Thomas Buerger, Thomas Gebauer, Frank Meyer and Zuhir Halloul. Division of Vascular Surgery, University Hospital, Otto von Guericke University, Magdeburg, ...
Nephrol Dial Transplant (2000) 15: 722–724
Nephrology Dialysis Transplantation
Case Report
Implantation of a new device for haemodialysis Thomas Buerger, Thomas Gebauer, Frank Meyer and Zuhir Halloul Division of Vascular Surgery, University Hospital, Otto von Guericke University, Magdeburg, Germany
Keywords: arteriovenous shunt; central venous access; haemodialysis; iliac vein; implantable device; vascular access
Introduction After the loss of all possible operative sites for conventional permanent vascular access for haemodialysis, only two alternative options remain: peritoneal dialysis or insertion of a percutaneous catheter. We describe a novel alternative—the implantation of two specifically designed subcutaneous devices via the external iliac vein.
further diagnostic revealed thrombotic occlusions of both femoral veins as well as the left iliac vein. In the right external iliac vein, filling defects were seen by contrast, but the right common iliac vein was found to be patent ( Figure 1). Therefore the right external iliac vein was chosen for the implantation of a subcutaneous device critical for maintenance of the life-saving haemodialysis treatment. A specifically designed, membraneless titanium device (LifeSiteTM; VascA, Inc., Tewksbury, MA, USA) ( Figure 2) was used. The advantage of this device is its mechanical valve, which
Case A 73-year-old woman with end-stage renal disease ( ESRD) due to analgesic nephropathy had been on haemodialysis for 10 years. The patient had undergone a total of 27 surgical interventions including the placement of multiple arteriovenous accesses and multiple revisions on upper and lower extremities. Furthermore the patient had had numerous central venous catheters, the exact number of which was unknown. Her medical history was also significant for chronic obstructive bronchitis and coronary heart disease. There was no definable coagulation disorder. The patient was transferred to Vascular Surgery because of a recurrent thrombosis of a left upper arm basilic vein AV fistula that had been constructed using a transposed vein 13 months previously. At the time of surgery, the proximal blood flow passed exclusively via venous collaterals. An alternative anastomosis to a more proximal vein was impossible because of occluded central veins, including both jugular and both subclavian veins. Duplex sonography and phlebography of the upper extremities confirmed these findings. In addition, a thrombosis of the superior vena cava extending into the right atrium was found. In the lower extremities, Correspondence and offprint requests to: Thomas Buerger MD, Division of Vascular Surgery, University Hospital, Otto von Guericke University, Leipziger Strasse 44, D-39120 Magdeburg, Germany.
Fig. 1. Documentation of blood flow through the right common iliac vein and vena cava. The femoral vein is occluded.
© 2000 European Renal Association–European Dialysis and Transplant Association
A new device for haemodialysis
Fig. 2. LifeSiteTM valve connected with the cannula (12-French radiopaque silicone catheter).
allows the use of a 14-gauge dialysis needle, and an internal pinch clamp that opens and closes the cannula when the needle is respectively inserted and removed. With the patient under general anaesthesia, surgery was performed via an oblique supra-inguinal incision and a extraperitoneal approach to the right external iliac vein. Two silicone cannulae (12 French) were placed under fluoroscopy using the Seldinger technique into the partially thrombosed external iliac vein from different insertion sites. The cannula tips were pushed forward to the level of the renal veins. The device valves were placed subcutaneously in the suprainguinal region (Figure 3). The first haemodialysis was done immediately after implantation of the devices with blood flow rates between 260 and 300 ml/min and without complications. After previous antithrombotic lock with heparin (4 ml/port), both ports were punctured again and rinsed with 1–2 ml of sodium hypochlorite solution (0.2%) for prophylaxis of infection. Using a 25-gauge needle, the antimicrobial solution does not enter the catheter, since the pinch is closed while irrigation is performed. No side-effects were caused by this solution. During the following 5 months, haemodialysis was performed with an effective blood flow of 280–340 ml/min (venous pressure, 170–205 mmHg) as documented on the dialysis protocols. There were no
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Fig. 3. The LifeSiteTM devices placed subcutaneously in the right lower abdomen shortly after puncture.
