title: Surgical, medical, and hardware adverse events in a series of 141 patients undergoing subthalamic deep brain stimulation for Parkinson disease.
abstract: 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.
authors.affiliation: Neurosurgery Department, University of Milano-Bicocca, Milan, Italy. vergani.franza@libero.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Vergani
authors.forename: Andrea
authors.initials: A
authors.lastname: Landi
authors.forename: David
authors.initials: D
authors.lastname: Pirillo
authors.forename: Roberto
authors.initials: R
authors.lastname: Cilia
authors.forename: Angelo
authors.initials: A
authors.lastname: Antonini
authors.forename: Erik P
authors.initials: EP
authors.lastname: Sganzerla
mesh_terms: 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