Background: Several peritoneal dialysis catheter (PDC) placement techniques have been described. The objective of this study was to compare the ﬂuoroscopy and ultrasound guidance technique with the laparoscopic technique. Methods: We retrospectively reviewed the medical records of 260 patients who had their ﬁrst PDC placed between January 2005 and June 2016. We compared the outcomes of the ﬂuoroscopic and ultrasound-guided catheter placement technique (radiologic group, n ¼ 50) with the laparoscopic catheter placement technique (laparoscopic group, n ¼ 190). The primary endpoint was complication-free catheter survival at 365 days. Secondary endpoints were complication-free catheter survival at 90 days, overall catheter survival at 90 and 365 days, median days to ﬁrst complication and median days to catheter removal. Results: In the radiologic group, the complication-free catheter survival at 90 and 365 days was 64% and 48%, respectively, while in the laparoscopic group it was 71% (P¼ 0.374) and 53% (P¼ 0.494), respectively. Catheter malfunction was signiﬁcantly higher in the laparoscopic group (30%) compared with the radiologic group (16%, P¼ 0.048). The overall catheter survival at 90 and 365 days was 76% and 52%, respectively, in the radiologic group, while in the laparoscopic group it was 88% (P¼ 0.0514) an 48% (P¼ 0.652), respectively. There was no signiﬁcant difference in the median days to ﬁrst complication and the median days to catheter removal between the two groups (P¼ 0.71). Conclusion: The technique of ﬂuoroscopic and ultrasound-guided PDC placement is a clinically effective and safe alternative to laparoscopic catheter placement with similar survival and complication rates. Key words: end-stage renal disease, ﬂuoroscopic, hemodialysis, laparoscopic, peritoneal dialysis catheter, ultrasound Received: May 21, 2017. Editorial decision: October 9, 2017 V C The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact email@example.com Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/549/4735326 by Ed 'DeepDyve' Gillespie user on 07 August 2018 550 | A.K. Abdel Aal et al. general anesthesia. Inclusion criteria were patients with CKD Introduction Stage 5 or ESRD who were 19 years of age and had their first Patients suffering from chronic kidney disease (CKD) and end- PDC placed during the study period. Exclusion criteria were stage renal disease (ESRD) who are undergoing renal replacement patients who had no follow-up after catheter placement in our therapy may elect to use peritoneal dialysis (PD) or hemodialysis institution, patients who had a PDC placed but not used during (HD) or pursue preemptive renal transplantation. The overall cost the study period because they did not meet the criteria for for patients receiving PD has been shown to be an average of $20 dialysis (embedded catheters) and patients who had their cath- 000 per year lower than for patients receiving in-center HD. In eters successfully placed after more than one attempt. Patients addition to the favorable economic landscape for PD, the patient- who required adhesiolysis, omentopexy or hernia repair during centric factors that may make PD a favorable dialysis option are laparoscopic PDC placement and patients with prior abdominal the ability to perform dialysis at home, largely during the night- surgery or severe obesity in both groups were not excluded. time to allow for more flexibility during the daytime, less interfer- Figure 1 shows the algorithm for patients’ inclusion and ence with employment schedule, ability to travel and fewer exclusion. dietary restrictions compared with in-center HD . Recent com- Demographic data were obtained from the patients’ medical parisons of early and late survival between PD and HD suggest an charts. Information regarding patients’ comorbidities was also early survival advantage to starting dialysis with PD and a similar recorded, including body mass index (BMI), coronary artery dis- longer-term survival at 5 years [2, 3]. ease, hypertension, congestive heart failure, peripheral vascular These factors have led some clinicians to call for a ‘PD first’ disease, diabetes or cerebral vascular disease that would affect position and to consider PD not just for the elective start to their eligibility to obtain general anesthesia for laparoscopic dialysis but for more urgent initiation of dialysis in patients catheter placement. Obesity, defined