CLINICAL TRIALS OF PACING MODE SELECTION
Section snippets
DUAL-CHAMBER VERSUS VENTRICULAR PACING
Since Zoll's115 report in 1952 of the first clinical application of cardiac pacing in the management of bradycardia, sinus node dysfunction and atrioventricular (AV) conduction disorders have remained the major indications for permanent pacemaker implantation in the United States12 and other parts of the world.38, 47, 75 Dual-chamber pacing has the theoretical advantage over single-chamber ventricular pacing in that it resembles normal cardiac physiology by maintaining synchrony of atrial and
CURRENT RECOMMENDATIONS
Largely based on nonrandomized observational data and expert opinions, statements in favor of dual-chamber pacing were made in guidelines published by the British Pacing and Electrophysiology Group (a specialist subgroup of the British Cardiac Society)20 and jointly by the American Heart Association (AHA) and the American College of Cardiology (ACC).26 The rate of dual-chamber pacemaker implantation, however, has remained lower than recommended in most countries: This low rate has been
SMALL CROSSOVER STUDIES
In an appraisal of current data on dual-chamber versus ventricular pacing,21 the authors (S. J. C., C. R. K.) summarized the results of many small crossover trials assessing the effect of pacing mode on effort tolerance (Table 1) and quality of life (Table 2). These studies suggest that dual-chamber pacing improves effort tolerance when compared with fixed-rate ventricular pacing but not with rate-adaptive ventricular pacing. The poorer performance with fixed-rate ventricular pacing was
Earlier Studies
In a subsequent review on survival in patients with pacemakers,10 the authors (S. J. C., C. R. K.) alluded to the conflicting retrospective data in the literature regarding pacing mode and survival benefits in patients paced for AV block: The findings of Alpert et al2 in 180 patients and Linde-Edelstam et al58 in 148 patients suggested probable survival benefits with physiologic pacing only in patients with congestive heart failure, whereas overall total mortality was similar in the two patient
PROSPECTIVE RANDOMIZED STUDIES
Three small-scale randomized, controlled studies on the effect of pacing mode selection on clinical outcome, survival, or quality of life have been reported (Table 6).
ONGOING CLINICAL TRIALS
Seven well-recognized but as yet unpublished randomized, controlled trials assess the effects of pacing mode selection on clinical outcomes, survival, or quality of life. Four studies have been completed, although not yet fully reported, and the other three are still in progress. These studies are summarized in Tables 7 and 8.
OTHER PACING TRIALS
As stated in the introductory section, clinical bradycardia from sick sinus syndrome or AV conduction disease has been the major indication for permanent pacemaker implantation worldwide.12, 38, 47, 75 Observational studies and prospective trials on pacing have been performed mainly on these patient populations. The discussion on pacemaker trials in this article has focused on the conventional comparison between physiologic (single-chamber atrial or dual-chamber) and nonphysiologic
CONCLUSIONS
Nonrandomized observational data appear to lend support to the theoretic advantage of physiologic pacing over nonphysiologic ventricular pacing in terms of major clinical outcomes and survival benefits. These studies are weak methodologically, however. The first prospective randomized, controlled trial on pacing mode selection, the Danish Study, was a relatively small-scale study on 225 elderly patients with sick sinus syndrome.8 After the initial 3.3 years of follow-up, ventricular pacing was
ACKNOWLEDGMENTS
We thank Dr. Anzhen Qi, of the Division of Cardiology, St. Paul's Hospital, Vancouver, for her assistance in the preparation of some of the tables and figures in this article.
References (116)
- et al.
Comparative survival after permanent ventricular and dual chamber pacing for patients with chronic high degree atrioventricular block with and without preexistent congestive heart failure
J Am Coll Cardiol
(1986) - et al.
Comparative survival following permanent ventricular and dual-chamber pacing for patients with chronic symptomatic sinus node dysfunction with and without congestive heart failure
Am Heart J
(1987) - et al.
Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome
Lancet
(1997) - et al.
Prospective randomised trial of atrial versus ventricular pacing in sick-sinus syndrome
Lancet
(1994) - et al.
Alterations in left ventricular relaxation during atrioventricular pacing in humans
J Am Coll Cardiol
(1990) - et al.
Survey of cardiac pacing in the United States in 1989
Am J Cardiol
(1992) - et al.
Experiences with atrial pacing
Am J Cardiol
(1988) - et al.
Natural history of sinus node disease treated with atrial pacing in 213 patients: Implications for selection of stimulation mode
J Am Coll Cardiol
(1992) - et al.
Canadian Atrial Fibrillation Anticoagulation (CAFA) study
J Am Coll Cardiol
(1991) - et al.
