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

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

Below-the-Knee Endovascular Revascularization: A Position Statement.

Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.

CIRSE Standards of Practice on Below-the-Knee Revascularisation.

The CIRSE Standards of Practice Committee established a writing group that was tasked with producing up-to-date recommendations for performing below-the-knee revascularisation, taking into account data on novel techniques, devices, and long-term outcomes that have emerged over the last decade. CIRSE Standards of Practice documents are not clinical practice guidelines or systematic reviews of the literature. This document is not intended to impose a standard of clinical patient care but recommends a reasonable approach to and best practices for performing below-the-knee revascularisation.

Anterolateral retrograde access to the distal popliteal artery and to the tibioperoneal trunk for recanalization of femoropopliteal chronic total occlusions.

OBJECTIVES: To describe and assess the safety of a technique for the percutaneous retrograde access to either the P3 segment of the popliteal artery or the tibioperoneal trunk (TPT) through the anterior muscle compartment of the leg to treat distal femoropopliteal chronic total occlusion (CTO). METHODS: After a failed antegrade attempt of endovascular recanalization of a femoropopliteal CTO, 41 symptomatic patients (29 men; mean age of 75.8 ± 8.4 years) underwent a percutaneous retrograde access by means of the puncture of the TPT in 15 cases (36.6%) and of the P3 tract of popliteal artery in 26 cases (63.4%). The puncture was performed on the anterolateral aspect of the proximal leg through the anterior muscle compartment with the patient in a standard supine position. Access to the vessel was obtained with a sheathless approach. After retrograde recanalization and guidewire rendezvous, the distal wire was retrieved proximally and a standard antegrade endovascular intervention was carried out. RESULTS: Retrograde access was achieved successfully in all patients. Recanalization was carried out in 16 cases (39.0%) with an endoluminal technique and in 25 cases (61.0%) in a subintimal fashion. Hemostasis was successfully attained in 31 patients (75.6%) by inflating a blood pressure cuff at the calf. In 11 cases (26.8%), the hemostasis was accomplished instead by means of a low-pressure ballooning as a bailout strategy for small residual bleedings. The transcutaneous oximetry at the 1-month follow-up from the procedure was significantly increased compared with the preprocedural values (10.4 ± 6.8 vs 42.4 ± 18.7 mm Hg; P < .01). No early or late postoperative access-related complications were observed at a mean follow-up of 12.6 ± 9.5 months. CONCLUSIONS: After a failed antegrade approach, the anterolateral retrograde puncture of the P3 or of the TPT is a valuable and safe technique to treat femoropopliteal CTOs in selected patients, regardless the distal spread of the lesion to the popliteal artery.

Precise Retrograde Supera Stenting of the Ostium (PRESTO) of the Superficial Femoral Artery for Complex Femoropopliteal Occlusions: The PRESTO Technique.

PURPOSE: To describe a novel technique designed to safely and precisely deploy the Supera stent accurately at the ostium of the proximal superficial femoral artery (SFA) without compromising the profunda and common femoral arteries. TECHNIQUE: After antegrade crossing of the chronic total occlusion (CTO) at the SFA ostium and accurate predilation of the entire SFA lesion, a retrograde arterial access is obtained. The Supera stent is navigated in retrograde fashion to position the first crown to be released just at the SFA ostium. Antegrade dilation is performed across the retrograde access site to obtain adequate hemostasis. The technique has been applied successfully in 21 patients (mean age 78.1±8.2 years; 13 men) with critical limb ischemia using retrograde Supera stenting from the proximal anterior tibial artery (n=6), the posterior tibial artery (n=2), retrograde stent puncture in the mid to distal SFA (n=2), the native distal SFA/proximal popliteal segment (n=6), and the distal anterior tibial artery (n=5). No complications were observed. CONCLUSION: Distal retrograde Supera stent passage and reverse deployment allow precise and safe Supera stenting at the SFA ostium.

Drug-coated balloon angioplasty for the management of recurring infrapopliteal disease in diabetic patients with critical limb ischemia.

