Pediatric VNS Surgery: Pay Now or Pay More Later

Pediatric VNS Surgery: Pay Now or Pay More Later
By: MICHELE G. SULLIVAN, Clinical Psychiatry News Digital Network

12/20/11
  

BALTIMORE – "Pay now, save later" could be the motto in the case of vagus nerve stimulation surgery for young Medicaid patients who have intractable epilepsy.

In a study of 30-month outcomes in 445 children, vagus nerve stimulation (VNS) surgery had nearly paid for itself within a year, and began to save taxpayers money soon afterward, Dr. Sandra Helmers reported at the annual meeting of the American Epilepsy Society.

Dr. Sandra Helmers
http://www.clinicalpsychiatrynews.com/uploads/RTEmagicC_r78406ph_Helmers_Sandra_ATL.jpg.jpg

"When we looked at the annual costs of emergency department and hospitalization before and after VNS surgery, we found that the overall cost savings began in the fifth or sixth quarter after surgery," and continued to increase in succeeding quarters, said Dr. Helmers, a neurologist at Emory University Hospital and Clinic, Atlanta. "This is the way we need to look at these treatments, in terms of real-world outcomes in both health and finances."

She and her colleagues divided the group of children by age: patients aged 1-11 years (238) and patients aged 12-17 years (207). All were Medicaid recipients.

Among the younger group, the mean age at the time of surgery was 7 years. All had still been having seizures despite medical therapy. They had tried a mean of four antiepileptic drugs before surgery, and 63% were on polytherapy.

The mean age at the time of surgery in the older group was 15 years. They had tried a mean of four antiepileptic drugs before surgery, and 64% were on polytherapy.

The cost of the surgery ranged from about $20,000 to $30,000, which is "fairly high relative to the preimplant costs," Dr. Helmers said.

But it didn’t take long before the savings began to show, in terms of decreased hospital and ED visits, she said. In the first 6 months after the surgery, the younger patients were 27% less likely to have an ED visit and 26% less likely to have a hospital admission than they were in the prior 6 months. The surgery resulted in savings, but the overall costs were not quite statistically significant ($17,831 vs. $18,220 quarterly [P = .052]) in the 6 months before and after surgery.

During their 6-month postsurgery period, older patients were 57% less likely to go to the ED and 56% less likely to have a hospital admission. Average total health care costs were significantly lower in the 6 months after surgery than the 6 months before ($14,068 vs. $19,047 quarterly [P = .002]).

Although VNS surgery did positively affect hospitalizations, it did not significantly change the number of antiepileptic drugs the children took, Dr. Helmers noted. "We can’t really say anything about adding new medications, because these were refractory patients and for them, another trial of medicine typically does not give much benefit."

The findings are encouraging, because they show that the short-term expense of stabilizing children’s intractable epilepsy brings long-term savings.

"It is difficult for these children to get this intervention. Health insurance is the major barrier to good care for epilepsy. And if you don’t have insurance, you are unlikely to get this."

Policy makers need to know this kind of information, she said. "This pays off [in the United States] just as it has been shown to in other parts of the world. In our country we don’t use data like these to dictate policy – but that is coming. How that will play out in the future is something we still don’t know."

Dr. Helmers had no financial disclosures.

http://www.clinicalpsychiatrynews.com/index.php?id=2623&type=98&tx_ttnews[tt_news]=94024&cHash=da03e20e36

Otolaryngol Head Neck Surg. 2011 Jan;144(1):123-4.

Surgical revision of vagus nerve stimulation electrodes in children.

Agarwal G, Wilfong AA, Edmonds JL Jr.

Source

University of Texas Medical School at Houston, Houston, Texas, USA.

Abstract

Use of vagus nerve stimulation (VNS) has increased in the past decade, resulting in frequent revision cases for device failure. The authors report their series of children who underwent reimplantation of the VNS device after removal of old electrodes and leads. Patients with medically refractory seizures who underwent revision of VNS electrodes were included (n = 23). Twenty patients had high lead impedance and underwent removal of the device and replacement of the VNS electrodes during the same procedure. In 3 patients, electrodes and the device had been removed previously at an outside institution because of infection. None of the patients experienced any major complications. Mean operative time was 2.3 ± 0.9 hours. The reimplanted device worked well in all patients, and seizure control was similar to or better than that reported with the previous device. Thus, implantation of the VNS electrodes is reversible, and it appears that the electrodes can be removed or replaced safely if the device is not functioning properly.

