Additional Device Information 9529 Reveal XT Insertable Cardiac Monitor The Reveal XT Insertable Cardiac Monitor is an implantable patientactivated and automatically activated monitoring system that records subcutaneous ECG and is indicated in the following cases: patients with clinical syndromes or situations at increased risk of cardiac arrhythmias patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia What Can I Do about Atrial Fibrillation (AF)? Possible risks associated with the implant of a Reveal XT Insertable Cardiac Monitor include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin and/or sensitivity to the device material. www.medtronic.com World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals) UC201003973 EN Medtronic, Inc. 2010. Minneapolis, MN. All Rights Reserved. Printed in USA. 05/2010 Treatment with a Reveal XT Insertable Cardiac Monitor is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary. For further information, please call the Medtronic toll-free number at 1(800) 551-5544 (7:00 a.m. to 6:00 p.m., Monday-Friday, Central Time) or see the Medtronic website at www.medtronic.com.
Debbie s Story A full schedule of entertaining friends, dancing, working as a cardiac care nurse, and babysitting her grand-dog, Jake, kept Debbie fit, happy, and busy nonstop. She thought she was in perfect health. So when Debbie started experiencing an uncomfortable heart fluttering which occasionally led to her passing out, she tried to ignore it. When the episodes became more frequent and more severe, Debbie could no longer deny that something was wrong. She made an appointment with a cardiologist (heart specialist). I had several heart-related tests and some short-term heart monitors to diagnose my problem, described Debbie. But none of the tests gave an answer. Scared and frustrated, I started to wonder if I was crazy. During an especially bad episode at work, Debbie s heart fluttering progressed until she lost consciousness. Because the other tests didn t provide enough information to make a diagnosis, Debbie s heart doctor suggested she try an insertable cardiac monitor. This device continuously records the heart s rate and rhythm and would help Debbie s doctor determine the cause of her episodes. Five days after the monitor was inserted during a simple outpatient Debbie and her husband, Don, enjoy long walks in the park. procedure, Debbie felt the same uncomfortable heart sensation. When I visited my doctor after that, he downloaded what the insertable cardiac monitor recorded during that episode, exclaimed Debbie. I was so excited that it captured an abnormal heart rhythm. It wasn t in my head after all! The upper chambers (atria) of Debbie s heart were beating very fast and irregularly, causing her symptoms. Based on this diagnosis, she was referred to an electrophysiologist (EP), a doctor specializing in heart rhythm disorders. The insertable cardiac monitor helped guide the EP in his diagnosis and the best treatment plan for Debbie. The EP first prescribed medication for Debbie s condition but she could not tolerate even a low dosage. He then performed an ablation procedure in which radiofrequency energy is used to destroy the abnormal electrical pathway in the heart tissue that is causing the heart rhythm disorder. Shortly after the ablation, Debbie felt her old energy and enthusiasm returning. I m so thankful the insertable cardiac monitor helped in diagnosing my condition, acknowledged Debbie. I m looking forward to starting ballet again and a lot more walks with my husband, Don, and my grand-dog, Jake. This story reflects one person s experience. Not every person will receive the same results. Talk to your doctor about your treatment options. Patients may experience surgical complications and/or monitoring may not uncover an underlying medical condition. With a device, there are surgical limitations and lifestyle limitations, such as avoiding exposure to magnets, which may impact device performance.
What Is AF? Atrial fibrillation (AF) occurs when the upper chambers of the heart, or atria, fibrillate. This means that they beat very fast and irregularly and therefore don t pump blood effectively to the rest of the body. Atrial fibrillation may cause you to experience symptoms of weakness and fatigue or uncomfortable heart sensations like a racing or irregular heartbeat. Because the blood doesn t pump efficiently, blood in the atria may pool and clot. If a clot dislodges, it can travel to the brain and cause a stroke. The American Heart Association found that approximately 15% of strokes occur in people with atrial fibrillation. The risk of atrial fibrillation developing increases with age. If AF is not treated, it may lead to chronic fatigue and heart failure. How Do I Know if I Have AF? Some people experience these symptoms of atrial fibrillation: Heart sensations including irregular heartbeats, thumping or pounding heartbeats, a feeling the heart is racing Chest discomfort Fainting or light-headedness Fatigue, shortness of breath, or weakness Others have no symptoms and discover that they have AF at a doctor s appointment. Even without symptoms, atrial fibrillation is a serious medical condition that can lead to complications. Make an appointment with your doctor if you have symptoms of atrial fibrillation. He or she may be able to confirm or rule out AF. Normal Heartbeat ECG Atrial Fibrillation ECG A small pulse of electric current spreads quickly through the heart to make the muscle contract. In atrial fibrillation, the heart s upper chambers quiver faster than the rest of the heart.
