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Peritoneal Ports for Treatment of Intractable Ascites
Peritoneal Ports for Treatment of Intractable Ascites Michael A. Savin, MD, Matthias J. Kirsch, MD, William J. Romano, MD, Steven K. Wang, MD, Paul J. Arpasi, MD, and Charito D. Mazon, RN, BSN
PURPOSE: To present clinical data for a new peritoneal port for minimally invasive treatment of intractable ascites that can be used for aspiration in a patient’s home. MATERIALS AND METHODS: Twenty-eight consecutive peritoneal ports were placed in 27 patients with intractable ascites. Ascites etiology was malignancy in 22 patients, cirrhosis in three, pancreatic duct injury in one, and unknown in one. Technical and clinical success and complications were evaluated until the time of death or the end of the study. RESULTS: All ports were inserted successfully with removal of all ascites, and all patients had immediate and complete symptom relief. Ascites was managed by periodic drainage, typically by a visiting nurse in the patient’s home. The long-term clinical success rate was 96%, with 26 of 27 patients exhibiting maintained relief of symptoms until death or the end of the study. The long-term patency rate was 100% after 1,810 patient-days. Only one patient (4%) had a major complication. This was a port leak that required port exchange. Subsequently, the patient developed bacterial peritonitis. CONCLUSION: Peritoneal ports appear to be a safe, effective, minimally invasive treatment for intractable ascites. This device allows for reliable ascites aspiration in the patient’s home. J Vasc Interv Radiol 2005; 16:363–368 Abbreviation:
TIPS ⫽ transjugular intrahepatic portosystemic shunt
ASCITES is the most common major complication of cirrhosis (1). It is also a common complication of advanced malignancies (2). Symptoms of marked abdominal distention, shortness of breath, diminished appetite, fatigue, and lower-extremity edema can significantly compromise a patient’s everyday function (2). Treatment options for intractable ascites include serial paracentesis, peritoneovenous shunting, liver transplantation, transFrom the Department of Radiology, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, Michigan 48073. Received July 21, 2004; revision requested August 16; final revision received September 17; accepted September 20. From the SIR 2004 Annual Meeting. Address correspondence to M.A.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. © SIR, 2005 DOI: 10.1097/01.RVI.0000147082.05392.2B
jugular intrahepatic portosystemic shunt (TIPS) creation, and tunneled peritoneal catheters that may be external or, more recently, attached to subcutaneous ports. In the past, permanent drainage catheters have not been considered viable treatment options for intractable ascites as a result of problems with infection, malposition, and occlusion (3,4). However, cuffed, tunneled peritoneal catheters have been used for many years for peritoneal dialysis with acceptable complication rates (5– 7). In 1999, 27,000 people received peritoneal dialysis in the United States, constituting 9% of the dialysis population, with mortality rates similar to or lower than those in hemodialysis patients (8). These catheters have generally been placed in operating rooms (5). Recently, 2-year catheter survival rates with percutaneous placement have been reported to be
49%– 82% (8). Rosenblum et al (9) described the use of a subcutaneous venous access port to treat refractory ascites with promising results in nine patients. It is therefore appropriate to evaluate a port specifically designed for peritoneal access as a means of controlling intractable ascites. We present a minimally invasive treatment for palliative drainage of symptomatic ascites in patients with advanced malignancy or cirrhosis. We report our clinical experience with a percutaneous implantable access system specifically designed for peritoneal access that allows debilitated patients to avoid repeated trips to the hospital for paracentesis.
MATERIALS AND METHODS This was a prospective study approved by the institutional review board of our institution.
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Figure 1. The Port-a-Cath peritoneal implantable access system.
Patients Between January 2002 and March 2004, the first 27 consecutive patients with symptomatic large-volume ascites underwent percutaneous placement of an implantable peritoneal access system designed to permit repeated access to the peritoneal cavity at our hospital. Twenty-two patients had malignant ascites with short life expectancy, one of whom had a hepatoma with alcoholic cirrhosis as well. Three patients had ascites caused by cirrhosis refractory to medical management, consisting of a sodium-restricted diet, diuretic agent therapy, and paracentesis. One patient had nonmalignant ascites of unknown etiology refractory to medical management and paracentesis. One patient had an intractable pancreatic duct leak after radical resection of a left renalcell carcinoma with partial pancreatectomy. The mean age was 67 years (range, 46 – 86 years). Eleven patients were men and 16 were women. Of the 22 patients with malignancies, five had colon cancer, three had pancreatic cancer, three had ovarian cancer, three had adenocarcinoma with unknown primary tumor, two had breast cancer, two had gastric cancer, two had hepatoma, one had cholangiocarcinoma, and one had duodenal cancer. One patient with malignancy had a failed peritoneovenous shunt and three others had been rejected for a peritoneovenous shunt because of short life expectancies and the invasive nature of the procedure. Of the three patients with ascites resulting from cirrhosis, the etiology
was hepatitis C in one, a combination of alcohol and ␣-1-antitrypsin deficiency in another, and cryptogenic etiology in the third. All three had ChildPugh class C disease. The patients with cirrhosis were not candidates for TIPS. Every patient had symptoms of abdominal discomfort, fatigue, diminished appetite related to ascites, and shortness of breath. Most patients had lower-extremity edema. All patients were followed until death or March 2004.
