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Initial results of a new access device for hemodialysis technical note
N W Levin1, P M Yang, D A Hatch
1Renal Research Institute and Beth Israel Medical Center, New York, New York; Hines VA Hospital, Hines, Illinois; Biolink Corporation, Middleboro, Massachusetts, USA.
Kidney International
|December 9, 1998
Summary
A new subcutaneous device offers improved vascular access for hemodialysis (HD) patients, demonstrating high blood flow and excellent patient satisfaction with a low complication rate.
Area of Science:
- Nephrology
- Medical Devices
- Vascular Surgery
Background:
- A novel subcutaneous device, DIALOCKtrade mark, is designed for vascular access in hemodialysis (HD) patients.
- It features a port-like valve implanted subcutaneously, connected to catheters in the right atrium via jugular veins.
Purpose of the Study:
- To evaluate the safety and efficacy of the DIALOCKtrade mark device for hemodialysis vascular access.
- To assess blood flow rates, pressures, adverse events, and patient/nurse satisfaction.
Main Methods:
- The DIALOCKtrade mark device was implanted in 10 outpatients under local anesthesia.
- Patients underwent hemodialysis three times weekly, with data collection on key performance and safety indicators.
Main Results:
- The device functioned successfully for over nine months in 90% of patients, facilitating immediate HD initiation.
- Consistent blood flows exceeding 300 ml/min were achieved with satisfactory venous and arterial pressures.
- Systemic infections occurred at a rate of 2.3 bacteremic episodes per 1000 patient-days, resolving without device removal; patient and nurse acceptance was excellent.
Conclusions:
- The DIALOCKtrade mark device represents a significant advancement in hemodialysis vascular access.
- It offers a safe and effective alternative with high patient and clinician satisfaction.