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Atrial Fibrillation (AFib) and Stroke

In Atrial Fibrillation (AFib), the top chambers of the heart quiver or flutter. This can cause blood to pool in the heart and form clots. When clots travel to the brain, they can cause a stroke. Most clots that lead to stroke are formed in an area of the heart called the left atrial appendage.1

AFIB TREATMENT OPTIONS TO REDUCE STROKE RISK

Medical Management

Anticoagulant medications help treat AFib by thinning the blood to reduce the risk of a clot forming. However, many people are not able take blood thinners due to:2

Increased risk of bleeding

Unpleasant side effects

Cost

The need for constant blood testing

Other medical conditions

Increased risk of bleeding

Unpleasant side effects

Cost

The need for constant blood testing

Other medical conditions

Catheter Ablation

Cardiac ablation is a procedure in which your doctor will access your heart through a blood vessel. A catheter (a long, steerable tube) will enter the vessel and be placed in your heart where diagnostic devices will be used to determine the area of the heart that needs to be treated. The doctor will use the catheter to apply energy to the targeted heart tissue. This will isolate the area from the rest of the heart and prevent it from producing AFib.
 

Left Atrial Appendage Occlusion

with the Amplatzer™ Amulet™ LAA Occluder is an atrial fibrillation treatment that completely closes the left atrial appendage (LAA) and immediately eliminates the need for blood thinners. The Amplatzer™ Amulet™ occluder: 

  • Permanently closes off a small area of the heart where clots are known to form.
  • Prevents clots formed in the appendage from escaping into the body.
  • Allows people to stop taking blood thinners (anticoagulants) immediately.
Amplatzer Amulet LAA Occluder is an atrial fibrillation treatment that completely closes the left atrial appendage

 

FACT: Amplatzer™ Amulet™ is the only device of its kind that offers immediate freedom from blood thinners. Learn more about closure of the left atrial appendage and how it works to reduce stroke risk.

DOWNLOAD THE GUIDE

If you have atrial fibrillation and are considering an alternative to long-term or life-long anticoagulants (blood thinners), your doctor may recommend the Amplatzer™ Amulet™ device to reduce your risk of stroke. The procedure to get an Amulet™ device is minimally invasive. Here’s what you should know:

  • The procedure is not open-heart surgery 
  • The procedure takes 1 to 2 hours
  • Most patients are out of the hospital within 24 hours
  • This type of procedure has been done for many years 
  • Physicians who place the Amulet™ have extensive training and experience 
Closure of the left atrial appendage with the Amplatzer™ Amulet™ LAAO

WATCH HOW THE AMPLATZER AMULET
DEVICE WORKS TO
REDUCE STROKE RISK

Closure of the left atrial appendage with the Amplatzer™ Amulet™ LAAO is demonstrated in this short video.

MAT-2114211 v2.0 | Item approved for U.S. use only.

References
  1. Onalan, O., & Crystal, E. (2007). Left atrial appendage exclusion for stroke prevention in patients with nonrheumatic atrial fibrillation. Stroke, 38(2), 624-630. 
  2. Levi, M., Hobbs, F. R., Jacobson, A. K., Pisters, R., Prisco, D., Bernardo, A., ... & Wuillemin, W. A. (2009, September). Improving antithrombotic management in patients with atrial fibrillation: current status and perspectives. In Seminars in thrombosis and hemostasis (Vol. 35, No. 6, p. 527).
Important Safety Information

AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER
INDICATION FOR USE

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

CONTRAINDICATIONS

The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

  • with the presence of intracardiac thrombus,
  • with active endocarditis or other infections producing bacteremia.
  • where placement of the device would interfere with any intracardiac or intravascular structures.

WARNINGS

  •  If the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
  • Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
  • Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.
  • The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • Do not use this device if the sterile package is open or damaged.
  • The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use on or before the expiration date that is printed on the product packaging label.

PRECAUTIONS

  • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
  • The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
  • The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
  • Ensure that the vasculature is adequate for the sheath size being selected.
  • The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
  • Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
  • Use in specific populations
    • Pregnancy – Minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

MRI SAFETY INFORMATION 

Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

  • Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
  • Maximum spatial gradient field of 19 T/m (1900 G/cm)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

  • Air embolism
  • Airway trauma
  • Allergic reaction
  • Anemia
  • Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
  • Arrhythmia
  • Atrial septal defect
  • Bleeding
  • Cardiac arrest
  • Cardiac tamponade
  • Chest pain/discomfort
  • Congestive heart failure
  • Death
  • Device embolization
  • Device erosion
  • Device malfunction
  • Device malposition
  • Device migration
  • Device-related thrombus
  • Fever
  • Hematuria
  • Hypertension/hypotension
  • Infection
  • Multi-organ failure
  • Myocardial infarction
  • Perforation
  • Pericardial effusion
  • Pleural effusion
  • Renal failure/dysfunction
  • Respiratory failure
  • Seizure
  • Significant residual flow
  • Stroke
  • Thrombocytopenia
  • Thromboembolism: peripheral and pulmonary
  • Thrombus formation 
  • Transient ischemic attack 
  • Valvular regurgitation/insufficiency
  • Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
  • Vessel trauma/injury
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