Background: The LifeSite Hemodialysis Access System is a subcutaneous valve with an internal pinch clamp that is actuated with a standard 14-gauge dialysis needle, connected to a single lumen cannula placed in the central venous circulation for hemodialysis (HD).
Methods: The LifeSite System (2 valves) was implanted in 23 patients with immediate dual-needle HD use. The cannulas were placed in either the jugular or the subclavian veins and were connected to the subcutaneous valves located in the upper chest area.
Results: The mean duration of device survival for the LifeSite System was 6.8 +/- 0.97 months. During this period, the device achieved prescription HD blood flow rates averaging 384.7 +/- 78.5 mL/min with a venous pressure of 223.2 +/- 60.3 mm Hg. After 125 patient months, device removal because of infection was at a rate of 2.5 per 1000 days, and there were no devices removed because of poor flow. The average Kt/V for these patients was 1.51.
Conclusion: This preliminary clinical study has validated the applicability of the LifeSite Hemodialysis Access System as an access for HD. It is easily implanted and easily used, provides safe and effective dialysis, and is well accepted by patients. It should be especially useful as a bridge device to allow for maturation of a native fistula and will provide an alternative for long-term use in patients in whom a peripheral dialysis access is not feasible.
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Background: Since 2005, three human clinical trials have been performed with the Wearable Artificial Kidney (WAK) and Wearable Ultrafiltration (WUF) device. The lack of an adequate vascular access (VA) has been pointed out as the main limitation to their implementation. Based on the current level of understanding, we will make the first conceptual proposal of an adequate VA suitable for the WAK and the WUF.
View Article and Find Full Text PDFBridging to a high flow upper arm native fistula for hemodialysis with the LifeSite Hemodialysis Access System.
J Vasc Access
October 2012
General Surgery, Bamberg County Hospital, Bamberg, South Carolina - USA.
Permanent vascular access for chronic hemodialysis requires a reliable structure with adequate blood flow. Endogenous arteriovenous (AV) fistulas offer the best outcomes, but standard radiocephalic fistulas are not always feasible. A reliable alternative is a transposed basilic vein-brachial artery AV fistula, which offers a number of advantages over synthetic AV grafts.
View Article and Find Full Text PDFSubcutaneous implantation of the LifeSite Hemodialysis Access System in the femoral vein.
J Vasc Access
October 2012
General Surgery, Bamberg County Hospital, Bamberg, South Carolina - USA.
Cannulation of the femoral vein is often necessary to provide immediate vascular access for hemodialysis patients in whom a functional permanent access is not available or in patients who have exhausted other access options. Femoral placement of dialysis catheters is typically short term - days, not months - and is associated with high rates of infection, occlusion, recirculation and intervention as well as a high risk of catheter dislodgment. A new, fully subcutaneous vascular access device - the LifeSite(R) Hemodialysis Access System (Vasca, Inc.
View Article and Find Full Text PDFEfficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months.
J Vasc Interv Radiol
March 2006
Yale University, New Haven, Connecticut, USA.
Purpose: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation.
Materials And Methods: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group.
Use of LifeSite port systems for hemodialysis in Germany.
Clin Nephrol
August 2005
Department of Nephrology and Rheumatology, Knappschaftskrankenhaus, Bottrop, Germany.
Aim: Studies haveshown lower infection rates of port systems compared to established, transcutaneous cuffed-tunneled dialysis catheters. This was shown in otherwise quite healthy patients starting hemodialysis treatment. It is unclear to what extent these results can be applied to countries such as Germany where, unlike the US, central venous access systems are used mainly for patients with a high comorbidity.
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