Open Conversion After Endovascular Aneurysm Sealing: Technical Features and Clinical Outcomes in 44 Patients

Abstract

Purpose To evaluate the technical features and clinical results after open conversion for complications following endovascular aneurysm sealing (EVAS). Materials and Methods From July 2013 to February 2020, 44 patients (mean age 72±8 years; 36 men) underwent an open conversion due to EVAS complications in a single center. Data were collected on patient characteristics, reasons for conversion, characteristics and duration of the procedure, condition of the polymer, blood loss, time in the intensive care unit (ICU), and intra/postoperative complications. The main outcome measure was mortality at 30 days and in follow-up. Data are presented as the median (IQR) and absolute range. Results On average, the open conversion took place 3 years after the initial EVAS implantation [median 37 months (IQR 23, 50); range 0–64]. Most patients were converted due migration (82%), aneurysm growth (77%), and/or endoleak (75%), with 21 patients (48%) having all 3 events. Less frequent diagnoses were aneurysm rupture (n=7), aortic infection (n=3), technical failure during implantation (n=2), and graft thrombosis (n=1). The majority of patients (n=26) were asymptomatic and converted electively, but 9 were operated on urgently and 9 emergently (7 late rupture and 2 due to technical failure). The median procedure duration was 178 minutes (IQR 149, 223; range 87–417), the median blood loss was 1100 mL (IQR 600, 2600; range 300–5000). Polymer degradation was mentioned in the operative reports of 18 cases (41%). Patients stayed a median of 3 days (IQR 2, 7; range 1–35) in the ICU, while the median length of stay in the hospital was 14 days (IQR 10, 20; range 0–93). The 30-day mortality was 23% (n=10). During a median follow-up of 3 months (IQR 0, 11; range 0–38), no additional deaths occurred, but 12 patients suffered from an adverse event. There were 3 cases of wound dehiscence after laparotomy, 2 cases of leg ischemia, 2 cases of renal failure, and individual cases of urinary obstruction, urinoma, paralytic ileus, gastrointestinal bleeding, and postoperative delirium. A non-elective setting was associated with a significantly increased mortality of 33% in urgent cases and 56% in emergent cases (p=0.007). Based on these results an algorithm for the management of EVAS complications was developed. Conclusion The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance. The presented algorithm offers a structured tool to avoid emergency conversions.

An International, Multicenter Retrospective Observational Study to Assess Technical Success and Clinical Outcomes of Patients Treated with an Endovascular Aneurysm Sealing Device for Type III Endoleak

“…In January 2019, unforeseen complications led to the stop of unrestricted sales and commercial use of the device. The main reason for this being a higher than anticipated migration and endoleak rate 25 leading to complex open conversions. However, sac-sealing devices might still have a future as primary procedures or as adjuncts for reintervention in complications, such as type III endoleak.…”

Focused Update on Patients Treated with the Nellix EndoVascular Aneurysm Sealing (EVAS) System from the European Society for Vascular Surgery (ESVS) Abdominal Aortic Aneurysm Clinical Practice Guidelines

“…13 A further contemporary series of 44 explantations for various indications also identified significantly poorer outcomes in urgent or emergency cases. 14 Therefore, these data would support early explantation of failing devices in fit patients in an elective setting.…”

Multicenter Comparative Analysis of Late Open Conversion in Patients With Adherence and Nonadherence to Instructions for Use Endovascular Aneurysm Repair

“…For patients operated urgently, our 30-day mortality rate was significantly higher than elective patients (40% vs 7.1%, p=0.038). The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance 27 and management at high-volume aortic referral centers. 28 Long-term results of the EVAR 1 trial have shown worse mortality in the EVAR group beyond 8 years, primarily the result of increased rates of secondary aneurysm sac rupture.…”

“…For patients operated urgently, our 30-day mortality rate was significantly higher than elective patients (40% vs 7.1%, p=0.038). The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance 27 and management at high-volume aortic referral centers. 28…”