ESC 2007 心脏起搏与再同步化指南

ESC Guidelines Guidelines for cardiac pacing and cardiac resynchronization therapy The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in Collaboration with the European Heart Rhythm Association Authors/Task Force Members: Panos E. Vardas* (Chairperson) (Greece); Angelo Auricchio (Switzerland); Jean-Jacques Blanc (France); Jean-Claude Daubert (France); Helmut Drexler (Germany); Hugo Ector (Belgium); Maurizio Gasparini (Italy); Cecilia Linde (Sweden); Francisco Bello Morgado (Portugal); Ali Oto (Turkey); Richard Sutton (UK); Maria Trusz-Gluza (Poland) ESC Committee for Practice Guidelines (CPG): Alec Vahanian (Chairperson) (France), John Camm (UK), Raffaele De Caterina (Italy), Veronica Dean (France), Kenneth Dickstein (Norway), Christian Funck-Brentano (France), Gerasimos Filippatos (Greece), Irene Hellemans (The Netherlands), Steen Dalby Kristensen (Denmark), Keith McGregor (France), Udo Sechtem (Germany), Sigmund Silber (Germany), Michal Tendera (Poland) Petr Widimsky (Czech Republic), Jose´ Luis Zamorano (Spain) Document Reviewers: Silvia G. Priori (Review Coordinator) (Italy), Carina Blomstro¨m-Lundqvist (Sweden), Michele Brignole (Italy), Josep Brugada Terradellas (Spain), John Camm (UK), Perez Castellano (Spain), John Cleland (UK), Jeronimo Farre (Spain), Martin Fromer (Switzerland), Jean-Yves Le Heuzey (France), Gregory YH Lip (UK), Jose Luis Merino (Spain), Annibale Sandro Montenero (Italy), Philippe Ritter (France) Martin Jan Schalij (The Netherlands), Christopher Stellbrink (Germany) Table of Contents Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . 2257 Introduction . . . . . . . . . . . . . . . . . . . . . . 2258 Pacing in bradyarrhythmia, syncope, and other specific conditions . . . . . . . . . . . . . . . . 2258 Cardiac resynchronization therapy . . . . . . . 2259 1. Pacing in arrhythmias . . . . . . . . . . . . . . . . 2259 1.1. Sinus node disease . . . . . . . . . . . . . . . . 2259 1.1.1. Indications for pacing in sinus node disease 2259 1.1.2. Choice of the pacing mode for patients with sinus node disease . . . . . . . . . . . . 2260 1.2. Atrioventricular and intraventricular conduction disturbances . . . . . . . . . . . . . 2262 1.2.1. Indications for pacing . . . . . . . . . . . . . 2262 1.2.2. Acquired atrioventricular block in special cases . . . . . . . . . . . . . . . . 2262 1.2.3. Pacing for chronic bifascicular and trifascicular block . . . . . . . . . . . . . . . 2263 1.2.4. Indications for pacing . . . . . . . . . . . . . 2263 1.2.5. Choice of pacing mode for patients with atrioventricular block . . . . . . . . . . 2264 1.3. Recent myocardial infarction . . . . . . . . . . 2265 1.3.1. Pacing in conduction disturbances related to acute myocardial infarction . . . . . . . . 2265 1.4. Reflex syncope . . . . . . . . . . . . . . . . . . 2266 1.4.1. Carotid sinus syndrome . . . . . . . . . . . . 2266 1.4.2. Vasovagal syncope . . . . . . . . . . . . . . . 2267 1.4.3. Adenosine-sensitive syncope . . . . . . . . . 2268 1.5. Paediatrics and congenital heart diseases . . . 2269 1.5.1. Sinus node dysfunction and bradycardia– tachycardia syndrome at young ages . . . . 2270 * Corresponding author: Panos Vardas, Department of Cardiology, Heraklion University Hospital, PO Box 1352 Stavrakia, GR-711 10 Heraklion (Crete), Greece. Tel: þ30 2810 392706; fax: þ30 2810 542 055; e-mail: cardio@med.uoc.gr The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only. No commercial use is authorized. No part of the ESC Guidelines may be translated or reproduced in any form without written permission from the ESC. Permission can be obtained upon submission of a written request to Oxford University Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC. Disclaimer. The ESC Guidelines represent the views of the ESC and were arrived at after careful consideration of the available evidence at the time they were written. Health professionals are encouraged to take them fully into account when exercising their clinical judgement. The guidelines do not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and where appropriate and necessary the patient’s guardian or carer. It is also the health professional’s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription. European Heart Journal (2007) 28, 2256–2295 doi:10.1093/eurheartj/ehm305 & The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org 1.5.2. Congenital atrioventricular block . . . . . . 2270 1.5.3. Atrioventricular block and cardiac surgery . 2270 1.5.4. Long QT syndrome . . . . . . . . . . . . . . . 2270 1.5.5. Adults with congenital heart disease . . . . 2270 1.5.6. Device and mode selection . . . . . . . . . . 2271 1.6. Cardiac transplantation . . . . . . . . . . . . . 2271 2. Pacing for specific conditions . . . . . . . . . . . . 2272 2.1. Hypertrophic cardiomyopathy . . . . . . . . . . 