TY - JOUR
T1 - Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair
AU - Zoethout, Aleksandra C.
AU - Hochstenbach, Iris
AU - van der Laan, Maarten J.
AU - de Vries, Jean Paul P.M.
AU - Reijnen, Michel M.P.J.
AU - Zeebregts, Clark J.
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2022/6
Y1 - 2022/6
N2 - Introduction: The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). Methods: A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. Results: A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%. Conclusion: There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.
AB - Introduction: The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). Methods: A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. Results: A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%. Conclusion: There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.
KW - aneurysm
KW - endoleak
KW - endovascular aneurysm repair
KW - endovascular treatment/therapy
KW - migration
KW - mortality
KW - reintervention
KW - systematic review
UR - http://www.scopus.com/inward/record.url?scp=85130002139&partnerID=8YFLogxK
U2 - 10.1177/15266028211047941
DO - 10.1177/15266028211047941
M3 - Review article
C2 - 34569337
AN - SCOPUS:85130002139
SN - 1526-6028
VL - 29
SP - 457
EP - 467
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
IS - 3
ER -