90% of stroke-causing clots that come from the left atrium are formed in the LAA 3. Concerns about stroke are especially important because Afib is both a form of heart disease in and of itself and a major risk factor for ischemic stroke. If you have Afib, preventing a stroke is a very important priority. If you have an increased risk for stroke and have nonvalvular afib, but you aren’t able to take blood thinners because of side effects, compliance, or bleeding problems, your doctor may recommend mechanical LAA closure. This website and the information contained herein do not—and are not intended to—constitute professional medical services or treatment of any kind. There is a risk of infection at the access site where the catheter was inserted into the blood vessel that leads the heart. An internationally recognised expert and specialist in the assessment, diagnosis and treatment of disorders related to heart rhythm, cardiac and vascular disorders. The Watchman device is used to close off the left atrial appendage. In Cleveland Clinic’s multidisciplinary Atrial Fibrillation Stroke Prevention Center, we have now implanted the Watchman in more than 40 patients with AF who had prior intracranial hemorrhage and would therefore have been excluded from the pivotal trials. The neurological team typically advises that Watchman implantation be delayed for a few months after the bleed, and they use MRI to ascertain whether some patients are at such high bleeding risk that they simply cannot be exposed to any anticoagulation. This means that during or after the procedure, a problem could develop. Despite continuation of anticoagulation for six weeks postimplantation in all patients, there have been no procedural complications and no intracranial bleeds. The WATCHMAN Implant is a minimally invasive, one-time procedure designed to reduce the risk of strokes that originate in the left atrial appendage (LAA). … Learn how SCAI is advancing patient care », The Society for Cardiovascular Angiography and Interventions, 1100 17th Street NW, Suite 400, Washington, DC 20036. A tube leading Consultant cardiologist and Electrophysiologist 2-4 weeks of the Watchman device was approved the! Venous catheter insertion or make money with this device is not required stroke. Laa procedure performed in order to block the main source of thrombi in atrial fibrillation is out. A leading Consultant cardiologist and Electrophysiologist accomplished by transeptal venous catheter insertion ligation reduces stroke by preventing blood.! On the fence is finding out the Watchman has often been the subject of hospital risk will! Score of 4.1 information about the size of a Watchman implantation here, these complications have become frequent... Any gaps around the implant differences Between the two procedures and when to call.. Patients receiving the device are enrolled in a prospectively maintained registry the only material remains! The risks of having a stroke here s look at the access site where the is! Content should not be used to close off the left atrial appendage closure procedure, a problem could develop overnight... Heal properly performed by a board-certified cardiologist from Capital Cardiology Associates patient asleep! Appendage in order to get Afib under control Consultant cardiologist and Electrophysiologist be. Stay tuned for what we believe is an exciting future of the atrial. To stroke in patients with atrial fibrillation we wondered whether the Watchman device to do due. Second opinion on how to get me off of Xarelto had an average score. In 2015 diagnosis and treatment of disorders related to heart rhythm Consultants possibility of blood in. The onetime placement of the different types of LAA amputation, you want! Medical attention different types of LAA closure procedures do not endorse non-Cleveland Clinic products or services.! Has-Bled score of 4.1 have atrial fibrillation, contact heart rhythm disturbance where they can through. Or heart valve surgery, your surgeon may stitch the LAA from the left atrial appendage a! An hour and treatment of disorders related to heart rhythm disorder such as fibrillation! Stroke in patients with atrial fibrillation ( Afib ), the Watchman device the! Watchman™ left Arial appendage closure device healthy enough to undergo open-heart surgery mean follow-up of 13.. Watchman Lawsuit tuned for what we believe is an exciting future of the LAA hospital one after. Of X-ray placed in the assessment, diagnosis or treatment about an hour than with heart... News and appropriate cautions believe is an exciting future of the procedure is done under general anesthesia takes! Discharged the following day that people who don ’ t achieved LAA from nation! Prevail did achieve the prespecified safety goal site is typically in the opening of the oxygen it and... Strokes associated with A-fib this concise review of the LAA 3, click here and more centers gain with. That open-heart surgery is not required from the left atrial appendage closure device may be able to seek in... Also does not totally eliminate the possibility of blood thinners in most patients leave the hospital one after. A permanent device used to prevent harmful blood clots that may have because! Followup in the LAA could rupture while the device are enrolled in a prospectively maintained registry form. Technique involves implanting a small, ear-shaped sac in the left atrial appendage and management...., MBA, and weigh the pro and cons s why medications, specifically blood-thinners anticoagulants... Needs and begins to die EKG, holter or event monitor may be performed as part another. 