Eur Heart J. 2010 Oct 28. [Epub ahead of print]

Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.

De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; for the CardioFit Multicenter Trial Investigators.

Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Abstract

Aims In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular (LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy. Methods and results This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. Conclusions This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.

PMID: 21030409 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/21030409

Nervenarzt. 2010 Oct 24. [Epub ahead of print]

[Therapeutic neuromodulation in primary headaches.]

[Article in German]

May A, Jürgens TP.

Institut für Systemische Neurowissenschaften und Kopfschmerzambulanz der Neurologischen Klinik, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Deutschland, a.may@uke.uni-hamburg.de.

Abstract

Neuromodulatory techniques have developed rapidly in the therapeutic management of refractory headaches. Invasive procedures comprise peripheral nerve stimulation (particularly occipital nerve stimulation), vagus nerve stimulation, cervical spinal cord stimulation and hypothalamic deep brain stimulation. Transcutaneous electrical nerve stimulation, repetitive transcranial magnetic stimulation and transcranial direct current stimulation are noninvasive variants. Based on current neuroimaging, neurophysiological and clinical studies occipital nerve stimulation and hypothalamic deep brain stimulation are recommended for patients with chronic cluster headache. Less convincing evidence can be found for their use in other refractory headaches such as chronic migraine. No clear recommendation can be given for the other neuromodulatory techniques. The emerging concept of intermittent stimulation of the sphenopalatine ganglion is nonetheless promising. Robust randomized and sham-controlled multicenter studies are needed before these therapeutic approaches are widely implemented. Due to the experimental nature all patients should be treated in clinical studies.It is essential to confirm the correct headache diagnosis and the refractory nature before an invasive approach is considered. Patients should generally be referred to specialized interdisciplinary outpatient departments which closely collaborate with neurosurgeons who are experienced in the implantation of neuromodulatory devices. It is crucial to ensure a competent postoperative follow-up with optimization of stimulation parameters and adjustment of medication.

PMID: 20972665 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/20972665

Eur J Paediatr Neurol. 2010 Oct 22. [Epub ahead of print]

Clinical course of young patients with Dravet syndrome after vagal nerve stimulation.

Zamponi N, Passamonti C, Cappanera S, Petrelli C.

Pediatric Neurology Department, Ospedali Riuniti, Ancona, Italy.

Abstract

Medical treatment of Dravet syndrome is disappointing. Ketogenic Diet and neurostimulation procedures as Vagus Nerve Stimulation (VNS) and Deep Brain Stimulation are in ongoing evaluation. In the present study, the long-term effectiveness of VNS on seizures, cognition and behavior was retrospectively evaluated in eight young patients with DS and medically refractory epilepsy (mean age at VNS implant: 10.28 years, range: 5-25). The average duration of treatment was 54 months (range: 12-120). Compared to baseline (mean: 55; standard deviation: 83, range: 4-200), the mean number of monthly seizures after VNS implantation was 39 ± 67 at 3 months, 42 ± 67 at 6 months and 38 ± 69 at twelve months (not significant comparisons). In particular, VNS produced a mean seizure rate reduction of 12% at three months, 6% at six months, and 31% at twelve months. All patients but three experienced some reduction in seizure burden (range: 33-61%) at twelve months. Seizure outcome after one year of stimulation was rated as Mc Hugh class II (50-79% reduction in seizure frequency) in four patients, class III (<50% reduction) in one patient and class V (no improvement) in three patients. In this small case series of patients with DS, VNS therapy had a clinically significant effect in reducing seizures at twelve months in four of the eight patients. Even in patients in whom seizure reduction was not dramatic, a slight improvement in alertness and communicative skills was seen. The long-term clinical course of two selected cases is discussed.
Copyright © 2010 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

PMID: 20971664 [PubMed - as supplied by publisher

http://www.ncbi.nlm.nih.gov/pubmed/20971664

Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of Crimes

October 14, 2010

Watch Out!  At FDLI Conference, Government Says More People Will Be Convicted of Crimes

By Douglas B. Farquhar –
At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries.  They also discussed how the types of prosecutions may be shifting away from charges based on off-label promotion of drugs and medical devices to charges based on threats to the safety and efficacy of FDA-regulated products, which include food, tobacco, medical devices, and drugs.

