From the Guidelines
Transcatheter mitral valve replacement (TMVR) with the Edwards Evoque system is indicated for patients with severe symptomatic mitral regurgitation who are at high or prohibitive surgical risk, as evidenced by recent studies such as the one published in JACC: Heart Failure in 2023 1. The ideal candidates for this procedure should have significant mitral regurgitation (grade 3+ or 4+) causing heart failure symptoms (NYHA class II-IV) despite optimal medical therapy, which typically includes ACE inhibitors/ARBs, beta-blockers, diuretics, and possibly aldosterone antagonists at maximally tolerated doses. Some key points to consider when evaluating patients for TMVR with the Evoque system include:
- Suitable mitral valve anatomy for the Evoque device, including appropriate annular dimensions and adequate landing zone
- Acceptable subvalvular structures
- Absence of severe mitral stenosis, severe left ventricular dysfunction, severe pulmonary hypertension, recent stroke or myocardial infarction, active endocarditis, or anatomical features incompatible with the device Patient selection requires comprehensive evaluation with:
- Echocardiography
- Cardiac CT
- Cardiac catheterization to assess valve anatomy, coronary status, and hemodynamics The procedure is performed under general anesthesia via transfemoral venous access with transseptal puncture to reach the mitral valve, as described in the study published in JACC: Heart Failure 1. This technology offers an important alternative for patients who cannot undergo surgical mitral valve repair or replacement due to excessive operative risk, providing symptom relief and potential improvement in quality of life and functional capacity, with studies showing reduced rates of HF hospitalizations compared to guideline-directed medical therapy alone 1.
From the Research
Indications for TMVR with Evoque
- The indications for Transcatheter Mitral Valve Repair (TMVR) with Evoque are based on the severity of mitral regurgitation (MR) and the patient's surgical risk 2, 3, 4, 5, 6.
- Patients with severe degenerative mitral regurgitation (DMR) who are at prohibitive surgical risk may be candidates for TMVR 2.
- High-surgical-risk patients with mitral regurgitation (MR) > or = grade 3+ may also be considered for TMVR 3.
- Patients with severe MR and endangered heart failure may benefit from TMVR as an alternative to surgical mitral valve repair 4.
- The REPAIR MR trial is designed to compare outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients 5.
- Echocardiography is essential to assess MR etiology and severity, and to determine optimal therapies, including TMVR 6.
Patient Selection
- Patients with severe primary MR who are at high or prohibitive risk for mitral valve surgery may be candidates for TMVR 5.
- Patients with severe secondary MR due to ischemia may be considered for TMVR, as well as coronary artery bypass grafts (CABG) or percutaneous coronary intervention (PCI) 6.
- Patients with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mmHg, or left ventricular end-systolic diameter ≥40 mm may also be considered for TMVR 5.
Clinical Outcomes
- TMVR has been shown to be associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year 2.
- The majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II 2.
- Clinical and echocardiographic outcomes were followed by telephones and clinics, and showed that patients who underwent emergent procedures had poorer long-term survival rates compared to those who received elective procedures 4.