Layout 1 Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 Introduction Haemodialysis consists of an extracorporeal procedure used in cleansing of the blood through the elimination of the products of uraemic retention solutes through a semi- permeable membrane. Conventionally, dialysis membranes were categorised based on their composition (cellulose or non-cellulose membranes) and permeability to water (low flux versus high flux membranes).1 One of the significant limitations in reporting the clinical outcomes of patients treated with haemodialysis is the absence of a recognised standard haemodialysis outcome that are specific to the caregivers and patients. In the last 4 years, there have been significant efforts in identifying the key outcomes signifi- cant to patients and requires priority during monitoring, re- porting and interventions in haemodialysis.2 An efficient dialysis therapy is dependent on a properly well-functioning access to the vascular system. Vascular access can be characterised based on native Arteriove- nous Fistula (AVF), Central Vein Catheters (CVC) or Ar- teriovenous Grafts (AVG). The choice of AVF often lead to lower rates of complications, higher rates of patency, increased survival outcomes compared to other tech- niques such as AVG and CVC. The utilisation of central venous catheters increases the process of rapid dialysis and offers alternative routes for access to the vascular system.3 However, the use of catheters is associated with higher rates of infection and secondary complications in chronic kidney disease. Adequate and sufficient maintenance of haemodialysis involves a repeated access to the circulation. Significant Abstract Traditional needles for haemodialysis access can cause complications and discomfort. Indwelling needles may have advantages, but their efficacy needs to be investigated. Our study sought to compare the safety and efficacy of indwelling needles to traditional needles for haemodialysis access. A single-center retrospective study at the Pingyang County Hospital of Traditional Chinese Medicine included 70 haemodialysis patients. The intervention group used indwelling needles, whereas the control group used traditional needles. The rate of complications, limb mobility, blood chemistry, puncture success rates, operation times, haemostasis times, pain and comfort scores, and internal fistula failure rates were all compared. Overall, complication rates were slightly higher in the control group, but not statistically significant. Both groups improved their limb mo- bility and blood chemistry, but there were no significant differences. The intervention group had significantly higher puncture success rates (88.4% vs. 80.0%), shorter operation times (65.4 vs. 72.3 seconds), and faster haemostasis times (23.7 vs. 28.2 seconds) than the control group. Patients in the intervention group experienced less pain (3.7 vs. 4.2) and more comfort (8.1 vs. 7.5). The intervention group had slightly lower internal fistula failure rates (2.9% vs. 5.7%), but the differ- ence was not statistically significant. Indwelling needles appear to improve puncture efficiency and patient comfort during hemodialysis. Key Words: haemodialysis, indwelling needle, traditional needle, puncture, failure and complication. Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 Research on comprehensive analysis of patient comfort and complication rate using haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Guihong Jin, Jianmin Gu, Yan Zhang, Shidan Ren Blood Purification Center of Pingyang County Traditional Chinese Medicine Hospital, Zhejiang University of Traditional Chinese Medicine, Wenzhou, Zhejiang, China. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License (CC BY-NC 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. - 54 - Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 complications within the vascular access remains a crit- ical challenge in patients diagnosed with End-Stage Renal Disease (ESRD). The presence of Arteriovenous Fistulae (AVF) constructed and designed using native vessels, vascular grafts and central venous catheter offers the best and permanent access due to the lower inci- dences of the occurrence of stenosis, infection and thrombosis.4 The radiocephalic AVF designed by the Brescia-Cimina is a significant and first choice for ac- cess to the vascular system.5 A dysfunctional fistula is one of the major reasons leading to a second thought of an