Realizzazione per via endovascolare della fistola artero-venosa per emodialisi: esperienza di un singolo centro

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Valentina Pistolesi

DOI: 10.69097/42-05-2025-05

Valentina Pistolesi1, Pierleone Lucatelli2, Laura Zeppilli1, Mario Barile1, Laura Pedata1, Mario Corona2, Santo Morabito1

1 Hemodialysis Unit, Azienda Ospedaliero-Universitaria Policlinico Umberto I, “Sapienza” Università̀ di Roma, Rome, Italy
2 Interventional Radiology Unit, Azienda Ospedaliero-Universitaria Policlinico Umberto I, “Sapienza” Università di Roma, Rome, Italy

Corrispondenza a:
Valentina Pistolesi, MD, PhD
UOSD Dialisi, Azienda Ospedaliero-Universitaria Policlinico Umberto I,
“Sapienza” Università di Roma
Viale del Policlinico, 155
00161 Rome, Italy
E-mail: valentina.pistolesi@uniroma1.it
Phone: +39 06 49974263

 

Abstract

I sistemi endovascolari rappresentano una tecnica interessante per la creazione non chirurgica della fistola artero-venosa (FAV) per emodialisi. L’obiettivo era valutare efficacia e sicurezza dell’applicazione di un sistema endovascolare per la creazione di FAV nei pazienti con ESRD trattati nel nostro centro.
Metodi. Il controllo ecografico con Color Doppler è stato utilizzato per valutare i criteri anatomici di idoneità del paziente. È stato effettuato un accurato follow-up clinico e strumentale post-procedura.
Risultati. La FAV endovascolare (endoFAV) è stata creata con successo in 7 pazienti in assenza di complicanze perioperatorie. Nel corso di alcune procedure sono state eseguite embolizzazione della vena brachiale (n = 4) e angioplastica (n = 1) per deviare una maggiore quantità di flusso attraverso la vena perforante verso le vene superficiali (vene cefalica, cubitale mediana e/o basilica). Il controllo ecografico con Color Doppler ha mostrato flussi ottimali a 24 ore, 7 giorni, 30 giorni, 6 e 12 mesi. Tutte le endoFAV hanno soddisfatto i criteri di maturazione entro il primo mese e sono state incannulate con successo. I tassi di pervietà primaria a 4, 6 e 18 mesi sono stati rispettivamente 100%, 85.7% e 71.4%. Il tasso di pervietà cumulativa durante il follow-up (mediana 16 mesi) è stato del 100%. Durante il follow-up, 2 pazienti hanno richiesto interventi correttivi con un tasso di reintervento di 0.21 procedure per paziente/anno.
Conclusioni. Lo studio conferma la sicurezza e l’efficacia di questa tecnica alternativa per la creazione della FAV. L’implementazione di un team ben preparato, che includa nefrologi e radiologi interventisti, è fondamentale per confezionare e mantenere una endoFAV ben funzionante.

Parole chiave: fistola arterovenosa, endovascolare, emodialisi, percutaneo, accesso vascolare

Ci spiace, ma questo articolo è disponibile soltanto in inglese.

Introduction

The choice of the optimal hemodialysis vascular access is part of the “action plan” that should be proposed and individualized for each patient with progressive chronic kidney disease (CKD) and/or with estimated glomerular filtration rate (eGFR) between 15 and 20 ml/min/1.73 m2 (End-Stage Kidney Disease Life-Plan) [1]. Timely planning and performing vascular access are crucial to obtain a functional hemodialysis access, essential for delivering adequate dialysis, and to avoid the risk of complications related to the use of temporary central venous catheters (CVC), thus limiting the need for subsequent interventions [1, 2].

In recent years a promising option for the creation of the arteriovenous fistulas (AVF) for hemodialysis derives from the implementation of 2 innovative techniques: percutaneous (Ellipsys) or endovascular (WavelinQ) [3, 4].

By using these systems, the site of AVF creation is in the proximal forearm. Indeed, both methods take advantage of the perforating vein as a connection between the deep venous circulation and the superficial venous circulation. Although the 2 techniques use a different approach to create an AVF, both have shown promising results in terms of maturation rate and subsequent use [3, 5–11]. The WavelinQ device (BD Medical, previously EverlinQ TVA) is a system of specific 4Fr arterial and venous catheters (Figure 1) guided inside the vessel under fluoroscopy that, by using radiofrequency (RF) energy, creates an arteriovenous communication in the deep circulation of the proximal forearm. The arterialization of the superficial veins occurs through the perforating vein [7, 12]. The choice of the WavelinQ technique includes a preliminary phase of careful evaluation of the patient aimed at assessing his eligibility to endovascular AVF (endoAVF) creation with this specific system. For this purpose, an accurate mapping through color Doppler ultrasound is crucial to ensure that the anatomical criteria essential for creating the endoAVF are met [6, 7].

The aim of the study was to evaluate the preliminary data about the feasibility, the efficacy, and the safety of the application of the WavelinQ technique to perform an endovascular AVF (endoAVF) in patients with end-stage kidney disease (ESKD) undergoing hemodialysis at the Dialysis Unit of the Policlinico Umberto I Hospital, Rome, Italy.

Figure 1. Main components of venous and arterial catheters of the WavelinQ device.
Figure 1. Main components of venous and arterial catheters of the WavelinQ device.

 

Patients and Methods

We performed a single-center retrospective analysis of ESKD patients who underwent endoAVF creation with the WavelinQ system between May 2023 and September 2024 at the Interventional Radiology Unit of the Policlinico Umberto I Hospital (Rome, Italy). Main data were prospectively recorded and retrospectively analyzed.

