Surgical Malpractice-Expanding the Standards for Use of Drug Eluting Stents

This articles addresses how cardiologist have expanded the standard of care for the use of drug eluting stents for financial gains.

EXPANDING THE MEDICAL MARKET BY EXPANDING THE STANDARD OF CARE FOR THE USE OF ANGIOPLASTY AND CORONARY STENTS

Modern medicine is big business. Cardiology is a 100 Billion dollar a year industry. As any business, the medical providers need new markets to grow the business. Consequently, at times, physicians and hospitals may promote and recommend surgeries that have little or no basis in science or have been proven to provide little medical benefit over more conservative approaches. One area of potential surgical abuse is in the area of interventional cardiology and the use of angioplasty and coronary stents.

A. UNNECESSARY CORONARY STENT PLACEMENT

The American College of Cardiology Guidelines require that a patient demonstrate objective evidence of ischemia prior to intervention. Furthermore, the FDA has only approved drug eluting stents to treat coronary artery disease where the lesion has been identified to be flow restrictive. However, many physicians routinely place drug eluting stents and older metal stents in coronary arteries for prophylactic purposes—that is, to prevent the further development of coronary artery disease. Despite this common practice, there is no study to show that placing a stent is effective at slowing the progression of coronary disease. On the other hand, numerous studies have demonstrated success with medication in slowing the progression of coronary artery disease. Indeed there is no evidence that a stent is more effective than medication at preventing a future myocardial infarction than medication for patients with “stable angina”.

Despite this evidence, many patients undergo angioplasty and stenting with minor chest pain and no evidence of ischemia. To justify the use of a stent, when questioned, one cardiologist attempt to expand the definition of” stable angina” or allude to the procedure as art and science and filled with judgment. Both explanations are misrepresentations of the state of the art of medicine, and appear to be attempts to expand the potential pool of patience who qualify for the procedure.

One of the primary defenses in any medical malpractice action is the physician judgment. The defense uses this magical card to explain why a physician would take a certain action despite a lack of scientific data to support the action. Essentially, the defense focuses on the gray areas of medicine where there is no right or wrong answer. The theme that medicine is not an exact science is played and the physician judgment defense fits perfectly to explain that physicians must make difficult decisions in light of little scientific data. In the context of interventional cardiology, with patients with stable angina and no evidence of ischemia, there is no judgment - the standard of care remains that medication should be used as opposed to a stent, because the risk of stent thrombosis and death outweighs any benefit of the stent.

Incredibly, when faced with a patient with moderate or non-significant disease, Physicians often will not discuss the available options with medication or the clinical trials that show that medication is as beneficial as intervention. The failure to discuss treatment options is a breach of informed consent. If you or a family member suffered an adverse event following the placement of a drug eluting stent, catheterization, or, angioplasty, please contact Mr. Lyon through the contact form at http://www.thelyonfirm.com/.