Publications by authors named "Ramon L Varcoe"

71 Publications

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

J Endovasc Ther 2021 Jun 9:15266028211023505. Epub 2021 Jun 9.

Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia.

Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group.

Materials And Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality.

Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I=0%).

Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population.

Systematic Review Registration: CRD42020216140.
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http://dx.doi.org/10.1177/15266028211023505DOI Listing
June 2021

Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

Ann Vasc Surg 2021 Apr 5. Epub 2021 Apr 5.

Department of Diagnostic and Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany.

Objectives: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation.

Methods: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention.

Results: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class.

Conclusion: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities.

Clinical Trial Registration: NCT02276313.
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http://dx.doi.org/10.1016/j.avsg.2021.02.050DOI Listing
April 2021

Trends and outcomes in Australian carotid artery revascularization surgery: 2010-2017.

ANZ J Surg 2021 06 22;91(6):1203-1210. Epub 2021 Mar 22.

Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Background: Carotid endarterectomy (CEA) and carotid artery stenting (CAS) reduce the risk of stroke in patients with severe carotid stenosis. The aim was to compare contemporary treatment trends and outcomes after CEA and CAS between states of Australia.

Methods: A retrospective analysis was conducted on data from the Australasian Vascular Audit between 2010 and 2017. The primary endpoint was perioperative stroke or death (S/D). We also analysed stroke and death independently and revascularization rates per 100 000 population.

Results: A total of 15 413 patients underwent carotid revascularization (CEA 14 070; CAS 1343). S/D rates were similar for CEA and CAS (1.9% versus 1.8%; P = 0.37; symptomatic 2.1% versus 2.3%; P = 0.12; asymptomatic 1.5% versus 1.1%; P = 0.67). Patients ≥80 years (2.7% versus 1.7%; P = 0.01), those who had shunts (2.2% versus 1.7%; P = 0.03) or surgery in teaching hospitals (2.6% versus 1.4%; P = 0.02) had higher rates of S/D after CEA. Patients whose proceduralist used a cerebral protection device had lower S/D rates after CAS for symptomatic disease (4.8% versus 2.2%; P = 0.03). There was a wide variation in practice between states, where CAS as a proportion of total carotid procedures ranged from 0% to 17%, and a wide variation in outcomes, with rates of S/D varying between 1.4-6.6% for CEA and 0-6.7% after CAS.

Conclusion: Outcomes after CAS are equivalent to CEA when performed by vascular surgeons, however significant variation exists for both choice of revascularization procedure and perioperative outcomes between states. Further investigation is needed to determine whether clinical care pathways should be revised to achieve consistency and quality of outcomes.
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http://dx.doi.org/10.1111/ans.16757DOI Listing
June 2021

The Relationship Between Carotid Revascularization Procedural Volume and Perioperative Outcomes in Australia and New Zealand.

Angiology 2021 Feb 4:3319721991717. Epub 2021 Feb 4.

Department of Surgery, Prince of Wales Hospital, Sydney, Australia.

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) prevent stroke in selected patients. However, each intervention carries a risk of perioperative complications including stroke or death (S/D). We aimed to determine the relationship between operator volume, hospital volume, and the perioperative risk of S/D in carotid revascularization in Australia and New Zealand. Retrospective analysis was performed on prospectively collected data extracted from the Australasian Vascular Audit between 2010 and 2017. Annual caseload volume was analyzed in quintiles (Q) using multivariate regression to assess its impact on perioperative S/D. Carotid endarterectomy procedures (n = 16 765) demonstrated higher S/D rates for lower-volume operators (2.21% for Q1-Q3 [1-17 annual cases] vs 1.76% for Q4-Q5 [18-61 annual cases]; odds ratio [OR]: 1.28; 95% CI: 1.001-1.64; = .049). Carotid artery stenting procedures (n = 1350) also demonstrated higher S/D rates for lower-volume operators (2.63% for Q1-Q3 [1-11 annual cases] vs 0.37% for Q4-Q5 [12-31 annual cases]; OR: 6.11; 95% CI: 1.27-29.33; = .024). No significant hospital volume-outcome effect was observed for either procedure. An inverse relationship was demonstrated between operator volume and perioperative S/D rates following CEA and CAS. Consideration of minimum operator thresholds, restructuring of services and networked referral pathways of care in Australia and New Zealand, would likely result in improved patient outcomes.
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http://dx.doi.org/10.1177/0003319721991717DOI Listing
February 2021

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data.

