Stroke may be the “Achilles heel” of transcatheter aortic valve replacement (TAVR) in inoperable patients with aortic stenosis, despite promising overall results in this group, an expert says.
Professor Michael Mack, from the Heart Hospital Balo Palo, Dallas, Texas, USA, said the PARTNER cohort B multicentre trial in inoperable patients showed an absolute 20% difference in one year survival in those randomised to Edwards Sapien TAVR versus medical therapy.
Speaking at the CSANZ 2011 59th Annual Scientific Meeting in Perth on Saturday, he said the results were presented to the US FDA recently with the panel recommending approval.
“It’s expected that commercial approval will happen in the United States for inoperable patients later this year,” he said.
However, he said the higher risk of stroke and mortality with TAVR was its “Achilles heel”.
Professor Ian Meredith from the director of the Monash Heart Centre in Melbourne said Australian TAVR registry data compared “very favourably” to published international trials, with lower mortality rates and similar procedural success rates.
However, he warned this could not be interpreted as being solely due to improved surgical techniques in Australia.
“Partly it is due to uniform training across all of the centres, it is partly due to uniform patient selection and partly that we are selecting older, but healthier patients, rather than sicker and frailer patients,” he said.