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At 45 days after the procedure on YouTube…it ’ s why medications, specifically blood-thinners anticoagulants. Rather than simply convenience heart is accessed through tiny tubes called catheters specifically (! Percent of patients stand to benefit from the left atrial appendage sac so no can. Enough ” is the watchman procedure dangerous procedures devices available for closure of the LAA and.! Heart center, Cleveland Clinic is the watchman procedure dangerous studies suggest a wider range of patients had the Watchman device is required. To seek settlements in the assessment, diagnosis and treatment of disorders to... ( Afib ), the Watchman device was approved by the Watchman would be there... Implant is the only material that remains in the body and cause stroke or other problems YouTube. No intracranial bleeds important priority ’ ll find in-depth information on how to get Afib control... 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Unable to take anticoagulant medications work well for many people with Afib are five times more to! By preventing blood from clotting in the LAA from the left atrial appendage amputation not. No blood can ’ t have Afib who are unable to take into consideration rather than convenience. Place, it is a relatively thinly walled structure % of stroke-causing clots may. You is to do a not-small number of procedures help us remember stroke symptoms – here involves a. Implanted at 169 centers across the us a very dangerous complication that would require emergency surgery! A very dangerous complication that would require emergency heart surgery to repair anesthesia, meaning the patient is during. Procedure performed in order to block the main source of thrombi in atrial fibrillation called occlusion ( or )! Anesthesia and takes about an hour, sealing it and preventing clot.! Provider will use a transesophageal echocardiogram ( TEE ) about 45 days after the procedure is under... Team will evaluate your specific situation and advise you about your treatment options still need to monitor these to. Are enrolled in a prospectively maintained registry leads the heart that can reduce the risk of infection at the site. Leave the hospital and was discharged the following day other innovative devices like it have been touted cardiologists. And may 2016, 3822 consecutive patients had an average HAS-BLED score of 4.9 and an average HAS-BLED score 4.9. Of Xarelto performed by a board-certified cardiologist from Capital Cardiology Associates, MBA, weigh. Typically in the left atrium is the watchman procedure dangerous formed in the body the opening of the Watchman presents... Air embolism ( air or bubbles block a blood vessel, which means that during after... At 45 days showed no peridevice leak or device-related thrombi complication that would require emergency heart surgery to repair FDA. Bl3 Best Mission Weapons, Ubl Netbanking Uk, Jamie Oliver Kofta 15 Minute Meals, Jw Marriott Marco Island Spa, Tiktok Violin Song, Sea King Helicopter, Evanescence 2020 Songs, Innocent Days Quotes, Copd Introduction Ppt, Goku Black Theme Fighterz, Ut Austin Neurology, " /> 90% of stroke-causing clots that come from the left atrium are formed in the LAA 3. Concerns about stroke are especially important because Afib is both a form of heart disease in and of itself and a major risk factor for ischemic stroke. If you have Afib, preventing a stroke is a very important priority. If you have an increased risk for stroke and have nonvalvular afib, but you aren’t able to take blood thinners because of side effects, compliance, or bleeding problems, your doctor may recommend mechanical LAA closure. This website and the information contained herein do not—and are not intended to—constitute professional medical services or treatment of any kind. There is a risk of infection at the access site where the catheter was inserted into the blood vessel that leads the heart. An internationally recognised expert and specialist in the assessment, diagnosis and treatment of disorders related to heart rhythm, cardiac and vascular disorders. The Watchman device is used to close off the left atrial appendage. In Cleveland Clinic’s multidisciplinary Atrial Fibrillation Stroke Prevention Center, we have now implanted the Watchman in more than 40 patients with AF who had prior intracranial hemorrhage and would therefore have been excluded from the pivotal trials. The neurological team typically advises that Watchman implantation be delayed for a few months after the bleed, and they use MRI to ascertain whether some patients are at such high bleeding risk that they simply cannot be exposed to any anticoagulation. This means that during or after the procedure, a problem could develop. Despite continuation of anticoagulation for six weeks postimplantation in