Medtronic Clinician Update on New Evolut Valve Data Reinforces Need For Patient Dialogue
Medtronic has issued a letter and developed web resources providing an update on long-term reintervention rates associated with its Evolut R and Evolut PRO transcatheter heart valves, drawing on complete six-year and partial seven-year follow-up data from the Evolut Low Risk Trial published on Feb. 16 in JACC.
While overall trial results showed low-risk patients with aortic stenosis experienced no significant differences in all-cause mortality or disabling stroke six years after undergoing either surgical aortic valve replacement or TAVR with a CoreValve, Evolut R, or Evolut PRO, 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 compared with 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. Read more.
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.”
Access CardioSmart shared decision-making tools to help guide patient discussions.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Follow-Up Studies