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| Q: Is there anything I can do to prevent strokes or TIA’s before I have my PFO closed? |
| The best prevention of strokes or TIA’s prior to catheter closure of the PFO is to take (1) 325 mg aspirin daily. This provides good anti-coagulation without causing bleeding issues. Some physicians will prescribe Plavix for their patients prior to closure. Aspirin and Plavix, in concert, provide good anticoagulation and anti-platelet aggregation prior to and after closure. |
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| Q: Should I stop exercising or participating in recreational activities? |
| Prior to PFO closure, we encourage our patients to continue their physical activities and recreational activities. However, after closure, you will have some restrictions of activity. Those restrictions include not lifting, pushing or pulling anything that weighs 50 lbs or more for 2-4 weeks. We also restrict any activities that may cause sudden movement or jarring in the upper torso. Some of those activities include: horseback riding, water skiing or snow skiing, rock climbing, skydiving, river rafting, off roading, mountain biking, ect. You should restrict yourself from those activities for the first 3 months following closure. |
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| Q: Will I be required to wear a medical ID bracelet or carry a card in my wallet after closure? |
| No, you will not need to wear a medical ID bracelet or carry a card for the PFO closure device. The PFO is an anatomic defect that you had had repaired. This does not mean you have heart disease. |
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| Q: Can I go through a metal detector or MRI scan without problems? |
| Yes, the device is compatible with a MRI scanner and will not present a problem in terms of the magnet. You can go through a security system or metal detector without setting off any alarms. If you do need a MRI scan, it would be advisable to inform your provider that you do have a device in your heart. We will provide you with the type of device you have prior to your discharge from the hospital. |
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| Q: Can I resume sexual activity following closure? |
| Yes, you can resume sexual activity following closure. We recommend that you allow for the small groin wound to heal prior to resuming sexual activity so that the wound does not get irritated or infected. This healing takes approximately 4-5 days. |
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| Q: What happens if I have similar symptoms after my PFO is closed? |
| We follow our patients closely following the procedure. The first month following closure is the most anxiety producing for patients. Some of the common symptoms following the procedure include palpitations (rapid heart rate or skipped beats), headache, chest pressure and occasional discomfort of the chest wall. If any of these symptoms persist and are concerning to you, we will schedule you to be seen in the office for an evaluation. We may order a chest x-ray or echo to assess the integrity of the device and, based on presentation and complaints, we may order another TEE (transesophageal echo). Once we have received the results, we treat or prescribe accordingly. |
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| Q: How long does it take for the device to heal? |
| Endothelialization, the process of tissue growth over the device, takes approximately 3-6 months depending on the size of the device used. |
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| Q: How am I evaluated after the procedure? |
We have a schedule of follow up for our patients that will allow for us to assess the device over the period of 6 months.
1 month following the procedure you will have a nurse visit in the office with the PFO coordinator. At that time a review of your symptoms and your status will be discussed. If there are concerning issues, the coordinator may request some of the above studies and discuss your case with Dr. Sorensen for further directions.
3 months following the procedure you will have a TCD (transcranial Doppler) study, a transthoracic echo (surface echo) and follow up visit with Dr. Sorensen. Your medications may be adjusted or continued based on the results of those studies.