PMID:

21493401

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/21493401

J Neurosurg Pediatr. 2011 Jun;7(6):671-5.

Vagal nerve stimulator infection: a lead-salvage protocol.

Wozniak SE, Thompson EM, Selden NR.

Source

Department of Neurological Surgery, Oregon Health & Science University, 3303 SW Bond Avenue, Portland, OR 97239, USA.

Abstract

OBJECT:

Vagal nerve stimulator (VNS) hardware infections are fraught with difficult management decisions. As with most implanted medical device-related infections, standard practice traditionally involves complete hardware removal, systemic antibiotic therapy, and subsequent reimplantation of the device. To avoid the potential morbidity of 2 repeat left carotid sheath surgical dissections, the authors have implemented a clinical protocol for managing VNS infections that involves generator removal and antibiotic therapy without lead removal.

METHODS:

A prospective, single-surgeon database was compared with hospital billing records to identify patients who underwent primary implantation or reimplantation of a VNS lead, generator, or both, from January 2001 to May 2010, at Oregon Health & Science University. From these records, the authors identified patients with VNS hardware infections and characterized their management, using a lead salvage protocol.

RESULTS:

In their review, the authors found a matching cohort of 206 children (age 3 months-17 years) who met the inclusion criteria. These children underwent 258 operations (including, in some children, multiple operations for generator end of life and/or lead malfunction). Six children experienced a single postimplantation infection (2.3% of the 258 operative cases), and no child experienced repeated infection. A lead-salvage protocol was used in 4 of 6 infected patients and was successful in 3 (75%), with clinical follow-up ranging from 10 months to 7.5 years. The fourth patient subsequently underwent lead removal and later reimplantation in standard fashion, with no adverse sequelae.

CONCLUSIONS:

Vagal nerve stimulator lead salvage is a safe and potentially advantageous strategy in the management of VNS-related infection. Further study is necessary to validate appropriate patient selection, success rates, and risks of this approach.

PMID:

21631207

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/21631207

Season's Greetings...

A brief video from Joyce and me to you and yours for a Happy Holiday Season including Joyce’s yearly update on her VNS Therapy.  Be sure to turn up the volume to hear Joyce.

Season’s Greetings

Herb

Eur Psychiatry. 2011 Nov 30. [Epub ahead of print]

Systematic review and meta-analysis of vagus nerve stimulation in the treatment of depression: Variable results based on study designs.

Martin JL, Martín-Sánchez E.

Source

School of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain.

Abstract

PURPOSE:

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

METHODS:

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

RESULTS:

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 (R(2)(Adj)) 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).

CONCLUSION:

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.
Copyright © 2011 Elsevier Masson SAS. All rights reserved.

PMID:

22137776

http://www.ncbi.nlm.nih.gov/pubmed/22137776

[PubMed - as supplied by publisher]

Clin Neurol Neurosurg. 2011 Nov 28. [Epub ahead of print]

Vagus nerve stimulation has a positive effect on mood in patients with refractory epilepsy.

Klinkenberg S, Majoie HJ, van der Heijden MM, Rijkers K, Leenen L, Aldenkamp AP.

Source

Department of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands.

Abstract

BACKGROUND:

Preliminary research on the efficacy of vagus nerve stimulation (VNS) indicated additional effects on neuropsychological variables like mood and quality of life (QOL).

OBJECTIVES:

The objectives of this prospective longitudinal observational cohort study were to assess the effects of VNS on mood, QOL and cognition in patients with refractory epilepsy and to determine whether these effects occur dependent of seizure control.

METHODS:

We included 41 patients with refractory epilepsy; treated with VNS as part of usual patient care. A neuropsychological battery was performed during baseline and repeated after 6 months of VNS in order to compare neuropsychological variables before and after VNS. All patients completed seizure diaries.

