FDA approves Amplatzer


News announcement from FDA you’ll be interested in if you’ve suffered a cryptogenic stroke from a suspected PFO and need more choice for treatment.


Update to Recent Post: Long Journey to Improve PFO Patient Voice and treatment Options for Cryptogenic Stroke

Wow, I have personally spent lots of time advocating for this important stroke/PFO patient matter over many, many years but hard work has now paid off.  The FDA announced last week the Amplatzer is now finally approved for recurrent cryptogenic stroke treatment in certain PFO patients!

Congrats and recognition for the commitment from the original team of PFO patients (formerly PFO Research Foundation in the US) that I began this important advocacy journey on with together so many years ago. Thank you!

Read the FDA Notice:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm

Take look back at my FDA testimony and this PFO journey background here:

http://www.know-stroke.org/a-long-journey-to-improve-pfo-patients-voice-and-treatment-options-for-cryptogenic-stroke/

bostonfinishlinedansereau
What a Journey !
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First AHA/ASA Stroke Recovery and Rehabilitation Guidelines


ASA logoOn May 4th in their publication Stroke,  the The American Heart Association/American Stroke Association (AHA/ASA) for the first time issued guidelines on stroke rehabilitation and recovery.  This scientific statement on rehabilitation is the 8th set of stroke guidelines from the American Stroke Association, and these guidelines focusing on recovery are the last of the association’s recommendations for the continuum of care for stroke patients and their families.

Grade the Guidelines

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How do you think the AHA/ASA did with their guidelines for stroke recovery and rehabilitation?  Do you think they hit the mark or fell short for stroke survivors and caregivers?

Give the guidelines a grade here:

 

I believe the guidelines scored a solid B (maybe minus).  Here’s my bottom line on the guidelines, and why I believe they fell short.

I just posted it to know-stroke.org. Check it out!

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FDA Circulatory System Devices Panel Votes to Approve Amplatzer PFO Occluder


Post by David Dansereau,MSPT

Know-Stroke.org

On May 24,2016 I provided patient testimony at the Circulatory System Device Panel at the FDA along with Bray Patrick-Lake and Peggy Mahrt of the PFO Research Foundation and several other patients who also traveled to Washington DC to share their stories.

Bray Patrick-Lake, David Dansereau,Peggy Mahrt provided patient testimony at the FDA Circulatory Device Panel for Amplatzer PFO Occluder. Photo courtesy of PFO Research Foundation

 

I wanted to share my FDA  testimony and my story of why it may finally be time to change my Facebook profile photo in today’s post on know-stroke.org

David Dansereau of Know-Stroke.org
David Dansereau of Know-Stroke.org

The Countdown is on for our NEW Know-Stroke.org Members Site


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Our KNOW-STROKE.org launch countdown is “Officially” on…

Get on our Ezine Subscription List or Get our Updates on our Facebook Page and learn when we flip the switch

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Take the Poll: Burning Brains. The REAL danger of teens smoking “spice” and stroke


know-stroke.org
Article by David Dansereau at Know-Stroke.org

Article by David Dansereau,MSPT

Read Now

http://www.know-stroke.org/burning-teens-brains-synthetic-marijuana-and-stroke.html

Never heard of “spice”?- READ NOW

Study sees rise in young stroke sufferers


http://mobile.reuters.com/article/idUSBRE8991KQ20121010?irpc=932

Is PFO closure Back in the “Dark Ages”?


Are Closure Devices for Patent Foramen Ovale (PFO) and Atrial Septal Defects (ASD) safe? Do they offer a better quality of life over medical management? Should you exercise with/without closure? What exercises are safe? Can you have sex with a PFO? Should you fly? Is scuba safe? Is device erosion a real risk? Will my insurance pay for PFO closure?

Why don’t we have these answers and more, why STILL don’t we have closure?

PFO Closure-Still in the Dark Ages? Know-Stroke.org

If you think that we are making progress in this important and potentially very profitable area of medicine, think again. For example, look at the information I’ve provided in this post from a large insurers website on PFO and particularly the policy benefits. Under the policy benefits look at what changes were made on “7/30/2010: Policy statement section revised.” I’ve highlighted it for you below.

If you take the time to compare the date of the policy changes to when a report was released a month prior that “put closure to PFO closure” you’ll see that we still haven’t really emerged from the “dark ages” with PFO closure 2 years after this study report was released. Read this great article on the PFO Research Foundation’s website for more on why one failed study proved costly for patients with PFO.