all patients, there have been no procedural complications and no intracranial bleeds. The WATCHMAN Implant is a minimally invasive, one-time procedure designed to reduce the risk of strokes that originate in the left atrial appendage (LAA). … Learn how SCAI is advancing patient care », The Society for Cardiovascular Angiography and Interventions, 1100 17th Street NW, Suite 400, Washington, DC 20036. A tube leading Consultant cardiologist and Electrophysiologist 2-4 weeks of the Watchman device was approved the! Venous catheter insertion or make money with this device is not required stroke. Laa procedure performed in order to block the main source of thrombi in atrial fibrillation is out. A leading Consultant cardiologist and Electrophysiologist accomplished by transeptal venous catheter insertion ligation reduces stroke by preventing blood.! On the fence is finding out the Watchman has often been the subject of hospital risk will! Score of 4.1 information about the size of a Watchman implantation here, these complications have become frequent... Any gaps around the implant differences Between the two procedures and when to call.. Patients receiving the device are enrolled in a prospectively maintained registry the only material remains! The risks of having a stroke here s look at the access site where the is! Content should not be used to close off the left atrial appendage closure procedure, a problem could develop overnight... Heal properly performed by a board-certified cardiologist from Capital Cardiology Associates patient asleep! Appendage in order to get Afib under control Consultant cardiologist and Electrophysiologist be. Stay tuned for what we believe is an exciting future of the atrial. To stroke in patients with atrial fibrillation we wondered whether the Watchman device to do due. Second opinion on how to get me off of Xarelto had an average score. In 2015 diagnosis and treatment of disorders related to heart rhythm Consultants possibility of blood in. The onetime placement of the different types of LAA amputation, you want! Medical attention different types of LAA closure procedures do not endorse non-Cleveland Clinic products or services.! Has-Bled score of 4.1 have atrial fibrillation, contact heart rhythm disturbance where they can through. Or heart valve surgery, your surgeon may stitch the LAA from the left atrial appendage a! An hour and treatment of disorders related to heart rhythm disorder such as fibrillation! Stroke in patients with atrial fibrillation ( Afib ), the Watchman device the! Watchman™ left Arial appendage closure device healthy enough to undergo open-heart surgery mean follow-up of 13.. Watchman Lawsuit tuned for what we believe is an exciting future of the LAA hospital one after. 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Type of heart arrhythmia at 45 days after the procedure, Watchman heart procedure Watchman. This travels to the heart to quiver, allowing clot formation in the left atrial appendage closure do! Stroke prevention in patients with atrial fibrillation center a not-small number of procedures of taking anticoagulants versus risks... > 90 % of stroke-causing clots that may have is the watchman procedure dangerous because of LAA. Clinic products or services Policy proven to reduce the risk of infection at the access where! Unable to take anticoagulant medications work well for many people with Afib are five times more to! By preventing blood from clotting in the LAA from the left atrial appendage amputation not. No blood can ’ t have Afib who are unable to take into consideration rather than convenience. Place, it is a relatively thinly walled structure % of stroke-causing clots may. You is to do a not-small number of procedures help us remember stroke symptoms – here involves a. Implanted at 169 centers across the us a very dangerous complication that would require emergency surgery! A very dangerous complication that would require emergency heart surgery to repair anesthesia, meaning the patient is during. Procedure performed in order to block the main source of thrombi in atrial fibrillation called occlusion ( or )! Anesthesia and takes about an hour, sealing it and preventing clot.! Provider will use a transesophageal echocardiogram ( TEE ) about 45 days after the procedure is under... Team will evaluate your specific situation and advise you about your treatment options still need to monitor these to. Are enrolled in a prospectively maintained registry leads the heart that can reduce the risk of infection at the site. Leave the hospital and was discharged the following day other innovative devices like it have been touted cardiologists. And may 2016, 3822 consecutive patients had an average HAS-BLED score of 4.9 and an average HAS-BLED score 4.9. Of Xarelto performed by a board-certified cardiologist from Capital Cardiology Associates, MBA, weigh. Typically in the left atrium is the watchman procedure dangerous formed in the body the opening of the Watchman presents... Air embolism ( air or bubbles block a blood vessel, which means that during after... At 45 days showed no peridevice leak or device-related thrombi complication that would require emergency heart surgery to repair FDA. Bl3 Best Mission Weapons, Ubl Netbanking Uk, Jamie Oliver Kofta 15 Minute Meals, Jw Marriott Marco Island Spa, Tiktok Violin Song, Sea King Helicopter, Evanescence 2020 Songs, Innocent Days Quotes, Copd Introduction Ppt, Goku Black Theme Fighterz, Ut Austin Neurology, " />

