CAJ | 학술논문

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.
배경 근거국내외만성심력쇠갈(심쇠)치료지남,좌심실사혈분수(LVEF)강저적심장성졸사고위인군이피렬입식입형심률전복제전기(ICD)혹심장재동보치료제전기(CRT-D)적Ⅰ류괄응증.아국만성심쇠환자심장성졸사적풍험정도여하?작위심장성졸사적일급예방,근거중국현상,제공중국ICD/CRT-D식입괄응증적증거시극대해결적중대문제.대우LVEF＜0.35동시QRS파증관(≥120 ms)적만성심쇠환자,식입기계응해수선심장재동보치료기박기(CRT-P)환시CRT-D(후자비전자적비용평균귀4～6만),저시국내외상미해결적문제.기본원리 심장성졸사발병솔고,창구성공솔저.목전ICD혹CRT-D작위최유효적예방심장성졸사적치료방식이피국외지남렬위Ⅰ유추천,병차재발체국가엄범응용.단기타인군결소ICD예방심장성졸사적대규모림상연구자료,조반구미적연구결과시부합괄?설계방안 만성심쇠환자일급예방연구(POSCD-China)시일항전첨성、다중심、주책연구,납입800례성공식입ICD、CRT-P혹CRT-D적만성심쇠환자,배제심장성졸사적이급예방병례.소유환자재접수기계식입전균안조만성심쇠치료지남접수우화적약물치료.계화수방24개월.소유환자적수방종점포괄전인사망、졸사、심혈관사망、재입원、심공능평급、실성심률실상、ICD혹CRT-D적전치료등.결론 POSCD-China연구장명학아국만성심쇠환자적졸사풍험,병비교LVEF강저합병QRS파증관적만성심쇠환자재심장성졸사일급예방치료시,접수CRT-P여CRT-D치료적차별.
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.