
Vascular Interventional Balloon Product Developer


Complications such as stenosis and occlusion of arteriovenous fistulas (AVFs) in hemodialysis patients significantly affect the function and usability of vascular access. Dense fibrosis or hyperplastic tissue makes it difficult to fully dilate some lesions with standard-pressure balloons, especially for refractory and long-segment stenosis, which are the main causes of surgical failure and low patency rates. The reasons may be related to the irregular tearing force exerted by the balloon on the intima and some neotissues of the media during percutaneous transluminal angioplasty (PTA), causing damage to endothelial blood vessels and triggering intense proliferation of vascular smooth muscle cells and macrophages. In recent years, there has been ongoing exploration and clinical research internationally on the use of high-pressure balloons, scoring balloons, and drug-coated balloons for PTA treatment of dialysis access. DK Medtech specializes in the research, development, and production of interventional medical devices for blood vessels, focusing on balloon innovation. They have developed the Dissolve™ AV Scoring Drug Balloon, which integrates "high pressure," "scoring," and "drug coating" to address multiple key challenges associated with hemodialysis access stenosis.
DK MedtechSpecial Launch[Professor Cao Hanhua from Kecheng District People's Hospital: Management of Recurrent Thrombosis in Complex Arteriovenous Fistula with Stenosis at the Venous Arch] 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, to perioperative management, etc., the aim is to promote the standardization of diagnosis and treatment for hemodialysis access stenosis, enhance technical exchange and experience sharing among doctors, with the hope of providing new ideas and methods for the future diagnosis and treatment of hemodialysis access, benefiting more clinical patients.

Recurrent Thrombosis
Management of Stenosis in Complex Arteriovenous Fistula with Cephalic Arch
Cao Hanhua, Kecheng District People's Hospital

Basic Information NO.1
Patient:Female, 60 years old.
Chief Complaint:Hemodialysis for 12 years, increased venous pressure for 4 days.
History of Present Illness:More than 12 years ago, the patient was switched from peritoneal dialysis to hemodialysis due to a diagnosis of "polycystic kidney disease, chronic kidney disease stage 5, and peritoneal dialysis-associated peritonitis." The vascular access was an autologous arteriovenous fistula in the left upper arm. The dialysis frequency was three times per week (Tuesday, Thursday, Saturday), with each session lasting four hours, and the hemodialysis process was generally smooth. From June 2023 to August 2023, the patient was hospitalized multiple times for surgical treatment due to thrombosis of the fistula. The last surgery was performed on August 21, 2023, which included upper limb venous catheter thrombolysis, catheter embolectomy, balloon dilation, and venography. The procedure went smoothly, and postoperatively, the fistula flow and venous pressure were adequate, with a smooth hemodialysis process. Four days ago, during hemodialysis, the patient’s venous pressure increased to a maximum of 280 mmHg, but the blood flow remained acceptable. The patient reported that the fistula wall felt significantly stiffer upon palpation compared to before, with no swelling in the left forearm, no pain, no numbness or discomfort in the extremities, and no chills or fever. For further diagnosis and treatment, the patient visited our hospital and was admitted under the outpatient diagnosis of "chronic kidney disease stage 5, arteriovenous fistula stenosis."
Past Medical History:The patient was diagnosed with "polycystic kidney disease and polycystic liver" over 14 years ago, at which time the serum creatinine level was 260 umol/L. Due to progressively increasing serum creatinine levels, the patient underwent dialysis treatment; Over 14 years ago, the patient was also diagnosed with "renal hypertension". In the past two months, the patient has been treated with Midodrine tablets for low blood pressure; The patient denies any history of trauma, blood transfusion, or allergies to drugs or food.
Physical Examination:Physical Examination: A longitudinal surgical scar approximately 2.5 cm in length is visible 2 cm above the transverse elbow crease of the right upper limb. The cephalic vein shows significant tortuosity with obvious aneurysmal dilation, and no skin lesions are present. Palpation: The skin temperature of both upper limbs is normal. A distinct pulse can be palpated at the arteriovenous fistula anastomosis site and 2 cm above it, accompanied by weak thrill. Auscultation: A unidirectional blowing murmur can be heard at the arteriovenous fistula anastomosis site.
Admission Diagnosis:Preoperative Diagnosis:
Stenosis of Arteriovenous Fistula;
Polycystic Kidney Disease, Chronic Kidney Disease Stage 5, Renal Anemia, Renal Hypertension, Hemodialysis Status;
Polycystic liver.
History of Vascular Access NO.2
Time | Main Treatment Process |
2023-06-15 | Recanalization of Left Upper Arm Cephalic Vein Arch Stenosis Occlusion + Catheter-directed Thrombolysis of Upper Limb Veins + 5mm High-pressure Balloon Dilation + Reconstruction of Cephalic Vein Arch |
2023-06-16 | Upper Limb Venous Catheter Thrombolysis + Surgical Thrombectomy + Cephalic Vein Arch Reconstruction + 6mm High-Pressure Balloon Dilation |
2023-08-21 | Upper Limb Venography + Superior Vena Cava Venography + Upper Limb Venous Catheter Thrombolysis + Catheter Embolectomy + 5mm High-Pressure Balloon Dilation |
Preoperative Analysis NO.3
Preoperative Analysis:The patient has a lesion in the cephalic vein arch and has undergone two previous reconstructions of the cephalic vein arch with PTA treatment. The last surgical treatment only lasted for two months, and another expansion requires a change in the treatment method to improve the therapeutic effect. This time, the use of a scoring drug-coated balloon is considered.
Surgical Objective
Main Objectives:Increase vascular diameter through PTA treatment with a scored drug-coated balloon;
Secondary Objective:Inhibit intimal hyperplasia and improve the patency rate of arteriovenous fistulas.
Surgical Strategy/Plan:Upper Limb Vein and Central Venous Angiography + Balloon Dilatation for Stenosis of Left Cephalic Vein and Left Subclavian Vein (Dissolve™ AV) under DSA.

