Plain Balloon Angioplasty Research Articles

A Comparison of Clinical Outcomes Following Femoro-Popliteal Bypass or Plain Balloon Angioplasty with Selective Bare Metal Stenting in the Bypass Versus Angioplasty in Severe Ischaemia of the Limb (Basil) Trial

Introduction - The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-1) trial is the only randomised controlled trial (RCT) to have compared a bypass surgery (BS) first with a best endovascular treatment (BET) first revascularisation strategy for the treatment of chronic limb threatening ischaemia (CTLI) due to infra-inguinal disease. BASIL-1 found that, in patients who survived for more than 2 years, BS was associated with better amputation free (AFS) and overall (OS) survival. However, these data included patients undergoing femoro-popliteal (FP) and infra-popliteal (IP) procedures. The aim of the present study is to examine outcomes in the sub-group of BASIL-1 patients who underwent FP BS or plain balloon angioplasty (PBA) +/- bare metal stent (BMS) in order to build equipoise for the BASIL-3 trial which is randomising CLTI patients to FP PBA +/- BMS vs drug coated balloon (DCB) +/- BMS vs primary drug eluting stent (DES). Methods - Outcome data were obtained from prospectively gathered BASIL-1 case record forms. Differences between BS and PBA+/-BMS were compared using the t-test, chi-squared and Wilcoxon rank sum tests according to the distribution of data using SAS v9.4. Results - A total of 311 BASIL-1 patients were studied; 128 undergoing primary SB (89 VB, 39 SynB) and 183 primary PBA+/-BMS. PBA+/-BMS patients were older and more likely to be current smokers, and SB patients were more likely to have chronic obstructive pulmonary disease (COPD). Immediate technical success was significantly better for SB (98% vs. 81%, p<0.0001). Patients undergoing SB had a longer mean index hospital admission (16 vs. 8 days, p=0.0001). However, at 12 months patients in both groups had spent an equivalent mean number of days (n = 17) in hospital. All-cause 30-day mortality was not statistically different between the two groups, PBA+/-BMS patients underwent more re-interventions within the first 30-days (2% vs 7%, p=0.06). There was no significant difference in AFS (HR 1.18, p=0.4), OS (HR 1.14, p=0.5) or LS (HR 1.09, p=0.8) between SB and PBA+/-BMS. However, FF-MALE (HR 1.51, p=0.04) and FF-R (HR=1.68, p=0.02) were significantly better following SB. FF-MALE (71% vs 58% vs 56%, p=0.02) was significantly better following VB. Resolution of rest pain (HR=0.84, p=0.2) and wound healing at 3 years (HR=0.78, p= 0.2) were similar in the two groups. Conclusion - This BASIL subgroup analysis indicates that although amputation rates and overall survival are similar, primary SB, especially VB, resulted in significantly fewer MALE and re-interventions than PBA+/-BMS. So, although an endovascular first revascularisation strategy may be a less resource intensive and morbid option in the short term, this appears unlikely to be the case in the long-term. Present data add further weight to the argument that, where possible, most patients presenting with CLTI due to FP disease should be offered VB as their primary revascularisation procedure where suitable autogenous conduit is available.

A Novel Epigenetic Drug-Eluting Balloon Angioplasty Device: Evaluation in a Large Animal Model of Neointimal Hyperplasia

Drug-eluting balloon catheters (DEBc) coated with paclitaxel (PTX) have been associated with potential safety concerns. An efficacious but less toxic balloon coating may reduce these outcomes. We evaluated a novel DEBc, Epi-Solve, coated with metacept-3 (MCT-3), a member of the histone deacetylase inhibitor (HDACi) class of epigenetic agents, in a large animal model of neointimal hyperplasia (NIH). Plain balloon angioplasty (PABA) catheters were ultrasonically coated with MCT-3 to generate Epi-Solve DEBc. An ovine model of NIH formation was established utilising partial left common carotid artery (LCA) ligation. Twenty-eight days post neointima (NI) induction, PABA, Epi-Solve or PTX-coated DEBc were deployed at the site of induced NI formation. Twenty-eight days post-intervention, ligated vessels were evaluated for attenuation of NI formation, gene expression profiles and immunohistochemical analysis. Epi-Solve DEBc demonstrated attenuation of NIH over no intervention and a trend to inhibition of NIH over PABA. Gene expression analysis and immunohistochemical studies identified significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA. Epi-Solve is a novel HDACi-coated DEBc which demonstrates significant anti-proliferative and anti-inflammatory signatures and reduced vascular endothelial cell activation compared to PABA in an ovine model and may afford endothelial protection.