The technical success was defined as the successful completion of the procedure, as well as the intraoperative control of the AVF blood flow by ultrasound. EndoAVF maturation was defined according to KDOQI 2019 criteria [1]. Perioperative complications have been defined as hand ischemia, bleeding, and infections.

The study was approved by the Territorial Ethical Committee of Lazio Area 1, Italy (No. 293/2025) on March 26, 2025. All participants provided written informed consent prior to participating.

Vascular mapping and procedure planning

To evaluate the eligibility of the patients for the creation of endoAVF, the vessels of both arms were accurately studied through a color Doppler ultrasound examination.

In particular, the potential access sites for the devices, the target vessels for the creation of the fistula, the presence and the adequacy of the perforating vein as a connection between the deep circulation and the superficial circulation, were carefully studied. Essential anatomical characteristics for WavelinQ system application are summarized in Figure 2. The patency and the depth with respect to the skin plane of any venipuncture sites (cephalic vein and/or basilic vein) were also evaluated. The WavelinQ system also requires that the distance between the ulnar or radial artery and their concomitant veins at the target fistula creation site is less than or equal to 2 mm. Finally, the presence of central venous stenosis and/or upper extremity venous occlusion on the same side as the planned AVF creation have been excluded. Depending on the access site considered suitable at color Doppler ultrasound examination, the parallel (same direction) or antiparallel (opposite direction) approach for the introduction of the 2 catheters has been scheduled.

Figure 2. Main eligibility criteria for endoAVF creation.
Figure 2. Main eligibility criteria for endoAVF creation. 

EndoAVF creation procedure

The procedure was performed in supine position and under local or brachial plexus block anaesthesia. The arm, which was designated for the endoAVF creation, was immobilized on a side table with the palm facing upward. Under ultrasound guidance, the arterial and venous catheters were percutaneously inserted. In the case of “parallel approach”, percutaneous access was obtained through the cannulation of the radial artery and its concomitant vein at the wrist or the brachial artery and its concomitant vein at the upper arm; in the case of “antiparallel approach”, the access was gained through the radial artery at the wrist while the brachial vein was accessed from the upper arm. By using fluoroscopy, the catheters advanced until the target creation site was reached (Figure 3a). Once placed in proximity, the magnets of the 2 catheters attracted each other, pulling the arterial and venous vessels closer together. After evaluating the correct alignment of the magnets (Figure 3b), it was possible to deliver the burst of RF energy (60 Watts for a duration of 0.7 seconds) through the electrode in the venous catheter, thus obtaining the communication between the artery and the vein. Then, an intraoperative arteriography was performed to verify the actual creation of the fistula (shunt of blood flow from the artery to the venous system) and to exclude any immediate complications such as blood extravasation or pseudoaneurysm formation. Moreover, the need to divert more flow through the perforator to the superficial veins (cephalic, median cubital and/or basilic veins) by embolization of the brachial vein (positioning of a coil) or by angioplasty of the outflowing veins (perforator vein, cephalic vein and/or basilic vein) was also assessed. Hemostasis after endovascular catheters removal was achieved through manual compression of the puncture sites (15 minutes for arterial access, 5 minutes for venous access).

Catheters advancement to the target creation site under fluoroscopic guidance
Figure 3 a) Catheters advancement to the target creation site under fluoroscopic guidance. In this case the “antiparallel approach” has been used (arterial access gained through the radial artery at the wrist, venous access obtained through the brachial vein from the upper arm). b) Fluoroscopic control of the correct alignment of the 2 magnets (yellow dashed rectangle). In both figures, the blue and red arrows indicate the venous and arterial catheter, while the blue and red asterisks indicate the venous and arterial rotational indicators, respectively.

Follow-up

The next phase involved short-term follow-up (24 hours, 7 days, 30 days) including blood flow rate measurement of the endoAVF by using color Doppler ultrasound, and medium- and long-term clinical/instrumental follow-up. Furthermore, timing of maturation and of venipuncture with 1 or 2 fistula needles were evaluated and recorded.

 

Results

The procedure was performed in 7 patients (6 male, 1 female) with ESKD. Main patients’ clinical characteristics are reported in Table I. Mean age was 53.9±21.6 years. Mean BMI was 28.3±6. Regarding timing for referral to the nephrologist, 3 (43%) patients were early-referral and 4 (57%) late-referral. Only one early-referral patient met clinical indications to begin renal replacement therapy before the creation of the endoAVF and thus a temporary vascular access (jugular CVC) was placed. All late-referral patients already had temporary or tunnelled CVC at the time of endoAVF creation.

The selected arm was non-dominant in 6 patients and dominant in 1 patient, due to the absence of anatomical eligibility criteria for the WavelinQ technique in the non-dominant arm. In only one case the AVF was performed on the side where the jugular CVC had previously been positioned; however, imaging confirmed the absence of central stenoses at the time of the procedure.

Table II shows the main anatomical characteristics recorded during pre-operative vascular mapping. Local anaesthesia was performed in 3 patients (43%), while brachial plexus anaesthesia was performed in 4 (57%). In 5 patients the approach was parallel (4 retrograde, 1 antegrade); in the remaining 2 patients an antiparallel approach was necessary (Table III). In all cases, the radial artery was chosen, and the anastomosis was created between the proximal radial artery and the lateral concomitant vein. The intraoperative arteriography confirmed the actual creation of the fistula in all patients. During the procedure, 4 patients (57%) underwent coil placement in the brachial vein, while intraoperative angioplasty was performed in 1 patient. No intra- or post-operative complications were observed (Table III). Mean duration of the procedure was 146 ± 35 minutes.

