Objectives: Identify and determine the frequency of adverse events related to STN-DBS for PD in a risks management strategy project.
Materials and Methods: Data from fifty consecutive patients were prospectively collected. Follow-up ranged from 5 to 36 months (median 17). There were 30 males and 20 females. Disease duration was 13G5 yearsand age at surgery 64G8. Pre-operative scores: Hoehn and Yahr OFF 3.4 G0.8, ON 2.5 G0.7; UPDRS OFF 46.8G14.4, ON 24.8G9.3; ADL 11 G5.2; dyskinesia 5.3 G2.4; fluctuations 3.9 G1.4. Pre-operative medication 1100 mgG500 mg ELD. Localization waswith MRI, and CRW frame wasused. One tract microelectrode recording obtained in most; macrostimulation carried out in 49; four daystrial stimulation in all; all patientsreceived per-operative antibiotic. A post-operative MRI obtained within 24 hours.
Results: Electrodesplacement took 3 h 50 m, and generator 1 h 10 m. Complicationswere: one frame displacement and two electrodes malposition leading to repositioning; one air embolus; one seizure and one panic crisis requiring rescheduling; one delayed infection and two connector wounds dehiscence requiring surgery; six transient confusional state. There was no hemorrage. Post-operative scores: UPDRS 27.7G11.6; ADL 12.7G6.7; dyskinesia 0.5G1.4; fluctuations0.3 G0.9. Twenty two patientsremained drug free; medication was decreased by 55% in the others. Conclusion: Identification and analysis of adverse events is a necessary step in surgical risks management. According to our surgical population and methodology, we confirm that the risk benefit ratio of STN-DBS in PD islow, and might improve further with some changesin management.