Vasc Med 2021 Apr 28;26(2):195-199. Epub 2021 Jan 28.

Department of Surgery, Northwest Clinics, Alkmaar, The Netherlands.

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.
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http://dx.doi.org/10.1177/1358863X20977907DOI Listing
April 2021

Safety and feasibility report on nonimplantable endovenous valve formation for the treatment of deep vein reflux.

J Vasc Surg Venous Lymphat Disord 2021 Jan 19. Epub 2021 Jan 19.

Department of Surgery, Prince of Wales Hospital and Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address:

Objective: Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study.

Methods: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale.

Results: Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days.

Conclusions: The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.
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http://dx.doi.org/10.1016/j.jvsv.2020.12.073DOI Listing
January 2021

A systematic review and meta-analysis of bioresorbable vascular scaffolds for below-the-knee arterial disease.

Int Angiol 2021 Feb 21;40(1):42-51. Epub 2020 Oct 21.

Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands.

Introduction: Different types of bioresorbable vascular scaffolds (BVSs) have been developed and used in below-the-knee (BTK) arterial diseases. This is the first study reviewing and analyzing the literature on BVS treatment for BTK arterial disease.

Evidence Acquisition: MEDLINE, Embase, and Cochrane were searched for studies published until October 21, 2019. The search, study selection, quality assessment, and data extraction were performed by 2 authors independently. Articles that studied the treatment of BTK arterial disease by using BVSs were eligible. Exclusion criteria were studies with a variant design (e.g. case reports <5 patients), non-BTK indications for BVS use, and nonhuman studies. Primary endpoint was 12-month primary patency. Secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, and amputation-free survival (AFS). Study quality was assessed by the Methodological Index for Non-randomized Studies score.

Evidence Synthesis: Five studies representing 155 patients with 160 treated limbs met the inclusion criteria. Pooled 12-month primary patency per limb was 90% (143/160; 95% confidence interval [CI]: 0.84-0.95), freedom from CD-TLR 96% (124/130; 95% CI: 0.91-0.99), limb salvage rate 97% (156/160; 95% CI: 0.94-1.00), survival rate 90% (112/125; 95% CI: 0.82-0.96), and AFS rate 89% (110/125; 95% CI: 0.81-0.94). Subgroup analyses of included Absorb BVS studies showed similar results. All studies were assessed as moderate quality.

Conclusions: This meta-analysis of case series showed good 12-month patency and clinical results with BVSs for BTK arterial disease, even in patients with multimorbidity and short but complex lesions. These results encourage a revival of this scaffold.
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http://dx.doi.org/10.23736/S0392-9590.20.04462-4DOI Listing
February 2021

Long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries.

Catheter Cardiovasc Interv 2021 01 10;97(1):142-149. Epub 2020 Oct 10.

Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia.

Objectives: The aim of this study was to perform a long-term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries.

Methods: A prospective, single-arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018.

Results: Fifty-five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65-97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy-one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow-up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very-late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb-salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7-95.8), 90.8% (80.7-95.8), 79.7% (65.8-88.4), 76.3% (61.1-86.2), 72.3% (55.5-83.4) and 97.2% (89.2-99.3), 97.2% (89.2-99.3), 90.7% (78.7-96.1), 90.7% (78.7-96.1), and 90.7% (78.7-96.1), respectively.

Conclusions: This long-term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below-the-knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.
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http://dx.doi.org/10.1002/ccd.29327DOI Listing
January 2021

Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.

J Vasc Surg 2021 01 2;73(1):311-322. Epub 2020 Sep 2.

Department of Interventional Radiology, Auckland Hospital and University of Auckland School of Medicine, Auckland, New Zealand.

Background: Peripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis.

Methods: We review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe.

Results: Immediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use.

Conclusions: The available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs.
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http://dx.doi.org/10.1016/j.jvs.2020.07.093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076887PMC
January 2021

The Relationship Between Operative Volume and Peri-operative Mortality After Non-elective Aortic Aneurysm Repair in Australia.