EndoAVF flows were monitored with color Doppler ultrasound over the brachial artery 24 hours, 7 days, 30 days, 6 and 12 months after the procedure (Table IV).

All patients met KDOQI maturation criteria within 1 month. EndoAVF venipuncture times were 53.6 ± 19 days (median 51) from the date of endoAVF creation (n = 5). In 2 early-referral patients on conservative therapy, the endoAVF was mature and adequate for venipuncture when the indication to start hemodialysis treatment was made. After the first month from the start of cannulation all endoAVF was deemed successfully used for hemodialysis (FUSH) [13].

The average follow-up time was 12.6 ± 6.2 months (median 12, range 5-21). Primary patency rates at 4, 6 and 18 months were 100%, 85.7%, and 71.4%, respectively. Cumulative patency rate during the entire follow-up period was 100%. During follow-up, 2 patients (29%) required corrective interventions with a re-intervention rate of 0.27 procedures per patient year (Table IV). In one case, due to the excessive flow dispersion in the deep circulation, embolization of the lateral brachial concomitant vein was needed approximately 15 months after endoAVF creation. The second patient underwent thrombectomy along with simultaneous percutaneous transluminal angioplasty (PTA) for venous side stenosis approximately 5 months after the endoAVF was performed (Table IV).

Age, years 53.9 ± 21.6
Male gender 6 (86%)
Smokers 2 (29%)
BMI 28.3±6
Diabetes mellitus 3 (43%)
Hypertension 5 (71%)
Patients on conservative medical therapy 2 (29%)
Patients already undergoing hemodialysis 5 (71%)
Early-referral 3 (43%)
Late-referral 4 (57%)
Previous vascular access
– Temporary contralateral trans-jugular CVC 2 (29%)
– Long-term ipsilateral trans-jugular CVC 1 (14%)
– Long-term contralateral trans-jugular CVC 1 (14%)
– Femoral CVC 1 (14%)
– No previous vascular access 2 (29%)
Table I. Main clinical characteristics of the patients (n=7). Continuous variables expressed as mean±SD; categorical variables expressed as n (%). CVC: central venous catheter.
PATIENT ID 1 2 3 4 5 6 7
Cephalic vein (mm)
Diameter/depth		 D d D d D d D d D d D d D d
· Proximal <2.5 n.a. 3.4 2.4 <2.5 n.a. <2.5 n.a. 3 4.8 2.5 6 <2.5 n.a.
· Middle <2.5 n.a. 3.6 2.3 <2.5 n.a. <2.5 n.a. 2.7 2.7 2.5 6 <2.5 n.a.
· Distal <2.5 n.a. 3.8 2.2 <2.5 n.a. 3.5 3.5 3.2 2.9 2.5 1.9 <2.5 n.a.
Basilic vein (mm)
Diameter/depth		 D d D d D d D d D d D d D d
· Proximal 6 6.7 7 14 2.5 6 6 11 5.2 1.5 2.5 6 4.1 6
· Middle 5.8 5.9 7 10 3.2 7.7 5.5 2.8 2.9 6 2.5 6 4 6
· Distal 6.7 4.1 5 11 3 2 4 3.8 3 3.2 3.2 4.1 4 4
Brachial artery
· Diameter (mm) 3.7 5 5.3 5.8 4.7 5 5
· Bifurcation
(above/below elbow)		 below below below below below below below
· Triphasic flow Yes Yes Yes Yes Yes Yes Yes
Perforating vein
Patency Yes Yes Yes Yes Yes Yes Yes
Diameter (mm) 2.8 2.4 2.9 3.3 3.5 3.6 3.8
Connection L.R.V. L.R.V./M.R.V. L.R.V. L.R.V. L.R.V. L.R.V./M.R.V. L.R.V./L.U.V.
Table II. Anatomical characteristics resulting from pre-operative vascular mapping. L.R.V.: Lateral radial vein; M.R.V.: Medial radial vein; L.U.V.: Lateral ulnar vein. n.a.: not applicable (depth not assessed in the case of inadequate vessel diameter).
PATIENT ID 1 2 3 4 5 6 7
Devices access sites
Radial artery diameter (mm) wrist 2.4 2.6 3.2 2.8 2.2 2 2.5
Lateral radial vein diameter (mm) <2 <2 <2 <2 2.2 2.1 2
Medial radial vein diameter (mm) <2 <2 <2 <2 2.2 2 <2
Brachial artery diameter (mm) 3.7 5 5.3 5.8 4.7 5 5
Lateral brachial vein diameter (mm) 3.7 3.5 <2 4.8 2.5 5 5
Medial brachial vein diameter (mm) 2 2.2 3.4 4.8 <2 <2 2.5
Creation site
Radial artery diameter (mm) 2.5 3 3.5 2.2 2.2 2.9 3.2
Lateral radial vein diameter (mm) 2.5 3.1 2.4 3.5 2.6 2.3 3
Medial radial vein diameter (mm) 4.8 <2 <2 3.6 <2 2.9 2
Intraoperative variables
Parallel/Antiparallel approach A A P P P P P
Intraoperative embolization No No Yes No Yes Yes Yes
PTA No Yes No No No No No
Complications No No No No No No No
Table III. Anatomical characteristics of endoAVF devices access sites, creation site, and intraoperative variables. PTA: percutaneous transluminal angioplasty
Blood flow rates (ml/min) measured at brachial artery
PATIENT ID 1 2 3 4 5 6 7 N=7
24 hours 550 600 800 750 360 450 450 566±163
7 days 1000 750 950 900 1200 600 450 836±254
30 days 1100 850 1000 900 1200 650 600 900±222
6 months 1000 700 1000 700 1100 1000 800 900±163
12 months 1200 700 1000 800 1100 1100 n.a. 983±194
Need for corrective interventions and timing from endoAVF creation
PATIENT ID 1 2 3 4 5 6 7
Procedure No Yes Yes No No No No
Coiling – 15 months – – – – –
PTA – – 5 months – – – –
Thrombectomy – – 5 months – – – –
Table IV. Blood flow rates and need for corrective interventions during the follow-up period. Data expressed as mean ± SD. PTA: percutaneous transluminal angioplasty. n.a.: not applicable

