Objective: The intent of this analysis was to characterize real-world safety of deep brain stimulation (DBS) in patients with ≤7.5 years between Parkinson’s disease (PD) onset and device implant.

Background: A randomized controlled study recently demonstrated the benefits of DBS of the subthalamic nucleus on quality of life and motor disability in patients with PD and early motor complications. The average disease duration in that study was 7.5 years compared to an average of more than 10 years in other studies of DBS for PD. The Implantable Systems Performance Registry (ISPR) is a prospective, long-term multicenter registry used to monitor the performance of products. This Medtronic registry reflects real-world product use and can be used to summarize safety aspects for various subgroups.

Methods: Baseline information and device/implant data are collected for patients who enroll in the registry. All patients are followed prospectively for events that are related to the device, implant procedure, and/or stimulation therapy. Adverse events are reported upon awareness. Safety characteristics were compared for the overall DBS population with PD and the subgroup with PD onset ≤7.5 years from DBS implant (Earlier in PD subset).

Results: As of January 31, 2015, there were 421 patients from 17 sites in 6 countries who reported both a date of first DBS implant and PD onset. Of this total DBS population, the Earlier in PD subset included 168 patients; this represented approximately 40% of the total DBS population. The rate of adverse and device events in the overall cohort was approximately 0.020 per month of follow-up. The event rate for the Earlier in PD subset was 0.017 per month of follow-up. The rate of serious events by etiology was consistent between the overall cohort and the Earlier in PD subset.

Conclusions: In general, there are no substantial differences in safety aspects between the Earlier in PD subset and the overall DBS patient cohort. Data from real-world use support the safety of DBS in patients with PD onset ≤7.5 years. Schuepbach WMM, Knudsen JRK, Volkmann J, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. 2013;368:610-22. Follett KA, Weaver FM, Stern M, et al. Pallidal versus subthalamic deep-brain stimulation for Parkinson’s disease. N Engl J Med. 2010;362(22):2077-2091.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-safety-of-deep-brain-stimulation-in-patients-with-7-5-years-between-disease-onset-and-device-implant/