Quick Background:

A report back in June of 2010 when a now bankrupt NMT Medical announced preliminary results of Closure 1 PFO/Stroke Trial really had the medical community and device industry at odds because the investigation failed to reach primary end point. Read more about it here…

Fast Forward

I’d like to think we are still making progress for patients with PFO. I realized at the time of release that even though the Closure 1 study was poorly designed and the device was not the best, that the press would be all over it. After all, I had comfort in knowing there is plenty of great hard work being done out of a desire and shear passion for progress by patients like myself and others who are involved with the PFO Research Foundation. But I have to say I am again questioning if we are indeed “back in the dark ages” with PFO closure. Over the last several weeks I’ve spoken with several patients by phone who could essentially have been me 6 years ago, when I had my stroke and it was revealed I had a PFO. All those questions I listed at the top of this post are the same ones these patients and many others with PFO still have unanswered. The fact remains, that “gray area” and that term “cryptogenic” stroke still haunts fellow PFO patients. If you are still faced with having more questions than answers when it comes to PFO (patent foramen ovale) closure, the best advice I can give is you have to get all the facts. I’d suggest, if you haven’t already start by getting a free copy of the PFO Patient Guide. That is a start, but the fact remains you still have to do the “heavy lifting”, that is the research, at a time when you probably are not feeling your best. Remember, a PFO closure procedure can cost between $30-60,000 so that should certainly be considered as well as if your insurance will cover it (should you be fortunate enough to be covered). Even with that said, be aware of your insurance companies policies, read the fine print, and be prepared. Here’s BCBS’s policy below, you should check your insurer and individual state as things change all the time in the insurance world, as I hopefully illustrated for you in this example. I’ve also included the text as it appears on BCBS website and the important insurance code references for medical procedures often related to PFO/ASD.

PFO DESCRIPTION

Patent Foramen Ovale (PFO), a component of fetal cardiovascular circulation, consists of a communication between the right and left atrium that functions as a vascular bypass of the uninflated lungs. The ductus arteriosus is another feature of the fetal cardiovascular circulation consisting of a connection between the pulmonary artery and the distal aorta. Prior to birth the foramen ovale is held open by the large flow of blood into the left atrium from the inferior vena cava. Over a course of months after birth, an increase in left atrial pressure and a decrease in right atrial pressure result in the permanent closure of the foramen ovale in most patients. However, a patent foramen ovale (PFOs) may be detected in 25% of adult patients. Although common, PFOs are typically clinically insignificant and are not associated with right to left shunting with blood. However, they may be associated with paradoxical embolus, in which an embolus arising in the venous circulation gains access to the arterial circulation through the PFO, resulting in a stroke or transient ischemic attack (TIA). Therefore, there has been interest in either open surgery or transcatheter approaches to close the PFO in patients with a history of embolic stroke of unknown cause, also known as cryptogenic stroke.

Cryptogenic stroke is defined as an ischemic stroke occurring in the absence of potential cardiac, pulmonary, vascular, or neurological sources.  An ischemic stroke is classified as cryptogenic in up to 40% of cases, and may be even higher in younger populations.  Conventional medical therapy consists of either antiplatelet therapy (aspirin, clopidrogel, or dipyramidole given alone or in combination) or oral anticoaguation with warfarin.  In general, patients with a known clotting disorder or evidence of pre-existing thromboembolism are treated with warfarin and patients without these risk factors are treated with antiplatelet agents.

Two transcatheter devices received approval for marketing from the U.S. Food and Drug Administration (FDA) in 2002 as a treatment for patients with cryptogenic stroke and patent foramen ovale: the CardioSeal Septal Occlusion System and the Amplatzer® Patent Foramen Ovale occluder.  Both received FDA approval through a Humanitarian Device Exemption (HDE), a category of FDA approval that is applicable to devices that are designed to treat a population of less than 4,000 patients per year.  This approval process requires the manufacturer to submit data on the safety and the probable clinical benefit.  Clinical trials validating the device effectiveness are not required.  The labeled indications of both limits the use of these devices to closure of PFO in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

Following this limited FDA approval, the use of PFO closure devices increased by over 50-fold, well in excess of the 4,000 per year threshold intended under the HDE.  As a result, in 2006, the FDA withdrew the HDE approval for these devices.  At this time, the FDA also reiterated the importance of randomized, controlled trials of PFO closure devices versus medical therapy, and noted that ongoing trials were hampered by slow enrollment.  Withdrawal of the HDE approval was, in part, intended to spur greater enrollment in ongoing randomized, controlled trials of these devices.  Currently, all uses of closure devices to treat PFO are off-label uses.

