Cost-effectiveness of transcatheter aortic valve replacement: overoptimistic study results and a call for publication of complete trial results

• EBM
• implantable cardioverter defibrillator (ICD)
• cardiac resynchronisation therapy
• left ventricular assist device
• percutaneous valve therapy

To the Editor We read with interest the article ‘Cost-effectiveness of transcatheter aortic valve replacement in patients ineligible for conventional aortic valve replacement’ published in Heart.1 In 2011, we prepared a Health Technology Assessment report on transcatheter aortic valve implantation (TAVI) at the Belgian Health Care Knowledge Centre (KCE), including a critical appraisal of the PARTNER trial and a health-economic evaluation. The economic evaluation in Heart concludes that TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis who are currently ineligible for surgical aortic valve replacement. Based on our critical appraisal of the PARTNER trial and the economic evaluation, we argue that the results and conclusions of the industry-sponsored economic evaluation are overoptimistic.

First, only the most favourable results seen in inoperable patients (PARTNER cohort B) were published in the New England Journal of Medicine.2 At the FDA meeting of 20 July 2011, additional data related to the randomised Continued Access trial were briefly presented. This trial was performed according to the same study protocol as the pivotal PARTNER cohort B. Whereas in the latter, 1-year mortality was much better with TAVI than with standard treatment, it was worse in the former (table 1).

In the pivotal trial, in contrast to the authors' claim, baseline characteristics were not well balanced: the logistic EuroSCORE, chronic obstructive pulmonary disease, atrial fibrillation and other characteristics all favoured the TAVI group. Anatomically inoperable patients are also over-represented …