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Persistent sciatic artery (PSA) is a rare congenital anomaly that may involve aneurysmal formations. During endovascular treatment for PSA aneurysm (PSAA) occlusion, guidewire crossing can be challenging due to complex anatomy. We report successful endovascular intervention for PSAA occlusion using the "direct tip injection in occlusive lesions (DIOL)" fashion, in which hydraulic pressure with contrast facilitates guidewire crossing by visualizing the vessel course and expanding the microchannel and vessel lumen. An 80-year-old woman presented with severe intermittent left calf claudication due to PSA occlusion with PSAA. Endovascular treatment was attempted for the occlusion; however, bidirectional wiring in the PSAA was unsuccessful. Therefore, bidirectional DIOL was applied; antegrade-DIOL visualized and enlarged the subintimal plane of the proximal PSAA, while retrograde-DIOL showed intramedial lumen enlargement in the middle and distal PSAA. Consequently, bidirectional guidewires were successfully advanced into the expanded lumen, achieving guidewire externalization. After balloon angioplasty, a self-expandable stent and three stent-grafts were implanted throughout the PSA occlusion, with stent-grafts overlapping around the hip joint to overcome chronic external compression. The final angiogram revealed sufficient blood flow, and the symptoms improved. A 2-year follow-up computed tomography angiography indicated no restenosis. Thus, the DIOL fashion facilitates guidewire crossing in complex occlusions. This case report highlights the successful guidewire crossing for the treatment of a persistent sciatic artery aneurysm (PSAA) occlusion, which can be challenging. The "direct tip injection in occlusive lesions" fashion, using hydraulic pressure with a contrast medium to facilitate guidewire crossing with visualization of the vessel course and expansion of the lesion lumen, is a valuable and safe method for guidewire crossing in PSAA occlusion. [ABSTRACT FROM AUTHOR]

Background Drug-eluting therapies remarkably reduce the incidence of restenosis and have revolutionized endovascular strategies for femoropopliteal lesions in patients with peripheral artery disease, nevertheless, concerns have arisen over the risk of aneurysmal degeneration after using an Eluvia polymer-based drug-eluting stent (DES). Case summary We present a case of an 80-year-old male who developed a giant aneurysm long-term after Eluvia implantation. He noticed a pulsatile mass in his thigh without any decrease in the ankle-brachial index 27 months after subintimal DES placement for superficial femoral artery (SFA) chronic total occlusion. Duplex ultrasonography (DUS) showed a giant cavity outside the vessel and a to-and-fro flow between the cavity and the SFA at the Elvia stents overlapped in the subintimal space. Endovascular-covered stents successfully sealed the cavity and reduced the size of the aneurysm at follow-up DUS. Discussion The aneurysmal degeneration, the so-called 'low echoic area' around the stent by ultrasound, is a relatively common finding after Eluvia DES implantation. It is thought to have little association with clinical events up to 2 years, however, the nature of this phenomenon remains unclear, and some cases present with clinical worsening. In this case, the development of a giant aneurysm could be induced by the overlapping stent not only by the local drug and polymer overdose but also by the increased mechanical force exerted against the fragile outer wall of the subintimal structure. [ABSTRACT FROM AUTHOR]

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.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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PURPOSERe-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.METHODSPrior 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.RESULTSA 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.CONCLUSIONWith 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.

With the development of advanced technologies, minimally invasive methods are becoming increasingly widespread in surgery, offering several advantages compared to traditional open surgery. In vascular surgery, endovascular revascularization methods are gaining increasing importance in the management of lower limb occlusive diseases. However, there are certain challenges that limit the effectiveness of endovascular revascularization and increase the likelihood of technical failure. One of the major challenges in endovascular revascularization of lower limb arteries is achieving re-entry into the vessel lumen during subintimal angioplasty. In certain cases, especially when there is severe atherosclerotic involvement of the vessel wall or calcification, the use of standard wire loop techniques may not always allow for re-entry into the true lumen of the vessel, and performing other surgical interventions may be limited or even impossible. Increasing the success rate of subintimal angioplasty will enhance the competitiveness of endovascular revascularization compared to open and hybrid reconstructive surgeries. Several techniques have been proposed to optimize the outcomes of endovascular revascularization, including the SAFARI technique, which combines antegrade and retrograde access for traversing complex occlusions. Re-entry devices equipped with specially curved needles at the catheter tip are used to direct the 0.014 inch wire into the true lumen of the vessel. Atherectomy devices with high-speed rotating blades driven by a motor are also employed to disrupt calcified plaques, creating a passage through heavily calcified occlusions that cannot be traversed by other means. These methods of optimizing the outcomes of endovascular revascularization can be used individually or in combination. We have analyzed the technical aspects of performing the mentioned procedures and their clinical outcomes based on literature sources. According to published data, the application of methods to optimize the outcomes of endovascular revascularization of infrainguinal arteries increases the success rate of these procedures to ≥90%. The widespread use of these methods is hindered by the high cost of re-entry and atherectomy devices. Accumulating our own experience will help improve the effectiveness of angioplasty in patients with chronic infrainguinal artery 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

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.

