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St. Jude Medical An educational handbook on Atrial Fibrillation Overview Risk of Stroke Suppressive Therapies Curative Therapies Clinical Trials References Atrial Fibrillation (AF) Cause, Effect, and Treatments AF is a very fast and disorganized heartbeat that occurs in the upper chambers of the heart (the atria). During AF, the atria may beat between 350 and 600 times per minute, making the atria appear to quiver (fibrillate) rather than beat. As a result, the heart loses its ability to pump efficiently, making AF a major risk factor for stroke.1-3 What Causes AF? AF is the most common type of abnormal heart rhythm. The estimated prevalence is 0.4% to 1% in the general population, increasing with age. Studies show a lower prevalence in those below the age of 60, increasing to 8% in those older than 80.1 The prevalence and impact of AF on clinical outcomes strongly suggests the need for effective treatment options. In the following pages you will find information on AF, treatment options, and research studies (sponsored by St. Jude Medical) aimed to improve the treatment of AF. Several conditions can contribute to the development of AF, including: ■■ High blood pressure ■■ Cardiomyopathy ■■ Coronary artery disease ■■ Congenital heart disease ■■ Chronic lung disease ■■ Pulmonary embolism ■■ Heart Failure What are the effects of AF? ■■ ■■ ■■ Increase risk of stroke1-3 Dizziness Palpitations ■■ ■■ Racing heart Lack of energy What are treatment options for AF? ■■ Suppressive therapies –– Drugs –– Electrical cardioversion –– Implantable devices ■■ Curative therapies –– Surgical ablation –– Catheter ablation Overview Risk of Stroke Suppressive Therapies Curative Therapies Risk of Stroke: One in every six strokes occurs in an AF patient4 ■■ ■■ ■■ Clinical Trials References Appropriate Therapy in AF Can Reduce the Risk of Stroke AF causes the heart to lose its ability to pump efficiently which can cause blood to pool and clot in the atria. Even small blood clots can cause problems if they leave the heart and travel to other parts of the body. They may clog arteries or disrupt blood supply to vital organs. If a blood clot moves to an artery in the brain – which often occurs in cases of AF – a stroke can occur. Numerous clinical trials have provided an extensive evidence base for the use of antithrombotic therapy in AF.7 A meta-analysis of 29 trials including 28,044 participants was conducted to characterize the efficacy and safety of antithrombotic agents for stroke prevention in patients who have AF. Of these trials, 6 evaluated the effect of adjusted-dose warfarin and cumulatively showed that adjusted-dose warfarin reduced stroke by 64%.8 Studies have shown that the risk of stroke for people with AF is two to seven times greater than for those without it.4 Data that date back to the late 1970’s showed that the rate of stroke was 5.6 times greater in patients with chronic AF than those who were free of AF.5 The Goals of an AF Treatment Plan Recent data from the ASSERT trial reports that even subclinical atrial tachyarrhythmias are associated with an increased risk of stroke (p<0.001).6 These results suggest that early notification of subclinical atrial tachyarrhythmias through device alerts and monitors may allow physicians to treat patients earlier with the appropriate pharmacological therapy to reduce the risk of stroke. The treatment prescribed for an AF patient is dependent on the severity of their AF, their symptoms, and their lifestyles. Treatment options can be placed in two categories: suppressive and curative. Both treatment options aim to: ■■ Restore a normal heart rhythm ■■ Control heart rate ■■ Reduce risk of stroke Overview Risk of Stroke Suppressive Therapies Curative Therapies Clinical Trials References Suppressive Therapies Work to Control Symptoms Implantable Devices Pharmacological Therapy A device such as an implantable defibrillator or pacemaker can be used to suppress the symptoms of AF with low-dose electrical energy. Several different types of medication can be used to treat AF. Some medicines can be used to help restore and maintain a normal heart rhythm and others may be prescribed to control heart rate. Anticoagulant medicines are often prescribed for people with AF to help reduce the risk of blood clots forming and causing a stroke. The AF Suppression™ algorithm is a feature on St. Jude Medical devices that is clinically proven to reduce AT/AF burden and improve quality of life by pacing in the atrium just above the intrinsic rate.9 Furthermore, these devices have programmable AT/AF alert triggers to provide real-time insight into changes in atrial arrhythmia status. Improved lead technology (such as the OptiSense® Optim® lead) results in more accurate atrial sensing and less far-field interference.10 In addition, some devices have alerts to notify physicians that their patient is having an AF episode. This type of timely notification may provide physicians with the opportunity for early intervention. Electrical Cardioversion Occasional episodes of AF can be treated electrically with a procedure called cardioversion. During the procedure, an electrical shock is delivered to the heart to stop AF and restore a normal heart rhythm. This procedure is performed at the hospital under temporary anesthesia. Overview Risk of Stroke Suppressive Therapies Curative Therapies Clinical Trials References Curative Therapies Are Designed to Eliminate the Cause of the Condition and Have the Potential to Cure Surgical Ablation Catheter Ablation Surgical ablation may be an option for those who cannot tolerate medication or for whom these and/or other therapies have been ineffective. During the catheter ablation procedure, small wires or electrode catheters are placed through a blood vessel into the heart to record electrical activity and help locate the problem