American College of Cardiology

GREGORATOS ET AL., ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices
http://www.acc.org/clinical/guidelines/pacemaker/incorporated/index.htm; 2002

ACC/AHA/NSAPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrythmia Devices—Full Text

A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Implantation)

Introduction

This revision of the “ACC/AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices” updates the previous versions published in 1984, 1991, and 1998. Revision of the statement was deemed necessary for two reasons: the publication of major studies that have advanced our knowledge of the natural history of bradyarrhythmias and tachyarrhythmias, which may be treated optimally with device therapy, and major advances in the technology of such devices.

The committee to revise the ACC/AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices was composed of both university-affiliated and practicing physicians. It included experts in the area of device therapy and follow-up, senior clinicians skilled in cardiovascular care, a general internist, and a cardiothoracic surgeon. The committee included representatives of the American College of Physicians, NASPE, and the Society of Thoracic Surgeons. The 1998 document was reviewed by three outside reviewers nominated by the ACC, three outside reviewers nominated by the AHA, and individuals representing the American College of Physicians and NASPE. The section “Pacing in Children and Adolescents” was reviewed by additional reviewers with special expertise in pediatric electrophysiology. The 2002 update was reviewed by two outside reviewers nominated by the ACC, two outside reviewers nominated by the AHA, and two outside reviewers nominated by the NASPE. The committee thanks all the reviewers for their comments. Many of their suggestions were incorporated into the final document.

The recommendations listed in this document are, whenever possible, evidence based. Pertinent medical literature in the English language was identified through a search of library databases, and a large number of publications were reviewed by committee members during the course of their discussions. Additionally, the committee reviewed documents related to the subject matter previously published by the ACC, AHA, and NASPE. References selected and published in this document are representative and not all-inclusive.

The committee reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as level A if the data were derived from multiple randomized clinical trials involving a large number of individuals. The committee ranked available evidence as level B when data were derived from a limited number of trials involving a comparatively small number of patients or from well-designed data analyses of nonrandomized studies or observational data registries. Evidence was ranked as level C when the consensus of experts was the primary source of the recommendation. In the narrative portions of these guidelines, evidence is generally presented in chronological order of development. Studies are identified as observational, randomized, prospective, or retrospective. The committee emphasizes that for certain conditions for which no other therapy is available, the indications for device therapy are based on expert consensus and years of clinical experience and are thus well supported, even though the evidence was ranked as level C. An analogous example is the use of penicillin in pneumococcal pneumonia where there are no randomized trials and only clinical experience. When indications at level C are supported by historical clinical data, appropriate references (e.g., case reports and clinical reviews) are cited if available. When level C indications are based strictly on committee consensus, no references are cited. In areas where sparse data were available (e.g., pacing in children and adolescents), a survey of current practices of major centers in North America was conducted to determine whether there was a consensus regarding specific pacing indications.

The final recommendations for indications for device therapy are expressed in the standard ACC/AHA format as follows:

Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful, and effective.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.

Class IIb: Usefulness/efficacy is less well established by evidence/opinion.

Class III: Conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful.

The focus of these guidelines is the appropriate use of devices (pacemakers and implantable cardioverter-defibrillators [ICDs]), not the treatment of cardiac arrhythmias. The fact that use of a device for treatment of a particular condition is listed as a Class I indication (beneficial, useful, and effective) does not preclude the use of other therapeutic modalities that may be equally effective. As with all clinical practice guidelines, the recommendations in this document focus on treatment of an average patient with a specific disorder and may be modified by patient comorbidities, limitation of life expectancy because of coexisting diseases, and other situations that only the primary treating physician may evaluate appropriately.

These guidelines include expanded sections on selection of pacemakers and ICDs; optimization of technology; cost; and follow-up of implanted devices. The follow-up section is relatively brief and is included for the sake of completeness, since in many instances, the type and frequency of follow-up examinations are device specific. The importance of adequate follow-up, however, cannot be overemphasized, because optimal results from an implanted device can be obtained only if the device is adjusted to changing clinical conditions.

The committee considered including a section on extraction of failed/unused leads, a topic of current interest, but elected not to do so in the absence of convincing evidence to support specific criteria for timing and methods of lead extraction. A policy statement on lead extraction from NASPE provides information on this topic (334). Similarly, the issue of when to discontinue long-term cardiac pacing or defibrillator therapy has not been studied sufficiently to allow formulation of appropriate guidelines despite the publication of isolated case reports (1). The committee therefore decided to defer inclusion of this topic until additional information is available.

The text accompanying the listed indications should be read carefully because it includes the rationale and supporting evidence for many of the indications, and in several instances, it includes a discussion of alternative acceptable therapies. Many of the indications are modified by the term “potentially reversible.” This term is used to indicate abnormal pathophysiology (e.g., complete heart block) that may be the result of reversible factors. Examples include complete heart block due to drug toxicity (digitalis), electrolyte abnormalities, diseases with inflammatory periatrioventricular node reaction (Lyme disease), and transient injury to the conduction system at the time of open heart surgery. When faced with a potentially reversible situation, the treating physician must decide how long a waiting period is justified before beginning device therapy. The committee recognizes that this statement does not address the issue of length of hospital stay vis-à-vis managed-care regulations. It is emphasized that these guidelines are not intended to address this issue, which falls strictly within the purview of the treating physician.

