Geisler BP, Osnabrugge RL, Huygens SA, Reardon MJ, Kappetein AP, Pietzsch JB. Cost-effectiveness of TAVI vs. surgical aortic valve replacement: the CoreValve high risk trial from a European perspective. Presentation at EuroPCR 2016. EuroIntervention: EuroPCR Book of Abstracts. 2016.

Objectives. To compare economic and clinical outcomes of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in high- but not extreme-risk surgical candidates in a European setting.

Methods and Results. A decision-analytic model was used to project long-term clinical outcomes and costs of the competing strategies. Clinical event probabilities and health-related quality of life (HRQoL) measurements were derived from two-year results of the CoreValve High Risk Study (mean age, 83; mean predicted 30-day mortality [STS PROM], 7.4%; mean logistic EuroSCORE 18%; Charlson comorbidity index ≥5 in 56% of the patients).

Clinical outcomes were modeled considering functional outcomes stratified by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and status pre- and post-stroke. In addition, the following other adverse events were taken into account: acute kidney injury, life-threatening or disabling bleeding, cardiogenic shock, major vascular complication, and permanent pacemaker implantation.

All costs were based on a detailed analysis of preoperative diagnostics, procedural, hospitalization and long-term care resource utilization, including costs of adverse events. Procedural resource utilization was determined using a micro-costing approach at a Dutch academic medical center. A TAVI device price of €18,661 was assumed. Costs and effects were discounted at 4% and 1.5% per annum, and a willingness-to-pay threshold of €80,000 per QALY was adopted.

The effects of parameter uncertainty were evaluated in deterministic sensitivity analyses. In addition, a “lean scenario” was explored for TAVI which assumed a shorter length of stay of 0.5 days in the intensive care unit and 2.5 days on a regular ward, as opposed to 1 and 6 days in the base case. In the early postoperative period, a more rapid recovery in HRQoL was observed with TAVI, along with improved functional outcomes evidenced by a higher proportion of patients in the higher KCCQ stratum. Mean projected survival increased by 0.65 life years (5.62 for TAVI vs. 4.97 for SAVR).

Over the lifetime horizon, TAVI was projected to add 0.41 (3.69 vs. 3.27) quality-adjusted life years (QALYs) at an increased cost of €9,048 (€51,068 vs. €42,020), resulting in an incremental cost-effectiveness ratio (ICER) of €21,946 per QALY gained.

Sensitivity analyses revealed that the main results were robust and relatively insensitive to changes in input parameters; most influential were discount rate for effectiveness, patient age, and proportion of female patients. Threshold analysis of the “lean scenario” indicated that a further cost reduction of approximately €5,400 would make TAVI the dominant strategy, providing superior clinical outcomes at overall cost savings compared to SAVR.

Conclusions. AVI for high-risk surgical candidates is a cost-effective treatment strategy in the studied setting at a level well below commonly accepted willingness-to-pay thresholds. This favorable health-economic value proposition can be expected to improve further in future years.