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Evaluation of Complications and Success Rate and openness Rate of arterioarterial Grafts in Dialysis Patients without Dialysis Vascular access

Running Head: Success Rate and openness Rate of arterioarterial Grafts

Hossein Hemmati

1,2

, Milad Sarafi

3,*

, Mohammad Sadegh Esmaeili Delshad

4

, Mohammad Taghi Ashoobi

4

, Habib Eslami Kanarsari

5

, Mohaya Farzin

6

1 Department of Vascular Surgery, Guilan University of Medical Sciences, Rasht, Iran 2Razi Clinical Research Development Unit, Guilan University of Medical Sciences, Rasht, Iran 3Razi Development Unit, Guilan University Clinical Research of Medical Sciences, Rasht, Iran 4Department of General Surgery, School of MedicineRazi Hospital Guilan University of Medical Sciences 5Inflammatory Lung Diseases Research Center, Department of Internal Medicine, Razi Hospital, School of

Medicine, Guilan University of Medical Sciences, Rasht, Iran

6Department of Physiology, Razi Clinical Research Development Unit,Guilan University of Medical Sciences, Rasht, Iran

Corresponding author: Dr. MiladSarafi

Razi Hospital, SardarJangal Street, Rasht, Guilan Province, Iran Email: Milad [email protected]

Postal code: 4144895655 Tel: +981333542460 Fax: +981333559787

ABSTRACT

Chronic renal failure has been considered as one of the main health problems in Asian countries. The term ESRD is a stage of CKD that causes uremic syndrome with the accumulation of toxins, fluids, and electrolytes. In the present study, the complications and success rate and openness of arterial graftswere investigated in dialysis patients without dialysis vascular access.The present study is a cross-sectional and descriptive study. The statistical population of the study population was patients who did not have suitable large deep veins in 2019 and 2020 and were candidates for arterioarterialgraft.The sample pf present study included patients who had multiple accesses to the upper and lower limbs and dysfunction in these limbs. Ten samples were investigated in this study. Inclusion criteria of the study included the patients for whom upper and lower limb venography was performed. In the case of inferior and superior vena cava obstruction and failure to establish flow with endovascular intervention, they became candidates for arterioarterialgraft and entered the study. Data were summarized in SPSS22software using tables and charts.In this study, 6 patients were male and 4 were female. The mean age of the patients was 57.45±8.6 years.

The largest number of patients (50%) had diabetes mellitus. One case of stenosis in anastomosis and one case of thrombosis were observed in the patients. The initial success rate in patients within 12 months was 80%.Arterioarterialgraft is a new technique and an alternative to specific conditions when other options fail. This technique can be considered for patients with central venous obstruction

.

Keywords

Arterioarterialgraft, Dialysis patients, Dialysis vessels

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Introduction

Chronic Kidney Disease (CKD) has been considered as one of the major health problems in Asian countries (1).

Chronic kidney disease is a pathophysiological process with multiple causes. It results in unstoppable decline in the number and function of nephrons and leads to end-stage renal disease in many cases (ESRD).The term ESRD is a stage of CKD that causes uremic syndrome with the accumulation of toxins, fluids, and electrolytes, unless toxins are removed from body by renal replacement therapy (RRT) (using dialysis or kidney transplantation) (2). It is estimated that at least 6% of the US adult population has stages 1 and 2 CKD. The prevalence of CDK has increased in countries including the United States and it has been associated with an increase in cardiovascular events, end stage renal disease, and high mortality rates (3). The incidence and prevalence of ESRD has increased dramatically since the 1990s, so that the number ofESRDcases in 1998 was double than thatin 1989. In addition, 29% of ESRD patients had successful Allograft, 63.1% were treated with hemodialysis, and 7.9% with peritoneal dialysis (4).

According to studies conducted by Aghighi et al., the number of ESRD patients increased by about 130% between the years 2000 and 2006 (6). In the United States, diabetes mellitus is the most common cause of ESRD, accounting for approximately 45% of newly diagnosed cases. The second most common cause of ESRD is hypertension, which is estimated to be the cause of 27% of ESRD cases. Other causes of ESRD include glomerulonephritis, and polycystic kidney disease (2).

