Use of the Zenith Fenestrated platform to rescue failing endovascular and open aortic reconstructions is safe and technically feasible

Abstract

Objective: Proximal neck dilation is a serious long-term complication directly causing the failure of endovascular aneurysm repair (EVAR) and open surgical repair (OSR) of abdominal aortic aneurysms. However, the implantation of a fenestrated device presents the opportunity for proximal extension of the aortic reconstruction into a healthy segment while maintaining patency of the visceral vessels. The objective of this investigation was to report perioperative and follow-up outcomes using the Zenith Fenestrated (ZFEN; Cook Medical, Bloomington, Ind) aortic stent system in salvaging previous aortic repairs undergoing type IA endoleak or aneurysmal degeneration of the proximal neck.

Methods: We performed a retrospective review of a prospectively maintained institutional database capturing all fenestrated EVAR (FEVAR) cases with the ZFEN platform. Fenestrated cases were classified as primary FEVAR or reoperative FEVAR (rFEVAR) after previous EVAR or OSR. Cohort comparisons were performed using Fisher exact tests and Student t-tests for categorical and continuous variables, respectively.

Results: Between October 2012 and March 2017, a total of 103 patients diagnosed with abdominal aortic aneurysm with an inadequate proximal seal zone for traditional EVAR were treated with ZFEN. In 12 patients, FEVAR was performed as a reoperation after previous EVAR (n = 6) or OSR (n = 6). The indications for rFEVAR were proximal neck dilation (>55 mm) after OSR (n = 6), type IA endoleak after EVAR (n = 5), and proximal neck dilation after EVAR without endoleak (n = 1). No difference in ability to achieve technical success was observed between primary FEVAR and rFEVAR (97.8% vs 100%; P = 1.00). In addition, there were no differences in estimated blood loss (363 vs 500 mL; P = .25) and intraoperative use of contrast material (97.3 vs 104.0 mL; P = .55). However, a significant increase in fluoroscopy time (61.1 vs 79.8 minutes; P = .04), radiation exposure (415.9 vs 606.3 rad; P = .02), and operative time (228.4 vs 287.6 minutes; P = .03) in the rFEVAR cohort was observed. In the 30-day perioperative period, there were no significant differences with regard to mortality (2.2% vs 0%; P = 1.0), major adverse cardiovascular events (5.5% vs 0%, P = 1.0), and stent-related adverse events (2.2% vs 0%; P = 1.0). There were no differences in rates of perioperative (5.5% vs 0%; P = 1.0) or follow-up reintervention after a mean follow-up duration of 20.8 months (18.6% vs 25.0%; P = .70).

Conclusions: FEVAR with the ZFEN platform of failed and failing aortic reconstructions due to disease progression is safe and feasible without increased morbidity and mortality in select patients. These preliminary results support the inclusion of ZFEN as a treatment option for aortic reintervention.

Keywords: Abdominal aortic aneurysm; FEVAR; Reintervention; Rescue; Zenith Fenestrated endograft.