Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Effect of radiofrequency catheter ablation of ventricular tachycardia on left ventricular function in patients with prior myocardial infarction.

INTRODUCTION: Successful RF ablation of VT late after MI can involve multiple applications and long lines of RF lesions. The impact on left ventricular function is potentially important, but not well defined. Quantitative echocardiography was used to determine the effect of radiofrequency (RF) ablation on left ventricular function in patients with ventricular tachycardia (VT) after myocardial infarction (MI). METHODS AND RESULTS: In 62 patients (55 men; age 67 +/- 1.1 yr.) who underwent RF ablation for VT late after MI, left ventricular ejection fraction (LVEF) was quantified from digitized echocardiograms performed 25 RF lesions (Pre-LVEF 28.5 +/- 11.1% vs. Post-LVEF 28.1 +/- 10.8%, p = 0.74) or for the 7 patients who received >40 RF lesions (Pre-LVEF 29.9 +/- 12.7% vs. Post-LVEF 29.2 +/- 6.2%, p = 0.84). Although LVEF did not change for the group, LVEF increased >5% in 12/62 (19.4%) pts and decreased >/=5% in 14/62 (22.5%) pts. Patients with a decrease in EF did not differ from the remaining patients with respect to age, gender, number of RF lesions, or use of a cooled RF catheter, but did have a better initial EF (38.8 +/- 12.2% versus 27.2 +/- 10.6%, p = 0.001). CONCLUSION: Multiple RF ablation lesions confined to infarct regions do not measurably affect LV function, but a cautious approach, confining ablation lesions to areas of scar, as was attempted in this study, seems prudent.