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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.

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.

During the recanalization of chronic total occlusions in the superficial femoral artery, severe calcification adds technical difficulty in guidewire crossing due to poor ultrasound visualization and uncontrollable guidewire manipulation. Herein, we present the case of a 70-year-old man with chronic total occlusion of the superficial femoral artery to report the “perivascular radiolucent line” indicating aspirated air in the subintimal space, which could be noted after a failed subintimal angioplasty. The perivascular radiolucent line helped a safe guidewire tail crossing by making the vascular wall visible. Physicians should be aware of the perivascular radiolucent line in case of failed subintimal angioplasty.

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.

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.

To report use of the Outback reentry device for targeted distal reentry during subintimal recanalization of chronic total occlusions (CTOs) in the infragenicular arteries.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.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.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.

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.

Endovascular therapy (EVT) has been accepted as a minimally invasive treatment for peripheral artery disease, and its applicability has been widened with the development of techniques and devices. A long, totally occluded lesion in the superficial femoral artery (SFA) is one of the most challenging lesions for EVT due to technical difficulties in wire-crossing. Recently, intentional subintimal recanalization is often considered as an alternative option for long SFA occlusions. Previous studies have shown that subintimal approach achieved superior technical success rate and similar patency rate, compared to conventional intraluminal approach. However, there is limited information about complications of the treatment with subintimal approach. Deep vein thrombosis (DVT) due to direct compression by pseudoaneurysm in the SFA, which subsequently develops pulmonary embolism (PE), is considered as a rare complication of subintimal angioplasty for the occlusive SFA lesion. We herein present a case of a patient who developed pseudoaneurysm formation in the SFA after EVT. Although initial EVT was performed successfully with subintimal approach, DVT and PE were caused by the SFA pseudoaneurysm at sub-acute phase following the initial procedure. The pseudoaneurysm was treated with implantation of a covered stent sealing the entry point, disappearing with no endoleak.

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.

Objective To assess a practice of claudicant revascularization with either subintimal angioplasty (SIA) plus stenting or femoropopliteal bypass. Methods All claudicants related to femoropopliteal occlusions treated either with above-the-knee femoropopliteal (AKFP) bypass (group 1) or SIA and stent (group 2) between 2004 and 2011 were reviewed. The two groups were analyzed with regard to patency and freedom from re-intervention. Results One hundred and fifty limbs were consecutively treated with AKFP bypass (n = 82), SIA plus stenting (n = 58), or SIA (n = 10). Bypasses were performed with synthetic grafts in 49 limbs (59.7%). Covered stents were used in 34 limbs (63%) and self-expandable stents in the remainder. Mean follow-up was 26 and 36 months, respectively, in group 1 and 2. At 24 months, primary, primary-assisted, and secondary patency for bypass versus SIA + stent groups was, respectively, 66.6 versus 70.1%, 76.5 versus 90.1%, and 88.2 versus 90.1%. Freedom from re-intervention rates at 12 and 36 months were, respectively, 78.8 and 68.4% for group 2 and 86.4% and 65.2% for group 1. Conclusion SIA plus stenting is an effective and useful option for the management of claudicants with femoropopliteal occlusions, and can be considered as complementary to surgical bypass.

Recently, subintimal angioplasty has been introduced as a bailout strategy to improve the success rate of PCI for vessels with CTO. However, the long-term outcome of subintimal angioplasty has not been determined, and a limitation of subintimal angioplasty is the uncertainty in making the re-entry point. We report two cases, where occlusive in-stent restenosis occurred in a stent implanted in the subintimal space of the RCA that had CTO. These two cases were successfully treated with bypass restenting across the struts of an occluded subintimal stent using a retrograde approach. A retrograde wire crossed the occluded segment through the lumen along the outside of the stent and reentered the inside of the stent across the stent struts. The reverse CART technique followed by multiple restenting across the stent struts restored antegrade flow. Follow-up angiography demonstrated the patency of the RCA.

