Aa
hole in my heart
I am wondering if anyone can tell me the best course of treatment? I recently had an echo done upon my complaints of chest pain and headaches coupled with my elevated heart rate. the results were a patent foramen ovale on the left side. The atrial septum is showing as mildly aneurysmal and there is also a note on the results about trace mitral regurgitation. So I guess what I'm asking is if surgery is necessasary as well as if it is the best option?
The things about Chinese products is that most of the time they just copy the design and make the products which any other company that have spent huge amount of money in R&D to make a product that is fit for using in human. The moment a company gets the approval from US FDA of any other competent authority the Chinese just start manufacturing them claiming it to be same as original and there have been number of in stances where a Physician using the Chinese products finds himself in trouble as the product which is claimed to be same as original malfunctions cause of manufacturing defects. Which the physician does not report cause of obvious reasons since he of she will be in trouble. Secondly they claim that Chinese products is Chinese FDA approved but in reality it is not above all no one in Medical Fraternity believes these authorities for the obvious reasons. Now here in India these companies claim that the product is CE approved meaning European Certified. Now no one asks them if the product is CE approved where it states that it is fit for human use.As you may be aware that we get CE approved for so many other electrical products such as Fridge, televisions and many OTHER products. This does not mean that we can implant TV fridge and other products in human. Even on the CE certificates it states that CE certificate does not mean that the product is FIT FOR HUMAN IMPLANTS. The certificate only certify that the product has been produced in under certain guidelines such as safety of the labour and some other criteria that needs to be followed to produce any XYZ products.
I am just trying to tell the people on the site to be aware of these things and should ask their physicians what is being used and if it is certified by the authorities. I agree that some time the approved product is priced higher than these copy cats but the patients should also understand that to manufacture a product there is so much of research and approval are done that the company has no other options but to charge more to recover the money. Above all there are many schemes that are being given by the government that can help a needy person who cannot afford. I would like to share a incidence that happened there was this physician who was using these Chinese products for his patients but it so happened that one of his close relatives was ill and for the relative he wanted to used the approved product only when asked why so he said I cannot use that product on my relatives but when asked you use ONLY Chinese in you patients that means you don't care about your patient's life. Now the very same physician tells his patients that these are the products available in market and the patients are the one deciding what needs to be used but the very same physician never fails to tell the patient that had id been my relative I would have only used this approved product and he says patients never ever ask for other products and they manage to arrange the money for the approved products. He says now I have a very sound sleep when he goes to bed......
I am just trying to tell the people on the site to be aware of these things and should ask their physicians what is being used and if it is certified by the authorities. I agree that some time the approved product is priced higher than these copy cats but the patients should also understand that to manufacture a product there is so much of research and approval are done that the company has no other options but to charge more to recover the money. Above all there are many schemes that are being given by the government that can help a needy person who cannot afford. I would like to share a incidence that happened there was this physician who was using these Chinese products for his patients but it so happened that one of his close relatives was ill and for the relative he wanted to used the approved product only when asked why so he said I cannot use that product on my relatives but when asked you use ONLY Chinese in you patients that means you don't care about your patient's life. Now the very same physician tells his patients that these are the products available in market and the patients are the one deciding what needs to be used but the very same physician never fails to tell the patient that had id been my relative I would have only used this approved product and he says patients never ever ask for other products and they manage to arrange the money for the approved products. He says now I have a very sound sleep when he goes to bed......
I'm not advocating nor selling anything. You stated sewing was the only method for closure, I provided links and information for adherence of material and procedure as you where not aware, so it seems. I have never mentioned anything regarding the copy cats Chinese as you call them...don't have any idea what you are talking about. Do you want to explain what you are talking about? Put it in understanding verbage so we all can understand and please explain why I should I or should not support the Chinese product.
That I am very well aware about the devices available but I did not know about Spider and If my guess is right this is also one of the copy cats Chinese product without any FDA or any other authorized approval. But you still have not answered my initial question to you regarding studies, approval and follow up results other than Chinese hospital.
QUOTE: "can I know how many implants have been done with this device (Spider) and is it approved by US FDA or any other FDA except the chienese and how many Multi center studies have been done with hospital out side of China".
Don't know, do you? There are many different devices (mechanisms) to close atrial (upper) chamber's septum (wall that separates left and right chambers) defects (ASD, PFO hole in the septum).
Don't know, do you? There are many different devices (mechanisms) to close atrial (upper) chamber's septum (wall that separates left and right chambers) defects (ASD, PFO hole in the septum).
Hi can I know how many implants have been done with this device (Spider) and is it approved by US FDA or any other FDA except the chienese and how many Multi center studies have been done with hospital out side of China. Please let me know since this is very interesting device which you have mentioned here and I also request you to kindly write the details regarding devices in a language that can be understood by all people on this site. Hope to hear back soon.
QUOTE: "Hi, I am not sure what kind of device is kenkeith is talking about. Since the device that are freely available to close these defects does not have any adhesive material"
>>>>>]As an alternative to sutures tissue adhesives may be used to link elements of disclosed closure device to one another, such as the bioremodelable sheet material to the occluding wires. " An exemplary tissue adhesive is BioGlue® (CryoLife, Inc.)."
