Impact of routine transoesophageal echocardiography on safety, outcomes, and cost of pulmonary vein ablation: inferences drawn from a decision analysis model.

AIMS: The practice of routine vs. selective transoesophageal echocardiography (TEE) surveillance for left atrial appendage or intracavitary thrombus prior to pulmonary vein isolation (PVI) varies widely as evidence to guide this decision in terms of important clinical outcomes is lacking. METHODS AND RESULTS: We constructed a decision analysis model to compare the cost-effectiveness of routine TEE for detection of left atrial thrombus vs. no TEE. The model incorporated health outcomes and costs. Markov methodology was used to follow patients as they transition through varying health states. We examined a hypothetical cohort of patients with symptomatic atrial fibrillation suitable for PVI, and expected outcomes were modelled over a period of 2 years. Simulated patients (SPs) undergoing a strategy of a routine TEE experienced significantly fewer transient ischemic attacks (TIAs) [OR 0.28 (0.22-0.37)], and debilitating strokes [OR 0.23 (0.15-0.33)]. Routine TEE led to an absolute risk reduction for stroke of 1.2% [number needed to treat (NNT) 84 (79-100)] and 1.9% for TIA [NNT 53 (48-59)]. The incremental cost-effectiveness ratio (ICER) for TEE was $226,608 per quality-adjusted life year (QALY). The ICER for TEE among high-risk SPs, with pre-existing clot in the left atrium, was $2232 per QALY. CONCLUSION: Decision analysis and microsimulation suggest that routine use of TEE in an unselected population prior to PVI lowers the incidence of cerebral thrombo-embolic events but with considerable cost per QALY.

Ejection fraction assessment and survival: an analysis of the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

BACKGROUND: Ejection fraction (EF) is an important method of mortality prediction among cardiac patients, and has been used to identify the highest risk patients for enrollment in the defibrillator primary prevention trials. Evidence suggests that measures of EF by different imaging modalities may not be equivalent. In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), the type of imaging modality for EF assessment was not mandated. METHODS: Baseline assessment of EF was performed using either echocardiography, radionuclide angiography (RNA), or contrast angiography. Multivariable analysis using a Cox proportional hazards model was used to examine whether the modality of assessing EF affected the likelihood of survival. RESULTS: Among the 2,521 patients enrolled in SCD-HeFT, EF was measured by RNA in 616 (24%), echocardiography in 1,469 (58%), and contrast angiography in 436 (17%). Mean EF as measured by RNA was 25.1% +/- 6.9%; by echocardiography, 23.8 +/- 6.9%; and by angiography, 21.9 +/- 6.9%. These measures were significantly different (P < .001), and each pairwise comparison differed significantly (P < .001 for each). Multivariable analysis showed no significant difference in survival between patients enrolled based on RNA versus echocardiography (HR 1.06, 95% CI 0.88-1.28), RNA versus angiography (HR 1.25, 95% CI 0.97-1.62), or echocardiography versus angiography (HR 1.18, 95% CI 0.94-1.48). CONCLUSIONS: Among patients enrolled in SCD-HeFT, the distribution of ejection fractions measured by radionuclide angiography differed from those measured by echocardiography or contrast angiograms. Survival did not differ according to modality of EF assessment.

Is defibrillation testing still necessary? A decision analysis and Markov model.

OBJECTIVE: To assess the impact of defibrillation threshold (DFT) testing of implanted cardioverter-defibrillators (ICDs) on survival. BACKGROUND: DFT testing is generally performed during implantation of ICDs to assess sensing and termination of ventricular fibrillation. It is common clinical practice to defibrillate ventricular fibrillation twice at an output at least 10 J below the maximum output of the device, providing a 10 J safety margin. However, there are few data regarding impact of DFT testing on outcomes. METHODS: Decision analysis and Monte Carlo simulation were used to assess expected outcomes of DFT testing. Survival of a hypothetical cohort of patients was assessed according to two strategies-routine DFT testing at time of ICD implant versus no DFT testing. Assumptions in the model were varied over a range of reasonable values to assess outcomes under a variety of scenarios. RESULTS: Five-year survival with DFT and no-DFT strategies were similar at 59.72% and 59.36%, respectively. The results were not sensitive to changing risk estimates for arrhythmia incidence and safety margin. Results of the Monte Carlo simulation were qualitatively similar to the base case scenario and consistent with a small and nonsignificant survival advantage with routine DFT testing. CONCLUSIONS: The impact of DFT testing on 5-year survival in ICD patients, if it exists, is small. Survival appears higher with DFT testing as long as annual risk of lethal arrhythmia or the risk of a narrow safety margin is at least 5%, although the incremental benefit is marginal and 95% confidence intervals cross zero. A prospective randomized study of DFT testing in modern devices is warranted.

Model study of AREDS antioxidant supplementation of AMD compared to Visudyne: a dominant strategy?

OBJECTIVES: In Ontario, Canada, in a cohort of all people initially aged 50-54 years, modeling whether the Age-Related Eye Disease Study (AREDS) antioxidant supplementation for stage 3 and 4 AMD would decrease the costs of photodynamic treatment with Visudyne. PERSPECTIVE: Third party payer, the Ontario Health Insurance Plan. METHODS: Using reported risk reductions, prevalence data by age and sex from the Beaver Dam studies, and yearly costs: AREDS 182.50 Canadian dollars, potential savings were calculated as the difference or incremental cost between the estimated medical costs for the untreated cohort of 17,000 Canadian dollars for Visudyne treatment of individuals with neovascularization and the same cohort if stage 3 and 4 AMD patients were treated with antioxidants, decreasing progression to neovascularization. Different scenarios were explored for sensitivity analysis of direct cost savings. RESULTS: For the Ontario cohort of approximately 788,000 aged 51-55 years in 2001, for photodynamic therapy of the untreated cohort, modeled costs were 1.7 billion Canadian dollars. AREDS treatment costs would be 513 million Canadian dollars. AREDS would reduce photodynamic therapy costs, a net saving of 431 million Canadian dollars, a saving of 547 Canadian dollars per person in the total cohort, or 6,753 Canadian dollars per stage 3 and 4 patient treated. To explore the sensitivity of this model to AMD incidence rather than prevalence data, Framingham incidence data were incorporated in the model: net savings of 70.3 million Canadian dollars were modeled using Framingham incidence data. CONCLUSION: Under reasonable assumptions, if the case progresses to wet AMD (1) AREDS with Visudyne is less expensive than Visudyne alone in every five-year time period for the cohort that is age 50-54 right now until they become 75-79; thus, the lifetime cost is lower; (2) AREDS with Visudyne yields more QALYs than Visudyne alone in every five-year interval; (3) under all but the most extreme assumptions, the conclusions reached are robust. Even when AREDS costs a little more, it yields more QALYs at a reasonable cost per QALY. Thus, AREDS antioxidant supplementation appears to be a dominant strategy for macular degeneration. Applied to the whole Canadian population, the potential medical cost savings for Visudyne treatment of neovascular AMD are 5.6 billion Canadian dollars in direct costs. These values would be tenfold higher for the USA, because of the currency and population size differences.