The Medicare Services Advisory Committee (MSAC) has recommended extending the availability of TAVI using a balloon-expandable valve (BEV) system for patients with symptomatic severe aortic stenosis to patients at intermediate risk for surgery.
The advice to the Minister supports the creation of a new MBS item number for TAVI using a BEV in this intermediate risk group on the grounds of acceptable safety, effectiveness and cost effectiveness compared with surgical aortic valve replacement.
The MSAC decision made late last year is agnostic of the type of device although the application was sponsored by Edwards Lifesciences for its SAPien 3 BEV system.
Interventional cardiologist Professor Ravinay Bhindi told the limbic the fact that MSAC was recommending the approval of TAVI in patients at intermediate risk for surgery was a huge advance that had been a long time coming.
“TGA have approved the device to be used in intermediate risk patients. The question has been about reimbursement around it and that has been a vexed issue,” he said.
Professor Bhindi, Head of Clinical Trials and Structural Heart Disease at North Shore Private and Royal North Shore Hospitals, said most of the international guidelines – in the US and Europe – have approved TAVI down to low risk patients.
“If we are down to intermediate risk then that would be a huge advance allowing more patients to be treated.”
He said there was a group of people, for example those in their early 80s with a couple of health issues, currently forced to have open heart surgery as they wouldn’t qualify for TAVI.
“Getting us down to intermediate risk is a really really big step in allowing us to provide our patients, and particularly older patients, with more choice.”
He said there was now strong evidence that surgery and TAVI were equivalent and most international guidelines have accepted this for a while.
“There will always be some element of subjectivity to it but nevertheless, the evidence supporting the equivalence of TAVI in the intermediate risk patients is strong and this decision allows our patients to have more choice and allows the heart team to consider the patients and the patients’ choice in making a decision about what is best for them.”
Stroke protection
The MSAC has also recommended a new MBS item number for a dual-filter cerebral embolic protection (CEP) device during TAVI in patients with symptomatic severe aortic stenosis who meet eligibility criteria for TAVI (high risk/inoperable and intermediate risk for surgery).
“MSAC accepted the evidence of non-inferior safety and superior effectiveness for CEP plus TAVI compared with TAVI alone,” the Public Summary Document said.
Professor Bhindi said given stroke was one of the most devastating complications of TAVI, any strategy to mitigate that risk was important.
“When you talk to older patients, a lot of them don’t really care about dying, they care about having a stroke which might leave them with a significant disability.”
“There are some people where the anatomy is unsuitable based on CT scan so you wouldn’t use it. But generally it’s fairly straightforward and adds about 1-2 mins to the procedure,” he said.
The MSAC applicant was Boston Scientific.