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.

Technical Success, Midterm Primary Patency, and Factors Affecting Primary Patency of Subintimal Angioplasty Followed by Vasculomimetic Stenting for Trans-Atlantic Intersociety Consensus II C and D Femoropopliteal Arterial Disease-A Prospective Study.

Background The best option among the endovascular options in long, complex femoropopliteal (FP) lesions, and factors affecting the patency have yet to be well described. There are few studies describing the mid- and long-term patency of endovascular stents in long-segment FP occlusions. Aim This study aimed to determine the technical success and mid-term patency of subintimal angioplasty with vasculomimetic stenting in Trans-Atlantic Inter-Society Consensus II (TASC) C and D FP disease. The patient and imaging factors that affect primary patency were also analyzed. Methods and Materials A single-center prospective study was performed on 52 consecutive patients undergoing endovascular treatment for TASC C and D FP disease from 2017 to 2021. Angioplasty with stenting was performed in all patients and followed up for 36 months. Endpoints were primary patency rates and amputation-free survival of the limb. Kaplan-Meier curves were used to see patency rates and amputation-free survival rates. Results A total of 52 patients underwent stenting with a technical success rate of 100% if the sub-intimal arterial flossing with antegrade-retrograde intervention (SAFARI) technique was used. Primary stent patency at 6, 12, 18, 24, and 36 months was 89.8, 81.4, 76.2, 71.4, and 62.5%, respectively. Amputation-free survival was 98, 95.6, 91.8, and 85.7% at 12, 24, 30, and 36 months, respectively. Cox proportional regression analysis showed smoking and vessel wall calcium score more than 270 degrees as independent predictors of loss of primary patency (hazard ratio 0.35 confidence interval [CI]: 0.003-0.448) and 0.102 (CI: 0.022-0.47), respectively. Conclusion Subintimal angioplasty with vasculomimetic stent has good midterm patency in and amputation-free survival in long-segment FP occlusions. Smoking and severe vessel wall calcification adversely affect patency.

Technical success and associated economic implications of conventional re-entry devices in subintimal recanalization of femoro-popliteal chronic total occlusions.

PURPOSE: Re-entry devices contribute to the high success rate of subintimal recanalization of chronic total occlusions (CTO). However, to date, there are no studies comparing the available conventional re-entry devices concerning the impact of their technical success on economic aspects, as these devices differ greatly in their acquisition costs. This prospective observational study intends to contribute to this question. METHODS: Prior to the start of the prospective study, all previous applications of the Outback® in femoro-popliteal CTO since its introduction to our hospital were analyzed retrospectively (n = 31). From June 2018 until January 2020, all patients with femoro-popliteal CTO treated with clear subintimal recanalization were included (n = 109). In the case of failed spontaneous re-entry, either the OffRoad® (study arm I, n = 20) or the Enteer® catheter (study arm II, n = 20) was used. If assisted re-entry failed, the Outback® device was used as a bailout. Baseline demographic and clinical data, morphologic characteristics, and technical success were documented. Additional per-patient costs due to the use of re-entry devices were analyzed. RESULTS: A retrospective evaluation of all Outback® applications revealed a technical success rate of 97% (30/31). In the prospective study, 63% (68/109) were successfully treated without using re-entry devices. The overall procedural success was 95% (103/109). In study arm I, the OffRoad® achieved a success rate of 45% (9/20), with a subsequent successful application of the Outback® in 80% (8/10) of the failed cases. In study arm II, the Enteer® was successfully employed in 60% (12/20) of cases, and the Outback® was then used successfully in a further 62% (5/8) of cases. Too large a distance between the device and the target lumen was a knockout criterion for all tested devices, leading to a subgroup analysis with the exclusion of three cases, resulting in a success rate of 47% for the OffRoad® and 67% for the Enteer® device. Furthermore, in severe calcification, only the Outback® reliably enabled revascularization. Significant savings of almost €600 were only achieved in study arm II according to German prices. CONCLUSION: With proper patient selection, a gradual approach with the Enteer® as the primarily used device, with the Outback® used additionally in case of failure, leads to significant savings and can be recommended. In severe calcification, the Outback® should be used as the primary device.

