Safety of Simple versus Advanced Patient Programmer: Results from Product Surveillance Registry (4251)

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-naive 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. Disclosure: Dr. Schiess has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Schiess has received research support from Medtronic. 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 $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 as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has received stock or an ownership interest from 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. 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 $500-$4,999 for serving as a Consultant for Biohaven. The institution of Dr. Martinez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen/Novartis. The institution of Dr. Martinez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. The institution of Dr. Martinez has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie/Allergan. The institution of Dr. Martinez has received research support from Medtronic. The institution of Dr. Martinez has received research support from Boston Scientific. Hui Xiong has received personal compensation for serving as an employee of Medtronic. An immediate family member of Hui Xiong has received personal compensation for serving as an employee of Medtronic. Kulwant Bhatia has received personal compensation for serving as an employee of Medtronic. Todd Weaver has received personal compensation for serving as an employee of Medtronic.