Updates from July, 2010 Toggle Comment Threads | Keyboard Shortcuts

  • David 3:39 am on July 10, 2010 Permalink | Reply
    Tags: blood thinning after stroke from PFO, , , patent foramen ovale treatment, ,   

    I am not a rat. I am a stroke survivor that had a congenital heart defect called PFO (patent foramen ovale) and I fought like hell to get it fixed 

    by David Dansereau for Know-Stroke.org

    Life after a stroke can be like living with a ticking time bomb.  The reality is that a second, possibly fatal stroke can very well follow the first.  In 2006, I survived a second stroke and shortly thereafter I vowed to make that one my last.  I researched all my treatment options, and as it turns out after 9 months of frustration I guess you could say I finally “qualified” to have my PFO closed “off label”.   What that really means is essentially my wife and I fought like hell to get a better chance at a treatment outcome we could both live with.   In the end, I weighed medical management (drug therapy) vs. surgically correcting my underlying heart defect.  My stroke could not be attributed to a disease process like hypertension or uncontrolled hyperlipidemia and no drugs or lifestyle modifications were going to be effective at reversing my risk of another stroke without possibly putting me at risk of further potential drug complications.  As the title of this post suggests, I was born with a congenital heart defect called a PFO that caused my stroke, and I decided a drug (yes, also used to kill rats) was not the therapy of choice for me for the rest of my life.

    My decision was not an easy one, but either is rehabilitating from a stroke and I say this cautiously knowing that many reading this may now be faced with the same difficult decision of how to best respond to take back their own health.

    I emphasize, you should speak with your own physician throughout the course of your own therapy and ask plenty of questions.  The decision I made was unique to how I envisioned I wanted to live my life after my stroke.  Your life goals should provide the blueprint for your own health plan, not your insurance carriers plan for your care.

    Honestly, I’ve had this article ready to post for several weeks now.  I actually started this response after a comment that appeared on my blog (know-stroke.org) about alternatives to thinning your blood. In response to my post I was asked through a private comment on my blog why I didn’t just stay on drug therapy after my stroke since Coumadin seemed like the “simple solution” to prevent another stroke.  Well, I have to put this out there that it simply isn’t quite that “simple”.

    Here’s what you should know:

    Yes, Warfarin is still used as rat poison.  This fact certainly got my attention when I was advised to start Coumadin therapy. I hope that you have already researched this medication on your own.  I mention it not to scare you but to make an important point:  If taken in large quantities, Warfarin (brand name Coumadin) can cause severe and even fatal bleeding. When given as a medication however and monitored by blood tests, it is reported to be safe but not without a long list of potential drug complications as reported by the National Institute of Health’s (NIH) Pub Med Website.  Here’s what they have to disclose on what side effects this antithrombotic medicine can cause:

    Warfarin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

    • gas
    • change in the way things taste
    • tiredness
    • pale skin
    • loss of hair
    • feeling cold or having chills

    If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

    • hives
    • rash
    • itching
    • difficulty breathing or swallowing
    • swelling of the face, throat, tongue, lips, or eyes
    • hoarseness
    • chest pain or pressure
    • swelling of the hands, feet, ankles, or lower legs
    • fever
    • infection
    • nausea
    • vomiting
    • diarrhea
    • loss of appetite
    • pain in the upper right part of the stomach
    • yellowing of the skin or eyes
    • flu-like symptoms
    • joint or muscle pain
    • difficultly in moving any part of your body
    • feelings of numbness, tingling, pricking, burning, or creeping on the skin
    • painful erection of the penis that lasts for hours

    You should also know that Warfarin may cause necrosis or gangrene (death of skin or other body tissues). Call your doctor immediately if you notice a purplish or darkened color to your skin, skin changes, ulcers, or an unusual problem in any area of your skin or body, or if you have a severe pain that occurs suddenly, or color or temperature change in any area of your body. Call your doctor immediately if your toes become painful or become purple or dark in color. You may need medical care right away to prevent amputation (removal) of your affected body part.

    Warfarin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    In case of emergency / overdose

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

    • bloody or red, or tarry bowel movements
    • spitting or coughing up blood
    • heavy bleeding with your menstrual period
    • pink, red, or dark brown urine
    • coughing up or vomiting material that looks like coffee grounds
    • small, flat, round red spots under the skin
    • unusual bruising or bleeding
    • continued oozing or bleeding from minor cuts

    Even rats it turns out can’t survive for long with all these possible complications of Warfarin (without getting their blood levels checked regularly I guess).  So, don’t be a rat.  If you are using blood thinning meds please get your blood checked regularly.

