Nervus Vagus Stimulatie Eerste ervaringen in Nederland René MF Sorel, psychiater ZGT Almelo

Nervus Vagus Stimulatie

Werkgroep NVS-D TWIN Medisch Spectrum Twente: Enschede Twente Institute Neuromodulation: Enschede Ziekenhuisgroep Twente: Hengelo Almelo TWIN

N.-vagusstimulatie Therapie Milde elektrische pulsen afgegeven aan de linker n. vagus in de nek die signalen afgeven aan de hersenen Automatische intermitterende stimulatie Magneet gebruik voor patiënt directe controle over bijwerkingen Eenvoudig te programmeren Vagus nerve stimulation (VNS) is delivered through a pacemaker-like pulse generator surgically implanted into a subcutaneous pocket in the left chest area below the left clavicle or in the left axilla. Since FDA approval in July 1997, the VNS Therapy pulse generator system has been implanted in more than 17,000 patients world-wide. Stimulation parameters are set through a telemetric wand that is held over the area of the implanted pulse generator and controlled through special software administered by the treating physician. Electrical pulses reach the brain via the left vagus nerve, where the lead is attached. Through programming, stimulation can be adjusted for each patient. Furthermore, patients can acutely control stimulation and side effects via a hand-held magnet.

Pulsgenerator en elektrode Model 101 9 mm dik Weegt 30 g Gaat 6-11-jaar mee The VNS Therapy pulse generator is similar physically to a heart pacemaker and is the approximate size of a thin stopwatch. However, unlike a pacemaker, the patient does not have to be concerned with normal appliances, security systems, etc. The Model 102 pulse generator is connected to a single-pin, bipolar lead, which is attached to the left vagus nerve in the cervical area. The VNS Therapy implant weighs just 25 g and is approximately 7 mm thick. The Model 100 generator was approximately twice as large and heavy as the new Model 102 and had a shorter battery life. The current Model 102 has a typical battery life of 6 to 11 years, based on commonly used parameters. Upon routine battery replacement, only the pulse generator is replaced, not the lead.

Patient characteristics number of patients: 10 sexratio: M/F:0/10 ! Age : 26 t/m 60 years (mean. 4y) uni/bipolar: all unipolar length of depression: 6 – 23y (mean. 11y) number of MDE’s: 1 – 8 (mean 3,5) medication: MAO-inhib.: 0 – 1 (mean 0,8) antidepressant: 2 – 6 (mean 4,5) moodstabilizor: 1 – 2 (mean 1,3)

Overall antidepressive effect (Overall effect: % HRSD ref Overall antidepressive effect (Overall effect: % HRSD ref. to baseline) 3 months 6 months 12months HRSD24 44% 59% 53%

Response Rate (Response: 50% reduction HRSD24) 3months 6months 12months HRSD24 30% 50% 50%

Remission (Remission: HRDS24 ≤ 10) 3 months 6 months 12 months HRDS24 30% 40% 37,5%

Antidepressive effect (Overall effect: % HRSD ref. to baseline) 3 mnth 6 mnth 12 mnth + 60% 66% - 17% 46% 37%

Response (Response: 50% reduction HRSD24) ECT 3mnth 6 mnth 12mnth + 50% 66% 60% - 0% 25% 33%

Remission (Remission: HRDS24 ≤ 10) ECT 3mnth 6 mnth 12mnth + 50% 60% - 0% 25% 33%

Bijwerkingen en complicaties Adverse effects (during ‘on’-period): Hoarseness: 70% (diminishing slowly) Feelings in throath: 40 % (diminishing quickly) Tooth pain: 10% (diminished  mA) surgeon complications Infections: none Hematoma: 10% (2 weeks) NVS-technique: none

Conclusies NVS: positief effect op depressies Optimaal effect na 3-6 maanden NVS: veilig en weinig complicaties Long-term effect lijkt positief NVS is mogelijk een alternatief voor ECT

Naaste toekomst voor NVS in Nederland Meer onderzoek naar antwoord op: Kan NVS een vervangende therapie zijn voor onderhoudsbehandeling? Kan NVS een alternatief zijn waar ECT gecontraindiceerd is?

Naaste toekomst voor NVS in Nederland CVZ gaat mogelijk de onderzoeksvragen FDA ??