Physician-modified endografts using an endoskeleton ePTFE platform for complex aortic aneurysms requiring a single fenestration: a proof-of-concept study

Abstract Background Endovascular interventions for complex aortic aneurysms—including juxtarenal abdominal aortic (JAAA), pararenal abdominal aortic (PRAAA), and thoracoabdominal aortic (TAAA) aneurysms—face inherent limitations, such as manufacturing delays and anatomical restrictions. In Japan, where commercial off-the-shelf branched or fenestrated devices remain limited, physician-modified endografts (PMEGs) represent a crucial practical alternative. Conventional polyester-based PMEGs, however, pose challenges regarding manual resheathing and fenestration site fragility. This study evaluated the safety and early- to mid-term clinical outcomes of PMEGs constructed using the endoskeleton-based, expanded polytetrafluoroethylene (ePTFE)-covered AFX VELA platform. Methods This retrospective study included four high-risk patients with complex aortic aneurysms requiring a single fenestration. All were unsuitable for open surgical repair (OSR), standard endovascular aneurysm repair (EVAR), or chimney endovascular aneurysm repair (ChEVAR) due to an infrarenal neck length (IRL) < 2 mm. Fenestrations were created via sharp ePTFE incision and reinforced with an expansile hydrogel coil. Following manual resheathing without dedicated crimping tools, target vessel cannulation and bridging stent reconstruction were performed. Endpoints included technical success, 30-day major adverse events (MAEs), target vessel patency, endoleaks, sac diameter changes, and reinterventions. Results The cohort (two men, two women; mean age, 73.0 years) presented with saccular aneurysms (one JAAA, two PRAAAs, and one Crawford type V TAAA). The mean maximum diameter was 54.3 mm, and all had an IRL of 0 mm. Technical success was 100%, with zero 30-day mortalities or MAEs. Over a 31.5-month mean follow-up, primary target vessel patency remained 100%, without endoleaks or required reinterventions. Aneurysm sac diameter regressed by 5 mm in two patients and remained stable in two. No aortic-related mortalities occurred. Conclusions This proof-of-concept study is the first to describe AFX VELA-based PMEGs and shows that the technique is feasible in carefully selected patients with complex aortic aneurysms. The procedure does not require dedicated crimping tools or complex resheathing maneuvers, whereas its mid- to long-term durability requires continued evaluation. Establishing a definitive clinical role will require larger prospective studies with extended follow-up.