OBJECTIVE: To describe the 1-year outcomes of recurring infrapopliteal disease after endovascular revascularization with the Lutonix drug-coated balloons (LDCB) in diabetic patients with critical limb ischemia (CLI), and to benchmark our findings with previously published objective performance goals (OPG) addressing safety and efficacy of new catheter-based therapies for CLI. METHODS: The present study was a retrospective, single-center, and single-arm trial of symptomatic diabetic patients with CLI, who underwent LDCB-angioplasty for recurring infrapopliteal disease. Acute procedural and technical success were recorded. TcPO2 metrics variations at baseline and follow up were analyzed. Freedom from clinically driven target lesion revascularization (CD-TLR) was calculated using Kaplan-Meier analysis, and outcomes compared with previously published OPG for infrapopliteal interventions. RESULTS: 21 patients (15 men; mean age 66,6±11,2 years) were followed-up for 356.5±159.2 days and 90.47% had 12-months follow up data available for analysis. TcPO2 increased (14.3±11.6mmHg to 53.8±11.7mmHg; p<0.05). Limb salvage rate was 100%, and 90.4% of patients achieved the combined endpoint of reduction in ulcer size/depth or complete healing. LDCB had superior efficacy (MALE+post-operative death, amputation free survival, freedom from re-intervention, limb salvage and survival rates), while attaining superior or equivalent safety (Major Adverse Limb Events, major adverse cardiovascular events and Amputation) endpoints for the overall, modified clinical and anatomical high-risk groups. CONCLUSIONS: Lutonix DCB is safe and effective for recurring infrapopliteal disease. It outperforms the OPG for CLI patients with clinical and anatomical high-risk features.

Feasibility and 1-Year outcomes of subintimal revascularization with supera® stenting of long femoropopliteal occlusions in critical limb ischemia: The "Supersub" Study.

BACKGROUND: Stent-based revascularization of long femoro-popliteal (FP) lesions has been mainly studied in claudicants and compromised by restenosis and stent fractures. The Supera® stent's biomimetic design allows enhanced fracture resistance. Data for Supera® stenting to treat long chronic total occlusions (CTOs) in patients with critical limb ischemia (CLI), are scarce. OBJECTIVE: To assess long-term outcomes of subintimal revascularization with Supera® stenting, for long FP CTOs in patients with CLI. METHODS: Prospective, single-center, single-arm study of 34 consecutive CLI patients with FP TASC C and D CTOs, who underwent Supera® stenting after subintimal crossing. Primary efficacy endpoint was 1-year patency and freedom from target lesion revascularization (TLR). Primary safety endpoint was the composite rate of freedom from death from any cause, major amputations, and TLR at a year. Secondary endpoints were stent integrity, clinical improvement, amputation free-survival, quality of life, and cost-efficiency. RESULTS: Mean lesion length was 27.9 ± 10.2 cm. Acute technical success was 100%. Primary patency was 94.1%. Freedom from TLR was 97.1%. Limb salvage was 100%. Clinical improvement was observed in 100% of patients: TC PO2 increased from 12.7 ± 6.2 to 54.8 ± 8.4 mm Hg (p < 0,0001); and 100% of patients experienced a shift in Rutherford to class 0 (p < 0.0001). There were no stents fractures. Amputation free-survival was 82.4%. CONCLUSIONS: Subintimal revascularization with Supera® stenting in CLI patients with long FP occlusions, is feasible and superior to validated efficacy performance goals. Larger multicenter studies are needed to validate the safety and efficacy of this novel alternative approach. © 2016 Wiley Periodicals, Inc.

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

PURPOSE: To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). METHODS: Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ≥4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator's discretion. Follow-up data were obtained 30 days after the procedure. RESULTS: Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. CONCLUSION: Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.

Automated Carbon Dioxide Angiography for the Evaluation and Endovascular Treatment of Diabetic Patients With Critical Limb Ischemia.

