Main topic

Gefässchirurgie 2019 · 24 (Suppl 1):S25–S31https://doi.org/10.1007/s00772-018-0500-yPublished online: 6 February 2019© The Author(s) 2019

T. Steinke1 · J. Rieck2 · L. Nuth1

1 Klinik für Gefäßchirurgie, Schön-Klinik Düsseldorf, Düsseldorf, Germany2Management Partner AngioConsult GmbH Speyer, Speyer, Germany

Endovascular arteriovenousfistula for hemodialysis access

The prevalence of end-stage renaldisease (ESRD) is increasing globallywhich imposes a huge economicburden on the healthcare systemdue to a tremendous logistic andeconomical effort. In order toreplace the kidney function byhemodialysis a vascular accessis required. The gold standardwhich has remained unchanged forover 50 years is still the surgicalcreation of a native arteriovenous(AV) fistula. New endovasculartechniques for creation of AV accesscan provide a sustainable potentialfor improvementof shuntplacement.

The chance for patients with progres-sive renal insufficiency or renal failureof receiving a donor organ is constantlydecreasing, as the number of availablekidney donors is significantly lower thanthe growing incidence of end-stage renaldisease (ESRD) [12, 19]. The use of anAV fistula (shunt) is the most effectiveway to perform hemodialysis with theleast amountof complicationsashasbeenshown in many studies and the result-ing guidelines [21, 24]; however, patientswith a matured AV fistula not only needto undergo dialysis three times per weekbut often also need to undergo multiplere-interventions to optimize or maintainthe vascular access [1].

Current problem situation

In 1966 Brescia et al. came up with a rev-olutionary approach, which was an en-

The German version of this article can befound under https://doi.org/10.1007/s00772-018-0466-9.

richment for all players involved in theprocess, whentheydescribedtheconnec-tion of an artery and a superficial veinto develop a high-quality vascular accessfor patients with ESRD and the need toreceive dialysis. [3]. Since then, vascularmedicine has further developed in paral-lel to neighboring disciplines. The use ofconstantly improving imaging and tech-nologically mature intervention materi-als, such as catheters, coils, endoanchorsand endoscopes, enables the use of mini-mally invasive vascular surgery for manydiseases that were previously only treat-able with open surgery (see, for exam-ple, the development in the treatment ofabdominal aortic aneurysms [15]). De-spite these achievements, not many peo-ple would have believed that hemodial-ysis access could be done without opensurgery a decade ago.

» Patients have a constantlydecreasing chance of receivinga donor organ

The surgical placement of an AV accessalone is very demanding and is subjectto errors. After surgical exposure of thevessels and dissection of the artery andthe vein, an anastomosis without torqueand twist is required. Even with a highlyprecise technique, there may be vessel ir-ritation, spasms, twist and turn phenom-ena orneointimal hyperplasia, which canall lead to early closure or disturbedmat-uration [1, 24]. In addition, an intensivepreoperative evaluation and selection ofthe region for anastomosis is essential forthe success of a shunt placement [10, 20].Furthermore, these patients are usuallyolderwithmultiple comorbidities and the

poor vascular conditions result in only afew treatment options. All these factorsresult in low primary shunt maturationwith high failure and/or high re-inter-vention rates [24].

Unfortunately, there are notmany sci-entific studies in thefieldofAVaccess andthe variations in the typeof access, opera-tive techniques and endpoints also makeit difficult to compare the results of thesestudies [1]. In Germany the majorityof surgical shunt procedures are carriedout outside university facilities, mostly inspecialized centers with predominantlylittle access to scientific resources. An-other structural difficulty in the treat-ment of dialysis patients with ESRD isthe variety of disciplines participating intreatment and in addition to nephrolo-gists (mostly in private practices), vas-cular surgeons, angiologists and radiol-ogists are also involved that occasionallyleads to competing interests among thetreating physicians. Combined with analready initiated certification process forAVfistula access centers [8], medical andtechnical progress and new methods ofshunt surgery have the potential to ad-dress many of these problems and alsoto reduce the economic burdens [18].