Combined use of beta-adrenergic blocking agents and long-term cardiac pacing for patients with the long QT syndrome
J Am Coll Cardiol
(1992)
Influence of cardiac pacing mode on the long-term development of atrial fibrillation
Am J Cardiol
Randomized prospective pilot study of long-term dual-site atrial pacing for prevention of atrial fibrillation
Mayo Clin Proc
Temporal dispersion of recovery of excitability in atrium and ventricle as a function of heart rate
Am Heart J
Deleterious effects of long-term single-chamber ventricular pacing in patients with sick sinus syndrome: The hidden benefits of dual-chamber pacing
J Am Coll Cardiol
Relation between mode of pacing and long-term survival in the very elderly
J Am Coll Cardiol
Hemodynamic importance of preserving the normal sequence of ventricular activation in permanent cardiac pacing
Am Heart J
Effects of long-term right ventricular apical pacing on left ventricular perfusion, innervation, function and histology
J Am Coll Cardiol
Contribution of atrial contraction to left ventricular filling in patients with sick sinus syndrome on AAI pacing
Int J Cardiol
Dual-chamber pacing for hypertrophic cardiomyopathy: A randomized, double-blind, crossover trial
J Am Coll Cardiol
Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: The Copenhagen AFASAK study
Lancet
Clinical and hemodynamic comparison of VVI versus DDD pacing in patients with DDD pacemakers
Am J Cardiol
Long-term pacing in sinus node disease: Effects of stimulation mode on cardiovascular morbidity and mortality
Am Heart J
Relative importance of activation sequence compared to atrioventricular synchrony in left ventricular function
Am J Cardiol
Relation of prognosis in sick sinus syndrome to age, conduction defects and modes of permanent cardiac pacing
Am J Cardiol
Single-chamber ventricular pacing is not associated with worsening heart failure in sick sinus syndrome
Am J Cardiol
Dual-chamber sequential pacing management of sinus node dysfunction: Advantages over single-chamber pacing
Am Heart J
Dual chamber pacemaker implantation has a higher early complication rate than single chamber pacing [letter; comment]
Pacing Clin Electrophysiol
Modulation of the arterial coronary blood flow by asynchronous activation with ventricular pacing
Pacing Clin Electrophysiol
Pacing in sick sinus syndrome—need for a prospective, randomized trial comparing atrial with dual chamber pacing [edit]
Pacing Clin Electrophysiol
Arterial thromboembolism in patients with sick sinus syndrome: Prediction from pacing mode, atrial fibrillation, and echocardiographic findings
Heart
The pacing therapies for CHF (PATH-CHF) Study
Am J Cardiol
Survival, quality-of-life, and clinical trials in pacemaker patients
Atrial versus ventricular stimulation in sick sinus syndrome: Effects on morbidity and mortality [abstr]
Pacing Clin Electrophysiol
Pacing mode and long-term survival in elderly patients with congestive heart failure: 1980–1985
J Interv Cardiovasc Electrophysiol
Is DDD superior to VVI pacing in mixed carotid sinus syndrome? An acute and medium-term study
Pacing Clin Electrophysiol
Systematic trial of pacing to prevent atrial fibrillation (STOP-AF) [edit]
Heart
Single chamber atrial pacing: An underused and cost-effective pacing modality in sinus node disease
Heart
Recommendations for pacemaker prescription for symptomatic bradycardia
Br Heart J
Dual-chamber versus ventricular pacing: Critical appraisal of current data
Circulation
Pathology of atrial fibrillation in man
Br Heart J
Cost implications of the British Pacing and Electrophysiology Group's recommendations for pacing
BMJ
The role of pacemaker therapy in the prevention of atrial fibrillation
Semin Interv Cardiol
Guidelines for implantation of cardiac pacemakers and antiarrhythmia devices
J Am Coll Cardiol
Long-term follow-up of patients treated with VVI pacing and sequential pacing with special reference to VA retrograde conduction
Pacing Clin Electrophysiol
EuroQol—a new facility for the measurement of health-related quality of life
Health Policy
Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation
N Engl J Med
Atrial synchronized ventricular pacing: Contribution of the chronotropic response to improved exercise performance
Pacing Clin Electrophysiol
Design and implementation of the Dual Site Atrial Pacing to Prevent Atrial Fibrillation (DAPPAF) clinical trial. DAPPAF Phase 1 Investigators
J Interv Cardiovasc Electrophysiol
Incidence of atrial fibrillation in patients with different mode of pacing: Long-term follow-up
Pacing Clin Electrophysiol
Atrial pacing periablation for prevention of paroxysmal atrial fibrillation. (PA)3 Study Investigators
Circulation
Cited by (17)
Clinical Trials of Pacing Modes
2007, Clinical Cardiac Pacing, Defibrillation, and Resynchronization TherapyClinical trials of pacing modes
2006, Clinical Cardiac Pacing, Defibrillation and Resynchronization TherapyPacing interventions for falls and syncope in the elderly
2002, Clinics in Geriatric MedicineCardiac pacing: A review
2001, Medical Clinics of North AmericaCitation Excerpt :In the third study, the Canadian Trial of Physiological Pacing (CTOPP), 2568 patients were randomized to physiologic (AAI or DDD) pacing or VVI pacing, and follow-up was for 3 years. Physiologic pacing reduced significantly the development of atrial fibrillation but did not result in improved survival.198,210 According to the results of the previously mentioned Danish trial, 3 years is not enough time to prove survival benefit from reduction in atrial fibrillation, but this effect may show up later.
Address reprint requests to Chuen Y. Tang, MBBS, Minneapolis Heart Institute, Abbott Northwestern Hospital, 920 East 28th Street, Suite 300, Minneapolis, MN 55407, e-mail: [email protected]