Long-term Outcomes in Patients Implanted with DBS Systems Capable of Directionality and Multiple Independent Current Control
Michael Okun1, Yarema Bezchlibnyk2, Kelly Foote1, Theresa Zesiewicz2, Alexander Papanastassiou3, Okeanis Vaou4, Jason Aldred5, Jonathan Jagid6, Corneliu Luca6, Vibhor Krishna7, Brian Dalm8, Jennifer Durphy9, Julie Pilitsis10, Leonard Verhagen Metman11, Drew Kern12, Yarema Bezchlibnyk2, Ritesh Ramdhani13, Bharathy Sundaram14, Derek Martinez15, Cong Zhi Zhao16, Mustafa Siddiqui17, Stephen Tatter18, Lilly Chen19, Rajat Shivacharan19, Jonathan Jagid20, Edward Goldberg19
1University of Florida, 2University of South Florida, 3University of Texas, San Antonio, 4UT Health San Antonio, 5Selkirk Neurology, 6University of Miami, 7University of North Carolina, Chapel Hill, 8Ohio State University, 9Albany Medical Center, 10University of Arizona, 11Northwestern University, 12University of Colorado, 13Northwell Health, 14Texas Institute for Neurological DIsorders, 15St. Lukes Regional Medical Center, 16St. Luke's Regional Medical Center, 17Wake Forest University School of Medicine, 18Wake Forest Univ School of Medicine, 19Boston Scientific Neuromodulation, 20University of Miami School of Medicine
Objective:
This on-going registry seeks to collect/analyze real-world clinical outcomes out to 2-years follow-up in levodopa-responsive Parkinson's disease (PD) patients implanted with DBS systems equipped with Multiple Independent Current Control (MICC) and Directionality.
Background:
Tracking those being treated for PD motor symptoms offers insight regarding the outcomes associated with the implanted DBS systems that are utilized by patients in the real-world clinical setting.
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 MOS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GI(), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.
Results:
Enrollment and device activation consists of 174-subjects (mean age: 64.2 ± 8.7 years, 68.5% male, disease duration 9.3 ± 5.1 years, n = 168) and 142-subjects, respectively. Assessment of MDS-UPDRS Ill in "off" medication condition demonstrated a 51% improvement (25-points, p<0.0001) in motor function at 6-months. This level of motor function improvement was maintained out to 1-year (22-point improvement) and to 2-years (24-point improvement) follow-up. As compared with baseline, over 93% of patients and over 89% of clinicians noted improvement (GIC) at 6-, 12-, and 24-months follow-up. Outcomes were improved in various quality life measures (PDQ-39): mobility, activities of daily living, bodily discomfort, emotional well-being, and stigma. To date, no lead fractures or unanticipated adverse events were reported. Additional results derived from on-going data collection will be presented.
Conclusions:
Following DBS, outcomes derived from this on-going multicenter, prospective registry demonstrated improved motor function, quality-of-life, and satisfaction. 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.
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