as a BMI30, was included presenting late in the course of their disease [1, 4, 5]. The recent and the BMI was classified into three categories: Class 1 is BMI interest in ‘urgent-start PD’ raised awareness of the need for of 30–<35, Class 2 is BMI of 35–<40 and Class 3 is BMI40. We more expeditious PD catheter (PDC) placement within 24–48 h also recorded the failed attempts when placing a PDC with each to avoid unnecessary use of temporary vascular access technique as well as the prior surgical history of the patients. catheters for HD . This requirement faces obstacles in some Advanced laparoscopic techniques such as adhesiolysis, omen- institutions that use laparoscopic PDC insertion but there topexy or hernia repairs were recorded if they were done simul- is suboptimal accessibility to surgical services for PDC place- taneously during laparoscopic PDC placement. ment, resulting in difficulties in clinic and operating room scheduling. These operational inefficiencies drew attention to a different technique for PDC placement by interventional radiologists and Study outcomes nephrologists using fluoroscopy and ultrasound guidance, pro- The primary endpoint was the occurrence of PDC-related com- viding a minimally invasive approach to catheter placement plications at 365 days (complication-free catheter survival at that avoids general anesthesia or operating room logistical bar- 365 days), which was a composite endpoint that includes riers [7–12]. mechanical, infectious, technical and miscellaneous complica- The objective of this study was to compare the outcomes of tions. The mechanical complications included catheter mal- PDC placement using fluoroscopic and ultrasound-guided function related to inadequate drainage from the catheter, technique with the laparoscopic technique. A recent study catheter leak through the exit site, and abdominal herniation. suggested PDC outcomes in prospective randomized trials The infectious complications included peritonitis, tunnel infec- may vary due to exclusion of obese patients and those who tion and exit site infection. The technical complications have had prior surgery, resulting in outcomes that represent included insertion failure, defined as an inability to insert the what can be achieved under the most favorable circumstances catheter or an inability to use the catheter after successful . Therefore, our study was designed to include obese insertion, muscle hematoma, intraperitoneal bleeding and patients and patients with prior surgery. We also included patients who underwent simultaneous adhesiolysis, omento- pexy or hernia repairs, because exclusion of these patients might have adversely affected the results in favor of the radio- logic technique. Materials and methods Study population The study was approved by our institutional review board and patient’s informed consent was waived. The medical records of 260 patients who initiated PD between January 2005 and June 2016 as identified from the interventional radiology and dialysis registries were retrospectively reviewed. The patient population was divided into two groups: the radiologic group, which included patients who had a PDC placed by the fluoroscopic and ultrasound-guided technique by interventional radiologists or interventional nephrologists under conscious sedation, and the laparoscopic group, which included patients who received PDC insertion by the laparoscopic technique by surgeons and under Fig. 1. Algorithm for patients’ inclusion and exclusion. Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/549/4735326 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Radiologic versus laparoscopic peritoneal catheters | 551 Table 1. Demographics and baseline characteristics of the radiologic bowel perforation. Miscellaneous complications includes all and laparoscopic groups other complications encountered during the follow-up period. Secondary endpoints were the occurrence of PDC-related Radiologic Laparoscopic complications at 90 days (complication-free catheter survival at group group 90 days), catheter removal at 90 days (catheter survival at 90 Characteristics (n ¼ 50), n (%) (n ¼ 190), n (%) P-value days), catheter removal at 365 days (overall catheter survival at 365 days), median days to first complication and median Age 56 (47, 66) 54 (40, 63) 0.102 days to catheter removal. Catheter complications from each Sex 0.027 