Eur J Vasc Endovasc Surg 2020 Oct 2;60(4):519-530. Epub 2020 Jul 2.

Department of Surgery, Prince of Wales Hospital, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; The Vascular Institute, Prince of Wales Hospital, Sydney, Australia. Electronic address:

Objective: Hospital and surgeon operative caseload is thought to be associated with peri-operative mortality following the non-elective repair of aortic aneurysms; however, whether such an association exists within the Australian healthcare setting is unknown.

Methods: The Australasian Vascular Audit was interrogated to identify patients undergoing non-elective (emergency [EMG] or semi-urgent [URG]) aortic aneurysm repair between 2010 and 2016, as well as their treating surgeon and hospital. Hierarchal logistic regression modelling was used to assess the impact of caseload on outcomes after both endovascular (EVAR) and open surgical repair (OSR).

Results: Volume counts were determined from 14 262 patients (4 121 OSR and 10 141 EVAR). After exclusion of elective procedures and duplicates, 1 153 EVAR (570 EMG and 583 URG) and 1 245 OSR (946 EMG and 299 URG) non-elective cases remained for the analysis. Crude mortality was 24.0% following OSR (EMG 29.2%; URG 7.7%) and 7.5% following EVAR (EMG 12.6%; URG 2.4%). Univariable analysis demonstrated an association between OSR mortality and hospital volume (quintile [Q] 1: 25.3%, Q2: 27.8%, Q3: 23.9%, Q4: 27.0%, Q5: 16.2%; p = .030), but not surgeon (Q1: 25.2%, Q2: 27.4%, Q3: 26.0%, Q4: 21.4%, Q5: 19.5%, p = .32). Multivariable analysis confirmed this association (odds ratio (OR) [95% CI]; Q1 vs 5: 1.91 [1.13-3.21], Q2 vs. 5: 2.01[1.24-3.25], Q3 vs. 5: 1.41 [0.86-2.29], Q4 vs. 5: 1.92 [1.17-3.15]; p = .020). The difference was most pronounced in the EMG OSR group [Q1 - 3 vs. 4-5] (OR 1.63 [1.07-2.48]; p = .020). Mortality after EVAR was not associated with either hospital (Q1: 6.3%, Q2: 10%, Q3: 6.8%, Q4: 4.5%, Q5: 10%; p = .14) or surgeon volume (Q1: 9.3%, Q2: 5.7%, Q3: 8.1%, Q4: 7.0%, Q5: 7.3%; p = .67).

Conclusion: There is an inverse correlation between hospital volume and peri-operative mortality following EMG open repair of aortic aneurysm. These data support restructuring Australian pathways of care to direct suspected ruptured aneurysm to institutions that reach a minimum volume threshold.
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http://dx.doi.org/10.1016/j.ejvs.2020.04.029DOI Listing
October 2020

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy.

J Endovasc Ther 2020 08 17;27(4):547-564. Epub 2020 Jun 17.

Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA.

Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.
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http://dx.doi.org/10.1177/1526602820931488DOI Listing
August 2020

Kounis Syndrome after Angioplasty of the Superficial Femoral Artery with Paclitaxel-Coated Balloon.

Ann Vasc Surg 2020 Nov 17;69:450.e17-450.e22. Epub 2020 Jun 17.

Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia; The Vascular Institute, Prince of Wales Hospital, Sydney, New South Wales, Australia.

Drug-coated balloons are used widely as a form of endovascular treatment for peripheral arterial disease, to improve patency by reducing neointimal hyperplasia and restenosis. We present a rare case of acute coronary syndrome secondary to anaphylaxis after inflation of a paclitaxel-coated balloon used to treat a recurrent superficial femoral artery stenosis.
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http://dx.doi.org/10.1016/j.avsg.2020.06.010DOI Listing
November 2020

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry.

J Endovasc Ther 2020 Aug 29;27(4):616-622. Epub 2020 May 29.

Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands.

To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (rug mpregnated Bioresorbable tent in sian opulation xtremity rterial evascularization) registry. A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.
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http://dx.doi.org/10.1177/1526602820922524DOI Listing
August 2020

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry.

J Endovasc Ther 2020 Oct 21;27(5):836-844. Epub 2020 May 21.

