Suitability of current off-the-shelf devices for endovascular TAAA repair: a systematic review

J Cardiovasc Surg (Torino). 2023 Oct;64(5):459-469. doi: 10.23736/S0021-9509.23.12704-2. Epub 2023 May 18.

Abstract

Introduction: The aim of the present study is to perform a systematic review of published papers regarding the suitability of the current off-the-shelf (OTS) devices for endovascular thoracoabdominal aortic aneurysm (TAAA) repair.

Evidence acquisition: A systematic review of the MEDLINE database via PubMed was performed in March 2023. All studies reporting the outcomes of the three currently available OTS stent-grafts: the Zenith t-Branch (Cook Medical, Bloomington, IN, USA), the Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE; W.L. Gore & Associates, Flagstaff, AZ, USA) and the E-nside Multibranch Stent-Graft System (Artivion, Kennesaw, GA, USA), were retrieved and further analyzed. The main endpoints were technical success, reintervention rate, and primary branch patency. Theoretical feasibility studies of these OTS devices were also included and separately analyzed.

Evidence synthesis: A total of 19 studies were published between 2014 and 2023. Thirteen clinical studies and six theoretical feasibility studies were included. Eleven studies reported the clinical outcomes of the t-Branch stent-graft, one detailed the observational results of the use of the E-nside endoprosthesis, and one described the TAMBE stent-graft results. The following data primarily involve the t-Branch device outcomes. A total of 1131 patients that underwent aneurysm repair using an OTS stent-graft were identified. Among those, 1002, 116 and 13 patients received a t-Branch, E-nside, and TAMBE stent-grafts, respectively. A total of 767 (67.8%) were men, with a mean age of 71.6±7.4 years old, and a mean Body Mass Index (BMI) of 26.3±3.8 kg/m2. Technical success ranged from 64% to 100%. A total of 4172 target visceral vessels (TVV) were planned for bridging, with a success rate ranging from 92 to 100%. The total of early and late reinterventions reported were 64 and 48, respectively, mainly due to endoleaks and visceral branch occlusions. Among the theoretical feasibility studies, six described the feasibility of the t-Branch device in a total of 661 patients, two described the E-nside and the TAMBE devices feasibility comprising 351 patients for each stent-graft. The overall feasibility of the t-Branch device varied from 39% to 88%, the E-nside from 43% to 75%, and the TAMBE stent-graft ranged from 33% to 94%.

Conclusions: This systematic review demonstrated a good suitability for the use of OTS endografts for the treatment of TAAA.