Denver Ascites Shunt PAK

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1 / Fr Denver Ascites Shunt PAK en fr de it es pt nl sv da fi no el ja Ascites Shunt Percutaneous Access Kit Kit de pose percutanée de shunt pour ascites Perkutanes Zugangs-Set für den Aszites-Shunt Kit di accesso percutaneo per shunt per ascite Set de acceso percutáneo para el shunt de ascitis Kit de Acesso Percutâneo do Shunt de Ascite Percutane toegangsset (PAK) voor ascites-shunt Kit med ascitesshunt för tillträde perkutant Perkutant adgangskit til ascites-shunt Askitessuntin perkutaaninen sisäänvientisetti Kit med ascitesshunt for perkutan tilgang Αναστόμωση ασκίτη κιτ υπ οδόριας π ρόσβασης 腹 腔 静 脈 シャント 経 皮 アクセスキット USA Rx Only 2 For Single Use Only Do not use if package is damaged CareFusion Corporation or one of its subsidiaries. All rights reserved. CareFusion 1500 Waukegan Road McGaw Park, IL USA For product inquiries or technical assistance: Denver, Silique, PreP-Centesis, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation, or one of its subsidiaries.

2 6 F 1( 6 en Kit Contents 1 Ascites Shunt, 15.5 Fr 2 Needles, 16 G 1 Syringe, 12 ml 2 J-Tip Guidewire, 60 cm 2 Valved Peel-Away Introducers, 16 Fr 1 Fast Track Tunneler 15" (38 cm) 1 Short Track Tunneler 6" (15 cm) 1 PreP-Centesis Drainage Catheter, 15.5 Fr 1 Extension Set with Roller Clamp and 16 G Vacuum Needle 1 5-in-1 Adapter 4 Chart Labels 1 Catheter Insertion Stylet with Cap Shunt Description The Denver Ascites Shunts are provided in two configurations as shown in Figure 1. All of the Denver Ascites Shunts are constructed from medical grade silicone. Each shunt consists of a fenestrated peritoneal catheter, a venous catheter, and a flexible pump chamber containing either one or two miter valves. The heart of the system is the valved pump chamber. The miter valve(s) contained within the pump chamber permit flow in only one direction. When the pressure in the peritoneal cavity is approximately 3 cm water higher than the central venous pressure, the valves open and permit flow through the shunt. In a double-valved shunt, the second valve serves as a check valve which helps prevent reflux of blood into the distal end of the venous catheter when the unit is manually pumped. In a single-valved shunt, reflux is prevented by manual occlusion of the venous catheter. The valves are made deliberately asymmetrical, causing them to be self-cleaning. Figure 1: Denver Ascites Shunts The venous tubing may be shortened for optional positioning in the superior vena cava and the peritoneal catheter may be shortened for the best placement in the peritoneal cavity. An integral barium sulfate stripe in the wall of the peritoneal and venous catheters permits visualization under fluoroscopy or with x-ray to confirm proper positioning at the time of surgery. Silique, a unique surface treatment, has been applied to the shunts. This treatment provides a smoother, less tacky surface with a lower coefficient of friction. Silique surface treatment is a permanent treatment that will not leach, wear, or flake off. Silique surface treatment does not change the bulk physical properties of silicone and therefore does not change the strength, flexibility, or flow properties of the shunt. The flow rate for each shunt is determined using water as the working media. All flow rates are determined at a temperature of 70º F (21º C) with a head pressure of 10 cm. Flow rates tend to increase as fluid temperature increases. Flow rates tend to decrease as the fluid becomes more viscous. Indications Peritoneo-venous shunting is indicated for patients with: chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management. persistent ascites who are not considered candidates for portal-venous shunting. persistent ascites that is non-responsive to standard medical management. primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intraabdominal pressure. Venous Catheter 0.39 cm OD Caution: Benefits of instituting 6 c peritoneo-venous m 0.23 cm ID (1.5 F r.) shunting in patients with neoplastic ascites should Rad iopaque be weighed against the potential hazards ofstri pe dissemination of ascitic fluid containing malignant Second Onecells. W ayv alve Suture Pad Peritoneo-venous shunting should also be irst One- W ayv alve considered for patients with hepatorenal syndrome, chylous ascites and idiopathic ascites. Rad iopaque Stri pe The valved peel-away introducer is intended Peritoneal for use Catheter in the percutaneous insertion of catheters in cm the O D 0.27cm ID venous system or peritoneal space. ( F r. ) The tunnelers are designed to 2assist 7c m in passing the venous catheter of a Denver Ascites Shunt subcutaneously from the subcostal incision to either 7.7cm the internal jugular or sub-clavian insertiion site. The pre-procedure drainage catheter is designed to PumpChamber remove ascites fluid from the peritoneal space prior to shunt placement. 6 c m (1.5 Fr.) 5.5 F r.) 27 c m 1