Clinical Case of Successful Endovascular Treatment of Obstructive Post-thrombotic Syndrome in the Lower Extremity With Plain Balloon Angioplasty as a Standalone Method

Clinical Case of Successful Endovascular Treatment of Obstructive Post-thrombotic Syndrome in the Lower Extremity With Plain Balloon Angioplasty as a Standalone Method

Balloon Angioplasty Versus Stenting for the Treatment of Failing Arteriovenous Grafts: A Meta-Analysis

Introduction - to assess the outcomes of plain balloon angioplasty versus stenting for the treatment of failed or malfunctioning haemodialysis arteriovenous grafts (AVGs) for chronic haemodialysis. Methods - A systematic search of the literature was undertaken using PUBMED, EMBASE and Cochrane databases from January 2000 to September 2016 for articles comparing balloon angioplasty versus stenting in the management of failed or malfunctioning haemodialysis AVGs. Results are reported as the odds ratio (OR) and 95% confidence interval (CI). Results - The search identified eight studies (1051 patients). Balloon angioplasty alone was used in 521 patients (49.6%) and stenting in 530 patients (50.4%). At the time of the endovascular re-intervention, the mean life of AVGs was 807.7±115.4 days for the balloon angioplasty and 714.2±96.3 days for the stenting group (p=0.92). All AVGs were located in the arm. Most procedures (98.1%) were performed across the venous anastomosis, while 88% of the patients in the stenting group received a stent-graft. The technical success rate was significantly higher in the stenting group (OR 0.16, 95% CI 0.08 to 0.31, p<0.001). At 12 months, loss of primary and secondary patency was significantly higher in patients undergoing plain balloon angioplasty compared to stenting, (OR 3.54, 95% CI 2.18 to 5.74, p<0.001) and (OR 1.82, 95% 1.17 to 2.82, p=0.008), respectively. Conclusion - Stenting is associated with better technical success and patency rates compared to plain angioplasty in treating failed or malfunctioning haemodialysis AVGs and thus it should be considered as the therapeutic strategy of choice.

IVUS Directed Stent Placement Decision in a Hybrid Procedure for Lower Limb Revascularization. is Angiography Enough?

Introduction: The decision of wether to implant a stent or not after endovascuar angioplasty of the Superficia femoral artery (SFA) is clasically based on arteriographic control. Neverthless, the angiographical signs in which stent implatation indication is based are subjective and unccurate. Intravascular ultrasound (IVUS) is an intraopertive, readily availabel tool that can help to decide when angiography is unconclusive. We present a case report in which IVUS confirmed a postangioplasty dissection with critical residual stenosis inadvertent in angiography. Methods: A 56 year old male patient with Rutherford 5 lower limb ischemia underwent hybrid revascularization consisting in surgical endarterectomy of the common femoral artery and endoavascular treatment of the SFA and anterior tibial artery. A very calcified short lesion at the SFA was initially dilated with plain balloon angioplasty, without evident residual stenosis and good outflow in angiographic control, but with turbulent flow at the treated segment. IVUS confirmed critical residual stenosis secondary to intimal dissection, indicating stent implantation. Stent dimensions were decided based on measurements obtained with IVUS, which helped to identify the length and diameter of the dissected arterial segment. Complete expansion of the stent was also assesed by IVUS control. Results: The patient recovered pedal pulse immediatelly after the procedure. 3 Months after revascularization all whounds at the foot had healed, without rest pain and complete patency of all the arterial treated segments assesed by dupplex ultrasound. Conclusion: Angiographic control after angioplasty of complex lessions at the SFA is sometimes misleading, avoiding detection of local complicactions at the treated segment and jeopardizing short term patency results of endovascular procedures. IVUS provides crucial additional information when deciding whether or not to implant a stent, and could become an essential tool for these procedures in the future, even displacing arteriography as a the gold-standard for post-angioplasty control image.

Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study

ObjectivesThe aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery. BackgroundDissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes. MethodsTOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization. ResultsPatients’ mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life. ConclusionsTOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty.

Mid-Term Limb Salvage Following Plain Balloon Angioplasty for Severe Limb Ischaemia due to Infra-Popliteal Disease: A Comparison of the Basil Trial (1999-2004) with a Contemporary Series (2009-2013)

Introduction - Despite the only available level 1 evidence (from the UK NIHR HTA- funded BASIL-1 trial, B-1) showing superior outcomes from bypass, in recent years, there has been an increasing trend towards offering endovascular revascularisation (ER) to patients with severe limb ischaemia (SLI). This is frequently justified by asserting that the results of ER are likely to be significantly better now than when B-1 patients were treated. The aim of this study is to compare midterm clinical outcomes in patients undergoing IP ER in the B-1 (1999-2004) with those observed a decade later (2009-2013) in a contemporary series (CS) from an academic tertiary vascular unit.

LEA 38. Retrograde Use of the Outback Re-entry Catheter in Complex Infrainguinal Arterial Recanalization

The objective of this study was to demonstrate the efficacy and safety of the Outback (Cordis, Santa Clara, Calif) re-entry catheter in complex retrograde subintimal infrainguinal arterial recanalization for patients affected by critical limb ischemia. Between 2015 and 2019, the Outback re-entry catheter was used to re-enter the true lumen in 29 patients with critical limb ischemia who underwent retrograde superficial femoral artery, with or without popliteal artery subintimal recanalization, after failed guidewire and catheter-assisted re-entry. The retrograde access site was distal superficial femoral artery in 21 patients, proximal anterior tibial artery in 5 patients (Fig 1), and proximal peroneal artery in 3 patients. The re-entry target was common femoral artery in 27 patients, proximal superficial femoral artery in 1 patient, and proximal anterior tibial artery in 1 patient. Technical success was 89% (26/29). In all the successful cases, the re-entry was accurate (Fig 2), without damage to the profunda femoral artery. In 25 of 26 successful cases, the lesion was stented after plain balloon angioplasty. Supera (Abbott, Abbott Park, Ill) stent (with the proximal one always deployed from the retrograde access) was the most commonly used stent in 19 cases. The Outback was inserted through a 6F sheath in 13 cases and without any sheath in 16 cases (always when the retrograde access was at the level of below-knee vessels), passing the device over a 0.018-inch guidewire. In all cases, there were no significant complications correlated to the retrograde access. The use of the Outback re-entry catheter after complex retrograde subintimal infrainguinal recanalization has been demonstrated to be effective and safe. The possibility of passing it over a 0.018-inch guidewire gives the chance of doing it without inserting a sheath, reducing the size of the access and possible complications.Fig 2Precise re-entry obtained at the level of the short superficial femoral artery stump and at the anterior tibial origin in two different cases, with wire always eventually passed into the sheath coming from the antegrade access.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Turbo-Power™ Laser Atherectomy Combined with Drug-coated Balloon Angioplasty is Associated with Improved One-Year Outcomes for the Treatment of Tosaka II and III Femoropopliteal In-stent Restenosis

BackgroundFemoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device. MethodsThis was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test. ResultsThe overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™ + DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™ + DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™ + DCB group vs 58.9% in the LA + BA group (p = .070). ConclusionsTurbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

P4143IL-6 production in the vascular adventitia and adventitia-media-crosstalk in neointima formation

