HeRO graft-The results of the cologne single center study.

OBJECTIVE: The HeRO graft is a technique for vascular access in patients with limited treatment options; however, the published results with the HeRO graft are diverging. We therefore conducted a single-center study. METHODS: Patient records between July 2014 and February 2020 from Vascular Access Unit of the Department of Vascular and Endovascular Surgery of University Clinic of Cologne (Germany) were reviewed. Retrospective data was analysed from patients with a HeRo graft (n = 18). RESULTS: Eighteen patients were enrolled in the study. The mean age of the patients was 62.8 ± 17.24 years. During the follow-up period, no patients died from complications related to the HeRO graft. Each patient had a mean of 1.94 concomitant diseases. The primary patency rates of the HeRO graft at 3, 6, 12, 18, and 24 months were 61.1%, 50%, 16.7%, 11.1%, and 5.6%, respectively. The secondary patency rates at the same time intervals were 77.8%, 72.8%, 55.6% 55.6%, and 55.6%, respectively. There were 44 re-operations per year, or 2.4 operations per patient. The main cause of acute complications was acute graft occlusions after HERO graft implantation. An infection after the graft implantation occurred in five (27.7%) patients, leading to graft explanation in 2 cases. CONCLUSION: The use of the HERO graft is a valuable alternative method for providing a durable dialysis access in patients with limited access options. The secondary patency and survival are good with a low infection rate.

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Gracz fistula is a feasible option after two failed percutaneous arteriovenous fistulae.

Two devices for the creation of an endovascular percutaneous (pAVF) endovascular (endoAVF) arteriovenous fistulae (AVF) are available: the Ellipsys and the WavelinQ-4F systems. The main difference is the location of the anastomosis, making it feasible to use both pAVFs and surgical Gracz-type AVF in an algorithm sequence. A 66-year-old male patient with end-stage kidney disease and HIV was referred for a creation of a dialysis access after failed peritoneal dialysis. A radial-radial WavelinQ-pAVF with simultaneous coil embolization of a brachial vein was created but failed within 4 weeks. Therefore, an Ellipsys-pAVF was successfully created between the proximal radial artery and perforating vein on the same arm. After 2 days, however, the Ellipsys-pAVF anastomosis occluded. The ipsilateral Gracz-AVF was created, anastomosing perforating vein with the antecubital brachial artery. Cannulations were started 28 days later. During the follow up of 807 days, the AVF remained patent with last known volume flow of 1500 ml/min and no need for secondary interventions. We report a successful creation of a Gracz-AVF after primary failed pAVFs created with both pAVF-systems in a single patient and in the same arm. Thus, based on that case we recommend creation of pAVF prior to Gracz-AVF as integral part of Vascular Access creation algorithm, based on each patient's life plan.

Novel external stenting for reconstruction of high flow arteriovenous fistula.

BACKGROUND: High-flow arteriovenous fistulae (HF-AVF) may lead to adverse cardiac remodeling in hemodialysis patients. We have investigated whether a novel external stent is safe and effective in reducing and stabilizing flow rates during a 1-year follow-up after HF-AVF reconstruction. METHODS: All patients with HF-AVF (access flow rate ⩾ 1500 ml/min), who underwent HF-AVF reconstruction with external stenting in two centers between June 2018 and May 2020, were included in this retrospective analysis. During HF-AVF reconstruction, the dilated vein segment was resected, underwent volume reduction, and was externally stabilized using a braided cobalt-chromium external stent. AVF flow rates were assessed preoperatively, intraoperatively, and at follow up visits using duplex ultrasound. RESULTS: Forty-three HF-AVFs in 42 patients were reconstructed and supported with an external stent (mean age 49 years, range 20-86 years; 74% men). Fifty-one percent were forearm AVFs, 49% were upper arm. The mean preoperative flow rate was 2622 ± 893 ml/min (range: 1500-6000 ml/min) and was decreased to 710 ± 221 ml/min (range: 300-1300 ml/min) intra-operatively after HF-AVF reconstruction. At 6 and 12-months follow-up, the mean flow rates were 1132 ± 320 ml/min (range: 470-1700 ml/min) and 1453 ± 888 ml/min (range: 300-3800 ml/min), respectively. Recurrence of high flow (>1500 ml/min) occurred in 16% and 25% of the patients at 6 and 12 months and primary patency rates were 86% and 70%, respectively. CONCLUSIONS: This early experience with novel external stenting for HF-AVF reconstruction demonstrates that it is a safe and effective method for reducing and stabilizing flow rates up to 1-year post procedure. Additional studies are required to evaluate the durability of this procedure over the longer term and assess its effect on cardiac remodeling.

Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience.

BACKGROUND: The VasQTM device was designed to improve the outcome of arteriovenous fistulae by optimizing the hemodynamics of the flow in the juxta-anastomotic region of the arteriovenous fistulae through tailored external support. The aim of the study was to evaluate the impact of the VasQ on outcome of radiocephalic arteriovenous fistulae in a real-world setting. METHODS: This was a single-center, retrospective analysis of patients with either fistula creation before or after dialysis initiation with implantation of the VasQ device during creation of end-to-side radiocephalic arteriovenous fistulae between June 2018 and May 2019. The flow rate and vein diameter were evaluated intraoperatively, at discharge within 48 h postprocedure and at a follow-up of 1, 3, 6, 9, and 12 months. RESULTS: Thirty-three VasQ devices were implanted during 33 radiocephalic arteriovenous fistula procedures. The study population comprised mostly of men, with an average age of 66 years. Mean intraoperative flow was 428 mL/min (range: 130-945). All patients were discharged with patent arteriovenous fistulae and mean fistula flow of 740 mL/min (range: 230-1300 mL/min). The primary patency was 100% and 79% at 3 and 6 months, respectively. Cumulative/secondary patency was 100% and 90% at 3 and 6 months, respectively. CONCLUSION: Data presented here suggest that the VasQ device has the potential to provide benefit to the functionality of radiocephalic arteriovenous fistulae.

The past and the future of vascular access surgery: Creation of percutaneous arteriovenous fistula using Ellipsys vascular access system in a patient with previous ipsilateral Scribner-shunt.

BACKGROUND: Sixty years after the first description of Scribner-shunt, and 54 years after publication of the first radio-cephalic arterio-venous fistula (AVF), endovascular percutaneous AVF (pAVF) was introduced. We report a successful case of Ellipsys-pAVF creation and use for hemodialysis in a patient with a previous ipsilateral Scribner-shunt. CASE: A 72-year old female patient with chronic kidney disease (CKD), previous right-sided Scribner-shunt and kidney transplant, underwent a successful creation of right-sided Ellipsys-pAVF. The procedure time was 12 min with intraoperative brachial artery volume flow of 720 ml/min. At 39 days, an ultrasound-guided balloon-angioplasty of the outflow cephalic vein stenosis was performed. Cannulations were started 41 days after the creation of pAVF. No additional interventions were required during the follow-up of 258 days with last follow-up volume flow of 1400 ml/min. CONCLUSIONS: This is the first report of the creation of pAVF in a patient with previous "traumatic" ipsilateral placement of a Scribner-shunt. It allows the creation of a small anastomosis in very short time, which can be successfully used for hemodialysis treatment on the same day, if necessary, and reduces the expected risk of high-flow AVF with associated peripheral steal and cardiac outcomes (especially in a patient with cardiomyopathy such this one).

Multicenter Experience with the Surfacer Inside-Out Access Catheter System in Patients with Thoracic Venous Obstruction: Results from the SAVE Registry.

