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Objective The optimal endovascular treatment for common iliac artery in stent re-stenosis has yet to be assessed. Treatment options include, among others, angioplasty alone and repeated stenting with covered stents. Methods This study retrospectively compared patency and target lesion revascularisation of these treatments. All patients who underwent endovascular treatment of common iliac artery in stent re-stenosis between 2007 and 2017 were included retrospectively. The primary end point was freedom from re-stenosis. Secondary endpoints were target lesion revascularisation rate (TLR) and freedom from occlusion during follow up. Results Seventy-four interventions were included, consisting of 37 angioplasties and 37 covered stent placements in 57 patients. Freedom from re-stenosis at four years was 72.6% (95% confidence interval [CI] 51.8% – 88.7%) in the covered stent group vs. 43.5% (95% CI 25.9% – 59.8%) in the percutaneous transluminal angioplasty (PTA) group (p = .003). The target lesion revascularisation (TLR) rate was 16.4% (95% CI 7.1% – 35.6%) and 43.6% (95% CI 28.0% – 63.2%) respectively (p = .020). There was no difference in freedom from occlusion; this was 90.8% (95% CI 73.9% – 97.0%) in the covered stent group and 79.1% (95% CI 58.4% – 90.3%) in the PTA group (p = .49). The difference in freedom from re-stenosis and TLR remained significant after sensitivity and multivariable analyses. Conclusion Covered stents offer better outcomes for common iliac artery in stent re-stenosis than angioplasty alone.

Background : Intra-operative image acquisition can be obtained indirectly (via verbal request to a technician) or directly (executed at the tableside, by a surgeon stepping on a foot pedal). Direct image acquisition could reduce the exposure time and thus the risk of radiation damage. The aim of this randomized controlled trial was to compare direct surgeon-controlled fluoroscopy with indirect technician-operated fluoroscopy during internal fixation of a hip fracture. Methods : From March 5, 2014 to August 19, 2015, 100 patients who had sustained a hip fracture that required internal fixation were enrolled. Patients were randomized between direct surgeon-controlled image acquisition using a foot pedal (n=52) and indirect image acquisition by a radiology technician (n=48). The primary outcome measure was the radiation exposure time; secondary outcome measures were the associated effective radiation dose and the dose area product. (DAP) Results : A total of 96 patients (with a median age of 84 years) were enrolled in this study. Eighty-nine (93%) patients had a pertrochanteric fracture. No statistically significant differences between direct image acquisition and indirect image acquisition were found for overall radiation time, total radiation dose or DAP for the total population. When adjusted for potential confounders, a difference in overall radiation time of 18.50 seconds (95% CI 2.19; 34.81, p=0.027) was found in favour of indirect image acquisition. Conclusion : This study showed statistically significantly lower radiation duration using indirect fluoroscopy for the total population and the pertrochanteric fracture subgroup when adjusted for several confounders. No significant effect on radiation dose and DAP was found.

Purpose: To evaluate the long-term results of remote iliac artery endarterectomy (RIAE) in 2 vascular referral centers and review existing literature. Methods: A retrospective analysis was conducted of 109 consecutive patients (mean age 64.2±10.7 years; 72 men) who underwent 113 RIAE procedures for lower limb ischemia from January 2004 to August 2015 at 2 vascular centers. The majority of limbs (82, 72.6%) had TASC II D lesions (31 TASC II C). Primary outcome measures were primary, assisted primary, and secondary patency. A comprehensive literature search was performed in the PubMed and EMBASE databases to identify all English-language studies published after 1990 reporting the results of RIAE. Results: Technical success was achieved in 95 (84.1%) of the 113 procedures. The complication rate was 13.7%, and 30-day mortality was 0%. At 5 years, primary patency was 78.2%, assisted primary patency was 83.4%, and secondary patency was 86.7%. Hemodynamic success was obtained in 91.7% of patients, and clinical improvement was observed in 95.2%. Freedom from major amputation was 94.7% at 5 years. The systematic review comprised 6 studies including 419 RIAEs, and pooled data showed results similar to the current study. Conclusion: For external iliac artery occlusions extending into the common femoral artery, RIAE appears to be a valuable hybrid treatment option. It combines acceptable morbidity and low mortality with good long-term patency. It has some advantages over an open surgical iliofemoral bypass or complete endovascular revascularization and could be the best treatment option in selected cases.

