Midterm Results Reported for Physician-Modified Endovascular Grafts to Treat Juxtarenal Aortic Aneurysms

 

February 1, 2017—In the Journal of Vascular Surgery (JVS), Benjamin W. Starnes, MD, et al published the midterm results from an ongoing physician-sponsored investigational device exemption (IDE) clinical trial evaluating physician-modified endovascular grafts (PMEGs) for the treatment of juxtarenal aortic aneurysms in patients who are deemed unfit for open repair (2017;65:294–302).

As summarized in JVS, data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on May 31, 2015, with outcomes analysis through December 31, 2015.

Primary safety and efficacy endpoints were used to measure treatment success. The primary safety endpoint was the proportion of patients who experienced a major adverse event within 30 days of the procedure. The primary efficacy endpoint was the proportion of patients who achieved treatment success.

Treatment success required the following at 12 months: technical success (defined as successful delivery and deployment of a PMEG with preservation of those branch vessels intended to be preserved), freedom from type I and type III endoleaks, stent graft migration > 10 mm, aortic aneurysm sack enlargement > 5 mm, and aortic aneurysm rupture or open conversion.

During the 50-month study period, 64 patients were enrolled; 60 began the implant procedure, and 59 received the PMEG implant. Length of hospital stay, aneurysm anatomy, and operative details were recorded and included aneurysm diameter (mean, 65.9 mm; range, 49–104 mm), proximal seal zone length (mean, 40.8 mm; range, 18.9–72.2 mm), graft manufacture time (mean, 55.1 minutes), procedure time (mean, 156.8 minutes), fluoroscopy time (mean, 39.6 minutes), contrast material use (mean, 75.3 mL), estimated blood loss (mean, 213 mL), length of hospital stay (mean, 4.1 days), and intensive care unit length of stay (mean, 2.2 days). There were 145 fenestrations made for 110 renal arteries and 38 superior mesenteric arteries (SMAs).

The investigators reported that one patient had an SMA stent placed before the procedure for severe stenosis, and one subject had the SMA stented during the procedure. Renal arteries were stented whenever possible (93%). There were 102 stented renal arteries in 58 patients. There were no open conversions or explantations. Thirty-day mortality was 5.1% (3/59). There were zero type Ia, one type Ib, and two type III endoleaks during follow-up, which were treated with successful reintervention. The overall rate of major adverse events at 30 days was 11.9%. The primary efficacy endpoints were achieved in 94.1% of patients.

The investigators concluded that these midterm results are favorable and verify their early report that endovascular repair with PMEGs is safe and effective for managing patients with juxtarenal aortic aneurysms. Furthermore, they stated that PMEGs have exceptional midterm rates of morbidity, mortality, and endoleak and may outperform standard endovascular aneurysm repair in favorable anatomy. In patients who are poor open surgical candidates and present with symptomatic or ruptured juxtarenal aortic aneurysms, PMEGs continue to be an extremely appealing option, as reliable off-the-shelf solutions are not widely available. Preoperative planning remains the key for success with use of these techniques, advised the investigators in JVS.

 

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