PURPOSE: To report the device performance and safety for the Surfacer Inside-Out access catheter system in patients with thoracic central venous obstruction (TCVO) requiring central venous access (CVA). MATERIALS AND METHODS: Five sites prospectively enrolled 30 patients requiring a tunneled dialysis catheter between February 2017 and September 2018 in the SAVE (Surfacer System to Facilitate Access in Venous Obstructions) registry. Patient demographics, medical history, and type of TCVO were documented at enrollment. Device performance and adverse events were collected during the procedure and upon hospital discharge. Twenty-nine of the 30 patients enrolled required CVA for hemodialysis. Retrospective classification of TCVOs according to SIR reporting standards showed 9 patients (30%) had Type 4 obstructions, 8 (26.7%) had Type 3, 5 (16.7%) had Type 2, and 8 (26.7%) had Type 1 obstruction. RESULTS: Central venous catheters (CVCs) were successfully placed in 29 of 30 patients (96.7%). The procedure was discontinued in 1 patient due to vascular anatomical tortuosity. All 29 patients with successful CVC placement achieved adequate catheter patency and tip positioning. There were no device-related adverse events, catheter malposition, or intra- or postprocedural complications. Mean time from device insertion to removal for the 29 patients who successfully completed the procedure was 24 ± 14.9 (range, 6-70) minutes. Mean fluoroscopy time was 6.8 ± 4.5 (range, 2.2-25.5) minutes. CONCLUSIONS: The Surfacer Inside-Out procedure provided an alternative option to restore right-sided CVA in patients with TCVO.

A Novel Inside-out Access Approach for Hemodialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion.

RATIONALE & OBJECTIVE: Left-sided internal jugular and all subclavian central venous catheters (CVCs) cause thoracic central vein occlusions (TCVOs) more often than right-sided internal jugular catheters. To enable right-sided CVC placement in patients with TCVO, an inside-out access (IOA) approach was established at 3 vascular access centers in Europe involving use of a novel IOA device advanced from the right femoral vein. In the current analysis, we assessed the eligibility and success rate of this IOA approach in a cohort of patients with TCVO requiring a tunneled dialysis catheter. STUDY DESIGN: Retrospective multicenter observational study. SETTING & PARTICIPANTS: 36 patients with TCVO treated in Vienna, Austria; Oxford, England; or Cologne, Germany, who required hemodialysis access between July 2016 and June 2018. EXPOSURE: Application of the IOA approach to gain vascular access. OUTCOME: The primary end point was the success rate of passing the TCVO to gain dialysis access using the IOA approach. Secondary end points were catheter patency at 3 months and procedure-related complications (early infections, bleeding, hematoma, and pericardial effusions). ANALYTICAL APPROACH: Descriptive statistics to characterize eligibility, success rate, and complications of the IOA approach. RESULTS: 36 patients with TCVO and history of multiple CVCs and arteriovenous fistulas were referred to the participating centers for vascular access. 32 (89%) patients were eligible for the IOA approach. 39 treatments were performed, with 7 patients undergoing the IOA procedure a second time more than 3 months after initial CVC placement. Dialysis access was established successfully in 38 of 39 (97%) implementations of the IOA procedure. Median intervention time was 43 minutes. No complications occurred. LIMITATIONS: No comparison to other methods to place CVCs and the observational study design. CONCLUSIONS: The IOA approach is a promising method to enable rapid access to the right jugular vein in the setting of pre-existing TCVO. Additional experience is needed to understand the generalizability of these observations.

AV fistula creation in paediatric patients: outcome is independent of demographics and fistula type reducing usage of venous catheters.

