Risks, Warnings, and Precautions
What Are the Possible Risks 1 Year After the Procedure?
The most common serious risks observed within 1 year of the MitraClip procedure in patients enrolled in the PR DMR Cohort include:
- Death from any cause occurred in 30 out of 127 patients (23.6%)
- Stroke occurred in 3 out of 127 patients (2.4%). Stroke is a condition where lack of blood flow to the brain causes rapid loss of brain function
- Ventilation longer than 48 hours occurred in 6 out of 127 patients (4.7%). This means that the use of a ventilator was required more than two days to help a patient breathe
- Major vascular complications occurred in 9 out of 127 patients (7.1%). Examples include a hematoma (large blood clot under the skin) or damage to the artery and surrounding veins where the catheter was inserted that requires surgical repair
- Bleeding events occurred in 25 out of 127 patients (19.7%). This refers to a loss of blood related to the procedure that required blood transfusion of 2 or more unit
- Kidney failure occurred in 5 out of 127 patients (3.9%)
- Gastrointestinal complications occurred in 3 out of 127 patients (2.4%)
- Septicemia occurred in 6 out of 127 patients (4.7%). Septicemia is a serious infection of the blood often caused by bacteria
- MitraClip therapy should only be used in patients with significant, symptomatic, degenerative mitral regurgitation who are too sick for mitral valve surgery.
- MitraClip therapy is intended to reduce mitral regurgitation. If mitral regurgitation is not reduced enough, you may not get the full treatment benefits of reduced hospitalizations and improvement in heart failure symptoms and quality of life expected from MitraClip therapy.
- MitraClip therapy should only be used in patients considered to be too sick for surgery. This is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, based on the presence of one or more surgical risk factors.
- The major clinical benefits of MitraClip therapy are reduction of mitral regurgitation, resulting in reduced hospitalizations and improvement in heart failure symptoms and quality of life. No benefit on how long a patient survives following MitraClip therapy has been demonstrated. How long the MitraClip device will last is unknown at this time.
- The first MitraClip device was implanted in 2003 and laboratory testing supports durability of the device over a period of 15 years. Regular medical follow-up is essential to evaluate how the MitraClip device is performing. Notify your doctor immediately if you experience the return of any symptoms related to mitral regurgitation.
- Patients who have undergone MitraClip therapy should receive prophylactic antibiotic therapy before any medical or dental procedure to minimize the possibility of infection.
- The safety and effectiveness of MitraClip therapy have not been established in patients who have functional (also called secondary) mitral regurgitation.
The safety and effectiveness of MitraClip therapy have not been established in patients who have specific mitral valve anatomy that may interfere with proper placement and positioning of the MitraClip device:
- A mitral valve opening that is too small
- Calcified mitral valve leaflets
- A cleft of the mitral valve leaflet
- A leaflet flail width or leaflet flail gap that is too large
- MitraClip therapy has not been tested in pregnant women or children or infants, and the device may not work for these patients.