Dingke Medical's Dissolve™ AV Scoring Drug-Coated Balloon for Refractory AVF Stenosis: A Case Series by Professor Wu Liang’s Access Team
DK Medtech
Vascular Interventional Balloon Product Developer
Stenosis of autologous/artificial arteriovenous fistula (AVF/AVG) is the most common complication in hemodialysis patients. Percutaneous transluminal angioplasty (PTA) has become the primary method for maintaining dialysis access. However, the blunt and irregular tearing of the intima and part of the media by traditional balloons during PTA excessively damages the endothelial vessels, causing intense proliferation of vascular smooth muscle cells and macrophages, which rapidly leads to restenosis.
In recent years, there has been continuous international exploration and clinical research on drug-coated balloons for PTA treatment of dialysis access. DK Medtech has developed the Dissolve™ AV Scoring Drug Balloon, which integrates three features—"scoring," "high-pressure," and "drug-coating"—and is the world's first third-generation drug balloon:
Directional Scoring: Uniform and regular intimal tearing to reduce damage from blunt rupture.
High Burst Pressure: For high-resistance lesions, improving technical success rate.
Paclitaxel Coating: Effectively Inhibits Excessive Proliferation of Smooth Muscle Cells.
DK Medtech Special Release[Professor Wu Liang's Access Team: Cutting Balloon Treatment for Refractory AVF Stenosis] Case Presentation, demonstrating the precise operation of each case and the clinical application of advanced equipment and instruments. From the formulation of treatment strategies for different cases, standardized intraoperative procedures and technical applications, complication prevention, perioperative management, etc., the aim is to promote the standardization of diagnosis and treatment for vascular stenosis and occlusive diseases, strengthen technical exchanges and experience sharing among doctors, with the hope of providing new ideas and methods for future diagnosis and treatment, benefiting more clinical patients.
Scored Drug-Coated Balloons for Refractory AVF Stenosis
Zheng Huixiao, Wu Liang from the Second Affiliated Hospital of Xingtai Medical College
Patient Information
Basic Information:Male, 71 years old.
Chief Complaint:Five years of hemodialysis, weakened thrill of arteriovenous fistula for 20 days.
History of Present Illness:The patient was diagnosed with "CKD Stage 5" five years ago and began hemodialysis treatment using an autologous arteriovenous fistula in the left forearm, three times per week. During this period, the patient underwent nine ultrasound-guided PTA procedures on the fistula due to venous outflow stenosis and occlusion.
Past Medical History:Hypertension for 28 years, with a maximum of 190/100 mmHg.
Physical Examination:The murmur and thrill of the left forearm fistula are weakened.
Admission Diagnosis:
Stenosis of Arteriovenous Fistula in Left Forearm.
Chronic Kidney Disease Stage 5 (Uremia);
Maintenance Hemodialysis;
Renal Anemia.
Grade 3 Hypertension (Very High Risk).
Previous interventional treatment
Time | Main Treatment Process |
2021-03-01 | Balloon Angioplasty of Left Forearm Arteriovenous Fistula (High-Pressure Balloon) |
2021-06-27 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
2021-11-08 | Balloon Angioplasty of Left Forearm Arteriovenous Fistula (High-Pressure Balloon) |
2022-06-22 | Balloon Angioplasty of Left Forearm Arteriovenous Fistula (High-Pressure Balloon) |
2022-10-24 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
2023-03-09 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
2023-07-03 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
2023-09-27 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
2024-01-26 | Balloon Angioplasty of Arteriovenous Fistula in Left Forearm (High-Pressure Balloon) |
Preoperative Analysis
Preoperative Analysis:The patient has undergone multiple PTA surgeries on the internal fistula, with severe stenosis in the venous outflow tract. Previous use of high-pressure balloon dilation showed unsatisfactory results. This hospitalization plans to treat the lesion using a high-pressure scoring drug-coated balloon.
