https://www.australiandoctor.com.au/news/cardiologists-urge-caution-tavi-amid-limited-data

Cardiologists urge caution on TAVI amid limited data

A new cardiologist-led campaign is pushing for more Australians with aortic stenosis to access a minimally invasive aortic valve replacement procedure and avoid open-heart surgery.

But leading interventional cardiologists have cautioned against a one-size-fits-all approach amid concerns over the durability of the valves in the absence of long-term data.

Launched last week, the Hope for Hearts campaign aims to raise awareness about the heart condition and calls for changes to national guidelines to broaden access to transcatheter aortic valve implantation (TAVI).

The campaign is funded by TAVI manufacturer Edwards Lifesciences, which has asked the Medical Services Advisory Committee to expand the MBS item for TAVI to include patients at intermediate risk of perioperative mortality with surgical aortic valve replacement.

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At present, Medicare only covers TAVI for patients at “unacceptably high risk” of perioperative mortality.

Dr Karl Poon, an interventional cardiologist who was involved in the campaign, says the key advantage of TAVI over surgery is the fast recovery time.

Read more: Is TAVR warranted in low risk patients?

“Most of the patients are discharged on day two after the procedure, and a lot of cases are done just under sedation without general anaesthetic,” said Dr Poon, who works at the St Andrew’s War Memorial Hospital in Brisbane, Qld.

Two New England Journal of Medicine studies published last month — and funded by valve manufacturers — showed favourable outcomes for TAVI in low-risk patients at 12 and 24 months, he said.

Investigators in both trials said that at least 10 years’ follow-up data was needed.

But the subsequent permanent pacemaker implantation rate among TAVI recipients in one study was “almost unacceptably high”, Dr Poon conceded.

“Even as a TAVI operator, I would be careful in just adopting this… I fundamentally object to anyone younger than 75 having a TAVI unless there’s a good reason,” he said.

A move into a low-risk and younger population will require at least 20-year outcome data, according to Associate Professor Jayme Bennetts, who is not involved in the campaign,

“The longevity of the transcatheter valves are still not clear even though it does look encouraging,” said Professor Bennetts, the director of cardiac and thoracic surgery at Flinders Medical Centre in Adelaide, SA.

“I think there are patients that should be considered for TAVI, but as a rule of thumb a broad call that all [aortic stenosis] patients should have transcatheter valves is incorrect.

“As soon as you move into the low-risk population, you tend to be moving into a lower age group of patients where longevity of the valve is going to be crucial.”

Rigorous assessment of patient risk by both cardiologists and surgeons is crucial, but he said surgical valve replacement was still the “gold-standard” treatment option.

Dr Poon said cardiologists are faced with an ethical dilemma about how they keep patients adequately informed.

“To properly provide them informed consent, [we] need to tell them that TAVI in selected patients with certain devices will give better short-term results, which is the truth,” he said.

“What I cannot tell them is long-term outcomes and I also emphasise that some patients are not suitable for TAVI.”

More information:

• MSAC application: TAVI via Transfemoral Delivery for Patients at Intermediate Risk for Surgery
• NEJM 2019 (Evolut Low Risk Trial)
• NEJM 2019 (PARTNER 3 Trial)