RESULTS:

Significant improvements were observed for both mood and QOL after 6 months of VNS; based on the results in the POMS and QOLIE-89 questionnaires (p<0.05). There was no significant change in cognition. Mean percentage change in seizure frequency was -9.0%, while 20% of the patients achieved a seizure frequency reduction of 50% or more. No significant correlation was found between changes in seizure frequency and improvements in mood or QOL.

CONCLUSIONS:

VNS is associated with improvements in both mood and QOL in patients with refractory epilepsy. Since these improvements appeared to be independent of seizure control, the results of this study indicate an additional antidepressant effect of VNS, which can be of extra value in view of the high co-morbidity of mood disturbances in patients with epilepsy.
Copyright © 2011 Elsevier B.V. All rights reserved.

PMID:

22130047

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22130047

October 31, 2011

Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy® Systems

HOUSTON, Oct. 31, 2011 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX), a global leader in medical devices for the treatment and management of epilepsy, today announced that the U.S. Food and Drug Administration ("FDA") approved a significant expansion of options for Magnetic Resonance Imaging ("MRI") use by patients who have the VNS Therapy System.
The expansion includes:

• New: All cylindrical MRI scanners with magnetic field strengths of 3.0 and 1.5 Tesla; Previous: GE Signa 1.5 Tesla scanner only
• New: Imaging of head and extremities, including knees, using transmit/receive coils; Previous: head imaging only using transmit/receive coils

"This approval will enable VNS Therapy System patients to obtain access to the faster, higher resolution imaging available with 3.0 Tesla MRI scanners," commented Dan Moore, Cyberonics' President & Chief Executive Officer. "Our VNS technology, coupled with this approval, provides physicians with expanded imaging options for patients with epilepsy.
"We are pleased that the FDA has been responsive to patient needs and granted this approval."

http://ir.cyberonics.com/releasedetail.cfm?ReleaseID=619246

Aust N Z J Psychiatry. 2011 Nov;45(11):923-938.

The emerging use of brain stimulation treatments for psychiatric disorders.

Fitzgerald PB.

Source

Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology and Psychiatry , The Alfred, First Floor Old Baker Building, Commercial Road, Melbourne, Victoria, 3004 , Australia.

Abstract

Objective: The aim of this study was to review the current state of development and application of a wide range of brain stimulation approaches in the treatment of psychiatric disorders. Method: The approaches reviewed include forms of minimally invasive magnetic and electrical stimulation, seizure induction, implanted devices and several highly novel approaches in early development. Results: An extensive range of brain stimulation approaches are now being widely used in the treatment of patients with psychiatric disorders, or actively investigated for this use. Both vagal nerve stimulation (VNS) and repetitive transcranial magnetic stimulation (rTMS) have been introduced into clinical practice in some countries. A small body of research suggests that VNS has some potentially long-lasting antidepressant effects in a minority of patients treated. rTMS has now been extensively investigated for over 15 years, with a large body of research now supporting its antidepressant effects. Further rTMS research needs to focus on defining the most appropriate stimulation methods and exploring its longer term use in maintenance protocols. Very early data suggest that magnetic seizure therapy (MST) has promise in the treatment of patients referred for electroconvulsive therapy: MST appears to have fewer side effects and may have similar efficacy. A number of other approaches including surgical and alternative forms of electrical stimulation appear to alter brain activity in a promising manner, but are in need of evaluation in more substantive patient samples. Conclusions: It appears likely that the range of psychiatric treatments available for patients will grow over the coming years to progressively include a number of novel brain stimulation techniques.

PMID:

22044172

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22044172

New Data Suggests VNS Effective in Managing Depression in Everyday Practice

on February 11, 2011 | Permalink | Comments (0)