    Certainly, both drug and device-based therapy for PFO carries risks. Antithrombotic medications, like all medicines, have their long list of warnings, but many times we do not take the time to read the fine print.  PFO closure devices, however, are also associated with device-specific complications such as fracture of device elements, device embolization or thrombus formation.

    Bottom Line:

    Optimal stroke prevention strategies in patients with PFOs have not been established.  I am confident a solution to improving patient care for PFO conditions exists and my involvement with the PFO Research Foundation supports this mission. Yes, I do hold a bias towards PFO closure because my own results have been incredibly positive.   While I did try medical options including antithrombotic medical therapy prior to PFO closure, they did not work in my case.  What I do know is I do think about the long term impact of the implantation of my PFO closure device, because the benefit of PFO closure in patients with stroke has not been clearly demonstrated, and remains unclear and at times controversial.   I hope to help do my part to advance this important PFO research, so I guess you could say I will need to be a rat to help advance the science.

    Resources:

    Pub Med Health

    http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000634#a682277-sideEffects

    Wikipedia

    http://en.wikipedia.org/wiki/Warfarin

     

    • Jeannie 3:14 am on July 14, 2010 Permalink | Reply

      Thank you for your informative article. I’m beginning to re-think my medical advice about my PFO

  • David 4:31 am on June 6, 2010 Permalink | Reply
    Tags: ,   

    Could help for migraines be in the heart?? 

    The PFO/migraine connection is an area “ripe for research” according to this recent article

    Doctor: Help for migraines is in the heart.

    How’d I know? Get on the PFO Research Foundation mailing list and you could know too…

    PFO Research Foundation

    ↑ Grab this Headline Animator

     

  • David 2:44 pm on March 13, 2010 Permalink | Reply
    Tags: , , Plavix and stroke, FDA MedWatch   

    Stroke survivors take note: FDA notice on Plavix 

    SOURCE: FDA MedWatch

    Plavix (clopidogrel):

    Reduced effectiveness in patients who are poor metabolizers

    Audience: Cardiology healthcare professionals, patients

    FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. The Boxed Warning in the drug label will include information to:

    • Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
    • Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
    • Advise healthcare professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

    Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. A data summary and additional information for healthcare professionals and patients are provided in the linked Drug Safety Communication.

    Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety Communication at:

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204256.htm

    Did you know? MedWatch is a free service of the FDA and you can opt in to their email list to get updates like this one delivered to you-no charge.  Visit the link to their site above to sign up.

    I’ve included this MedWatch update as many of my readers are stroke survivors and may be on Plavix.  If you have specific concerns about this update and how it may apply to you please contact your physician. I am simply making sure you are informed.  You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htm

    Source:  U.S. Food & Drug Administration (FDA).

     

  • David 4:28 pm on May 12, 2009 Permalink | Reply  

    AHA Press release on PFO: More patients needed in clinical trials to find treatment for heart condition linked to certain strokes 

     Article source: American Heart Association media room

     

    ASA logo

    News Releases
    More patients needed in clinical trials to find treatment for heart condition linked to certain strokes
    Statement Highlights:

    Patent foramen ovale (PFO), an opening between the two chambers of the heart, has been associated with some strokes for which there has been no identifiable cause.
    Due to a lack of solid research and clinical evidence, there is no established ideal way to treat PFO.
    This statement identifies a number of ongoing trials for PFO and calls for doctors to enroll appropriate patients in these trials that could one day lead to a definitive treatment for this condition.

    DALLAS, May 11, 2009 — The American Heart Association and the American College of Cardiology are calling on doctors to enroll more patients in clinical trials for catheter-based closure of patent foramen ovale (PFO), a condition caused when an opening between the two chambers of the heart fails to close at birth. Due to a lack of conclusive research on the management of PFO after stroke or transient ischemic attack, there is currently no clearly established treatment for this condition.

    View the full science advisory here

    This “call to action” advisory is published in Circulation: Journal of the American Heart Association and the Journal of the American College of Cardiology. The American Academy of Neurology has affirmed the value of this science advisory.

    The advisory writing group notes there are a number of ongoing clinical trials looking at patients with PFO and cryptogenic strokes, which are strokes with no identifiable cause after an extensive search.

    Enrollment in the trials has lagged and the off-label use of PFO closure devices has accelerated, jeopardizing the funding of some studies and the scientific validity of others. “Off-label” indicates when a device or drug is used to treat a condition not listed on its label. This is a common practice, especially for older drugs or devices that perhaps have found new uses but not been put through the rigors of FDA testing and approval for the new use.