group were also recorded. The data on catheter placement, Male 29 (58) 77 (41) complications and removal were obtained from the patients’ Female 21 (42) 113 (59) BMI 27 (26, 32) 28 (24, 35) 0.916 electronic medical records and from a prospective dialysis Diabetes 25 (50) 90 (47) 0.740 access database. Hypertension 44 (88) 178 (94) 0.223 Coronary artery disease 17 (34) 42 (22) 0.082 Congestive heart failure 14 (28) 43 (23) 0.427 Technique of radiologic and laparoscopic catheter Peripheral vascular disease 8 (16) 21 (11) 0.339 placement Cerebrovascular disease 3 (6) 11 (6) 0.999 Radiologic PDC placement using fluoroscopy and ultrasound guidance has been previously described and was performed by a Median (25th and 75th percentiles in parentheses). three interventional radiologists and one interventional neph- rologist each with at least 5 years of experience [7, 9, 12]. A Table 2. BMI characteristics of the radiologic and laparoscopic micropuncture set was used to access the peritoneum. The lap- groups aroscopic catheter insertion was performed by one surgeon with at least 5 years experience in placing PD catheters using Radiologic Laparoscopic this technique. The laparoscopic technique was previously BMI group (n ¼ 50), n (%) group (n ¼ 190), n (%) P-value described in the literature . Total (30) 15 (30) 68 (35.8) 0.44 Class 1 (30–< 35) 11 (22) 28 (14.7) 0.22 Statistical analysis Class 2 (35–< 40) 4 (8) 25 (13.2) 0.32 Class 3 (40) 0 (0) 15 (7.9) 0.04 Medians and interquartile ranges (IQRs) were calculated for con- tinuous variables and frequencies and percentages were calcu- lated for categorical variables. Differences between the two groups were compared using Fisher’s exact test and Kruskal– Table 3. Simultaneous advanced techniques in the laparoscopic Wallis one-way analysis of variance. Complication-free survival groups and overall catheter survival curves were estimated using the Kaplan–Meier approach. The log-rank tests were used to assess Laparoscopic technique n (%) homogeneity across strata. Total 34 (17.9) Omentopexy 19 (10) Hernia repair 15 (7.9) Results There was a significant difference in the gender between both groups (P ¼ 0.03), with more males in the radiologic group and Prior surgical procedures were performed in 19 patients more females in the laparoscopic group. Apart from this, there (38%) in the radiologic group compared with 92 patients (48.4%) were no significant differences in the patient’s demographics or in the laparoscopic group (P ¼ 0.19) (Table 4). The most common comorbidities (Table 1). The radiologic group comprised a total surgical procedure performed in both groups was hysterectomy, of 50 patients while the laparoscopic group comprised 190 which accounted for 7 patients (36.8%) and 28 patients (30.4%) patients. The radiologic group consisted of 21 females and 29 in the radiologic and laparoscopic groups, respectively. Other males with a median age of 56.3 years (IQR 47.17–66.41). The lap- surgical procedures performed included abdominal exploration, aroscopic group included 113 females and 77 males with a appendectomy, cesarean section, cholecystectomy, colon sur- median age of 54.3 years (IQR 40.26–63.41). Obesity in the radio- gery, fundoplication, gastric bypass, kidney transplantation, logic and laparoscopic groups was seen in 15 patients (30%) and myomectomy, nephrectomy, salpingo-oophrectomy and tubal 68 patients (35.8%), respectively (P ¼ 0.44) (Table 2). In the radio- ligation. logic group, 11 patients (73.3%) and 4 patients (26.7%) were Class The complication-free catheter survival at 90 days was 64% 1 and 2 obesity, respectively. There was no Class 3 obesity in the in the radiologic group and 71% in the laparoscopic group, radiologic group. In the laparoscopic group, 28 patients (41.2%), which was not significant (P ¼ 0.374). The complication-free 25 patients (36.8%) and 15 patients (22%) were Class 1, 2 and 3 catheter survival at 365 days was 48% in the radiologic group obesity, respectively. Advanced techniques were simultane- and 53% in the laparoscopic group, respectively, which was also ously employed during laparoscopic PDC placement in 34 not significant (P ¼ 0.494). Catheter complication rates and patients (17.9%), which included laparoscopic hernia repair in complication-free survival times for the radiologic and laparo- 15 patients (7.9%) and laparoscopic omentopexy in 19 patients scopic