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Physician Modified Endografts for the Treatment of Elective, Symptomatic and Ruptured Juxtarenal Abdominal Aortic Aneurysms
Benjamin W. Starnes, *Sara Zettervall, *Allison Larimore, Niten Singh
Surgery, University of Washington, Mercer Island, WA
Objective
The objective of this study was to report long term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms.
Methods
Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 9, 2023. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The efficacy end point was the proportion of subjects 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 intended branch vessels; and
freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion.
Results
During the 140-month study period, 211 patients were enrolled; 188 began the implant procedure and 186 received PMEG. 42 patients died during the study period. A total of 14 were deemed lost to follow up. Forty-seven completed the five year follow-up period and 59 remain active in follow-up visits.
Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.6 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), Graft modification time (mean, 49.2 min), procedure time (mean, 138.7 min), fluoroscopy time (mean, 34.2 min), contrast material use (mean, 92.1 mL), EBL (mean, 122.3 mL), and length of hospital stay (mean, 4.0 days) with ICU length of stay (mean, 1.7 days).
There were 520 fenestrations made for 351 renal arteries, 163 superior mesenteric arteries (SMAs), and 6 celiac arteries (Figure 1). One patient had an SMA stent placed before the procedure, thirteen had the SMA stented during the procedure, and 2 stented after the procedure. Renal arteries were stented whenever possible (96%). There were 337 stented renal arteries in 186 patients. A total of 3 ruptures were recorded on days 1460, 1346, and 830. Thirty-day all-cause mortality was 3.8% (7/186). There were zero type Ia, one type Ib, and seven type III endoleaks during follow-up treated with successful reintervention at the one year period. The overall rate of major adverse events at 30 days was 16.1% (30/186). Technical success was 93.6% and overall treatment success 84.3%.
Conclusions
PMEG has exceptional long term rates of morbidity, mortality, and endoleak. In patients who are poor open surgical candidates who present with symptomatic or ruptured juxtarenal aortic aneurysms, PMEG continues to be an extremely appealing option as timely and reliable off-the-shelf solutions are not widely available.
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