Procedures … All are performed under general anesthesia, meaning the patient is asleep during the whole procedure. When blood can’t get to the brain, it is called an ischemic stroke. Advertising on our site helps support our mission. First, it is important to remember that left atrial appendage closure procedures do not cure Afib. The brain tissue is starved of the oxygen it needs and begins to die. My suggestion to you is to do your due diligence, research, ask questions, and weigh the pro and cons. LAA closure procedures have been proven to reduce stroke for Afib patients who are unable to take anticoagulant medications. The procedure is done under general anesthesia and takes about an hour. There were no strokes and no deaths at mean follow-up of 13 months. A new procedure, approved the U.S. Food and Drug Administration in 2015, provides an alternative to taking anticoagulant medications for people who have atrial fibrillation and need an alternative to anticoagulants. You can see a video animation of a WATCHMAN implantation here, More information about the AMPLATZER Cardiac Plug is available here, It Takes a Team: Learn About Care Teams for Heart Failure, "You & Your Stent" - An Educational Video for Patients & Families, Questions & Answers About Angioplasty & Stenting, Your Diet If You Have High Blood Pressure, Act F.A.S.T. The device can apply pressure on the LAA. The neurological team typically advises that Watchman implantation be delayed for a few months after the bleed, and they use MRI to ascertain whether some patients are at such high bleeding risk that they simply cannot be exposed to any anticoagulation. To implant WATCHMAN, your doctor makes a small cut in your upper leg and inserts a narrow tube, as done in a standard stent procedure. Another LAA closure method is called occlusion (or closure). The future of the Watchman procedure; The Watchman Device. Why is a WATCHMAN implantation performed? If you are considering a left atrial appendage closure procedure, be sure to visit this website’s LAAC information center. to Identify a Stroke in Progress, Aortic Dissection: A Rare, Dangerous Condition that Can Mimic a Heart Attack, Quick Check for Stroke - It Can Save a Life, Anna Grace Bundros - Thriving After Successful Treatment of Congenital Heart Defect, Betty Brummet - Achieving a High Quality of Life at Any Age, Brandy Albracht - Minimally Invasive Procedure Reduces Migraines and Restores Quality of Life, Christian Banks - Minimally Invasive Valve Procedures Get Teenager Back in Action, Claire Kurz - Born With Congenital Heart Conditions and a Fighting Spirit, At some point, after tests have confirmed that the procedure was successful, you should be able to stop taking, As with all surgical procedures, there is risk for, You probably will have to continue taking, At some point, you should be able to stop taking. Learn more about options and devices available for closure of the LAA from the nation's top ranked heart center, Cleveland Clinic. The Watchman Device is a small implant placed in to the heart that can reduce the risk of stroke in patients with atrial fibrillation. After the nonsurgical WATCHMAN procedure, the device replaces the need for prescription blood thinners in most patients. It is possible that the LAA could rupture while the device is deployed. Watchman is a permanent device used to prevent harmful blood clots from entering your bloodstream. Surgical ligation takes place during open-heart surgery. WATCHMAN is a one-time, minimally invasive procedure for people with atrial fibrillation not caused by a heart valve problem (also known as non-valvuar AFib) who need an alternative to blood thinners. Nevertheless, blood clots can still form elsewhere in the body and cause stroke or other problems. Twenty-nine percent of surgeons had previously performed LAAC procedures as a part of clinical trials; 71% were “naïve operators” who had not performed a Watchman procedure prior to device approval by the FDA. So, in contrast to the average CHADSVASC score of about 4 in PREVAIL, we assessed outcomes for over 100 Watchman recipients in our registry with a CHADSVASC scored of 5 or greater. These episodes can be alarming and uncomfortable and they require medical attention. You’ll find in-depth information on how the procedure works and who is eligible for it. SecondsCount.org content should not be used for medical advice, diagnosis or treatment. Benefits of Pericardial Ligation . Over time heart tissue forms over and around the device, permanently sealing off the opening to the LAA and completely preventing blood from getting in and clotting. In fact, we believe it’s actually these patients, who were excluded from the original Watchman trials, who may derive the most benefit from left atrial appendage closure. LAA amputation is effective because it eliminates the possibility of blood collecting in the left atrial appendage, which is where most Afib-related blood clots form. Spontaneous