Abstract Details

Title Long-Term Motor Function and Quality of Life Outcomes from a Prospective, International DBS Registry

Topic Movement Disorders

Presentation(s) P10 - Poster Session 10 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-003

Background Large patient data registries may facilitate insights regarding real world, clinical use of DBS. Furthermore, no registry database currently exists for a multiple-source, constant-current DBS system.

Objective We report the collected outcomes from a large-scale registry of a Deep Brain Stimulation (DBS) system capable of Multiple Independent Current Source Control (MICC) in the management of symptoms of levodopa-responsive Parkinson's disease (PD).

Design/Methods The Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. The Vercise DBS system (Boston Scientific) is a multiple-source, constant-current system. Subjects were followed up to 3-years post implantation where their overall improvement in quality of life and PD motor symptoms was evaluated. Clinical endpoints evaluated at baseline and during study follow included Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change. Subjects underwent either sleep or awake DBS implantation procedures.

Results To date, 822 patients have been enrolled (752 implanted). Improvement in quality-of-life (QoL), as assessed by PDQ-39, demonstrated improvement following implant at 6-months (-6.1-point change, p<0.0001) and up to 2-years (-2.4-point change) as compared with Baseline. Subjects with milder impairment (1545). This trend was also noted in subjects with worse disease state at Baseline (Hoehn & Yahr ≥3) who reported a greater improvement in PDQ-39 summary index. At 1-year post-implant (n=272), a 32% improvement in MDS-UPDRS III scores (stim on/meds off) compared with baseline was reported and sustained up to 2-years (n=51). Stable neuro-psychometric status (BDI-II, MoCA) was also reported. The safety profile was comparable to other published reports.

Conclusions This DBS registry represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current DBS system.

Authors/Disclosures
Guenther Deuschl, MD, FAAN (Dept. of Neurology, Christain-Albrechts Univ) PRESENTER	Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific Cavion Functional Neuromodulation. The institution of Dr. Deuschl has received research support from Medtronic. Dr. Deuschl has received publishing royalties from a publication relating to health care.
Roshini Jain	Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific.
	No disclosure on file
	No disclosure on file
Michael Barbe	No disclosure on file
Steffen Paschen	No disclosure on file
Chong S. Lee, MD, FRCPC (CHA Bundang Medical Center, CHA University)	Dr. Lee has nothing to disclose.
Andrea Kuehn	Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific.
	No disclosure on file