The term “symptomatic bradycardia” is used frequently throughout this document. Symptomatic bradycardia is defined as a documented bradyarrhythmia that is directly responsible for development of the clinical manifestations of frank syncope or near syncope, transient dizziness or lightheadedness, and confusional states resulting from cerebral hypoperfusion attributable to slow heart rate. Fatigue, exercise intolerance, and frank congestive failure may also result from bradycardia. These symptoms may occur at rest and/or with exertion. Definite correlation of symptoms with a bradyarrhythmia is required to fulfill the criteria that define symptomatic bradycardia. Caution should be exercised not to confuse physiologic sinus bradycardia (as occurs in highly trained athletes) with pathological bradyarrhythmias. Occasionally, symptoms may become apparent only in retrospect after antibradycardia pacing. Nevertheless, the universal application of pacing therapy to treat a specific heart rate cannot be recommended except in specific circumstances, as detailed subsequently.

In these guidelines, the terms “persistent,” “transient,” and “not expected to resolve” are frequently used. These terms are not specifically defined because the time element varies in different clinical conditions. The treating physician must use appropriate clinical judgment and available data in deciding when a condition is persistent or when it can be expected to be transient. Section I-C, “Pacing for Atrioventricular Block Associated With Acute Myocardial Infarction,” overlaps with the “ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction” (335) and includes expanded indications and stylistic changes. The statement “incidental finding at electrophysiologic study” is used several times in this document and does not mean that such a study is indicated. Appropriate indications for electrophysiologic studies have been published (3).

The section on indications for ICDs has been updated and enlarged to reflect the numerous new developments in this field and the voluminous literature related to the efficacy of these devices in the treatment of sudden cardiac death and malignant ventricular arrhythmias. Indications for ICDs are continuously changing and can be expected to change further as ongoing large-scale trials are reported. Thus, the ICD indications may require revision in the next 2 to 3 years. In this document, the term “mortality” is used to indicate all-cause mortality unless otherwise specified. The committee elected to use all-cause mortality because of the variable definition of sudden death and the developing consensus to use allcause mortality as the most appropriate end point of clinical trials (4,5).

These guidelines are not designed to specify training or credentials required for physicians to use device therapy. Nevertheless, in view of the complexity of both cognitive and technical aspects of device therapy, only appropriately trained physicians should use device therapy. Appropriate training guidelines for physicians have been published previously (6,336).

The 2002 update reflects what the committee believes are the most relevant and significant advances in pacemaker/ICD therapy since the publication of these guidelines in the Journal of the American College of Cardiology and Circulation in 1998 (337,338). An extensive literature survey was conducted, and 113 new references have been added since the original publication of these guidelines in 1998. The new references are numbered 334 to 447 and are listed together at the end of the reference list.

In preparing this update, the committee was guided by the following principles:

1. Changes in recommendations and levels of evidence were made either because of new randomized trials or because of the accumulation of new clinical evidence and the development of clinical consensus.
2. The Committee is cognizant of the healthcare, logistic, and financial implications of recent trials and factored these considerations in arriving at the class level of certain recommendations.
3. Minor wording changes were made to render some of the original recommendations more precise.
4. The committee wishes to re-emphasize that the recommendations in this guideline apply to most patients but may require modification by existing situations that only the primary treating physician can evaluate properly.
5. All of the listed recommendations for implantation of a device presume the absence of inciting causes that may be eliminated without detriment to the patient (e.g., nonessential drug therapy).
6. The committee endeavored to maintain consistency of recommendations in this and other previously published guidelines. In the section on atrioventricular (AV) block associated with acute myocardial infarction (AMI), the recommendations follow closely those in the ACC/AHA Guidelines for the Management of Patients With Acute Myocardial Infarction (335). However, because of the rapid evolution of pacemaker/ICD science, it has not always been possible to maintain consistency with other published guidelines. An example of such a discrepancy can be found in Section I-H, where the recommendation for biventricular pacing in selected patients with heart failure has been listed as Class IIa, whereas in the ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult (339), biventricular pacing is cited as an investigational procedure.

The ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices was approved for publication by the AHA Science and Advisory Coordinating Committee and the North American Society of Pacing and Electrophysiology in August 2002 and the ACC Board of Trustees in September 2002. These guidelines will be reviewed 1 year after publication and yearly thereafter and considered current unless the Task Force on Practice Guidelines revises or withdraws them from circulation.

© 2002 by the American College of Cardiology Foundation, American Heart Association, Inc., and North American Society for Pacing and Electrophysiology