Division of Vascular and Endovascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.

Purpose: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR).

Materials And Methods: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups.

Results: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07).

Conclusion: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.
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http://dx.doi.org/10.1177/1526602820923827DOI Listing
October 2020

Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study.

J Endovasc Ther 2020 Aug 18;27(4):658-665. Epub 2020 May 18.

Vascular Service, Department of Surgery, Changi General Hospital, Singapore.

To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16-63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5-15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.
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http://dx.doi.org/10.1177/1526602820922179DOI Listing
August 2020

Re: 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.

J Vasc Interv Radiol 2020 06 4;31(6):1030-1032. Epub 2020 May 4.

Department of Surgery, Vascular Institute, Prince of Wales Hospital, University of New South Wales, Sydney, Australia.

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http://dx.doi.org/10.1016/j.jvir.2020.02.032DOI Listing
June 2020

Nitinol stent-assisted maturation of the dysfunctional cannulation zone in the immature arteriovenous fistula.

J Vasc Access 2020 Nov 24;21(6):908-916. Epub 2020 Mar 24.

Department of Vascular Surgery, Westmead Hospital, Westmead, NSW, Australia.

Introduction: The native arteriovenous fistula may remain immature despite adequate arterial inflow after formation. This may occur when the puncturable vein segment (cannulation zone) is too small to be reliably punctured, occluded or too deep under the skin for needle access. We performed stenting (stent-assisted maturation) of arteriovenous fistulas with an immature cannulation zone, allowing for a large subcutaneous channel which could then be immediately punctured for dialysis.

Methods: We performed a retrospective review of 49 patients (mean age was 58.7 ± 16.09 (12-83) years, mean arteriovenous fistula age of 162.6 ± 27.28 days) with end-stage renal failure who underwent balloon dilatation and bare-metal stent implantation (1.6 ± 0.67 (1-3) stents, median diameter and length of 8 (5-14) mm and 80 (40-150) mm, respectively) through their cannulation zone (forced maturation). Radiocephalic (35 arteriovenous fistulas), brachiocephalic (10 arteriovenous fistulas) and autogenous loop arteriovenous fistulas (4 arteriovenous fistulas) were included with 30 patients (61.2%) having an inadequate cannulation zone venous diameter, 9 patients (18.4%) having an absent cannulation zone and 10 patients (20.4%) having a patent cannulation zone deeper than 1 cm which was not reliably puncturable. The study was conducted over 9 years (January 2008-December 2016) with implantation of the SMART stent and Absolute Pro stent in 61.2% and 38.8%, respectively. Long-term outcomes including primary useable segmental and access circuit patency as well as assisted primary access circuit patency, rate of re-intervention, technical success and complications were analysed.

Results: At 6 months, 12 months and 4 years, respectively, cannulation zone primary patency was 84.4%, 74.4% and 56.1% and access circuit primary patency was 62.2%, 45.3% and 23.2%; however, assisted primary access circuit patency was 95.6%, 91.1% and 83.8%, achieved with an endovascular re-intervention rate of 0.53 procedures/year with only four thrombosed circuits occurring.

Discussion: Forced maturation using nitinol stents allows for long-term haemodialysis access with a low rate of re-intervention.
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http://dx.doi.org/10.1177/1129729820911787DOI Listing
November 2020

Long-term Results of 180 Consecutive Patients with Abdominal Aortic Aneurysm Treated with the Endurant Stent Graft System.

Ann Vasc Surg 2020 Aug 20;67:265-273. Epub 2020 Mar 20.

Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia; The Vascular Institute, Prince of Wales Hospital, Sydney, New South Wales, Australia.

Background: Registry studies have shown that the Endurant stent graft is associated with low rates of all-cause and aneurysm-related mortality when used for the endovascular treatment of abdominal aortic aneurysm (AAA). However, many were limited by length of follow-up and all had a proportion of patients lost to follow-up. The aim of this study is to report results from a large, real-world experience using Endurant, utilizing methods to ensure complete ascertainment of mortality.

Methods: This study describes a large, single vascular unit experience using the Endurant stent graft in consecutive patients treated between August 2008 and March 2019.

