Botched Removal of Pacemaker and Defibrillator Lead Wires Can Result in Wrongful Death
10.2.15 Millions of Americans are afflicted with heart rhythm disorders requiring the insertion of pacemakers or implanted defibrillators. These devices utilize leads, a wire that runs from a pacemaker or implantable defibrillator into the heart’s chambers. The lead wire attaches to the heart muscle and “assists” the heart maintain rhythm through the emission of electrical signals from the device as the patient requires it. Like anything device that is implanted in the human body, over time, scar tissue forms around the leads making their removal, at the appropriate time, more difficult. Typically, during a removal procedure, an electrophysiologist (a doctor who specializes in heart rhythm disorder) uses a laser to burn through the scar tissue encapsulating the lead wires. However, in order to accomplish this, the laser must go through the major vein leading to the heart and into the chamber of the heart where the lead is attached. No matter what the doctor’s level of experience and skill is in performing this procedure, the tearing of the vein (or tearing of the heart) is an unavoidable risk that results in internal bleeding. If the bleeding is not effectively repaired immediately, that blood loss can be fatal.
Recent studies have found that although only heart specialists perform this procedure, the rate of major complications is between 1.4% and 5.1%. It is also estimated that between 10,000 and 15,000 lead wires are extracted each year around the world. Despite this high risk of a major complication and high number of procedures being performed, the physicians who perform this procedure typically do not do it in a traditional operating room, but rather, do it in a standard catheterization lab with a surgical team that is “on-call” only and a heart bypass machine that is nowhere to be found. For a procedure that could go horribly wrong, and in which patient rescue depends upon surgical intervention within minutes, its routine performance in a non-operating room setting is mind-boggling. Within the last 10 years, Duke University Medical Center bucked this trend, issuing a policy that required laser lead extractions to be performed in an operating room with a cardiothoracic surgeon present after concluding that it was likely that patients would die during this procedure if a major complication occurred and the patient was not in an operating room with an available surgeon and bypass machine.
Despite this fact, many doctors continue to put their patients at risk of needless harm. A more recent survey of physicians who perform laser lead extractions in 2010 found that 64% of them still perform the procedure in a non-OR setting. 25% of the surgeons also indicated that they perform the procedure without the presence of a surgeon or bypass machine.
If you or a loved one has suffered a serious injury or death as the result of a laser lead extraction that was performed in a catheterization lab and/or without the presence of a surgeon or bypass machine, call our attorneys for a free consultation at (410) 385-2225. Our medical malpractice team routinely handles these kinds of cases in the Baltimore and Washington D.C. areas.