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 the 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 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness 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: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%.
CONCLUSIONS: PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.