Impact of intravascular ultrasound parameters and platelet reactivity on primary patency after drug-coated balloon angioplasty for femoropopliteal artery disease.

Although the superiority of DCBs to uncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions has been demonstrated, the association of clinical factors, including anatomical features evaluated by intravascular ultrasound (IVUS) and platelet reactivity, with the loss of patency has not been systematically studied. The current prospective, observational study enrolled 160 consecutive patients (male 67.5%, mean age 74.7 ± 9.7 years) with 213 FP lesions treated with DCBs under IVUS evaluation. The platelet reactivity was measured in P2Y12 reaction units for all of the patients at the DCB treatment. The primary end point was primary patency at 12 months, while the secondary end points were freedom from target lesion revascularization (TLR), all-cause death, major target limb amputation and bleeding events at 12 months. Mean lesion length was 11.9 ± 9.4 cm and 34 (16.0%) were chronic total occlusions (CTOs). Thirty-four (16.0%) were severely calcified lesions. Primary patency by Kaplan-Meier estimate was 79.2% at 12 months, while the 12-month freedom from TLR, all-cause death and bleeding events were observed in 89.1%, 93.4% and 97.4%, respectively. There were no major target limb amputations through 12 months. Multivariate analysis showed that subintimal angioplasty for CTO lesions was a sole risk factor for loss of 12-month primary patency, while other IVUS parameters and platelet reactivity were not.

Subintimal Crossing of Chronic Total Occlusions in Peripheral Arteries With a Dual Guidewire Balloon Catheter: The PRAESTO Study.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of antegrade fenestration re-entry (AFR) using a dual guidewire angioplasty balloon for chronic total occlusion (CTO) in patients with peripheral artery disease (PAD). MATERIAL AND METHODS: This is a retrospective score matching analysis study comparing a study cohort composed of PAD patients with CTO treated with AFR subintimal recanalization using a dual guidewire angioplasty balloon and a matched control group, selected on baseline cardiovascular risk factor and lesions characteristics, treated with a conventional subintimal recanalization. Procedure outcomes include procedural success, successful subintimal re-entry, need for distal puncture, procedural time, fluoroscopy time, and dose area product. Clinical variables, including primary patency, freedom from amputation, freedom from re-interventions, and freedom from death, were used to compare the study groups. RESULTS: Thirty patients in the study group were compared with 60 patients in the matched control group (mean age, male). A significant higher subintimal re-entry success (100% vs 76.7% in control group, p=0.004) and lower need of distal tibial punction (0 vs 14 [23.3%] patients in control group, p=0.004) were observed in the study group. A surgical conversion to bypass was needed in 5 patients in the control group. Shorter procedural and fluoroscopy time were observed in the study group (41.1±10.8 minutes vs 146.6±62. and 16.7±3.5 minutes vs 34.3±14.2 minutes in control group respectively, p<0.001 and p<0.001). Lower DAP were observed in the study group (914.1±309.9 µGym² vs 2026.5±845.7 µGym² in control group p<0.001). No significant difference were observed in terms of primary patency, mortality, amputation, and freedom from re-intervention. CONCLUSION: AFR using the Presto dual guidewire balloon is a step forward for crossing CTO which allows a simplified and quick treatment of BTK and ATK lesions compared with conventional approaches without increase of procedural risk and maintaining good clinical outcomes.

Complex multilevel and multivessel endovascular revascularization through an occluded femoral-popliteal bypass in a patient with chronic limb threatening ischemia.

Chronic limb-threatening ischemia (CLTI) represents the end stage of peripheral artery disease, a problem of growing prevalence and increased health care costs around the globe. CLTI is a highly morbid disease, incurring significant mortality, limb loss, pain, and diminished health-related quality of life. The major cause of non-traumatic lower extremity amputation are related to diabetes and CLTI. Between 2% to 3% of patients with peripheral artery disease present with a severe case of CLTI, a condition that is correlated with multilevel and multivessel arterial disease, calcification, and chronic total occlusions. Multiple technical strategies to successfully cross long occlusions in arterial segments have been described. Recanalization can be performed using endoluminal, subintimal, and retrograde techniques. We report a case of complex multilevel and multivessel endovascular revascularization through an occluded femoro-popliteal bypass in a patient with CLTI.

Revascularización endovascular compleja multinivel y multivaso a través de un bypass fémoro-poplíteo ocluído en paciente con isquemia crónica con amenaza para las extremidades inferiores / Complex multilevel and multivessel endovascular revascularization through an occluded femoral-popliteal bypass in a patient with chronic limb threatening ischemia

Resumen La isquemia crónica con amenaza para las extremidades inferiores (ICAEI) representa el estadio final de la enfermedad arterial periférica, un problema de prevalencia creciente que conlleva el aumento de los costos de salud en todo el mundo. La ICAEI es una enfermedad con elevada morbilidad, generando mortalidad significativa, pérdida de miembros, dolor y disminución de la calidad de vida. La principal causa de amputaciones no-traumáticas de miembros inferiores está relacionada a la diabetes y a la ICAEI. Entre un 2% y 3% de los pacientes con enfermedad arterial periférica se presentan con un caso grave de ICAEI, condición que se correlaciona con enfermedad arterial multinivel y multiarterial, calcificación y oclusiones totales crónicas. Se describieron varias estrategias técnicas para cruzar con éxito largas oclusiones en segmentos arteriales. Se puede realizar la recanalización utilizando técnicas endoluminales, subintimales y retrógradas. Relatamos un caso de revascularización endovascular compleja multinivel y multiarterial a través de un bypass fémoro-poplíteo en una paciente con ICAEI.

Abstract Chronic limb-threatening ischemia (CLTI) represents the end stage of peripheral artery disease, a problem of growing prevalence and increased health care costs around the globe. CLTI is a highly morbid disease, incurring significant mortality, limb loss, pain, and diminished health-related quality of life. The major cause of non-traumatic lower extremity amputation are related to diabetes and CLTI. Between 2% to 3% of patients with peripheral artery disease present with a severe case of CLTI, a condition that is correlated with multilevel and multivessel arterial disease, calcification, and chronic total occlusions. Multiple technical strategies to successfully cross long occlusions in arterial segments have been described. Recanalization can be performed using endoluminal, subintimal, and retrograde techniques. We report a case of complex multilevel and multivessel endovascular revascularization through an occluded femoro-popliteal bypass in a patient with CLTI.

Use and effectiveness of Pioneer re-entry device for subintimal true lumen re-entry: single-centre data and a review of the literature.

INTRODUCTION: During subintimal angioplasty (SIA), it is not always possible to re-enter the vessel lumen due to a variety of factors. Recanalization using hydrophilic wires and catheters alone, apart from its potential technical failure, is also limited by minimal control over the re-entry point. This is frequently well beyond the point of occlusion, thus often compromising important collaterals. In order to bypass the obstruction and attain controlled re-entry into the lumen of the diseased vessel, a re-entry device (RED) may be required. This paper assesses our centre's experience with the safety and efficacy of the Pioneer re-entry system and systematically reviews the pertinent literature. METHOD: A single centre retrospective study of subintimal angioplasty involving the use of the Pioneer Plus intravascular guided reentry catheter was performed. Patient demographics including age, gender, risk factors, comorbidities clinical indication and complications were recorded. Lesion characteristics, including location and severity of calcification were also assessed. A systematic literature review of all reported studies where the Pioneer RED was used for iliac and lower limb revascularization was conducted by 2 of the authors using the PubMed (MEDLINE) and EMBASE databases. RESULTS: The study comprised 30 cases. Technical success was 97%. A small, quickly resolved extravasation was the only device related complication. These results are in line with the systematic review which identified 16 studies using the Pioneer RED, reporting a technical success rate of 87.4-100% (median = 100%) and complication rate of 0-25.8% (median = 0%). However, due to heterogeneity in definitions of technical success, data was not pooled.

Effect of temperature-sensitive nanogel combined with angioplasty on sICAM-1 and VE-cadherin in lower extremity arterial occlusion rabbits.

The study was to explore the effect of subintimal angioplasty (SIA) on the levels of soluble intercellular adhesion molecule-1 (sICAM-1) and vascular endothelial cadherin (VE-cadherin) in the rabbit model of lower extremity arterial occlusion. Specifically, the poly(N-isopropylacrylamide-co-butyl methacrylate) (PIB) temperature-sensitive nanogel was prepared, and the cytotoxicity of direct and indirect contact with PIB temperature-sensitive gel was analyzed then. Subsequently, the PIB temperature-sensitive gel was injected to the New Zealand white rabbit to prepare the lower extremity arterial occlusion model. The healthy control, model group, and SIA group were compared for the serum lipids, fibrinogen (Fbg), fibrinogen (Fbg), and fibrinogen (Fbg) levels. The results showed that the cell proliferation activity and survival rate were always higher than 90% under different concentrations of PIB temperature-sensitive gels. Compared with the model group, the SIA group had increased total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), and Fbg levels, but decreased high-density lipoprotein (HDL) level (P < 0.05); decreased TXB2, ET-1, and ICAM-1 levels, but increased levels of 6-Keto-PGF1α and NO (P < 0.05); and decreased sICAM-1 and VE-cadherin levels (P < 0.05). It showed that PIB temperature-sensitive nanogel can elicit vascular embolism, and SIA is suggested in the treatment of lower extremity arterial occlusion.

Endovascular revascularization of chronic total arterial occlusion of the lower limb using the SAFARI technique.

The SAFARI technique or Subintimal Arterial Flossing with Antegrade-Retrograde Intervention is an endovascular procedure that allows recanalization of Chronic Total Occlusive (CTO) lesions when conventional subintimal angioplasty is unsuccessful. Retrograde access is usually obtained through the popliteal, anterior tibial, dorsalis pedis artery, or posterior tibial arteries and may potentially provide more options for endovascular interventions in limb salvage. The case of an 81-year-old man with a history of uncontrolled hypertension, diabetes mellitus, and dyslipidemia is presented. He presented with a cutaneous ulcer on the right lower limb with torpid evolution and poor healing. The Doppler ultrasound and arteriographic study revealed a CTO lesion of the popliteal artery that was not a candidate for antegrade endovascular revascularization, but was successfully treated using the SAFARI technique. The patient had no perioperative complications, the wound showed better healing, and he was discharged with an indication of daily dressings and control by an external outpatient clinic.

A técnica SAFARI, ou Subintimal Arterial Flossing with Antegrade-Retrograde Intervention, é um procedimento endovascular que permite a recanalização de lesões por oclusão total crônica (OTC) em caso de fracasso da angioplastia subintimal convencional. O acesso retrógrado é geralmente obtido através da artéria poplítea, tibial anterior, pediosa ou tibial posterior e pode fornecer mais alternativas de intervenções endovasculares para o salvamento do membro. É apresentado o caso de um homem de 81 anos com histórico de hipertenção não controlada, diabetes melito e dislipidemia. Ele apresentava uma lesão ulcerativa cutânea no membro inferior direito com evolução tórpida e má cicatrização. O ultrassom Doppler e o estudo arteriográfico revelaram uma lesão por OTC na artéria poplítea. O paciente não era candidato a revascularização endovascular anterógrada; sendo assim, esta foi realizada com successo utilizando a técnica SAFARI. O paciente não apresentou complicações perioperatórias e recebeu alta com indicação de cuidados diários com a ferida e controle em um ambulatório externo. Além disso, a ferida apresentou melhor cicatrização.

Histological Analysis of a Long Term Patent Subintimal Canal in the Superficial Femoral Artery.

INTRODUCTION: Subintimal angioplasty (SIA) was introduced in the late 1980s and is a supplement to bypass surgery. Adaptation of the technique has been hampered by high rates of early intervention to maintain patency, but the long term assisted patency is good. REPORT: The superficial femoral and popliteal artery containing a patent subintimal canal were explanted from a patient who died in the authors' ward. Histological analysis indicated that the lumen was created in the medial layer of the vessel wall. A collagen rich neointima and fragmented internal elastic lamina were observed, presumably as a result of activated smooth muscle cells. The luminal surface was partly covered by a single layer of CD31, von Willebrand factor, and partly CD144 positive cells. An early atherosclerotic lesion was observed distally in the subintimal canal. DISCUSSION: Remodelling and neo-cellularisation of the vascular wall after SIA are described. Notably, hallmarks of early and late stage atherosclerotic disease were evident throughout the subintimal canal. These observations require confirmation in a larger number of specimens but underscore the need for surveillance after SIA.

Endovascular revascularization of chronic total arterial occlusion of the lower limb using the SAFARI technique / Revascularização endovascular utilizando a técnica SAFARI em casos de oclusão arterial total do membro inferior

Abstract The SAFARI technique or Subintimal Arterial Flossing with Antegrade-Retrograde Intervention is an endovascular procedure that allows recanalization of Chronic Total Occlusive (CTO) lesions when conventional subintimal angioplasty is unsuccessful. Retrograde access is usually obtained through the popliteal, anterior tibial, dorsalis pedis artery, or posterior tibial arteries and may potentially provide more options for endovascular interventions in limb salvage. The case of an 81-year-old man with a history of uncontrolled hypertension, diabetes mellitus, and dyslipidemia is presented. He presented with a cutaneous ulcer on the right lower limb with torpid evolution and poor healing. The Doppler ultrasound and arteriographic study revealed a CTO lesion of the popliteal artery that was not a candidate for antegrade endovascular revascularization, but was successfully treated using the SAFARI technique. The patient had no perioperative complications, the wound showed better healing, and he was discharged with an indication of daily dressings and control by an external outpatient clinic.

Resumo A técnica SAFARI, ou Subintimal Arterial Flossing with Antegrade-Retrograde Intervention, é um procedimento endovascular que permite a recanalização de lesões por oclusão total crônica (OTC) em caso de fracasso da angioplastia subintimal convencional. O acesso retrógrado é geralmente obtido através da artéria poplítea, tibial anterior, pediosa ou tibial posterior e pode fornecer mais alternativas de intervenções endovasculares para o salvamento do membro. É apresentado o caso de um homem de 81 anos com histórico de hipertenção não controlada, diabetes melito e dislipidemia. Ele apresentava uma lesão ulcerativa cutânea no membro inferior direito com evolução tórpida e má cicatrização. O ultrassom Doppler e o estudo arteriográfico revelaram uma lesão por OTC na artéria poplítea. O paciente não era candidato a revascularização endovascular anterógrada; sendo assim, esta foi realizada com successo utilizando a técnica SAFARI. O paciente não apresentou complicações perioperatórias e recebeu alta com indicação de cuidados diários com a ferida e controle em um ambulatório externo. Além disso, a ferida apresentou melhor cicatrização.

Use, Safety and Effectiveness of Subintimal Angioplasty and Re-Entry Devices for the Treatment of Femoropopliteal Chronic Total Occlusions: A Systematic Review of 87 Studies and 4,665 Patients.

BACKGROUND: Subintimal angioplasty (SIA) is often utilized to cross femoropopliteal (FP) artery chronic total occlusions (CTOs). Re-entry devices (RED) can further assist with true lumen re-entry. OBJECTIVE: To systematically review the literature for studies reporting on the use of SIA, with or without RED. METHODS: A systematic review according to the PRISMA guidelines was performed. Quantitative synthesis was applied when possible. RESULTS: 87 studies and 4665 patients (5161 lesions) were included (63.9% male). 46.7% of patients had critical limb ischemia at the time of the intervention. Two RED types were used (Pioneer and Outback). Sixty-eight studies included lesions treated with SIA without RED, 17 studies included lesions treated with RED only, and two studies included a comparison between the two treatment methods. In total, 3898 (83.6%) patients were treated with SIA without RED and 754 (12.2%) with RED. Procedural success rate ranged from 64.5%-100% (92.5% for SIA without RED, 88.3% for RED cases). The complication rate ranged from 1.6% - 28% among different studies (cumulative rates: SIA: 9.1%, RED 9.3%). Perforations occurred in 1.6% of the total population (n = 46). Primary patency at one year ranged from 22% to 94.1%. Newer studies had a higher patency rate, ranging from 70% to 94.1%. CONCLUSION: SIA with or without RED is a valuable alternative to intraluminal crossing for endovascular treatment of FP CTOs. Procedural success was excellent for both techniques, while the cumulative complication rate was numerically lower in the RED group. Short- and long-term outcomes were acceptable for both techniques.

Use, Safety and Effectiveness of Subintimal Angioplasty and Re-Entry Devices for the Treatment of Iliac Artery Chronic Total Occlusions: A Systematic Review of 30 Studies and 1112 Lesions.

BACKGROUND: Management of iliac artery occlusive disease has changed dramatically over the past few decades. Secondary to advancement in endovascular technologies and techniques, percutaneous interventions have gradually replaced open surgical approaches even for the most difficult cases. In difficult to cross chronic total occlusions (CTO) of the iliac artery, subintimal angioplasty (SIA) with or without the use of re-entry devices (RED) offers a valuable alternative to intra-luminal crossing. OBJECTIVE: To systematically review the literature for studies reporting procedural or short- and long-term clinical outcomes after the use of SIA, with or without RED use for iliac CTOs. METHODS: PRISMA guidelines were followed. Literature search (PubMed, Cochrane CENTRAL and EMBASE) and data extraction were performed by two independent researchers. Quantitative synthesis of the reported outcomes was applied when possible. RESULTS: Thirty studies met the inclusion criteria and were selected as eligible for this systematic review, with a total of 1002 patients (61.3% males) and 1112 lesions treated with SIA. RED were used in 21.9% of the lesions. Critical limb ischemia was the indication in 51.4%. The overall procedural success rates were 85.8% for SIA and 88.5% for RED. The complication rate ranged from 0 to 10% among different series, but overall it was similar among the two groups (6.9% in the RED group and 6.7% among the SIA group). One year primary patency rates were around 60% in the RED. In the SIA only arm, there was a large heterogeneity, with patency rates ranging from 51.7% to 96.8%. CONCLUSION: SIA with or without RED use is a safe and effective treatment for the treatment of iliac artery CTOs. Future studies are needed to delineate whether intraluminal crossing or SIA is more effective for endovascular treatment of iliac CTOs.

Clinical Outcomes of Subintimal vs. Intraluminal Revascularization Approaches for Long Femoropopliteal Occlusions in a Korean Multicenter Retrospective Registry Cohort.

BACKGROUND: There are limited data comparing the outcomes of subintimal vs. intraluminal approach in the treatment of long femoropopliteal artery occlusions. The objective of this study was to investigate the efficacy and safety of the subintimal approach for long femoropopliteal artery occlusions.Methods and Results:From a multicenter retrospective registry cohort, we included a total of 461 patients with 487 femoropopliteal artery occlusions classified as Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II C/D for this analysis. We compared the immediate and mid-term outcomes of subintimal vs. intraluminal approaches. There were 228 patients with 243 limbs in the subintimal group, and 233 patients with 244 limbs in the intraluminal group. Baseline clinical and lesion characteristics were comparable between the 2 groups. The technical success rate was significantly higher in the subintimal group than in the intraluminal group (95.1% vs. 89.8%, P=0.041). The clinical primary patency (67.5% vs. 73.4% at 12 months, 54.0% vs. 61.3% at 24 months; P=0.086) and target lesion revascularization (TLR)-free survival (89.5% vs. 86.3% at 12 months, 77.6% vs. 76.0% at 24 months; P=0.710) did not differ significantly between the subintimal and the intraluminal groups. CONCLUSIONS: In long femoropopliteal occlusions, the subintimal approach achieved a higher technical success rate and similar mid-term primary patency and TLR-free survival compared with intraluminal approach.

Long-term outcomes after re-entry device use for recanalization of common iliac artery chronic total occlusions.

