December 16, 2017

UMass docs tackle key problem in liver transplant process

Print More

Last July, the Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) asked for public comment on a proposal to reform the liver transplantation system in the United States. The plan, “Enhancing Liver Distribution,” proposed placing a 150-nautical-mile-radius sharing circle around donor hospitals.

The OPTN/UNOS Board of Directors approved the proposal earlier this month, although no implementation date has been established.

Dr. Adel Bozorgzadeh, chief of the Organ Transplantation division at UMass Memorial Medical Center, was critical of the plan.

“This is really not necessarily as helpful to our region at all, because if you put Boston and draw a circle around it, half of that circle is in the ocean. You know, where am I going to get livers out in the ocean? There are sharks; there are not humans,” he said.

As of Dec. 1, there were 14,086 people nationwide on the official liver transplant waiting list, according to the UNOS. The most recent data by its partner organization, the Scientific Registry of Transplant Recipients (SRTR), shows that in 2015, 1,673 patients died awaiting a liver transplant, 6,474 received the transplant, and 14,047 remained on the waitlist by year’s end.

While facing the additional burden of geographic disparities imposed by the national organ transplant system, surgeons such as Dr. Bozorgzadeh already navigate a turbulent system.

The current system

The underpinning of the American liver transplant system is a decades-old, heavily scrutinized and unadjusted map dividing the country into 11 regions and 58 local donor service areas. In regions largely drawn along state borders, the hearts, livers and lungs that are both needed and available mostly stay within that area. Massachusetts is in Region 1.

Courtesy UMass Medical School

Dr. Adel Bozorgzadeh

By Oct. 31, according to data compiled by UNOS in Region 1, for nearly each liver donated for transplantation in 2017, two patients had been added to the ballooning waitlist. In fact, none of the 11 regions are at or above a 1-to-1 ratio between newly donated livers and new candidates for transplantation.

Despite the nationwide disparity between available organs and candidates, critics of the current system argue that the more overt regional variations violate a 1998 ruling by the U.S. Department of Health and Human Services that set forth the policy framework in place ever since.

Implemented in 2000, HHS’s “The Final Rule” policy dictated that “neither place of residence or place of listing shall be a major determinant of access to a transplant” when crafting policies around “the equitable allocation of cadaveric organs among potential systems.”

The other elements of the rule, such as grouping transplant candidates “by status categories ordered from most to least medically urgent,” are familiar to anyone who indulges in daytime or prime-time television medical dramas. In liver transplants, candidates are provided what is known as a MELD – short for Model for End-Stage Liver Disease – score ranging from 6 (less ill) to 40 (gravely ill).

As reported in a 2011 paper, there is a range of 10.4 (22.1-32.5) among average MELD scores at the time of transplant depending on donation service area. The researchers concluded that “the overall risk of death for a liver transplant candidate varies markedly based on geographic location,” and that “reorganizing organ distribution has the potential to decrease death rates nationally and simultaneously reduce cost by lowering the average MELD [score] at transplant.”

The entirety of New England and New York were categorized within the mean MELD score of 29 or greater at the time of liver transplantation.

Sommer Gentry, a professor of mathematics at the U.S. Naval Academy and a member of the Scientific Registry of Transplant Recipients – the analysis arm of the federal government’s policy-making structure – favors a more consolidated system than the current regional one.

Both Gentry and Dr. Bozorgzadeh argue the current system is a historical accident — one that was made in haste to treat patients, but which calcified to the exclusion of ethical and empirical analysis.

“[The rules] were never intended to address issues of sharing organs equitably across the country,” Gentry said. Nowadays, he said, “because there is such a severe organ shortage and there’s national information about who is out there waiting for it, you can see very clearly that people are being disadvantaged because of their ZIP code.”

Yet reforming the system has proved quixotic — in part because of added complications.

Regarding the latter, Gentry points to a previous assumption that if individuals moved away from focusing on the country’s 58 local service areas and prioritized the regional map, outcomes would improve.

“We found that that would actually make the problem worse, because the 11 region boundaries are drawn to separate regions of high organ supply from high organ demand,” Gentry said.

Bolstered by a series of comprehensive analyses, Gentry’s conclusion is simple: “Literally every system that we have tested is better than [what] we have now.”

Inherent in changing the system of liver allocation is the negative influence on transplant candidates within regions currently richer in available organs. Shifting the determinations of life and death in this country, as expected, brings controversy.

“The opposition to geographic equity in transplants is intense,” said Gentry, noting a 1999 Institute of Medicine report finding “strong statistical evidence that increasing the size of the population served in liver allocation will result in more opportunities to transplant sicker patients without adversely affecting less sick patients,” and encouraging further federal oversight. Those instructions were met with intense lobbying.