groups are shown in Table 5. (10%) (Table 3). Failed placement from the first attempt was Catheter malfunction and peritonitis were the most frequent seen in two (4%) and four (2%) patients in the radiologic and lap- complications in both groups. Catheter malfunction occurred in aroscopic groups, respectively. These patients were excluded 57 patients (30%) in the laparoscopic group, which was signifi- from the statistical analysis. cantly higher compared with 8 patients (16%) in the radiologic Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/549/4735326 by Ed 'DeepDyve' Gillespie user on 07 August 2018 552 | A.K. Abdel Aal et al. Table 4. Prior surgical procedures in the radiologic and laparoscopic groups Radiologic Laparoscopic group (n ¼ 50), group (n ¼ 190), Type of surgery n (%) n (%) P-value Total 19 (38) 92 (48.4) 0.19 Abdominal exploration 2 (4) 2 (1) 0.15 Appendectomy 1 (2) 3 (1.6) 0.84 Cesarean section 2 (4) 22 (11.6) 0.11 Cholecystectomy 2 (4) 6 (3.2) 0.77 Colon surgery 0 (0) 5 (2.6) 0.25 Fundoplication 0 (0) 1 (0.5) 0.61 Gastric bypass 1 (2) 1 (0.5) 0.31 Hysterectomy 7 (14) 28 (14.7) 0.90 Kidney transplantation 3 (6) 6 (3.2) 0.35 Myomectomy 0 (0) 1 (0.5) 0.61 Nephrectomy 0 (0) 8 (4.2) 0.14 Salpingo-oophorectomy 0 (0) 3 (1.6) 0.37 Fig. 2. Kaplan–Meier survival curves for catheter complication in the radiologic Tubal ligation 1 (2) 6 (3.2) 0.67 and laparoscopic groups. Table 6. Overall catheter survival for radiologic and laparoscopic Table 5. Catheter complication rates and complication-free catheter groups survival times for radiologic and laparoscopic groups Radiologic Laparoscopic Radiologic Laparoscopic (n ¼ 50), n (%) (n ¼ 190), n (%) P-value (n ¼ 50), n (%) (n ¼ 190), n (%) P-value Total catheter removal 12 (24) 59 (31) 0.321 Total complications 31 (62) 119 (63) Overall survival at 90 days 35 (70) 136 (72) 0.051 Exit site infections 2 (4) 10 (5) 0.999 Overall survival at 365 days 24 (48) 75 (39) 0.652 Peritonitis 8 (16) 32 (17) 0.887 Days until removal 396 (118, 1335) 347 (143, 624) 0.709 Catheter malfunction 8 (16) 57 (30) 0.048 Catheter leak 5 (10) 6 (3) 0.055 Median (25th and 75th percentiles in parentheses). Primary leak 1 (2) 2 (1) 0.506 Muscle hematoma or 3 (6) 3 (2) 0.107 bleeding Bowel perforation 1 (2) 0 (0) 0.208 Hernia 3 (6) 9 (5) 0.718 Complication-free survival 32 (64) 134 (71) 0.374 at 90 days Complication-free survival 24 (48) 101 (53) 0.494 at 365 days Complication-free days 124 (17, 531) 162 (64, 383) 0.541 Median (25th and 75th percentiles in parentheses). group (P ¼ 0.048). Peritonitis occurred in 8 patients (16%) in the radiologic group compared with 32 patients (17%) in the laparo- scopic group, which was not statistically significant (P ¼ 0.887). Bowel perforation occurred in only one case in the radiologic group and was treated conservatively by overnight observation and antibiotic administration. The remaining complications occurred at a higher rate in the laparoscopic group compared with the radiologic group, but without statistical significance. Fig. 3. Kaplan–Meier survival curves for catheter removal in the radiologic and The median time to the first complication in the radiologic laparoscopic groups. group was 124 days (IQR 17–531), which was not significantly different than 162 days (IQR 64–383) in the laparoscopic group (P significantly different from 347 days (IQR 143–624) in the laparo- ¼ 0.54) (Table 2). Kaplan–Meier survival analysis showed no sig- scopic group (P ¼ 0.71) (Table 6). Kaplan–Meier survival analysis nificant difference in the overall complication-free survival showed no significant difference in the overall catheter survival between both groups (P ¼ 0.37) (Figure 2). between both groups (P ¼ 0.50) (Figure 3). The overall catheter survival at 90 days was 70% in the radio- logic group and 72% in the laparoscopic group, which was not significantly different (P ¼ 0.0514). The overall catheter survival Discussion at 365 days was 48% in the radiologic group and 39% in the laparoscopic group, which was not significantly different PDC can be placed using either the laparoscopic technique (P ¼ 0.652). The median time to catheter removal was 396 days by surgeons or the percutaneous image-guided approach (IQR 118–1335) in the radiologic group, which was not by interventional radiologists. Several published studies Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/549/4735326 by