OBJECTIVE: To examine the impact of re-entry device (RED) use on 1- and 5-year outcomes after endovascular treatment of common iliac artery (CIA) chronic total Occlusions (CTOs). BACKGROUND: There are not enough data regarding the long-term safety and efficacy of RED. METHODS: We performed a two-center retrospective study of 115 patients (140 lesions) undergoing CIA CTO endovascular intervention between 2006 and 2016. Baseline characteristics and long-term outcomes were described. A Cox proportional hazard model was developed to determine if REDs were associated with target lesion revascularization (TLR) or major adverse limb events (MALE) after 1 and 5 years. RESULTS: Among 140 lesions, 43 (31%) required use of a RED. The mean age was 63.9 years and the majority (n = 80) of patients were male. An antegrade crossing approach and treatment of restenotic lesions were less common in the RED group (10% vs. 29%, P < .05 and 0% vs. 21%, P < .05, respectively). There were no significant differences in Rutherford class, pre-procedure ABI, or patient presentation. The procedural complication rates were similar between the two groups. The 1- and 5-year TLR rates for lesions treated with re-entry device vs. standard approaches were 11% vs. 9%; P = 0.8 and 29% vs. 29%; P = 0.9 respectively. The 1 and 5-year MALE rates for lesions treated with re-entry device were 5% vs. 6%; P = 0.8 and 11% vs. 11%; P = 0.9 respectively. CONCLUSIONS: This retrospective analysis found that recanalization of CIA occlusions using a RED is safe and is associated with long-term clinical outcomes similar to that of standard crossing techniques.

Initial Experience With the Outback Catheter for Targeted Reentry During Subintimal Angioplasty of the Infragenicular Arteries.

PURPOSE: To report use of the Outback reentry device for targeted distal reentry during subintimal recanalization of chronic total occlusions (CTOs) in the infragenicular arteries. METHODS: During an 18-month period, the Outback device was applied in 10 patients (mean age 71.8±18.8 years; 8 men) to achieve reentry at the infragenicular segment following either unsuccessful spontaneous reentry after subintimal crossing of a CTO or when a targeted reentry was desired. The mean occlusion length was 117.5±101.0 mm. Technical (device) success, overall procedure success, and reentry accuracy are reported, along with any major or minor complications. RESULTS: The device was technically successful in achieving reentry in 9 of 10 cases; overall procedure success was achieved in 8 owing to heavy calcifications in a distal posterior tibial artery and a distal popliteal artery. The reentry accuracy was 10.8±14.6 mm. There were no major complications and only 3 minor sequelae, including 2 dissections and 1 small perforation; all were treated successfully with stenting. CONCLUSION: The Outback device has a high technical success rate in achieving targeted true lumen reentry in infragenicular subintimal angioplasty when spontaneous reentry is not possible or a targeted reentry is desirable.

The use of a Colapinto TIPS Needle under cone-beam computed tomography guidance for true lumen re-entry in subintimal recanalization of chronic iliac artery occlusion.

BACKGROUND: To report the technique and clinical outcome of subintimal re-entry in chronic iliac artery occlusion by using a Colapinto transjugular intrahepatic portosystemic shunt (TIPS) needle under rotational angiography (cone-beam computed tomography; CT) imaging guidance. METHODS: Patients with chronic iliac artery occlusion with earlier failed attempts at conventional percutaneous recanalization during the past 5 years were enrolled in our study. In these patients, an ipsilateral femoral access route was routinely utilized in a retrograde fashion. A Colapinto TIPS Needle was used to aid the true lumen re-entry after failed conventional intraluminal or subintimal guidewire and catheter-based techniques. The puncture was directed under rotational angiography cone-beam CT guidance to re-enter the abdominal aorta. Bare metallic stents 8-10 mm in diameter were deployed in the common iliac artery, and followed by balloon dilation. RESULTS: Ten patients (9 male; median age, 75 years) were included in our investigation. The average occlusion length was 10.2 cm (range, 4-15 cm). According to the Trans-Atlantic Inter-Society Consensus (TASC) II classification, there were five patients each with Class B and D lesions. Successful re-entry was achieved in all patients without procedure-related complications. The ankle-brachial index (ABI) values increased from 0.38-0.79 to 0.75-1.28 after the procedure. Imaging follow-up (> 6 months) was available in six patients with patency of all stented iliac artery. Thereafter, no complaints of recurrent clinical symptoms occurred during the follow-up period. CONCLUSION: The use of Colapinto TIPS needle, especially under cone-beam CT image guidance, appears to be safe and effective to re-enter the true lumen in a subintimal angioplasty for a difficult chronic total iliac occlusion.