    “We must have enough patients followed for an adequate time in these trials to make the data valid and the findings strong,” said Patrick O’Gara, M.D., chair of the writing group and director of Clinical Cardiology at Brigham and Women’s Hospital in Boston. “The completion and peer review of these trials are critical to establishing the evidence base needed to help us make informed decisions regarding the best care for patients with this condition.”

    Potential treatments for PFO are important for reducing stroke risk. The advisory cites research that shows PFO present in 33.8 percent to 43.9 percent of patients with cryptogenic stroke. A PFO is usually detected by echocardiography during evaluations after a stroke.

    Although “optimal” treatment for PFO isn’t established, current options for treatment include drug therapy with either anti-platelet agents like aspirin or vitamin K antagonists such as warfarin, surgical repair, or closing the opening with catheter-based (percutaneous) devices. Surgical repair is not usually recommended unless a patient is already undergoing surgery for another reason.

    Current American Heart Association/American Stroke Association guidelines recommend anti-platelet medication as the first-line therapy for PFO. Warfarin should be considered if there is an additional indication for anticoagulation. They say that there isn’t enough evidence to recommend closing a PFO after a first stroke, but that closure may be considered for patients with recurrent cryptogenic stroke despite optimal medical therapy.

    The choice between drug therapy and catheter-based repair has been intensely debated. To date, adequately powered, randomized, prospective clinical trials comparing drug therapy with catheter-based repair have yet to be completed.

    Three Food and Drug Administration (FDA) advisory committee meetings (1997, 2002 & 2007) have affirmed the need for completing appropriately sized randomized controlled clinical trials to compare drug therapy with percutaneous device closure. As yet, no device for PFO closure is approved by the FDA.

    In addition to the call for doctors to refer more patients to the ongoing trials, the advisory group recommends the data from these trials should be pooled where appropriate and that the “off-label” use of closure devices should be curtailed.

    More information on the ongoing trials for patients with PFO can be found at http://www.clinicaltrials.gov and http://www.strokecenter.org/trials.

    Co-authors include Gloria Catha, Steven R. Messe, M.D.; John C. Ring and E. Murat Tuzcu, M.D. Author disclosures are available on the manuscript.

    ###

    The American Heart Association receives funding primarily from individuals, foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are disclosed at http://www.americanheart.org/corporatefunding.

    NR09-1051 (Circ/O’Gara)

    About the American College of Cardiology (ACC):
    The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 37,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. For more information, visit http://www.acc.org.

    About the American Heart Association (AHA):
    The American Heart Association is the nation’s oldest and largest voluntary health organization dedicated to building healthier lives, free of heart disease and stroke. These diseases, America’s No. 1 and No. 3 killers, with all other cardiovascular diseases claim nearly 870,000 lives a year. In fiscal year 2006-07 the association invested more than $554 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. To learn more, call 1-800-AHA-USA1 or visit http://www.americanheart.org

     

  • David 2:13 am on September 9, 2008 Permalink | Reply
    Tags: gaming technology and PT, , stroke and physical therapy, wii-habilitation   

    Do stroke victims work harder using new gaming technologies? 

    Research Update:

    Recently I had the chance to try out the Nintendo Wii Fit system for the first time. I’ll plan to follow up with a post later on my thoughts on this device as a stroke rehabilitation tool. Since using the system and forming my own opinion, I wanted to research how other therapists might be embracing this emerging technology. In the short time I have been following this “Wii-habilitation” movement I have to say I receive 4-5 google alerts each day with updates from both therapy and gaming blogs using the term wii-habilitation. This post from a CNET News Blog caught my eye because it showed how cutting edge rehabilitation centers around the country are starting to receive research grants to study how effective Wii and other gaming devices can be to help stroke survivors retrain lost motor skills and regain function.

    This from the CNET Blog :

    “And now researchers at the University of South Carolina are turning the trend into a research project that will study exactly how well the Wii and other games can help stroke victims recover motor skills and overcome a fear of falling after their trauma.

    The research is part of a new $2 million grant from philanthropic group the Robert Wood Johnson Foundation, which will be administered by the University of California Santa Barbara’s Health Games Research Center. On Thursday, the two organizations announced that 12 different research projects, including USC’s Wii project, will receive funding of up to $200,000 each to study how interactive games can be used to improve public health and the health care profession. The studies will last between one to two years.”

     

  • David 11:07 pm on March 21, 2008 Permalink | Reply
    Tags: cardioseal,   

    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.

     

    • Steve 4:34 pm on November 11, 2008 Permalink | Reply

      I went swimming two weeks post op. I forgot to take medication beforehand and naturally experienced increased elevated heart rate. I stopped as soon as I realized. Is there any chance of rupture. Any advice, please?

