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Beyond Bypass: Next Generation Coronary Revascularization

Traditional coronary artery bypass graft (CABG) surgery has been refined to be the most effective long-term treatment for occluded coronary arteries. Yet it remains a major surgical procedure that is traumatic for patients. Various minimally-invasive approaches to cardiac surgery have been developed but adoption rates are slow because these new procedures don't yet measure up to traditional CABG and because heart surgeons are slow adopters of new technology. Recent discoveries in coronary physiology have opened the door for new approaches to creating cardiac perfusion in a patient with occluded vessels. But this requires physicians to re-think what they were taught in medical school. One such approach, which involves direct vascularization from the ventricle, is being pursued by three companies: Percardia, HeartStent and Ventrica. Another company, TransVascular, is taking a broader approach by using the venous system to bypass arterial blockages. Approaches that require physicians to think differently about basic science, along with the tortuous clinical and regulatory path for new cardiac surgery devices and the cautious nature of cardiothoracic surgeons, present significant challenges to these start-up companies.

by Stephen Levin

Stephen Oesterle, MD, Director of Invasive Cardiology at Massachusetts General Hospital , recalls being approached 17 years ago about using tiny slotted metal tubes to maintain patency in coronary arteries, and dismissing the idea out of hand. Today, of course, stents have become the standard of care in treating many patients with coronary artery disease (CAD). Oesterle acknowledges that he now keeps that experience in mind when approached with an idea for a new device or procedure about which he is initially skeptical. And skeptical is exactly how he felt about Percardia Inc. 's technology when Nancy Briefs, the company's president and CEO, first contacted him. Percardia's technology (as well as that of two other myocardial revascularization start-ups, HeartStent Corp. and Ventrica Inc. ) relies on being able to create coronary flow when the heart is in systole (the phase in which the heart is pumping) as opposed to diastole (when the heart is at rest), which is contrary to traditional cardiac physiology. "My initial question was, ‘Can this possibly happen

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