PURPOSE: To test the safety, efficacy, and diagnostic accuracy of automated carbon dioxide (CO2) angiography (ACDA) for the evaluation of diabetic patients with critical limb ischemia (CLI) and baseline renal insufficiency and compare ACDA with iodinated contrast medium (ICM) during endovascular treatment. METHODS: From November 2014 to January 2015, 36 consecutive diabetic patients (mean age 74.8±5.8 years; 27 men) with stage ≥3 chronic kidney disease (CKD ≥3) and CLI underwent lower limb angiography with both CO2 and ICM followed by balloon angioplasty in a prospective single-center study. The primary outcome measure was the safety and efficacy of ACDA as the exclusive agent to guide angioplasty in this cohort. The secondary outcomes were the safety and diagnostic accuracy of ACDA injection as compared with ICM digital subtraction angiography (DSA) for invasive evaluation of these patients. RESULTS: ACDA safely and effectively guided angioplasty in all patients without complications. Transcutaneous oxygen pressure improved from 11.8±6.3 to 58.4±7.6 mm Hg (p<0.001). There were no complications related to ACDA during diagnostic imaging and no significant changes in the estimated glomerular filtration rate from baseline to 24 hours (44.7±13.3 vs 47.0±0.8 mL/min/1.73 m(2); nonsignificant). The diagnostic accuracy of CO2 was 89.8% (sensitivity 92.3%; specificity 75%; positive predictive value 95.5%; negative predictive value 63.1%). There was no statistically significant difference in the qualitative diagnostic accuracy between the media (p=0.197). CONCLUSION: ACDA is an accurate, safe, and effective technique that can be utilized to guide endovascular interventions in diabetics with CLI and baseline CKD ≥3. Larger multicenter randomized studies are needed to validate these results.

Guidewires for lower extremity artery angioplasty: a review.

The guidewire (GW) is probably the most important tool for the endovascular treatment of arterial obstructions. In fact, the treatment of a lesion is only possible when the GW is passed beyond the target lesion. Lower limb percutaneous arterial revascularisation can be achieved using a variety of GWs which may differ in calibre, body, tip or coating. As the choice of an appropriate GW is critical for the success of a lower limb artery angioplasty, knowledge of the properties and performances of different GWs should be well known in order to tailor the choice of the device to the lesion characteristics and location, as well as to the intended revascularisation strategy. The aim of the present paper is to describe the constructive characteristics of GWs for lower limb arterial revascularisation, and to evaluate groups of GWs for each segment of the lower limb arterial vasculature.

Treating calf and pedal vessel disease: the extremes of intervention.

Recent developments in catheter, balloon, and guidewire technology have increased the scope for endovascular treatments in the management of complex and challenging disease in the calf and foot. The antegrade femoral approach remains the starting point for most interventions, but there is a growing role for procedures performed from unconventional access such as the pedal arteries. This article reviews the indications for intervention, atypical access, and the choice of equipment for these extreme interventions.

Antegrade pedal approach for recanalizing occlusions in the opposing circulatory pathway of the foot when a retrograde puncture is not possible.

PURPOSE: To describe a novel technical strategy to approach below-the-ankle chronic total occlusions after failed antegrade recanalization in patients who are not candidates for retrograde puncture. TECHNIQUE: After a failure of antegrade recanalization of the tibial and foot vessels, an antegrade pedal access can be performed in the pedal or plantar artery. After crossing the plantar arch and the occlusions in the opposing circulation pathway of the foot, a rendezvous with the antegrade catheter is performed, followed by final angioplasty and hemostasis. CONCLUSION: An antegrade pedal approach to the opposing circulation in the foot may be considered for below-the-ankle recanalization after standard antegrade recanalization failure in patients who are not candidates for a retrograde puncture.

Angiosomes: how do they affect my treatment?