How Is AF Diagnosed? Your doctor will very likely give you a thorough physical examination and ask you questions about your symptoms and medical history. Detecting atrial fibrillation and quantifying it can be challenging. Your doctor may use one or more of the following tests to determine if you have atrial fibrillation: Echocardiogram A wand-like device called a transducer is placed on the chest. Sound waves are bounced off the heart and produce a video image of the heart in motion. This provides a moving picture of the heart structure and its pumping ability. Electrocardiogram (ECG) This simple test records the electrical activity of the heart. Patches with wires attached are placed on a person s chest, arms, and legs. The wires are connected to a monitor, which can record abnormal findings with the heart s electrical impulses. The test usually takes just a few minutes. Event Recorder A portable device, this recorder is worn continuously on the wrist or waist from several days up to 1 month. When a person experiences a symptom, he or she can push a button and the device will record the heart s electrical activity at that time. Holter Monitor This test uses patches placed on the chest with wires that are connected to a portable monitor. It records the heart s electrical activity continuously for 1 to 2 days during normal daily activities. When a person experiences a symptom, he or she can push a button and the device will record the heart s rhythm at that time. Reveal XT Insertable Cardiac Monitor If a person s symptoms are infrequent or unpredictable, this small device can monitor heart rhythms for up to 36 months without patches or wires. The monitor is inserted under the skin in a simple outpatient procedure and records the heart s activity automatically or by using a patient activator. Results can be sent remotely to the doctor s office or reviewed during an in-office visit. Stress Test When a person exercises, the heart has to beat harder and faster to provide enough oxygen throughout the body. Some heart conditions are easier to diagnose during exercise. For a stress test, a person walks or runs on a treadmill while the heart s activity is monitored for abnormal heart rhythms.
What Are My Options if I Have AF? Treating atrial fibrillation is important since AF can cause a stroke. The American Heart Association recommends aggressive treatment for atrial fibrillation whether you feel symptoms or not. You and your doctor can discuss which treatment would be best for you and your heart condition. The Major Goals in Treating Atrial Fibrillation Are: Prevent blood clots to decrease the risk of stroke Control the heart rate to allow the ventricles enough time to completely fill Some pacemakers and ICD defibrillators to detect and treat atrial fibrillation early and suppress the onset of AF Open-heart surgery to create scar tissue to block abnormal electrical circuits causing AF Once atrial fibrillation is thought to be suppressed, care must still be taken to monitor for recurrences of AF. Even if there are no symptoms, atrial fibrillation can cause stroke. Reset the heart rhythm to allow the atria and ventricles (lower heart chambers) to work together more efficiently The Following Treatments May Be Prescribed for Atrial Fibrillation: Medication to control the heart rate or rhythm Anticoagulation or blood thinning therapy to prevent clots from forming Cardioversion to reset an abnormal heart rhythm back to normal, either through an electric shock given to the heart during anesthesia, or medication Catheter ablation to direct radiofrequency energy or freezing temperatures through a long, thin tube (catheter), inserted in an artery, to destroy abnormal electrical pathways in the heart tissue
Can I Prevent AF? Some risk factors that contribute to atrial fibrillation can be controlled or modified, like managing high blood pressure and reducing alcohol consumption. Some risk factors you cannot control, such as your advancing age and family history. Controllable Risk Factors: High cholesterol High blood pressure Heart disease Smoking Excess weight Metabolic syndrome Stress Alcohol abuse Lack of exercise Some medications Sleep apnea Thyroid disorders Where Can I Get More Information? For more information about atrial fibrillation or to read more stories of people who have had a Reveal XT Insertable Cardiac Monitor, visit www.medtronic.com or call the toll-free Medtronic patient information line: 1 (800) 551-5544. Non-Controllable Risk Factors: Family history Advancing age Heart disorders from birth Gender males have a higher incidence of AF