12-13-2010 VNS Therapy Joyce's 11th Year.

http://www.youtube.com/v/K7R-jpDS4WY?

Neuro Endocrinol Lett. 2010 Nov 21;31(5). [Epub ahead of print]

The role of the vagus nerve in depression.

Ondicova K, Pecenák J, Mravec B.

Institute of Pathophysiology, Faculty of Medicine, Comenius University, Slovakia. boris.mravec@fmed.uniba.sk.

Abstract

The etiopathogenesis of depression is a highly complex process characterized by several neurobiological alterations including decreased monoamine neurotransmission in the brain, dysregulated hypothalamic-pituitary-adrenal axis activity, decreased neuronal plasticity, and chronic inflammation in the brain and peripheral tissues. Experimental and clinical studies indicate that the vagus nerve may influence these processes. The importance of the vagus nerve in the etiopathogenesis of depression is further supported by its involvement in the induction of sickness behavior, as well as by clinical studies confirming a beneficial effect of vagus nerve stimulation in depressed patients. The aim of this article is to describe current knowledge of aferent and efferent vagal pathways role in the development and progression of depression.

PMID: 21173739 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/21173739

COST-EFFECTIVENESS OF CYBERONICS’ VNS THERAPY®SYSTEM FOR EPILEPSY REINFORCED BY 1,600-PATIENT EMORY UNIVERSITY SCHOOL OF MEDICINE STUDY

For Release Tuesday, December 21, 2010; 9:00 AM ET

 COST-EFFECTIVENESS OF CYBERONICS’ VNS THERAPY^®SYSTEM FOR EPILEPSY REINFORCED BY
1,600-PATIENT EMORY UNIVERSITY SCHOOL OF MEDICINE STUDY

 

HOUSTON, Texas, December 21, 2010 -- Cyberonics, Inc. (NASDAQ:CYBX) announced today that the VNS Therapy System, the only FDA-approved implantable medical device for the treatment of refractory epilepsy, was featured in 22 poster presentations and in the Plenary II session on neurostimulation at the annual American Epilepsy Society Meeting that took place recently in San Antonio, Texas.
Of particular significance at the meeting, Sandra Helmers, M.D., Associate
Professor of Neurology at the Emory School of Medicine, presented the results
of a study entitled, “Characteristics and Clinical and Economic Outcomes in
MEDICAID Patients Receiving Vagus Nerve Stimulation Therapy for the Treatment
of Refractory Epilepsy.”  Dr. Helmers and colleagues at Emory University
School of Medicine and The Analysis Group, an economic consultant, analyzed
data from five Medicaid state claims databases, including Florida, Iowa,
Kansas, Missouri, and New Jersey, to evaluate trends over time in
epilepsy-related health problems, healthcare utilization and healthcare costs.
The studyresults confirmed that the use of vagus nerve stimulation (VNS) therapy in
patients with refractory epilepsy is associated with:

• Lower occurrence of epilepsy-related co-morbidities.  Patients experienced fewer injuries and other health issues after being implanted with the VNS Therapy System, compared to the period before implantation.
• Lower healthcare utilization. All-cause hospitalizations and emergency room visits significantly     decreased over time after implantation with the VNS Therapy System, compared to the six months prior to implantation.
• Significant long-term cost savings.  With a reduction in healthcare utilization and co-morbidities as a result of VNS therapy, there are significant net total healthcare cost savings beginning 18 months after implantation.

These results confirm numerous prior studies demonstrating significant reductions in
both emergency room visits and inpatient admissions.  “This study again
shows the long-term clinical benefits of VNS.  Additionally, it addresses
an increasingly relevant aspect of treatment options –  cost effectiveness
over the long term,”  noted Dr. Helmers.

“This Emory University study reaffirms the safety, efficacy, cost effectiveness, and
quality-of-life benefits of the VNS Therapy System,” said Dan Moore, President
and Chief Executive Officer of Cyberonics. “Worldwide, more than 60,000
patients with epilepsy have received VNS therapy, and these patients are
consistently opting to continue treatment, which is evidenced by an initial
re-implant rate that exceeds 70 percent.  These study findings further
establish VNS therapy as a beneficial option for patients with medically
refractory epilepsy who are not candidates for resective surgery, or who have
failed resective surgery.” 

About Cyberonics, Inc. and the VNS Therapy^®System

Cyberonics, Inc. (NASDAQ:CYBX) is a medical technology company with core expertise in
neuromodulation.  The company developed and markets the VNS Therapy
System, which is FDA-approved for the treatment of refractory epilepsy and
treatment-resistant depression.  The VNS Therapy System uses a surgically
implanted medical device that delivers electrical pulsed signals to the vagus
nerve.  Cyberonics markets the VNS Therapy System in selected markets
worldwide.
Additional information on Cyberonics and VNS therapy is available at www.cyberonics.com.
Contact Information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332
ir@cyberonics.com

J Chem Neuroanat. 2010 Dec 15. [Epub ahead of print]

The chemical neuroanatomy of vagus nerve stimulation.

Ruffoli R, Giorgi FS, Pizzanelli C, Murri L, Paparelli A, Fornai F.

