ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article
A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines)
The current update of the ACC/AHA/NASPE Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices includes several significant changes in the recommendations and in the supporting narrative portion. In this summary, we list the updated recommendations along with the respective 1998 recommendations, each one accompanied by a brief comment outlining the rationale for the changes, additions, or deletions. All new or revised recommendations are listed in the second column and appear in boldface type. References that support either the 1998 recommendations that have not changed or the new or revised recommendations are noted in parentheses at the end of each recommendation. The reader is referred to the full-text version of the guidelines posted on the American College of Cardiology (ACC), American Heart Association (AHA), and North American Society for Pacing and Electrophysiology (NASPE) World Wide Web sites for a more detailed exposition of the rationale for these changes. In addition to the recommendation changes listed here, this update includes an expanded section on the selection of pacemakers and implantable cardioverter-defibrillators (ICDs) that reflects the technical advances that have taken place since 1998. A brief expanded summary of pacemaker follow-up procedures is also new to these guidelines. For both of these expanded sections, the reader is referred to the online full-text version.
In preparing this update, the committee was guided by the following principles:
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.
The committee is cognizant of the healthcare, logistic, and financial implications of recent trials and factored in these considerations in arriving at the class level of certain recommendations.
Minor wording changes were made to render some recommendations more precise.
The committee wishes to re-emphasize that the recommendations in the guideline apply to most patients but may require modification by existing situations that only the primary treating physician can evaluate properly.
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 (eg, nonessential drug therapy).
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 Guideline for the Management of Patients With Acute Myocardial Infarction.1 However, given the rapid evolution of pacemaker/ICD science, it has not always been possible to maintain consistency with other guidelines. An example of such a discrepancy can be found in Section I-H, in which the recommendation for biventricular pacing in selected patients with heart failure has been listed under Class IIa, whereas in the ACC/AHA Guideline for the Evaluation and Management of Chronic Heart Failure in the Adult,2 biventricular pacing is cited as an investigational procedure.
The ACC/AHA classifications I, II, and III are used to summarize indications as follows:
Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is 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.
IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.
IIb: Usefulness/efficacy is less well established by evidence/opinion.
Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful.
The weight of the evidence was ranked highest (A) if the data were derived from multiple randomized clinical trials that involved large numbers of patients and intermediate (B) if the data were derived from a limited number of randomized trials that involved small numbers of patients or from careful analyses of nonrandomized studies or observational registries. A lower rank (C) was given when expert consensus was the primary basis for the recommendation. ⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓
This document was approved by the American College of Cardiology Foundation Board of Trustees in September 2002, the American Heart Association Science Advisory and Coordinating Committee in August 2002, and the North American Society for Pacing and Electrophysiology in August 2002.
The ACC/AHA Task Force on Practice Guidelines makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated as changes occur. The conflict of interest information for the writing committee members is posted on the ACC, AHA, and NASPE Web sites with the full-length version of the update.
When citing this document, the ACC, the AHA, and NASPE would appreciate the following citation format: Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation. 2002;106:2145–2161.
Copies: This document is available on the World Wide Web sites of the ACC (www.acc.org), the AHA (www.americanheart.org), and NASPE (www.naspe.org). A single copy of the complete guidelines is available by calling 800-253-4636 (US only) or writing the American College of Cardiology Foundation, Resource Center, 9111 Old Georgetown Rd, Bethesda, MD 20814-1699 (ask for No. 71-0237). To obtain a copy of the Summary Article, ask for reprint No. 71-0236. To purchase additional reprints (specify version and reprint number): up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 410-528-4426, fax 410-528-4264, or e-mail firstname.lastname@example.org.
- ↵Ryan TJ, Antman EM, Brooks NH, et al. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1999; 34: 890–911.
- ↵Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure) developed in collaboration with the International Society for Heart and Lung Transplantation endorsed by the Heart Failure Society of America. J Am Coll Cardiol. 2001; 38: 2101–2113.
- Shaw DB, Holman RR, Gowers JI. Survival in sinoatrial disorder (sick-sinus syndrome). BMJ. 1980; 280: 139–141.
- Langberg JJ, Chin MC, Rosenqvist M, et al. Catheter ablation of the atrioventricular junction with radiofrequency energy. Circulation. 1989; 80: 1527–1535.
- Charles R, Holt S, Kay JM, Epstein EJ, Rees JR. Myocardial ultrastructure and the development of atrioventricular block in Kearns-Sayre syndrome. Circulation. 1981; 63: 214–219.
- Strasberg B, Amat YL, Dhingra R, et al. Natural history of chronic second-degree atrioventricular nodal block. Circulation. 1981; 63: 1043–1049.
- Recommendations for pacemaker prescription for symptomatic bradycardia: report of a working party of the British Pacing and Electrophysiology Group. Br Heart J. 1991; 66: 185–191.
- Shaw DB, Kekwick CA, Veale D, Gowers J, Whistance T. Survival in second degree atrioventricular block. Br Heart J. 1985; 53: 587–593.
