Early Outcomes from the Multicentre Standardised PHysician-Modified 4-Fenestrated Endograft REgistry (S.PH.E.RE.)

Objective: The objective of the study was to investigate the safety, efficacy, and early outcomes of a novel standardised approach to 4-fenestrated physician modified endograft (sPMEG) in the treatment of very large and urgent complex abdominal aortic aneurysms (cAAAs). Methods: Prospective multicentre study (S.PH.E.RE., Standardized Physician-modified 4-fenestrated Endograft Registry). The Valiant Captivia endograft (Medtronic, Minneapolis, MN, USA) was used for on bench modifications. Planning of fenestration position, technique, and procedure were standardised across the participating centres. Primary endpoints were technical success and early mortality. Secondary endpoints were sPMEG instability, major adverse events, and re-intervention at 30 days. Graft geometrical integrity and target vessel to fenestration misalignment (TV-FM) were evaluated on post-operative computed tomography angiogram. Results: There were 50 cAAAs from 13 centres with a median follow up of 8 months. Mean age was 78 ± 18 years, with a Society for Vascular Surgery comorbidity score of 15 ± 5 and a mean maximum aneurysm diameter of 75 ± 19 mm. There were 9 (18%) short neck, 18 (36%) juxtarenal, 15 (30%) pararenal abdominal aortic, and 8 (16%) Extent IV thoraco-abdominal aneurysms. Thirty-two patients (64%) were treated electively, while 13 (26%) had a symptomatic and 5 (10%) had a ruptured aneurysm. Graft modification time was 128 ± 33 minutes, and total operating time was 196 ± 96 minutes. No intra-operative graft related complications were reported. Overall technical success rate was 96%, with failure to cannulate two target renal vessels. Thirty day mortality was 0%, and the major adverse event rate was 8%. Related re-intervention occurred in 4%. No graft related type I endoleak, disconnection, or fracture were reported. All patients had successful early follow up imaging, and post-implantation geometrical analysis showed 100% integrity of the main graft and 194 reinforced fenestrations. Vertical TV-FM was detected in 1% , and horizontal TV-FM in 2%. Conclusion: This real life registry using 4-fenestrated sPMEG for the treatment of very large and urgent cAAAs showed excellent technical implantation safety, efficacy, and early outcomes, despite the high comorbidity rate of patients. Longer term follow up is needed to better define the clinical role of this standardised PMEG approach.