 

Discussion

The arteriovenous fistula represents the vascular access of first choice for ESKD patients requiring hemodialysis [1, 2]. In recent years, two different techniques have been proposed to create a fistula in the proximal forearm percutaneously without the need for a surgical incision [3, 4]. Among these non-surgical AVF creation options, the WavelinQ EndoAVF System is indicated to perform an arteriovenous connection between the radial artery and its concomitant vein or the ulnar artery and its concomitant vein in patients with well-defined anatomical characteristics. From the anastomosis the blood flows through the perforating vein into the superficial circulation, thus allowing the arterialization of cephalic and/or basilic vein.

Our preliminary experience allows to confirm the efficacy and safety of the endovascular procedure by using the WavelinQ System. Indeed, in the first 7 patients who underwent the procedure of endoAVF creation at our center the technical success was 100%. During the observation period (>12 months in 4 cases and >5 months in the remaining patients) primary and cumulative patency rates were 71.4% and 100%, respectively. Moreover, no peri-operative complications such as vascular lesions or arm ischemia occurred. Although obtained in a limited sample of patients, these findings agree with literature data [8, 11, 14, 15]. For example, in a study of pooled data from three prospective, multicenter, single-arm trials procedural success was achieved in 116 patients (96.7%), while the primary and secondary patency rates were 71.9% and 87.8% at 6 months, respectively [8]. More recently, in a prospective, single-center study including a total of 20 patients, technical success was 100% in absence of serious adverse events; at 6-month follow-up, the primary and cumulative patency rates were 65% and 75%, respectively [11]. Moreover, Inston et al, comparing a single-center series of WavelinQ endoAVF with a matched series of surgically created radiocephalic AVF, reported a significantly greater mean primary patency in the endoAVF group (362 ± 240 vs 235 ± 210 days, p<0.05) [14].

Pre-operative vessel mapping is an important step in identifying patients who can successfully undergo an endoAVF procedure. Thus, an accurate ultrasound examination plays a key role to assess the presence of the specific anatomical characteristics required to create a well-functioning fistula by using this system. For this purpose, we have implemented a well-trained specialized team including nephrologist and interventional radiologist to take advantage of their specific skills in the crucial phase of patient’s selection. Moreover, it is well recognized that this collaboration is also essential to achieve and maintain a functional AVF. Starting from this assumption, at our hospital, during the intraoperative phase nephrologists and interventional radiologists together evaluate the need for further intraprocedural interventions aimed at diverting greater blood flow towards the superficial veins. Thus, in our experience, 5 out of 7 patients underwent coil placement in the brachial vein or intraoperative angioplasty. These procedures facilitated the maturation of the endoAVF and possibly contributed to limit the need for subsequent re-interventions. In our patients, procedures aimed at maintaining the patency of the access and strengthening the inflow and outflow, were necessary in only 2 cases. In this regard, the need for subsequent procedures to facilitate the maturation of the AVF, intended as PTA or coiling on deep circulation veins, has been reported in few cases also by other authors. Indeed, data published so far seems to show that, compared to the surgical approach, the WavelinQ technique requires fewer re-interventions, thus compensating potential higher initial costs [16–18]. In particular, in a propensity score study matching 60 endoAVF with 60 surgical AVF patients, Yang et al found that the endoAVF group required significantly fewer post-creation procedures with consequently lower mean costs within the first year [16]. Furthermore, a cost-effectiveness and budget impact analysis, conducted in hemodialysis patients from the prospective of the Italian Healthcare Service, suggested that endoAVF could be a cost-saving strategy compared to surgical AVF creation [18].

Post-procedure follow-up is an essential component in access management. Indeed, regular follow-up makes it possible to verify that the endoAVF is properly working to deliver adequate dialysis and to timely identify the need for corrective measures, thus allowing to significantly increase the AVF lifespan. The follow-up phase involves careful routine monitoring even in the period following the start of endoAVF venipuncture. The role of the nephrologist become central when maturation is completed and endoAVF can begin to be used. To minimize the failure risk of the first venipunctures, the right approach is to identify possible sites for correctly positioning the needles through ultrasound evaluation. A good practice is to assign an experienced operator (physician or nurse) to perform the first cannulations. In our experience, within the first 4 weeks from the start of venipuncture, all endoAVF were considered successfully used for dialysis, that is, they were used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month, delivering the prescribed dialysis within the prescribed time frame [13].