areas responsible for AF. During this procedure a physician applies energy to the outside of the heart, creating a lesion or scar that blocks abnormal electrical signals that cause AF. Patients who undergo cardiac surgery, such as a valve replacement or coronary artery bypass graft (CABG), may be advised to undergo AF ablation at the same time. After locating these areas a physician uses an ablation catheter to apply high-frequency energy to the inside of the heart, creating a lesion or scar. As a result, the tissue’s electrical pathway is isolated from the rest of the heart–making this tissue incapable of producing or sustaining AF. Potential risks of this procedure may include bleeding, swelling or bruising where the catheters were inserted, infection, damage to blood vessels, blood clots, damage of the heart’s normal electrical system, and risk related to anesthesia. Potential benefits of this minimally invasive procedure may include permanent cessation of the arrhythmia requiring no other treatment, freedom from long-term use of blood thinning medications, and a relatively fast recovery. Currently St. Jude Medical does not have surgical and catheter ablation tools that have an FDA approved indication for treatment of AF. Catheter inserted through a blood vessle in the groin Catheter inserted through a blood vessle in the arm Overview Risk of Stroke Suppressive Therapies Curative Therapies Clinical Trials References St. Jude Medical is dedicated to the development of safe and effective device-based treatment options for atrial fibrillation. Highlighted below are St. Jude Medical sponsored clinical studies that focus on AF. CABANA: Catheter Ablation versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial11 ■■ The CABANA trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating AF will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF. MAGIC-AF: Modified Stepwise Ablation Guided by Low Dose Ibutilide in Chronic Atrial Fibrillation12 ■■ The aim of the MAGIC-AF trial is to determine if administering a standard dose of the drug ibutilide at a standard time in the procedure can allow for a reduction in the ablation procedure time. STAR-AF: Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial13 ■■ The purpose of this study was to compare the following AF ablation techniques: ablation of complex fractionated electrograms (CFE) alone, pulmonary vein isolation (PVI) alone, and combined PVI and CFE (PVI +CFE). This study showed that compared to PVI and CFE alone, the combination of PVI+CFE had the highest freedom from AF in patients presenting with high-burden paroxysmal/persistent AF. IRASE AF: Irrigated Ablation System Evaluation for AF14 ■■ The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation. ASSERT: Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial15 ■■ The ASSERT study demonstrated that in device patients with no prior history of AF, subclinical atrial tachyarrhythmias are associated with an 2.49-fold increase risk of stroke or system embolism (p=0.007) and a 5.56-fold increase risk of clinical atrial fibrillation (p<0.001) Overview Risk of Stroke Suppressive Therapies Curative Therapies Clinical Trials References References 1.Fuster V, et al. 2011 ACC/AHA/HRS Focused Updates Incorporated ino the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation: A Report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice. Circulation.2011; 123: e269-e367. 2.Wolf PA, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991. 22: 83-988 3.Hohnloser SH, ASSERT Investigators and Committees, et al. Asymptomatic atrial fibrilla¬tion and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial (ASSERT). Am Heart J. 2006 Sep;152(3):442-7. 4.Fuster V, et al. 2011 ACC/AHA/HRS Focused Updates Incorporated ino the ACC/AHA/ESC 2006 Guidelines for Management of Patients with Atrial Fibrillation: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice. Circulation.2011; 123: e269-e367. 5.Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham Study. Neurology 1978; 28(10):973-7. 6.Healey JS; ASSERT Investigators, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. 7.Task force for the management of atrial fibrillation of the European Society of Cardiology. Guidelines for the management of atrial fibrillation. European Heart Journal. 2010;31:2369-2429. 8.Hart RG, et al.Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. 9.Attuel P, et al. Patients reported statistically significant improved QOL in 7 categories out of 9 in the SF-36 standard questionnaire. INOVA study. Europace Supplements. 2003; 4: B66. Abstract A42-6. 10. Tendril™ FSR Model 1699T Lead Study PMA and Final Report (IDE#G050207). 11. ClinicalTrials.gov ID # NCT00911508. 12. ClinicalTrials.gov ID # NCT01014741. 13. Verma A, et al. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR-AF): A Randomized, Multicentre, International Trial. Eur Heart J. 2010 Jun; 31(11): 1344-56. 14. ClinicalTrials.gov ID # NCT01056328. 15. Healey JS, ASSERT Investigators, et al. Subclinical Atrial Fibrillation and the Risk of Stroke. New England Journal of Medicine. 2012 Jan 12; 366:120-9. ATRIAL FIBRILLATION Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota 55117 USA +1 651 756 2000 +1 651 756 3301 Fax CARDIAC RHYTHM MANAGEMENT Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, California 91342 USA +1 818 362 6822 +1 818 364 5814 Fax CARDIOVASCULAR St. Jude Medical AB Veddestavägen 19 SE-175 84 Järfälla Sweden +46 8 474 40 00 +46 8 760 95 42 Fax NEUROMODULATION U.S. Division 6300 Bee Cave Road Building Two, Suite 100 Austin, Texas 78746 USA +1 512 732 7400 +1 512 732 2418 Fax SJMprofessional.com Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted, ® or TM indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical, Inc. or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2012 St. Jude Medical, Inc. All rights reserved. Item no. N-01120.