The incidence of ESRD is on the rise and kidney transplantation faces limitations due to the economic and cultural conditions of Iran. Hence, establishment of an appropriate vascular access to treat this disease, monitor and control it, timely prevention and treatment of complications, and ultimately reducing hospitalization and reducing costs is essential (7, 8).The ideal vascular access allows sufficient flow for dialysis (>300 cc / min) and can be used for a long period with minimal side effects (4). It takes at least 4-6 weeks (ideally 3-4 months) for anarteriovenous fistula (AVF) to mature. Thus, a vascular access should be established early in the process of renal failure (9). Various methods are used for vascular access in dialysis patients, including vascular access using a central venous catheter and permanent vascular access (10). Beforeestablishing vascular access, all staff and nurses should be trained to protect the arteries of ESRD patients to avoid catheterization and recurrent cephalic venous blood sampling due to increased sclerosis or thrombosis (11). Patients with a history of subclavian central venous catheterization for more than three weeks are in significant risk of central venous stenosis, followed by increased venous blood pressure and hand edema after placement (12).

The National Kidney Association of America considers the Brecio-cimino fistula to be the first choice of vascular access, so that it is recommended for at least 50% of ESRD patients who visit for the first time for vascular access placement. If this fistula is placed, the second option would be elbow fistula, a PTFE graft or a vein transferred to arm (13, 10).In short, three main forms of vascular accesses (arteriovenousfistulas,arteriovenous grafts, and venous double-lumen catheters) are used for dialysis of patients with end-stage renal disease. For many reasons, arteriovenous fistulas are the preferred access in dialysis patients (18-14). In 2005, Banger et al reported the results of a group of 20 patients undergoing artery-to-axillary artery intervention with PTFE transplants. The diameter of PTFE transplant was determined by the size of the axillary artery.The need for endovascular or open correction was observed in 30% of patients. The primary and secondary openness rateduring 6 months was 90% and 93%, respectively. However, the follow-up period was only 7 months. Limb ischemia occurred in a patient who developed a thrombosis, but it was resolved after a thrombectomy. In three other patients, thrombosis occurred without symptoms of limb ischemia (18). In a study conducted by Abdelmieniem Fareed et al, 15 patients underwent arterial to axillary artery graft. Primary and secondary openness rate in one year was 73.3% and 86.6%, respectively. Severe infection during graft occurred in 2 patients at 11 and 27 months later. One patient died after another six months.

Two patients developed pseudoaneurysms at one point after 20 and 28 months due to multiple punctures (19).Arterioarterial access methods in patients with limb ischemia can be associated with previous access and high- efficiency heart failure. Arterioarterial access methods do not provide as much flow as arteriovenous access methods (Banger preferred to an average flow rate of 165mL / min). Since dialysis blood flow of more than 400 ml / min can cause recirculation and arm pain, it may be necessary to manage patients with slower blood flow for longer periods to provide appropriate treatment for dialysis.Thus, the present study was conducted to evaluate the complications and the success rate and openness of arterioarterial grafts in dialysis patients without dialysis venous access.

Materials and Methods

This study is a descriptive and cross-sectional type of study. It was conducted in Razi Educational and Research Center of Rasht affiliated to Gilan University of Medical Sciences and Health Services. The statistical population of

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the study consisted of patients who did not have suitable deep veins (including subclavian, internal jugular and femoral veins) and were candidates for arterioarterial graft in 2019 and 2020.The sample of the study included the patients who had multiple accesses to the upper and lower limbs and had dysfunction in these limbs. Tensamples wereinvestigated in this study. Inclusion criteria of the study included patients for whom upper and lower limb venography was performed in case of obstruction of inferior and superior vena cava and failure to establish flow with endovascular intervention, they became candidates for arterial graft and entered the study. Patients underwent segmental pressure measurement and Color Doppler Ultrasound before operation and if they had atherosclerosis or chronic ischemia, they were excluded from the study. All patients signed a consent form before undergoingarterioarterial graft