Surgical Procedure NO.4
After puncturing the cephalic vein of the upper arm, a 7F vascular sheath was inserted. The guidewire passed through the tortuous segment of the cephalic vein, and the catheter was advanced into the superior vena cava via the cephalic vein. A 5mm high-pressure balloon was used for dilation at 18 ATM, maintained for 2 minutes. Post-procedure angiography showed rebound of the stenotic lesion.

Post-procedure angiography showed improvement in the stenotic lesion, no contrast extravasation, and a minimum lumen diameter of 3.6 mm at the most narrowed site.

A 7mm high-pressure balloon was inserted through a guidewire exchange and repeatedly dilated at the stenotic lesion located at the junction of the left cephalic vein and subclavian vein. The balloon was difficult to fully expand, and repeated dilations were performed twice at 16ATM, with a maintenance time of 2 minutes.

Post-procedure angiography showed improvement in the stenotic lesion, no contrast extravasation, and a minimum lumen diameter of 4.19 mm at the most narrowed site.

Heparin saline pre-flush preparation ready: 6mm×6cm scored drug-coated balloon (DK Medtech Dissolve™ AV) was exchanged over the guidewire and positioned. The scored drug-coated balloon (DK Medtech Dissolve™ AV) was then inflated at 22-26 ATM for a duration of 2 minutes and 30 seconds.


Post-procedure angiography showed significant resolution of the stenotic lesion, with the narrowest point measuring 4.28 mm in diameter.

