Setting Up a Successful Vagus Nerve Stimulation Service for Patients With Difficult-to-Treat Depression

Abstract

Background: A substantial number of patients with major depressive disorder (MDD) do not sufficiently remit after the first lines of antidepressant treatments, making them vulnerable to poor clinical outcomes. Patients who have not had adequate resolution of their depressive symptoms after four antidepressant treatments and/or have been experiencing their current episode of MDD for two years or more (with insufficient responses to adequate antidepressant treatments) should be evaluated for antidepressant vagus nerve stimulation (VNS Therapy). Adjunctive VNS Therapy is a promising long-term treatment option for patients with difficult-to-treat depression (DTD), offering significantly improved remission rates in comparison with usual treatments. However, VNS Therapy requires specialized treatment centers to support patients. Materials and Methods:In this narrative review, we aim to outline the necessary steps for setting up an antidepressant VNS Therapy service in an efficient manner.Results: Establishing a VNS Therapy service requires several high-level considerations: initiation of a collaborative multidisciplinary team of health care professionals; developing a surgical pathway for implantation; consideration of reimbursement and health care coverage; setting up a specialist clinic to identify optimal candidates for VNS Therapy; educating patients and their families about VNS Therapy; and training health care providers on patient-specific VNS Therapy treatment and long-term treatment management.Conclusions: Antidepressant VNS Therapy is a promising treatment option for the long-term treatment of patients with DTD. We have successfully initiated four VNS Therapy service centers for DTD in the United States, Austria, and Germany. Based on our experiences and lessons learned, herein, we have provided advice to psychiatric centers planning to set up a VNS Therapy service for their patients with DTD.

Impact of Adjunctive VNS on Drug Load, Depression Severity, and Number of Neuromodulatory Maintenance Treatments

“…This analysis revealed a significant decrease in the mean number of neuromodulatory maintenance sessions (ECT or esketamine) after six months of VNS treatment compared to the first six months of VNS. These results support the assumption of a delayed onset of the antidepressant action of VNS [17]. The number of maintenance sessions was higher in the first half of the observation period when VNS presumably did not exert full antidepressant efficacy.…”

“…Furthermore, medication reduction was not the primary goal of this study or treatment, and the patients were treated in a naturalistic design. Given that the onset of antidepressant efficacy of VNS may occur with a latency of several months [17], it is reasonable to maintain medication for relapse prevention even in cases of improvement. Interestingly, patients with a history of ECT non-response had a higher medication load both at baseline and at 12 months, which can be explained by the strategy that in the case of ECT non-response treatment options are limited and healthcare professionals may tend to intensify medication more strongly than in ECT responders.…”

Treatment‐resistant depression: definition, prevalence, detection, management, and investigational interventions

“…VNS has proven to be efficacious in patients with higher-order TRD (i.e., equal or greater than four prior antidepressants), and has also demonstrated durability of eff ect with maintenance treatment [234][235][236] . The FDA has approved VNS in TRD patients with a history of at least four prior failed antidepressants.…”

Vagusnervstimulation (VNS) als Behandlungsoption für Depressionen

“…9-18 % angegeben, wobei unzureichende Wirksamkeit, Dysfunktion des Geräts oder Infektionen die häufigsten Ursachen darstellen [9]. Für die Indikation chronische und therapieresistente Depression erfolgten bislang mehr als 4000 Implantation weltweit [7], wobei genau Zahlen für Deutschland nicht vorliegen.…”

“…Ein Elektrodenkabel, welches unter der Haut geführt wird, verbindet das Aggregat mit den Elektroden am Nerv. Bei der VNS erfolgt kein invasiver Eingriff am Gehirn [7]. Nach psychiatrischer Indikationsstellung erfolgt die Operation in der Regel neurochirurgisch ambulant oder im Rahmen eines stationären Aufenthaltes mit einer Übernachtung.…”