In our opinion, endoAVF appears to offer an interesting opportunity among vascular access creation options. The use of the deep circulation expands the anatomical options for the creation of AVF, preserves the patient’s venous circulation without precluding any subsequent endovascular or surgical approach [14]. It should also be considered that the anastomosis is performed without dissection and traumatism of the vessels and surrounding tissues, with a possible lower predisposition to a subsequent development of aneurysms and venous stenosis [15, 19]; the former are often a cause of discomfort for patients. Moreover, the minimally invasive technique does not produce surgical scarring that could disfigure the arm. In this regard, an aspect that should not be overlooked is patient satisfaction [20]. In fact, in the examined cases the endoAVF had minimal aesthetic impact and no patient complained of symptoms (e.g., pain, paresthesia) or functional limitation of the affected arm.

 

Conclusion

This study, although it includes a limited number of patients and it is characterized by a relatively short follow-up period, confirms that the WavelinQ technique, if performed by operators well-trained in performing and monitoring of endoAVF, could be considered safe and effective. This innovative and constantly evolving technique adds a further option in the choice of optimal vascular access for the hemodialysis patient with the aim of ensuring ever greater personalization of therapeutic choices.

 

Bibliography

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Salvataggio nella fistola in caso di ischemia distale o alta portata. Revisione della letteratura delle tecniche chirurgiche ed endovascolari con proposta di algoritmo decisionale

Pubblicato il Scarica PDF

Marco Taurisano

DOI: 10.69097/42-01-2025-06

Marco Taurisano¹, Cosma Cortese², Andrea Mancini³, Marcello Napoli⁴

1 UO Nefrologia e Dialisi, Ospedale “Santa Caterina Novella”, Galatina, Lecce
2 UOC Nefrologia, Dialisi e Trapianto Policlinico di Bari
3 UOC Nefrologia e Dialisi, Ospedale “Di Venere”, Bari
4 UOC Nefrologia e Dialisi, Ospedale “Vito Fazzi”, Lecce

Corrispondenza a:
Marco Taurisano
UO Nefrologia e Dialisi, Ospedale “Santa Caterina Novella”, Galatina, Lecce
Via Roma, 73013 Galatina LE
Cell. +39 3801843301
E-mail: taurisanomarco@tiscali.it

 

Abstract

La fistola artero-venosa (FAV) rappresenta l’accesso vascolare di scelta per i pazienti in emodialisi cronica, grazie alle minori complicanze infettive e trombotiche, alla ridotta morbidità e mortalità e alla maggiore durata rispetto ai cateteri venosi centrali. Tuttavia, l’allestimento di una FAV sta diventando sempre più ostico a causa dell’aumento della prevalenza di malattie croniche come il diabete, l’ipertensione e le patologie cardiovascolari, principali cause di insufficienza renale allo stadio terminale. Queste comorbidità, insieme all’invecchiamento della popolazione in dialisi, hanno portato a un incremento delle malattie vascolari periferiche, complicando la gestione delle FAV. Questo lavoro discute due principali complicazioni delle FAV: l’Ischemia Distale (HAIDI) e la FAV ad alta portata. L’HAIDI è caratterizzata da ischemia distale dovuta a una ridotta perfusione capillare, che può portare a esiti gravi come necrosi tissutale e amputazioni digitali. Circa il 5% dei pazienti in emodialisi con FAV sviluppano HAIDI, richiedendo trattamenti correttivi. Le FAV ad alto flusso, definite da un flusso sanguigno eccessivo che altera la dinamica circolatoria complessiva, rappresentano un’altra sfida significativa, soprattutto nei pazienti con compromissione cardiovascolare. La gestione di queste complicazioni è complessa e spesso richiede tecniche specializzate per preservare la FAV ed evitare la sua chiusura. Questa rassegna presenta tecniche sia chirurgiche che endovascolari per ridurre il flusso delle FAV e migliorare la perfusione distale. Le tecniche discusse includono approcci sul versante venoso della FAV come la legatura, la plicatura, il banding, l’interposizione di innesti protesici e vari interventi arteriosi come la legatura dell’arteria radiale distale o la sua embolizzazione. Inoltre, la rassegna presenta tecniche per il rimodellamento dell’anastomosi, offrendo approcci innovativi nella gestione delle complicazioni delle FAV. La rassegna si conclude con la proposta di un algoritmo decisionale per guidare i clinici nella selezione degli interventi più appropriati in base alle specifiche complicazioni legate alla FAV, assicurando i migliori esiti per i pazienti in emodialisi. Questa panoramica sottolinea l’importanza di strategie terapeutiche personalizzate nella gestione delle complicazioni delle FAV.

Parole chiave: fistola ad alto flusso, HAIDI, FAV, chirurgia, endovascolare

Ci spiace, ma questo articolo è disponibile soltanto in inglese.

Introduction

The preferred vascular access in chronic hemodialysis patients is represented by arteriovenous fistula (AVF), considering lower incidence of infectious and thrombotic complications, reduced morbidity and mortality, and longer durability compared to central venous catheters [1, 2]. However, currently, setting up AVFs with native vessels is becoming increasingly challenging due to the increasing prevalence of chronic diseases such as the leading causes of end-stage renal disease (ESRD) (diabetes, hypertension, heart diseases) coupled with the aging of the dialysis population, resulting in an increase in peripheral vascular diseases [3]. In this scenario distal fistulas are often created in patients with advanced peripheral vascular diseases or proximal fistulas. The major issues in such conditions, as known, are represented by distal ischemic syndrome associated with hemodialysis access (Hemodialysis Access-Induced Distal Ischemia – HAIDI) and high-flow AVF.