The innovative endovascularapproach

There are essentially two companies pur-suing anendovascularAVfistula creationtechnology. Both systems are based ona similar concept, such as:4 Vessels are not clamped, not mobi-

lized and not dissected and are notanastomosed by sutures.

4 The AV anastomosis is located inthe deep vascular system, where the

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Perforating vein

Basilic vein

Cephalic vein

Brachial artery

Radial artery

Ulnar artery

Fig. 18 Anatomical representation of vascular relationships in the cubital fossa (Reproducedwithkind permission of TVAMedical. This figure is not part of the OpenAccess agreement)

Duplicated perforating veins

Anastomosis

Brachial artery

Left upper arm

Ulnar artery

Radial artery

Cephalic vein Antibrachial cephalic vein

Deepaccompanying

veinBasilic vein

Fig. 28 Situation following endoAVFwith duplicated perforating veins

artery is usually accompanied by oneor two concomitant veins.

4 The AV anastomosis is located in theproximal forearm, close or slightlydistal to the perforating vein, whichis necessary for this procedure.

4 The AV anastomosis is created withheat/radiofrequency through anendovascular catheter system.

» An endovascular AV fistula isplaced in the deep vein close tothe cubital fossa

Comparable with traditional surgical ap-proaches, a preprocedural ultrasound as-

sessment to evaluate the vascular statusis mandatory in both innovative proce-dures. The decisive factor for creation ofan endovascular AV fistula (endoAVF)is the assessment of the perforator, thevein close to the cubital fossa that con-nects the deep systemwith the superficialvenous system (. Fig. 1). The adequatediameter should be approximately 2mmand as straight a configuration as possibleto either the cephalic or basilic vein isfavorable. The perforating vein has mul-tiple anatomical variations and can alsobe present as a duplication (. Fig. 2). Inaddition, analogue to surgical planning,the superficial veins should have a mini-mum diameter of 2mm along the wholelength.

An endoAVF is created in the areaof the cubital fossa in the deep vascularsystem, either between the ulnar arteryand the accompanying vein or the radialarteryandradial vein. Theseaccompany-ingveins are connected to theperforatingvein at the level of the cubital fossa sothat a direct outflow to the superficialsystem is possible [2].

The most comparable surgical proce-dure in the same anatomical localizationis the Gracz fistula, where the brachialartery is connected with the venous per-forator in order to achieve maturation ofboth the cephalic and thebasilic veins [5].Surgical variations, such as connectingthe radial or ulnar artery with the perfo-rating vein have also been described inthe literature [9]. . Fig. 1 shows a sim-plified typical anatomical illustration ofthe vascular system of the right arm.Deviations, such as differences in ves-sel diameter, high brachial bifurcations(approximately 10%) or nonexistent per-forating veins are identified prior to theendoAVF procedure through the ultra-sound/duplex examination.

EverlinQ™/WavelinQ system

The first generation everlinQ™ system(TVA Medical, Austin, TX, USA) hadtwo 6Fr catheters, which were insertedvia theupperarmintothevascularsystem(artery and accompanying vein). Sincethe endof2017aCE-approved4Frdevicehas replaced the old 6Fr system in Eu-rope. Both catheters are equipped withvery potent magnets in order to adaptthe target vessels (artery and vein) forcreation of the anastomosis. The arte-rial device has a small ceramic saddlebetween the magnets (. Fig. 3) and thevenous device has an arcuate electrodethat ideally should perfectly sit in theceramic saddle.