Department of Human Morphology and Applied Biology, University of Pisa, Via Roma 55, 56100 Pisa, Italy.

Abstract

In this short overview a reappraisal of the anatomical connections of vagal afferents is reported. The manuscript moves from classic neuroanatomy to review details of vagus nerve anatomy which are now becoming more and more relevant for clinical outcomes (i.e. the therapeutic use of vagus nerve stimulation). In drawing such an updated odology of central vagal connections the anatomical basis subserving the neurochemical effects of vagal stimulation are addressed. In detail, apart from the thalamic projection of central vagal afferents, the monoaminergic systems appear to play a pivotal role. Stemming from the chemical neuroanatomy of monoamines such as serotonin and norepinephrine the widespread effects of vagal stimulation on cerebral cortical activity are better elucidated. This refers both to the antiepileptic effects and most recently to the beneficial effects of vagal stimulation in mood and cognitive disorders.

PMID: 21167932 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21167932

Epilepsy Behav. 2010 Dec 15. [Epub ahead of print]

Mania following vagus nerve stimulation: A case report and review of the literature.

Gerson R, Murray E, Price B, Frankel M, Douglass LM, Cunningham M.

Department of Child and Adolescent Psychiatry, New York University, New York, NY, USA.

Abstract

Vagus nerve stimulation (VNS) is an increasingly used therapy for patients with treatment-refractory epilepsy and depression. Hypomanic and manic symptoms are a rare but recognized adverse effect of VNS treatment. Here we describe a case in which VNS treatment in a patient with epilepsy and unipolar depression was associated with the rapid development of manic symptoms. The patient's manic symptoms resolved with temporary discontinuation of the VNS current, and the patient was eventually able to resume VNS treatment with good effect and without further manic symptoms. Mania is a rare but serious side effect of VNS; however, in this case and in the majority of reported cases of VNS-associated mania, symptoms resolve and VNS can be safely administered.

PMID: 21167787 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21167787

Heart Fail Rev. 2010 Dec 17. [Epub ahead of print]

Vagus nerve stimulation: from pre-clinical to clinical application: challenges and future directions.

De Ferrari GM, Schwartz PJ.

Department of Cardiology, Fondazione IRCCS Policlinico S. Matteo, Viale Golgi 19, 27100, Pavia, Italy, g.deferrari@smatteo.pv.it.

Abstract

Vagus nerve stimulation was performed experimentally for the first time more than 150 years ago. In the 1980s and 1990s, vagus nerve stimulation was shown, both in the anesthetized and in the conscious animal, to exert marked antiarrhythmic effects, particularly during acute myocardial ischemia. There is a strong rationale for a beneficial effect of augmented vagal activity in the setting of chronic heart failure. Studies in experimental models of heart failure showed that chronic vagus nerve stimulation exerts beneficial effects on left ventricular function and on survival. Vagus nerve stimulation is approved in man for refractory epilepsy and depression. The first-in-man study performed in 32 patients with chronic heart failure suggests that vagus nerve stimulation was safe and well tolerated. Six months of open-label treatment was associated with significant improvements (P < 0.001) in NYHA class, quality of life, 6-min walk test, LV ejection fraction (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. Mechanisms of action may include the following: heart rate, anti-adrenergic, anti-apoptotic, and anti-inflammatory effects as well as an increase in nitric oxide. Controlled clinical trials will start soon to assess whether vagus nerve stimulation can indeed represent a new non-pharmacological approach for the treatment of symptomatic heart failure.

PMID: 21165697 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21165697

Pharmacopsychiatry. 2010 Dec 14. [Epub ahead of print]

Changes in Gustatory Perceptions of Patients with Major Depression Treated with Vagus Nerve Stimulation (VNS).

Sperling W, Biermann T, Spannenberger R, Clepce M, Padberg F, Reulbach U, Kornhuber J, Thuerauf N.

Department of Psychiatry and Psychotherapy, University Hospital of Erlangen, Erlangen, Germany.

Abstract

BACKGROUND: Olfactory and gustatory functions were investigated before and during vagus nerve stimulation (VNS) in a group of 9 patients with therapy-resistant depression, implanted with a VNS system.

METHODS: Gustation and olfaction were tested using standard sniffing tests. Subjects participated in 2 sessions with the vagal stimulator switched on and off, respectively.

RESULTS: Under conditions of stimulation of the VNS, there were statistically significant differences of the threshold of perception, with an intensification of the taste "sweet" (Z=-2.0; p=0.048) and "bitter" (Z=-2.5; p=0.011) compared to the "off-mode". A statistical trend (Z=-1.7; p=0.098) for increased intensity of the taste "salty" was observed, however, these results would supposedly disappear after correction for multiple testing presumably due to the large number of variables and the small sample size. There were no statistically relevant differences concerning olfactory perception.

CONCLUSIONS: The changes of gustatory perception under conditions of vagal nerve stimulation observed in this study show another important central nervous effect of vagal stimulation on the limbic system that might be of importance in the elucidation of mechanisms of action of VNS especially on refractory depression.

© Georg Thieme Verlag KG Stuttgart · New York.

 

PMID: 21157695 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21157695