliance" on his desk.

"A foolish consistency is the hobgoblin of little minds, adored by little statesman and philosophers and devines. With consistency a great soul has simply nothing to do... Speak what you think today in hard words and tomorrow speak what tomorrow in hard words again, though it contradict everything you said today."

Breidenbach didn't beef up just his sewing skills or his laboratory results to prepare for his toughest surgical challenge. Between 1996 and 1999, he gave his mind an overhaul.

During that time, Breidenbach recalled challenges while climbing in the Cascades, the Canadian Rockies and the Dolomites of Northern Italy. He says undertaking a groundbreaking surgical procedure and climbing a 3000-foot ice face are not so different.

In climbing a mountain, anything can go sour. The climber has to study the shape and grade of the face. He has to understand the equipment, the mountain's weather patterns and his own mind. It takes more time to prepare than to do the climb.

"I'm a risk taker, but I calculate my risks," Breidenbach said. "I don't like taking crazy risks."

A nerve specialist, Breidenbach needed to broaden his knowledge before doing his transplant. So after working a typical 15-hour day at Kleinert Kutz, Breidenbach made sure his bedtime stories were immunology, neurophysiology and medical ethics.

"I had to go back to square one," he said. "I just couldn't be a technician and say, 'Hand me the transplant and I'll sew it on.'"

As he primed himself, he reminded himself to be ready for anything.

"I thrive on change. Not only in my intellectual life do I embrace change, but in every aspect of my life," Breidenbach said.

To make sure his team was just as prepared, Breidenbach would run brainstorming sessions with his associates imagining catastrophes and their reactions. That way, he figured, they'd be comfortable in an emergency.

For three years, at 6:30 AM every Thursday, he held meetings to hash out the project with colleagues. Anyone who had something to say about it was asked to attend. At the first meeting, only six people came. Eventually that number grew to 40.

"This included nurses, physical therapists, brace people, immunologists, tissue-typing lab (workers), transplantation surgeons, psychologists, social workers," Breidenbach said.

"We systematically worked through every problem."

Contributed by Joseph I. Scott, Long Beach, CA


Time for the annual statement on CycloRepel, the transplant recipient's own systemic insect repellent. A change was noted this season, of which the essence proves what we have been saying all along - Cyclosporine is probably the only known systemic insect repellent for use by humans. Of course, it is available by prescription only and unlike some other newer drags is not available on the Internet or out the "backdoor" of the local pharmacy. It is that prescription that is so crucial. My dosage was lowered by half last year due to the advent of the Big C. This spring I immediately noticed that I was once again fair game for the very aggressive mosquitoes. However, around here it's also been a banner year for ticks. My wife, Sue, hardly has a day go by without at least chasing a tick somewhere on her body, if not indeed removing one that has already started lunch. I have picked one tick off my arm all year, and that one was in high gear trying to get anywhere else but on me. So even at a lower rate, Cyclo-Repel again wins the day. And we all wondered what Sandoz would do when the patent ran out - merge with another company, raise the price, change the name to Neoral and go for a contract to inject the military along with their anthrax shots.

There was quite a bit of reaction to the PVCS story of my recent hospital visit last month. Many wrote in thanks for the proffered humor over similar events they had undergone. And yes, it was meant to be humorous. A few others, including my own medical doctor, eye surgeon, father; as well as a heart transplant patient from the same hospital, made gallant and perhaps partially justifiable reasons why such things can occur. They also pointed out that I hadn't been harmed in anyway, and thus overall, the care had been good. My father, being a 94-year-old realist, wonders if per chance "If you publicized a bad scene this time, will they be looking for you the next time around?" I think he's suggesting that if I think I had room problems this time, next time I could easily be parked on the elevator to the 6th floor in the 5 floor hospital. I haven't told him about the nurse last year who took great pleasure in coming to see me when I was in the hospital undergoing chemo and radiation therapy. She enjoyed watching me squirm while she told stories about how they would have to cut a hole in my stomach to feed me when my throat closed off due to swelling from the radiation therapy. We're still friends, but she really had me going. Thank you Squibb for Xanax on those days! But, with luck, we haven't heard the last of the story. A Tx recipient writer in Texas is going to try to turn it into a "reading play" with an early 2000 opening. It may also appear in a support group newsletter for head and neck cancer.