3 Contraindications Peritoneo-venous shunting is contraindicated for patients with: peritonitis possible non-sterile ascitic fluid or intraabdominal infection acute tubular necrosis or primary renal failure extremely high bilirubin and /or creatinine levels In general, shunting should be avoided in the presence of any systemic infection. Patients with a recent history of gastrointestinal bleeding should be evaluated for portal hypertension. Correction of the portal hypertension should be considered prior to insertion of a peritoneo-venous shunt. The presence of marginal cardiac function is a relative contraindication to shunt placement for those patients who may not tolerate the increased circulatory load associated with peritoneo-venous shunting. Use of the subclavian vein for catheterization is not recommended for individuals who may require the construction of a permanent venous access for hemodialysis. Thrombosis or severe stenosis of the subclavian vein, which may result from the presence of the venous catheter, is not compatible with an A-V fistula in the ipsilateral arm. Contraindications of the Valved Peel-Away Introducer The valved peel-away introducer is not designed for use in the arterial system or as a hemostatic device. Warnings Particulate matter or venous thrombosis may cause shunt occlusion, necessitating revision or replacement of the shunt. Resistance to compression of the pump chamber may be an indication that the venous catheter or pump chamber is occluded. Should the pump chamber fail to refill readily, the peritoneal catheter may be occluded. (See Testing Shunt Function on page 10) Never inject directly into the tubing portion of the shunt, as leakage or tearing of the catheter may occur. Wipe the venous catheter with a sterile solution immediately prior to insertion into the vein, taking care that no blood products remain on the catheter. Because maximum fluid flow occurs when there is the greatest difference in pressure between the peritoneal and venous ends of the shunt, it is advisable to minimize the time the patient is supine immediately after shunt placement to avoid fluid overload. (See Postoperative Management on page 10) The insertion point into the subclavian vein must be carefully chosen. If the catheter is inserted too far medially, compression between the clavicle and the first rib may lead to decreased flow or severing the venous end of the shunt. To avoid blood reflux into the venous catheter when pumping the single-valved shunt, it is important for the patient to be in a supine position. After compressing the pump catheter but before releasing it, the venous catheter should be occluded by pressing or pinching it through the skin. In patients with peritoneo-venous shunts, care must be taken to avoid air entering the shunt when laparoscopic surgery or abdominal endoscopic procedures are performed. The peritoneo-venous shunt is only intended for peritoneo-venous use. Cautions For single use only. Re-use may result in a nonfunctional product or contribute to cross contamination. Use sterile technique in all phases of the use of this product. Individual patient anatomy and physician technique may require procedural variations. Benefits of instituting peritoneo-venous shunting in patients with neoplastic ascites should be weighed against the potential hazards of dissemination of ascitic fluid containing malignant cells. Exercise extreme care to prevent the shunt from coming in contact with bare fingers, towels, drapes, talc, or any linty or granular surfaces. Silicone rubber is highly electrostatic and, as a result, attracts airborne particles and surface contaminants that could produce tissue reaction. Use rubber-shod instruments when handling the shunt. Possible cuts or tears can occur if rubbershod instruments are not used. Avoid excessive handling of the shunt. Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures. Confirm shunt patency prior to insertion. Prime the shunt prior to insertion to eliminate large air bubbles from the chamber and catheters. (See Preparation of the Shunt on page 4) This device should only be used by physicians thoroughly trained in the technique of percutaneous access of the subclavian, IJ, or saphenous vein. Care should be taken when draining ascites, as rapid evacuation of ascitic fluid may result in circulatory or vascular collapse. It is important to use an oblique approach while passing through the peritoneum, to minimize the chance of ascitic fluid leakage. Do not allow the guidewire to inadvertently advance totally within the patient. It is very important to peel the sheath away from the catheter in a symmetrical manner. If the catheter begins to withdraw while the sheath is being peeled, hold the catheter in place and carefully peel the sheath away symmetrically. 2

4 Do not use forceps on the introducer to break its handle and/or peel the sheath. The peel-away sheath should withdraw freely from the body. If resistance is encountered, do not force the peeling action of the sheath or its withdrawal. Make procedural corrections, then continue. Damage to or embolization of the guidewire may result if it is withdrawn through the needle. Do not use introducers or guidewires that differ in size from the components supplied in the kit. The valved peel-away introducer is designed to reduce blood loss and the risk of air intake but it is not a hemostasis value. It is not intended to create a complete two-way seal nor is it intended for arterial use. The valve of the peel-away introducer will substantially reduce air intake. At -12 mm Hg vacuum pressure, the introducer may allow up to 4 cc/sec of air to pass through the valve. The valve of the peel-away introducer will substantially reduce the rate of blood flow but some blood loss through the valve may occur. The roller clamp must be fully closed to occlude the drainage line. When not connected to a suction source, make sure the roller clamp is fully closed. Otherwise, the drainage line may allow air into the body or let fluid leak out. When connecting to a vacuum bottle, make sure the roller clamp on the drainage line is fully closed. Otherwise, it is possible for some, or all, of the vacuum in the bottle to be lost. Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler. Always cut the catheter free of the tunneler. Do not try to separate the catheter from the tunneler by pulling. Insertion into artery may cause excessive bleeding and/or other complications. Potential complications of percutaneous insertion include, but may not be limited to pneumothorax, hematoma formation, brachial plexus injury, injury to mediastinal or visceral structures, sepsis/infections, excessive bleeding, and vessel damage. Individual patient anatomy, such as a thin, weak abdominal wall, may require procedural variations to reduce the risk of leakage around the catheter. Individual patient anatomy, such as obesity or loose subcutaneous tissue, may require procedural variations to reduce the risk of inadvertent catheter withdrawal from the vein. Peritoneal fibrosis has been observed in some patients with peritoneo-venous shunts. Repairing hernias before shunt insertion and promptly treating intra-abdominal inflammation may reduce the risk of this complication. Potential Complications/Side Effects Potential complication of venous ascites shunt implantation and use include, but may not be limited to the following: infections, fluid overload, acute heart failure, pulmonary edema, shunt occlusion, air/pulmonary embolism, neoplastic dissemination, abnormalities of coagulation, DIC, blood vessel damage, excessive bleeding, post shunt coagulation, peritoneal fibrosis, and circulatory/vascular collapse and/or acute cardiac failure. Potential Complications of the Valved Peel- Away Introducer Subclavian artery puncture Inadvertent vessel puncture Thrombosis Pneumothorax Hemothorax Air embolism Hematoma formation Brachial plexus injury Subclavian vein thrombosis Wound infection Mediastinal widening Sterility This product has been sterilized by ethylene oxide. It is for single use only. Do not resterilize. Carefusion will not be responsible for any product that is resterilized, nor accept for credit or exchange any product that has been opened but not used. Do not use the product if package is damaged. To help prevent damage to sterile packaging, it is recommended that products be stored in the product box. Preoperative Management, Denver Shunt Placement Proper medical and surgical procedures are the responsibility of the physician. The appropriateness of any procedure must be based upon the needs of the patient. The following baseline evaluations should be considered prior to implanting the shunt: Measurement of abdominal girth and weight. SMA12, SMA6, CBC, serum creatinine and BUN. Urine output and a 24-hour urine analysis for electrolytes. Coagulation profile. Cardiac function. Systemic prophylactic antibiotic therapy is indicated for patients undergoing peritoneo-venous shunting and should be initiated preoperatively. 3

5 Preparation of the Shunt 1. Using sterile technique, immerse the entire shunt in sterile saline solution. Note: The single-valved shunt will be difficult to prime if the venous catheter tip is not completely submerged. Compress the pump chamber repeatedly until the entire shunt is filled with fluid and flow is established. 2. Expel any remaining air bubbles by elevating the venous end of the shunt and alternately tapping and compressing the pump chamber while the entire peritoneal catheter remains immersed in the solution. Continue to pump the shunt body until all air bubbles are removed. 3. Occasionally, the leaves of the silicone valve will adhere, and the priming technique described above will fail to institute flow. This may be remedied by squeezing the miter valve edgewise while rolling the pump chamber at the site of the valve between the thumb and index finger (thus opening the valve), and then vigorously pumping fluid through the shunt. This maneuver assures patency of the shunt before insertion without damaging the valve mechanism. 4. The venous catheter should always be kept elevated when the filled shunt is transferred from the preparation pan to the patient. Otherwise, the fluid will drain quickly from the device, leaving it full of air. If this should occur, the shunt must be refilled with fluid before it is implanted. Patient Preparation The procedure may be performed under local anesthesia with preoperative sedation and analgesia or under general anesthesia as the situation warrants. A venous line should be established. The patient should be cleaned aseptically from the chin to the symphysis pubis and from the midline laterally to the posterior axillary line. An EKG monitor should be in place. It is important to drain most of the ascitic fluid prior to shunt placement. This will reduce the risk of fluid overload and may reduce the possibility of postshunt coagulopathy in the postoperative period. Refer to Obtaining Peritoneal Access and Ascites Drainage Instructions on page 4 and 5. Part of the ascitic fluid removed may be replaced with normal saline or lactated Ringer s solution as the patient s fluid volume necessitates. For some patients it may be appropriate to drain all the fluid, and replace with a volume equal to one-half of the drained fluid. Caution: Care should be taken when draining ascites, as rapid evacuation of ascitic fluid may result in circulatory or vascular collapse. In patients with malignant ascites and normal coagulation studies, it may also be useful to administer heparin into the peritoneal cavity to reduce risk of thrombosis about the venous end of the shunt and the aggregation of peritoneal debris within the pump chamber. Prepare Valved Peel-Away Introducers 1. Remove the sheath/dilator assemblies from the package. Remove dilator from the sheath. 