Despite clear warnings in medical literature, electrophysiologists continue to engage in the gravely dangerous practice of removing leads in catherization labs. Millions of Americans experience heart rhythm disorders (arrhythmia) which may require the implantation of pacemakers or defibrillators to regulate the heart rate. These devices connect to the heart muscle with leads—wires that run from the device to the heart’s chamber—which transmit electrical signals to assist the heart in maintaining a normal rate.
Lead extractions are the most dangerous procedure in the field of electrophysiology with roughly 15,000 performed annually. In fact, the rate of major complications ranges from 1.4% to 5.1%, regardless of the doctor’s experience. Statistically speaking, any doctor who regularly performs laser extractions will run into a major complication.
Though leads connected for less than a year can usually be removed with limited risk, the extraction of chronically implanted leads carries a significant risk of serious injury or death. In lengthier implants, scar tissue envelops the point at which the lead attaches to the heart and acts like shrink-wrap around the leads. Thus, to extract the leads, heart specialists must feed a laser sheath through the superior vena cava—the major vein leading to the heart—and burn through the scar tissue to remove the lead. With a wall thickness around 1 mm, the superior vena cava is particularly susceptible to perforation by the sheath. Such a disruption presents the most devastating complication because the resulting blood loss is often deadly unless the perforation is repaired immediately.
In recognition of the serious complications associated with lead extractions, medical literature maintains that lead extractions should be performed in operating rooms (OR) with an appropriate surgical team on standby and equipment to handle procedures such as sternotomy, thoracotomy, and cardiac and vascular repair. Operating in the OR allows cardio-surgical teams to intervene in a timely manner should a complication arise. Following this approach saves a life every 100 or 200 procedures.
Yet, electrophysiologists regularly perform extractions in catherization labs which lack the necessary resources to immediately respond to any major complications. A 2010 survey of lead extractions revealed that 64% of doctors who performed the procedure did so in catherization labs and 25% of those doctors did so without a surgeon or bypass machine at hand. This practice is particularly dangerous because usually there is not enough time to transfer the patient to the OR and mobilize a surgical team. Once the superior vena cava is torn, delays in surgical response of more than 5-10 minutes typically result in the death of the patient. Given the costs associated with the use of an operating room and staffing extra personnel, doctors and hospitals are hesitant to move away from extractions in catherization labs. Thus, doctors are unnecessarily and negligently putting their patients in harm’s way.
Doctors and hospitals alike must be held responsible for such egregious conduct. The attorneys at Abramson, Brown, & Dugan have extensive experience investigating and resolving various medical malpractice cases. If you or a loved one suffered death or serious injury due to lead extractions performed in a catherization lab, with or without the presence of surgeon or bypass machine, contact one of our attorneys today to discuss your specific case.
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