Payment for Immunosuppression After Organ Transplantation
Bertram L. Kasiske, MD; David Cohen, MD; Michael R. Lucey, MD; John F. Neylan, MD; for the American Society of Transplantation Dramatic improvements in organ transplantation have meant that a growing number of patients must take ex pensive immunosuppressive medications for the rest of their lives. Currently, Medicare covers most transplantation procedures in the United States, but ends coverage for outpatient immunosuppressive medications after 36 months. Evidence suggests that at least some patients have reduced immunosuppression and their transplants fail because they cannot afford these medication costs. In the years since the advent of effective immunosuppressive therapy, the US Congress has struggled with this issue, and in 1999 temporarily extended medication coverage for eligible patients (based on age and disability) by 8 months. However, a more permanent solution is needed. We advocate that Medicare should cover the cost of all immunosuppressive therapy for all solid organ transplant recipients who cannot afford to pay.
A number of potentially cost-effective approaches could be taken, but, in any case, something must be done to ensure that transplants do not fail because recipients cannot pay for immunosuppression.
JAMA. 2000;283:2445-2450 In Greek mythology, the gods punished Tantalus by giving him an unquenchable thirst and water that moved out of reach whenever he tried to drink. Today, we may be similarly punishing organ transplant recipients by offering them a gift of life, then denying them access to necessary but expensive immunosuppressive medications. Dramatic improvements have occurred in organ transplantation. However, all patients (except the rare recipient of a transplant from an identical twin) must take immunosuppressive medication indefinitely.1-3 Medicare and many other payers do not routinely cover outpatient medications. The adverse consequences of this policy for elderly and disabled patients have recently been reviewed.4 However, nowhere is the issue more critical than for payment of immunosuppressive therapy. The limited options to pay for expensive immunosuppressive medications negatively impact patients’ lives and likely play a role in medication nonadherence, which is increasingly identified as a major cause of transplant failure.
It is difficult to precisely determine the number of transplants that are lost as a result of nonadherence. Most patients will not divulge nonadherence, not only because of shame and embarrassment, but also because admitting to nonadherence may make them less desirable candidates for retransplantation. However, it is certain that at least some organs fail as a result of medication nonadherence, and it is equally certain that the likelihood of nonadherence is increased by an inability to pay for medications. Immunosuppressive medications have been key to the success of organ transplantation, but the question of how to pay for this expensive therapy has plagued the United States Congress for the past quarter century. In 1972, Congress made treatment of end-stage renal disease (ESRD) a unique entitlement under Medicare. Costs of renal transplantation, exclusive of immunosuppressive medication, were covered for 1 year. However, at that time, only 40% survived 1 year with a functioning kidney transplant, and the relatively ineffective immunosuppressive medications were not prohibitively expensive.
In 1978, Congress extended Medicare coverage for renal transplantation from 1 to 3 years but did not address payment of outpatient immunosuppression. With better immunosuppressive therapy, transplantation became increasingly successful and Congress passed the landmark National Organ Transplantation Act of 1984. This legislation authorized a National Task Force on Organ Transplantation, established the Organ Procurement and Transplantation Network, and authorized payment for immunosuppressive medications for 1 year after Medicare-covered renal transplantation. The task force returned to Congress with a clear recommendation that Medicare and other payers cover immunosuppressive medications not only for kidney but all organ transplants.5 With the introduction of the effective (but expensive) immunosuppressive drug cyclosporine, extrarenal transplantation also moved from the experimental to the routine.
In a series of policy changes between 1986 and 1991, Congress authorized payment for transplantation and 1 year of immunosuppressive medications for heart and liver transplant recipients, but only for elderly and/or disabled patients who qualified for Medicare benefits. In 1987, Congress asked the Institute of Medicine (IOM) to evaluate the Medicare ESRD program. In its final report, the IOM recommended that “Congress eliminate the three-year limit on Medicare eligibility for ESRD patients who are successful transplant recipients and authorize an entitlement equal to that of ESRD patients who are treated by dialysis.”6 In 1992, Congress went halfway by authorizing an extension of the time limit for immunosuppressive drug coverage from 1 to 3 years. In 1997, Congress asked the IOM to study the issue of extending payment for immunosuppressive medications after organ transplantation beyond the 3-year limit. The IOM concluded,”. . . the rationale for eliminating the current time limits for coverage of immunosuppressive drugs for all solid organ transplant recipients is strong.
“Late in 1999, Congress authorized the secretary of Health and Human Services to temporarily extend Immunosuppression coverage for organ transplant recipients beyond the current 3-year limit. However, only patients who are Medicare-eligible, based on age and disability and not based on ESRD entitlement, qualify for this temporary extension. The new benefit is to be administered by the secretary through 2003. As part of the legislation, the secretary was directed to report back to Congress on the effect of the change and to make recommendations for a permanent solution. On one hand, this legislation may be viewed as a step in the right direction. On the other hand, it does not solve the problem and only postpones the difficult decisions that need to be made.
COSTS TO PATIENTS
Organ transplantation is an expensive therapy, even for patients with adequate health insurance coverage. Costs may include travel, lodging, and meals whenever the patient comes to the transplant center for evaluation or follow-up. Frequent visits may also require a significant amount of uncompensated time away from work for both the patient and family members. Out-of-pocket medical expenses usually include premiums, deductibles, and co-payments for health insurance. Patients who are unemployed due to illness and no longer qualify for employer-sponsored insurance are forced to pay the full cost of insurance premiums if they remain eligible. CO-payments for extensive immunosuppressive drugs can be sizable. The average cost of immunosupressive agents may be as high as $10,000 to $14,000 per year for kidney transplant recipients (Table 1). For patients with low family incomes, these medication and health care costs directly compete with the provision of other basic necessities.
