Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.

J Neurosurg. 2015 Mar;122(3):532-5. doi: 10.3171/2014.10.JNS14640. Epub 2014 Dec 19.

Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.

Robinson LC¹, Winston KR.

Author information

• ¹Department of Neurosurgery, University of Colorado School of Medicine, Aurora;

Abstract

OBJECT:

This investigation was done to examine, following implantation of vagus nerve stimulators, the relationship of vocal cord paralysis to the inner diameter of the coils used to attach the stimulator lead to the nerve.

METHODS:

All data in this investigation were collected, as mandated by the FDA, by the manufacturer of vagus nerve stimulators and were made available without restrictions for analysis by the authors. The data reflect all initial device implantations in the United States for the period from 1997 through 2012.

RESULTS:

Vocal cord paralysis was reported in 193 of 51,882 implantations. In patients aged 18 years and older, the incidence of paralysis was 0.26% when the stimulator leads had coil diameters of 3 mm and 0.51% when the leads had 2-mm-diameter coils (p < 0.05). Across all age groups, the incidence of vocal cord paralysis increased with age at implantation for leads having 2-mm-diameter coils.

CONCLUSIONS:

In patients aged 18 years and older, vocal cord paralysis occurred at almost twice the rate with the implantation of vagus nerve stimulator leads having 2-mm-diameter coils than with leads having 3-mm-diameter coils. The incidence of vocal cord paralysis increases with patient age at implantation.

KEYWORDS:

VNS = vagus nerve stimulation; complications; epilepsy; vagus nerve injury; vagus nerve stimulator lead; vocal cord paralysis

PMID:

25526267

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/25526267

VNS Therapy for Depression - Another taste of governmental bureaucracy and its ineptitude...

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, April 21, 2015 11:02 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director; Courtney Turner; Davonda Roberts - Nurse Consultant, HHS/CMS
Subject: VNS Therapy for Depression - Another taste of governmental bureaucracy and its ineptitude...

Dear Madam Secretary Burwell et al,

This early morning I received a lovely and caring telephone call from Ms. Davonda Roberts, Nurse Consultant out of your Atlanta, Ga Medicare office following up on an email I sent you and others on January 8, 2015.  I expressed my appreciation for her telephone call and for seeking to assist me this morning.  The fact is and the reality is someone in the executive offices of HHS/CMS in the Washington DC bureaucracy took my email message and simply shoved the message on down the line to this lovely woman who had no idea of my struggles and advocacy these past two years or the events surrounding the VNS Therapy for Depression and the issues.

A simple analysis from my viewpoint after some two (2) years of advocacy to obtain medical coverage for VNS Depression Patients implanted prior to the CMS determination of May 4, 2007 is that our health care bureaucracy is so voluminous that literally “One hand does not know what the other hand is doing” and that no one and I do mean no one is really knowledgeable how to promptly and effectively assist our citizen patients.

Almost two (2) years into this struggle I learn about the doctrine of “Continuity of Care.” Yet no one but no one in all of HHS/CMS acknowledged or cited the doctrine of “Continuity of Care” to insure the medical coverage for these patients.  I have appealed to you and your predecessor Kathleen Sebelius numerous times for “Compassionate Use” of this therapy for these patients when all this time the doctrine of “Continuity of Care” existed in your records which should have promptly insured coverage and care for these patients.

I am truly embarrassed for you and for all the agencies you direct.

Worse yet is the fact I received another communication recently from a woman having Medicare coverage and difficulty obtaining replacement surgery for her depleted device.  She called Courtney Turner without receiving a return call.

Doesn’t anyone within the bureaucracy comprehend the urgency of these health care matters?

Lastly, I am also truly flabbergasted by the fact that another individual also contacted me that he was covered by Florida Blue, a private health insurance carrier. and they too have continued to deny him replacement therapy.  I realize and have heard it numerous times that CMS has no control over private health insurance companies.  What about “Continuity of Care”?  Is there not anyone in all of the HHS bureaucracy with enough authority, intelligence and moxie to call Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) to inform him of “Continuity of Care” to assist this patient in rightfully obtaining replacement prosthesis?

How much longer do these ineptitude, immoral and egregious acts have to continue?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.

BMC Psychiatry. 2015 Mar 31;15(1):64.

Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.

Albert U¹, Maina G², Aguglia A³, Vitalucci A⁴, Bogetto F⁵, Fronda C⁶, Ducati A⁷, Lanotte M⁸.

