Mission in Action | Medtronic Clinician Update on New Evolut Valve Data Reinforces Need For Patient Dialogue
New long-term data from the Evolut Low Risk trial published in JACC underscore how emerging science and evidence continue to shape patient-centered care in structural heart disease – an approach central to the ACC's Vision of using science, knowledge and innovation to optimize patient care and outcomes. As a result of the new data, Medtronic has issued a clinician letter and accompanying web resources, reinforcing the importance of informed, ongoing dialogue between clinicians and patients as treatment decisions evolve over time.
While overall six-year follow-up data on reintervention rates associated with CoreValve, Evolut R and Evolut PRO transcatheter heart valves showed low-risk patients with aortic stenosis experienced no significant differences in all-cause mortality or disabling stroke after undergoing either surgical aortic valve replacement or TAVR, investigators saw higher reintervention rates among patients assigned to TAVR compared with surgery – a difference largely driven by increased rates of aortic regurgitation. Specifically, 5.5% of patients in the TAVR cohort required reintervention vs. 3.3% in the surgery group. Further increases in the incidence of reintervention among those in the TAVR group (9.8%) vs. surgery (6%) were observed in an additional analysis of available seven-year data.
According to the Medtronic letter, the recent Evolut Low Risk publication "supports existing patient management recommendations and underscores the importance of adhering to current Instructions for Use (IFU), including guidance on balloon post-dilation." The following patient management recommendations are also included:
- Physicians treating patients with a transcatheter bioprosthetic heart valve should adhere to guideline-directed follow-up, including routine surveillance with annual echocardiograms.
- When implanting the Evolut valves, it is very important to follow implantation best practices and current IFU on balloon post-dilation.
"The latest Evolut Low Risk findings and subsequent letter are an important reminder to engage with patients – both current and future – about their care," says ACC Chief Medical Officer Richard J. Kovacs, MD, MACC. "The ACC encourages all clinicians who care for patients with heart valve disease to review the Medtronic letter and related materials and to engage in open conversations about valve type, long-term surveillance and potential implications for ongoing care. These shared decision-making discussions can help to ensure that treatment plans align with patient expectations while supporting long-term health and peace of mind."
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Cardiology Magazine, ACC Publications, CM-Apr-2026, Transcatheter Aortic Valve Replacement, Heart Valve Diseases, Aortic Valve