CURRENT METHODS OF PAYMENT
Assistance in paying for immunosuppressive medications may come from employer-sponsored health insurance, private insurance, Medicare, Medicaid, other state insurance programs, drug manufacturer— sponsored programs, or nonprofit organizations. Medicare part A pays for most organ transplants. Medicare eligibility requirements include having worked and paid into the Social Security system and either age older than 65 years, disability for at least 2 years, or need for ESRD treatment. Until the recent legislation, Medicare had reimbursed 80% of the cost of approved medications under part B for a maximum of 36 months after transplantation. Nonkidney transplant recipients could not receive Medicare medication benefits if they were not eligible for Medicare at the time of transplantation. Under 1999 Medicare part B, patients must pay a monthly premium of $45.50 and an annual $100 deductible.
There are 10 supplemental Medicare coverage (Medigap) programs offered nationwide, and only 3 of these include medication assistance; 2 cover 50% of medication costs up to $1250 per year (with a $250 deductible) and 1 covers 50% of medication costs up to $3000 annually (with a $250 deductible). Medicaid eligibility is limited to those who are (1) categorically needy, (2) receiving general assistance, (3) receiving Aid to Families With Dependent Children, (4) receiving supplemental security disability, or (5) medically needy (usually established after spending assets down to a minimal level). Qualifications include age older than 65 years or disability and income below the federal poverty guidelines. Full-or-part-time employment disqualifies patients from Medicaid or increases their spend-down limit. Many states place limits on the number of prescriptions that are covered. Six states cover only 3 per month, 2 states cover 5 per month, 3 states cover 6 per month, and 1 state covers 10 per month.
In addition, 28 states have special programs that help pay for medications for kidney transplant recipients. Patients may also qualify for pharmaceutical company assistance programs. The manufacturer determines eligibility but, generally, patients must be ineligible for other insurance that covers medications, and they must also prove that there is insufficient family income to pay for medications. The transplant center must initiate applications and must reapply every 3 or 6 months. Several charitable organizations provide emergency or short-term medication assistance on a case-by-case basis. Although it appears at first glance that there are many programs to help patients pay for medications after transplantation, all of these programs have stringent requirements and are only temporary. Many patients in low-income jobs earn too much to qualify for financial aid, yet earn too little to afford private insurance. In addition, locating and applying for assistance programs to pay for medication is itself a significant barrier.
The incidence of medication nonadherence after renal transplantation has been reported to be as low as 4.7% and as high as 45% to 55%. Most centers that have carefully reviewed their experience have reported the incidence of nonadherence to be 15% to 25%. 11-17 Differences in the reported incidence may in part reflect differences in the method by which nonadherence is measured. Nonadherence has been assessed through retrospective reviews of medical records, 10-12 patient surveys, 14, 15, 17 pill counts, 16 and blood levels of cyclosporine.8, 9, 13 Each of these methods has strengths and weaknesses.
Nonadherence may be a common cause of graft failure, especially in the late post-transplantation period. In 1 study of 531 patients, nonadherence (detected by low cyclosporine blood levels and confirmed by patient interviews) caused 11% of all graft failures over a 5-year period.8 Another study reported that 22% of graft failures in the late post-transplantation period were attributable to nonadherence. 18 Bergmann et all 9 reported that 52% of patients who lost their kidney transplants to rejection were nonadherent to medications. It is likely that studies underestimate the true frequency of graft loss due to nonadherence.
Chronic allograft nephropathy is the most common reason renal transplant recipients return to dialysis. However, Gaston et al 20 found that many patients who lost their transplanted kidneys because of chronic alograft nephropathy were, in fact, nonadherent with their medications. Thus, nonadherence may be a more common cause of late renal allograft failure than previously recognized. Some studies found that nonadherence to medication is more common among patients of lower socioeconomic status 10, 11 and those who are unemployed.9 Medication nonadherence is also more common among racial minorities,8, 9, 12 but this likely reflects their low socioeconomic status. 11 For example, in a study of 196 renal transplants, the incidence of nonadherence was greater in African Americans compared with non-Hispanic whites (30% Vs 12%). However, more Af rican American patients werejudged to have lower socioeconomic status (54% Vs 14%). The incidence of nonadherence was similar in both racial groups when only those in the lower socioeconomic status group were analyzed separately (10 [50%] of 20 African Americans Vs 8 [38%] of 21 non-Hispanic whites [P>.05]).11 These data suggest that differences in nonadherence among racial minorities can be attributed to their lower socioeconomic status.
