Our Lady of Lourdes Medical Center, a designated comprehensive stroke center, recently performed its first procedures using a device to close a hole between the chambers of the heart. The hole, called a patent foramen ovale (PFO), is a congenital heart defect and can cause ischemic strokes.
Ibrahim Moussa, D.O.,F.A.C.C.,FSCAI, discusses a device that Lourdes interventional cardiologists are using is called a GORE CARDIOFORM Septal Occluder to permanently close the hole. It is made of fabric similar to that found in durable waterproof clothing.
Lourdes Offers New Device to Help Reduce Stroke Risk in Patients with Heart Defect
From the Show: Lourdes Health Talk
Summary:
Air Date: 2/25/19
Duration: 10 Minutes
Transcription:
Melanie Cole (Host): Our Lady of Lourdes Medical Center now offers a new device to help reduce stroke risk in patients with heart defect and you might be surprised by what’s it made of. My guest today is Dr. Ibrahim Moussa. He’s an interventional cardiologist with Lourdes Health System. Dr. Moussa, tell us a little bit about patent foramen ovale and atrial septal defects. What are they and how common are they in the general population?
Ibrahim Moussa, D.O., F.A.C.C., FSCAI (Guest): Hi and thanks for giving me the opportunity to discuss this interesting topic. So, patent foramen ovale and atrial septal defects as we know, the heart is made out of four chambers. There are two top chambers and two bottom chambers. During fetal development; those chambers kind of start as being one big chamber and they divide into four. The topic of discussion is the top two chambers and they have a divider between them. It’s called the atrial septum. That septum is made out of two membranes and they grow into each other and they close that hole during normal fetal development. The hole stays open as we grow into our mother’s womb because it is important as it carries the blood from the placenta, oxygenated blood and gives a route for that oxygenated blood to get to the brain and vital tissues. As we are born, when we are born and take our first breath; that hole closes. Some people have persistent hole, it doesn’t close right. It doesn’t seal and if that hole remains slightly open; it’s called a patent foramen ovale and if it stays wide open; it’s an atrial septal defect. I hope this kind of answers the question.
Host: Is this something that you detect right at birth? Are there some symptoms and if the person is older, and it hasn’t been detected; have these been associated with migraines and I mean how would you know if you had one?
Dr. Moussa: Okay so, we don’t really screen for patent foramen ovale at birth. The atrial septal defects are actually more noticeable, and they can – if they are big enough, they can lead to the baby looking blue at birth or hypoxic or low oxygen level because there is quite a bit of shunting. In those situations, we – the pediatric cardiologist will do an echocardiogram and they are picked up. The PFO is actually – are very common. Twenty percent of the population walk around with a patent foramen ovale. They come in different shapes and sizes. So, they could be pinhole, completely asymptomatic and some of them are more pronounced that there’s a flap almost like a curtain that opens and closes intermittently depending on the pressures and the straining. If the person is straining, lifting something heavy and those have been associated with a stroke and migraines actually.
We detect them incidentally most of the time when somebody gets an echocardiogram for other reasons. We don’t – there is no indication to screen for them in the general population because like I said, 20% of us walk around with a hole in our heart that is so insignificant and unfortunately, sometimes the first time we detect them is when a person gets a stroke.
Host: When is surgery to close the hole a discussion? Tell us about this new device that Lourdes interventional cardiologists are using called the GORE CARDIOFORM and is it really made of the fabric that’s similar to that found in durable waterproof clothing like GORETEX?
Dr. Moussa: Correct. So, when we are looking to evaluate a patient who had a stroke, we look for – there are many reasons a patient could have a stroke, but recently new studies showed that there is benefit to closing PFOs in the younger population that you ruled out every other cause of stroke. And they are called cryptogenic stroke. The way – the procedure is done usually through the groin, a minimally invasive procedure. It requires a 24-hour hospital stay, but the FDA recently approved the CARDIOFORM devices made out of GORTEX, correct. And it’s made out of two discs. One disc sits in the left atrium and the other disc sits on the right side and over time, the body seals the hole by growing a layer of skin if you would around those discs and completely seals the hole that’s causing what we call a paradoxical embolus or blood clot going from the right side to the left side and going to the brain and causing the stroke.
