J Nephrol DOI 10.1007/s40620-015-0198-9
ORIGINAL ARTICLE
Use of iliac vein tunneled cuffed catheters in elderly hemodialysis patients: a single-center retrospective study Lihua Wang1 • Fang Wei1 • Guijiang Sun1 • Haiyan Chen1 Haibo Yu1 • Aili Jiang1,2
•
Received: 24 February 2015 / Accepted: 11 April 2015 Ó Italian Society of Nephrology 2015
Abstract Background Until now, the survival of iliac vein tunneled cuffed catheters (TCCs) used in elderly patients has not been fully investigated. Accordingly, we evaluated their use in elderly hemodialysis patients with no other venous access options. Methods A total of 70 elderly patients with iliac vein TCCs undergoing chronic hemodialysis were included in this study. Patients’ baseline anthropometric and laboratory parameters were measured. Incidence of catheter dysfunction and of catheter-related infection was documented. Results During the study period, a total of 99 new tunneled dialysis catheters were placed. Technical success rate was 100 %. Median infection-free survival and dysfunction-free survival after catheterization was 617 and 875 catheter days, respectively. Mean survival time per catheter was 1067 catheter days, corresponding to a total observation period of 65369 catheters days. Conclusions Iliac TCC is both technically feasible and effective for hemodialysis in elderly patients with no other venous access options.
& Aili Jiang [email protected] 1
Department of Kidney Disease and Blood Purification Centre, Institute of Urology and Key Laboratory of Tianjin, 2nd Hospital of Tianjin Medical University, Tianjin, People’s Republic of China
2
23rd, Pingjiang Road, Hexi District, Tianjin 300211, People’s Republic of China
Keywords Hemodialysis Iliac tunneled cuffed catheter Elderly patients
Introduction Recently, tunneled cuffed catheters (TCCs) have been widely used for vascular access in hemodialysis patients. Among these patients, the number of elderly patients is increasing rapidly [1]. Meanwhile, comorbid conditions, such as vascular disease and especially complications associated with diabetes and cardiovascular disease (CVD), are also progressively increasing, which in turn makes the elderly more likely to prefer a TCC to a fistula for longterm dialysis [2]. In some respects, the tunneled hemodialysis catheter is superior to arteriovenous fistula (AVF) or grafts; for example, it is easily inserted, requires no vein puncture, and can be immediately used [3, 4]. However, there is also concern regarding the high morbidity and mortality that are associated with catheters, as costs per person per year to maintain hemodialysis are steadily rising [5]. Currently, there are a few entry points for tunneled hemodialysis catheters, including the iliac veins [6, 7]. These catheters may be an option for those patients in whom it is difficult to create an AVF or AVF graft and those with bilateral central vein occlusion, making it impossible to place a dialysis catheter in the chest. Although studies regarding the outcome and complications of long-term tunneled catheters have been performed, to our knowledge the survival rate (primary patency) of iliac vein TCCs used in elderly patients has not been fully investigated [8]. Therefore, we undertook this retrospective study to analyze the survival rate of iliac vein TCCs in elderly patients undergoing chronic hemodialysis.
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J Nephrol
Patients and methods
Table 1 Baseline characteristics of the study patients Parameter
Mean ± SD
Patients, n
70
Patients A total of 70 incident dialysis patients aged over 65 years between January 2011 and December 2013 were included in the study. Patients suffering from varices of both lower limbs or with bleeding tendency were excluded. The mean age of the patients was 72 years at the start of study. The causes of end-stage renal disease (ESRD) in the study population were: diabetic nephropathy (40 %), primary glomerulonephritis (29 %), hypertensive nephropathy (20 %), and undetermined disease (11 %). All of the patients (100 %) included in our study had a history of catheter insertion into both the right and left internal jugular veins. Some of them (11 %) had had fistula before but had no useable vascular access left, while others were deemed not suitable for an AVF because of difficulty to create a fistula due to peripheral vascular disease (34 %) or cardiac dysfunction (55 %). Computed axial tomographic (CAT) angiography was performed in general to confirm the unsuitability of using a central venous catheter in the jugular vein, excepting in the case of immobilized patients or those with severe comorbidities. The subclavian was excluded for cannulation as it anatomically joins into the internal jugular vein. The femoral vein was also excluded for cannulation due to our concern about infection risk. The patients were undergoing continuous hemodialysis three times a week with a double-pool Kt/V target dose of not less than 1.2. Clinical data from the treatment as well as nursing records of the patients were collected. All of the indwelling catheters used during the observation period of this study were included in the analysis. The clinical characteristics of the patients receiving iliac vein TCC are listed in Table 1.