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large pocket of ascites and to exclude loculations. The access site was usually chosen in a lower quadrant lateral to the expected course of the inferior epigastric artery. If the patient slept on his or her side, the nondependent side was chosen for the port as long as adequate ascites was present for access on that side. The port site was chosen over a bone to allow for easy needle access. Usually the site was over the inferior aspect of the lower ribs in the anterior midclavicular line. Occasionally, if the patient had too little soft tissue over the ribs, a port site over the ilium just inferior and posterior to the anterior superior iliac spine was chosen. The patient’s hair was shaved from the surgical field. The field was prepared with povidone iodine solution. The operators were required to wear head and face coverings and the technologists and patient were required to wear face coverings. Access to the room was restricted to the team performing the procedure. Patients received conscious sedation with midazolam and fentanyl. Lidocaine with epinephrine was used for local anesthesia. Prophylactic preprocedural antibiotic coverage for skin flora with intravenous cefazolin was administered.
Patient Preparation Laboratory studies included measurement of prothrombin time and partial thromboplastin time as well as a complete blood count with platelets. Prothrombin time should be less than 15 seconds (International Normalized Ratio was not used as a threshold), partial thromboplastin time should be near normal, and platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding. Peritoneal fluid was evaluated for infection with a cell count, white cell differential, and culture. There should be no infection at the time of port placement. Ascites albumin level was also evaluated. At least a moderate amount of ascites should be present at the time of port placement to help insure placement of the catheter in an optimal location. Peritoneal ports were placed in a radiology procedure room with sonographic and fluoroscopic guidance. Sonography was performed before the surgical preparation to localize an area in the abdomen in which there was a
Peritoneal Port The Port-a-Cath peritoneal implantable access system (Smiths Medical, St. Paul, MN) was used in all cases. It consists of a portal and a catheter (Fig 1), both of which are similar to, but larger than, central venous access ports. The larger size makes access easier and may decrease the rate of catheter occlusion. The portal is placed under the skin for access with a Huber needle. It consists of a hollow titanium cylinder with a rubber septum on top for needle access and a needle stop floor for tactile feedback. The portal base is 2.52 cm and height is 1.52 cm. The catheter attaches to the side of the port. It is made of polyurethane and is 15 F (5 mm) in outer diameter and has a 2.6-mm inner diameter with multiple side holes along the intraperitoneal portion. The catheter also has a cuff for the portion in the tunnel to secure the catheter and protect against tunnel infections.
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sutures (2– 0 Vicryl deep and 4 – 0 Vicryl superficial). The ascites access site is closed with subcutaneous absorbable suture and dermal nonabsorbable suture to prevent outward leakage of peritoneal fluid. The port is accessed with a 19-gauge Huber needle and port aspiration is then performed to remove the remainder of the ascites. The port is then flushed with 20 mL of heparinized saline solution (100 IU/mL). A sterile dressing is applied. Outpatient Catheter Care
Figure 2. Port pocket and subcutaneous tunnel. The port pocket has been created superior to the incision over the left lower ribs (arrow). The catheter has been pulled through the tunnel. Ascites access with wire and small sheath in the left lower quadrant (arrowhead).
Technique Ascites access.—After the surgical preparation, an 18-gauge needle is used to access the ascites. The needle is passed through the subcutaneous tissues, parallel to the skin, for several centimeters in a zigzag course to minimize leakage at the puncture site. After spontaneous drainage of uncomplicated ascites is confirmed, a 0.035-inch-diameter guide wire is passed into the ascites. Generally, the guide wire falls into the most dependent portion of the cavity, but this is not necessary to ensure adequate drainage. At this point, a partial paracentesis is performed with a multiple–side hole drainage catheter or a sheath. If a sheath is used, it is helpful to create side holes with a needle to prevent occlusion of the end of the catheter as a result of suction against viscera. It is important to leave a significant portion of the ascites to allow placement of the port catheter. Port pocket and tunnel creation.— The port pocket is usually created over the anterolateral lower ribs (Fig
2). It is made through a 3-cm skin incision. After the pocket is created, the port is initially loosely sutured to the deep subcutaneous tissue with two nonabsorbable sutures without knotting them. A subcutaneous tunnel is created between the pocket and the ascites entrance site with use of a metal tunneler (Medcomp, Harleysville, PA). The intraperitoneal end of the catheter is affixed to the tunneler and pulled through the tunnel from the port pocket end. Port placement.—The catheter is cut to length and secured to the port connector fitting. The port is placed in the pocket and then secured by tying the previously placed sutures. Over the guide wire, serial dilation is performed, followed by placement of a 16-F peel-away sheath over the guide wire into the peritoneal cavity (Fig 3). The catheter is then advanced through the peel-away sheath into the ascites and the peel-away sheath is removed. Adequate function is confirmed by aspirating the port. Then, the port site is closed with two layers of subcutaneous absorbable
Most patients were provided with visiting nurse care, usually through hospice. Nurses were instructed in wound and catheter care and fluid drainage. Insurance covered all hospice care costs. All costs were not necessarily covered by insurance for patients who were not in hospice care. The frequency of home visits was usually 1–2 times per week and was tailored to symptom recurrence. To identify volume depletion and infection, nurses monitored orthostatic vital signs and temperature as well as amount and character of ascites aspirated. The technique for port access is similar to that for central venous chest ports. Sterile technique consisted of preparation with alcohol wipes followed by povidone iodine swabs. The port was then accessed with a largebore Huber needle (19 gauge; Smiths Medical) to achieve higher flow and shorten aspiration time. The needle was connected to vacuum bottles. As a guideline, a maximum aspiration volume of 3 L was established to avoid volume depletion. If the orthostatic systolic blood pressure decreased more than 20 mm Hg, port aspiration was postponed. The port was flushed with 20 mL of heparinized saline solution (2,000 IU heparin) after each use. Study Endpoints Data were collected via chart review. Procedural data included inpatient versus outpatient status, technical success of port placement, immediate removal of ascites, immediate symptom relief, and immediate complications. Longterm follow-up data included duration of symptom relief, requirement for further catheter manipulation, requirement for subsequent paracentesis, duration of
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port patency, location where port aspiration was performed, and complications. Complications were classified as major or minor according to Society of Interventional Radiology reporting standards (10).