Abstract Background The aim of this study was to analyze the impact of the adventitial layer on vascular remodeling processes and to define the underlying cellular mechanisms. Methods and results Morphometric analysis of human coronary arteries and of murine femoral arteries at several times following vascular intervention revealed a significant correlation of neointimal and adventitial thickening (R2=0.6845, P&lt;0.001 for human samples; R2=0.6845, P&lt;0.001 for human samples. Immunohistochemical staining for the proliferation marker Ki-67 was performed 7, 14, and 21 days following injury of the murine femoral artery. Formation of a neointimal lesion at 21 days was preceded by high adventitial proliferation rates at 7 and 14 days (85.00±6.041 Ki67+adventitial cells vs. 5.118±0.633 Ki-67+neointimal cells at 7d, P&lt;0.0014; 28.80±5.240 Ki-67+adv. cells vs. 19.40±2.468 Ki-67+neoint. cells at 14d, P&lt;0.006, n=17). Complete removal of the adventitial layer prevented neointima formation, attributing pivotal importance to the adventitial layer (luminal stenosis: 71.73±3.77% vs. 7.44±1.71%, n=5, P&lt;0.0001). Re-transplantation of the aortic adventitia of ubiquitously GFP expressing C57BL/6-Tg (CAG-EGFP)1Osb/Jmice around the medial vascular layer of the femoral artery where the native adventitia has been removed completely restored neointima formation. Importantly, only very view GFP+cells were present in the neointimal layer, indicating that a direct contribution of adventitial cells to the neointimal lesion represents an extremely rare event. To investigate a potential paracrine effect of the activated adventitial layer, we explanted adventitial transplants 14 days following injury and transplantation and incubated the respective samples in serum-free media for 24 hours. BrdU incorporation assays and scratch wound assays revealed significantly increased proliferation and migration rates of human coronary artery SMCs in response to the supernatant of adventitial transplants compared to the supernatant of control samples. Further secretome analyses of the same adventitial supernatants identified predominantly interleukin (IL)-6 to trigger SMC proliferation and migration. Accordingly, serum-free media incubated with adventitial grafts of IL-6−/− mice prevented SMC proliferation and migration. Transplantation of the adventitia of IL-6−/− mice into C57BL/6J wild type mice was not sufficient to trigger neointima formation. Plain old balloon angioplasty, bare metal stent implantation, or drug-eluting stent implantation in swine coronary arteries and analysis for Ki-67+ cell counts supported the hypothesis in the large animal model and a more clinical setting. Conclusion Acute vascular injury is followed by an expansion of cytokine-producing adventitial cells, whose paracrine function and especially whose release of IL-6 is essential for the subsequent induction of the proliferation and migration of local SMC and thus for neointima formation.

Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries

ObjectiveDrug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease. MethodsWe queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies. ResultsOf 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P < .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%). ConclusionsThere has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES.

A Comparison of Clinical Outcomes Following Femoropopliteal Bypass or Plain Balloon Angioplasty with Selective Bare Metal Stenting in the Bypass Versus Angioplasty in Severe Ischaemia of the Limb (BASIL) Trial

To compare outcomes in patients with chronic limb threatening ischaemia (CLTI) due to femoropopliteal (FP), with or without infrapopliteal (IP), disease who underwent FP (vein or synthetic) open surgical bypass (OSB), or plain balloon angioplasty (PBA), with or without bare metal stenting (BMS), in the Bypass versus Angioplasty in Severe Ischaemia of the Limb (BASIL-1) trial. Data were extracted from BASIL-1 case record forms. Outcomes reported include immediate technical success, freedom from major adverse limb events (FF-MALE) and further re-intervention (FF-R), amputation free survival (AFS), overall survival (OS), and limb salvage (LS). Patients underwent primary OSB (n = 128; 89 vein, 39 synthetic) or primary PBA (n = 183; six had BMS). Mean follow up was 46.2 and 43.6 months respectively. Patients were well matched at baseline except that PBA ± BMS patients were significantly more likely to be current smokers. There was no difference in overall or IP (runoff) Bollinger angiogram scores between groups. Immediate technical success was significantly higher for OSB (98% vs. 81%; p < .001). OSB was associated with a longer mean index hospital admission (p = .001), but there was no difference in hospital days at 12 months. FF-MALE (hazard ratio [HR] 1.51; p = .04) and FF-R (HR 1.68; p = .02) but not AFS (HR 1.18; p = .4), OS (HR 1.14; p = .5), and LS (HR 1.09; p = .8) were significantly better after OSB. Although AFS, OS, and LS were similar in the two groups, OSB was associated with significantly fewer MALE and re-interventions. So, while PBA ± BMS may be a less resource intensive (expensive) and morbid option in the short term, this appears unlikely to be the case in the longer term. Present data add further weight to the argument that, where possible, patients presenting with CLTI due to FP disease should be offered OSB as their primary revascularisation procedure.

