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Abstract Details

Monitoring Safety and Effectiveness of Deep Brain Stimulation Systems in a Real-World Population: The Product Surveillance Registry
Movement Disorders
P1 - Poster Session 1 (5:30 PM-6:30 PM)
10-025
The Product Surveillance Registry (PSR) was developed to prospectively track device performance and outcomes data in deep brain stimulation (DBS) patients utilizing a standard format.
DBS is a well-established, effective therapy in the treatment of movement disorders such as Parkinson’s disease (PD), Essential Tremor (ET), and Dystonia. Barriers to DBS include patient safety concerns, burden of patient management, and a potentially long and complex implant procedure. To assess these concerns, the PSR collects long-term, real-world data to monitor safety and performance with a goal of informing patients and clinicians. 
The PSR is a prospective, long-term, multi-center global DBS registry originated in 2009. The PSR enrolls both newly-implanted patients as well as patients receiving a replacement device. Each group is followed prospectively for events related to device, procedure and therapy. 

2,520 patients have been enrolled at 38 centers since July 31, 2018; 1689 received their first device (67%); mean age 62 ± 12 years; 61.5% male. Mean years from disease onset to DBS implant for therapy-naive patients was 12.7 years ± 10.2 years. Most common indications for DBS were PD, ET, and Dystonia. Device survival rates (freedom from product performance events) showed Medtronic DBS neurostimulator survival at 98% at 5 years, lead survival greater than 87% at 8 years, and extension survival at 96% at 8 years. Most common non-product performance (clinical) events included issues with stimulation, wound site infections, and worsening depression. For all indications, survival from lead revision or explant was 98.2% (95% CI: 97.6% to 98.6%) at 6 months and 92.4% (95% CI: 90.5% to 94.0%) at 8 years.

 
The PSR prospectively captures valuable real-world information from a heterogeneous group of centers. This information is used to guide future product development efforts aimed at improving product reliability and quality and inform clinicians and patients on safety and effectiveness.
Authors/Disclosures
Fernando L. Pagan, MD, FAAN (Georgetown University Hospital Dept of Neurology)
PRESENTER 		Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for US World Meds. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has stock in Keiferx. The institution of Dr. Pagan has received research support from US World Meds. The institution of Dr. Pagan has received research support from Novartis.
Mya C. Schiess, MD, FAAN (Univ of Texas-Houston Med School) Dr. Schiess has nothing to disclose.
Leonard Verhagen Metman, MD, PhD (Northwestern University) Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerevel. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers.
George M. Plotkin, MD, PhD The institution of Dr. Plotkin has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic.
Kenneth P. Martinez, MD (Neurology & Pain Specialty Center) The institution of Dr. Martinez has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. The institution of Dr. Martinez has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie/Allergan. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. The institution of Dr. Martinez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie/Allergan. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merz. The institution of Dr. Martinez has received research support from Medtronic. The institution of Dr. Martinez has received research support from Abbvie/Allergan.