Iterative steerable sharp recanalization as an escalation strategy for chronic venous stent occlusions

Abstract

Chronic venous stent occlusions represent a difficult subset of venous disease which can result from endothelialized stent struts, dense neointimal hyperplasia, and loss of a discernible intraluminal channel. These occlusions can lead to symptoms of recurrent venous hypertension, debilitating extremity symptoms, or loss of vascular access. Conventional blunt recanalization techniques frequently fail, as guidewires deflect into subintimal planes or collateral pathways or are unable to traverse dense, organized thrombus. These cases necessitate escalation to sharp recanalization strategies. The report describes sharp recanalization of chronic in-stent venous occlusions using the TipsStar Steerable Cannula.

Chronic venous stent occlusions represent a difficult subset of venous disease, often resulting from endothelialized stent struts, dense neointimal hyperplasia, and the loss of a discernible intraluminal channel.1, 2, 3 These occlusions may lead to recurrent venous hypertension, debilitating extremity symptoms, or loss of vascular access.⁴ Conventional blunt recanalization techniques frequently fail, as guidewires deflect into subintimal planes or collateral pathways or are unable to traverse dense, organized thrombus, thereby necessitating escalation to sharp recanalization strategies.^4,5

A variety of sharp recanalization techniques have been described for the treatment of chronic venous stent occlusions, including the use of transseptal or biopsy needles, transjugular intrahepatic portosystemic shunt (TIPS) access sets, and radiofrequency wires, with reported technical success rates of approximately 80% to 90%.^5,6 However, these techniques may be limited by reduced directional control, potentially leading to multiple sharp advancement maneuvers near critical structures.⁶ The TipsStar Steerable Cannula (BD) is a key component of the Liverty TIPS Access Set (BD) and allows real-time adjustment of the metal cannula tip angle for more precise targeting during sharp recanalization. The TipsStar Steerable Cannula features a stiff cannula with a 3.5-mm outer diameter and a 52.3-cm working length with an incrementally adjustable tip angle of up to 75° controlled via a rotatory handle at the cannula hub. Earlier reports have demonstrated the feasibility of using this system for chronic native venous occlusions.⁶ The present report describes sharp recanalization of chronic in-stent occlusions using the TipsStar Steerable Cannula. Patient consent was obtained for publication of this article. Institutional review board approval was obtained for preparation of this report.

Patient 1

A 48-year-old man with inferior vena cava filter-associated bilateral iliocaval thrombosis underwent complex filter removal and kissing iliocaval stent reconstruction with 14-mm Abre venous stents (Medtronic), with left iliofemoral stent extension using 14-mm and 12-mm Abre venous stents. The patient was discharged on apixaban and aspirin and subsequently presented 86 days postprocedure with recurrent swelling of the left lower extremity. Intervention at the time of presentation was aborted because the patient was unable to lie prone and could not be adequately sedated owing to an upper respiratory infection. Subsequent left lower ascending venography, performed 194 days after the initial stent placement, demonstrated total chronic occlusion of the left iliocaval and iliofemoral stent constructs (Fig 1, A). Numerous attempts at blunt recanalization were performed using a stiff angled Glidewire (Terumo), various angled catheters, and/or a TriForce Coaxial System (Cook Medical). Initial sharp recanalization attempts were performed using the back end of a Glidewire. When these maneuvers failed, the technique was escalated using the TipsStar Steerable Cannula and a 21-gauge Chiba needle (Cook Medical, Bloomington, IN). A TipsStar Steerable Cannula (BD) was advanced from a left popliteal venous access. The cannula's angle and torque were adjusted within the vessel using multiplanar fluoroscopic guidance to confirm alignment. A 21-gauge, 65-cm Chiba biopsy needle was coaxially advanced through the metal cannula to traverse 4.1 cm of the in-stent occlusion while staying within the stent lumen (Fig 1, B). This allowed a wire to be advanced cranially into the inferior vena cava, followed by balloon dilation and stent relining. Completion venography demonstrated brisk inline flow from the left popliteal vein through the relined iliofemoral and iliocaval stent construct to the right atrium (Fig 1, C). Completion intravascular ultrasound study was performed to assess stent expansion and evaluate for residual intraluminal thrombus. The patient was observed overnight and discharged on postprocedure day 1 on apixaban, clopidogrel, and aspirin.

Fig 1.

A, Left lower extremity ascending venography demonstrated total chronic occlusion of the iliocaval and iliofemoral stent constructs (solid arrow). B, A 21-gauge 65-cm Chiba biopsy needle (solid arrow) was coaxially advanced through the metal cannula (dashed arrow) to traverse 4.1 cm of the in-stent occlusion while staying within the stent lumen. Sharp recanalization facilitated through-and-through wire access for left iliofemoral stent relining with a 14-mm Abre venous stent (Medtronic). C, Completion left lower extremity ascending venography demonstrated in-line flow through the stent construct.

