Objective: To analyze the long-term safety of Deep Brain Stimulation (DBS) procedures for patients with movement disorders.

Background: DBS is currently indicated to treat several symptoms of different movement disorders, mainly Parkinson’s disease (PD), dystonia and Tourette syndrome (TS). At present, only few systemic observations on long-term safety are available.

Methods: We conducted a standardized recording and analysis of all the adverse events or side effects presented by the 261 consecutive adult or pediatric patients (166 PD patients, 88 patients with primary or acquired dystonia, 5 patients with TS, one patients with Huntington disease and one with tremor) who underwent DBS surgery from January 1996 to December 2015 at Carlo Besta Institute. Adverse events and side effects were collected and classified as transient, persistent (if not improved by turning the stimulator off for a short while), stimulation-induced (present at optimal stimulation parameters, but improved when stimulator was turned off or stimulation settings were changed), device-related, or unrelated to the procedure or stimulation.

Results: By average, post-operative FU was 58.8 ±43.8 months. A total of 530 leads (average 1.9 ±0.5 per patient) was implanted; among them, 29 leads were implanted after the removal of the previous ones, respectively following lead fracture (72.4%), infection (17.2%) or malpositioning/migration (10.4%). The frequency of transient intra/perioperative adverse events was 3.8% (10/261 patients), mainly confusion or hallucinations. Transient (1.5%) or persistent (0.8%) neurological deficits were associated to the brain procedures. Bacterial infections at pulse generator implantation site or along the extension was demonstrated in 7 patients (2.7%). In all of them, but two, appropriate medication or lead re-implant resolved the problem. Device-related complications included several unexplained switching-off of either or both pulse generators, in 8 patients, leading to significant motor worsening. The incidence of adverse events and side effects was comparable between PD and dystonic patients.

Conclusions: Our data suggest that the DBS procedures, if performed with accuracy and after strict patient selection criteria, are relatively safe and reassuring and the global burden of complications is acceptable, even in the long-term follow-up.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-of-deep-brain-stimulation-for-movement-disorders-a-single-centre-long-term-standardized-recording-and-analysis/