Five Year Outcomes of a Prospective, Multi-Center Trial Evaluating Deep Brain Stimulation with a New Multiple Source, Constant-Current Rechargeable System in Parkinson’s Disease (P4.052)

Objective: To evaluate the long-term follow up of patients in the VANTAGE Study that employed a DBS system with multiple independent current control (MICC) in the management of symptoms of Parkinson’s disease. Background: We postulated that a multiple-source, constant-current DBS device (CE marked) permitting a well-defined distribution of current would lead to motor improvement in patients with Parkinson’s disease (PD). The study demonstrated highly significant improved motor function (p Design/Methods: VANTAGE is a prospective, multi-center, non-randomized, open-label trial sponsored by Boston Scientific. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise, Boston Scientific) targeting the subthalamic nucleus and followed up to five years post-lead placement. Assessments included UPDRS III scores in the meds off condition, quality of life such as Parkinson’s Disease Questionnaire (PDQ-39), Modified Schwab and England (SE), etc. Adverse events were collected. Results: At four years post-lead placement, quality of life as assessed by PDQ-39, SE continued to show improvement as compared to baseline. Additionally, the usage of anti-parkinsonian medications continued to show a similar trend as reported earlier. This report will present the long-term motor outcomes and quality of life results at 5 years post-lead placement. Conclusions: The collected outcomes from the VANTAGE clinical trial will inform clinicians on use of this system, and its flexibility to manage symptoms of idiopathic PD. Study Supported by: Boston Scientific Disclosure: Dr. Timmermann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Jain has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Jain has received research support from Boston Scientific. Dr. Van Dyck has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Chen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Brucke has nothing to disclose. Dr. Seijo has nothing to disclose. Dr. Suarez San Martin has nothing to disclose. Dr. Visser-Vandewalle has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Medtronic and St Jude Medical; grants from Medtronic, St Jude medical, SAPIENS and Boston Scientific. Dr. Visser-Vandewalle has received research support from Medtronic, St Jude Medical, SAPIENS and Boston Scientific. Dr. Barbe has nothing to disclose. Dr. Gill has nothing to disclose. Dr. Whone has nothing to disclose. Dr. Porta has nothing to disclose. Dr. Servello has nothing to disclose. Dr. Alesch has nothing to disclose.