Age, years
70 ± 6
Male sex, n (%)
40 (57.1)
Body weight post-HD, kg
62.2 ± 10.6
Dialytic age, months
48 ± 24
ESRD cause, n (%) Diabetes
28 (40)
Glomerulonephritis
20 (29)
Hypertension
14 (20)
Unknown
8 (11)
Comorbidities, n (%) Malnutrition
11 (16)
Tumor
4 (6)
Peripheral vascular disease
21 (30)
Cardiac dysfunction
34 (48)
SD, standard deviation; HD, hemodialysis; ESRD, end-stage renal disease
Tunneled hemodialysis catheter insertion
Fig. 1 Procedure of catheter placement
Before catheter placement, information about the risks and benefits of the procedure was provided to all patients, and signed written consent forms were obtained. The intervention was carried out by two experienced nephrologists. Before insertion, the anatomy of the iliac vein was monitored by ultrasound. All TCCs in this study were inserted under local anesthesia in a hospital-based operating room setting with blood pressure, oxygen saturation, and electrocardiographic monitoring. Dual-lumen 14.5 French Palindrome tunneled-cuffed hemodialysis catheters with lengths of 28–45 cm for iliac veins (Covidien, Mansfield, MA, USA) were used. The techniques used in this study have been previously published [9, 10].
After local anesthesia by applying 5 ml of 2 % lidocaine subcutaneously, the Seldinger technique was used to insert the catheter, with ultrasound guidance, by puncturing the iliac vein at an angle of *45°. Then, a subcutaneous pouch was made by a blunt dissection near the catheter and, after an incision lateral to the umbilicus, a subcutaneous tunnel was made between the incision and the pouch using a blunt procedure (Figs. 1, 2). Following the placement of the catheter, an abdominal x-ray was taken to confirm the correct localization of the tip of the catheter in the proximal inferior vena cava (range from the first to the fourth lumbar vertebra) (Fig. 3); the success rate of catheter placement was 100 %. Then, the
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indwelling to the time of the first catheter exchange. The infection-free survival rate was calculated from the time of catheter insertion to the time of the first episode of catheter-related bacteremia. The dysfunction-free survival rate of the catheter was analyzed from the time of insertion to the time of the first episode of arterial pressure \-250 mmHg or frequent pressure alarm at Qb \300 ml/ min despite changes in the patient’s position. Additionally, a progressive Qb decline of [10 % during a hemodialysis session compared to baseline was considered an indication of catheter dysfunction [33]. Follow-up information including death, dialysis modality change, transfer to another facility, or catheter removal was collected. Management of catheter infection and dysfunction Fig. 2 A 14-F 28-cm iliac vein tunneled cuffed catheter after insertion into the right iliac vein
Fig. 3 X-ray test showing the catheter tip positioned in the inferior vena cava
function of the catheter was checked by vigorous saline flushes with a 20-ml syringe. Finally, the vein incision site was closed, and the catheter was secured to the skin in the vicinity of the exit site with a 3-0 nylon suture. Clinical parameters Demographic and clinical information, including patients’ age, sex, and comorbidities, was collected. The catheter survival rate was analyzed from the time of catheter
During each dialysis session, the catheter and exit site were cleansed with 70 % alcohol and chlorhexidine and dressed appropriately with a sterile dressing. Exit-site infection was diagnosed by evidence of redness, swelling, and drainage from the exit site, in which case patients usually received daily treatment on the exit site with a 5 % povidone-iodine solution in combination with intravenous (IV) vancomycin empirically. In the absence of a more plausible infective source, a swab was used for diagnosis. Tunnel infection was diagnosed by evidence of infection in the tunnel extending proximal to the cuff, and included erythema, tenderness, and induration in the tissues overlying the catheter at[2 cm from the exit site [11]. When a patient developed fever or chills, then catheter-related bacteremia was suspected, in which case blood cultures, both from the catheter lumen and peripheral blood, were made. The measurement of the differential time to positivity (DTP) between blood cultures drawn through the catheter lumen and a peripheral vein was used as a diagnostic indicator of catheter-related bacteremia. A DTP of [120 min was used as a criterion for culture positivity [32]. In such cases, patients underwent systemic treatment with antibiotics in combination with an antibiotic lock protocol [12–14]. For the systemic antibiotic treatment, patients were started on empiric antibiotic therapy, which usually began with vancomycin and was subsequently modified according to the culture results. The systemic antibiotic daily regimen consisted of the following: IV vancomycin (8–15 mg/kg); cefodizime (25–30 mg/kg); meropenem (15–20 mg/kg); voriconazole (12–15 mg/kg). Meanwhile, the antibiotic lock protocol included the following: gentamycin (1 mg/ml) and heparin (5,000 units/ml saline) empirically at each hemodialysis session. The average duration of the antibiotic treatment was 21 days, depending on both clinical assessment and culture results. When persistent fever or positive surveillance blood cultures occurred, patients were scheduled for catheter exchange even if they were receiving the directed antimicrobial therapy.
