Reinterventions and Sac Dynamics after Fenestrated Endovascular Aortic Repair with Physician-Modified Endografts for Index Aneurysm Repair and Following Proximal Failure of Prior Endovascular Aortic Repair.

OBJECTIVE: The high frequency of reinterventions after Fenestrated Endovascular Aortic Repair (FEVAR) with Physician Modified Endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal.

METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the FDA in support of an Investigational Device Exemption trial. We excluded patients with aortic dissection (5), type I-III thoracoabdominal aneurysms (13), non-elective procedures (4), and prior aortic surgery other than EVAR (8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary-FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary-FEVAR). The primary outcomes were freedom-from reintervention and sac dynamics (regression as ≥5mm decrease, expansion as ≥5mm increase, and stability as <5mm increase or decrease) at 3-years. Secondary outcomes were perioperative mortality and 3-year survival.

RESULTS: Of the 92 patients included, 56 (61%) underwent primary-FEVAR and 36 (39%) underwent secondary-FEVAR. Secondary-FEVAR patients were older (78 years [IQR 74.5-83.5] vs 73 years [69-78.5], p<0.001), more frequently male (86% vs 68%, p=.048), and had larger aneurysms (72.5mm [65.5-81] vs 59mm [55-65], p<0.001). Perioperative mortality was 1.8% for primary-FEVAR and 2.7% for secondary-FEVAR (p=0.75). At 3-years, overall survival was 84% for index-FEVAR and 71% for secondary-FEVAR (p=0.086). Freedom-from reintervention was significantly higher for index-FEVAR than secondary-FEVAR, specifically 82% versus 38% at 3-years (p<0.001). Primary-FEVAR also had more desirable sac dynamics relative to secondary-FEVAR at 3-years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded, p=.038).

CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary-FEVAR, less than a quarter of patients have undergone reintervention at 3 years and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary-FEVAR, over half of patients have undergone reintervention and over a third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary-FEVAR.