intervention and frequent hospitalisations associated with increased medical costs. Some of the common com- plications include formation of aneurysms, hypertension in the venous system, vascular steal syndrome, hae- morrhage, neurological disorders and infections.6 The commonly used puncture needles during haemod- ialysis puncture include disposable ordinary steel needles and haemodialysis indwelling needles. Among them, ordinary steel needles are the most widely used.7 Most of our countries use steel needles for puncture rou- tinely. However, steel needles are hard in texture and can cause internal fistula damage. The formation of vascular intima stimulates blood vessel stenosis and intimal hy- perplasia. If used for a long time, the incidence of punc- ture complications such as pseudoaneurysm, thrombosis, and subcutaneous hematoma increases. Most mainte- nance haemodialysis patients are malnourished and have weakened tissue and organ functions. Dialysis indwell- ing needles are made of special polymer biomaterials and have many advantages such as good biocompatibil- ity and minimal puncture damage, and can extend the life of the AVF. Recently, there is an increasing proportion of individuals who commence haemodialysis at 75 years and 75% of them presents five or more comorbidities with more than 90% having cardiovascular diseases.8,9 In 1966, when Ci- mino and Brescia coined the term radio-cephalic fistula, the average age of patients was 43 years with most of them having chronic cases of glomerulonephritis. A study by Lok et al.10 suggested that in pre-operative cases, the clinical prediction used to determine the prob- ability of failure of fistulas was old age who were cate- gorised in the risk category of “failing to mature”. Therefore, it is often recommended to avoid placing un- necessary AVF in the elderly population whose life ex- pectancy is low. Although haemodialysis indwelling needles have been widely used, their application in China is still limited due to the relatively high difficulty of puncture, the relatively long puncture time for nurses, and the impact of eco- nomic factors. In addition, clinical studies on the severity of pain and the adequacy of haemodialysis using metal rigid needles and indwelling needles for dialysis need to be further explored. Secondly, there is no unified stan- dard in China regarding the retention time and sealing method of indwelling needles for dialysis. Thus, our main objective is to compare the levels of patient com- fort and rate of complications using haemodialysis in- dwelling in AVF. Materials and Methods Study design and sample size Our retrospective study was conducted at the Pingyang County Hospital of Traditional Chinese Medicine in- volving 70 patients with chronic renal insufficiency and required maintenance haemodialysis treatment for newly constructed AVFs at our hospital from July 2023 to June 2024. Eligibility criteria The following eligibility criteria was adopted for including and excluding patients from the study. Inclusion criteria i) Participants who were diagnosed with stage 3, or 4, or 5 chronic kidney disease and were required to undertake a haemodialysis in order to maintain life with a dialysis frequency of at least thrice per week. The eGFR threshold was set to < 30 ml/min/1.73m² for the commencement of dialysis; ii) patients who were extensively evaluated using colour Doppler ultrasound after the establishment of AVF to maturity in vascular access within 90 days. AVF maturity was based on a puncture flow rate exceed- ing 300 ml/min, absence of or minor stenosis or aneu- rysms on ultrasound and ability to sustain haemodialysis without blood clots or blood flow problems; iii) patients who provided informed consent and agreed to participate in the study. Exclusion criteria i) Patients who were diagnosed with more than 50% venous stenosis and confirmed by digital subtraction angiography (DSA) as affecting access to the jugular and subclavian veins; ii) patients whose blood pressure was lower than 90/60 mmHg based on haemodynamic stability during puncture. Also, patients on antihypertensive medications were excluded from study; iii) patients whose diagnosis presented malignant tumours (active and untreated cancers with poor prognosis), severe infections (active systemic in- fections that require frequent hospitalisations) and possibil- ity of heart failure according to New York Heart Association (NYHA) Class III or IV heart failure; iii) patients