Less-Invasive Repair of the Mitral Valve

A new method of treating mitral regurgitation (MR) provides a less-invasive alternative to open-heart surgery.

A new percutaneous mitral valve repair system called E-valve involves suturing the free edge of the anterior leaflet of the mitral valve to a corresponding portion on the posterior leaflet, creating a point of permanent coaptation: the joining together or fitting of two surfaces. This creates a functional double orifice during diastole. The valve continues to open on both sides of the suture, allowing ample blood flow through the valve from the left atrium to left ventricle, while assuring proper leaflet coaptation and effective valve closure when blood is pumped from the left ventricle to the rest of the body. This edge-to-edge (E2E) technique is performed with or without adjunctive annuloplasty.

A steerable guide catheter is inserted into the femoral vein at the groin and provides a conduit to access the mitral valve. The implantable clip, called MitraClip, is delivered to the site with a proprietary clip delivery system, and is then used to grasp and join the leaflets of the mitral valve. If necessary, a second clip may be placed. The principal benefit of the system is that it enables the clinician to repair the mitral valve while the heart is beating, without cardiopulmonary bypass (CPB) and without the need for a thoracotomy or sternotomy. If the physician is not satisfied with initial clip placement, the system is designed to allow for repositioning or removal of the MitraClip. This safety feature is intended to preserve the patient's conventional surgical options and outlook.

The Mitraclip is being developed by Evalve (Menlo Park, CA, USA). Clinical trial data of phase II of a study called EVEREST (endovascular valve edge-to-edge repair study), involving the first 92 non-randomized patients with completed 30-day follow-up and echocardiographic core lab analysis, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2006 annual meeting, held in Washington (D.C., USA) in October 2006.

"The MitraClip offers patients a less invasive option with faster recovery and could create a paradigm shift in MR treatment. We are encouraged by the results to date, which show we are able to achieve and, more importantly, maintain a clinically meaningful reduction in MR in a majority of patients undergoing the procedure,” said Dr. Ted Feldman, a professor of medicine and director of the cardiac catheterization laboratory at Evanston Northwestern Hospital (IL, USA) and co-principal investigator of the EVEREST trial.



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Evalve
Evanston Northwestern Hospital