Professor Dai Xianpeng: Application of High-Pressure Scoring Drug-Coated Balloon in Hemodialysis Patients with Arteriovenous Fistula Stenosis
DK Medtech
Vascular Interventional Balloon Product Developer
Stenosis of autologous or 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 rapidly results in restenosis.
In recent years, there have been continuous explorations and clinical studies internationally on drug-coated balloons and other devices used for PTA treatment in dialysis access. DK Medtech has developed Dissolve.®AV Scoring Drug-Coated Balloon, integrating "scoring," "high-pressure," and "drug-coating" three features in one, is the world's first third-generation drug-coated balloon:
Directional Scoring: Uniform and regular tearing of the intima 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 Dai Xianpeng: Application of High-Pressure Scoring Drug-Coated Balloons in AV Fistula Stenosis in Dialysis Patients] Case Presentation, demonstrating the detailed operations 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, and other aspects, 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.
High-Pressure Scoring Drug-Coated Balloon Applied in Dialysis Patients with Arteriovenous Fistula Stenosis
The Second Affiliated Hospital of Nanhua University
Dai Xianpeng
Patient Information
Basic Information:Elderly Male.
Chief Complaint:Regular hemodialysis for over 2 years, left forearm arteriovenous fistula dysfunction for 3 days.
History of Present Illness:Two years ago, the patient was diagnosed with chronic renal failure at another hospital due to elevated creatinine and uremic toxin levels. An arteriovenous fistula surgery was performed, followed by regular hemodialysis three times a week, with generally stable conditions. Six months ago, during hemodialysis, it was noted that the flow through the dialysis catheter was suboptimal, but dialysis could still be performed. The patient did not experience nausea, vomiting, abdominal pain, bloating, chest tightness, chest pain, coughing, sputum production, headache, or syncope. Three days ago, the patient became completely unable to undergo dialysis. For further diagnosis and treatment, the patient came to our hospital seeking reconstruction of the dialysis access. The outpatient department admitted the patient to our department under the diagnosis of "chronic renal insufficiency with stenosis and thrombosis of the arteriovenous fistula." Since the onset of the disease, the patient’s mental state, appetite, and sleep have been poor, with daily urine output of about 500-800ml, normal bowel movements, and no significant recent changes in weight.
Past Medical History:History of "hypertension" for over 10 years, with the highest blood pressure recorded at 180/? mmHg. Currently taking "Felodipine 1 tablet qd" regularly to control blood pressure, but blood pressure remains poorly controlled. Denies history of "diabetes, coronary heart disease"; denies history of infectious diseases such as "typhoid, tuberculosis, hepatitis". Has a history of "cervical surgery (details unknown)", and denies history of trauma or blood transfusion. Denies history of food or drug allergies, and vaccination history is unclear.
Physical Examination:A surgical scar of approximately 5cm is visible on the left forearm, with a faint thrill palpable over the arteriovenous fistula.
Admission Diagnosis:
Stenosis and thrombosis of arteriovenous fistula in the left forearm;
Chronic renal insufficiency, uremic stage.
Previous interventional treatment
Time | Main Treatment Process |
2022 | Left Upper Limb Arteriovenous Fistula Surgery |
Preoperative Analysis
Preoperative Analysis:The patient is an elderly male with stenosis of the arteriovenous fistula in the left forearm, and severe stenotic lesions in the venous outflow tract, mainly characterized by hyperplastic venous intimal stenosis.
Surgical Objective:
Main Objectives:Open narrowed lesions, prevent recoil, and meet the blood flow requirements for regular dialysis;
Secondary Objectives:Maintain Long-Term Patency.
Surgical Strategy/Plan:Scored Drug-Coated Balloon for PTA Procedure. Expect the use of a scored balloon to uniformly tear the hyperplastic intima, effectively shape the blood vessel, and simultaneously apply paclitaxel locally to inhibit smooth muscle cell migration and proliferation, preventing restenosis in the medium to long term.。
Surgical Procedure
Retrograde puncture of the cephalic vein above the elbow joint, insertion of a 7F vascular sheath, proximal radial artery angiography: significant stenosis at the proximal end of the cephalic vein.
The black mud loach guidewire with a single-bend catheter passed through the radial artery and the occluded segment of the fistula. Angiography suggested an end-to-end anastomosis, with no significant imaging observed distal to the anastomosis.
4mm*80mm balloon dilation of the cephalic vein and anastomosis, significant "waist sign" observed during dilation, repeat angiography still shows stenosis of the fistula.
4mm*80mm Balloon Second Expansion
Import 6mm*80mmHigh-Pressure Scoring Drug-Coated BalloonDilation, pressure 20atm, maintained for 2min
High-Pressure Scoring Drug-Coated BalloonAfter depressurization, reinflate to 20 atm and maintain for 3 minutes for secondary dilation.
Angiography shows that the stenotic segment of the cephalic vein has been fully dilated, with significant improvement in blood flow.
Follow-up
Discharge Status:A significant thrill could be palpated at the site of the fistula post-surgery, with obvious vascular murmurs heard during auscultation. On the second day after surgery, the patient underwent hemodialysis, and the dialysis effect was satisfactory.
Case Summary
Case Characteristics:Internal fistula failure, severe stenotic lesions in the venous outflow tract, mainly manifested as venous intimal hyperplastic stenosis.
Key Points of Preoperative Assessment：
Location, length, and degree of stenosis, characteristics of stenosis;
Exclude arterial inflow tract and central venous stenotic lesions.
Surgical Strategy/Technical Key Points:
Single-bend catheter with guidewire passing through the stenotic segment;
Select the appropriate balloon for pre-dilation;
The pressure maintenance time of the scored drug-coated balloon should be more than 2 minutes to ensure the opening of the stenosis and the full permeation of paclitaxel.
