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PROCEDURES HEART FAILURE DEVICE IMPLANT What is a heart failure device (CRT device)? A heart failure device, also called a CRT device, treats certain types of heart failure. When the heart's lower chambers (ventricles) pump or contract in an uncoordinated way, it is called dyssynchrony. The CRT device treats dyssynchrony. CRT stands for cardiac resynchronization therapy. It gets its name because the device helps “resynchronize,” or re-coordinate, the pumping of the ventricles. A device implant is a procedure that uses local numbing. General anesthesia usually is not needed. There are two types of CRT devices: • A CRT-P device is a special kind of pacemaker. A regular pacemaker sends tiny amounts of energy to one side of the heart. This electrical treatment is called pacing therapy. A CRT device delivers pacing to both ventricles—both sides of the heart. This is why the CRT-P device is sometimes called a biventricular pacemaker. • A CRT-D device offers the same type of pacing therapy described as a CRTP device. But it also has a built-in implantable cardioverter defibrillator (ICD). In the CRT-D device, the ICD can treat dangerously fast abnormal heart rhythms (arrhythmias). Fast arrhythmias, like ventricular tachycardia (VT) or ventricular fibrillation (VF), put people at risk of sudden cardiac arrest (SCA). If not treated immediately with defibrillation, SCA can result in sudden cardiac death (SCD). And in people with heart failure, SCD occurs at 6-9 times the rate of the general population. Many people benefit from a CRT device because it helps relieve symptoms of heart failure. However, the device is not effective for everyone with heart failure. An implanted device needs to be checked regularly to review information that is Heart Failure Device Implant HEARTISTRY brought to you by Boston Scientific Corporation Page 1 of 3 stored in the device and to monitor settings. These checks can happen in the clinic or from the comfort of the patient’s home using remote monitoring. Remote monitoring uses a small piece of equipment that can sit on a bedside table to collect data from the cardiac device. Data is collected on a daily or weekly basis depending upon how the system is programmed and the type of device implanted. It sends information through a a standard analog phone line to a secure website that only the patient’s healthcare support team can access. In many cases, remote monitoring means that the patient needs to make fewer trips to the doctor's office for device follow-up visits. Not all devices can be checked using remote monitoring. How is the implant procedure done? A CRT-P or CRT-D system has two parts. Device—the device is quite small and easily fits in the palm of your hand. It contains small computerized parts that run on a battery. Leads—the leads are thin, insulated wires that connect the device to your heart. The leads carry electrical signals back and forth between your heart and your device. Your doctor inserts the leads through a small incision, usually near your collarbone. Your doctor gently steers the leads through your blood vessels and into your heart. Your doctor can see where the leads are going by watching a video screen with real-time, moving x-rays called fluoroscopy. The doctor connects the leads to the device and tests to make sure both work together to deliver treatment. Your doctor then places the device just under the skin near your collarbone and stitches the incision closed. What can I expect? Usually you are told not to eat or drink anything for a number of hours before the procedure. You undress and put on a hospital gown or sheet. Your procedure will be performed in a ”cath lab." You lie on an exam table and an intravenous (IV) line is put into your arm. The IV delivers fluids and medications during the procedure. The medication makes you groggy, but not unconscious. The doctor makes a small incision near your collarbone to insert the leads. The area will be numbed so you shouldn't feel pain, but you may feel some pressure as the leads are inserted. If you have a CRT-D device implant, you may be sedated when the device is tested, since it delivers a shock to your heart. Most people do not need to be sedated if they have a CRT-P device implanted. You may be in the hospital overnight, and there may be tenderness at the incision site. Most people have a fairly quick recovery. Heart Failure Device Implant HEARTISTRY brought to you by Boston Scientific Corporation Page 2 of 3 Important Safety Information Medications, procedures and tests can have some risks and possible side effects. Results may vary from patient to patient. This information is not meant to replace advice from your doctor. Be sure to talk to your doctor about these risks and possible side effects. Cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) are used to treat heart failure patients who have symptoms despite the best available drug therapy. These patients also have an electrical condition in which the lower chambers of the heart contract in an uncoordinated way and a mechanical condition in which the heart pumps less blood than normal. CRT-Ps and CRT-Ds are not for everyone including people with separate implantable cardioverter-defibrillators (CRT-P only) or certain steroid allergies. Procedure risks include infection, tissue damage, and kidney failure. In some cases, the device may be unable to respond to your heart rhythm (CRT-P only) or may be unable to respond to irregular heartbeats or may deliver inappropriate shocks (CRT-D only). In rare cases severe complications or device failure can occur. Electrical or magnetic fields can affect the device. Only your doctor knows what is right for you. Boston Scientific is a trademark and HEARTISTRY is a service mark of Boston Scientific Corporation. Heart Failure Device Implant HEARTISTRY brought to you by Boston Scientific Corporation Page 3 of 3