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HRS/ACC/AHA Expert Consensus Statement on the Use of Implantable Cardioverter-Defibrillator Therapy in Patients Who Are Not Included or Not Well Represented in Clinical Trials

      The implantable cardioverter defibrillator (ICD) has emerged as an important treatment option for selected patients who are at risk of sudden cardiac death. Randomized trials have consistently shown that ICD implantation reduces mortality in patients with heart failure and reduced left ventricular function, as well as in patients who have suffered a cardiac arrest.
      • Bardy G.H.
      • Lee K.L.
      • Mark D.B.
      • et al.
      for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators
      Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure.
      • Moss A.J.
      • Zareba W.
      • Hall W.J.
      • Klein H.
      • Wilber D.J.
      • Cannom D.S.
      • Daubert J.P.
      • Higgins S.L.
      • Brown M.W.
      • Andrews M.L.
      for the Multicenter Automatic Defibrillator Implantation Trial II Investigators
      Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction.
      Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators
      A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias.
      Recommendations on the use of the ICD in clinical practice have been provided in four important guideline documents sponsored by the American College of Cardiology (ACC), the American Heart Association (AHA), Heart Rhythm Society (HRS), and the European Society of Cardiology (ESC).
      • Yancy C.W.
      • Jessup M.
      • Bozkurt B.
      • et al.
      for the ACC/AHA Task Force Members
      2013 ACC/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
      • Epstein A.E.
      • Dimarco J.P.
      • Ellenbogen K.A.
      • Estes III, N.A.M.
      • Freedman R.A.
      • Gettes L.S.
      • Gillinov A.M.
      • Gregoratos G.
      • Hammill S.C.
      • Hayes D.L.
      • Hlatky M.A.
      • Newby L.K.
      • Page R.L.
      • Schoenfeld M.H.
      • Silka M.J.
      • Stevenson L.W.
      • Sweeney M.O.
      ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices)
      Developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons.
      • Zipes D.P.
      • Camm A.J.
      • Borggrefe M.
      • Buxton A.E.
      • Chaitman B.
      • Fromer M.
      • Gregoratos G.
      • Klein G.
      • Moss A.J.
      • Myerburg R.J.
      • Priori S.G.
      • Quinones M.A.
      • Roden D.M.
      • Silka M.J.
      • Tracy C.
      ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death—executive summary: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death)
      Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.
      • O’Gara P.T.
      • Kushner F.G.
      • Ascheim D.D.
      • Casey Jr, D.E.
      • Chung M.K.
      • de Lemos J.A.
      • Ettinger S.M.
      • Fang J.C.
      • Fesmire F.M.
      • Franklin B.A.
      • Granger C.B.
      • Krumholz H.M.
      • Linderbaum J.A.
      • Morrow D.A.
      • Newby L.K.
      • Ornato J.P.
      • Ou N.
      • Radford M.J.
      • Tamis-Holland J.E.
      • Tommaso C.L.
      • Tracy C.M.
      • Woo Y.J.
      • Zhao D.X.
      2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
      Developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions.
      For each indication for ICD therapy, both a Class of indication (I, II, or III) and level of evidence for the indication (A, B, or C) are provided. To ensure that recommendations are evidence-based, Class I recommendations are typically based on the results of prospective randomized clinical trials. For example, in the ACC/AHA/HRS 2012 Focused Update of the ACC/AHA/HRS 2008 Guidelines on Device-Based Therapy, no new recommendations on the indications for ICD therapy were made, with the important exception of ICDs that also provide cardiac resynchronization therapy (CRT-D).
      • Tracy C.M.
      • Epstein A.E.
      • Darbar D.
      • DiMarco J.P.
      • Dunbar S.B.
      • Estes 3rd, N.A.M.
      • Ferguson Jr, T.B.
      • Hammill S.C.
      • Karasik P.E.
      • Link M.S.
      • Marine J.E.
      • Schoenfeld M.H.
      • Shanker A.J.
      • Silka M.J.
      • Stevenson L.W.
      • Stevenson W.G.
      • Varosy P.D.
      2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons.
      The lack of new recommendations reflects the fact that clinical trials over this period of time have focused on studying the effectiveness of ICDs that provide CRT therapy and not on the outcomes of non-CRT defibrillators. Randomized clinical trials study the effects of a particular treatment on a carefully selected and relatively homogeneous group of patients who meet specific inclusion and exclusion criteria for a particular clinical trial. Consistent with this approach, the indications for ICD therapy developed in the various guideline statements are limited to the specific populations of patients who participated in these clinical trials. Although the resulting guidelines are of great value, clinicians are often asked to make decisions regarding ICD therapy in patient populations who were not included or who were poorly represented in prior clinical trials. For these patients, there are no specific indications for ICD therapy. The purpose of this consensus statement is to provide clinicians with guidance on the use of ICD therapy in the management of some common populations of patients who are not represented in clinical trials and who therefore are not specifically included in the various guidelines that provide indications for ICD therapy. However, recommendations made in this document cannot account for all the nuances of clinical medicine and cannot replace careful clinical judgment for the care of an individual patient.

      Keywords

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