PFO and CardioSeal info


Source: ClevelandClinic.org

Patent Foramen Ovale

Your septum

  • The septum is the muscular wall separating the heart into the left and right sides.
  • The atrial septum is the wall separating the atria (the two upper chambers).
  • The ventricular septum is the wall separating the ventricles (the two lower chambers).

Patent Foramen Ovale (PFO)

The foramen ovale is a small hole located in atrial septum that is used during fetal circulation to speed up the travel of blood through the heart. When in the womb,a baby does not use it’s own lungs for oxygen-rich blood, it relies on the mother to provide oxygen rich blood from the placenta through the umbilical cord to the fetus. Therefore, blood can travel from the veins to the right side of the baby’s heart and cross to the left side of the heart through the foramen ovale and skip the trip to the baby’s lungs.

Normally the foramen ovale closes at birth when increased blood pressure on the left side of the heart forces the opening to close.

If the atrial septum does not close properly, it is called a patent foramen ovale. This type of defect generally works like a flap valve, only opening during certain conditions when there is more pressure inside the chest. This increased pressure occurs when people strain while having a bowel movement, cough, or sneeze.

If the pressure is great enough, blood may travel from the right atrium to the left atrium. If there is a clot or particles in the blood traveling in the right side of the heart, it can cross the PFO, enter the left atrium, and travel out of the heart and to the brain (causing a stroke) or into a coronary artery (causing a heart attack).

How Common is Patent Foramen Ovale?

The prevalence of PFO is about 25 percent in the general population. In patients who have stroke of unknown cause (cryptogenic stroke), the prevalence of PFO increases to about 40 percent. This is especially true in patients who have had a stroke at age less than 55 years. (http://stroke.ahajournals.org/cgi/content/full/37/2/577)

A PFO can be associated with atrial septal aneurysm, which is characterized by excessive mobility of the atrial septum.

Symptoms of PFO

Most patients do not have any symptoms with PFO.

Stroke and PFO: About 40 percent of patients who have an ischemic stroke have no known cause (called cryptogenic stroke). PFO is present and associated with an increase in stroke in about 40 percent of cases. The most common symptoms of stroke are:

  • weakness or numbness of the face, arm or leg on one side of the body
  • loss of vision or dimming (like a curtain falling) in one or both eyes
  • loss of speech, difficulty talking or understanding what others are saying
    sudden, severe headache with no known cause
  • loss of balance, unstable walking, usually combined with another symptom

Click here to learn more about stroke

Migraine headache and PFO: Migraine headaches are more common in patients with PFO. While it seems as though closure of PFO results in improvement of migraine symptoms, larger studies are needed to confirm this finding.

Diagnosis of PFO

Patent Foramen Ovale can be detected by echocardiogram. In some cases the patient is asked to cough or perform the Valsalva maneuver to increase pressure in the right atrium. This can increase the flow of blood from the right to left atrium. Transesophageal echo, can provide a closer and more detailed view of the PFO.

Treatment for Patent Foramen Ovale (PFO)

Medical management

People with PFO do not need any treatment if there is no associated problems, such as a stroke. Patients who have had a stroke or transient ischemic attack (TIA) may be placed on some type of blood thinner medication, such as aspirin, plavix (clopidogrel), or coumadin (warfarin) to prevent recurrent stroke.

Non-surgical treatment: Cardiac implant

In some patients a cardiologist and a neurologist may reccomend closure of PFO. Most frequently, percutaneous rather than surgical closure is preferred. As part of the procedure, you will first undergo a cardiac catheterization. During this test, catheters (hollow, flexible, tube) will be inserted into the veins in your groins and advanced to your heart. A balloon may be placed across the opening to determine the size and location of the hole in your heart. Measurements are taken of the pressure inside your heart chambers. A tiny catheter with an echo transducer is placed in the heart for imaging.

If the cardiac catheterization shows your PFO is an appropriate size and in an appropriate location for closure with this device, the cardiologist will position the device to close the hole.

Two closure devices

Currently there are no specially designed devices for PFO closure that is approved by the FDA. In patients that closure is indicated, devices that are approved for other heart defects are used.

CardioSEAL® device
Photo used with permission from NMT Medical*

The CardioSEAL® device is a small double umbrella arms attached to Dacron fabric. It is folded into a special catheter, similar to the catheter used during your catheterization. The special catheter is inserted into a vein in the leg and advanced into the heart and through the hole. The device is slowly pushed out of the special catheter allowing each umbrella to open up and cover each side of the hole (like a sandwich) and close it. When the device is in proper position, it is released from the special catheter. Over time, heart tissue grows over the implant, becoming part of the heart.

