Technology continues to challenge cardiologists' ability to distinguish between clinical benefit and financial reward. For the past half-century, we have been the beneficiaries of a seemingly limitless volume of patients that can support the investment in expensive technological research. At the same time, we have a blank check authority to pay for technology, regardless of clinical value, which would never be invested in rare diseases or even a more commonplace disease. As a result, we have at our disposal a variety of new technologies such as stents, defibrillators, and artificial hearts, often provided without a clear understanding of the clinical question to which they apply.
Now we are faced with the dilemma of how to include CT angiography (CTA) into the balance between what is clinically beneficial to the patient and the economics required to support the technology and the practicing cardiologist. The dazzling image of the coronary vessels, displayed by CTA in living color and in three dimensions, can be seen with a click of the mouse on anyone visiting the New York Times Web site. Wouldn't you want to have a 3D picture of your heart, particularly if it could ensure your survival? You could even print it and hang it over your mantelpiece with a warm cozy fire to show your friends on a cold winter's night.
What does it really show us? As we moved the technology from 8 slices to 16, 32, and now 64, the pictures have become more and more elegant. But according to many experts in this technology, they will never become sensitive enough to give us the insight into the question of when and if we will have an occlusion of a specific coronary artery. And yet this is the message that is being conveyed to the general public. For the asymptomatic patient, it is being sold as a screening test. In the symptomatic and acute coronary syndromes patients, it is proposed as a noninvasive test to indicate the need for early intervention. There are few data to support either position. Nevertheless, many hospitals and physicians have invested more than a million dollars each for a scanner.
In an appropriateness study carried out by the American College of Cardiology Foundation, experts in the field found little to suggest that the CTA would provide any important information in regard to the occurrence of an acute coronary occlusion (J. Am. Coll. Cardiol. 2006;48:1475-97). In addition, it is becoming clear that there is considerable radiation risk to the patient. Some would suggest that this is not important in view of the age of the usual cardiac patient, although some physicians are suggesting annual or biannual CTA studies to evaluate “disease progression.”
Last December, the Centers for Medicare and Medicaid Services floated a proposal to cover CTA for acute coronary syndromes patients only if they were enrolled in a CMS trial. The intent was to gather data to understand the clinical benefit of the CTA in that clinical syndrome. The response was a storm of protests from the CTA practitioners and the ACC, whose CEO, Dr. Jack Lewin, said that this “noninvasive clinical tool … has been clinically proven to be effective in diagnosing coronary artery disease.” As a result, the CMS backed down and Medicare, as well as many private insurers, will now pay for CTA in the setting of symptomatic patients. However, the CMS will not pay for CTA in asymptomatic patients. So if you are feeling well and just want to entertain your friends, you will have to pay the $1,000 out of your own pocket.
It is not entirely clear whether the players in the battle for CTA coverage actually are interested in collecting data that would answer the clinical issue at hand. It is clear that many physicians believe in the value of this new technology. Nevertheless, the economics of CTA raise significant questions about the motivation of physicians advocating the test, which should be resolved with a clinical trial. In time, it is likely that someone will carry out a study that will confirm or negate the value of CTA. The tragedy is that with a CMS-directed trial, the data would be forthcoming much sooner, before needless radiation risks to patients had occurred, and before a lot of money was spent on a test with questionable clinical import.