Impact of the multicenter automatic defibrillator implantation trial on clinical practice.
Impact of the multicenter automatic defibrillator implantation trial on clinical practice.
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多中心自动除颤器植入试验对临床实践的影响。
DOI：
10.1111/j.1542-474x.2006.00061.x
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Ellinor,PatrickT
中科院分区：
文献类型：
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作者：
Ho,IvanCK;Passeri,JonathanJ;Guy,MaryL;Ruskin,JeremyN;Ellinor,PatrickT
背景：第一个多中心自动除颤器植入试验（MADIT‐I）是一个具有里程碑意义的研究，确定了一个植入式心律转复除颤器（ICD）治疗缺血性心肌病的高风险患者的死亡率显着降低，但该试验对临床实践的直接和间接影响是未知的。方法：我们进行了一项回顾性分析，679例患者接受了直接ICD植入在1994年和2000年之间在一个单一的学术中心。在植入ICD时确定每例患者的基线特征，并确定所有患者截至2004年1月1日的生命状态。结果：根据MADIT‐I标准植入ICD的患者人数从1994年的1.4%增加到2000年的6.1%。另外确定了60例符合许多但非全部试验标准的患者，包括近期血运重建或心肌梗死、晕厥或射血分数≥ 35%的患者。在这个扩展的MADIT‐I子集中，接受ICD的患者数量也从1994年的5.6%增加到2000年的14.6%。平均随访4.7年期间，MADIT‐I组的死亡率显著高于扩展MADIT‐ I组或其余的一级预防和二级预防亚组。结论：MADIT‐I不仅导致接受预防性ICD植入的患者数量增加，而且在临床实践中，它还被外推至比最初研究具有不同程度风险的更广泛人群。
Background:The first multicenter automatic defibrillator implantation trial (MADIT‐I) was a landmark study that identified a significant reduction in mortality among high‐risk patients with ischemic cardiomyopathy treated prophylactically with an implantable cardioverter defibrillator (ICD), yet the direct and indirect impact of this trial on clinical practice is unknown.Methods:We performed a retrospective analysis of the 679 patients who underwent primary ICD implantation between 1994 and 2000 at a single academic center. The baseline characteristics of each patient were determined at the time of ICD implantation, and the vital status of all patients was determined as of January 1, 2004.Results:The number of patients who received an ICD based on the MADIT‐I criteria increased from 1.4% in 1994 to 6.1% in 2000. An additional 60 patients were identified that met many but not all of the trial criteria and consisted of patients with a history of a recent revascularization or myocardial infarction, syncope, or an ejection fraction ≥35%. The number of patients who received ICDs in this expanded MADIT‐I subset also grew from 5.6% in 1994 to 14.6% in 2000. Mortality during a mean follow‐up of 4.7 years was significantly higher in the MADIT‐I group than in the expanded MADIT‐I, or the remaining primary prevention and secondary prevention subsets.Conclusion:The MADIT‐I has not only led to an increase in the number of patients undergoing prophylactic ICD implantation, but in clinical practice it has also been extrapolated to a broader population that has a different degree of risk than originally studied.