Avoiding the Use of a Femoral Bridging Catheter Using a Two-stage Hemodialysis Reliable Outflow (HeRO) Graft Implantation Technique

Abstract

Purpose

To evaluate a two-stage Hemodialysis Reliable Outflow (HeRO) implantation technique that avoids the use of a femoral bridging catheter versus the conventional one-stage technique requiring a bridging catheter in selected patients.

Methods

A retrospective review was performed on 20 end-stage renal disease patients with an internal jugular vein (IJV) catheter selected for two-stage HeRO implantation at our institution between January 2010 and March 2013. The arterial graft component (AGC) was implanted without anastomosing it to the target artery (first stage). After AGC incorporation, the venous outflow component was inserted (second stage). The preexisting IJV catheter was maintained for hemodialysis access during the interstage period. Patient characteristics, patency using Kaplan-Meier method and infection rates were analyzed.

Results

A total of 17 patients with a mean age of 59 years (70.6% women) completed the two-stage procedure. During the interstage period (mean 12 weeks, range 4-22 weeks), no graft- or surgery-related infection occurred. The need of a femoral bridging catheter was avoided by utilizing the preexisting IJV dialysis catheter. The accumulated HeRO days were 3,916 days with a mean follow-up of 7.7 months (range 1-22.6 months). The HeRO-related infection rate was 0.3/1,000 days. The primary assisted and secondary patency rates at 6 months were 69% and 82%, respectively, which were similar to those of arteriovenous grafts. Staging conferred immediate vascular accessibility.

Conclusions

Avoiding the use of a femoral bridging catheter using the two-stage technique may lower infection rate, with comparable primary assisted and secondary patency to arteriovenous grafts and added benefit of immediate cannulatability in this subset of patients.

Keywords

Catheter-dependent Contralateral central venous occlusion Hemodialysis Reliable Outflow (HeRO) graft Two-stage technique

Introduction

Autogenous arteriovenous (AV) fistulae are the optimal option for hemodialysis access, followed by synthetic AV grafts (1, 2). Yet, in a subset of patients with end-stage renal disease (ESRD) on chronic hemodialysis, repeat interventions and multiple vascular accesses lead to the exhaustion of these preferred access options in the long run. In such cases, tunneled dialysis catheters (TDCs) have been increasingly used as a last resort (3). However, literature reports that TDCs are related with increased risk of infection. Furthermore, central vein stenosis or occlusion is a frequent complication of patients with long-term TDC use (4, 5). Hence, whenever feasible, converting a hemodialysis TDC to a long-term AV access is highly desirable.

For use in catheter-dependent ESRD patients as a graft, the US Food and Drug Administration approved the Hemodialysis Reliable Outflow (HeRO) graft in 2008. This new graft is made of two components: a conventional expanded polytetrafluoroethylene (ePTFE) arterial graft component and a silicone venous outflow component. The ePTFE graft component is to establish arterial inflow in the upper extremity of choice; the venous outflow component is inserted directly into a central vein with its distal tip positioned at the cavo-atrial junction. These two components are completely implanted subcutaneously, and connected subsequently via a titanium connector. This coupling results in blood to flow from the inflow artery directly into the central venous system, thereby bypassing central venous stenosis (6 -8). Thus, for catheter-dependent ESRD patients with central venous occlusion, the HeRO graft can offer an additional opportunity for an upper extremity subcutaneous hemodialysis vascular access.

Nevertheless, there is one drawback to the HeRO graft. For safe cannulation, the ePTFE graft component requires time for tissue incorporation, necessitating a femoral bridging catheter that carries a high infection risk. To overcome this obstacle, some have suggested replacing a part of the ePTFE graft component with early cannulatable grafts, such as Flixene graft or Vectra graft (8, 9). Using this approach, successful cannulations within 24 to 72 hours postimplant have been reported (10, 11). However, even this short waiting period can be problematic in patients who need immediate commencement of hemodialysis, and complicates the operative insertion of a HeRO graft. In an effort to circumvent the aforementioned limitations in internal jugular vein (IJV) catheter-dependent patients with contralateral central venous occlusion, we devised a novel two-stage HeRO implantation technique that has been recently described in the Journal of Vascular Access (12).

