A study published ahead of print in the Journal of the American College of Cardiology suggests that the use of transcatheter aortic valve implantation (TAVI) devices varies greatly across Europe and that, overall, the therapy is underused. Furthermore, the study indicates that this underuse is closely associated with national economic indices and reimbursement strategies.
Darren Mylotte, Department of Interventional Cardiology, McGill University Health Center, Montreal, Canada, and others wrote that while anecdotal evidence suggests that TAVI use varies great across Europe, TAVI use in Europe (and factors influencing its use) have not been formally described. They added such information could have “implications for healthcare resource allocation, service deployment planning, assessing equitable patient access, and physician training”. Therefore, Mylotte et al aimed to “address this information gap” by examining trends in TAVI implantation rates and centres across 11 European countries since the intervention was CE marked in 2007. They stated: “In addition, we investigated the factors that may influence the heterogeneous adoption of this novel technology across nations.”
Using data from national registries and databases from the 11 countries (Germany, France, Italy, UK and Northern Ireland, Spain, The Netherlands, Switzerland, Belgium, Portugal, Denmark, and Ireland), the authors identified 158,371 potential TAVI candidates (patients with severe aortic stenosis, who are either inoperable or at high surgical risk). However of these candidates, there were only 28,400 TAVI recipients. Mylotte et al commented: “Thus, the calculated weight average TAVI penetration rate in 2011 was 17.9%.” They added that Germany had the highest penetration rate (36.2%) while Portugal had the lowest penetration rate (3.4%).
According to the authors, gross domestic product (GDP) per capita—thought to be a reliable indicator of a country’s standard of living—was not associated with TAVI use. However, they reported that the number of TAVI implants per million was significantly associated with healthcare spending as a percentage of GDP (p=0.025) and was significantly associated with healthcare spending per capita (p=0.005). They added that although not significant, a trend for increased TAVI use among countries in which healthcare was principally funded by social insurance (eg. Germany) compared with countries in which healthcare was principally funded by taxation (eg. UK) was also observed. Furthermore, Mylotte et al commented: “TAVI-specific reimbursement systems were associated with a 3.3-fold higher number of TAVI implants per million (≥75 years) than constrained systems (p=0.002).”
To validate their findings, the authors used data from BIBA MedTech datasets for TAVI implant numbers. They said: “There was satisfactory agreement between the two sources of information and both provided similar results and conclusions.”
Summarising their results, Mylotte et al commented: “Not surprisingly, the lowest TAVI implantation rates were found in Spain, Portugal, and Ireland who are currently experiencing substantial economic hardship. In these nations, the medical device industry could provide additional support to develop and maintain TAVI programmes.”
They added that adoption of new technology, such as TAVI, was a “slow process” as it required hard clinical evidence, physician training, and clinical and financial planning. However, the authors said that as TAVI was associated with therapeutic benefit in inoperable patients, its known cost-effectiveness, and its less invasive nature, “the protracted uptake of TAVI technology may have negative consequences for patients, physicians, and administrators. Although TAVI penetration is not necessarily a surrogate for quality of medical care, it may suggest the need for enhanced patient access to novel and potentially life-saving therapies.”
Study author Nicolo Piazza, Department of Cardiovascular, German Heart Center, Munich, Germany, told Cardiovascular News: “The results of this study may provide benchmark performance measures (eg. average number of TAVI procedures a centre should be performing) and also may also provide regulatory and government bodies information to better structure TAVI resource use (eg. too many or too little centres within a country or region).”