HAIDI is characterized by the onset of ischemia of varying severity at the extremities of the limb where the AVF is present due to reduced capillary perfusion caused by reduced blood arrival or resistance to its outflow [4]. This condition can occur acutely within a few hours after fistula creation (more frequently in grafts) with serious consequences up to possible loss of hand function. The chronic form (more commonly observed in AVFs with autologous vessels), albeit rare, is more common and usually of milder severity but can still result in tissue necrosis, sometimes necessitating digital amputations [5, 6]. It is estimated that about 5% of all hemodialysis patients with AVF develop distal ischemic syndrome requiring corrective treatment [7]. From an etiopathogenetic point of view, the involved mechanisms appear complex and not yet fully defined.

According to some authors, the main factor would be the drop in arterial pressures towards the hand due to a non-physiological readjustment of the arterial circulation after fistula creation (especially in patients with advanced vascular diseases due to diabetes, older age with severe atherosclerosis) with poor or absent remodeling, resulting in a progressive loss of perfusion pressures towards the periphery [8]. Healthy individuals’ arteries are sufficiently elastic and capable of initiating such remodeling, maintaining perfusion pressures downstream. Conversely, diabetic and vasculopathic patients often have high arterial wall stiffness or actual stenotic lesions, not guaranteeing adequate wall remodeling [9]. Another mechanism implicated to varying degrees in the determination of HAIDI is the “steal” phenomenon that physiologically occurs in AVFs created without terminalization of the artery. The principle underlying the determination of a retrograde (centripetal) flow from the hand to the anastomosis is related to the fact that the distal artery “prefers” to channel flow into a low-resistance district (the efferent vein) rather than a high-resistance district (the resistive arterial vessels of the hand). This mechanism occurs “physiologically” in all AVFs where the distal artery of the anastomosis is not terminalized. The steal becomes pathological, causing distal ischemia when it is quantitatively excessive, as in the case of high-flow AVFs with excessively large anastomoses (this is referred to as true steal) or in case of maladaptation of the distal arterial circulation as explained earlier [10]. Also, preexisting or subsequently formed proximal or distal arterial stenotic lesions in the AVF can be responsible for worsening distal ischemia after AVF creation [11, 12]. Finally, another cause of distal ischemia can be represented by venous blood stagnation in the hand caused by the presence of arterialized venous collaterals directed towards the hand or in the presence of venous outflow stenosis. This is referred to as stagnant venous ischemia [13]. From what has been said, the etiopathological mechanisms determining distal ischemia can be multiple and often concomitant and not always easy to identify (Table 1).

Mechanisms Causes
Proximal or distal preexisting arterial inflow reduction Arterial stenosis
Arterial system maladaptation Vasculopathy with calcification and increased arterial stiffness
True steel High flow fistula with big anastomosis
Stagnant venous ischemia Hand directed venous collaterals, outflow stenosis
Table 1. HAIDI etiopathogenesis. This table shows the main causes with the respective mechanisms underlying the development of distal ischemia in arteriovenous fistulas.

The definition of high-flow AVF varies and is ambiguous. Certainly, AVFs with high flow are those in which hemodynamics are influenced by blood flow far exceeding that required for hemodialysis, compromising overall circulatory dynamics [14]. The cardiovascular tolerance of a high-flow AVF is variable, with young patients able to tolerate flows of up to 3 liters per minute without hemodynamic compromise [15]. Some authors have identified a cut-off value between 1.5 and 2 l/min to define a high-flow AVF even in the absence of symptoms [16–18]. The Vascular Access Society indicates values above 1-1.5 l/min and associates an additional parameter, the “cardiopulmonary recirculation” (CPR), which is the ratio between the flow of the AVF and the cardiac output. When this index is >20%, there may be a risk of high-output decompensation. In short, it is not the absolute value of AVF flow that defines high flow but the ratio between its flow and the cardiovascular system’s capacity of that patient to maintain adequate cardiac output to manage the increased venous return without going into failure [19].

Distal ischemia and high-flow fistula conditions represent major issues in hemodialysis patients, difficult to manage outside specialized centers. Frequently, AVF ligation is the method used to resolve the issue, but it results in the loss of access for the patient. Bearing in mind the importance of maintaining AVF as a preferred vascular access, this work will present commonly used surgical and endovascular techniques, as well as new proposals, to restore proper AVF functioning by resolving ischemic issues or excessive flow. The techniques mentioned here can be classified into techniques involving intervention on the vein or artery and techniques of “remodeling” the anastomosis.

 

Vein

Vein Ligation

With this technique, the efferent vein of the anastomosis is exposed, and a silk ligature is applied and knotted to reduce the vein diameter (Figure 1a) aiming to decrease its flow rate [20]. Some authors suggest applying multiple ligatures to achieve an effective reduction in flow rate [21]. Some authors have developed a percutaneous, ultrasound-guided procedure, without surgical incision, for reducing the diameter of the efferent vein using a silk ligature [22]. The procedure involves using two needles, one in its normal configuration and the other curved; the curved needle, under ultrasound guidance, is used to pass beneath the venous vessel to be ligated, near the anastomosis. Through this needle, a silk ligature is then passed. The straight needle is passed above the vessel; through this, the silk ligature is brought back to the initial point for knotting. In the 26 patients treated this way, the authors describe a reduction in flow rate from 2196 to 679 ml/min, with these values maintained at one year follow-up, and a procedure duration of only 8.5 minutes.

Intraoperative monitoring of flow using color Doppler in procedures for reducing the diameter of the efferent vein can guide the extent and concomitant reduction of flow to the desired value [21, 23].

Figure 1. In this picture are presented main vein techniques to manage pathological AVFs.
Figure 1. In this picture are presented main vein techniques to manage pathological AVFs.