Objectives: This study aims to compare the immediate and mid-term outcomes of subintimal angioplasty (SIA) of chronic total occlusions (CTOs) of superficial femoral artery (SFA) versus popliteal artery (PA) and to identify possible predictors of loss of limb-based patency (LBP)., Methods: This is a retrospective analysis of chronic lower-limb ischemia (CLI) patients (Rutherford classes 3-6) presenting with CTO of SFA or PA treated by SIA and selective stenting in the period 2018 to 2021. Immediate outcomes were compared between the SFA and PA groups, including technical success, perioperative complications, and 30-day major amputation and mortality rates. Mid-term outcomes for technically successful procedures included limb-based patency (LBP), wound healing rate, amputation-free survival (AFS), and major adverse limb events (MALEs)., Results: A total of 450 CLI patients underwent SIA of CTO at the SFA (n=260, 57.8%) and the PA (n=190, 42.2%). The indication for revascularization was chronic limb-threatening ischemia in 80.8% of SFA group and 84.2% of PA group. Technical success rate was higher in the PA group compared to the SFA group (96.3% vs 91.2%; p=0.03). The 30-day amputation rates were comparable between the SFA and PA groups (7.7% vs 6.8%, p=0.7, respectively). No perioperative mortality or systemic major complications occurred in the present study. Kaplan-Meier estimate of the 1-year rates were significantly better for SFA group regarding LBP (82% for SFA group vs 43% for PA group, p=0.006), AFS (88% vs 64%, p=0.02), and wound healing (79% vs 58%, p=0.027), respectively. The number of runoff vessels was the only factor associated with loss of LBP (hazard ratio [HR], 0.055; 95% confidence interval [CI]: 0.001-3.020, p=0.039)., Conclusions: Subintimal angioplasty is an effective and safe endovascular treatment option of CTO at SFA and PA with satisfactory immediate outcomes. The mid-term outcomes, however, are better for SFA lesions in terms of improved LBP, AFS, and wound healing rates., Clinical Impact: Subintimal angioplasty is a valuable tool in the armamentarium of endovascular surgeons, as re-entry devices aren't always widely accessible. This study aims to assess the technical outcomes of peripheral vascular interventions for infrainguinal chronic total occlusions and identify possible predictors for successful subintimal angioplasty .Subintimal angioplasty is an effective treatment option for infrainguinal CTO with difference in result of immediate outcomes in popliteal lesions and SFA lesions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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. [ABSTRACT FROM AUTHOR]

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.

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. [ABSTRACT FROM AUTHOR]

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., (© 2024 Wiley Periodicals LLC.)

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. [ABSTRACT FROM AUTHOR]

Subintimal angioplasty of lower limb arterial occlusion carries a relatively higher risk of vessel perforation compared to transluminal angioplasty. Vessel perforation is a potentially life threatening complication which requires prompt recognition and management. They are usually managed by endovascular techniques such as low-pressure balloon tamponade, covered stents, and coil embolization of the ruptured artery. We describe a technique of treating vessel perforation following balloon angioplasty. Patient developed a large perforation of the proximal superficial femoral artery (SFA) after balloon inflation during subintimal angioplasty of complete SFA occlusion. Following failure of balloon tamponade in sealing the perforation, we successfully treated it by deploying an embolization coil at the site of perforation through the vessel wall followed by balloon tamponade. Our technique could be a useful relatively inexpensive alternative treatment option in the management of vessel perforation compared to covered stents.