PURPOSE: Even though early transplantation is still the first-line therapy in paediatric patients with end-stage renal disease (ESRD), up to 30% of these patients still require haemodialysis (HD). Creating an arteriovenous fistula (AVF) is quite challenging, particularly in children, leading to disproportional use of catheters. In this paper, we describe our experience in the creation of AVF with currently no in-dwelling catheters in children and adolescents on HD. METHODS: From January 2009 to December 2013, there were 34 patients rated as unfit for transplantation for at least the next 6 months or who had already been on HD through a central venous catheter (CVC). Three patients aged between 12 months and 3 years and weighing 9-12 kg were not suitable for AVF. Finally 31 patients, from 6 to 19 years of age with a mean weight of 43.3 ± 14.5 kg (19-80 kg), were assigned to the alternative of AVF. RESULTS: During the above-mentioned time period, 31 patients were provided with 32 AVFs; 26 received a distal radiocephalic fistula, five a Gracz-type fistula and one a brachio-basilic fistula. All but two fistulae matured primarily, within an average time of 45 (range: 16-191) days until the first dialysis. The fistula's 1-year primary and primary assisted patency rates were 78% and 94%, respectively. CONCLUSIONS: The creation of a native vascular access is an effective and durable procedure in paediatric and adolescent patients. It reduces using of CVCs and is appropriate both for long-term treatment and as a bridging procedure until renal transplantation.

Thoracic type Ia endoleak: direct percutaneous coil embolization of the aortic arch at the blood entry site after TEVAR and double-chimney stent-grafts.

OBJECTIVES: To introduce a novel percutaneous technique to stop blood entry at the lesser aortic arch curvature by coil embolisation in type Ia endoleak after TEVAR. METHODS: A 61-year-old Marfan patient presented with type Ia endoleak of the aortic arch and a growing aortic arch pseudoaneurysm after TEVAR. Multiple preceding operations and interventions made an endovascular approach unsuccessful. Direct percutaneous puncture of the aneurysmal sac would have cured the sign, but not the cause of blood entry at the lesser curvature of the aortic arch. Direct CT-guided percutaneous puncture of the blood entry site in the aortic arch with fluoroscopically guided coil embolisation using detachable extra-long coils was successfully performed. RESULTS: Three weeks after the intervention, the patient developed fever because of superinfection of the pseudoaneurysm. The blood cultures and CT-guided mediastinal aspirate were sterile. After intravenous administration of antibiotics, the fever disappeared and the patient recovered. Six-month follow-up showed permanent closure of the endoleak and a shrinking aneurysmal sac. CONCLUSIONS: Direct percutaneous puncture of the aortic arch at the blood entry site of a thoracic type Ia endoleak after TEVAR and double-chimney stent-grafts with coil embolisation of the wedge-shaped space between the lesser aortic curvature and the stent-graft is possible. KEY POINTS: Endoleaks after thoracic endovascular aortic repair are common in 15-30 %. Most endoleaks can be treated by endovascular means. Direct percutaneous endoleak repair is described as a bail-out option. Direct percutaneous aortic arch coil embolisation of type 1a endoleak is possible. Antibiotic prophylaxis should be administered case by case, considering individual risk factors.

Results of an observational study in carotid surgery using absorbable suture material.

BACKGROUND: Absorbable sutures are not well accepted for reconstruction in high-pressure arterial segments because the suture line might break and aneurysmal changes could develop. This hypothesis was checked in the clinical setting of carotid surgery. METHODS: The morphology of the carotid artery was evaluated by color-coded ultrasound in four groups of patients: group A, 25 patients who underwent standard carotid endarterectomy and patchplasty, including a transverse plication for which absorbable sutures had been used; group B, 10 patients who underwent eversion endarterectomy and reinsertion using absorbable sutures; group C, 15 patients who underwent standard carotid endarterectomy and patchplasty without a transverse placation; group D, 20 patients who suffered from atherosclerotic disease but did not have previous carotid surgery or other carotid pathology. All operations had been performed at least 3 years earlier than the actual examination. RESULTS: Along the internal carotid artery, where an aneurysmal change would have been expected to occur, no differences in absolute size or calculated elliptical cross-sectional vessel area were found. Patients after eversion endarterectomy did not show signs of aneurysmal changes in the area of reinsertion at the carotid bifurcation. CONCLUSIONS: Even in the long-term, for this group of patients, no significant aneurysmal changes of arterial reconstructions in carotid surgery performed with absorbable sutures were observed.