I was a co-chair of the conference, which was sponsored by the Food and Drug Law Institute (“FDLI”) in Washington, D.C., along with Jennifer Bragg of the law firm Skadden, Arps, Slate, Meager & Flom.  The Annual FDLI Enforcement Conference gathers together as speakers the decision-makers on enforcement and compliance from all of the major Centers at FDA (Food, Medical Devices, Advertising and Promotion, Drugs, Veterinary Drugs, and Biologics), the top enforcement officer for the agency (Eric Blumberg, FDA Deputy Chief Counsel for Litigation) and the head of the Office of Consumer Litigation, the litigating arm for FDA at the federal Department of Justice (Eugene Thirolf).

In what was probably the most concentrated collection of enforcement speakers gathered at an industry event, nearly all of the speakers predicted an increase in the number of prosecutions of individuals for violations of the Federal Food, Drug, and Cosmetic Act, the statute that governs manufacture and distribution of FDA-regulated products.  The Conference focused on strict-liability prosecutions under the so-called Park doctrine (also covered in an HPM-sponsored webinar last week), and the officials predicted an increase of prosecutions of responsible corporate officials, even if there is no proof that they participated in, encouraged, or even had knowledge of the violations.  Speakers from the government, industry, and private law firms (that would include yours truly) discussed how it is imperative that top corporate officials implement policies and procedures that effectively prevent violations from occurring, with a special emphasis on ensuring that no unapproved claims are made in promotional materials for drugs and devices, that reports of safety problems are filed with FDA promptly and accurately, that officials do not ignore problems discovered in testing of manufactured products, and that drugs and devices are manufactured in accordance with regulations setting current Good Manufacturing Practice.

The trade press has already reported that the government may especially be looking at prosecuting officials for off-label promotion because they feel that the huge monetary settlements with drug and device companies (reportedly more than $9 billion in the last ten years) are not getting the job done.
In addition:

• Blumberg indicated that he expects that criminal investigations will focus on distribution of unapproved new drugs, failure to report unexpected adverse events caused by medical products, and “flagrant” off-label promotion (that is, advertising, company-sponsored programs, pitches by sales reps, and other promotional material which encourages the use of the products for conditions or treatments other than those approved in the labeling).
• Each of the FDA Center compliance directors reported that they are cooperating much more closely with FDA’s Office of Criminal Investigations.
• Howard Sklamberg, Director of FDA’s Office of Enforcement, noted that Class I recalls (the most serious category of recalls) will generally lead to increased FDA inspections and scrutiny of an FDA-regulated company.
• Thirolf mentioned that he anticipates seeing more criminal investigations and prosecutions focused on safety issues, rather than just off-label promotions.  He confirmed, in response to a particularly astute question (that would be from me) that safety issues include distribution of defective products, failure to report adverse events, and fraudulent reporting of testing data or false documentation of manufacturing processes and procedures.

One of the speakers also said that there were 70 whistleblower cases that were filed last year against device and drug companies that are currently being investigated by the federal government.

For more information about the conference, or to get a copy of a CD audio recording of the proceedings, visit www.fdli.org.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/10/watch-out-at-fdli-conference-government-says-more-people-will-be-convicted-of-crimes.html

Chronic intermittent vagal nerve stimulation in the treatment of refractory epilepsy:..

Cir Cir. 2010 Jan-Feb;78(1):15-23, 24.

Chronic intermittent vagal nerve stimulation in the treatment of refractory epilepsy: experience in Mexico with 35 cases.

[Article in English, Spanish]

Alonso-Vanegas MA, Austria-Velásquez J, López-Gómez M, Brust-Mascher E.

Subdirección de Neurocirugía, profesor de Posgrado en Cirugía de Epilepsia, Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez," México, D.F., Mexico. alonsomario@hotmail.com

Abstract

BACKGROUND: The role of vagal nerve stimulation (VNS) in the treatment of refractory epilepsy is still evolving and requires precision through extensive description of acute and chronic results, adverse effects and complications in specific populations.
METHODS: We selected patients with refractory epilepsy subjected to VNS who had completed at least a 12-month followup. Descriptive and inferential statistics were used to review and assess the effects of VNS on seizure frequency/intensity, memory, alertness, mood, postictal recovery, and quality of life (subjective scale, QoL IE-31 inventory) as well as factors (gender, age, age of onset, time of surgery, stimulation parameters, seizure frequency and type) associated with clinical response. We describe stimulation parameters, complications and adverse effects compared to other series.
RESULTS: We selected 35 patients with an age range of 5-48 years; 18 patients presented partial epilepsy and 17 generalized epilepsy. All procedures and wound healing were uneventful, and no infections were reported. Median reduction in seizure frequency was 55.65% (p <0.001). Four patients showed improvement of >90%. Two patients became seizure free, whereas seizure frequency increased in two patients. The subjectively qualified response to treatment was good in 33 patients. The mean global increase in the QoLIE-31 Scale was 12.6 (p = 0.020). Improvements in memory, mood, alertness and postictal recovery period were documented. Only seizure type showed statistically significant association with clinical response. Adverse effects were transitory and responded to changes in stimulation parameters.
CONCLUSIONS: VNS is a safe, feasible, well-tolerated and effective palliative treatment in appropriately selected cases of refractory partial and multifocal generalized seizures.