The purpose of this study was to evaluate the two-stage HeRO implantation technique that avoids the use of a femoral bridging catheter versus the conventional one-stage implantation requiring a femoral bridging catheter in this subset of patients, with respect to infection, patency and intervention rates. This study also sought to compare the outcomes of the two-stage placement with those of conventional AV grafts based on previously published literature.

Methods and Materials

We performed a retrospective review of 20 consecutive ESRD patients selected for two-staged HeRO implantation at our institution between January 2010 and March 2013. Patients were offered this two-staged implantation if they were older than 18, IJV catheter-dependent for hemodialysis with contralateral central venous occlusion and had no other traditional upper extremity AV access option available. The suitability of each patient to undergo two-staged HeRO implantation was decided after all candidate patients underwent a complete history and physical examination, as well as an assessment of the adequacy of arterial inflow. Informed consent was obtained from each patient, and one vascular surgeon performed all two-staged HeRO placement procedures.

Approval from the Institutional Review Board was obtained. Data were collected from time of the first stage procedure to last available follow-up. Analysis was conducted on the deidentified data with respect to demographics, comorbidities, infection rates, HeRO patency and intervention rates. Frequency and descriptive statistics were calculated. Infection rate was calculated as a rate per 1,000 catheter days. Primary, primary assisted and secondary patency were calculated using Kaplan-Meier method.

Two-stage HeRO graft implantation technique

The first stage is to implant the ePTFE graft component in the upper arm ipsilateral to the concurrent IJV catheter. Two to three incisions are performed in the upper arm. The graft component is then tunneled through these incisions in a gentle curve. The proximal arterial end of the ePTFE component is folded over and placed subcutaneously without anastomosing it to the target inflow artery. The preexisting IJV catheter is kept to provide continuous dialysis access during the inter-stage period (Fig. 1). After confirming maturation of the graft component, the second stage is initiated with reopening of the arterial incision site. The ePTFE arterial end is freed, thrombectomized and anastomosed to the target artery. The preexisting IJV catheter is then exchanged with the venous outflow component. Subsequently, two components are connected via a titanium connector in the standard fashion, converting it into a HeRO access graft that now allows immediate access (Fig. 2) (12).

Fig. 1

The first stage. The expanded polytetrafluoroethylene graft component is tunneled through incisions, folded over and placed in the subcutaneous tissue.

Fig. 2

The second stage, (a) Reopened arterial and connector incision sites; (b) the chest wall catheter is freed and the jugular entrance site is opened; (c) the venous outflow component is tunneled from the internal jugular vein site to the connector site in a standard fashion; (d) coupling of the venous outflow component to the expanded polytetrafluoroethylene component.

Results

From January 2010 to March 2013, a total of 20 IJV catheter-dependent ESRD patients with contralateral central venous occlusion were selected for two-staged HeRO implantation at our institution. Of these, 17 patients completed the two-staged procedure, while 3 patients were lost to follow-up after the first stage. All of the patients had multiple failed vascular accesses prior to this HeRO attempt and ran out of options for a standard AV vascular access in the upper arm.

The patients consisted of 12 females and 5 males with a mean age of 59 years (range 25 to 86 years). The vast majority of the patients (n = 14, 82.3%) were African-American. The most common comorbidity was hypertension (n = 13, 76.5%), followed by diabetes mellitus (n = 10, 58.8%). Three patients (17.6%) were morbidly obese, while two patients (11.8%) had prior renal transplant. Characteristics of the patients are summarized in Table I.

Table I

Patient characteristics

Variable	Value (N = 17)
Age, mean (range)	59.2 (25-86)
Female	12 (70.6%)
African-American	14 (82.3%)
Caucasian	2 (11.8%)
Asian	1 (5.9%)
Diabetes	10 (58.8%)
Hypertension	13 (76.5%)
Coronary artery disease	7 (41.2%)
Peripheral vascular disease	7 (41.2%)
Prior renal transplant	2 (11.8%)
Morbid obesity	3 (17.6%)

In the first stage, arterial inflow was gained from the axillary artery in the majority of the patients (n = 12, 70.6%); the brachial artery was used in the rest of the patients (n = 5, 29.4%). The mean interstage interval (between the first and the second stage) period was 11.6 months (range 3.9 to 22 months). During the second stage, the venous outflow component was inserted using preexisting IJV catheters as a conduit to place the guidewire. The left IJV site was more commonly used (n = 11, 64.7%). With all patients using IJV catheters at the time of HeRO placement, the technical success was achieved in all patients (n = 17, 100%). The mean period of follow-up after the second stage (postimplant) was 7.7 months (range 0.9 to 22.6 months), resulting in accumulated HeRO days of 3,916 days (Tab. II).