Follow-up NO.5
Discharge Status:Good postoperative thrill of the internal fistula, no abnormal pulsation was palpated. Postoperative dialysis went smoothly with a dialysis flow rate of 260ml/min and venous pressure of 98mmHg. No pain was reported at the internal fistula site during dialysis.
Case Summary NO.6
Case Characteristics:The patient experienced repeated thrombosis of the internal fistula and had undergone PTA treatment twice before, with the last dilation lasting less than 2 months.
Preoperative Assessment Key Points:Preoperative thorough evaluation of the patient's intimal hyperplasia and vascular calcification degree in the fistula vessel to formulate a reasonable surgical plan.
Surgical Strategy/Technical Key Points:The Dissolve™ AV scoring drug-coated balloon is the optimal choice for fully dilating hyperplastic intima, inhibiting postoperative intimal hyperplasia, and addressing calcified stenotic lesions, thanks to its high-pressure, scoring, and drug-coated advantages.
Device Features/Usage Tips:
Preoperative balloon needs only to be flushed with saline in the balloon catheter lumen; soaking of the balloon end is not recommended to avoid drug loss.
Do not remove the coating protective sleeve; advance the balloon along the guidewire to the sheath opening until it is locked at the sheath opening.
If the lesion has been fully dilated before the filling pressure is less than RBP, please maintain the pressure for 2 minutes to ensure adequate drug adhesion. If the lesion has not been fully dilated when the filling pressure reaches RBP, still maintain the pressure for 2 minutes, then release the pressure and rotate the balloon approximately 60° before re-dilating to RBP, and maintain the pressure for 1 minute. If there is significant residual stenosis or elastic recoil in the lesion, post-dilation can be performed using an ultra-high-pressure balloon or a high-pressure balloon with a diameter 1mm larger than Dissolve AV.
Surgical Record NO.7
1. 2023-06-15 Revascularization of Left Upper Arm Cephalic Vein Arch Stenosis Occlusion + Catheter-directed Thrombolysis of Upper Limb Veins + 5mm High-pressure Balloon Dilation + Cephalic Vein Arch Reconstruction
The patient lies in a supine position. Preoperative color Doppler ultrasound examination showed that the entire length of the arteriovenous fistula from the anastomosis to the cephalic vein arch in the upper arm was tortuous, dilated, and thrombosed. After routine disinfection and draping, a 6F vascular sheath was inserted towards the anastomosis at the site of fistula dilation in the middle of the upper arm. Under vascular ultrasound guidance, a 0.35 super-smooth guidewire was advanced to the brachial artery. A Boston Scientific MUSTANG 5*40mm dilation balloon (produced by Boston Scientific) was then advanced over the guidewire. After withdrawing the guidewire, 100,000 units of urokinase were injected into the balloon. A 6F vascular sheath was placed 5 cm upstream from the anastomosis towards the proximal end under vascular ultrasound guidance with a 0.35 super-smooth guidewire. However, the guidewire could not pass through the tortuous segment in the upper-middle part of the upper arm. A Boston Scientific MUSTANG 5*40mm dilation balloon was advanced over the guidewire, and after withdrawing the guidewire, 100,000 units of urokinase were injected into the balloon. The balloon was used to compress the thrombus, and most of it dissolved, restoring blood flow. The 6F vascular sheath in the middle of the upper arm was removed, and the puncture site was sutured with a 5.0 vascular suture. Again, a 6F vascular sheath was inserted towards the proximal end at the tortuous part of the upper arm under vascular ultrasound guidance with a 0.35 super-smooth guidewire. The guidewire could not pass through the cephalic vein arch. A Boston Scientific MUSTANG 5*40mm dilation balloon was advanced over the guidewire, and after withdrawing the guidewire, 100,000 units of urokinase were injected into the balloon. The balloon was used to compress the thrombus, and most of it dissolved, restoring blood flow. However, the occluded segment of the cephalic vein arch still could not be passed through. Another attempt was made to pass through the stenotic segment of the cephalic vein arch using the balloon in conjunction with the guidewire. A 0.14 guidewire was used but still could not pass through. During an attempt with the 0.35 guidewire, the guidewire became lodged and fractured, leaving a residual fragment at the cephalic vein arch, where a thrombus formed again in the cephalic vein arch. After informing the patient's family, open surgery was performed.
The patient underwent brachial plexus anesthesia, followed by re-disinfection and draping. A 3 cm surgical incision was made in the middle segment of the upper arm to free a 2 cm length of the cephalic vein, which was controlled with a rubber band to stop blood flow. A 7 cm incision was then made 1 cm below the mid-clavicle to bluntly dissect the cephalic vein arch. The cephalic vein arch was found to be tortuous and dilated, with a stenosis of approximately 3 cm at the junction with the subclavian vein. The vessel was transected at the stenotic site, and a complete 5 cm long segment of 0.35 guidewire tip was removed. Upon releasing the blood flow, a thrombus measuring about 10 x 0.8 cm was expelled. Color Doppler ultrasound confirmed no residual thrombus within the arteriovenous fistula. A Boston Scientific 5*40mm angioplasty balloon (MUSTANG) was used to dilate the cephalic vein arch near the subclavian vein. After dilation, a 2 cm oblique incision was made to trim the stenotic area and valves. The tortuous cephalic vein was repaired with a 7.0 vascular suture patch. Following restoration of blood flow, the vessel diameter measured approximately 0.4 cm. Color Doppler ultrasound showed smooth blood flow. After thorough hemostasis, the vascular sheath was removed, and the incisions were sutured layer by layer. The operation was completed.
