Sudden cardiac death and congestive heart failure : diagnosis and treatment : proceedings of the Symposium on New Drugs and Devices, held at Philadelphia, PA, October 26 and 27, 1982

In Harch of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and imple­ mentors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and under­ standing would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of antiarrhythmic agents were and are currently available to treat patients with such disorders in the United States. These agents are needed not only for the treatment of patients with sustained ventricular tachyarrhythmias which produce life-threatening hemodynamic consequences but also and in fact more potentially important as a prophylactic measure in the high risk patient subject to sudden cardiac death. This book represents the proceedings of the third of these Symposiums whose purpose was to evaluate the clinical research methodology and models used in the evaluation of ne" antiarrhythmic agents for not only acute therapeutic inter­ vention but also for the prophylaxis of sudden cardiac death. In addition, new devices have evolved over the past few years that can detect and treat life-threatening cardiac arrhythmias and the evaluation of efficacy and safety of these devices is detailed. Front Matter....Pages I-XV Do Animal Models Predict Results in Man?....Pages 1-12 Application of Pharmacologic Principles in the Evaluation of New Antiarrhythmic Agents....Pages 13-30 Characterization of Antiarrhythmic Drugs....Pages 31-38 New Antiarrhythmic Agents: Basic Considerations....Pages 39-45 How should Ventricular Arrhythmias be Classified and which Patients should be Treated?....Pages 46-63 Study Design for Patients with Chronic Ventricular Ectopy: Determination Of Efficacy And Tolerance....Pages 64-73 Chronic Tolerance to Antirrhythmic Therapy 2. How to Handle Emergemcy Drug Request....Pages 74-83 Efficacy Models for Patients with Chronic Ventricular Arrhytmias....Pages 84-94 The Value of Electrophysiologic Testing in Predicting Long-Term Efficacy of Antiarrhythmic Drugs in Patients with Life-Threatening Ventricular Arrhythmias....Pages 95-102 Efficacy Models: Acute Ventricular Arrhythmias....Pages 103-104 A Look to the Future: Outpatient Placebo Controlled Trials of Antiarrhythmic Drug Efficacy in Patients with Life Threatening Ventricular Arrhythmias....Pages 105-109 Efficacy Models: Acute Ventricular Arrhytmias....Pages 110-121 Protocol Design for Sudden Death Prevention....Pages 122-129 Do Beta Blockers Prevent Sudden Cardiac Death?....Pages 130-139 Does Non Beta-Blocking Antiarrhythmic Therapy Prevent Sudden Cardiac Death?....Pages 140-154 Current Problems in the Evaluation and Approval of New Antiarrhythmic Agents....Pages 155-163 Sudden Death: Can it Now be Used as an Endpoint?....Pages 164-182 New Devices: Pacemakers in the Treatment of Arrhythmias and Prevention of Sudden Cardiac Death....Pages 183-184 Transvenous Cardioversion to Treat Tachyarrhythmias....Pages 185-198 The Role of Permanently Implanted Pacemakers in the Therapy of Recurrent Tachyarrhythmias....Pages 199-209 Clinical Evalutaion of an Implantable Automatic Cardioverter Defibrillator....Pages 210-220 Evaluation of Devices for the Prevention of Sudden Death: Study Design for Safety and Efficacy of the Devices....Pages 221-226 New Device Approval by the Food and Drug Administration....Pages 227-235 New Devices: Pacemakers in the Treatment of Arrhythmias and Prevention of Sudden Cardiac Death....Pages 236-249 Pharmacologic Principles in the Use of New Inotropic Agents....Pages 250-255 The Clinical Assessment of a Inotropic Drugs....Pages 256-269 New Cardiac Inotropic Agents....Pages 270-281 Remarks....Pages 282-291 Back Matter....Pages 292-302 In March of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and implementors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and understanding would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of antiarrhythmic agents were and are currently available to treat patients with such disorders in the United States. These agents are needed not only for the treatment of patients with sustained ventricular tachyarrhythmias which produce life-threatening hemodynamic consequences but also and in fact more potentially important as a prophylactic measure in the high risk patient subject to sudden cardiac death. This book represents the proceedings of the third of these Symposiums whose purpose was to evaluate the clinical research methodology and models used in the evaluation of ne" antiarrhythmic agents for not only acute therapeutic intervention but also for the prophylaxis of sudden cardiac death. In addition, new devices have evolved over the past few years that can detect and treat life-threatening cardiac arrhythmias and the evaluation of efficacy and safety of these devices is detailed