“It was a period called ‘The Liver Wars,’ and this is like ‘Liver Wars 2.0.’ ”

Yet even when applied, Dr. Bozorgzadeh characterizes the 9 million population zone advocated 20 years ago by the Institute of Medicine and utilized for the current regional system as ambivalent or neglectful to social policy – think seatbelt and helmet laws. It also advances disparities in the Northeast.

“It is not homogeneous. It is not like everywhere you put like 10 million people you have, let’s say, 10,000 people with cirrhosis. So, they were wrong, and that’s why you have so much disparity of organs” available within regions, he said.

Difference of opinion

Dr. Raymond Lynch of Emory University, a Massachusetts native, pushes against the zero-sum perspective. He looks strictly at person-to-organ prevalence, noting a variety of impediments to organ transplantation that define winners and losers beyond geographic location.

“I think that the principle that you have to follow is who has the least protection and who’s the most vulnerable, and you try to do what maximizes the benefit to them or minimizes harm to them, but is otherwise just to the rest of society,” he said.

Dr. Lynch notes that the conversation around reform is evaluated through the lens of those on the official organ transplant waitlist, which is inherently misguided. “Basically, framing the beginning of the debate in that way directs the whole entirety of the debate in one logical outcome,” he said.

Dr. Lynch wants to incorporate considerations pertaining to overall liver care, liver disease screening, and access assurances for lower-income and rural individuals.

“There are many, many people in rural and poor areas of the country who have liver disease and could benefit from transplant, but either never get diagnosed or never get referred to a transplant center,” he said. “Or, if they do get referred, they don’t finish the evaluation, or they don’t get listed because of insurance reasons.”

He was supportive of the 1999 Institutes of Medicine report calling on geographic reforms. At the time, it found that access to health insurance and high-quality healthcare services were “the most important predictors of equity in access to transplant services.”

Dr. Lynch’s own research highlights the role of local health conditions, called Community Health Scores, finding that those within high-risk counties had the greatest waitlist mortality, and living more than 25 miles from a transplant center increased mortality risk for patients.

Dr. Bozorgzadeh faces the issues of disparities described by Dr. Lynch daily, creating a one-two punch before transplantation even begins.

UMass Memorial Medical Center is the westernmost facility in Massachusetts equipped to perform liver transplants. According to SRTR, there are five other programs for adult liver transplantation programs in Massachusetts: Lahey Clinic Medical Center in Burlington; and Boston-based Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Boston Children’s Hospital and Tufts Medical Center.

Out of these programs, UMass Memorial Medical Center performed the third-largest number of liver transplants in 2016, with its total of 72 behind Lahey Clinic (93) and MGH (74). Tufts was not assessed by the SRTR.

With few public transportation options for those seeking to travel to the UMass Medical campus from suburbs or far-flung counties, Dr. Bozorgzadeh said he is regularly confronted with the reality of treating individuals whose economic realities add an immediate burden.

“There are some of our patients here [who] cannot afford gas to drive their car” to the medical center, he said.

Other ways

With the scarcity of organs faced by individuals awaiting transplantation in areas like the Northeast, recourse often takes the form of moving from one region to another. Steve Jobs, the mercurial scion of Apple, did just that in 2009, with his move to Tennessee for a liver transplant.

But there are many who can’t afford that shift in their lives – particularly if daily transportation costs drain an already tight budget.

“[Would you] expect for me to tell them to go to Florida to get their transplant? That’s sad — of course not,” said Dr. Bozorgzadeh. “I mean, we had to go out of our way. We had to increase dimension.”

Increasing “dimensions” comes largely in the form of using organs that deviate from the standard criteria used to assess an organ. These criteria are both subjective and objective, inputting such factors as the age of the donor, the cause of the donor’s death, and, from a physiological perspective, the quality of the organs themselves.

While consumers often walk away from blemished apples in the grocery store, that latitude isn’t available for people desperately awaiting an organ in Massachusetts, where availability is relatively scarce. While waiting, these individuals may vomit uncontrollably, lack the energy to arise from bed, experience medication side effects and approach multiple-organ system failure.

While those experiences may seem dreadful, providing information about the risks and realities associated with organ transplants – particularly for extended criteria organs – is something Dr. Bozorgzadeh doesn’t sugarcoat.

“I don’t sugarcoat it, and I am very honest and straightforward with the patients in delineating and describing and telling them what the risk of dying is as a result. And those conversations never end without me mentioning and actually emphasizing several times, that at the time the offer comes, they can turn down that organ, and their position on the list will not be changed.

“I’ve had patients that have told me, ‘Give me a cow liver’ … I had a patient that said that exact thing to me, because no one else in this world understood … how sick he was.”

Dr. Bozorgzadeh works with the team at UMass Memorial in cutting-edge and highly technical organ transplants through laparoscopic live-liver donations.

