US EditionMedtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients
- On March 30, 2025, Medtronic plc announced late-breaking five-year data from the Evolut Low Risk Trial, presented at the American College of Cardiology's Annual Scientific Session & Expo and published in JACC, demonstrating the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients with a predicted 30-day mortality risk of less than 3%.
- The Evolut Low Risk Trial was a randomized study involving 1,414 patients, with 730 receiving TAVR using a Medtronic Evolut R, PRO, or CoreValve and 684 undergoing surgery.
- At five years, the Evolut TAVR system demonstrated lasting clinical outcomes comparable to surgery, with a numerically lower rate of all-cause mortality or disabling stroke, and showed strong valve performance with significantly larger effective orifice areas and lower mean gradients compared to surgery.
- According to Kendra J. Grubb, vice president and chief medical officer of Structural Heart at Medtronic, "At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality,", while Michael J. Reardon, M.D., principal investigator of the trial, stated that the lower mortality risk and strong valve performance is meaningful for clinicians.
- The Evolut Low Risk Trial data and SMART trial results, according to Medtronic, support Evolut TAVR as a safe and durable alternative to surgery for patients with severe aortic stenosis, regardless of surgical risk, reinforcing the importance of personalized treatment decisions, although an editorial by Tsuyoshi Kaneko, MD, highlights the need for 10-year data to fully understand long-term safety and effectiveness.
35 Articles
35 Articles
An Italian hospital performs an unprecedented operation in the world to a patient with Morchio syndrome
The Hospital San Camillo Forlanini in Rome successfully performed an unprecedented worldwide intervention by implanting a new aortic valve on a previously damaged prosthesis to a patient with Morchio syndrome, the first time this intervention was done to a patient with this rare genetic pathology that affects one in 300,000 people.The procedure called 'TAVI to TAVI' (Transcatheter Aortic Valve Implantation) consisted of the transfemoral implanta…
Five-year outcomes similar for low-risk patients receiving transcatheter, surgical aortic valve replacement
Patients with severe aortic stenosis at low surgical risk who underwent supra-annular, self-expanding Evolut transcatheter aortic valve replacement (TAVR) had similar rates of death or disabling stroke at five years compared with those whose valves were replaced through standard open heart surgery, based on new follow-up data from the Evolut Low Risk trial presented at the American College of Cardiology's Annual Scientific Session (ACC.25) on Ma…
Bismarck Tribune
Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients
GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic…
SGLT2 Inhibitors Progressing to New Standard After TAVI
CHICAGO — For older patients at high risk for a heart failure event who are scheduled for transcatheter aortic valve implantation (TAVI), dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, reduces the risk for death and heart failure events by almost 30%, the randomized DapaTAVI trial shows. The two questions addressed in this “pragmatic” trial […] The post SGLT2 Inhibitors Progressing to New Standard After TAVI first appeared on…
5-Year TAVR, Surgery Outcomes Similar in Low-Risk Patients
CHICAGO — Five years after treatment, patients with severe aortic stenosis had comparable rates of all-cause mortality or disabling stroke, whether they received transcatheter aortic valve replacement (TAVR) or surgery, according to midterm results from the Evolut Low Risk trial. The randomized, multicenter, international study compared the safety and efficacy of the Evolut TAVR system with surgery in patients with a low — less than 3% — 30-day …
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