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An arterial pressure of \-250 mmHg or a frequent pressure alarm at Qb \300 ml/min were considered indicators of catheter dysfunction according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF/DOQI) published guidelines [15]. Catheters were instilled with 5000 IU/ml of urokinase per port when the blood flow was less than 250 ml/min [16]. When this declotting procedure failed, 10,000 IU/ml of urokinase was used to fill the catheters for 40 min. If the second declotting procedure with urokinase failed, the catheters were exchanged, or catheter placement into a new site was scheduled. The dialysis parameters of the iliac vein TCCs are listed in Table 2.
Continuous variables are expressed as mean ± standard deviation or as the median (range, minimum to maximum) if the variable is not normally distributed; categorical variables are presented as frequencies (%). The catheter survival was analyzed using the Kaplan–Meier method with a log-rank test; p values and confidence intervals (CIs) were estimated in a two-tailed fashion. The difference was considered statistically significant at p \ 0.05. The statistical analysis was performed using the SPSS version 20.0 software (SPSSÒ software version 20.0.0; IBM Corp., Armonk, NY, USA).
the skin cultures contained Gram-positive bacteria, the remaining 10.9 % Gram-negative bacteria. Gram-positive species were involved in 98 % of the tunnel infections, while only 2 % were found to contain Gram-negative species. For positive blood cultures, Gram-positive species were found in 98 % of the cases, and fungus was found in 2 % of the cultures. The average catheter primary patency (time from initial insertion to first catheter exchange or use of urokinase) was 426 catheter days, while the incidence of catheter dysfunction was 0.8 per 1000 catheter days, and the median dysfunction-free survival was 875 catheter days. The 12and 24-month assisted primary patency rates were 82.9 and 80 %, respectively, while the 12- and 24-month secondary patency rates were 65.7 and 72.9 %, respectively. A total of 29 patients required a catheter exchange with the iliac vein TCC (Table 3); 24 of these (83 %) were due to persistent low blood flow after declotting procedure failure and 5 (17 %) were due to refractory infections after antibiotic treatment. When catheter survival was estimated by Kaplan–Meier survival analysis, the mean survival of the new tunneled dialysis catheter was 344.9 ± 64.5 catheter days (total of 24,146 days) in the first year, 691.8 ± 71.8 catheter days (total of 48,425 days) in the second year, and 933.8 ± 169.6 catheter days (total of 65,369 days) in the third year (Fig. 4).
Results
Discussion
The technical success rate for catheter insertion was 100 %. Severe complications, such as severe retroperitoneal bleeding, arterial or venous laceration, and cardiac perforation were not observed among the early complications. During the study period, 9 patients died (12.8 %), 4 due to neoplastic cachexia, 3 to severe infections, and 2 to heart failure. A total of 99 new tunneled dialysis catheters were indwelled. The incidence of infection was 2.1 per 1000 catheter days, while the primary infection days (time from initial placement to the first episode of infection) was 232 catheter days, and the median infection-free survival was 617 catheter days. In the case of exit-site infection, 89.1 % of
In terms of the site of insertion of TCC, the internal jugular vein is the first choice for most patients [17]. However, for some patients with a history of catheter insertion or peripheral venous problems, venous stenosis may occur, which may lead to the failure of a new catheter placement. Recently, Christoph Betz et al. reported the use of the iliac vein as an insertion site for a TCC, which offers another choice for patients [9]. In this study, all the patients had difficulty to create AVF and had exhausted all alternative vascular accesses. In addition, while for younger and healthier hemodialysis patients a fistula appears to be the access of choice, for most older and/or more severe patients who are prone to fistula failure and associated complications, and also tend to have a shorter life
Statistical analysis
Table 2 Dialysis parameters of the iliac vein tunneled cuffed catheters Mean ± SD
Table 3 Catheter exchange in study patients
Range
Period of follow-up
Patients requiring catheter exchange, n (%)
Kt/V
1.2 ± 0.13
0.9–1.56
First year
Effective Blood Flow, ml/min
254 ± 15
220–280
Second year
10 (14 %)
Weekly dialysis duration, h
11.6 ± 0.8
9–12
Third year
12 (17 %)
123
7 (10 %)
J Nephrol Fig. 4 Kaplan–Meier plots of survival rate of iliac vein tunneled cuffed catheter