2. Slide the valve over the sheath opening, and insert the dilator through the valve and lock in place using the rotating collar (Figure 2). Rotating Collar Figure 2: Valved Peel-Away Introducer Preparation Obtaining Peritoneal Access Caution: Individual patient anatomy, such as a thin, weak abdominal wall, may require procedural variations to reduce the risk of leakage around the catheter. 1. If needed, rotate the patient to the right side; this will allow the ascitic fluid to pool in the right abdominal gutter. 2. Using the subcostal incision, carefully pass the needle assembly obliquely through the abdominal wall into the peritoneal cavity. The entrance into the peritoneal cavity is usually recognized by a distinct loss of resistance as the needle passes through the posterior fascia. Aspirate to confirm there is free flow of ascitic fluid. Caution: It is important to use an oblique approach while passing through the peritoneum, to minimize the chance of ascitic fluid leakage. 3. After entering the peritoneal cavity, advance the needle a short distance into the cavity, taking care to avoid injury to the visceral structures. Once needle placement is achieved, remove needle leaving sheath in place. 4. Insert the J-Tip guidewire into the peritoneal cavity through the sheath. Advance the guidewire several centimeters into the peritoneal cavity and then remove the introducer sheath leaving an appropriate amount of guidewire exposed. Caution: Do not allow the guidewire to inadvertently advance totally within the patient. Caution: Damage to or embolization of the guidewire may result if it is withdrawn through the needle. 4

6 5. Pass the 16 Fr. valved peel-away introducer (dilator and peel-away sheath) over the guidewire through the external oblique fascia. Use a rotational movement while advancing the dilator and sheath, to help prevent any sheath damage. The posterior fascia may offer some resistance during this maneuver. 6. Remove the dilator and guidewire from the introducer/dilator assembly by unlocking the rotating collar and gently withdrawing the dilator from the sheath. 7. If the ascitic fluid has not yet been drained, it can be done at this time using the PreP-Centesis catheter included in the Denver shunt procedure tray. (See Patient Preparation on page 4). If ascitic fluid has already been drained, skip ahead to Peritoneo-Jugular Placement, Obtaining Venous Access. Ascites Drainage Instructions using the PreP-Centesis Catheter Prior to use, clamp the drainage line completely closed using the roller clamp found on the tubing. Caution: The roller clamp must be fully closed to occlude the drainage line. When not connected to a suction source, make sure the roller clamp is fully closed. Otherwise, the drainage line may allow air into the body or let fluid leak out. Caution: When connecting to a vacuum bottle make sure the roller clamp on the drainage line is fully closed. Otherwise, it is possible for some, or all, of the vacuum in the bottle to be lost. 1. Insert the tip of the catheter insertion stylet through the first fenestration of the catheter (closest to the adapter) and advance it into the catheter toward the tip (away from adapter). (Figure 3). 3. Advance the catheter with stylet through the valve all the way until the hub of the stylet is at the top of the sheath. 4. Pull the stylet out of the catheter. Continue pushing the catheter into the sheath advancing it until all the fenestrations are within the peritoneal cavity. This can be verified under fluoroscopy as fenestrations are located along the barium sulfate stripe. Note: Do not break the handle and peel the sheath at this time. 5. If using a vacuum bottle, the 16 G needle is already attached to the Luer fitting on the drainage line. If using wall suction, remove the 16 G needle and attach the 5-in-1 adapter to the Luer fitting on the drainage line. 6. Connect the drainage line to the vacuum/suction source. 7. Open the roller clamp on the drainage line to begin drainage. You can reduce the flow rate as needed with the roller clamp. Caution: Care should be taken when draining ascites, as rapid evacuation of ascitic fluid may result in circulatory or vascular collapse. 8. If you need to change to a new vacuum bottle or suction source for any reason, close the roller clamp on the drainage line. Remove the drainage line from the vacuum/suction source and connect to a new vacuum bottle or suction source. Reopen the roller clamp to resume draining. 9. When the desired amount of fluid has been removed, close the roller clamp on the drainage line. 10.Remove the drainage catheter from the peel-away sheath. If the valve is being used on the peelaway sheath, the dilator does not need to be reinserted. If the valve is not being used, reinsert the dilator to block fluid flow until the peritoneal end of the shunt is placed. 11.Disconnect the drainage line from the vacuum bottle or suction source. Figure 3: Catheter Stylet Insertion 2. Ensure the base of the stylet hub is pushed all the way up against the catheter such that the tip of the catheter insertion stylet is just past the 3rd to last fenestration near the tip of the catheter. 5