Surgery was performed in patients under general anesthesia and after injection of prophylactic antibiotics. A longitudinal cut was created in the mid-thigh near the inner edge of the Sartorius muscle to explore the superficial femoral artery. The Sartorius muscle was pushed away and the superficial femoral artery explored and mobilized in all directions. After creating a subcutaneous loop tunnel in the anterior external route of thigh, a 6 mm diameter PTFE graft was placed in it. The superficial femoral artery was cut and the graft was placed on both ends of the anastomosis artery with 0-6 polypropylene thread. Accordingly, the created access could be used without the need to turn the patient's limb outwards. The features of this access were informed to nephrologist and dialysis unit. They were also recommended not to use this access to inject the drug and to press the puncture site for more than 15 minutes after removing the needle. The dialysis rate was 300 ml per minute.Heparin injection was continued for about 30 minutes before the end of hemodialysis. In addition, the needle puncture site was changed periodically to prevent possible pseudo-aneurysm. The patient was discharged 48 hours after surgery and with prescribing 325 mg of aspirin daily. All patients were visited in a vascular subspecialty clinic in the first week and then every 3 months.

Clinical evaluations were performed with Doppler ultrasound in each visit. Data collection form was used to record the data. Experts confirmed the accuracy of the data collection form. The patients' age, gender, and underlying diseases were recorded on their admission. After placement of fistula, they were also examined in terms of bruit and thrilland the results were recorded in the patient's form.Then, the patients were followed-up for 1.5 months, 3 months, 6 months and 12 months after fistula placement in terms of success rate, openness rate, and complications, and the results were recorded in the patient’sdata collection form. The collected data were entered into SPSS-22 software. Frequency tables and statistical charts are used to show the distribution of data.

Results

The present study was conducted on 10 patients referred to Razi Research and Medical Center in Rasht who were candidates for arterioarterial graft. Among the patients studied, 6 (60%) were male and 4 (40%) were female. The mean age of the patients was 57.45 ± 8.6 years and most of the patients (5 patients, 50%) were in the age range of 50 to 55 years. 50% of patients had diabetes mellitus, 30% had HTN and 20% had diabetes and HTN. Among the studied patients, one case of stenosis in anastomosis and one case of thrombosis was observed. In other patients, no complication was observed (Table 1).Investigating the initial success rate of the studied patients showed that only two cases of thrombosis and anastomosis disorder were observed during 12 months and the initial success rate was 80% (Chart 1).

Table 1: Frequency distribution of demographic indicators of patients

Variable f %

Gender Male 6 60%

Female 4 40%

Age groups 50-55 years 5 50%

55-60 years 2 20%

60-65 years 1 10%

65-70 years 2 20%

Underlying diseases

DM 5 50%

HTN 3 30%

DM+HTN 2 20%

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Complicati ons in patients

Without complication

8 80%

stenosis in anastomosis

1 10%

thrombosis 1 10%

Chart 1: Initial success rate in the studied patients

Discussion and Conclusion

Despite the challenges of placement of complex AV access and its associated complications, its placement is usually justified and preferred to the use of a tunnel dialysis catheter. In some patients, venous catheters cannot be selected for hemodialysis if radiological or surgical interventions fail to remove the obstruction due to central venous obstruction, such as stenosis.Therefore, a subset of patients with difficult vascular access requires more complex access methods. If complex vascular access is required, the surgeon should have a detailed description of the previously created accesses and the reasons for their non-functioning, as well as the exact vascular anatomy. Since the complications of placement of vascular access in the upper limb are less in comparison to other sites, before attempting to create access to non-upper limb sites, the surgeon should ensure that there are no alternatives in the upper limb. Non-upper limb sites include lower limb arteriovenous fistula, lower limb artificial graft, and artificial chest graft.

