title: Development of the subcutaneous implantable cardioverter-defibrillator for reducing sudden cardiac death.
abstract: Implantable cardioverter-defibrillators (ICDs) detect ventricular arrhythmias responsible for causing sudden cardiac arrest and then deliver a high-voltage defibrillation shock to terminate the arrhythmia and restore normal cardiac function. Conventional transveneous ICD (TV-ICD) systems require one or more leads to be implanted into the heart through the venous anatomy. While TV-ICDs are well tolerated by most patients, the invasive approach can be associated with severe complications, including systemic infection, cardiac injuries, and lead failures. An entirely subcutaneous ICD (S-ICD) system was developed as a less invasive alternative to TV-ICDs without requiring leads in or on the heart. The S-ICD system provides therapy with a left lateral pulse generator and parasternal electrode configuration that is placed under the skin outside the rib cage, resulting in a much lower risk profile. Advances in defibrillation research and far-field sensing combined to enable development of the commercial S-ICD system. An investigation device exemption (IDE) clinical investigation followed, with FDA approval in September 2012. Evaluation of the long-term performance of the S-ICD system continues, with two independent postmarket registries and a prospective randomized head-to-head trial versus the transvenous ICD.
authors.affiliation: Cardiac Rhythm Management Division, Boston Scientific Corporation, Arden Hills, Minnesota.
authors.forename: Rick
authors.initials: R
authors.lastname: Sanghera
authors.forename: Richard
authors.initials: R
authors.lastname: Sanders
authors.forename: Michael
authors.initials: M
authors.lastname: Husby
authors.forename: James G
authors.initials: JG
authors.lastname: Bentsen
mesh_terms: D002986:Clinical Trials as Topic / Q000295:instrumentation / Q000639:trends; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000639:trends*; D004867:Equipment Design / Q000295:instrumentation / Q000639:trends*; D006801:Humans; D040521:Subcutaneous Tissue; D017180:Tachycardia, Ventricular / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*
keywords: S-ICD; implantable cardioverter-defibrillator; subcutaneous implantable cardioverter-defibrillator; sudden cardiac arrest; ventricular arrhythmias; ventricular fibrillation