IMPACT OF INSUFFICIENT INSURANCE COVERAGE
The potential causes of nonadherence to pre scribed medication are numerous and complex. It is virtually impossible to ascertain how often the inability to pay for medications contributes to medication nonadherence and results in graft failure. However, Sanders et al 2l reported that patients with drawn from cyclosporine therapy because they could not afford to pay had a higher rate of graft failure than patients who continued receiving cyclosporine. After instituting an indigent drug payment program, the difference in graft survival between these underinsured and fully insured patients disappeared.22 In 1992, Congress extended Medicare payment for outpatient immunosuppression from 1 to 3 years. Woodward et al 23 compared 1-year and 3-year renal al lograft survival rates for patients with only 1-year Medicare coverage with that of patients with 3 years of coverage. They stratified patients by median family income, determined by ZIP code mapping. Lower-in come patients receiving transplants with only 1 year of coverage had no difference in 1-year graft survival but significantly lower 3-year graft survival compared with higher- income patients (72% Vs 77%; P<.001). In contrast, lower-income patients receiving transplants with 3 years of coverage had no difference in 3-year graft survival compared with higher-income patients (78% Vs 80%, respectively; P>.05).23 This study was uncontrolled; therefore, other explanations for these results are possible. Nevertheless, the results are consistent with the notion that outpatient coverage for immunosuppressive medications could significantly improve allograft survival.
COSTS TO MEDICARE
Few data are available to determine the true costs of transplantation. An analysis of Medicare expenditures suggests that the annual costs of maintaining a renal allograft are substantially less than the initial costs or the costs of graft failure (Figure 1). Most of the cost of maintaining a kidney transplant after the first year can be attributed to the cost of immunosuppression. Renal transplantation provides significant savings compared with maintenance dialysis. The break-even point between the Medicare reimbursed costs of renal transplantation and dialysis is now 3.1 years overall, 3.2 years for cadaver donor transplants, and 2.8 years for living donor transplants (Figure 2). This has improved from 4.6 years in 198924 be cause of improved kidney transplant survival rates and increased costs for dialysis.
The cumulative costs per life-year over 10 years are $26,400 for living donor kid ney transplantation, $29,900 for cadaver donor kidney transplantation, and $42,000 for dialysis. Ten-year cumulative savings (per patient) are $99,300 for recipients of cadavence donor kidneys, $139,300 for living related transplants, and $107,300 on average for renal transplants overall (Paul Eggers, PhD, unpublished data, 1998). These figures exclude expenses not reimbursed by Medicare. There may be less cost savings from preventing gratt taiiure of heart, lung, and liver transplants since these recipients usually die when the graft fails. Some, however, undergo retranspiantation, and the cost of retransplantation may be as high as $300,000. In addition, many un dergo costly last-ditch efforts to salvage allograft function in intensive care settings. Recently, the IOM commissioned the Lewin Group, a Washington, DC—based health and human services consulting firm, to prepare cost estimates for expanded Medicare coverage of outpatient immunosuppression. 7 Using standard Congressional Budget Office methods, they calculated the cost to Medicare of eliminating the current 3-year limit on payment for immunosuppressive medications.
They calculated costs separately for kidney and other transplants and made several key assumptions: (1) Coverage would be extended either to patients who remain Medicare-eligible 3 years after transplantation or to patients who are Medicare-eligible or who qualify under the ESRD entitlement (calculations were made for both strategies). (2) The Medicare secondary payer requirement would be extended from 30 months to indefinitely, thereby reducing by 25% the number of patients who would otherwise increase the cost to Medicare. (3) The annual cost to Medicare for outpatient immunosuppression (for all organ trans plants) would be $5400 per patient in 2000, with an annual increase of 4%. This cost would continue to include a 20% co-payment and a 5% discount from the “average wholesale price” of the drugs. (4) The kidney transplant population was estimated to grow by 8.6% per year, based on trends from 1995-1997. The expected growth in the number of extrarenal organ recipients surviving longer than 3 years was also based on current trends. (5) The annual kidney graft failure rate due to nonadherence to immunosuppressive medications would be about one third of the annual weighted average graft failure rate of 7% (ie, about 2.5% per year). (6) For kidneys, there would be a 12% annual mortality after graft failure, but 10% of survivors with failed renal allografts would undergo retransplantation each year, representing potential cost savings if graft failure is prevented.
For other organs, there would be no cost savings since virtually all retransplantations for heart, lung, and liver recipients occur during the first year. Data underlying the assumptions on the growth in the number of patients, the graft failure rate, the cost of a failed renal allograft, and the cost of dialysis and retransplantation were provided by the Health Care Financing Administration (Paul Eggers, PhD, unpublished data, l999).7 Assuming that the coverage extension would apply to Medicare-eligible patients and patients qualifying under the ESRD entitlement, the Lewin Group estimated that the net 5-year cost to Medicare of extending outpatient coverage for kidney transplant recipients would be $848 million. The gross cost for kidney transplants would be $1678 million, while the savings from preventing kidney allograft failure would be $830 million. The gross cost for all other organ transplants would be $212 million (with no projected savings) and the total net cost for extending coverage for all organs would $1060 million. Assuming that the coverage extension would apply only to patients who were Medicare-eligible at 3 years after transplantation, the net 5-year cost to Medicare for kidney transplant recipients would be $566 million, the gross cost for kidney transplants would be $1120 million, and the savings from preventing kidney allograft failure would be $554 million. The gross cost for all other organ trans plants would be $212 million and the total net cost for extending coverage for all organ transplants would be $778 million.
IMPLICATIONS OF RECENT LEGISLATION
Near the end of 1999, Congress included a provision in the Medicare, Medicaid, and State Children Health Insurance Programs (SCHIP) Balanced Budget Refinement Act of 1999 (~227) that extended Medicare payment for immunosuppressive drugs. The provision, signed into law by President Clinton, temporarily extends Medicare coverage, but only to Medicare-eligible organ transplant recipients (ie, those who are disabled or 65 years of age). Kidney transplant patients who previously qualified for 36 months of coverage based on ESRD entitlement were not included. For organ transplant recipients whose coverage ends in 2000, the existing coverage will be extended by 8 months, from 36 to 44 months. For those whose coverage ends in 2001-2003, coverage will be extended to 44 or 48 months (the law does not specify exactly how much).
