Fenestrated TEVAR Using a Guidewire Fixator for Anchoring in Aortic Arch Target Vessels

Abstract

Purpose: To report a new facilitated method for securing target vessel access during single fenestrated and branched thoracic endovascular repair using a guidewire fixator. Technique: The Liungman Guidewire Fixator (LGF) includes a 0.035-inch guidewire that is fitted with a stopper close to the distal end and a self-expanding anchoring element that is freely movable over the guidewire to the point of the stopper. The technique of using a LGF for anchoring in a target vessel is described in a 75-year-old woman with a 53-mm saccular arch aneurysm. She was treated with a fenestrated Zenith stent-graft that had a catheter-preloaded fenestration for the left subclavian artery (LSA) and a scallop for the left common carotid artery. To avoid through-and-through wire and brachial access, the LGF was used to secure the guidewire in the LSA during stent-graft deployment. Conclusion: The use of an LGF for anchoring in the target LSA during fenestrated arch endografting was feasible and safe.

Keywords

aortic aneurysm aortic arch fenestrated stent-graft guidewire fixator left subclavian artery thoracic aorta thoracic endovascular aortic repair

Introduction

Thoracic endovascular aortic repair (TEVAR) using fenestrated and branched stent-grafts (f/br-TEVAR) is an increasingly utilized treatment method for thoracic aortic arch aneurysm.^1–5 Current practice entails use of a through-and-through guidewire access to the target vessel from a brachial or axillary access to the common femoral artery (CFA) access for a single fenestration or branch to the left subclavian artery (LSA).^6–8 Although a through-and-through wire offers stability and support, a brachial, axillary, or subclavian access involves the risk of hemorrhage and arterial damage. Furthermore, it requires time to access, close, and manage the puncture during the procedure.^9–12 A new method for establishing stable access to a single target vessel in f/br-TEVAR is described here. Instead of a brachiofemoral through-and-through wire, a braided guidewire fixator introduced from a femoral access is used to anchor the distal end of a guidewire in the LSA, ensuring stable access to the target vessel during deployment of a f/br stent-graft.

Technique

Device Description

The Liungman Guidewire Fixator (LGF; Endovascular Development AB, Uppsala, Sweden) is Conformité Européenne–certified to facilitate temporary fixation of a guidewire in an artery and has previously been investigated for clinical safety and functionality in precertification clinical trials. The LGF includes a 0.035-inch guidewire that is fitted with a stopper close to the distal end and a self-expanding anchoring element that is freely movable over the guidewire to the point of the stopper (Figure 1). The self-expanding braided nitinol mesh delivers radial force to secure the position of the guidewire against the vessel wall. Tension on the guidewire causes the distal stopper to interact with the distal end of the anchoring element, causing longitudinal compression. Because of the braided design, the longitudinal compression causes radial expansion, resulting in an increased anchoring force on the guidewire. If too much tension is applied, the anchoring element infolds at the distal end, which reduces the radial force and causes loss of fixation in the artery. This safety feature reduces the risk of arterial trauma. The LGF is positioned and retrieved through a 7-F sheath using the retrieval catheter that employs a connection thread to connect to the LGF.¹³ The fixator is available in 3 sizes (8, 11, and 14 mm) to facilitate its use in arteries between 5 and 13 mm by a minimum of 1-mm oversizing.

Illustrative Case

The use of a LGF for anchoring in a target vessel during f/br-TEVAR is illustrated in a 75-year-old woman with an asymptomatic 53-mm saccular arch pseudoaneurysm at the level of the LSA (Figure 2, A and B). Patient consent was obtained for the planned treatment. The 40/36-×166-mm fenestrated endograft (Cook Europe, Bjaeverskov, Denmark) was designed with an 8-mm circular fenestration for the LSA and a 20-mm wide, 15-mm deep scallop for the left common carotid artery (Figure 2, C and D). The fenestration was preloaded with a guidewire and catheter, and constraining wires were used to stage endograft deployment. The stent-graft delivery system was precurved and fitted with a pro-form tip capture and fully tied down scallop edges (Figure 2E).

Deployment Procedure

A right femoral cutdown and percutaneous left femoral access were performed. From a right CFA access a 12-F, 45-cm Check-Flo sheath (Cook Europe) was placed in the distal aortic arch. The LSA was catheterized using a 4-F H1 catheter (Cordis Corporation, a Cardinal Health company, Milpitas, CA, USA); an 8-F, 80-cm Flexor Ansel sheath (Cook Europe) was positioned in the intended fixation zone of the LSA, distally to the left vertebral artery (Figure 3A).