Results: One-hundred eighty patients (mean age 76.0 ± 8.6 years; 90% male) with mean AAA diameter of 57.5 ± 10.5 mm underwent endovascular aneurysm repair (EVAR). Technical success was achieved in all cases. At median follow-up of 55.0 months (interquartile range 29.8-79.0), 51 (28.3%) patients had died. Kaplan-Meier estimate of 5-year overall survival and freedom from aneurysm-related death was 71.6% and 99.4%, respectively. Lower survival rates were observed in patients who underwent EVAR at age ≥80 years (59.2% vs. 78.3%, P < 0.01) and with aneurysm diameter ≥70 mm (55.6% vs. 73.8%, P = 0.03). Thirteen endoleaks (7.2%; 4 type 1A, 2 type 1B, 7 type 2) were observed during follow-up (mean time from implantation 8.7 ± 4.2, range 1-52 months). Eleven patients (6.1%) required secondary intervention for limb occlusion (n = 7), endoleak (n = 3), and restenosis (n = 1). Patients treated within (n = 104; 57.8%) and outside (n = 76; 42.2%) the manufacturer's instructions for use (IFU) had similar rates of endoleak (7 [6.7%] vs. 6 [7.9%]; P = 0.76), secondary re-intervention (7 [6.7%] vs. 4 [5.3%]; P = 0.74) and overall-survival (72 [69.2%] vs. 55 [72.3%]; P = 0.46).

Conclusions: Results from this real-world study of consecutive patients treated for AAA using the Endurant stent graft demonstrate that it is safe and effective, with excellent long-term outcomes for anatomy that falls both inside and outside IFU recommendations.
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http://dx.doi.org/10.1016/j.avsg.2020.02.020DOI Listing
August 2020

Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

J Endovasc Ther 2020 04 18;27(2):175-185. Epub 2020 Feb 18.

Department of Surgery, Prince of Wales Hospital, Sydney, NSW, Australia.

Purpose: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI).

Materials And Methods: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI).

Results: The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45).

Conclusion: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
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http://dx.doi.org/10.1177/1526602820904783DOI Listing
April 2020

Use of Paclitaxel Eluting Stents in Arteriovenous Fistulas: A Pilot Study.

Vasc Specialist Int 2019 Dec 31;35(4):225-231. Epub 2019 Dec 31.

Department of Surgery, Prince of Wales Hospital, Australia.

Purpose: We report short-term patency outcomes of a proof of concept study conducted to determine the efficacy of drug-eluting stent (DES) for the treatment of arteriovenous fistula (AVF) stenosis in hemodialysis patients.

Materials And Methods: This is a single-center, retrospective observational study involving 10 patients with AVF dysfunction treated with DESs between January 2017 and December 2017. The primary outcome was AVF patency confirmed by sonographic and clinical assessment at 1 month and 6 to 9 months after treatment.

Results: A total of 12 DESs were deployed in 10 patients with dysfunctional AVF (radiocephalic: 7, brachiocephalic: 3). During the early follow up (mean: 28.6 days), primary access circuit and DES patency was 100%, with an average volume flow rate of 886.4 mL/min. Nine patients were available for short-term follow up (mean: 202.4 days; 1 unrelated death), with a mean volume flow rate of 1,048.9 mL/min. The primary DES patency was 7/9 (77.8%), and 3 patients required angioplasty at other parts of the circuit (primary access circuit patency: 4/9 [44.4%]). The assisted primary access circuit patency was 77.8%. In 2 patients, the ultrasound revealed that the DESs were thrombosed without any antecedent stenosis; they were salvaged with angioplasty. Both patients previously underwent 2 DESs implanted and recently stopped dual antiplatelet therapy. B-mode sonographic assessment at all timepoints showed minimal intimal ingrowth on the stent struts.

Conclusion: This study demonstrates acceptable short-term patency for DESs in the treatment of AVF stenosis. Dual antiplatelet therapy is probably mandatory in the short term.
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http://dx.doi.org/10.5758/vsi.2019.35.4.225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941774PMC
December 2019

Tracking geometric and hemodynamic alterations of an arteriovenous fistula through patient-specific modelling.

Comput Methods Programs Biomed 2020 Apr 12;186:105203. Epub 2019 Nov 12.

