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.
Vergani
Francesco
F
Neurosurgery Department, University of Milano-Bicocca, Milan, Italy. vergani.franza@libero.it
Landi
Andrea
A
Pirillo
David
D
Cilia
Roberto
R
Antonini
Angelo
A
Sganzerla
Erik P
EP
D000368:Aged; D000075202:Contraindications; D046690:Deep Brain Stimulation / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D004566:Electrodes / Q000009:adverse effects / Q000592:standards; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007049:Iatrogenic Disease / Q000517:prevention & control; D020300:Intracranial Hemorrhages / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D007431:Intraoperative Complications / Q000209:etiology* / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009026:Mortality; D010300:Parkinson Disease / Q000503:physiopathology / Q000628:therapy*; D011015:Pneumonia, Aspiration / Q000209:etiology / Q000517:prevention & control; D011183:Postoperative Complications / Q000209:etiology* / Q000473:pathology; D012189:Retrospective Studies; D018570:Risk Assessment / Q000592:standards; D013238:Stereotaxic Techniques / Q000009:adverse effects / Q000295:instrumentation; D020531:Subthalamic Nucleus / Q000033:anatomy & histology / Q000502:physiology / Q000601:surgery*; D013530:Surgical Wound Infection / Q000209:etiology / Q000517:prevention & control