Sorry to hear about the financial problems of T.R.I.O. According to the letter sent to non-Chapter members, they've cut back on many member services and reverted almost totally to lobbying Congress until they get the finances back under control. The Annual Conference, I think scheduled for Cleveland this fall has been canceled as well as all direct member communications. It is this last mentioned that causes me real concern. Granted T.R.I.O. was not originally structured as a support group, but support goes at least two ways, and if the members have no communication from their organization, there is very little reason they will have to continue their financial offerings. I will also say, without a great deal of personal knowledge, that Lisa Kory seems to have done an excellent job over recent years, but they've got her trying to generate her own salary and all expenses and then still find time to carry out the Board's programs. No one can do that. It's going to take a Hagman, or a Mantle or Sangstat Foundation, or others of that ilk to provide some surety of funding base for the association out and keep it that way.

WASHINGTON (Reuters) - When Sen. Edward Kennedy of Massachusetts speaks out on health care, as he does often, he can get very loud, very excited, and very red in the face. So after one very Kennedyesque tirade Wednesday, Assistant Republican Senate leader Don Nickles of Oklahoma -- a political enemy but not a personal one --joked about needing to "call Dr. Frist." Tennessee Republican Bill Frist is a heart transplant surgeon who co-authored the Republican Patients Bill of Rights and who strongly opposes Kennedy's Democratic version. Without missing a beat, Kennedy rose to his feet and roared, "We couldn't get Dr. Frist under the access to specialists provisions of the Republican bill." Laughing, Nickles said he was relieved that Kennedy's flushed face was not a symptom of a heart attack, but couldn't resist adding that if Kennedy had been stricken he wondered "if mouth to mouth resuscitation was needed, who would volunteer?"

Australian Gene Therapy Possible Heart Treatment

By Michael Perry

SYDNEY, Aug 6 (Reuters) - Australian researchers said on Friday they had discovered a gene therapy which promotes the growth of skeletal muscle cells which could be used to strengthen weak hearts and even be an alternative to heart transplants.

The Victor Chang Cardiac Research Institute in Sydney said the gene therapy, which caused the enlargement and strengthening of skeletal muscle cells, could also be used to treat muscle weakness due to aging, fractures and inherited muscle disorders.

The Institute's executive director Professor Robert Graham told Reuters the gene therapy "may be an alternative to heart transplant."

"Skeletal muscle cells divide from birth unlike heart cells. You could take skeletal cells from a calf and inject them into the heart and stimulate growth to repair sear tissue after a heart attack," Graham said.

"We have tested it on mice and made what we call 'Schwarzenegger' mice," he said.

The gene therapy discovery has been published in the latest edition of medical journal Nature. The researchers said that when an insulin-like growth factor called "1" was encoded on a gene called IGF it promoted skeletal muscle growth.

"Vitally delivered IGF- 1 genes induce local skeletal muscle hypertrophy and attenuate age-related skeletal muscle atrophy, restoring and improving muscle mass and strength in mice," the researchers wrote.

The Institute said the gene pathway has previously thought only to be operative in cells in the immune system.

"Its involvement in beneficial enlargement of skeletal muscle was entirely unsuspected," said Graham.

The Institute said that between the age of 30 and 80 years humans lose a third of muscle mass, which results in the elderly being unsteady and frequent falls and broken bones.

"Administration of the gene for the muscle growth factor may prevent muscle loss, hasten recovery and reduce the requirements for prolonged hospitalization," said Graham.

"We are delighted with this discovery because of its broad implications for a variety of conditions," he said.

But Graham cautioned that more controlled studies would have to be performed before the gene therapy was developed for clinical use.

Transplant System Changes Supported

By Laura Meckler- Associated Press Writer

WASHINGTON (AP 7/21/99) -- The nation's transplant system should do more to help the sickest patients, the Institute of Medicine concludes in a much-anticipated report on how to distribute scarce livers.

