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Backgrounder

Ansprechpartner Presse:
Kathleen Janasz, Public Relations, 763-526-3676
Tracy McNulty, Public Relations, 763-526-2492
Joey Lomicky, Public Relations, 763-526-2494

Implantable Cardioverter-Defibrillator (ICD) Backgrounder


Implantable Cardioverter-Defibrillators (ICDs)

Overview
Implantable cardioverter-defibrillators (ICDs) have been saving lives for nearly 30 years by delivering a lifesaving shock or painless pacing to stop life-threatening fast or irregular heartbeats.

  • Irregular heartbeats, also known as ventricular arrhythmias, can lead to sudden cardiac death, a condition that kills approximately 295,000 people each year in the United States.1
  • An estimated 650,000 Americans and nearly 1 million patients worldwide have an ICD or cardiac resynchronization therapy-defibrillator (CRT-D) to protect against dangerously erratic heartbeats.2

What Defibrillators Do

  • ICDs administer electrical shocks or painless pacing therapy to stop ventricular fibrillation (VF) – a lethal condition in which the heart quivers chaotically and pumps little or no blood.
  • ICDs also stop ventricular tachycardia (VT), and other less problematic arrhythmias.
  • ICDs collect information physicians can use to program the device to the exact needs of the patient.

Effectiveness

  • ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.3,4
  • Medtronic estimates more than 70,000 lives have been saved by implantable defibrillators over the past five years. 5

Implantation and Testing

  • Implantation of an ICD takes only about one hour, and sometimes can be done on an outpatient basis.
  • Implantation is minimally invasive surgery. A physician injects local anesthesia and makes an incision about four inches long in the upper chest. The ICD is inserted and the leads are maneuvered through a vein into the heart.
  • The physician programs the ICD and tests it before closing the incision.

Modern ICDs Are Highly Sophisticated

  • They are designed to ensure that impulses are delivered only when needed.
  • Today’s devices often deliver pain-free rhythm-regulating therapy without the patient being aware of it.

Who Might Benefit from an ICD?6

  • People who have intermittent ventricular tachycardia (VT), in which the heart beats suddenly and speeds up to dangerous levels without warning.
  • People who have survived an episode of sudden cardiac arrest.
  • People who have survived a myocardial infarction (heart attack) and have impaired pumping function in the lower chambers (ventricles).

How Long Do ICDs last?

  • ICDs will effectively guard against sudden cardiac arrest for up to approximately seven years, depending on the model of the device and the individual patient use.

1American Heart Association. Heart Disease and Stroke Statistics–2010 Update. Circulation. Available at http://www.americanheart.org/presenter.jhtml?identifier=3000090.

2 Medtronic data on file. 2010.

3 Zipes, DP, Roberts, D. for the Pacemaker-Cardioverter-Defibrillator investigators. Results of the International Study of the Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59-65.

4 Volosin et. al. “Virtual ICD: A Model to Evaluate Shock Reduction Strategies.” Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-125).

5 Medtronic data on file. 2010.

6 Epstein, A, DiMarco, J, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities. j.hrthm. June 2008: 5 (6): e1-e62.

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 life-threatening 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.

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