| Abstract|| |
To evaluate the efficacy our new, three-cuff peritoneal dialysis (PD) catheter, with the low-entry technique and to study its impact on catheter survival and mechanical and infectious complications, we prospectively used it in 36 incident PD patients and compared the results with those of conventional double-cuff PD Tenckhoff catheters with the classic approach used in 37 patients. The study was carried out at our university hospital over a period of 18 months. At the end of the study, significantly higher survival rate was observed with the use of new catheter compared with the conventional two-cuff Tenckhoff catheter, 91.7% and 73%, respectively, (P <0.01); the difference in catheter survival was due to a lower incidence (P < 0.01) of catheter-tip migration and a lower incidence (P <0.01) of peritonitis. Dialysis fill and drain times were significantly shorter and Kt/V was better with our new catheter. In conclusion, the study suggests superiority of our new catheter and our new technique over the conventional one in terms of catheter survival. This is due to less incidences of catheter tip migration in addition to lower peritonitis rates. Dialysis adequacy was better because of shortened fill and drain time.
|How to cite this article:|
Al-Hwiesh AK. A modified peritoneal dialysis catheter with a new technique: Farewell to catheter migration. Saudi J Kidney Dis Transpl 2016;27:281-9
|How to cite this URL:|
Al-Hwiesh AK. A modified peritoneal dialysis catheter with a new technique: Farewell to catheter migration. Saudi J Kidney Dis Transpl [serial online] 2016 [cited 2020 Jan 28];27:281-9. Available from: http://www.sjkdt.org/text.asp?2016/27/2/281/178261
| Introduction|| |
Many peritoneal dialysis (PD) catheters have been developed over the years to address the most common complications associated with PD access such as catheter tip migration, peritoneal leak, peritonitis, exit site infection, and catheter entrapment. Despite many innovative designs, no catheter proved superior to double cuff Tenckhoff catheter.
The most appropriate PD catheter is the one that can be positioned deep in pelvis, can be kept out of reach of the omentum, and can provide an exit site that is easily visible and free of belt line. There is no consensus in the literature concerning the superiority of one particular PD catheter design and length over the other and each method of catheter insertion has its benefits and proponents, but no technique has been shown to be preferable over the other. 
In 1992, Dipolo  modified the classical Tenckhoff catheter with the aim to reduce catheter migration. He added material with high specific weight (tungsten cylinder at the distal end of the catheter) that tends to gravitate, especially when the patients are in erect position. Although different studies showed low incidence of migration with this selflocated catheter, others reported some drawbacks. Russo et al of the Bari group,  reported increased incidence of adhesions (visceroomental and viscero-visceral) that complicated removal of the self-located catheters. This complication is most likely due to the sudden increase in diameter between the silastic and the tungsten cylinder. Another possibility is that the presence of a foreign body in the peritoneal cavity causes a peritoneal reaction and formation of inflammatory scar tissue. In addition, the cost considerations might be important; with costs amounting to approximately US$310, the self-locating catheter is about 70% more expensive then the simple straight Tenckhoff catheter. 
We, at King Fahd Hospital of the University (KFHU), developed a new PD catheter and a new technique for laparoscopic catheter insertion. The new catheter has three cuffs, and the new method totally should eliminate the possibility of catheter-tip migration, significantly reduce the incidence of peritonitis, and improve both dialysis adequacy and technical survival of the PD catheter.
We aimed, in this study, to evaluate the efficacy our new PD catheter and the lowentry technique, and study its impact on catheter survival and mechanical and infectious complications.
| Materials and Methods|| |
We studied a total of 73 incident PD patients followed up at the PD Unit of KFHU over a period of 18 months (December 2012-June 2014). The patients were randomized into two groups; 37 patients in whom the conventional double-cuffed Tenckhoff catheters were inserted (Tenckhoff catheters with coiled end, Merit Medica) and 36 patients in whom the new catheter (triple-cuff) and the new technique were applied. We used the adaptive randomization method recommended by many researchers as a valid randomization method that takes stratification of prognostic variables into account for a relatively small sample size. ,,
The internal diameter of both the conventional catheter and the triple-cuff one was 3.5 mm. The length of the conventional Tenckhoff catheter was shortened by 5 cm to be equal in length to the new triple-cuff PD catheter. All the catheters were inserted laparoscopically under general anesthesia by one surgical team. All the catheters were evaluated for mechanical and infectious complications and the overall technical survival was analyzed separately in regard to the catheter type and the insertion technique. All the patients used automated PD (APD). Patients with previous abdominal or pelvic surgery or with history of peritonitis besides pregnant ladies were excluded from the study. Written informed consents were obtained from all the patients. All investigations adhered to the Declaration of Helsinki. All patients were >18 years of age and the study was approved by the KFHU and UD Research and Ethical Boards.
