In general, the most dreaded complication associated with atrial fibrillation (A-fib) is the occurrence of stroke. The first line of defense is usually a blood thinner–an oral medication taken to reduce the risk. But for some patients, these are not a safe solution. In these cases, a new implantable device called the Watchman™, may help.
Listen in as Manish Shah, MD, an electrophysiologist at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, explains the benefits of the Watchman.
MedStar Washington Hospital Center is the first in the region to implant this device.
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New Device Reduces Risk of Stroke in A-Fib Patients
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Learn more about Manish Shah, MD
Manish Shah, MD
Manish Shah, MD, is the Program Director of Cardiac Electrophysiology Training at MedStar Washington Hospital Center and MedStar Georgetown University Hospital, as part of MedStar Heart & Vascular Institute. He is board certified in cardiac electrophysiology, as well as cardiovascular disease, and is a recipient of the general cardiology faculty teaching award at MedStar Georgetown University Hospital.Learn more about Manish Shah, MD
Transcription:
New Device Reduces Risk of Stroke in A-Fib Patients
Melanie Cole (Host): Atrial fibrillation, or AFib, affects nearly three million people in the United States. It's often described as feeling like a fish jumping in your chest, although many people feel no symptoms. For people who have atrial fibrillation, blood clots that can cause strokes are a danger. The Watchman Device may be the answer to issues related to AFIB. My guest today is Dr. Manish Shah. He's an electrophysiologist with MedStar Heart and Vascular Institute at MedStar Washington Hospital Center. Welcome to the show, Dr. Shah. Tell the listeners first: what is atrial fibrillation?
Dr. Manish Shah (Guest): Thank you very much. Atrial fibrillation is an irregular heart rhythm problem, and it typically involves the top chamber of the heart. And as you stated earlier, it can certainly be responsible for patients experiencing palpitations or a flip-flopping sensation in their heart, or in their chest, rather. It can also account for symptoms such as fatigue, or shortness of breath, or feeling like you just don't have the same amount of energy as you normally do when you exercise. Those are all good reasons when we begin to suspect atrial fibrillation in our patients.
Melanie: If somebody has it and it's undiagnosed, are there some risks for untreated atrial fibrillation?
Dr. Shah: Absolutely. In general, the most dreaded complication associated with atrial fibrillation is the occurrence of stroke, and we know that patients who have atrial fibrillation and other risk factors, such as being over the age of 65, for example, or having high blood pressure--those are all risk factors that can increase your risk of stroke. And, specifically, we know that if you, for example, carry two such risk factors, your stroke can be at least 3-4% per year or even higher, putting you at very high risk for having a stroke, long-term.
Melanie: So, then, what do you typically do when someone has atrial fibrillation? What's the first line of defense?
Dr. Shah: In general, when we see somebody who has atrial fibrillation and who we believe is at elevated risk of having a stroke, our first line therapy is really going to deal with protecting them from stroke by administering them a blood thinner. Those are oral medications that they can take either once or twice a day to help reduce their risk of stroke. But, some patients do not qualify for that blood thinner or are not good candidates for being on a blood thinner, essentially because they're at an increased risk of bleeding or have had trouble with bleeding issues in the past.
Melanie: So, if people are not a candidate for those first line treatments, what is the Watchman and who would be a candidate for this?
Dr. Shah: So, the Watchman Device is a new device that has recently entered the United States market. It previously has been in Europe for almost ten years, now and has been part of a large investigational trial in the United States about ten years ago. But, fortunately, it has recently gained FDA approval and is part of our armamentarium to really help those patients who are at risk for stroke and atrial fibrillation. We specifically begin to think about the Watchman Device in patients who are either at a high risk of bleeding, or who have had some bleeding problems while on a blood thinner for their treatment of atrial fibrillation.
Melanie: So, then, does it reduce the risk of stroke, as well as those blood thinners? Tell us a little bit about what it actually does.
Dr. Shah: Yes. So, the Watchman Device has been shown through two large, well-constructed, randomized, controlled trials which are best quality trials, that the Watchman Device is as good as taking the blood thinner Warfarin, or Coumadin. We also know that one of its major benefits is that it reduces, by a large amount, the risk of having a bleeding event inside of the brain, which is called a hemorrhagic stroke and long-term, that is really the major benefit of the Watchman Device, is that it, overall, will protect you as well as being on a blood thinner, and it also will protect you from having a bleeding event inside of your brain, if you were, for example, were taking a blood thinner like Coumadin or Warfarin.
Melanie: Tell us about the Watchman procedure, Dr. Shah.
Dr. Shah: So, the Watchman procedure is a very simple procedure. It involves putting a catheter--a catheter is a plastic tube, pretty small; less than the size of your pencil--and we put it into the blood vessel down in the groin area. That catheter passes up to the heart, and the Watchman Device is essentially a self-expanding structure. So, it emerges from the catheter and is placed into the top chamber of the heart on the left hand side. We have a name for that. We call it the “left atrial appendage”. That's where the device is placed and that's where most blood clots form in patients who have atrial fibrillation. And so, by essentially covering that appendage, that pouch which is coming off the top chamber of the heart, it will prevent blood clots from leaving the heart and going to your brain and thereby preventing you from having a stroke long-term.