Topics: Service Lines, Neurosciences

A study released earlier this week from the University of Pennsylvania School of Medicine demonstrated that Vagus Nerve Stimulation (VNS) is as effective in treating depression in clinical practice as was shown in clinical trials. VNS is a treatment where short bursts of electric activity are administered to targeted loci in the brain via the vagus nerve. A pulse generator is implanted under the skin near the chest and leads are threaded to the vagus nerve. VNS was approved for epilepsy in 1997 and for treatment-resistant depression in 2005. Though approved for depression, VNS is used for the most part as a last ditch option for medically refractory epilepsy. Increasing recognition, clinical data, and established reimbursement paradigms have allowed VNS to be used more widely for epilepsy than for depression.
In this new study, published in the Journal of Clinical Psychiatry by Cristancho and colleagues, VNS was implanted in 15 patients with treatment-resistant depression (10 had Major Depressive Disorder and 5 had Bipolar Disorder). Though the study was relatively small and performed on a limited number of people, the findings do show that VNS is a feasible and effective treatment for depressed patients who do not respond positively to medication management. Using the Beck Depression Inventory, the mean scores fell from 37.8 to 24.6 from using VNS for 12 months, with one case of remission. When using the Hamilton Depression Rating Scale instead of the Beck Depression Inventory as an outcome measure, six patients (43 percent) responded well to VNS and two patients went into remission at 12 months.
Studies such as these demonstrate that VNS is a viable treatment option for depression. Additional studies, with larger sample sizes and increased follow-up times, will add to the repertoire of clinical data justifying VNS for depression and likely enhance uptake. While clinical trials and practical outcomes may increase acceptance of VNS for depression, insurance coverage and reimbursement decisions will ultimately influence use. Since VNS is a surgical procedure with device costs of approximately $20K, most patients will only undergo treatment if covered by insurance. Currently, restrictive reimbursement from Medicare and commercial payers has hindered VNS use. The University of Pennsylvania study researchers noted that most patients were denied VNS coverage until a detailed clinical justification for VNS use was submitted by the provider.

http://www.advisory.com/Research/Technology-Insights/The-Pipeline/2011/02/New-Data-Suggests-VNS-Effective-in-Managing-Depression-in-Everyday-Practice

Neurosurgery. 2010 Dec;67(2 Suppl Operative):457-60.

Revision of vagal nerve stimulator electrodes through a posterior cervical triangle approach: technical note.

O'Neill BR, Wilberger JE.

Source

Division of Pediatric Neurosurgery, The Children's Hospital, University of Colorado, Aurora, Colorado, USA. Boneill35@gmail.com

Abstract

BACKGROUND:

We describe an approach to vagal nerve stimulator (VNS) lead replacement through the posterior cervical triangle. Scar around the structures of the carotid sheath is avoided and new leads are placed on a pristine section of the vagus nerve proximal to the original site.

CLINICAL PRESENTATION:

Skin incision from the implantation surgery is incorporated and extended to allow access to the posterior border of the sternocleidomastoid muscle (SCM). Dissection proceeds along the posterior border of the SCM. The SCM and jugular vein are retracted anterior to expose a fresh segment of the vagal nerve immediately superficial to the carotid artery and proximal to the original electrode site. Once the nerve is adequately exposed, electrode placement proceeds in the standard fashion. Dysfunctional electrodes are left in place, and the lead wire is cut as near the electrodes as can be easily accessed. Three patients have undergone lead revision with this approach. Lead placement was successful and free from complications in all cases.

CONCLUSION:

The posterior cervical triangle approach provides a virgin dissection plane for VNS revision.

PMID:

21099572

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/21099572

Can J Neurol Sci. 2011 Nov;38(6):902-8.

Vagus nerve stimulation for epilepsy: the notre-dame hospital experience.

Qiabi M, Bouthillier A, Carmant L, Nguyen DK.

Source

Division of Neurology, Montreal University Hospital Centre, Montreal, Quebec, Canada.