Patient 2

A 35-year-old woman with Factor V Leiden deficiency and antithrombin Budapest III mutations presented with bilateral lower extremity pain in the setting of reoccluded caval and bilateral iliocaval/iliofemoral stent constructs. The initial intervention had been performed at an outside hospital 7 years ago, and the patient most recently underwent in-stent thrombectomy and thrombolysis approximately 3 years earlier. Given the worsening symptoms, the patient returned for stent recanalization.

From the left popliteal vein, ascending venography demonstrated chronic total occlusion of the left iliofemoral, iliocaval, and caval stent constructs (Fig 2, A). Numerous attempts at blunt recanalization, performed in the same fashion as described for patient 1, were unsuccessful because of dense neointimal hyperplasia and the lack of discernable intraluminal channel. Sharp recanalization using the TipsStar Steerable Cannula and a 21-gauge needle was then performed to incrementally cross the 13.2-cm in-stent occlusion, while the angle and torque of the sheath were adjusted in real time to stay within the stent lumen (Fig 2, B and C). Following angioplasty, the stent constructs were relined using new venous dedicated stents. Completion bilateral lower extremity venography demonstrated in-line flow through the bilateral stent constructs to the right atrium (Fig 2, D). Completion intravascular ultrasound study was performed. The patient was discharged on postprocedure day 3 following hematological optimization with enoxaparin and warfarin.

Fig 2.

A, Left lower extremity ascending venography demonstrated total chronic occlusion of the iliocaval and caval stent constructs. Sharp recanalization at the proximal (B) and midportion (C) of the 13.2-cm occluded segment with a 21-gauge needle (solid arrows) advanced through the TipsStar Steerable Cannula (dashed arrows). Sharp recanalization facilitated through-and-through wire access for caval and bilateral iliocaval stent relining using Abre venous stents (Medtronic) in the intrahepatic inferior vena cava (20 mm), in a kissing configuration from the inferior vena cava to the bilateral common iliac veins (14 mm), bilateral common iliac to common iliac veins (14 mm), and extension from the bilateral external iliac to common femoral veins (12 mm). D, Completion bilateral lower extremity venography demonstrated in-line flow through the bilateral stent construct.

The use of a steerable cannula device for sharp recanalization of chronic venous stent occlusion offers several conceptual and practical advantages in complex venous interventions. Real-time, iterative, operator-controlled adjustment of the cannula tip angle and torque enables safe incremental advancement of the recanalization needle while staying within the stent lumen.⁶ Although other steerable sheaths exist to facilitate vessel selection via adjustable tip angulation, they do not provide the same rigid torquability and perforation resistance as the TipsStar Steerable Cannula that enabled sharp recanalization of these tough occlusions. In this series, a 21-gauge Chiba biopsy needle was selected rather than the 18-gauge needle provided with the Liverty TIPS Access Set to enhance safety of the technique using a smaller caliber needle.

Compared with transseptal/biopsy needles and other conventional TIPS access sets, which are typically fixed-angle systems with limited directional control, a steerable cannula enables real-time in situ trajectory control adjustment without repeated device removal, loss of access, or empiric reangulation.⁶ This capability may be particularly advantageous in chronic venous stent occlusions refractory to conventional blunt recanalization techniques, where the existing stent outlines the desired trajectory and an escalation to sharp recanalization can be pursued relatively safely.⁷ In contrast to radiofrequency wire-based techniques, this approach maintains pushability and tactile feedback without reliance on energy delivery that may be disrupted by metal contact.⁵ As with any sharp recanalization approach, proper technique mandates multiplanar fluoroscopic views to confirm optimal needle-tip trajectory and alignment before sharp in-stent traversal. This technique may not be suitable in cases of long-segment occlusions without clear delineation of the desired recanalization course.

A steerable cannula represents a valuable addition to the armamentarium of sharp recanalization devices and warrants further investigation to define its optimal role and long-term outcomes.

Funding

None.

Data availability

Data will be made available upon reasonable request.

Ethical approval and consent to participate

All procedures performed in studies involving human participants were conducted in accordance with the ethical standards of the institutional or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Patient consent was obtained for publication of this article.

Disclosures

E.J.M. is a consultant for Biogen, Guerbet, Inari Medical, and Vector Surgical. J.F.B.C. is a consultant for Inari Medical. The remaining authors report no conflicts.