Melanie: How long is the Watchman left in?
Dr. Shah: It will stay with you for your entire life. So, this is not a device that has to be exchanged or changed. Once it's implanted, your body actually lays its own tissue over top of it, essentially sealing it off from the rest of the heart and it stays with you for the rest of your life.
Melanie: So, what have you learned from the first 100 cases?
Dr. Shah: So, it's really been an amazing experience here at the hospital center. We're proud to say that we've done our 100th Watchman implant and we've had a remarkable track record with it. I think the greatest thing that we've learned about it is that it's a safe and simple procedure to do. Your overall risks are less than about 1 in 50 that we can cause any type of problem in patients and most patients will leave the following day after the procedure. They don't have any discomfort or any pain whatsoever.
Melanie: And, what do you see that the future holds for stroke reduction in AFib patients?
Dr. Shah: I think that the Watchman Device is going to play a large role in managing some of our most difficult patients who have atrial fibrillation. So, certainly now, we see that the Watchman Device is going to be used for patients who are at high risk of bleeding, or those patients who have had some type of bleeding issue when on a blood thinner, but in the future, I anticipate we'll be using it on patients who are at lower risk of bleeding because I think the data behind the Watchman Device is likely to be favorable as we begin to treat patients who have atrial fibrillation earlier in their disease, of course, as opposed to later on. So, you know, if you ask me what's going to happen five to ten years from now, it's possible that when a patient presents to us with atrial fibrillation, they are likely going to have the procedure to treat them for atrial fibrillation, called an “ablation” and, at the same time, we may be thinking about putting in a Watchman Device for those patients. Now, obviously, we need some trials to really demonstrate benefits, but I anticipate that being the future of the device.
Melanie: So, Dr. Shah, in just the last few minutes, give us your best advice for patients who suffer from atrial fibrillation and what you really want them to know.
Dr. Shah: I think that the first thing that they should know is that atrial fibrillation is a disease that can carry symptoms and those symptoms can be debilitating in some patients and require treatment and that treatment is catheter ablation for atrial fibrillation. For those patients who do not have symptoms with their atrial fibrillation and are at a high risk of bleeding, or have had bleeding problems on a blood thinner, those are patients who we should think very strongly about the Watchman Device. I think it's a safe, effective technology for them and one that will likely provide them with lifelong benefits in terms of protection from stroke without taking or carrying the risks of bleeding that occur when you're taking a blood thinner.
Melanie: Thank you so much, Dr. Shah, for being with us today. You're listening to Medical Intel with MedStar Washington Hospital Center and for more information, you can go to www.medstarheartinstitute.org. That's www.medstarheartinstitute.org. This is Melanie Cole. Thanks so much for listening.
New Device Reduces Risk of Stroke in A-Fib Patients
Melanie Cole (Host): Atrial fibrillation, or AFib, affects nearly three million people in the United States. It's often described as feeling like a fish jumping in your chest, although many people feel no symptoms. For people who have atrial fibrillation, blood clots that can cause strokes are a danger. The Watchman Device may be the answer to issues related to AFIB. My guest today is Dr. Manish Shah. He's an electrophysiologist with MedStar Heart and Vascular Institute at MedStar Washington Hospital Center. Welcome to the show, Dr. Shah. Tell the listeners first: what is atrial fibrillation?
Dr. Manish Shah (Guest): Thank you very much. Atrial fibrillation is an irregular heart rhythm problem, and it typically involves the top chamber of the heart. And as you stated earlier, it can certainly be responsible for patients experiencing palpitations or a flip-flopping sensation in their heart, or in their chest, rather. It can also account for symptoms such as fatigue, or shortness of breath, or feeling like you just don't have the same amount of energy as you normally do when you exercise. Those are all good reasons when we begin to suspect atrial fibrillation in our patients.
Melanie: If somebody has it and it's undiagnosed, are there some risks for untreated atrial fibrillation?
Dr. Shah: Absolutely. In general, the most dreaded complication associated with atrial fibrillation is the occurrence of stroke, and we know that patients who have atrial fibrillation and other risk factors, such as being over the age of 65, for example, or having high blood pressure--those are all risk factors that can increase your risk of stroke. And, specifically, we know that if you, for example, carry two such risk factors, your stroke can be at least 3-4% per year or even higher, putting you at very high risk for having a stroke, long-term.
Melanie: So, then, what do you typically do when someone has atrial fibrillation? What's the first line of defense?
Dr. Shah: In general, when we see somebody who has atrial fibrillation and who we believe is at elevated risk of having a stroke, our first line therapy is really going to deal with protecting them from stroke by administering them a blood thinner. Those are oral medications that they can take either once or twice a day to help reduce their risk of stroke. But, some patients do not qualify for that blood thinner or are not good candidates for being on a blood thinner, essentially because they're at an increased risk of bleeding or have had trouble with bleeding issues in the past.
