PYTHAGORAS study
Boston-based Lombard Medical Technologies, Inc announced in August that it had opened its Pythagoras AAA stent graft trial to include patients with infra-renal neck angles from 60° to 90° at eligible sites. Since then, recruitment into the trial has accelerated as more centers have joined to explore using the Aorfix™ stent graft in this challenging range of anatomy. The first three high angle cases have been completed successfully at Dartmouth-Hitchcock Medical Center, Lebanon, NH and Sentara Heart Hospital in Norfolk, VA. Dr Mark Fillinger, the Principal Investigator for the US trial performed the first procedure in a high-angle neck and said, “The disease in this case had caused a sharp angulation in the aorta to 79°, which the trial is specifically designed to address. In addition, there was a less-than-ideal cone shape to the attachment site, and a sharp angulation above the attachment site as well. I do not believe that any other available stent graft could have treated this aneurysm properly, and the patient had been waiting for Aorfix™ to become available in this clinical trial. We are very pleased with the result and so is the patient.” The second and third high angle cases were treated by Dr Jean M Panneton in Norfolk, VA, who commented, “The first of these cases had a sharply angled neck and, on the right side, a very short proximal landing zone. Removing the delivery system caused a small endoleak at the point of the bend and I used the Aorfix cuff to correct this. Another time I might use a Meier wire and pull it back a little so that the floppy tip doesn’t push the delivery system so hard against the wall. The delivery system is very flexible so this technique should work well. The graft did a good job in a difficult case.” The third high neck angle patient had the most challenging anatomy to be treated by Aorfix™ in the US. The procedure was also carried out by Dr Panneton who commented, “I had originally planned this case with an approved graft but really there is not a commercial graft available to treat this kind of anatomy. The Aorfix™ fitted into the neck very well and the aneurysm is nicely excluded.” Pre-Op image of the third Pythagoras high angle case performed at Sentara Heart. Angulation of 88° is present within the infrarenal neck. PI at Sentara Heart in Norfolk, VA, Dr Marc Glickman commented, “We have implanted 7 Aorfixes in the Pythagoras trial so far. 2 cases have reached follow up of 6 months and M2S measurements show sac volume reduction of 23% in one and 15% in the other. I’m excited by the potential for this device in a wide range of anatomies.” The Pythagoras study is introducing new investigational sites to the trial at a brisk pace, “We expect to announce that we have 20 active sites in Pythagoras in the next few weeks”, explains Peter Phillips, President of LMT, Inc. “We have taken on and trained some very experienced site specialists to ensure that all cases are fully supported by Aorfix™ technical experts in the OR. Training both our staff and our users is of paramount importance, particularly in challenging anatomies. Our site specialists are there to learn and to share tips and techniques between sites so that we can all advance practice in this area.” Lombard is actively encouraging centers that are outside the trial but wish to provide an endovascular option, to refer patients with highly angled necks to Pythagoras investigators. The company has a dedicated email address for enquiries about referrals:- [email protected]. The company can also be contacted by phone: (617) 527-4100.