Preoperative ultrasound is used to de-termine whether an ulnar or radial anas-tomosis is to be placed. Decisive are herethe caliber of the vessels and the config-uration of the perforating vein. At thesame time the access site is determined.The newer 4Fr system enables a wristaccess either from the radial or the ulnarside if the diameters of the vessel are suf-ficient, otherwise access via the brachial

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vessels is performed. As in the case of theEllipsys system(AvenuMedical, San JuanCapistrano, CA,USA) a venous punctureof the superficial upper arm veins withsubsequent navigation via the perforat-ing vein into the deep venous system ispossible.

The procedure usually starts witha light sedation of the patient followedby local anesthesia at the puncture site.The arm to be treated is placed and fixedon a carbon arm board transparent toimaging to prevent movement due tomyoclonus triggered by radiofrequencyimpulse-induced neurostimulation dur-ing energy delivery (more frequent andmore severe in creation of an ulnar fistuladue to proximity of the medial nerve).Following duplex sonography-guidedpuncture 0.014′′ guidewires are insertedin both vessels up to the planned siteof the anastomosis. The two cathetersare positioned via these wires and flu-oroscopic imaging is used to check thecorrect positioning and coaptation.

The preset high-frequency (HF) en-ergy of 60W is applied bymanual controland a preprogrammed timer for 0.7 s tocreate the endoAVF. The created anasto-mosis always has the same dimensionswith the size and length of the saddleon the arterial catheter (approximately4mm in length and 1mm wide). No im-plant or suture material remains at theendoAVF site.

» The introduction of the 4Frsystem more than halved theradiation exposure

The result is documented by angiogra-phy. In these procedures a pronouncedintraoperative vessel spasm is often seenafter HF application (see . Fig. 4), pos-sibly triggered by thermal effects, smallhematomas or electrical stimulation thatcan usually no longer be detected in theearly postoperative phase. In most pro-cedures a coil embolization of the deepbrachialvein(. Fig. 2) isperformedprox-imal to the anastomosis and the perfo-rating vein to increase the outflow intothe superficial venous system. The an-ticipated venous congestion triggered bythis procedure has so far only been seen

Abstract · Zusammenfassung

Gefässchirurgie 2019 · 24 (Suppl 1):S25–S31 https://doi.org/10.1007/s00772-018-0500-y© The Author(s) 2019

T. Steinke · J. Rieck · L. Nuth

Endovascular arteriovenous fistula for hemodialysis access

AbstractBackground. Hemodialysis arteriovenousfistulas (AVFs) are inconstantly used primarilydue to problems with maturation, earlythrombosis and patient nonacceptance. Anendovascular approach to fistula creationwithout open surgery offers anotherhemodialysis vascular access option.Methods. Published studies as well as ourown clinical experienceand remarkable singlecenter cases are analyzed. Basic literature isreported and expert opinions are discussed.Results. AVFs with fused anastomoses (AvenuMedical, Ellipsys) were created in 95.0%(102/107) of patients. Primary flow anddiameter endpoints were achieved in 86.0%(92/107) of patients. In the NEAT study (NovelEndovascular Access Trial, using the everlinQ6Fr system), 80 patients were enrolled. In theEASE study and in all of our patients (accessfrom the wrist) using the novel 4 Fr everlinQ

system, an endoAVF was successfully created.Due to the unique anatomy and vessels usedto create endoAVFs, those studieswere single-arm studies without a surgical comparator.Conclusions. An endoAVF can be reliablycreated using different catheter-basedsystems, without open surgery and withminimal complications. EndoAVFs can besuccessfully used for hemodialysis anddemonstrated a high 12-months cumulativepatency in several studies. In the future, itmay be an alternative for achieving AVFs forhemodialysis patients in need of a vascularaccess.

