Abstract Details

Title Safety of Simple versus Advanced Patient Programmer: Results from Product Surveillance Registry

Topic Movement Disorders

Presentation(s) Movement Disorders Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 104

Objective Deep Brain Stimulation (DBS) is a well-established treatment for movement disorders. Clinic visits can be minimized by allowing patients to adjust their device independently. The current analysis compared the occurrence of serious adverse events of simple (physician only adjusted) versus advanced (physician and patient adjusted) programming of DBS implants studied in a large global registry.

Background To achieve optimal performance, patients undergo time-consuming programming to adjust parameters. The use of an interactive (advanced) programming feature allows clinicians to define settings on patient programmers and enables their patients to self-adjust therapy programs in between clinic visits.

Design/Methods The Product Surveillance Registry (PSR) was established, as a prospective long-term, multi-center global registry to monitor the reliability and safety of DBS systems. Current analysis represents the data from 297 DBS therapy-naïve Parkinson’s patients (306 devices) collected at 27 centers from July 2013 through April 2020. The serious clinical adverse event and programming-related serious clinical adverse event rates were calculated within 9 months following implantation. The adverse event rate was compared between simple versus advanced programming using Fisher’s Exact test.

Results There is no significant difference in age and other baseline characteristics between the two groups and 25.6% of the patients in the analysis cohort used the advanced programming feature. The occurrence of serious clinical adverse events within 9 months was significantly higher in simple programming modes (11.76% versus 2.63%; p-value=0.0209). The programming-related serious adverse event rate did not reach statistical significance (1.81% in simple mode; 1.32% in advanced mode; p-value=1.00).

Conclusions The data from real-world usage of DBS implants supports the safety of advanced programming management and supports the safety of remote self-programming adjustments, thus reducing additional clinic visits. Further analysis/comparison between the two programming modes may be conducted to better understand the safety/effectiveness of advanced mode patient programming for future technical innovations and remote care options.

Authors/Disclosures
Mya C. Schiess, MD, F�鶹��ýӳ�� (Univ of Texas-Houston Med School) PRESENTER	Dr. Schiess has nothing to disclose.
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.
Fernando L. Pagan, MD, F�鶹��ýӳ�� (Georgetown University Hospital Dept of Neurology)	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.
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.
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.
	No disclosure on file
Kulwant Bhatia (Medtronic, Inc.)	Kulwant Bhatia has received personal compensation for serving as an employee of Medtronic.
	No disclosure on file

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