1. Pilots on Coumadin (Anticoagulation therapy)
The FAA is going to be more stringent in the use of anticoagulation in chronic or paroxysmal atrial fibrillation (AFIB). AFIB and a history of stroke, transient ischemic attack, moderate to severe left ventricular dysfunction, mitral valve disease, coronary heart disease, prosthetic heart valve or age >75 are considered high risk.
Lesser risks are hypertension, diabetes mellitus, thyrotoxicosis, and age 65-74. With age <65 and absent risk factors, aspirin is acceptable and if risk factors are present, then warfarin is required. In ages 65 to 75 with absent risk factors, aspirin or warfarin is acceptable. If the risk factors are present, warfarin is required. In age >75, warfarin is required.
We want the INR levels to be between 2.0 and 3.0. We are now going to allow the AME to send in the monthly values (we want the airman to have the INR level determined monthly) every 6 months for first-class and every 12 months for second and third. The airman is required to bring all these values into the AME. The way we look at the INR’s is that we want 80% of the values to be between 2.0 and 3.0. We will be satisfied with values as low as 1.6 or as high as 3.5. If they are not within that range, then we shall withdraw the authorization for a special issuance.
2. AFIB treatment
In chronic AFIB, when we request a 24 hr. Holter monitor and there are sinus pauses >2.5 sec., we will withdraw the authorization. Likewise, if the resting heart rate is 100 or there are episodes where the heart rate exceeds 130-140 BPM with minimal exertion, we will withdraw the authorization. This is regardless of whether the airman is being treated with digitalis, beta-blockers, or calcium channel agents.
3. Heart valve replacement
Follow-up for a simple heart valve replacement when there is no evidence of coronary heart disease will be a clinical status report, CVE, standard ECG, and Doppler echocardio-gram every 6 months for first- and second- class and annually for third-class.
4. Heart valve replacement and warfarin
In mechanical heart valve replacement where the airman is taking -warfarin, there will be the requirement for 80% of the INR’s to be between 2.5 and 3.5.
5. Multiple heart valve replacements
Multiple heart valve replacements will be denied all classes of medical certificates. We do grant medical certification to airmen who have had the Ross Procedure. This is where the pulmonic valve is transplanted to the aortic position and the pulmonic valve is replaced with a bioprosthesis.
6. Coronary recovery and testing
In the medical certification of myocardial infarction, angina pectoris, coronary bypass grafting, -coronary angioplasty, coronary atherectomy, and coronary stent placement, we still require a 6-month observation or grounding period. First- and second-class airmen are required to have a 6-month post-event heart catheterization.
If you recall, we had been requesting the follow-up recertification material every 6 months for first-and second-class airmen and every 12 months for third-class. We are now going to require a CVE and maximal Bruce Protocol Stress test every 12 months and a CVE and maximal Bruce Stress Radionuclide Scan every 24 months.
Please note that our cardiology consultants reserve the right to request 6- and 12-month follow-up reports, as before, depending on the airman’s particular case. We will extend the follow-up requirements when the airman demonstrates stability.
Please be aware that we are not legally allowed to place any restrictions on a first-class medical other than eye, hearing, color vision, or a time limitation. We can place restrictions on second- and third-class medical certificates. In other words you/we cannot place a restriction of SIMULATOR DUTIES ONLY on a first-class medical. We can, for example, place the restriction NOT VALID FOR CARRYING PASSENGERS OR CARGO FOR COMPENSATION OR HIRE on a second-class medical.
8. Pacemaker dependency
We have not been granting medical certification to first- and second-class airmen with pacemaker dependency. We define this as a heart rate of no less than 40 BPM when the pacemaker is turned down to its lowest rate or completely off.
9. Pacemaker observation period
We are now going to grant medical certification in cardiac pacemakers after a 2-month observation period, -instead of the previous 6-month observation period. This assumes that there is no evidence of coronary artery disease or the need for heart valve replacement. This will include replacement of generator, lead system, or both.