Miller Technique

An improvement over the previous technique involves ligating the efferent vein with a ligature assisted by the presence of an inflated angioplasty balloon inside the lumen to define controlled ligature caliber (Figure 1b). This is referred to as minimally invasive limited ligation endoluminal-assisted revision (MILLER) [24, 25]. This technique has shown technical success close to 100%, with clinical success in 50% of patients with distal ischemia and 100% of patients with high-flow fistulas [26]. Some authors have applied the same principle of controlling the extent of ligature.

Vein Plication

In this technique, after isolating the efferent vein of the AVF, a continuous suture is performed on the vein using a Satinsky clamp, resulting in a reduction in diameter (Figure 1c). Flow monitoring using Doppler helps determine the extent of plication before venoplasty [27]. Some authors have shown technical success in all cases treated, with symptom reduction in 92% and an average flow reduction of 600 ml/min [28].

Vein Banding

Like vein ligation but using a PTFE strip to create a sleeve approximately 20-30 mm in length wrapped around the efferent vein shortly after the anastomosis (Figure 1d). This technique has shown good success rates and maintenance of access functionality at 1 year [29]. Complications reported with this technique include band migration or venous aneurysmal dilatation both pre- and post-anastomosis [30]. To avoid these issues, some authors have proposed T-banding, characterized by using a portion of a PTFE prosthesis that is longitudinally opened and trimmed to fashion a structure capable of wrapping around the anastomotic chamber with the afferent and efferent arteries and the segment of the efferent vein, reducing its diameter but avoiding the complications [31]. With this method, these authors have shown a 44% reduction in flow with a primary and secondary clinical success of 72% and 90%, respectively.

Prosthetic Graft Interposition

After surgical dissection with isolation of the efferent vein, it is sectioned and a 5 mm prosthetic segment is interposed, 5 to 2 cm away from the anastomotic chamber (Figure 1e). This technique has shown technical success in 100% of 25 patients, with clinical improvement in 96% of treated patients [32]. Advantages include a lower recurrence rate of high flow, with a higher risk of access infections or thrombosis compared to simple banding [33].

Endovascular Vein Diameter Reduction

Several endovascular techniques have been described to reduce the diameter of the efferent vein, resulting in reduced flow. Some authors have placed a covered stent, flared at one end, at the post-anastomotic segment of the efferent vein, resulting in a reduction in the usable lumen diameter (Figure 1f), with improvement in ischemic symptoms and fistula flow reduction [34]. Other authors have used a similar technique in three patients, but in which a larger caliber, longer covered stent is inserted into a smaller caliber and shorter covered stent, creating an hourglass-shaped structure (Figure 1g), adhering at the ends to the vein wall but having an internal segment of smaller caliber, reducing flow in the AVF [35].

Management of Stagnant Venous Ischemia

In this condition, the presence of arterialized venous collateral vessels directed towards the hand, with or without obstruction in proximal outflow vessels, can result in increased pressure in the capillary venous side of the hand, resulting in “warm” ischemia, associated with edema. This condition can be resolved by ligating the vessels directed towards the hand with possible treatment of venous stenotic lesions when indicated (Figure 1h) [36].

 

Artery

Distal Artery Ligation

In distal forearm fistulas constructed with the radial artery, which is non-terminalized, distal radial artery ligation (DRAL) (Figure 2a) can be a resolving method for improving ischemic syndrome by interrupting retrograde flow from the hand to the fistula [37]. This procedure should only be performed after assessing the capacity of the ulnar artery, with the palmar arch, to provide adequate vascularization of the hand and is indicated for the treatment of distal ischemic syndrome [38].

Figure 2. In this picture are presented main artery techniques to manage pathological AVFs.
Figure 2. In this picture are presented main artery techniques to manage pathological AVFs.

Proximal Artery Ligation

Proximal radial artery ligation (PRAL) (Figure 2b) is used to reduce flow in AVFs with the radial artery in the distal forearm. AVF patency will be ensured by retrograde flow from the distal radial artery, through the palmar arch and the ulnar artery. In this case as well, the patency of these structures should be established before the procedure to avoid complete closure of the fistula. Burquelot et al. demonstrated a success rate of flow reduction in 92% of cases, with primary patency at 1 and 2 years of 88% and 74%, respectively, in 37 patients [39].

Distal Radial Artery Embolization

Unlike the previously described techniques, interruption of arterial flow in the distal radial artery can be performed endovascularly, using embolization coils [38, 40, 41] (Figure 2c). The endovascular approach can allow simultaneous treatment of stenotic lesions of the brachial, proximal radial, or ulnar arteries [42], reducing procedural times with less invasiveness compared to surgical approaches.

Angioplasty of Stenotic Lesions

The presence of stenotic lesions in the arterial system supplying the AVF can cause various forms of distal ischemic injury. Stenosis on the ulnar side can cause reduced blood flow to the hand in patients with distal radio-cephalic fistulas due to physiological “steal” from the radial artery [42, 43], or in proximal accesses with brachial artery stenosis and associated radial or ulnar artery lesions [44]. Endovascular treatment of such lesions with angioplasty can lead to rapid improvement in patient symptoms, with minimally invasive and rapid procedures (Figure 2d). The presence of calcified stenotic lesions can pose challenges. Recently, new techniques have been developed and used by vascular surgeons and cardiologists. Intravascular lithotripsy (IVL) allows for the fragmentation of calcium by emitting sound waves from a device placed inside the vessel [45]. We have recently begun using this equipment in the treatment of pre-existing arterial stenotic lesions at the time of fistula creation [46, 47] or in failed fistulas during maturation [48]. This opens the possibility of using this tool in the future for the treatment of calcified stenotic lesions causing distal ischemic syndrome.