7 Peritoneo-Jugular Placement Obtaining Venous Access Fluoroscopy will need to be available in the operating room and ready for use during the procedure. The internal jugular route is recommended (Figure 4) unless previous surgery or trauma induces unacceptable complications. Some surgeons may prefer to use the subclavian route. In those cases in which the internal jugular or subclavian is not acceptable, the peritoneo-saphenous route (See Peritoneo-Saphenous Placement on page 9) may be preferred. 7. Using fluoroscopy, identify when the guidewire is in the proper position, then remove the introducer sheath. Caution: Damage to or embolization of the guidewire may result if it is withdrawn through the needle. Preparing Pump Chamber Pocket 1. Infiltrate the incision site with 1% lidocaine hydrochloride, USP. 2. Anesthetize the location for the pump chamber by infiltrating with 1% lidocaine hydrochloride, USP. 3. Make a small (5 cm) incision 4-6 cm below the costal margin in the upper right quadrant of the abdomen. Make the incision just lateral to the nipple line. Carry the dissection down to the external oblique fascia. 4. Prepare the pump chamber site by making a pocket with blunt dissection, superiorly and laterally from the incision, gently separating the subcutaneous tissue from the fascia (Figure 5). The pocket should be positioned so that the pump chamber lies immediately over the lower rib cage to facilitate manual compression of the pump chamber. Ensure the pocket size is long enough to accommodate the pump without any restrictions. Note: Avoid placing pump over the floating ribs. Figure 4: Peritoneo-Jugular Placement 1. Place the patient in the supine position with the head slightly extended. 2. Select a jugular venous puncture sight slightly above the clavicle. 3. Anesthetize the area by first infiltrating the skin with 1% lidocaine hydrochloride, USP. 4. Insert the venous access needle. Advance the needle slowly, with gentle aspiration of the syringe until venous blood is freely aspirated. 5. Remove the needle leaving the sheath in place. 6. Insert the J-Tip guidewire into the internal jugular vein through the sheath. While advancing the guidewire into the superior vena cava, the patient s head should be returned to the midline. As the guidewire is advanced, the EKG monitor should be observed for the possible development of arrhythmias. Should this occur, the guidewire should be withdrawn slowly until a normal rhythm has been re-established. Caution: Do not allow the guidewire to inadvertently advance totally within the patient. Figure 5: Creating a Pocket for Pump Chamber 6

8 Peritoneal Catheter Insertion 1. Insert the peritoneal limb of the shunt into the peel-away sheath Note: To prevent kinking the catheter, it may be necessary to advance in small steps by grasping the catheter close to the sheath. 2. After the catheter has been positioned, crack the sheath handle in half. 3. Peel the non-valved side of the handle partially away from the catheter. 4. Near the valve, hold the catheter firmly in position and pull the valve off the catheter (Figure 6). Hold catheter or lead in position Pull valve and sheath off Figure 6: Removal of Peel-Away Sheath from Patient Note: It is normal to experience some resistance while pulling the catheter through the slit on the valve. 5. Remove the sheath in a symmetrical manner, exercising care not to withdraw the catheter. Caution: Do not use forceps on the introducer to break its handle and /or peel the sheath. Caution: It is very important to peel the sheath away from the catheter in a symmetrical manner. If the catheter begins to withdraw while the sheath is being peeled, hold the catheter in place and carefully peel the sheath away symmetrically. Caution: The peel-away sheath should withdraw freely from the body. If resistance is encountered, do not force the peeling action of the sheath or its withdrawal. Make procedural corrections, then continue. 6. Check shunt function by compressing the pump chamber several times. There should be a free flow of fluid, which is enhanced by pumping. Once flow has been established, place a rubber shod clamp across the tip of the venous catheter. Caution: The clamp should be covered with rubber to avoid damage to the venous catheter. Tunneling Procedure Using the Denver Fast Track Tunneler Set: 1. Attach the shunt s venous catheter to the barbed end of the 15 (38 cm) Fast Track Tunneler. The catheter should be eased over the barbs and advanced until the catheter s leading edge abuts the flange of the tunneler. (Figure 7) Figure 7 2. A suture may be tied circumferentially around the catheter, just above the barbed portion, to hold the catheter more securely. Remove the clamp from the catheter. Note: For a one-step tunneling procedure using either the Internal Jugular or Subclavian Denver shunt placement technique, follow steps 3 8 below. For a two step tunneling procedure using the Internal Jugular placement technique, skip to steps 9 16 below. 3. Insert the tapered tip of the tunneler into the subcostal incision and advance it up toward the internal jugular or sub-clavian insertion site, along a path lateral to the breast. Caution: Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler. 4. Once the tip of the tunneler has passed lateral to the breast, begin directing it medially toward the internal jugular or sub-clavian insertion site. Note: If using the guidewire or sheath approach to venous access, make a small (approximately 2 cm) incision through the insertion site. 5. Pass the tunneler out through the internal jugular or sub-clavian insertion site. Continue to advance the venous catheter carefully through the tunnel until the shunt s pump chamber is properly positioned in the previously dissected pump chamber pocket. 6. Assure that there are no kinks in the catheter. 7. Once the catheter has been threaded through the internal jugular or sub-clavian insertion site, cut the catheter just proximal to the barbed end of the tunneler. Caution: Always cut the catheter free of the tunneler. Do not try to separate them by pulling. 8. Complete the shunt placement procedure by skipping to Step 17. Two step tunneling procedure using the internal jugular Denver Shunt placement technique 9. Continue after step 2, make a small incision (approximately 2 cm) just below the clavicle. 7