Abstract

Purpose: Retrospective study assessing the efficacy and tolerability of vagus nerve stimulation (VNS) for the treatment of refractory epilepsy at Notre-Dame Hospital. Methodology: Chart review of all adult epileptic patients treated by VNS with ≥ 1 year follow-up. Responders were defined as patients with ≥ 50% reduction of baseline seizure frequency. Results: Thirty-four patients (14M; mean age = 29.9 yrs) received a VNS. Sub-pectoralis implantation (n = 25) was more frequent than subcutaneous (n = 9). Most patients suffered from intractable partial epilepsy. After 6 months, 12 months, 24 months, and 36 months, 14/34 patients (41%), 16/34 patients (47%), 17/30 patients (57%) and 12/20 patients (60%) respectively were responders. Two patients (6%) became seizure-free. Complications related to implantation were minor: eight cases of limited cervical hypoesthesia, two minor scar infections and one Horner syndrome. Adverse events (voice hoarseness, throat paresthesia, coughing) related to stimulation were generally mild and tended to wane over time. However, a reduction in seizure frequency did not translate into a reduction in medication, as only 9% of responders had less antiepileptic medication at last follow-up compared to baseline. Conclusion: VNS as practiced at Notre-Dame hospital is an efficacious and safe treatment for refractory epilepsy. Quotas allotted to epilepsy centers in the province of Quebec should be lifted or increased to allow more patients to benefit from this therapeutic device.

PMID:

22030430

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/22030430

New York Times

Venture Capitalists Put Money on Easing Medical Device Rules

By BARRY MEIER and JANET ROBERTS

Published: October 25, 2011

One afternoon last spring, a little-known congressman from Minnesota made an impassioned plea before a House oversight committee.

Rein in the Food and Drug Administration’s uncertain approval process for new medical devices, urged the Minnesota congressman, Erik Paulsen, or Minnesota and other states stand to lose up to 400,000 jobs because of lost investment in the device industry.

Over the following month, Mr. Paulsen’s campaign committee took in $74,000 from people with a stake in device regulation, much of it from executives affiliated with venture capital funds and their spouses. Now Mr. Paulsen, a two-term Republican, is a sponsor of a bill that would make it easier to bring new medical products to market.

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

People associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years, according to an analysis of federal contributions by The New York Times.

Though such people donate for many reasons, about 20 percent of the money from the 182 donors identified by The Times went directly to candidates and political action committees supporting a streamlining of F.D.A. policy or other issues of importance to medical products producers. The total contributions from such donors could be much higher; The Times limited its analysis to individuals affiliated with venture capital funds that have joined two lobbying associations.

Investment funds and business groups have also increased their lobbying in Washington and have generated a stream of reports arguing that regulations are crippling innovation and driving away investment.

Simply put, the industry’s champions argue that the F.D.A. suffers from high personnel turnover, an unwieldy bureaucracy and a regimen that forces start-up device companies to run new and costly tests constantly, often duplicating past efforts.

“This is about survival,” said Michael Carusi, a general manager at an investment fund in Palo Alto, Calif., Advanced Technology Ventures, who contributed $1,000 to Mr. Paulsen. “We are deeply concerned about the future.”

Medical devices encompass a wide array of products, such as heart defibrillators, artificial joints and diagnostic equipment.

Lobbying to smooth the approval process has intensified over the last year as Congress prepares to reauthorize the law that requires device producers to pay fees to the F.D.A., fees that are used to pay the agency’s operating costs. Lawmakers have an opportunity to alter the agency’s regulatory procedures for the first time since the law last came up for renewal in 2007.

An industry lobbying group, the National Venture Capital Association, has intensified its focus on device regulation. In 2010, the association, which lobbies on many issues, spent more than $2.5 million, according to data from the nonpartisan Center for Responsive Politics. About $350,000 of that was related to devices, drugs and health care, a figure that is expected to increase to $450,000 this year, said an association spokeswoman, Emily Mendell.

While it is not unusual for businesses to point to regulation as a barrier to economic and job growth, medical device investors have found a particularly receptive audience on Capitol Hill in recent months. In October alone, 10 bills have been introduced by Republicans in the House to speed up the F.D.A. device approval process; in the Senate, similar legislation has been introduced by Amy Klobuchar, a Democrat of Minnesota.

Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”

The letter, signed by Henry A. Waxman of California, Diana DeGette of Colorado, John Dingell of Michigan and Frank Pallone of New Jersey, also urged that hearings be held on the metal hip problem and similar issues.

Venture fund executives like Mr. Carusi and lawmakers like Mr. Paulsen insist that they are equally concerned about safety. However, in their view, a big part of the problem at the F.D.A. is philosophical; top officials, these critics say, have overreacted to recent episodes involving flawed products and become risk-averse. As a result, devices are available first in Europe, they say.