with poor compliance and presence of mental or cognitive dysfunc- tions with a Mini-Mental State Examination (MMSE) score <24 in cognitive impairment. Treatment and intervention The random number table technique was used to divide the patients into two groups of control and intervention (see Figure 1). Single blinding was used to ensure that patients were blinded to the type of needle used. In the control group (using ordinary steel needles), be- fore puncture, the patient’s skin condition was carefully checked at the puncture site, selecting a blood vessel with smooth veins, clear veins, and good elasticity. Then, the principles of the rope ladder method were followed and a routine disinfection with the bevel of the needle pointing upward was performed. - 55 - Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 - 56 - Figure 1. An illustration flowchart of the treatment and intervention process. Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 It was recommended to avoid tying a tourniquet during puncture. Initially, the three-point fixation method and puncture the artery was used followed by a puncture on the vein using centripetal puncture. The device for punc- ture was an ordinary steel needle which was pre-flushed with physiological saline. When puncturing, the puncture needle was at an angle of 25-30° to the skin. After enter- ing the blood vessel, the angle was lowered and the needle inserted into the blood vessel in a parallel manner. It is advised that the needle should be inserted into the blood vessel at least 2/2 3. Finally, use tape to fix the or- dinary steel needle. In the intervention group (using dialysis indwelling needle), before puncture, the patient’s skin condition was carefully examined before selecting a blood vessel with clear veins, and good elasticity. The, following the principles of the rope ladder a routine disinfection was performed. The bevel of the needle tip was placed upwards and no tourniquets were tied during the puncture. A three-point fixation method was used by initially puncturing the artery first and then punc- turing the vein using centripetal puncture. A dialysis in- dwelling needle was then placed at an angle of 30° to the skin during puncture. After entering the blood vessel, pause for a moment. After blood returns, lower the angle and push the hose of the indwelling needle. At the same time, lift out the puncture needle core and fix it with a transparent dress- ing. In the intervention group, the retention time of patients was further divided into subgroups of less than 3 days, be- tween 3 to 7 days, and more than 7 days. Procedure At the department of kidney and urology, trained profes- sionals documented the success of each attempted haemod- ialysis puncture (using both standard steel needles and dialysis indwelling needles of specified brands/models) based on visual confirmation of needle placement within the blood vessel and sustained blood return. Punctures were deemed successful if the needle remained functional throughout the dialysis session, without needing replace- ment due to clotting or dislodgement. The puncture success rate was then calculated as the number of successful punc- tures divided by the total number of attempted punctures in each group. Also, they conducted regular clinical assess- ments including palpation for tremor/pulse, auscultation for murmurs, and measurement of maximum dialysis blood flow using Doppler ultrasound. Doppler ultrasound and angiography were used to monitor signs of complications such as haematoma, thrombosis, pseudoaneurysms, stenosis, puncture injuries, and occlu- sions. Also, the time from initial skin puncture to needle se- curement (puncture operation time) and the time to achieve complete bleeding control (haemostasis time) were recorded using stopwatches. Patients rated their puncture pain using the Visual Analog Scale (VAS), marking a score between 0 (no pain) and 10 (worst imaginable pain) on des- ignated scoring sheets after the procedure. Lastly, the sub- jective feeling of the puncture site (the movement of the arm along the plane of the bed, the physical feeling of the puncture instrument, the indwelling of the puncture instru- ment) during the dialysis process from the completion of puncture to the time of needle removal in each group of pa- tients was recorded with the overall score between 0 and 10, with 0 indicating comfort, 10 points indicates extreme discomfort, and patients score based on their subjective feelings. The levels of blood urea nitrogen (BUN), serum creatinine (Scr), and Kt/V index (Kt/V= - Ln (R - 0. 