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BACKGROUNDER Cardiac Resynchronization Therapy Overview Cardiac resynchronization therapy (CRT) is a treatment for heart failure that uses an implantable device to improve the pumping efficiency of the heart. In healthy people, the four chambers of the heart contract in synchrony to move blood through the body (people experience this as their heartbeat). However, for many patients with heart failure, the electrical impulses that coordinate the contractions of the heart’s chambers may be impaired. As a result, in up to 30 percent of people who have advanced heart failure – or 10 percent of all people with heart failure – the two lower chambers (ventricles) no longer contract at the same time. This may worsen the symptoms of the disease, which include shortness of breath, fatigue, and swelling of the feet and ankles. In cardiac resynchronization therapy, a stopwatch-sized device is implanted in the upper chest in an attempt to resynchronize the contractions of the ventricles by sending tiny electrical impulses to the heart muscle. Resynchronizing the contractions of the ventricles can help the heart pump blood throughout the body more efficiently and reduce the symptoms. Cardiac resynchronization therapy, also known as biventricular pacing, is intended to complement standard drug treatment, and dietary and lifestyle modifications. Exclusive Features and Technology Medtronic’s latest cardiac resynchronization therapy-defibrillator (CRT-D) devices are part of the Protecta™ portfolio and offer SmartShock™ Technology, a Medtronic exclusive feature that distinguishes between life threatening and non-life threatening arrhythmias and electrical noise within the device system in order to reduce inappropriate shocks. Findings from the Virtual ICD study, based on a statistical model, shows that 98 percent of patients with SmartShock Technology will be free of inappropriate shocks one year after implant and 92 percent will be free of inappropriate shock five years after implant.1 Within the Protecta family of devices, Protecta XT devices feature OptiVol® 2.0 Fluid Status Monitoring, a Medtronic-exclusive feature that measures changes in fluid buildup in heart failure patients to predict worsening heart failure.2 Featuring Medtronic’s proprietary Conexus® Wireless Telemetry, device information is automatically and wirelessly transmitted through a patient’s home monitor to a secure Web site in the physician’s office via the Medtronic CareLink® Network, the industry’s largest remote monitoring network. If the system detects notable changes in the patient’s condition or device status, a notification will be sent to the physician, allowing the physician to make treatment decisions before the condition worsens. CRT System Implantation A specially trained electrophysiologists, cardiologist or cardiovascular surgeon implants the CRT system. The devices are implanted under the skin in the chest area. Three very thin insulated wires (leads), with tiny electrodes on their distal ends, are maneuvered through veins from the device to the heart: One lead is placed to touch the inner wall of the right atrium; another to touch the inner wall of the right ventricle; and the third lead is threaded through the coronary sinus and placed to touch the outer wall of the left ventricle. The implantation procedure is typically done with local anesthesia, so the patient remains conscious. Because of the need to implant the third lead to pace the left ventricle, the procedure takes longer than a regular pacemaker implant. The typical procedure time is between two-tothree hours and patients usually stay in the hospital overnight. Therapy Benefits For patients with heart failure who have electrical conduction problems of the heart, CRT improves the flow of blood from the heart and throughout the body, which may result in fewer symptoms, reduced hospitalizations and reduced mortality.3 About Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world. CONTACT: Wendy Dougherty (763) 526-2853 [email protected] Brief Statement Medtronic ICDs and CRT-ICDs Medtronic Implantable Cardioverter Defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Medtronic Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of lifethreatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration. Contraindications Medtronic ICDs and CRT-ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, or patients who have a unipolar pacemaker. Medtronic ICDs are also contraindicated for patients whose primary disorder is bradyarrhythmia. Warnings and Precautions Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization. Potential Complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Volosin et. al. “Virtual ICD: A Model to Evaluate Shock Reduction Strategies.” Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-125). 2 Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Superior Performance of Intrathoracic Impedance-Derived fluid Index versus Daily Weight monitoring in Heart Failure Patients: Results of the Fluid Accumulation Status Trial (FAST) J Card Fail. Nov. 2009 Vol. 15(9): 813. 3 Anand, I, Carson, P, et al. Cardiac Resynchronization Therapy Reduces the Risk of Hospitalizations in Patients With Advanced Heart Failure. Results From the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) Trial. Circulation. Feb. 9, 2009. Published online. 1 ###