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Medtronic's Evolut TAVR System Shows Positive Outcomes in Aortic Stenosis Treatment

• Medtronic's Optimize PRO study demonstrates positive outcomes using the cusp overlap technique (COT) with the Evolut TAVR system in treating severe aortic stenosis. • The study reported a low 30-day permanent pacemaker implantation rate of 6.4% with COT compliance and no moderate or severe aortic regurgitation at discharge. • A pooled analysis showed improvement in paravalvular leak (PVL) rates post-TAVR, with severity decreasing from moderate to none/trace over three years. • The primary endpoint of all-cause mortality or all stroke at 30 days was reported at 5.1%, highlighting the safety and efficacy of the Evolut TAVR system.

Medtronic has announced new clinical data from the Optimize PRO study, evaluating its Evolut transcatheter aortic valve replacement (TAVR) system for treating symptomatic severe aortic stenosis (SASS). The findings, presented at PCR London Valves 2024, offer insights for implanters globally. The Optimize PRO study, conducted across 50 centers, assessed the cusp overlap technique (COT) with the Evolut PRO and PRO+ devices.

Optimize PRO Study Results

The Optimize PRO study demonstrated positive procedural and clinical outcomes when using the cusp overlap technique (COT) with the Evolut PRO and PRO+ devices. The study reported a low rate of new 30-day permanent pacemaker implantation at 6.4% with COT compliance. There was also an absence of moderate or severe aortic regurgitation at discharge. The primary endpoint of all-cause mortality or all stroke at 30 days was reported at 5.1%, with all-cause mortality at 0.8%, disabling stroke at 1.7%, and cardiovascular rehospitalization at 5.7%.
The study also assessed the performance of the valve and procedural outcomes associated with an optimized TAVR care pathway, leveraging COT for Evolut valve deployment. This technique aims to assist implanters in achieving optimal implant depth to minimize conduction system interaction.

Paravalvular Leak Analysis

In addition to the Optimize PRO study, a pooled analysis of patients treated with the Evolut PRO valve was presented. This analysis showed improvement in paravalvular leak (PVL) rates over time post-TAVR. The study analyzed core lab echocardiographic data from 620 subjects across various trials. The PVL severity at 30 days post-discharge was 60.8% none/trace, 36.0% mild, 2.9% moderate and 0.3% severe. At the three-year follow-up, PVL severity improved to 79.8% none/trace, 19.6% mild, 0.6% moderate, and no severe cases.

Leadership Insights

Nina Goodheart, president of the structural heart and aortic business at Medtronic, stated, "With the Evolut TAVR system, we are committed to improving outcomes for patients while maintaining exceptional safety and efficiency. The data presented at London Valves 2024 further establishes Medtronic and Evolut as leaders in supporting and sharing the robust clinical evidence physicians need to make the best decisions for their patients when choosing and performing TAVR."
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Reference News

[1]
Medtronic reports outcomes from aortic stenosis treatment study of TAVR system
finance.yahoo.com · Nov 29, 2024

Medtronic presented new clinical data on its Evolut TAVR system at PCR London Valves 2024, showing positive outcomes in ...

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