RESULTS Immediate Results Twenty-eight ports were placed in the first 27 consecutive patients. All had successful insertion with removal of all ascites. Ten ports were placed in outpatients and 18 were placed in inpatients. All patients had immediate and complete relief of symptoms. There were no immediate major complications. There was one minor complication, a hematoma at the port placement site in a patient with pancreatic carcinoma. The hemoglobin level did not change and the patient underwent conservative management. Long-term Results
Figure 3. (a) Port in place before suturing. (b) Radiograph of port in a different patient.
Twenty-six of 27 patients (96%) showed maintained relief of symptoms until death or the end of this study and 25 of 27 patients (92%) were treated successfully without further catheter manipulation, antibiotic therapy, or repeat paracentesis. One patient (4%) had a clinical failure. He had his port placed the day after paracentesis and loculated ascites was not recognized at the time of placement, likely because of the presence of only minimal residual ascites at the time of port placement. Because the catheter was placed into a loculated collection, the patient required additional paracenteses to maintain symptom relief. He declined placement of a second port. One patient (4%) had two major delayed complications. This patient had ascites caused by end-stage cirrhosis resulting from alcohol and ␣-1-antitrypsin deficiency. The first complication was persistent leakage at the port site. The patient had been in the hospital with congestive heart failure after a cardiac catheterization for what proved to be uncorrectable coronary artery disease and developed acute, superimposed on chronic, renal failure that required initiation of dialysis. During the hospitalization, repeated attempts were inadvertently made by the admitting service to
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access the port with a coring needle rather than a noncoring Huber needle. This may have damaged the rubber septum of the port, as the patient subsequently developed intractable leakage at the port site, leading to port removal after 80 days of service. A second port was placed. However, the patient developed bacterial peritonitis and died of multiple organ failure. The etiology of the peritonitis was likely multifactorial. The long-term primary patency rate of ports was 100%. Twenty-seven patients were treated for a total of 1,810 port-days (5 years) without a single occlusion that did not respond to a 20-mL saline solution flush. Twentytwo patients died during the course of the study, consistent with the severity of their underlying disease. Among them, the mean duration of catheter function was 6.9 weeks (range, 1– 40 weeks), with complete relief of symptoms in all but one patient. Five patients were alive as of March 2004 with a mean duration of catheter function of 21.5 weeks (range, 3– 48 weeks), and all had complete relief of symptoms caused by ascites. Twenty-two patients (82%) were treated at home and two (7%) were treated as outpatients in our clinic because of patient preference as well as insurance coverage limitations for home care. Three patients (11%) were treated in the hospital because of other medical problems.
DISCUSSION Intractable large-volume ascites is often disabling and decreases quality of life. Currently available treatments include serial paracentesis, peritoneovenous shunting, liver transplantation, TIPS creation, and tunneled peritoneal catheters that may be external or subcutaneous ports. Other treatments that have been reported include a peritoneogastric shunt, which has resulted in a high incidence of early occlusion (11), and peritoneal-urinary drainage (12), which is an invasive procedure that requires general anesthesia in a patient population in which palliation is the primary concern. Serial paracentesis can be performed with or without ultrasound guidance and has the advantage of being relatively easy to perform. It has been shown to have a major complication rate as low as 1% (13). Disadvan-
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tages include the requirement for repeated trips to the hospital. The procedure can also be difficult, painful, or unsuccessful. The risk of bleeding may be higher in patients receiving anticoagulation. There is also fluid, electrolyte, and protein loss. Peritoneovenous shunting has the advantage that hospital visits are not required for drainage and there are no fluid, electrolyte, or protein losses. Disadvantages include the relative invasiveness of the procedure, particularly when the shunt is placed surgically. Reports of poor long-term patency and excessive complications, including disseminated intravascular coagulation, and no survival advantage compared with medical therapy in controlled trials have led to nearabandonment of this procedure (1). Liver transplantation for cirrhotic ascites has the unique advantage that survival may be improved. The 12month survival rate in patients with cirrhosis and refractory ascites is only 25% (1). Disadvantages include the fact that patients may wait as long as 12–18 months in some areas (1), and many patients, including those with malignancies, are not candidates. TIPS has the advantages that hospital visits are not required for drainage and there are no fluid, protein, or electrolyte losses. Disadvantages include complications such as encephalopathy in as many as 20% of patients. Surveillance is required to evaluate for shunt stenosis. TIPS is generally contraindicated as a treatment for malignant ascites (14,15), even though it has recently been performed successfully in a small series (16). Tunneled peritoneal catheters with an external component for drainage, placed percutaneously, have recently been described (2,8,17–19). Advantages include easy access and ability to drain ascites in the home without nursing assistance. Disadvantages relative to a peritoneal port include the theoretically higher risk of infection, the risk of dislodgement, and the more intrusive nature of a large external catheter. In a series of 24 patients with malignant ascites treated with a tunneled external catheter, four (17%) developed symptomatic bacterial peritonitis (2). In a series of 10 patients with malignant ascites, there were no catheter-related infections, but one catheter was inadvertently dislodged (17).
