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A one-size-fits-all fenestrated graft for iliac aneurysms?

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Reserving enthusiasm

Vascular surgeons are like cobblers – we try to make the perfect pair of shoes for each customer. While all aneurysm operations are similar in principle, in reality each successful operation depends on a unique blend of surgical skill and experience applied to the individual anatomy of each patient. By combining endovascular and open surgical skills, vascular surgeons are enticed to develop ever more innovative solutions for complex problems. Dr. Kelly should be congratulated for thinking outside the box and applying his imagination and skill to the solution of this common clinical scenario. While I am intrigued by the technique, I will reserve my enthusiastic endorsement because of the relatively high cost and the fact the common iliac artery must be sufficiently large to accommodate the physician-modified bifurcated graft. Others have described the use of "stacked" Gore Excluder device to achieve a similar result. And the Cook Iliac Branched Device is nearing approval. In the long run, the FDA needs to adopt policies that encourage rather discourage innovation in the development of novel surgical treatments. The current onerous IDE process is excessively complex and expensive. Physician-modified endografts fill an important gap in our ability to deliver quality, customized care for every patient. And there is no evidence that innovation in vascular surgery has been harmful to patients. After all, every operation is "physician modified."

Dr. John F. Eidt is a vascular surgeon at the Greenville (South Carolina) Health System, and an associate medical editor for Vascular Specialist.


 

THE ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY

A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.

While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.

Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry

Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.

*CORRECTION, 10/29/2013: An earlier version of this article misstated the name of the annual meeting of the Midwestern Vascular Surgical Society.

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