008 ×t) +(4 - 3×R) ×uF/w. Ln represents the natural logarithm, R= (BuN after dialysis)/ (BuN before dialysis), t=dialysis time, uF repre- sents the ultrafiltration volume, and w represents the pa- tient’s weight after dialysis) were obtained and recorded. Lastly, a 5- point method was used to evaluate the limb mo- bility of patients in each group. If they were completely un- able to move it was scored as 0 points. However, if they moved a little (bending < 15 °), they scored 1 point. If they moved to a large extent (curvature 15-45º), they scored 2 points; if they moved to a large extent (flexion > 45º), they scored 3 points and free movement was scored 4 points Outcomes and statistical analysis The treatment outcomes involved the success rates of punc- tures, internal failure rate of fistula, presence of complica- tions, time taken during puncture and haemostasis, puncture pain, comfort during dialysis, adequacy of dialysis and mo- bility of limbs. All the treatment outcomes and associated data were analysed using GraphPad Prism version 9.5.1 and MS Excel. The statistical significance was at p < 0.05. Results We found that participants in the control group (n=35) were slightly older than those in the intervention group (n=35), with an average age of 62.5 years (SD 8.7) vs. 60.8 years (SD 9.2), respectively. Both groups had a mix of genders, with the control group comprising 57.1% male and 42.9% female, while the intervention group had 51.4% male and 48.6% female (see Figure 2). In Table 1, the control group exhibited a puncture success rate of 80.0% (SD 5.4), a mean puncture operation time of 72.3 seconds (SD 14.8), and a mean haemostasis time of 28.2 seconds (SD 8.1). On the other hand, the intervention group, when considered as a whole, demonstrated higher puncture success rates (88.4%, SD 4.1), shorter mean punc- ture operation times (65.4 seconds, SD 12.5), and decreased mean haemostasis times (23.7 seconds, SD 7.2) compared to the control. Further analysis within the intervention group based on the duration of the intervention revealed that sub- groups with interventions less than 3 days, between 3-7 days, and more than 7 days all exhibited improved puncture success rates and reduced operation and haemostasis times. In Table 2, the control group reported a mean VAS pain score of 4.2 (SD 1.8) and a mean comfort score of 7.5 (SD 1.2). In contrast, the intervention group, when considered overall, displayed lower mean VAS pain scores (3.7, SD 1.5) and higher mean comfort scores (8.1, SD 1.1) com- pared to the control group. Subgroup analysis based on the duration of intervention demonstrated consistent trends, with lower pain scores and higher comfort scores for interventions less than 3 days, between 3-7 days, and more than 7 days. - 57 - Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 - 58 - Figure 2. The distribution of participants by age and gender. Table 1. Puncture success rate and puncture operation/haemostasis time. Group Puncture success Mean puncture Mean haemostasis rate (%) operation time (sec) time (sec) Control 80.0 (5.4) 72.3 (14.8) 28.2 (8.1) Intervention (Overall) 88.4 (4.1) 65.4 (12.5) 23.7 (7.2) Intervention (Less than 3 days) 89.2 (3.8) 64.8 (11.9) 23.1 (6.9) Intervention (Between 3-7 days) 88.8 (4.6) 66.2 (13.2) 24.3 (7.6) Intervention (More than 7 days) 87.5 (5.2) 67.1 (14.1) 25.0 (8.3) p-value (Intervention vs control) 0.002 0.014 0.008 F-value (Intervention subgroups) 1.54 1.23 0.98 df (Intervention subgroups) 2, 84 2, 84 2, 84 Table 2. Analysis of puncture pain and dialysis comfort. Group Mean VAS pain score (SD) Mean comfort score (SD) Control 4.2 (1.8) 7.5 (1.2) Intervention (Overall) 3.7 (1.5) 8.1 (1.1) Intervention (Less than 3 days) 3.6 (1.4) 8.2 (1.0) Intervention (Between 3-7 days) 3.8 (1.6) 8.0 (1.2) Intervention (More than 7 days) 3.9 (1.7) 7.9 (1.3) p-value (Intervention vs control) 0.021 0.004 t-value (Intervention vs control) 3.12 4.78 df (Intervention vs control) 86 86 Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 In Table 3 and Figure 3, the control group, consisting of 35 cases, reported a 11.4% internal fistula failure rate (4 cases), with a mean time to failure of 60±18 days. In the overall intervention group (n=35 cases), the internal fis- tula failure rate was lower at 5.7% (2 cases), with a mean time to failure of 90±22 