Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients.

PURPOSE: To retrospectively assess the safety and efficacy of percutaneous arteriovenous fistula (pAVF) creation with the WavelinQ 4-F EndoAVF System. MATERIALS AND METHODS: From February 2018 to June 2020, 30 pAVFs were created in 30 consecutive patients (men; age, 55.3 years ± 13.6). Of the 30 patients, 21 (70%) were already on hemodialysis using a central venous catheter. The primary outcome measures were technical success, complications, and cannulation rate. The secondary outcome measures included the number of secondary procedures needed for cannulation, maintenance time to cannulation, and pAVF survival. RESULTS: Technical success was 100%. The adverse event rate was 6.7% (2/30), including a pseudoaneurysm of the brachial artery that developed immediately after sheath removal and an aneurysm of the anastomosis 17 days after the procedure, which was treated with a covered stent placed in the arterial side. The mean follow-up was 547 days ± 315.7 (range, 14-1,071 days). The cannulation rate was 86.7% (26/30). The mean time to cannulation was 61.3 days ± 32.5 (range, 15-135 days). The mean follow-up after cannulation was 566.2 days ± 252.7 (range, 35-1,041 days). Four pAVFs were thrombosed after cannulation, with 2 of them successfully declotted. Sixteen interventions were needed to achieve cannulation after the index procedure in 15 patients (overall, 0.53 procedures/patient). Seven maintenance endovascular interventions (following cannulation) were performed during the follow-up period in 6 patients (overall, 0.27 procedures/patient, 0.17 procedures/patient-years). For the pAVFs that were cannulated, patency was 96% at 1 year, and 82% at 2 and 3 years, according to the Kaplan-Meier survival analysis. CONCLUSIONS: This initial experience suggests that pAVF creation is safe and can be successfully performed with high maturation and long-term patency rates. Larger-scale prospective studies are needed to validate the results.

Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European, Multicenter, Single-Arm Retrospective Analysis.

INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results.

PURPOSE: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. MATERIALS AND METHODS: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. RESULTS: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). CONCLUSIONS: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Use of the Covera Stent Graft for the Treatment of Dysfunctional or Thrombosed Arteriovenous Grafts: A Retrospective Analysis of 64 Patients.

PURPOSE: To retrospectively evaluate the safety and effectiveness of the Covera stent graft (SG) for the treatment of dysfunctional or thrombosed arteriovenous grafts (AVGs). MATERIALS AND METHODS: Within 29 months (February 2016-August 2018), 79 patients underwent Covera SG placement in the authors' department for the treatment of dysfunctional AVGs. Data were available for 64 patients who underwent 64 procedures, using 64 devices. Minimum follow-up was 6 months, unless reintervention occurred. Mean follow-up was 277 days (6-923 days). Treatment characteristics were 51 cases with venous-graft anastomosis (VGA) stenosis (79.7%), 13 cases of puncture zone stenosis (20.3%), 14 cases of in SG stenosis (21.9%), 8 cases of pseudoaneurysm treatment (12.5%) (1 treatment area might have had more than 1 characteristic). Thirty-six patients presented with thrombosis (56.2%), and 31 of 64 case were de novo treatment areas (48.4%). Primary outcome measurements were technical success and post-intervention primary patency (PIPP) at 6 months, whereas secondary outcome measurements included factors influencing primary outcome. RESULTS: Technical success was 100%. Median PIPP was 336 days, and 73.6% of treatment areas were patent at 6 months. There were no significant differences in terms of PIPP when de novo treatment areas were compared with restenotic areas (519 vs. 320 days, respectively; P = .1); patients who presented with versus those who presented without thrombosis (320 vs. 583 days, respectively; P = .07); puncture zone stenosis or elsewhere (329 vs. 686 days, respectively; P = .52); and VGA stenosis or elsewhere (336 vs. 335 days, respectively; P = .9). CONCLUSIONS: Use of the Covera SG for AVG treatment was safe and effective in every type of treatment area presented in this retrospective analysis.

Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy.

