Jul 19, 2021

Increasing Access to Improved Patient Outcomes with the Latest Innovation in TAVI

We may reach retirement, but our hearts don’t get a break. In fact once we reach 65, approximately 20 percent of us will experience aortic stenosis, a hardening or narrowing of the aortic...

close-up of heart surgery

We may reach retirement, but our hearts don’t get a break. In fact once we reach 65, approximately 20 percent of us will experience aortic stenosis, a hardening or narrowing of the aortic valve.1 Though some people may be asymptomatic, most people with AS will eventually experience symptoms such as fatigue, chest pains, and breathlessness, which negatively impact an individual's daily activities.

 Severe aortic stenosis occurs when the aortic valve becomes diseased (stenotic) and valve leaflets thicken and stiffen. Left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.2

Severe Aortic Stenosis and TAVI

Traditionally, the most common therapy for severe AS is open-heart surgical valve replacement (SAVR), which can require a week-long recovery in hospital.

Its minimally invasive counterpart, Transcatheter Aortic Valve Implantation (TAVI), was developed in 2002 and has proven to be an effective option that results in both shorter hospitals stays and improved 30-day quality-of-life scores when compared to SAVR.3

TAVI was initially indicated for patients with severe AS who were at an extremely high risk of surgical mortality, making them poor candidates for SAVR. Recently, Medtronic has received a  licence from Health Canada for an expanded indication for the Evolut™ TAVI system to include low and medium risk patients, as well as those with bicuspid aortic valves who are at extreme, high and intermediate risk.

Increased Access to Proven Performance

Approximately 3000 TAVI procedures are currently performed annually in Canada. Considering the recent change in indication to include low risk and bicuspid patients, the number of eligible patients for TAVI is now estimated to be over 10,000. *

“The new iterations incorporated into the Evolut PRO+ are in keeping with expanding the technology to a broader population of younger patients and those with challenging anatomies,” said Dr. Nicolo Piazza, interventional cardiologist at McGill University Health Centre. “More specifically, the addition of an external tissue wrap to the large 34 mm valve size provides additional confidence in treating patients with larger anatomies and mitigating the risks of paravalvular aortic regurgitation. Furthermore, the lower vascular profile will benefit patients with smaller vascular anatomies and reduce vascular event rates. Importantly, Evolut PRO+ system maintains its excellent hemodynamic advantages across the annular spectrum.“

Evolut PRO+ is the newest generation of Medtronic’s TAVI line, built on the proven self-expanding, supra-annular Evolut platform.

“The proven hemodynamic performance of our Evolut family of devices, now coupled with the lower vascular access profile of the Evolut PRO+, will allow more patients to be treated by a transfemoral approach rather than alternative access methods,” said Mitch Leschuk, director of Medtronic Canada’s Cardiovascular Portfolio.

Evolut Pro Family

Meet the Evolut PRO + family

The Evolut PRO+ TAVI System is now available in four valve sizes – the 34mm system can access vessels down to 6mm, with the 23, 26 and 29mm systems access those down to 5mm.

The system is designed with an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus. It also includes an integrated, inline sheath, which allows physicians to treat patients with a range of anatomical variations with a low delivery profile.

Consistent with the Evolut platform design, the PRO+ valve is designed with a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing, helping to reduce the degree of residual perivalvular regurgitation.

The Evolut TAVI platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVI systems, is now indicated for symptomatic severe native aortic stenosis patients across all surgical risk categories (extreme, high, intermediate, and low) in Canada.

Learn more about Evolut Pro +

 TAVI can help save on health system costs: Read the economic study 

1  American Heart Association. Aortic Stenosis Overview

2 Badran, A A et al. “Unoperated severe aortic stenosis: decision making in an adult UK-based population.” Annals of the Royal College of Surgeons of England vol. 94,6 (2012): 416-21. doi:10.1308/003588412X13171221591817

3Popma JJ, et al., on behalf of the Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. DOI:10.1056/NEJMoa1816885

* Data on file