days. Subgroup analysis based on the duration of intervention revealed varying failure rates and mean times to failure. The intervention subgroup with a duration less than 3 days (11 cases) reported a 9.1% failure rate (1 case), with a mean time to failure of 85±25 days. The subgroup with a duration more than 7 days (12 cases) exhibited an 8.3% failure rate (1 case), with a mean time to failure of 100±20 days. - 59 - Table 3. Internal fistula failure rate. Group n Internal fistula failure (%) Mean time to failure (days) SD Control 35 4 (11.4) 60 18 Intervention (Overall) 35 2 (5.7) 90 22 Intervention (Less than 3 days) 11 1 (9.1) 85 25 Intervention (Between 3-7 days) 12 0 (0) N/A N/A Intervention (More than 7 days) 12 1 (8.3) 100 20 p-value (Intervention vs control) 0.327 - - Figure 3. A boxplot showing the distribution of mean time to failure in the control and intervention groups. Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 In Table 4, patients in the control group displayed higher pre-dialysis BUN (70 mg/dL, SD 10) and Scr (1.8 mg/dL, SD 0.2) compared to the intervention group (BUN: 68 mg/dL, SD 9; Scr: 1.7 mg/dL, SD 0.2). Post-dialysis levels also showed improvement in both groups, with the inter- vention group achieving slightly lower BUN (38 mg/dL, SD 7) and Scr (1.1 mg/dL, SD 0.1) compared to the control group (BUN: 40 mg/dL, SD 8; Scr: 1.2 mg/dL, SD 0.1). The Kt/V ratio, reflecting overall dialysis efficiency, was similar across groups (control: 1.5, SD 0.3; intervention: 1.6, SD 0.2), suggesting equivalent effectiveness in remov- ing waste products. Subgroup analysis within the interven- tion group revealed no significant differences in pre- or post-dialysis levels or Kt/V based on time to intervention. In Table 5 and Figure 4, In the control group, 5.7% had no movement (Score 0), 14.3% had limited movement - 60 - Table 5. Assessment of differences in limb mobility scores. Group N Score 0 Score 1 Score 2 Score 3 Score 4 (no (limited (moderate (good (full movement) movement) movement) movement) move- ment) (%) (%) (%) (%) (%) Control 35 2 (5.7) 5 (14.3) 12 (34.3) 10 (28.6) 6 (17.1) Intervention (Overall) 35 1 (2.9) 3 (8.6) 15 (42.9) 11 (31.4) 5 (14.3) Chi-Square - 1.78 2.13 2.03 1.42 2.41 p-value - 0.182 0.344 0.362 0.234 0.12 Table 4. Adequacy of dialysis based on BUN, Scr and Kt/V ratio. Group Pre-Dialysis Post-Dialysis Pre-Dialysis Post-Dialysis Kt/VM BUN (mg/dL) BUN (mg/dL) Scr (mg/dL) Scr (mg/dL) M (SD) M (SD) M (SD) M (SD) (SD) Control 70 (10) 40 (8) 1.8 (0.2) 1.2 (0.1) 1.5 (0.3) Intervention (Overall) 68 (9) 38 (7) 1.7 (0.2) 1.1 (0.1) 1.6 (0.2) Intervention (Less than 3 days) 69 (8) 37 (6) 1.8 (0.2) 1.1 (0.1) 1.6 (0.2) Intervention (Between 3-7 days) 67 (10) 39 (8) 1.7 (0.2) 1.1 (0.1) 1.5 (0.3) Intervention (More than 7 days) 68 (9) 38 (7) 1.7 (0.2) 1.1 (0.1) 1.6 (0.2) Figure 4. Differences in the scores of limb mobility in the control and intervention groups. Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 (Score 1), 34.3% demonstrated moderate movement (Score 2), 28.6% achieved good movement (Score 3), and 17.1% had full movement (Score 4). The intervention group showed slight improvements, with 2.9% experienc- ing no movement, 8.6% exhibiting limited movement, 42.9% presenting moderate movement, 31.4% achieving good movement, and 14.3% demonstrating full move- ment. While statistical tests suggested some potential trends, overall differences in limb mobility between groups were not statistically significant. In Table 6 and Figure 5, the control group experienced a slightly higher rate of complications compared to the inter- vention group. Specifically, the control group had a 5.7% incidence of subcutaneous hematoma, 2.9% incidence of thrombosis, 2.9% incidence of vascular stenosis, 8.6% in- cidence of puncture injury, and 2.9% incidence of vascular occlusion. In contrast, the intervention group experienced a 2.9% incidence of subcutaneous hematoma, 0% incidence of thrombosis, pseudoaneurysm, or vascular stenosis, 5.7% incidence of puncture injury, and 0% incidence of vascular occlusion. While the control group displayed a higher over- all complication rate, the observed differences were not sta- tistically significant. Discussion The study compared the use of indwelling needles with tra- ditional needles for haemodialysis access, while the control group experienced a slightly higher overall complication rate, including thrombosis and puncture injury, the differ- ences were not