KeywordsArteriovenous fistulas · Hemodialysis ·Catheter · Anastomosis, arteriovenous ·Dialysis

Endovaskuläre Anastomosetechniken in der Shuntchirurgie

ZusammenfassungHintergrund. Chirurgisch angelegtearteriovenöse (AV-)Fisteln zur Hämodialyseentwickeln sich gelegentlich zögerlich oderreifen nach ihrer Anlage nur unzureichendaus. Dazu kommen Frühverschlüsse,überwiegend aufgrund lokaler anastomo-sennaher Thrombosen. Die Akzeptanz derterminal niereninsuffizienten Patienten fürwiederholte chirurgische Prozeduren istgering. Die endovaskuläre Anlage der AV-Fisteln, ohne offen operativen Eingriff, kanneine Alternative darstellen.Methode. Wir berichten über unsereeigenen klinischen Erfahrungen, die aktuelleStudienlage und den direkten internationalenAustausch der Anwender der verschiedenentechnischen Systeme.Ergebnisse. Die „Fused-anastomoses-Technik“ (Ellipsys®, Avenu Medical, San JuanCapistrano, CA, USA) war in 95,0% (102/107)bei der Anlage von endovaskulären AV-Fisteln(endoAVF) erfolgreich. In der NEAT-Studie(„Novel Endovascular Access Trial“, everlinQ™6Fr-System, TVA medical, Austin, TX, USA)wurden 80 Patienten eingeschlossen. In der

EASE-Studie („Endovascular Access SystemEnhancement“) und bei unseren Patientenmit radialem Zugang konnte mit dem neuen4Fr-everlinQ™-System bei allen Patientenerfolgreich eine endoAVF angelegt werden.Aufgrund der besonderen anatomischenAnforderungen sind diese Studien durchihren Single-arm-Charakter und die fehlendechirurgische Vergleichsgruppe in der Aussagenoch limitiert.Schlussfolgerung. EndoAVF können mithoher Erfolgsquote und niedriger Komplika-tionsrate angelegt werden. Die erwähntenStudien zeigen auch nach 12 Monaten einegute funktionelle primäre und kumulativeOffenheitsrate. EndoAVF stellen, bei zu er-wartender weiterer technischer Entwicklungund Verbesserung der Kathetersysteme, inder Zukunft eine mögliche Alternative zuchirurgischen AV-Fisteln dar.

SchlüsselwörterArteriovenöse Fisteln · Hämodialyse ·Katheter · Anastomose, arteriovenös · Dialyse

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Arterial catheter

Venous catheterCoil

Anastomosis

a b

Fig. 39 EverlinQ4™/endoAVFplacement viaa radial artery access.a Catheter in target posi-tion. b Successful endoAVFwith coil in the deep ac-companying vein

AnastomosisCephalic vein

Basilic vein

Perforating vein

Vascular spasmBrachial artery

Left upper arm

Vascular spasm

Brachial artery

Ulnar artery

Radial artery

Basilic vein

Anastomosis

Perforating vein

Left upper arm

Fig. 48 Typical vascular spasm following administration of high-frequency energy

in a mild form in 1 of the 26 patientstreated so far. Other publications havealso not reported comparable problemsregarding this issue [6, 7, 11, 14, 17].

Although many steps in this pro-cedure can be carried out by ultra-sound guidance, angiographic imagingis still required. In the series withthe 6Fr system, the average area-doseproduct was 2.15Gy/cm2 (minimum0.82Gy/cm2, maximum 4.89Gy/cm2,median 1.77Gy/cm2). The introductionof the 4Fr system more than halved theradiation exposure with an average area-dose product of 0.91Gy/cm2 (minimum0.41Gy/cm2, maximum 1.74Gy/cm2,median 0.78Gy/cm2). Radosa et al. re-ported values almost 20 times higherwith the same procedure (6Fr) whereamean area-dose product of 46.4Gy/cm2

was reported [16], which is a higher ex-posure dose than in diagnostic coronaryangiography (27.2Gy/cm2) and percu-taneous transluminal angioplasty (PTA,25Gy/cm2) but a lower exposure dosethan in percutaneous coronary interven-

tions (56.8Gy/cm2) or a PTA with stentimplantations (97Gy/cm2) [13].

