Cohen Israel, Raskin Daniel, Barash Yiftach, Silverberg Daniel, Halak Moshe, Khaitovich Boris
Department of Diagnostic Imaging, Sheba Medical Center, Tel HaShomer, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
J Endovasc Ther. 2025 Aug;32(4):1165-1171. doi: 10.1177/15266028231204264. Epub 2023 Oct 17.
To describe a single-center experience in the treatment of chronic limb-threatening ischemia (CLTI) with the application of BeBack catheter (Bentley InnoMed, Germany) in patients with arterial chronic total occlusion (CTO).
A retrospective review of patients who underwent limb revascularizations using the BeBack catheter between 2015 and 2022. All patients had an initial failed attempt using a traditional guidewire and catheter technique. Technical success was considered whenever a successful re-entry or lesion crossing using the study device was achieved. Procedural success was defined as recanalization of the occluded artery with residual stenosis of less than 30%, and improvement in ankle-brachial index (ABI) after 24 hours. A Rutherford score was assigned to each limb and affected anatomical segments and lesion length were documented. Procedural access sites and complications were noted.
The study included 72 patients who underwent 78 procedures using the BeBack crossing catheter. Procedural success was achieved in 91% of cases, with a technical success rate of 92.3%. The most frequently involved occluded segments were the femoral and popliteal arteries. The average ABI improved from 0.59 to 0.95 after the procedure. The most used access site was the contralateral femoral, and the BeBack catheter was employed on 85 occasions. Only 1 patient suffered a severe immediate adverse effect, and during the 30-day follow-up period, 2 patients needed reintervention. Unfortunately, 3 patients died during the follow-up period.
The BeBack catheter offers a viable option for the treatment of patients with chronic total occlusion, with high procedural success and a low complication rate.Clinical ImpactThe BeBack catheter presents a notable advancement for clinicians managing chronic limb-threatening ischemia (CLTI) and arterial chronic total occlusion (CTO), showcasing over 90% procedural and technical success rates in this study. Its adept ability to navigate and recanalize occluded segments provides a robust alternative, especially when traditional techniques falter. This innovation may chane clinical strategies in vascular interventions, offering an efficient and reliable option, thereby potentially enhancing patient outcomes in limb revascularizations.
描述在动脉慢性完全闭塞（CTO）患者中应用BeBack导管（德国本特利创新医疗公司）治疗慢性肢体威胁性缺血（CLTI）的单中心经验。
回顾性分析2015年至2022年间使用BeBack导管进行肢体血运重建的患者。所有患者最初使用传统导丝和导管技术尝试均失败。只要使用研究器械成功重新进入或穿过病变，即视为技术成功。手术成功定义为闭塞动脉再通，残余狭窄小于30%，且24小时后踝肱指数（ABI）改善。为每个肢体分配卢瑟福评分，并记录受影响的解剖节段和病变长度。记录手术入路部位和并发症。
该研究纳入72例患者，使用BeBack穿刺导管进行了78例手术。91%的病例手术成功，技术成功率为92.3%。最常受累闭塞节段为股动脉和腘动脉。术后平均ABI从0.59提高到0.95。最常用的入路部位是对侧股动脉，BeBack导管使用了85次。仅1例患者出现严重即刻不良反应，在30天随访期内，2例患者需要再次干预。不幸的是，3例患者在随访期内死亡。
BeBack导管为慢性完全闭塞患者的治疗提供了一种可行选择，手术成功率高，并发症发生率低。临床影响BeBack导管为管理慢性肢体威胁性缺血（CLTI）和动脉慢性完全闭塞（CTO）的临床医生带来了显著进展，本研究显示其手术成功率和技术成功率超过90%。其在闭塞节段导航和再通的熟练能力提供了一种有力的替代方法，尤其是在传统技术失败时。这一创新可能会改变血管介入的临床策略，提供一种高效可靠的选择，从而有可能改善肢体血运重建的患者预后。
