Why the study?
Real-world safety and efficacy data were needed for coil embolization during EVAR of AAA for prophylactic endoleak prevention or as a reintervention for endoleak repair using Cerenovus coils.
Coil embolization during or after EVAR for AAA using Cerenovus coils is associated with high 30-day reintervention-free survival and low rates of endoleak at 1 year.
Real-world coil embolization data in EVAR may inform technique; leaves open need for prospective trials on efficacy and safety.
OBJECTIVE: This study assessed the real-world safety and efficacy of coil embolization during endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) for prophylactic endoleak prevention or as a reintervention for endoleak repair, using the Cerenovus family of coils (Cerenovus, Irvine, CA, USA). METHODS: This was a multicenter, retrospective cohort study of consecutive patients who underwent embolization of branching arteries during EVAR of an AAA or as a reintervention for endoleak repair, using Cerenovus coils between January 2017 and December 2021 in Japan. The primary outcome was 30-day reintervention-free survival, defined as cardiovascular mortality or any complication requiring reintervention within 30 days post procedure. Secondary outcomes included conversion to open surgical repair, length of hospitalization, and the following outcomes through 30 days and 1-year post procedure: occurrence of endoleak (Type I-V), reintervention, complications not requiring reintervention, aneurysm-related mortality, coil migration, and all-cause mortality. RESULTS: A total of 306 patients (mean age 76.7 ± 7.8; 16.7% [51/306] female) were included in the study. Infrarenal AAA were most common (175/306; 57.2%), and the mean aneurysm size was 52.1 ± 10.9 mm. At 30 days, reintervention-free survival was achieved in 96.4% (295/306) of the patients; 9 (2.9%) patients required reintervention, and 2 (0.7%) died from cardiovascular causes through 30 days. One (1/305; 0.3%) patient underwent conversion to open repair. The mean length of hospitalization was 8.6 ± 7.2 days. Complications not requiring reintervention occurred in 3.9% (12/306) of the patients through 30-days and 12.4% (38/306) through 1-year. Endoleak occurred in 2.9% (9/306) of the patients at 30 days and 9.5% (29/306) at 1 year. Coil migration and aneurysm rupture were not reported for any patient. Aneurysm-related mortalities occurred in 0.0% (0/305) at 30 days and 0.3% (1/303) at 1 year. All-cause mortalities occurred in 0.7% (2/306) at 30 days and 3.3% (10/304) at 1 year. CONCLUSIONS: This study demonstrated that the use of Cerenovus coils yielded a high rate of 30-day-reintervention-free survival and low rates of type II endoleak occurrence and recurrence at the target vessel through 30 days and 1 year in patients following EVAR of an AAA with coil embolization, either for prophylactic endoleak prevention during EVAR or as a reintervention to repair an endoleak.
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Yagami et al. (2024) studied this question.
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