This case involves an elderly female patient who was given an EKG after experiencing persistent chest pain for several weeks. A heart block was diagnosed and a pacemaker was implanted. While the patient was recovering from the surgery, she developed severe pain in her chest. The patient went to the hospital and it was determined that the lead detached and perforated the cardiac tissue. The pacemaker was removed then replaced. Following the replacement procedure, an infection was suspected and a pericardial window was ordered. The procedure revealed signs of infection around the lead and a subsequent culture revealed an anaerobic bacterial infection. In spite of antibiotic treatment, the patient’s cardiac function continued to worsen.
Question(s) For Expert Witness
- 1. How often do you place pacemakers?
- 2. What is the technique used to attach and verify that the leads are in the correct place in a case like the one described?
- 3. What is the protocol for managing a patient with suspected perforation to cardiac tissue?
Expert Witness Response E-201512
I am a clinical cardiac electrophysiologist and regularly implant cardiac rhythm devices (ie. pacemakers) and perform cardiac ablations in patients with cardiac arrhythmias. The standard of care is to use fluoroscopy to confirm that the leads are placed in the right anatomical location in the heart. After the leads are implanted, we ensure that they work adequately by evaluating the electrical performance of the leads. We confirm that the leads and pacemaker are working properly after implantation by chest X-ray and device interrogation. The protocol for managing a patient with suspected perforation to cardiac tissue is to confirm the presence of pericardial effusion using an echocardiogram. If there is evidence of hemodynamic compromise, pericardial fluid is drained using a pericardial drain. Rarely, patients may need cardiac surgery to manage a pericardial effusion that cannot be managed with a percutaneous drain. I have published 44 peer-reviewed papers in the field of electrophysiology. I have specifically published on the risk of bleeding associated with using antithrombotic therapy after implantable cardioverter defibrillator implantation and the risk of permanent pacemaker implantation after cardiac surgery.
Expert Witness Response E-230139
I conduct procedures in the electrophysiology lab 3-4 days per week. Approximately 90% of my procedures are pacemaker/defibrillator related (both implantation and removal/extraction). I implant about 250 pacemakers/defibrillators per year. The techniques vary depending on the type of lead (active fixation vs passive fixation). Most leads implanted these days are active fixation (screw-in). Access is gained into the vein and the lead is advanced into whichever chamber it is intended to go. When there is fluoroscopic (x-ray) evidence that the lead has contacted tissue in the right place, the screw is extended by turning part of the proximal portion of the lead in a clockwise direction (usually about 15-20 times). Next, the electrical properties of the lead are tested indicating how well the lead is in contact with the tissue. The protocol for management of an acute dislodgement or perforation usually includes a “lead revision” or repositioning of the lead in question. If the suspicion for perforation is high, I usually have a TEE inserted to watch for the development of an effusion and a pericardiocentesis tray available to place a drain. I am in the process of compiling my institution’s data on this specific topic (lead dislodgements) in order to look for any potential risk factors or processes that could be changed to prevent them in the future.