Objective: To present procedure-related safety of DBS IPG battery replacements and variations of therapeutic performance within the ADROIT post-market study.

Background: DBS implantable pulse generator (IPG) options include primary cell and rechargeable cell batteries. While primary cell batteries require no patient interaction to sustain therapy over their lifetime, surgical replacement upon battery depletion is required. This has raised interest regarding potential risks associated with the additional surgical interventions, and whether therapy performance is maintained following primary cell IPG replacement. Information from a large, real-world study to best inform patient care and battery selection is needed for the DBS field.

Method: ADROIT is a large, international, prospective, post-market, observational study at up to 50 centers collecting long-term safety and effectiveness data on Abbott DBS systems. Participants are enrolled prior to implant or IPG replacement and assessed at 6 months and annually for 5 years. Participants receiving DBS systems for the first-time or those receiving battery replacements for existing systems are eligible to enroll.

Results: As of December 2022, 87 participants across 8 sites in ADROIT were enrolled to replace existing IPGs with an Abbott Infinity IPG. These included 56 replacements of an existing Infinity IPG, and 23 replacements of Legacy Abbott systems. For participants with IPG replacement surgeries recorded, 1.2% (1/85) experienced an event adjudicated to be procedure related: worsening of symptoms related to gait which could be partially resolved with programming. No infections occurred in the 85 logged battery replacements. Of 62 participants completing the 6-month visit at the time of this analysis, 19 Parkinson’s disease and 11 disabling tremor were assessed with medication-on and stimulation-on at baseline and 6-months. Participants showed effective maintenance of therapy via no mean change of MDS-UPDRS part (0.9 ± 15 (2.6%, p=0.86)) and FTM-TRS (-3.6 ± 11.8 (-9.6%, p=0.68)).

Conclusion: Evaluation of primary cell battery replacement safety and performance can help inform battery selection and its associated risks. The ADROIT study has thus far shown minimal procedure-related events and effective therapy maintenance, providing continued evidence that with proper surgical technique and use of antibiotics, primary cell battery replacement is safe and effective.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-performance-of-dbs-primary-cell-ipg-replacement-an-interim-report-from-the-adroit-study/