HeRO graft—The results of the cologne single center study

Abstract

Objective

The HeRO graft is a technique for vascular access in patients with limited treatment options; however, the published results with the HeRO graft are diverging. We therefore conducted a single-center study.

Methods

Results

Eighteen patients were enrolled in the study. The mean age of the patients was 62.8 ± 17.24 years. During the follow-up period, no patients died from complications related to the HeRO graft. Each patient had a mean of 1.94 concomitant diseases. The primary patency rates of the HeRO graft at 3, 6, 12, 18, and 24 months were 61.1%, 50%, 16.7%, 11.1%, and 5.6%, respectively. The secondary patency rates at the same time intervals were 77.8%, 72.8%, 55.6% 55.6%, and 55.6%, respectively. There were 44 re-operations per year, or 2.4 operations per patient. The main cause of acute complications was acute graft occlusions after HERO graft implantation. An infection after the graft implantation occurred in five (27.7%) patients, leading to graft explanation in 2 cases.

Conclusion

The use of the HERO graft is a valuable alternative method for providing a durable dialysis access in patients with limited access options. The secondary patency and survival are good with a low infection rate.

Keywords

HERO Graft patency survival dialyses shunt

Introduction

Central vein stenosis and occlusion (CVSO) is one of the main reasons for fistula and graft failure in the current hemodialysis population.^1,2

The HeRO graft (Merit medical systems, Inc. 1600 West Merit Parkway South Jordan UT 84095 USA) is a technique which combines the technology of a catheter with the advantages of a vascular graft.

The central venous catheter component is connected to the vascular graft and provides the graft with a nearly perfect outflow to the right atrium. As it is positioned subcutaneously, this combination is designed to avoid the typical drawbacks of the catheter, including high rates of infection and mortality.

In the current ESVS access guidelines, the HeRO graft is described as one of the possible options for creating a vascular access in patients with occluded upper arm and/or central veins.³

However, the clinical results of the HeRO graft are diverging. In particular, the primary and secondary patency, the infection rate and the frequency of redo procedures are points of concern, particularly in comparison to lower extremity AV grafts (LEAVG). This data is largely based on several studies performed by research groups in the USA. It is generally accepted that there are significant differences between the USA, Europe, Asia, and the DOPPS¹¹ study, demonstrating very contradictory data that requires further analysis and development. This fact is associated not only with the fact that the frequency of using native fistula varies in different countries, but also because their successful use in different regions differs significantly. In particular, AVf was used successfully in 87% of cases in Japan and only in 67% in Europe/ANZ, and 64% in the United States.

We are now reporting the results of a single-center study of HeRO graft implantation in patients with critically limited options for vascular access creation.

Materials and methods

Patient records between July 2014 and February 2020 from Vascular Access Unit of the Department of Vascular and Endovascular Surgery of University Clinic of Cologne (Germany) were reviewed. Retrospective data was analyzed from patients with a HeRo graft (n = 18). The decision to implant the device was made individually for each patient and was undertaken on an interdisciplinary basis within the cologne vascular access center, involving collaboration between surgeons, nephrologists, and radiologists. Our study is a single-center, retrospective analysis, performed in line with the requirements of the local ethics committee of University Hospital of Cologne and adhering to the Declaration of Helsinki.

The patency of the created fistulae was defined in accordance with the “recommended standards for reports dealing with arteriovenous haemodialysis accesses.”⁴ Primary patency (PP) was defined as the time interval between fistula creation and the time of any surgical or endovascular intervention designed to maintain or re-establish patency or the time of patency measurement. Secondary patency was the interval from the time of access placement until access abandonment, thrombosis, or the time of patency measurement including intervening manipulations (surgical or endovascular interventions) designed to re-establish functionality in thrombosed access.

Study characteristics

We analyzed the demographic details, re-intervention rate along with its reasons, as well as primary and secondary patency, and the infection rate.

Statistical analysis

Continuous data are presented as median and range, categorical data as numbers, unless otherwise specified. HeRo patency rates were estimated using the Kaplan–Meier method. Patients who died with a patent fistula were censored. All evaluations were performed using the statistical package SPSS for Mac, release 25.0 (SPSS, Chicago, IL, USA).

