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Electrophysiology

Heart failure management

Learn more about therapy options to treat heart failure patients.

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Brief Statement: Medtronic IPGs
Brief Statement: CRT IPGs and CRT ICDs
Brief Statement: ICDs

Implantable Pulse Generators (IPG) ISW

Brief statement: Medtronic IPG

Indications

Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity and increases in activity. Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. See device manuals for the accepted patient conditions warranting chronic cardiac pacing. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in patients with one or more of the above pacing indications.

MRI SureScan IPGs: A complete SureScan pacing system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads.

Contraindications

IPGs are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator. There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient's age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. Antitachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway. Medtronic Kappa^™ 400 Series pacemakers are contraindicated for use with epicardial leads and with abdominal implantation.

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.

MRI SureScan IPGs only: No lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region. For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. Patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on must have no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms. It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks). Pace polarity parameters are set to Bipolar for programming MRI SureScan to On (Advisa MRI only); or a SureScan pacing system is implanted with a lead impedance value of ≥ 200 Ω and ≤ 1500 Ω. Revo MRI patients must have pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms and a SureScan pacing system that has been implanted for a minimum of 6 weeks.

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 arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

MRI SureScan IPGs: SureScan pacing systems have been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. See the appropriate product MRI SureScan Technical Manual before performing an MRI Scan. For further information, please call Medtronic at 1-800-328-2518 and/or consult www.medtronic.com or www.mrisurescan.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

MAJ_84705

Implantable Cardioverter Defibrillators ISW

Brief statement: Medtronic ICD

Indications

Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Some ICDs are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.

MRI Conditions for Use

Medtronic SureScan ICD systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Patients with MRI SureScan ICDs may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When SureScan systems are programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. When a single coil SureScan defibrillation lead is used, a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan DF-1 defibrillation system. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.

Contraindications

ICDs are contraindicated in patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.

Warnings and precautions

Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history and the system must be implanted in the left or right pectoral region.

Potential adverse events

Potential adverse events include, but are not limited to, body rejection phenomena, device migration, erosion through the skin, muscle and/or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional complication for ICDs is the acceleration of ventricular tachycardia. Potential MRI complications for the SureScan system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MRI induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan is programmed to On; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer. See the MRI SureScan Technical Manual before performing an MRI Scan.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or http://www.mrisurescan.com/.

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician.

MAJ_84705

Personalized care for heart failure patients

Our unique cardiac resynchronization therapy (CRT) portfolio of devices provides personalized patient care. Medtronic CRT-D and CRT-P devices include a variety of comprehensive features, exclusive algorithms, and implant solutions designed to treat your heart failure patients.

CRT systems

Medtronic is focused on innovative options to help your heart failure patients feel better with our advanced therapies and monitoring solutions.^1–9

More about CRT systems

Managing your patients

Our advanced therapies, monitoring solutions, and management services are designed to help you help your heart failure patients feel better, while improving the efficiency and effectiveness of heart failure care.^1–9

More about managing patients

Reduce complications

Reducing procedure-related complications is now more important than ever. Learn about the TYRX™ absorbable antibacterial envelope, an innovative solution aimed to improve procedure-related outcomes.¹⁰

More about TYRX™

Resources

Products

Gold MR, et al. Reduced 30-day hospital readmissions in systolic heart failure patients with cardiac resynchronization therapy: Evidence from 5 randomized controlled trials. Poster presented: AHA; November 16, 2014.
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005;352(15):1539–1549. doi: 10.1056/NEJMoa050496.
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure (the CArdiac REsynchronization-Heart Failure [CARE-HF] trial extension phase). Eur Heart J. 2006;27(16):1928–1932. doi: 10.1093/eurheartj/ehl099.
Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350(21):2140–2150. doi: 10.1056/NEJMoa032423.
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002;346(24):1845–1853. doi: 10.1056/NEJMoa013168.
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003;289(20):2685–2694. doi: 10.1001/jama.289.20.2685.
Linde C, Abraham WT, Gold MR, et al. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll. Cardiol. 2008;52(23):1834–1843. doi: 10.1016/j.jacc.2008.08.027.
Tang AS, Wells GA, Talajic M, et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010;363(25):2385–2395. doi: 10.1056/NEJMoa1009540.
Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329–1338. doi: 10.1056/NEJMoa0906431.
Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med. 2019;380(20):1895–1905. doi: 10.1056/NEJMoa1901111.

Heart failure management

Implantable Pulse Generators (IPG) ISW

Brief statement: Medtronic IPG

Implantable Cardioverter Defibrillators ISW

Brief statement: Medtronic ICD

Personalized care for heart failure patients

CRT systems

Managing your patients

Reduce complications

Resources

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