Host: That’s fascinating. So, this septal occlude, this thing that closes off the hole, it’s made of this material which I think is just so interesting. Why was that material chosen, do you think? Does it allow flow back and forth? What is it actually doing?
Dr. Moussa: The material has been used in surgical devices and implants for many years and it’s been safe, proving to be safe and the body doesn’t reject it. As you know, there are certain material foreign bodies that are implanted in the human body; it’s going to be rejected. The body will mount a reaction to it, clot it off. But this device fabric was chosen for that first and then because of its flexibility and conformability to the structure, the cardiac structure, because the heart is actually three dimensional. This is pretty flexible and when it sits there it actually takes the shape of the right atrium and the shape of the left atrium and has low risk of an infection or eroding into adjacent structures.
Host: That’s so cool. Will this GORE implant be affected by medical imaging methods, household appliances, security sensors? Once it’s implanted, is it then something that needs to be cared for or watched?
Dr. Moussa: So, after the implant, people – we tell our patients to avoid contact sports for one month. They are on baby aspirin for life and Plavix which is another antiplatelet to give the chance to the body to coat the device with a layer of skin, so it does – no clots form on it. Really there is no issues with MRIs. We advise the patient if they are going – undergoing dental procedures to have prophylaxis with antibiotics to prevent the device from being infected again, until the body coats it with a layer of cells. So, the main issues with – or the main concerns or care is the six months after the implant. But after that, they can lead a normal life. It shouldn’t interfere with anything that they are doing, x-rays, MRIs, walking through the scanner at the airport.
Host: Doctor how do you select optimal candidates for this procedure? Tell us a little bit about patient selection criteria and do you have some outcome predictions?
Dr. Moussa: Yes. So, as I mentioned before, 20% of the population walk around with a small hole in their heart and we don’t want to close every single one of them because some of them are completely asymptomatic. So, a lot of thought and a multidisciplinary approach goes into the decision making of who gets a closure device. Usually, it has to be a cryptogenic stroke that means we ruled out every other cause of stroke like atrial fibrillation or an irregular heart rhythm that can cause blood clots to form in the heart to begin with. Clots inside the heart on the left side cause bivalve problems, plaque in the main vessel of the body called the aorta, blockage in the brain arteries, so once all of these have been ruled out and we find that there’s a hole in the heart; in a younger person from their teenage years to their 60s, and the hole looks like it’s high risk to transmit a blood clot from the right side to the left side; these are the patients that are being shown based on studies to benefit from closure device.
The reason why we close them because otherwise those patients, if we don’t close their hole, they will end up with – or their PFO, they will end up on blood thinners for the rest of their life and giving a young person who is a 28-year-old or 30-year-old blood thinners, strong blood thinners for the rest of their life carries its own risks of bleeding. Post closure, they only need to be on blood thinners for six months and then they lead a normal life after that.
Host: What a fascinating topic Dr. Moussa. Wrap it up for us. What would you like the listeners to take away from this knowledge of PFOs, atrial septal defects and this new GORE CARDIOFORM septal occlude that you are able to use at Lourdes Medical Center?
Dr. Moussa: So, first not all patients with a PFO require closure. A thorough analysis of potential stroke risk factors is important prior to putting the device in. I want to emphasize that if the patient qualifies for the procedure it is a simple minimally invasive procedure with a 24-hour hospital stay done through the vein – through a vein from the groin. And certain features of a PFO picked up usually by an echocardiogram shows whether it is risky or not risky. And the trial that looked at these if our listeners are interested is called the RESPECT trial demonstrated reduction in recurrent stroke among carefully selected patients with a PFO.