"The current system is reasonably effective and equitable, but... it operates without effective supervision and oversight and could be more efficient in its allocation of livers to those with the most urgent medical needs," said a preface to the report, released Tuesday.

During a heated battle last year, Congress postponed the Clinton administration's attempt to overhaul the transplant-allocation system and ordered the Institute of Medicine to study the issue.

The administration has tried to break down geographic barriers in the system, saying the odds of getting a transplant shouldn't depend on where a patient lives. It has ordered that more organs go to the sickest patients. But the United Network for Organ Sharing, which runs the nation's transplant system, complained that giving more organs to the sickest would lead to more deaths, since sicker patients are less likely to survive after surgery.

The institute sided with the administration, saying the nation had already decided that the sickest patients should have first crack at organs within local areas and within regions. The report found other objections to a new system also largely unfounded, including predictions that changes would discourages donation and prompt smaller centers to close.

Each year, about 4,000 people die waiting for transplants, and about 62,000 are waiting at any given time. All sides support increased donation as the ultimate solution.

The Institute of Medicine, part of the National Academy of Sciences, focused its report on livers because that's where most of the controversy has centered. Its research included a new analysis of the 68,000 patients who were on the liver waiting list between 1995 and 1999.

Specifically, the report recommends creating larger regions in which livers would be allocated to patients in decreasing order of medical urgency, with the sickest patients getting first chance. Each area should include at least 9 million people, the study said. The current system relies on local areas with as few as 1 million people.

The report also recommends that the federal government assert more control over the network that runs the transplant system and the network release more data to the public about transplants -- both of which the network has resisted.

The Department of Health and Human Services welcomed the report's conclusions.

"These findings make clear that changes are urgently needed to produce better and fairer outcomes for our nation's organ transplant patients," HHS Secretary Donna Shalala said in a statement.

The controversy intensified last year when the HHS issued a broad set of rules governing the transplant system and asserting its authority over the transplant network. Among other things, the HHS ordered the network to create a system for allocating organs that did not consider geography as a major factor.

The current system relies heavily on where an organ is donated. Livers, for instance, are offered first inside a local area, with the sickest patients getting first chance, and then in decreasing order of medical urgency. If there are no local matches, they are offered regionally and then nationally.

The transplant network strongly objected to the HHS regulation, successfully lobbying Congress to postpone it until this fall.

On Tuesday, the network emphasized that the study found the system "reasonably equitable" for the sickest liver patients, even though it was less fair for less-sick patients. And network officials said they hope the report will prompt the HHS to back off its position.

"It's time for the government to withdraw the regulation, to reconsider it and then to rewrite," said Margo Akerman, a kidney transplant recipient from Knoxville, Tenn., who serves on the network's board.

That's not likely. Shalala said her agency will press ahead, though she noted that it plans to modify the regulation before it becomes final. The original regulation has been widely interpreted as a call for a single national waiting list for transplants, but HHS officials have insisted that's not what they want.

Last month, the network come closer to the HHS position. It moved to offer more livers to patients classified as "Status 1" -those whose livers suddenly fall and who are given less than a week to live. The new policy applies inside the network's 11 regions, meaning liven will go to these very ill patients before they are offered to less-ill people inside the region.

But the Institute of Medicine's recommendations go further, saying that broader sharing of livers should apply to all patients, not just to those in Status 1.

Sangstat Will Continue to Offer Low Cost Therapy

FREMONT, Calif.--(BW HealthWire 7/22/ 99)--SangStat, The Transplant Company (Nasdaq:SANG), today announced that it will continue to offer a lower cost cyclosporine therapy. This statement is in response to Novartis filing a patent infringement lawsuit against SangShat in the United Kingdom. The suit mirrors the lawsuit previously filed by Novartis against SangStat in the United States.

SangStat believes that both the UK and US suits are without merit, and has filed a counterclaim against Novartis Pharmaceutical Corporation in the US action, alleging that Novartis has engaged in an illegal campaign to monopolize and restrain competition in the US market for chronic immunosuppressants, including cyclosporine products. The counterclaim was filed earlier this year as part of SangStat's answer in the patent infringement suit. It says that Novartis has violated the antitrust laws by engaging in a series of anticompetitive acts designed and intended to exclude SangStat from the market.