expectancy, the risks outweigh the benefits of this procedure [18, 19]. Therefore, it may be more beneficial for elderly patients to choose a TCC for definitive access. Similar to other kinds of TCC, iliac vein TCC has associated complications, such as thrombosis formation, catheter-related infections, and venous stenosis. In this study, the infection rate in the iliac TCC group was not lower than that reported for femoral catheters in other reports [30, 31], albeit a direct comparison between different studies is difficult. We anticipated that a low site of catheter insertion may have less chance of exposure to infection [20]. Furthermore, as most of the patients in the iliac vein TCC group were in a more severe condition and immobilized, they remained in the hospital and thus had a greater access to antibiotic treatment, which may have also contributed to the reduced infection rate. It has been reported that thrombosis is the main cause of catheter dysfunction [21–23, 34]. In this study, catheter dysfunction was a common reason for catheter exchange, possibly because iliac vein TCCs are prone to kinking, accompanied by occlusion due to gravity when patients stand. Moreover, endothelial injury may be enhanced from wall contact with a longer course, especially during physiologic movements, which in turn stimulates fibrotic pathways [24, 25]. In addition, blood flow reduction, accompanied by local trauma to the venous wall were likely risk factors for dialysis inadequacy in these patients [24, 25]. However, in our study, some patients were in more severe condition and immobilized, which may have contributed to reduce the contact between the endothelium of
the veins and catheter during movement as suggested in previous studies [27–29]. Among the significant limitations of our study is its observational design. Similarly, the patient number was small and there was no ideal control group available for comparison, which may limit our conclusions. In addition, data from other studies cannot be compared with ours due to discrepancies that may be related to differences in study methodologies, e.g. the use of retrospective versus prospective approaches, distinct culture techniques, and study sample differences (age or race), which may impact the results [26, 30, 31]. Equally important, the elderly patients in our study had several comorbidities, which is different from other studies. Thus our study provides information on the choice of vascular site as well as useful information to guide clinicians in making decisions with regard to catheter insertion for elderly patients. In conclusion, the placement and use of iliac vein TCCs is safe and a technically feasible option for hemodialysis in elderly patients, with an acceptable incidence of infection and dysfunction rate. For this type of study, formal consent is not required. Conflict of interest of interest.
The authors declare that they have no conflict
Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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17. Hayashi R, Huang E, Nissenson AR (2006) Vascular access for hemodialysis. Nat Clin Pract Nephrol 2(9):504–513. doi:10.1038/ ncpneph0239 18. Xue JL, Dahl D, Ebben JP et al (2003) The association of initial hemodialysis access type with mortality outcomes in elderlyly Medicare ESRD patients. Am J Kidney Dis 42:1013–1019. doi:10.1016/j.ajkd.2003.07.004 19. Work J (2001) Chronic catheter placement. Sem Dial 14:436–440. doi:10.1046/j.1525-139x.2001.00108.x 20. Martı´n-Pen˜a A, Luque Ma´rquez R, Guerrero MJ et al (2012) Tunneled hemodialysis catheter-related bloodstream infections: a prospective multicenter cohort study from Spain. J Vasc Access 3(2):239–245. doi:10.5301/jva.5000034 21. Banerjee Satyaki (2009) Dialysis catheters and their common complications: an update. TheScientificWorldJOURNAL 18(9):1294–1299. doi:10.1100/tsw.2009.145 22. Wilkin TD, Kraus MA, Lane KA, Trerotola SO (2003) Internal jugular vein thrombosis associated with hemodialysis catheters. Radiology 228:697–700. doi:10.1148/radiol.2283020681 23. Liangos O, Gul A, Madias NE, Jaber BL (2006) Long-term management of the tunneled venous catheter. Semin Dial 19:158–164. doi:10.1111/j.1525-139X.2006.00143.x 24. Shanaah A, Brier M, Dwyer A (2013) Fibrin sheath and its relation to subsequent events after tunneled dialysis catheter exchange. Semin Dial 26(6):733–737. doi:10.1111/sdi.12074 25. Oliver MJ, Mendelsson DC, Quinn RR et al (2007) Catheter patency and function after catheter sheath disruption: a pilot study. Clin J Am Soc Nephrol 2:1201–1206. doi:10.2215/CJN.01910507 26. Maya ID, Allon M (2005) Outcomes of tunneled femoral hemodialysis catheters: comparison with internal jugular vein catheters. Kidney Int 68(6):2886–2889. doi:10.1111/j.1523-1755. 