Transcatheter aortic valve replacement (TAVR) in Western Europe appears to have traveled a bumpy road since its approval in 2007, based on an analysis of its uptake in 11 countries. TAVR is underutilized and adoption varied by country, possibly due to economic and reimbursement constraints. The study was published online May 22 in the Journal of the American College of Cardiology.
Both the Sapien (Edwards Lifesciences) and CoreValve (Medtronic) valve systems received CE mark in Europe in 2007 as treatment for patients with severe aortic stenosis who are at high surgical risk. Darren Mylotte, MD, of McGill University Health Centre in Montreal, and colleagues tracked utilization trends in TAVR adoption between approval and 2011 to assess its uptake and factors that may affect market penetration.
They obtained registry and reimbursement data from 11 countries: Germany, France, Italy, the U.K. and Northern Ireland, Spain, the Netherlands, Switzerland, Belgium, Denmark and the Republic of Ireland. They also cross-referenced registry data with data from BIBA MedTech, a market analysis firm that has tracked TAVR use since 2009, and collected demographic and economic data from the European Union and the Organization for Economic Co-operation and Development. For reimbursement, they compared two pathways, depending on the national system: complete or constrained (partial) reimbursement.
Between 2007 and 2011, 34,317 patients underwent TAVR, with 45.9 percent of cases performed in Germany. Italy and France had the second and third highest rates, at 14.9 percent and 12.9 percent. The number of annual implants grew from 455 in 2007 to 14,946 in 2011 and the number of implanting centers rose from 37 to 342.
France had the highest annual increase in procedural volume (61 percent) and Ireland the lowest (minus 15 percent), followed by Portugal (minus 3 percent). Portugal also chalked up the lowest number of TAVR implants per million in population (6.1) compared with Germany, the highest, at 88.7.
Mylotte et al determined that were 28,400 living TAVR recipients and 158,371 potential candidates, for a weighted average penetration rate of 17.9 percent in 2011. Germany achieved the highest penetration rate, at 36.2 percent, and Portugal the lowest, at 3.4 percent.
Germany, France, Switzerland and Denmark offered complete reimbursement (although its introduction year varied) while the U.K., Spain, the Netherlands, Belgium, Portugal and Ireland had constrained reimbursement. They excluded Italy from the reimbursement analysis because reimbursement systems varied by province.
Reimbursement strategy impacted utilization. Systems where TAVR procedures were reimbursed through a therapy-specific national diagnosis-related group tariff had three times the number of procedures per million for those 75 years old or older and more than two times as many implants per center than constrained systems.
Mylotte et al pointed out that countries battered by economic troubles such as Portugal, Spain and Ireland showed the lowest implantation rates. Variability in TAVR use may reveal gaps in care; they recommended that industry step up and provide additional support to facilitate adoption. They underscored the role of reimbursement and funding on the adoption of new technologies, and wrote that the 17.9 percent penetration rate suggests TVAR is underutilized.
“The adoption of new technology can be a slow process. It requires a threshold of hard clinical evidence, device iteration, physician training, clinical and financial planning,” Mylotte and colleagues wrote. “Moreover, the cultural change required to embrace new therapies often evolves gradually. Given the therapeutic benefit associated with TAVR in inoperable patients (number needed to treat = 5), the demonstrable cost-effectiveness in both excessive and high-risk cohorts, and the less invasive nature of TAVR procedures, the protracted uptake of TAVR technology may have negative consequences for patients, physicians, and administrators.”
They wrote that registry data should be considered estimates that may underestimate TAVR use and likely included patients treated off-label.