Anastomosis

RUDI

Revision Using Distal Inflow (RUDI) is a surgical technique used to revise the anastomosis in fistulas with the brachial artery associated with distal ischemia with or without high flow. The technique involves isolating the anastomosis, ligating the efferent vein, and applying a prosthetic bridge between the post-ligation vein segment and the radial or ulnar artery [49, 50] (Figure 3a). This method remodels a proximal fistula with the brachial artery into a “distal” fistula by distal transposition of the inflow. This results in a reduction in access flow as well as reduced steal from the brachial artery. Variants of this technique have been described, involving ligation of the efferent vein, its sectioning with transposition and anastomosis with the radial or ulnar artery [51]. Literature reports a 50% reduction in access flow, improvement in symptoms and ischemic lesions, with primary patency at 3 and 12 months of 80% and 100% respectively [52]. Other authors described primary and secondary patency at 3 years of 48% and 84% respectively, with a postoperative flow reduction of approximately 65% [53]. Mallios recently described a new technique, performed on a patient, named endo-RUDI, in which he created an anastomosis between the proximal radial artery and the radial vein using the Ellipsys endovascular system and subsequently, during surgical time, anastomosed the basilic vein (efferent of the previous brachio-basilic access) with the radial vein, ligating the previous anastomosis. This achieved distalization of the inflow [54].

Figure 3. In this picture are presented main techniques to remodeling AVFs anastomosis
Figure 3. In this picture are presented main techniques to remodeling AVFs anastomosis

DRILL

Distal Revascularization with Interval Ligation (DRILL) is used to treat distal ischemic syndromes with or without high flow by “proximalizing” the bifurcation of the brachial artery in patients with proximal fistulas with the brachial artery. A prosthetic bridge (or using autologous veins such as the saphenous) is placed between the artery (brachial or axillary) upstream of the anastomosis and the brachial artery downstream of the anastomosis, followed by ligation of the artery between the anastomosis (with the vein) and the new distal anastomosis (Figure 3b). This remodels the pathological access as if it were a fistula with a terminalized radial or ulnar artery [55]. A challenge with this technique is that distal arterial perfusion depends on graft patency; therefore, some authors recommend not ligating the artery between the two anastomoses, although this limits the effectiveness of the procedure in reducing access flow. Literature reports an 80% technical success rate [56] with primary access patency rates at 12 and 24 months of 87% and 79% respectively [57].

PAI

Proximalization of Arterial Inflow (PAI). By placing a junctional prosthetic bridge between the brachial or axillary artery and the efferent vein of the fistula with ligation of the vein in the iuxtanastomotic tract, the access is remodeled by “recreating” a high bifurcation of the artery, eliminating the previous anastomosis (Figure 3c). In this procedure, useful for reducing symptoms related to distal ischemia in AVFs with or without high flow, the brachial artery is not ligated as in DRILL, avoiding possible complications of distal vascularization in case of graft thrombosis [58]. Graft thrombosis will result in non-functioning of the vascular access, without compromising upper limb vascularization. With this technique, primary and secondary patency rates of 87% and 90% at 1 year and 67% and 78% at 3 years are described, with a significant improvement in ischemic symptoms [59].

Radial Artery Transposition

This technique described by Bourquelot [60] reduces the flow of a pathological access with the brachial artery by dissecting the radial artery, proximally transposing it, and anastomosing it with the efferent vein of the previous AVF, suppressing the old anastomosis (Figure 3d). This creates a new end-to-end anastomosis with the radial artery, effectively reducing its flow through a modification of the inflow, which will be supplied by the radial artery. Technical success is reported in 91% of cases, with a 66% reduction in fistula flow. Primary patency at one and three years was 61% and 40% respectively, with secondary patency of 89% and 70%.

From the preceding chapters, it is evident that the techniques currently used to reduce the flow of a vascular access or to improve distal perfusion are diverse. These techniques may involve the venous compartment, the arterial compartment, or act through “remodeling” of the anastomosis. There are both surgical and endovascular techniques, some well-established and others emerging. Some of the described procedures have a greater impact on the flow of the AVF, while others focus on improving distal perfusion. As previously described, the pathophysiological aspects of high-flow fistulas and distal ischemic syndrome are often intertwined. Therefore, in practical terms, we may encounter three types of issues, which are easy to diagnose: high-flow fistulas without distal ischemic syndrome, high-flow fistulas with distal ischemic syndrome, and fistulas with distal ischemic syndrome without high flow. The aim of this review is to propose a decision-making algorithm, based on literature data, to indicate which procedures to implement for addressing these three categories (Table 2, Figure 4).

Reducing flow Reducing ischemia
Vein
Vein ligature +++ +
Miller technique +++ +
Vein plication +++ +
Vein banding +++ +
Prosthetic interposition +++ +
Endovascular vein caliper reduction +++ +
Artery
DRAL + ++
PRAL ++ –
Distal radial artery embolization + ++
Stenotic lesion angioplasty – +++
Anastomosis
RUDI + +++
DRILL + +++
PAI + +++
Radial artery transposition ++ +
Table 2. Available techniques. This table represents the effectiveness of the various techniques described in achieving flow rate reduction and/or improvement of ischemia in arteriovenous fistulas.
Figure 4. In this picture are presented decisional make algorithm to hang AVFs pathology in case of high flow with or without associated ischemia.
Figure 4. In this picture are presented decisional make algorithm to hang AVFs pathology in case of high flow with or without associated ischemia.

 

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