Results

The patients demographic data is demonstrated in Table 1. The device was successfully implanted. All these patients had been offered groin access but they rejected this option. A left sided HeRO graft implantation was performed in 4 cases. There were no groin implants. No major intraoperative complications were observed during the implantation.

Table 1.

Demographics.

	OVERALL
Number of subjects	18
Mean age	62.8 ± 17.24
Gender	9m/9f
DM	2 (11.1%)
CAD	2 (11.1%)
Hypertension	9 (55.5%)
Heart failure	5 (27.7%)
COPD	1 (5.5%)
TIA/Stroke	2 (11.1%)
PAD/Diabetes foot	1 (5.5%)
Cancer	3 (16.6%)
Kidney transplantation	3 (16.6%)
Time of hemodialysis (mean - years)	10.7 ± 8.3

No mortality was in the follow-up period.

The primary patency rates of the HeRO graft at 3, 6, 12, 18, and 24 months were 61.1%, 50%, 16.7%, 11.1%, and 5.6%, respectively (Figure 1). The secondary patency rates at the same time were 77.8%, 72.8%, 55.6% 55.6%, and 55.6%, respectively (Figure 2).

Figure 1.

Kaplan–Meier primary patency of Hemodialysis Reliable Outflow (HeRO) grafts. The primary patency rates of the HeRO graft at 3, 6, 12, 18, and months were 61.1%, 50%, 16.7%, 11.1%, and 5.6%, respectively.

Figure 2.

Kaplan–Meier secondary patency after HeRO graft implantation. The secondary patency rates at the same time were 77.8%, 72.8%, 55.6% 55.6%, and 55.6%, respectively.

There were 44 re-operations per year, or 2.4 operations per patient. The main cause of acute complications was acute graft occlusions after HERO graft implantation. An infection after the graft implantation occurred in five (27.7%) patients, leading to graft explanation in 2 cases. However, 10 re-operations were performed in one patient, which was associated with repeated thrombosis of the graft during the follow-up.

At the same time, Surfacer device was used for HeRO graft implantation in 5 cases due to severe VCS or occlusion. There was no periprocedural complications noted.

In another two cases, the infection appeared just subcutaneously and was treated only by antibiotics without any surgical procedure. In two cases, HeRO graft was explanted after successful kidney transplantation.

The primary patency rates achieved in the present study, as well as published data from the largest single and multicenter studies, are shown in Table 2.

Table 2.

One-year PP, SP, and infection rate of HeRO G.

Authors/year			Number of patients	Centers/Country	One year PP	One year SP (%)	Infection rate
Present study			18	Single center)/Germany	16,7%	55.6	16.6%
Hunter J.P	(2018)	[7]	52	Multicenter (9 centers)/UK and Ireland	40.9%	76.5	7.6%
Ladenheim E	(2017)	[9]	40	Single center/USA	30%	71	12.5%
Perry JW^a	(2017)	[10]	10	Single center/USA	50%	70	20%
Brownie ER.	(2016)	[11]	33	Single center/USA	15%	88	21%
Naffouje SA	(2016)	[12]	34	Single center/USA	25%	71.8	20.5%
Yoon WJ^b	(2015)	[13]	20	Single center/USA	n.a	68	5%
Kudlaty EA	(2015)	[14]	21	Single center/USA	29%	53.5	15%
Torrent DJ	(2014)	[15]	41	Single center/USA	8.4%	53.7	NS^c
Nassar G.M.	(2014)	[16]	52	Multicenter/USA	34.8%	67.6	3.8%
Steerman SN	(2013)	[17]	59	Single center/USA	40%	57	5%
Kokkosis AA	(2013)	[18]	11	Multicenter (2 clinics)/USA	54.5%	45.5	18.1%
Wallace JR	(2013)	[8]	19	Single center/USA	11%	32	10.5%
Gage SM	(2012)	[19]	164	Multicenter (4 clinics)/USA	40.8%	90.8	4.3%

^aHeRO graft modified with an ACUSEAL graft.

^bTwo-stage HeRO implantation. The arterial graft component (AGC) was implanted without anastomosing it to the target artery (first stage) and, after AGC incorporation, the venous outflow component was inserted (second stage).

^cNS—none specified.

