APOLLO Trial
Now actively enrolling for
the APOLLO Trial
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 Valve Replacement
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.
Which patients are
eligible?
Potential candidates for the APOLLO trial have the following
characteristics:
- Moderate to severe or severe symptomatic mitral
regurgitation as defined by the American Society of Echocardiography 2017
Guidelines and Standards
- Determined by a multidisciplinary heart team to be a
candidate for bioprosthetic mitral valve replacement
- No prior mitral valve surgery
Contact Us
For a full list of inclusions/exclusion criteria or to refer
a patient:
- Thomas Gleason, MD and Conrad Smith,MD, are the principal investigators at UPMC. If you see a patient you
believe may qualify, please call Kathryn Ferchak, PA-C, clinical director, at
412-864-2632 or email MitralCenter@upmc.edu.
- For more information about additional treatments
at the Center for Mitral Valve Disease, please visit www.upmc.com/MitralValve.