The number of diabetic patients is actually increasing all around the world, consequently, critical limb ischemia and ischemic diabetic foot disorders related to the presence of diabetic occlusive arterial disease will represent in the next few years a challenging issue for vascular specialists. Revascularization represents one step in the treatment for the multidisciplinary team, reestablishing an adequate blood flow to the wound area, essential for healing and avoiding major amputations. The targets of revascularization can be established to obtain a "complete" revascularization, treating all tibial and foot vessels or following the angiosome and wound-related artery model, obtaining direct blood flow for the wound. In this article, we summarize our experience in endovascular treatment of diabetic critical limb ischemia, focusing on the angiosome and wound-related artery model of revascularization and the technical challenges in treating below-the-knee and below-the-ankle vessels.

Prolonged high-pressure balloon angioplasty of femoropopliteal lesions: Impact on stent implantation rate and mid-term outcome.

OBJECTIVES: To assess the impact on stent implantation rate and mid-term outcomes of prolonged high pressure angioplasty of femoropopliteal lesions. METHODS: We retrospectively enrolled 620 consecutive patients from January 2011 to December 2011 (75.6 ± 12.3 years, 355 males, 76.5% in Rutherford class 5-6), referred for critical limb ischemia and submitted to prolonged high-pressure angioplasty of femoropopliteal lesions. The definition of prolonged high-pressure angioplasty includes dilation to at least 18 atm for at least 120 s. Procedural data, and clinical and instrumental follow-up were analyzed to assess stent implantation rate and mid-term outcomes. RESULTS: The preferred approach was ipsilateral femoral antegrade in 433/620 patients (69.7%) and contralateral cross-over in 164/620 (26.4%) and popliteal retrograde + femoral antegrade in 23/620 (3.7%). Techniques included subintimal angioplasty in 427/620 patients (68.8%) and endoluminal angioplasty in 193/620 patients (31.2%). The prolonged high pressure balloon angioplasty procedure was successful in 86.2% (minor intra-procedural complications rate 15.7 %), stent implantation was performed in 74 patients (11.9%), with a significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 00.1) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01), a primary patency rate of 86.7%, restenosis of 18.6 % on Doppler ultrasound and a target lesion revascularization of 14.8% at a mean follow-up of 18.1 ± 6.4 months (range 1-24 months). Secondary patency rate was 87.7%. CONCLUSIONS: Prolonged high pressure angioplasty of femoropopliteal lesions appears to be safe and effective allowing for an acceptable patency and restenosis rates on mid-term.

Discomfort assessment in peripheral angiography: randomized clinical trial of Iodixanol 270 versus Ioversol 320 in diabetics with critical limb ischemia.

OBJECTIVES: To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media (CM) and the impact on diagnostic efficacy in diabetics with critical limb ischemia (CLI). BACKGROUND: Arterial revascularization is a mainstay in patients with CLI. Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results, and it could vary related to the CM agents. METHODS: One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective, double-blind, randomized, parallel-group clinical trial. Injection-associated discomfort was assessed by Visual Analogic Scale (VAS). Diagnostic efficacy and safety up to 1 week were evaluated. RESULTS: The incidence of pain has been around 50% of the all population in study, with lesser incidence of pain (25.7% vs 74.3%; P < 0.0001) and of heat sensation (55.4% vs 85.1%; P < 0.0001), after Iodixanol than after Ioversol injection. Discomfort mean score, according to VAS assessment, was less in the Iodixanol group (8.1 ± 15.3) than in the Ioversol group (36.0 ± 29.7), after first injection (P < 0.001) and for all injections (P < 0.001). A significant difference was also observed in favor of Iodixanol (P < 0.001), respect to mean score of discomfort and heat sensation, assessed by the operators after all the CM injections. CONCLUSIONS: Iodixanol caused less frequent and severe discomfort, characterized as pain and heat during intra-arterial administration compared with Ioversol. The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes.

The clinical utility of below-the-ankle angioplasty using "transmetatarsal artery access" in complex cases of CLI.