Objective: The aim of this study was to evaluate duplex ultrasound arterial mapping (DUAM) as the sole imaging modality when planning for bypass surgery (BS) and endovascular revascularization (EvR) in patients with critical limb ischemia for TransAtlantic Inter-Society Consensus (TASC) II C/D infrainguinal lesions. Methods: This was a retrospective review evaluating the accuracy of DUAM as the sole imaging tool in determining patient suitability for BS vs EvR. Primary outcomes were the sensitivity and specificity of DUAM compared with intraoperative digital subtraction angiography. Secondary outcomes were procedural, hemodynamic, and clinical outcomes, amputation-free survival, and freedom from major adverse clinical events. Results: From 2002 to 2012, a total of 4783 patients with peripheral arterial disease were referred, of whom 622 critical limb ischemia patients underwent revascularization for TASC C and D lesions (EvR: n = 423; BS: n = 199). Seventyfour percent of EvR and 82% of BS were performed for TASC D (P = .218). The DUAM showed sensitivity of 97% and specificity of 98% in identifying lesions requiring intervention. Of the 520 procedures performed with DUAM alone, there was no difference regarding the number of procedures performed for occlusive or de novo lesions (EvR: 65% and 71%; BS: 87% and 78%; P = .056). Immediate clinical improvement to the Rutherford category

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.

Os autores relatam um caso de estenose de artéria hepática transplantada tratada com angioplastia e stent, que evoluiu para trombose completa após 30 dias do procedimento. Realizada trombólise intra-arterial e angioplastia subintimal com sucesso. Controle angiotomográfico após 90 dias demonstra perviedade da artéria hepática.

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.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.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).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.

The subintimal angioplasty is one of the most frequent techniques used for total chronic occlusion (CTO) treatment. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We present a case of a 85-yearold man with symptomatic CTO of the left superficial femoral artery (SFA). After initially unsuccessful subintimal recanalization with Confianza wire, Pioneer Plus Catheter with Intravascular Ultrasound Volcano system guidance were used for a true lumen re-entry. Finally lesion was treated with angioplasty and stents. Procedure was successful without complications, no residual stenosis was noted. The patient was discharged home four hours after procedure. The one day and three weeks follow up showed no vascular complications and the patient had no residual symptoms. The ankle-brachial index of the left extremity has improved from baseline 0.22 to 0.98.

The last 20 years have seen considerable advances in the management of vascular diseases both in non-invasive imaging and minimally invasive surgical interventions. Colour duplex ultrasonography provides non-invasive and increasingly high-resolution anatomic and haemodynamic vascular information. This has been complimented by the development of minimally invasive interventional procedures such as subintimal angioplasty and endovenous treatments, all of which can be performed under local anaesthesia. These advances can now be utilized to improve both the assessment and management of patients with chronic leg ulceration where the aetiology is usually vascular and mostly primary venous insufficiency. Using non-invasive Doppler pressures and colour duplex imaging, the anatomic and haemodynamic pattern of the underlying vascular disease (and consequently the pathophysiology) can be precisely determined. This enables appropriate planning and targeting of effective management from an early stage in the history of any particular ulcer. This paper highlights the importance of achieving accurate diagnosis and instituting effective treatments that are appropriately targeted at the underlying pathophysiology, in patients with chronic leg ulceration, and describes how recent advances in technology and interventions have substantially increased the tools available to the vascular specialist. Thus allowing safe and effective management of what can otherwise become a prolonged or recurrent disease process.