Backround. Intermittent claudication is a classic symptom of peripheral arterial disease. It is mainly treated conservatively but if this fails, a form of revascularization is indicated. The revascularization in chronic occlusion of femoropopliteal region is currently performed by two basic methods: the standard method of surgical bypass and the newer miniinvasive alternative represented by the endovascular method. The treatment of patients with solely claudication and long occlusion of femoropopliteal region remains controversial. The aim of this minireview was to determine whether surgical bypass is still the best method of choice in a time of endovascular techniques. Methods: A MEDLINE search for original and review articles using key terms, intermittent claudication and long femoropopliteal oclusion. Results and Conclusion: No ideal treatment for long occlusions of the femoropopliteal segment has been established to date. It is clear that the role of endovascular techniques in the treatment of SFA occlusions is increasing. It remains that, lower risk patients with claudication should be examined to assess the quality of veins suitable for revascularization and bypass should be selected as the first method of choice.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Pacientes diabéticos portadores de doença ateroesclerótica obliterativa periférica e lesões complexas de partes moles são freqüentemente tratados por amputação primária. Os autores relatam o caso de paciente de 66 anos, sexo feminino, portadora de múltiplas comorbidades, apresentando volumoso abscesso plantar esquerdo e lesão femoral superficial conforme TASC C. Optou-se por realizar revascularização endovascular do membro inferior esquerdo por técnica de angioplastia subintimal sem o emprego de stent ou endoprótese. A abordagem combinada de revascularização endovascular do membro inferior associada a cuidados intensivos com feridas de pés diabéticos deve sempre ser considerada antes da amputação. Assim, sugere-se a técnica de angioplastia subintimal como uma opção em pacientes de elevado risco cirúrgico portadores de feridas complexas nas extremidades.Diabetic patients presenting with both peripheral vascular disease and complex soft-tissue defects are often treated by primary amputation. We report the case of a 66-year-old female patient with multiple comorbid conditions. She presented left foot plantar abscess and TASC C superficial femoral lesion. Endovascular revascularization of the left lower limb was performed employing the subintimal angioplasty technique, without stenting or endografting. This combined approach of lower limb revascularization associated with intensive care in diabetic foot wounds should always be considered before amputation. We recommend subintimal angioplasty as an option for high-risk patients with complex limb wounds.

Purpose: To report midterm outcomes after subintimal vs intraluminal drug-eluting stent (DES) implantation for femoropopliteal (FP) chronic total occlusion (CTO). Methods: This subanalysis of the prospective, multicenter ZEPHYR study (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) included 176 patients (mean age 74±8 years; 130 men) with 192 de novo FP CTOs that were evaluated by intravascular ultrasound after successful guidewire crossing. The primary outcome was the 2-year restenosis rate after subintimal (n=73) or intraluminal (n=119) DES implantation. Propensity score matching extracted 61 matched pairs (mean age 75 years; 49 men) for patency analysis to minimize baseline intergroup differences. Restenosis rates are reported with the 95% confidence interval (CI). Results: The 1-year restenosis rates in the groups with subintimal and intraluminal DES implantation were 45% (95% CI 32% to 59%) and 35% (95% CI 22% to 49%), respectively (p=0.352), whereas the corresponding rates at 2 years were not significantly different (p=0.648) at 56% (95% CI 41% to 71%) and 51% (95% CI 34% to 68%). Baseline characteristics had no significant interaction effect on the association of subintimal angioplasty with restenosis risk. Conclusion: In FP CTO, 2-year restenosis rates were comparable after subintimal or intraluminal DES implantation. [ABSTRACT FROM AUTHOR]

Objectives: To describe the hydrodynamic boost (HB) technique and report our preliminary results with this technique in the subintimal angioplasty of below-the-knee vessels.Methods: HB was used in 23 cases (14 males, mean age 73 ± 12 years) of critical limb ischemia, with long chronic total occlusion of tibial arteries extended to the ankle level. The operator performs a manual injection of diluted contrast dye through a 4 F catheter into the subintimal space, close to the patent true distal lumen, in order to achieve a tear in the intimal flap and a connection with the true lumen.Results: In 19/23 (83 %) cases, the HB was effective in creating a connection between the subintimal space and the true distal lumen and it was possible to advance a wire and to conclude the procedure. In 4/23 (17 %) lesions, the HB failed and the procedure was successfully completed by retrograde approach. No major complications occurred. Mean length between catheter tip and re-entry point was 8 ± 5 mm.Conclusions: HB seems to be a feasible, safe and effective re-entry technique in distal below-the-knee vessels. This method represents an easy option for re-entry that extends the possibility of antegrade approach to obtain a successful revascularization.Key Points: • In subintimal angioplasty of below-the-knee vessel re-entry can represent a challenge. • Inability to re-enter may determine the failure of the revascularization procedure. • HB is a novel re-entry technique feasible in distal below-the-knee vessels. • HB may increase the success rate of antegrade approach. • In case of failure, retrograde approach remains feasible. [ABSTRACT FROM AUTHOR]

