Pre-Emptive Embolization of the Aneurysm Sac or Aortic Side Branches in Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials

Background To investigate outcomes of pre-emptive embolization of the aneurysm sac or aortic side branches in endovascular aneurysm repair (EVAR). Methods The review was reported as per Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 with a preregistered protocol. Bibliographic sources (MEDLINE, Embase, and CENTRAL) were searched using subject headings and free text terms. Randomized controlled trials comparing EVAR with versus without embolization were included. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI) applying the Mantel–Haenszel method. Continuous outcomes were summarized using mean difference (MD) and 95% CI applying the inverse variance method. The certainty of evidence was appraised with the Grading of Recommendations Assessment, Development, and Evaluation framework. Version 2 of the Cochrane tool was used to assess the risk of bias. Trial sequential analysis assumed alpha = 5% and power = 80%. Results Four randomized controlled trials were included. No significant difference was found in aneurysm-related mortality (RD 0.00, 95% CI −0.03 to 0.03), overall mortality (OR 1.85, 95% CI 0.42–8.13), aneurysm rupture (RD 0.00, 95% CI −0.03 to 0.03), type II endoleak-related reintervention (RD -0.07, 95% CI −0.21 to 0.06), procedure time (MD 20.12, 95% CI −11.54 to 51.77), or fluoroscopy time (MD 11.17, 95% CI −11.22 to 33.56). Patients with pre-emptive embolization had significantly lower odds of type II endoleak (OR 0.45, 95% CI 0.26–0.78) and sac expansion (OR 0.19, 95% CI 0.07–0.52). The risk of bias was high for all outcomes. The certainty of evidence was very low for all outcomes, except for type II endoleak, for which it was low. Trial sequential analysis showed an inconclusive result for overall mortality and type II endoleak-related reintervention but confirmed the advantage of embolization in reducing type II endoleak and sac expansion. Conclusions Limited, low certainty data suggest pre-emptive embolization confers no clinical benefits in EVAR. To investigate outcomes of pre-emptive embolization of the aneurysm sac or aortic side branches in endovascular aneurysm repair (EVAR). The review was reported as per Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020 with a preregistered protocol. Bibliographic sources (MEDLINE, Embase, and CENTRAL) were searched using subject headings and free text terms. Randomized controlled trials comparing EVAR with versus without embolization were included. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI) applying the Mantel–Haenszel method. Continuous outcomes were summarized using mean difference (MD) and 95% CI applying the inverse variance method. The certainty of evidence was appraised with the Grading of Recommendations Assessment, Development, and Evaluation framework. Version 2 of the Cochrane tool was used to assess the risk of bias. Trial sequential analysis assumed alpha = 5% and power = 80%. Four randomized controlled trials were included. No significant difference was found in aneurysm-related mortality (RD 0.00, 95% CI −0.03 to 0.03), overall mortality (OR 1.85, 95% CI 0.42–8.13), aneurysm rupture (RD 0.00, 95% CI −0.03 to 0.03), type II endoleak-related reintervention (RD -0.07, 95% CI −0.21 to 0.06), procedure time (MD 20.12, 95% CI −11.54 to 51.77), or fluoroscopy time (MD 11.17, 95% CI −11.22 to 33.56). Patients with pre-emptive embolization had significantly lower odds of type II endoleak (OR 0.45, 95% CI 0.26–0.78) and sac expansion (OR 0.19, 95% CI 0.07–0.52). The risk of bias was high for all outcomes. The certainty of evidence was very low for all outcomes, except for type II endoleak, for which it was low. Trial sequential analysis showed an inconclusive result for overall mortality and type II endoleak-related reintervention but confirmed the advantage of embolization in reducing type II endoleak and sac expansion. Limited, low certainty data suggest pre-emptive embolization confers no clinical benefits in EVAR.