Clinic of Diagnostic and Interventional Radiology, University Hospital Augsburg, Augsburg, Germany.
Diagn Interv Radiol. 2023 May 31;29(3):492-499. doi: 10.4274/dir.2022.221107. Epub 2023 Feb 13.
Re-entry devices contribute to the high success rate of subintimal recanalization of chronic total occlusions (CTO). However, to date, there are no studies comparing the available conventional re-entry devices concerning the impact of their technical success on economic aspects, as these devices differ greatly in their acquisition costs. This prospective observational study intends to contribute to this question.
Prior to the start of the prospective study, all previous applications of the Outback in femoro-popliteal CTO since its introduction to our hospital were analyzed retrospectively (n = 31). From June 2018 until January 2020, all patients with femoro-popliteal CTO treated with clear subintimal recanalization were included (n = 109). In the case of failed spontaneous re-entry, either the OffRoad (study arm I, n = 20) or the Enteer catheter (study arm II, n = 20) was used. If assisted re-entry failed, the Outback device was used as a bailout. Baseline demographic and clinical data, morphologic characteristics, and technical success were documented. Additional per-patient costs due to the use of re-entry devices were analyzed.
A retrospective evaluation of all Outback applications revealed a technical success rate of 97% (30/31). In the prospective study, 63% (68/109) were successfully treated without using re-entry devices. The overall procedural success was 95% (103/109). In study arm I, the OffRoad achieved a success rate of 45% (9/20), with a subsequent successful application of the Outback in 80% (8/10) of the failed cases. In study arm II, the Enteer was successfully employed in 60% (12/20) of cases, and the Outback was then used successfully in a further 62% (5/8) of cases. Too large a distance between the device and the target lumen was a knockout criterion for all tested devices, leading to a subgroup analysis with the exclusion of three cases, resulting in a success rate of 47% for the OffRoad and 67% for the Enteer device. Furthermore, in severe calcification, only the Outback reliably enabled revascularization. Significant savings of almost €600 were only achieved in study arm II according to German prices.
With proper patient selection, a gradual approach with the Enteer as the primarily used device, with the Outback used additionally in case of failure, leads to significant savings and can be recommended. In severe calcification, the Outback should be used as the primary device.
再进入装置有助于提高慢性完全闭塞（CTO）的内膜下再通的高成功率。然而，迄今为止，尚无研究比较现有常规再进入装置对经济方面的影响，因为这些装置在购置成本上有很大差异。本前瞻性观察性研究旨在探讨这一问题。
在开始前瞻性研究之前，回顾性分析了 Outback 在我院引入后用于治疗股浅动脉 CTO 的所有先前应用（n = 31）。从 2018 年 6 月至 2020 年 1 月，所有采用明确的内膜下再通技术治疗的股浅动脉 CTO 患者均纳入研究（n = 109）。如果自发性再进入失败，采用 OffRoad（研究臂 I，n = 20）或 Enteer 导管（研究臂 II，n = 20）。如果辅助再进入失败，则使用 Outback 装置作为挽救措施。记录基线人口统计学和临床数据、形态特征和技术成功率。分析因使用再进入装置而产生的额外患者费用。
对所有 Outback 应用的回顾性评估显示，技术成功率为 97%（30/31）。在前瞻性研究中，63%（68/109）的患者无需使用再进入装置即可成功治疗。总手术成功率为 95%（103/109）。在研究臂 I 中，OffRoad 的成功率为 45%（9/20），随后在 80%（8/10）的失败病例中成功应用了 Outback。在研究臂 II 中，Enteer 导管的成功率为 60%（12/20），随后有 62%（5/8）的病例成功应用了 Outback。测试设备的一个淘汰标准是设备与目标管腔之间的距离过大，因此进行了排除 3 例的亚组分析，结果显示 OffRoad 的成功率为 47%，Enteer 装置的成功率为 67%。此外，在严重钙化的情况下，只有 Outback 能可靠地实现血运重建。根据德国价格，仅在研究臂 II 中才实现了近 600 欧元的显著节省。
在适当的患者选择基础上，采用逐渐递进的方法，首先使用 Enteer 装置，失败时再使用 Outback 装置，可显著节约成本，值得推荐。在严重钙化的情况下，应将 Outback 作为首选装置。
