When hospital trustees gathered in Charleston last summer, they received some welcome news.
The heart transplant program at the Medical University of South Carolina — the only one in the state — was up and running again. Federal inspectors had identified zero deficiencies during a visit earlier that year.
“What we’re passionate about, what we’re best in the world at doing is performing complex procedures,” MUSC’s cardiology chief told the trustees, “and there’s no complex disease or disorder we care for like advanced heart failure.”
The announcement marked a turnaround for MUSC’s heart transplant program, which in recent years has suffered a string of significant setbacks.
Five years ago, MUSC suspended all heart transplants after a series of failures and at least one patient death. Hospital leaders relaunched the program nine months later only to find out in early 2017 that Medicare decided to stop reimbursing MUSC for the procedure because the hospital's heart transplant volume was too low. At one point, hospital leaders debated whether to reopen MUSC's heart transplant program at all.
If they hadn’t, heart transplant patients in South Carolina would have been forced to travel somewhere else for surgery.
"Patients in South Carolina don’t want to travel to another state. It’s a hardship to travel five hours to Duke or three hours to Charlotte," Dr. Tom Di Salvo, the cardiology director, told The Post and Courier. "It’s mission-critical that MUSC offers patients every aspect of care that any other large, competitive academic medical center in the United States can offer."
Medicare has since resumed payments for heart transplants at MUSC, but a report published in January by the Scientific Registry of Transplant Recipients, which tracks transplant data on behalf of the federal government, indicates the volume of heart transplants at MUSC still lags behind other transplant centers in the Southeast.
Between July 1, 2015, and Dec. 31, 2017, MUSC performed 22 heart transplants, compared with 88 at Emory University Hospital in Atlanta and 149 at Duke University Hospital during the same period.
Di Salvo argued in a recent interview that the registry publishes outdated data. Volume is still improving, he said, and he anticipated two critically ill MUSC patients will likely have transplants in the next two weeks.
He also told the board of trustees during that Aug. 10 meeting that more than 90 percent of heart transplant patients at MUSC survive at least a year after surgery.
There was no way to know at the time that seven days later an Army veteran named Jeffrey Colen would be admitted to MUSC to wait for a new heart.
Or that exactly eight weeks after that board meeting, Colen would die in the hospital because his transplant failed.
'A catastrophic complication'
Jeffrey Colen retired from the Army about a year before he was dispatched to Puerto Rico as a private contractor.
There, 14 months ago, he was placed in charge of a seaport where boats brought in brand-new street light poles for the ravaged island. All of the old lights had been destroyed by Hurricane Maria.
It was work he was familiar with — Colen was a transportation specialist in the military. And even though he knew it would keep him away from home in Summerville for about six months, he hoped the gig would eventually land him a contract with the Federal Emergency Management Agency.
But then he started feeling short of breath.
"Babe, every time I walk, I feel like I'm about to pass out," Colen, who was 47 at the time, told his wife Regine during a phone call.
Colen saw a VA doctor in San Juan who told him nothing was wrong. The doctor said Colen was a young guy and that he should get back to work.
"No, I'm not young," Colen insisted when he returned to the hospital the next week. "Something is going on."
His instincts were right. An echocardiogram revealed Colen's heart was only working at 30 percent capacity. He needed emergency surgery.
Doctors in Puerto Rico implanted a cardioverter defibrillator that was designed to shock his heart if it failed. He returned home on March 30 and hoped his medical issues were behind him. He and Regine took their children and grandchildren on a cruise.
But on May 21, Regine found him passed out in their kitchen. Jeffrey had suffered a heart attack, and the defibrillator installed in Puerto Rico hadn't fired.
A surgeon at Trident Medical Center in North Charleston implanted a new defibrillator but referred Colen to the Medical University of South Carolina. He needed another procedure called an ablation and maybe even a heart transplant.
The next several months were marked by procedures, tests, surgery and shocks. Colen's defibrillator kept firing. In Walmart. At home. It was clear that his heart was failing. He needed a new one — and fast. His prognosis became so grave, the transplant team at MUSC insisted that he stay at the hospital. It was safer to wait there — at the only heart transplant center in South Carolina.
A donor heart became available, and on Sept. 28, after 45 days on the fifth floor of MUSC's Ashley River Tower, Colen received the heart transplant that was supposed to save his life.
Instead, he died.