Subintimal angioplasty of lower limb arterial occlusion carries a relatively higher risk of vessel perforation compared to transluminal angioplasty. Vessel perforation is a potentially life threatening complication which requires prompt recognition and management. They are usually managed by endovascular techniques such as low-pressure balloon tamponade, covered stents, and coil embolization of the ruptured artery. We describe a technique of treating vessel perforation following balloon angioplasty. Patient developed a large perforation of the proximal superficial femoral artery (SFA) after balloon inflation during subintimal angioplasty of complete SFA occlusion. Following failure of balloon tamponade in sealing the perforation, we successfully treated it by deploying an embolization coil at the site of perforation through the vessel wall followed by balloon tamponade. Our technique could be a useful relatively inexpensive alternative treatment option in the management of vessel perforation compared to covered stents. [ABSTRACT FROM AUTHOR]

Backround. Intermittent claudication is a classic symptom of peripheral arterial disease. It is mainly treated conservatively but if this fails, a form of revascularization is indicated. The revascularization in chronic occlusion of femoropopliteal region is currently performed by two basic methods: the standard method of surgical bypass and the newer miniinvasive alternative represented by the endovascular method. The treatment of patients with solely claudication and long occlusion of femoropopliteal region remains controversial. The aim of this minireview was to determine whether surgical bypass is still the best method of choice in a time of endovascular techniques. Methods. A MEDLINE search for original and review articles using key terms, intermittent claudication and long femoropopliteal oclusion. Results and Conclusion. No ideal treatment for long occlusions of the femoropopliteal segment has been established to date. It is clear that the role of endovascular techniques in the treatment of SFA occlusions is increasing. It remains that, lower risk patients with claudication should be examined to assess the quality of veins suitable for revascularization and bypass should be selected as the first method of choice. [ABSTRACT FROM AUTHOR]

Objective: The aim of this article was to report our results of subintimal angioplasty (SIA) of long superficial femoral artery (SFA) occlusions and try to appreciate factors that affect patency following this type of intervention in critical lower limb ischemia (CLI) patients. Patients and methods: The current series was conducted prospectively over a 1-year period. Forty cases, 40 limbs (mean age = 65.8 years old) with long SFA occlusion (>15 cm) and patent popliteal artery continuous with at least one leg artery runoff were included. Exclusion criteria were: renal impairment, nonatherosclerotic occlusions (thrombosis, dissection, or compression), short SFA occlusions (<15 cm), or non-SIA revascularization intervention. Results were considered successful with primary technical success combined with improving ischemic rest pain or healing wounds following minor amputations. Nonrecanalization or major amputations were considered failures. One-year patency and salvage rates were calculated. Factors that affected patency such as patent leg arteries and TASC grading were analyzed. Results: Results were considered successful in 34 (85%) patients and failure was noticed in six (15%) cases. At the end of the first follow-up year, the primary patency rate was 75% and the salvage rate was 87.5%. The 1-year patency rate was higher in TASC C patients (85.7%) in comparison with TASC D cases (69.2%). The patency rate was 50% or less with one patent leg artery and 80% or more with two or three patent leg arteries. Conclusion: SIA is a good alternative for recanalization of chronic long SFA total occlusions in CLI patients with acceptable 1-year patency rates. Number of patent leg arteries is an important determinant of durable procedures. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study sought to compare the outcomes of spot stenting versus long stenting after intentional subintimal approach for long femoropopliteal chronic total occlusions (CTO). BACKGROUND: The optimal stenting strategy following the subintimal recanalization of long femoropopliteal chronic total occlusions has not been investigated. METHODS: A total of 196 limbs in 163 patients, implanted with bare nitinol stents after subintimal approach in long femoropopliteal occlusions (lesion length 25 ± 8 cm), were retrospectively analyzed. The primary patency was compared between spot stenting (n = 129) and long stenting (n = 67). RESULTS: Baseline characteristics and immediate procedural results were similar between groups. Adjusted-primary patency (47% vs. 77%, p < 0.001) and adjusted-freedom from target lesion revascularization (52% vs. 84%, p < 0.001) at 2 years were significantly lower in the long stenting group than in the spot stenting group. The incidence of stent fracture, fracture type, and restenosis pattern did not differ between groups. Long stenting was an independent predictor of restenosis (hazard ratio [HR]: 2.0) along with other risk factors such as nonuse of clopidogrel (HR: 3.3) or cilostazol (HR: 2.2), small stent diameter (HR: 0.6), poor run-off (HR: 1.9), and post-procedural ankle-brachial index (HR: 0.1). Compared with spot stenting after adjustment using inverse probability of treatment weighting, long stenting, especially involving the P2 or P3 segment of the popliteal artery, was independently associated with 7.5-fold increases in restenosis risk (p < 0.001). CONCLUSIONS: The primary patency was significantly higher with spot stenting than with long stenting following subintimal approach for long femoropopliteal chronic total occlusions. The risk of restenosis was especially higher when long stenting was extended to the distal popliteal artery. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the phenomenon of distal embolization during subintimal angioplasty with or without stenting of femoropopliteal chronic total occlusions (CTOs). Methods: This prospective study included 40 consecutive patients (35 men; mean age 65.4±9.3 years) who underwent subintimal angioplasty alone (n=14) or with stenting (n=26) of CTOs in the femoropopliteal segment. A Spider protection filter was used to capture any possible macro- or microemboli generated during balloon inflation/stenting. Arterial outflow was angiographically checked during each consecutive procedural step. All filters were examined on site for macroscopic material, while the first 20 filters underwent further histopathological qualitative and semiquantitative analysis using a CH-to 3+ score. Results: There was no angiographically or clinically evident distal embolization. Macroscopic particulate debris was not detected in any filter. Histopathology confirmed the absence of macroemboli but revealed microembolic material (diameter <100 µm) in all filters (20/20). The mean number of particles detected was 9.4±4.5 (range 5-17). Histopathological findings included fibrin conglomerates (20/20), trapped erythrocytes (19/20), inflammatory cells (16/ 20), calcification minerals (6/20), extracellular matrix (6/20), cholesterol clefts (6/20), and endothelial cells (6/20). Captured material was classified as fresh and old thrombus in 7/20 and 4/20 cases, respectively. Semiquantitative analysis demonstrated that the collected microparticles consisted primarily of fibrin conglomerates (median score 2+), trapped erythrocytes (median score 1+), and inflammatory cells (median score 1+). Conclusion: Macroscopically evident emboli were not detected following subintimal angioplasty or stenting of femoropopliteal CTOs. Microscopic debris was present in all filters. The clinical significance of the phenomenon remains to be determined. [ABSTRACT FROM AUTHOR]