A catheter based occlusion device for sealing tissue openings, the device comprising:a guiding catheter,a delivery catheter; anda septal occluder includinga first disk-like member for deployment proximate to a first side of a tissue opening;a second disk-like member for deployment proximate a second side of a tissue opening; anda connector portion for connecting the first and second disk-like members, wherein the connector portion includes at least one aperture effective to dispense an adhesive into said tissue opening.
Read more: http://www.faqs.org/patents/app/20090264920#ixzz10BE51G6M
The closure device includes biocompatible or bioremodelable sheet materials connected to the occluding wires so as to provide a covering, which is suitably configured to close a bodily passageway. When using bioremodelable sheet material as a covering, the bioremodelable sheet material is preferably designed to promote angiogenesis and endothelialization of the implanted closure device. In particular, the bioremodelable sheet material is capable of remodeling the surrounding tissues, such that upon implantation in a patient, the bioremodelable sheet material is degraded and replaced by the patient's endogenous tissues. As the bioremodelable sheet material is remodeled by host tissues, the bodily opening becomes stably closed, obviating concerns about migration of the device.
Read more: http://www.faqs.org/patents/app/20090062844#ixzz10BDG5UmH
Congratulations, you are like 30% of the population with a patent foramen ovale (depending on what study you read).
Its rarely treated and just noted on echocardiograms.
Having an aneurysmal septum is associated with this finding. Youve had it since birth when the hole in your heart needed for fetal circulation bypasses the lungs as it reaches the right side of the heart, its baffled into the left heart to be pumped to the body.
Upon the first breath, theoretically a flap should close and the hole closed. But its very common that it does not.
Although technically it is an atrial septal defect, that term is usually reserved for larger holes that occur from failure of certain tissue to grow and results in larger shunts that can be associated with more problems.
Patent foramen ovales are rarely treated, can you imagine 1/3 of the population having invasive heart procedures to correct this?
Trace mitral regurgitation is also called physiological as there is always a trace of "closing volume" as the leaflets close. Mitral regurgitation is not relevant until it is at least moderate in which case it would be followed with echocardiograms every couple of years or so.
Only if it is or becomes severe would treatment be considered and that is after being followed where Left ventricular function starts to show a decrease or if there becomes an increase in pulmonary pressures.
Of which does not concern a person with trace mitral regurgitation as it will not progress. The technology is so sensitive that closing volume can be seen on nearly every individual when having a more transesophageal echocardiogram done where the images are even clearer.
Bottom line:
You are normal
Its rarely treated and just noted on echocardiograms.
Having an aneurysmal septum is associated with this finding. Youve had it since birth when the hole in your heart needed for fetal circulation bypasses the lungs as it reaches the right side of the heart, its baffled into the left heart to be pumped to the body.
Upon the first breath, theoretically a flap should close and the hole closed. But its very common that it does not.
Although technically it is an atrial septal defect, that term is usually reserved for larger holes that occur from failure of certain tissue to grow and results in larger shunts that can be associated with more problems.
Patent foramen ovales are rarely treated, can you imagine 1/3 of the population having invasive heart procedures to correct this?
Trace mitral regurgitation is also called physiological as there is always a trace of "closing volume" as the leaflets close. Mitral regurgitation is not relevant until it is at least moderate in which case it would be followed with echocardiograms every couple of years or so.
Only if it is or becomes severe would treatment be considered and that is after being followed where Left ventricular function starts to show a decrease or if there becomes an increase in pulmonary pressures.
Of which does not concern a person with trace mitral regurgitation as it will not progress. The technology is so sensitive that closing volume can be seen on nearly every individual when having a more transesophageal echocardiogram done where the images are even clearer.
Bottom line:
You are normal
Hi, I am not sure what kind of device is kenkeith is talking about. Since the device that are freely available to close these defects does not have any adhesive material. They actually are made of nitionol wire with polyester fabric which is hand sewn. Its like an umbrella with two discs which is attached with a waist in between. Now days I think there are around 60% to 70% closures of ASD, VSD and PDA are DONE WITH these devices. If you can find time you can visit www.amplatzer.com and can check the information you are looking for.
Atrial septal defect treatment depends on the size and location of the defect and the associated heart abnormalities. People who don't have any symptoms or cardiac enlargement may need only observation. Does your symptoms relate to ASD?
Trace, mild, etc.mitral valve regurgitation is not considered medically significant. If there are no symptoms or heart arrhythmia with your anomaly, there should be periodic monitoring and testing. See a good cardiologist experienced for ASD repair if necessary. If you have a small ASD without symptoms or heart rhythm disturbances, you'll require periodic monitoring and testing by a cardiologist with experience in congenital heart disease to determine the need and timing for ASD repair.
Cardiologists conduct nonsurgical closure when possible to avoid the need for open-heart surgery. It is done with a cath moving a device made of adhesive material to close the defect.
Hope this helps, and if you have any aother question, you are welcome to respond. Take care.
Trace, mild, etc.mitral valve regurgitation is not considered medically significant. If there are no symptoms or heart arrhythmia with your anomaly, there should be periodic monitoring and testing. See a good cardiologist experienced for ASD repair if necessary. If you have a small ASD without symptoms or heart rhythm disturbances, you'll require periodic monitoring and testing by a cardiologist with experience in congenital heart disease to determine the need and timing for ASD repair.
Cardiologists conduct nonsurgical closure when possible to avoid the need for open-heart surgery. It is done with a cath moving a device made of adhesive material to close the defect.
Hope this helps, and if you have any aother question, you are welcome to respond. Take care.
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