2272 2.1.1. The rationale for short atrioventricular delay DDD pacing in hypertrophic obstructive cardiomyopathy . . . . . . . . . 2272 2.1.2. Therapy delivery and programming . . . . . 2272 2.1.3. Indications for pacing in hypertrophic obstructive cardiomyopathy . . . . . . . . . 2273 2.2. Sleep apnoea . . . . . . . . . . . . . . . . . . . 2273 3. Cardiac resynchronization therapy in patients with heart failure . . . . . . . . . . . . . . . . . . . . . 2273 3.1. Introduction . . . . . . . . . . . . . . . . . . . . 2273 3.1.1. Rationale of cardiac resynchronization . . . 2273 3.1.2. Evidence-based clinical effects of cardiac resynchronization therapy . . . . . . . . . . 2274 3.1.3. Cost-effectiveness issues . . . . . . . . . . . 2275 3.1.4. Unresolved issues . . . . . . . . . . . . . . . 2275 3.1.5. Programming recommendations . . . . . . . 2278 3.2. Recommendations . . . . . . . . . . . . . . . . 2278 3.2.1. Recommendations for the use of cardiac resynchronization therapy by biventricular pacemaker (CRT-P) or biventricular pacemaker combined with an implantable cardioverter defibrillator (CRT-D) in heart failure patients . 2278 3.2.2. Recommendations for the use of biventricular pacing in heart failure patients with a concomitant indication for permanent pacing 2278 3.2.3 Recommendations for the use of an implantable cardioverter defibrillator combined with biventricular pacemaker (CRT-D) in heart failure patients with an indication for an implantable cardioverter defibrillator . . . . . . . . . . . . . . . . . . 2278 3.2.4 Recommendations for the use of biventricular pacing in heart failure patients with permanent atrial fibrillation . . . . . . 2278 Appendix A: pacemaker follow-up . . . . . . . . . 2278 The main objectives, structure, and function of the pacemaker clinic . . . . . . . . . . . . . 2279 Pre-discharge assessment and long-term follow-up methodology . . . . . . . . . . . . . . 2280 Complications, failures, and side effects of pacemaker treatment . . . . . . . . . . . . . 2280 Special issues related to the paced patient’s life . . . . . . . . . . . . . . . . . . . 2280 Appendix B: technical considerations and requirements for implanting cardiac resynchronization therapy devices . . . . . . . . . 2281 Technical and personnel requirements for centres intending to implant cardiac resynchronization therapy devices . . . . . . . 2282 Scheduling patient for cardiac resynchronization therapy . . . . . . . . . . . . 2282 Characterization of coronary sinus anatomy . 2282 Requirements for the operating theatre . . . . 2282 Personnel requirements during cardiac resynchronization therapy implantation . . . . 2284 Clinical competence for implanting cardiac resynchronization therapy devices . . . . . . . 2284 Minimum training for competence . . . . . . 2284 Maintenance of competence . . . . . . . . . 2285 Further practical cardiac resynchronization therapy implant recommendations . . . . . 2285 Follow-up . . . . . . . . . . . . . . . . . . . . . 2285 Long-term follow-up . . . . . . . . . . . . . 2285 Abbreviations . . . . . . . . . . . . . . . . . . . . . 2286 Clinical trial acronyms . . . . . . . . . . . . . . . . 2286 References . . . . . . . . . . . . . . . . . . . . . . 2287 Preamble Guidelines and Expert Consensus Documents summarize and evaluate all currently available evidence on a particular issue with the aim to assist physicians in selecting the best management strategies for a typical patient, suffering from a given condition, taking into account the impact on outcome, as well as the risk–benefit ratio of particular diag- nostic or therapeutic means. Guidelines are no substitutes for textbooks. The legal implications of medical guidelines have been discussed previously. A great number of Guidelines and Expert Consensus Docu- ments have been issued in recent years by the European Society of Cardiology (ESC) as well as by other societies and organizations. Because of the impact on clinical prac- tice, quality criteria for development of guidelines have been established in order to make all decisions transparent to the user. The recommendations for formulating and issuing ESC Guidelines and Expert Consensus Documents can be found on the ESC website (http://www.escardio. org/knowledge/guidelines/rules). In brief, experts in the field are selected and undertake a comprehensive review of the published evidence for man- agement and/or prevention of a given condition. A critical evaluation of diagnostic and therapeutic procedures is per- formed including the assessment of the risk/benefit ratio. Estimates of expected health outcomes for larger societies are included, where data exist. The level of evidence and the strength of recommendation of particular treatment options are weighed and graded according to pre-defined scales, as