The differences are so obvious thatthey cannot simply be explained by theintensive intraoperativeuseofultrasoundalone.

Clinical results of the everlinQ™/WavelinQ system

The first clinical results of this procedurehave been compiled in the FLEX study,a prospective clinical evaluation of to-tal vascular access (TVA). Technical suc-cess was achieved in 32 out of 33 cases(97.0%). In 96.0% of the patients, theshunt was matured after 3 months andcould be used for dialysis [17]. In themultinational and multicenter novel en-dovascular access trial (NEAT) follow-up study, 80 patients (20 roll in, 60 inthe analysis) were treated with the 6Frsystem and analyzed. A high techni-cal success rate (98%) and usability ofthe fistula (functional patency 87%) wasachieved [11]. TheEASE study reporting

data from the newer 4Fr system has onlybeen presented at the time of publicationof this article (a publication is in prepara-tion). All patients successfully receivedan endoAVF ([22]; . Table 1).

Ellipsys® system

The Ellipsys® system from Avenu Medi-cal (. Fig. 5) creates an endoAVF usinga single 6Fr catheter that thermally con-nects the vessels. The suitability andthe strategic procedure for this systemare also determined sonographically.Dr. A. Mallios, with great personalexperience in Paris (personal communi-cation) and Avenu Medical, describe theprocedures that were performed guidedonly by ultrasound and therefore withoutradiation exposure and contrast media.This procedure starts with a punctureof a superficial vein (either cephalic orbasilic vein) on the upper arm to navi-gate from there through the perforatorto the deep venous system. With theaid of ultrasound the radial artery is

S28 Gefässchirurgie · Suppl 1 · 2019

Table 1 Overview of the endovascular anastomosis techniques

EverlinQ™/WavelinQ Ellipsys®Number of nec-essary vascularaccesses

2 1

Possibleanastomosislocations

Ulnar vein/ulnar artery Perforating vein/radial artery

Radial vein/radial artery

Brachial vein/brachial artery

Access route Via brachial artery and vein to-wards elbow

Direct puncture via the perforatingvein

Via brachial artery and basilic veintowards elbow

Via brachial artery and cephalicvein towards elbow

From wrist via radial artery andradial vein

From wrist via ulnar artery andulnar vein

Or alternatively in rendezvousprocedure from proximal and distal

Additional inter-ventions in theprimary proce-dure

If necessary coiling of the deepvein proximal to the anastomosis

Regular PTA of the anastomosis withthe perforating veinCoiling of the deep vein proximal tothe anastomosis only in exceptionalcases

Technical success 98% in NEAT 95% in PIVOTAL trial

97% in FLEX 88% in TRAD trial

Cumulativepatency

84% in NEAT 12 months 86.7% in PIVOTAL trial 12 months

96.2% in FLEX 6 months 75% in TRAD trial 12 months

Functionalpatency

92% in NEAT 12 months 92.3% in PIVOTAL trial 12 months

n.r. in FLEX 75% in TRAD trial 12 months

n.r. not reported, PTA percutaneous transluminal angioplasty

localized from the vein and puncturedand a guidewire is placed distally in theartery. The Ellipsys® device is insertedvia the 0.014′′ guidewire and advancedto the defined target region. The catheterhas two contact plates, of which one isplaced in the vein and the other in theartery. The anastomosis is created byelectrical impulses of up to 15 s before thesystem is removed and the success cannow be checked with either ultrasoundor angiography.

An immediatePTAof theanastomosisand the perforating vein is increasinglybeing carried out. In this respect there isa significant difference between the twosystems: while PTA is possible or evenrecommendedusing the Ellipsys® system[14], for the everlinQ™ system a postpro-cedural PTA cannot be recommended atany time because directly after creationthe anastomosis is still too fragile.

