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Monika Herten,1 Giovanni B Torsello,1,2 Eva Schönefeld,3 Stefan Stahlhoff2 1Department of Vascular and Endovascular Surgery, University Hospital Münster, 2Department of Vascular Surgery, St Franziskus Hospital, Münster, 3Institute for Education and Student Affairs, University Hospital Münster, Münster, Germany Abstract: Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs. Keywords: drug-coated balloon, critical limb ischemia, peripheral artery disease, restenosis, atherectomy, stent restenosis

Purpose: Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss and widely considered to be a contributing factor in early failure or later restenosis. The Serranator balloon has been designed to provide a controlled lumen gain while minimizing vessel injury. The objective of this study was to assess the ability to define and measure postangioplasty recoil in infrapopliteal arteries and to compare recoil after serration angioplasty and plain balloon angioplasty (POBA)., Methods: This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis., Results: This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Arterial recoil (>10%) occurred in 25% of Serranator-treated lesions versus 64% in POBA-treated lesions (p=0.02. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). There was no significant difference in technical success (100% for both), dissection rate between Serranator (5%) and POBA (5.2%)., Conclusions: Arterial recoil occurs after infrapopliteal angioplasty. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes., Clinical Impact: Prior studies have demonstrated over 90% recoil in patients after balloon angioplasty (POBA) of the infrapopliteal vessels, which significantly impacts the durability and impact of endovascular interventions in this clinical space. This study compared recoil after infrapopliteal angioplasty with serration angioplasty and POBA. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: PAS is a consultant for Cagent, Boston Scientific, Medtronic, Philips, Silk Road, LimFlow, Surmodics, Abbott (DSMB). RG is the Chief Technical Officer and VP Clinical Research at Cagent and a Cagent Vascular stockholder. ML is a Cagent Vascular stockholder. The rest of authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: In patients with iliofemoral chronic venous disease (CVD) secondary to post-thrombotic or non-thrombotic obstruction, venous outflow obstruction after adequate anticoagulation alone is still frequent and post-thrombotic syndrome is a common complication. Thus, we aimed to evaluate mid-term effectiveness and safety of a novel braided venous stent for venous outflow obstruction treatment. Patients and methods: Consecutive patients who underwent venous recanalization with a new braided, closed cell, venous stent for non- or post-thrombotic CVD were eligible for inclusion in our retrospective, observational study. Effectiveness outcomes were primary patency and change in the revised venous clinical severity score (rVCSS) and the clinical score of the comprehensive classification system for chronic venous disease (CEAP) at 6- and 12-month follow-up. Safety outcomes were recurrent DVT, clinically driven target vein revascularization, index limb major amputation, or death. Results: A total of 67 participants (50.7% female, aged 46.7±18.1 years) who underwent blueflow Venous Stent implantation between February 2018 and March 2019 were enrolled. Primary patency of the target segment was present in 91.7% (95%CI: 76.8-97.7) of participants at the 6-month examination and in 79.8% (95%CI: 66.4-93.2) at the 12-month examination. Twelve-month primary patency was 91.7% (95%CI: 76.0-100) in non-thrombotic, and 72.6% (95%CI: 53.9-91.3) in postthrombotic disease (log-rank p=0.14). Median rVCSS improved from 8 (interquartile range [IQR]: 9-7) at baseline to 4 (IQR: 6.3-2.8) at 12 months (p<0.001) with a substantial clinical improvement of ≥2 points in 86.1% (31 of 36 participants). No significant association of rVCSS improvement with thrombotic pathogenesis could be found. Median clinical CEAP score improved from 3 (IQR: 3-3) to 2 (IQR: 3-2), p>0.001. No safety signal occurred. Conclusions: blueflow Venous Stent implantation for the treatment of iliofemoral CVD was associated with promising patency and favorable clinical improvement over the mid-term.

Background : Endovascular venous stenting with dedicated venous stents for the treatment of chronic venous outflow obstruction is developing as efficacious alternative to conservative therapy or open surgery. However, so far, mid- and long-term evidence on effectiveness and safety is poor. Patients and methods : The prospective, single-center, observational study enrolled consecutive patients with chronic non-thrombotic iliac vein lesions (NIVL) or post-thrombotic iliofemoral obstructions (PTO). From February 2016 to April 2017, patients underwent implantation of open cell, self-expandable dedicated venous stents. Short-term symptomatic improvement, patency, and complication rate were favorable. Evaluation at 2-years included improvement in the revised venous clinical severity score (rVCSS), patency, stent migration, major target limb events, clinically important pulmonary embolism, major bleeding, and all-cause mortality. Results : A total of 79 patients (57 ± 16 years, 44 female) were evaluated. At 2 years, rVCCS improved by 4.3 ± 2.7 (p < 0.001). Substantial clinical improvement of ≥ 2 score points was achieved in 86.4% (38 of 44) of patients. Improvement was not associated with thrombotic pathogenesis (regression coefficient [B] with PTO = 0.6 [95%CI: -1.1 to 2.3], p = 0.48). At 2 years, all ulcers (in 8 of 79 patients) were healed and none recurred. Two-year primary patency was 95.5% (95%CI: 86.5 to 98.5) with no difference between NIVL- and PTO-patients (log-rank p = 0.83). Target vessel revascularization was conducted in two PTO- and one NIVL-patients in the period of 34 days to 156 days from index procedure, resulting in a secondary patency of 100%. No stent migration, target limb deep vein thrombosis, major amputation, pulmonary embolism, or death occurred. Conclusions : Venovo venous open cell self-expanding stent implantation for chronic outflow obstruction was efficacious and provided a sufficient level of safety throughout 2 years.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I 2  = 68.4 %], PMT 96 %, [I 2 [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I bet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I 2  = 15.6 %] versus 94 %; Q bet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I 2  = 0 %] versus 1.0 % [I 2  = 0 %]; Q bet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I 2  = 56 %] versus 91.3 % [I 2  = 91.7 %]; Q bet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Q bet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Q bet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