outlined in Tables 1 and 2. The experts of the writing panels have provided disclosure statements of all relationships they may have which might be perceived as real or potential sources of conflicts of interest. These disclosure forms are kept on file at the Table 1 Classes of recommendations Class I Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective Class II Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure Class IIa Weight of evidence/opinion is in favour of usefulness/efficacy Class IIb Usefulness/efficacy is less well established by evidence/opinion Class III Evidence or general agreement that the given treatment or procedure is not useful/effective and in some cases may be harmful ESC Guidelines 2257 European Heart House, headquarters of the ESC. Any changes in conflict of interest that arise during the writing period must be notified to the ESC. The Task Force report was entirely supported financially by the ESC and was devel- oped without any involvement of the industry. The ESC Committee for Practice Guidelines (CPG) super- vises and coordinates the preparation of new Guidelines and Expert Consensus Documents produced by Task Forces, expert groups, or consensus panels. The Committee is also responsible for the endorsement process of these Guidelines and Expert Consensus Documents or statements. Once the document has been finalized and approved by all the experts involved in the Task Force, it is submitted to outside specialists for review. The document is revised, and finally approved by the CPG and subsequently published. After publication, dissemination of the message is of para- mount importance. Pocket-sized versions and personal digital assistant-downloadable versions are useful at the point of care. Some surveys have shown that the intended end-users are sometimes not aware of the existence of guidelines or simply do not translate them into practice so this is why implementation programmes for new guidelines form an important component of the dissemination of knowledge. Meetings are organized by the ESC and directed towards its member National Societies and key opinion leaders in Europe. Implementation meetings can also be undertaken at national levels, once the guidelines have been endorsed by the ESC member societies, and translated into the national language. Implementation programmes are needed because it has been shown that the outcome of disease may be favourably influenced by the thorough appli- cation of clinical recommendations. Thus, the task of writing Guidelines or Expert Consensus documents covers not only the integration of the most recent research, but also the creation of educational tools and implementation programmes for the recommendations. The loop between clinical research, writing of guidelines, and implementing them into clinical practice can then only be completed, if surveys and registries are performed to verify that real-life daily practice is in keeping with what is recommended in the guidelines. Such surveys and registries also make it possible to evaluate the impact of implementation of the guidelines on patient outcomes. Guidelines and recommendations should help the physicians to make decisions in their daily practice; however, the ulti- mate judgement regarding the care of an individual patient must be made by the physician in charge of his/her care. Introduction Cardiac pacing has been used in the treatment of bradyar- rhythmias for more than 50 years and during that time both clinical practice and an impressive body of research have proved its effectiveness objectively, in terms of par- ameters that includes the patient’s quality of life, morbid- ity, and mortality. There can also be no doubt that the related technology has made great strides over the same period.1–4 Today, thanks to developments in microelectronics, the devices are smaller, the programming options wider, and the pacing leads thinner but longer lasting than before. All these developments, in both hardware and software, have aimed at the primary goal of appropriate electrical correc- tion of pulse and conduction defects in such a way as to simulate the natural, inherent electrical function of the heart as closely as possible and to satisfy the patient’s needs while minimizing side effects. In addition, increased device longevity and the elimination of major and minor complications resulting from treatment have also been the constant aims of both manufacturers and physicians. During the last 12 years, electrical stimulation has advanced further, into the realm of ventricular resynchroni- zation as an adjunctive therapy for patients with drug-refractory heart failure and ventricular conduction delay. It must be remembered that cardiac pacing for both bradyarrhythmia and cardiac resynchronization therapy (CRT) was first used clinically