Access Devices Foster Team Spirit
In the United State, the heart team approach that sees surgeons and interventional cardiologists working together is required by the Food and Drug Administration approval of the Edwards’ Sapien valve. The Centers for Medicare & Medicaid Services have also made the joint participation of the two clinical specialties a condition of reimbursement. But even in Europe, where many centers have a choice to use one specialty or the other, the two groups still opt to work together because it’s important, when treating patients with heart valve disease, to be able to adapt to a particular patient’s circumstances. Cardiovascular industry veteran Jim Greene, now CEO of Apica Cardiovascular, says, "These are very old patients with very high risk scores. They are absolutely the worst patients I have ever seen." In Greene’s experience, clinicians are truly working together in teams, not just paying lip service to the concept. They’re jointly making decisions based on peripheral problems, the pumping function of the heart, carotid access and how much potential there is for stroke. "When this becomes truly endoscopic and percutaneous, you will see cardiologists doing transapical procedures and surgeons doing transfemoral TAVI. They are cross-training even now," Mr. Greene says. Cardiac surgeon and serial medical device entrepreneur Dr. Frank Litvack, chairman of Entourage Medical, says, "Clearly, the better the transfemoral access method and adjunct closure devices get, the more pressure there will be on the transapical area to improve, and the better the transapical devices get, the more pressure there will be on the transfemoral side." Many companies in this space are thus working on both sides of the problem to make available different access options for different patients – a patient-centered, rather than clinician-centered approach.
Dr. Litvack has participated in the development of the field of interventional cardiology since the 1980s, and he says this time, there is great partnership from the surgeon community. "Back in the ’80s and ’90s, surgeons tried to fight coronary interventions," he recalls. "But now they recognize there is an important place for these structural interventions and that they should participate and assist in the process."
Indeed, TAVI is only the first major intervention for structural heart disease. Many others lie ahead. Transcatheter treatment of the mitral valve is next and it’s an enormous market. More than 50% of the 5.2 million people with heart failure in the US suffer from mitral regurgitation. After a decade of development, this market is finally emerging. In June 2012, CardiAQ Valve Technologies Inc. became the first company to begin clinical trials of a transcatheter prosthetic mitral valve. Mitral valves will require much larger delivery systems (29F) and will benefit from a straight shot to the mitral annulus through the apex.
Other up and coming indications include the endovascular repair of abdominal aortic and thoracic aortic aneurysms, a potential market for large-bore closure devices. This is a growing market where least-invasive technology has the opportunity to electively treat a larger proportion of the 1.1 million people in the US who have abdominal aortic aneurysms.
Better transapical access could enable miniature LVADs (left ventricular assist devices) to be delivered to the left ventricle through the apex without the need to put very sick patients on cardiopulmonary bypass, which would be a breakthrough therapy for end-stage heart failure patients, a strategy of Apica Cardiovascular.
Certain types of electrophysiology ablations will also be easier to do transapically. When the foci of ablation are located in the mitral valve annulus area, it is much easier to get to the pulmonary vein from the apex and up through the mitral valve.
Micro Interventional Devices sees the potential to use its transapical access platform to treat patent foramen ovale and other congenital heart defects. It’s becoming clear that if companies succeed with their new access and closure devices, they’ll be doing more than offering procedural refinements for TAVI. They’ll be creating the gateway to interventional therapies for structural heart disease.
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