Abstract: A best evidence topic in surgery was written according to a structured protocol. The question addressed how subintimal angioplasty (SIA) compares to transluminal angioplasty (TA) for the treatment of femoral occlusive disease. One hundred and thirty two papers were found using the reported search; the 5 which represented the best evidence to answer the question are discussed. The evidence on this subject is limited; there are no randomised controlled trials (RCTs) comparing SIA to TA for pathologically equivalent lesions. However SIA remains a safe and effective alternative to surgical bypass grafting when TA cannot be performed. [Copyright &y& Elsevier]

Purpose: To investigate the midterm outcomes of subintimal angioplasty in occluded superficial femoral arteries (SFA) and evaluate the clinical and procedural factors affecting these results. Methods: Between April 2004 and April 2012, 150 patients (122 men; mean age 69±10 years) with chronic total occlusions in the SFA underwent subintimal angioplasty with primary stenting in 172 limbs. The average lesion length was 22.6±8.5 cm. Stents were routinely implanted at the proximal entry into the subintimal channel. The primary endpoint was binary restenosis. Results: Technical success was achieved in 161 (94%) limbs; there were no procedure-related deaths or complications requiring surgery, but distal embolization and arterial perforation occurred in 2 and 4 limbs, respectively. The cumulative freedom from binary restenosis rates at 1 and 3 years were 77% and 59%, respectively, in the entire study group. The 96 patients without critical limb ischemia (CLI) had significantly higher patency rates at 1 and 3 years (84% and 66%, respectively) than the 54 patients with CLI (66% and 43%, respectively; p=0.011). Based on multivariate analysis, a larger number of stents, lower post-procedure ankle-brachial index, and lower body mass index were each independent predictors of binary restenosis. Conclusion: Subintimal angioplasty with routine stenting at the proximal stump is safe and effective for the treatment of chronic total SFA occlusions. [ABSTRACT FROM AUTHOR]