Clinical results of the Ellipsys®system

The first published study with theEllipsys® device showed a technicalsuccess rate of 88.0% (23 out of 26 pa-tients). Of these endoAVFs 22 werepatent after 6 weeks with an averagetime to starting dialysis of 108 days. Toimprove maturation of the shunts, 48%of the patients had to be treated with anadditional PTA [6].

» These methods potentiallyprovide economic benefits

The second published paper describedthe American approval study at five cen-ters in the USA. In 95.0% of the patients(102 out of 107 in total) an endoAVFwas successfully created. Severe adverse

events were not observed and a 2-needledialysis could be achieved in 88.0% of thepatients. In this study additional inter-ventions were also necessary in 99 pa-tients. A total of 205 were necessaryto enable maturation of the shunt, in-cluding 113 PTAs of the anastomosis in77 patients, 42 coil embolizations of thedeep venous system in 34 patients, 34 cu-bital vein occlusions were carried out in33patients (17 ligatures and17 emboliza-tions), side branches of accessory super-ficial veins were embolized 40 times in37patientsand28surgical transpositions.In order to maintain primary and func-tional patency another 66 interventions,including 51 PTAs, 10 embolizations and8 stents (multiple mentions) were per-formed in 36 patients. Among thesea functional patency of 98.4%, 98.4%and 92.3% was described after 90, 180and 360 days, respectively [7]. In 2018Mallios et al. reported similar results in34 patients, with a technical success of96% and a cumulative patency rate of92% over an average follow-up period of141 days (53–229 days) [14].

Both technologies are currently be-ing further evaluated in postcommercialregistries and/or monocentric surveys inEurope. The aim is not only to ensurecontinuous proof of the feasibility andeffectiveness of the methods but also toexamine the economic benefits that thesemethods potentially provide.

Both the Ellipsys® and the everlinQ™(6Fr) system devices received U.S. Foodand Drug Administration (FDA) ap-proval on 22 June 2018 and are thereforecommercially available in the USA [23].

The company TVA Medical was ac-quired by BectonDickenson (BD) in July2018 andwithin the framework of the in-tegration the catheter system is availableunder the new name of the WavelinQendoAVF system.

Economic considerations

Innovative procedures are often criti-cised for the high costs. Also, with theendoAVF procedures, the initial costsfor the catheters are significantly highercompared to surgical AVF creation.In Germany, the everlinQ procedurehas a new investigation and treatment

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Fig. 59 Placement of theendoAVFwith the Ellipsys®device. a Puncture of theradial artery via the perfo-rating vein,bplacementof thewire and the sheath,c the contact plates gripboth vessel walls,d directcurrent creates the anas-tomosis. (reproducedwithkind permission of AvenuMedical. This figure is notpart of the OpenAccessagreement)

method (NUB) status 1 since 2016,whichallows hospitals to negotiate a dedicatedreimbursement with the health insur-ance companies for this procedure. Thisstatus 1 is only granted when the costdeficit for such new procedures with thecurrently available codes within in thediagnosis-related groups (DRG) systemis so large that an additional budgetmust be negotiated. Since 2018 bothprocedures can be documented withan individual procedural code (codes8-83c.c and 8-83c.d) but only the ever-linQ method still has the NUB status 1[4].

Introducing a new medical techni-cal device onto the market requires im-mense financial and administrative ef-forts in order to make the new productmarketable and takes many years. Theselling price must also justify the treat-ment in the healthcare system froma costefficiency perspective. The everlinQ de-vice was analyzed under this aspect in2017. Yang et al. [25] compared theresults of the NEAT study with an his-torical cohort from American insurancedata that showed pretty much the samepatient demographics. More than 1 yearafter surgical and endovascular creationof an AV fistula the complications, re-

interventions and central vein catheter(CVC) exposure times were compared.Significantly lower rates of angioplasty,thrombectomy, surgical revision, CVC,grafts, new fistula creations and access-related infections in the endoAVF groupled to a saving benefit of over US$11,000compared to conventional surgical cre-ation of AV access.