2005.00762.x 27. Asif A (2008) Reducing the morbidity of tunneled hemodialysis catheters–a symposium. Semin Dial 21(6):503. doi:10.1111/j. 1525-139X 28. Moist LM, Trpeski L, Na Y et al (2008) Increased hemodialysis catheter use in Canada and associated mortality risk: data from the Canadian Organ Replacement Registry 2001–2004. Clin J Am Soc Nephrol 3:1726–1732. doi:10.2215/CJN.01240308 29. Apostolou T (2007) Quality of life in the elderlyly patients on dialysis. Int Urol Nephrol 39:679–683. doi:10.1016/j.urology. 2006.09.004 30. Herrington William G, Nye Helen J, Haynes Richard J, Winearls Christopher G, Vaux Emma C (2013) Does prophylactic anticoagulation reduce the risk of femoral tunneled dialysis catheterrelated complications? J Vasc Access 14(2):135–142. doi:10. 5301/jva.5000117 31. Hinchliffe WT, Ahmed S, Mansy H (2011) Bilateral cuffed tunnelled femoral dialysis catheters. Int J Nephrol Renovasc Dis 4:137–138. doi:10.2147/IJNRD.S25687 32. Blot F, Nitenberg G, Chachaty E et al (1999) Diagnosis of catheter related bacteraemia: a prospective comparison of the time to positivity of hub-blood versus peripheral-blood cultures. Lancet 354:1071–1077. doi:10.1016/S0140-6736(98)11134-0 33. Besarab A, Pandey R (2011) Catheter management in hemodialysis patients: delivering adequate flow. Clin J Am Soc Nephrol 6(1):227–234. doi:10.2215/CJN.04840610 34. Forneris G, Savio D, Quaretti P et al (2014) Dealing with stuck hemodialysis catheter: state of the art and tips for the nephrologist. J Nephrol 27:619–625. doi:10.1007/s40620-014-0150-4
ORIGINAL ARTICLE
Use of iliac vein tunneled cuffed catheters in elderly hemodialysis patients: a single-center retrospective study Lihua Wang1 • Fang Wei1 • Guijiang Sun1 • Haiyan Chen1 Haibo Yu1 • Aili Jiang1,2
•
Received: 24 February 2015 / Accepted: 11 April 2015 Ó Italian Society of Nephrology 2015
Abstract Background Until now, the survival of iliac vein tunneled cuffed catheters (TCCs) used in elderly patients has not been fully investigated. Accordingly, we evaluated their use in elderly hemodialysis patients with no other venous access options. Methods A total of 70 elderly patients with iliac vein TCCs undergoing chronic hemodialysis were included in this study. Patients’ baseline anthropometric and laboratory parameters were measured. Incidence of catheter dysfunction and of catheter-related infection was documented. Results During the study period, a total of 99 new tunneled dialysis catheters were placed. Technical success rate was 100 %. Median infection-free survival and dysfunction-free survival after catheterization was 617 and 875 catheter days, respectively. Mean survival time per catheter was 1067 catheter days, corresponding to a total observation period of 65369 catheters days. Conclusions Iliac TCC is both technically feasible and effective for hemodialysis in elderly patients with no other venous access options.
& Aili Jiang [email protected] 1
Department of Kidney Disease and Blood Purification Centre, Institute of Urology and Key Laboratory of Tianjin, 2nd Hospital of Tianjin Medical University, Tianjin, People’s Republic of China
2
23rd, Pingjiang Road, Hexi District, Tianjin 300211, People’s Republic of China
Keywords Hemodialysis Iliac tunneled cuffed catheter Elderly patients
Introduction Recently, tunneled cuffed catheters (TCCs) have been widely used for vascular access in hemodialysis patients. Among these patients, the number of elderly patients is increasing rapidly [1]. Meanwhile, comorbid conditions, such as vascular disease and especially complications associated with diabetes and cardiovascular disease (CVD), are also progressively increasing, which in turn makes the elderly more likely to prefer a TCC to a fistula for longterm dialysis [2]. In some respects, the tunneled hemodialysis catheter is superior to arteriovenous fistula (AVF) or grafts; for example, it is easily inserted, requires no vein puncture, and can be immediately used [3, 4]. However, there is also concern regarding the high morbidity and mortality that are associated with catheters, as costs per person per year to maintain hemodialysis are steadily rising [5]. Currently, there are a few entry points for tunneled hemodialysis catheters, including the iliac veins [6, 7]. These catheters may be an option for those patients in whom it is difficult to create an AVF or AVF graft and those with bilateral central vein occlusion, making it impossible to place a dialysis catheter in the chest. Although studies regarding the outcome and complications of long-term tunneled catheters have been performed, to our knowledge the survival rate (primary patency) of iliac vein TCCs used in elderly patients has not been fully investigated [8]. Therefore, we undertook this retrospective study to analyze the survival rate of iliac vein TCCs in elderly patients undergoing chronic hemodialysis.
