Objective: In this report, we describe preliminary real-world clinical outcomes and patient experience following hybrid DBS conversion procedures at our center.

Background: Hybrid replacement procedures have recently been introduced (1-4) for patients previously implanted with conventional single-source deep brain stimulation (DBS) systems who may experience limitations in clinical benefit or device functionality over time. This approach employs an adapter to connect existing DBS leads to a next-generation implantable pulse generator (IPG) featuring advanced programming capabilities.

Method: In this multicenter retrospective study (NCT03664609), consecutive patients previously implanted with conventional single-source DBS systems underwent hybrid conversion to a Boston Scientific IPG using a compatible adapter. Clinical assessments, programming parameters, and motivations for conversion were documented. Data collection was performed by site personnel under standard clinical practice without sponsor involvement.

Results: To date, eleven consecutive patients (52% female) have been included. In most cases, conversion was performed due to battery depletion of the prior implantable pulse generator. Over an average 12-year history of DBS therapy, patients had received up to six IPGs. Existing DBS leads were retained and were positioned in the subthalamic nucleus (STN; n = 4), globus pallidus internus (GPi; n = 4), or ventral intermediate nucleus of the thalamus (Vim; n = 3). At two years following conversion, data from three patients with Parkinson’s disease demonstrated significant improvement in UPDRS Part III scores under Stim ON/Med ON and Stim ON/Med OFF conditions compared with Stim OFF/Med OFF. Overall, clinical outcomes before and after conversion were comparable.

Conclusion: Conversion to an advanced neurostimulator maintained clinical efficacy while supporting improved device utilization. Hybrid IPG replacement represents a safe and clinically valuable strategy for patients initially treated with conventional single-source DBS technology.

References: 1. Disep I. Ojukwu, et al. Conversion to Hybrid Deep Brain Stimulation System to Enable Multi-Contact Fractionation Can be Therapeutic. Movement Disorders, 2022. DOI: 10.1002/mds.29007
2. Derrick Soh, et al. Hybrid deep brain stimulation system to manage stimulation-induced side effects in essential tremor patients. Parkinsonism and Related Disorders 2018, DOI: 10.1016/j.parkreldis.2018.07.013
3. T. Wirth, et al. Feasibility of changing for a rechargeable constant current neurostimulator in Parkinson’s disease. Revue Neurologique, 2020. DOI: 10.1016/j.neurol.2020.02.007
4. G. Chri van der Linden, et al. Impact of two different rechargeable pulse generators on parkinsonian patients with deep brain stimulation [Abstract]. MDS conference 2022.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-clinical-outcomes-and-patient-experience-following-hybrid-dbs-conversion-to-a-neurostimulator-with-advanced-current-steering/