Introduction of vagus nerve stimulation into a maintenance electroconvulsive therapy regimen: a case study and cost analysis.
ABSTRACT This case report describes the outcome of a patient implanted with the vagus nerve stimulation (VNS) device while receiving maintenance electroconvulsive treatment (M-ECT) and compares the costs of treatment options for treatment-resistant depression.
The patient, a male, aged 47 years with bipolar I disorder, treatment-resistant depression, and a 13-year history of depressions, was receiving M-ECT at 2-week intervals as well as antidepressant medications when he was implanted with the VNS device. His depression was assessed with the Montgomery-Asberg Depression Rating Scale. The cost analysis of treatment modalities placed M-ECT at $800 to $1000 per treatment and VNS at approximately $3900 annually (surgery, device, and office visits, approximately $31,300, was prorated over 8 years).
Antidepressants and other medications were used in combination and were gradually changed while the patient was receiving electroconvulsive therapy. The patient improved with VNS and was able to discontinue M-ECT. His Montgomery-Asberg Depression Rating Scale scores had fluctuated between 2 and 56, but, after VNS, the scores decreased to a level consistent with remission and have remained at those levels. The patient reported feeling as well as he had felt at any time he could remember, began an exercise program, and lost 30 lbs. During the 10 months before implantation, 14 electroconvulsive therapy treatments cost $11,200 to $14,000. For 10 months after implantation, 7 M-ECT treatments ($5600-$7000) plus prorated VNS ($3250) equaled $8850 to $10,250, $2350 to $3750 less than before implantation.
This patient improved with VNS and was able to discontinue M-ECT. Introducing VNS effected a cost savings over M-ECT.
- American Journal of Psychiatry 09/2013; 170(9):1059-61. · 14.72 Impact Factor
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ABSTRACT: To compare response and remission rates in depressed patients with chronic treatment-resistant depression (TRD) treated with vagus nerve stimulation (VNS) Therapy® plus treatment as usual (VNS + TAU) or TAU alone in a meta-analysis using Bayesian hierarchical models. Six outpatient, multicenter, clinical trials that have evaluated VNS + TAU or TAU in TRD, including two single-arm studies of VNS + TAU (n = 60 and n = 74), a randomized study of VNS + TAU versus TAU (n = 235), a randomized study of VNS + TAU comparing different VNS stimulation intensities (n = 331), a nonrandomized registry of VNS + TAU versus TAU (n = 636), and a single-arm study of TAU (n = 124) to provide longer-term, control data for comparison with VNS-treated patients. A systematic review of individual patient-level data based on the intent-to-treat principle, including all patients who contributed more than one post-baseline visit. Response was based on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impressions scale's Improvement subscale (CGI-I), as these were the two clinician-rated measures common across all or most studies. Remission was based on the MADRS. Outcomes were compared from baseline up to 96 weeks of treatment with VNS + TAU (n = 1035) versus TAU (n = 425). The MADRS response rate for VNS + TAU at 12, 24, 48, and 96 weeks were 12%, 18%, 28%, and 32% versus 4%, 7%, 12%, and 14% for TAU. The MADRS remission rate for VNS + TAU at 12, 24, 48, and 96 weeks were 3%, 5%, 10%, and 14% versus 1%, 1%, 2%, and 4%, for TAU. Adjunctive VNS Therapy was associated with a greater likelihood of response (odds ratio [OR] = 3.19, 95% confidence interval [CI]: 2.12, 4.66) and remission (OR = 4.99, CI: 2.93, 7.76), compared with TAU. For patients who had responded to VNS + TAU at 24 weeks, sustained response was more likely at 48 weeks (OR = 1.98, CI: 1.34, 3.01) and at 96 weeks (OR = 3.42, CI: 1.78, 7.31). Similar results were observed for CGI-I response. For patients with chronic TRD, VNS + TAU has greater response and remission rates that are more likely to persist than TAU.Medical Devices: Evidence and Research 01/2013; 6:17-35.
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ABSTRACT: BACKGROUND: Patients with treatment-resistant depression (TRD) who showed partial response to pharmacological and psychotherapeutic interventions need a trial of neuromodulation therapies (NTs). OBJECTIVE: This paper aims to review evidence-based data on the use of NTs in TRD. METHOD: Using keywords and combined-word strategy, multiple computer searches of PubMed, Google Scholar, Quertle(R), and Medline were conducted for retrieving relevant articles published in English-language peer-reviewed journals (2000-2012). Those papers that addressed NTs in TRD were retained for extensive review. RESULTS: Despite methodological challenges, a range of 30%-93% of TRD patients showed substantial improvement to one of the NTs. One hundred-percent improvement was reported in two single-case studies on deep brain stimulation. Some studies reported no benefits from transcranial direct current stimulation. NTs were reported to have good clinical efficacy, better safety margin, and benign side-effect profile. Data are limited regarding randomized clinical trials, long-term efficacy, and cost-effectiveness of these approaches. Both modified electroconvulsive therapy and magnetic seizure therapy were associated with reversible but disturbing neurocognitive adverse effects. Besides clinical utility, NTs including approaches on the horizon may unlock the biological basis underlying mood disorders including TRD. CONCLUSION: NTs are promising in patients with TRD, as the majority of them show good clinical response measured by standardized depression scales. NTs need further technological refinements and optimization together with continuing well-designed studies that recruit larger numbers of participants with TRD.Medical Devices: Evidence and Research 01/2012; 5:53-65.