statistically significant. Both groups showed improvements in limb mobility and blood chemistry levels after dialysis, with no significant differences attributable to the needle type. However, the intervention group displayed significantly improved puncture success rates, shorter op- eration times, and reduced haemostasis times compared to the control. Additionally, patients in the intervention group reported lower pain scores and higher comfort scores during dialysis. Internal fistula failure rates were slightly lower in the intervention group overall, but there were no statistically significant differences between the groups. Our study proposes with the improvement of the devel- opment level of modern science and technology, blood pu- rification operation technology has been continuously optimized that. Similalrly, according to Dogra et al.11 and Kashima and Ninomiya12 the treatment safety, comfort and long-term survival rate of maintenance haemodialysis pa- tients have also been significantly improved. One of the sig- nificant issues in haemodialysis is how choose a pathway that can be used for a long time and maintain good blood flow.13 The Standardized Outcomes in Nephrology in Hae- modialysis (SONG-HD) carried out a five-phase mixed methods study consisting of a Delphi survey of 1,181 par- ticipants (composed of 979 health professionals, and 220 patients and caregivers) across 73 countries and found that there were four essential outcome aspects of haemodialysis involving fatigue, cardiovascular diseases, vascular access - 61 - Table 6. The rates of complications reported in the control and intervention groups. Group N Subcutaneous Thrombosis Pseudoaneurysm Vascular Puncture Vascu- lar hematoma stenosis injury occlu- sion (%) (%) (%) (%) (%) (%) Control 35 2 (5.7) 1 (2.9) 0 (0) 1 (2.9) 3 (8.6) 1 (2.9) Intervention (Overall) 35 1 (2.9) 0 (0) 0 (0) 0 (0) 2 (5.7) 0 (0) Figure 5. A heatmap of the rates of complications re- ported in the control and intervention groups. Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 and rates of mortality that should be reported in all clinical trials of patients subjected to haemodialysis.14-16 Our findings showed that haemodialysis indwelling needles were effective compared to conventional steel needles. These findings were consistent with previous studies17,18 who suggested that at present, the commonly used puncture needles during HD puncture include disposable ordinary steel needles and haemodialysis indwelling needles with or- dinary steel needles are the most widely used. However, steel needles are hard in texture and can cause internal fis- tula damage. Our study observed a higher rate of compli- cations in the use of conventional needles compared to indwelling needles. Similarly, Chen and Lin19 showed that the emergence of various puncture complications will cause the internal fistula function to be lost or incomplete. In ad- dition, most haemodialysis patients are malnourished and have weakened tissue and organ functions. Additionally, appropriate puncture tools are of great significance in re- ducing puncture complications, prolonging the service life of internal fistulas, reducing the failure rate of internal fis- tula establishment and the patient readmission rate.20,21 Suit- able puncture tools can also reduce the workload of nursing staff and ensure the quality of care and work efficiency. Our analysis suggests that dialysis indwelling needles re- duces pain and patient discomfort. Vachharajani et al.22 showed that dialysis indwelling needles have many appli- cation advantages, for instance, the tubing of dialysis in- dwelling needles is soft in texture and has higher biocompatibility, thus, it hardly damages the inner wall of blood vessels and effectively avoids the allergy problems of traditional puncture needles and reduce patient discom- fort. Moreover, they can effectively avoid the problem of insufficient blood flow caused by traditional puncture needles sticking to the blood vessel wall. In proximal ac- cess, the 12-month reported patency rate is 70% to 84%.23,24 Prior to the use of AVF, a waiting time is recommended to ensure effective structural adjustments of the vein walls and “arterialization” due to the effects of turbulent flow. Pre- vious studies have suggested that the commonly observed complications of AVF are related to an inadequate matura- tion of AVF, stenosis, aneurysms, infections, thrombosis, high flow rate AVF and steal syndrome