Surgeon Does Not Secure Leads During Pacemaker Placement

This case involves a forty-seven-year-old female who had a pacemaker installed when she was twenty-five-years-old. Approximately fifteen years following the placement of her pacemaker, there was a suspicion that the patient contracted an infection in the leads of the device. The treating surgeon decided to implant a new pacemaker, but he decided to leave the infected leads in place. About a year later, the patient had a scheduled back x-ray, and the imaging technician identified cardiac lead wires appearing out of place. This physician chose not to cap and suture the leads to the chest wall. The cardiothoracic surgeon suggested that no intervention was needed and said there was no reason to operate on the patient for this issue. During the months that followed, the patient developed significant hemodynamic flow complications and required corrective surgery. Following her treatment, the patient suffered from permanent vascular complications, which included intractable leg edema.

Question(s) For Expert Witness

1. Did this patient require further investigation once the leads were determined to be out of place?

Expert Witness Response E-000069

Pacing systems consist of a pulse generator and pacing leads. With permanent systems, endocardial leads are inserted transvenously and advanced to the right ventricle and/or atrium, where they are implanted into the myocardial tissue. The pulse generator is placed subcutaneously or sub-muscularly secured in the chest wall. Lead dislodgement generally occurs within two days of device implantation and may be seen on chest radiography. Alternatively, fluctuating impedance may be a subtle clue, as the patient may have normal impedance when the lead is in contact with the endocardium, but infinite (or very high) impedance when the lead is dislodged. Free-floating ventricular leads may trigger malignant arrhythmias and for the surgeon to claim that no intervention was needed in the patient of this case is, in my opinion, undoubtedly negligent.