UAB Synopsis, Vol. 26, No. 35, October 1, 2007

Based largely on UAB data, the Federal Aviation Administration (FAA) will allow private pilots who have had a heart transplant to fly airplanes by granting a class III medical certificate. The criteria for issuing the certificate are based on a study, ¡°The Case for Selective Re-issuance of Medical Certificates to Allow Pilots Who Have Received a Heart Transplant to Resume Flying¡± (J Heart Lung Transplant. 2005;24[3]:259-269), authored by David C. McGiffin, MD, and colleagues.

The study used clinical data from the Cardiac Transplant Research Database, a national repository of information about patients undergoing cardiac transplantation. This database, which has contributed considerable new information to the field of heart transplantation, is based at UAB under the direction of James K. Kirklin, MD, professor and director, Division of Cardiothoracic Surgery; David C. Naftel, PhD, professor, Division of Cardiothoracic Surgery; and Robert C. Bourge, MD, professor and director, Division of Cardiovascular Disease.

The FAA has been reluctant to reissue medical certificates to pilots after they have had a heart transplant, based on a concern that coronary allograft vasculopathy could result in incapacitation.

Medical standards adopted for flight crews are based on the notion that event rates for complete incapacitation should be expressed in the same units as aircraft accident rates. An incapacitation rate of <1% per year for a pilot is regarded as an acceptable risk, thus the ¡°1% rule¡± has been informally adopted as the cardiovascular event rate criterion in the United States and applies to air transport, corporate, and private pilots. In 1989 the FAA discontinued its practice of reissuing medical certificates for pilots who had undergone heart transplants. The FAA did not reconsider the issue until recently because it was believed that it would not comply with the 1% rate ¡ª the major concern being the development of coronary allograft vasculopathy and its unpredictable natural history and propensity for causing sudden death.

In 1998 a study examined the risks of sudden unexpected death after cardiac transplantation and identified a group of recipients at low risk of sudden-onset death (but not ¡Ü1%), but it was not reassuring enough for the FAA to change its policy.

The FAA, partly in response to persistent requests from pilots who were heart transplant recipients to consider recertification, approached UAB to establish criteria for possible special issuance of medical certificates. Robert Brown, database administrator in the Division of Cardiothoracic Surgery, analyzed clinical data from the Cardiac Transplant Research Database at UAB to precisely define a group of recipients who would have a risk of death low enough for the FAA to accept.

The study determined a number of criteria that would be mandatory for consideration of reissuance of a medical certificate after an anniversary evaluation (at least 12 months posttransplant), including:

• No angiographic coronary allograft vasculopathy;
• Normal left ventricular systolic function;
• No treated rejection in the 2 years before anniversary evaluation;
• No hemodynamically compromising rejection at any time since transplant;
• No infection within the previous 6 months;
• Therapy for infection >6 months before anniversary evaluation has been completed with no residual sequelae;
• No nonskin malignancy since transplantation;
• No lymphoma within 2 years of the anniversary evaluation; and
• No pre- or posttransplant insulin-dependent diabetes.

The analysis determined these criteria would predict a 1-year risk of 0.3% for sudden-onset death and 1% for death from any cause during the year after the first anniversary. The highest actual observed mortality in any year with these criteria was 0.8% from sudden-onset death and 1.4% from death from any cause.

The first person to qualify for reissuance of a Class III medical certificate was UAB patient Skip Monaghan, who received his transplant on January 28, 2003 and flew again as a pilot in command in July 2007 for the first time since 2001.