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A pacemaker is a small, low-voltage, battery-powered, implantable device that monitors and sends electrical pulses to the heart. When it senses an arrhythmia or lack of heartbeat, it sends an electrical impulse to your heart to establish a normal rhythm. A pacemaker also stores important information about your heart rhythms and rates that your doctor can use to ensure you receive the best possible treatments and therapies. Some pacemakers also treat heart failure by resynchronizing electrical impulses in the heart’s four chambers, improving the heart’s ability to pump blood to the body effectively and efficiently.
A healthy heart has a natural pacemaker called the sinus node that is one of the principal elements of the cardiac conduction system, which controls the heart rate. It generates electrical impulses which move throughout the heart muscle and stimulate the heart to contract and pump blood. If you have been diagnosed with an arrhythmia (irregular heartbeat), bradycardia (slow heartbeat), or heart failure, your doctor may have decided a pacemaker is right for you.
Pacing is the process in which regulating or changing the timing or intensity of your heartbeat, or cardiac contractions, are made. Depending on your symptoms and the specific heart condition, your doctor may prescribe a different type of pacemaker.
Pacemakers can be classified in two ways -
Based on its design:
Or based on its pacing characteristics:
A traditional pacemaker is implanted under the skin in the chest area and connected to leads that attach to the heart wall.
A leadless pacemaker is implanted in your heart through a blood vessel in your leg. This type of pacemaker is smaller than the volume of a AAA battery and does not require leads.
A traditional pacemaker is a pacing system with two parts. A pulse generator is implanted under the skin, most commonly in the chest. Leads, the second part of the system, act as an information highway. Leads are implanted with the pulse generator to carry electrical impulses from the pulse generator to the heart, and then relay information about the heart’s natural activity back to the pulse generator.
After your implant and during checkups your doctor will use a programmer. A programmer is a specially-designed computer made to communicate with your pulse generator or leadless device. It is an important tool for adjusting and customizing your pacemaker to your needs.
Unlike traditional pacemakers, leadless pacemakers (LP) reside entirely in the heart. That means there are no leads, no chest incisions and no permanent pocket under the skin.
A catheter that contains the LP is passed through a small incision in the groin and threaded into the heart using a minimally invasive procedure where the LP is then secured into the interior wall muscle of your heart
After your implant and during checkups your doctor will use a programmer. A programmer is a specially-designed computer made to communicate with your pulse generator or leadless device. It is an important tool for adjusting and customizing your pacemaker to your needs.
Traditional Pacemaker Heart Placement
Leadless Pacemaker Heart Placement
Young, vibrant, active – and living her best life with Abbott’s Aveir™ VR Leadless Pacemaker. Chelsey needed a pacemaker, and Aveir VR’s leadless pacemaker design was the ideal solution for her active lifestyle.
With no wires and no arm restrictions, Aveir VR leadless pacemaker got her back to the gym and back to life - it’s her safety net. “It catches me when I need it.”
During the implant procedure, you are either given a general anesthetic or conscious sedation. Conscious sedation is a combination of medicines to help you relax (a sedative) and to block pain (an anesthetic). If you receive conscious sedation, you may be able to hear and even talk with the medical team during the procedure, and team members may have instructions for you.
You may feel some pressure while the team implants your device, but you should not feel any pain. The duration of the procedure depends on the kind of device you are receiving as well as your specific anatomy. This means the physician needs time to locate good positioning of the system. Implanting a pacemaker can take several hours.
Immediately after your procedure, you will be moved to recovery for observation. You may feel discomfort and most likely will be tired. You may stay in the hospital for several hours up to several days. Your physician will estimate the time needed to stay in the hospital, depending on your individual needs.
Your doctor will let you know when you can resume normal activity. You may have to adjust your overall pattern of activity and be aware of new things around you that you may not have paid attention to before. However, your symptoms should improve. There will be follow-up appointments after your surgery and check-ups throughout the year.
Some pacemakers use wireless remote monitoring and others require a wand or skin electrodes for communication.
Remote monitoring is a way for your pacemaker to communicate information about your heart’s activity directly to your doctor’s office or clinic. It works for you any time of the day and on any day of the week. It is a way for your pacemaker to communicate with your doctor without you having to see your doctor in person. It may reduce your number of hospital or clinic visits and make sure your doctor has the information they need about your heart.
Remote monitoring works via the Merlin@home™ transmitter. This transmitter syncs with your pacemaker and collects data about your heart’s activity. This data is shared with your doctor’s office and monitors activity such as heart rate and rhythm, as well as information about the device itself.
Find answers to your questions about both traditional and leadless pacemakers, including the implantation procedure, safety and use, and daily living with your device.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications:
The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:
• Normal sinus rhythm with rare episodes of A-V block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P system with pacing leads is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation. Implantation of a CRT-P is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure; the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ¢35% and a prolonged QRS duration. Implantation of a leadless pacemaker system is indicated for patients with significant bradycardia and normal sinus rhythm with rare episodes of A-V block or sinus arrest; chronic atrial fibrillation; severe physical disability. Rate-Modulated Pacing is indicated for people with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those people exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for people with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for people with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in people with one or more of the above pacing indications.
Leadless Pacemaker System Intended Use: Leadless pacemakers (LP) are designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population. The delivery catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
MRI Safety Information: MR Conditional pacemakers and CRT-Ps are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to the instructions in the MRI-Ready Systems Manual. Scanning under different conditions may result in severe patient injury or death or device malfunction.
Contraindications: Single-chamber pulse generators, dual-chamber pulse generators, and CRT-Ps are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-adaptive pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression™ algorithm (dual-chamber pulse generators, CRT-Ps) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-chamber pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-chamber atrial pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help.
Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism; device embolism; body rejection phenomena; cardiac tamponade or perforation; hematoma, excessive bleeding hematoma, seroma; formation of fibrotic tissue, local tissue reaction; inability to interrogate or program due to programmer or device malfunction; infection; erosion; interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic; lead malfunction due to conductor fracture or insulation degradation; loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface or due to embolization or fibrotic tissue response at the LP electrode; loss of desired pacing and/or sensing due to lead displacement or dislodgement or mechanical malfunction of the LP (non-battery related), body reaction at electrode interface, or lead malfunction (fracture or damage to insulation); loss of normal device function due to battery failure or component malfunction; pacemaker migration or pocket erosion; pectoral muscle or diaphragmatic stimulation; phrenic nerve stimulation; pneumothorax/hemothorax; device migration and pocket erosion; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; cardiac/coronary sinus dissection (CRT-Ps only); cardiac/coronary sinus perforation (CRT-Ps only); coronary sinus or cardiac vein thrombosis (CRT-Ps only); inability to interrogate or program due to programmer or pacemaker malfunction; increased capture threshold; thrombosis; death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: thromboembolism; air embolism; local and systemic infection; arterial puncture; bleeding or hematoma at puncture site; perforation (femoral vein or other structures); thrombus formation; embolization of the LP; venous dissection (femoral vein or other structures).
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
MAT-2105184 v5.0