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J Nephrol
Patients and methods
Table 1 Baseline characteristics of the study patients Parameter
Mean ± SD
Patients, n
70
Patients A total of 70 incident dialysis patients aged over 65 years between January 2011 and December 2013 were included in the study. Patients suffering from varices of both lower limbs or with bleeding tendency were excluded. The mean age of the patients was 72 years at the start of study. The causes of end-stage renal disease (ESRD) in the study population were: diabetic nephropathy (40 %), primary glomerulonephritis (29 %), hypertensive nephropathy (20 %), and undetermined disease (11 %). All of the patients (100 %) included in our study had a history of catheter insertion into both the right and left internal jugular veins. Some of them (11 %) had had fistula before but had no useable vascular access left, while others were deemed not suitable for an AVF because of difficulty to create a fistula due to peripheral vascular disease (34 %) or cardiac dysfunction (55 %). Computed axial tomographic (CAT) angiography was performed in general to confirm the unsuitability of using a central venous catheter in the jugular vein, excepting in the case of immobilized patients or those with severe comorbidities. The subclavian was excluded for cannulation as it anatomically joins into the internal jugular vein. The femoral vein was also excluded for cannulation due to our concern about infection risk. The patients were undergoing continuous hemodialysis three times a week with a double-pool Kt/V target dose of not less than 1.2. Clinical data from the treatment as well as nursing records of the patients were collected. All of the indwelling catheters used during the observation period of this study were included in the analysis. The clinical characteristics of the patients receiving iliac vein TCC are listed in Table 1.
Age, years
70 ± 6
Male sex, n (%)
40 (57.1)
Body weight post-HD, kg
62.2 ± 10.6
Dialytic age, months
48 ± 24
ESRD cause, n (%) Diabetes
28 (40)
Glomerulonephritis
20 (29)
Hypertension
14 (20)
Unknown
8 (11)
Comorbidities, n (%) Malnutrition
11 (16)
Tumor
4 (6)
Peripheral vascular disease
21 (30)
Cardiac dysfunction
34 (48)
SD, standard deviation; HD, hemodialysis; ESRD, end-stage renal disease
Tunneled hemodialysis catheter insertion
Fig. 1 Procedure of catheter placement
Before catheter placement, information about the risks and benefits of the procedure was provided to all patients, and signed written consent forms were obtained. The intervention was carried out by two experienced nephrologists. Before insertion, the anatomy of the iliac vein was monitored by ultrasound. All TCCs in this study were inserted under local anesthesia in a hospital-based operating room setting with blood pressure, oxygen saturation, and electrocardiographic monitoring. Dual-lumen 14.5 French Palindrome tunneled-cuffed hemodialysis catheters with lengths of 28–45 cm for iliac veins (Covidien, Mansfield, MA, USA) were used. The techniques used in this study have been previously published [9, 10].
