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UPMC has been selected as a center for the APOLLO Trial which sets to evaluate the safety and efficacy of Medtronic Intrepid ™ TMVR system in patients with moderate to severe or severe symptomatic mitral regurgitation.
Mitral regurgitation is the most common form of valvular heart disease. The prevalence of mitral regurgitation increases with age. There are two etiologies of mitral regurgitation – primary and secondary. It is important to understand this as the pathogenesis, prognosis and management differs with each. Primary MR occurs when there is an abnormality of the mitral valve apparatus. Secondary MR occurs when the mitral valve apparatus is normal but there is an abnormality in left ventricular function.
The first line treatment for severe primary (degenerative) mitral regurgitation is surgical mitral valve repair. When repair is not favorable, surgical mitral valve replacement is performed. As you can imagine with the incidence and prevalence of mitral regurgitation increasing with age, these older adult patients have more comorbidities that may make them high risk for standard surgical approaches thus creating a need for less invasive treatment options.
In severe secondary (functional) mitral regurgitation, isolated mitral valve surgery is not generally recommended as there is no proven mortality benefit and the long-term effect on symptoms is uncertain. These patients overall have a poorer prognosis as a result of the underlying LV dysfunction and cardiomyopathic process that occurs. For patients with severe functional MR undergoing CABG, mitral valve surgery with replacement over repair is suggested.
The development of transcatheter therapies for mitral regurgitation has greatly increased over the last decade to provide a less invasive approach to treating MR.
The Medtronic Intrepid™ TMVR system is designed for trans-apical access with delivery of a self-expanding bioprosthetic bovine pericardial valve within the native mitral valve with the intention to restore normal function and relieve mitral regurgitation. Its use is intended for both primary and secondary mitral regurgitation. In a standard surgical valve implant the valve is sewn into the heart with the chest fully open and the patient on cardiopulmonary bypass support. With the Intrepid™ TMVR system the valve is implanted through a less invasive mini-thoracotomy approach and does not require cardiopulmonary bypass support or stopping of the heart. This reduces the risks associated with the more invasive surgery and thus may speed recovery. This concept is similar to the transapical transcatheter aortic valve implantation systems for aortic valve disease.
Potential candidates for the APOLLO trial have the following characteristics:
For a full list of inclusions/exclusion criteria or to refer a patient: