A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Tips and Tricks for Simple and Complex Below-the-Ankle Punctures.

CLINICAL IMPACT: When the standard endovascular crossing maneuvers have failed during CLTI recanalization procedures and the distal below-the-knee or proximal below-the-ankle retrograde access is not possible due to chronic occlusion of the vessels, mastering the more distal and complex retrograde BTA punctures may be advantageous.There are scanty reports regarding the retrograde puncture of the mid and forefoot vessels. The aim of this article is to review different tips and tricks related to these techniques to help operators to apply them in specific scenarios to eventually improve procedural success rate.

Digital variance angiography in patients undergoing lower limb arterial recanalization: cost-effectiveness analysis within the English healthcare setting.

Aim: Digital variance angiography (DVA) is a recently developed image processing method capable of improving image quality compared with the traditionally used digital subtraction angiography (DSA), among patients undergoing lower limb x-ray angiography. This study aims to explore the potential cost-effectiveness of DVA from an English National Health Service perspective. Materials & methods: A two-part economic model, consisting of a decision tree and a Markov model, was developed to consider the costs and health outcomes associated with the use of DVA as part of current practice imaging, compared with x-ray angiography using standard DSA. The model explored the impact of DVA on the development of acute kidney injury (AKI), chronic kidney disease and radiation-induced cancer over a lifetime horizon. Both deterministic and probabilistic analyses were performed to assess the cost per quality-adjusted life-year (QALY). Results: Base-case results indicate that DVA results in cost savings of £309 per patient, with QALYs also improving (+0.025) over a lifetime. As shown in sensitivity analysis, a key driver of model results is the relative risk (RR) reduction of contrast-associated acute kidney injury associated with use of DVA. The intervention also decreases the risk of carcinoma over a lifetime. Scenario analyses show that cost savings range from £310 to £553, with QALY gains ranging from 0.048 to 0.109 per patient. Conclusion: The use of DVA could result in a decrease in costs and an increase in QALYs over a lifetime, compared with existing imaging practice. The potential for this technology to offer an economically viable alternative to existing image processing methods, through a reduction in contrast media volume and radiation exposure, has been demonstrated.

Antegrade Crossing Techniques for Hard Proximal Occlusion Caps Without the Use of Dedicated Chronic Total Occlusion Devices: A Pictorial Review.

CLINICAL IMPACT: Infra-inguinal Chronic Total Occlusions recanalisation is considered technically challenging. The conventional manipulation of standard guidewires and catheters has proven to be successful in a considerable percentage of cases but success rate could dramatically drop in presence of challenging lesions. The additional use of retrograde access and re-entry devices could increase technical success but could negatively affect procedural time and overall costs. Twenty different techniques of Chronic Total Occlusions antegrade crossing are hereby described with appropriate schematic representations. The aim is to help operators to apply them in specific anatomy subsets and clinical presentations and ultimately to increase procedural success rate.

Optimal activated clotting time during peripheral artery endovascular procedures: cutting the gordian knot.

All endovascular procedures need an effective anticoagulation regimen that avoids thrombo-embolic complications due to the insertion and manipulation of various intravascular devices. Systemic heparinization reduces the risk of thrombosis but there is no conclusive evidence regarding the correct use of anticoagulant medications and accordant monitoring, especially in endovascular peripheral arterial procedures. Anticoagulation must be maintained during the whole vascular procedure, especially during partial or complete blood flow interruption. Reaching and maintaining the correct coagulative status is mandatory to avoid or reduce thromboembolic complications that could limit the procedure's effectiveness or be harmful to the patient. Patients' baseline variables and procedure-related elements can influence the way anticoagulation should be administered and how coagulative status has to be monitored. This review aimed to clarify the critical points of anticoagulation and monitoring management for non-cardiac arterial procedures in order to understand the best way to manage vascular procedures anticoagulation.

Possible use of Digital Variance Angiography in Liver Transarterial Chemoembolization: A Retrospective Observational Study.

PURPOSE: Digital variance angiography (DVA), a recently developed image processing technology, provided higher contrast-to-noise ratio (CNR) and better image quality (IQ) during lower limb interventions than digital subtraction angiography (DSA). Our aim was to investigate whether this quality improvement can be observed also during liver transarterial chemoembolization (TACE). MATERIALS AND METHODS: We retrospectively compared the CNR and IQ parameters of DSA and DVA images from 25 patients (65% male, mean ± SD age: 67.5 ± 11.2 years) underwent TACE intervention at our institute. CNR was calculated on 50 images. IQ of every image set was evaluated by 5 experts using 4-grade Likert scales. Both single image evaluation and paired image comparison were performed in a blinded and randomized manner. The diagnostic value was evaluated based on the possibility to identify lesions and feeding arteries. RESULTS: DVA provided significantly higher CNR (mean CNRDVA/CNRDSA was 1.33). DVA images received significantly higher individual Likert score (mean ± SEM 3.34 ± 0,08 vs. 2.89 ± 0.11, Wilcoxon signed-rank p < 0.001) and proved to be superior also in paired comparisons (median comparison score 1.60 [IQR:2.40], one sample Wilcoxon p < 0.001 compared to equal quality level). DSA could not detect lesion and feeding artery in 28 and 36% of cases, and allowed clear detection only in 22% and 16%, respectively. In contrast, DVA failed only in 8 and 18% and clearly revealed lesions and feeding arteries in 32 and 26%, respectively. CONCLUSION: In our study, DVA provided higher quality images and better diagnostic insight than DSA; therefore, DVA could represent a useful tool in liver TACE interventions. LEVEL OF EVIDENCE: III Non-consecutive study.

Target Balloon-Assisted Antegrade and Retrograde Use of Re-Entry Catheters in Complex Chronic Total Occlusions.

Purpose, Retrograde recanalizations have gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well described adjunct for antegrade recanalizations. We present our experience with target balloon-assisted antegrade and retrograde recanalizations using re-entry devices in challenging chronic total occlusions. MATERIALS AND METHODS: We report data from a retrospective multicenter registry. Eligibility criteria included either antegrade or retrograde use of the OutbackTM or GoBackTM re-entry catheter in combination with a balloon as a target to accomplish wire passage, when conventional antegrade and retrograde recanalization attempts had been unsuccessful. Procedural outcomes included technical success (defined as wire passage though the occlusion and delivery of adjunctive therapy with <30% residual stenosis at final angiogram), safety (periprocedural complications, e.g., bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from target lesion revascularization after 12-months follow-up). RESULTS: Thirty-six consecutive patients underwent target balloon-assisted recanalization attempts. Fourteen (39 %) patients had a history of open vascular surgery in the index limb. Fifteen patients were claudications (Rutherford Class 2 or 3, 21 presented with chronic limb threatening limb ischemia (Rutherford Class 4 to 6). The locations of the occlusive lesions were as follows: iliac arteries in 3 cases, femoropopliteal artery in 39 cases, and in below-the-knee arteries in 12 cases. In 15 cases, recanalization was attempted in multilevel occlusions. Retrograde access was attempted in 1 case in the common femoral artery, in the femoropopliteal segment in 10 cases, in below-the-knee arteries in 23 cases, and finally in 2 patients via the brachial artery. In 10 cases, the re-entry devices were inserted via the retrograde access site. Technical success was achieved in 34 (94 %) patients. There were 3 periprocedural complications, none directly related to the target balloon-assisted re-entry maneuver. Amputation-free survival was 87.8 % and freedom from clinically driven target lesion revascularization was 86.6 % after 12-months follow-up. CONCLUSION: Target balloon-assisted use of re-entry devices in chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

Re-entry catheters in subintimal lower limb recanalization: up to date.

In their daily practice, vascular specialists face the challenge of treating peripheral artery disease (PAD) of the lower limbs. During the last decade, there has been an increasing adoption of endovascular techniques worldwide and a simultaneous expansion of the endovascular instrument portfolio to improve technical results during PAD treatment. The proper use of dedicated endovascular devices is essential to achieve technical success. To know indication, mechanism of action, and possible complications of different devices is of paramount importance to achieve immediate procedural success in the shortest time possible and long-term patency of the treated vessels. All the re-entry catheters on the market are presented with their own unique characteristics. The pros and cons of the use of these devices is also discussed and compared to other possible recanalization strategies. The re-entry devices have been demonstrated to be effective in increasing the procedural success rate, in limiting the dissection of distal healthy vessel segments and shortening the procedural time. They should therefore be considered part of essential tools in the treatment of lower limb chronic total occlusions especially for clinicians who do not feel comfortable in performing retrograde access.

Removal of Partially Deployed Supera Stents: Case-Based Review and Technical Considerations.

PURPOSE: Maldeployment of the Supera stent system can result in primary technical failure, inferior primary patency, and poorer patient outcomes. The purpose of this article is to present a case series illustrating the conditions required to perform optimal stent deployment, and if necessary, undertake successful stent removal following maldeployment. TECHNIQUE: Two key failures of effective Supera deployment are elongation and invagination. Several technical factors should be considered to reduce the risk of maldeployment: aggressive target vessel predilation, the use of multiple fluoroscopic views, slow deployment with controlled forward pressure applied on the delivery device, "sandwich packing" of the stent above and below target lesions, and the "pulling back" of invagination. To successfully retrieve a partially deployed stent, 3 factors should be considered: the percentage of the stent already deployed, the distance from the distal tip of the introducing sheath to the proximal extent of the deployed stent, and the severity of proximal vessel disease. The higher these factors, the greater the risk of stent detachment and failed retrieval. CONCLUSION: In this series of 6 cases of maldeployment, the removal of a partially deployed Supera stent appeared to be feasible and safe, with success dependent on selected technical and anatomical considerations.

Retrograde use of the Outback re-entry catheter in complex infrainguinal arterial recanalizations.

OBJECTIVE/BACKGROUND: Retrograde recanalizations gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well-described adjunct for antegrade recanalizations. We present our experience with retrograde, infrainguinal recanalizations using the Outback re-entry catheter in challenging chronic total occlusions. METHODS: We report data from a retrospective multicenter registry in complex retrograde recanalizations. Eligibility criteria included retrograde infrainguinal use of the Outback re-entry catheter where both conventional antegrade and retrograde recanalizations had been unsuccessful. Procedural outcomes included technical success (defined as successful wire passage and delivery of adjunctive therapy with <30% residual stenosis), safety (periprocedural complications, eg, bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from clinically driven target lesion revascularization [cd-TLR]). RESULTS: Forty-five consecutive patients underwent retrograde, infrainguinal recanalization attempts with the Outback re-entry catheter between February 2015 and August 2020. Thirty (67%) patients had a history of open vascular surgery in the index limb. In four patients, recanalizations were even more challenging due to previous surgical removal and/or ligation of the proximal segment of the superficial femoral artery. The retrograde access site of the Outback catheter was the femoropopliteal segment in 31 (69%) patients and crural vessels in 14 (31%) patients. The re-entry target sites were as follows: common femoral artery in 31 (69%) patients, superficial femoral artery in 9 (20%) patients, popliteal artery in 1 patient, and below-the-knee arteries in 2 patients. In four patients, the needle of the re-entry device was targeted to an inflated balloon, inserted via the antegrade route. The Outback re-entry catheter was placed via a 6-French sheath in 19 (42%) cases and sheathless in 26 (58%) cases. Technical success was achieved in 41 (91%) patients There were two instances of distal embolizations and three bleeding episodes. Amputation-free survival was 100% at 30 days, and after 12 months, freedom from cd-TLR was 95% at 30 days and 75% at 12 months of follow-up. Female sex was an independent predictor for cd-TLR at 12 months of follow-up. CONCLUSIONS: Retrograde use of the Outback re-entry catheter in infrainguinal chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study.

OBJECTIVE: This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). MATERIALS AND METHODS: Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. RESULTS: A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4-6) and 52% with IC (Rutherford 1-3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42-90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1-91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). CONCLUSION: Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.

Distal Re-Entry to Treat Lower Limb Chronic Total Occlusions Using a Novel Electrically Guided Re-Entry Catheter.

INTRODUCTION: Endovascular treatment of challenging infra-inguinal peripheral vascular disease is increasingly common because of new techniques and improved tools. The use of a novel electrically guided 5 F re-entry catheter is presented. By emitting a minute electrical field, detected by a target wire inserted from an opposing access, the catheter's orientation is accurately displayed to the operator, allowing precise re-entry without the need for fluoroscopic alignment. REPORT: An 84 year old man with tissue loss was treated for a long occlusion of the superficial femoral artery and tibial vessels. Successful subintimal recanalisation was achieved with the help of the ePATH re-entry catheter, restoring inline flow to the foot. CONCLUSION: This re-entry catheter benefits from an intuitive alignment method, smaller profile, and operator adjustable needle travel, making it a versatile tool for endovascular cases.

A systematic review of the ipsilateral retrograde approach to the treatment of femoropopliteal arterial lesions.

OBJECTIVE: The endovascular treatment of femoropopliteal lesions is an integral part of managing peripheral arterial disease. The antegrade approach is the most widely used technique with good evidence for its safety and efficacy. However, crossing a lesion, particularly chronic total occlusions (CTO), can be technically challenging and so the retrograde approach is increasingly used to maximize the chances of procedural success. The objective of this systematic review was, therefore, to assess the safety and effectiveness of the ipsilateral retrograde approach to femoropopliteal lesions. METHODS: A systematic review conforming to the PRISMA standards was undertaken. MEDLINE, EMBASE, and The Cochrane Register were searched between January 1, 1988, and January 1, 2020. Full-text, English-language, peer-reviewed articles pertaining to peripheral arterial disease, endovascular intervention and access site were included. RESULTS: A total of 8599 articles were screened, of which 38, involving 1940 patients undergoing 2184 retrograde procedures, were included. The mean number of patients per study was 51.1, with three studies including fewer than 10 and four more than 100 patients. The reported follow-up ranged from 30 days to 3 years, and six articles did not report any long-term outcome data. A retrograde approach was used as the primary access route in 45.% of procedures (648/1438) with relevant data. Primary technical success was achieved in 88% (1920/2184; 64%-100%) with a reported complication rate of 11% (235/2117; 0%-27%). Overall, the quality of evidence was poor, with just seven articles deemed to be of high quality with a low risk of bias. A meta-analysis was not deemed appropriate owing to heterogeneity of data. CONCLUSIONS: An ipsilateral retrograde approach to femoropopliteal lesions has good primary technical success and a low rate of complications. It has a promising role as a bailout, or even a primary access technique, in complex lesions. Patient positioning, puncture site and technique, lesion anatomy, and the size of catheters and devices used are important considerations to achieve the best outcomes. There remains a paucity of robust evidence for its superiority over traditional antegrade approaches, and further work is required to identify the optimal technique and those patients who would benefit most from the approach.

Pledget Reinforcement and Tractional Compression as Adjunctive Techniques for Suture-Mediated Closure (SMC) in Percutaneous Endovascular Aneurysm Repair (pEVAR): A Retrospective Observational Cohort Study.

BACKGROUND: Percutaneous endovascular aneurysm repair (pEVAR) is commonly utilized and requires the use of suture-mediated closure (SMC) devices to ensure adequate femoral artery hemostasis. Despite the use of such devices, puncture-related complications remain relatively common. We introduced two new adjuncts (pledget reinforcement and tractional compression) along with SMC to reduce such puncture-related complications. The aim of the study was to assess the efficacy and safety of the new adjunct techniques. METHODS: This retrospective observational cohort study examines the impact of two adjunctive techniques on puncture-related complications compared with the previous year data before this new introduction of adjunct techniques. RESULTS: Sixty-one percutaneous femoral punctures (in 31 patients) utilizing adjunct techniques for closure (the adjunct group) were retrospectively compared with 89 punctures (in 46 patients) closed with standard SMC technique (the standard group). The use of adjunctive techniques led to a significant reduction in overall puncture-related complications (3/61 (4.9%) vs. 20/89 (22.5%), P = 0.0106) and the need for emergent surgical repair after failed hemostasis (2/61 (3.3%) vs. 13/89 (14.6%), P = 0.037). CONCLUSIONS: These novel adjunctive techniques (pledget reinforcement and tractional compression) of SMC for pEVAR reduce puncture-related complications and increase the confidence to offer percutaneous techniques for more patients.

Carbon dioxide angiography during peripheral angioplasty procedures significantly reduces the risk of contrast-induced nephropathy in patients with chronic kidney disease.

BACKGROUND: Iodinated contrast media are amongst the most frequently prescribed medications, however, their use is not without complications. With contrast-induced nephropathy constituting a major concern, alternative non-iodine based approaches have been explored such as carbon dioxide angiography. The purpose of this study is to report the incidence of contrast-induced nephropathy following carbon dioxide angiography in patients with impaired renal function that underwent peripheral angioplasty compared with a historical cohort of patients that underwent angioplasty with use of solely iodine contrast medium. The historical cohort of patients treated with iodinated contrast was used as control. Baseline demographics and renal function tests were recorded. Primary outcome was incidence of contrast-induced nephropathy within 48-72 h post intervention. Receiver-Operating-Characteristic curve analysis was used to correlate the volume of iodinated contrast with the risk of contrast-induced nephropathy. RESULTS: Carbon Dioxide was used as an alternative to iodinated contrast media in patients with impaired renal function (eGFR<60mls/min/1.73 m2) undergoing peripheral angioplasty procedures. Fifty, consecutive patients (baseline eGFR = 38.6 ± 13.2mls/min/1.73 m2) were included in a prospective clinical audit. These were matched (1:2) with a historical cohort of patients (baseline eGFR = 43.3 ± 12.2mls/min/1.73 m2) treated with Iodinated contrast media. The incidence of contrast-induced nephropathy was 14% (n = 7/50) in case of carbon dioxide vs. 29% (n = 29/100) in the matched cohort group (p = 0.045). Receiver-Operating-Characteristic analysis showed that use of >25mls of contrast was 94.4% (95% CI:81-99%) sensitive in predicting contrast-induced nephropathy. CONCLUSION: Carbon dioxide imaging during peripheral angioplasty procedures protects against contrast-induced nephropathy. Use of >25mls of iodinated contrast media in high-risk patients is a predictor of contrast-induced nephropathy.

Retrograde insertion of the outback reentry device from a tibial artery for complex infrainguinal recanalization.

INTRODUCTION: Recanalization in an antegrade fashion in complex infrainguinal arterial disease can prove challenging and use of the Outback re-entry device via a retrograde approach may be an option. CASE PRESENTATION: Using an antegrade approach we were unable to cross the native occluded superficial femoral artery in a patient after two occluded bypasses, with ulcers and was unfit for general anaesthesia. We successfully attempted retrograde re-entry using an Outback device via a phantom segment of the anterior tibial artery. After angioplasty and stenting a satisfactory result was achieved with one artery runoff. CONCLUSIONS: At the 24 months follow up reconstruction was patent and ulcers were healed after 4 months. The outcome of more cases will be decisive for the broader applicability of this technique.