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Of 29 patients with malignant ascites, two catheters were inadvertently dislodged and there were two cases of abdominal wall cellulitis and one case of persistent leakage around the catheter (18). Cuffed, tunneled, percutaneously placed peritoneal ports were first described by Rosenblum et al in 2002 (9). The ports used were modified venous access ports. Nine patients with cirrhotic refractory ascites were treated with 10 ports. There were three cases of bacterial peritonitis (33% of patients) and one case of catheter obstruction (10% of catheters). This is an update of our first report of the use of a peritoneal port specifically designed to permit repeated access to the peritoneal cavity (20). Compared with the device used by Rosenblum et al (9), this catheter is larger in caliber and has multiple precut side holes. These properties may explain the 100% patency rate in this study. Rosenblum et al (9) reported that two of three cases of peritonitis were associated with peritoneal fluid leakage at the port site. They suggested that these infections could have been prevented with improved suture technique with use of more closely spaced sutures and that late suture removal 10 –14 days after port placement was beneficial for further wound healing. Attention to these suture details may in part explain the lower infection rate (4%) in this study. Another possible explanation for the low infection rate in this study is that 22 of the 27 patients had malignant ascites and only three had cirrhosis (one had a pancreatic duct injury, one had an unknown etiology). Our only case of peritonitis was in a patient with cirrhosis, for a peritonitis rate in patients with cirrhosis of 33%, identical to the 33% rate in the report of Rosenblum et al (9). Spontaneous bacterial peritonitis is much more common in patients with ascites with underlying cirrhosis than in patients with malignancies (21). Spontaneous bacterial peritonitis occurs in 8%–10% of patients with cirrhotic ascites, but only a rare case report has described spontaneous bacterial peritonitis in patients with cancer with ascites (22). In a study of 101 patients undergoing paracentesis for malignant ascites, no patients had spontaneous bacterial peritonitis (22).
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Finally, placement of the port over a bony surface and the larger port size appears to provide an easier target for nurses to access the port. In conclusion, peritoneal ports appear to be a safe, effective treatment option for intractable ascites, particularly those resulting from malignancy. In this study, the initial success rate was 100%, and in the long term, the patency rate was 100%, success rate was 96%, and major complication rate was 4%. Because port placement is a minimally invasive procedure, visiting nurses can perform drainage and monitor patients in their homes. Port aspiration can be performed in some cases by patients or family members without nursing assistance. In comparison with tunneled peritoneal catheters with external components, the complication rate appears to be lower. For patients undergoing serial paracentesis, it eliminates the need for multiple hospital visits.
5.
6.
7.
8.
9.
10. References 1. Runyon BA. Management of adult patients with ascites caused by cirrhosis. Hepatology 1998; 27:264 –272. 2. O’Neill MJ, Weissleder R, Gervais DA, Hahn PF, Mueller PR. Tunneled peritoneal catheter placement under sonographic and fluoroscopic guidance in the palliative treatment of malignant ascites. AJR Am J Roentgenol 2001; 177: 615– 618. 3. Ross GJ, Kessler HB, Clair MR, et al. Sonographically guided paracentesis for palliation of symptomatic malignant ascites. AJR Am J Roentgenol 1989; 153:1309 –1311. 4. Belfort MA, Stevens PJ, DeHaek K, Soeters R, Krige JEJ. A new approach to the management of malignant ascites; a permanently implanted abdom-
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13. 14.
inal drain. Eur J Surg Oncol 1990; 16: 47–53. Allon M, Soucie JM, Macon EJ. Complications with permanent peritoneal dialysis catheters: experience with 154 percutaneously placed catheters. Nephron 1988; 48:8 –11. Bailie GR, Eisle G. Continuous ambulatory peritoneal dialysis: a review of its mechanics, advantages, complications, and areas of controversy. Ann Pharmacother 1992; 26:1409 –1420. Gloor HJ, Nichold WK, Sorkin MI. Peritoneal access and related complications in continuous ambulatory dialysis. Am J Med 1983; 74:593–598. Georgiades CS, Geschwind JFH. Percutaneous peritoneal dialysis catheter placement for the management of endstage renal disease: technique and comparison with the surgical approach. Tech Vasc Interv Radiol 2002; 5:103–107. Rosenblum DI, Geisinger MA, Newman JS, et al. Use of subcutaneous venous access ports to treat refractory ascites. J Vasc Interv Radiol 2001; 12: 1343–1346. Leoni CJ, Potter JE, Rosen MP, Brophy DP, Lang EV. Classifying complications of interventional procedures: a survey of practicing radiologists. J Vasc Interv Radiol 2001; 12:55–59. Lorentzen T, Sengelov L, Nolsoe CP, Khattar SC, Karstrup S, von der Maase H. Ultrasonically guided insertion of a peritoneo-gastric shunt in patients with malignant ascites. Acta Radiol 1995; 36:481– 484. Rozenblit GN, Del Guercio LRM, Rundback JH, Poplausky MR, Lebovics E. Peritoneal-urinary drainage for treatment of refractory ascites: a pilot study. J Vasc Interv Radiol 1998; 9:998 – 1005. Runyon BA. Paracentesis of ascitic fluid: a safe procedure. Arch Intern Med 1986; 146:2259 –2261. Hidajat N, Vogl T, Stobbe H, et al.
