article · British journal of surgery
The frozen elephant trunk procedure is a primary surgical approach for treating complex aortic conditions because it reduces the need for secondary operations. This systematic review evaluated the performance of four main hybrid prostheses across 40 studies covering 6,168 patients: E-vita, Thoraflex, Frozenix-J, and Cronus. Thirty-day mortality rates were 7 percent for both Thoraflex and E-vita, 5 percent for Cronus, and 2 percent for Frozenix-J. Distal stent graft-induced new entry rates peaked in the E-vita group at 8 percent and were lowest with Frozenix-J at 4 percent. Thoraflex showed higher rates of stroke, spinal cord injury, and reinterventions at 8 percent, 3 percent, and 17 percent respectively. Cronus recorded the lowest stroke and spinal cord injury rates at 1 percent, while Frozenix-J recorded 3 percent. Due to study heterogeneity, direct comparisons could not be conducted, but less widely available devices showed favourable outcomes.
Aortic surgery is high-risk, and selecting the most effective surgical implant can significantly improve patient survival and reduce severe complications like stroke or paralysis. By compiling evidence on both common and less widely available prostheses, this analysis helps surgeons understand the varying performance profiles and risks associated with specific device designs.
This work informs clinical decision-makers, vascular surgeons, and medical device manufacturers by benchmarking commercially available surgical prostheses that are already applied and tested in clinical practice. The findings could guide procurement choices in healthcare systems and influence future aortic stent graft design, particularly by highlighting the favourable performance of less widely distributed devices like Cronus and Frozenix-J.
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Abstract Introduction The frozen elephant trunk (FET) procedure remains the mainstay treatment for managing complex aortic pathologies due to its ability to minimise the necessity for second-stage surgeries. The technique utilises hybrid prostheses, and although Thoraflex and E-vita have demonstrated favourable outcomes, much less is known about Cronus and Frozenix-J. This systematic review aims to evaluate the efficacy of the main FET prostheses. Methods A comprehensive search of major databases was performed, and relevant studies were identified by two independent reviewers. MetaXL 5.0 was used to calculate pooled rates for early mortality, stroke, Spinal cord injury (SCI), dSINE and reinterventions. Results In total 40 studies were included, encompassing a total of 6168 patients (2605 E-vita, 1566 Thoraflex, 1416 Frozenix-J and 578 Cronus). The 30-day mortality rates were similar for Thoraflex and E-vita 7% (95 CI 5.0-8.0), 5% for Cronus and 2% for Frozenix J. The dSINE rates were highest among the E-vita group (8%) and lowest using Frozenix-J (4%). Similarly, the stroke, SCI and reintervention rates were higher with Thoraflex (8%, 3% and 17% respectively) compared to other prostheses. While the stroke and SCI rates were lowest among Cronus studies (1%). Frozenix-J reported lower stroke and SCI rates (3%). A direct comparison between prostheses could not be performed due to the heterogeneity of studies. Conclusion Each prosthesis features a unique design and features resulting in varying clinical outcomes. Although there are limited studies, the available data suggests favourable outcomes using less widely available prostheses such as Cronus and Frozenix-J prostheses.
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DOI: 10.1093/bjs/znaf042.078
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