School of Mechanical and Manufacturing Engineering, University of New South Wales, Sydney, 2052, NSW, Australia. Electronic address:

Background And Objective: The use of patient-specific CFD modelling for arteriovenous fistulae (AVF) has shown great clinical potential for improving surveillance, yet the use of imaging modes such as MRI and CT for the 3D geometry acquisition presents high costs and exposure risks, preventing regular use. We have developed an ultrasound based procedure to bypass these limitations.

Methods: A scanning procedure and processing pipeline was developed specifically for CFD modelling of AVFs, using a freehand ultrasound setup combining B-mode scanning with 3D probe motion tracking. The scanning procedure involves sweeping along the vasculature to create a high density stack of B-mode frames containing the lumen geometry. This stack is converted into a continuous volume and transient flow waveforms are recorded at the boundaries, synchronised with ECG and automatically digitised, forming realistic boundary conditions for the CFD models. This is demonstrated on a diseased patient-specific AVF.

Results: The three scans obtained using this procedure varied in geometry and flow behaviour, with regions of disease located in the first two scans. The outcome of the second procedure seen in the third scan indicated successful restoration with no sites of disease and higher flow. The models gave insight into the lumenal changes in diameter for both the artery and vein segments, as well as characterising hemodynamic behaviours in both the diseased and restored states. Vascular segment resistances obtained from the CFD models indicate a significant reduction once disease was removed, resulting in much higher flows enabling the patient to resume dialysis.

Conclusion: The methodology described in this study allowed for a multifaceted analysis and high level tracking in terms of both geometry and flow behaviours for a patient case, demonstrating significant clinical utility and practicality, as well as enabling further research into vascular disease progression in AVFs through longitudinal analysis.
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http://dx.doi.org/10.1016/j.cmpb.2019.105203DOI Listing
April 2020

Dynamic Banding (DYBAND) Technique for Symptomatic High-Flow Fistulae.

Vasc Endovascular Surg 2020 Jan 10;54(1):5-11. Epub 2019 Sep 10.

Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia.

Introduction: High flow rates may develop in arteriovenous fistula (AVF), resulting in clinical syndromes of steal, aneurysmal fistula, or high-output cardiac failure. Various techniques with varying success have been advocated to treat this difficult problem. We present a hemodynamically validated novel banding technique.

Methods: We designed a computational fluid dynamic (CFD) model of the native high-flow AVF and tested various juxta-anastomotic venous diameters to determine the effect on AVF blood flow and pressure. We translated this principle in our banding technique, wherein adjustable banding was performed in conjunction with ultrasound-guided brachial artery flow measurement to determine the optimal band diameter. Polyurethane patch was used to fashion the adjustable band. Patient demographics, AVF flow parameters pre- and postintervention, operative intervention, and ultrasound follow-up data were collected prospectively.

Results: Our CFD testing demonstrated that the band diameter needed to achieve optimal distal blood pressure and preserve AVF flow depending on blood pressure, end capillary pressure, venous pressure, and vascular diameters. Five patients subsequently underwent dynamic banding of symptomatic high-flow AVF. Mean brachial artery blood flow rates pre- and postbanding were 2964 mL/min (confidence interval [CI]: 1487-4440 mL/min) and 1099 mL/min (CI: 571.7-1627 mL/min), respectively ( = .01). All patients had symptomatic improvement, and at a mean follow-up of 1 year, this benefit was sustained with no AVF thrombosis or loss.

Conclusion: Adjustable dynamic band using ultrasound-guided brachial artery flow shows promising results in producing accurate AVF blood flow reduction with sustained efficacy in the short term for patients with symptomatic high-flow AVF.
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http://dx.doi.org/10.1177/1538574419874934DOI Listing
January 2020

Mortality After Paclitaxel-Coated Device Use in Dialysis Access: A Systematic Review and Meta-Analysis.

J Endovasc Ther 2019 10 28;26(5):600-612. Epub 2019 Aug 28.

Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia.

To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). At the pooled mean follow-up of 13.5 months (median 12, range 6-24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; =0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.
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http://dx.doi.org/10.1177/1526602819872154DOI Listing
October 2019

Histopathology of Iliocaval Venous In-Stent Restenosis Treated With Directional Atherectomy.

J Endovasc Ther 2019 10 20;26(5):742-746. Epub 2019 Jun 20.