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Transjugular intrahepatic portosystemic shunt: experiences at a liver transplantation center. Acta Radiol 2000; 41:474 – 478. Malinchoc M, Kamath PS, Gordon FD, Peine CJ, Rank J, ter Borg PC. A model to predict poor survival in patients undergoing transjugular intrahepatic portosystemic shunts. Hepatology 2000; 31:864 – 871. Wallace M, Swaim M. Transjugular intrahepatic portosystemic shunts through hepatic neoplasms. J Vasc Interv Radiol 2003; 14:501–507. Richard HM, Coldwell DM, Boyd-Kranis RL, Murthy R, Van Echo DA. PleuRx tunneled catheter in the management of malignant ascites. J Vasc Interv Radiol 2001; 12:373–375. Barnett TD, Rubins J. Placement of a permanent tunneled peritoneal drainage catheter for palliation of malignant ascites: a simplified percutaneous approach. J Vasc Interv Radiol 2002; 13: 379 –383. Sartori S, Nielsen I, Trevisani L, et al. Sonographically guided peritoneal catheter placement in the palliation of malignant ascites in end-stage malignancies. AJR Am J Roentgenol 2002; 179:1618 –1620. Savin MA, Thanawalla FA, Kirsch MJ, Romano WJ, Salem R, Wang SK. Implantable peritoneal access system for palliative treatment of refractory ascites [abstract]. J Vasc Interv Radiol 2003; 14(suppl):S97. Romero A, Pérez-Arellano JL, González-Villarón L, Brock JH, Muñoz Bellido JL, DeCastro S. Effect of transferring concentration on bacterial growth in human ascitic fluid from cirrhotic and neoplastic patients. Eur J Clin Invest 1993; 23:699 –705. Kurtz RC, Bronzo RL. Does spontaneous bacterial peritonitis occur in malignant ascites? Am J Gastroenterol 1982; 77:146 –148.
PURPOSE: To present clinical data for a new peritoneal port for minimally invasive treatment of intractable ascites that can be used for aspiration in a patient’s home. MATERIALS AND METHODS: Twenty-eight consecutive peritoneal ports were placed in 27 patients with intractable ascites. Ascites etiology was malignancy in 22 patients, cirrhosis in three, pancreatic duct injury in one, and unknown in one. Technical and clinical success and complications were evaluated until the time of death or the end of the study. RESULTS: All ports were inserted successfully with removal of all ascites, and all patients had immediate and complete symptom relief. Ascites was managed by periodic drainage, typically by a visiting nurse in the patient’s home. The long-term clinical success rate was 96%, with 26 of 27 patients exhibiting maintained relief of symptoms until death or the end of the study. The long-term patency rate was 100% after 1,810 patient-days. Only one patient (4%) had a major complication. This was a port leak that required port exchange. Subsequently, the patient developed bacterial peritonitis. CONCLUSION: Peritoneal ports appear to be a safe, effective, minimally invasive treatment for intractable ascites. This device allows for reliable ascites aspiration in the patient’s home. J Vasc Interv Radiol 2005; 16:363–368 Abbreviation:
TIPS ⫽ transjugular intrahepatic portosystemic shunt
ASCITES is the most common major complication of cirrhosis (1). It is also a common complication of advanced malignancies (2). Symptoms of marked abdominal distention, shortness of breath, diminished appetite, fatigue, and lower-extremity edema can significantly compromise a patient’s everyday function (2). Treatment options for intractable ascites include serial paracentesis, peritoneovenous shunting, liver transplantation, transFrom the Department of Radiology, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, Michigan 48073. Received July 21, 2004; revision requested August 16; final revision received September 17; accepted September 20. From the SIR 2004 Annual Meeting. Address correspondence to M.A.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. © SIR, 2005 DOI: 10.1097/01.RVI.0000147082.05392.2B
jugular intrahepatic portosystemic shunt (TIPS) creation, and tunneled peritoneal catheters that may be external or, more recently, attached to subcutaneous ports. In the past, permanent drainage catheters have not been considered viable treatment options for intractable ascites as a result of problems with infection, malposition, and occlusion (3,4). However, cuffed, tunneled peritoneal catheters have been used for many years for peritoneal dialysis with acceptable complication rates (5– 7). In 1999, 27,000 people received peritoneal dialysis in the United States, constituting 9% of the dialysis population, with mortality rates similar to or lower than those in hemodialysis patients (8). These catheters have generally been placed in operating rooms (5). Recently, 2-year catheter survival rates with percutaneous placement have been reported to be
49%– 82% (8). Rosenblum et al (9) described the use of a subcutaneous venous access port to treat refractory ascites with promising results in nine patients. It is therefore appropriate to evaluate a port specifically designed for peritoneal access as a means of controlling intractable ascites. We present a minimally invasive treatment for palliative drainage of symptomatic ascites in patients with advanced malignancy or cirrhosis. We report our clinical experience with a percutaneous implantable access system specifically designed for peritoneal access that allows debilitated patients to avoid repeated trips to the hospital for paracentesis.
