EPV005 - DIRECTIONAL DBS LEADS IMPLANTED UNDER GENERAL ANESTHESIA VS. SEDATION: FINDINGS FROM AN INTERNATIONAL PROSPECTIVE STUDY (ID 193)
- Jan Vesper, Germany
- Jan Vesper, Germany
- Kim Burchiel, United States of America
- Matthew Brodsky, United States of America
- Brian Kopell, United States of America
- Julie Pilitsis, United States of America
- Nestor Tomycz, United States of America
- Leonard Verhagen, United States of America
- Girish Nair, Australia
- Andrew Evans, Australia
- Wolfgang Hamel, Germany
- Pablo Mir, Spain
- Monika Pötter-Nerger, Germany
- Joohi Jimenez-Shahed, United States of America
- Philipp J. Slotty, Germany
- Sergiu Groppa, Germany
- Sean Nagels, United States of America
- Florence Defresne, Belgium
- Edward Karst, United States of America
- Binith Cheeran, United States of America
- Alfons Schnitzler, Germany
Abstract
Introduction
Traditionally, deep brain stimulation (DBS) leads are implanted under local anesthesia or conscious sedation to allow intraoperative testing for effects (awake procedure). Recently, asleep DBS has been investigated. Two different approaches exist to enable lead implantation under general anesthesia with intubation (asleep procedure): 1) using intraoperative image-guided targeting only and 2) reducing anesthesia to allow for microelectrode recording.
Methods/Materials
The PROGRESS study compared therapeutic window (TW), the difference in amplitude between side effect threshold and minimum therapeutic current, for directional vs. omnidirectional stimulation in subjects receiving STN DBS for Parkinson’s disease. This post-hoc analysis compares therapeutic window and UPDRS motor scores at 3, 6 and 12 months in subjects with awake vs. asleep procedures.
Results
The PROGRESS study enrolled 234 subjects and met its primary endpoint of superiority with 90.6% of subjects having a wider TW using directional stimulation. A total of 160 subjects underwent an awake procedure and 69 subjects underwent an asleep procedure. Three months after initial programming, directional stimulation increased TW by 0.84 mA for the awake implants (2.18±1.36 mA for omnidirectional stimulation; 3.02±1.30 mA for directional; p<0.001)) and 0.88 mA for the asleep implants (1.92±1.22 mA for omnidirectional stimulation; 2.83±1.53 mA for directional; p<0.001). At three months, UPDRS motor scores on medication were 42.4% lower in the awake group and 43.1% in the asleep group, compared to off stimulation scores. At 6 months, the improvement remained similar with 44.6% reduction in UPDRS motor scores in the awake group and 41.6% in the asleep group. Additional results including 12-month data will be available for presentation.
Discussion
In a large international study, directional stimulation was associated with a similar increase in therapeutic window, regardless if the DBS system was implanted using an asleep versus awake procedure. UPDRS motor score improved similarly in both groups. Asleep DBS was able to achieve a comparable range of symptom relief, and may offer more comfort to the patients.
Conclusions
Directional programming increased therapeutic window when using either an awake or asleep procedure for DBS implant.
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