ICD植入适应证指南及大型临床试验介绍.ppt

SBP：收缩压 ？心肌酶谱：可提示VT/VF是否可逆 第二点可提示：没有再发； 血电解质： 所有晕厥都是脑供血不足引起；多数为血管迷走性。心脏原因引起的相对少。 25 28 EP指导治疗：EP诱发后推抗心律失常药观察效果 21 22 非缺血性心肌病： The primary endpoint of the trial is overall survival. The trial has a power to detect a 25% change in mortality. In addition to looking at survival in total the trial will assess the survival in a number of sub segments of the trial population. Although these are very interesting questions there are limitations since the trial is not designed to specifically test these questions. The subsegments include: ischemic, non-ischemic, New York Heart Class II and III The analysis will also look at the consistency of effect across age, gender, race, EF, QRS width and others In addition to examining overall survival the trial will examine cause specific survival, HF morbidity and mortality, quality of life and cost effectiveness. The trial has a power to detect a 25% change in mortality after 2.5 years of f/u and the fact that it hasn’t been stopped indicates that the treatment impact is not significantly worse than nor better than 25%. If the therapy was unsafe or if the trial was futile it would have been stopped by the data safety and monitoring board. SCD-HeFT is a Landmark Study of SCA in HF Large, randomized, double-blind, placebo controlled 2.5 year follow-up Proscribed programming approach Minimized pacing therapy The study design is a prospective randomized control trial comparing Amiodarone or ICD to Optimal medical Therapy in patients who present with ischemic or non-ischemic dilated cardiomyopathy in NYHA class II or III who are on an ACE inhibitor and a beta blockers with an EF of less than or equal to 35% at the time of enrollment SCD-HeFT is a trial of ICDs and Amio in patients with HF The ICD in the study is the Medtronic MicroJewel II, 7223 CX The trial has the Power to detect a 25% change in mortality at 2.5 years of f/u. ACE, diuretics, Dig, BB, Spironolactone, statins HF of 3 months duration Reductions in mortality wi