Authors' recommendations: Sudden cardiac death (SCD) can result from ventricular tachyarrhythmia, which includes ventricular tachycardia (VT), ventricular fibrillation, and infrequently, torsade de pointes, a form of VT. These are rapid and/or irregular heart rates due to interruption of normal electrical impulses that regulate heartbeat originating in the heart ventricles that can cause inadequate blood pumping. Description of Technology: The Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System (Boston Scientific Corp.) differs from a transvenous implantable cardioverter defibrillator (TV-ICD) device because its leads are placed subcutaneously, rather than transvenously. The S-ICD System electrode is inserted under the skin and implanted outside of the rib cage in a left lateral position at the sixth rib between the mid and anterior axillary lines, with the leads inserted through 2 parasternal incisions parallel to it and 1 to 2 centimeters to the left of the sternal midline. The S-ICD System provides cardioversion and short-term postshock backup pacing, but does not provide pacemaking for bradycardia, cardiac resynchronization therapy (CRT), or continuous antitachycardia pacing (ATP). Patient Population: The S-ICD System is intended to provide defibrillation therapy in the event of life-threatening ventricular tachyarrhythmia episodes. S-ICD poses potential advantages for patients in whom transvenous lead placement is difficult due to vascular access challenges, patients with high risk of bacteremia, patients who are immunocompromised, patients who have had a previous TV-ICD removed for infection, and in younger patients who could have lifelong complications from TV-ICD. S-ICD devices are contraindicated in patients with any of the following: symptomatic bradycardia; incessant VT; spontaneous, frequently recurring VT that is reliably terminated with ATP. In addition, S-ICD does not provide ongoing CRT and thus is not appropriate for patients who need CRT. S-ICD does not have a continuous pacemaking option and therefore cannot treat patients who require continuous ATP. Accurate prediction of which patients will have potentially life-threatening arrhythmia will be important for optimal patient selection. Clinical Alternatives: Alternatives to S-ICD include: TV-ICDs; nonwearable or wearable automatic external (nonimplanted) cardioverter defibrillators; pharmacological treatment with antiarrhythmic drugs or neurohormonal agents; electrical ablation of the portion of the heart generating abnormal signals; cardiac surgery, such as coronary artery bypass grafting, excision of VT foci or left ventricular aneurysms, aortic valve replacement, or heart transplant; or some combination of these alternatives.

Project Status: Completed

Year Published: 2017

URL for published report: The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=16005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: Winifred S. Hayes, Inc