Patients with severe critical limb ischemia (CLI) due to long tibial artery occlusions are often poor candidates for surgical revascularization and frequently end up with a lower limb amputation. Subintimal angioplasty (SA) offers a minimally invasive alternative for limb salvage in this severely compromised patient population. The objective of this study was to evaluate the results of SA in patients with CLI caused by long tibial occlusions who have no surgical options for revascularization and are facing amputation. We retrospectively reviewed all consecutive patients with CLI due to long tibial occlusions who were scheduled for amputation because they had no surgical options for revascularization and who were treated by SA. A total of 26 procedures in 25 patients (14 males; mean age, 70 +/- A 15 [SD] years) were evaluated. Technical success rate was 88% (23/26). There were four complications, which were treated conservatively. Finally, in 10 of 26 limbs, no amputation was needed. A major amputation was needed in 10 limbs (7 below-knee amputations and 3 above-knee amputations). Half of the major amputations took place within 3 months after the procedure. Cumulative freedom of major amputation after 12 months was 59% (SE = 11%). In six limbs, amputation was limited to a minor amputation. Seven patients (28%) died during follow-up. In conclusion, SA of the tibial arteries seem to be a valuable treatment option to prevent major amputation in patients with CLI who are facing amputation due to lack of surgical options

Objectives The aim of this study was to determine accurate estimates of the success rate of subintimal angioplasty in terms of ability to recanalise occluded vessels, patency over time and limb salvage rates. Design A meta-analysis of published literature. Materials All studies reporting unique patient data published in English language between 1989 and 2008. Methods Separate meta-analyses were performed for immediate technical success, 12-month patency rates and 12-month limb salvage rates. Longer-term outcomes were analyzed in separate meta-analyses. Meta-regression was applied to determine whether any of these outcomes had improved over time. Results Pooled estimates for technical success, primary patency at 12 months and limb salvage at 12 months were 85.7% (95% confidence interval: 83.3%–87.7%, 2810 limbs), 55.8% (95% confidence interval: 47.9%–63.4%, 1342 limbs), and 89.3% (95% confidence interval: 85.5%–92.2%, 2810 limbs), respectively. Regression analysis demonstrated no significant change in outcomes over time. There was some evidence of publication bias, however, after adjusting for this there was little change in the pooled outcome estimates. Conclusions This study demonstrates that the outcomes for subintimal angioplasty are good and that this method should be considered as an alternative to surgical bypass.

Purpose To determine the clinical outcomes and success rates after percutaneous subintimal angioplasty (SIA) in patients with lower-limb occlusive lesions causing intermittent claudication (IC) or critical limb ischemia (CLI) at midterm to long-term follow-up. The secondary aim was to elicit factors predictive of a successful outcome. Materials and Methods Between January 1999 and June 2006, 75 consecutive patients (45 men; age range, 46–91 years; CLI in 79%) underwent SIA of iliac and infrainguinal (84%) occlusions. Outcomes were determined on an intent-to-treat basis. The composite endpoint of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up, which was defined as the development of IC, CLI, or need for subsequent endovascular or surgical revascularization. Actuarial freedom from MACO was assessed via Kaplan-Meier curves and multivariable Cox proportional-hazards regression. Results SIA was performed on 75 lesions, with an initial procedure success rate of 83% ( n = 62). Procedure failure was caused by heavily calcified lesions ( n = 5) and failure of reentry ( n = 8). A total of 56.3% of patients with claudication were free from ipsilateral claudication at follow-up (mean, 32 months; range, 1–64 months), and those with CLI had a 79.7% limb salvage rate at a mean follow-up of 30.7 months (range, 0.5–91 months). On Cox regression analysis, the following variables were identified as independent predictors of MACO within the limb treated with SIA: ABI after SIA (hazard ratio, 0.21; 95% CI, 0.05–0.89; P = .035) and number of patent runoff vessels (ie, ≤1 vs ≥2; hazard ratio, 0.29; 95% CI, 0.15–0.59; P = .001). Conclusions SIA is a feasible therapeutic option for occlusive atherosclerotic lesions in IC and CLI and is the evolving preferred strategy in CLI and perhaps IC with long-segment occlusions.

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.

The objective of this study was to summarize outcomes of subintimal angioplasty (SA) for peripheral arterial occlusive disease. The Cochrane Library, Medline and Embase databases were searched to perform a systematic review of the literature from 1966 through May 2007 on outcomes of SA for peripheral arterial occlusive disease of the infrainguinal vessels. The keywords “percutaneous intentional extraluminal revascularization,” “subintimal angioplasty,” “peripheral arterial disease,” “femoral artery,” “popliteal artery,” and “tibial artery” were used. Assessment of study quality was done using a form based on a checklist of the Dutch Cochrane Centre. The recorded outcomes were technical and clinical success, primary (assisted) patency, limb salvage, complications, and survival, in relation to the clinical grade of disease (intermittent claudication or critical limb ischemia [CLI] or mixed) and location of lesion (femoropopliteal, crural, or mixed). Twenty-three cohort studies including a total of 1549 patients (range, 27 to 148) were included in this review. Methodological and reporting quality were moderate, e.g., there was selection bias and reporting was not done according to the reporting standards. These and significant clinical heterogeneity obstructed a meta-analysis. Reports about length of the lesion and TASC classification were too various to summarize or were not mentioned at all. The technical success rates varied between 80% and 90%, with lower rates for crural lesions compared with femoral lesions. Complication rates ranged between 8% and 17% and most complications were minor. After 1 year, clinical success was between 50% and 70%, primary patency was around 50% and limb salvage varied from 80% to 90%. In conclusion, taking into account the methodological shortcomings of the included studies, SA can play an important role in the treatment of peripheral arterial disease, especially in the case of critical limb ischemia. Despite the moderate patency rates after one year, SA may serve as a “temporary bypass” to provide wound healing and limb salvage.

The endovascular recanalization of long infrainguinal arterial occlusions has made significant progress in the past decade. The technique of subintimal angioplasty has opened the door to the treatment of lesions uncross-able using standard transluminal approaches. With the advent of new wires and catheters designed to traverse long lesions, and reentry devices used to facilitate the subintimal approach, percutaneous treatment has made substantial inroads into territory previously dominated by surgical bypass. Advances in stent technology have improved deliverability and patency in these difficult applications. Percutaneously delivered covered endografts into the femoropopliteal segment may allow better patency by performing like endoluminal prosthetic bypasses. In this article, we review the latest technology available to treat occlusions of the femoropopliteal arterial segment.

Purpose: To evaluate long-term patency and clinical efficacy of subintimal angioplasty (SAP) of occluded infrainguinal arteries 3 years post procedure. Methods: One hundred eighty-one patients (92 men; median age 79 years) underwent attempted SAP in 193 limbs with occluded infrainguinal arteries during the period 1999 to 2001. Nearly half (83, 46%) of the patients had diabetes. Most (172, 95%) had critical ischemia (Fontaine classification >II). All patients surviving at least 3 years after the procedures were followed in January 2005 with questionnaires, clinical examinations, ankle-brachial index measurements, and duplex ultrasonography. All data were collected prospectively and analyzed retrospectively. Results: The primary technical success in the entire cohort was 77% (148/193). Thirty-day mortality was 10% (19/181); 113 (62%) patients died before the 3-year follow-up. In the 68 (38%) survivors (71 limbs), patency at 49.2 months (IQR 40.8-57.6) was 40% (26/65 limbs imaged by duplex). The TASC classification did not affect technical or clinical outcomes. Forty-six (68%) of the survivors presented with clinical improvement (lower Fontaine classification at postoperative follow-up versus baseline). The limb salvage at >3 years was 86% in the 58 primarily successful SAPs and 38% in the 13 procedures that failed initially. Conclusion: SAP is a minimally invasive option for patients with critical limb ischemia. A primary technical success is essential for good clinical outcome and primary technical failure is more devastating than late occlusion. TASC classification and length of the SAP are of poor predictive value. More data are needed to confirm the efficacy of SAP. (Less)

To describe the hydrodynamic boost (HB) technique and report our preliminary results with this technique in the subintimal angioplasty of below-the-knee vessels. 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. 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. 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. • 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.