OBJECTIVE. The purpose of this study is to compare the safety and efficacy of the bedside ultrasound (US)-guided trocar technique versus the US- and fluoroscopy-guided Seldinger technique for percutaneous cholecystostomy (PC). SUBJECTS AND METHODS. This prospective noninferiority study compared the bedside US-guided trocar technique for PC (the trocar group; 53 patients [28 men and 25 women]; mean [± SD] age, 74.31 ± 16.19 years) with the US- and fluoroscopy-guided Seldinger technique for PC (the Seldinger group; 52 patients [26 men and 26 women], mean age, 79.92 ± 13.38 years) in consecutive patients undergoing PC at two large tertiary university hospitals. The primary endpoints were technical success and procedure-related complication rates. Secondary endpoints included procedural duration, pain assessment, and clinical success after up to 3 months of follow-up. RESULTS. PC was successfully performed for all 105 patients. The clinical success rate was similar between the two study groups (86.8% in the trocar group vs 76.9% in the Seldinger group; p = 0.09). Mean procedural time was significantly lower in the trocar group than in the Seldinger group (1.77 ± 1.62 vs 4.88 ± 2.68 min; p < 0.0001). Significantly more procedure-related complications were noted in the Seldinger group than in the trocar group (11.5% vs 1.9%; p = 0.02). Among patients in the Seldinger group, bile leak occurred in 7.7%, abscess formation in 1.9%, and gallbladder rupture in 1.9%. No procedure-related death was noted. Minor bleeding occurred in one patient (1.9%) in the trocar group, but the bleeding resolved on its own. The mean pain score during the procedure was significantly lower in the Seldinger group than in the trocar group (3.2 ± 1.77 vs 4.76 ± 2.17; p = 0.01). At 12 hours after the procedure, the mean pain score was significantly lower for patients in the trocar group (0.78 ± 1.0 vs 3.12 ± 1.36; p = 0.0001). CONCLUSION. Use of the bedside US-guided trocar technique for PC was equally effective as the Seldinger technique but was associated with fewer procedure-related complications, required less procedural time, and resulted in decreased postprocedural pain, compared with fluoroscopically guided PC using the Seldinger technique.

Use of Drug-Coated Balloons in Dysfunctional Arteriovenous Dialysis Access Treatment: The Effect of Consecutive Treatments on Lesion Patency.

PURPOSE: A retrospective longitudinal analysis was performed to evaluate the outcome of consecutive treatments with drug-coated balloons (DCBs) in dysfunctional arteriovenous (AV) dialysis access (fistulae and grafts). MATERIALS AND METHODS: From January 2015 to December 2017, 339 DCBs were used in 257 procedures in 165 patients with dysfunctional accesses. Of these, 38 patients had ≥ 2 procedures and were included in the analysis. A total of 112 procedures were performed with 133 devices (22 patients treated twice, 4 treated 3 times, 7 treated 4 times, 2 treated 5 times, and 3 treated 6 times). Mean balloon diameter was 8.13 mm (min-max range, 3-12 mm) and length was 63.16 mm (min-max range, 40-150 mm). Primary outcome measures were safety and effectiveness based on the noninferiority hypothesis that the second treatment would be as effective as the first regarding postintervention primary patency (PIPP). Secondary outcome measures included independent factors that may influence outcomes. RESULTS: Mean lesion follow-up was 617 d (range, 175-1,100 d). Median PIPP durations were 216.5 d for the first intervention and 280 d for the second (P = .37; hazard ratio, 1.271; 95% confidence interval, 0.75-2.16). There was a significant difference in PIPP in favor of the second intervention when patients with only 2 interventions (22 of 38; 57.9%) were included (first intervention, 269 d; second intervention, 520 d; P = .03; hazard ratio, 2.354; 95% confidence interval, 1.087-5.098). CONCLUSIONS: There was no significant difference in PIPP between the first and second DCB procedures. Results suggest consistency in PIPP with the use of DCBs regardless of aging AV access.

Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Dialysis Access: Results from a Randomized Controlled Trial.

PURPOSE: To compare the clinically-assessed intervention-free period (IFP) of paclitaxel-coated balloon (PCB) vs conventional balloon angioplasty (CBA) for the treatment of symptomatic central venous stenosis (CVS) in dialysis access. MATERIALS AND METHODS: Within 20 months, 40 dialysis patients (19/40 arteriovenous fistulae [AVFs] and 21/40 arteriovenous grafts [AVGs]) were randomized to undergo angioplasty either with a PCB (PCB group, n = 20; 14/20 male; age: 56.7) or CBA (CBA group, n = 20; 15/20 male; age: 57). There were 15/20 restenotic lesions in PCB group and 12/20 in CBA group. In 25/40 cases, patients had an ipslateral catheter insertion in the past. Primary endpoint was clinically-assessed intervention-free period (IFP) of the treated segment at 6 months, while secondary endpoints included complication rates during follow-up period and identification of factors influencing IFP. RESULTS: Median IFP was significantly better in PCB group (PCB group: 179 days, vs CBA group: 124.5 days, P = .026). Mean follow-up period was 180 days (range, 5-479). There was no significant difference between AVGs and AVFs (P = .17), treatment of de novo vs restenotic lesions (P = .33), or prior presence of catheter insertion (P = .21). No complications were observed. In restenotic lesions in PCB group, longitudinal comparison between treatments also showed a significant difference in favor of PCB treatment (median IFP in PCB* group 177 vs 91 days in CBA* group; P = .01). CONCLUSIONS: In this prospective study, PCB had significantly better results compared with CBA for the treatment of symptomatic central venous stenosis in dialysis access. Retrospective longitudinal comparison of treatments in the same patients also showed a significant difference in favor of PCBs.

Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial.

PURPOSE: To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). MATERIALS AND METHODS: Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. RESULTS: Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. CONCLUSIONS: In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.

Prospective, Multicenter, Observational Study to Evaluate a Cell-Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion within the Dialysis Outflow Circuit of an Arteriovenous (AV) Fistula or AV Graft (The WRAP Registry).

PURPOSE: Dysfunctional vascular access due to stenosis/occlusion within the arteriovenous fistula or graft (AVF/AVG) negatively affects the clinical management of patients undergoing hemodialysis. Results from the feasibility study of the WRAPSODY™ Cell-Impermeable Endoprosthesis demonstrated that the device can achieve high patency rates and maintain integrity of the dialysis outflow circuit. This study was designed to assess real-world evidence of safety and efficacy outcomes following device placement. MATERIALS AND METHODS: This is a prospective, multicenter, non-investigational, post-market observational study of 500 patients at up to 50 centers worldwide with a mature AVF/AVG dialysis access (≥ 1 hemodialysis session) who experience stenosis/occlusion of the outflow circuit prior to placement of WRAPSODY. Patients will be divided into the following two cohorts: peripheral or central thoracic. Primary outcome measures include target lesion primary patency (TLPP) at 6 months and procedure and/or device-related events through 30 days post-procedure. Secondary outcome measures include TLPP, safety events, and the number of interventions needed to maintain patency through the 24 month study period. Exploratory endpoints include time to access abandonment, resumption of successful dialysis, functional patency, and pending available imaging data, any incidence of stent fractures, migration, or edge stenosis. Study enrollment began in June 2022, the last patient visit is expected in 2026. DISCUSSION: It is expected that this study will provide real-world evidence regarding the performance of the WRAPSODY device in a diverse population of patients, which may encourage its use in the continuum of hemodialysis access management. TRIAL REGISTRATION: NCT05062291.

Polymer-coated paclitaxel-eluting stents for the treatment of stenosed native arteriovenous fistulas: Long-term results from the ELUDIA study.

BACKGROUND: Percutaneous transluminal angioplasty is the preferred treatment of stenosed failing arteriovenous fistulas (AVF) but is hampered by increasing rates of vascular restenosis because of development of myointimal hyperplasia. METHODS: This multicenter observational study of polymer-coated low-dose paclitaxel-eluting stents (ELUvia stents by Boston Scientific) in stenosed AVF undergoing hemoDIAlysis (ELUDIA) was jointly conducted in three tertiary hospitals from Greece and Singapore. Failure of AVF was defined according to K-DOQI criteria and significant fistula stenosis (>50%DS by visual estimate) was determined with subtraction angiography. Patients were considered for ELUVIA stent insertion based on significant elastic recoil following balloon angioplasty for the treatment of a single vascular stenosis within a native AVF. The primary outcome measure was sustained long-term patency of the treated lesion/fistula circuit defined as successful stent placement with resumption of uninterrupted hemodialysis and without significant vascular restenosis (50%DS threshold) or other secondary interventions during follow-up. RESULTS: Some 23 patients received the ELUVIA paclitaxel-eluting stent (eight radiocephalic, 12 brachiocephalic, and three transposed brachiobasilic native AVFs). Mean AVF age at the time of failure was 33.9 ± 20.4 months. Treated lesions included 12 stenoses at the juxta-anastomotic segment, nine at the outflow veins, and two cephalic arch lesions with a mean diameter stenosis of 86 ± 8%. Median stent diameter and length used were 7 mm and 40 mm, respectively. After a median follow-up period of 20 months, some 18 stents out of 23 cases remained patent (cumulative rate 78.3%) without any clinical or imaging evidence of recurrent stenosis. Estimated primary patency of the ELUVIA stents was 80.6% and of the corresponding fistula circuit 65.1% at 2 years by Kaplan-Meier methods. CONCLUSIONS: This observational study has shown promising long-term results of polymer-coated paclitaxel-eluting stents for the treatment of failing arteriovenous fistulas. Large-scale controlled studies are necessary.

Injury to the Medial Superior Genicular Artery After Isolated Posterior Cruciate Ligament Reconstruction: A Case Report.