OBJECTIVES: To appraise clinical results of foot arteries recanalization using percutaneous retrograde transmetatarsal arteries access followed by retrograde recanalization of foot and tibial vessels. BACKGROUND: Arterial revascularization by means of percutaneous transluminal angioplasty (PTA) is a mainstay in the management of patients with critical limb ischemia (CLI). Nonetheless, when employing standard approaches, success rate remain suboptimal. We report the clinical results of foot arteries recanalization through transmetatarsal artery access. METHODS: From September 2011 to November 2012, 38 patients (28 men; mean age 73.2 ± 11.4 years) underwent transmetatarsal artery access after antegrade recanalization failure, followed by retrograde recanalization of the foot and tibial vessels. The primary end point was TcPO2 improvement. The secondary end point was limb salvage rate, amputation-free survival rate and radiation exposure. RESULTS: Technical success (ability to deliver the balloon across the lesion and inflate it at nominal pressure) was achieved in 33 (86.84%) of cases, with <50% residual stenosis and no complications. Failures were because of spasm or no true lumen re-entry. During follow-up (mean 6.7 ± 2.3 months/range 1-14) clinical improvement was observed in the patients having technical success, with TcPO2 increasing, from 10.3 ± 7.6 to 50.7 ± 8.2 mm Hg, avoiding major amputations. Amputation-free survival rate calculated by Kaplan-Meier analysis was 81.5% at 12 months. Radiation exposition was major than in patients treated by antegrade way (45.5 ± 56.1 vs. 52.5 ± 11.5 min of fluoroscopy and 69.1 ± 83.2 vs. 94 ± 26.5 Gym(2) of X-ray dose; P < 0.001). CONCLUSION: Transmetatarsal artery access appears feasible and beneficial in cases with a failed antegrade recanalization and unsuitable for retrograde pedal/plantar access.

Critical limb ischemia in association with Charcot neuroarthropathy: complex endovascular therapy for limb salvage.

Charcot neuroarthropathy is a low-incidence complication of diabetic foot and is associated with ankle and hind foot deformity. Patients who have not developed deep ulcers are managed with offloading and supportive bracing or orthopedic arthrodesis. In patients who have developed ulcers and severe ankle instability and deformity, below-the-knee amputation is often indicated, especially when deformity and cutaneous involvement result in osteomyelitis. Ischemic association has not been described but can be present as a part of peripheral arterial disease in the diabetic population. In this extreme and advanced stage of combined neuroischemic diabetic foot disease, revascularization strategies can support surgical and orthopedic therapy, thus preventing osteomyelitis and leading to limb and foot salvage.

Direct stent puncture technique for intraluminal stent recanalization in the superficial femoral and popliteal arteries in-stent occlusion: outcomes from a prospective clinical analysis of diabetics with critical limb ischemia.

PURPOSE: To evaluate the efficacy and safety of "Direct Stent Puncture" technique for intraluminal stent recanalization in the femoro-popliteal segments. METHODS AND MATERIALS: A cohort of diabetics who had symptomatic in-stent occlusion of the superficial femoral or popliteal arteries underwent endovascular recanalization. After antegrade failure, direct stent puncture technique was performed. The primary end-point was to efficacy assessment, intended as technical success and clinical improvement. The secondary end-point was safety assessment, intended as free of complication rate. RESULTS: Fifty-four patients (37 men; 73.6±8.5 years) underwent direct stent puncture technique, after several unsuccessful antegrade attempts to cross the occluded stent. Technical success for intraluminal stent recanalization was achieved in 53/54 (98.2%) of cases and failed in 1/54 (1.8%). Clinical improvement was obtained in 51/54 (94.4%) of cases, with regression of the clinical symptoms and improvement of the TcPO2, from 3±18 mmHg to 43±11 mmHg after 15 days (p<0.001). Free of complications rate was 92.5%. In 2/54 (3.7%) of cases distal embolization occurred, in 1/54 (1.9%) case a sudden vessel thrombosis was diagnosed after 12 hours and in 1/54 (1.9%) case hematoma at the stent puncture site was observed. CONCLUSIONS: Direct Stent Puncture technique is an efficacy and safety option for intraluminal stent recanalization in the femoro-popliteal segment in-stent occlusion.