Melanie: So, if people are not a candidate for those first line treatments, what is the Watchman and who would be a candidate for this?
Dr. Shah: So, the Watchman Device is a new device that has recently entered the United States market. It previously has been in Europe for almost ten years, now and has been part of a large investigational trial in the United States about ten years ago. But, fortunately, it has recently gained FDA approval and is part of our armamentarium to really help those patients who are at risk for stroke and atrial fibrillation. We specifically begin to think about the Watchman Device in patients who are either at a high risk of bleeding, or who have had some bleeding problems while on a blood thinner for their treatment of atrial fibrillation.
Melanie: So, then, does it reduce the risk of stroke, as well as those blood thinners? Tell us a little bit about what it actually does.
Dr. Shah: Yes. So, the Watchman Device has been shown through two large, well-constructed, randomized, controlled trials which are best quality trials, that the Watchman Device is as good as taking the blood thinner Warfarin, or Coumadin. We also know that one of its major benefits is that it reduces, by a large amount, the risk of having a bleeding event inside of the brain, which is called a hemorrhagic stroke and long-term, that is really the major benefit of the Watchman Device, is that it, overall, will protect you as well as being on a blood thinner, and it also will protect you from having a bleeding event inside of your brain, if you were, for example, were taking a blood thinner like Coumadin or Warfarin.
Melanie: Tell us about the Watchman procedure, Dr. Shah.
Dr. Shah: So, the Watchman procedure is a very simple procedure. It involves putting a catheter--a catheter is a plastic tube, pretty small; less than the size of your pencil--and we put it into the blood vessel down in the groin area. That catheter passes up to the heart, and the Watchman Device is essentially a self-expanding structure. So, it emerges from the catheter and is placed into the top chamber of the heart on the left hand side. We have a name for that. We call it the “left atrial appendage”. That's where the device is placed and that's where most blood clots form in patients who have atrial fibrillation. And so, by essentially covering that appendage, that pouch which is coming off the top chamber of the heart, it will prevent blood clots from leaving the heart and going to your brain and thereby preventing you from having a stroke long-term.
Melanie: How long is the Watchman left in?
Dr. Shah: It will stay with you for your entire life. So, this is not a device that has to be exchanged or changed. Once it's implanted, your body actually lays its own tissue over top of it, essentially sealing it off from the rest of the heart and it stays with you for the rest of your life.
Melanie: So, what have you learned from the first 100 cases?
Dr. Shah: So, it's really been an amazing experience here at the hospital center. We're proud to say that we've done our 100th Watchman implant and we've had a remarkable track record with it. I think the greatest thing that we've learned about it is that it's a safe and simple procedure to do. Your overall risks are less than about 1 in 50 that we can cause any type of problem in patients and most patients will leave the following day after the procedure. They don't have any discomfort or any pain whatsoever.
Melanie: And, what do you see that the future holds for stroke reduction in AFib patients?
Dr. Shah: I think that the Watchman Device is going to play a large role in managing some of our most difficult patients who have atrial fibrillation. So, certainly now, we see that the Watchman Device is going to be used for patients who are at high risk of bleeding, or those patients who have had some type of bleeding issue when on a blood thinner, but in the future, I anticipate we'll be using it on patients who are at lower risk of bleeding because I think the data behind the Watchman Device is likely to be favorable as we begin to treat patients who have atrial fibrillation earlier in their disease, of course, as opposed to later on. So, you know, if you ask me what's going to happen five to ten years from now, it's possible that when a patient presents to us with atrial fibrillation, they are likely going to have the procedure to treat them for atrial fibrillation, called an “ablation” and, at the same time, we may be thinking about putting in a Watchman Device for those patients. Now, obviously, we need some trials to really demonstrate benefits, but I anticipate that being the future of the device.
Melanie: So, Dr. Shah, in just the last few minutes, give us your best advice for patients who suffer from atrial fibrillation and what you really want them to know.
Dr. Shah: I think that the first thing that they should know is that atrial fibrillation is a disease that can carry symptoms and those symptoms can be debilitating in some patients and require treatment and that treatment is catheter ablation for atrial fibrillation. For those patients who do not have symptoms with their atrial fibrillation and are at a high risk of bleeding, or have had bleeding problems on a blood thinner, those are patients who we should think very strongly about the Watchman Device. I think it's a safe, effective technology for them and one that will likely provide them with lifelong benefits in terms of protection from stroke without taking or carrying the risks of bleeding that occur when you're taking a blood thinner.
Melanie: Thank you so much, Dr. Shah, for being with us today. You're listening to Medical Intel with MedStar Washington Hospital Center and for more information, you can go to www.medstarheartinstitute.org. That's www.medstarheartinstitute.org. This is Melanie Cole. Thanks so much for listening.