Concerns over minimally invasive heart valve surgery

July 31, 2012

A new type of heart valve surgery known as transcatheter aortic valve implantation "cannot be justified on medical or cost effectiveness grounds" warn experts in a paper published in BMJ today.

Hans Van Brabandt from the Belgian Health Care Knowledge Centre and colleagues describe the procedure as "risky and costly" and call for better regulation and transparency around the use of such high risk medical devices.

TAVI is a minimally for patients with aortic who are too old or too ill for conventional . In patients who are suitable for conventional surgery, survival after TAVI is equivalent to conventional surgery, but the risk of stroke is higher. TAVI is also much more expensive than conventional surgery.

Since its introduction 10 years ago, around 40,000 procedures have been carried out worldwide.

TAVI is classed as a medical device. In Europe this means it needs only a simple quality certificate (CE mark) to gain access to the market, putting TAVI on the same footing as domestic appliances such as toasters. In contrast, the (FDA) demands trial evidence before it can license any innovative device. Thus TAVI was in use in Europe four years before the US.

However, guidance from the UK National Institute for Health and Clinical Excellence (NICE) says that the evidence for TAVI in patients who are suitable for is "inadequate."

The authors agree. After rigorous analysis of all the available data, combined with a study of real world TAVI practice in Europe, they conclude that "the arguments supporting the widespread use of TAVI do not stand up to scrutiny."

They also raise concerns about access to full trial data on TAVI and a lack of disclosure of financial interests among trial investigators.

They believe that Europe's regulatory system "should require high quality randomised trials to show clinical efficacy and safety before granting marketing approval to innovative, high risk medical devices."

They also call for a major improvement in transparency of information "to allow clinicians to practise evidence based medicine, patients to make informed decisions, and health technology assessment agencies to make the right judgements."

Explore further: Gender differences in clinical presentation and outcome of transcatheter aortic valve implantation

More information: Paper online:

Related Stories

Results of the STACCATO Trial reported at TCT 2011

November 10, 2011

Researchers leading a clinical trial said that transapical transcatheter aortic valve implantation (a-TAVI) may be inferior to surgical aortic valve replacement (SAVR) in operable elderly patients. However results were only ...

Recommended for you

No new heart muscle cells in mice after the newborn period

November 5, 2015

A new study from Sweden's Karolinska Institutet shows that new heart muscle cells in mice are mainly formed directly after birth. After the neonatal period the number of heart muscle cells does not change, and A new study ...

Nanotechnology could spur new heart treatment

October 29, 2015

A new nanoparticle developed by University of Michigan researchers could be the key to a targeted therapy for cardiac arrhythmia, a condition that causes the heart to beat erratically and can lead to heart attack and stroke.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.