Living Kidney Donor Dilemma: Willing But Unable to Donate

[Clark]

http://www.renalandurologynews.com/living-kidney-donor-donation-transplant-willing-unable/article/374123/

Living Kidney Donor Dilemma: Willing But Unable to Donate

Despite public awareness campaigns and innovative approaches such as kidney paired donation, living kidney donation (LKD) in the U.S. has been declining.

Data from the Organ Procurement and Transplantation Network (OPTN) show that the number of living donor transplants increased from 1,817 in 1988 to a peak of 6,647 in 2004, and then dipped to 6,573 in 2005. In 2013, 5,735 LKDs took place. The decline in living donor transplants has occurred mainly among blood relatives, OPTN data show.

The number of recipients receiving a kidney from a living blood relative (such as a parent, child, or sibling) decreased from 4,340 in 2004 to 2,886 in 2013 (a 33.5% drop), whereas the number of recipients of a kidney from a living donor who is not a blood relative (such as a spouse or an anonymous donor or an unrelated individual participating in a paired donation) actually increased during that period from 2,307 to 2,847 (a 23.4% increase).

Nephrologist Jane C. Tan, MD, an associate professor of medicine at Stanford University in Palo Alto, Calif., pointed out that living donation may have spiked in the early to mid 2000's due to multiple reasons, including increased public awareness, greater use of donor chains, and desensitization protocols, and this “gave a transient bump in living donation.”

“This would be the ‘low hanging fruit' phenomenon,” said Dr. Tan, who is a member of the American Society of Nephrology's Transplant Advisory Group (TAG). “Those who were eligible and very ready to donate did so during that era. To what extent the recent downward trend represents additional barriers to living donation or a new steady state is yet unclear.”

Medical exclusions
Michelle A. Josephson, MD, professor of nephrology at the University of Chicago and chair of TAG, said the LKD decline may be due in part to a growing prevalence of obesity, diabetes, and hypertension in the U.S. As a result, increasing numbers of potential donors may have these medical conditions, which are common reasons for medically ruling out individuals as donors, Dr. Josephson said.

Research findings document that medical conditions are a major reason for donor exclusion. In a study of 484 prospective living kidney donors at Stanford's transplant center, Dr. Tan and colleagues found that 229 individuals were excluded from donation. Of these, 150 were excluded for medical reasons, mainly obesity, hypertension, abnormal glucose tolerance, and nephrolithiasis, according to results published in Clinical Transplantation (2011;25:697-704).

In a study presented at this year's World Transplant Congress in San Francisco, Uday S. Nori, MD, and colleagues at The Ohio State University Wexner Medical Center in Columbus found that hypertension, glucose intolerance, and high body mass index accounted for 60% of all medical deferrals.

At last year's American Transplant Congress in Seattle, Zoe A. Stewart, MD, PhD, of the University of Iowa Hospitals and Clinics in Iowa City, presented findings of a study involving 450 living kidney donor candidates, of whom 398 were rejected for donation and 52 were approved.

Rejected candidates had a mean BMI of 28.9 kg/m2, which was significantly higher than the mean 25.9 kg/m2 for the approved group. Of candidates approved for donation, only 11.5% were obese (BMI above 30) and 88.5% were non-obese (BMI below 30).

Heidi M. Schaefer, MD, a nephrologist and an associate professor of medicine at Vanderbilt University School of Medicine in Nashville, Tenn., noted that her institution's transplant center turns down about 40% of potential living kidney donors for medical reasons.

“We have become more stringent over the past 10 years, in particular with 24-hour urine protein cutoffs and blood glucose cutoffs,” said Dr. Schaefer, who also is a TAG member. In addition, the center is seeing larger numbers of older and marginal donors. “Both factors are probably contributing to our inability to increase our living donor pool at our institution,” Dr. Schaefer said.