Features/Usage Tips of the Device:
Select the appropriate puncture sheath;
Smooth balloon passage;
Easily open narrow lesions;
The balloon retraction is good.
Expert Introduction
Professor Xianpeng Dai
Surgeon of This Case
Associate Chief Physician, Master's Graduate Supervisor, Deputy Director of the Vascular Surgery Department at the Second Affiliated Hospital of Nanhua University, Secretary of the Fifth Party Branch.
Member of the Traumatology Group, Vascular Surgery Branch, Chinese Medical Doctor Association;Member of the Grassroots Expert Committee of the Peripheral Vascular Disease Professional Committee of the Chinese Society of Microcirculation;Member of the Tumor Angiology Expert Committee of the Endovascular Specialty Committee of the Chinese Medical Doctor Association;Member of the Venous Thromboembolism (VTE) Prevention and Screening Group, Youth Expert Committee, International Vascular Union (China);Member of the Dialysis Access Group, Vascular Surgery Branch, China International Exchange and Promotion Association for Medical and Healthcare;Member of the Vascular Surgery Professional Committee of the Hunan Medical Association;Member of the Hernia and Abdominal Wall Surgery Group, Surgery Professional Committee, Hunan Medical Association;Youth Committee Member of the Vascular Surgery Specialty Committee of the Hunan Province Medical Doctor Association;Chairman of the Vascular Surgery Professional Committee of Hengyang Medical Association,Deputy Chairman of the Professional Committee of the Hengyang Medical Association Intervention Quality Control Center;Deputy Chairman of the Interventional Medicine Professional Committee of Hengyang Medical Association;Deputy Chairman of the Hernia and Abdominal Wall Surgery Group, General Surgery Professional Committee, Hengyang Medical Association;Group Leader of the Vascular Access Group, Professional Committee of Vascular Surgery, Hengyang City;Deputy Group Leader of the Portal Hypertension Group, Vascular Surgery Professional Committee, Hengyang City.
Graduated from Nanhua University in 2003, furthered studies in vascular surgery at the Second Xiangya Hospital of Central South University in 2008 under the guidance of renowned Chinese vascular surgery expert Professor Chang Shu. At the end of 2014, was invited to visit and study (as a guest doctor) at the Pediatric Surgery Department of the Children's Medical Center, Evangelisches Krankenhaus Bielefeld (Bielefeld Christian Hospital) in North Rhine-Westphalia, Germany. Repeatedly awarded titles such as "Star Employee," "Outstanding Party Member," "Excellent Teacher," "Active Trade Union Member," and "Outstanding Communicator" by the hospital; recognized as a young academic leader within the hospital. Awarded the hospital’s "Top Ten Employees" title in 2016 and the "Hunan Province Outstanding Mentor" title in 2023. Presided over and participated in more than ten provincial and municipal research projects, and published over 20 academic papers.
Department Introduction
National Key Specialty Base for Standardized Resident Physician Training in Surgery; Key Clinical Specialty in Hunan Province; Clinical Medical Research Center for Thrombotic Disease Prevention and Treatment in Hunan Province; The First National Standardized Diagnosis and Treatment Center for Venous Diseases in Hunan Province; Deputy Chair Unit of the Youth Committee of the Peripheral Vascular Disease Professional Committee of the Chinese Society for Microcirculation; Deputy Chair Unit of the Vascular Surgery Specialty Committee of the Hunan Medical Association; Vice President Unit of the Vascular Surgeons Branch of the Hunan Medical Doctor Association; Vice Chair Unit of the Hunan Venous Thromboembolism (VTE) Prevention and Treatment Alliance; Vice Chair Unit of the Hunan Interventional Medicine Alliance; Vice President Unit of the Hunan Hemorrhagic Disease Alliance; The earliest established vascular disease specialty in the Xiangnan region; Appropriate Technology Promotion Base of Hunan Provincial Health Commission; Hengyang Base for Standardized Endovascular Training by the Peripheral Vascular Disease Professional Committee of the Chinese Society for Microcirculation; Chair Unit of the Vascular Surgery Specialty Committee of the Hengyang Medical Association; Chair Unit of the Hengyang VTE Prevention and Treatment Alliance.
The department boasts strong technical capabilities, with 12 doctors: 2 professors/chief physicians, 6 associate chief physicians, 4 doctors with a Ph.D., and 5 with a master's degree. Additionally, the department has a well-trained, highly skilled, and service-oriented specialized nursing team, comprising 15 nursing staff: 1 chief nurse, 11 senior nurses, and 12 with a bachelor's degree or higher. It was the first department in our hospital to implement model wards for quality nursing services. The department has repeatedly won the First Prize for Outstanding Natural Science Papers in Hengyang City and has been honored multiple times in the Hunan Province Medical Skills Innovation and Entrepreneurship Competition, including one First Prize, three Second Prizes, and one Third Prize. It also received one of the top ten new medical technologies in Hengyang City in 2023.
All medical staff in the vascular surgery department adhere to the hospital motto of "Sincerity in Medicine, Precision in Skill, Integrity in Action, and Wisdom in Conduct," practice the core values of "Excellence in Medicine, Benevolence in Virtue, Striving for Innovation," follow the department’s guiding principles of "Virtue and Benevolence, Mastery of Skills, Innovation, and Dedication," and promote the team spirit of "Win-Win Cooperation, Unity, and Shared Success." They are committed to building a research-oriented vascular surgery center that leads within the province and is renowned nationwide, and they wholeheartedly provide safe, high-quality, and patient-centered medical care services to the broad patient population!
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