The United States Patent and Trademark Office has issued to SangStat two separate patents, Patent No. 5,766,629 (June, 1998) and Patent No. 5,827,822 (October 1998) covering SangStat's proprietary cyclosporine formulation technology, 'CPLF', for developing multiple formulations and dosage forms of cyclosporine including SangCya(TM) (Cyclosporine Oral Solution, USP (MODIFIED)). SangCya oral solution is the company's first cyclosporine product covered by these patents.

While SangCya oral solution was approved by the FDA based on bioequivalence to Neoral(R) oral solution, the Novartis patents asserted in both the US and the UK lawsuits do not cover Neoral but rather an alternative cyclosporine delivery system. The lawsuit does not prevent SangStat from selling SangCya oral solution nor does it affect the regulatory path for SangStat's cyclosporine capsules.

"The new Novartis suit was not unexpected as it follows a long line of previous attempts to stifle competition, including suing the FDA," said Jean-Jacques Bienaime, SangStat President and Chief Executive Officer. "We believe that Novartis' latest action will be unsuccessful. Our countersuit is intended to ensure fair competition for life-saying therapies which are crucial for hundred-of. thousands transplant recipients."

About SangCya oral solution.

On October 31, 1998 the US Food and Drug Administration"(FDA) granted marketing clearance and an AB (bioequivalent) rating to SangStat's SangCya oral solution for prevention of rejection in solid organ transplant recipients. This rating allows pharmacists to substitute SangCya oral solution for the brand drug Neoral oral solution. SangCya oral solution was also approved in the UK on January 28, 1999 for prevention of rejection in solid organ transplant recipients as well as other autoimmune disease indications.

More than 200,000 recipients of organ transplants in the U.S. and Europe require daily treatment with immunosuppressive medication to prevent graft rejection. Cyclosporine is the most commonly prescribed immunosuppressive drug used to prevent rejection of transplanted organs.

Currently, it is marketed by Novartis as Sandimmune(R) and Neoral and by SangStat as SangCya oral solution; combined worldwide sales for the cyclosporine products were approximately $1.3 billion in 1998. The cost to recipients for cyclosporine therapy currently is estimated at between $5,000 and $7,000 per year. SangCya oral solution is priced approximately 28% less than Neoral oral solution current pricing, which should result in an average annual saving of $1,600 per patient.

Transplant Drug Gets Key Ok

(UPI 7/28/99) A transplant-rejection drug derived from soil organisms on Easter Island received a key endorsement from a Food and Drug Administration panel.

Sirolimus, shown to be safe and effective in preventing rejection of transplanted kidneys, is manufactured under the trade name of Rapamune by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products, Madison, N.J.

The FDA committee voted unanimously in favor of the drug, but final FDA approval is required before it can be marketed.

More than 1,200 patients in nine countries helped show that Sirolimus was at least as effective as other drugs on the market for preventing organ rejection. Sirolimus comes from a kind of fungi found in soil on Easter Island, a remote spot of land in the Pacific roughly midway between Chile and French Polynesia.

Kidney transplantation is the most common type of transplant procedure in the United States, with about 12,000 performed in 1998.

Patients who receive transplant organs have to take a life-long regimen of anti-rejection drugs which suppress their natural immune system.

Mayor: All Citizens Be Organ Donors

LAYTONSVILLE, Md. (AP 7/16/99) -- The mayor of this tiny town is looking for a big gesture from its 285 residents: He wants all of them to register as organ donors. At a picnic Thursday night, Charles White plied his constituents with fried chicken, soft drinks and plenty of encouragement. About 60 of the 100 families who live here turned in pledge cards.

"This is a start," said White, who hopes to register everyone by summer's end.

"We've done research, and, as far as we know, no other community in America has done this," said Barbara Kerr, spokeswoman for First Family Pledge, a program set up by the American Society of Transplant Surgeons.

Still, some Laytonsville residents remained skeptical. Donna Potcner remembered the moments her family spent together after the deaths of her parents.