More than 90 percent of heart transplant recipients in the U.S. survive at least one year after surgery. Why did Jeffrey Colen die so soon?
Because the donor heart didn't work — at least not in Colen's chest cavity.
"Even with exhaustive review, it’s sometimes even impossible to know why that is the case," said Di Salvo, the cardiology director at MUSC.
He acknowledged that the transplant team at MUSC experienced "one tragic loss" in October. He did not mention Jeffrey Colen by name but explained the fatality was the result of "primary graft dysfunction" — "a catastrophic complication which has been reviewed in tremendous detail.”
Colen’s death demands such scrutiny because each heart transplant failure marks a potential setback as the hospital works to rebuild a successful program. Surgeons at MUSC only transplant one or two hearts a month. One death upends their statistics.
"That’s what happened in this one instance. The heart started to malfunction. Every attempt was made to rescue it," Di Salvo said. "That’s going to happen at the best transplant programs around the country."
So far, Regine Colen has found the hospital’s official answers surrounding her husband’s death lacking. She charged that doctors at MUSC knowingly gave him a diseased donor heart and underlined a portion of his autopsy report that speculates the donor heart may have suffered from "preexisting ischemic damage," or reduced blood flow.
She also said none of MUSC’s past problems with heart transplant patients were explained to her husband last year when he was waiting for surgery. In fact, the hospital's website boasts that heart transplant recipients at MUSC "experience above average transplant success rates" and that MUSC has a "100 percent survival rate one year after transplant."
MUSC spokeswoman Heather Woolwine said the hospital communicated to patients, both verbally and in writing, when the heart transplant program was de-certified by Medicare and when it was voluntarily suspended. And all patients are shown and asked to acknowledge the hospital's 1-year survival rate, she said.
But Colen was admitted to the hospital after both the suspension and the de-certification had been lifted. Regine said she only learned of the program's history by reading old news articles.
If they'd known the whole story, she said, they would have sought a heart transplant somewhere else.
Stops and starts
Heart disease is common. Heart transplants are not.
In fact, heart disease accounts for nearly one-quarter of all deaths in the United States every year — more than 600,000 fatalities, according to the Centers for Disease Control and Prevention. But only 2,200 heart transplants are performed annually, partly because demand for donor organs exceeds the supply.
"Heart disease is epidemic in the southeastern United States. Heart transplants are infrequent because we’re limited by donors," Di Salvo said.
Because the number of heart transplants performed each year is relatively low, few hospitals offer them.
MUSC is the only one among South Carolina's 61 hospitals that performs the procedure. North Carolina has more than 120 hospitals, but only four offer heart transplants.
This allows hospitals that specialize in the procedure to pull in more patients. Higher transplant volume generally correlates with better outcomes.
That's why the Scientific Registry of Transplant Recipients keeps tabs on both transplant volume — the number of procedures performed at any given hospital — and survival rates. Both numbers are considered important ways to gauge quality.
The registry's most recent report, published Jan. 7, shows heart transplant volume at MUSC is among the lowest in this part of the country and patients at MUSC likely face a 21 percent higher risk of graft failure compared with an average program. An estimated 89 percent of heart transplant patients at MUSC who received a new heart between mid-2015 and late-2017 were expected to survive at least one year after surgery.
These numbers used to be worse.
Between Jan. 1, 2013, and June 30, 2015, only 58 percent of heart transplant recipients at MUSC were likely to survive within three years of their surgery and they faced a 111 percent higher risk of graft failure than patients at other transplant hospitals.
These numbers are what prompted MUSC to suspend all heart transplants in early 2014 and transfer patients on the waiting list to other transplant centers.
During this suspension, the hospital brought in experts from top transplant programs around the country and from the United Network of Organ Sharing to evaluate what went wrong. They made several minor recommendations dealing with the technical aspects of donor harvesting and the preservative solution to transport organs. The hospital adopted their suggestions, but "there was no smoking gun that was found," Di Salvo said.
MUSC reopened its heart transplant program in 2015.
But the hospital's transplant problems didn't end there.
In 2017, Medicare informed MUSC that it would stop paying for heart transplants at the hospital because volume was too low — fewer than one transplant was performed per month.
The federal government pays for nearly half of all heart transplants in the United States every year, and the procedure can easily cost hundreds of thousands of dollars. Medicare has a vested interest in directing patients to hospitals with the best outcomes.