Objectives To describe our experience with iatrogenic arterio-venous fistula (AVF) occurring during lower limb subintimal angioplasty, their management and the final clinical, radiological outcome. Design Retrospective review of case series from two centres, from a computerised database over a period of five years. Material Twelve patients whose lower limb subintimal angioplasty was complicated by Iatrogenic AVF. Results The Majority of AVF occurred at the popliteal trifurcation vessels. And the incidence of this complication in our case series was 0.8%. This was managed with a variety of techniques-Coil embolisation, balloon tamponade, alternative dissection and stent placement. In one patient, the fistula was left open intentionally. All twelve patients had a successful angioplasty. The overall technical success rate for AVF ablation was eighty percent. Conclusions AVF is a potential complication of angioplasty. The majority can be managed by endovascular means during the angioplasty procedure with good technical success.

ObjectiveThe acute technical failure of endovascular treatment of chronic total occlusions (CTOs) is most often due to the inability to re-enter the true lumen after occlusion is crossed in a subintimal plane. This study reports our initial experience with true lumen re-entry devices in the treatment of CTOs.MethodsPatients with treatment of CTOs were identified from our vascular registry. All patients in whom the Pioneer catheter or the Outback catheter were used were also identified from a prospectively maintained separate database of cases in which true lumen re-entry devices were used. We used procedural data from the prospective database and reviewed the medical records. Lesion character and location, access type, location of true lumen re-entry, stent usage, procedural times, and complications, were tabulated.ResultsFrom August 2003 to December 2004, endovascular techniques were used to treat 87 CTOs in 58 iliac and 29 superficial femoral arteries. In 24 (26%), the true lumen could not be re-entered by using standard catheter and wire techniques. The true lumen was not initially re-entered in 20 (34%) of 58 of treated iliac CTOs and four (13%) of 29 of treated superficial femoral artery CTOs (73% TASC C and D lesions). Intravascular ultrasound-guided true lumen re-entry using the Pioneer catheter (21 CTOs), or fluoroscopic-guided true lumen re-entry using the Outback catheter (3 CTOs) was successful in achieving true lumen re-entry in all cases at the location desired. Total time of re-entry catheter manipulation required to achieve re-entry was

The interest in and overall usage of endovascular procedures for the treatment of lower extremity ischemia continues to grow at a rapid pace. An increasing number of centers throughout the world are gaining experience with subintimal angioplasty. Promising results have been reported and the application of the technique has been expanded to include the iliac and crural arteries. The technique of subintimal angioplasty and several variations are discussed. Although primary patency rates compared with bypass are relatively low for patients undergoing subintimal angioplasty, limb salvage rates remain high. When a subintimal angioplasty fails, it frequently does so without the recurrence of symptoms, especially when a gangrenous lesion or ulcer has healed. Given the many advantages of this technique, which include reduced anesthesia requirements, a minimally invasive approach, and potential reductions in length of stay and cost, subintimal angioplasty will continue to have a role in the treatment of lower extremity ischemia. When applied judiciously, bypass options may be preserved. This does not, however, mean that the availability of this technique should be used as justification to lower the threshold for the treatment.

Introduction Subintimal angioplasty is a well-recognised treatment method for stenosis and occlusions in peripheral arterial occlusive disease. In patients with extensive atherosclerosis, large pelvic collateral networks may signify concomitant mesenterial artery disease. Case report We describe a patient in whom a percutaneous subintimal angioplasty of the external iliac artery was complicated by acute bowel ischaemia due to occlusion of important mesenteric collaterals. After urgent bypass surgery, the patient made a full recovery. Conclusion This report emphasises the importance of recognising mesenteric collateral formation from the iliac arteries in endovascular procedures, as the mesenterial vascularisation may depend heavily on it.

