Invasive vagus nerve stimulation (VNS) is an adjunctive long-term treatment option for chronic and recurrent difficult-to-treat depression (DTD).

In this prospective observational open-label case series we report on the effects of invasive VNS on depression severity, medication load and the need of maintenance electroconvulsive therapy (ECT) and esketamine treatment after 12 months.

Patients were treated with invasive VNS according to clinical indication. All patients were included in the Restore-Life-Study. The assessment of depression severity (MADRS) and concomitant treatment was performed at baseline and in 3-months intervals postoperatively over a 12 months period.

Twelve patients were treated with adjunctive VNS due to unipolar (n=10) and bipolar (n=2) depression. The majority of patients were female (n=9). The mean age at baseline was 53.8 years (range 38-66). Patients were severely affected by a variety of depression symptoms which was reflected in high MADRS Scores (median 29, mean 28) at baseline. All patients received at least 2 or more psychotropic drugs at baseline. After 12 months of VNS a clear reduction of MADRS Scores (41 % on average) was seen (12-months MADRS Score median 17, mean 18). After 12 months, one patient each was discontinued from maintenance ECT and esketamine, respectively. The median of drug load was reduced from 4,56 to 4,06 after 12 months.

Invasive VNS is an effective treatment option in the long-term management of DTD to reduce the need of concomitant drug dose and maintenance treatment.

E Kavakbasi received speaker fees from Livanova. BT Baune received speaker and advisor fees from Livanova. The patients were included in the Restore-Life Study sponsored by LivaNova.

Vagus nerve stimulation (VNS) is a neuromodulation technique approved for Treatment-Resistant Depression (TRD). Evidence regarding its long-term efficacy and safety is still scarce.

To descriptively report a case series of 3 patients undergoing adjunctive VNS for TRD with an over 10-year follow-up.

We investigated outcomes of clinical interest in patients with ongoing VNS for at least 10 years after the device implantation. They had participated in a larger single-arm interventional study conducted at the University Hospital of Padua. They were diagnosed with chronic unipolar (1), recurrent unipolar (1), and bipolar (1) TRD.

Our 3 cases had an average 14-year history of psychiatric disease before surgery. Afterward, all subjects achieved clinical remission within two years. 2 patients experienced relapses within the first 4 years of treatment (respectively, 1 and 2 episodes). The other case showed a recurrent trend of brief relapses every two years. Only 1 individual needed to be admitted to the psychiatric unit once. None of them committed suicidal attempts. Prescription of antidepressants remained almost unchanged after the first two years. 2 individuals improved and 1 maintained their working position. Common adverse events were voice alteration (3/3), neck pain (2/3), and cough (2/3).

Very few cases of 10-year VNS for TRD have been reported so far. For our subjects, VNS was most likely to have a major impact on the clinical course of the disease. This treatment can be a safe and effective adjunctive intervention in a subgroup of patients with TRD.

Vagus Nerve Stimulation (VNS) is a neuromodulatory intervention which involves attaching an electrode to the vagus nerve. Studies investigating VNS as an acute treatment method for treatment resistent depression have shown very limited results, however there are data suggesting that VNS might have a beneficial effect on a longer term. There are also studies that suggest that a history of response to ECT might indicate a higher response rate to VNS. VNS was suggested as treatment for a patient who received maintenance ECT for treatment resistant unipolar depression during 9 years. 3 months after VNS was implanted, ECT was stopped due to the Covid-19 pandemic. In this case study we will review the patient’s response to treatment with VNS and the sudden stop of long-term ECT treatment.

To review the response to acute and maintenance ECT and VNS in this patient diagnosed with treatment resistant unipolar depression, and to compare this to the data suggesting VNS as an alternative treatment method for maintenance ECT in patients with treatment resistant depression.

Using the extensive data collected during the patient’s treatment, we will review the clinical response and side-effect burden of this patient to acute and maintenance ECT and to VNS.

The patient showed a vast improvement in depressive symptoms a few months after start of VNS treatment, while long-term maintenance ECT was stopped.

This patient’s response to VNS supports the data suggesting VNS as an alternative treatment method for maintenance ECT in patients with treatment resistant depression.

This patient received VNS treatment as part of a study conducted in our centre (UPC KULeuven) with support of Livanova. Me nor my supervisor (prof. Sienaert Pascal) are directly involved in this study. I have received no financial or other compensation fr

Tuberous sclerosis complex (TSC) is a rare genetic disorder that commonly leads to drug-resistant epilepsy in affected patients. This study aimed to determine whether the underlying genetic mutation (TSC1 vs. TSC2) predicts seizure outcomes following surgical treatments for epilepsy.

We retrospectively assessed TSC patients using the TSC Natural History Database core registry. Data review focused on outcomes in patients treated with surgical resection or vagus nerve stimulation.

A total of 42 patients with a TSC1 mutation, and 145 patients with a TSC2 mutation, were identified. We observed a distinct clinical phenotype: children with TSC2 mutations tended to be diagnosed with TSC at a younger age than those with a TSC1 mutation (p < 0.001), were more likely to have infantile spasms (p < 0.001), and to get to surgery at a later age (p = 0.003). Among this TSC2 cohort, seizure control following resective epilepsy surgery was achieved in less than half (47%) the study sample. In contrast, patients with TSC1 mutations tended to have more favorable postsurgical outcomes; seizure control was achieved in 66% of this group.

TSC2 mutations result in a more severe epilepsy phenotype that is also less responsive to resective surgery. It is important to consider this distinct clinical disposition when counseling families preoperatively with respect to seizure freedom. Larger samples are required to better characterize the independent effects of genetic mutation, infantile spasms, and duration of epilepsy as they relate to seizure control following resective or neuromodulatory epilepsy surgery.

To determine the efficacy of vagus nerve stimulation (VNS) for treatment of depression.

We conducted a systematic review and meta-analysis of analytical studies. Efficacy was evaluated according to severity of illness and percentage of responders.

We identified 687 references. Of these, 14 met the selection criteria and were included in the review. The meta-analysis of efficacy for uncontrolled studies showed a significant reduction in scores at the Hamilton Depression Rating Scale endpoint, and the percentage of responders was 31.8% ([23.2% to 41.8%], P<0.001). However, the randomised control trial which covered a sample of 235 patients with depression, reported no statistically significant differences between the active intervention and placebo groups (OR=1.61 [95%CI 0.72 to 3.62]; P = 0.25). To study the cause of this heterogeneity, a meta-regression was performed. The adjusted coefficient of determination (R2Adj) was 0.84, which implies that an 84% variation in effect size across the studies was explained by baseline severity of depression (P<0.0001).

Currently, insufficient data are available to describe VNS as effective in the treatment of depression. In addition, it cannot be ruled out that the positive results observed in the uncontrolled studies might have been mainly due to a placebo effect.