Shelley Wood

May 17, 2012

May 17, 2012 (Paris, France) — New data unveiled at EuroPCR 2012 yesterday are offering a fresh snapshot of just how quickly the number of TAVI procedures is increasing in Europe and where these are taking place.

Since the first devices were approved in Europe in 2007, Germany has led the continent in implantations: by 2011, Germany hospitals had implanted a full 43% of all TAVI devices in Europe, the same proportion it held in 2010, as reported by heartwire last November. In a distant second place was France, with 13% of procedures, followed by Italy and the UK/Ireland, with 10% and 7%, respectively.

Presenting the data, Dr Nicolo Piazza (German Heart Center, Munich) noted that for Europe as a whole, TAVI procedures have more than tripled in recent years, from 4498 in 2009, rising to 14 599 in 2010, and to 18 372 in 2011. The average implantation rate for Europe was 40.9 per million inhabitants in 2011, up from 32.6 in 2010.

Broken down by nation, only a handful of countries showed significant increases from one year to the next: Germany's rate per million rose from less than 80 in 2010 to 96 in 2011, Austria's rose from 50 to 76, Denmark's rate rose from less than 40 to 60, and Norway's doubled from about 12 to 25 per million. Other countries, like Switzerland and the Netherlands, remained more static, at just under 80 and just under 50 per million, respectively, in both years.

Those increases tend to reflect countries where diagnosis-related-group (DRG) payments have been instituted covering the full cost of the procedure. For example, in Germany, Austria, and Switzerland, the DRG covers all costs, likely explaining the high use of TAVI procedures in those countries. France covers all costs but limits performance of the procedure to 33 centers, while in the UK a decision to proceed with a TAVI is negotiated at the local level.

During the Q&A following Piazza's presentation, Dr Peter Wenaweser (Bern University Hospital, Switzerland) asked Piazza whether reimbursement was the only driver of differences between countries or whether "excellence of the heart team" also accounted for the variability.

Piazza's answer was "both," acknowledging that the high cost of the procedure and who is paying for it would inevitably shape procedure numbers, but he also stressed the role of physician leaders and hospitals and the "drive and willingness to start a program."

Piazza also attempted to gauge how many TAVI-suited patients go untreated in the UK, a number he acknowledged was "something very difficult to calculate."

Using published reports on the prevalence of severe, symptomatic AF; estimates of what proportion are deemed "inoperable"; plus rates of nonreferral for surgery, Piazza came up with an estimate of more 150 000 patients in Europe, at any one time, who are likely good candidates for TAVI. That number is just 1% of patients 75 years of age or older with severe aortic stenosis.

But those numbers may, in truth, vary widely, he acknowledged, since his calculations are based on published assumptions that are already shifting. For one, Wenaweser pointed out, the oft-quoted estimate that "one-third" of patients are never referred for aortic-valve surgery has been declining, as surgeons, faced with some attrition of their patient base, tackle more complex cases. On the other hand, registry reviews from a range of European centers are also clarifying that many "inoperable" patients treated with TAVI in the heady early days of device approval in Europe were likely not suitable for the percutaneous procedure (and should have been managed medically) or were in fact patients who could have done well with surgical valve replacement.

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