Use of Surfacer,an inside-out device,in tandem with HeRO graft for creation of vascular access: Case report of three patients with 18-months follow up

Introduction

Thoracic central vein occlusion (TCVO) remains an unfortunate complication associated with the long-term use of dialysis and central venous catheters. Having exhausted options of upper extremity access, these patients resort to lower extremity access or even trans-lumbar catheter options which carry significant morbidity and infection risk. ¹ The sharp internal recanalization of central vein occlusion was first described in 1999 by Farrell et al. ² using a Rosch-Uchida needle or a coaxial sheathed needle with a stylet. This technique however was limited to short segment occlusions in view of safety concerns in using a needle to traverse long segments. Subsequently Elayi et al. ³ described in 2011 the use of inside-out central venous access (IOCVA) technique using a transseptal sheath set with a modified transseptal needle to guide a 0.018″ needle wire for the inside–out puncture via a percutaneous femoral approach. The Surfacer Inside-Out Access Catheter System (“Surfacer”; Bluegrass Vascular Technologies, Inc., San Antonio, TX, USA) is a novel specialized device-based solution to restore access in TCVO based on the IOCVA technique with its first-in-human experience published in 2013. ⁴ Hemodialysis Reliable Outflow (HeRO) graft (Hemosphere, a Cryolife Inc Company, Eden Prairie, Minn) is a graft indicated for use in patients who have central vein stenosis or occlusions. The HeRO graft has a conventional upper arm graft which is connected to a venous outflow component (VOC); the tip of which is in the right atrium thereby providing flow past the central stenosis or occlusion. We describe our experience in using the Surfacer in tandem with HeRO graft for creation of upper limb vascular access in three patients with previously failed attempts at conventional crossing of TCVO. To our knowledge, this is the first time where the outcomes of this technique with 18-months mean follow-up are reported.

Materials and methods

A single institution, retrospective review of three consecutive cases from November 2018 to February 2021 was conducted (institutional ethics review board review exemption; reference: 2018/2114).

The Surfacer device consists of a plunger-controlled handle attached to a rigid 95-cm steel shaft, loaded onto a 0.024″ (0.60 mm) outer diameter, 180-cm long guidewire with a sharp tip, and an incorporated deflectable needle guide. It is introduced through an 8 Fr sheath in the right femoral vein to the level of occlusion. This Inside-Out technique can only be performed for right-sided TCVO with at least 1 cm of patent superior vena cava (SVC) above the right atrium, and access can only be obtained via the right femoral vein. Under fluoroscopic guidance, the trajectory of the needle guide is aligned with the target exit site on the skin placed just above the head of the right clavicle (Figure 1(a)). The sharp recanalization wire is advanced through the needle guide using the plunger on the device handle and exteriorized through the skin marker (Figure 1(b)). Using the established inside-out wire access, balloon angioplasty of the SVC is performed for pre-dilation prior to introducing a peel-away sheath across the occlusion (Figure 1(c)). The graft component of the HeRO graft is then tunneled from deltopectoral groove and anastomosed to the brachial artery or a pre-existing arterialized arteriovenous (AV) fistula. The venous outflow component (VOC) is then inserted through the peel away sheath to rest in the right atria-ventricular junction. The other end of the VOC is then connected at the deltopectoral groove to the subcutaneously tunneled graft from the arm using a SuperHeRO adapter. The SuperHeRO adapter allows flexibility in graft selection and enables the use of early-cannulation grafts.

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Figure 1.

(a) Under fluoroscopic guidance, the trajectory of the needle guide is aligned with the target exit site on the skin placed just above the head of the right clavicle, (b) the sharp recanalization wire is advanced through the needle guide using the plunger on the device handle and exteriorized through the skin marker, and (c) using the established inside-out wire access, a peel-away sheath is introduced across the occlusion.

Results

Patient demographics are summarized in Table 1. All three patients had TCVO (Figure 2—A, B, and C); and all had failed prior conventional attempts at TCVO crossing. All three patients had also previously exhausted conventional upper limb vascular access methods and had relative contraindications to lower limb access such as pre-existing peripheral vascular disease. Patients B and C were already on femoral catheters and patient A had recurrent central venous stenosis which had poor results despite multiple interventions. All procedures were performed under general anesthesia and yielded a 100% technical success rate with mean operative time of 140 min (range 98–205 min). Operative time in patient C included failed attempts at conventional wire crossing of the TCVO and hence was significantly longer at 205 min, whereas patient A and B procedures were completed in 98 and 119 min respectively. All three patients were continued on their antiplatelet agents for other co-morbidities peri-operatively. Early cannulation Flixene 6 mm grafts were used in patients B and C, while a Propaten 6 mm graft anastomosed to a pre-existing arterialized fistula was used in patient A due to the unavailability of early cannulation grafts at the time of operation. Early cannulation by post-operative day (POD) 3 was achieved in all three patients including patient A by cannulation of her pre-existing fistula. Patient A developed hematoma from cannulation during dialysis on POD 7 requiring surgical evacuation of hematoma and hemostasis. No early complications occurred in patients B and C. The average length of hospital stay was 6.7 days and the mean follow up was 18 months. Patient A achieved primary patency until day 282 when she expired from causes unrelated to dialysis access. Patient B and C had primary patency of 100 and 216 days respectively. Patient B developed graft partial thrombosis on day 100 requiring percutaneous thrombolysis. Patient C developed graft thrombosis on day 216, day 223, and day 591 requiring percutaneous thrombolysis. Flow was successfully established in both patients and their grafts remain in use with assisted primary patency of 719 days (2-years) in patient B and secondary patency of 593 days (18-months) in patient C at time of writing, with average rate of 1.2 interventions per year required to maintain patency.