After local anesthesia by applying 5 ml of 2 % lidocaine subcutaneously, the Seldinger technique was used to insert the catheter, with ultrasound guidance, by puncturing the iliac vein at an angle of *45°. Then, a subcutaneous pouch was made by a blunt dissection near the catheter and, after an incision lateral to the umbilicus, a subcutaneous tunnel was made between the incision and the pouch using a blunt procedure (Figs. 1, 2). Following the placement of the catheter, an abdominal x-ray was taken to confirm the correct localization of the tip of the catheter in the proximal inferior vena cava (range from the first to the fourth lumbar vertebra) (Fig. 3); the success rate of catheter placement was 100 %. Then, the
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indwelling to the time of the first catheter exchange. The infection-free survival rate was calculated from the time of catheter insertion to the time of the first episode of catheter-related bacteremia. The dysfunction-free survival rate of the catheter was analyzed from the time of insertion to the time of the first episode of arterial pressure \-250 mmHg or frequent pressure alarm at Qb \300 ml/ min despite changes in the patient’s position. Additionally, a progressive Qb decline of [10 % during a hemodialysis session compared to baseline was considered an indication of catheter dysfunction [33]. Follow-up information including death, dialysis modality change, transfer to another facility, or catheter removal was collected. Management of catheter infection and dysfunction Fig. 2 A 14-F 28-cm iliac vein tunneled cuffed catheter after insertion into the right iliac vein
Fig. 3 X-ray test showing the catheter tip positioned in the inferior vena cava
function of the catheter was checked by vigorous saline flushes with a 20-ml syringe. Finally, the vein incision site was closed, and the catheter was secured to the skin in the vicinity of the exit site with a 3-0 nylon suture. Clinical parameters Demographic and clinical information, including patients’ age, sex, and comorbidities, was collected. The catheter survival rate was analyzed from the time of catheter
During each dialysis session, the catheter and exit site were cleansed with 70 % alcohol and chlorhexidine and dressed appropriately with a sterile dressing. Exit-site infection was diagnosed by evidence of redness, swelling, and drainage from the exit site, in which case patients usually received daily treatment on the exit site with a 5 % povidone-iodine solution in combination with intravenous (IV) vancomycin empirically. In the absence of a more plausible infective source, a swab was used for diagnosis. Tunnel infection was diagnosed by evidence of infection in the tunnel extending proximal to the cuff, and included erythema, tenderness, and induration in the tissues overlying the catheter at[2 cm from the exit site [11]. When a patient developed fever or chills, then catheter-related bacteremia was suspected, in which case blood cultures, both from the catheter lumen and peripheral blood, were made. The measurement of the differential time to positivity (DTP) between blood cultures drawn through the catheter lumen and a peripheral vein was used as a diagnostic indicator of catheter-related bacteremia. A DTP of [120 min was used as a criterion for culture positivity [32]. In such cases, patients underwent systemic treatment with antibiotics in combination with an antibiotic lock protocol [12–14]. For the systemic antibiotic treatment, patients were started on empiric antibiotic therapy, which usually began with vancomycin and was subsequently modified according to the culture results. The systemic antibiotic daily regimen consisted of the following: IV vancomycin (8–15 mg/kg); cefodizime (25–30 mg/kg); meropenem (15–20 mg/kg); voriconazole (12–15 mg/kg). Meanwhile, the antibiotic lock protocol included the following: gentamycin (1 mg/ml) and heparin (5,000 units/ml saline) empirically at each hemodialysis session. The average duration of the antibiotic treatment was 21 days, depending on both clinical assessment and culture results. When persistent fever or positive surveillance blood cultures occurred, patients were scheduled for catheter exchange even if they were receiving the directed antimicrobial therapy.
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An arterial pressure of \-250 mmHg or a frequent pressure alarm at Qb \300 ml/min were considered indicators of catheter dysfunction according to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF/DOQI) published guidelines [15]. Catheters were instilled with 5000 IU/ml of urokinase per port when the blood flow was less than 250 ml/min [16]. When this declotting procedure failed, 10,000 IU/ml of urokinase was used to fill the catheters for 40 min. If the second declotting procedure with urokinase failed, the catheters were exchanged, or catheter placement into a new site was scheduled. The dialysis parameters of the iliac vein TCCs are listed in Table 2.
Continuous variables are expressed as mean ± standard deviation or as the median (range, minimum to maximum) if the variable is not normally distributed; categorical variables are presented as frequencies (%). The catheter survival was analyzed using the Kaplan–Meier method with a log-rank test; p values and confidence intervals (CIs) were estimated in a two-tailed fashion. The difference was considered statistically significant at p \ 0.05. The statistical analysis was performed using the SPSS version 20.0 software (SPSSÒ software version 20.0.0; IBM Corp., Armonk, NY, USA).
the skin cultures contained Gram-positive bacteria, the remaining 10.9 % Gram-negative bacteria. Gram-positive species were involved in 98 % of the tunnel infections, while only 2 % were found to contain Gram-negative species. For positive blood cultures, Gram-positive species were found in 98 % of the cases, and fungus was found in 2 % of the cultures. The average catheter primary patency (time from initial insertion to first catheter exchange or use of urokinase) was 426 catheter days, while the incidence of catheter dysfunction was 0.8 per 1000 catheter days, and the median dysfunction-free survival was 875 catheter days. The 12and 24-month assisted primary patency rates were 82.9 and 80 %, respectively, while the 12- and 24-month secondary patency rates were 65.7 and 72.9 %, respectively. A total of 29 patients required a catheter exchange with the iliac vein TCC (Table 3); 24 of these (83 %) were due to persistent low blood flow after declotting procedure failure and 5 (17 %) were due to refractory infections after antibiotic treatment. When catheter survival was estimated by Kaplan–Meier survival analysis, the mean survival of the new tunneled dialysis catheter was 344.9 ± 64.5 catheter days (total of 24,146 days) in the first year, 691.8 ± 71.8 catheter days (total of 48,425 days) in the second year, and 933.8 ± 169.6 catheter days (total of 65,369 days) in the third year (Fig. 4).