Host: Thank you so much. What a fascinating topic. Thank you for coming on with us today Dr. Moussa and explaining it so very clearly so that people really have an understanding of this material and this implant and how it can help reduce the risk of stroke. This is Lourdes Health Talk. For more information please visit www.lourdesnet.org, that’s www.lourdesnet.org. This is Melanie Cole. Thanks so much for tuning in.
Melanie Cole (Host): Our Lady of Lourdes Medical Center now offers a new device to help reduce stroke risk in patients with heart defect and you might be surprised by what’s it made of. My guest today is Dr. Ibrahim Moussa. He’s an interventional cardiologist with Lourdes Health System. Dr. Moussa, tell us a little bit about patent foramen ovale and atrial septal defects. What are they and how common are they in the general population?
Ibrahim Moussa, D.O., F.A.C.C., FSCAI (Guest): Hi and thanks for giving me the opportunity to discuss this interesting topic. So, patent foramen ovale and atrial septal defects as we know, the heart is made out of four chambers. There are two top chambers and two bottom chambers. During fetal development; those chambers kind of start as being one big chamber and they divide into four. The topic of discussion is the top two chambers and they have a divider between them. It’s called the atrial septum. That septum is made out of two membranes and they grow into each other and they close that hole during normal fetal development. The hole stays open as we grow into our mother’s womb because it is important as it carries the blood from the placenta, oxygenated blood and gives a route for that oxygenated blood to get to the brain and vital tissues. As we are born, when we are born and take our first breath; that hole closes. Some people have persistent hole, it doesn’t close right. It doesn’t seal and if that hole remains slightly open; it’s called a patent foramen ovale and if it stays wide open; it’s an atrial septal defect. I hope this kind of answers the question.
Host: Is this something that you detect right at birth? Are there some symptoms and if the person is older, and it hasn’t been detected; have these been associated with migraines and I mean how would you know if you had one?
Dr. Moussa: Okay so, we don’t really screen for patent foramen ovale at birth. The atrial septal defects are actually more noticeable, and they can – if they are big enough, they can lead to the baby looking blue at birth or hypoxic or low oxygen level because there is quite a bit of shunting. In those situations, we – the pediatric cardiologist will do an echocardiogram and they are picked up. The PFO is actually – are very common. Twenty percent of the population walk around with a patent foramen ovale. They come in different shapes and sizes. So, they could be pinhole, completely asymptomatic and some of them are more pronounced that there’s a flap almost like a curtain that opens and closes intermittently depending on the pressures and the straining. If the person is straining, lifting something heavy and those have been associated with a stroke and migraines actually.
We detect them incidentally most of the time when somebody gets an echocardiogram for other reasons. We don’t – there is no indication to screen for them in the general population because like I said, 20% of us walk around with a hole in our heart that is so insignificant and unfortunately, sometimes the first time we detect them is when a person gets a stroke.
Host: When is surgery to close the hole a discussion? Tell us about this new device that Lourdes interventional cardiologists are using called the GORE CARDIOFORM and is it really made of the fabric that’s similar to that found in durable waterproof clothing like GORETEX?
Dr. Moussa: Correct. So, when we are looking to evaluate a patient who had a stroke, we look for – there are many reasons a patient could have a stroke, but recently new studies showed that there is benefit to closing PFOs in the younger population that you ruled out every other cause of stroke. And they are called cryptogenic stroke. The way – the procedure is done usually through the groin, a minimally invasive procedure. It requires a 24-hour hospital stay, but the FDA recently approved the CARDIOFORM devices made out of GORTEX, correct. And it’s made out of two discs. One disc sits in the left atrium and the other disc sits on the right side and over time, the body seals the hole by growing a layer of skin if you would around those discs and completely seals the hole that’s causing what we call a paradoxical embolus or blood clot going from the right side to the left side and going to the brain and causing the stroke.