Purpose: To report successful subintimal angioplasty of a lengthy femorotibial occlusion in a patient with Buerger's disease, with wound healing and limb salvage. Case Report: A 38-year-old female heavy smoker was referred to our hospital for treatment of extensive infectious tissue loss, with severe foot pain 1 month after early failure of a distal bypass graft. Angiography revealed total occlusion in the femoropopliteal and infrapopliteal arteries. Endovascular recanalization was attempted in order to establish "straight-line flow" to the foot on the verge of limb loss. The subintimal angioplasty technique with a 0.014-inch hydrophilic guidewire facilitated successful crossing of the occlusive femoropopliteal and posterior tibial arteries. The lesions were serially dilated (standard and cutting balloons). Angiography demonstrated antegrade flow to the foot without flow-limiting dissection, and the serious pain dramatically disappeared. Complete wound healing was observed 5 months after initial revascularization with the assistance of repeat angioplasty for restenosis. Conclusion: Contemporary endovascular therapy using the subintimal angioplasty technique could represent a viable option for Buerger's disease. [ABSTRACT FROM AUTHOR]

AIM: To evaluate the benefit of endovascular peripheral revascularization on glucose control in patients with chronic limb ischemia. METHODS AND RESULTS: Over a 12 month period, 61 patients (41 male, range 49-88 years of age) presenting with critical limb ischemia (CLI) were treated according to the Trans Atlantic Inter Society Consensus (TASC II) guidelines. After discharge, all patients were asked to measure their glucose level three times daily, and glycated hemoglobin was checked monthly up to 12 months, as well as to fill a questionnaire to assess their Quality of Life (QoL). The revascularization procedure was successful in 90% of cases. Glycemic control and glycated hemoglobin in 22 diabetic patients subgroup were significantly improved after the treatment and remained stable over the follow-up period. There was a significant improvement in QoL that increased steadily from the operation and to reach a plateau after six months. CONCLUSIONS: Peripheral percutaneous angioplasty in subjects with CLI significantly improves glycemic control and ameliorates QoL. Revascularization positively effects also long-term diabetes control as well as QoL. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this article is to report the results of a prospective single-center study analyzing the long-term clinical and angiographic outcomes of subintimal angioplasty (SIA) for the treatment of chronic total occlusions (CTOs) of the femoropopliteal artery. Materials and Methods: Patients with severe intermittent claudication or critical limb ischemia (CLI) were enrolled in the study. All lesions were treated with SIA and provisional stenting. Primary end points were technical success, patient survival, limb salvage, lesion primary patency, angiographic binary restenosis (>50%), and target lesion revascularization (TLR). Regular clinical and angiographic follow-up was set at 6 and 12 months and yearly thereafter. Study end points were calculated with life-table survival analysis. Proportional-hazards regression analysis with a Cox-model was applied to adjust for confounding factors of heterogeneity. Results: Between May 2004 and July 2009, 98 patients (105 limbs, patient age 69.3 ± 9.9 years) were included in the study. Technical success rate was 91.4% with a lesion length of 121 ± 77 mm. Limb-salvage and survival rates were 88.7% and 84.1% at 3 years, respectively. After 12, 24, and 36 months, primary patency was 80.1%, 42.3%, and 29.0%, angiographic binary restenosis was 37.2%, 68.6%, and 80.0%, and TLR was 84.8%, 73.0%, and 64.5%, respectively. CLI was the only adverse predictor for decreased primary patency (hazard ratio [HR] 0.36; 95% confidence interval [CI] 0.16-0.80, p = 0.012), whereas significantly less restenosis was detected after spot stenting of the entry and/or re-entry site (HR 0.31; 95% CI 0.10-0.89, p = 0.01 and HR 0.20; 95% CI 0.07-0.56, p = 0.002, respectively). Conclusions: Subintimal angioplasty is a safe and effective revascularization technique for the treatment of CTOs of the femoropopliteal artery. Provisional stenting may have a role at the subintimal entry or true lumen re-entry site. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to measure the in vivo platelet activation and thrombin generation in arterial blood after passing a subintimal conduit. Methods: Subintimal percutaneous transluminal angioplasty (SPTA) is a technique where a subintimal channel is created, allowing recanalization of long peripheral arterial occlusion. From 10 patients with intermittent claudication, undergoing successful SPTA for femoropopliteal occlusive disease, we collected antecubital venous blood samples immediately before treatment, preprocedural arterial blood samples taken at the entry level proximal to the vessel occlusion, and subsequently at the reentry level after successful recanalization. Venous follow-up blood samples were taken after 24 hours. Plasma concentrations of β-thromboglobulin (β-TG), RANTES, and Prothrombin fragment (F1 ++ 2), were determined by immunoassay. Fibrinogen binding to platelets, leukocyte-platelet adhesion, and P-selectin were determined by flow cytometry. Results: We found a statistically significant transluminal increase in the plasma concentrations of RANTES, β-TG and F1 ++ 2 ( p == 0.002, 0.001 and 0.001 respectively), which all normalized within 24 hours. Platelet-leukocyte aggregates significantly decreased after 24 hours compared with preprocedural and preentry levels (3.26% versus 5.26 %, p == 0.017). P-selectin expression on circulating platelets was statistically significantly increased in the blood sample taken at the re-entry level compared with the pre-procedural and pre-entry level ( p == 0.007). After 24 hours there was no statistically significant difference to pre-procedural levels. There was no significant change in platelet fibrinogen binding at any levels. Conclusion: When passing a subintimal conduit, in vivo sampled blood demonstrated an extremely rapid and substantial uniform platelet activation and thrombin generation. [ABSTRACT FROM AUTHOR]

