Bilman Victor, Rinaldi Enrico, Loschi Diletta, Sheick-Yousif Basheer, Melissano Germano
Department of Vascular Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Department of Vascular Surgery, Vita-Salute San Raffaele University School of Medicine, IRCCS San Raffaele Hospital, Milan, Italy.
J Cardiovasc Surg (Torino). 2023 Oct;64(5):459-469. doi: 10.23736/S0021-9509.23.12704-2. Epub 2023 May 18.
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.
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.
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/m. 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%.
This systematic review demonstrated a good suitability for the use of OTS endografts for the treatment of TAAA.
本研究的目的是对已发表的关于当前现成（OTS）装置用于血管腔内胸腹主动脉瘤（TAAA）修复的适用性的论文进行系统评价。
2023年3月通过PubMed对MEDLINE数据库进行了系统评价。检索并进一步分析了所有报告三种当前可用OTS支架移植物结果的研究：Zenith t-Branch（美国印第安纳州布卢明顿市库克医疗公司）、戈尔胸腹分支血管内假体（TAMBE；美国亚利桑那州弗拉格斯塔夫市W.L.戈尔公司）和E-nside多分支支架移植物系统（美国佐治亚州肯尼索市Artivion公司）。主要终点为技术成功率、再次干预率和主要分支通畅率。这些OTS装置的理论可行性研究也被纳入并单独分析。
2014年至2023年间共发表了19项研究。其中包括13项临床研究和6项理论可行性研究。11项研究报告了t-Branch支架移植物的临床结果，1项详细描述了使用E-nside血管内假体的观察结果，1项描述了TAMBE支架移植物的结果。以下数据主要涉及t-Branch装置的结果。共确定了1131例使用OTS支架移植物进行动脉瘤修复的患者。其中，分别有1002例、116例和13例患者接受了t-Branch、E-nside和TAMBE支架移植物。共有767例（67.8%）为男性，平均年龄为71.6±7.4岁，平均体重指数（BMI）为26.3±3.8kg/m²。技术成功率在64%至100%之间。共计划对4172条目标内脏血管（TVV）进行搭桥，成功率在92%至100%之间。报告的早期和晚期再次干预分别为64例和48例，主要原因是内漏和内脏分支闭塞。在理论可行性研究中，6项描述了t-Branch装置在总共661例患者中的可行性，2项描述了E-nside和TAMBE装置的可行性，每种支架移植物包括351例患者。t-Branch装置的总体可行性在39%至88%之间，E-nside在43%至75%之间，TAMBE支架移植物在33%至94%之间。
本系统评价表明OTS血管内移植物用于治疗TAAA具有良好的适用性。
