Feasibility study of ultrasound-guided, power-assisted needle insertion for hemodialysis cannulation using an innovative, handheld device.
Authors
Affiliations (6)
Affiliations (6)
- Vascular Surgery, Connecticut Vascular Center, North Haven, CT, USA.
- Palo Alto Medical Foundation for Health Care Research and Education, Mountain View, CA, USA.
- Department of Medicine (Nephrology), Stanford University School of Medicine, Stanford, CA, USA.
- Bluff City Vascular (Aligned with Lifeline Vascular Care), Memphis, TN, USA.
- Nano Medical Clinic, Olmazor District, Tashkent, Uzbekistan.
- Territorial Medical Association of Yangiyul District, Yangiyul District, Uzbekistan.
Abstract
Vascular access (VA) for hemodialysis is achieved through arteriovenous fistulas (AVF), arteriovenous grafts (AVG), or central venous access devices (CVAD). Hemodialysis remains the most common modality of kidney replacement therapy, and its continued success depends on the reliability and integrity of the patient's vascular access. The current standard for assessing VA involves the "look, listen, and feel" method, which is highly dependent on the operator's skill and experience. An innovative device has been developed to support the current approach by enabling machine-learning-trained, ultrasound-guided, power-assisted needle insertion for cannulation. This first-in-human pilot study aimed to evaluate the feasibility of using the device to insert a single standard dialysis needle into the AVF of the arm prior to routine dialysis cannulation. Patients receiving dialysis at a single institution over a 1-day period were recruited and consented to participate. Under operator control, the device was used to insert a needle into the AVF in preparation for a patient's dialysis session. Unlike conventional ultrasound-guided techniques, the device enables operator alignment to the centerline of the AVF without requiring visual interpretation of ultrasound images using machine-learning-trained guidance. Observations related to safety and efficacy were recorded. A total of eight needle insertion attempts were performed in seven patients. In 6 of 7 procedures, the dialysis needle was successfully inserted into the AVF in the first attempt, confirmed by blood flashback. The first patient had two attempts without vessel entry, while the remaining six patients achieved successful access on the first attempt. No complications were reported. The study demonstrates the feasibility of using an ultrasound-guided, power-assisted needle insertion device for vascular access in hemodialysis. These findings lay the groundwork for future studies using this innovative technology. This study is registered with the ISRCTN registry (ISRCTN22547122).