The triple-cuff PD catheter is composed of silicone-rubber, and it has the following features [Figure 1]:
- Its length of the catheter (from the proximal to the distal end) is 57 cm
- The distance from the distal cuff to pores is only 2 cm
- The length of coiled segment is 18 cm
- The distance between the second (middle) and third (distal) cuff is 10 cm
- The distance between the first (proximal) and second cuff is 5 cm
- The distance from the proximal cuff and the proximal end of the catheter is 24 cm.
The triple-cuff catheter was inserted while the patient was placed in the supine position under general anesthesia using aseptic precautions. A Veress needle was used to create pneumoperitoneum at pressure of 10-12 mm Hg. A 5-mm port was inserted in right hypo chondriac region at the midclavicular line, 2 cm below the costal margin for laparoscopic camera (30°). Then, diagnostic laparoscopy was performed to rule out adhesions or herniations, and to help in assessing the size of omentum.
The operating table was then placed in about 30° trendelenburg position. A small incision (about 1 cm) was made at the lateral aspect of the rectus muscle in the suprapubic area through which the trocar with the pull-away sheath was introduced at an oblique angle. The peritoneum was then entered followed by removal of the trocar leaving the pull-away sheath in place. Dilatation of the oblique passage was performed by a small dilator followed by a larger one. The three-cuff PD catheter was then introduced caudally and obliquely through the pull-away sheath over a 90-cm stylet into the peritoneal cavity. The tip of the PD catheter was placed in the pouch of Douglas or the rectovesical pouch in females and males, respectively. The PD catheter was advanced to a level that allows the external cuff to be in position at the anterior surface of the rectus muscle; the stylet was then removed and the external cuff was secured with pursestring suture on the fascia anterior to the rectus muscle. Then, a subcutaneous tunnel was created for the catheter with selection of a midway point at the umblicocrestal line to be the output of the catheter so that the catheter passage would be oblique. The end of the catheter attached to a stylet was advanced into the tunnel and pulled out from the abovementioned point; the second cuff is about 10 cm from the distal one and the proximal cuff is 2 cm from the exit site.
[Figure 2] demonstrates the final position of the triple-cuffed PD catheter, its oblique pathway through the subcutaneous tissue, rectus muscle into the peritoneal cavity and the tunnel position. The function of the catheter was checked by flushing normal saline to rule out kinking or obstruction. Then, the position of the catheter tip inside the pelvis was confirmed by plain X-ray [Figure 3]. The skin incisions of the camera port and entrance were sutured. Xylocain with adrenaline diluted in normal saline was injected in the incision site and in the tunnel space.
|Figure 2: Demonstrates the final position of the triple-cuffed PD catheter, its oblique pathway through the subcutaneous tissue, rectus muscle into the peritoneal cavity. Notice, the low exit-site, the oblique tunnel and the short intraperitoneal segment.|
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Antibiotic prophylaxis was given with a firstgeneration cephalosporin administered intravenously prior to the procedure. APD was generally instituted 14 days after PD catheter insertion. Patient training was performed during this period with low volume exchanges. The drainage time was recorded for each patient separately; the mean time was then calculated in each group. The outflow (drainage volume) was considered to be diminished if it was <50% of the fill volume.
The conventional Tenckhoff catheters was inserted using the technique described by Maio R, et al  The patient was placed in a supine position, and general anesthesia and intravenous antibiotics were administered. A Veress needle was used to create pneumoperitoneum at pressure of 10-12 mm Hg. The Veress needle was replaced with a 10 mm port and laparoscopy was performed to look for adhesions or other anatomical abnormalities. Under direct vision a 5-mm port was inserted in the right iliac fossa. A small (1 cm) skin incision was made 2-3 cm lateral and inferior to the umbilicus at the lateral border of the anterior rectus muscle, and a second 5-mm port was placed in a left paramedian location and tunneled in a caudal direction through the rectus sheath into the peritoneal cavity. Both the 5 mm ports were aligned and an Endograsp was inserted through the lower right quadrant port and brought it out through the paramedian port. The paramedian port was then removed but the tip of the Endograsp remained outside the abdominal cavity. A grasper was used to catch the intraperitoneal portion of the Tenckhoff catheter tip which was slowly pulled inside the peritoneal cavity through the tunnel created in the abdominal wall. The deep cuff was located at the medial edge of the muscle within the rectus sheath and the intraabdominal portion of the catheter was placed in Douglas pouch between the visceral and parietal peritoneum. The subcutaneous tunnel tract and skin exit site were directed downward or laterally. The subcutaneous cuff was placed at a distance of about 2 cm from the exit wound. The entire procedure was done under laparoscopic vision. Catheter patency was checked repeatedly to ensure the adequate inflow and outflow without leakage. The laparoscope was then removed and the pneumoperitoneum was allowed to deflate. The laparoscopic port site was closed and the skin wounds were sutured.