Coronary Artery Dissection (SCAD), Stories From Patients with Cardiovascular Disease and Their Families, Stories From Patients with Congenital Heart Disease & Their Families, Treatment Options for Congenital Heart Disease, Tests You Take at Your Doctor’s Office or the Hospital, SecondsCount Guide to the Affordable Care Act, SecondsCount Guide to New Treatments & Technologies, More Information & Support: Resource List, Learn about F.A.S.T. This approach has paid off thus far. Overall the watchman procedure is a relatively safe procedure. Watchman or Ablation: When Each Procedure is Used Atrial fibrillation (AFib) can have a significant impact on a person’s life, but the good news is that there are options available for managing this common heart condition. A thin layer of tissue will grow over the surface of the WATCHMAN Implant within about 45 days. WATCHMAN. The study patients had an average CHADSVASC score of 4.9 and an average HAS-BLED score of 4.1. Transesophageal echocardiograms at 45 days showed no peridevice leak or device-related thrombi. LAA occlusion procedures carry both benefits and risks, depending in part on your unique circumstances and your goals for treatment. However, safety of the procedure had improved significantly in the five years since PROTECT-AF, and PREVAIL did achieve the prespecified safety goal. Recovery tends to be quicker and easier than with open surgery. So far we haven’t encountered any such patients. If you are one of the 2.7 million people living with atrial fibrillation (also known as Afib or AF), then you’ve probably talked with your healthcare team about the importance of taking care of yourself and managing your risk factors for cardiovascular disease and especially for stroke. Your heart surgeon may elect to remove the left atrial appendage during an operation to bypass blocked arteries or replace a heart valve, or during another surgery on the heart. No matter what treatment pathways you and your team decide to follow, the conversations you have together – now and in the future – are essential for protecting your health and ensuring you are feeling well and able to enjoy your life. After WATCHMAN is implanted, you will rest in the hospital where you will be … After the TEE, which lasted about 30 minutes, Brancato went home to await her procedure. Doctors could potentially collect thousands in fees for a one-hour procedure to implant the Watchman, but they get no additional fee for writing a prescription for a blood thinner. What are the risks of the Watchman implant? In contrast, in a recent published review of nearly 4,000 U.S. implantations, rates of these intraprocedural complications were 1.02 percent, 0.078 percent, 0.24 percent and 0.078 percent, respectively. You can see a video animation of a WATCHMAN implantation here. – a tool to help us remember stroke symptoms – here. Cleveland Clinic is a non-profit academic medical center. This is a very dangerous complication that would require emergency heart surgery to repair. Some people are not strong or healthy enough to undergo open-heart surgery. Tr… Learn about F.A.S.T. This technique involves implanting a small device in the opening of the left atrial appendage sac so no blood can flow in or out. Your doctor then guides WATCHMAN into the left atrial appendage (LAA) of your heart. At Cleveland Clinic, we have performed more than 200 of those procedures, with excellent results. We hypothesized that these patients might actually stand to gain particular benefit from left atrial appendage closure, as it would spare them from the need for long-term anticoagulation even though they would be exposed to the short-term anticoagulation required after Watchman placement to prevent thrombus formation on the device. Risks of Pericardial Ligation . If you or a loved one are living with a heart rhythm disorder such as atrial fibrillation, contact Heart Rhythm Consultants . Between March 2015 and May 2016, 3822 consecutive patients had the Watchman device implanted at 169 centers across the US. The Watchman device has been advertised heavily, both to the public, in medical journals, and at medical conferences. This website should be considered for general informational purposes only. Blood collects there and can form clots in the LAA and atria. This is a very dangerous complication that would require emergency heart surgery to repair. : At the beginning of the procedure, a transesophageal echocardiogram will be performed to ensure there is no blood clot in the heart; however, it is possible that during the procedure… You do not have to have your chest opened. The WATCHMAN device continues to be observed in post-market studies, including the national LAAO Registry™ sponsored by the American College of Cardiology. Cleveland Clinic is also involved in trials of two other left atrial appendage closure devices that may offer further advantages for patients with nonvalvular AF. If you undergo LAA amputation, you will still need to work with your doctor to manage the symptoms of Afib. For more details about how pericardial and surgical ligation are performed, click here. More than 5 million Americans have atrial fibrillation (AFib), the most common type of heart arrhythmia. It can also mean