Physician-Modified Endovascular Grafts Shown to Be Effective Treatment Option

June 17, 2011—The Society for Vascular Surgery announced that a new study shows that physician-modified endovascular grafts (PMEGs) are an effective method of treating juxtarenal aortic aneurysms in patients who are considered to be unsuitable for open surgical repair. The study was presented at the society's 2011 annual meeting in Chicago.

According to the SVS, Benjamin W. Starnes, MD, requested an outside review of the safety and efficacy of a physician-modification of a US Food and Drug Administration–approved device, the Zenith Flex endovascular graft (Cook Medical, Bloomington, IN), for the treatment of abdominal aortic aneurysms.

“PMEG therapy is used to preserve branch vessels when used in the treatment of patients with elective, symptomatic, or ruptured juxtarenal aortic aneurysms,” stated Dr. Starnes. “The data were taken from a prospective, consecutively enrolling, nonrandomized single-institution evaluation.”

Dr. Starnes noted that 47 patients underwent fenestrated endovascular repair using a PMEG during a 3-year period. Of these 47 patients, 38 (80%) were symptomatic or had rapid aneurysm expansion. Also, 80% of all patients were American Society of Anesthesiologists category III or IV. Eighty-two fenestrations were created for 58 renal arteries, 16 superior mesenteric arteries, and three celiac arteries. The remaining fenestration repairs were for accessory vessels.

The mean follow-up was 103 days (range, 62–442 d). The mean contrast usage was 98 cc, and the mean fluoroscopy time was 48 minutes.

The investigators reported that there were six complications (12.7%). Three complications (6.4%) were access related. The three procedure-related complications (6.4%) included one stroke, one renal failure, and one branch artery dissection. On follow-up, six patients (12.8%) had endoleak. One patient with an endoleak had aneurysm sac expansion at 1 year, requiring secondary intervention.

There was no operative mortality. The in-hospital and 30-day mortality rate was 2%, with one patient dying due to aspiration after successful endovascular repair. Two patients died during follow-up: one at 58 days due to cessation of dialysis and one at 485 days due to stent graft migration and occlusion of the superior mesenteric artery. There were two deaths in the first year, one in the second, and zero in the most recent year of experience.

“Our study showed that a PMEG is a safe and effective alternative for treating patients with juxtarenal aneurysms who have no other alternatives for repair,” commented Dr. Starnes, who added that longer-term follow-up is needed to assess the durability of repair and potential for device-related complications.

In early 2011, the US Food and Drug Administration and Centers for Medicare & Medicaid Services approved an investigator-initiated investigational device exemption study to be conducted by Dr. Starnes. The study will have an anticipated enrollment of 150 patients. This is the only approved PMEG study in the United States, stated the SVS.