Ed 'DeepDyve' Gillespie user on 07 August 2018 Radiologic versus laparoscopic peritoneal catheters | 553 comparing both techniques were retrospective and were limited representative of what can be achieved in the most favorable mostly by inherent selection bias and institution-specific clini- circumstances. cal practices, which makes the interpretation of catheter out- Recently the same group published a retrospective cohort comes difficult. In clinical practice, patients with prior surgery study comparing radiologically and laparoscopically placed as well as obese patients are usually referred for laparoscopic PDCs . Similar to the current study, there was no significant placement, while patients with advanced age and with multiple difference between the radiologic and laparoscopic groups comorbidities are referred for percutaneous image-guided regarding complication-free catheter survival or overall catheter placement since these patients usually have one or more fac- survival at 365 days . The overall patient survival, however, tors that make them ineligible to receive general anesthesia. In was statistically significantly higher for the laparoscopic group, the current study there was no significant difference in the BMI, due to the significant patient comorbidities and frail patients in prior surgical procedures or other comorbidities between the the radiologic group, which was an inherent limitation of the radiologic and laparoscopic groups. On the other hand, patients study resulting from the selection bias when patients were who underwent adhesiolysis, omentopexy and hernia repair referred to either technique. during laparoscopic catheter placement were not excluded from Several published retrospective studies comparing the out- the study since these advanced laparoscopic techniques are comes of traditional surgical placement of PDCs with the radio- now standard and have been shown to significantly improve logic percutaneous image-guided technique concluded that the laparoscopically placed catheters. Excluding these patients will radiologic placement outcomes were comparable, yet allowed adversely skew the outcomes in favor of the radiologic group. for more outpatient procedures, facilitated a more planned The results of this study show that there were significantly outpatient PD training and transition to home therapy and is more males in the radiologic group and significantly more a viable option compared to traditional surgical approaches females in the laparoscopic group. This bias may be due to the [15–19]. assumption by the referring nephrologists and other clinicians Placement of PDCs by image-guided percutaneous techni- that males will tolerate the radiologic procedure, which was ques received renewed interest after reports of more rapid ini- done under conscious sedation, while females are more likely tiation of PD in patients presenting late in the course of their to require general anesthesia. disease and needing more urgent PD therapy. To allow for the The results of this study indicate that the complication-free rapid initiation of PD, many centers have developed pathways catheter survival at 90 and 365 days as well as the overall cathe- for image-guided percutaneous placement of PDCs by inter- ter survival at 90 and 365 days were similar in both groups. ventional radiologists followed by assisted-PD treatments Among the various complications encountered in our study in given by PD nurses in the outpatient setting until the patient both groups, catheter malfunction appears to be the only com- has clinically improved and is able to be trained in self-care at plication that was significantly higher in the laparoscopic group home . Development of the percutaneous image-guided when compared with the radiologic group. Bowel perforation technique for placement of PDC as well as advancement in the was the only complication that was encountered exclusively in skill set among interventional radiologists in placing these one case in the radiologic group and occurred during the catheters has helped tremendously in the establishment of authors’ early experience with the radiologic percutaneous urgent-start PD programs . Fluoroscopic-guided techniques image-guided technique. Therefore the radiologic percutaneous may also be used to attempt to restore function in those PDCs image-guided technique is not inferior to the laparoscopic