This case takes place in New York and involves a female patient who had a pacemaker placed. The leads used were manufactured by a well-known medical device manufacturer, and were to be monitored for lead failure. Several years after the pacemaker was placed, the patient presented to her cardiologist – at which point it was recommended that they remove one of the leads. During surgery for removal of the lead, the surgeon decided to remove an additional lead. A complication occurred during this part of the procedure, resulting in the patient passing away. While a complication like the one identified is a known risk of the procedure, there was no informed consent to remove the additional lead for this patient. Further, this had never been discussed with the patient and her family. Medically, there was no reason to remove this lead as it had been functioning properly.
Question(s) For Expert Witness
- 1. Do you routinely perform the procedure in question?
- 2. If so, do you believe it's a departure from the SOC to remove a lead without a signed informed consent / discussing this procedure with the patient?
- 3. Intra-operatively, given the presence of significant blood and a large laceration, should the procedure have been aborted or, at the very least, should radiographic testing been ordered?
Expert Witness Response E-006662
I do perform this procedure. Although we routinely tell patients ahead of time that we always prepare for all possibilities during these procedures, it often is difficult to predict whether another lead may need to be removed as well. Sometimes the other lead needs to be removed to facilitate the removal of the problematic lead. Therefore I believe this does occur sometimes, though again we try to tell patients that unforeseen circumstances may change our procedure. A new pericardial effusion during an extraction procedure almost always means there has been a tear of some type. This is presumably why the cardiac surgeons were called into the procedure. I would have to examine the details and timing of what occurred next, whether there was intervention for the pericardial effusion at its initial discovery. That should have prevented the patient’s demise.
Expert Witness Response E-007567
I routinely perform lead extractions like the one described in this case overview. Informed consent in a case like this should always include potential removal of all leads as inadvertent injury to bystander leads is always a possibility. This is not always spelled out specifically in the consent, but it would represent a deviation from standard of care if the surgeon failed to discuss this possibility. It’s not clear to me how the pericardial effusion (fluid) was diagnosed. Usually, this would be done using imaging such as echocardiography. Additional, imaging beyond ultrasound would not be indicated, but a significant pericardial effusion would be reason enough to abort the procedure. More details surrounding the involvement of the surgical team and what was done after the pericardial fluid was identified would be helpful in determining appropriateness of care.