Table II

Two-stage HeRO graft implantation specifics

Variable	Value (N = 17)
Technical success	17 (100%)
Arterial inflow
Axillary artery	12 (70.6%)
Brachial artery	5 (29.4%)
VOC insertion site
Left IJV	11 (64.7%)
Right IJV	6 (35.3%)
Interstage interval, mean (range) (weeks)	11.6 (3.9-22)
Follow-up, mean (range) (mo)	7.7 (0.9-22.6)
Accumulated HeRO-days	3,916

HeRO = Hemodialysis Reliable Outflow; IJV = internal jugular vein; VOC = venous outflow component.

No surgery-related or graft-related infection occurred between the first and second stages. Overall, one HeRO-related infection episode occurred at 1 month after completion of the second stage, leading to explantation of the HeRO graft to resolve the problem. The resulting two-stage HeRO-related infection rate was 0.3/1,000 days. We compared our infection outcome with that of the conventional one-stage study done by Katzman et al (the FDA clinical trial) (6) as well as by Wallace et al (nonindustry-sponsored study) (13). The arteriovenous graft (AVG)-related infection rate of 14.9% (658/4,406), reported in the meta-analysis study conducted by Murad et al, was used to compare our result (14). Summary and comparison with other studies are described in Table III.

Table III

Infection rate: two-stage vs. one-stage vs. AVG literature

	Two-stage	Conventional one-stage		AVGs
		Katzman et al (6)	Wallace et al (13)	Murad et al (14)
Inter-stage interval (n)	0
Bridging period (n)		7	0
Postimplant (n)	1	0	2
Overall HeRO-related infection rate
% (n/N)	5.9 (1/17)	19.4 (7/36)	11.1 (2/18)	14.9 (658/4,406)
Per 1,000 days	0.3	0.7	0.5	N/A

AVGs = arteriovenous grafts; n = number of infections; N = total number of HeRO implants; N/A = not available.

Using Kaplan-Meier method, two-stage HeRO primary patency, assisted primary patency and secondary patency at 1 month were 46%, 94% and 100%, respectively. At 6 months, primary patency was 13%, assisted primary patency was 69% and secondary patency was 82%. At 12 months, two-stage HeRO had a primary patency of 0%, assisted primary patency of 59% and secondary patency of 68%. The Kaplan-Meier estimates on patency are depicted in Figure 3. Overall, 59 interventions were performed to maintain or reestablish patency, resulting in a two-stage HeRO intervention rate of 5.4 per HeRO year. We adopted and used the AVG patency and intervention literature control rates reported in the Katzman et al study. We compared our patency and intervention outcomes with other published data on the conventional one-stage implantation as well as the AVG literature control rates as shown in Table IV.

Fig. 3

Kaplan-Meier estimates of patency rates after completion of the two-staged Hemodialysis Reliable Outflow implantation.

Table IV

Comparison of the patency and intervention rates

	Two-stage	Conventional one-stage		AVG literature (6, 14, 15)
		Katzman (6)	Wallace (13)
Primary patency (%)
6 mo	13		39	58
12 mo	0		11	42
Primary assisted patency (%)
6 mo	69			68
8.6 mo		86.1
12 mo	59			52
Secondary patency (%)
6 mo	82		60	76
8.6 mo		72.2
12 mo	68		32	65
Intervention (/HeRO year)	5.4	2.5	3.0	1.6-2.4

AVG = arteriovenous graft; HeRO = Hemodialysis Reliable Outflow.

Discussion

Higher incidence of infection complications related with TDCs favors conversion of central vein catheter dependency for hemodialysis to dialysis using AVGs whenever possible. While the HeRO graft can provide a novel means of obtaining a subcutaneous AV access, placement of this new graft in the catheter-dependent patients with contralateral central venous occlusion necessitates a femoral hemodialysis bridging TDC. In the two-staged HeRO implantation, instead of creating a new femoral bridging TDC, the pre-existing IJV catheter is utilized on the following grounds.