9 10.Insert the tapered tip of the tunneler into the subcostal incision and advance it up toward the subclavicular incision, along a path lateral to the breast. Caution: Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler. 11.Once the tip of the tunneler has passed lateral to the breast, begin directing it medially toward the subclavicular incision. 12.Pass the tunneler out through the sub-clavicular incision. Continue to advance the venous catheter carefully through the tunnel until the shunt s pump chamber is properly positioned in the previously dissected pump chamber pocket. 13.The catheter may be cut from the 15 (38 cm) Fast Track tunneler and attached to the 6 (15 cm) Short Track tunneler if needed to complete the tunneling step. Caution: Always cut the catheter free of the tunneler. Do not try to separate them by pulling. 14. Insert the tapered tip of the tunneler into the subclavicular incision and advance it over the clavicle, up toward the internal jugular insertion site. Note: If using the guidewire or sheath approach to venous access, make a small (approximately 2 cm) incision through the insertion site. 15.Pass the tunneler out through the internal jugular incision and gently pull the remainder of the catheter out, ensuring there are no kinks in the catheter. Note: Ensure that there are no kinks in the tunneled portion of the catheter. 16.Cut the catheter from the 6 (15 cm) Short Track Tunneler just proximal to the barbed end of the tunneler. Caution: Always cut the catheter free of the tunneler. Do not try to separate the catheter from the tunneler by pulling. 17.There should be free flow of ascitic fluid from the tip of the venous catheter. If there is no free flow of fluid, press the pump chamber several times to verify shunt function. After flow has been confirmed, clamp the venous catheter. 18.Place several 3-0 monofilament sutures through the suture pad on either side of the pump chamber to prevent rotation. 19.In patients with excessive subcutaneous tissue, it is advisable to thin the tissue down to approximately ¼ over the pump chamber to facilitate locating the chamber later. 20.It is advisable to mark the skin over the lower two-thirds of the pump chamber so that the patient or attendant will have no difficulty locating the proper position for pumping. Venous Catheter Insertion Caution: Individual patient anatomy, such as obesity or loose subcutaneous tissue, may require procedural variations to reduce the risk of inadvertent catheter withdrawal from the vein. 1. Measure the venous catheter of the shunt to allow the tip to lie at the junction of the superior vena cava and the right atrium. This can be judged by making a gentle curve along the clavicle and extending the catheter down to the second intercostal space on the chest wall. Cut off the rest of the catheter, making the cut transverse to the long axis of the catheter. Note: Placement of the venous catheter tip above the level of the cavo-atrial junction may lead to occlusion or encapsulation of the catheter. 2. Introduce the dilator with peel-away sheath over the guidewire and advance it through the fascia. The fascia often presents some resistance, but applying steady pressure will allow the dilator to slip into the vein. 3. Remove the guidewire and dilator from the sheath. 4. Remove the clamp from the venous catheter and once again ensure that there is free flow of ascetic fluid. Warning: Wipe the venous catheter with a sterile solution immediately prior to insertion into the vein, taking care that no blood products remain on the catheter. 6. Insert the venous catheter into the internal jugular vein through the peel-away sheath and advance it to the cavo-atrial junction. Under fluoroscopy, or with x-ray, confirm that the shunt is in the correct position, as shown in Figure 4, with no kinks in the tubing. Note: To prevent kinking the catheter, it may be necessary to advance in small steps by grasping the catheter close to the sheath. 7. Once the proper position has been confirmed, crack the sheath handle in half. Peel the nonvalved side of the handle partially away from the catheter. 8. Near the valve, hold the catheter firmly in position and pull the valve off the catheter (Figure 6). Note: it is normal to experience some resistance while pulling the catheter or lead through the slit on the valve. 9. Remove the sheath in a symmetrical manner, exercising care not to withdraw the catheter. Caution: Do not use forceps on the introducer to break its handle and /or peel the sheath. Caution: It is very important to peel the sheath away from the catheter in a symmetrical manner. If the catheter begins to withdraw while the sheath is being peeled, hold the catheter in place and carefully peel the sheath away symmetrically. Caution: The peel-away sheath should withdraw freely from the body. If resistance is encountered, do not force the peeling action of the sheath or its withdrawal. Make procedural corrections, then continue. Closing Procedure Irrigate both incisions with antibiotic solution, and close in layers. Finally, mark the pump location with an X to allow the patient to know the location of the pump. 8

