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Hidden
Benefits? A new access for peritoneal dialysis
Please note, this page is a summary of the full conference speech (click here for the full transcript - including photographs of the LifeSite Device).
Maggi Steele
Research Sister, Renal Unit, St Helier Hospital, Carshalton Surrey.
EDTNA representative on the British Renal Society.
"The LifeSite device is a fully subcutaneous system in which all aspects of the device and the catheter are implanted under the skin and there is no external portion. And it is this feature which may reduce the incidence of access-associated infections in peritoneal dialysis", said Ms Steele.
In the LifeSite patient there was nothing to be seen externally other than a small bump over the iliac crest. It was this design feature together with the access procedure itself which might have the hidden benefit of reducing line-associated infections. The other potential benefit was improved body image.
Her unit was conducting a very small-scale clinical study where 20 patients would be randomised, so that ten would receive LifeSite devices and ten standard Tenckhoff, all on APD therapy using Home Choice machines. The randomisation was carried out by Vasca, the American company which manufactured the device. The division was more male than female, with the age range from 27 to 69.
A standard Tenckhoff catheter and a titanium metal device were placed subcutaneously. The titanium device had an internal pinch clamp which was accessed with a standard fistula needle - a 14 gauge needle - which had a special connector to the dialysate line. A couple of what Ms Steele called ball bearings were parted only when the 14 gauge needle went into place and this in turn operated a spring mechanism so there was continuity between the dialysate lines externally and the internal catheter. The access procedure itself caused a buttonhole site to be formed, because the needle went in in exactly the same place every time it was accessed.
Part of the study was looking at the patients' acceptance, and patients were asked to complete a very simple questionnaire. All had said that needle insertion was virtually painless, with very little discomfort. The patients found the exit site care of the LifeSite device relatively easy.
"Over in America, this device is used for haemodialysis and it does have FDA approval," said Ms Steele.
"The number of haemodialysis patients using the LifeSite device now number in the 5,000s. Their studies do show improved rates of line-associated infections, so we need to see if this is going to be the case with peritoneal dialysis as well," said Ms Steele.
Please note, this page is a summary of the full conference speech (click here for the full transcript - including photographs of the LifeSite Device).
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