One-year duplex ultrasound-assessed closure outcomes of percutaneous endovenous microwave ablation for the treatment of varicose veins of the lower limbs.

PURPOSE: This study aims to investigate the safety and efficacy of a new device using microwave technology for the endovenous ablation of the great saphenous vein (GSV) causing symptomatic lower limb varicose veins (LLVV). MATERIALS AND METHODS: This prospective, single-arm, single-center, cohort study investigated the safety and effectiveness of endovenous microwave ablation for the treatment of symptomatic LLVV. Enrollment period was set between January and December 2020. Primary safety endpoint was the occurrence of procedure-related complications and primary efficacy endpoint was anatomical success defined as the duplex ultrasound (DUS)-proven GSV occlusion at 1 year follow-up. Secondary endpoints included 1-year clinical success (CEAP classification improvement), repeat procedures rate due to GSV recanalization, and pain assessment at 24 h post treatment. RESULTS: In total, 50 patients (42 female; mean age: 62 ± 12 years) with 64 limbs were treated. No procedure-related complications were noted. Technical success was 95.3% (61/64 GSVs), as three cases of GSV recanalization were detected. Clinical success was 100%, as in all cases symptoms improvement by at least one grade according to CEAP classification, was achieved. Mean CEAP grade significantly improved from 3.3 ± 0.72 (median: 3) at baseline to 1.8 ± 0.85 (median: 2) at 1-year (p < 0.0001). There were no repeat procedures due to GSC recanalization. The median 24-h VAS value was 2 (mean: 1.9 ± 1.4). CONCLUSIONS: Endovenous microwave ablation was safe and effective for the treatment of varicose veins, achieving high 1-year GSV occlusion rates.

Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.

PURPOSE: To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. MATERIAL AND METHODS: A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7 mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7 atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4 min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. RESULTS: Mean lesion length was 40 ± 28.5 mm. Mean time follow up was 36 months ± 10.46 months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21 days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. CONCLUSIONS: Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.

VOLume flow assistance for optimizing outcomes of dysfunctional autologous arteriovenous fistula Angioplasty: the VOLA Pilot Study.

OBJECTIVES: To investigate the feasibility of VF-assisted angioplasty (VFA) in dysfunctional AVF using sequential intraprocedural duplex ultrasound (DUS), to utilize intraprocedural VF as a quantifiable, functional endpoint in endovascular treatment. METHODS: This prospective study included 20 consecutive patients (23 lesions; 16 men; mean age 67 ± 16 years) with dysfunctional AVF undergoing fluoroscopically guided balloon angioplasty between June 2019 and May 2020. Primary endpoints were quantification of outcome using sequential DUS VF analysis following each dilation, 6-month target lesion re-intervention (TLR)-free rate, standard technical success, procedural success (achievement of a postprocedural VF value equal (or 10% less) or superior to the baseline steady-state access), and correlation between procedural success and TLR-free rate. Secondary endpoints included 6-month lesion late lumen loss (LLL), correlation between balloon diameter used and intraprocedural VF values, and correlation between VF and LLL at 6 months follow-up. RESULTS: Mean VF increase was 168.5% ± 102.5% (range: 24.24-493.33%). Procedural success was 80% (16/20 cases). VFA improved procedural success by 20% (4/20 cases) compared to standard assessment (< 30% residual stenosis and palpable thrill). TLR-free rate was 78.3% and 67.3% at 6 and 12 months. Significantly less TLR was noted in cases of procedural success (82.4% vs. 66.7% 6 months; p = 0.041). Unweighted linear regression showed a significant positive relationship between diameter of balloon and VF (146.9 ± 42.3 mL/min VF gain per mm of balloon diameter; p = 0.001, R2 = 0.23) and a significant negative relationship between LLL and VF decline at follow-up (102.0 ± 34.6 mL/min loss per mm of LLL; p = 0.01, R2 = 0.35). Optimal VF cutoff value and percentile increase to predict access failure were 720 mL/min (sensitivity 58.3%, specificity 71.4%) and 153% (sensitivity 66.7%, specificity 85.7%), respectively. CONCLUSION: Intraprocedural VF assessment could be used to optimize AVF angioplasty. KEY POINTS: • A newly proposed functional endpoint of angioplasty in dysfunctional dialysis fistula was evaluated and angioplasty outcome was quantified using volume flow (VF) assessment with sequential intraprocedural DUS. • Intraprocedural VF assessment improved immediate procedural success; increased balloon diameter was correlated with VF gain and late lumen loss with VF decline. • Intraprocedural VF values ≥ to baseline steady-state values were correlated with less re-interventions.

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.

Editor's Choice - Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). METHOD: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. RESULTS: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. CONCLUSION: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.

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.

