SAFETY AND EFFECTIVENESS OF HEMODIALYSIS ACCESS CREATION USING HEMODIALYSIS RELIABLE OUTFLOW IN END-STAGE RENAL DISEASE: SYSTEMATIC REVIEW
Author(s)
EUNJI PARK, MPH, Hae-rim Han, MS.
National Evidence-based Healthcare Collaborating Agency, Seoul, Korea, Republic of.
National Evidence-based Healthcare Collaborating Agency, Seoul, Korea, Republic of.
OBJECTIVES: The Hemodialysis Reliable Outflow (HeRO) device, designated by the Korean Ministry of Food and Drug Safety as an Orphan Medical Device or a Device in Urgent Need of Introduction, serves end-stage renal disease (ESRD) patients who cannot obtain upper-extremity vascular access due to exhausted vessels or central venous stenosis. We conducted a new health technology assessment (nHTA) to evaluate its inclusion in the Korean National Health Insurance (NHI) benefit list.
METHODS: Safety and effectiveness were assessed through a systematic review and a guideline review of the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI). Literature searches were conducted in Ovid-MEDLINE, Ovid-EMBASE, the Cochrane Library, and four Korean databases on April 26, 2022. Study selection and data extraction followed a predefined protocol, and risk of bias was assessed using the Scottish Intercollegiate Guidelines Network checklist. The assessment was performed in consultation with clinical experts in radiology, vascular surgery, nephrology, and thoracic surgery.
RESULTS: Of 428 records retrieved, 18 studies were included: four cohort studies comparing HeRO to tunneled central venous catheters (CVCs), femoral arteriovenous fistulae (fAVFs), or femoral arteriovenous grafts (fAVGs), and fourteen case series. HeRO was associated with fewer overall complications than CVC and fAVF. Two cohort studies reported superior patency for fAVF/fAVG versus HeRO; however, HeRO patients had higher rates of central venous stenosis, limiting direct comparability. Meta-analysis yielded a pooled primary patency of 30.3% (95% CI: 17.3-43.4%) and secondary patency of 71.2% (95% CI: 59.9-82.4%). KDOQI recommends HeRO for patients requiring long-term hemodialysis with exhausted upper-extremity vascular access.
CONCLUSIONS: The nHTA committee assessed hemodialysis access creation using HeRO as safe and effective (level of evidence D), documented in Ministry of Health and Welfare Bulletin No. 2022-224, supporting its inclusion in the NHI benefit list to expand options for patients with limited upper-extremity vascular access.
METHODS: Safety and effectiveness were assessed through a systematic review and a guideline review of the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI). Literature searches were conducted in Ovid-MEDLINE, Ovid-EMBASE, the Cochrane Library, and four Korean databases on April 26, 2022. Study selection and data extraction followed a predefined protocol, and risk of bias was assessed using the Scottish Intercollegiate Guidelines Network checklist. The assessment was performed in consultation with clinical experts in radiology, vascular surgery, nephrology, and thoracic surgery.
RESULTS: Of 428 records retrieved, 18 studies were included: four cohort studies comparing HeRO to tunneled central venous catheters (CVCs), femoral arteriovenous fistulae (fAVFs), or femoral arteriovenous grafts (fAVGs), and fourteen case series. HeRO was associated with fewer overall complications than CVC and fAVF. Two cohort studies reported superior patency for fAVF/fAVG versus HeRO; however, HeRO patients had higher rates of central venous stenosis, limiting direct comparability. Meta-analysis yielded a pooled primary patency of 30.3% (95% CI: 17.3-43.4%) and secondary patency of 71.2% (95% CI: 59.9-82.4%). KDOQI recommends HeRO for patients requiring long-term hemodialysis with exhausted upper-extremity vascular access.
CONCLUSIONS: The nHTA committee assessed hemodialysis access creation using HeRO as safe and effective (level of evidence D), documented in Ministry of Health and Welfare Bulletin No. 2022-224, supporting its inclusion in the NHI benefit list to expand options for patients with limited upper-extremity vascular access.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA120
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Urinary/Kidney Disorders