Results
Discussion
The technical success rate for catheter insertion was 100 %. Severe complications, such as severe retroperitoneal bleeding, arterial or venous laceration, and cardiac perforation were not observed among the early complications. During the study period, 9 patients died (12.8 %), 4 due to neoplastic cachexia, 3 to severe infections, and 2 to heart failure. A total of 99 new tunneled dialysis catheters were indwelled. The incidence of infection was 2.1 per 1000 catheter days, while the primary infection days (time from initial placement to the first episode of infection) was 232 catheter days, and the median infection-free survival was 617 catheter days. In the case of exit-site infection, 89.1 % of
In terms of the site of insertion of TCC, the internal jugular vein is the first choice for most patients [17]. However, for some patients with a history of catheter insertion or peripheral venous problems, venous stenosis may occur, which may lead to the failure of a new catheter placement. Recently, Christoph Betz et al. reported the use of the iliac vein as an insertion site for a TCC, which offers another choice for patients [9]. In this study, all the patients had difficulty to create AVF and had exhausted all alternative vascular accesses. In addition, while for younger and healthier hemodialysis patients a fistula appears to be the access of choice, for most older and/or more severe patients who are prone to fistula failure and associated complications, and also tend to have a shorter life
Statistical analysis
Table 2 Dialysis parameters of the iliac vein tunneled cuffed catheters Mean ± SD
Table 3 Catheter exchange in study patients
Range
Period of follow-up
Patients requiring catheter exchange, n (%)
Kt/V
1.2 ± 0.13
0.9–1.56
First year
Effective Blood Flow, ml/min
254 ± 15
220–280
Second year
10 (14 %)
Weekly dialysis duration, h
11.6 ± 0.8
9–12
Third year
12 (17 %)
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7 (10 %)
J Nephrol Fig. 4 Kaplan–Meier plots of survival rate of iliac vein tunneled cuffed catheter
expectancy, the risks outweigh the benefits of this procedure [18, 19]. Therefore, it may be more beneficial for elderly patients to choose a TCC for definitive access. Similar to other kinds of TCC, iliac vein TCC has associated complications, such as thrombosis formation, catheter-related infections, and venous stenosis. In this study, the infection rate in the iliac TCC group was not lower than that reported for femoral catheters in other reports [30, 31], albeit a direct comparison between different studies is difficult. We anticipated that a low site of catheter insertion may have less chance of exposure to infection [20]. Furthermore, as most of the patients in the iliac vein TCC group were in a more severe condition and immobilized, they remained in the hospital and thus had a greater access to antibiotic treatment, which may have also contributed to the reduced infection rate. It has been reported that thrombosis is the main cause of catheter dysfunction [21–23, 34]. In this study, catheter dysfunction was a common reason for catheter exchange, possibly because iliac vein TCCs are prone to kinking, accompanied by occlusion due to gravity when patients stand. Moreover, endothelial injury may be enhanced from wall contact with a longer course, especially during physiologic movements, which in turn stimulates fibrotic pathways [24, 25]. In addition, blood flow reduction, accompanied by local trauma to the venous wall were likely risk factors for dialysis inadequacy in these patients [24, 25]. However, in our study, some patients were in more severe condition and immobilized, which may have contributed to reduce the contact between the endothelium of
the veins and catheter during movement as suggested in previous studies [27–29]. Among the significant limitations of our study is its observational design. Similarly, the patient number was small and there was no ideal control group available for comparison, which may limit our conclusions. In addition, data from other studies cannot be compared with ours due to discrepancies that may be related to differences in study methodologies, e.g. the use of retrospective versus prospective approaches, distinct culture techniques, and study sample differences (age or race), which may impact the results [26, 30, 31]. Equally important, the elderly patients in our study had several comorbidities, which is different from other studies. Thus our study provides information on the choice of vascular site as well as useful information to guide clinicians in making decisions with regard to catheter insertion for elderly patients. In conclusion, the placement and use of iliac vein TCCs is safe and a technically feasible option for hemodialysis in elderly patients, with an acceptable incidence of infection and dysfunction rate. For this type of study, formal consent is not required. Conflict of interest of interest.
The authors declare that they have no conflict
Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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