Access opens for minimally invasive heart treatment

Australians living with symptoms of severe aortic stenosis will now have access to a minimally invasive heart treatment that was previously reserved for only the sickest patients. Public access to the treatment means that patients no longer face open heart surgery as their only option.

Previously, the Evolut Transcatheter Aortic Valve Implantation (TAVI) system was only available to older, sicker patients, but now, younger¹ and more active Australians with less severe forms of the disease can also qualify — a move anticipated to reduce risk of death, stroke and other cardiovascular events during the procedure and allow patients to leave hospital faster and recover sooner.²

The therapy indication is one of the first in the country to go through the Therapeutic Goods Administration’s priority review pathway for approval of therapeutic goods as part of the MMDR (Medicine and Medical Devices Review) recommendations. The priority review pathway facilitates a new review pathway for therapeutic goods so that Australian patients can benefit from new technologies quickly. This approval means that Australians are among the first in the world to benefit from greater access to this technology.

“The goal in treating any patient is to help them return to active living as quickly as possible,” said Associate Professor Tony Walton, Deputy Director and Head of Catheter Laboratory, Interventional Cardiologist at Alfred Health, Melbourne and lead principal investigator in the Evolut Low Risk Trial in Australia.

“The availability of this treatment for all Australians living with aortic stenosis is a very important development in helping to deliver this.

“To date we have seen good results with older, sicker patients, so the opportunity to return younger, more active patients — who we would consider at low risk of complication during surgery — to good health more quickly is very exciting. We also expect to see improved heart function due to the system’s blood flow properties, helping many patients resume their pre-aortic stenosis activity.”

More than 50,000 Australians currently live with some form of severe aortic stenosis³ with 38% of this population^4–5 previously unable to access the minimally invasive treatment. The expanded use of this therapy means an additional 20,000 Australians could now qualify.

According to Dr Walton, expanded access to the TAVI system for Australians signals a shift in the future treatment of heart valve disease as more patients will now have the option to receive a minimally invasive alternative to surgery.

“It is important that we expand access to a less-invasive treatment option to all patients with heart valve disease regardless of their surgical risk,” he said.

“I hope this means that more patients who may benefit receive the treatment they need, and we can decrease needless deaths from aortic stenosis in this country.

“While surgical valve replacement will still be an option for many patients, we anticipate TAVI to be accepted as an important valve replacement therapy in patients for whom it is an appropriate treatment option. Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.”

References

1. Earlier CoreValve Evolut TAVR trials enrolled patients at an average age of 80 to 83 while the Evolut Low Risk trial enrolled patients at an average age of 74.
2. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. DOI: 10.1056/NEJMoa1816885.
3. AIHW National Data Cardiovascular Disease 2019 (https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/cardiovascular-health-compendium/data).
4. Medtronic data on file (Williamson M, Pollack A, Raffoul N, Yoo J, Granger R. Aortic Stenosis: a feasibility study. Sydney; NPS MedicineWise, May 2018).
5. STS Adult Cardiac Database. 2010 Harvest, Isolated AVR.

Image credit: ©stock.adobe.com/au/Fabio Balbi