Host: That’s fascinating. So, this septal occlude, this thing that closes off the hole, it’s made of this material which I think is just so interesting. Why was that material chosen, do you think? Does it allow flow back and forth? What is it actually doing?
Dr. Moussa: The material has been used in surgical devices and implants for many years and it’s been safe, proving to be safe and the body doesn’t reject it. As you know, there are certain material foreign bodies that are implanted in the human body; it’s going to be rejected. The body will mount a reaction to it, clot it off. But this device fabric was chosen for that first and then because of its flexibility and conformability to the structure, the cardiac structure, because the heart is actually three dimensional. This is pretty flexible and when it sits there it actually takes the shape of the right atrium and the shape of the left atrium and has low risk of an infection or eroding into adjacent structures.
Host: That’s so cool. Will this GORE implant be affected by medical imaging methods, household appliances, security sensors? Once it’s implanted, is it then something that needs to be cared for or watched?
Dr. Moussa: So, after the implant, people – we tell our patients to avoid contact sports for one month. They are on baby aspirin for life and Plavix which is another antiplatelet to give the chance to the body to coat the device with a layer of skin, so it does – no clots form on it. Really there is no issues with MRIs. We advise the patient if they are going – undergoing dental procedures to have prophylaxis with antibiotics to prevent the device from being infected again, until the body coats it with a layer of cells. So, the main issues with – or the main concerns or care is the six months after the implant. But after that, they can lead a normal life. It shouldn’t interfere with anything that they are doing, x-rays, MRIs, walking through the scanner at the airport.
Host: Doctor how do you select optimal candidates for this procedure? Tell us a little bit about patient selection criteria and do you have some outcome predictions?
Dr. Moussa: Yes. So, as I mentioned before, 20% of the population walk around with a small hole in their heart and we don’t want to close every single one of them because some of them are completely asymptomatic. So, a lot of thought and a multidisciplinary approach goes into the decision making of who gets a closure device. Usually, it has to be a cryptogenic stroke that means we ruled out every other cause of stroke like atrial fibrillation or an irregular heart rhythm that can cause blood clots to form in the heart to begin with. Clots inside the heart on the left side cause bivalve problems, plaque in the main vessel of the body called the aorta, blockage in the brain arteries, so once all of these have been ruled out and we find that there’s a hole in the heart; in a younger person from their teenage years to their 60s, and the hole looks like it’s high risk to transmit a blood clot from the right side to the left side; these are the patients that are being shown based on studies to benefit from closure device.
The reason why we close them because otherwise those patients, if we don’t close their hole, they will end up with – or their PFO, they will end up on blood thinners for the rest of their life and giving a young person who is a 28-year-old or 30-year-old blood thinners, strong blood thinners for the rest of their life carries its own risks of bleeding. Post closure, they only need to be on blood thinners for six months and then they lead a normal life after that.
Host: What a fascinating topic Dr. Moussa. Wrap it up for us. What would you like the listeners to take away from this knowledge of PFOs, atrial septal defects and this new GORE CARDIOFORM septal occlude that you are able to use at Lourdes Medical Center?
Dr. Moussa: So, first not all patients with a PFO require closure. A thorough analysis of potential stroke risk factors is important prior to putting the device in. I want to emphasize that if the patient qualifies for the procedure it is a simple minimally invasive procedure with a 24-hour hospital stay done through the vein – through a vein from the groin. And certain features of a PFO picked up usually by an echocardiogram shows whether it is risky or not risky. And the trial that looked at these if our listeners are interested is called the RESPECT trial demonstrated reduction in recurrent stroke among carefully selected patients with a PFO.
Host: Thank you so much. What a fascinating topic. Thank you for coming on with us today Dr. Moussa and explaining it so very clearly so that people really have an understanding of this material and this implant and how it can help reduce the risk of stroke. This is Lourdes Health Talk. For more information please visit www.lourdesnet.org, that’s www.lourdesnet.org. This is Melanie Cole. Thanks so much for tuning in.
