OBJECTIVES:

TAVI (Transcatheter Aortic Valve Implantation) is a minimally invasive alternative to surgical replacement of the aortic valve (sAVR) and the only treatment option for those considered at too high risk for surgery. We present here the results of a cost-effectiveness analysis of TAVI in inoperable and high risk patients in France based on the most recent clinical data derived from third generation valves.

METHODS:

An Excel based Markov model evaluated economic and clinical outcomes in patients undergoing TAVI, sAVR or medical management (MM) over a 15 year time horizon. Clinical inputs were derived from the PARTNER 1 and 2 clinical trials and quality of life (QoL) utilities derived from study data and transformed into French values. Mortality projections were extrapolated from Kaplan Meier survival estimates. All costs including index admissions, complications, rehabilitation, etc. were derived from French sources. All results were discounted annually by 4.0%. Sensitivity and scenario analyses were performed.

RESULTS:

TAVI was associated with increased quality of life in both inoperable and high risk patients of 1.6162 and 0.5495 quality-adjusted life years (QALYs) compared with sAVR and MM respectively. At currently reimbursed costs for TAVI, the ICER in inoperable patients was €11784 per QALY gained and for high risk patients TAVI was dominant with cost savings of €2003 per patient. Deterministic and probabilistic sensitivity analyses showed the results were generally robust and impacted most by changes in assumptions to procedural costs and mortality.

CONCLUSIONS:

TAVI delivers substantial clinical benefits in terms of improved life expectancy and quality-adjusted life expectancy in inoperable and high risk patients. For inoperable patients the ICER for TAVI versus sAVR would generally be considered to represent a cost‑effective therapy and for high risk patients TAVI is a cost saving option.