Subintimal angioplasty is a relatively new endovascular approach for the treatment of patients with femoropoliteal or tibial artery occlusion. The procedure involves intentionally creating a false channel or dissection around an arterial occlusion, then reentering the true lumen distally. The procedure has a relatively low incidence of complications and a high rate of technical success. Short-term patency has been fair in some reports and poor in others. Long-term results are not available. Aspirin and possibly anticoagulation or antiplatelet agents may improve technical success and short-term patency. Further studies with longer follow-up are required before it can be recommended as a potentially viable alternative to arterial bypass.

PURPOSE To compare the 30-day morbidity, mortality, length of hospital stay, and patency rates in patients with critically ischemic limbs treated with subintimal angioplasty (SA) versus standard bypass surgery. METHOD Between October 2001 and August 2003, 137 patients (74 women; mean age 70 years, range 43-92) with critical limb ischemia underwent subintimal angioplasty (n=88) or bypass surgery (n=49) for superficial femoral artery (SFA) or aortoiliac lesions. All patients had lesions classified as C or D according to the TransAtlantic Inter-Society Consensus. Data was retrieved from hospital inpatient inquiry and VascuBase. Parallel group comparison was used in performing a prospective observational study. RESULTS Primary technical success was 100% for both SA and bypass grafting. Thirty-day survival was 100% in the SFA-SA and aortoiliac bypass groups and 96% and 93%, respectively, in the SFA bypass and aortoiliac SA groups. Limb salvage was 97% and 82% in the SFA-SA and SFA bypass groups, respectively; at the aortoiliac levels, the rates were 100% and 86% for SA versus bypass. Subintimal angioplasty significantly reduced hospital stay (p

l l Purpose: To present our experience with subintimal recanalization of chronic iliac occlu- sions and retrospectively compare the results of this technique with those of standard intraluminal recanalization Methods: A retrospective review was conducted of 98 patients (91 men; mean age 61610 years, range 37-77) with unilateral chronic iliac occlusions who underwent standard intra- luminal recanalization or subintimal recanalization if intraluminal wire passage failed. The technical success, complications, and patency rates were statistically compared between groups. Results: In 59 (60%) of 98 patients, the occlusions were successfully crossed with ipsilateral intraluminal recanalization, while failure of intraluminal recanalization in the remaining 39 led to attempted subintimal recanalization (ipsilateral in 17 and antegrade-retrograde in 22). Overall, ipsilateral intraluminal recanalization was technically successful in 56 (57%) of 98 patients; subintimal recanalization was successful in 35 (90%) of 39 patients. Tech- nical success was only 29% in 17 patients who underwent subintimal recanalization via an ipsilateral retrograde approach. During a follow of 27616 months, primary and assisted primary patencies were not significantly different between the patients treated with intra- luminal versus subintimal recanalization (p50.81 and 0.64, respectively). Conclusions: Subintimal recanalization is a safe and effective supplement to standard in- traluminal recanalization techniques in the endovascular treatment of chronic iliac occlu- sions. Because of the poor outcome associated with the ipsilateral route, subintimal re- canalization of these lesions should preferably be performed via a combined antegrade-retrograde approach. J Endovasc Ther 2004;11:107-118

Percutaneous treatment of peripheral arterial disease has evolved greatly. The prevalence of superficial femoral artery occlusions has necessitated new devices and techniques to treat these patients percutaneously. Presently several therapies are available or under investigation. These range from stents, drug eluting stents, covered stents, cryoangioplasty, laser recanilization, blunt micro dissection, and subintimal angioplasty. This paper will discuss the indications, technique, and results of subintimal angioplasty.