Purpose: To evaluate the efficacy, feasibility, and long-term outcomes of the Zenith ZBIS iliac branch device (IBD) to preserve internal iliac artery (IIA) perfusion in a large Dutch multicenter cohort. Methods: Between September 2004 and August 2015, 140 patients (mean age 70.9 +/- 7.4 years; 130 men) with 162 IBD implantations were identified in 7 vascular centers. The indication for IBD implantation was an abdominal aortic aneurysm > 55 mm with a concomitant common iliac artery (CIA) aneurysm > 20 mm (n=40), a CIA aneurysm with a diameter > 30 mm (n=89), or revision of a type Ib endoleak after endovascular aneurysm repair (n=11). Results: Technical success (aneurysm exclusion, no type I or III endoleak, and a patent IIA) was obtained in 157 (96.9%) of 162 IBD implantations. Six (4.3%) patients developed major complications; 2 (1.4%) died. Mean follow-up was 26.6 +/- 24.1 months, during which 17 (12.1%) IBD-associated secondary interventions were performed. Including technical failures and intentional IIA embolizations, 15 (9.3%) IIA branch occlusions were identified; buttock claudication developed in 6 of these patients. The freedom from secondary intervention estimate was 75.9% (95% confidence interval 59.7 to 86.3) at 5 years. Conclusion: CIA aneurysms can be treated safely and effectively by IBDs with preservation of antegrade flow to the IIA. Secondary interventions are indicated in > 10% of patients during follow-up but can be performed endovascularly in most.

The optimal percutaneous treatment for femoropopliteal arterial occlusive disease has yet to be assessed. This systematic review and meta-analysis assessed the efficacy of drug-eluting balloons (DEBs) compared with uncoated balloons (UCBs) for the treatment of femoropopliteal arterial occlusive disease.We used Preferred Reporting Items for Systematic Reviews and Meta-Analysis Statement (PRISMA) standards to systematically search the electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for trials comparing DEBs vs UCBs in the femoropopliteal arteries. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. All data were systematically pooled, and meta-analysis was performed on binary restenosis, late lumen loss (LLL), target lesion revascularization (TLR), major amputation, mortality, and changes in the ankle-brachial index and the Rutherford-Baker classification.From 364 screened articles, we included nine trials, all of which had a low risk of bias. We found a significant reduction of binary restenosis at 6 months (14.3% vs 40.1%; P .0001), binary restenosis at 1 year (26.6% vs 47.4%; P = .008), LLL at 6 months (-0.80 mm; P .00001), TLR at 1 year (10.4% vs 26.9; P = .0008), and TLR at 2 years (13.8% vs 40.7%; P = .0003) after DEB angioplasty compared with UCB angioplasty. The difference in amputation rate and mortality was not significant. Definitions on changes in ankle-brachial index and Rutherford classifications were heterogeneous and, therefore, could not be pooled in sufficient numbers.Compared with UCB angioplasty, the use of DEBs increases the durability of the treatment effect in femoropopliteal arterial disease, expressed by a significant decrease of binary restenosis, LLL, and TLR at short-term and midterm follow-up.

Introduction During the past decade, endovascular treatment has become the treatment of choice for all types of aortoiliac occlusive disease, including TASC C and D lesions. Patency rates, however, are still below those of open surgical techniques. One propagated technique to improve patency rates is the use of covered stents. This review assessed the available literature on covered stents for aortoiliac occlusive disease. Evidence acquisition An extensive search was performed of the MEDLINE, Embase, and Cochrane databases. All studies reporting on covered stents, including stent grafts for endovascular aneurysm repair, were included. A systematic review and meta-analysis was performed. Evidence synthesis We identified 19 studies comprising 12 single-arm series, 6 retrospective series, and 1 randomized controlled trial. The meta-analysis did not show a significant difference in primary patency at 1, 2, and 3 to 5 years for covered stents compared with bare-metal stents (91.7% vs. 88.5%, 85.4% vs. 80.9%, and 80.7% vs. 72.0%, respectively). Several studies found a significant difference in TASC C and D lesions in favor of covered stents. Conclusions High-quality evidence supporting the use of covered stents for aortoiliac occlusive arterial disease is limited. The use of covered stents in TASC C and D lesions may improve patency rates. However, because the TASC classification is very heterogeneous, more research is needed to identify specifically which lesion characteristics might benefit most from covered stent placement.

