Surgical and Clinical Procedure
epilepsy/seizure, seizure
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
The patients needed to have a minimum of 2 full consecutive calendar months of seizure diary before DBS surgery. At the baseline visit, seizure diary data and other inclusion and exclusion criteria were reviewed to determine whether patients remained eligible to continue participation in the study. The implant visit was then performed according to the physician's standard clinical practice. To ensure the use of CE-marked implantable devices, the protocol called for implant with Medtronic Model 3387 DBS leads (Medtronic PLC, Dublin, Ireland), connected to a dual channel Activa PC Neurostimulator (Medtronic) via extensions tunneled subcutaneously, according to the labeling. However, the final selection of the leads was performed by the DBS center. DBS electrodes were aimed to be implanted in the ANT bilaterally using a stereotactic technique. The implantation procedure was performed per local standard clinical practice. Lead positions were verified postoperatively with MRI and/or CT. The decision of a need for reimplantation was based on the clinical judgment of the operating center. Timing and dosage of stimulation, we well as medication adjustments were per each center's chosen clinical practice, but mainly driven by SANTE study advised practice.Once enrolled, patients were followed at least for 24 months (to comply with the primary objective of the registry). An extension of the follow-up to 5 years was implemented in February 2016, that is, after some patients had already exited the original study, and was discontinued when all subjects reached 2 years, that is, before some subjects could reach 5 years. Follow-up visits took place according to clinical practice. Visits were grouped in intervals of 3, 6, and every 6 months thereafter. Adverse events and/or device events were reported per the Clinical investigation of medical devices for human subjects—good clinical practice (ISO 14155:2011), which calls for any change in frequency or severity of a symptom to be reported. All events (including worsening of epilepsy/seizure) were classified using the Medical Dictionary for Regulatory Activities version 22.0; an external adjudication committee reviewed all adverse events for potential relation to DBS devices, programming, or procedures. Medications were coded using World Health Organization Drug version 2b2016SEP.