MATERIALS AND METHODS This was a prospective study approved by the institutional review board of our institution.
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Figure 1. The Port-a-Cath peritoneal implantable access system.
Patients Between January 2002 and March 2004, the first 27 consecutive patients with symptomatic large-volume ascites underwent percutaneous placement of an implantable peritoneal access system designed to permit repeated access to the peritoneal cavity at our hospital. Twenty-two patients had malignant ascites with short life expectancy, one of whom had a hepatoma with alcoholic cirrhosis as well. Three patients had ascites caused by cirrhosis refractory to medical management, consisting of a sodium-restricted diet, diuretic agent therapy, and paracentesis. One patient had nonmalignant ascites of unknown etiology refractory to medical management and paracentesis. One patient had an intractable pancreatic duct leak after radical resection of a left renalcell carcinoma with partial pancreatectomy. The mean age was 67 years (range, 46 – 86 years). Eleven patients were men and 16 were women. Of the 22 patients with malignancies, five had colon cancer, three had pancreatic cancer, three had ovarian cancer, three had adenocarcinoma with unknown primary tumor, two had breast cancer, two had gastric cancer, two had hepatoma, one had cholangiocarcinoma, and one had duodenal cancer. One patient with malignancy had a failed peritoneovenous shunt and three others had been rejected for a peritoneovenous shunt because of short life expectancies and the invasive nature of the procedure. Of the three patients with ascites resulting from cirrhosis, the etiology
was hepatitis C in one, a combination of alcohol and ␣-1-antitrypsin deficiency in another, and cryptogenic etiology in the third. All three had ChildPugh class C disease. The patients with cirrhosis were not candidates for TIPS. Every patient had symptoms of abdominal discomfort, fatigue, diminished appetite related to ascites, and shortness of breath. Most patients had lower-extremity edema. All patients were followed until death or March 2004.
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large pocket of ascites and to exclude loculations. The access site was usually chosen in a lower quadrant lateral to the expected course of the inferior epigastric artery. If the patient slept on his or her side, the nondependent side was chosen for the port as long as adequate ascites was present for access on that side. The port site was chosen over a bone to allow for easy needle access. Usually the site was over the inferior aspect of the lower ribs in the anterior midclavicular line. Occasionally, if the patient had too little soft tissue over the ribs, a port site over the ilium just inferior and posterior to the anterior superior iliac spine was chosen. The patient’s hair was shaved from the surgical field. The field was prepared with povidone iodine solution. The operators were required to wear head and face coverings and the technologists and patient were required to wear face coverings. Access to the room was restricted to the team performing the procedure. Patients received conscious sedation with midazolam and fentanyl. Lidocaine with epinephrine was used for local anesthesia. Prophylactic preprocedural antibiotic coverage for skin flora with intravenous cefazolin was administered.
Patient Preparation Laboratory studies included measurement of prothrombin time and partial thromboplastin time as well as a complete blood count with platelets. Prothrombin time should be less than 15 seconds (International Normalized Ratio was not used as a threshold), partial thromboplastin time should be near normal, and platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding. Peritoneal fluid was evaluated for infection with a cell count, white cell differential, and culture. There should be no infection at the time of port placement. Ascites albumin level was also evaluated. At least a moderate amount of ascites should be present at the time of port placement to help insure placement of the catheter in an optimal location. Peritoneal ports were placed in a radiology procedure room with sonographic and fluoroscopic guidance. Sonography was performed before the surgical preparation to localize an area in the abdomen in which there was a
Peritoneal Port The Port-a-Cath peritoneal implantable access system (Smiths Medical, St. Paul, MN) was used in all cases. It consists of a portal and a catheter (Fig 1), both of which are similar to, but larger than, central venous access ports. The larger size makes access easier and may decrease the rate of catheter occlusion. The portal is placed under the skin for access with a Huber needle. It consists of a hollow titanium cylinder with a rubber septum on top for needle access and a needle stop floor for tactile feedback. The portal base is 2.52 cm and height is 1.52 cm. The catheter attaches to the side of the port. It is made of polyurethane and is 15 F (5 mm) in outer diameter and has a 2.6-mm inner diameter with multiple side holes along the intraperitoneal portion. The catheter also has a cuff for the portion in the tunnel to secure the catheter and protect against tunnel infections.
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sutures (2– 0 Vicryl deep and 4 – 0 Vicryl superficial). The ascites access site is closed with subcutaneous absorbable suture and dermal nonabsorbable suture to prevent outward leakage of peritoneal fluid. The port is accessed with a 19-gauge Huber needle and port aspiration is then performed to remove the remainder of the ascites. The port is then flushed with 20 mL of heparinized saline solution (100 IU/mL). A sterile dressing is applied. Outpatient Catheter Care
Figure 2. Port pocket and subcutaneous tunnel. The port pocket has been created superior to the incision over the left lower ribs (arrow). The catheter has been pulled through the tunnel. Ascites access with wire and small sheath in the left lower quadrant (arrowhead).