PMID: 20226124 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/20226124

VNS and ECT

J ECT. 2007 Jun;23(2):114-9.

Introduction of vagus nerve stimulation into a maintenance electroconvulsive therapy regimen: a case study and cost analysis.

Warnell RL, Elahi N.

Department of Psychiatry, Loma Linda University, Loma Linda, CA 92354, USA. rwarnell@ahs.llumc.edu

Abstract

OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: This patient improved with VNS and was able to discontinue M-ECT. Introducing VNS effected a cost savings over M-ECT.

PMID: 17548984 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/17548984

Arkansas Surgical Hospital Celebrates with A Day of Giving

3 days ago

Posted in News,
Centers For
Medicare And Medicaid Services (CMS), Economics, Events, Finance, Healthcare, Insurance, Operating Room (OR), OR
Arena, Procedures, Surgical Hospitals

On Oct. 2^nd, Arkansas Surgical Hospital (AHS)
continued celebrating its five year anniversary with a Day of Giving, offering
free surgery for patients with specific surgical needs.  The surgeons and staff
identified patients within their practices who had been suffering from back
pain, knee pain, hip pain and other conditions, but who hadn’t been able to
arrange for the needed treatment.  On Saturday, Oct. 2, they came together on
their day off to donate their time and skills to help these patients.  Companies
that manufacture implants donated supplies and implants; hospital staff came in
and provided the needed care for these patients.  The result was a day of free
surgical care for a group of people who needed surgery but who would not be able
to afford it on their own.

The patients chosen for the event had a variety of needs and circumstances,
such as the woman who had a Vagal Nerve Stimulator (VNS) implanted to help with
severe depression. This implant is recommended for patients as a part of
treatment for debilitating depression that doesn’t respond to ordinary methods. 
She had previously had the VNS implanted with the procedure being covered by
Medicare. The VNS worked for her, allowing her to enjoy a normal life – until
the device needed replacement. New Medicare guidelines no longer cover the VNS,
so the she was left with a nonfunctioning implant and untreated depression.
Cyberonics, the manufacturer of the $15,000 VSN device, donated the implant, and
ASH staff donated their time to perform the surgery. Cyberonics even sent a
surgical representative to assist the physician with the surgery...

http://www.surgistrategies.com/news/2010/10/arkansas-surgical-hospital-celebrates-with-a-day.aspx

Greetings...

Hi to one and all,

 

I've recently closed the website VNSdepression.com which I instituted on or about 2004 shortly after the device manufacturer Cyberonics closed down their patient message forum.  A couple of years later my website was hacked and much of the information I researched and uploaded was lost to the Internet and readership.  I started over as I had more available time and the computer guru I enlisted also had the time to help me.

 

I still retain all my information while continuing research relating to VNS Therapy as well as other treatment options relating to MDD.  The computer guru who established the website for me upgraded and made changes to the message forum and site programs several months ago and from there things got out of hand so much so that I could no longer upload or change information, send emails and post messages properly.  Since I have little patience or know how and little interest to sit before a computer screen to learn how to correct these glitches and bugs without the guru, who is unavailable, I decided I had enough.

I'll share my commentaries, musings and information either here or on the VNS Depression Facebook page I also established.  

 

Quickly and for those not familiar with my efforts and proactive mental health advocacy I have been a very, very long time support person and health care advocate for my spouse, Joyce.  She was one of the earliest study subjects for VNS Therapy for Depression and in her case the therapy in my opinion and that of her attending physicians has been remarkable.  Joyce has been almost continuously depression free for about 11 years. 

 

Thankfully, Joyce and I are doing well and I have little time to spend on the computer as we're both enjoyably busy and involved socially and those activities are far more valuable for our precious time.

 

My email address is also available to all who might have serious interest in discussing the therapy privately if necessary.  I shall make time available.

 

As always, I wish all those challenged by these heinous disorders wellness.

 

Warmly,

Herb

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com/