- Hindman MC, Wagner GS, JaRo M, et al. The clinical significance of bundle branch block complicating acute myocardial infarction, 2: indications for temporary and permanent pacemaker insertion. Circulation. 1978; 58: 689–699.
- Penton GB, Miller H, Levine SA. Some clinical features of complete heart block. Circulation. 1956; 13: 801–824.
- Dhingra RC, Denes P, Wu D, Chuquimia R, Rosen KM. The significance of second degree atrioventricular block and bundle branch block: observations regarding site and type of block. Circulation. 1974; 49: 638–646.
- Ranganathan N, Dhurandhar R, Phillips JH, Wigle ED. His Bundle electrogram in bundle-branch block. Circulation. 1972; 45: 282–294.
- Josephson ME. Clinical cardiac electrophysiology: techniques and interpretations. 2nd ed. Philadelphia: Lea & Febiger, 1993: 145.
- Kulbertus H, Collignon P. Association of right bundle-branch block with left superior or inferior intraventricular block: its relation to complete heart block and Adams- Stokes syndrome. Br Heart J. 1969; 31: 435–440.
- Scheinman MM, Peters RW, Modin G, Brennan M, Mies C, O’Young J. Prognostic value of infranodal conduction time in patients with chronic bundle branch block. Circulation. 1977; 56: 240–244.
- Dhingra RC, Wyndham C, Bauernfeind R, et al. Significance of block distal to the His bundle induced by atrial pacing in patients with chronic bifascicular block. Circulation. 1979; 60: 1455–1464.
- Ginks WR, Sutton R, Oh W, Leatham A. Long-term prognosis after acute anterior infarction with atrioventricular block. Br Heart J. 1977; 39: 186–189.
- Ryan TJ, Anderson JL, Antman EM, et al. ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1996; 28: 1328–1428.
- Rasmussen K. Chronic sinus node disease: natural course and indications for pacing. Eur Heart J. 1981; 2: 455–459.
- Rubenstein JJ, Schulman CL, Yurchak PM, DeSanctis RW. Clinical spectrum of the sick sinus syndrome. Circulation. 1972; 46: 5–13.
- Sutton R, Brignole M, Menozzi C, et al, for the Vasovagal Syncope International Study (VASIS) Investigators. Dual-chamber pacing in the treatment of neurally mediated tilt-positive cardioinhibitory syncope: pacemaker versus no therapy: a multicenter randomized study. Circulation. 2000; 102: 294–299.
- Ammirati F, Colivicchi F, Santini M. Permanent cardiac pacing versus medical treatment for the prevention of recurrent vasovagal syncope: a multicenter, randomized, controlled trial. Circulation. 2001; 104: 52–57.
- Mackintosh AF. Sinuatrial disease in young people. Br Heart J. 1981; 45: 62–66.
- Kertesz N, McQuinn T, Collins E, Friedman R. Surgical Atrioventricular block in 888 congenital heart operations: new implications for early implantation of a permanent pacemaker [abstract]. PACE. 1996; 19: 613.
- Michaelsson M, Jonzon A, Riesenfeld T. Isolated congenital complete atrioventricular block in adult life: a prospective study. Circulation. 1995; 92: 442–449.
- Pinsky WW, Gillette PC, Garson A Jr, McNamara DG. Diagnosis, management, and long-term results of patients with congenital complete atrioventricular block. Pediatrics. 1982; 69: 728–733.
- Moss AJ, Liu JE, Gottlieb S, Locati EH, Schwartz PJ, Robinson JL. Efficacy of permanent pacing in the management of high-risk patients with long QT syndrome. Circulation. 1991; 84: 1524–1529.
- Solti F, Szatmary L, Vecsey T, Renyi-Vamos F Jr, Bodor E. Congenital complete heart block associated with QT prolongation. Eur Heart J. 1992; 13: 1080–1083.
- Krongrad E. Prognosis for patients with congenital heart disease and postoperative intraventricular conduction defects. Circulation. 1978; 57: 867–870.
- Fananapazir L, Epstein ND, Curiel RV, Panza JA, Tripodi D, McAreavey D. Long-term results of dual-chamber (DDD) pacing in obstructive hypertrophic cardiomyopathy: evidence for progressive symptomatic and hemodynamic improvement and reduction of left ventricular hypertrophy. Circulation. 1994; 90: 2731–2742.
- Nishimura RA, Hayes DL, Ilstrup DM, Holmes DR Jr, Tajik AJ. Effect of dual-chamber pacing on systolic and diastolic function in patients with hypertrophic cardiomyopathy: acute Doppler echocardiographic and catheterization hemodynamic study. J Am Coll Cardiol. 1996; 27: 421–430.
- Kappenberger L, Linde C, Daubert C, et al, for the PIC Study Group. Pacing in hypertrophic obstructive cardiomyopathy: a randomized crossover study. Eur Heart J. 1997; 18: 1249–1256.