The dilator of the 8-F, 80-cm sheath and the guidewire were replaced by a 280-cm LGF guidewire. Using the retrieval catheter, the LGF was then advanced over the guidewire until it was in position at the tip of the sheath. The sheath was then retracted over the catheter until the fixator was fully deployed and expanded in the artery (Figure 3B). After the position of the LGF was confirmed by digital subtraction angiography, the fixator was detached by counterclockwise rotation (two and a half turns) of the retrieval catheter. The catheter and sheath were then removed from the target artery, leaving the anchored LGF guidewire in place. Via a side puncture of the 12-F sheath a pigtail catheter was used to position an extra-stiff double curved Lunderquist guidewire in the ascending aorta in the usual manner. An angiography catheter was introduced from the left femoral access site.

The stent-graft was prepared in the local standard way by flushing with CO₂ and saline.¹⁴ The transport wire in the preloaded catheter was removed and the catheter was flushed with saline. After removing the 12-F sheath and manually compressing the site at the groin, the anchored LGF guidewire was then fed into the tip of the preloaded catheter, while the Lunderquist wire was introduced in the central cannula of the delivery system of the fenestrated stent-graft.

The delivery system was advanced over both wires to the level of the LSA. Tension on the LGF guidewire caused it to twist with the Lunderquist wire. The LGF guidewire was then pushed forward, and the Lunderquist guidewire was retracted until the LGF guidewire could be retracted and aligned without twisting. After repositioning the Lunderquist guidewire in the ascending aorta, the delivery system was advanced further until the fenestration was aligned with the LSA (Figures 3C and 4A), as identified by the radiopaque markers of the fenestration on the stent-graft. Continuous tension was applied to the LGF during stent-graft deployment to continuously recover excess wire, preventing entanglement with the top of the stent-graft or the scallop. Throughout the deployment (Figures 3D and 4B), the stent-graft position and alignment were stable and verified by fluoroscopy.

The alignment and position were again verified by angiography before the graft was completely deployed by removing the spiral stabilization wire and the 2 sets of proximal release wires. The dilator of the delivery system was retracted and positioned close to the sheath, leaving enough space between the sheath and tip for the LGF wire to travel freely. The complete delivery system was then retrieved, while maintaining the LGF wire. On removal of the sheath from the femoral access, manual control was used for hemostasis. A 12-F sheath was inserted over the LGF guidewire, and hemostasis was secured using the vessel loops on the CFA.

An 8-F guide sheath was inserted over the LGF guidewire through the fenestration into the stent-graft and positioned in the LSA, crossing the fenestration. The distal fixation allowed modest tension and smooth tracking of the sheath to the desired position. With the tip of the sheath in position close to the proximal end of the anchoring element, the dilator was removed and the LGF retrieval catheter was inserted. The retrieval catheter was advanced and engaged with the fixator through clockwise rotation, and the LGF was collapsed and retrieved by advancing the sheath (Figures 3E and 4C-E). The retrieval catheter and the fixator were then completely removed through the sheath over the wire, leaving the LGF guidewire and the 8-F sheath in the LSA. Finally, the 10-×38-mm bridging covered stent (Advanta V12; Atrium Maquet Getinge Group, Mijdrecht, the Netherlands) was inserted and deployed over the LGF guidewire (Figure 3F).

Final angiography confirmed stent-graft position as intended, without visible endoleak (Figure 5A). The LSA was patent, with unimpeded flow and without any sign of trauma (Figure 4F). Computed tomography angiography on the third postoperative day showed full aneurysm exclusion (Figure 5, B and C).

Discussion

As shown above, it is possible to complete a single fenestrated TEVAR using a guidewire fixator. Upper extremity access to allow for a through-and-through wire can be avoided, while the option remains to apply tension to the LGF wire that secures access to the target vessel.

Brachial access, although usually requiring a limited amount of time, can add significant complexity to an already challenging procedure. Snaring maneuvers that are needed to establish a brachiofemoral through-and-through wire carry a risk of embolization if performed at the level of the aortic arch and require additional materials that can be saved using the LGF. Embolization risks may be reduced by performing the snaring inside the brachial artery rather than in the aortic arch, and radial access techniques may further limit upper extremity access complications.

Upper extremity access site complications are not frequently reported but may require secondary operations and carry the risk of occlusion of the access vessel.¹⁵ Access site complications can also have a significant impact on hospital stay and treatment costs. Manual compression of brachial and radial access sites requires time in the operating room; eliminating the upper extremity access could save the cost of materials for pneumatic compression.