Discussion

Over the past decade, significant experience has been gained in the use of the HeRO graft, particularly in the USA.^5,6 Fewer implants have been performed in Europe, as the device was approved 5 years later and possibly because more demanding indications have been applied.⁷ The present study is the single center study on the outcomes of the HeRO graft from Europe.

We achieved a high technical success rate correlating well with the published data from the USA and even surpasses some studies, such as that of Wallas et al.⁸

The reason for our high success rate might be our aggressive use of interventional techniques, including the inside-out device (Surfacer) for cases with totally occluded or severely stenosed central vessels.

Primary patency

The most important point of criticism of the use of HeRO has been the low primary and secondary patency rates—especially when compared to AVFs and AVG.⁶

Our results (1-year primary patency of 16.7%) are comparable with the results of two single center studies from the USA. Only one study showed a 1-year PP of 54.5%.¹⁸ However, this was the study with the lowest number of patients (eleven patients in two centers).

Thrombotic occlusions are the main cause of HeRO dysfunction. In our study, the number of revisions was 44, corresponding to a total of 2.4 operations (all reasons) for each patient and 2.2 operations for each patient due to acute graft occlusion. According to several authors, the number of revisions is between 1.5 and 2.5 interventions per patient per year.^16,19,20 According to Steerman et al.,¹⁷ up to 93% of the revisions during the first year are due to thrombectomy. In our study, the number of revisions were comparable with date from other authors.

Secondary patency

Our secondary patency at 1 year was high and which is similar to some others single centers from USA.^14,15,17

Given the fact that one of the main components of the HeRO graft is the PTFE graft, it seems most appropriate to compare the outcome of HeRO grafts to that of PTFE grafts (AVG) also as there is no available autologous material in this cohort.

In the systematic review of T.S. Huber et al.²¹ of 34 publications, it was shown that PP and SP of AVGs at 6 and 18 months after implantation were 58% and 33%, and 76% and 55%, respectively. In a recently published randomized trial,²² a comparison of the heparin-bonded graft (Propaten) versus standard graft showed that PP during the first year was 14% for heparin-bonded grafts and 12% for standard ePTFE and SP was 83% for heparin-bonded grafts versus 81% for standard grafts. In a systematic review and meta-analysis by M.K. Lazaridies,²³ it was shown that pooled 6 months and 1-year PP were not significantly different between heparin-bonded AV grafts and standard prosthetic AV grafts. In addition, the authors concluded that the heparin-bonded AV grafts offered no distinct advantage over standard prosthetic AV grafts and their preferential use in access surgery could not be recommended.

The HeRO graft should normally only be used for cases with severe stenosis/occlusions rather than native AVF and where a simple AVG cannot be used. It would therefore have been expected that the results for the HeRO graft would have been lower than was actually found. The basis for criticisms of the HeRO G is the fact that its PP is much worse than native A-V fistula

The average age of patients in our study was higher than in other studies,^8,10,12,15 as was the rate of diabetes mellitus. Notably, in the British and Irish study,⁷ the prevalence of diabetes mellitus was higher that observed in our study. In the same time, in the American study,⁹ the prevalence of diabetes mellitus was higher than in our study, potentially influenced by the high percentage of Afro-American participants, who are known to have a higher incidence of diabetes.

Periprosthetic infections develop in up to 21% of cases and often necessitate partial or complete graft explant. The mean incidence of graft infection is 10.1%,⁶ although a range of values have been published. In our study, graft infections at the 1-year follow-up were seen in three cases. However, only two grafts had to be explanted. In Table 2, the infection rate after HeRO implant in the present study and compared with other published data can be seen.

The main risk factors for the development of graft infection include a history of positive blood culture at graft implantation, obesity, low patient compliance, ipsilateral implantation of the graft with respect to the previous tunneled dialysis catheter (TDC), and TDC implantation. Griffin et al.²⁴ compared the early HeRO graft infection rates in a primary and a staged implantation approach. They demonstrated that a staged HeRO implantation did not increase the early infection risk compared with conventional primary implantation.

An alternative to HeRO would be to use a lower limb AVf or AVG in the lower limb. A number of authors are currently discussing the use of a femoral access as an alternative to HeRO graft on the upper limb. S.N. Steerman et al.¹⁷ compared HeRO G with lower extremity arteriovenous grafts and found similar results for the secondary patency and for all-cause mortality. However, the Kudlaty et al.¹⁴ study showed that PP was higher for HeRO at 12 months than for AVG and the rate of infectious complications which were twice as high in AVG than in HeRO.