The law also directs the secretary of Health and Human Services to submit a report to Congress by March 1, 2003, on the operation of this new service. This report is to include an analysis of its impact and recommendations regarding the appropriate cost-effective method for providing cover age of immunosuppressive drugs under the Medicare program on a permanent basis. The secretary is to identify potential modifications that would best promote the objectives of improving health outcomes, achieving cost savings, and meeting the needs of those Medicare beneficiaries who, because of income or other factors, would be less likely to maintain an immunosuppressive drug regimen. In this legislation, Congress has postponed making a decision on providing permanent coverage of immunosuppressive medications.
In addition, by excluding kidney transplant patients who currently qualify for as sistance under the ESRD entitlement, it is possible that the law will provide a further inducement for renal transplant recipients to apply for or maintain disability assistance. Moreover, it appears that there is no provision to extend the current 30-month requirement for other payers to provide coverage, and there is certainly no inducement for them to provide additional coverage. Finally, the directive for the secretary to provide Congress with a report on the impact of this new Medicare policy by March 1, 2003, will be virtually impossible to fulfill. Even if an analysis of outcomes could be conducted using sound, scientific principles, the duration of follow-up after the policy change takes effect will be too short to provide meaningful data. Indeed, data on outcomes will be available for only a minority of the affected patients, given lag times in data reporting and collection. Thus, Congress and the president may have stumbled in their attempt to sidestep this important issue.
Any debate over who should pay for immuosuppression to maintain functioning organ transplants will be a debate over cost shifting. Under the current payment system, it is difficult to know what share of the cost of immunosuppression is borne directly by underinsured patients, employer-sponsored or other private insurance, the federal government, states, the pharmaceutical industry, or other sources. However, there may be actual savings to the entire health care system from decreased graft failure. A system that would guarantee payment for all immunosuppression after organ transplantation would have advantages and disadvantages. The US health care system is characterized by a multitude of payers, and a single payment system would shift costs and make it difficult to calculate system-wide savings from increased coverage. It is certain that at least some patients decrease the amount of immunosuppressive medications they take because of inability to pay.
It is highly likely that this leads to graft failure in at least some instances. However, the very nature of the problem may preclude accurately measuring the monetary impact of policy changes, since this would require measuring an element of human behavior motivated by pride and self-respect. Not to be lost in all of the financial arguments is the purpose of organ transplantation, to prolong life and relieve suffering. Any payment system that fails to maximize these goals is a failure, no matter how much money is saved or spent. In this era of direct or indirect rationing of health care, money spent on organ transplant recipients could be spent instead on patients with other needs. Indeed, if Medicare coverage for immunosuppression is extended, shouldn’t other essential medications be covered as well? If organ transplant recipients receive this benefit, why not other Medicare recipients?4 The benefits of organ transplantation are dramatic and well documented, and our society has decided that its citizens should have an equal right and opportunity to enjoy the benefits of organ transplantation. We have decided that this life-saving procedure should not be denied because an individual cannot pay. However, after offering the dream, we then withhold the reality by making it difficult if not impossible for many recipients to obtain the medications necessary to maintain their transplanted organs.
Clearly, we have only gone halfway. In the looming debate over a major reform of Medicare, choices will need to be made Health care will need to be rationed. Orn way to ration the health care dollar is to avoid paying for outpatient medications. This decision may be appropriate for many affordable medications and, perhaps, for medications that have not been clearly shown to provide benefit. However, immunosuppression for organ transplant recipients is an example of outpatient medication that is clearly effective but out of reach for many patients. There are several possible approaches that could be taken to remedy the situation. The easiest but most expensive approach would be for Medicare to provide complete coverage for any and all prescribed immunosuppression. Alternatively, a system of coverage could pay only for the least expensive immunosuppression regimen and insist that coverage for more expensive regimens be based on sound medical evidence that they are cost-effective. The cost of medications could possibly be reduced by direct purchase contracts; such an approach has undoubtedly helped to keep the cost of immunosuppressive medications lower in Europe than in the United States.
In any case, we believe that Medicare should cover the cost of immunosuppressive therapy for all solid organ transplant recipients who cannot afford to pay. Whatever scheme is adopted, a national program to assist patients who need help in paying for immunosuppressive medications after organ transplantation may be the only way to ensure that all recipients are provided with the means to maintain their functioning transplanted organs. This may be the only equitable and ethical fulfillment of the tantalizing but sometimes empty promise of organ transplantation.
JAMA, Vol. 283 No. 18, May 10, 2000
Doctors Find Offbeat Heart Remedy
By Hilary Waidman - The Hartford Courant, July 02, 2000
Doctors at Yale-New Haven Hospital say they have come up with a revolutionary approach to heart transplants that could save the lives of people who now face near-certain death.
Instead of removing a whole diseased heart, the doctors have developed a method by which a new heart is attached to the healthy half of the original organ. The patient is left with one-and-a-half hearts.
The technique, which works in dogs, could be tried in the first human within three to six months, said Dr. John Elefteriades, chief of cardiothoracic surgery at the Yale School of Medicine.
