EMBARGOED RELEASE, JUNE 17, 2011, 8:28 AM
May 16, 2011
Treatment deemed safe for elective, symptomatic ruptured juxtarenal aortic aneurysms
CHICAGO--Physician modified endovascular grafts (PMEG) can be an effective method of treating juxtarenal aortic aneurysms in patients considered to be unsuitable for open surgical repair, according to a study presented at the 65th Vascular Annual Meeting of the Society for Vascular Surgery®.
Benjamin W. Starnes, MD, chief of the vascular surgery division and professor of surgery at the University of Washington in Seattle, WA, requested an outside review of the safety and efficacy of physician modification of a currently FDA-approved device (COOK Zenith Flex).
“PMEG therapy is used to preserve branch vessels when used in the treatment of patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms,” said Dr. Starnes. “The data was taken from a prospective, consecutively enrolling, non-randomized single institution evaluation.”
Dr. Starnes noted that 47 patients underwent fenestrated endovascular repair using PMEG over a three-year period. Thirty-eight of the 47 patients (80 percent) were symptomatic or had rapid aneurysm expansion. Eighty percent of all patients were ASA category III or IV. Eighty-two fenestrations were created for 58 renal arteries, 16 superior mesenteric arteries and 3 celiac arteries. The rest of the fenestration repairs were for accessory vessels.
Mean follow-up was 103 days (range 62-442). Mean contrast usage and fluoroscopy time were 98cc and 48 minutes, respectively. There were six complications (12.7 percent). Three (6.4 percent) were access related and three (6.4 percent) were procedure related and included one stroke, one case of renal failure and one branch artery dissection. On follow up, only six patients (12.8 percent) had endoleak. One patient with endoleak had aneurysm sac expansion at 1 year requiring secondary intervention.
There was no operative mortality. In-hospital and at 30-day mortality was 2 percent, with one patient expiring due to aspiration on the ward 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 SMA. 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 PMEG is a safe and effective alternative for treating patients with juxtarenal aneurysms who have no other alternatives for repair,” said 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 FDA and CMS approved an investigator-initiated Investigational Device Exemption study to be conducted by Dr. Starnes in Seattle. This is the only approved PMEG study in the United States, with an anticipated enrollment of 150 patients.
About the Society for Vascular Surgery
The Society for Vascular Surgery® (SVS) is a not-for-profit professional medical society, composed primarily of vascular surgeons, that seeks to advance excellence and innovation in vascular health through education, advocacy, research, and public awareness. SVS is the national advocate for 3,350 specialty-trained vascular surgeons and other medical professionals who are dedicated to the prevention and cure of vascular disease. Visit its Web site at www.VascularWeb.org
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