According to a number of authors, there is a high risk of limb ischemia—up to 10%^25,26—as well as limb loss—up to 7%, as they are caused by violation of arterial blood circulation and concomitant infection. However, when using a HeRO, the risk of blood flow steal does not seem to be higher. In published large-scale studies, there are no documented cases of amputation of the upper limb due to ischemia after HeRO implantation.

All patients considered suitable for HeRO graft in the present study were offered the alternative of a groin access. However, the patients all refused this option, for a variety reasons. Especially the young patients—or at least those still working on a regular basis— declined the groin access because their quality of life would significant worsen. Secondly, patients were reluctant that hemodialysis should be carried out by puncture of the graft in the lower limb. Moreover, the groin location of AVG and regular punction can significantly increase the risk of developing infectious complications in the area of graft implantation, and the development of limb ischemia with the risk of subsequent amputation. Wallas J.R. et al.⁸ also included a significant number of patients with a prior renal transplant (53%) who after transplant rejection/decreased function received a HeRO graft.

According to a number of authors, PP and SP for fAVG reach 48% and 69%, respectively, in the first year.^25,26 In addition, a direct comparison of an AVG in the lower extremity with the results obtained with an HeRO implantation is of doubtful value, as the risk factors are fundamentally different in different body regions, in particular the conditions of microbial contamination.

Some new studies demonstrated a good result of Surfacer device implementation also for HeRO graft implantation. This technique could be very useful in case of severe stenosis and occlusion of VCS especially for patients whom indicated HeRO graft implantation.

Limitations of our study

Despite the single center character of the study, it is retrospective on heterogenous population. The selection of the patients was not standardized, as was not the surgical technique.

Conclusion

The HERO graft is an alternative method for permanent vascular access that can be used for patients on continuous hemodialysis. The results, in particular, survival, SP, and a low incidence of infectious complications were acceptable.

Footnotes

Author contributions

Matoussevitch V—data collection and analysis, statistical analysis, and critical analysis of the article. Dorweiler B—article writing, statistical analysis, and critical analysis of the article. Kalmykov E—data collection and analysis, article writing, and statistical analysis.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

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

ORCID iDs

Egan Kalmykov

Vladimir Matoussevitch

Appendix

References

Krishna

Eason

Allon

. Central venous occlusion in the hemodialysis patient. Am J Kidney Dis 2016; 68(5): 803–807. DOI: 10.1053/j.ajkd.2016.05.017.

Agarwal

. Central vein stenosis. Am J Kidney Dis 2013; 61(6): 1001–1015. DOI: 10.1053/j.ajkd.2012.10.024.

Schmidli

Widmer

Basile

, et al. Editor’s choice - vascular access: 2018 clinical practice guidelines of the European society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg 2018; 55(6): 757–818. DOI: 10.1016/j.ejvs.2018.02.001.

Sidawy

Gray

Besarab

, et al. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg 2002; 35(3): 603–610.

Kalmykov

. An overview of the cologne symposium on issue of vascular access in patients on programmed hemodialysis (“Kölner dialyseshunt symposium”, June, 24-25, 2016 Year). Novosti Khirurgii 2017; 25(2): 211–214.

Al Shakarchi

Houston

Jones

, et al. A review on the hemodialysis reliable outflow (HeRO) graft for haemodialysis vascular access. Eur J Vasc Endovasc Surg 2015; 50(1): 108–113. DOI: 10.1016/j.ejvs.2015.03.059.

Hunter

Knight

Inston

, et al. The United Kingdom and Ireland experience of the Haemodialysis Reliable Outflow graft for vascular access. J Vasc Access 2018; 20(1): 12–18. DOI: 10.1177/1129729818770588.

Wallace

Chaer

Dillavou

. Report on the Hemodialysis Reliable Outflow (HeRO) experience in dialysis patients with central venous occlusions. J Vasc Surg 2013; 58(3): 742–747. DOI: 10.1016/j.jvs.2013.02.018.

