09 April 2012

Live Liver Donor Dies - Substandard Care a Factor?

Story first appeared on CNN.

2,500 live donors have shared liver in past 25 years; 4 have died since 1999

(CNN) - Before dawn on her 57th birthday, the donor's wife and her husband, the donor, piled into their brother-in-law's Lexus in Pelham, New Hampshire, with the donor's wife and her sister in the back seat and the men up front.  They never would have expected to end up needing the services of a Wrongful Death Lawyer in Westwood, Mass.

As the donor's wife sat in the waiting room with her sister that May morning two years ago, she prayed her husband's liver lobe would cure her brother-in-law. She prayed for her husband, too, but she was less worried about him, since she says the surgeons had reassured them while liver donation wasn't without risks, it was safe for him, a 56-year-old man in good health.

Neither of her prayers came true. Her brother-in-law died less than a year later, after receiving the transplanted part of the liver. He was 58. Her husband died that very day on the operating room table.
The donor, an electrician for the Florida Department of Transportation, was one of more than 4,500 people in the United States in the past 25 years who have donated a section of their liver while still alive. Death is rare -- besides this instance, only three other donors have died since 1999. 

The relatives of the other donors -- they died in 1999, 2002 and 2010 -- have gone public, but this is the first time the wife has discussed her husband's death.

Living organ transplants are a miracle of modern medicine. In all, more than 100,000 people in the U.S. have donated a kidney, a liver lobe or another body part while still alive to save someone else's life. Most of the time, the surgeries go well. Not only are donor deaths rare, but major complications of any kind are the exception rather than the rule.

This makes it all the more difficult to understand why he was one of the few who didn't make it.
After her husband was wheeled into surgery, the wife, her father-in-law and sister walked around the block a bit and got a bite to eat in the hospital cafeteria. Then shortly after 1 p.m., about four and a half hours after the surgery began, she says the coordinator of the transplant team came out to talk to them.

Sitting next to her, their knees nearly touching and speaking in a near whisper, she says the coordinator told her they were having trouble getting her husband's blood to coagulate and that an expert had been called in. Then about an hour later, the coordinator came out again to say her husband was having irregular heart rhythms.

The coordinator's cell phone rang, and she answered it. She hung up and rubbed the wife's arm, which she found strange, and told her she'd be back in five minutes.

When she returned, she asked the family to come into a small, private waiting room. The donor's wife remembers her father-in-law screaming, but the coordinator wouldn't say anything. The family sat there for about 40 minutes. Then the coordinator asked the family to go into a conference room farther away from the waiting area.

Suddenly the conference room filled with doctors, counselors and pastoral staff.

She stayed with her husband's body until the coroner came to take him away. She says the next day people from the hospital called her six times, offering condolences and to pay for her husband's funeral. She didn't want to talk to them.

Then in July, about two months after her husband's death, she stopped by her post office after grocery shopping to pick up her mail. In her box was a thick envelope from the Massachusetts Department of Public Health. Inside was a nine-page report with the details of what happened during the surgery.
Finally, she thought, her questions would be answered. Finally, she would find out why her husband died.

The Department of Public Health report gives a rare and gruesome picture of a surgical procedure gone horribly wrong.  A Medical Malpractice Lawyer in Detroit has been following the case.

The department's account is based on medical records, operating room communications and two days of interviews with the attending transplant surgeon and other doctors, nurses and administrators.
After she and her sister kissed their husbands good-bye, the men were wheeled into separate operating rooms. Everything went fine until about four hours into the operation, when a vein that carries blood away from the liver partially tore off and started bleeding.

The donor's surgeons immediately called for assistance. More doctors and nurses arrived in his operating room. It was to be the beginning of a two-and-a-half-hour fight to save him.

The partially torn vein came all the way off, and doctors sewed up that tear, but then they noticed bleeding coming from somewhere else. As they searched for the source, a clamp on a vein got knocked off, injuring the vein. Repairing that injury, they noticed more tears. They fixed those tears, all the while giving him blood products and drugs to raise his blood pressure.

It seemed like he might be getting better, but then he started to bleed from several areas all at once. His heart started to beat very fast. Doctors performed CPR and when that failed, they cut his chest open, massaged his heart directly, and shot drugs into his heart to get it going again. But none of it worked.

The donor was pronounced dead at 3:01 p.m. on May 24, 2010.

A spokeswoman for the Lahey Clinic, one of the largest liver transplant centers in the country, declined to comment about the details in the state's report. Lahey voluntarily stopped operating on living liver donors for about four months.

The Massachusetts Department of Public Health did not cite the hospital for any deficiencies. The Lahey Clinic conducted its own internal investigation into the donor's death and hired outsiders to conduct an external investigation. Lahey declined CNN's request for copies of both these reports.
The donor's widow read the Department of Public Health report sitting in her car in the parking lot of the Tampa post office. As she read the details of her husband's failed surgery, she wondered whether all the tears and bleeding were anyone's fault or were they just unavoidable consequences of surgery, inevitable events that statistically speaking happen sometimes, and he was just unlucky?

Three other items in the Department of Public Health report raised even more questions.

First, she found out he had been given a pre-operative EKG, and it was abnormal. It showed he might possibly have had a past heart attack, but then follow-up testing showed no evidence of poor blood flow to his heart.

The report doesn't say whether the donor knew about his abnormal EKG, or if a cardiologist was called in to evaluate whether his heart was strong enough to tolerate surgery. The Lahey Clinic spokeswoman, declined to answer questions about the EKG or about any aspect of the surgery or pre-operative care.

Secondly, the report pointed out that a special, high-speed blood pump wasn't used to give the donor blood.