A description of the method was published in the June issue of the medical journal The Annals of Thoracic Surgery and was met by heart surgeons with a combination of fascination and caution.
“It’s kind of a clever idea,” said Dr. Verdi J. DiSesa, chairman of the department of cardiovascular-thoracic surgery at Rush Presbyterian-St. Luke’s Medical Center in Chicago.
“But they may be proposing an elaborate solution to something we already have therapies for.”
DiSesa, who wrote a commentary about the approach for the journal, also echoed the fears of others who said that the Yale method might make sicker people eligible for heart transplants. With donor hearts already in short supply, that could increase competition for an already too-small pool of organs. Every year, there are about 7,500 people in the United States on waiting lists for new hearts, and only about 2,500 get transplants, largely because of a donor shortage, said Dr. Jonathan Hammond, a heart surgeon at Hartford Hospital.
But Elefteriades said his method seems to solve one of the most vexing problems for surgeons and patients - failure of the donor heart because it is not strong enough to overcome a type of lung damage common in people who have suffered from chronic heart failure.
Elefteriades stressed that most patients do well after a heart transplant. He came up with the one-and-a-half heart idea out of frustration after watching his sickest patients die either because they did not qualify for a heart transplant, or because the donor heart failed.
“We said, ‘Let’s think of something we haven’t thought of. Let’s be creative,” said the 49-year-old surgeon, who has been transplanting hearts for 16 years.
Understanding the idea requires a quick anatomy refresher. The heart is a muscular pump just a bit larger than your fist. It is split in two parts - the right and left ventricles.
After blood delivers oxygen throughout the body, it returns to the right side of the heart. From there, the right ventricle pumps the bluish blood into the lungs where its oxygen is replenished and carbon dioxide is removed.
From the lungs, the bright red, oxygenated blood returns to the left side of the heart, or left ventricle, which pumps it out to the body again.
In patients with heart disease, the left side generally becomes weak and can no longer efficiently pump red blood through the body. As a result, the bluish blood backs up in the right ventricle. This causes the right side of the heart to work harder and can dramatically increase the blood pressure in the lungs.
Under so much pressure, the arteries in the lungs become thick and leathery, making the right side of the heart work even harder.
People with the most severe form of this condition face certain death without a heart transplant. Even with a transplant, 40 percent still die after surgery because the right side of the new heart fails.
“We’ve all watched these young people die - one or two a year,” Elefteriades said.
Even for people who do not have life-threatening lung pressure, a heart transplant can be perilous. One in 10 heart recipients dies before leaving the hospital, again largely because of failure of the right side of the donor heart.
The problem is easy to visualize by thinking of the heart as a weight trainer at the local gym.
The right side of a damaged heart has been working out, pumping against the high blood pressure in the lungs. Imagine a pro football player, bench-pressing 500 pounds. By comparison, a newly implanted heart has been working out in a healthy body - more like a weekend athlete curling 20 pounds just to stay in shape.
Confronted with the 500-pound weight that was being pumped by the old, muscle-bound right ventricle, the right side of the new heart fails.
Dr. Christiaan Barnard - who completed the first successful human heart transplant in 1967 in Cape Town, South Africa - recognized this problem. He tried to address it by simply attaching a healthy “piggyback” heart to a damaged heart, leaving the patient with two hearts.
But the old left heart continued to cause problems, including sending blood clots to the brain and lungs. And the two hearts made the chest so crowded that the right lung was damaged or collapsed. Thus, the two-heart concept never really caught on in the United States.
Elefteriades wondered if there was a way to use the still-strong right side. He likened conventional transplants to throwing out the baby with the bath water.
“The paradox is you’re throwing away this good right heart,” he said, reiterating that in most cases of heart failure, only the left side fails.
“So the basic problem is how do you transplant half a heart?” added his colleague, Dr. Gary S. Kopf, a heart surgeon at Yale-New Haven Hospital.
The Beat Goes On
Less than two years ago, Elefteriades and his team went to the autopsy lab to find out if it was possible to separate the two sides of the heart like Siamese twins and have each side continue to function.
After they decided it was structurally possible, they tried the procedure on laboratory dogs and discovered that the right ventricle continued beating after the left side was removed.
They then managed to rig up connections between a donor heart and the remaining right ventricle. Both right ventricles continue to pump independently, with both hooked up to the pulmonary artery, which sends blood to the lungs. The setup takes pressure off the donor heart.
All of the dogs survived.
Because the experiment was performed on dogs with normal lung pressure, Yale’s ethical advisory board, which must approve research on human subjects, has asked Elefteriades and his team to try the one-and-a-half heart transplant on dogs with high lung pressure.
Those experiments are about to begin. If they are successful, the first person could have one-and-a-half hearts within six months, Elefteriades said.
He said the first guinea pig would be a person whose condition is so dire that only a heart-lung transplant would offer hope for survival. Heart-lung transplants are so rare that only 15 were performed in the United States last year, he said.
Ultimately, Elefteriades said, the technique could reduce the number of deaths from right-heart failure after transplant. It also might increase the number of donor hearts available by allowing transplant doctors to use weaker donor hearts. And it could make transplant an option for patients who would otherwise be ineligible because of their high lung pressure. But Hammond, the Hartford Hospital cardiac surgeon, was less enthusiastic. He said many of the problems addressed by the Yale approach can already be taken care of with pressure-lowering medications and a mechanical pump that supports the new heart while lung pressure is being re duced. “The biggest problem is donor avail ability,” Hammond said. “The last thing we need to be doing is increasing the recipient pool.”