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A Hole in the Heart-Good PFO Tipsheet by stroke.org


Patent Foramen Ovale (PFO) and Stroke

Line General

Source: stroke.org and AMA Medical
Have you had a stroke or TIA (transient ischemic attack or mini-stroke) “out of the blue” with no obvious risk factors? Did doctors check to see if the stroke or TIA may have been caused by a “hole” in the heart called a patent foramen ovale (PFO)? About one in five Americans has a PFO. Many don’t know it until a medical condition like a stroke or TIA occurs. PFOs often have no symptoms but they may increase your risk for stroke and TIA. Many PFO-related strokes are called cryptogenic, meaning they have no apparent cause.
What is a PFO?
Line General
All people are born with flap-like openings in their hearts. But, for most, the opening closes by itself shortly after birth.
In some people, an open flap remains between the two upper chambers of the heart (the left and right atria). This opening can allow a blood clot from one part of the body to travel through the flap and up to the brain, causing a stroke.
What can you do about it?
Line General
The first step is to get a diagnosis. An ultrasound of the heart, called an echocardiogram, can show doctors if a PFO is present.
The second step is to ask your doctor about treatment options. Currently, there are two main treatment methods for PFO: medicines or PFO closure, which can include open-heart surgery or a newer procedure that closes the flap without major surgery.
The medicines don’t treat the actual PFO. They can control clotting factors in the blood so stroke-causing blood clots are less likely to form in the first place.
Open-heart surgery is rarely used for people who don’t respond to the drugs. But, as with any major surgery, patients and their doctors need to weigh the risks of the surgery with the benefits before moving ahead with this treatment option. In recent years, a new approach has been developed enabling doctors to seal the PFO without major surgery. An implanted closure device, which can resemble a tiny two-ended umbrella, is delivered to the PFO using a small tube threaded to the heart from a vein in the thigh. The implant is inserted through the flap and released from the tube. It expands and tissue grows in and around the implant to seal the PFO from both sides. This procedure requires minimal recovery time. Currently, the U.S. Food and Drug Administration (FDA) allows this treatment method only for “humanitarian” uses, meaning that the procedure is only used for people who don’t respond to the medicines and have already had a second stroke.
On-going Research
Line General
Which is the better treatment option: medicine or PFO closure? That question still needs to be answered.
The good news is that research now is being conducted to see if PFO-closure implant procedures are better than medications at helping reduce the risk of recurrent stroke in stroke and TIA survivors. But, the only way scientists will have meaningful research studies is if they have enough people participating.
If you or someone you know has had a PFO-related stroke or TIA and is interested in learning more about treatment options for the PFO through a clinical trial, you can get more information about clinical trials by calling 1-800-STROKES (800-787-6537) or by visiting the Clinical Trials Resource Center.
As a participant in a clinical trial, you are carefully evaluated by doctors and receive extensive follow-up care. During your treatment, you may also receive the latest version of a current PFO closure device. The FDA has approved a prior version of this device and more than 15,000 people around the world have been treated with this procedure. You will also be helping medical science find the most effective treatment to lower the number of PFO-related strokes and TIAs


Additional Resources
Line General

This web page was sponsored by an unrestricted educational grant from AGA Medical.

A reply to Tedy Bruschi’s “Never Give Up” book


I sent this letter off back in August of 2007.  I’ve been inspired by the recent phone calls and posts that have come in with stories all too similar to mine. Because of these stories, I’m going to begin to fill in the gaps of my stroke story and timeine with the purpose of helping others paint a clear picture of what still needs to be done to improve awareness with cryptogenic stroke.  That begins with a personal letter I had filed away that I had sent off to Tedy and Heidi Bruschi after reading the book “Never Give Up”.  I was reminded of the letter after hearing in the news yesterday that Tedy has renewed his contract with the New England Patriots-which by the way, is great news for New England.  I hope he also finds time to renew his efforts with spreading the word about fighting stroke.  Anyway, here’s what I am referring to:

Originally written 6 August 2007

 

Dear Tedy and Heidi;

 

I just finished reading Never Give Up and I felt compelled to send a note off to you both.  I clearly admit I was one of those doubters you referred to in your book.  Having three small children of my own, I could not even consider why you would risk returning to play football in the NFL.  I know now how blind I was to what you and Heidi had gone through. Unfortunately, I learned first hand this life lesson and then later it was reinforced by reading your book.

