Transcatheter aortic valve implantation (TAVI): risky and costly.

Around the world, tens of thousands of people have been treated for a life threatening heart condition using a minimally invasive technique that many see as the wave of the future. Transcatheter aortic valve implantation (TAVI) offers hope to patients too old or too ill for conventional aortic valve replacement operations, and since its introduction 10 years ago it has spread swiftly—by the end of 2011, an estimated 40 000 transcatheter implantations had been done. But serious unanswered questions remain over the clinical outcomes and the cost effectiveness of TAVI, as well as the regulatory process that enabled it to gain such a large market so rapidly, particularly in Europe. Aortic stenosis, the progressive failure of the aortic valve to open fully, is the commonest type of valve disease in elderly people. It is usually treated by valve replacement surgery, but around a third of those who might benefit are turned down because the risks of surgery are too high or because problems such as a calcified aorta or scarring from previous surgery make them unsuitable for surgery. Untreated, most will die within five years. TAVI offers an alternative, in which a replacement valve is introduced through an artery via a small incision (usually the femoral artery) or, less often, surgically with an incision into the chest and then into the left ventricular apex—the transapical approach. The numbers who could potentially benefit from TAVI are very large. Almost 3% of people over 75 have aortic valve disease, which means that in England alone there are more than 100 000 patients in whom aortic valve surgery might at a given moment be contemplated. But only around 1200 aortic valve replacements are carried out in this age group in England each year. This helps explain the enthusiasm with which TAVI has been taken up, and the large potential market. In April 2011, a New York securities analyst for the financial services company Wells Fargo estimated that TAVI could generate more than $2.4bn (£1.5bn; €2bn) in sales in the US and account for more than a third of aortic valve replacements by 2015.Cardiologists in the US also expect growing demand from patients who are suitable for conventional surgery but who prefer the quicker and less painful transcatheter option. Data reported at the European Society of Cardiology (EuroPCR) meeting in Paris inMay suggested that transcatheter procedures have more than tripled in Europe since 2009, rising to 18 372 in 2011. Germany is far ahead of other European nations, being responsible for 43% of all TAVIs, followed by France (13%), Italy (10%), and the UK and Ireland (7%). Approval processes