Utility of BeBack crossing catheter in fistula creation during percutaneous deep vein arterialization

For patients with “no-option” chronic limb-threatening ischemia, a final attempt can be made for limb salvage in the form of percutaneous deep vein arterialization (pDVA). In the present study, we describe five cases of pDVA using a BeBack crossing catheter (Bentley InnoMed GmbH; previously, the GoBack crossing catheter; Upstream Peripheral Technologies). From November 2021 to July 2022, five patients underwent pDVA using the BeBack crossing catheter. The demographic data, procedural details, and patient outcomes were recorded. Successful vascular crossing was achieved in all five cases using the BeBack device. No surgical complications were encountered. The limb salvage rate was 60%, and the wound closure rate was 40%. No mortalities occurred during the follow-up period. The findings from the present study demonstrate that the use of the BeBack crossing catheter for pDVA is safe and feasible.

Deep venous arterialization (DVA) represents a final attempt at limb salvage before major amputation becomes necessary. 1During the past decade, percutaneous DVA (pDVA) using a propriety device (LimFLow; LimFlow Inc) has been shown to be feasible, with respectable outcomes for the "no-option" chronic limb-threatening ischemia (CLTI) population. 2,3n the present study, we describe five cases of pDVA using the BeBack crossing catheter (Bentley InnoMed GmbH; previously, the GoBack crossing catheter; Upstream Peripheral Technologies; Fig 1).The BeBack crossing catheter is a single-lumen crossing catheter with a directionally controlled, curved nitinol needle tip.The needle has an adjustable protrusion length from a straight (2-3 mm) to a fully curved (11 mm) position.The directionally controlled needle can be deployed to various lengths and angulation.It supports 0.018-in.and 0.014-in.catheter guidewires for the 4F and 2.9F versions, respectively.The device is useful for both intraluminal crossing and subintimal reentry.

CASE REPORT
This report fulfills our institution's criteria for an ethics board waiver.Using our institution's electronic medical records, five patients with "no-hope" CLTI who underwent pDVA from November 2021 to July 2022 using the BeBack crossing catheter were identified.All five patients provided written informed consent for the report of their case details and imaging studies.
Operative technique.For intraoperative anticoagulation, the patients received an initial dose of heparin at 75 U/kg, with a 1000-U bolus every hour.Under ultrasound guidance, the common femoral artery was accessed.Simultaneous arteriography and venography were performed with contrast administration via injection through an antegrade femoral arterial sheath (long 6F or 7F sheath) and a retrograde venous sheath (5F radial sheath) placed in the distal posterior tibial vein (PTV) to delineate the segment of the posterior tibial artery and PTV in proximity for easy arteriovenous (AV) crossing.
The BeBack crossing catheter was used as the reentry device to target an inflated balloon (5 mm Â 100 mm) within the PTV introduced via the venous sheath.The "C-marker" of the BeBack device was aligned tangential to the balloon, followed by needle puncture of the mid-balloon (Fig 2; Supplementary Video, online only).An inflated venous balloon has the advantage of providing a large three-dimensional target, allowing for direct visualization of balloon rupture to confirm venous entry, and the ability to shuttle the crossing wire down to the level of the venous sheath within the punctured balloon chamber.
Once the AV fistula (AVF) was created, antegrade wiring down the PTV to reach the lateral plantar vein was performed.
Crossing the venous valves can be achieved using a diagnostic 4F Berenstein catheter (Tempo Aqua; Cordis Corp), combined with a 0.014-in.or 0.018-in.Nitinol guidewire with high tip retention property (eg, Command wire; Abbott Vascular), using the "dancing wire technique." 3om the Department of Diagnostic Radiology, a and Department of General Surgery, b Tan Tock Seng Hospital.
Author conflict of interest: none.
Additional material for this article may be found online at www.jvscit.org.
The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.Further focalization of flow (ie, opacification of the forefoot veins) can be performed by embolization of the perforator veins w3 to 4 weeks after the procedure.Angiographic images were recorded before and after the procedure to document technical success (Figs 3 and 4).