Ladenheim

Lulic

Lum

, et al. Primary and secondary patencies of transposed femoral vein fistulas are significantly greater than with the HeRO graft. J Vasc Access 2017; 18(3): 232–237. DOI: 10.5301/jva.5000697.

10.

Perry

Hardy

Agarwal

, et al. Safety and efficacy of a modified HeRO dialysis device in achieving early graft cannulation: a single-institution experience. J Vasc Surg Cases Innov Tech 2017; 3(3): 175–179. DOI: 10.1016/j.jvscit.2017.05.001.

11.

Brownie

Kensinger

Feurer

, et al. A comparison of patency and interventions in thigh versus Hemodialysis Reliable Outflow grafts for chronic hemodialysis vascular access. J Vasc Surg 2016; 64(5): 1392–1399. DOI: 10.1016/j.jvs.2016.04.055.

12.

Naffouje

Tzvetanov

Bui

, et al. Obesity increases the risk of primary nonfunction and early access loss and decreases overall patency in patients who underwent hemodialysis reliable outflow device placement. Ann Vasc Surg 2016; 36: 236–243. DOI: 10.1016/j.avsg.2016.03.014.

13.

Yoon

Lorelli

. Avoiding the use of a femoral bridging catheter using a two-stage Hemodialysis Reliable Outflow (HeRO) graft implantation technique. J Vasc Access 2015; 16(3): 189–194. DOI: 10.5301/jva.5000325.

14.

Kudlaty

Pan

Allemang

, et al. The end stage of dialysis access: femoral graft or HeRO vascular access device. Ann Vasc Surg 2015; 29(1): 90–97. DOI: 10.1016/j.avsg.2014.06.001.

15.

Torrent

Maness

Kachare

, et al. Examining Hemodialysis Reliable Outflow catheter performance and cost in hemodialysis access. J Surg Res 2014; 192(1): 1–5. DOI: 10.1016/j.jss.2014.03.016.

16.

Nassar

Glickman

McLafferty

, et al. A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients. Semin Dial 2014; 27(3): 310–318. DOI: 10.1111/sdi.12173.

17.

Steerman

Wagner

Higgins

, et al. Outcomes comparison of HeRO and lower extremity arteriovenous grafts in patients with long-standing renal failure. J Vasc Surg. 2013; 57(3): 776–783. DOI: 10.1016/j.jvs.2012.09.040.

18.

Kokkosis

Abramowitz

Schwitzer

, et al. Experience of HeRO dialysis graft placement in a challenging population. Vasc Endovasc Surg 2013; 47(4): 278–280. DOI: 10.1177/1538574413481117.

19.

Gage

Katzman

Ross

, et al. Multi-center experience of 164 consecutive hemodialysis reliable outflow (HeRO) graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg 2012; 44(1): 93–99.

20.

Katzman

McLafferty

Ross

, et al. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg 2009; 50(3): 600–607. DOI: 10.1016/j.jvs.2009.04.014.

21.

Huber

Carter

, et al. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg 2003; 38(5): 1005–1011.

22.

Shemesh

Goldin

Hijazi

, et al. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg 2015; 62(1): 115–122. DOI: 10.1016/j.jvs.2015.01.056.

23.

Lazarides

Argyriou

Antoniou

, et al. Lack of evidence for use of heparin-bonded grafts in access surgery: a meta-analysis. Semin Vasc Surg 2016; 29(4): 192–197. DOI: 10.1053/j.semvascsurg.2016.08.003.

24.

Griffin

Gage

Lawson

, et al. Early infection risk with primary versus staged Hemodialysis Reliable Outflow (HeRO) graft implantation. J Vasc Surg 2017; 65(1): 136–141. DOI: 10.1016/j.jvs.2016.07.114.

25.

Geenen

Nyilas

Stephen

, et al. Prosthetic lower extremity hemodialysis access grafts have satisfactory patency despite a high incidence of infection. J Vasc Surg 2010; 52(6): 1546–1550. DOI: 10.1016/j.jvs.2010.06.162.

26.

Antoniou

Lazarides

Georgiadis

, et al. Lower-extremity arteriovenous access for haemodialysis: a systematic review. Eur J Vasc Endovasc Surg 2009; 38(3): 365–372. DOI: 10.1016/j.ejvs.2009.06.003.