“The key is to strike the right balance,” said Dr. Josh Makower, a device developer and a consultant to New Enterprise Associates, a venture fund in Palo Alto.

F.D.A. officials said they have recently tried to address investors’ concerns by announcing programs to encourage innovation and reduce regulatory burdens. Still, the head of the agency’s device division, Dr. Jeffrey E. Shuren, said that executives like Dr. Makower seemed more interested in politicizing the issue than resolving it through discussion.

“The dialogue has become more political and adversarial,” Dr. Shuren said.

Some medical experts have also questioned recent studies about the negative impact of regulations, calling the reviews flawed in methodology.

William Vodra, a lawyer in Washington who has worked closely with medical device producers, said that investors had legitimate concerns about regulatory speed. That is because the approval of a new device can begin a process in which a start-up company is acquired by a larger manufacturer and early investors profit by cashing out.

But such investors may be less interested in what happens to that device after it reaches the market because they have already moved on, said Mr. Vodra, who served on an Institute of Medicine panel that recently concluded the F.D.A. failed to properly assess the safety and effectiveness of many new devices.

Mr. Paulsen, the Minnesota congressman, did not respond to requests for an interview. But a spokesman, Tom Erickson, said that the lawmaker’s testimony this spring was unrelated to any campaign donations and reflected his long-held view that the F.D.A. was undermining an industry crucial to Minnesota.

“He gave his testimony because he feels these jobs are being threatened by an inconsistent and unpredictable F.D.A.,” Mr. Erickson said. Mr. Paulsen, along with Democrats and Republicans from states that are home to device makers, has also sought to repeal a tax on sales imposed on the industry under the health care overhaul law.

Dr. Makower, the venture fund consultant, has donated $5,000 to Mr. Paulsen, records show.

“I think that he understands this issue,” said Dr. Makower.

http://www.nytimes.com/2011/10/26/business/venture-capitalists-join-push-to-ease-fda-rules-for-medical-device-industry.html

New treatment increases brain activity to battle severe depression

Published: Monday, September 26, 2011, 6:03 AM Updated: Monday, September 26, 2011, 8:20 AM

By Sue Thoms | The Grand Rapids PressMLive.com

Cory Morse | The Grand Rapids PressSmiling again: Phyllis Myers, of Grand Rapids, received a new, noninvasive medical treatment, called transcranial magnetic stimulation, to treat severe depression. She said the treatment, along with psychotherapy, has helped. “For people like me, there is hope, “ Myers said.

It wasn’t long ago that Phyllis Myers felt wrapped in a fog of confusion and despair.
She read obituaries and envied the people who died in car accidents. She prayed to God to spare a child from having cancer by giving it to her.
She battled her depression with every tool she could find: She took two antidepressants, saw a psychotherapist, went for daily walks and used light therapy in winter. She forced herself out of bed every morning and stayed involved in social activities.
Still, she felt “totally debilitated.” She gave up her home-based quilting business because the cognitive effects of depression left her unable to recall how to use the software for her quilting machine.
“It felt like I was spiritually abandoned,” said Myers, a petite 60-year-old Grand Rapids woman with three children and four grandchildren.
When she was offered the option of trying transcranial magnetic stimulation, a new therapy for severe depression, Myers didn’t hesitate: She said, “Sign me up.”
Today, a year after receiving treatment, she finds it difficult to describe the changes in her life.
“Unbelievable,” she said. “I’m almost back to where I was before. I’m at 90 percent.”
She leans forward over her cup of coffee and grins.
“Maybe even 95.”
She laughs.
The treatment, called TMS, is a relatively new approach to treating severe depression. Approved in 2008 by the U.S. Food and Drug Administration, it is available locally only through Psychiatric Associates of West Michigan.
Dr. Henry Mulder said he and his partner, Dr. Phil Fox, were eager to provide the treatment after following its progress through clinical trials.

Katie Greene | The Grand Rapids PressBetter treatment? Dr. Henry Mulder sits in a chair used with the transcranial magnetic stimulation device at Psychiatric Associates in Kentwood. The device, which Mulder has been using with patients for about a year, uses magnetic stimulation of the brain to treat severe depression.