Conclusion

An EndoAVF can even now be createdwith a higher success rates and low com-plication rates. Under study conditionsand with appropriate patient selection,both commercially available catheter sys-tems demonstrated high functional pri-mary and cumulative patency rates evenafter 12 months. It appears that themarginally lower AV fistula flow vol-umes distributed over a greater outflowarea bring positive effects to the long-term function and secondary degenera-tion of the access stretch. In patients whono longer have superficial veins availabledue tomultiple intravenousaccesspoints,drug abuse, skin burns or a long historyof dialysis, an initial endovascular anas-tomosis of deep veins and arteries beforea planned elevation and/or transposition

is a very attractive scenario to addanativeoption to the AV access repertoire.

» An EndoAVF can now becreated with a higher successrates and low complication rates

The progressive technical developmentof catheter systems extends the possibil-ities for endovascular shunt placementand new less invasive options will con-tinue to be introduced. Germany hasa great standing for vascular treatment,so it is the perfect country to attract newtechnologies such as endoAVFwhich areminimally invasive, more cost-effectiveand lead to better quality of life for pa-tients and ultimately to avoid central ve-nous transient or long-term catheteriza-tion in hemodialysis patients. Nephrolo-gists and also well-informed patients arelooking for alternatives to the classicalsurgical AV fistula placement and thegruelling revision interventions.

Practical conclusion

4 For the standard placement of theendoAVF the perforating vein isindispensable.

S30 Gefässchirurgie · Suppl 1 · 2019

4 Two procedures are currently com-mercially available.

4 Ultrasound and a high-quality radio-logical imaging are necessary.

4 The technical success rates in thestudies were >90%.

4 Endovascular experience is recom-mended for the procedure.

4 The high material costs require anadditional remuneration (NUB).

4 The patient acceptance is good.4 The different shunt characteristics

necessitate a close cooperation withthe referring nephrologists.

Corresponding address

Dr. T. SteinkeKlinik für Gefäßchirurgie,Schön-Klinik DüsseldorfAm Heerdter Krankenhaus 2,40549 Düsseldorf, Germanyvascular-center-duesseldorf@gmx.de

Acknowledgements. The authors are grateful tothe companies for providing the graphic and imagematerial.

Compliance with ethicalguidelines

Conflict of interest. T. Steinke declares that hereceived travelling expenses and advisory fees fromBD/Bard, TVAMedical,Meritmedical. J. Rieck is anemployeeofAngioConsultGmbH,whichuntil recentlyundertook advisory activities for TVAMedical. L. Nuthdeclares that she has no competing interests.

This article does not contain any studieswith humanparticipants or animals performedby anyof the au-thors.

The supplement containing this article is not spon-soredby industry.

OpenAccess. Thisarticle isdistributedunderthetermsof the Creative CommonsAttribution 4.0 InternationalLicense (http://creativecommons.org/licenses/by/4.0/), which permits unrestricteduse, distribution,and reproduction in anymedium, provided yougiveappropriate credit to the original author(s) and thesource, providea link totheCreativeCommons license,and indicate if changesweremade.

Literatur

1. Al-Jaishi A, Oliver M, Thomas S, Lok C et al (2014)Patency rates of the arteriovenous fistula forhemodialysis: a systematic review and meta-analysis. AmJKidneyDis6(3):464–478

2. Berge MT, Yo T, Kerver A, Smet A, Kleinrensink G(2011) Perforating veins: an anatomical approachto arteriovenous fistula performance in theforearm. Eur JVascEndovascSurg42:103–106

3. Brescia M, Cimino J, Appel K, Hurwich B (1966)Chronic hemodialysis using venipuncture anda surgically created arteriovenous fistula. N Engl JMed275:1089–1092

4. Deutsches Institut für medizinische Dokumen-tationundInformation. (2018)www.dimdi.de

5. Gracz K, Ing T, Soung L, Armbruster K, SeimS, Merkel F (1977) Proximal forearm fistula formaintenancehemodialysis. Kidney Int11:71–75