"I just don't know if I would want to be rushed right off" after dying she said. "I still have the image in my mind of having family time with my brothers and sisters with the body. It's just a wonderful thing."

An estimated 4,000 patients die each year in the United States while waiting for donated organs.

World Heart Test Plans Skip A Beat - Oops!

By Susan Taylor

OTTAWA (Reuters 7/22/99) - As it ticks toward human testing of its artificial heart device, World Heart Corp. said Thursday that a faulty battery could delay its schedule.

The Ottawa-based firm, which turned in a smaller-than-expected second quarter loss Thursday, said it is now working with its U.S. supplier to determine what caused the problem.

During testing July 16, one of the 10 battery cells in an emergency backup power device for the heart over-heated and then created a gas that burst the battery cell.

The battery, which hasn't yet been tested on humans, lasts 90 minutes--or 30 minutes longer than a less-powerful battery which has already passed testing.

"We believe it will take three to five weeks to find out if it is reparable or not," said World Heart president Dr. Tofy Mussivand. "And if it is not repairable, then we go back to this battery."

World Heart had hoped to implant its first artificial heart in December, but that schedule may be pushed back to January, 2000. The company can't yet predict if there will be a delay or how long it will last, but it said clinical trials should conclude in the fourth quarter of 2000.

World Heart's implant device, named HEARTSAVERvad, uses a unique energy system to assist the pumping function of a patient's natural heart or take over me function entirely if necessary. The system, which weighs about 800 grams, does not require removal of the patient's heart.

The battery-powered device has no wires that extend out through the skin--that allows patients the same mobility as recipients of human heart transplants. The design also allows doctors to monitor or control the device's function remotely, using satellites or phone lines.

There are only 4,000 human hearts available internationally for transplant each year, while 44,000 people in Canada alone die from heart disease annually.

In the U.S., about 4.9 million people have heart failure with 400,000 new cases diagnosed each year. Girl Ordered To Have Heart Transplant LONDON, (UPI 7/16/99) -- A 15 -year-old gift, who said she would rather die than live with someone else's heart, has undergone a heart transplant following a high-court ruling that the operation should take place against the girl's wishes.

High Court Justice Robert Lionel Johnson cleared the way for Thursday's procedure, saying the risk of the girl's resentment outweighed the certainty of her death. Hospital officials say the girl, identified only as "M," is in satisfactory condition after the heart transplant.

Doctors said M was a healthy child a few weeks ago, but was close to death by late last week because of a heart condition. She was told by her mother and medical personnel that she would soon die without a transplant, but she said she did not want to spend her life taking anti-rejection drugs.

She reportedly told her lawyers that while she did not want to die, "I would rather die with 15 years of my own heart."

She relented on Wednesday after begin told of Johnson's ruling, which allowed the procedure to take place without the girl's consent. The girl's mother had already agreed to the operation by physicians .at Freemans Hospital in Newcastle-upon-Tyne.

Peter Harris, the girl s lawyer, tells the London Telegraph: "While one cannot say she accepted the judge's decision, she was, I think, resigned to the fact. She didn't challenge it in any way. It came as an enormous relief to her parents."

Johnson said the girl was "too overwhelmed" to make an informed decision on her own.

In his decision, Johnson wrote: "If the operation is successful, then M will live with the consequence of my decision, in a very striking sense." He said the risk of the operation compared to the risk "that she will carry with her for the rest of her life resentment about what has been done to her. Whatever that risk may be.. it has to be matched against, not simply the risk, but the certainty of death."

The event has caused a debate in the British medical community about the rights of consent for a young person.

Dr. Vivienne Nathanson, of the British Medical Association, tells the London Telegraph, "Doctors find these situations very difficult because all their instincts are to provide life-saving treatment, but equally they are very reluctant to override the wishes of an unwilling patients who may not recover as well if treatment has been imposed."

Nathanson adds, "In many cases, there :will be enough time for careful consensus to be reached between the patient, the parents and the doctors, but in an emergency it is understandable that doctors would want to seek a rapid decision from the court.

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