on behalf of the PARTNER InvestigatorsBackground-In patients with severe aortic stenosis who cannot have surgery, transcatheter aortic valve replacement (TAVR) has been shown to improve survival and quality of life compared with standard therapy, but the costs and cost-effectiveness of this strategy are not yet known. Methods and Results-The PARTNER trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgery to TAVR (nϭ179) or standard therapy (nϭ179). Empirical data regarding survival, quality of life, medical resource use, and hospital costs were collected during the trial and used to project life expectancy, quality-adjusted life expectancy, and lifetime medical care costs to estimate the incremental cost-effectiveness of TAVR from a US perspective. For patients treated with TAVR, mean costs for the initial procedure and hospitalization were $42 806 and $78 542, respectively. Follow-up costs through 12 months were lower with TAVR ($29 289 versus $53 621) because of reduced hospitalization rates, but cumulative 1-year costs remained higher ($106 076 versus $53 621). We projected that over a patient's lifetime, TAVR would increase discounted life expectancy by 1.6 years (1.3 quality-adjusted life-years) at an incremental cost of $79 837. The incremental cost-effectiveness ratio for TAVR was thus estimated at $50 200 per year of life gained or $61 889 per quality-adjusted life-year gained. These results were stable across a broad range of uncertainty and sensitivity analyses. Conclusions-For patients with severe aortic stenosis who are not candidates for surgery, TAVR increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR.

Background-In patients with paroxysmal atrial fibrillation (AF), catheter ablation maintains sinus rhythm more effectively than antiarrhythmic drugs (AADs), but its effect on symptoms and quality of life (QOL) has not been fully characterized. Methods and Results-We evaluated symptoms and QOL in a multicenter, randomized trial comparing catheter ablation with AADs as second-line treatment for patients with paroxysmal AF. The Short Form (SF)-36 health survey and the AF Symptom Checklist were administered at baseline and 3, 6, and 9 months after a blanking or dose-titration period.The primary between-group comparisons were conducted at 3 months because of permitted crossover from AAD to ablation beyond this time. Additional analyses based on subsequent follow-up were performed, including the construction of mixed linear regression models to assess the impact of multiple factors on follow-up QOL scores. At baseline in both the ablation (nϭ103) and the AAD (nϭ56) groups, 7 of 8 SF-36 scales were well below population norms, as were the physical (PCS) and mental (MCS) summary scores. At 3 months, the same 7 SF-36 scales were significantly (PϽ0.01) higher in the ablation than in the AAD group, as were the PCS (52.0Ϯ7.

Among U.S. patients in the ACUITY trial, bivalirudin monotherapy compared with heparin + GPI resulted in similar protection from ischemic events, reduced bleeding, and shorter length of stay. Despite higher drug costs, aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy. Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).

Background-Sirolimus-eluting stents (SESs) were recently shown to be superior to vascular brachytherapy for the treatment of restenosis within a bare metal stent. No economic comparison of these alternative strategies has yet been reported.