In contrast to patent foramen ovale, which represents the persistence of normal fetal cardiovascular physiology, atrial septal defects (ASDs) represent an abnormality in the development of the heart that results in free communication between the atria. ASDs are categorized according to their anatomy. For example, ostium secundum ASDs are the third most common form of congenital heart disorder and one of the most common congenital cardiac malformations in adults, accounting for 30%–40% of these patients over the age of 40. Ostium secundum describes defects that are located midseptally and are typically near the fossa ovalis. Ostium primum defects lie immediately adjacent to the atrioventricular valves and occur commonly in patients with Down’s syndrome. Sinus venous defects occur high in the atrial septum and are frequently associated with anomalies of the pulmonary veins. The ASD often goes unnoticed for decades because the physical signs are subtle and the clinical sequelae are mild. However, virtually all patients who survive into their sixth decade are symptomatic; less than 50% of patients survive beyond 40 to 50 years due to heart failure or pulmonary hypertension related to the left-to-right shunt. Patients with ASDs are also at risk for paradoxical emboli.

Repair of ASDs is recommended for those with pulmonary systemic flows exceeding 1.5:1.0. Despite the success of operative repair, there has been interest in developing a catheter-based approach to ASD repair in order to avoid the risks and morbidity of open heart surgery. A variety of devices have been researched over the past 20 years; technical challenges include minimizing the size of device so that smaller catheters can be used; developing techniques to properly center the device across the ASD, and ensuring that the device can be easily retrieved or repositioned if necessary. Late failures due to mechanical fatigue have also been a concern. Early devices such as the Rashkind hook device and the Lock Clamshell device were limited by their large size and technical malfunctions. At present, there are 2 devices that are FDA approved for ASD closure: the AMPLATZERSeptal Occluder, and the GORE HELEX  Septal Occluder.

POLICY

Closure of patent foramen ovale using a transcatheter approach is considered investigational. (There are currently no transcatheter devices with FDA approval or clearance for this indication.)

Transcatheter closure of secundum atrial septal defects may be considered medically necessary when using a device that has been FDA approved for that purpose and used according to the labeled indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

POLICY HISTORY

5/2001: Approved by Medical Policy Advisory Committee (MPAC)

2/13/2002: Investigational definition added

4/18/2002: Type of Service and Place of Service deleted. Code Reference section completed.

6/4/2002: Amplatzer® Septal Occluder and Amplatzer® Patent Foramen Occluder receive FDA approval

3/6/2003: Code Reference section updated

4/17/2003: Code Reference section updated

11/5/2003: Code Reference section updated, ICD-9 diagnosis code V12.59 deleted, HCPCS C1817 deleted

4/22/2004: CPT code 93580 note added

1/23/2007: Policy reviewed, no changes

1/6/2009: Policy reviewed, investigational language per the closure of a patent foramen ovale inserted

7/30/2010: Policy statement section revised.  Closure of patent foramen ovale using a transcatheter approach is considered investigational.  There are currently no transcatheter devices with FDA approval or clearance for this indication. Code Reference section revised to remove ICD-9 diagnosis codes 435.8, 444.9 and 745.61. CPT Codes 37204 and 75894 and ICD-9 Procedure Code 35.71 were removed from the Covered Codes Table because of changes in policy statement (closure of PFO are now considered investigational).  Description was revised for ICD-9 Diagnosis code 745.5.

09/28/2011: Policy reviewed; no changes.

05/09/2012: Removed link to Amplatzer® Devices policy and added link to Transcatheter Closure of Patent Ductus Arteriosus policy.

 

 

INSURANCE CODE REFERENCE

Covered Codes

Code Number Description
CPT-4
93580 Percutaneous transcatheter closure of congenital interatrial communication (i.e., fontan fenstration, atrial septal defect) with implant Note: Trans-esophageal echocardiography services (93303-93317 and intracardiac echocardiography (93662) can be reported separately and in addition to code 93580.Codes 93501, 93529-93533, 93539, 93543, and 93555 should not be reported in addition to codes 93580. According to CPT coding guidelines, these services are included in code 93580.
ICD-9 Procedure
35.52 Repair of atrial septal defect with prosthesis, closed technique
ICD-9 Diagnosis
745.5 Ostium secundum type atrial septal defect (Description revised 07-30-2010)

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.09

http://www.medicalnewstoday.com/releases/192267.php

http://pforesearch.org/?q=blog/closure-i

http://pforesearch.org/?q=content/patient-guide-pfo

Bottom line:

The answer to the question,

“Can you have Sex with a PFO”?

I am not a physician, so you’ll have to ask your own. Be prepared, your doctor may say after all, they must have in the dark ages, right?

David Dansereau,MSPT

Know-Stroke.org