As he works in the moment to ensure access to available livers for transplantation, he works more broadly to promote a less invasive and more sustainable means of cultivating a culture of organ donation in the form of live-liver transplantation.

Currently, the use of live liver donors for transplants is relatively rare in the U.S. According to data released by SRTR, of the 7,127 adult liver transplants that occurred in 2015, 359 (about 5 percent) came from living donors.

By contrast, 942 of the 1,398 liver transplants conducted during the same year in South Korea were from living donors.

“The big issue that we have in the U.S. is that we have been so blessed with a robust and effective organ procurement system,” said Dr. Davis C. Mulligan, chief of Transplantation and Immunology at the Transplantation Center at Yale New Haven Hospital and a professor at Yale School of Medicine.

“What’s happened in the U.S. is that the deceased donor supply is certainly far short of the need, and the fact that the quality of the deceased donors compared to what we used to have [15 and 20 years ago] has changed,” he said.

These changes to quality and quantity come from a more robustly designed and aware society, plus a shifting medical field. More organs donated today are older and arise from deaths of people with comorbidities than in years past.

This change, plus the geographic burdens, has led doctors to increase the use of living donor transplants, Dr. Mulligan said.

“It’s been the areas of the country where living donation has been this growing need, and it takes areas like ours – the Northeast, and West Coast – to really kind of drive that [effort] to do these life-saving transplants,” he said, pointing to Regions 1, 9 and 5 as prominent places of discussion.

Dr. Bozorgzadeh’s own push to expand the living-donor transplant system is built on a conviction to promote health and reduce disparities. “The rest of the world is really going after this living-donor process like there really is no end to it. Granted that they don’t have deceased donor [and] granted that we have deceased donor,” he said. “But that’s an excuse in my opinion, because there is no way that you can hide the fact that of the 17,000 people waiting for [a] liver transplant, 20 percent of them die every year while they’re waiting,” he said.

His push toward living-donor transplants echoes a chief concern of Dr. Lynch, who said the current system “doesn’t even take into account those patients that could benefit from liver transplant but [are not put] on the transplant list because there is already a significant shortage of organs.”

Live liver transplants locally

Following approval in the summer of 2010 by the Organ Procurement and Transplantation Network and UNOS, Bozorgzadeh and UMass Memorial began pursuing the integration of a live liver program in Central Massachusetts.
By creating this reform, Dr. Bozorgzadeh aims to change the perceptions both patients and prospective donors have toward liver donation.

“If you just tell someone, ‘Oh you just have to take four weeks’ time off from work’ as opposed to four months off … that will be the difference,” he said. “Then a lot more people would consider coming forward to then donate. And that’s really why we think that it is really important for us to develop it now.”

The liver’s capacity to regenerate allows for transplantation to occur without harvesting the entire liver. When a portion of the liver is harvested from a living donor, the partial livers of both donor and recipient grow together to ultimately form a complete organs.

From a technical standpoint, Dr. Bozorgzadeh utilizes laparoscopic surgery – essentially surgery accomplished by making a small incision into a patient’s body. He’s applying and perfecting a technique that could grow has exemplary implications for growing the donor network and encouraging broader care for those suffering from liver disease.

“If you can do it laparoscopically through a small incision, that wouldn’t really impact that person’s ability to go back and do physical work — to be a police officer; to be a professional athlete; to be a construction worker; or to be a factory worker,” Dr. Bozorgzadeh said. “Then you will offer it to a much larger number of people.”

Between 2013 and 2016, UMass performed 14 living-donor liver transplants. In both efforts, Dr. Bozorgzadeh credits the UMass Memorial Department of Surgery — particularly Chairman of Surgery Dr. Demetrius Litwin — for what he calls “mind-boggling” devotion to the entire transplantation program, along withnd the key help provided by caregivers who work alongside surgical staff.

All of those assets, Dr. Bozorgzadeh said, add up to ““I think all of those assets all together adds up to being able to accept patients no one else wants to accept and organs no one wants to accept, and create an outcome that far surpasses [that of] those that take much less challenging patients [and] much better organs,” Dr. Bozorgzadeh said.

As systemic reform remains elusive, Dr. Bozorgzadeh continues to use institutional support and his own convictions as anchor, sail, and spyglass to navigate a ship otherwise left adrift.

One thought on “UMass docs tackle key problem in liver transplant process

  1. Nice article Alex…everything that was written was so true…I am on the transplant list at UMASS and having met Dr B. during my evaluation, I know that he is so dedicated and caring. I hope he can save me and I will not be one to die waiting for a liver. So Alex, do you want to donate half your liver to me? We could make real headlines here. I guess it is not nice asking you that…I do not know you and you do not know me! Oh Well…I am just a retired educator who would like to be around for a while…I have things to accomplish!

    Cynthia

Leave a Reply

Your email address will not be published. Required fields are marked *