Medtronic has revealed the results of a cost-effectiveness model comparing transcatheter aortic valve implantation (TAVI) with the CoreValve System to medical management. Presented at EuroPCR (21–24 May, Paris, France), the UK-based analysis compared the “real world” Medtronic CoreValve ADVANCE study to the medical management cohort of the PARTNER B study and found that the CoreValve System was cost-effective. Patients participating in this study had severe aortic stenosis and were unable to undergo surgery.
According to a Medtronic press release, for both treatment pathways the cost-effectiveness model compared the benefits (including life years gained and improvement in quality of life) to lifetime costs (including procedure, device, physician, hospitalisations and other measures) from the perspective of the National Health Service (NHS) in the UK. Well below many developed countries’ cost-effectiveness thresholds, the cost of TAVI with the CoreValve System to gain a year of life was £7,700, and the cost per QALY gained was near £11,300.
“With the low mortality and stroke rates, and the overall improvement in quality of life found in the ADVANCE study, TAVI with CoreValve has shown its worth in medical terms. What this study does is benchmark the financial costs: We can now compare the cost-effectiveness of this intervention against other accepted therapies delivered in a national healthcare delivery system. What we find is that despite the high costs of TAVI, it stacks up extremely favorably in terms of QALYs. In short, it is cost effective,” concluded Stephen Brecker, St George’s Hospital in London, UK, who presented the cost-effectiveness data at EuroPCR. “It is gratifying to know that in addition to excellent outcomes, in the current economic climate TAVI with CoreValve represents good value for healthcare spending.”
The CoreValve ADVANCE study was conducted across 44 centers in 12 countries. In ADVANCE, clinical endpoints are calculated according to Valve Academic Research Consortium (VARC) standardised definitions. All data were independently monitored, all adverse events related to primary endpoints were adjudicated by an independent clinical events committee (CEC), and all cerebrovascular events (including stroke and other events) were adjudicated by an independent neurologist using neuroimaging and systematic NIH Stroke Scale assessments.
According to the company, since receiving CE mark in 2007, the CoreValve System has been implanted in more than 40,000 patients in more than 60 countries. The CoreValve System is available in four valve sizes (23mm, 26mm, 29mm and 31mm), each deliverable via transfemoral, subclavian and direct aortic access through a low-profile, 18Fr delivery catheter. It is not currently approved for commercial use in the USA and is currently undergoing clinical trials in that territory.