Aortic remodeling, distal stent-graft induced new entry and endoleak following frozen elephant trunk: A systematic review and meta-analysis.

Background: The introduction of the frozen elephant trunk (FET) technique for total arch replacement (TAR) has revolutionized the field of aortovascular surgery. However, although FET yields excellent results, the risk of certain complications requiring secondary intervention remains present, negating its one-step hybrid advantage over conventional techniques. This systematic review and meta-analysis sought to evaluate controversies regarding the incidence of FET-related complications, with a focus on aortic remodeling, distal stent-graft induced new entry (dSINE) and endoleak, in patients with type A aortic dissection (TAAD) and/or thoracic aortic aneurysm.
Materials and Methods: A comprehensive literature search was conducted using multiple electronic databases including EMBASE, Scopus, and PubMed/MEDLINE to identify evidence on TAR with FET in patients with TAAD and/or aneurysm. Studies published up until January 2022 were included, and after applying exclusion criteria, a total of 43 studies were extracted.
Results: A total of 5068 patients who underwent FET procedure were included. The pooled estimates of dSINE and endoleak were 2% (95% confidence interval [CI] 0.01-0.06, I ²  = 78%) and 3% (95% CI 0.01-0.11, I ²  = 89%), respectively. The pooled rate of secondary thoracic endovascular aortic repair (TEVAR) post-FET was 7% (95% CI 0.05-0.12, I ²  = 89%) while the pooled rate of false lumen thrombosis at the level of stent-graft was 91% (95% CI 0.75-0.97, I ²  = 92%). After subgroup analysis, heterogeneity for distal stent-graft induced new entry (dSINE) and endoleak resolved among European patients, where Thoraflex Hybrid (THP) and E-Vita stent-grafts were used (both I ²  = 0%). In addition, heterogeneity for secondary TEVAR after FET resolved among Asians receiving Cronus (I ²  = 15.1%) and Frozenix stent-grafts (I ²  = 1%).
Conclusion: Our results showed that the FET procedure in patients with TAAD and/or aneurysm is associated with excellent results, with a particularly low incidence of dSINE and endoleak as well as highly favorable aortic remodeling. However the type of stent-graft and the study location were sources of heterogeneity, emphasizing the need for multicenter studies directly comparing FET grafts. Finally, THP can be considered the primary FET device choice due to its superior results.
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