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Table 1.

Patient demographics and Results.

Patient	Age (y)/Gender	Indication	TCVO classification	Anti-coagulation/Anti-platelet agents	Operative time (min)	Graft anastomosis	Time to cannulation (days)	Primary patency (days)	Assisted primary patency (days)	Secondary patency	18-months access patency/[Number of interventions required per year]
A	55/F	Recurrent central vein stenosis	Type 2A	Aspirin and Clopidogrel	98	Propaten 6 mm to pre-existing right BC AVF	1	282*	NA*	NA*	NA*/[NA]
B	70/F	Dependent on femoral catheter	Type 3	Clopidogrel	119	Flixene 6 mm to pre-existing right BC AVF	2	100	719	NA	Yes/[0.5]
C	63/M	Dependent on femoral catheter	Type 4	Aspirin	205 ^	Flixene 6 mm to right brachial artery	3	216	NA	593	Yes/[2]

*

Patient A expired on day 282 from causes unrelated to dialysis access.

^

Patient C operative time included failed attempts at conventional crossing of TCVO prior to proceeding to Surfacer.

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Figure 2.

TCVO in patients A (type 2A), B (type 3), and C (type 4).

Discussion

The HeRO graft has been shown to maintain long-term access for hemodialysis patients with central venous stenosis or occlusion with performance comparable to conventional AV grafts and superior to TDC in terms of patency, intervention, and infection rates. ⁵ However it still requires traversing of the VOC across the central vein which cannot be achieved in TCVO with conventional wire access. The Surfacer device restores access to the central vein and when used together with the HeRO graft is able to avoid TDC dependence in challenging hemodialysis patients with TCVO. Our results show that patency and intervention rates using this tandem technique is comparable to when the HeRO graft is used alone. ⁵

The Surfacer device utilizes the anatomical relations of the right central vein where a nearly straight line extends from the right femoral vein to the head of the right clavicle. A rigid catheter system inserted via the right femoral vein will be naturally aimed at the anterior margin of occluded central venous segments toward the head of the right clavicle. All critical structures including hilar vessels, airways, major arteries, and pleura, lie posterior to the central vein at the level of the clavicular head. At this level, only the head of clavicle, soft tissue, and skin lies anterior to the central vein. Hence by directing the needle anteriorly, safe inside-out recanalization of the central vein can be achieved. ³ The Surfacer system can be used for all four TCVO types as described by The Society of Interventional Radiology (SIR) ⁶ : type 1 (unilateral occlusion of the IJV or SCV), type 2 (unilateral occlusion of the BCV), type 3 (bilateral occlusion of the BCV including the confluence above the azygos), and type 4 (occlusion of the SVC between the azygos vein and the right atrium).

However due to the rigidity of the Surfacer system, conditions which prevent safe straight-line traversing of the device, such as excessive spinal curvature, vascular tortuosity, vascular anomalies including aneurysmal diseases of the ascending aortic arch, and brachiocephalic trunk which displace normal anatomical position of the central veins, are relative contraindications. These conditions could lead to difficulty in advancing the device or lead to an altered course of the device with high risk complications similar to central venous needle recanalization. ⁷ For the same reason, the device is contraindicated for use via access from the left femoral vein due to the more oblique course of the left iliac vein and its steep angle with the inferior vena cava (IVC). At least 1 cm of patent SVC is required to confirm exit of the sheath from the right atrium into the SVC prior to advancing the sharp tip of the Surfacer device. Other contraindications include occlusion of the right femoral vein, iliac vein, IVC, or thrombosis within a vessel to be crossed by the Surfacer System. Special precautions are advised for patients with coagulation disorders and patients on anti-coagulation therapy, though our results have shown that the procedure can be done safely in patients on anti-platelet agents.

The Surfacer device received the European CE mark and became commercially available outside of the United States (US) in 2016 following the results of a single-center safety and feasibility study with 12 patients achieving 100% technical success published in 2013. ⁴ Following that, the safety and efficacy of the Surfacer device has been shown in the post-market prospective, multicentre, single-arm, international European “SAVE ( Surfacer System to Facilitate Access in VEnous Occlusions)” registry published in October 2020 ⁸ as well as the US arm “SAVE-US” pre-market investigational device exemption study published in January 2021. ⁹ Technical success in achieving central venous access with the Surfacer device was reported as 96.7% (29 out of 30 patients) in the SAVE registry and 90.0% (27 out of 30 patients) in the SAVE-US study, with no device-related adverse events or catheter malposition. In both studies, technical failure was due to vascular tortuosity discovered intraprocedurally. Although there have been reports describing the simultaneous combination of Surfacer and HeRO graft, ¹⁰ to our knowledge, this is the first time where the outcomes of this technique with 18-months mean follow-up are reported.

We report three cases where the Surfacer device used together with HeRO graft was a feasible and safe technique to avoid catheter femoral dependence in patients where conventional attempts to cross the TCVO have failed. In all three patients, salvage of vascular access was achieved with long term assisted primary patency without significant complications or adverse events from the procedure.