Purpose: To assess the practical application and acute outcomes of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting. Materials and Methods: Fifty-one consecutive patients who underwent endovascular revascularization for symptomatic peripheral artery disease and experienced 63 dissections requiring treatment were included in the prospective, single-center, single-arm study between January and June 2019. Thirty-nine (76.5%) lesions were ≥10 cm in length, 33 (64.7%) were totally occluded, and 13 (25.5%) were severely calcified. Fifty-six (88.9%) dissections were classified as severe. Dissections were treated either by means of the 6-F above-the-knee (ATK) or the 4-F below-the-knee (BTK) Tack Endovascular System. Observational outcomes were conditions and scopes of application. Clinical outcomes were acute technical and procedural success as well as safety. Results: Lesions were revascularized with 2.3±0.8 attempts such as standard balloon angioplasty, drug-coated balloon angioplasty, atherectomy, and/or lithotripsy. The Endovascular System was applied in 60 (95.2%) of 63 dissections. All dissections of the femoral artery were treated with the ATK system, and all infrapopliteal dissections with the BTK system. Both systems were successfully applied in popliteal artery dissections. Dissection length predicted the number of Tack implants deployed. Technical success was achieved in 98.3% (59 of 60 dissections). No major adverse event or device-related complication occurred during the procedure. Conclusion: Acute results in effectiveness and safety of the Tack Endovascular System for infrainguinal dissection repair in a real-world setting are promising.

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery., Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR)., Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99)., Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

Background: Thrombogenicity and neointimal hyperplasia are major causes for synthetic vascular graft failure. Bioactive coatings like heparin have improved patency by reducing thrombogenicity, but neointimal hyperplasia still remains an unsolved problem. Surface coatings with heparan sulfate (HS), the major component of the glycocalyx of endothelial cells, have shown reduced platelet and cell adhesion in vitro. The aim of the study was to evaluate the in vivo surface properties of expanded ePTFE vascular grafts with a semisynthetic HS-like coating (SSHS)., Methods: ePTFE vascular grafts (n = 16, diameter 3.5 mm) covalently coated with SSHS were compared with uncoated grafts (n = 16) of the same diameter in a carotid interposition model in 16 sheep. The grafts were harvested at 20 wk for histological and morphometric analysis., Results: SSHS-coated grafts showed less neointima formation than uncoated grafts (P < 0.001). There was no evidence for cell or protein adhesion to SSHS-coated grafts, whereas the surface of uncoated ePTFE grafts was covered with a confluent circular layer of neointima. No difference was found concerning reactions at the anastomotic site of the genuine carotid vessel, both groups displayed neointimal hyperplasia., Conclusions: ePTFE grafts covalently coated with a semisynthetic SSHS-glycosaminoglycan successfully mimicked the endothelial glycocalyx. They displayed excellent antiadhesive properties preventing neointimal formation on the graft surface. The results indicate that a biomimetic SSHS coating may be a useful component of bioengineered grafts and an alternative to synthetic surfaces and endothelial seeding., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR)., Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Follow-up examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months., Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434)., Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR., (© The Author(s) 2015.)

Objective: Although drug-eluting balloons (DEBs) have shown promising results treating de novo (DN) atherosclerotic lesions and appear to have been widely adopted in Europe, their long-term efficacy in the broad spectrum of femoropopliteal restenosis (RE) remains to be proven. The purpose of the study was to assess the efficacy of paclitaxel-DEBs in restenotic (stented and nonstented) vs DN stenotic femoropopliteal arteries., Methods: The study prospectively enrolled 100 patients undergoing femoropopliteal endovascular intervention by DEB for RE or DN stenosis. Patients who received additive atherectomy were excluded. The primary end point was the primary patency (PP) rate at 12 months. Secondary end points were sustained clinical improvement and clinically driven target lesion revascularization., Results: DEBs were used to treat 105 limbs for intermittent claudication (82 [78%]) or critical limb ischemia (23 [22%]) in 100 patients. Of these, 111 lesions were DN stenosis (46 [41%]) or RE (65 [59%]). The overall PP was 86% at 6 months and 74% at 12 months. PP of DN stenosis was higher at 6 months (93% vs 81%) and was significantly (P = .021) better than RE at 12 months (85% vs 68%). Sustained clinical improvement based on Rutherford classification was significant in both groups (P < .001). Target lesion revascularization was significantly lower in DN stenosis compared with RE at 12 months (15% vs 32%; P = .021)., Conclusions: DEB angioplasty is an effective therapy for DN femoropopliteal lesions. The results of DEB angioplasty for RE are inferior compared with DN stenosis after 12 months. Nevertheless, results of DEB angioplasty for RE seem comparable with technically more demanding literature-derived strategies., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)