Procedural and perioperative results in patients treated with fenestrated endovascular aneurysm repair planned by automated software in a physician-sponsored investigational device exemption trial of physician-modified endografts

Abstract

ObjectiveFenestrated endovascular aneurysm repair (FEVAR) has been used successfully to treat patients with juxtarenal abdominal aortic aneurysms (JAAAs). Barriers to wide adoption of FEVAR include complexity in planning of fenestration locations on endografts. The purpose of this study was to validate the use of automated planning software to design fenestrated endografts and to treat patients with complex abdominal aortic aneurysms. MethodsPatients with JAAA who were not candidates for open repair were enrolled into the automated planning arm of an ongoing investigational device exemption clinical trial and treated with FEVAR. Patient-specific fenestration size and location were determined by automated planning software using patient imaging data and algorithms that account for the interaction between the endograft delivery system and angulated aortic anatomy. Standard, off-the-shelf abdominal aortic aneurysm endografts from multiple manufacturers were modified on the back table by the physician according to the automated graft plan in the form of a patient-specific three-dimensional printed cylindrical template. Endografts typically included fenestrations for the superior mesenteric artery and both renal arteries. Procedural, perioperative, and long-term clinical and imaging data were collected per protocol. ResultsThirty nonoperative JAAA candidate patients (American Society of Anesthesiologists class ≥3) were consented and treated with fenestrated endografts planned by automated software. The mean age was 74 ± 7 (61-86) years. The mean aneurysm diameter was 61.3 mm (range, 49-96 mm), and the mean infrarenal neck length was 6.1 mm (range, 2-15 mm). At the index procedure, 100% (30/30) of the patient-specific, surgeon-modified grafts were implanted with preservation of 97% (84/87) of branch vessels and a mean final proximal seal zone length of 41.9 mm (range, 27.3-60.6 mm). Three renal arteries were not cannulated during the index procedure because of complications not related to graft planning. The 30-day mortality rate in these high-risk JAAA patients was 6.7% (2/30), and both deaths were unrelated to the aneurysm. The 30-day major adverse event rate was 16.7% (5/30). There were no type IA or type III endoleaks, ruptures, or conversions to open surgery through 30 days. ConclusionsThis automated FEVAR planning software accurately and efficiently identifies fenestration locations for vital branch arteries, thus simplifying the planning process and facilitating the FEVAR procedure. Validated automated FEVAR planning could help bring this beneficial therapy to most patients harboring JAAAs.