One theme of this column is that publications prepared by health care providers, drug companies and their professional organizations are often long on benefits and short on risks. I’ve often compared the little pamphlets on some medical procedures, which are generally all sweetness, light and benefit, and the informed consent forms, often prepared by attorneys, which stack up an alarming array of risks running all the way up to paralysis and death. And I came upon a compelling illustration of this theme when doing research on atrial fibrillation, the most common form of heart arrhythmia, which afflicts about 2.3 million Americans. Dr. Peter Kowey, a cardiologist at Lankenau Hospital and a leading authority on atrial fibrillation, says that atrial fibrillation is now becoming an epidemic.
Atrial fibrillation isn’t ordinarily life threatening, but it can lead to heart failure and stroke. It can also produce symptoms that are annoying and sometimes hard to live with. In atrial fibrillation the electrical signals that control heart rate become chaotic and cause the atria, the upper chamber of the heart, to quiver or fibrillate. This causes the heart to beat more rapidly and irregularly. It is associated with aging, particularly after 60. With the aging of the population, the number of people with atrial fibrillation is likely to dramatically escalate.
I reviewed atrial fibrillation publications from three of the world’s leading medical institutions and authorities on heart disease: Guide to Atrial Fibrillation from Johns Hopkins Medicine, Atrial Fibrillation Treatment Guide from the Cleveland Clinic and an item in the health letter, Mayo Clinic Women’s Healthsource entitled Atrial Fibrillation: An Abnormal Rhythm that Requires Attention.
What struck me was not one of the three publications had even a word to say about the risks and efficacy of a common remedy for atrial fibrillation called catheter ablation. It is described in the Mayo Clinic health letter as follows: “In this procedure, thin wires, catheters, are threaded into your heart to destroy the small areas of your heart muscle that cause the rapid electrical signals that make your atria fibrillate, a means of rhythm control.”
Now you might imagine that when you start threading thin wires into your leg and then into your circulatory system from all the way into your heart, something may go wrong along the way, and well it may.
Among the minor complications are wound bleeding and wound infection. And, then, there are the major complications: damage to blood vessels and the heart that might require surgical intervention, bringing on another frightening batch of possible complications. In addition, there are cardiac tamponade, narrowing of the pulmonary vein, damage to the nerve supplying the diaphragm, stroke, formation of abnormal communication between the esophagus and the heart, and death – a 0.2 percent rate – due to controllable complications.
Wouldn’t you think that the Cleveland Clinic, Johns Hopkins and Mayo would have room for a couple of sentences to let potential patients know the full story?
I have to admit that I may have some bad vibes about catheter ablation for atrial fibrillation. I’ve known only two people who have had it and one died on the operating table. I hope my unconscious mind is not, therefore, telling me that this procedure has a 50 percent mortality rate and, if I am, I hope I can overcome any resulting bias in my journalistic endeavors.
Now, let’s take a look at what these three great institutions have to say about complications from this procedure.
Cleveland Clinic – Many consider this to be the No. 1 health care provider for cardiac care. But this eminent institution, in the publication in question, has not a single word to say about risks and complications, whether minor or major. It does make a reference to the complications of another treatment for atrial fibrillation. In discussing drugs for rhythm control, it writes, “Some rhythm control medications may actually cause more arrhythmias, so, it is important to talk to your doctor about symptoms and any changes in your condition.” I might add, with all due respects to the great mavens at the Cleveland Clinic, that you might want to discuss with your doctor whether there are safer, alternative treatments such as relying only on rate control medications, which are considered a safer option. Rate control medications include digoxin (Lanoxin), beta- blockers such as metoprolol and calcium channel blocks such as diltiazem (Cardizem). The latter two of these drugs are used for other purposes, such as the treatment of high blood pressure. In case you’re interested, some of the drugs used for rhythm control are sotalol (Betapace) and amiodarone (Cordarone). Often, these drugs require a hospital stay with the benefit of a heart monitor to test the heart’s reaction to them.
Johns Hopkins – In discussing catheter ablation for atrial fibrillation, the Hopkins publication states: “The efficacy of this outpatient technique is high in appropriate patients, and the risk is minimal.” I can’t say this is an adequate discussion of the risks and complications, but you be the judge. What’s more, there is solid authority, if not consensus, that the long-term efficacy of catheter ablation is still unknown. So, it is with regret that I accuse Hopkins of overselling atrial fibrillation. Again, strangely, in my opinion, the Hopkins people point out the serious side effects of the drugs used to treat atrial fibrillation, but not the serious side effects of the catheter ablation procedure. This suggests, perhaps, that the document was written by the cardiologists – electrophysiologists, the electricians of the heart – who do the cardiac ablations rather than the cardiologists who do not and usually try to manage atrial fibrillation with drugs or other non-invasive treatments. Hopkins does make reference to drugs used for treatment, noting that they “can have serious side effects.” However, for some reason, they don’t mention death, among the long catalog of possible outcomes.
Mayo Clinic – This distinguished institution doesn’t have a word on the risks or complications of atrial fibrillation. But it has room for complications of drugs: “The medications used in rhythm control … can potentially cause more side effects – including nausea, dizziness, fatigue and, possibly, another heart rhythm abnormality.”
The three publications are equally deficient in discussing efficacy, i.e., whether the procedure actually ends the atrial fibrillation or, if not, for how long. The Cleveland Clinic gives no hint that the procedure may not work or may do so for only a brief period. My reading of their material is that the publications suggest the procedure always works, which would be seriously misleading.
Hopkins merely says, “The efficacy of this outpatient technique is high in appropriate patients….” Again, I think this is simply wrong, as the long-term efficacy is unknown.
Finally, the Mayo Clinic doesn’t have a word to say about efficacy.
I hope I haven’t painted too grim a picture of atrial fibrillation. I’m just painting a grim picture of medical publications. I credit Mayo for this sound observation: “If you have atrial fibrillation, it’s possible to lead a normal, active life. However, it’s important to work closely with your doctor to find the right treatment.” Also, for the millions who have atrial fibrillation, I should point out that Winston Churchill had atrial fibrillation all during World War II and, at that time, there were no good treatments for it.
I should thank Dr. Kowey, the cardiologist at Lankenau Hospital quoted above. I attended one of his lectures on atrial fibrillation and he educated me on the pros as well as the cons of the catheter ablation. Of course, Dr. Kowey is not responsible for anything said in this column other than his direct quote.
Herb Denenberg has served as Pennsylvania Insurance Commission, Pennsylvania Public Utility Commissioner, and the Loman Professor at the Wharton School. Since 1973, he has been a member of the Institute of Medicine of the National Academy of the Sciences, the body that advises Congress on Healthcare matters. He has frequently testified before Congress on insurance and health care issues.