Mitral Valve Disease: The Treatment Evolution Continues
The transcatheter therapy revolution that began with the aortic valve nearly two decades ago has ultimately transformed the treatment of aortic stenosis for patients at all risk levels for surgery. This metamorphosis from open surgery to a less-invasive procedure is now being applied to the care of patients with mitral valve disease.
Perhaps nowhere is the development of new practices and procedures for valve disease more apparent than at the NewYork-Presbyterian Hospital, where heart teams comprised of imaging experts, interventional cardiologists, and cardiac surgeons led the way as principal investigators of seminal trials in TAVR. They are now spearheading the latest trials in transcatheter therapies for mitral valve repair and replacement.
Affiliated with NewYork-Presbyterian Hospital’s prestigious academic medical partners – Columbia University Irving Medical Center and Weill Cornell Medicine – our cardiovascular faculty are applying their collective expertise to evaluate innovative treatment options that can minimize the risks and maximize the outcomes for patients with mitral valve disease.
Heart valve disease experts have learned from earlier feasibility studies that transcatheter treatment of mitral valve disease is more complicated than its aortic counterpart. NewYork-Presbyterian Hospital’s heart teams continue to lead clinical trials in novel treatment approaches attempting to address the complex anatomy of the mitral valve in patients with symptomatic disease. These include:
Columbia faculty served as co-principal investigators of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) for patients who are symptomatic, despite optimal medical therapy, with moderate to severe or severe functional (secondary) mitral regurgitation. The study’s findings demonstrated that transcatheter mitral valve repair significantly reduced hospitalizations and mortality as compared to medical therapy alone. Now FDA-approved, MitraClip is a low-risk, catheter-based procedure that clips the two leaflets together to decrease mitral regurgitation through a transcatheter transseptal approach.
Transcatheter Mitral Valve Replacement (TMVR)
Faculty from Columbia and Weill Cornell Medicine are leading two ongoing pivotal trials evaluating transcatheter mitral valve replacement as an alternative to surgery. TMVR has the potential to treat patients who do not currently have another viable transcatheter therapy option.
The Intrepid™ TMVR prosthesis, first evaluated in a multinational pilot study from 13 sites including Columbia University, is a minimally invasive alternative to surgical mitral valve replacement for symptomatic mitral regurgitation. The Columbia University team is now leading the first randomized trial – APOLLO – in patients with moderate to severe symptomatic mitral regurgitation. The Intrepid device features self-expanding, dual stent technology with a bovine pericardial tissue valve to facilitate catheter-based implantation without the need for open-heart surgery. Eligible patients will be randomized against conventional surgical valve replacement. Patients with suitable valve anatomy but considered non-surgical candidates will be enrolled into a parallel TMVR registry.
Weill Cornell faculty have begun enrolling patients in a pivotal study – the SUMMIT trial – of the Tendyne™ TMVR system for symptomatic, moderate-to-severe or greater mitral regurgitation. Patients will be randomized to Tendyne implantation or MitraClip, as long as the anatomy is suitable for both approaches. Parallel registries allow for Tendyne implantation in those patients not amenable to MitraClip and those with severe mitral annular calcification. The tri-leaflet, bioprosthetic valve, which is available in multiple sizes, is implanted via a transapical approach and the device is stabilized by a tether attached to an apical pad. It is the first repositionable and fully retrievable replacement valve and conforms to a broad range of anatomies allowing for better outcomes.
With groundbreaking studies of new devices and systems for mitral valve disease in progress, patients are routinely referred to NewYork-Presbyterian Hospital to take advantage of treatment options not readily available elsewhere. Importantly, as our heart team members readily point out, while most patients might anticipate that transcatheter procedures are ideal, at times this is not necessarily so. Therefore, it is vital to seek care where multispecialty heart teams can guide patients to the right treatment for their unique circumstances and provide the approach – non-surgical or surgical – that achieves the best outcomes.