Financial consequences
Another potential barrier to LKD is concern about the financial consequences of donation. It takes weeks or months to recuperate from a nephrectomy, and this may mean lost wages for employed individuals who would have to take time off from their jobs.

James R. Rodrigue, PhD, of Beth Israel Deaconess Medical Center in Boston, and colleagues surveyed recipients of kidneys from deceased and live donors and patients on a waiting list for a kidney transplant and found that almost half of respondents reported not asking potential living kidney donor about considering donation because of concern about the impact of lost income on the donors or their families.

In addition, 36% reported being told by a family member or friend that they were willing to donate but were concerned about potential lost income. Wait-listed patients and recipients of a deceased donor kidney transplant (DDKT) were more likely than recipients of a live donor kidney transplant (LDKT) not to talk to others about living kidney donation (51% and  61% vs. 31%) and more likely to have others not pursue LKD evaluation. Lower income and African-American patients were significantly more likely to report not having talked to someone about LKD and to have someone not pursue LKD because of financial concerns.

Many patients, especially those on a waiting list and those who received a DDKT after years on a waiting list, may decide not to pursue LDKT due to concerns about the financial impact on the donor, Dr. Rodrigue and his colleagues stated in a poster presented at this year's World Transplant Congress. In addition, two-thirds of potential living kidney donors who expressed financial concern to the patient did not initiate evaluation.

“These findings highlight that potential lost income following LKD may be a more significant barrier to LDKT than previously thought, especially for low income and Black patients,” they wrote. “Removing this disincentive may attenuate the national decline in LDKT.”


Insurance concerns
Potential donors also might be reluctant to donate a kidney because they are worried about how this would affect their ability to obtain and keep health and life insurance. In a study recently published online ahead of print in the American Journal of Transplantation, a team at Johns Hopkins University in Baltimore led by Dorry Segev, MD, PhD, demonstrated the potential negative impact of LKD on the ability to change or initiate health and life insurance following donation.

They surveyed 1,046 individuals who donated a kidney at their institution from 1970 to 2011. Among 395 donors who changed or initiated health insurance after donation, 27 (7%) reported difficulty. Of these, 15 were denied altogether, 12 were charged a higher premium, and 8 were told they had a pre-existing condition because they were kidney donors.

Among 186 donors who changed or initiated life insurance after donation, 46 (25%) reported difficulty. Of these, 23 were denied altogether, 27 were charged a higher premium, and 17 were told they had a pre-existing condition because they were kidney donors.

“These practices by insurers create unnecessary burden and stress for those choosing to donate and could negatively impact the likelihood of live kidney donation among those considering donation,” the authors concluded.

The subjects in the study had donated a kidney prior to January 1, 2014, when discrimination in the provision of health insurance based on pre-existing conditions became illegal under the Patients Protection and Affordable Care Act (ACA), the authors noted, “so insurance companies can no longer refuse health insurance to live kidney donors or charge them a higher insurance rate. However, numerous attempts have been made to repeal the law. If protections for live kidney donors are repealed in the future, the difficulties we report here will likely resurface.”

Furthermore, Dr. Segev's team pointed out that ACA does not apply to life insurance, “which was more commonly a source of difficulty for live kidney donors in our study than was health insurance.”

With lower death rates than the general population, Dr. Segev and his colleagues stated, kidney donors represent excellent candidates for health and life insurance. “Failure to provide insurance to donors harms those who have willingly undergone an invasive procedure on behalf of an ESRD patient; it also makes poor financial sense for insurance companies.”

“It is incumbent upon the transplant community to provide accurate and comprehensive information about the health status of live donors in order to inform insurance companies of donors' excellent insurability,” they concluded. “Additionally, regulation may be required to prevent discrimination against live kidney donors.”

Congressional initiative
Such legislation already is being considered by the U.S. House of Representatives. Rep. Jerrold Nadler (D-NY) and Rep. Michael Burgess (R-TX) in July introduced the Living Donor Protection Act to promote organ donation and protect the rights of living donors. “Organ donation saves Medicare millions of dollars every year,” Nadler noted in a press release.