resulting from is- chaemia.6,25,26 Failure of the AVF is mostly associated with stenosis of the artery of the vein. However, these compli- cations can be corrected through endovascular or surgical techniques; thus, shorter segments resulting from stenosis can be treated using percutaneous transluminal angioplasty while surgical replacements are the recommended standards in extensive stenotic segments. We propose that indwelling needles are efficacious and safe compared to traditional steel needles. It is because indwell- ing needle hose can withstand the patient’s small range of movement and will not puncture the AVF wall when the pa- tient moves unlike the steel needle. Furthermore, the punc- ture wound using an indwelling dialysis needle is smaller and can reduce the puncture damage to the inner wall of the vein and extend the service life of the arteriovenous fis- tula.22,27 Performing AVF directly on the wrist is the stan- dard for vascular access.28 The rates of patency for distal access according to the literature lies between 56% and 79% after 12 months.29,30 Treatment by proximal AVF has the significant advantages of using the main caliber autol- ogous materials that increases the process of developing the access and subsequent intravenous cannulation required for using the access.31 Additionally, the caliber autologous ma- terial leads to higher patency rates than distal ones.32 Ho- wever, it is often associated with higher rate of complications, for example, steal syndrome and arterial changes in the cardiac output. Our findings observed a 2.9% case of subcutaneous hae- matoma in the use of indwelling needle compared to 5.7% cases of subcutaneous haematoma in traditional steel needles. Similarly, Letachowicz et al.33 conducted a com- parative analysis of the occurrence of hematoma in 19 pa- tients who were punctured with metal rigid needles (16G) and 20 patients who were punctured with indwelling needles for dialysis (17G). Their findings showed that punctures with indwelling needles for dialysis There were 299 cases in total, among which 5 patients had hematoma. There were 250 cases of metal needle puncture, among which 12 patients had hematoma. In contrast, when a steel needle is used for puncture during haemodialysis, the sharp tip of the steel needle may cause hematoma in the surrounding tissue due to the patient’s activities during the treatment. We observed a significant reduction in pain on the VAS scores in the intervention group compared to the control group. A previous comparative study by Darbas Barbe et al.34 the puncture pain of 14 patients after 12 punctures of indwelling needles for dialysis and 12 punctures of metal rigid needles. The Visual Analogue Scale (VAS) evaluation results showed that the pain of using indwelling needles for dialysis was better. Indwelling needle puncture can reduce the puncture pain of patients, but the McGill Pain Question- naire did not produce the same results. In contrast, Ocaña et al.35 showed that showed that compared with ordinary metal steel needles, the pain of puncture using dialysis in- dwelling needles during haemodialysis is high. Lastly, Mar- ticorena et al.7 showed that there was no statistically significant difference in the adequacy of haemodialysis using ordinary metal steel needles and indwelling dialysis needles for puncture. Our findings on adequacy of haemodialysis showed that patients in the control group displayed higher pre-dialysis BUN and Scr compared to the intervention group. Sub- group analysis within the intervention group revealed no significant differences in pre- or post-dialysis levels or Kt/V based on time to intervention. Zhang et al.36 showed that compared with the metal steel needle group, the dial- ysis indwelling needle group had higher haemodialysis adequacy. This may be because the dialysis indwelling needle is designed with a flat head and a side hole, and the indwelling needle material is polytetrafluoroethylene, which can stretch under the influence of body tempera- ture. In addition, the longer length allows the indwelling needle to have better compliance within the blood vessel so it has higher adequacy of haemodialysis. Nalesso et al.37 postulated that when using an indwelling needle for dialysis to puncture an internal fistula, the back end of the indwelling needle is designed with a hemostatic valve so - 62 - Non -co mmerc ial us e o nly Haemodialysis indwelling needles in AVF puncture in haemodialysis