device-related complications (e.g. thrombosis or infection). The initial sensitivity of the surgical wound and the slight pain caused by puncture disappeared almost completely. The patient was able to return to her previous daily routine without any limitations. On the days between the haemodialysis sessions/procedures, the patient could even take a bath without dressing. The new devices have not only been well tolerated by the patient but also well handled and accepted by the nursing staff. A further radiological study revealed a complete occlusion of the previously partially thrombosed right iliac vein. However, there were no clinical symptoms or complications concerning the vascular access.
Discussion Permanent indwelling catheters are used with increasing frequency for haemodialysis, but they are associated with an increased risk of infection and thrombosis. In general, catheter placement is indicated in patients with limited peripheral access due to loss of all possible sites for conventional vascular access, in case of contraindication to conventional vascular access such as in severe CHF, or in patients with limited life expectancy. Central venous catheters are usually placed into the
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subclavian or jugular veins. In many cases an alternative approach is necessary, most frequently via the femoral veins [1,2]. In very few cases, a percutaneous translumbar approach to gain vascular access has been described [3]. In our patient, vascular access was achieved by a supra-inguinal oblique incision with an extraperitoneal approach to the iliac vessels along the external iliac vein. The distal thrombotic occlusions did not allow the commonly used transfemoral catheter insertion. Despite more extensive surgical trauma, the procedure allowed better surgical access, placement of the sheaths and cannulae under direct vision, and safer control of bleeding accessory vessels. The supra-inguinal subcutaneous placement of the devices avoids contact with the more infectious inguinal region, the common problem with femoral catheters. In addition, the support provided by the inguinal ligament facilitates and enhances the safety of puncturing the devices. To our knowledge, this supra-inguinal location for a subcutaneous device for haemodialysis has not been utilized previously, although the authors have used it when placing chemotherapy ports [4]. The intravenous Port-a-Cath has been established as permanent central venous access since the middle 1980s, in particular, for chemotherapy of haematologic malignancies and carcinomas or for parenteral nutrition [4,5]. The Port-a-Cath offers safer handling and lower complication rates than percutaneous catheters [6,7]. Until recently, haemodialysis using vascular access via a subcutaneous device was not available. The vulnerability of the septum, which became susceptible to infection through the necessary use of largebore needles, and the presence of non-linear blood flow within the chamber made it unsuitable for dialysis which requires high blood flow rates. This can generate cell damage and stimulate thrombus formation at the required high flow rates [8]. The novel LifeSiteTM is specifically designed for haemodialysis. In our experience, this device can be also used to provide vascular access for chemotherapy and stem cell separation (unpublished data). To access the system and establish high blood flow rates, a standard 14-gauge needle is inserted through the skin into the LifeSiteTM valve’s internal metal taper seal. Insertion of the needle opens the valve’s internal pinch clamp to allow blood flow through the cannula. When the dialysis needle is withdrawn, the same pinch clamp closes the valve and prevents further flow. Maximal flow rates of 450–480 ml/min can be achieved [9].
T. Buerger et al.
In addition to thrombosis, infection is a typical complication, which limits function of intravenous Port-a-Caths. Therefore, the device is additionally designed to allow irrigation of the valve pocket with an antimicrobial solution to prevent infections. Because of a smaller needle size (25-gauge) used for the irrigation, this procedure does not open the pinch clamp, nor can it damage the valve. As with the recently introduced DialockTM-System (Biolink, Corp., Middlebora, MA, USA), in which a metallic port-like valve device is connected with twin silicone catheters, the haemodialysis LifeSiteTM device and the venous insertion site for the cannula is currently undergoing world-wide clinical studies to assess follow-up and outcome in haemodialysis patients. Our recent results and those published by other groups are very promising for the use of such devices for haemodialysis [8–10]. Acknowledgements. The authors thank Linda Kesselring MS ELS, and Dr John Moran for editorial assistance.
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