Firstly, earlier studies showed IJV catheters were less likely to result in catheter-related infection when compared with the use of femoral TDCs (16, 17). In the Katzman meta-analysis study, the calculated IJV TDC-related infection rate was 2.3/1,000 catheter days, while the reported femoral TDC-related infection rates ranged from 3.6 to 6.9/1,000 catheter days (6). Based on these reports, a femoral TDC could result in 3.6% to 12.9% higher risk of infection compared with an IJV TDC, considering 4 weeks as an ePTFE graft maturation period. In addition, according to the decision analytic model for selecting hemodialysis access developed by Dageforde et al, infection is the primary determinant of the cost of hemodialysis (18). These findings suggest averting the need of a new femoral catheter placement by utilizing an indwelling IJV catheter would abate infection episodes in this subset of patients, thereby reducing morbidity and healthcare costs.

Our study with the two-staged procedure demonstrated an infection rate of 0.3/1,000 days, which was lower than those reported for the conventional one-stage procedures by Katzman et al (0.7/1,000 days) (6) and by Wallace et al (0.5/1,000 days) (13). Although our sample size was small, the two-stage bacteremia rate of 5.9% (1/17) was also considerably lower than Murad's AVG infection rate of 14.9% (658/4,406) (14). Of note, no infection episode occurred between the first and the second stages. This outcome supports that reopening and manipulating a subcutaneously placed prosthetic graft 4 weeks later does not increase the risk of infection. It is also noteworthy that Wallace et al did not experience any infection episode during the bridging period (13), whereas all HeRO-related infections in the Katzman study occurred while a bridging TDC was in use (Tab. III) (6). Further studies could add further clarity on these findings.

In addition to reduced infection rate, implanting a HeRO in two stages allows time for the ePTFE graft component to mature before initiation of the second stage procedure. As a result, this two-stage technique confers immediate postimplant cannulatability as an added benefit. In particular, for the subgroup of patients who present with the urgent hemodialysis challenge, the cannulation limitation of the conventional one-stage implantation can be resolved using this two-stage technique described previously (12).

Utilization of preexisting IJV catheters serves two purposes: first, to provide continuous hemodialysis access during the interstage period; second, to use as a conduit for placing the guidewire for insertion of the venous outflow component during the second stage. Notably, the IJV that is sheltering a TDC is the only accessible central vein in this subset of patients. With its tip already positioned at the right atrium, technically, exchange of an IJV catheter for the venous outflow component can be carried out with a high success rate. In our experience, we attained a HeRO placement success rate of 100% (17/17). Successful conversion of indwelling catheters into a HeRO without any complications has also been documented in previous publications (10, 11, 13). Furthermore, with secured wire access to the central venous system prior to preexisting TDC removal, the venous outflow component can be inserted routinely without adjunctive technique such as percutaneous transluminal angioplasty.

In comparing our two-stage patency rates with those from the previously published studies of the conventional one-stage procedure, we found our primary and primary assisted patency rates were significantly lower than other studies. However, our secondary patency rates of 82% at 6 months and 68% at 12 months were more than those of the Wallace study, 60% at 6 months and 32% at 12 months (13), while comparable to that of Katzman's study at 8.6 months (6). When compared with the AVG literature patency control rates reported in the Katzman study, our primary assisted and secondary patency rates were comparable at both 6 and 12 months, while observing significantly less primary patency rates in our study (Tab. IV). With respect to intervention rate, we observed a significantly higher rate of 5.4/HeRO-year compared with both one-stage studies, 2.5/HeRO-year for the Katzman study and 3.0/HeRO-year for the Wallace study, as well as with the AVG literature control rates ranged from 1.6 to 2.4/HeRO-year (Tab. IV). Our aggressive and low threshold for intervention may have contributed to our higher intervention rate, but led to primary assisted and secondary patency rates that rival those of AVGs.

The limitation to our study includes the small number of patients and retrospective nature of the study. A large, prospective study is warranted to confirm our findings.

In conclusion, this study suggests that avoiding the use of a femoral bridging hemodialysis catheter using the two-stage HeRO graft implantation technique may lower infection rate, with comparable primary assisted and secondary patency to AV grafts and added benefit of immediate cannulatability in the subset of patients with contralateral central venous occlusion.

Footnotes

Conflict of interest: The authors have no conflicts of interest to declare.

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