Low-Dose Paclitaxel-Coated Balloon Angioplasty versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 6-Month Results in a Tertiary Care Hospital of Central India

Abstract Introduction Superficial femoral and popliteal arteries are the most common locations of peripheral vascular disease (PVD). Endovascular interventional therapy including drug-coated balloon (DEB) angioplasty or percutaneous transluminal angioplasty (PTA) and stenting are important options for treatment of PVD. Aims and Objectives The main objective is to compare the efficacy of DEB over PTA with optional stenting in management of obstructive femoropopliteal lesions in terms of 6-month patency rate. Materials and Methods The clinical experimental study was carried out in a tertiary care center over duration of 2 years. All symptomatic patients having lower limb PVD in femoropopliteal segment were included. Total 37 patients were included in this study in which 16 underwent plain balloon angioplasty (with 3 patients undergoing bare metal stenting [BMS]) and 21 additional underwent DEB angioplasty. Patients with previously intervened lesions, primary lesion failure, major ischemic tissue loss, poor aortoiliac or common femoral inflow, or end-stage kidney disorders were excluded. Result At 1-month follow-up, patency rates in DEB and conventional PTA ± BMS were 85.71% and 87.5%, respectively. On 6-month follow-up, patency rates were found to be 71.4% versus 37.5%, respectively (p = 0.039; significant). In case of occluded lesions, on 6-month follow-up, patency rate in DEB group was higher than that in plain balloon group (66.7% vs. 25%). In both the cohorts, success rate, i.e., patency rates were more in short and intermediate length lesions than long segment lesions. DEB was found to be superior to plain angioplasty with optional stenting in terms of 6-month patency rate.

One-stage hybrid management of patients with critical limb ischemia due to complex multilevel arterial occlusions

Aim To evaluate the safety and efficacy of one-stage hybrid revascularization modality in patients with complex multifocal arterial occlusive lesions. Patients and methods A prospective study design was established. Included patients were those admitted to the Vascular and Endovascular Surgery Department between November 2015 and November 2016 and presenting with Rutherford stages 5 and 6 critical limb ischemia due to multilevel arterial occlusion involving common femoral artery and one or both of inflow (iliac) and outflow arteries (superficial femoral and leg arteries) with nonsignificant aortic lesions and underwent a one-stage hybrid revascularization procedure aiming limb salvage. Common femoral artery endarterectomy was a fixed step in all cases. For inflow lesions; plain balloon angioplasty with bare metal stenting was first attempted then a femoro-femoral bypass if failed the endovascular approach. For outflow lesions, plain balloon angioplasty with selective stenting was tried in all cases and to stop if failed provided the presence of sufficient profunda flow. The study end points were 1-year primary patency, secondary patency, limb salvage, and complication rates. Results This study included 30 patients (30 limbs), with a mean age of 65±10.28 years. Technical success was achieved in 46 (95.8%) of 48 performed procedures and hemodynamic or clinical success in all patients (100%). Twelve-month primary and secondary patency rates were 67 and 80%, respectively. One-year limb salvage rate was 93.3%. Postoperative complications were reported in four (13.3%) cases. Conclusion One-stage hybrid procedures may be considered a safe and effective modality in the treatment of patients with critical limb ischemia due to multilevel complex arterial occlusions.

Is vessel prep necessary before treating the superficial femoral artery?