in Europe.4,5,264,265 The guidelines for the appropriate use of pacemaker devices presented in this document, a joint European Society of Cardiology (ESC) and EHRA initiative, aim to provide for the first time in Europe an up-to-date specialists’ view of the field. The guidelines cover two main areas: the first includes permanent pacing in bradyarrhythmias, syncope, and other specific conditions, whereas the second refers to ventricular resynchronization as an adjunct therapy in patients with heart failure. Pacing in bradyarrhythmia, syncope, and other specific conditions The recommendations for pacing in bradyarrhythmias were based on an extensive review of the literature, old and new, with a view to reaching evidence-based conclusions. Where the literature is lacking, mainly with regard to con- ditions where no other therapy could replace pacing, the recommendations are based on expert consensus. The guidelines that follow concern patients who have permanent and irreversible disturbances of the systems for generation and conduction of the cardiac stimulus. The text will often make reference to the fact that the decision to implant a device depends on the accurate judgement of the treating physician, who must determine whether the damage is of a permanent and irreversible nature. When the pathophysiology of the condition is judged to be fully reversible, for example, in the case of drug effects (digitalis intoxication) or electrolyte disturbances, or most likely reversible, such as in inflammatory or ischaemic myo- cardial disease, the bradyarrhythmic condition should be treated initially without permanent implantable device therapy. Of course, in daily practice, the nature of the dis- turbances of stimulus production and conduction is often ambiguous and the permanence of the condition is unclear. As mentioned above, the focus of these guidelines is the appropriate use of pacemakers in patients with bradyar- rhythmias. Obviously, the work of the committee would be Table 2 Levels of evidence Level of evidence A Data derived from multiple randomized clinical trials or meta-analyses Level of evidence B Data derived from a single randomized clinical trial or large non-randomized studies Level of evidence C Consensus of opinion of the experts and/or small studies, retrospective studies, and registries ESC Guidelines2258 incomplete if it limited itself only to recommendations con- cerning indications for pacing and failed to include consider- ation of the proper pacing mode in each case. It was therefore considered essential to cover in this report the proposed pacing modes for each condition. On the other hand, the committee decided that the docu- ment should not include recommendations for the choice of pacing leads or for their extraction or replacement. These subjects will be covered by forthcoming EHRA documents. Cardiac resynchronization therapy Cardiac pacing as an adjunct therapy for heart failure began to be the subject of scientific research at the start of the 1990s. The first pacing modality to be examined was dual- chamber pacing with a short atrioventricular (AV) delay, in patients with heart failure but without the classical bradyar- rhythmic indications for pacing. The first studies in this area gave promising results. Acute and short-term improvements resulted from the optimization of left ventricular (LV) filling and a reduction in pre-systolic mitral regurgitation. Unfortu- nately, the initial results were not confirmed by subsequent studies and the early hopes raised by dual-chamber pacing with a short AV delay for heart failure patients were not fulfilled. In contrast, atrio-biventricular pacing for patients with symptomatic heart failure and intra- or interventricular con- duction disturbances has proved beneficial. During the last decade, a number of studies have established a theoretical basis for this new therapy and have drawn related con- clusions regarding the importance of resynchronization in terms of improving symptoms, morbidity, and mortality in these patients. This document presents the recommendations of the com- mittee concerning indications for CRT based on the most recent studies. 1. Pacing in arrhythmias 1.1. Sinus node disease Sinus node disease, also known as sick sinus syndrome, des- ignates a spectrum of sinoatrial dysfunction that ranges from the usually benign sinus bradycardia to sinus arrest or to the so-called bradycardia–tachycardia syndrome.6 The latter is characterized by the development of paroxysmal atrial tachyarrhythmias in patients with sinus bradycardia or sinoatrial block. Some patients with frequent, repetitive, long-lasting episodes, or atrial fibrillation (AF) may remodel their atrial myocardium, including the sinoatrial region, and are prone to systemic embolism.7 In patients with sinus arrest, the