Prof. Qiu Mingsheng: Application of Scoring Drug-Coated Balloon in Recurrent Stenosis of Hemodialysis Access Fistula
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 can cause excessive damage to the endothelial vessels, leading to intense proliferation of vascular smooth muscle cells and macrophages, which quickly results in restenosis.
In recent years, there has been continuous international exploration and clinical research on drug-coated balloons and other devices 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." This is the world's first third-generation drug balloon:
Directional Scoring: Uniform and regular tearing of the intima to reduce damage from blunt splitting.
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 Ming-Sheng Qiu: Application of Scoring Drug-Coated Balloons in Repeatedly Stenotic Dialysis Fistula Lesions] Case Presentation, demonstrating the meticulous 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 Applied in Repeated Stenosis
Dialysis Fistula Lesions
Qiu Mingsheng, the First People's Hospital of Zhumadian City
Patient Information
Basic Information:The patient is a 47-year-old female.
Chief Complaint:Decreased thrill of the internal fistula was noted for 1 week.
History of Present Illness:One week ago, the patient was found to have weakened thrill in the left forearm fistula during dialysis, with the fistula primarily showing pulsation. There was no limb pain or local redness and swelling. The pump blood flow rate was 180ml/min.
Past Medical History:Suffering from "systemic lupus erythematosus" for 10 years, renal failure for 3 years, and started hemodialysis treatment 1 year ago, with no history of "diabetes".
Physical Examination:
Visual Examination:The skin of the left upper limb is normal, with no swelling in the arm. A surgical scar approximately 3cm in length running vertically is visible 2cm above the wrist crease of the left upper limb. Rope ladder puncture scars are visible on the cephalic vein, with no aneurysmal dilation observed and no signs of skin ulceration.
Palpation:The skin temperature of the left upper limb is normal. A pulse and weak thrill can be palpated at the anastomosis of the internal fistula. The venous segment about 4 cm in length above the anastomosis is cord-like and stiff, with a thrill palpable in the proximal end that transmits towards the proximal direction.
Auscultation:A fine, weak, blowing murmur can be heard at the anastomosis site of the internal fistula, and a high-pitched, short blowing murmur can be heard at the arterial puncture site.
Color Doppler Ultrasound Examination:Venous intimal hyperplastic stenosis near the anastomosis, vessel diameter 1.9mm, length 50mm, preoperative brachial artery flow 265ml/min.。
Admission Diagnosis:
Chronic Kidney Disease Stage 5, Maintenance Hemodialysis;
Stenosis of Arteriovenous Fistula in Left Upper Limb (Type I).
Previous interventional treatment
Time | Main Treatment Process |
May 2022 | Due to the discovery of renal failure during examination, an autologous arteriovenous fistula was established in the left forearm. |
October 2022 | Application of Left Forearm Arteriovenous Fistula for Hemodialysis Treatment |
January 2023 | Type I Stenosis and Occlusion of Arteriovenous Fistula in Left Forearm Treated with PTA |
April 2023 | Type I Stenosis and Occlusion of Left Forearm Arteriovenous Fistula Treated with PTA |
September 2023 | Type I stenosis of arteriovenous fistula in the left forearm with insufficient blood flow underwent PTA treatment. |
January 2024 | Type I Stenosis of Left Forearm Arteriovenous Fistula with Insufficient Blood Flow |
Preoperative Analysis
Preoperative Analysis:The patient has stenosis of the arteriovenous fistula in the left forearm, and has undergone multiple PTA treatments. Two months after the last treatment, restenosis occurred with significant intimal hyperplasia at the stenotic site; the effect of repeated dilation treatment cannot be guaranteed.
Surgical Objective:
Main Objectives:Use scored drug-coated balloons to dilate narrowed lesions, reducing intimal hyperplasia, with residual stenosis less than 15% post-dilation.
Secondary Objectives:No bleeding or endometrial tearing.
Surgical Strategy/Plan:
Under B-ultrasound guidance, enter the sheath;
Under DSA guidance, angiography was performed, and a guidewire and catheter were inserted to complete the endovascular balloon angioplasty.Dissolve AV Peripheral Scoring Drug-Coated Balloon Dilatation Catheter ).
Surgical Procedure
Through the retrograde approach of the cephalic vein along the transverse elbow line, a 6F sheath was inserted. The proximal end of the cephalic vein was pressurized for angiography to confirm the distal path of the cephalic vein.