10 Peritoneo-Saphenous Placement Groin Incision 1. Make a small oblique incision 4 cm below the inguinal ligament. Extend this incision through the subcutaneous tissues to expose the greater saphenous vein. Trace the vein superiorly to the junction with the femoral vein at the fossa ovalis (Figure 8). Figure 8: Peritoneo-Saphenous Placement 2. Place two 2-0 loop ties around the greater saphenous vein for traction. 3. After securing the saphenous vein, use blunt dissection to make a tunnel superiorly and laterally to the anterior superior iliac spine, creating a pocket for positioning the pump chamber on the iliac crest. 4. Irrigate the incision with sterile antibiotic solution and pack loosely with a gauze sponge. Abdominal Incision Make a 5 to 7 cm McBurney-type incision in the right lower quadrant of the abdomen to expose the external oblique fascia. Tunneling Procedure 1. Use blunt dissection to make a tunnel from the abdominal incision to the iliac crest. 2. Pass forceps from the groin incision through the tunnel to the abdominal incision. 3. Using the forceps, pull a 10 Fr bullet-tip catheter from the abdominal incision to the groin incision. 4. Insert the tip of the 10 Fr catheter into the tip of the peritoneal catheter of the shunt, and secure with a suture. 5. Withdraw the catheter from the abdominal incision with the peritoneal catheter following. Position the shunt pump chamber over the anterior iliac spine. Cut the tunneling catheter from the peritoneal catheter. Note: Ensure that there are no kinks in the tunneled portion of the catheter. Insertion into the Peritoneal Cavity 1. Place two purse-string sutures in the fascia and peritoneum, one 1.5 cm and the other 2 cm in diameter. 2. If the ascitic fluid has not yet been drained and partially replaced with sterile saline or lactated Ringer s solution, it can be done at this time (see Patient Preparation on page 4). Caution: Care should be taken when draining ascites, as rapid evacuation of ascitic fluid may result in circulatory or vascular collapse. 3. Incise the fascia and peritoneum in the center of the purse-strings. Insert the peritoneal catheter into the right lower quadrant of the abdomen and direct into either the right gutter or the pelvis. 4. Secure the purse-string sutures around the peritoneal catheter, taking care to achieve watertight closure without restricting the catheter lumen. Caution: Exercise care when placing ligatures to avoid cutting or occluding the catheters. Do not use stainless steel ligatures. 5. Check shunt function by compressing the pump chamber several times. There should be a free flow of fluid out of the venous catheter tip, which is enhanced by pumping. Once flow has been confirmed, place a rubber-shod clamp across the peritoneal catheter. Caution: Use rubber-shod instruments when handling the shunt. Possible cuts or tears can occur if rubber-shod instruments are not used. Avoid excessive handling of the shunt. 6. Secure the pump chamber to the fascia over the iliac crest by placing 3-0 monofilament sutures through the suture pad on either side of the pump chamber to prevent rotation. 7. Irrigate the abdominal incision with antibiotic solution and close in layers. Insertion into the Saphenous Vein 1. Measure the venous catheter to determine the length necessary for proper placement in the vena cava within the chest. This is accomplished by measuring the venous catheter from the fossa ovalis along the course of the femoral vein, iliac vein, and inferior vena cava to approximately 5 cm above the xiphoid process. Allow an extra 5 cm for flexibility in placement within the thoracic cavity. Cut the catheter obliquely at this point. The oblique angle will facilitate insertion into the vein. 2. Make a small longitudinal incision in the saphenous vein between the two loop ties. Release the distal loop tie. 3. Insert the venous catheter and thread it up the saphenous vein into the femoral vein, iliac vein, and on into the inferior vena cava in the chest. Unclamp the peritoneal catheter. 4. After obtaining hemostasis, confirm the venous catheter tip is in the inferior vena cava using fluoroscopy or x-ray. The tip of the venous catheter must lie above the diaphragm. Correct the position of the venous catheter as needed. 9

11 5. After proper positioning of the catheter in the chest, securely tie a 2-0 monofilament ligature about the venous catheter, using care not to restrict the lumen. 6. Release and remove the remaining loop tie. 7. Irrigate the groin incision with antibiotic solution and close in layers. Postoperative Management Warning: Because maximum fluid flow occurs when there is the greatest difference in pressure between the peritoneal and venous ends of the shunt, it is advisable to minimize the time the patient is supine immediately after shunt placement to avoid fluid overload. Immediately after the patient has arrived in the recovery room, elevate the head of the bed to a 45 angle. Administer diuretics as indicated. Obtain hematocrit and D.I.C. profiles. Measure urinary output hourly. After the initial hematocrit and D.I.C. profiles are evaluated, place the patient in the horizontal position for a period of 10 to 15 minutes. Examine the patient frequently for signs of fluid overload. If signs of fluid overload occur, return the patient to a sitting position to slow or stop ascitic fluid flow and initiate corrective measures. After 10 to 15 minutes, return the patient to the 45 angle position. This pattern should be repeated until the patient has reached a stable circulatory status and no significant drops in platelet count, hemoglobin, or fibrinogen levels have occurred. If there are changes indicating that clinical D.I.C. may occur, return the patient to the 45 angle. Treatment with fresh plasma, platelets, cryoprecipitate, or heparin should be considered. Maintain diuretic therapy postoperatively until the patient s edema and ascites are gone. The use of an abdominal binder should be omitted in the immediate postoperative period as it may contribute to fluid overload. Incentive breathing exercises to increase pulmonary