Surgical Objective:
Main Objectives:Open up the stenotic lesion to meet the dialysis blood flow requirements.
Secondary Objectives:Prevent rebound, extend the usage time of patients' internal fistulas, and reduce the number of patient interventions.
Surgical Strategy/Plan:PTA was performed again using the DK Medtech Dissolve™ AV Scoring Drug-Coated Balloon.
Preoperative Assessment
Radial artery-cephalic vein fistula, stenosis of the median cubital vein and basilic vein.
The distance from the stenosis to the anastomosis is 17cm, with the narrowest inner diameter approximately 0.8mm and a length of about 2.89cm.
Blood flow is significantly reduced at the site of stenosis.
Brachial artery blood flow 262.2 ml/min.
Surgical Procedure
The patient lies in a supine position, with the left forearm abducted. After routine disinfection and draping, brachial plexus anesthesia is administered. The puncture needle is inserted, and upon observing the outflow of arteriovenous fistula blood, a guidewire is advanced. The needle is withdrawn, and a 7F vascular sheath is inserted. Heparin 20mg is then administered intravenously.
A 6.0*40mm DK Medtech Dissolve™ AV high-pressure scoring drug-coated balloon was advanced over the guidewire.
The balloon was anchored at the stenotic lesion and dilated three times at 20 atm, with the first dilation lasting 3 minutes and the second and third dilations lasting 1 minute each.
After the dilation was completed, the stenosis inner diameter was remeasured at 3.6mm.
After the dilation was completed, blood flow significantly improved.
Measurement of brachial artery flow (with sheath) 1234.8 ml/min.
Follow-up
Discharge Status:The patient was discharged smoothly and is currently undergoing regular dialysis with good function of the internal fistula.
Case Summary
Case Characteristics:The patient has been on dialysis for 5 years and has undergone PTA surgery multiple times due to stenosis or occlusion of the arteriovenous fistula. The venous outflow tract has severe stenotic lesions, mainly characterized by venous intimal hyperplastic stenosis. The effect of repeated high-pressure balloon dilatation has been unsatisfactory, with short-term postoperative recurrence of restenosis.
Preoperative Assessment Key Points:Location and degree of stenosis, characteristics of stenosis;Exclude arterial inflow stenosis.
Surgical Strategy/Technical Key Points:Fully open the stenosis, ensure sufficient balloon inflation time to guarantee adequate paclitaxel infiltration.
Features/Usage Tips of the Device:
Smooth balloon passage;
Easily open narrow lesions;
The balloon retraction is good.
Expert Introduction
Director Zheng Huixiao
Surgical Guidance
Director of the Department of Nephrology, Second Affiliated Hospital of Xingtai Medical College, Chief Physician;Director of Xingtai City Kidney Disease Treatment Center;Director of Xingtai City Kidney Disease Quality Control Center;Director of the Kidney Disease Prevention Professional Committee of the Xingtai City Preventive Medicine Association;Vice Chairman of the Nephrology Branch of the Xingtai Medical Association;Deputy Director of the Xingtai Blood Purification Quality Control Center;Member of the Hebei Medical Association's Nephrology Branch;Member of the Nephrology Physicians Branch of the Hebei Provincial Medical Association;Member of the Blood Purification Management Branch of Hebei Provincial Hospital Association;Standing Committee Member of the Nephrology Professional Committee of Hebei Pharmaceutical Association;Standing Committee Member of the Nephrology and Blood Purification Professional Committee of the Hebei Province Women Physicians Association.