Objective Direct revascularization (DR), according to the angiosome concept, provides direct blood flow to the site of tissue loss in patients with critical limb ischemia (CLI). DR may lead to improved outcomes; however, evidence for this is controversial. This systematic review and meta-analysis investigated the outcomes of surgical and endovascular DR compared with indirect revascularization (IR) in patients with CLI. Methods A systematic review was undertaken using the Cochrane Collaboration specified tool, and a meta-analysis was done according to the MOOSE (Meta-analysis of Observational Studies in Epidemiology) criteria. The electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched for studies of DR compared with IR in patients with CLI with tissue loss. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. When possible, data were systematically pooled, and a meta-analysis was performed for wound healing, major amputation, amputation-free survival, and overall survival. Results Of 306 screened abstracts, 19 cohort studies with 3932 patients were included. Nine scored 7 or higher on the Newcastle-Ottawa score. DR significantly improved wound healing (risk ratio [RR], 0.60; 95% confidence interval [CI], 0.51-0.71), major amputation (RR, 0.56; 95% CI, 0.47-0.67), and amputation-free survival rates (RR, 0.83; 95% CI, 0.69-1.00) compared with IR. This significance was lost in major amputation on sensitivity analysis for bypass studies. No significant difference was found in overall survival. In studies stratifying for collaterals, no differences between DR and IR were found in wound healing or major amputations in the presence of collaterals. Conclusions DR significantly improves wound healing and major amputation rates after endovascular treatment in patients with CLI, supporting the angiosome theory. In the presence of collaterals, outcomes after IR are similar to outcomes after DR. Alternatively, patients without collaterals may benefit even more from DR as a primary treatment strategy. The angiosome theory is less applicable in bypass surgery, because bypasses are generally anastomosed to the least affected artery, with runoff passing the ankle to maintain bypass patency.

Objective To describe the patency of percutaneous transluminal angioplasty (PTA) of autologous infrainguinal bypasses at risk. Methods This was a retrospective single-center cohort study of consecutive patients who underwent primary PTA of an infrainguinal autologous bypass at risk from January 2009 to December 2013. Duplex ultrasound surveillance was performed for at least 1 year after PTA. The primary study end point was the number of secondary interventions. Secondary end points were freedom from recurrent stenosis or bypass occlusion and the patency of the infrainguinal autologous bypass at 1 year after primary PTA. Results A total of 69 infrainguinal bypasses at risk in 69 patients were identified and treated with PTA. Technical success was achieved in 91%. The median follow-up was 17 months (range, 1-58 months). During follow-up, 30 bypasses (43%) remained free of significant stenosis or bypass occlusion, 29 bypasses (42%) developed recurrent stenosis, and 10 bypasses (14%) occluded. Rates of primary assisted, and secondary patency at 1 year were 84%, and 86%. Five (7%) major amputations were performed, all after bypass occlusion. Conclusions Secondary interventions after PTA of a bypass at risk are common. However, repeated secondary interventions of autologous infrainguinal bypasses at risk result in patency rates of more than 80% at 1 year.