6. Hull J, Elizondo-RiojasG, BishopW,Voneida-ReynaY (2017) Thermal resistance anastomosis devicefor the percutaneous creation of arteriovenousfistulae for hemodialysis. J Vasc Interv Radiol28:380–387

7. Hull J, JenningsW, Cooper R, Waheed U, SchaeferM, Narayan R (2017) The pivotal multicenter trialofultrasound-guidedpercutaneousarteriovenousfistula creation for hemodialysis access. J VascIntervRadiol29:149–158.e5

8. Interdisziplinäre Arbeitsgruppe zum Dialysezu-gang(2017)www.clarcert.com

9. Konner K (2003) The initial creation of nativearteriovenous fistulas: surgical aspects and theirimpact on the practice of nephrology. Semin Dial16:291–298

10. KrönungG(2011)Dialyseshunts. Thieme,Stuttgart11. Lok C et al (2017) Endovascular proximal forearm

arteriovenous fistula for hemodialysis access:results of the prospective, Multicenter NovelEndovascular Access trial (NEAT). Am J Kidney Dis70:486–497

12. Lozano RN (2012) Global and regional mortalityfrom 235 causes of death for 20 age groups in1990 and 2010: a systematic analysis for theGlobal Burden of Disease Study 2010. Lancet380:2095–2128

13. Majewska N, Blaszak M, Juszkat R, FrankiewiczM, Makalowski M, Majewski W (2011) Patients’radiationdosesduringtheimplantationofstentsincarotid, renal, iliac, femoral and popliteal arteries.Eur JVascEndovascSurg41:372–377

14. Mallios A, Jennings W, Boura B, Costanzo A,Borquelot P, Combes M (2018) Early results ofpercutaneous arteriovenous fistula creation withthe ellipsys vascular access system. J Vasc Surg.https://doi.org/10.1016/j.jvs.2018.01.036

15. Parodi JP (1991) Transfemoral intraluminal graftimplantationforabdominalaorticaneurysms. AnnVascSurg6:491–499

16. Radosa C, Radosa JC, Weiss N, Schmidt CS, WerthS, Hofmockel T, Plodeck V, Gatzweiler C, LaniadoM,HoffmannR (2017) Endovascular creation of anarteriovenous fistula (endoAVF) for hemodialysisaccess: first results. Cardiovasc Intervent Radiol40:1545–1551

17. Rajan D, Ebner A, Desai S, Cohn W (2015)Percutaneous creation of an arteriovenous fistulafor hemodialysis access. J Vasc Interv Radiol26(4):484–490. https://doi.org/10.1016/j.jvir.2014.12.018

18. SchonD(2007) Increasingtheuseofarteriovenousfistula in hemodialysis: economic benefits andeconomic barriers. Clin J Am Soc Nephrol2:268–276

19. Segerer K, Wanner C (2014) Niere und ableitendeHarnwege. Springer,Heidelberg,Berlin

20. Shenoy S (2009) Surgical anatomy of upper arm:what is needed for AVF planning. J Vasc Access10:223–232

21. Sidawy A, Gray R, Henry M, Ascher E et al (2002)Recommended standards for reports dealingwitharteriovenous hemodialysis accesses. J Vasc Surg35:603–610

22. Steinke, T. (2018). Clinical experience and latestclinical datawith thenewestEndoAVF technology.PresentedatLINC2018,Feb1.

23. U.S. Food&Drug Administration (2018) www.fda.gov

24. Vascular Access Group (2006) Clinical practiceguidelinesfor vascular access. Am J Kidney Dis48:248–273

25. Yang S, Lok Ch, Arnold R, Rajan D, Glickman M(2017) Comparison of post-creation proceduresand costs between surgical and an endovascularapproach to arteriovenous fistula creation. J VascAccess18:8–14

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