Wu Liang, Deputy Director
Surgeon of This Case
Deputy Director of the Department of Nephrology, Second Affiliated Hospital of Xingtai Medical College, and Head of Nephrology Unit 2, under the tutelage of Professors Yuzhu Wang and Baoxing Wang,Master of Medicine, Associate Chief Physician.Vice Chairman of the Xingtai Blood Purification Quality Control Center;Youth Committee Member of the Nephrology Branch of Hebei Province Medical Association;Member of the Nephrology Branch of the Hebei Province Association of Integrative Medicine;Member of the Hebei Province Vascular Access and Interventional Nephrology Professional Committee; Vice Chairman of the Xingtai City Preventive Medicine Association Parathyroid Disease Prevention and Treatment Professional Committee;Member of the Nephrology Branch of the Xingtai Medical Association; Member of the Xingtai Prevention of Kidney Disease Committee;Member of the Xingtai City Kidney Disease Vascular Access Team;Member of the Xingtai City Diabetes Prevention Professional Committee.
Department Introduction
The Department of Nephrology at the Second Affiliated Hospital of Xingtai Medical College has 140 beds, including 50 dialysis beds, and a medical staff of 56 people, among whom 8 hold senior professional titles, 1 holds a doctorate, and 11 are master's degree holders. The team structure is well-balanced, with rich clinical experience in the prevention, diagnosis, and treatment of kidney diseases. It serves as the Kidney Disease Treatment Center of Xingtai City, the Kidney Disease Quality Control Center of Xingtai City, the initiating unit of the Xingtai City Kidney Disease Alliance, and a collaborative hospital for vascular access with Haidian Hospital. The department comprises three wards: Nephrology I, Nephrology II, and Nephrology III.
Nephrology Department 1: Currently equipped with 50 hemodialysis machines, 3 bedside hemofiltration machines, and a large-scale water treatment system. It is the first hospital in Xingtai City to use imported water machines, ensuring high-quality dialysis water. A variety of blood purification technologies have been implemented: high-flux hemodialysis, online hemofiltration, hemoperfusion, bedside blood purification, plasma exchange, artificial liver technology, etc.; pediatric hemodialysis technology has also been introduced; additional services include far-infrared fistula maintenance, traditional Chinese medicine fistula care, indwelling needle fistula puncture for dialysis, cycling exercise during dialysis, and hemodialysis exercise routines.
Department of Nephrology II: Vascular access technology is the main feature and advantage, and it is also in a leading position in this field in the Xingtai region. It specializes in the establishment of difficult vascular accesses and the treatment of their complications, such as high-position arteriovenous fistulas, transposition arteriovenous fistulas, superficialization of deep fistulas, PTFE artificial blood vessel arteriovenous fistula surgery, catheter placement and replacement with Dacron cuffs, aneurysmectomy, repair surgery, thrombectomy of arteriovenous fistulas, balloon dilatation under DSA or ultrasound guidance, interventional treatment of central venous lesions. The department provides integrated treatment for vascular access of dialysis patients including establishment, monitoring, early detection, and early repair, extending the lifeline of patients. To provide convenient diagnosis and treatment for patients, a day surgery model has been introduced.
Department of Nephrology III: Specializes in the diagnosis and treatment of various primary and secondary glomerular diseases, renal tubulointerstitial disorders, and peritoneal dialysis. Conditions treated include IgA nephropathy, membranous nephropathy, focal segmental glomerulosclerosis, diabetic nephropathy, lupus nephritis, hepatitis B virus-associated glomerulonephritis, renal amyloidosis, vasculitis-related kidney damage, and acute kidney injury. The department is equipped with a KICU ward and a day-care ward, and offers diagnostic and therapeutic technologies such as renal biopsy, renal pathology, colonic dialysis, peritoneal dialysis, peritoneal dialysis catheterization, and clinical laboratory testing for kidney diseases. Facilities include automated peritoneal dialysis machines, fluorescence microscopes, phase-contrast microscopes, high-end enema machines, fully automated specific protein analyzers, and fully automated chemiluminescence analyzers. Six multidisciplinary kidney disease management teams have been established, focusing on peritoneal dialysis, diabetic nephropathy, IgA nephropathy, membranous nephropathy, lupus nephritis, and secondary hyperparathyroidism. These teams have significantly extended the life expectancy and improved the quality of life for patients with kidney disease.