The standard of care for treating symptomatic peripheral arterial disease has been percutaneous transluminal angioplasty with or without stenting over the last couple of years. This endovascular treatment of claudicants or patients with critical limb ischemia has increased in numbers and has even surpassed open surgery. Our daily practice has evolved to an endovascular-first approach, especially in the femoropopliteal region, being the most frequently treated vessel. However, neointimal hyperplasia and elastic recoil leading to target lesion restenosis or occlusion after initial successful treatment is not uncommon. In recent years, drug-eluting technologies on balloons or stents have been investigated as a potential solution for this problem with excellent results compared to plain-old balloon angioplasty. Nonetheless in the majority of those trials, the bailout stenting rate increased with lesion complexity, albeit it in long or heavily calcified lesions due to flow-limiting dissections, elastic recoil or the calcium barrier preventing adequate drug uptake. There is a need for vessel preparation in order to ameliorate drug delivery, especially in complex lesions. Multiple devices are available to prepare even the most challenging lesions for drug uptake or stenting, by achieving maximal luminal gain and by minimizing dissections. This review aims to give an overview of the most common modalities for vessel preparation in the superficial femoral artery beside plain old balloon angioplasty together with an overview of the current literature of each device in the superficial femoral artery.

Comparison of the efficacy of using paclitaxel-eluting balloon and plain balloon angioplasty for arteriovenous fistula in hemodialysis patients

Introduction: Arteriovanous (AV) access failure is one of the main problems in patients with end stage renal disease (ESRD), who receive hemodialysis. Balloon angioplasty is a favorable method for managing vascular access failure. The purpose of this study was to compare the six-month efficacy of paclitaxel-eluting balloon and plain balloon angioplasty in failed AV access cases among hemodialysis patients.&#x0D; Methods: In this quasi-experimental study (http://en.irct.ir/trial/35333), 50 hemodialysis patients with failure of AV access (stenosis &gt; 50%), who were candidates for angioplasty, were included. They were divided to receive either paclitaxel-eluting balloon (25 patients) or plain balloon (25 patients) angioplasty. Patients were followed up for six months with color Doppler ultrasonography and clinical examination for the hemodynamic success rate of angioplasty.&#x0D; Results: After six months, 19 patients (76%) in paclitaxel-eluting balloon angioplasty group achieved hemodynamic success, which was significantly higher than plain balloon angioplasty group (13 patients, 52%) (P = 0.012). Age, gender, diabetes mellitus, hypertension, and location of AVF (snuff box, forearm, and antecubital fossa) did not associate with hemodynamic success rate in any group.&#x0D; Conclusion: The use of angioplasty with paclitaxel-eluting balloon was superior to plain balloon angioplasty for failed AV access cases in hemodialysis patients. It is recommended to use paclitaxeleluting balloon angioplasty in patients with failure of AV access and requirement for balloon angioplasty.&#x0D;

RS01. Mortality After Paclitaxel-Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery

A recent meta-analysis of 4663 patients reported higher 2- and 5-year mortality in patients with femoral-popliteal artery occlusive disease treated with paclitaxel-coated balloons and stents compared with plain balloon angioplasty and bare metal stenting. Our aim was to compare mortality after similar treatments using a multicenter vascular registry. Patients (n = 6992) without prior peripheral vascular intervention undergoing endovascular treatment of superficial femoral-popliteal artery occlusive disease in the Vascular Quality Initiative (VQI) were studied from September 2016 to September 2017. All-cause mortality was compared between patients treated with nondrug-coated devices (n = 3905) versus paclitaxel-coated balloons and/or eluting stents (paclitaxel group; n = 3087). Mortality rates with hazard ratios (HR) and 95% confidence intervals (CI) were compared between unadjusted and propensity matched cohorts and illustrated by Kaplan-Meier analysis. Subgroup analysis was performed for intermittent claudication and critical limb ischemia (CLI). Mortality was higher in the nondrug group (13.4%) compared with the paclitaxel group (10.8%) in the unmatched cohorts (HR, 0.80; 95% CI, 0.69-0.93; P < .01). After 1:1 propensity matching the paclitaxel (n = 2440) and nondrug-coated device (n = 2440) groups were similar except for differences at the extremes of age and symptom status (CLI 54% vs 59% respectively; P < .01). Mortality was similar for the nondrug group (13.2%) and paclitaxel group (11.5%) after propensity matching (HR, 0.87; 95% CI, 0.73-1.04; P = .12) at a mean follow-up of 509 days (17 months; range, 0-813 days [0-27 months]). Subgroup analysis of patients with claudication showed no mortality difference in the matched cohorts; nondrug coated device (5.1%; n = 41/804) and paclitaxel (3.8%; n = 32/842; HR, 0.74; 95% CI, 0.46-1.17; P = .20). Subgroup analysis of patients with CLI showed no mortality difference in the matched cohorts; nondrug-coated device (18.9%; n = 191/1012) and paclitaxel (18.5%; n = 200/1081) groups (HR, 0.99; 95% CI, 0.81-1.20; P = .90). By Kaplan-Meier analysis mortality was similar in the paclitaxel versus nondrug device group (Fig). At a mean follow-up of 17 months, mortality is similar for patients with claudication and CLI after treatment of femoral-popliteal occlusive disease with paclitaxel coated and nondrug coated devices. Additional VQI analysis is planned for 2019 to assess for mortality differences at later time points. This work highlights the potential use of the VQI for surveillance of the safety of new peripheral arterial devices.

