New Societal Guidelines Recommend Subcutaneous Implantable Cardioverter-Defibrillator for Patients with Ventricular Arrhythmias at Risk of Sudden Cardiac Death

Updated guidelines issued by the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) now formally recommend the use of a subcutaneous implantable cardioverter-defibrillator (S-ICD) for the treatment of patients with ventricular arrhythmias and the prevention of sudden cardiac death.¹ The Boston Scientific EMBLEM™ MRI S-ICD System is the only S-ICD on the market, and the only implantable defibrillator available that provides protection for patients at risk of sudden cardiac death without touching the heart.

Co-published in Circulation, the Journal of the American College of Cardiology (JACC) and the Heart Rhythm Journal (HRJ), the "2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" supports the use of an S-ICD device with a Class IIa recommendation for all patients who meet the criteria for an implantable cardioverter-defibrillator (ICD) without a need for pacing. The guidelines also strongly recommend the use of an S-ICD device as the standard of care with a Class I recommendation for the subset of these patients who have inadequate vascular access or are at high risk for infection, including those with diabetes mellitus.

Patients at high risk for infection often have limited venous access which can result in a prolonged or failed implantation of a transvenous ICD (TV-ICD). Per a recent analysis of more than 6,400 patients, those implanted with TV-ICD were at an eight-fold higher rate of lead complications than patients who received an S-ICD device.²

"The addition of the S-ICD System to these clinical guidelines reinforces the value this device can bring to a broad ICD-indicated patient population, through avoidance of transvenous lead-specific complications," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. "The clinical significance of the updated guidelines provides a call to action for physicians to include the S-ICD System in shared decision making with their ICD-indicated patients."

Earlier this year, the HRS recommended private health insurance companies update any limited or unavailable coverage to ensure all patients with appropriate clinical rationale have access to therapy with the S-ICD device. Positive coverage policies for the S-ICD System have been established by the Centers for Medicare and Medicaid Services and private payers representing more than 90% of insured individuals in the U.S.

The S-ICD System is included in the European Society of Cardiology guidelines, published in 2015, for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.

For more information on the EMBLEM MRI S-ICD System, visit www.bostonscientific.com/sicd.    

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¹ Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL, 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death, Heart Rhythm. 2017. doi: 10.1016/j.hrthm.2017.10.036.

² Indranill Basu-Ray, et al. "Subcutaneous Versus Transvenous Implantable Defibrillator Therapy." JACC: Clinical Electrophysiology. Sep 2017, 496; DOI: 10.1016/j.jacep.2017.07.017