“It cuts health care costs by as much as two-thirds by reducing the need for dialysis and other expensive medical interventions to treat chronic illnesses. Yet, after taking this heroic step to save a life, living organ donors may unfortunately face discrimination when they try to take medical leave or buy insurance—our bill would address that injustice.”

Among other provisions, the bill would prohibit life, disability, and long-term care insurance companies from denying or limiting coverage and from change higher premiums for living organ donors. It would clarify that living organ donors may use the Family and Medical Leave Act time to recover from the surgeries and procedures involved in their donation.

To defray from expenses associated with living organ donation, 13 states have enacted laws allowing for $10,000 organ donation tax deductions, according to the American Society of Transplantation website. A few states, such as Idaho, Missouri, and Virginia provide for a paid leave of absence for state employees who become living organ donors.

Studies May Help Quantify Risk of Living Kidney Donation
Amid a decline in living kidney donation (LKD) nationally in the U.S., emerging evidence suggests that LKD may be associated with greater risks than previously thought.

For example, a study led by Hallvard Holdaas, MD, of Oslo University Hospital in Oslo, Norway, found that living kidney donors had an 11.4 times increased risk of end-stage renal disease (ESRD), a 40% increased risk of cardiovascular death, and a 30% increased risk of death from any cause compared with a control group of potentially eligible kidney donors. The median follow-up times for the donors and controls were 15.1 years and 24.9 years, respectively.

“Our findings raise some medical and ethical considerations regarding live-kidney donation,” the authors wrote in Kidney International (2014;86:162-167). “The present study indicates potential increased long-term risks for kidney failure and mortality in kidney donors.”

The researchers noted, however, that this must be put into perspective. Living donor transplantation has been a necessary and essential part of providing ESRD patients with freedom from dialysis and enabling transplant recipients to enjoy a superior quality of life, Dr. Holdaas and his colleagues pointed out. “Most potential living donors are willing to accept a degree of risk when the recipient is a family member of a close friend,” they stated.

A separate study of 96,217 living kidney donors led by Dorry Segev, MD, PhD, an abdominal transplant surgeon at Johns Hopkins University in Baltimore, found that the incidence rate of ESRD was 30.8 per 10,000 among living donors compared with 3.9 per 10,000 among healthy matched controls, but still much lower than individuals in the general population, according to a report published in the Journal of the American Medical Association (JAMA 2014;311:579-586). The median follow-up for donors and controls was 7.6 and 15.0 years, respectively.

Furthermore, contrary to the study by Dr. Holdaas' team, Dr. Segev's group found no increased risk of death among living kidney donors in a prior study of 80,247 donors, which also was published in JAMA (2010;303:959-966).

“I definitely think the findings [of these studies] need to be made part of informed consent discussions,” Dr. Segev said, “but I think the findings are actually quite reassuring, given the extremely low risk of ESRD in kidney donors, and I have not found in my own clinical practice that donors are surprised or dissuaded by this information. Rather, they seem to appreciate the careful work that has gone into making sure donating a kidney is safe.”

At the 2014 World Transplant Congress in San Francisco, researchers presented the findings of a study showing that LKD is associated with a modestly increased long-term risk of gout. A team led by Ngan N. Lam, MD, of the London Health Sciences Centre in London, Ontario, studied 1,988 living kidney donors and 19,880 matched healthy non-donors who were followed for a median of 8.4 years.

The median age at the index date of the donors and matched controls was 43 years. Gout developed in significantly more donors than non-donors (3.4% vs. 2.0%), a difference that translated into a 60% increased risk of gout among living donors, according to a poster presentation.

In addition, significantly more donors than non-donors received prescriptions of the gout medicines allopurinol or colchicine (3.8% vs. 1.3%), which translated into a 3.2 times increased likelihood of a gout medication prescription.