ventilation should only be done with the patient in the sitting position, as this can contribute to fluid overload in the early postoperative period with the patient in the supine position. To reduce the risk of thrombosis around the venous catheter, consider daily administration of enteric aspirin. In some patients with malignant ascites, mini-dose heparin therapy may be beneficial. Patients should be cautioned to avoid falls or collisions. If either condition occurs, the patient should have the position and integrity of the shunt evaluated. Caution: In patients with peritoneo-venous shunts, care must be taken to avoid air entering the shunt when laparoscopic surgery is performed. Shunt Maintenance To help reduce the formation of thrombosis at and within the tip of the venous catheter and to help maintain continued patency of the valves, daily prophylactic compression of the pump chamber is recommended. Instruct the patient to percutaneously compress the pump chamber forcibly at least twenty times, with the patient in the supine position, once prior to bedtime and once prior to rising in the morning. Warning: To avoid blood reflux into the venous catheter when pumping the single-valved shunt, it is important for the patient to be in a supine position. After compressing the pump chamber but before releasing it, the venous catheter should be occluded by pressing or pinching it through the skin. Warning: Particulate matter or venous thrombosis may cause shunt occlusion, necessitating revision or replacement of the shunt. Resistance to compression of the pump chamber may be an indication that the venous catheter or pump chamber is occluded. Should the pump chamber fail to refill readily, the peritoneal catheter may be occluded. Testing Shunt Function 1. Daily measurement of abdominal girth and weight should provide evidence of continued proper function of the shunt. 2. To assess patency of the venous catheter and pump chamber, place the patient in the supine position. Compression of the pump chamber should afford very little resistance. Resistance to compression indicates occlusion of the venous catheter or pump chamber. (Figure 9) Warning: To avoid blood reflux into the venous catheter when pumping the single-valved shunt, it is important for the patient to be in a supine position. After compressing the pump chamber but before releasing it, the venous catheter should be occluded by pressing or pinching it through the skin. Figure 9: Shunt Compression If the shunt has been compressed several times but remains resistant to compression, further investigation with radiopaque contrast medium is warranted. 10

12 An injection of 5 to 10 ml of radiopaque contrast media with a 25 or 26 gauge non-coring needle into the pump chamber should rapidly disperse through the venous catheter into the superior vena cava. Caution: Never inject directly into the tubing portion of the shunt as leakage or tearing of the catheter may occur. 3. Should shunt failure occur due to clot formation in the superior vena cava, obtain a venogram (or use cross-sectional imaging) by simultaneous injections in the right and left arms with radiopaque material. After discerning the extent of the clot formation, therapy may be instituted in one of several ways. Several patients have been treated with infusion of a thrombolytic agent through the pump chamber with successful resolution of the clot formation (clinical references available on request). The benefits of thrombolytic agent infusion must be weighed against the potential hazards of bleeding in these patients. In other patients, fibrin may accumulate within the venous catheter. This requires a simple replacement of the venous catheter. Replacement catheters and nylon connectors are available for this purpose (See Ordering Information). Instructions for shunt revision are supplied with replacement components. 4. Test the patency of the peritoneal component by compressing the pump chamber. In patients with single-valved shunts, it is necessary to percutaneously occlude the venous catheter when releasing compression. It is not necessary to occlude the venous catheter when testing the double-valved shunt. When compression is released (with the venous catheter deliberately occluded for the single-valved shunt), the pump body should rapidly refill, indicating patency of the peritoneal position of the system. Should the pump chamber fail to refill rapidly from the peritoneal side, indicating obstruction of the peritoneal portion, replacement of the peritoneal catheter is indicated. This may be performed using local anesthesia and sedation. Replacement catheters and connectors are available for this purpose (See Ordering Information). 5. Additional evidence of patency can be provided by Doppler flow meter testing or injection of sulfur colloid labeled with technetium into the peritoneal cavity. Ordering Information REF Product Description Denver 15.5 Fr. PAK, Double-Valved Shunt Denver 15.5 Fr. PAK, Single Valved Shunt Components for Revision Nylon Connector (two per box) Fr Venous Catheter (60 cm) Fr Fenestrated Catheter (27 cm) Fr Introducer Set Fr Introducer Set Warranty CareFusion warrants that this medical device is free from defects in both materials and workmanship. The above warranties are in lieu of all other warranties, either expressed or implied, including any warranty of merchantability or fitness for a particular purpose. Suitability for use of the medical device for any surgical procedure shall be determined by the user. CareFusion shall not be liable for incidental or consequential damages of any kind. 11

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