Professor of Neurosurgery Heinrich-Heine-Universität Düsseldorf Dusseldorf, Germany
Introduction: The main goal of Deep Brain Stimulation (DBS) therapy is to achieve optimal outcomes while avoiding side effects. The challenging anatomy surrounding DBS targets requires precise control of neurostimulation. Directional DBS systems can deliver specific amounts of current to each contact using Multiple Independent Current Control (MICC), and this capability has been shown to increase therapeutic window under controlled study conditions (Dembek 2017; Schnitzler 2022). In so doing, vertical and horizontal steering of cathodic and/or anodic current can be achieved, thereby providing flexible programming options to deliver stimulation while minimizing side effects (Steigerwald 2016) (Kirsch 2018).
Methods: This is a prospective, multicenter (International), registry of up to 1500-patients implanted with directional MICC-based DBS systems (Vercise, Boston Scientific), per standard-of-care. Participants are being followed up to 3-years post- implantation whereby quality-of-life, motor symptoms improvement, overall satisfaction, and other disease aspects are measured. Adverse events and device-related complications are collected.
Results: A total of 815-patients have been evaluated. Quality-of-life as assessed by PDQ-39 out to 2-years demonstrated sustained clinically significant improvement (minimal clinically important difference [MCID] >4.7-points) despite an expected 5-point worsening due to disease progression (p < 0.001) (Horvath 2017; Reuther 2007). Improvement in motor function (MDS-UPDRS III Meds-OFF ) versus baseline were also noted (35% reduction at 2-year; p< 0.0001). To date, with >1500 directional leads implanted, no lead breakages have been reported.
Conclusion : This on-going registry represents the first large-scale collection of real-world, long-term outcomes using MICC-based directional DBS systems. Use of directional DBS systems in clinical practice has been demonstrated to be beneficial per increases in therapeutic window and associated positive outcomes. Results from this on-going evaluation demonstrate sustained improvement in overall outcomes with the use of directional DBS systems.
