Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for Parkinson disease.

BACKGROUND: Subthalamic deep brain stimulation has proved significant efficacy in the treatment of Parkinson disease. Adverse events, due to surgical and hardware-related complications, must be clearly addressed to properly balance the cost-effectiveness of the therapy. In addition, limited data exists about medical adverse events after surgery.
METHODS: One hundred forty-one patients undergoing subthalamic deep brain stimulation for Parkinson disease from 1998 to 2007 were considered. Medical records, operative notes, clinical findings at follow-up and final outcome were accurately recorded to identify surgical- and hardware-related complications, infections and delayed adverse medical events.
RESULTS: Five hundred twenty-two surgical procedures were performed, including electrodes positioning and impulse programmable generators implantation and substitutions. Mean follow-up of the patients was 4.6 years (9 months-10 years). Surgical complications were observed in 5.6% of patients, including two hemorrhages (1.4%) and three (2.1%) inabilities to complete the surgical procedure. Medical delayed adverse events affected 1.4% of patients, with a patient having a fatal aspiration pneumonia. Infections were seen in 5.6% of patients; removal of the hardware was necessary in 3.6%. Hardware-adverse events were observed in 7% of patients, generally requiring minor surgery. Direct surgical mortality was 0%; overall mortality was 0.7% and permanent surgical morbidity was 0.7%.
CONCLUSIONS: Deep brain stimulation can be regarded as a safe procedure. Mortality and permanent morbidity are very low, and surgical complications are relatively rare. Nevertheless, minor complications are not infrequent; hence the importance of continuous monitoring of the patients during the follow-up period.