RESULTS
The demographic information of the five patients (four men and one woman; mean age, 64 years; range, 58-70 years) is included in Table I.The procedural details are presented in Table II, and the preoperative clinical parameters are listed in Table III.
All patients had successful crossing with the BeBack device with formation of DVA.No postoperative complications were encountered in any of the cases.Three of the five patients had partial technical success.Two cases of limb loss occurred.Patient 1 underwent a below knee amputation at w8 months after DVA creation, after occlusion of the DVA stent.Patient 3 underwent a below knee amputation at w1 month after DVA creation because of severe rest pain from forefoot and hindfoot gangrene, despite a vascular duplex ultrasound scan demonstrating patent DVA.Patient 4 developed DVA occlusion w8 months after the procedure.Overall, the limb salvage rate was 60%, and the wound closure rate was 40%.No mortalities occurred during the follow-up period.

DISCUSSION
Patients with CLTI experience increased rates of lower limb amputation.DVA provides a viable treatment option for "no-option" CLTI, with limb salvage rates of #75% at 12 months. 1Percutaneous femoropopliteal bypass using the PQ Bypass detour system (PQ Bypass) is a promising treatment alternative for patients with long-segment femoropopliteal lesions.However, percutaneous femoropopliteal bypass was beyond the scope of our technical report.A Singapore pilot study using a proprietary endovascular pDVA device reported a 100% technical success rate, with no above ankle amputations, deaths, or major reinterventions at 30 days. 3Although a dedicated device for pDVA will allow for a more standardized procedure, access to the proprietary device remains limited outside the setting of clinical trials.Off-the-shelf pDVA, therefore, represents a viable option.
The Japan DEPARTURE (deep venous Arterialization procedure for patients with no-option chronic limbthreatening ischemia in Japan) study demonstrated safe and efficacious results of pDVA for patients with no-option CLTI. 4 Our study differs in that they used various techniques, including a venous arterialization simplified technique, a modified venous arterialization simplified technique, an AV-spear technique, and a reentry device for AVF creation.
Compared with other devices, such as the Outback Re-Entry Catheter (Cordis), we found that the long, directionally controlled, curved needle tip of the BeBack crossing catheter is a unique feature that allows for reentry with comparative ease.In the present study, we demonstrated that the use of the BeBack crossing catheter in pDVA is safe and feasible, with successful vascular    Journal of Vascular Surgery Cases, Innovations and Techniques crossing in all five cases, with no surgical complications encountered.The various technical success rates reflect the infancy of pDVA and the associated learning curve.

CONCLUSIONS
In the present study, we have demonstrated that the use of the BeBack crossing catheter for pDVA is safe and feasible.
2468-4287 Ó 2023 The Author(s).Published by Elsevier Inc. on behalf of Society for Vascular Surgery.This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).https://doi.org/10.1016/j.jvscit.2023.101201In the infrapopliteal venous segment, deployment of stent grafts (eg, Viabahn; W.L. Gore & Associates) renders the venous valves incompetent and also covers the venous perforators, which could result in steal syndrome.Retrograde stent grafting typically extends from the mid-calcaneum in an overlapping fashion across the AVF into the supplying artery and postdilated with 4-to 5-mm angioplasty balloons.For the inframalleolar venous segment, balloon valvulotomy was performed using 3to 4-mm angioplasty balloons or semi-inflated cutting balloons.

Fig 2 .
Fig 2. Intraoperative fluoroscopic image demonstrating the ruptured venous balloon target, with crossing of the wire from the posterior tibial artery into the posterior tibial vein (PTV).

Fig 3 .
Fig 3. A and B, Intraoperative angiographic images demonstrating diffuse atherosclerotic disease in the lower limb arteries.