Routine exit-site care by the patient consisted of daily washing with anti-bacterial soap, thorough drying, cleaning with iodine solution, and application of a small amount of mupirocin ointment (approximately 10 mg, a 1/4 inch dab) around the catheter exit-site using a cotton swab. Catheters were anchored with tape and small gauze dressing to prevent exit-site trauma. The exit-site was examined by the physician and a trained nurse at each clinic visit. Signs and symptoms of exit site infection and/or peritonitis were explained to the patients at each visit, and they were instructed to report to the unit once infection was suspected or occurred. Swabs and cultures were obtained from the drainage, from around the catheter and from any exit-site discharge.
Patients of both groups were observed over 18 months period for mechanical and infectious complications. Catheter tip migration was diagnosed by serial abdominal X-rays and omental wrapping was considered whenever there was poor inflow and outflow in the absence of other mechanical complications.
| Statistical Analysis|| |
The statistical analysis was performed using the SPSS for Windows Version 20 (IBM, Inc., New York, USA). Continuous variables were expressed as means ± standard deviation or median and interquartile range [IQR; 25 th (Q1) to 75 th (Q3) percentiles] and categorical variables were expressed as percentage. Nonparametric Spearman rank test was used for continuous variables correlations and MannWhitney test used for the comparison of both groups of patients. P values were not adjusted for multiple testing and therefore should be considered descriptive.
| Results|| |
[Table 1] shows the demographic characteristics of our patients. Over 18-month period, 84 PD catheters were implanted in 73 patients. Of these, 47 conventional Tenckhoff catheters were used in 37 patients (ten catheters were reinserted) and 37 triple-cuff PD catheters were implanted by the new technique in 36 patients (one catheter replacement), P <0.01 [Table 2] and [Table 3]. Patients were followed for up to 18 months with a median observation time 13.2 (IQR 7.4-14.5) months. [Table 3] illustrates the technical complications of all catheters. Five (13.5%) catheters were lost in the group of the conventional Tenckhoff catheter (P <0.01); four (10.8%) of these were attributable to catheter migration and one (2.7%) because of unresolved omental wrapping. Catheter migration was 0% in the group of the three-cuff PD catheter as compared to 16.2% with the conventional Tenckhoff catheter (P <0.01). Omental wrapping was more frequent with the conventional Tenckhoff catheter (16.2% vs. 2.8%, P <0.01). Five episodes of leakage occurred; three with the conventional Tenckhoff catheter and two with the triple-cuff PD catheter (P <0.05). Three of them responded to conservative management and two were treated by surgical intervention.
The 19 identified infectious complications included eight episodes of peritonitis, two with tunnel infections and nine exit-site infections (ESIs). Staphylococcus epidermidis was the most common pathogens it was isolated in 10 cases; this was followed by Pseudomonas aeruginosa in four cases, Staphylococcus aureus in four cases and one case with unidentified infection. Tunnel infection in the group of the conventional Tenckhoff catheter necessitated removal of the catheter and reinsertion of new one without identification of a causative agent. In the three-cuff PD catheter group, the segment of PD catheter impeded in the tunnel was replaced by a new segment leaving the PD catheter with one cuff, the tunnel was cleansed and infection responded well to antibiotics. Most of ESIs resolved with local mupirocin ointment and gentamicin cream. With the new triple-cuff PD catheter, both dialysis fill and drain times were significantly shorter (P <0.01) as clearly shown in [Table 4] and in the video links:
Of the infectious complications, peritonitis occurred in 16.2% and 5.6% of the first and second groups respectively (P <0.01). Five of the conventional Tenckhoff catheters (4 unresolved peritonitis and 1 with tunnel infection) and one triple-cuff PD catheter (peritonitis) have to be removed (P <0.05). The difference in exit-site and tunnel infections was not significant [Table 3]. [Figure 4] depicts the overall catheter survival censored for losses related to catheter complications. At 18-month, the overall catheter survival was 73% and 91.7% for the conventional Tenckhoff catheter and the triple-cuff PD catheter respectively (P <0.01).
|Figure 4: Technical survival of the two types of PD catheters over 18-month period.|
Click here to view
| Discussion|| |
Migration of the PD catheter from the pelvis to the upper abdomen frequently results in PD failure and removal of the catheter. Previous studies compared PD catheter survival in various catheter configurations. These studies included single-cuff and double-cuff, straight end, and curled-end catheters, and showed incidence of catheter migration ranging from 5%-35% depending on the catheter type. ,,,,,,, Most of these studies, however, had a small patient sample or no control group, or they compared non-equivalent catheters. ,, Over 18-month period, we examined the conventional double-cuff Tenckhoff catheter and our new low-entry site triple-cuff PD catheter. The comparison showed significantly lower incidence of catheter tip migration and peritonitis and a higher catheter technical survival rate for the new catheter and the new technique. Double-cuffed Tenckhoff catheters are still widely used in many countries in spite of their higher rates of outflow failure due to catheter migration and catheter-related infections. ,,, Despite improvement in catheter survival rate over the last few years, catheter tip migration and catheter related infections still frequently occur causing significant morbidity and in many instances requiring catheter removal. 