Along the 6F sheath guidewire catheter, enter the proximal end of the radial artery anastomosis, and confirm with catheter angiography.
Due to insufficient imaging of the stenosis at the anastomotic site, contrast was re-administered by compressing the proximal end of the cephalic vein, revealing the diameter (approximately 1.6 mm) and length (approximately 50 mm) of the stenotic segment near the anastomosis.
A 6mm*60mm Dissolve AV high-pressure scoring drug balloon was advanced along the sheath and inflated to 20atm to achieve full expansion of the stenosis.
After the balloon is fully expanded, perform two inflations at 20atm+12atm, each maintaining pressure for 2 minutes, to ensure the drug is fully adhered to the vessel wall.
After dilation, balloon catheter anastomosis angiography showed good dilation effect of the stenotic segment, with an inner diameter reaching (5.8mm) and no significant rebound (residual stenosis less than 15%).
Follow-up
Discharge Status:Good postoperative thrill of the internal fistula, no abnormal pulsation detected, and postoperative color Doppler ultrasound examination of the stenotic segment.Inner Diameter5.5mm, brachial artery flow 884ml/min, dialysis proceeded smoothly on the same day (pump-controlled blood flow rate 220ml/min), outpatient follow-up scheduled for 3 months later.
Case Summary
Case Characteristics:The patient underwent repeated angioplasty for arteriovenous fistula stenosis in the left upper limb more than three times within a year, with the last dilation lasting less than three months.
Preoperative Assessment Key Points:It is necessary to understand the characteristics of scored drug-coated balloons and select a balloon of the appropriate size based on the lesion location, the inner diameter, and length of the blood vessels surrounding the stenotic area.
Surgical Strategy/Technical Key Points:Based on the degree of intimal hyperplasia at the stenotic site and the pressure previously used for balloon dilation, select the appropriate scoring drug. The scoring drug balloon Dissolve AV offers the combined advantages of high pressure, scoring, and drug coating.
Device Features / Usage Tips:It is recommended to use a larger sheath for easy insertion and removal of the scoring drug-coated balloon. After the balloon is fully expanded, maintain pressure for at least 3 minutes to ensure adequate drug adherence to the vessel wall.
Expert Introduction
Dr. Ming-Sheng Qiu, Chief Physician
Surgeon of This Case
Chief Physician, Master of Medicine, Director of the Department of Nephrology at Zhumadian First People's Hospital; Vice Chairman of Zhumadian Kidney Disease Association; Vice Chairman of Zhumadian Integrated Traditional Chinese and Western Medicine Association; Member of Henan Kidney Disease Association; Standing Committee Member of Henan Science Popularization Association Kidney Disease Branch; Expert in Medical Accident Technical Appraisal of Henan Medical Association; Health Popularization Expert of Yicheng District, Zhumadian City;Zhumadian Young Science and Technology Talent; Zhumadian Top Talent; Zhumadian Academic Leader; Zhumadian Tianzhong Science and Technology Innovation Youth.
Department Introduction
The Nephrology Department of Zhumadian First People's Hospital was established in 2012. The department currently has 1 chief physician, 3 deputy chief physicians, 6 attending physicians, and 2 resident physicians, including 4 master's degree holders. There is also 1 chief nurse, 3 senior nurses, 7 nurses, and 4 nursing staff.
The nephrology department has 72 open beds, 23 hemodialysis machines, and 5 CRRT machines. The main services provided in the ward include diagnosis, treatment, teaching, and clinical research for renal diseases. The department has extensive clinical experience in treating primary and secondary glomerular diseases such as acute and chronic glomerulonephritis, nephrotic syndrome, IgA nephropathy, Henoch-Schönlein purpura nephritis, lupus nephritis, diabetic nephropathy, hypertensive renal damage, small vessel vasculitis renal damage, tubulointerstitial diseases, urinary tract infections, and acute and chronic renal failure. The department offers various procedures including hemodialysis, peritoneal dialysis, colon dialysis, renal biopsy puncture, renal cyst puncture sclerotherapy, arteriovenous vascular anastomosis, medium- and long-term dialysis catheter implantation, peritoneal dialysis catheter implantation, ultrasound (DSA)-guided balloon angioplasty for arteriovenous fistula stenosis or occlusion (PTA), central venous stenosis or occlusion recanalization with covered stent implantation, and other techniques.
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