That doesn't mean transplant centers with high volume and great reputations are necessarily safest. An investigation published last year by the Houston Chronicle and ProPublica found that heart transplant fatalities at Baylor St. Luke’s Medical Center in Texas have substantially increased, even though the hospital has long been considered one of the premier transplant centers in the world.
For its part, MUSC was able to demonstrate to Medicare that its volume had improved. The insurer reinstated payments last spring and more than a dozen MUSC patients are currently on the heart transplant waiting list.
Elliot Hutchinson has gotten to know some of these men and women. He received his new heart at MUSC on April Fool's Day nearly three years ago. He had been diagnosed with a genetic heart defect more than a decade earlier and knew he was running out of time.
"Things were getting rough," he remembered. "We just didn’t know how much more my heart could take."
Hutchinson, 39, a former firefighter who lives in Summerville, had considered waiting for a heart transplant at Johns Hopkins Medical Center in Baltimore. But his physicians there recommended MUSC. Now, he speaks to patients on the waiting list about his experience and their concerns.
"I am more than satisfied. I have doctors who let me call them at home," Hutchinson said. "Second to none, I can’t say enough about MUSC."
James Dewees likewise sang MUSC's praises during the hospital board meeting in August. He had a heart transplant at MUSC in June.
"The heart started beating as soon they placed it," said Dewees, 52, who lives in Summerville. He spent 10 days in recovery, four in the ICU. "I was walking two days after surgery."
"One of the biggest things is getting used to the heart beat," he said, because his former heart beat was “very sporadic.”
"This one is steady and strong."
'The worst decision'
Jeffrey Colen found out he was getting a new heart on Sept. 28. Surgery was scheduled for 7:30 that night, then postponed until the next day.
The transplant team explained to Colen and his wife that the donor heart was considered high risk, but they recommended he proceed with surgery anyway. The donor tested negative for hepatitis C and HIV and hadn't been incarcerated.
Regine, a nurse practitioner by training, remembered they were told "the heart is very, very young and the person, at one point, was a (substance) user." Records revealed that the donor organ was flown in from Florida.
The next day, the procedure to transplant Colen's heart lasted several hours. Regine and her daughter weren't able to see him in the ICU until about 10 p.m.
"When I saw him, I knew my husband was already dead. That minute. My husband’s lips were blue," Regine said.
He would survive less than a week.
At 7:06 a.m. the morning following surgery, Regine got a call from the hospital informing her that her husband was critically ill. Surgeons had to perform an emergency operation in the middle of the night. The hospital said his new heart wasn't working.
"What do you mean it was a bad heart? When did the emergency happen? Why didn’t you call me? You took my husband back to the OR and you didn’t call anybody?"
In a letter dated Jan. 14, Sheila Scarbrough, a quality director at MUSC, acknowledged to Regine that staff "obviously did not communicate with you as well as we should have, and for that, I apologize on behalf of our entire hospital." But she insisted members of the "entire Transplant Team did everything in their power to save your husband."
The letter also confirmed that the donor heart had undergone a procedure some years earlier commonly used to correct an abnormal rhythm. But Scarbrough wrote to Colen that the test used to measure heart function indicated that it was working well before it was transplanted. An echocardiogram from the Florida hospital revealed no abnormalities.
"Mrs. Colen, I know you think something was wrong with the heart, but that is simply not the case," Scarbrough wrote. "Your husband was doing well after surgery. I know he didn't look well, but all of his vital signs were stable and his heart function was stable until it suddenly changed after 2 a.m."
"I was heartbroken. I wanted to scream," Regine said after she read the letter.
On Oct. 5, Regine made the decision to remove her husband from life support. He died in 16 minutes.
"It was the worst decision I ever made," she said. "I don’t know if I did not unplug that machine, if my husband would be here today."
Since then, Regine has buried her husband at the Beaufort National Cemetery and has combed through his autopsy report and medical records. She has asked MUSC questions and filed a complaint with the S.C. Department of Health and Environmental Control.
A DHEC spokesman confirmed that one complaint regarding heart transplant surgery at MUSC is the subject of an ongoing investigation.
Regine has also contacted lawyers but hasn't filed any legal action against the hospital.
"The thing is, I don’t want MUSC’s money. The money is not going to bring my husband back," she said. "I just need MUSC to give me answers and make sure that does not happen to another patient."
Reach Lauren Sausser at 843-937-5598.