Department of Vascular Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia.

To report the use of directional atherectomy to treat venous in-stent restenosis (ISR) and subsequent histopathological analysis of retrieved intrastent tissue. A 55-year-old man presented with recurrent symptoms of venous congestion following iliofemoral stenting. The stents were found to be occluded on imaging. Directional atherectomy was used to recanalize the iliofemoral venous stents, which provided significant symptom relief. Tissue retrieved from within the stent demonstrated patterns of cellular components similar to arterial ISR. At 6-month follow-up, the stents remain patent, with no evidence of further ISR. Directional atherectomy is a potential treatment option for iliofemoral venous ISR. The pathological process of venous ISR demonstrates cellular changes similar to arterial ISR.
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http://dx.doi.org/10.1177/1526602819857240DOI Listing
October 2019

Paclitaxel and Mortality: The Dose Argument Is Critical.

J Endovasc Ther 2019 08 9;26(4):467-470. Epub 2019 Jun 9.

6 University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.

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http://dx.doi.org/10.1177/1526602819857241DOI Listing
August 2019

The current state of surgical bypass versus drug eluting stents for long femoropopliteal occlusive lesions.

J Cardiovasc Surg (Torino) 2019 Aug 2;60(4):450-455. Epub 2019 May 2.

Department of Surgery, Prince of Wales Hospital, Sydney, Australia -

Considerable advances have been made over the last decade in the management of patients with peripheral artery disease. Historically, endovascular treatment has been the accepted approach for short lesions and surgical bypass for long, complex femoropopliteal lesions. However, bypass surgery holds significant risk of mortality and morbidity for the patient. That toll includes prolonged hospitalization, as well as the potential for wound healing and systemic complications, all of which are intensified by the ageing population. Advances in endovascular devices, such as drug eluting stents present an alternative, minimally invasive treatment option which may more suitable for complex lesions in a high-risk population. The aim of this review is to discuss the current literature which addresses surgical bypass and drug eluting stents, particularly for the treatment of long, complex femoropopliteal disease.
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http://dx.doi.org/10.23736/S0021-9509.19.10984-6DOI Listing
August 2019

Interwoven Nitinol Stents to Treat Radiocephalic Anastomotic Arteriovenous Fistula Stenosis.

J Endovasc Ther 2019 06 11;26(3):394-401. Epub 2019 Apr 11.

1 Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia.

Purpose: To determine the clinical outcomes in hemodialysis patients after implantation of a Supera stent to treat juxta-anastomotic stenosis in radiocephalic arteriovenous fistulas (AVF).

Materials And Methods: A single-center retrospective study was conducted of 42 consecutive patients (mean age 66.7 years, range 40-84; 26 men) who had a failing AVF due to juxta-anastomotic stenosis treated with the interwoven Supera stent between February 2014 and February 2018. A third of the patients had previous juxta-anastomotic intervention (either balloon angioplasty or open surgical revision).

Results: The stent was inserted successfully in all patients. Overall mean follow-up was 12.2±8.2 months (range 3.8-38.3). Juxta-anastomotic segment primary patency estimates at 6 and 12 months were 92.5% and 59.8%, respectively, with assisted primary patency rates of 97.5% and 92.9%. Reintervention (elective drug-coated balloon angioplasty) occurred at a rate of 0.31 procedures/year. Two AVFs thrombosed during the 1-year follow-up and were revascularized using balloon angioplasty. Ultrasound measurements of brachial artery flow rates increased significantly from 543.5±96.72 mL/min (range 430-644) before intervention to 919.2±355.9 mL/min (range 200-1600) after intervention (p=0.047). Arterial pressures on hemodialysis improved from -142.3±24.9 mm Hg (range -100 to -180) to -123.4±21.9 mm Hg (range -100 to -184; p=0.051). No AVFs were lost or abandoned during the follow-up period.

Conclusion: The interwoven Supera stent is a promising treatment for failing AVFs with juxta-anastomotic stenosis. Encouraging 1-year primary and assisted primary patency was demonstrated, with a low reintervention rate. This treatment facilitates long-term maintenance of AVF vascular accesses.
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http://dx.doi.org/10.1177/1526602819842851DOI Listing
June 2019
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