INITIAL RESULTS OF A NEW ACCESS DEVICE FOR HEMODIALYSIS - TECHNICAL NOTE

Background. A new subcutaneous device (DIALOCK(TM)) provides vascular access to patients who currently require hemodialysis (HD). The device consists of a port-like valve, implanted subcutaneously below the cla vicle, which provides a linear flow passage to two catheters placed in the right atrium via the internal or external jugular vein. The valve is accessed percutaneously with needle-cannulas that functionally con vert the device to twin catheters for connecting the patient to the HD lines. Methods. The device was implanted in 10 outpatients under loca l anesthesia. Patients used the device during dialysis 3 times/week, a nd data were collected on blood flow, pressures, adverse events and pa tient and nurse satisfaction. Results. The device was used for HD almo st immediately (median 3 days after implantation) and functioned succe ssfully for more than nine months (mean +/- so 7.3 +/- 1.5) in all but one patient who died of unrelated causes after one month; there were >800 dialysis sessions total. Blood flows over 300 ml/min were consist ently achieved (average 326 +/- 40) with venous and arterial pressures of 200 +/- 44 and -246 +/- 29 mm Hg: respectively. After 66 patient-m onths, condition of the needle puncture sites remained satisfactory. F ive systemic infections occurred in four patients, producing 2.3 bacte remic episodes per 1000 patient-days. All resolved without the need fo r device removal. There were no infections at the puncture sites. Two patients required fibrin sheath stripping of their catheters, one whos e heparin lock was not changed for 23 days (for reasons unrelated to t he device). Patient and nurse acceptance was excellent. Conclusion. Th e device represents a positive improvement in the area of HD access.