The left atrial appendage (LAA) is a small sac located in the muscle wall of the left atrium, which is located in the top left chamber of the heart. Normally, when the heart contracts with each heartbeat, the blood in the left atrium and the LAA is squeezed out of the left atrium and into the left ventricle, which is located in the bottom left chamber of the heart. WHAT IS ATRIAL FIBRILLATION? In the case of Atrial Fibrillation, the electrical impulses that control the heartbeat do not travel the way they’re supposed to, in an orderly fashion. Instead, many impulses happen all at once and spread through the atria in a chaotic manner. When this happens, the atria does not have enough time to contract and effectively squeeze blood into the ventricles, and because the LAA is a small sac, blood can collect there and form into clots in the LAA and the atria. Blood clots can cause a stroke, which is why people with the condition of Atrial Fibrillation are 5 to 7 times more likely to have a stroke than those without this condition. WHAT IS THE WATCHMAN? The WATCHMAN device has been approved by the FDA: To reduce the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation who are at increased risk of stroke or systemic embolism but are not candidate from long term anticoagulation as well as who have an appropriate reason to want treatment with non – medication alternative to warfarin. The WATCHMAN Device is a parachute-shaped, self-expanding device that closes the LAA. It was tested in several studies that showed the device was a good alternative treatment for patients who cannot tolerate treatment with medication. The WATCHMAN device is implanted percutaneously (through the skin) in the electrophysiology (EP) lab. The implant procedure does not require surgery; however, general anesthesia may be used during the procedure. A catheter sheath is inserted into a vein near the groin and guided across the septum, which is a muscular wall that divides the right and left sides of the heart to the opening of the LAA. The device is placed in the opening of the LAA. This seals off the LAA and keeps it from releasing clots.
The WATCHMAN Left Atrial Appendage Closure Device is implanted at the opening of the left atrial appendage and is intended to prevent left atrial appendage blood clots from entering your blood stream and potentially causing a stroke. It is made of materials that are common to many medical devices. The implant is designed to be a one-time implant that does not need to be replaced.
-Helps reduce stroke risk
-Patients with the Watchman Device can typically stop strong blood thinning medication such as Coumadin 45 days after the device is implanted therefore decreasing the chance of bleeding complications and the need to take daily medicines. There is the reduced cost associated with not needing to take a lifetime worth of blood thinner.
-As with any invasive procedure there are risks associated. The good news is that the risk of complication is small, and has continued to decrease as the cardiologists performing and planning the procedure have continued to gain experience and make the procedure safer.
A small puncture is made into a vein in your groin. A long, thin tube, called a catheter, is inserted into the vein and advanced into the right atrium of the heart. Another puncture is made through a thin muscle wall between the right atrium and the left atrium so that the catheter can be advanced into the left atrium. A thinner catheter is then advanced into the left atrial appendage under X-ray guidance. The WATCHMAN Implant is tightly compressed within the catheter and is passed through the catheter into the left atrial appendage. The physician will make sure that the implant is in the right place within the left atrial appendage and then deploy the implant (much like opening up a folded umbrella). After the procedure, the WATCHMAN Implant is the only material that remains in the body. A thin layer of tissue will grow over the surface of the WATCHMAN Implant within about 45 days.
The WATCHMAN Implant is placed into your heart using a minimally invasive procedure in a cardiac catheterization laboratory or electrophysiology laboratory by a physician and his/her team who have experience and training in the WATCHMAN implantation technique. In preparation for the implant, you will be lying on your back on a table while you are continuously monitored throughout the procedure by medical personnel. X-rays and echocardiograms (a special type of ultrasound picture) will be used to help visualize the heart while the implant is being advanced into the correct position in your heart. Contrast media (dye) will also be injected to help guide the implant placement. You will be given a general and/or local anesthetic by your doctor to minimize any discomfort during the procedure.
After WATCHMAN is implanted, you will rest in the hospital where you will be monitored during your recovery from the procedure. It may be one or more days before you are discharged home, and your doctor will determine how long you need to be in the hospital. Your doctor will instruct you to take warfarin and aspirin after your implant. After your WATCHMAN Implant has been in place for a minimum of 45 days, your doctor will take pictures of your heart by means of a test called a TEE (transesophageal echocardiogram) to determine if the implant has closed the opening of the left atrial appendage. Your doctor may stop your warfarin medication at that time, depending on the result of this test. If your doctor chooses to stop your warfarin he/she will prescribe a new blood thinning medication called clopidogrel (Plavix®) until 6 months after your implant procedure, and your aspirin dose may increase. At about 12 months after your WATCHMAN Implant, your doctor will schedule another TEE to check on the device and make sure that your LAA is still closed.
As with any invasive procedure there are risks associated. The good news is that the risk of complication is small, and has continued to decrease as the cardiologists performing and planning the procedure have continued to gain experience and make the procedure safer. Damage to the leg vessels – Remember the procedure is carried out through the vessels of the leg and there is a small chance of damage here. If there is damage, then this can usually be taken care of without too much difficulty. Infection – Antibiotics are given appropriately to minimize any risk. Infection could theoretically occur at the entrance site on the leg or on the device itself; this would be extremely rare, however. Damage to the heart structures – The heart structures are often thin and there is always a chance of causing tears in the heart linings and escape of fluid in to the sac around the heart, known as a pericardial effusion. In some cases this would require emergency surgery or at least insertion of a drain in to the sac around the heart. In experienced hands this is a rare complication. Device Embolization – The Watchman Device, if not seated properly, could theoretically come loose and essentially float freely until it became trapped in a heart structure. This would typically require cardiac surgery to retrieve the device. The good news is that with an extensive procedural checklist in place to ensure the device is stable, this complication hardly ever occurs
How soon can I resume normal daily activities?
The majority of people return to normal daily activities within a few days following the procedure. Check with your doctor before resuming your usual activities.
Can I undergo MRI or scanner testing with the WATCHMAN Implant?
MRI safety testing has shown that the WATCHMAN Left Atrial Appendage Closure Device is “MRI Conditional” and that a patient with a WATCHMAN Implant may safely undergo an MRI scan under certain conditions listed on the WATCHMAN Device Implant Card. Prior to undergoing an MRI scan, inform your doctor or MRI technologist that you have a WATCHMAN Left Atrial Appendage Closure Device, and show them the WATCHMAN Device Implant Card.
What kind of patients can benefit from the WATCHMAN procedure?
The WATCHMA is intended to prevent thrombus to escape from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with AF not caused by heart valve problems. If you are at risk of stroke, should take oral anticoagulants but are either unable or unwilling to take them because of associated risks (high risk for bleedings included), you may benefit from the WATCHMAN Left Atrial Appendage Closure Implant.
How long does a Watchman Device last?
Many Watchman Devices have been implanted over the last decade worldwide and data regarding the durability of the Watchman Implant is accumulating. Shortly after placement the body’s own lining covers the device, essentially incorporating it into the body. Essentially if correctly done, the procedure should last lifelong with regards to occlusion of the left atrial appendage.