“It’s really been exciting,” said Mulder, the former president of medical staff at Pine Rest Christian Mental Health Services.
The treatment involves a trans-cranial magnetic stimulator, which looks similar to an X-ray machine at a dentist’s office. It produces an electromagnetic field that pulses in and out, stimulating activity in the brain cells about an inch deep.
Mulder said MRI brain scans show it causes an immediate increase in activity in the brain’s parietal cortex, which is transmitted to the amygdala, a structure deep in the brain that is involved with mood.
“Those areas of the brain that are underactive in depression get stimulated back up to their normal activity level,” he said.
A patient usually receives 30 to 36 daily treatments, each lasting 39 minutes.
“The most improvement we see is two weeks after treatment,” Mulder said.
Treatment continues until no more progress is seen. However, some patients report improvement continues for a month or two afterward.
Mulder’s office has treated nearly 30 patients since acquiring the machine 15 months ago. Only one has come back for a refresher treatment.
“It works well with people who have failed many drug trials,” he said. “We’ve treated a lot of people who have failed three, four medication trials, or more than that.”
Finding better treatments for severe depression is crucial, Mulder said. Despite the development of new of anti-depressants and growing acceptance of medications, many patients still are debilitated by the disease.

CHANGING OUR MINDS

Amid all the talk about health care, discussion of mental illness barely rises to a whisper. Yet in violence or in silent suffering, it often is a matter of life for death. All this year, The Press plans to challenge stigmas and myths, bringing into focus people and their problems — and hope for those who suffer. We are committed to providing tools for readers to deal with their own loved ones’ problems. And telling your stories.
This week, we look at the impact mental illness can have on families. Fear, sorrow, frustration and guilt all can afflict the loved ones of a mentally ill person. But help is available. And, we examine a woman’s experience with a new therapy for depression and the clinical trials that are being conducted in West Michigan.
• Complete coverage

An estimated 14 million Americans have major depression each year, and about 7.2 million receive treatment, according to a 2003 study published in the Journal of the American Medical Association, Mulder said. However, about 4 million are not adequately helped by treatment, or they cannot tolerate the side effects of medication.
For those, one alternative available is electroconvulsive therapy.
Although ECT got a bad reputation in the early days of its use, when high doses of electricity were used without anesthesia, the treatment is considered “a lifesaver” today by some patients, said Mark Eastburg, chief executive officer of Pine Rest.
ECT, which uses electrical currents to produce a brief seizure, is administered to patients under anesthesia who are temporarily paralyzed.
Studies show TMS is less than or equally as effective as electroconvulsive therapy, which also is used to treat severe depression, Mulder said. But he sees TMS as offering a couple of advantages — patients don’t have to undergo anesthesia, and they are able to drive and work immediately after treatment.
Neuronetics, the company that makes the $90,000 TMS device, has about 350 machines in use nationwide. It cites National Institutes of Health studies showing more than half of patients report significant improvement in their depression, and about a third experience complete remission.
Mulder said his statistics are better because he keeps patients on medication while undergoing treatment, so they benefit from the combined effect. The studies on the device required patients to be off medication.
“TMS stimulates the activity of the cells, and the medication improves the transmission of impulses between nerve cells, so you’re kind of hitting the same problem in two places,” Mulder said. “It definitely works better when used in combination.”
Myers was fortunate her insurer, Priority Health, covered the cost of treatments. Most insurers do not, Mulder said.
At a cost of $300 per session, a series of treatments runs $9,000 to $10,000.
When Myers underwent daily treatments, she felt a tapping sensation on her scalp. It was uncomfortable, she said, but not painful.
The results were evident almost immediately, however. Within days, she felt better. Within a couple of weeks, she launched a home-based business with her daughter making and selling granola bars.
She has not yet achieved her goal to live without medications. She still takes Cymbalta and Lexapro — although she has reduced the dose of Cymbalta.
“My psychologist recommended I stay on it through the winter, because winters are really, really hard for me,” she said.
Still, she said she is far ahead of where she was before treatment.
“I’m thrilled,” she said. “I’m just thrilled.”
E-mail Sue Thoms: sthoms@grpress.com

http://www.mlive.com/health/index.ssf/2011/09/new_treatment_increases_brain.html