Background Atherosclerosis of the iliac artery may result in a stenosis or occlusion, which is defined as iliac artery occlusive disease. A range of surgical and endovascular treatment options are available. Open surgical procedures have excellent patency rates but at the cost of substantial morbidity and mortality. Endovascular treatment has good safety and short-term efficacy with decreased morbidity, complications and costs compared with open surgical procedures. Both percutaneous transluminal angioplasty (PTA) and stenting are commonly used endovascular treatment options for iliac artery occlusive disease. A stenotic or occlusive lesion of the iliac artery can be treated successfully by PTA alone. If PTA alone is technically unsuccessful, additional stent placement is indicated. Alternatively, a stent could be placed primarily to treat an iliac artery stenosis or occlusion (primary stenting, PS). However, there is limited evidence to prove which endovascular treatment strategy is superior for stenotic and occlusive lesions of the iliac arteries. This is an update of the review first published in 2015. Objectives To assess the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. Search methods The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 24 September 2019. We also undertook reference checking and citation searching to identify additional studies. Selection criteria We included all randomised controlled trials (RCTs) comparing percutaneous transluminal angioplasty and primary stenting for iliac artery occlusive disease. We excluded quasi-randomised trials, case reports, case-control or cohort studies. We did not exclude studies based on the language of publication. Data collection and analysis Two authors independently selected suitable trials, extracted data, assessed trial quality and performed data analyses. When there was disagreement, consensus would be reached first by discussion between the two authors and, if needed, through consultation with a third author. We used GRADE criteria to assess the certainty of the evidence and presented the main results in a 'Summary of findings' table. The main outcomes of interest were technical success, complications, symptomatic improvement of peripheral arterial disease (PAD), patency, reinterventions, resolutions of symptoms and signs, and improvement in walking distance as reported by the patient. Main results We identified no new studies for this update. Previously, we identified two RCTs, with a combined total of 397 participants, as meeting the selection criteria. One study included mostly stenotic lesions (95%), whereas the second study included only iliac artery occlusions. Heterogeneity between these two studies meant it was not possible to pool the data. Both studies were of moderate methodological quality with some risk of bias relating to selective reporting and non-blinding of participants and personnel. Both studies occurred in the 1990s and techniques have since evolved. We assessed the overall certainty of the evidence to be low. We downgraded by two levels: one for risk of bias concerns and one for imprecision and indirectness. There was no evidence of a difference following percutaneous transluminal angioplasty (PTA) with selective stenting compared to primary stenting (PS) in technical success rates in either the study involving stenotic lesions (odds ratio (OR) 1.51, 95% confidence interval (CI) 0.77 to 2.99; 279 participants; low certainty evidence); or the study involving iliac artery occlusions (OR 2.95, 95% CI 0.12 to 73.90; 112 participants; low certainty evidence). In one trial, PTA of iliac artery occlusions resulted in a higher rate of major complications, especially distal embolisation (OR 4.50 95% CI 1.18 to 17.14; 1 study, 112 participants; low certainty evidence). Immediate complications were similar in the second study (OR 1.81, 95% CI 0.64 to 5.13; 1 study, 279 participants; low certainty evidence). Neither study reported on delayed complications. No evidence of a difference was seen in symptomatic improvement (OR 1.03, 95% CI 0.47 to 2.27; 1 study, 157 participants; low certainty evidence). The second study did not provide data but reported no differences. For the outcome of patency, no evidence of a difference was seen in the study involving iliac occlusion at two years (OR 1.60, 95% CI 0.34 to 7.44; 1 study, 57 participants; low certainty evidence); or the study involving stenotic lesions at two years (71.3% in the PS group versus 69.9% in the PTA group). Only one study reported on reintervention (six to eight years, OR 1.22, 95% CI 0.67 to 2.23; 1 study, 279 participants; low certainty evidence); and resolution of symptoms and signs (12 months, OR 1.14, 95% CI 0.65 to 2.00; 1 study, 219 participants; low certainty evidence), with no evidence of a difference detected in either outcome. Neither study reported on improvement in walking distance as reported by the patient. Authors' conclusions There is insufficient evidence to make general conclusions about the effects of percutaneous transluminal angioplasty versus primary stenting for stenotic and occlusive lesions of the iliac artery. Data from one study indicate that primary stenting in iliac artery occlusions may result in lower distal embolisation rates (low certainty evidence). The evidence in this review, based on two studies, was assessed as low certainty, with downgrading decisions based on limitations in risk of bias, imprecision and indirectness. More studies are required to strengthen our confidence in the results.

Background Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. Methods/Design This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included. The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment. The primary endpoint is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure-related parameters. Trial registration Dutch Trial Register, NTR3381.