Breaking News: New Medtronic Evolut Low-Risk TAVR Clinical Trial Results

Once again, we’re hearing more promising news about low risk transcatheter aortic valve replacement (TAVR) clinical trial.

Medtronic, a healthcare technology company and global leader in heart valve manufacturing, recently announced its 4-year outcomes from the Medtronic Evolut Low Risk TAVR Clinical Trial, and the research continues to yield encouraging results.

So you know, the U.S. Food and Drug Administration (FDA) first approved TAVR procedures in 2011 for patients at extreme risk who are not candidates for surgical aortic valve replacement (SAVR) with severe aortic stenosis. In 2016, intermediate surgical risk patients were approved for the TAVR procedure. The Medtronic Evolut Low Risk TAVR Clinical Trial, which evaluates TAVR against SAVR for low surgical risk patients, helped extend the FDA’s TAVR approval for low-risk patients in 2019. However, even with the FDA approval, Medtronic continues to follow the patients involved in the study and report the statistical results each year.

For this reason, I was very excited to be able to connect with Dr. Michael Reardon, Professor of Cardiovascular Surgery at Houston Methodist in Houston, Texas, and Co-Principal Investigator of the Medtronic Evolut Low Risk TAVR Clinical Trial while at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, California. Dr. Reardon was at TCT specifically to share the late-breaking results of the Medtronic Evolut Low Risk TAVR Clinical Trial, and he was kind enough to share the details with us.

Key Learnings About The 4-Year Results From The Evolut Low Risk Clinical Trial

• Interest in TAVR remains very high for aortic stenosis patients. “Everybody is interested in TAVR,” Dr. Reardon said. “The reason people are so interested in TAVR is because it behaves differently than surgery. As a heart surgeon, I can tell you we do great surgery. We get good results, but TAVR is far less invasive,” he said. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding and need for permanent pacemaker.  For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Please talk to your doctor to decide whether this therapy is right for you.
• Dr. Reardon told us that his average patient goes home the day after a TAVR procedure, and within one week, that average patient returns to entirely normal activity. The bigger question is, how will TAVR patients do over time? “That’s the data we’re looking for in this trial to help educate our patients and physicians in making this difficult lifetime management decision.”

• The latest study results evaluated several key indicators for TAVR within low risk populations. For those unfamiliar with the clinical trial, Dr. Reardon told us exactly what they were studying. “We took people we thought were at low risk and randomly assigned them to either having TAVR with the Medtronic valve or surgery where the surgeon got to pick the valve,” he said. The patients are followed year after year, and they watch for several different things, including:
  • Clinical outcomes
  • How well the valve is working
  • Failing valves
  • Long-term clinical outcomes, unexpected complications

• “The information we have so far for the Medtronic TAVR valve is that it not only maintains the early advantage, but its advantage widens over time,” Dr. Reardon said.
• This advantage can be seen in what Dr. Reardon shared about the definitive “Top Findings” from this research. The Medtronic TAVR had significantly better hemodynamics (blood flow) after one-year compared to surgery and has remained that way through four years. Additionally, Dr. Reardon said they’ve shown good outcomes, with the all-cause mortality and disabling stroke rates between TAVR and SAVR widening yearly for the first four years.¹
• The Medtronic Evolut Low Risk TAVR Clinical Trial is following patients for ten years; typically, these studies are reported at one, two, five, and ten years. However, Dr. Reardon told us they’ve been reporting results yearly and plan to continue reporting each year through the end of the trial. “This is important information, not just for patients, but for the physicians who care for them and help make lifetime decisions in treating their aortic stenosis.”
• The statements and information presented herein may be the opinion of the individual physician featured and is not intended to constitute medical advice.

Thank you, Dr. Reardon, Houston Methodist, and Medtronic!

On behalf of our patient community, thank you to Dr. Michael Reardon for sharing this incredible news from the Medtronic Evolut Low Risk TAVR Clinical Trial. We would also like to thank Medtronic for its ongoing research into the revolutionary technology and life-changing devices that continue to transform the lives of heart valve patients worldwide!

Related Links:

• See the new Medtronic TAVR Procedure Educational Microsite
• Research 50 Leading Heart Teams the Specialize in Medtronic TAVR
• Free eBook: What 7 Facts Should You Know About TAVR?

Keep on tickin!
Adam

P.S. For the deaf and hard-of-hearing members of our patient community, I have provided a written transcript of this interview below.

References:

1. Reardon M, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Aortic Stenosis Patients at Low Surgical Risk: 4-Year Outcomes from the Evolut Low Risk Trial. Presented at TCT; October 2023.