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    Interventional procedure overview of aortic remodelling hybrid stent insertion during surgical repair of an acute type A aortic dissection

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    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/follow-up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Bozso SJ, Nagendran J, MacArthur, RGG et al. (2019) Dissected aorta repair through stent implantation trial: Canadian results. The Journal of thoracic and cardiovascular surgery 157(5): 1763-71

    Single-arm trial

    n=16

    Follow-up: mean 130 days (SD 94)

    Preliminary results suggest that the AMDS is a safe, feasible and reproducible adjunct to current surgical approaches for ATAD I repair. Further, the AMDS manages malperfusion and promotes early positive remodelling in the aortic arch and distal dissected segments, with favourable FL closure rates at follow-up. Ongoing follow-up will provide additional insight into the long-term effects of the AMDS.

    This study reported the initial experience with the AMDS and its sample was included in Bozso (2021) which reported the acute and midterm outcomes of the DARTS trial (n=46, follow up, median 631 days).

    Elbatarny M, Youssef A, Bozso SJ et al. (2020) Repair of acute type A dissection with distal malperfusion using a novel hybrid arch device. Multimed Man Cardiothorac Surg.

    Case report

    n=1

    The use of the AMDS uncovered aortic stent represents an attractive novel solution for patients with acute type A aortic dissection. Advantages include the ability to seal the distal anastomosis, depressurise the FL, and address distal malperfusion, without arch vessel intervention or risk of spinal cord ischemia. The simplicity of the technique makes it a viable option for widespread adoption. However, further study is required to clarify the exact role of the AMDS device in the armamentarium of treatment options for patients with acute type A aortic dissection.

    Tutorial with limited efficacy outcomes reported for the single case.

    Greason KL (2018) Did the investigators hit the aortic dissection bullseye with DARTS? The journal of thoracic and cardiovascular surgery

    Review

    Dissected aorta repair through stent implantation represents a paradigm change in the management of acute ascending aortic dissection.

    Review article

    Luthra S and Tsang GM (2021) Concurrent stabilisation of "downstream" aorta during acute type A aortic dissection repair. J Thorac Cardiovasc Surg: 1-3

    Review

    The dissected aorta repair through stent implantation trial reported malperfusion-related mortality of 7.7%, malperfusion resolution in 95.5%, paralysis in 0%, new postoperative stroke in 6.5%, and aortic arch remodelling in 100%. However, the number of patients is small and follow-up is short.

    Review article

    Montagner M, Heck R, Kofler M et al. (2020) New hybrid prosthesis for acute type a aortic dissection. Surgical Technology International 36: 1-5

    Review

    The AMDS seems to achieve effective sealing of the FL at the distal anastomosis and rapid expansion of the TL, thereby depressurising the FL and increasing TL perfusion. Without adding significant time or complexity to the standard procedure, the AMDS could provide effective and reliable management of malperfusions, induce positive aortic remodelling and reduce reintervention rates. However, this hope has to be proven once long-term data become available.

    Review article

    Waterford SD, Moon CJ and Moon MR (2019) Arch stenting in type A aortic dissection: tread lightly. Ann Thorac Surg 108: 1593-5

    Review

    This article does not highlight the greatest promise of the AMDS device: false lumen remodelling with a potential for decreased intervention on the distal aorta at long-term follow-up. For the time being, type A aortic dissection repair with ascending aortic or hemiarch replacement remains the best operation for restoration of true lumen flow.

    Review article