| James Kirklin|
Skip Monaghan, a Georgia businessman and private pilot, recently returned to familiar heights on the wings of data compiled at UAB. The Federal Aviation Administration (FAA), reversing its previous policy, now will allow private pilots who have had a heart transplant – like Monaghan – to fly airplanes by granting them a class III medical certificate.
“When you get a handle on prolonging life with therapies like heart transplantation, the added bonus of returning a near-normal quality of life to the patient is a huge bonus,” says James K. Kirklin, M.D., professor and director of the Division of Cardiothoracic Surgery.
The criteria for issuing the certificate are based on a study authored by David McGiffin, M.D., professor of surgery and internationally recognized expert in heart and lung transplant.
The study used clinical data from the Cardiac Transplant Research Database (CTRD), a national repository of information about patients undergoing cardiac transplant, which is based at UAB. The database is under the direction of Kirklin; David Naftel, Ph.D., professor in Cardiothoracic Surgery; and Robert Bourge, M.D., professor and director of the Division of Cardiovascular Disease.
The FAA had been reluctant to reissue medical certificates to pilots after they have had a heart transplant based on a concern that coronary allograft vasculopathy — or chronic rejection — could incapacitate them.
The FAA, partly in response to persistent requests for recertification by private pilots who were heart-transplant recipients, approached UAB to establish criteria for special issuance of medical certificates.
Robert Brown, database administrator in Cardiothoracic Surgery, analyzed clinical data from the CTRD to precisely define a group of recipients who would have a risk of death low enough for the FAA to accept.
The authors suggested criteria for consideration after an evaluation at least one year post-transplant. Some of those criteria included:
• No chronic rejection
• No treated rejection in the previous two years
• No infection within the previous six months
• No pre- or post-transplant insulin-dependent diabetes
“Our risk-factor models for sudden death or future rejection found that the risk of any of those events was so low that the probability of sudden death or any of these events was less than 1 percent in the next year,” Kirklin says. “That falls within the FAA guidelines for an acceptable risk and was the basis for the recommendation.”
This proposal only was possible because the database enabled researchers to examine risk factors and outcomes for these events.
“It was on the basis of that and the integrity of this research group that the FAA agreed that we now have some evidence-based criteria to allow us to make a decision for somebody to safely fly a plane,” Kirklin says. “There was not sufficient evidence to keep them from flying.”
Quality of life
Kirklin, McGiffin and Naftel had numerous discussions about erring in favor of safety. “We had to remember, if we’re wrong and someone was to crash their private plane and cause the death of other people, it would be catastrophic,” Kirklin says. But the results were favorable, giving people like Monaghan a chance to resume an activity that was a key part of his life prior to his transplant here at UAB.
“I was excited,” Monaghan says when learning he could fly again. “No pun intended, but I was on Cloud Nine. I was floating around the house like a kid at Christmas.”
Kirklin says it’s sometimes easy to forget that people who are afflicted with a chronic condition such as heart failure are like patients with any other medical condition: They have a life full of quality indicators, and disease has stolen from them things they want to do.
“I think this is an example where the art of medicine sometimes isn’t enough,” Kirklin says. “If you’re going to restore the quality of life, particularly in a contentious environment like flying, you’ve got to have serious outcomes research.
“You can’t just practice the art of medicine,” he says. “You’ve got to get data and analyze it over a sustained period of time in a serious way, especially if you’re going to provide the kind of analyses that allow people to return to an area that entails some unusual hazards or responsibilities. You’ve got to be able to provide the data that it’s safe.”
Kirklin says it takes about 10 years of data to identify risk factors with reliable statistics. He anticipates issues similar to this one coming to the forefront. Mechanical support devices and circulatory support devices have been approved for chronic therapy for two years. Now, Kirklin’s team is using new, smaller, rotary pumps for chronic support, not just as a bridge to transplantation.
“Transplantation was going through this in the 1980s, and mechanical circulatory support is going to go through it again in the next decade,” Kirklin says. “All these same issues are going to be investigated with patients on pumps.”
So when can a patient on a pump be a pilot? What is the potential for device failure within a three-hour period when the pilot is on the plane? “It’s just a matter of time before these types of question come up,” he says. “Hopefully with this large national database we’ll be able to answer the same questions for them.”
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