Aim Comparison between intraluminal and subintimal angioplasty with review of technique, factors affecting the success and complications with special emphasis on factors that could predict the wire route meanwhile using simple techniques. Methods This is a non-randomized study with prospectively collected data that included 159 patients presented from 2011 to 2014 to the vascular surgery department with critical chronic lower limb ischemia due to atherosclerotic femoropopliteal occlusive disease for whom percutaneous angioplasty was done. Patients presenting with nonsalvageable limbs requiring primary major amputation and non-atherosclerotic causes of CLI were excluded. Results 75.5% of the lesionswere crossed transluminally while 19.5% of the lesions were crossed subintimally. In 8 cases (5%) the lesion could not be passed. The overall technical success to pass the lesion was 95%. On 24 months follow up, 1ry patency, 2ry patency, limb salvage in intraluminal group are 56.8%, 60.2% and 66.1% respectively while in subintimal group 46.7%, 46.7% and 60% respectively. Subintimal was more in the TASC D, lesion more than 10 cm and in contralateral access (P value was

The endoluminal femoropopliteal bypass is a minimally invasive treatment modality for occlusive superficial femoral artery disease. Technical failure of endovascular treatment of chronic total occlusions is often caused by the inability to re-enter the true lumen. Re-entry devices have a high technical success-rate, but increased procedural costs. We describe an alternative technique using an ipsilateral combined antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass. In a supine position, with the leg elevated at 30 degrees, the popliteal artery is punctured and a 4F introducer sheath is introduced. The occlusion is crossed from distal to proximal and the wire is advanced through a 6F sheath that is positioned in the common femoral artery. The occlusion is predilated from proximal and the "re-entry" site is identified on an angiogram. The wire is then withdrawn into the balloon catheter and advanced intraluminally into one of the crural vessels. After confirming the intraluminal position of the wire, the 4F sheath is removed, and the endoluminal bypass is created in a standardized fashion. The ipsilateral antegrade-retrograde approach is a fast, inexpensive, and easy-to-learn technique, using standard materials only. The distal entry of the occlusion will lead to a minimization of the length of the endoluminal bypass, thereby possibly sparing collaterals and future surgical options. (J Vase Surg 2011;54:1205-7.)

To investigate the phenomenon of distal embolization during subintimal angioplasty with or without stenting of femoropopliteal chronic total occlusions (CTOs).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 0+ to 3+ score.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 (diameter100 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+).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.

WOS: 000351491700017 PubMed: 24846517 Background: This study was conducted to evaluate the initial and mid-term patency rates of chronic total femoropopliteal artery (FPA) occlusions treated by subintimal angioplasty (SIA) and stenting. Methods: From March 2010 to February 2013, 74 patients were included in the study. Seventy two patients with total occlusion of the FPA and good distal runoff (2 or 3 patent vessels) were treated with percutaneous SIA and stenting. All patients had severe claudication or critical limb ischemia. In all cases, the procedure was performed with a contralateral approach. Follow-up was done at 6 months with clinical evaluation and color-Doppler. If it was necessary, peripheric angiography was performed. Results: Immediate technical success was achieved in 72 (97%) patients. Two (3%) distal embolizations, 2 (3%) groin hematomas, 1 (1%) femoral pseudoaneurysm and 1 (1%) rupture of the junction-external iliac-superficial femoral artery occurred. All of the complications were treated successfully. Total occlusion in 1 patient and critical occlusion in 3 patients were showed at the 6th month. Patency rate at the sixth month was 94% with a stent length of 13.4 +/- 8.2 cm. Conclusions: Percutaneous SIA and stenting for chronic total of the FPA occlusion showed good initial and mid-term patency rates, with few periprocedural complications.