 

You see, in the Fall of 2006, I had a stroke at age 39 from the same cause, a PFO that was never detected at birth.  I feel like I am just now on the same journey back home as I write this note.  In many ways, even though I had my PFO closed on May 1, 2007  and have worked through most of the physical limitations from the stroke, I am still going through much of the emotional recovery you described so well. 

 

I admit I was angry with you for quite some time Tedy.  I know, you’re thinking you don’t even know me, so it is unfair for me to make that statement.   When doctors finally found out what had caused my stroke, I was reaching out for help to find answers.  No one could help me sort through what decision my wife and I needed to make to get me healthy again.   The real reason I said I was angry with you was that I was so desperate to speak with someone who had come out on the other side after the PFO procedure and returned to their regular life and you were the only “young face” of stroke I knew of.  I sent emails to you through the Pats website, left messages by phone at Gillette Stadium all to no replies.  I am no longer angry after reading your story, and realize your position and the energy it took to recover.  It was not even that I expected a personal reply, it was more that I was thinking here is a guy that the world knows and loves and he is being silent about this at a time when he could be making an enormous impact in stroke awareness.  I could not have been more wrong. My sincere apologies.

 

Part of my educational journey to get some answers led me to meeting Zach Blackburn through the ASA American Stroke Association) and your organization.  I am so glad I went up to Framingham to meet him personally.  I shared both my enthusiasm and frustration with him during our meeting.  At the time I was still awaiting a decision before the PFO committee at MGH and I was in a mental state where I needed to put things back “in my own hands”.  I spelled out my frustration with Zack about not having enough resources for young stroke survivors and the lack of education/knowledge for PFO’s and especially that related to the brain/heart connection.  I wanted to make some changes and I brought up a copy of my own story (which I had written out of frustration) to him. He probably feels I was all hype at my convictions to get national attention for this component of needed stroke education, but I promise to you I am only more dedicated to this cause now, after closure, than at the time of that meeting back in March.  (I’ve included a copy of my story if you would like to learn more.)  I am sure Zack dismissed my enthusiasm and placed this article on his desk, but I plan to speak to him more on this topic at our next Tedy’s Team event this weekend.

 

 

As you’ll learn if you skip through the PFO background information, and go to what I call my “Oprah moment”  – this is where our stories go off course and it is this part of my story that I need to see to a better end for future stroke survivors.

 

I could relate to the trips back and forth to MGH, all the testing, even getting mad at the doctors up there at times (I had more then one angry moment with Dr. Palacios), and I even was laughing at the description of your stomach from the heparin injections post-op because my midsection looked just the same.  While there were so many similarities to my own situation and I owed the same “thank you’s” to many of the same doctors and support staff at MGH after my procedure, I also experienced a much different approach to getting to the decision to close my PFO.  If you read my story, you’ll learn more, but the short of it is so much more attention to this topic is needed.  I know you must realize you both are in a position to impact so many lives in a positive way and that is why I hope you are planning now for your own “Oprah moment” to take your important message nationally.

 

My biased judgment of your book is that there will undoubtedly need to be a “part 2” because it is that good.  I expect you’ll be flooded with stories like my own and would need to follow-up with the impact your book will present.  I believe, as does most every person in New England, you both have a powerful message to get out there and perhaps the book is just the beginning.  

 

In closing, after meeting several of Tedy’s Team members for the first time last week in Marlboro, it is clear I am on the right team to help you both get this job done.  I also had the opportunity to be introduced to a real genuine stroke hero when I met you, Heidi, briefly that evening.  I know that I would not be standing today without the support of my own hero, my wife Lisa.  Tedy, you describe there are two faces of stroke, young and old.  I think there is also a third face and it is the face of the real stroke heroes, the person(s) you lean on for support when you are going through this process-the caregivers and loved ones who step up and keep you strong.    Quite honestly, I was feeling a bit overwhelmed last week when I thought of the tasks that lie ahead.  I was getting puzzled by how to create the “Oprah moment” this stroke education campaign needs in the media to raise awareness. Your book, along with a reminder from my stroke hero Lisa, came at just the right time and has me back on track focused on what needs to be accomplished. 

 

Please let me know if there is anything I can do to help you both get to that “Oprah moment”.  In the meantime please keep quarterbacking this cause and I’ll continue to do my part on your team.  

 

Best of health,

 

 

David Dansereau (401) 632-0868

Stroke Survivor

 

PS- My coming back song has been “Give a Little Bit”, I prefer the remake by the Goo Goo Dolls.  Load it up some time and listen to the lyrics.