2. Upper Limb Venous Catheter Thrombolysis + Surgical Thrombectomy + Cephalic Vein Arch Reconstruction + 6mm High-Pressure Balloon Dilation on 2023-06-16
The patient lies in a supine position, exposing the left upper limb. Preoperative color Doppler ultrasound examination showed thrombosis throughout the arteriovenous fistula anastomosis to the cephalic vein arch. After routine disinfection and draping, the original mid-upper arm skin incision was separated to expose the cephalic vein. A 0.5 cm longitudinal venotomy was performed, and a vascular clamp was used to remove the thrombus. Blood flow was restored, ejecting multiple small thrombi. The vessel was sutured with 7-0 vascular sutures. Simultaneously, the original mid-clavicle skin incision was separated to expose the cephalic vein arch. The vessel was disconnected at the original suture site, and a long segment of thrombus was removed with a vascular clamp. Heparin saline was used for flushing, and the proximal vessel was found to be patent upon exploration. The tortuous part of the cephalic vein was trimmed and anastomosed with 7-0 vascular sutures. After restoring blood flow, re-thrombosis of the distal arteriovenous fistula was observed, and stenosis was visible in the cephalic vein near the shoulder. The original vascular suture in the mid-upper arm was incised again, and the thrombus was removed with a vascular clamp. A 6F vascular sheath was inserted into the mid-upper arm, and 100,000 units of urokinase were injected before inserting a 0.35 super-slip guidewire. A Boston Scientific MUSTANG 6*40mm dilation balloon was advanced along the guidewire to compress the thrombus. The direction of the vascular sheath was adjusted, and the guidewire was advanced proximally. A Boston Scientific MUSTANG 6*40mm dilation balloon was then inserted along the guidewire to the stenotic area of the cephalic vein near the shoulder. The stenosis was dilated three times at 16-20 ATM, expanding from 2mm to 4mm. The balloon was removed, and the blood flow signal increased. Bleeding occurred again at the cephalic vein near the mid-clavicle, likely due to vascular sclerosis and thin vessel walls. The area was resutured with 7-0 vascular sutures. Color Doppler ultrasound confirmed continuous arteriovenous fistula blood flow without significant thrombosis, and thrill was palpable. The vascular sheath was removed, and the subcutaneous tissue and skin of the mid-upper arm and mid-clavicle were sutured successively. Sterile dressings were applied.
3. Upper extremity venography + Superior vena cava venography + Catheter-directed thrombolysis of upper extremity veins + Catheter aspiration thrombectomy + 5mm high-pressure balloon dilation on 2023-08-21
The patient lies in a supine position. After routine disinfection and draping, the puncture site is selected near the shoulder on the left cephalic vein of the upper arm. Successful puncture is achieved towards the distal end. Heparin is administered intravenously for prophylactic anticoagulation, and an 8Fr vascular sheath is inserted. Under ultrasound guidance, the guidewire is adjusted and, with the assistance of a balloon catheter, passes smoothly through the thrombus in the cephalic vein of the upper arm and successfully reaches the anastomosis site. The guidewire is then withdrawn, and urokinase is injected locally into the thrombus via the balloon for thrombolysis. After local massage to partially dissolve and soften the thrombus, the guidewire is exchanged to insert and connect the thrombectomy catheter (AcoStream by Aortec) system. Under ultrasound guidance, repeated thrombus aspiration begins within the thrombus, aspirating most of the thrombus distal to the puncture site. With increased pressure in the proximal lumen, an 8Fr vascular sheath is subsequently inserted from the lower segment of the upper arm towards the proximal end. Attempts are made to pass through the tortuous lumen of the mid-upper arm to reach the proximal thrombus site via the guidewire, but repeated attempts fail. The proximal sheath is then reversed towards the proximal end, and a guidewire is inserted through the sheath. With the aid of the guidewire, the thrombectomy catheter is placed at the occluded cephalic vein arch and thrombus is aspirated from the proximal to the distal end. Afterwards, a guidewire and a 5*60mm balloon are inserted through the sheath and successfully passed through the occluded lesion of the cephalic vein arch into the left subclavian vein. Gradual dilation is performed repeatedly at 8-22 ATM, restoring flow in the locally occluded lesion and the confluence of the subclavian vein. Post-dilation, the lumen is recanalized, and blood flow is partially restored. Follow-up ultrasound indicates residual thrombus near the anastomosis area in the middle and lower segments of the upper arm. An 8Fr vascular sheath is again inserted towards the distal end in the mid-cephalic vein, and the thrombectomy system is inserted through the sheath for thrombectomy. Most of the thrombus is aspirated, and thrombus detachment occurs, drifting to the cephalic vein arch. Thrombectomy is again performed using the thrombectomy system via the proximal sheath, combined with biopsy forceps for thrombus removal. Subsequently, a 5*60mm balloon is used to dilate at the cephalic vein arch, with the longest sustained inflation time being one minute. After completion, the local lumen is recanalized, and ultrasound shows a minimum inner diameter of 3mm. Angiography through the sheath confirms recanalization of the cephalic vein in the upper arm, the cephalic vein arch, the left subclavian vein, the left brachiocephalic vein, and the superior vena cava. Significant thrill is noted in the cephalic vein of the upper arm. The balloon, guidewire, and vascular sheath are sequentially removed, and the puncture site is sutured with 5-0 PROLENE thread. Hemostasis is achieved, followed by dressing application, concluding the procedure.

