Health economic evaluation of single-lead atrial pacing vs. dual-chamber pacing in sick sinus syndrome.

AIMS: The recent Danish Multicentre Randomized Trial on Single-Lead Atrial (AAIR) Pacing versus Dual-Chamber (DDDR) Pacing in Sick Sinus Syndrome (DANPACE) suggested DDDR pacing as standard care. However, previous findings supported the routine use of AAIR pacing. This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome. METHODS AND RESULTS: A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system's perspective. The main outcomes were lifetime costs, quality-adjusted lifeyears (QALYs), and net monetary benefit. Quality-adjusted lifeyears were calculated by utilizing community-based preferences. Costs were calculated by utilizing the extensive data on resource consumption, from the DANPACE trial. Data were pooled and adjusted for baseline differences. Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay (WTP) threshold of £20,000/QALY, and most analyses using a WTP of £30,000/QALY. When pooling the data and adjusting for baseline differences, Monte Carlo simulations revealed a 51-71% probability of DDDR pacing being cost-effective at a WTP of £20,000/QALY, and a 42-58% probability at a WTP of £30,000/QALY. Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity. The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged. CONCLUSION: Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients.

The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.

OBJECTIVES: To estimate the effectiveness and cost-effectiveness of dual-chamber pacemakers versus single-chamber atrial or single-chamber ventricular pacemakers in the treatment of bradycardia due to sick sinus syndrome (SSS) or atrioventricular block (AVB). DATA SOURCES: Electronic databases and relevant Internet sites. Contact with device manufacturers and experts in the field. REVIEW METHODS: A systematic review was carried out of randomised controlled trials (RCTs). The quality of selected studies was appraised using standard frameworks. Meta-analyses, using random effects models, were carried out where appropriate. Limited exploration of heterogeneity was possible. Critical appraisal of economic evaluations was carried out using two frameworks. A decision-analytic model was developed using a Markov approach, to estimate the cost-effectiveness of dual-chamber versus ventricular or atrial pacing over 5 and 10 years as cost per quality-adjusted life-year (QALY). Uncertainty was explored using one-way and probabilistic sensitivity analyses. RESULTS: The searches retrieved a systematic review of effectiveness and cost-effectiveness published in 2002, four parallel group RCTs and 28 cross-over trials. Dual-chamber pacing was associated with lower rates of atrial fibrillation, particularly in SSS, than ventricular pacing, and prevents pacemaker syndrome. Higher rates of atrial fibrillation were seen with dual-chamber pacing than with atrial pacing. Complications occurred more frequently in dual-chamber pacemaker insertion. The cost of a dual-chamber system, over 5 years, including cost of complications and subsequent clinical events in the population, was estimated to be around 7400 pounds. The overall cost difference between single and dual systems is not large over this period: around 700 pounds more for dual-chamber devices. The cost-effectiveness of dual-chamber compared with ventricular pacing was estimated to be around 8500 pounds per QALY in AVB and 9500 pounds in SSS over 5 years, and around 5500 pounds per QALY in both populations over 10 years. Under more conservative assumptions, the cost-effectiveness of dual-chamber pacing is around 30,000 pounds per QALY. The probabilistic sensitivity analysis showed that, under the base-case assumptions, dual-chamber pacing is likely to be considered cost-effective at levels of willingness to pay that are generally considered acceptable by policy makers. In contrast, atrial pacing may be cost-effective compared with dual-chamber pacing. CONCLUSIONS: Dual-chamber pacing results in small but potentially important benefits in populations with SSS and/or AVB compared with ventricular pacemakers. Pacemaker syndrome is a crucial factor in determining cost-effectiveness; however, difficulties in standardising diagnosis and measurement of severity make it difficult to quantify. Dual-chamber pacing is in common usage in the UK. Recipients are more likely to be younger. Insufficient evidence is currently available to inform policy on specific groups who may benefit most from pacing with dual-chamber devices. Further important research is underway. Outstanding research priorities include the economic evaluation of UKPACE studies of the classification, diagnosis and utility associated with pacemaker syndrome and evidence on the effectiveness of pacemakers in children.

The mode selection trial (MOST) in sinus node dysfunction: design, rationale, and baseline characteristics of the first 1000 patients.

BACKGROUND: More than 200,000 permanent pacemakers will be implanted in the United States in 2000 at a cost of more than $2 billion. Sick sinus syndrome (SSS) will likely account for approximately half of all cases necessitating implantation. Pacemaker technology permits the selection of ventricular (single-chamber) or dual-chamber devices. However, clinical and outcomes data are inadequate to support a clear recommendation that one or the other type of device be used. METHODS: The Mode Selection Trial (MOST) is a single-blind study supported by the National Heart, Lung, and Blood Institute designed to enroll 2000 patients with SSS. All patients will receive a DDDR pacemaker programmed to VVIR or DDDR before implantation. The average time of follow-up will be 3 years. MOST has a >90% power to detect a 25% reduction in the primary end point-nonfatal stroke or total (all cause) mortality-in the DDDR-treated group. Secondary end points will include health-related quality of life and cost effectiveness, atrial fibrillation, and development of pacemaker syndrome. Prespecified subgroups for analysis will include women and the elderly. Enrollment was completed in October 1999, with a total of 2010 patients. RESULTS: The median age of the first 1000 enrolled patients is 74 years, with 25% of patients 80 years or older. Women comprise 49%, and 17% are nonwhite, predominantly black (13%). Before pacemaker implantation, 22% of patients reported a history of congestive heart failure, 11% coronary angioplasty, and 25% coronary bypass surgery. Supraventricular tachycardia including atrial fibrillation was present in 53% of patients. A prior stroke was reported by 12%. Antiarrhythmic therapy was in use in 18% of patients. CONCLUSIONS: MOST will fill the clinical need for carefully designed prospective studies to define the benefits of dual-chamber versus single-chamber ventricular pacing in patients with SSS. The MOST population is typical of the overall pacemaker population in the United States. Thus the final results of MOST should be clinically generalizable.

Cost benefit analysis of single and dual chamber pacing for sick sinus syndrome and atrioventricular block. An economic sensitivity analysis of the literature.

The benefits of dual (DDD) over single chamber pacing (VVI) have been demonstrated in haemodynamics, exercise capacity, quality of life and reduced complications in atrioventricular block and sick sinus syndrome. The literature was reviewed to provide complication rates for dual and VVI pacing. Cost calculations were based on United Kingdom 1991 prices. Over a 10-year period, a computer model calculated the incidence and prevalence of atrial fibrillation, stroke, permanent disability, heart failure and mortality in six patient categories: sick sinus syndrome paced VVI, sick sinus syndrome upgraded to DDD, sick sinus syndrome paced DDD from outset, atrioventricular block paced VVI and those upgraded to DDD and atrioventricular block paced initially DDD. Calculations were based on intention to treat. The 10 year survival with DDD vs VVI pacing was 71% vs 57% in sick sinus syndrome and 61% vs 51%, respectively, in atrioventricular block. In both indications the prevalence of heart failure in the 10 year survivors was 60% lower with DDD pacing. In sick sinus syndrome patients paced VVI, 36% had severe disability while only 8% experienced this with DDD pacing. For atrioventricular block the figures were, respectively, 22% vs 3%. The difference in 10 year cumulative cost between VVI and DDD is 13 times the purchase price of a VVI pulse generator for sick sinus syndrome and 7 times for atrioventricular block. In the third year after implantation the cumulative costs of DDD were lower than for VVI for both indications. Dual chamber pacing for both indications, sick sinus syndrome and atrioventricular block, is both clinically and cost effective.