Broken heart: US House committee seeks answers after North East man's heart valve fails
Michael Carlo's new heart valve worked well at first following his 2017 surgery. Simple tasks like climbing a set of stairs no longer left the then-14-year-old North East boy out of breath.
Within four years, however, Carlo's symptoms were worse than ever. He constantly complained of chest pain, fatigue and shortness of breath.
Subsequent tests revealed the heart valve that surgeons had implanted in Carlo at Pittsburgh Children's Hospital of UPMC had failed more than a decade before its expected expiration.
"One of the (valve's) leaflets was just flopping in the wind, according to what the surgeon told us," said Ann-Marie Swanson, Carlo's mother and a longtime registered nurse. "About 45% of the blood that was supposed to get pumped to his lungs was leaking back into his heart's ventricle."
Carlo and his mother said they believe, based on Carlo's medical records, that UPMC installed an experimental valve in 2017 without getting his or Swanson's informed consent. That valve was replaced in 2022 with a more traditional heart valve at the Mayo Clinic.
In an effort to find answers, Swanson and Carlo, who is now 21, said they have contacted UPMC, the Pennsylvania Department of Human Services, Pennsylvania Medical Board, Pennsylvania Department of Health, U.S. Food & Drug Administration, Pennsylvania Office of Inspector General, state Rep. Jake Banta and U.S. Rep. Mike Kelly.
Kelly's office referred the family's inquiry to the House Committee on Energy and Commerce, the Pittsburgh Post-Gazette reported. On Feb. 23, the committee issued a letter stating it is investigating the allegation, among others, and whether the FDA is providing adequate oversight for experimental medical devices.
UPMC officials denied the family's allegations. In an email, a UPMC spokeswoman said, "UPMC Children's obtains the necessary informed consent for care provided to patients."
First surgery performed when Carlo was 23 months old
Carlo was born with a heart defect, a hole in the wall between his lower heart chambers, known as ventricles. He underwent open-heart surgery when he was just 23 months old.
A surgeon at University Hospitals Rainbow Babies & Children's Hospital in Cleveland repaired the hole but discovered that the defect had damaged Carlo's aortic valve beyond repair.
"We were told Michael would eventually need aortic valve replacement surgery, probably by the time he was five," Swanson said.
Carlo's heart outlasted the prediction, performing well enough to delay surgery until he was 14.
"By then, I just didn't have much energy," Carlo said. "I had to stop some of my activities, like gymnastics."
Diagnostic tests showed that Carlo's heart was not pumping efficiently, his heart muscle was beginning to enlarge and part of his aorta was dilated and expanded.
It was time to replace his aortic valve.
UPMC surgeons tried fixing heart valve, then had to replace it
Carlo underwent surgery at UPMC Children's Hospital in October 2017. Surgeons tried to repair the valve, even though Swanson had been told years earlier the valve was "too far gone" to repair and that a valve replacement was needed.
In fact, the repair failed almost immediately, and Carlo was taken back to the operating room the next day. What happened during that surgery is under dispute.
Carlo and Swanson claim surgeons installed an experimental valve, assembled in the operating room, that was not approved by the FDA. They also claim they were not told the valve was experimental and not approved by the FDA.
"For all patients who undergo cardiac procedures, all materials used in their treatment are FDA-approved," the UPMC spokeswoman said.
"But records show that the material is FDA-approved to replace sections of blood vessels, not heart valves," Swanson said.
Carlo suffered post-operative complications following the second surgery — including blood loss and pericarditis, inflammation of the membrane around the heart — but his condition eventually stabilized. He was discharged from UPMC Children's Hospital about a week after surgery.
The surgery appeared to have worked. Carlo's health improved, and he was able to play high school baseball, work part-time jobs and lead a more active life.
That lasted until October 2021, when the fatigue returned, accompanied by consistent chest pain and shortness of breath.
"Walking up stairs made me feel lightheaded," Carlo said. "And the symptoms were getting worse."
Heart valve only lasted five years, not the usual 20 or more
Carlo saw a UPMC cardiologist, who ordered diagnostic tests that showed the 45% of the blood that his heart was supposed to be pumping to his lungs was leaking back into the ventricle.
More tests were scheduled. They confirmed the leakage, Swanson said.
"The cardiologist proposed doing an exploratory transcatheter procedure to fix the valve," Swanson said. "At this point, we just wanted someone to remove the whole thing and replace it."
"It feels like I have a ticking time bomb inside of me," Carlo said.
Heart valves often last 20 years or longer without a decrease in efficiency, according to the American Heart Association. Carlo's valve lasted five.
Swanson researched experimental heart valves and lack of informed consent, and they decided to go elsewhere for any additional surgeries. Carlo eventually underwent valve replacement surgery at the Mayo Clinic in Rochester, Minnesota.
Surgeons not only had to replace the valve, but they also had to install a new graft that UPMC surgeons had used to replace Carlo's pulmonary artery.
"We didn't know UPMC had removed the pulmonary vessel," Swanson said. "We only knew they were taking a little of the vessel's tissue."
It took Carlo nearly eight months to recover completely from the surgery. He is now feeling better than he has in years. He works full time for a landscaping business.
"The only limits I have are weight limitations," Carlo said. "I can't lift anything strenuous."
No records of a 'MASA valve' being approved by the FDA
Frustrated by the surprises and problems with the 2017 surgeries, Swanson began investigating the valve UPMC Children's surgeons placed in her son. It was repeatedly referred to as a MASA valve in Carlo's medical records.
She couldn't find any record of such a valve being approved by the FDA.
A UPMC Children's Hospital compliance officer noted in a report that the term "MASA valve" described in the medical records is a term "used colloquially." It did not represent the type of valve Carlo has installed: a tri-leaflet PTFE valve conduit, the Post-Gazette reported.
"But the Mayo Clinic also described it as a MASA valve in my son's records with them," Swanson said.
Swanson and Carlo expressed their concerns to various government agencies and officials. Kelly, of Butler, R-16th Dist., who is Carlo's U.S. representative, referred the matter to the House committee, the Post-Gazette reported.
Besides issuing the Feb. 23 letter, the committee has also called on the FDA to look into the issue of informed consent. FDA officials had originally told Kelly's office it didn't have the authority to do that.
The House committee said in a letter that the FDA does, in fact, have that authority when it comes to experimental medical devices, the Post-Gazette reported.
Committee members expect a response from the FDA by mid-April, a spokesman said.
Swanson and Carlo want UPMC, surgeons held accountable
It's unclear where the committee's investigation will go. A committee spokesman said it's unlikely a hearing will be scheduled, though Carlo and Swanson said they would be willing to travel to Washington, D.C., and testify.
The mother and son said they simply want some answers, and for the hospitals and surgeons involved to be held accountable. They said they haven't ruled out filing a lawsuit against UPMC and the surgeons.
"Not only was what they did unethical and immoral, it was also criminal," Swanson said.
Contact David Bruce at dbruce@timesnews.com. Follow him on X @ETNBruce.
This article originally appeared on Erie Times-News: US House seeking answers after North East man's heart valve fails