Zanu et al. reported that arterioarterial graft did not cause a problem with regard to vascular access for hemodialysis in patients with low cardiac output (20).The above-mentioned result is consistent with results of the present study. No cardiac complications were recorded in patients during the study period. Thus, it is necessary to increase the accuracy about the patients with heart failure as candidates for arterioarterial treatment. Based on the present study and previous studies, arterioarterialgraft is another way to provide access to hemodialysis. The present study revealed that arterioarterialgraft in patients was disrupted in only two patients, which one case was resolved with thrombectomy and the other case was resolved with re-surgery and re-anastomosis. Due to the unfavorable vascular conditions and lack of alternatives in these patients, the vascular access route is acceptable. Although arterioarterial graft is a treatment procedure to provide vascular access for hemodialysis, this procedure might be associated with side effects. For example, in the case of a thrombosis, immediate thrombectomy is necessary since if thrombectomy is not performed in this case, it will lead to ischemia and the risk of organ loss. However, arterioarterial obstruction was observed in only one patient in our study, and the patient tolerated it well. In the study conducted by Saldago et al., three cases of arterial thrombosis were observed (7). In the study conducted by Li et al.,

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eight patients were affected by postoperative leg swelling and there was an obstruction of the transplant but no lower limb ischemia was reported (8).In the study conducted by Zanu et al., four patients received thrombosis (20). In another study conducted by Abdelmieniem Fareed et al., severe infection occurred in 2 patients 11 and 27 months later. One patient died after six months. Two patients were affected by pseudo-aneurysms at one point after 20 and 28 months due to multiple punctures (19).Saldago et al. (2012) described a superficial femoral artery transposition technique for vascular access. In this study, five complications of needle cannulation were reported: two cases of bleeding due to arterial rupture, two cases of pseudo-aneurysm, one case of infectious pseudo-aneurysm, and three cases of arterial thrombosis (21). It can be stated that superficial femoral artery thrombosis has not led to severe ischemia due to a healthy deep femoral artery. In addition, if graft inflammation occurs, it should be resolved by graft removal. In the present study, severe inflammation was not observed.

Arterioarterial obstruction can sometimes cause potential problems such as ischemia, pseudo-aneurysm, and embolism. In the present study, none of the patients developed embolism and no particular problem was observed.

Arterioarterial obstruction may cause pseudo-aneurysm at blood sampling site, but it can be easily resolved.In fact, if the blood sampling technique is performed carefully, then pseudo-aneurysm can be avoided. Knee et al. (20) reported that painful recirculation was observed at speeds greater than 400 ml / min. They believed that this phenomenon occurs due to increased pressure in the arterial wall. In our study, the speed was adjusted at 300 ml / min and no painful recirculation was observed. Although the results of the study are acceptable, the absence of a control group is one of the important limitations of this study. In addition, due to the above-mentioned complications, a precise definition of the conditions for prescribing arterioarterial is necessary. AVF is still the best route for hemodialysis and it can be stated thatarterioarterialgraft is an alternative for patients without the possibility of conventional vascular access. One of the problems of this study is the limitation in long-term follow-up of patients. However, the success rate of all artificial grafts is limited and is usually reported for a maximum of 6-18 months.In our study, the initial patency was 80%, while in the study conducted by Zanu et al., it was reported at 73% (20), and in the study conducted by Li et al (22), it was reported at 94%. In another study conducted by Abdelmieniem Fareed et al., the initial patency was 73.3%in 15 patients studied (19). The results of this study revealed that arterioarterialgraft is a new technique and an alternative to specific conditions when all access options fail. This technique can be considered for patients with central venous obstruction. Appropriate initial patency and relatively low complication rate in these patients in our study indicate that this method is a treatment method in patients when other access options fail.

Abbreviations

CKD:Chronic Kidney Disease,ESRD: end-stage renal disease in many cases,RRT:renal replacement therapy, AVF:

arteriovenous fistula

Acknowledgments

The authors wish to thanks Razi Clinical Research Development Unit of Guilan University of Medical Sciences for their technical supports.

Funding

This study was supported financially by the research council from Guilan University of Medical Sciences [grant number 1170]

Funding support None.

Availability of data and materials

The datasets used and/or analyzed during the current study are available fromthe corresponding author on reasonable request.

Ethics approval and consent to participate

The study design was approved by the regional Ethics Committee of Guilan University of Medical Sciences (IR.GUMS.REC.1399.212) and was in accordance with the declaration of Helsinki. However, the ethics committee waived the need for informed consent since only the medical records were used.

Consent for publication

Not applicable. All samples either swabs or aspiration were obtained from patients as parts of routine sampling during their hospitalization period, so the regional ethical committee waived the need for informed consent.

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Competing interests

The authors declare that they have no competing interests.

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