Early Outcomes from the Multicentre Standardised PHysician Modified Four Fenestration Endograft REgistry (S.PH.E.RE.)

Abstract

Objective: The objective of the study was to investigate the safety, efficacy, and early outcomes of a novel standardised approach to a four fenestration physician modified endograft (sPMEG) in the treatment of very large and urgent complex abdominal aortic aneurysms (cAAAs).

Methods: This was a prospective multicentre study (S.PH.E.RE., Standardised PHysician modified four fenestration 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 death. Secondary endpoints were sPMEG instability, major adverse events, and re-intervention at 30 days. Graft geometric integrity and target vessel to fenestration misalignment (TV-FM) were evaluated on post-operative computed tomography angiograms.

Results: There were 50 cAAAs from 13 centres with a median follow up of 8 months. The mean age was 78 ± 18 years, with a Society for Vascular Surgery comorbidity score of 16 ± 5 and a mean maximum aneurysm diameter of 75 ± 19 mm. There were nine (18%) short neck, 18 (36%) juxtarenal, 15 (30%) pararenal abdominal aortic, and eight (16%) extent IV thoraco-abdominal aneurysms. Thirty-two patients (64%) were treated electively, while 13 (26%) had a symptomatic and five (10%) had a ruptured aneurysm. Mean graft modification time was 128 ± 33 minutes and mean total operating time was 196 ± 96 minutes. No intra-operative graft related complications were reported. Overall technical success was 96%, with failure to cannulate two target renal vessels. The 30 day mortality rate 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 was reported at 30 days. All patients had successful early follow up imaging, and post-implantation geometric 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 four fenestration sPMEGs for the treatment of very large and urgent cAAAs showed excellent technical implantation safety, efficacy, and early outcomes, despite the high patient comorbidity rates. Longer term follow up is needed to better define the clinical role of this sPMEG approach.

Keywords: Aortic aneurysm; Endograft; Endovascular aortic repair; Fenestrated endovascular aortic repair; Multicentre study; Physician modified endograft.