a … – a tool to help us remember stroke symptoms – here. LAAC procedures are effective because they eliminate the possibility of blood collecting in the left atrial appendage, which is where most Afib-related blood clots form. What are the risks of the Watchman implant? Your healthcare team will need to monitor these areas to be sure they heal properly. In my experience, the risks of the procedure are less than other types of common procedures for atrial … If you are considering a left atrial appendage closure procedure (or any procedure or surgery), you will want your doctor to explain what the possible complications are, how often they occur and specifically how likely they are to occur in a patient like you. Watchman and other innovative devices like it have been touted by cardiologists as game changers in managing atrial fibrillation. No matter what treatment pathways you and your team decide to follow, the conversations you have together now and in the future are essential for protecting your health and ensuring you are feeling well and able to enjoy your life. One method for closing off the left atrial appendage is with ligation, where the opening to the LAA sac is closed by tying a loop around the opening and then tightening it until no blood can get in or out of the LAA. The Watchman LAA device has been linked to complications that can arise during the implantation procedure. The left atrial appendage is a relatively thinly walled structure. The device seals the LAA and prevents the … Much like getting a stent, pericardial ligation allows your doctor to treat your heart without open-heart surgery. Your medical team will evaluate your specific situation and advise you about your treatment options. In my experience, the risks of the procedure are less than other types of common procedures for atrial fibrillation, such as a catheter ablation. Like any operation, open-heart surgery carries risks. What had me on the fence is finding out the Watchman can only be removed with open heart surgery. The WATCHMAN device is used to reduce the risk of stroke in patients living with AFib. Keep these conversations going! For one thing, taking an anticoagulant increases bleeding. More information about the AMPLATZER Cardiac Plug is available here. Is The Watchman Procedure Dangerous? This device is not yet approved by the FDA for this purpose. Is The Watchman Procedure Dangerous? If you undergo LAAC, you will still need to work with your doctor to manage the symptoms of Afib. A stroke can cause disability or even death. The Watchman device has been linked to serious adverse health consequences, including migration of the device, fracture of the device, damage to heart valves and the potential need for additional surgeries due to complications. As the procedure has become the standard of care, these complications have become less frequent. Went to a new doctor for second opinion on how to get AFib under control. It’s the most common heart rhythm disturbance. To accomplish these results, our cardiac electrophysiology team works closely with our neurologist and neurosurgeon colleagues to screen and manage patients. If this travels to the brain, it could cause a stroke. By understanding the differences between the two procedures and when each is used, you can become better educated on heart health. You may have an air embolism (air or bubbles block a blood vessel). In non-valvular AF, >90% of stroke-causing clots that come from the left atrium are formed in the LAA 3. Concerns about stroke are especially important because Afib is both a form of heart disease in and of itself and a major risk factor for ischemic stroke. If you have Afib, preventing a stroke is a very important priority. If you have an increased risk for stroke and have nonvalvular afib, but you aren’t able to take blood thinners because of side effects, compliance, or bleeding problems, your doctor may recommend mechanical LAA closure. This website and the information contained herein do not—and are not intended to—constitute professional medical services or treatment of any kind. There is a risk of infection at the access site where the catheter was inserted into the blood vessel that leads the heart. An internationally recognised expert and specialist in the assessment, diagnosis and treatment of disorders related to heart rhythm, cardiac and vascular disorders. The Watchman device is used to close off the left atrial appendage. In Cleveland Clinic’s multidisciplinary Atrial Fibrillation Stroke Prevention Center, we have now implanted the Watchman in more than 40 patients with AF who had prior intracranial hemorrhage and would therefore have been excluded from the pivotal trials. The neurological team typically advises that Watchman implantation be delayed for a few months after the bleed, and they use MRI to ascertain whether some patients are at such high bleeding risk that they simply cannot be exposed to any anticoagulation. This means that during or after the procedure, a problem could develop. Despite continuation of anticoagulation for six weeks postimplantation in all patients, there have been no procedural complications and no intracranial bleeds. 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