Tom Giangiulio and wife Carin
“It was a 10+-year ordeal.” That’s how 59-year old Tom Giangiulio described his sometimes ups – and often downs – of battling heart disease. Despite taking heart medications for many years – and undergoing open heart surgery –Tom’s heart continued to get worse. After being referred to Penn, he was deemed eligible for the heart transplant waiting list, but, at 6’2” and 240 pounds– and with O positive blood type – his chances of finding a match would be especially hard.
This was not a particularly unusual case, but when word of a new groundbreaking clinical trial at Penn made its way to Tom and his family, they made a courageous decision that would save Tom’s life… and lead the way for others.
Each year in the United States, transplant surgeons perform 2,300 heart transplants, but, with nearly 4,000 names on the waiting list, “hundreds on that list die waiting,” said Rhondalyn McLean, MD, medical director of Penn’s Heart Transplant program. By April 2016, after more than two years on the waiting list –and several admissions to the Hospital of the University of Pennsylvania – Tom’s heart was giving out. He was readmitted – and remained – at HUP hoping and waiting.
Around that same time, researchers at Penn were investigating the possibility of transplanting donor hearts infected with the hepatitis C virus (HCV) into patients who did not already have the disease. A 2016 Penn study had shown tremendous success transplanting HCV kidneys and then treating the recipients with an antivrial medication to eradicate the disease. All 10 patients were cured of their contracted HCV in the first phase of the clinical trial and now Penn researchers were hoping to translate that success with heart transplantation, beginning with Tom.
Getting a HCV-positive donor heart is, tragically, getting easier, due to the opioid epidemic. “A lot of these heart donors are those who shared needles and died of a drug overdose, in their 20s or 30s,” McLean said, a “silver lining” for those on the heart transplant waiting list.
Ironically, opioids can destroy a life but “they do not directly affect the heart,” said David Goldberg, MD, an assistant professor of Medicine who led the trial on HCV-positive kidneys and is co-leading the heart transplant study with McLean and Peter Reese, MD, of Medicine and Epidemiology. There’s a potential for up to 800 more heart transplants each year.
McLean approached Tom with the option in April 2017 but there was a caveat: he would be the first person to receive an HCV-infected heart in the clinical study. Did he want to take that chance? After discussing it, Tom and Carin decided it was his best hope. “When I heard about people receiving kidneys who were then cured, I said ‘Let’s do it’.”
The match came in June 2017. “When the gurney came to bring me to the operating room I jumped out of bed and practically sprinted to get there!” Tom said, laughing. “The transport guy made me sit back down, to remove the heart monitoring equipment.”
“Tom was a terrific candidate. He told me ‘I just want to live, doc,’” McLean said. “As a physician, as a person, that speaks to you.”
Three days after Tom underwent a successful heart transplant, the results of a blood test showed he was HCV positive. Like the kidney transplant patients, he received 12 weeks of Zepatier therapy and was clear of the disease when retested three months later. McLean called him. “She said ‘We’re having a party. It’s official: you’re cured of Hep C!’”
Since Tom’s surgery, another eight patients have received an HCV heart transplant as part of Penn’s study. With promising trial results, Goldberg and team have received approval to perform 10 more heart transplants, which would bring the total to 19, but in order for this to be a standard of care for heart transplant patients, “the procedure needs to be done more broadly. Funding will help us make this a standard of care,” saving hundreds of more lives.
Tom, meanwhile, continues his recovery. Although he can’t yet return to his job in active construction, he goes to the office daily. And while he once barely felt his old heart’s presence, his new one “is beating strongly.”