Purpose: To report a retrospective, single-center study that evaluates technical and clinical outcomes from subintimal recanalization of femoropopliteal chronic total occlusions (CTO) facilitated by the Outback re-entry catheter. Methods: The Outback catheter was required to complete recanalization of femoropopliteal CTOs (mean lesion length 195±91 mm) in 118 limbs of 113 patients (77 men; mean age 70±10 years). In 80/118 (67.8%) limbs, treatment was performed for claudication and in the remaining 38 (32.2%) for critical limb ischemia (CLI). Technical and procedural success, clinical outcome, and cumulative patency rates in follow-up were evaluated. Results: Re-entry was accomplished in 108/118 limbs (91.5%) with recanalization completed in 107/118 (90.7%). Of these, only 61/107 (57%) arteries were left with a residual stenosis <30%. Complications included minor bleeding of the target vessel (5/118, 4.2%) and minor hematoma/pseudoaneurysm at the access site (6/118, 5.1%). Acute reocclusion developed in 2/118 cases (1.7%) without major complication. After 12 months, primary patency was 56.7%, assisted primary patency 83.1%, and secondary patency 89.1%. Primary patency was significantly reduced in limbs with residual stenosis. Over a median 15-month follow-up (range 2-32), 4 major and 2 minor amputations were performed in patients with CLI. Conclusion: The Outback catheter is a reliable tool to recanalize challenging chronic femoropopliteal occlusions after failed guidewire re-entry. Restenosis rates are high, which may be due to the severity and extent of disease in these patients, who are particularly challenging. [ABSTRACT FROM AUTHOR]

Abstract: Aim: The aim of this prospective study was to assess the clinical effectiveness and related midterm patency of subintimal angioplasty (SAP) in patients suffering from critical limb ischaemia (CLI) in a single tertiary care university centre. The secondary aim was to evaluate the safety and clinical effectiveness of using a re-entry device when re-canalisation by SAP was unsuccessful. Methods: From January 2005 to December 2007, consecutive patients suffering from CLI (Rutherford clinical categories: 4–6) were treated with SAP. All patients included in the study had occluded SFA (TASC C and D) and underwent clinical and ultrasound follow-up examinations at day 30 and at 3, 6, 9 and 12 months, and then yearly. A re-entry device (Outback, Cordis Corporation, Miami Lakes, Florida, USA in all cases) was only used when re-canalisation by simple SAP was unsuccessful, and stenting was used when residual stenosis was >30% or there was a flow-limiting dissection. Factors that could modify the outcome were analysed. Results: In this study, 145 patients were treated, with a technical success rate of 83.5% (121 of 145) for simple SAP. Stenting was performed in 43% (n =62) of successful SAP procedures. No death occurred in the perioperative period, while the 30-day mortality was 4.8% (7 of 145). The re-entry device (Outback) was used in 24 cases (16.5%). The technical success of the re-entry device was 79% (19 of 24), with a 90% success rate of stent placement at the site of re-entry. Complications occurred in 6.2% of all procedures (n =9) (three arterial perforations (2.1%), three distal embolisations (2.1%), two femoral artery pseudo-aneurysms (1.4%) and one arterio-venous fistula (0.7%)). Factors capable of independently affecting the patency were renal insufficiency (p =0.03), current smoking (p =0.01) and diabetes (p =0.04). The primary patency at 1 and 3 years was 70% and 34% and the secondary patency at 1 and 3 years was 77% and 43%, respectively. At the same time intervals, the limb-salvage rate was 88% and 49%. Conclusions: SAP with the aid of a re-entry device for TASC C and D lesions of the SFA seems to be safe and clinically effective in patients suffering from CLI, according to the experience at our centre. Further follow-up and more data are necessary to confirm these findings. [Copyright &y& Elsevier]

