Real-world Outcomes Using DBS Systems with Directionality and Multiple Independent Current Control: USA Experience
Michael Okun1, Kelly Foote1, Theresa Zesiewicz2, Yarema Bezchlibnyk2, Alexander Papanastassiou3, Juan Ramirez Castaneda3, Jonathan Carlson4, Jason Aldred5, Vibhor Krishna6, Corneliu Luca7, Jonathan Jagid8, Jennifer Durphy9, Leonard Verhagen Metman10, Sepehr Sani11, Steven Ojemann12, Drew Kern12, Ritesh Ramdhani13, David Weintraub14, Abdolreza Siadati15, Bharathy Sundaram16, Cong Zhi Zhao17, Derek Martinez18, Mustafa Siddiqui19, Stephen Tatter20, Lilly Chen21, Edward Goldberg21
1University of Florida, 2University of South Florida, 3University of Texas, San Antonio, 4Inland Neurosurgery and Spine, 5Selkirk Neurology, 6University of North Carolina, Chapel Hill, 7University of Miami, 8University of Miami School of Medicine, 9Albany Medical Center, 10Northwestern University, 11Rush University Medical Center, 12University of Colorado, 13Northwell Health, 14Nassau University Medical Center, 15Forth Worth Brain and Spine Institute, 16Texas Institute for Neurological DIsorders, 17St. Luke'S Neurology, 18St. Luke's Regional Medical Center, 19Wake Forest University School of Medicine, 20Wake Forest Univ School of Medicine, 21Boston Scientific Neuromodulation
Objective:
Here, we present preliminary outcomes from an ongoing prospective, multicenter outcomes registry conducted at centers in the United States consisting of patients implanted with directional Deep Brain Stimulation (DBS) Systems capable of multiple independent current control (MICC) for use in management of the motor signs and symptoms in Ievodopa-responsive Parkinson's disease (PD).
Background:
DBS is an effective strategy for reducing PD motor complications. Clinical data collected from a wide variety of implanting centers (based on standard of care) treating PD patients may help provide addtional insights regarding real-world, clinical use and outcomes of DBS.
Design/Methods:
Prospectively-enrolled participants were implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant- current system, and assessed up to 3-years post-implantation as part of an on-going DBS patient outcomes registry (clinicaltrials.gov identifier: NCT02071134). Clinical measures recorded at baseline and during follow-up included MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications were also collected.
Results:
To date, a total of 141-subjects (mean age: 64.0 ± 9.0 years, 71.5% male, disease duration 9.4 ± 5.1 years, n=137) have been enrolled to date, and 116 of these have undergone device activation. A 53.4% improvement (27-points, p<0.0001) in motor function was noted at 6-months as assessed by the MDS-UPDRS III in the "off'' medication condition. At 6-months follow-up, over 95% of subjects and over 90% of clinicians noted improvement as compared with Baseline. To date, no lead fractures or unanticipated adverse events were reported. Additional and updated data will be presented.
Conclusions:
Real-world outcomes from this large, prospective, multicenter outcomes registry demonstrated improvement in motor function, quality-of-life, and satisfaction following DBS. This on-going registry will continue to provide insight regarding application of MICC-based directional DBS Systems for PD as applied in real-world settings.