cath- that have inflow or outflow disturbances, have migrated out of eter placement technique even in patient groups that in clinical the pelvic location or have been occlude with fibrin or tissue. practice are typically considered high risk or ineligible for the Various fluoroscopic stiff wire manipulations have been radiologic approach. described in the literature and may offer a more cost-effective The results of the current study are slightly different than and expeditious pathway toward catheter revision compared some of the studies published in the literature. In a prospective with referring the patient to surgical PDC revision or reposi- trial, Voss et al. randomly assigned 113 patients to either tioning [22–24]. fluoroscopic placement of a PDC under local anesthetic versus The current study adds to the emerging literature suggesting laparoscopic placement under general anesthesia. The primary that in centers with dedicated interventional radiology staff outcome was complication-free catheter survival (complications experienced in PDC placement, catheter outcomes can be com- secondary to mechanical or infectious causes) at 1 year. parable to laparoscopically placed catheters and therefore may Secondary endpoints included catheter removal, procedure offer a minimally invasive and cost-effective catheter place- time, procedure pain, length of inpatient admissions, procedure ment option. room time utilization and direct hospital costs. The complication- A limitation of this study includes its retrospective nature free catheter survival was significantly higher in the radiologic resulting in inherent selection bias. However, the existence of group (42.5%) when compared to the laparoscopic group (18.1%; prospective dialysis registries at our center as well as the pro- P ¼ 0.03). Higher complication rates in the laparoscopic group spective collection of information on dialysis access procedures included increased peritonitis and leak events. Hospital costs provide a high degree of confidence that the information on were significantly higher in the laparoscopic group. The results catheter placement, complications and removal is accurate and demonstrated the non-inferiority of fluoroscopically placed PDCs. complete. The small sample size is another limitation. The However, the study was limited by several factors. First, the health study represents a single-center experience and the results can- care professionals who participated in this study were experts not be generalized. and trained to manage these study patients, which does not rep- resent the natural circumstances elsewhere. Second, the patients Conclusion included in the study were atypical, with exclusion of obese patients. Lastly, the patients included in the study were likely to In conclusion, the fluoroscopy and ultrasound-guided mini- receivebettercarethanthe usual circumstances regardless of the mally invasive technique for placement of PDCs can be per- treatment allocation. The results of the study were therefore formed safely and provides a clinically effective alternative to Downloaded from https://academic.oup.com/ckj/article-abstract/11/4/549/4735326 by Ed 'DeepDyve' Gillespie user on 07 August 2018 554 | A.K. Abdel Aal et al. 12. Abdel-Aal AK, Dybbro P, Hathaway P et al. Best practices the laparoscopic technique, with similar survival and complica- tion rates. This technique also allows for expeditious placement consensus protocol for peritoneal dialysis catheter place- of PDCs in late-referred patients with ESRD and therefore facili- ment by interventional radiologists. Perit Dial Int 2014; 34: tates urgent-start PD and avoids the need for placement of tem- 481–493 porary vascular access catheters. 13. Maher E, Wolley M, Abbas SA et al. Fluoroscopic versus laparoscopic implantation of peritoneal dialysis catheters: a retrospective cohort study. J Vasc Interv Radiol 2014; 25: Conflict of interest statement 895–903 A.K.A.A. is a consultant for Abbott Medical, Bard Peripheral 14. Voss D, Hawkins S, Poole G et al. Radiological versus surgical Vascular, Baxter Healthcare, Boston Scientific and W. L. Gore. S.S.G. implantation of ﬁrst catheter for peritoneal dialysis: a randomized non-inferiority trial. 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Clinical Kidney Journal – Oxford University Press
Published: Aug 1, 2018
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