2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management

2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management
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DOI:
10.1016/j.hrthm.2012.07.025
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发表时间:
2012-09-01
期刊:
影响因子:
5.5
通讯作者:
Zamorano, Jose Luis
Zamorano, Jose Luis
中科院分区:
医学2区
文献类型:
--
作者:
Daubert, Jean-Claude;Saxon, Leslie;Zamorano, Jose Luis

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心脏再同步治疗是近25年来出现的最成功的心力衰竭治疗方法之一,适用于≏25%-30%的症状性心力衰竭患者。自10多年前首次批准该疗法以来,全球已有数十万例植入物。监管部门的批准主要基于对照临床试验,与目前植入CRT设备的患者相比,CRT患者的定义要窄得多。根据先前研究的结果、设计和规模,专家一致的指南为最有望从CRT中受益的患者群体提供了方向。CRT适应症的更新预计将在本日历年进行,但不是本文件的重点。1-5心脏再同步治疗可以与除颤治疗一起进行,也可以不与除颤治疗一起进行。在本文件中,术语CRT适用于CRT起搏器(CRT-P)或CRT除颤器(CRT-D)。如果该段只涉及一种治疗方法,则设备类型将列为CRT-P或CRT-D。负责患者药物治疗方案的医生通常会推荐患者考虑CRT。为了确保对CRT的最佳反应,植入手术的医生需要对患者的心力衰竭状态进行独立评估,并确保患者正在接受指南指导的药物治疗,以改善临床状况,减少住院和死亡率。植入医生应参与对患者的后续护理和监测,并确保与管理患者临床护理的其他医生进行护理协调。这包括对患者症状的评估,以及诊断设备数据和编程。从历史上看,植入过程的技术方面一直受到极大的关注,特别是左心室(LV)导联的放置。放置经静脉心外膜LV导联对于实现心脏再同步化以及显著改善收缩功能障碍、QRS延迟和心力衰竭患者的症状、生活质量、改善LV功能、住院和死亡率至关重要。随着操作员经验的增加和植入工具的进步,现在已经实现了成功的CRT植入。90%的病例。这允许更多和更新对患者、设备和导联选择的关注。此外,独立于CRT设备或作为CRT设备一部分的心力衰竭诊断测试和设备的进步要求人们越来越多地认识到CRT在心力衰竭患者的整体疾病管理中的作用。这份文件代表了在CRT治疗心力衰竭方面具有临床和研究专长的多学科医生小组的努力。这一共识声明的目的是在临床证据不确定的情况下,用共识意见填补知识空白。该文件涉及CRT接受者的植入前、植入和植入后的管理。该文件的建议总结了写作小组的共识意见,以匿名投票的方式获得写作委员会70%或更多成员的支持。
BackgroundCardiac resynchronization therapy (CRT) is one of the most successful heart failure therapies to emerge in the last 25 years and is applicable to≏ 25–30% of patients with symptomatic heart failure. Since initial approval of the therapy over 10 years ago, there have been hundreds of thousands of implants worldwide. Regulatory approval, largely based on controlled clinical trials, defines a much narrower population of patients for CRT than the patients that are currently implanted with CRT devices. Expert consensus guidelines provide direction as to the population of patients most expected to benefit from CRT, based on the findings, design, and size of prior studies. Updates to indications for CRT are expected in this calendar year and are not the focus of this document. 1–5 Cardiac resynchronization therapy can be administered with or without defibrillation therapy. For the purposes of this document, the term CRT applies to either a CRT-pacemaker (CRT-P) or CRT-defibrillator (CRT-D). If the paragraph is relevant to only one type of therapy, the device type will be listed as CRT-P or CRT-D. The physician responsible for the patients’ medical therapy regimen typically refers patients for consideration of CRT. Ensuring an optimal response to CRT requires the implanting physician make an independent assessment of the patient’s heart failure status and assure that the patient is on guideline-directed medical therapy demonstrated to improve clinical status, and reduce hospitalization and mortality. The implanting physician should participate in the follow-up care and the monitoring of the patient as well as ensure care coordination with other physicians managing the patient’s clinical care. This includes assessment of patient symptoms, as well as diagnostic device data and programming. Historically, significant attention has been placed on the technical aspects of the implant procedure, particularly placement of the left ventricular (LV) lead. Placement of the transvenous epicardial LV lead is critical to achieving cardiac resynchronization and to garnering the dramatic improvement in symptoms, quality of life, improvement in LV function, hospitalization, and mortality rates in patients with systolic dysfunction, QRS delay, and heart failure. With the increase in operator experience and advancement in implant tools, a successful CRT implant is now achieved in. 90% of cases. This allows for additional and updated focus on the patient, device, and lead selection. Further, advances in heart failure diagnostic tests and devices that are independent of or a part of CRT devices require an increasing awareness of the role of CRT in the overall disease management of heart failure patients. This document represents the efforts of a multi-disciplinary group of physicians with clinical and investigational expertise in CRT for treatment of heart failure. The purpose of this consensus statement is to fill in knowledge gaps with consensus opinion where the clinical evidence is less than certain. The document addresses the pre-implant, implant, and post-implant management of the CRT recipient. The document’s recommendations summarize the writing group’s consensus opinions supported by 70% or greater of the writing committee by anonymous vote.