10. Epilepsy, seizures, brain injury
Applicants with epilepsy will now be considered after a 10-year seizure-free period and 3 years of being off anticonvulsant medications.
Airmen with a single seizure will be considered after a 4-year seizure-free period and 2 years off anticonvulsants.
11. Requip (ropinirole) no longer allowed
Since Requip (ropinirole), which is used in the treatment of Parkinson’s disease, now carries the same warning as Mirapex (pramipexole), we are no longer allowing it in airmen. These medications have been associated with the sudden falling asleep of individuals. This falling asleep has occurred up to 1 year after the initiation of therapy, many times without warning. The events have occurred while operating a motor vehicle. I recently performed a literature search because some of our AMEs said that if the dose is reduced, this side effect would not occur. However, I could find no studies or literature to support this claim.
12. Provigil (modafinil) no longer allowed
Provigil (modafinil), a wakefulness-promoting agent that is utilized in excessive daytime somnolence, is not allowed in aviation duties.
An answer to a question
At the recent aviation medical examiner seminar in Salt Lake City, someone said that we need to advise AMEs more frequently in the Bulletin about changes: “Let us know about recent regulatory changes (known to AOPA but not AMEs), e.g., the prior use of Ritalin-like drugs under [question] 18m and psycho tests now needed; deferment of sleep apnea patients.”
Without going into the diagnosis of Attention Deficit Disorder (ADD), I’ll discuss the way the Aerospace Medical Certification Division handles such cases.
If a young airman reports the diagnosis of ADD and is taking any of the common medications —Ritalin -(methylphenidate hydrochloride), Adderall (combination dextroamphetamine and amphetamine), or Dex-edrine (amphetamine)—he or she will be denied medical certification. The condition and the medications are incompatible with aviation duties for any class.
If the applicant reports being off the medications for 90 days and we receive evidence from the treating physician or counselor of good performance in school and the applicant is not demonstrating any attention deficit-related issues, we will likely grant medical certification. In all cases, you should provide us with an adequate statement from the treating physician as to how the diagnosis was made, the response to the treatment, and how the prospective airman currently performs while off the medications. This will allow us to make a determination as to eligibility to fly.
If there is any question as to whether the airman still is having the difficulties associated with this condition, then we shall require the airman to be off the medication and have three psychologic tests: the Trail-Making Test, the Wisconsin Card Sorting Test, and the Paced Auditory Serial Addition Test (PASAT). These test the individual’s capabilities of performing in a multitasking situation. We will also accept, in lieu of the above tests, the TOVA – Test of Variable Attention — or the Conners Continuous Performance Test.
Another common situation is the case of a child with ADD whose father notes that he has had similar problems as a youngster and either persuades a physician to prescribe Ritalin or the father takes some of his child’s medication. Let’s say this father happens to be an airman, and he reports on the FAA Medical Examination that he takes Ritalin. We now have a policy that if this airman persists in taking the medication because he notes that his concentration is improved, we will ask that airman to discontinue the use of the Ritalin for 72 hr and take the above-mentioned tests. When we receive the testing results, we will forward the case to the Chief Psychiatrist in the Office of Aerospace Medicine in Washington, DC, for review. Our Chief Psychiatrist would also like to follow these airmen. If the airman does not have Adult Attention Deficit Disorder, we will likely allow him to fly, providing he discontinue the Ritalin 24 hr prior to flight. We will not allow certification to the airman if he is on any other medication than the Ritalin.
As for the medical certification of sleep apnea, the AME should defer the case to the Regional Flight Surgeon or the AMCD unless the airman provides the proper information, in which case you may phone us and receive a telephonic authorization. When an airman indicates having this condition, we will require the proof of diagnosis, such as a polysomnogram. You should also obtain the operative notes of any surgical procedures that have been performed to correct the condition. We also need a current status of the medical condition to include any current treatment and whether the treatment has been successful. If the airman has not received any treatment, and the symptoms are persistent or not completely successful, we will require a Maintenance of Wakefulness Test. Please note that we do not accept the “placing of tennis balls in the back of pajamas” method of treatment for sleep apnea.