European TAVR Usage Tied to Economics, Reimbursement

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Transcatheter aortic valve replacement (TAVR) is vastly underutilized in European patients with severe aortic stenosis, according to a study published in the July 16, 2013, issue of the Journal of the American College of Cardiology. The results also indicate that TAVR usage varies by region and is heavily dependent on economics and reimbursement policies.

Nicolo Piazza, MD, PhD, of McGill University Health Center (Montreal, Canada) and German Heart Center Munich (Munich, Germany), and colleagues used registry data and an implantation-based TAVR market tracker to analyze usage rates and patterns in 11 European countries between 2007 and 2011.

TAVR Flourishes in Germany

During the study period, 34,317 patients underwent TAVR. Almost half of all implantations were performed in Germany (45.9%), with Italy (14.9%) and France (12.9%) reporting another one-quarter of procedures combined. Ireland (0.4%) reported the lowest number of implantations.

The highest annual increases in procedural volume in 2011 were seen in France (61%) and Germany (49%), but Ireland (-15%) and Portugal (-3%) observed declines. Overall, the annual number of TAVR procedures increased 33-fold, although the annual procedural volume growth rate decreased from 429% in 2008 to 40% in 2011.

In 2011, the number of procedures per million individuals ranged from 6.1 in Portugal to 88.7 in Germany, with an overall mean of 32.9 ± 24.9 implantations. For patients 75 years and older, the mean rose to 398 ± 283. The number of centers performing TAVR also increased nine-fold during the study period from 37 to 342, with the majority of those in Germany and Italy, while Portugal, Denmark, and Ireland had only 3 each.

Overall, the weighted average TAVR penetration rate throughout Europe was 17.9% in 2011. Germany and Switzerland had the highest individual rates, while Portugal and Spain had the lowest.

Lastly, the researchers compared TAVR usage with economic and reimbursement indices and found a correlation between both the number of implantations per million patients ≥ 75 years old and health care spending as a percentage of gross domestic product (P = 0.025) and health care spending per capita (P = 0.005). There was a trend toward increased TAVR use in nations with socialized health care compared with nations whose insurance is funded by taxation (P = 0.056). Furthermore, TAVR-specific reimbursement systems were associated with a 3.3-fold higher number of implantations per million patients ≥ 75 years old than constrained systems (P = 0.002). Nations with procedural reimbursement were also associated with 2.5 times more implantations per center than those without (P = 0.008).

‘Sizeable Treatment Gap’ Remains

“Despite the rapid adoption of TAVR across Europe, our findings indicate that a sizeable treatment gap remains for high/prohibitive surgical risk patients with severe aortic stenosis,” Dr. Piazza and colleagues write.

Several reasons exist for the divergence of TAVR usage among countries, they observe. “The economic challenge of providing progressive care for an aging population has mandated that the use of new medical device technologies be not only determined by the expectation of improved clinical outcomes but also by cost effectiveness,” the authors note. “It is axiomatic, therefore, that the magnitude of health care resources influences the adoption of new medical device technology.” Because Spain, Portugal, and Ireland are currently experiencing economic hardship, it is not surprising that they report the lowest TAVR rates, they add.

Since procedural reimbursement and health care funding have been previously shown to influence the use of ICDs and coronary stents, the authors write that these systems are “critical factors in determining the adoption of new medical device technology.” Still, “[o]ur estimates of TAVR penetration suggest that TAVR remains underutilized in Western Europe.

“The adoption of new technology can be a slow process,” they continue. “It requires a threshold of robust clinical evidence, device iteration, physician training, and clinical and financial planning. Moreover, the cultural change required to embrace new therapies often evolves gradually.”

Dr. Piazza and colleagues argue that TAVR penetration may not necessarily be a surrogate for quality of medical care but, “may suggest the need for enhanced patient access to novel and potentially life-saving therapies.” Looking at nations with higher penetration rates, “a move toward treating patients at less extreme surgical risk may be emerging,” they observe.

 

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Source:
Mylotte D, Osnabrugge RLJ, Windecker S, et al. Transcatheter aortic valve replacement in Europe: Adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013;62:210-219.

 

 

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