Technique Ascites access.—After the surgical preparation, an 18-gauge needle is used to access the ascites. The needle is passed through the subcutaneous tissues, parallel to the skin, for several centimeters in a zigzag course to minimize leakage at the puncture site. After spontaneous drainage of uncomplicated ascites is confirmed, a 0.035-inch-diameter guide wire is passed into the ascites. Generally, the guide wire falls into the most dependent portion of the cavity, but this is not necessary to ensure adequate drainage. At this point, a partial paracentesis is performed with a multiple–side hole drainage catheter or a sheath. If a sheath is used, it is helpful to create side holes with a needle to prevent occlusion of the end of the catheter as a result of suction against viscera. It is important to leave a significant portion of the ascites to allow placement of the port catheter. Port pocket and tunnel creation.— The port pocket is usually created over the anterolateral lower ribs (Fig
2). It is made through a 3-cm skin incision. After the pocket is created, the port is initially loosely sutured to the deep subcutaneous tissue with two nonabsorbable sutures without knotting them. A subcutaneous tunnel is created between the pocket and the ascites entrance site with use of a metal tunneler (Medcomp, Harleysville, PA). The intraperitoneal end of the catheter is affixed to the tunneler and pulled through the tunnel from the port pocket end. Port placement.—The catheter is cut to length and secured to the port connector fitting. The port is placed in the pocket and then secured by tying the previously placed sutures. Over the guide wire, serial dilation is performed, followed by placement of a 16-F peel-away sheath over the guide wire into the peritoneal cavity (Fig 3). The catheter is then advanced through the peel-away sheath into the ascites and the peel-away sheath is removed. Adequate function is confirmed by aspirating the port. Then, the port site is closed with two layers of subcutaneous absorbable
Most patients were provided with visiting nurse care, usually through hospice. Nurses were instructed in wound and catheter care and fluid drainage. Insurance covered all hospice care costs. All costs were not necessarily covered by insurance for patients who were not in hospice care. The frequency of home visits was usually 1–2 times per week and was tailored to symptom recurrence. To identify volume depletion and infection, nurses monitored orthostatic vital signs and temperature as well as amount and character of ascites aspirated. The technique for port access is similar to that for central venous chest ports. Sterile technique consisted of preparation with alcohol wipes followed by povidone iodine swabs. The port was then accessed with a largebore Huber needle (19 gauge; Smiths Medical) to achieve higher flow and shorten aspiration time. The needle was connected to vacuum bottles. As a guideline, a maximum aspiration volume of 3 L was established to avoid volume depletion. If the orthostatic systolic blood pressure decreased more than 20 mm Hg, port aspiration was postponed. The port was flushed with 20 mL of heparinized saline solution (2,000 IU heparin) after each use. Study Endpoints Data were collected via chart review. Procedural data included inpatient versus outpatient status, technical success of port placement, immediate removal of ascites, immediate symptom relief, and immediate complications. Longterm follow-up data included duration of symptom relief, requirement for further catheter manipulation, requirement for subsequent paracentesis, duration of
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port patency, location where port aspiration was performed, and complications. Complications were classified as major or minor according to Society of Interventional Radiology reporting standards (10).
RESULTS Immediate Results Twenty-eight ports were placed in the first 27 consecutive patients. All had successful insertion with removal of all ascites. Ten ports were placed in outpatients and 18 were placed in inpatients. All patients had immediate and complete relief of symptoms. There were no immediate major complications. There was one minor complication, a hematoma at the port placement site in a patient with pancreatic carcinoma. The hemoglobin level did not change and the patient underwent conservative management. Long-term Results
Figure 3. (a) Port in place before suturing. (b) Radiograph of port in a different patient.
Twenty-six of 27 patients (96%) showed maintained relief of symptoms until death or the end of this study and 25 of 27 patients (92%) were treated successfully without further catheter manipulation, antibiotic therapy, or repeat paracentesis. One patient (4%) had a clinical failure. He had his port placed the day after paracentesis and loculated ascites was not recognized at the time of placement, likely because of the presence of only minimal residual ascites at the time of port placement. Because the catheter was placed into a loculated collection, the patient required additional paracenteses to maintain symptom relief. He declined placement of a second port. One patient (4%) had two major delayed complications. This patient had ascites caused by end-stage cirrhosis resulting from alcohol and ␣-1-antitrypsin deficiency. The first complication was persistent leakage at the port site. The patient had been in the hospital with congestive heart failure after a cardiac catheterization for what proved to be uncorrectable coronary artery disease and developed acute, superimposed on chronic, renal failure that required initiation of dialysis. During the hospitalization, repeated attempts were inadvertently made by the admitting service to
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access the port with a coring needle rather than a noncoring Huber needle. This may have damaged the rubber septum of the port, as the patient subsequently developed intractable leakage at the port site, leading to port removal after 80 days of service. A second port was placed. However, the patient developed bacterial peritonitis and died of multiple organ failure. The etiology of the peritonitis was likely multifactorial. The long-term primary patency rate of ports was 100%. Twenty-seven patients were treated for a total of 1,810 port-days (5 years) without a single occlusion that did not respond to a 20-mL saline solution flush. Twentytwo patients died during the course of the study, consistent with the severity of their underlying disease. Among them, the mean duration of catheter function was 6.9 weeks (range, 1– 40 weeks), with complete relief of symptoms in all but one patient. Five patients were alive as of March 2004 with a mean duration of catheter function of 21.5 weeks (range, 3– 48 weeks), and all had complete relief of symptoms caused by ascites. Twenty-two patients (82%) were treated at home and two (7%) were treated as outpatients in our clinic because of patient preference as well as insurance coverage limitations for home care. Three patients (11%) were treated in the hospital because of other medical problems.