    • David 2:14 am on November 22, 2008 Permalink | Reply

      Steve;
      Two weeks post op is way too early to be pushing your luck with going swimming (in my opinion). Even more than getting your heart elevated too fast so soon after PFO closure, you are doing an activity that forces you to hold your breath and increases pressure. Slow it down and let that thing heal,PLEASE. Getting it out of your ticker, if it moves before your body had firmly embedded it in the septum, is a major possibly(open heart) procedure and not worth the risk.

    • lindasue 3:22 am on July 14, 2009 Permalink | Reply

      I had a cardioSEAL pfo device placed in 2007. I recently had a chest injury which I think resulted in a fractured sternum/xiphoid process. I Had xrays today, still awaiting the report. I, however, saw an xray done 4 days after the injury and the lateral view of the sternum showed a perfect butterfly as it would look ready to fly away with round wings outstretched and 2 antennas. I received info that it should look like a single butterfly at rest, with overlying wings. The radiologist said in his report that it was some kind of closure device, “overlying” the heart, and didn’t mention it was any where near the pfo closure, and no mention of the device still closing the hole. I had a echocardiogram and a bubble study on Friday, and the dr. says it is still in place, should look like a spider, no problem, and no bubbles went to the wrong side. Do you think it possible that 1/2 of the device is loose and moved? My other NP called and said another dr looked at previous xrays, and the current one and says it is still the same place.( I should say that on Mon I was vomiting blood, and the next day had to go to the ER due to a BP of 198/130 and 9/10 pain in my stomach), But there was no overlying pattern, just a single outline of 1 pair perfect butterfly wings. I have had worse uncontrolled BP’s since the injury, major upper stomach pain just under the sternum/xiphoid process area, and no one seems to think it possible that could move and it is perfect. I wonder what happened. What do you think?

  • David 7:25 pm on March 21, 2008 Permalink | Reply
    Tags: , hole in the heart, , uncontrollable stroke risk factors   

    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.

     

  • David 3:48 pm on February 11, 2008 Permalink | Reply
    Tags: , , ,   

    Respect Trial and crypotogenic stroke 

    Source: http://www.amplatzer.com

    also see link at end of article from patient education resources

    Respect Trial – United States

    AMPLATZER® PFO Occluder – Notice of Availability – Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.

    Respect Logo

    THE HEART AND STROKE CONNECTION

    Evidence indicates there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke. Cryptogenic stroke is a stroke that occurs without the normal symptoms associated with stroke.

    Patent Foramen Ovale is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent (or open) Foramen Ovale (PFO) results.

    It is not known what the best treatment is to reduce the risk of a recurrent stroke. AGA Medical Corporation is conducting the RESPECT Clinical Trial to investigate whether closure of PFO is superior to medical management in preventing recurrent cryptogenic strokes.

    Patients 18-60 years of age who have been diagnosed with one cryptogenic stroke and confirmation of a PFO may qualify for the RESPECT Trial. Trial design is a prospective multi-center randomized clinical trial to evaluate safety and efficacy. Closure of the PFO with the AMPLATZER® PFO Occluder, or treatment with the current medical standard of care are used to compare for efficacy and safety.

    Links:

    Learn more about the RESPECT Trial
     

  • David 9:00 pm on February 10, 2008 Permalink | Reply
    Tags: amplatzer, ,   

    Migraine Clinical Trial 

    I’ve added this information to my blog in response to the many requests I received for individuals searching for more information on the migraine/PFO connection. This information below was snagged directly from the patient education area of the website for the Amplatzer PFO occluder (the device I had implanted in May 07). The link at the bottom of this article will direct you to  their site and the clinical trial.

    AMPLATZER® PFO Occluder – Notice of Availability -

    Caution: Investigational device. Limited by Federal (U.S.) law to investigational use.

    Premium

    THE HEART AND MIGRAINE CONNECTION

    Patent Foramen Ovale is a defect in the atrial septum, the wall between the two upper chambers of the heart. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results.

    Retrospective research has shown that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, and severity of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought. The Premium Trial is designed to evaluate the effectiveness of PFO closure as a treatment for migraine. The trial is a prospective, randomized, sham-controlled, double blind, multi-center study to evaluate safety and efficacy.

    To participate, patients must be 18-55 years of age with migraine (with or without aura) reported to have a 3 month history of 6-14 headache days per month and confirmed presence of a PFO. Participants will either have closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only.

    Links:

    Learn More About the Premium Migraine Clinical Trial
     

c
compose new post
j
next post/next comment
k
previous post/previous comment
r
reply
e
edit
o
show/hide comments
t
go to top
l
go to login
h
show/hide help
esc
cancel