Type 0 Patients Pose Medical Irony
By LAURA MECKLER - AP Writer
WASHINGTON (AP 6/14/00)— in a medical irony, Americans with blood type 0 — universal donors who can give to anyone — are the least likely to receive a new liver, heart or lung.
That’s because their organs are trans planted into patients with all sorts of blood types, extending the wait for type 0 patients who can only use type 0 organs.
As a result, very sick liver patients with blood type 0 are one and a half times more likely to die waiting for a transplant than similar patients with other types, according to statistics from the United Network for Organ Sharing, which runs the nation’s transplant system.
“It’s inherently unfair,” said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania Health System. “It doesn’t make any sense to penalize them because of a biological accident.”
Hoping to rectify the disparity, the network is considering new restrictions on the use of type 0 organs. The proposal would affect liver transplants, raising the bar for how sick non-O patients must be before they are offered 0 livers.
The challenge is to balance the needs of individual patients with the goals of a national system. On any given day, experts say, it makes sense to give a type 0 liver or heart to a very sick patient with blood type A or B, rather than a type 0 patient who is stable and can wait longer.
“It’s very hard to make a decision based on policy of what’s best for the whole community when you have a patient in front of you. You want to take care of the sickest patient first,” said Dr. Todd Howard, who directs the liver and kidneys transplant programs at Barnes-Jewish Hospital in St. Louis.
As policy makers grapple with the issue, type 0 patients seem less concerned with fairness, said Howard, who also chairs the network’s liver transplant committee.
David Somerville, who is still waiting for a new liver after six years, remembers hearing that his type 0 blood would hurt his chances, with someone telling him sarcastically, “Oh lucky you, you’re type 0,” he recalled.
“When you look at the statistics, it doesn’t seem like it should be right,” said Somerville, 51, of Latrobe, Pa., outside Pittsburgh. “But that’s what we have to deal with.”
This disparity is distinct from the higher-profile dispute over whether to give organs to the sickest patients first, or to those who live nearby. That geographic debate is complicated by politics and economics, because a change in policy could result in some hospitals getting more organs for transplant than others.
In the case of type 0 patients, the issues are medical and ethical.
The statistics differ by organ, but in each case, people with blood type 0 wait longer for transplants.
For livers in 1994-96, the typical type 0 patient waited a year and nine days. That’s four months longer than those with blood type B and more than five months longer than patients with blood type A, according to statistics from the network’s 1997 report on waiting times, the most recent available.
For heart transplants, type 0 patients wait more than four times as long as patients with AB blood, and more than twice as long as those with A or B.
In the case of kidneys, type 0 patients face similar disparities, although statistics show that patients with type B blood wait the longest. That’s because there are a disproportionate number of black patients waiting for new kidneys, and they are more likely to have type B blood.
For lungs, type 0 organs are reserved for type 0 patients, and the disparities are smallest.
Across the board, patients with AB type get organs fastest, because they can accept organs of any blood type.
A recent study in five Southeastern states found that, for certain liver transplant patients, the chances of dying while waiting for a transplant were zero if you had blood type AB.
The chance of dying was 22 percent with blood type B, 35 percent for type A and 50 percent for type 0.
The change being considered by the trans plant network would affect patients who are in the hospital but do not face imminent death. It would prohibit use of 0 livers for these patients with blood types A or AB. Patients with blood type B, which is quite rare, could still get 0 livers.
Even with the policy change, for every one person who gets a new organ, another won’t. Last year, 6,012 people died waiting for all types of organs.
Howard said he often feels like he’s re-arranging deck chairs on the Titanic.
“That’s what we’re doing all the time,” he said. “At least we’re keeping the ship balanced while it’s going down.”
Travel has an entire new dimension as a transplant recipient, especially crossing an international border. First of all there’s the matter of drugs. The customs information sheets say one must be prepared to show either proper prescription for each drug carried across the line, or lacking such a document, the actual containers in which the drugs have been dispensed. Past experience indicates the matter will never come up, yet visions of being stuck forever in the customs line at some minor league station prompts packing of bottles and boxes so that all can be proved to be legal if called upon. And as usual, the subject never came up.
Then there’s the terrible multiplication test, if one takes two capsules twice per day for 13 days of the trip, how many capsules does one need to take for 15 days assuming there is an emergency somewhere along the line causing a delay. Answer: Learn early-on you will be wrong no matter how carefully you figure, just throw in an extra box or vial and make sure to take the phone number of your pharmacist; did I tell you about the time I was on a barge on the Mississippi and discovered I would run out of cyclo half way through the trip because my 2 X # of days should have been 4 X # of days?
Now the above doesn’t cover the area of “needle tracks” on the arms. One of the last paid vampires blood techies to use my one and only “sweet spot” inside my right elbow, managed to set up a beautiful pattern of now seemingly permanent needle tracks, so common to dope addicts. Needless to say my border crossings now demand a costume including long-sleeved shirt, no matter what the weather.
As we stopped at the ticket taker just prior to driving on board the jet ferry from Bar Harbor to Yarmouth, NS, he commented, “Now that’s a plate we don’t see every day. I hope you are doing well.” I thought to myself how provincial people in Maine must be when a Virginia license plate becomes worthy of comment. It was actually several days later when it dawned on me what he was referring to; I have one of Tx Claude Brady’s “Organ Donation Works - Heart Recipient” Transplant Awareness. Inc. license frames both front and rear on the Upbeatmobile. They also must work, because that had to be what caught his eye. Almost wish I could send the guy a card saying, “Very well, thanks for asking.” By the way Claude’s entire line of transplant promotion materials can be viewed at: www.transplantawareness.org or call 888-262-9232 for a catalog.