Peritoneal catheter migration is not an uncommon complication of PD and requires prompt action to restore catheter function. Various nonsurgical options are available, including manipulation under fluoroscopy by guidewire or Fogarty catheter, and catheter exchange. However, in some instances, surgical intervention is necessary to restore function.  To overcome these problems, various catheter designs and insertion techniques have been described but the number of the concerned prospective and randomized studies is quite small.  When migration occurs, dialysate can be infused but drainage of the fluid from the peritoneal cavity is difficult. Suture fixation of the catheter tip through open laparotomy or laparoscopic method has been introduced to prevent catheter migration. , The drawback of the open laparotomy technique is the large lower abdominal incision, which is associated with significant morbidity, including adhesion, incisional hernia and intestinal obstruction.
With our catheter, prevention of catheter-tip migration is very simple as the small portion of the catheter inside the peritoneal cavity is already well fixed deeply by the distal cuff. This makes it nearly impossible for the catheter to migrate as we showed in our study where migration incidence was 0. In addition, the deep position of our new catheter compared to the conventional double-cuff Tenckhoff catheter may explain the significantly lower incidence of omental wrapping and catheter malfunction.
Catheter-related infection is the most serious of all complications. The swan-neck catheter- with a permanent bend at the intramural portion and a downward exit-was developed to minimize the risk of catheter-related infection. Improvement in the ESI rate was reported,  but randomized controlled studies have not confirmed that improvement.  In a prospective and randomized study, Eklund BH et  concluded that catheter configuration did not influence the catheter related infectious or other complications and equal results were obtained with both double-cuff permanently bent Swan-neck and the two-cuff Tenckhoff catheters. With our new catheter, the rate of ESI and tunnel infection is comparable to that with the conventional double-cuff Tenckhoff catheter. The rate of peritonitis, however, is significantly lower with our new catheter and new technique; two incidents over 18 months compared with six (16.2%) incidents with the conventional double-cuff Tenckhoff catheter, this is probably attributed to the presence of three cuffs, which act as three barriers against infection. In addition, the relatively short portion of our PD catheter inside the peritoneal cavity could have played a role in minimizing the rate of peritonitis. One major disadvantage of the Swan-neck catheter is that if tip migration occurs, the catheter cannot be repositioned by a guide-wire manipulation, and therefore surgical intervention is often required.
One drawback of our new catheter is that its removal requires two incisions instead of one (in case of the conventional Tenckhoff catheter), however, in addition to its previously described benefits, it has the major advantage of the significant shortening of the fill and drain time, which was attributed to the short intraperitoneal segment. At the end of an exchange, the time spent draining the peritoneal cavity is often longer and more variable than that needed to fill the cavity, and drain time therefore occupies a larger portion of the total dialysis time. , In APD, the fill and drain periods combined were shown to account for 35-55% of the total dialysis time,  which inevitably diminishes dialysis efficiency. Shortening of the drain time, therefore, is expected to improve dialysis efficacy as seen with our new catheter and new technique [Table 3]. Another advantage of our new catheter (although confirmed in one case only) is that it can still be spared in case of tunnel infection as the part of the catheter proximal to the third cuff can be externalized leaving the PD catheter functioning with one cuff in place.
| Conclusion|| |
The triple-cuff PD catheter demonstrated 0 rate of catheter migration compared with the conventional Tenckhoff PD catheter. Dialysis adequacy improved be-cause of shortened fill and drain times. Catheter survival exceeded the International Society for Peritoneal Dialysis recommendation, and the peritonitis rate was very low. We believe that our technique of implanting the triple-cuff PD catheter can help to minimize catheter complications, particularly migration and infection. Our data need to be confirmed in larger prospective randomized trials comparing it with other modern catheter designs.
| Acknowledgment|| |
The authors thank all the Peritoneal Dialysis Unit staff at King Fahd Hospital of the University. The authors also extend their appreciation to the staff and technicians of the laparoscopy unit for their remarkable help and support during the preparation of this study.
Conflict of Interest
The author have no relationship with pharmaceutical companies or other entities such as employment contracts, consultancy, advisory boards, speaker bureaus, membership of Board Directors, stock ownership that could be perceived to represent a financial conflict of interest.
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Abdullah Khalaf Al-Hwiesh
Department of Internal Medicine, Nephrology Division, King Fahd Hospital of the University, Dammam University, Al Khobar
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]