DISCUSSION Intractable large-volume ascites is often disabling and decreases quality of life. Currently available treatments include serial paracentesis, peritoneovenous shunting, liver transplantation, TIPS creation, and tunneled peritoneal catheters that may be external or subcutaneous ports. Other treatments that have been reported include a peritoneogastric shunt, which has resulted in a high incidence of early occlusion (11), and peritoneal-urinary drainage (12), which is an invasive procedure that requires general anesthesia in a patient population in which palliation is the primary concern. Serial paracentesis can be performed with or without ultrasound guidance and has the advantage of being relatively easy to perform. It has been shown to have a major complication rate as low as 1% (13). Disadvan-
Savin et al
tages include the requirement for repeated trips to the hospital. The procedure can also be difficult, painful, or unsuccessful. The risk of bleeding may be higher in patients receiving anticoagulation. There is also fluid, electrolyte, and protein loss. Peritoneovenous shunting has the advantage that hospital visits are not required for drainage and there are no fluid, electrolyte, or protein losses. Disadvantages include the relative invasiveness of the procedure, particularly when the shunt is placed surgically. Reports of poor long-term patency and excessive complications, including disseminated intravascular coagulation, and no survival advantage compared with medical therapy in controlled trials have led to nearabandonment of this procedure (1). Liver transplantation for cirrhotic ascites has the unique advantage that survival may be improved. The 12month survival rate in patients with cirrhosis and refractory ascites is only 25% (1). Disadvantages include the fact that patients may wait as long as 12–18 months in some areas (1), and many patients, including those with malignancies, are not candidates. TIPS has the advantages that hospital visits are not required for drainage and there are no fluid, protein, or electrolyte losses. Disadvantages include complications such as encephalopathy in as many as 20% of patients. Surveillance is required to evaluate for shunt stenosis. TIPS is generally contraindicated as a treatment for malignant ascites (14,15), even though it has recently been performed successfully in a small series (16). Tunneled peritoneal catheters with an external component for drainage, placed percutaneously, have recently been described (2,8,17–19). Advantages include easy access and ability to drain ascites in the home without nursing assistance. Disadvantages relative to a peritoneal port include the theoretically higher risk of infection, the risk of dislodgement, and the more intrusive nature of a large external catheter. In a series of 24 patients with malignant ascites treated with a tunneled external catheter, four (17%) developed symptomatic bacterial peritonitis (2). In a series of 10 patients with malignant ascites, there were no catheter-related infections, but one catheter was inadvertently dislodged (17).
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Of 29 patients with malignant ascites, two catheters were inadvertently dislodged and there were two cases of abdominal wall cellulitis and one case of persistent leakage around the catheter (18). Cuffed, tunneled, percutaneously placed peritoneal ports were first described by Rosenblum et al in 2002 (9). The ports used were modified venous access ports. Nine patients with cirrhotic refractory ascites were treated with 10 ports. There were three cases of bacterial peritonitis (33% of patients) and one case of catheter obstruction (10% of catheters). This is an update of our first report of the use of a peritoneal port specifically designed to permit repeated access to the peritoneal cavity (20). Compared with the device used by Rosenblum et al (9), this catheter is larger in caliber and has multiple precut side holes. These properties may explain the 100% patency rate in this study. Rosenblum et al (9) reported that two of three cases of peritonitis were associated with peritoneal fluid leakage at the port site. They suggested that these infections could have been prevented with improved suture technique with use of more closely spaced sutures and that late suture removal 10 –14 days after port placement was beneficial for further wound healing. Attention to these suture details may in part explain the lower infection rate (4%) in this study. Another possible explanation for the low infection rate in this study is that 22 of the 27 patients had malignant ascites and only three had cirrhosis (one had a pancreatic duct injury, one had an unknown etiology). Our only case of peritonitis was in a patient with cirrhosis, for a peritonitis rate in patients with cirrhosis of 33%, identical to the 33% rate in the report of Rosenblum et al (9). Spontaneous bacterial peritonitis is much more common in patients with ascites with underlying cirrhosis than in patients with malignancies (21). Spontaneous bacterial peritonitis occurs in 8%–10% of patients with cirrhotic ascites, but only a rare case report has described spontaneous bacterial peritonitis in patients with cancer with ascites (22). In a study of 101 patients undergoing paracentesis for malignant ascites, no patients had spontaneous bacterial peritonitis (22).
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Finally, placement of the port over a bony surface and the larger port size appears to provide an easier target for nurses to access the port. In conclusion, peritoneal ports appear to be a safe, effective treatment option for intractable ascites, particularly those resulting from malignancy. In this study, the initial success rate was 100%, and in the long term, the patency rate was 100%, success rate was 96%, and major complication rate was 4%. Because port placement is a minimally invasive procedure, visiting nurses can perform drainage and monitor patients in their homes. Port aspiration can be performed in some cases by patients or family members without nursing assistance. In comparison with tunneled peritoneal catheters with external components, the complication rate appears to be lower. For patients undergoing serial paracentesis, it eliminates the need for multiple hospital visits.
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