Then there’s the matter of those occasional drug side effects that we all know so very much control our daily living. Why I just know for certain that when I inadvertently repositioned a certain Cape Breton Island mailbox by backing into it that the real cause was my acquired addiction to prednisone. I mean why else on earth would I have thrown a tantrum and carelessly turned the car around without due caution? Certainly not because we had missed a turn for the 17th time. I’m even going to have a Band-Aid painted on the “ding” it left, rather than do the scientific research required to convince the insurance company it was out of my control.
UNOS Could Have Competition
By Laura Meckler - Associated Press Writer
WASHINGTON (AP 65/14/00) — A newly formed Pittsburgh firm is bidding to run the nation’s transplant network, giving the government a chance to snatch the contract away from the organization that has fought its efforts to give more organs to the sickest patients.
The new firm, called the Center for the Sup port of the Transplant Committee, argues that it can save up to 5,000 lives each year by recruiting more organ donors, distributing organs more fairly and improving the matching of organs and transplant patients.
Like the Department of Health and Human Services, it argues that more organs should go to the sickest patients.
It will compete with the United Network for Organ Sharing, which has run the system since 1987, often clashing with HHS. The contracts generally run for three years, with options for extensions.
HHS plans to award the new contract by Sept. 30. It would not say if there are other bidders, and these are the only two that have identified themselves publicly.
The new nonprofit firm is made up of two Pittsburgh companies: a research firm with ties to the University of Pittsburgh, which has lobbied heavily for new organ distribution policies; and a data-management company — Management Science Associates — that argues its experience placing cable TV ads and marketing Bugles snacks can be applied to organ transplants.
Consad Research Corp. worked for the University of Pittsburgh for six years, developing research that supported the university’s crusade for new policies that would have sent more organs to the sickest patients, many of whom come to the university.
Consad no longer works for the university, said company vice president Mark A. Joensen. He acknowledged that his expertise comes from working on that contract, and he predicted that those who support the United Network for Organ Sharing will paint the new bid as “a take over by Pittsburgh.”
UNOS Executive Director Walter Graham declined to comment on the Pittsburgh connection but expressed skepticism that another organization can do a better job on or gan transplants.
“We’ve got the best minds in the country working on this,” he said. “We continue to find improvements but there’s no one big thing that anybody has identified that’s going to make a huge difference.”
The new company submitted on Tuesday the final piece of its bid to run the transplant network and the scientific registry, which collects data on transplantation.
Over the years, UNOS has faced little competition in keeping the contract to run the system. Rand Corp., a well-known research firm, considered bidding but withdrew in November, saying it didn't want to get mixed up in the nasty battle over transplant policy.
HHS wants organs to be distributed over a wider geographical area so more organs will go to the sickest patients. UNOS, reflecting the concerns of many transplant centers, defends the current system that gives local hospitals first crack at donations, even if there are sicker patients elsewhere.
The new bidder says it can save lives with broader distribution and promises a better job marketing organ donation and working with local organ banks to improve their recruitment efforts. Joensen said it would also work more vigorously to force substandard organ transplant programs to improve their medical techniques.
Joensen’s firm has joined with Management Science Associates, the data company, even though it has never worked on organ transplants. It says its commercial experience can be brought to bear on the transplant system.
Alfred A. Kuehn, the company’s chairman, said his firm developed a way for advertisers to target their buys on cable TV, developed more effective ways for steel mills to operate and is working to improve analysis of cancer cells to identify proper treatments. He said his company also concluded that Bugles would be a snack-food success for General Mills, saving the company millions it planned for market testing.
It all deals with sophisticated management of data, Kuehn said: “We have been able to more cost-effectively handle very large databases and to search for things in data that others haven’t seen.”
U.S., Italian Doctors Report Transplant Test
CHICAGO (Reuters 5/15/00) - A new test may enable surgeons to determine if a patient’s body will reject a heart or liver transplant days or even weeks before it would happen, buying valuable treatment time, researchers reported on Monday.
The test uses cells cultured from the patient’s immune system to measure the immune system’s readiness to attack the new organ and the system’s ability to resist the attack. It was developed by Nicole Suciu-Foca of Columbia University in New York and Raffaello Cortesini of the University of Rome, and their colleagues. The test was described at a meeting in Chicago of the American Society of Transplant Surgeons and the American Society of Transplantation.
The study covered 55 heart and 14 liver transplant patients who were followed for from one to 24 weeks after the surgery.
The report said a high number of cells known as T-helper and T-cytotoxic indicated a high chance of rejection in seven to 13 days, while high numbers of T-supressor cells indicated acceptance of the new organ in 10 to 14 weeks.
US Man Awaiting Transplant Dies After Organ Mix-Up
CHICAGO (Reuters 6/14/00) - Doctors preparing a patient for a kidney transplant last month were aghast to discover an organ bank had mistakenly sent them a donated heart instead, the organ bank admitted Wednesday.
The patient, 31-year-old John Sherman, died in a Springfield, Illinois hospital Sunday without ever getting a suitable kidney.