6 months following the procedure, you will have the same studies performed that were done at 3 months. By the 6th month, we expect that endothelialization and anatomical seal of the device has occurred. Based on the individual findings, medications may be continued. |
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| Q: Will the abnormalities of my MRI heal after this procedure? |
| No, the findings on MRI are permanent. However, the purpose of closing the PFO is to prevent any further neurological damage from occurring. It is important that you discuss the findings on MRI with your neurologist and that you address questions of a neurological nature with them. |
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| Q: Is the Amplatzer device FDA approved? |
Yes, the Amplatzer PFO and ASD devices are both approved by the FDA.However, the PFO device is regulated by the FDA and is governed by the HDE
(Humanitarian Device Exemption). In order for the PFO device to be used,the patient must meet specific criteria as set forth by the FDA. |
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| Q: What is the purpose of closing the PFO? |
| The ONLY indication for closure of the PFO is for stroke prevention. If you meet criteria for closure, you have had a stroke or TIA (transient ischemic attacks, “mini strokes”). The reason for closure is to reduce your stroke risk from 20% to less than 1% with transcatheter closure of the PFO. |
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| Q: If I was born with this defect, why am I having symptoms now and not earlier in my life? |
| We do not fully understand the mechanism for symptoms that occur in individuals with PFO. What we do understand is that the strokes or TIA’s are random and unpredictable. |
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| Q: If I do not meet criteria for closure, what do I need to do? |
| The hard part is to tell someone that they have a PFO but they don’t meet criteria for closure. However, the good news is that individuals understand that they do have this structural defect and that there are preventative measures to take to avoid TIA’s or stroke. Those measures are anti-coagulants: Plavix, Aspirin or Coumadin. All patients that do not meet criteria for closure are advised to take an anti-coagulant or a combination of anti-coagulants. This will be determined individually and is based on lab values and history. Your cardiologist or neurologist will recommend appropriate medication for you. |
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| Q: When will this device be released for those who do not meet criteria? |
| In order for any medical device to be released for general use in the population, the device must be evaluated in clinical trials. Currently, there are 2 clinical trials for the PFO devices on the market. It is likely that the clinical trials will be ongoing for at least 24 months at this time. |
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| Q: Are there side effects of Plavix and/or Aspirin? |
| Apirin and Plavix can cause some stomach irritation. We recommend taking your Aspirin with food. Plavix is best taken in the evenings. If you experience stomach irritation, you can use an over the counter medication like Prilosec or Prevacid to help with the discomfort. If you notice any rectal bleeding or blood in the urine, please call us immediately. This is very uncommon but should be addressed if this occurs. |
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| Q: Can migraines be improved by PFO closure? |
| Some patients have experienced relief of their migraine headaches following PFO closure. At this time, PFO closure is still being performed for prevention of stroke and not for the treatment of migraine headaches. There are currently 3 clinical trials in the United States that are designed to determine if PFO closure is effective in the treatment of migraine. The clinical trials are sponsored by 3 manufacturers of the PFO closure devices. Premium is the clinical trial sponsored by AGA Medical, the manufacturer of the Amplatzer device. The other trials are sponsored by NMT Medical (MIST 2); the manufacturer of the CardioSeal and Starflex devices and the third trial is sponsored by St.Jude’s called the Escape trial. The clinical trials are available in limited geographical locations in the United States. To find a clinical research site in your area, you should go to the website of the manufacturer of the devices. |
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| Q: How do I enroll in the Clinical Trials? |
| The trials are randomized and not everyone will be eligible for participation. There are specific questions that must be answered prior to determining if an individual is eligible for participation. The pre-screening questions are available on the website of the manufacturer. |
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| Q: What centers are participating in the clinical trials? |
| LDS Hospital is a participating center for the Premium Migraine trial sponsored by AGA Medical. There are no other centers in Utah participating at this time. You can get more information on other sites by going to the manufacturers’ website. LDS Hospital will accept applicants from the following states: Utah, Wyoming, Idaho, Montana, New Mexico, Nevada and Arizona. Once again, the best way to determine if you are eligible to participate is to get on the website of the manufacturers and find information on the clinical trials. Our website for application for the trial is: UtahMigraine.com or you can link from our home page. |
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| Q: How will I know if I am eligible for participation? |
| In regards to the Premium trial, after you have completed the eligibility questionnaire on the appropriate website, you will receive a message on the website whether or not you are eligible for further consideration. If you are eligible for consideration, you will be contacted by a coordinator who will review your information with you and will complete a more detailed medical history with you. This will be done by telephone. If you are not eligible, a coordinator will also contact you to review other options and to help direct you to continued care. |