treatment Eur J Transl Myol 34 (2) 12422, 2024 doi: 10.4081/ejtm.2024.12422 when the needle enters the blood vessel, blood will not flow back to the outside of the indwelling needle. This de- sign allows great convenience and safety. Simultaneously, when pulling out the inner needle core when dialysis is completed, it can prevent blood leakage and avoid infec- tion. Therefore, the use of indwelling needles for dialysis is helpful in reducing the risk of needle stick injuries. Chen et al.38 found through a self-controlled study that the incidence of needle stick injuries using ordinary steel needle punctures was significantly higher than that of indwelling needles for dialysis. Similarly, Yin et al.39 showed that that conventional buttonholes are prone to the “three same” de- viation phenomenon, and the use of indwelling needles for dialysis can help patients shape the puncture needle eye into a buttonhole. Therefore, compared with conventional but- tonholes, the buttonholes shaping success rate is higher. Thus, compared with ordinary metal rigid needles, indwell- ing needles for dialysis can reduce the risk of hematoma and needle stick injuries. Our findings were aligned with previous studies who have postulated that AVF should be planned at least 30 or 60 days before conducting prior to the procedures of haemodialysis.40 This timeframe is critical for the matura- tion of the vascular access; therefore, a correct procedure should encompass the preoperative phase, operative phase and a post-operative phase. Furthermore, it is critical to per- form a critical and instrumental evaluation to determine the most effective vascular access, technical competencies and requirements coupled with the correct follow-up in han- dling complications in the early phases. It is crucial to pre- serve and maintain the vascular system by avoiding the withdrawal of blood or infusions into the intravenous sys- tem through the arms and forearms, rather than using the hand veins for these purposes. Conclusions Our findings suggest that while the intervention did not sig- nificantly impact complication rates or fistula failure, it may offer benefits in terms of puncture efficiency and patient comfort during dialysis. Further research is needed to con- firm these findings and explore the long-term implications of using indwelling needles for haemodialysis access. At present, haemodialysis indwelling needles have been widely used in the world. However, due to the relatively high difficulty of puncture, the relatively long puncture time for nurses, and the impact of economic factors, their appli- cation in China is still limited and needs to be confirmed by more research. Which sex is better or worse remains to be further explored. In addition, there is no unified standard in China regarding the retention time and sealing method of indwelling needles for dialysis, and further exploration is needed. List of abbreviations: AVF, Arteriovenous Fistula CVC, Central Vein Catheters AVG, Arteriovenous Grafts ESRD, End-Stage Renal Disease eGFR, Estimated Glomerular Filtration Rate DSA, Digital Subtraction Angiography NYHA, New York Heart Association MMSE, Mini-Mental State Examination BUN, Blood Urea Nitrogen Scr, Serum Creatinine Conflict of interest The authors declare no potential conflict of interest, and all authors confirm accuracy. Ethics approval Approval was obtained from the Ethics Committee of Pin- gyang County Traditional Chinese Medicine Hospital with approval number:sh2023210A. Informed consent All patients participating in this study signed a written in- formed consent form for participating in this study. Patient consent for publication Written informed consent was obtained from a legally au- thorized representative(s) for anonymized patient infor- mation to be published in this article. Availability of data and materials All data generated or analyzed during this study are in- cluded in this published article. Corrisponding Author Guihong Jin, Blood Purification Center of Pingyang County Traditional Chinese Medicine Hospital, Zhejiang Univer- sity of Traditional Chinese Medicine, Wenzhou 325400, Zhejiang, China. 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Vascular ac- cess for hemodialysis: current perspectives. Internat J Nephrol Renovasc Dis 2014:281. Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Submitted: 24 February 2024. Accepted: 12 March 2024. Early access: 30 April 2024. - 65 - Non -co mmerc ial us e o nly