CLINICAL TRIAL
JOURNAL ARTICLE
Add like
Add dislike
Add to saved papers

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts.

OBJECTIVE: To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.

METHODS: A nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial was used. Data collected on patients treated with PMEG between April 2011 and August 2012 were analyzed. Subjects were followed with computed tomography, visceral duplex, and four-view X-ray at 30 days, 6 months, and 1 year. The protocol was designed to include follow-up to 5 years. The primary safety end point was the proportion of subjects who experienced a major adverse event (MAE) within 30 days of the procedure. The primary efficacy end point was the proportion of subjects experiencing treatment success.

RESULTS: During the 16-month study period, 28 patients were consented and 26 underwent endovascular repair using PMEGs. Anatomic, operative details, and length of stay were recorded and included aneurysm diameter (mean, 62.5 mm), proximal neck length (mean, 4.4 mm), graft manufacture time (mean, 59.7 minutes), procedure time (mean, 169 minutes), fluoroscopy time (mean, 42.8 minutes), total contrast usage (mean, 63 mL), estimated blood loss (mean, 221 mL), and length of hospital stay (mean, 4.9 days). There were 63 fenestrations created for 48 renal arteries and 15 superior mesenteric arteries. Renal artery fenestrations were stented whenever possible (96%) and superior mesenteric artery fenestrations were all left unstented. There were no unanticipated adverse device events, no MAEs, and only a single minor adverse device event treated with a successful reintervention. At 30 days, there were no type I or III endoleaks and only four type II endoleaks (15.4%). Two patients died during the study period, one at day 23 from respiratory failure (in-hospital and 30-day mortality = 3.8%) and one at day 210 from urosepsis and congestive heart failure. MAEs occurred in 11.5% of patients at 30 days. The primary efficacy end point was achieved in 87.5% of patients (technical success 100%, freedom from migration, rupture or conversion, type I or III endoleaks, or sac enlargement = 100%, 100%, 87.5%, and 87.5%, respectively).

CONCLUSIONS: These preliminary data suggest that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. Endovascular repair with PMEG has acceptable early rates of morbidity, mortality, and endoleak. This endovascular aortic strategy is particularly appealing for those patients presenting with symptomatic or ruptured aortic aneurysms until reliable off-the-shelf solutions become widely available.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app