26 June, 2020
Australians among first in the world to open access for life-saving minimally invasive heart treatment to all patients
Medtronic is proud to share a significant step forward in indication expansion for Transcatheter Aortic Valve Implantation (TAVI) in Australia. The self-expanding platforms Evolut™ R (284003) and Evolut™ Pro (319850) are now included on the ARTG for relief of aortic stenosis in patients with symptomatic heart disease, who are judged by a heart team to be appropriate for the transcatheter heart valve replacement therapy.
Traditionally older, sicker patients, only qualified for the Evolut™ Transcatheter Aortic Valve Implantation (TAVI) system. Now Australian patients with less severe forms of the disease can also receive it. This means that Australian patients with severe aortic stenosis or bicuspid aortic valve stenosis in all risk categories (extreme, high, intermediate and low), could now have access to the treatment if their heart team considers that they qualify for the treatment.
The expanded indication approval is based on clinical data from the global, prospective, randomised, multi-centres Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) against surgical aortic valve replacement (SAVR) in more than 1,400 patients.
TAVI is a minimally invasive, catheter-based procedure to replace the aortic valve. TAVI procedure does not require open-heart surgery. Instead, with TAVI, the heart is accessed via an artery. Using imaging and a delivery system, the physician threads the compressed bioprosthetic heart valve through the catheter and positions it within the diseased valve. After positioning the bioprosthetic valve, the physician begins deploying the valve. When deployment is complete, the bioprosthetic valve is fully expanded within the diseased native valve. After testing the new valve function, the physician removes the catheter and closes the incision.
Aortic stenosis (AS) is the most common valvular disease worldwide.1 Severe aortic stenosis, occurs when the aortic valve becomes diseased (stenotic). The valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities.2
Aortic valve stenosis ranges from mild to severe. In Australia, more than 50,000 people currently live with some form of aortic stenosis3 with 38% of this population4,5 previously unable to access the minimally invasive treatment. The expanded use of this therapy means an additional 20,000 Australians could now qualify.
Bicuspid aortic valves are a congenital heart defect affecting 1-2 percent of the general population and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid). 6 Further, bicuspid aortic valve stenosis represents almost 2% percent of severe symptomatic aortic stenosis patient population in Australia.⁶
References
- Minamino-Muta E, Kato T, Morimoto T, et al. Causes of Death in Patients with Severe Aortic Stenosis: An Observational study. Sci Rep. 2017;7(1):14723. Published 2017 Nov 7. doi:10.1038/s41598-017-15316-6
- https://www.mayoclinic.org/diseases-conditions/aortic-stenosis/symptoms-causes/syc-20353139
- AIHW National Data Cardiovascular Disease 2019 (https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/cardiovascular-health-compendium/data)
- Medtronic data on file (Williamson M, Pollack A, Raffoul N, Yoo J, Granger R. Aortic Stenosis: a feasibility study. Sydney; NPS MedicineWise, May 2018)
- STS Adult Cardiac Database. 2010 Harvest, Isolated AVR.
- Clinical incidence and penetration from ANZ market data on file, Ward. Heart, 2000