CASE: A 19-year-old male patient with isolated posterior cruciate ligament (PCL) rupture underwent arthroscopic reconstruction using reinforced synthetic ligament (LARS system). Three weeks postoperatively, he presented with active bleeding from the medial side of his knee, near the proximal interference screw. An angiogram revealed extravasation from the medial superior genicular artery which was successfully embolized. One week later, he returned with active bleeding from the same area, located just under the initial coiling; a second embolization during superselective angiography was successful. CONCLUSION: Although rare, minor vascular injuries are a risk inherent to PCL surgery.

Revisiting endovascular treatment in below-the-knee disease. Are drug-eluting stents the best option?

Patients with below-the-knee arterial disease are primarily individuals suffering from critical limb ischemia (CLI), while a large percentage of these patients are also suffering from diabetes or chronic renal failure or both. Available data from randomized controlled trials and their meta-analysis demonstrated that the use of infrapopliteal drug-eluting stents (DES), in short- to medium- length lesions, obtains significantly better results compared to plain balloon angioplasty and bare metal stenting with regards to vascular restenosis, target lesion revascularization, wound healing and amputations. Nonetheless, the use of this technology in every-day clinical practice remains limited mainly due to concerns regarding the deployment of a permanent metallic scaffold and the possibility of valid future therapeutic perspectives. However, in the majority of the cases, these concerns are not scientifically justified. Large-scale, multicenter randomized controlled trials, investigating a significantly larger number of patients than those already published, would provide more solid evidence and consolidate the use of infrapopliteal DES in CLI patients. Moreover, there is still little evidence on whether this technology can be as effective for longer below-the-knee lesions, where a considerable number of DES is required. The development and investigation of new, longer balloon-expanding or perhaps self-expanding DES could be the answer to this problem.

A survival guide for endovascular declotting in dialysis access: procedures, devices, and a statistical analysis of 3,000 cases.

INTRODUCTION: Thrombosis is the most important access-related complication. Several declotting procedures have been suggested falling mainly into two categories; thrombolysis-dependent and thrombectomy-dependent. AREAS COVERED: Seventeen studies after 2001 have been published on percutaneous treatment of thrombosed vascular access. Authors performed a systematic review of these studies together with a parametric meta-analysis of data available investigating clinical success, postintervention assisted primary patency (PAPP) and independent factors that could influence outcome measures. EXPERT COMMENTARY: A shift to thrombectomy-dependent procedures is observed with a view to diminishing complications from the use of thrombolytic agents. Arteriovenous fistulas provide significantly better PAPP, while newer studies show improved, non-significant results compared with older ones. The role of improvement of devices for subsequent angioplasty is of equal importance, if not more, for improved declotting results.

Lysis-Assisted Balloon (LAB) Thrombectomy. A Declotting Technique for the Treatment of Thrombosed Arteriovenous Dialysis Grafts. 5-Year Experience of 241 Endovascular Procedures.

BACKGROUND: This is a retrospective single-center analysis investigating the results of a percutaneous lysis-assisted balloon (LAB) thrombectomy procedure for the treatment of thrombosed arteriovenous dialysis grafts (AVGs). MATERIALS AND METHODS: Within 5 years (January 2012-December 2016), 291 declotting procedures were performed for the treatment of thrombosed dialysis arteriovenous fistulas or grafts. Data were available for 129 patients (75 men, 58.1%) with an AVG, undergoing 241 procedures [1.87 procedures/patient (1-10)]. Procedure includes initial lysis with 5 mg recombinant tissue plasminogen activator followed by thrombectomy with a high-pressure balloon for thrombus maceration using "facing sheaths" technique. 61 patients had ≥ 2 declotting procedures. In 80 cases (80/241; 33.2%), a stent graft (SG) was used for treatment of persistent stenosis. Main primary outcome measures were clinical success and postintervention assisted primary patency (PAPP). Secondary outcome measures included procedural complications and investigation of independent factors that could influence circuit survival. RESULTS: Median PAPP was 434 days according to Kaplan-Meier survival analysis. Clinical success was 96.26%. In six cases (6/241, 2.49%) declotting failed and a catheter was placed. There were 16 minor (16/241, 6.64%) and no major complications. There was no significant difference in circuit survival regardless of SG use (No SG 406 days vs. SG 349 days; p = 0.24). There was a significant difference in favor of the second declotting compared to the first in 61 patients (first: 162 days vs. second: 447 days; p < 0.0001). CONCLUSION: LAB thrombectomy resulted in high-circuit survival rates with increased technical success and minimum complications without the use of thrombectomy devices.