Author information

• ¹Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. umberto.albert@unito.it.
• ²Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. giuseppe.maina@unito.it.
• ³Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. andrea_aguglia@yahoo.it.
• ⁴Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alberto.vitalucci@unito.it.
• ⁵Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. filippo.bogetto@unito.it.
• ⁶Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. chiara.fronda@unito.it.
• ⁷Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alessandro.ducati@unito.it.
• ⁸Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. michele.lanotte@unito.it.

Abstract

BACKGROUND:

Limited therapeutic options are available for patients with treatment-refractory major depression who do not respond to routinely available therapies. Vagus nerve stimulation showed adjunctive antidepressant effect in chronic treatment resistant depression, even though available studies rarely exceed 2-year follow up. We report a naturalistic 5-year follow up of five patients who received VNS implant for resistant depression (3 patients with major depressive disorder and 2 with bipolar disorder).

METHODS:

Response was defined as a reduction of the 17-item HDRS total score ≥50% with respect to baseline, remission as a score ≤7.

RESULTS:

Response and remission rates were both 40% (2/5) after 1 year, and 60% (3/5) at 5 years. Two patients withdrew from the study because of side effects or inefficacy of stimulation.

CONCLUSIONS:

Our case series showed that long-term VNS may be effective in reducing severity of depression in a small but significant minority of patients, although two patients had stimulation terminated because of adverse effects and/or refusal to continue the study.

PMID:

25884606

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/25884606

Treatment for stroke victims shows ‘promising’ results

 

• Wednesday 11th March 2015

Treatment for stroke victims shows ‘promising’ results

Them trial recruited 20 patients in Glasgow and Newcastle. Picture: John Devlin

 

TIM BUGLER

22:58 Tuesday 10 March 2015 00:00 Wednesday 11 March 2015

A GROUND-BREAKING new treatment to help stroke patients regain the use of their arms has shown “promising” ­results.

Vagus nerve stimulation (VNS) uses small doses of electricity to encourage the growth of new neural connections in the brain.

It has now been shown to help patients improve arm function by a greater degree than standard physiotherapy alone.

A stroke happens as a result of a loss of blood supply to a part of the brain, leading to tissue death and loss of functions controlled by the affected brain area. Around 85 per cent of stroke victims seen at the stroke clinic at Glasgow’s Western Infirmary have arm weakness, which persists to a significant degree in half of these.

The two-year trial, which recruited 20 patients in Glasgow and Newcastle-upon-Tyne with long-term arm weakness after their stroke, involved the implantation of a small electrical device into the body.

The device is similar to a pacemaker and is implanted in the chest. It is then connected to the vagus nerve in the neck using thin wires that are also implanted. Scientists decided to stimulate the vagus nerve as it connects to structures in the brain involved in recovery from injury. The idea was to take ­advantage of neuroplasticity – the natural ability of the brain to form new neural connections.

Pairing the vagus nerve stimulation with traditional rehabilitation encourages the brain to form new, stronger neural connections. The researchers in this study hoped this process would significantly improve arm function during the recovery process following the stroke.

The study recruited volunteers who had suffered ischaemic stroke at least six months earlier with moderately severe arm problems. The patients were split into two groups, one receiving intensive physiotherapy alone, the other receiving physiotherapy paired with VNS.

When patients followed the study protocol in full, there was a significantly greater improvement in a measure of arm function called the upper extremity Fugl-Meyer score.

The scores of VNS treated patients were six points higher than those who did not receive VNS in addition to their physiotherapy. When patients have such a large change in their score, noticeable improvements in arm related tasks can be ­observed on a daily basis.

Dr Jesse Dawson, of the Institute of Cardiovascular and Medical Sciences at Glasgow University, who led the trial, said: “Our initial study demonstrates that VNS paired therapy holds promise. Greater improvements in arm function were observed in patients using VNS paired therapy compared to participants using traditional rehabilitation alone.

“We need to do larger trials to confirm our findings and determine if the widespread adoption of this technique could benefit post-stroke patients with upper limb deficits. These initial results are certainly encouraging and warrant further investigation.”

The trial was run with Texas-based biomedical company MicroTransponder, which developed the “Vivistim” device.

http://www.scotsman.com/news/health/treatment-for-stroke-victims-shows-promising-results-1-3715354

Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue)

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, February 28, 2015 3:18 PM
To: Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: Battling Florida Blue...

To Joyce’s fellow patients et al,

I need your help.  If anyone out there reading this message knows the direct email address for Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) I would gratefully appreciate your assistance by sending me the address.