A significant risk during the procedure is that the side branch wire is trapped by the top stent on stent-graft deployment. This risk is different from that associated with a brachial through-and-through wire because the fixator may not be removed easily. If the wire is trapped, the wire can be removed as described in the instructions for use via a brachial access. A conventional snare is used to catch the J-looped tip of the LGF wire and fixator and remove it through a 7-F sheath. However, since loading of Cook fenestrated arch endografts has been modified with restraints on all protruding stent tops and scallop edges, wire entanglement has not been observed in our experience.

In the case illustrated here, another solution for entanglement of the branch wire and central leading wire is to rotate the delivery system, as reported by Joseph et al.⁷ However, with a precurved delivery system as used in this case, such a maneuver involves considerable risk.

As an alternative to the order of bridging graft placement in the illustrative case, the fixator could be retrieved after deployment of the bridging stent-graft, provided there is enough distal length in the target artery. Also, if a different guidewire is desired for deployment of the bridging graft, the LGF guidewire could be replaced after removal of the fixator.

The technique of placing an LGF in a target vessel may be applied to target vessels in fenestrated endovascular aneurysm repair or iliac branch devices to secure target vessel access.

Conclusion

The use of an LGF in a single fenestrated TEVAR for the LSA appears feasible and safe. Brachial access could be avoided while guidewire access to the precatheterized target vessel was stable and tolerated significant tension.

Footnotes

Acknowledgements

We wish to acknowledge support from the Swedish innovation agency Vinnova.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Tilo Kölbel is a proctor for William Cook Europe and receives research and educational grants and has intellectual property rights with Cook Inc. Krister Liungman has ownership in Endovascular Development AB, which owns the intellectual property of the Ljungman Guidewire Fixator. Linus Bosaeus is employed by Endovascular Development AB.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

References

Greenberg

Qureshi

Fenestrated and branched devices in the pipeline. J Vasc Surg. 2010;52(4 suppl):15S–21S.

Spear

Clough

Fabre

et al . Total endovascular treatment of aortic arch disease using an arch endograft with 3 inner branches. J Endovasc Ther. 2017;24:534–538.

Tsilimparis

Debus

von Kodolitsch

Branched versus fenestrated endografts for endovascular repair of aortic arch lesions. J Vasc Surg. 2016;64:592–599.

Stanley

Mylankal

Tibballs

et al . Branch thoracic stent graft repair for arch aneurysm. ANZ J Surg. 2012; 82:348–351.

Spear

Haulon

Ohki

et al . Subsequent results for arch aneurysm repair with inner branched endografts. Eur J Vasc Endovasc Surg. 2016;51:380–385.

Roselli

Arko

3rd Thompson

; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015;62:1465–1471.

Joseph

Premkumar

Thomson

et al . Externalized guidewires to facilitate fenestrated endograft deployment in the aortic arch. J Endovasc Ther. 2016;23:160–171.

Patel

Dake

Bavaria

et al . Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicentre trial of the Gore thoracic branch endoprosthesis. Ann Thorac Surg. 2016;102:1190–1198.

Alvarez-Tostado

Moise

Bena

et al . The brachial artery: a critical access for endovascular procedures. J Vasc Surg. 2009;49:378–385.

10.

Gulbins

Pritisanac

Ennker

Axillary versus femoral cannulation for aortic surgery: Enough evidence for a general recommendation?

Ann Thorac Surg. 2007;83:1219–1224.

11.

Schachner

Vertacnik

Laufer

et al . Axillary artery cannulation in surgery of the ascending aorta and the aortic arch. Eur J Cardiothorac Surg. 2002;22:445–447.

12.

Strauch

Spielvogel

Lauten

et al . Axillary artery cannulation: Routine use in ascending aorta and aortic arch replacement. Ann Thorac Surg. 2004;78:103–108.

13.

Bosaeus

Mani

Wanhainen

et al . Novel device, a temporary guidewire fixator. Vascular. 2016;24:604–609.

14.

Kölbel

Rohlffs

Wipper

et al . Carbon dioxide flushing technique to prevent cerebral arterial air embolism and stroke during TEVAR. J Endovasc Ther. 2016;23:393–395.

15.

Treitl

König

Reiser

et al . Complications of transbrachial arterial access for peripheral endovascular interventions. J Endovasc Ther. 2015;22:63–70.