Expert Introduction

Professor Cao Hanhua
Surgeon of This Case
Vice President of Kecheng District People's Hospital, Director of the Nephrology Department, Chief Physician.
Leader of the leading discipline in county-level hospitals in Zhejiang Province, Rising Star in Zhejiang Medical Field, 115 Talent in Quzhou City, Member of the Nephrology Branch of Zhejiang Medical Association, Member of the Nephrology Branch of Quzhou Medical Association, Youth Member of the Rheumatology Branch of Zhejiang Medical Association.
Expertise: Diagnosis and treatment of kidney diseases and rheumatic diseases. Accumulated rich experience in the treatment of refractory nephropathy and maintenance of complex vascular access. Pioneered the implementation of percutaneous peritoneal dialysis catheter insertion in Zhejiang Province. The techniques for establishing and maintaining complex fistulas are at an advanced level in Zhejiang.

Department Introduction


The Nephrology Department of Kecheng District People's Hospital is a leading medical discipline at the county level in Zhejiang Province.Key Clinical Specialty Construction Project of Zhejiang Province,Key Discipline of Quzhou City, Key Collaborative Department of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University, Application and Promotion Unit for Hemodialysis Access Establishment and Maintenance Technology under the National Health Industry Enterprise Management Association, Member Unit of the Yangtze River Delta Vascular Access Alliance. The department has established several provincial expert workstations. The department has 2 chief physicians, 4 associate chief physicians, 4 attending physicians, and 3 resident physicians. Professor Weiqin Lin and Professor Jianyong Wu from the Kidney Disease Center of the First Affiliated Hospital of Zhejiang University, as well as Professor Hua Li from the Kidney Disease Center of Sir Run Run Shaw Hospital affiliated with Zhejiang University, regularly visit the hospital for consultations, surgeries, and professional guidance. Currently, the department has 45 open beds and 83 hemodialysis machine positions, serving over 200 patients on long-term maintenance dialysis. The number of vascular access surgeries and dialysis sessions performed annually ranks among the top in the Quzhou region. The department was the first in western Zhejiang to carry out laparoscopic peritoneal dialysis catheter implantation, parathyroidectomy with transplantation, balloon dilation and stent placement for fistula stenosis, and interventional procedures for central venous stenotic lesions.
Main Diseases Treated:Chronic nephritis, nephrotic syndrome, IgA nephropathy, diabetic nephropathy, hypertensive nephropathy, multiple myeloma-associated nephropathy, chronic renal failure, urinary tract infection, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, scleroderma, dermatomyositis, etc.
Main Surgeries Performed:Renal biopsy, temporary hemodialysis catheter insertion, semi-permanent hemodialysis catheter with polyester cuff insertion, autologous arteriovenous fistula formation, artificial vessel arteriovenous fistula formation, thrombectomy of autologous/artificial vessel arteriovenous fistula, balloon angioplasty and stent placement for autologous/artificial vessel arteriovenous fistula, immediate puncture type artificial vessel arteriovenous fistula formation, interventional treatment of central venous lesions under DSA, peritoneal dialysis catheter insertion, parathyroidectomy with autotransplantation, etc. Annual surgical volume exceeds 600 cases, ranking among the top in nephrology specialties across Zhejiang Province.
Main Medical Technology:Diagnosis and treatment of early-stage kidney disease, immunosuppressive therapy for chronic kidney disease, hemodialysis, hemofiltration, diagnosis and treatment of complications related to end-stage kidney disease, peritoneal dialysis, etc.
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