Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case.

We report the first-in-human mitral valve repair using percutaneous technology that creates a "surgical-like" edge-to-edge repair. A catheter-delivered clip was introduced transseptally from the femoral vein, advanced through the mitral orifice, retracted to grasp the leaflets, and detached to create a functional double-orifice valve. The patient had an uncomplicated post-procedural course. Echocardiography at 1- and 2-years post procedure showed mild mitral regurgitation and positive ventricular remodeling. The success of this case suggests that percutaneous mitral valve repair may be a feasible therapy for certain patients suffering from mitral regurgitation.

Percutaneous aortic valve replacement and mitral valve repair.

For mitral regurgitation and aortic valve disease warranting replacement, the surgical approach has been the mainstay therapy since the 1960s. Technological advances have provided potentially less invasive alternatives to surgery. Novel catheter-based techniques include aortic valve replacement with a valved stent, and devices aimed at reconfiguring the annulus or approximating a portion of the leaflets for mitral regurgitation. The main considerations regarding aortic valved stents include device anchoring and orientation, potential restriction of coronary flow, optimal method of delivery, ideal leaflet material, stent characteristics, and valve durability. The catheter-based approaches to mitral regurgitation are undergoing further experimental and clinical evaluations, and its success will be partially dependent on a thorough understanding of the underlying valvular pathology. Patient selection will be a critical component in the long-term efficacy of these new therapies. Close collaboration among the cardiovascular specialists and biomedical engineers will enable the development of safe and effective devices.

Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response.

BACKGROUND: Surgical edge-to-edge repair has been used in the treatment of mitral regurgitation. We evaluated the ability of a catheter-delivered clip (Evalve, Inc) to achieve edge-to-edge mitral valve approximation without cardiopulmonary bypass and the healing response of this technique. METHODS AND RESULTS: Twenty-one pigs underwent general anesthesia and left thoracotomy. A 10F flexible delivery catheter with a clip was placed into the left atrium. With echocardiographic and fluoroscopic guidance, the clip grasped and approximated the mid portion of the anterior and posterior leaflets. After a double orifice had been confirmed, the clip was detached and the catheter withdrawn. All animals survived and had successful clip placement. Three animals were euthanized at 4 weeks, 9 at 12 weeks, 1 at 17 weeks, 7 at 24 weeks, and 1 at 52 weeks. The clip was well positioned, with leaflet approximation in all animals except 1, in which the clip separated from the posterior leaflet at 4 weeks without affecting valve function. The clip was modified and implanted in 4 pigs; all were intact at 12 to 24 weeks. Scanning electron microscopy showed clip encapsulation with complete endothelialization. Mitral stenosis and thromboembolism did not develop. Two animals developed endocarditis (1 at 12 weeks and 1 at 17 weeks). Progressive healing occurred in all other animals. CONCLUSIONS: Edge-to-edge mitral valve approximation can be successfully and reliably achieved with a catheter-delivered clip without cardiopulmonary bypass, resulting in durable healing. The success of this device supports the development of a percutaneous catheter-based system for mitral valve repair.

Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model.

BACKGROUND: The edge-to-edge technique is an accepted method for the surgical repair of a regurgitant mitral valve. This study reports the initial use of an endovascular technology that enables a double-orifice edge-to-edge mitral valve repair without cardiopulmonary bypass in an animal model. METHODS AND RESULTS: Adult pigs (n=14) were anesthetized, and left thoracotomy was performed for epicardial echo imaging. Using femoral vein access, a steerable guide catheter was placed transseptally into the left atrium. An implantable clip designed to grasp and approximate the middle scallops of the anterior and posterior mitral leaflets was introduced through the guide catheter. The clip was opened in the left atrium, advanced through the mitral orifice, and retracted to grasp the leaflet edges. When a functional double-orifice valve was confirmed by echo, the clip was closed to coapt the leaflets and detached from the delivery catheter. Before final clip detachment, echo demonstrated a double orifice in all 14 animals. In 2 studies, the clip released from the anterior mitral leaflet. Retrospective analysis of echo images indicated an incomplete grasp of the anterior leaflet. Immediate postmortem examination revealed that the clip successfully approximated the middle scallops of the anterior and posterior leaflets in all 12 double-orifice studies. CONCLUSIONS: This study demonstrates for the first time that an endovascular system can be successfully used to perform the edge-to-edge repair technique in a nondiseased porcine model. This technique is potentially applicable as a percutaneous catheterization laboratory procedure for the treatment of mitral regurgitation in humans.