Introduction popliteal embolectomy and the final patient was sucessfully treated with conservative management (Table Percutaneous transluminal angioplasty (PTA) is an 1). established technique in the management of arterial 5000 IU of Heparin are given routinely prior to disease. The incidence of distal embolisation in our angioplasty through the catheter and Aspirin institution during both subintimal angioplasty and 75–150 mg OD, following the procedure. This protocol transluminal angioplasty is 3.5%. This compares to is not modified following successful aspiration or recently published complication rates of transluminal pushing and parking of emboli. angioplasty of 3.7% and a 2.5% rate of occlusive An 8 French embolectomy non-tapered teflon coated complications in a larger series of 1141 patients. Concatheter is used to attempt removal of embolus by ventionally the options for embolectomy would be to aspiration in the first instance. The technique involves consider aspiration, thrombolysis or surgical readvancing the catheter over a guidewire to the level moval. We have employed an alternative technique of the embolus until free back bleeding has ceased. in the event of failure to aspirate an embolus, which Suction is then applied with the use of a 50 ml syringe. involves pushing the embolus distally. Suction is maintained whilst the catheter is moved to and fro in the artery to aid engagement of the embolic material. The catheter is then withdrawn to the sheath with constant suction maintained and finally extracted, Technique with the haemostasis valve removed to prevent dislodgement. The technique was employed in six patients (four However, in some cases the applied suction fails to male), age range 62 to 85, between February 1997 engage the embolus. In these cases when there is more and August 1999. Of the six patients, PTA was being than one runoff vessel, the technique of ‘‘push and performed for critical ischaemia in five and inpark’’ becomes applicable. The same 8F non-tapered termittent claudication in one. One thousand and catheter without the wire is used to push the embolus. twenty-seven angioplasties were performed during The favoured straight path usually lands the embolus this period. In patients with thromboembolic cominto the peroneal artery. The aim is to leave at least plications, aspiration was successful in 68% of attempts one remaining vessel with free flow. Placing the wire with the technique of push and park used in 21%. Of the remaining 11%, two patients went on to have into the artery with the poorest distal circulation may below knee amputations, one patient had a surgical allow selection of the vessel into which the embolus is pushed and has been adopted for future cases. Modifying the technique in this way would have the ∗ Please address all correspondence to: A. Higginson, Department of Radiology, Leicester Royal Infirmary, Leicester LE1 5WW, U.K. added advantage of avoiding pushing the catheter

Objectives: to evaluate the feasibility and preliminary results at 1 year of subintimal angioplasty of tibial occlusions in critical limb ischaemia (CLI). Material: from December 1997 to December 1999, we intended to treat 36 patients and 40 limbs by subintimal angioplasty of occlusions of tibial vessels. Thirty-one had gangrene or ulceration and nine had rest pain. Twenty-seven occlusions were more than 10 cm, 10 were 5 to 10 cm and three were less than 5 cm in length. Three patients had an occluded previous ipsilateral bypass graft. All patients were followed 3 monthly for a median of 10 months by means of clinical and duplex examination. Results: the technical success rate was 78% (31/40). Nine technical failures were treated by conventional surgery or angioplasty of another diseased tibial vessel. The clinical success rate was 68% (27/40). Four below-the-knee amputations were performed despite a patent recanalisation. Primary and secondary patency rates at 12 months were 56% (72% without technical failures). The 12-month limb salvage rate was 81% and survival rate was 78%. Three of five complications were treated by endovascular procedures. The length of occlusion (>10 cm) but not the location of distal re-entry, the type of vessel re-entry and the presence of diabetes are predictors of technical success and patency. Conclusions: subintimal angioplasty can be used to treat tibial occlusions in patients with CLI. Technical failure does not preclude conventional surgery and complications may often be treated by endovascular procedures. However, the durability of angioplasty is as yet uncertain.

Purpose: To describe an open approach to subintimal angioplasty. Technique: Through a subinguinal incision and arteriotomy over the superficial femoral artery origin, the opening of a subintimal channel is created surgically. The subintimal plane is advanced distally with a guidewire, and this neolumen is expanded with sequential balloon dilations. The atherosclerotic core is dissected proximally in the common femoral artery and tacked down to ensure inflow. A patch graft closes the arteriotomy. Conclusions: Open subintimal angioplasty is a simple, minimally invasive alternative treatment for complete SFA occlusion. Long-term follow-up in a large group of patients will be necessary to determine the durability of the false arterial lumen.