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: Tavi study shows low mortality rate, improvement in function at 30 days

More information: Paper online: www.bmj.com/cgi/doi/10.1136/bmj.e4710

Related Stories

Tavi study shows low mortality rate, improvement in function at 30 days

March 26, 2012
Patients who underwent transcatheter aortic valve implantation (TAVI) at experienced medical centers had significant improvement in valve function as well as low mortality and stroke rates at 30 days, according to research ...

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 ...

Expandable prosthesis resolves advanced aortic valve disease

September 30, 2011
Among individuals 65 years and older, as many as 30 percent have aortic valve sclerosis or stenosis and as a result of their deteriorating health, they cannot enjoy a normal lifestyle.

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

August 29, 2011
Severe aortic stenosis (AS) is increasing in frequency as the population ages. For a subset of patients in whom surgical conventional aortic valve replacement is excluded due to severe co-morbidities, an alternative to surgical ...

Recommended for you

Early study shows shoe attachment can help stroke patients improve their gait

December 14, 2017
A new device created at the University of South Florida – and including a cross-disciplinary team of experts from USF engineering, physical therapy and neurology – is showing early promise for helping correct the signature ...

Scientists rewrite our understanding of how arteries mend

December 13, 2017
Scientists from The University of Manchester have discovered how the severity of trauma to arterial blood vessels governs how the body repairs itself.

Deadly heart rhythm halted by noninvasive radiation therapy

December 13, 2017
Radiation therapy often is used to treat cancer patients. Now, doctors at Washington University School of Medicine in St. Louis have shown that radiation therapy—aimed directly at the heart—can be used to treat patients ...

Ultra-thin tissue samples could help to understand and treat heart disease

December 12, 2017
A new method for preparing ultra-thin slices of heart tissue in the lab could help scientists to study how cells behave inside a beating heart.

Young diabetics could have seven times higher risk for sudden cardiac death

December 12, 2017
Young diabetics could have seven times more risk of dying from sudden cardiac arrest than their peers who don't have diabetes, according to new research.

Research reveals how diabetes in pregnancy affects baby's heart

December 12, 2017
Researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have discovered how high glucose levels—whether caused by diabetes or other factors—keep heart cells from maturing ...

0 comments

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.