Wilder,
An ambitious idea, and as they said, one that's failed many times before. Here are some areas of concern.
"If our human clinical studies demonstrate graft effectiveness at least comparable to SVGs"
They mention that they have some animal data already. It seems that establishing non-inferiority to svg (or animal equivalent) in the animal model would be priority #1, and one that I would need to see before considering an investment. Maybe there's some reason this can't be done first, and if so, I'd like to hear it.
"Another major source of frustration is that 50-60% of all grafts tend to lose patency within five to seven years, requiring additional procedures for a patient that is often more frail. Based on our research and knowledge of flow dynamics, we believe this degradation in patency results in part from connecting a conventional vein or artery graft from a high flow area (such as the aorta) to a low flow region (such as the coronary artery). Small diameter vessels and low flow can be contributory factors to clotting and tissue formation, each of which can result in occlusion. "
This is the problem CGTK has made great progess in. The more of the data I review, the more I believe it has a convincing solution (actually the biggest problem with svg).
"Over the last several years, the total number of patients undergoing bypass surgery has decreased as a result of new, less invasive therapies such as pharmacotherapy, angioplasty and stenting"
Yes, and in fact, the whole paradigm of cabg as the preferred procedure may undergo a shift within then next decade. Stenting may supersede cabg.
"We have reviewed the previous artificial graft work and believe continuous high blood flow and pressure coupled with drug combinations, are the critical elements necessary to adequately limit or obviate clotting and tissue formation in an artificial graft system, each of which can adversely impact vessel patency. "
So my question here is, what is the exact role of the flow limiter? Obviously you can't just create an aorto-venous shunt, so the pressures distal to the "flow limiter" are going to be low. But they are identifying high flow as critical to limit clotting, etc. Unfortunately, there is still one part of their system that is low flow, so maybe this problem hasn't been solved.
One last comment. The prospectus is kinda heavy on the pain and suffering that svg harvesting causes. It acknowledges that complications can be reduced to 5% with endoscopic removal. So the question would be - Why learn an entirely new procedure (Holly), instead of brushing up on your endoscopic skills. BTW, the svg harvesting is usually done by the CT fellow, not the actual CT attending - it's considered sorta a hum drum part of the overall surgery. |