I am trying to advocate for a fellow VNS Depression patient being denied coverage for the replacement of his/her prosthesis as a private pay subscriber.

Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield,

I would appreciate if you could give me Mr. Geraghty’s direct email address.  I am aware and thank you for the assistance you previously gave to one of your VNS Depression patients by paying for her replacement and based upon what she had told me you did so stating, “continuity of care”.  At the time I did not fully understand the significance of the term as I now know it establishes a medical precedence and practice which Medicare/Medicaid and the private insurance carriers should have been adhering to.  I would also ask, if possible, if you would contact your fellow CEO and apprise him of the patient that his company has been denying medical coverage.  If necessary I’m sure the patient would supply you with personal information so that Mr. Geraghty would see to the expediting of this case.  Just let me know.

It is truly shameful and anxiety ridden that these implanted patients with a medical device and I have to shamefully fight tooth and nail with our last once of strength for that which already exists in medical doctrine and practice buried somewhere in the vestiges of HHS and no one knowledgeable enough throughout these bureaucracies to come forth to rightfully help these patients and rectify the situation by stating, “continuity of care”.

Shameful, shameful, shameful on all you bureaucrats who sit back, spout platitudes, collect your checks and really make no effort to reach out and truly help with a few exceptions, that’s unfortunately the way I see things based upon my lengthy advocacy for these patients.

Shame on you all for not comprehending what it is like to help keep someone alive!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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Still battling Florida Blue…

From: (redacted)
Sent: Saturday, February 28, 2015 9:58 AM
To: Herbert Stein
Subject: RE: DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION

Hi Herbert.
Got your call and the email updates. Thank you.
I take it from the document, this decision is not overturning the 2013 to cover battery replacement but rather rejects the argument that the previous decision to stop coverage of new implants was not based on full record of evidence. Is this your thoughts?
I am working with a case manager at Cyberonics and I am awaiting a predetermination of benefits. I expect it will be denied. I have starting collecting all my medical records. Also I have started a draft of a personal statement.
My next step will be to find the direct contact info of Florida Blues CEO.
I will keep you up yo date if how this transpires.
Again thank you for your continued support to all if us.
Sincerely
(Redacted)
Sent from my Windows Phone

---

 

From: Herbert Stein [Redacted]
Sent: Saturday, February 28, 2015 12:57 PM
To: (Redacted)
Subject: RE: DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION

(Redacted),

My understanding of this recent appeal decision is that they are upholding the May 4, 2007 decision to not pay for any implants or care of new patients on or after that date.

While denying insurance coverage to new patients it goes on further to state for the first time in this recent appeal decision, in writing, the care and replacement of the device rightfully for Medicare/Medicaid patients implanted prior to May 4, 2007 under the doctrine or law of “continuity of care”.  I further interpret this decision to mean that the private health insurers, who normally follow CMS’s lead, should also follow the “continuity of care” doctrine as quoted below:

(1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).

Not being a legal authority I can only express my opinion based upon my readings but were I in your position I certainly would emphasize and strongly hang my hat on the above information and decisions to encourage, enforce and coerce your insurance carrier to relent and do the right thing.

If you’re able to obtain an email address for Florida Blue CEO I’ll jump immediately on advocating for your cause.

I’m here and available to encourage and support your efforts.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, February 27, 2015 4:09 AM




Subject: DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION



To Joyce’s fellow patients et al,



At long last the decision I’ve been waiting to read from the DEPARTMENTAL APPEALS BOARD dated December 30, 2014 or in the words of Jerry Seinfeld, “Yada, Yada, Yada”.



 DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION



 I quickly read through the document at this late hour and of utmost importance to the VNS Medicare/Medicaid patients and to the privately insured patients, in my opinion, starts with page 62 paragraph VII.
 


The key words are “continuity of care”:



 (1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).



In essence as I read these words it has established Medicare/Medicaid coverage and for the private health insured patients this “continuity of care” should be, in my opinion, the medical and legal basis to pursue and assert one’s rights to obtain continuing care and replacement for one’s VNS Therapy for Depression.  This would override any garbage handed down by one’s health insurer that the therapy is experimental and not approved by CMS.
 


At the same time I tip my hat and express my sincere appreciation to Drs. Aaronson, Moreno, Buser, Rush and others in aiding our cause as well as their humanity and understanding the special needs of these unique patients.



Sincerely,
Herb



Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
(954) 349-8733



vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com
http://www.vnstherapy.wordpress.com



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