Abstract: Introduction: This study aims to assess the patency, the clinical success and the limb-salvage rates of combined subintimal (SA) coupled to endoluminal angioplasty (EA) as the initial treatment of ischaemic inferior-limb ulcers in diabetic patients and to study the influence of other concurrent factors in the tissue-healing process. Materials and method: Since September 2002 until December 2007, a consecutive series of 176 limbs with manifold ischaemic wounds in 161 diabetic patients were treated by associated multilevel angioplasties in a multidisciplinary ‘diabetic-foot team’ (a third-line diabetic-care institution integrating two departmental hospitals). There were 98 associated SA with EA procedures, 26 re-vascularisations by single SA technique and 52 others including selective multilevel EAs that were retrospectively reviewed. The mean follow-up period was 22.1 months (in the range of 1–50 months) by clinical and duplex evaluation (every 6 months). Results: The initial technical success was noted in 149 limbs (84%). For the single or associated SA procedures, 102 of 124 procedures were successful (82%) and 145 of 150 of the miscellaneous EAs (96%) evinced an equally favourable outcome. The 27 initially failed endovascular procedures (22 SA and five EA) required 16 surgical re-vascularisation, eight adjuvant endovascular procedures besides three amputations. A total of 21 secondary and five tertiary angioplasties were equally necessary during the entire follow-up period of these patients. The 30-day survival rate was 99% (one patient died from myocardial infarction). In a intention-to-treat analysis, the cumulative primary and secondary patencies at 12, 24, 36 and 48 months were 62%, 45%, 41% and 38%, together with 80%, 69%, 66% and 66%, respectively. The aggregate clinical success rates at the same intervals were 86%, 77%, 70% and 69%, while the corresponding limb-salvage proportions showed 89%, 83%, 80% and 80%, respectively. The primary patency was negatively affected at 1 and 4 years by the length of the occluded segment (>10cm) and the end-stage renal disease (ESRD) (p <0.0001). The limb-salvage rates were unfavourably influenced at the same periods by the extent of tissue defects (>3cm), the ESRD and the presence of osteomyelitis. In addition, at 4 years, the age (>70 years), the accompanying peripheral neuropathy, the bedridden status and the presence of cardiac failure (left ventricular ejection fraction (LVEF)<30%) appeared equally as negative predictors (p <0.0001) for wound healing and limb rescue. Conclusion: Primary angioplasty represents a low aggressive and efficacious method to improve the healing process in diabetic ischaemic ulcers. However, beyond appropriate re-vascularisation, even repetitive if necessary, achieving satisfactory limb-salvage rates probably implies a multidisciplinary control of the presenting risk factors for wound healing as well. [Copyright &y& Elsevier]

Abstract: Objectives: To report results of subintimal angioplasty (SA) of superficial femoral artery occlusions and to compare these results with percutaneous transluminal angioplasty (PTA) of similar lesions. Design: Prospective study. Patients: In the period from June 2002 to August 2006, 73 SA procedures were performed in 71 patients and 75 PTA procedures were performed in 75 patients. Methods: All cases treated with SA or PTA for superficial femoral artery occlusions were prospectively registered and reviewed. Assessments of comorbidities, indication for procedure, run-off, occlusion length, calcification of the artery and graft patency were recorded. Results: The technical success rate of SA was 87.7% versus 81.3% for PTA. Primary patency rates in the SA group at 1, 6, 12, 24 months were respectively 84.9±4.2, 71.2±5.1, 68.5±5.3 and 65.8±5.2%; in the PTA group – 81.3±4.4, 45.3±5.7, 42.7±5.6 and 38.7±5.5% respectively. At the same time-points primary assisted patency rates were in SA group 84.9±4.2, 83.6±4.2, 71.2±5.2 and 68.5±5.3%; and in the PTA group 81.3±4.4, 62.5±5.5, 44±5.6 and 42.7±5.6%. Calcification was associated with SA failure. There were no amputations in the follow up of either SA or PTA procedures. Conclusion: Results from subintimal angioplasty of superficial femoral artery occlusions was superior to the results of PTA. [Copyright &y& Elsevier]