慢性心力衰竭患者心脏性猝死的一级预防研究：基本原理和设计方案

Primary prevention of sudden cardiac death in patients with chronic heart failure-multicenter prospective registry study in China（POSCD-China）：rationale and design

背景 根据国内外慢性心力衰竭（心衰）治疗指南,左心室射血分数（LVEF）降低的心脏性猝死高危人群已被列入植入型心律转复除颤器（ICD）或心脏再同步治疗除颤器（CRT-D）的Ⅰ类适应证.我国慢性心衰患者心脏性猝死的风险程度如何？作为心脏性猝死的一级预防,根据中国现状,提供中国ICD/CRT-D植入适应证的证据是亟待解决的重大问题.对于LVEF＜0.35同时QRS波增宽（≥120 ms）的慢性心衰患者,植入器械应该首选心脏再同步治疗起搏器（CRT-P）还是CRT-D（后者比前者的费用平均贵4～6万）,这是国内外尚未解决的问题.基本原理 心脏性猝死发病率高,抢救成功率低.目前ICD或CRT-D作为最有效的预防心脏性猝死的治疗方式已被国外指南列为Ⅰ类推荐,并且在发达国家广泛应用.但其他人群缺少ICD预防心脏性猝死的大规模临床研究资料,照搬欧美的研究结果是否合适？设计方案 慢性心衰患者一级预防研究（POSCD-China）是一项前瞻性、多中心、注册研究,纳入800例成功植入ICD、CRT-P或CRT-D的慢性心衰患者,排除心脏性猝死的二级预防病例.所有患者在接受器械植入前均按照慢性心衰治疗指南接受优化的药物治疗.计划随访24个月.所有患者的随访终点包括全因死亡、猝死、心血管死亡、再入院、心功能评级、室性心律失常、ICD或CRT-D的电治疗等.结论 POSCD-China研究将明确我国慢性心衰患者的猝死风险,并比较LVEF降低合并QRS波增宽的慢性心衰患者在心脏性猝死一级预防治疗时,接受CRT-P与CRT-D治疗的差别.

Background According to the domestic and foreign guidelines for therapies of chronic heart failure,implantable cardioverter defibrillator （ICD） or cardiac resynchronization therapy with defibrillator function （CRT-D） has been listed as Class Ⅰ indication for patients with degraded left ventricular ejection fraction （LVEF） （≤0.35） and increased risk of sudden cardiac death （SCD）.However,to what extent the Chinese patients with chronic heart failure are at risk of SCD？ It is crucial to provide evidences for indications of ICD/CRT-D implantation as a measure of primary prevention of SCD according to the status quo of our country.For patients with chronic heart failure with LVEF of ≤0.35 and QRS duration of ≥120 ms,is it better to choose a pacemaker that only has function of cardiac resynchronization （CRT-P） or to choose a CRT-D that has an extra defibrillator function but are the cost of 40 000 to 60 000 RMB more expensive？ This question has not been answered by previous domestic and foreign researches.Rationale The incidence of SCD is at a high level whereas the success rate of rescue remains low.ICD and CRT-D has been listed as Class Ⅰ recommendation for prevention of SCD as the most efficient measure.However,we lack data of from large scale clinical researches for prevention of SCD in eastern Asian population.And probably it is not suitable that only to follow the European or American guidelines.Design POSCD-China is a national prospective multicenter registry.Eight hundred patients with chronic heart failure who has successful ICD/CRT-P/CRT-D implantations are included while implantations for secondary prevention of SCD are excluded.All patients included will have been treated with optimal medications following the guidelines before the device implantation.The follow-up period is planned for 24 months.Endpoints include all-cause death,sudden death,cardiovascular death,rehospitalization,cardiac function classification,ventricular arrhythmia and electric discharge of ICD/CRT-P/CRT-D.Conclusion POSCD-China registry will reveal the risks of SCD in Chinese patients with chronic heart failure,and compare the effects of primary prevention of SCD between CRT-P and CRT-D implantations in patients with chronic heart failure with degraded LVEF and prolonged QRS duration.