Paclitaxel-coated balloon in the treatment of recurrent dysfunctional arteriovenous access, real-world experience and longitudinal follow up.

Dysfunctional arteriovenous (AV) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis. This study was performed to evaluate the impact of paclitaxel-coated Balloon (PCB) on the patency of AV access with recurrent stenoses. We retrospectively studied haemodialysis patients who presented to our centre with recurrent AV access dysfunction and compared intervention-free patency using plain balloon versus PCB. A total of 147 patients were followed up longitudinally. Intervention-free patency was better following PCB compared to previous intervention using plain balloons (6.4 ± 5.8 versus 4.0 ± 3.7, P < 0.01). The 3- and 6-month patency rates after PCB were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, P < 0.01 and 42.9% versus 15.6%, P < 0.01 respectively. Kaplan-Meier survival analysis of circuit patency demonstrated the superiority of PCB over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (P < 0.01 and P = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with PCB (P < 0.01). Age of AV access and the number of previous interventions were found to be significant predictors of patency following PCB intervention. Arteriovenous access intervention with PCB was shown to be superior compared to plain balloon in the treatment of both non-thrombosed and thrombosed AV accesses in our multi-ethnic population.

Femoral-popliteal Arteriosclerosis Obliterans:Review of Evidence-based Studies on Drug-eluting Endovascular Treatment

Atherosclerosis-related diseases have increasingly become health concerns with the increased living conditions and aging.Globally,about 200 million people have suffered from arteriosclerosis obliterans(ASO),which can even be life-threatening in some cases.The past seven decades have witnessed the rapid advances in the treatment of ASO,which has developed from surgery to endovascular interventions including plain balloon angioplasty,bare metal stent placement,drug-coated balloon,and drug-eluting stent.However,the roles of these new techniques for femoral-popliteal lesions,especially their real-world clinical outcomes and indications,remain unclear.This article reviews the latest evidences on the use of drug-eluting devices in treating femoral-popliteal arteriosclerosis obliterans.

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives

An ageing population and the increasing prevalence of cardiovascular risk factors have aggravated the burden of peripheral artery disease (PAD). Despite advances in the pharmacological treatment of atherosclerosis, many patients with symptomatic PAD require invasive procedures to reduce the symptoms of claudication, salvage tissue and prevent amputation and subsequent disability in those with critical limb ischaemia. After significant advances in endovascular treatment over the past two decades, these techniques are widely accepted as first-choice treatment in the majority of patients with PAD. However, in patients with severely calcified lesions, standard endovascular treatment such as plain or drug-coated balloon (DCB) angioplasty may fail due to vessel recoil or severe dissection in the acute setting, and intimal hyperplasia in the long term. With the use of percutaneous plaque modification and debulking techniques based on atherectomy, such calcified lesions can be tackled more easily after removal or fragmentation of atherosclerotic plaque. More homogeneous balloon expansion at lower pressures can be achieved after atherectomy, which reduces barotrauma while allowing better drug delivery to the vessel wall during DCB angioplasty avoids the need for stent placement. There are four principal methods of direct atherectomy available at the present time: directional atherectomy, rotational atherectomy, orbital atherectomy and hybrid atherectomy. In this article, we provide a short overview of these techniques and the current evidence from clinical trials to support their use.