Using an approach adapted from an established surgical technique, the device demonstrated it could reduce MR severity from moderate-severe or severe to moderate or lower. Importantly, the MR reduction achieved at 30 days is maintained at one year in 93% of patients and 74% of all patients treated have avoided open heart surgery.
Left unchecked, severe MR can lead to congestive heart failure or serious heart rhythm irregularities. The device holds together a portion of the two leaflets of the mitral valve to facilitate closure of the valve. The percutaneous valve repair procedure is performed by interventional cardiologists in the catheterisation laboratory under general anaesthesia on a beating heart. In addition to improving blood flow through the heart, the procedure may also improve left-ventricular function and relieve symptoms such as the fatigue and shortness-of-breath that often affect patients with chronic significant MR.
The trial included 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms (fatigue, shortness of breath, chest pain) or had a weakened left ventricle. Results showed that 93% of those patients who experienced a significant MR reduction at one month maintained the reduction at 6 months. MR severity did not increase from six to 12 months in any of the patients with completed 12-month follow-up. Of the group of patients who received a clip, 83% remained free from surgery.
“These initial results are very encouraging in that not only did we observe a reduction in MR at six months, but the durability of the repair has held up in those patients who have completed 12-month follow up”, said principal investigator Ted Feldman, M.D., director of the cardiac catheterisation lab at Evanston Hospital in Evanston, IL.
MEDICA.de; Source: Cardiovascular Research Foundation