Development of a new approach to vascular access
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Published on: April 1, 2022
J Megerman1, N W Levin, T S Ing
1Biolink Corporation, Middleboro, Massachusetts 02346, USA.
Insights
A new Dialock device offers a promising solution for hemodialysis vascular access, significantly reducing infection rates and improving blood flow compared to traditional catheters.
Area of Science:
- Nephrology
- Vascular Surgery
- Biomedical Engineering
Background:
- Vascular access is critical for hemodialysis (HD) patients, yet current methods like fistulas, grafts, and catheters contribute significantly to morbidity and healthcare costs.
- Central venous catheters, while common, are prone to infection due to their external protrusion and complex internal structure.
- Existing subcutaneous ports for HD access face challenges with degradable septums and non-linear flow paths, leading to infection and thrombus formation.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel vascular access device, the Dialock, for hemodialysis.
- To address the limitations of current hemodialysis vascular access methods, particularly the high infection rates and complications associated with central venous catheters.
Main Methods:
- A pilot study was conducted involving 23 hemodialysis patients utilizing the new Dialock vascular access device.
- The study assessed the device's performance concerning infection rates, blood flow sustainability, and patient outcomes over a one-year period.
Main Results:
- The Dialock device demonstrated a 78% cumulative survival rate after one year of use.
- Patients using the Dialock experienced a reduced rate of infection compared to those using traditional catheters.
- The device maintained a sustained blood flow rate of 330 ml/min, crucial for effective hemodialysis.
Conclusions:
- The Dialock represents a significant advancement in hemodialysis vascular access, offering improved safety and efficacy.
- Its design, featuring a mechanical valve and linear flow path, effectively mitigates common complications like infection and thrombus formation.
- Further investigation and wider adoption of the Dialock could substantially decrease morbidity and hospitalization costs in hemodialysis patients.
Abstract:
Three modes of access for hemodialysis (HD) have been available for over 20 years, the native arterial to venous (A-V) fistula, the polytetrafluorethylene (PTFE) graft fistula, and the central venous catheter. Overall, vascular access remains the single most costly source of morbidity and hospitalization in HD patients, indicating a severe need for improvement in this area. A significant contributor to access morbidity is the HD catheter, which protrudes through the skin and is subject to frequent infection. Subcutaneous ports have been developed to overcome this problem with catheters, but their application to HD has been elusive for 2 reasons, the use of a degradable septum that becomes vulnerable to infection with the use of large bore needles and the presence of a nonlinear flow path which produces damage to blood cells and stimulates thrombus formation at the required high flow rates. A new device, the Dialock, overcomes these objections by its use of a mechanical valve that maintains a linear flow path without directly contacting the blood. Results of a pilot study with 23 patients demonstrated a 78% cumulative survival rate after 1 year with a reduced rate of infection compared to catheters and sustained blood flow of 330 ml/min. The device represents a most promising advance in vascular access.