Objective: To describe surgical practices in a cohort of patients with Parkinson’s disease (PD) undergoing deep brain stimulation (DBS).

Background: DBS is well-established to improve PD motor symptoms. However, disparities in motor and non-motor outcomes exist. Real-world data (RWD) captured in a patient registry can establish real-world evidence (RWE) of best practices to fill knowledge gaps related to DBS that cannot be accomplished through randomized trials.

Method: 20 participating sites prospectively collect data elements representing a combination of clinical data and patient reported outcomes.  An electronic data repository facilitates data review for completeness and subject retention in the registry. Surgical data captured includes a modified frailty index, information about surgery staging and duration, targeting and laterality, lead and pulse generator types, method of stereotaxis, anesthesia methods, infection control measures, surgical complications, discharge disposition, readmission and return to the operating room.

Results: 132 subjects have complete baseline data revealing variable disease and psychosocial characteristics. Amongst 76 completed surgeries, the mean modified frailty index was 0.23 (median 0.18, IQR 0.18-0.27). 74% were implanted in the subthalamic nucleus and 23% in the globus pallidus interna. 79% were bilateral procedures and most were staged using various stereotactic equipment. Intraoperative sedatives (68%) consisted mostly of propofol and/or dexmetomidine. Infection control measures included pre-operative sterile scrub and sterile prep of the operative site (100%), pre-operative intravenous antibiotics (95%), intra-operative antibiotic irrigation (89%), vancomycin powder (39%), and post-operative antibiotics (68%).  One (1.4%) intraoperative complication was reported, consisting of an intraoperative hemorrhage that resolved without sequelae. The final discharge disposition for all subjects was to home. Two patients were readmitted to the hospital within 30 days of lead implantation and involved an unplanned return to the OR. At 6 months (n=19), the majority of patients improved across motor and non-motor measures.

Conclusion: These early results confirm feasibility of RWD collection related to DBS procedures for PD. Through analysis of this data, combined with long term follow-up, RWE related to best surgical practices can be generated.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/preliminary-real-world-surgical-data-collection-in-rad-pd/