The $20,000 device pumps blood at least three times faster than other pumps. Called a Belmont Pump, it's saved soldiers' lives as they lay massively bleeding on battlefields in Afghanistan and Iraq.
Lahey owns a Belmont Pump. At the time of the surgery, it was nearby in the receiving patient's operating room. But as the donor lay bleeding to death for two and a half hours, no one brought it in to his operating room.

Thirdly, the report describes how the surgeons never activated a set of procedures used when a patient is massively bleeding.  Called the "Massive Blood Transfusion Protocol," it directs surgeons to call the hospital's transfusion services and activate a set of procedures so a patient who's bleeding profusely can most efficiently get the blood products he needs.

The report notes that surgeons thought none of these things -- the abnormal EKG, the lack of the high-speed pump, the inactivated protocol -- contributed to his death.

Based on the lack of proper care, the clinic could be held liable for wrongful death, states a Salt Lake Medical Malpractice Lawyer.

Nonetheless, the report shows the hospital did think they could have done some things differently.
After the donor's death, staff questioned whether there needed to be a "higher standard" when evaluating patients with abnormal EKGs. They said it would have been "nice" to have had a Belmont Pump in the room. They educated staff about activating the blood transfusion protocol.

In the end, the Department of Public Health report didn't answer the widow's questions as she'd hoped. She still didn't know what had killed her husband. Nearly two years after her husband's death, she still has no peace and no closure.

The donor's widow located the widow of a donor who died in 2002.  She was introduced to a friend who may have been able to shed some light on the situation.

That friend was a nurse in Ohio who donated a kidney to her sister in 1994. Now an associate at the Center for Biomedical Ethics at Metrohealth Medical Center and Case Western Reserve University in Cleveland, the nurse has developed an interest in the ethics of living organ donation.  Working with the nurse, the donor's widow found out there was something else she didn't know about her husband’s surgery.

Most liver donors in the United States have "open" surgeries with a long incision across the abdomen. According to medical records obtained by CNN, her husband had laparoscopically assisted surgery, a minimally invasive technique with three very small cuts.

The advantage of "lap-assisted" surgery is a much easier recovery for the patient. The down side, surgeons say, is if a patient starts bleeding it can be harder to find the source since they can only look through small incisions rather than a very large one.

The nurse told her that she thought the Lahey surgeons might not have had much experience with "lap-assisted" surgeries on liver donors. The technique had only been used for a few years in the United States when her husband had his surgery, and some surgeons were trying it out for the first time.

A patient safety expert at Johns Hopkins University School of Medicine in Baltimore agrees.
A spokeswoman for Lahey declined to say how many laparoscopic liver donor surgeries had been done at Lahey before the donor's operation.

Three months after her husband died, another live donor died after donating a liver lobe to his brother in Colorado. His death received a great deal of media attention, and the American Society of Transplant Surgeons released a statement.

Now, nearly two years after her husband's death, after poring over the Department of Public Health report and her husband's medical records, she still wonders whether she could have done anything to keep from losing her husband on her 57th birthday.

She says there's one thing she knows she would have done differently. She had only enough time off work to fly from Florida to Boston for the surgery itself, so she wasn't there for his pre-operative testing. He did that on his own.

Now she wonders if Lahey gave her husband all the information he needed to make a smart decision about whether to go under the knife.

An inspection seven months after her husband's death by the federal Centers for Medicare & Medicaid Services (CMS) revealed that Lahey violated several federal rules for informing and protecting donors.

Under these regulations, each donor is supposed to be told about how other organ donors fared after their surgeries, both nationwide and at Lahey specifically. Studying the records for seven liver donors, CMS found Lahey failed to provide all of them with the most current surgical outcomes.
The chairman of surgery at Lahey when the donor died, agrees that the data wasn't as up-to-date as it should have been.

The CMS report noted that Lahey was out of compliance in another area.

Transplant centers are supposed to assign a staff person, such as a doctor or social worker, to be an independent advocate for the donor. The donor advocate is supposed to take into account only the donor's concerns -- for example, in this case, the abnormal EKG findings -- and not the concerns of the recipient, since sometimes there can be a conflict of interest between the two.

To make sure the advocate is focused solely on the donor, there's supposed to be a "wall" between the donor advocate and the recipient's team, but federal inspectors observed Lahey's donor advocate going on medical rounds and participating in meetings run by the recipient's team.

According to CMS, the hospital corrected the problems and was back in compliance with federal regulations about three months later.

The widow knows she may never get all her questions answered about why her husband died that May afternoon.

She looks back on the day her husband made the decision to donate part of his liver with a mixture of sadness and pride. It was Thanksgiving Day, 2009, and they were at a Cracker Barrel in Tampa with their two grown sons.

During dinner, her cell phone rang. When she answered the call and heard her sister crying, she excused herself to take the call outside.

When she returned to the table, she told her husband and their sons the bad news.  Her brother-in-law was very ill and would die if he did not receive a liver donation soon.  Getting a liver from a cadaver was out of the question since he was so sick he'd never live long enough to get off the waiting list.  Her husband and son immediately volunteered to get tested as possible liver donors for their family member.

Before the son could protest, the donor told his son he'd fly to Boston first to get tested first, and if he wasn't a match, then his son could try. That turned out not to be necessary, as the tests showed him was a perfect match.  Before the donor flew to Boston for the transplant, the couple's other son, saw his father off at the Tampa airport.

In retrospect, the other son wishes he had advised his father to get a second opinion from another doctor about whether he was healthy enough to give away 60% of his liver -- from a doctor who didn't stand to financially gain from the transplant.

But his family says before the transplant, the donor wasn't looking for advice. He was looking to do good. Being a living donor was just an extension of the goodwill he did in his regular life, they say, like helping elderly people in his church with their home repairs for free.

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