On October 24, 2023, Medtronic at the 35th TCT Conference (Global Interventional Cardiology Forum)Announced the 4-year positive follow-up results of the Evolut Low Risk study.

The Evolut Low Risk Study is an international, multicenter, non-inferiority randomized controlled trial, representing a significant leap forward in the field of TAVR for surgical low-risk patients.

The 4-year follow-up results published this time suggest that,Medtronic Evolut Transcatheter Aortic Valve Replacement (TAVR) System Demonstrates Superior Outcomes and Sustained Valve Performance, with Hemodynamics Significantly Better than Surgical Aortic Valve Replacement (SAVR).Only Evolut TAVR has consistently reported a lower and distinct mortality or disabling stroke rate compared to the most advanced surgeries over four years.

Previous studies have already shown that,The Evolut platform is the only TAVR platform that has demonstrated superior durability to SAVR in randomized trials over 5 and 10 years.This new evidence release marks another step forward for the application of TAVR in low-risk surgical patients.

For patients with severe aortic stenosis, Transcatheter Aortic Valve Replacement (TAVR) has become an established treatment method, especially for those at high surgical risk. TAVR has demonstrated non-inferior efficacy compared to Surgical Aortic Valve Replacement (SAVR).

However, for patients at low surgical risk, there is still a lack of randomized controlled trials with longer follow-up periods comparing TAVR and SAVR treatments.

Evolut Low Risk Study: A study aimed to evaluate the safety and effectiveness of the Evolut TAVR system compared with surgical aortic valve replacement (SAVR) in patients at low surgical risk. Low-risk patients, defined in the trial as those with a predicted 30-day mortality risk of <3% based on multidisciplinary local heart team assessments, were randomized to either the TAVR group or the SAVR group.

In the TAVR group, self-expanding supra-annular valves were used (CoreValve, Evolut R, or Evolut PRO, all from Medtronic), while in the SAVR group, the choice of valve was determined by the surgeon, but no mechanical valves were used.A total of 1,414 patients underwent implantation (730 TAVR; 684 SAVR).

The study results indicate that, compared to SAVR, Evolut TAVR continued to achieve favorable outcomes in the primary endpoint of all-cause mortality or disabling stroke at four years.At four years, compared with SAVR (14.1%), the risk of death or disabling stroke was reduced by 26% in TAVR (10.7%) (p=0.05).Over time, the absolute difference in clinical benefits for patients with Evolut TAVR compared to surgical procedures continues to increase at the four-year mark.

The research results also showed,TThe all-cause mortality, disabling stroke, or aortic valve rehospitalization rate was 18.0% in the AVR group and 22.4% in the SAVR group (p=0.04).

Nina Goodheart, Senior Vice President of Medtronic's Cardiovascular Portfolio and President of the Structural Heart and Aortic business, stated: The low-risk patient study data from Medtronic presented today at TCT demonstrates our continued commitment to generating evidence on our Evolut TAVR platform to provide treatment options for the growing population of low-risk symptomatic severe aortic stenosis patients. By equipping physicians with the latest minimally invasive, clinically validated technologies, we aim to support advanced lifelong patient care and achieve the best possible patient outcomes.

In TAVR procedures, commissural alignment is a key factor for facilitating subsequent coronary interventions, improving coronary blood flow, and enhancing valve hemodynamic performance. It may also be beneficial for future repeat TAVR procedures. The fourth-generation Evolut technology is equipped with gold marker points on the stent frame, allowing operators to directly visualize the depth and leaflet position during implantation.

MoreoverThe Evolut FX system features a redesigned catheter tip, offering a smoother and more flexible insertion profile with 360 degrees of free movement.Like its predecessor, the Evolut PRO+, the Evolut FX includes four valve sizes suitable for the widest range of indicated patients.

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Aortic Stenosis is a heart condition that occurs when the aortic valve narrows, preventing it from opening and closing properly, which forces the heart to work harder to pump blood to the rest of the body. The increased pressure within the heart can lead to weakening and dysfunction. Severe aortic stenosis is a life-threatening condition affecting 3.4% of elderly individuals worldwide. Among patients with severe symptoms, as many as 50% may die within one year if they do not receive appropriate treatment.

After 20 years of development, transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe aortic stenosis, becoming the standard of care across the entire spectrum of surgical risk. With advancements in TAVR technology, it is anticipated that more patients will avoid open-heart surgery while achieving better outcomes.

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