“It’s an unfortunate mistake, but the employee has been with the organization for more than four years and has never made a mistake like this before,” said Dave Bosch, a spokesman for the Regional Organ Bank of Illinois, which allocates roughly 800 organs for transplant a year.
The coordinator was not fired, Bosch told Reuters.
Sherman’s planned May 12 surgery had progressed to the point where doctors had made an incision and prepared nerve endings for the trans plant.
Updates from Dr. Goodpump’s Heart Garage
Revolutionary New Total Artificial Heart One Step Closer to Reality
Salt Lake City, PRNewswire 5/24/00 — A revolutionary new total artificial heart being devel oped by researchers at LDS Hospital, the Utah Artificial Heart Institute, and MedQuest Products Inc. is one step closer to reality thanks to a new $4.2 million grant awarded to the team by the National Institutes of Health.
The four-year grant is the first award given to artificial heart researchers under the Nil-I’s new Bioengineering Research Partnership program. The award was announced by the NIH’s National Heart, Lung, and Blood Institute in Bethesda, MD.
“This grant reaffirms Utah’s world leader ship in the development and clinical use of artificial heart technology,” says James W. Long, MD, director of the artificial heart program at LDS Hospital, and an investigator on the grant.
The Utah-led team is the only recipient of significant NIH funds to complete the development of a new, revolutionary magnetically-sus pended total artificial heart, known as the HeartQuest. The HeartQuest total artificial heart offers heart failure patients the promise of im proved reliability and longevity over existing artificial hearts since it contains no friction-based internal parts that are prone to wear out over time. The HeartQuest will also be 30 to 40 percent of the size of existing total artificial hearts.
“The HeartQuest total artificial heart has a rotor that is suspended in a magnetic field so there are no internal touching parts,” says Dr. Don Olsen, president of the Utah Artificial Heart In stitute, and the grant’s lead investigator. “Because of this unique design, we believe it may add 10 to 20 years of quality life for hundreds of thousands of people who would otherwise die of heart failure every year.”
The HeartQuest artificial heart development will continue to be supported through funding by the LDS Hospital-Deseret Foundation’s Heart & Lung Research Foundation. This philanthropic-based support has been complemented by the NIH grant. The development team expects to soon obtain additional financial support to reach the goal of clinical delivery of the HeartQuest total artificial heart in 2002.
LDS Hospital revived the use of the total artificial heart in Utah in April of 1995, when a team led by Dr. Long successfully implanted a CardioWest C-70 total artificial heart in Boise resident Al Marsden as a bridge-to-transplantation. LDS Hospital was only the third center in the nation to implant the C-70 and the first Utah medical center to implant a total artificial heart since Dr. Barney Clark was implanted with a permanent total artificial heart at the University of Utah in 1982. LDS Hospital currently is the only Utah center implanting total artificial hearts. Contributed by Tx Dave Cannavo, Boston
Arizona Boy Gets Mechanical Heart Transplant
By Arthur H. Rotstein - Associated Press Writer
TUCSON, AZ (AP 7/3/00) — A 7-year-old Arizona boy received a heart transplant Monday after becoming the first patient in North America to receive a child-sized artificial heart pump.
Carlos Ochoa of Nogales received the heart in a six-hour operation at University Medical Center, where he was listed in critical but stable condition. He had suffered from restrictive cardiomyopathy, a condition that caused his heart to become stiff, limiting its pumping ability.
Dr. Francisco Arabia, who performed the transplant, said the new heart was working well and the surgery went without complications.
Carlos hr. Jack G. Copeland, chief of cardiovascular and thoracic surgery at the University of Arizona’s Sarver Heart Center, permission to use the heart pump on an emergency basis.
The device, which comes in several sizes and is the only one of its kind suitable for implantation in children, is used in Europe. But it did not undergo testing in this country as required by the FDA because of the costs its manufacturer would have incurred.
“We’re convinced this is a good thing and feel very comfortable using the device,” Copeland said last month.
He said its successful use in Carlos might encourage other research and testing of artificial hearts and pumps for American children.
Surgeons in France Give Patient Electronic Heart
PARIS (Reuters 6/5/00) - Surgeons at a French hospital said Monday they had given a patient an electronic heart in an operation that was only the second of its kind. The artificial heart, whose battery is implanted in the body and can be recharged without the risk of infection accompanying previous techniques, was given to a 70- year-old diabetic with a history of heart disease.
Professor lradj Gandjbakhch, who headed the surgical team during the operation at Paris’s La Pitie-Salpetriere hospital, said the battery implanted behind the abdomen could be recharged through the skin from a coil outside the body.
Technology had previously allowed only for re-charging artificial hearts through a cable running through a catheter to an external battery, leading to the risk of infection and the need for patients to carry the battery with them. The same operation as the one in Paris was carried out for the first time in October when an American patient received a similar heart in Germany.
The apparatus, made by the Arrow firm in the United States, had been tested on animals for seven years before a human was involved. Contributed by Tx Dave Cannavo, Boston
Disclaimer: The material in this document has been collected by Don Marshall and friends. New ideas and materials are welcome all the time. Nothing herein is ever to be construed as medical advice. As a policy, Upbeat is sent upon request to heart and heart/lung transplant recipients and other interested parties. Donations of $15 per year, or more, from TX recipients, if not a burden, are vital. From all others the donation is specifically requested. The date shown after the name on the address label indicates the last time a donation was received. Please make checks payable to Don Marshall, as we cannot afford to become nonprofit. Send materials, letters, or checks to:
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