From the Guidelines
A MitraClip is a percutaneous mitral valve repair device used to treat mitral regurgitation (MR).
Key Characteristics of the MitraClip
- It is a transcatheter edge-to-edge repair device that approximates the anterior and posterior leaflets of the mitral valve to restore coaptation and create a double orifice valve.
- The device is approved for use in the United States for treatment of selected patients with primary MR and symptomatic patients with moderate-to-severe or severe secondary MR who have a left ventricular ejection fraction (LVEF) >20% and <50% and an LV end-systolic dimension <70 mm, whose symptoms and MR severity persist despite maximally tolerated guideline-directed management and therapy (GDMT) as determined by a multidisciplinary team (MDT) experienced in evaluating and treating HF and MV disease 1.
- The MitraClip has been shown to reduce the grade of MR, improve symptoms, and decrease hospitalizations for heart failure in patients with severe secondary MR, as demonstrated in the COAPT trial 1.
Clinical Evidence Supporting the Use of the MitraClip
- The COAPT trial demonstrated a significant reduction in hospitalizations for heart failure and all-cause mortality in patients with severe secondary MR treated with the MitraClip compared to those receiving guideline-directed medical therapy (GDMT) alone 1.
- The MITRA-FR trial, however, showed no difference in the primary endpoint of all-cause death or unplanned hospitalizations for heart failure at 12 months between patients treated with the MitraClip and those receiving GDMT alone 1.
- The differences in outcomes between the COAPT and MITRA-FR trials may be explained by the proportionality hypothesis, which suggests that patients with disproportionate severe MR may benefit more from MitraClip therapy than those with proportionate MR 1.
Important Considerations for the Use of the MitraClip
- Optimal GDMT is essential before referral for MitraClip therapy, as it can lead to reversal of cardiac remodeling, reduction of LV volumes, and a concomitant reduction in functional MR 1.
- The MitraClip is not a substitute for surgical repair, and surgery is still recommended for patients with severe primary degenerative MR who are candidates for surgical repair 1.
From the Research
Overview of MitraClip
- The MitraClip is a transcatheter mitral valve repair system used to treat mitral regurgitation (MR) 2, 3, 4.
- It is a percutaneous device that mimics the Alfieri surgical edge-to-edge technique for mitral valve repair 2, 3.
- The MitraClip has been approved for clinical use in Europe, the US, and Japan, particularly for aging and inoperable or high-risk patients for heart surgery 2.
Indications and Patient Selection
- The MitraClip is used to treat patients with symptomatic severe mitral regurgitation or signs of left ventricular dilatation or dysfunction who are at high risk for surgical intervention 4.
- Patient selection is crucial, and randomized clinical trials have optimized patient selection for the MitraClip procedure 2.
- The latest generation MitraClip can increase procedural success, even in patients with challenging mitral valve anatomy 2.
Efficacy and Safety
- The MitraClip has been shown to be safe and effective in reducing mitral regurgitation and improving functional class and reducing heart failure hospitalizations 3, 4, 5.
- The device has been associated with low adverse event rates compared to mitral surgery, but complications can occur, including bleeding, acute kidney failure, procedure-induced mitral stenosis, and iatrogenic atrial septal defect 6.
- The MitraClip appears to be a safe therapeutic option for patients with functional mitral valve regurgitation who are considered to be at high surgical risk 5.
Technical Features and Future Directions
- The latest generation MitraClip has novel technical features to facilitate device handling, decrease complication rates, and allow the treatment of even complex lesions 6.
- Ongoing randomized trials will further define the role of MitraClip in the management of heart failure patients with secondary mitral regurgitation 4.
- Further developments in device design and procedural technique will continue to expand the range of patients who can be treated with the MitraClip 4.