The Rollercoaster of Paclitaxel in the Lower Limbs and Skeletons in the Closet: An Opinion Review.

There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.

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.

Outcome Predictors in Civilian and Iatrogenic Arterial Trauma.

BACKGROUND: Our aim was to identify predictors of mortality and limb loss in iatrogenic and civilian arterial trauma. METHODS: Cases were identified by searching prospectively maintained registries. Multivariable logistic regression was used to identify independent outcome predictors. RESULTS: During the study period, 285 patients with arterial trauma were managed with endovascular (n = 20) or open (n = 265) repair. Iatrogenic injuries increased in frequency during the course of the study, from 23.9% during the first decade to 35.9 and 55.7% during the second and third decade, respectively (p < 0.001). Endovascular management increased in frequency during the course of the study, from 0% during the first decade to 5.1 and 11.1% during the second and third decade, respectively (p = 0.005). Mortality was 9.8%, and limb loss (in cases with injury of the aorta or limb arteries, n = 259) was 6.2%. Independent predictors of mortality included increased age (odds ratio, 95% confidence interval [OR, 95% CI] 1.05 (1.02-1.07), p < 0.001), blunt trauma (OR [95% CI] 4.8 (1.9-12.2), p = 0.001) and the number of RBC units transfused intraoperatively (OR [95% CI] 1.25 (1.1-1.4), p = 0.001). Independent predictors of limb loss included the first half of the study period (OR [95% CI] 3.9 (1.1-14.1), p = 0.04), lower extremity arterial trauma (vs upper extremity, aortic, common or external iliac artery trauma, OR [95% CI] 8.3 (1.9-35.7), p = 0.004), bone fracture (OR [95% CI] 16.9 (4.7-62.5), p < 0.001) and the number of RBC units transfused intraoperatively (OR [95% CI] 1.16 (1.02-1.33), p = 0.024). CONCLUSION: Increasingly iatrogenic in cause and managed by endovascular methods, arterial trauma remains a problem associated with significant mortality and limb loss. Identification of unfavourable outcome predictors may help clinicians involved with arterial trauma to escalate the level of care.

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A formal systematic review and study-level meta-analysis of randomized controlled trials investigating treatment of the infrapopliteal arteries with paclitaxel-coated balloons compared with conventional balloon angioplasty for critical limb ischemia (CLI) was conducted. Medical databases and online content were last screened in September 2019. The primary safety and efficacy endpoint was amputation-free survival defined as freedom from all-cause death and major amputation. Target lesion revascularization (TLR) constituted a secondary efficacy endpoint. Summary effects were synthesized with a random-effects model. Some 8 randomized controlled trials with 1,420 patients (97% CLI) were analyzed up to 1 year follow-up. Amputation-free survival was significantly worse in case of paclitaxel (13.7% crude risk of death or limb loss compared to 9.4% in case of uncoated balloon angioplasty; hazard ratio 1.52; 95% confidence interval: 1.12-2.07, p = .008). TLR was significantly reduced in case of paclitaxel (11.8% crude risk of TLR versus 25.6% in control; risk ratio 0.53; 95% confidence interval: 0.35-0.81, p = .004). The harm signal was evident when examining the high-dose (3.0-3.5 µg/mm2) devices, but attenuated below significance in case of a low-dose (2.0 µg/mm2) device. Actual causes remain largely unknown, but non-target paclitaxel embolization is a plausible mechanism.

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.

Recent developments in endovascular interventions to sustain vascular access patency in haemodialysis patients.

There is amassed evidence regarding the use of endovascular procedures for the treatment of vascular access stenosis and thrombosis. A review was conducted based on available randomized trials, cohort studies and retrospective analyses published after 2000 on endovascular treatment of dysfunctional and thrombosed vascular access, with an aim to illustrate the available device and procedural options. The use of paclitaxel-coated balloons, cutting balloons and covered stents is described in the field of vascular access stenosis. The broad spectrum of available devices and endovascular declotting procedures ranging from thrombolysis to thrombectomy is also discussed. Overall, in this review we demonstrate the increasing role of endovascular procedures in vascular access treatment and the improved patency outcomes provided by the implementation of novel endovascular devices. Moreover, the improvement of post-intervention primary patency rates after endovascular declotting procedures and the shift to more thrombectomy-dependent procedures over time is also highlighted. In conclusion, endovascular treatment of dialysis access stenosis and thrombosis has an established role, owing to the implementation of sophisticated devices, allowing, when needed, the simultaneous treatment of thrombosis and the underlying stenosis.

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.

Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease: Systematic Review and Bayesian Network Meta-analysis of Randomized Controlled Trials.

PURPOSE: To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries. METHODS: Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed. RESULTS: There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency. CONCLUSION: Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound healing compared to BA and BMS. DES also significantly reduced amputations compared with PCB.