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Dr Richard M. Green (Rochester, NY). Dr. Carpenter, that was nicely presented. Can you give us a sense—you've used a lot of different devices—as to what the specific role of this graft will be, what the advantages are, disadvantages are, relative to some of the others. There are a lot of the same anatomic indications for the currently approved devices.

Dr Jeffrey P. Carpenter. That's an excellent question: Where does this device fit in?

I think what distinguishes it from the other devices, of course, is the fact that it's a balloon-expandable device. It offers the ability to make very fine adjustments during deployment. It deploys quite accurately.

The high radial force is another feature of it that is unique. It will straighten an angulated aortic neck. I've had trouble getting self-expanding devices to seal in the angulated situation; and, of course, the remedial procedure for that problem is placement of a balloon-expandable stent in the neck. Here you're starting with a high radial force situation from the outset.

I'm also very impressed with the sac regression data and the effective prevention of AAA rupture.

Dr Robert B. Rutherford (Corpus Christi, Tex). Am I correct that only 79 of the 227 were the first iteration?

Dr Carpenter. That's correct.

Dr Rutherford. They must be bifurcation endografts only, then. And what were the changes that were made in the redesigned endografts that are leading to these improved results in terms of wireform fractures? Originally it was said that they were going to thicken the wireforms and do something else to them, like burnish them; but it has not been made clear exactly what changes were made that now have led to these improved results.

Dr Carpenter. That's precisely it, Dr Rutherford. The wires are made of the same material, just thickened.

Dr Jacob Buth (Eindhoven, The Netherlands). Thank you for this nice presentation.

Can you elaborate a bit more on the differences between the Lifepath and other devices, for instance, with regard to the available size range of this particular device. I believe the maximum sizes are smaller than for the other device brands, which may be due to a thicker fabric. Can you confirm that?

Dr Carpenter. The fabric is a full-thickness, surgical weight polyester. In the trial the device was used to treat aneurysms between 19-mm and 27-mm diameter neck. There is an aortic cuff available up to 31 mm, which should be able to extend that range to 29 mm. And I know the Lifepath team is planning larger sizes. But for the purposes of the trial, we treated 19-mm to 27-mm neck diameters.

Dr Buth. And thinking of the previous talk, are there any specific oversizing recommendations? I thought it was a bit different in Lifepath from other devices.

Dr Carpenter. That's an excellent point. The sizing issues are different owing to the balloon-expandable delivery. Diameter measurements are performed intima to intima. Oversizing is less than with other devices. The protocol specifies 10% to 15%. In practice, most of us oversize about 10%.

Dr Buth. Were there breaks with the protocol in the two ruptures?

Dr Carpenter. I do not believe that there were breaks that were identified. We've been over those patients many times. At the time of conversion, both were described to have extremely thin aortas.