- Maron BJ, Nishimura RA, McKenna WJ, Rakowski H, Josephson ME, Kieval RS. Assessment of permanent dual-chamber pacing as a treatment for drug- refractory symptomatic patients with obstructive hypertrophic cardiomyopathy: a randomized, double-blind, crossover study (M-PATHY). Circulation. 1999; 99: 2927–2933.
- Saksena S, Poczobutt-Johanos M, Castle LW, et al, for the Guardian Multicenter Investigators Group. Long-term multicenter experience with a second-generation implantable pacemaker-defibrillator in patients with malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 1992; 19: 490–499.
- Bardy GH, Troutman C, Poole JE, et al. Clinical experience with a tiered-therapy, multiprogrammable antiarrhythmia device. Circulation. 1992; 85: 1689–1698.
- Powell AC, Fuchs T, Finkelstein DM, et al. Influence of implantable cardioverter-defibrillators on the long-term prognosis of survivors of out-of-hospital cardiac arrest. Circulation. 1993; 88: 1083–1092.
- Zipes DP, Roberts D, for the Pacemaker-Cardioverter-Defibrillator Investigators. Results of the international study of the implantable pacemaker cardioverter-defibrillator: a comparison of epicardial and endocardial lead systems. Circulation. 1995; 92: 59–65.
- Wever EF, Hauer RN, Schrijvers G, et al. Cost-effectiveness of implantable defibrillator as first-choice therapy versus electrophysiologically guided, tiered strategy in postinfarct sudden death survivors: a randomized study. Circulation. 1996; 93: 489–496.
- Morady F, Harvey M, Kalbfleisch SJ, el Atassi R, Calkins H, Langberg JJ. Radiofrequency catheter ablation of ventricular tachycardia in patients with coronary artery disease. Circulation. 1993; 87: 363–372.
- Wever EF, Hauer RN, van Capelle FL, et al. Randomized study of implantable defibrillator as first-choice therapy versus conventional strategy in postinfarct sudden death survivors. Circulation. 1995; 91: 2195–2203.
- Krol RB, Saksena S. Clinical trials of antiarrhythmic drugs in recipients of implantable cardioverter-defibrillators. In: Saksena S, Luderitz B, eds. Interventional electrophysiology. Armonk: Futura Publishing Co, 1996: 365–375.
- Connolly SJ, Gent M, Roberts RS, et al. Canadian implantable defibrillator study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation. 2000; 101: 1297–1302.
- Kuck KH, Cappato R, Siebels J, Ruppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH). Circulation. 2000; 102: 748–754.
- Bocker D, Haverkamp W, Block M, Borggrefe M, Hammel D, Breithardt G. Comparison of d,l-sotalol and implantable defibrillators for treatment of sustained ventricular tachycardia or fibrillation in patients with coronary artery disease. Circulation. 1996; 94: 151–157.
- Saksena S, Moss AJ, Giorgeberidze I, et al. Factors associated with shock delivery in the Multicenter Automatic Defibrillator Implantation Trial [MADIT] [abstract]. J Am Coll Cardiol. 1997; 29 (Suppl A): 79A.
- Sweeney MO, Ruskin JN, Garan H, et al. Influence of the implantable cardioverter/defibrillator on sudden death and total mortality in patients evaluated for cardiac transplantation. Circulation. 1995; 92: 3273–3281.
- Garson A Jr, Dick M, Fournier A, et al. The long QT syndrome in children: an international study of 287 patients. Circulation. 1993; 87: 1866–1872.
- Wichter T, Block M, Bocker D, Borggrefe G, Breithardt G. Cardioverter-defibrillator therapy in a high-risk subgroup of patients with arrhythmogenic right ventricular disease [abstract]. J Am Coll Cardiol. 1993; 21: 127A.
- Wilber DJ, Olshansky B, Moran JF, Scanlon PJ. Electrophysiological testing and nonsustained ventricular tachycardia: use and limitations in patients with coronary artery disease and impaired ventricular function. Circulation. 1990; 82: 350–358.
- Priori SG, Napolitano C, Gasparini M, et al. Natural history of Brugada syndrome: insights for risk stratification and management. Circulation. 2002; 105: 1342–1347.
- Stevenson WG, Khan H, Sager P, et al. Identification of reentry circuit sites during catheter mapping and radiofrequency ablation of ventricular tachycardia late after myocardial infarction. Circulation. 1993; 88: 1647–1670.
- Hindricks G, for the Multicentre European Radiofrequency Survey (MERFS) investigators of the Working Group on Arrhythmias of the European Society of Cardiology. The Multicentre European Radiofrequency Survey (MERFS): complications of radiofrequency catheter ablation of arrhythmias. Eur Heart J. 1993; 14: 1644–1653.
- Klein LS, Shih HT, Hackett FK, Zipes DP, Miles WM. Radiofrequency catheter ablation of ventricular tachycardia in patients without structural heart disease. Circulation. 1992; 85: 1666–1674.
- Anderson JL, Hallstrom AP, Epstein AE, et al, for the AVID Investigators. Design and results of the Antiarrhythmics Vs Implantable Defibrillators (AVID) registry. Circulation. 1999; 99: 1692–1699.