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.

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.

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.

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.

Endovenous ablation of incompetent truncal veins and their perforators with a new radiofrequency system. Mid-term outcomes.

This is a prospective trial investigating endovenous radiofrequency ablation with the EVRF system for the treatment of symptomatic varicose veins. Primary endpoints include one-year anatomical and clinical success and procedure-related complications. Secondary endpoints include adjunctive procedures and recanalization rates, periprocedural pain assessment, and time return to normal activities. In 60 patients with 74 limbs, 58 great saphenous vein, 11 small saphenous vein, 2 anterior accessory saphenous vein, and 3 perforators were ablated. Additional ablations for further improvement were necessary in 28.4%. Clinical success was 94.6%. Anatomical success was 96.0% at one month and 89.2% at one year. Primary ablation success was 77%. Revascularization occurred in 12.1%. Clinically driven repeat ablation rate was 4.0%. Perforator ablation due to segmental revascularization was performed in 5.4%. Complications included one puncture-site infection, three scars, two cases of transient paresthesia, and one skin pigmentation. Periprocedural mean pain score was 2.4 ± 2.6. In 27.0% cases, the patients used analgesics and mean time return was 1.2 ± 0.5 days. The EVRF system yields satisfactory clinical and anatomical midterm outcomes with very low complication rates.

Feasibility of endovascular recanalization of occluded infrapopliteal drug-eluting stents.

PURPOSE: To investigate the safety and feasibility of percutaneous endovascular recanalization of late total occlusions of infrapopliteal drug-eluting stents (DES). METHODS: A retrospective study investigated all 408 infrapopliteal stent procedures performed in 367 patients between January 2007 and October 2013 to identify those who underwent percutaneous reintervention for symptomatic infrapopliteal balloon-expandable DES occlusion. The search identified 49 patients with at least one infrapopliteal DES occlusion in 61 (14.9%) of 408 limbs. Seven (14.3%) patients were excluded from the analysis owing to asymptomatic status (n=6) and acute thrombotic occlusion (n=1), leaving 42 patients who underwent endovascular revascularization of occluded stents in 54 limbs. The study's primary outcomes were technical success and complication rates of endovascular recanalization, while secondary outcomes included limb salvage and the identification of factors influencing primary results. RESULTS: Technical success was 90.7% (49/54 procedures). Technical failure was seen only in cases of stent collapse and overlapping native popliteal artery-infrapopliteal stent occlusion. According to Kaplan-Meier analysis, survival was 89.6%, 81.1%, and 73.5% at 1, 2, and 3 years, respectively, while limb salvage rates were 86.1%, 79.3%, and 72.7% at the same time points. There was 1 (1.8%) case of distal embolization. No factors influencing outcomes could be identified. CONCLUSION: Percutaneous recanalization of infrapopliteal stent total occlusions is safe and feasible. Technical failure was noted in cases of stent deformation occurring at the pedal artery and in overlapping native popliteal artery-infrapopliteal stent occlusion.

Transauricular balloon angioplasty in rabbit thoracic aorta: a novel model of experimental restenosis.

BACKGROUND: The aim of this study was to demonstrate a percutaneous transauricular method of balloon angioplasty in high-cholesterol fed rabbits, as an innovative atherosclerosis model. METHODS: Twenty male New Zealand rabbits were randomly divided into two groups of ten animals, as follows: atherogenic diet plus balloon angioplasty (group A) and atherogenic diet alone (group B). Balloon angioplasty was performed in the descending thoracic aorta through percutaneous catheterization of the auricular artery. Eight additional animals fed regular diet were served as long term control. At the end of 9 week period, rabbits were euthanized and thoracic aortas were isolated for histological, immunohistochemical and biochemical analysis. RESULTS: Atherogenic diet induced severe hypercholesterolemia in both group A and B (2802 ± 188.59 and 4423 ± 493.39 mg/dl respectively) compared to the control animals (55.5 ± 11.82 mg/dl; P < 0.001). Group A atherosclerotic lesions appeared to be more advanced histologically (20% type IV and 80% type V) compared to group B lesions (50% type III and 50% type IV). Group A compared to group B atherosclerotic lesions demonstrated similar percentage of macrophages (79.5 ± 9.56% versus 84 ± 12.2%; P = 0.869), more smooth muscle cells (61 ± 14.10% versus 40.5 ± 17.07; P = 0.027), increased intima/media ratio (1.20 ± 0.50 versus 0.62 ± 0.13; P = 0.015) despite the similar degree of intimal hyperplasia (9768 ± 1826.79 µm² versus 12205 ± 8789.23 µm²; P = 0.796), and further significant lumen deterioration (23722 ± 4508.11 versus 41967 ± 20344.61 µm²; P = 0.05) and total vessel area reduction (42350 ± 5819.70 versus 73190 ± 38902.79 µm²; P = 0.022). Group A and B animals revealed similar nitrated protein percentage (P = NS), but significantly higher protein nitration compared to control group (P < 0.01; P < 0.01, respectively). No deaths or systemic complications were reported. CONCLUSION: Transauricular balloon angioplasty constitutes a safe, minimally invasive and highly successful model of induced atherosclerosis in hyperlipidaemic rabbits.