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.

Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study.

BACKGROUND: The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque. METHODS: The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab. RESULTS: 97 (77 in USA) PAD subjects (51 male, mean 70.5 years [range 46-86]) with 107 lesions were treated with B-Laser™ (average length 5.4 cm [range 1-24], 29.0% infrapopliteal. 77.6% calcification [26.2% severe], 21.5% chronic total occlusions, 20.6% re-stenotic). Average reduction in residual stenosis post B-Laser™ alone was 33.6 ± 14.2%. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. Duplex patency was 96.8% at 30-days and 85.6% at 6 months (95.7% 6-month patency with severe calcification), and did not differ between POBA vs. DCB sub-groups. ABI, Rutherford category and WIQ all improved. There was one MAE and three TLRs out of 101 lesions. No procedural distal embolization was noted and there were no major device-related dissections. CONCLUSIONS: Experience with the B-Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.

Multidisciplinary Care for Critical Limb Ischemia: Current Gaps and Opportunities for Improvement.

Critical limb ischemia (CLI), defined as ischemic rest pain or nonhealing ulceration due to arterial insufficiency, represents the most severe and limb-threatening manifestation of peripheral artery disease. A major challenge in the optimal treatment of CLI is that multiple specialties participate in the care of this complex patient population. As a result, the care of patients with CLI is often fragmented, and multidisciplinary societal guidelines have not focused specifically on the care of patients with CLI. Furthermore, multidisciplinary care has the potential to improve patient outcomes, as no single medical specialty addresses all the facets of care necessary to reduce cardiovascular and limb-related morbidity in this complex patient population. This review identifies current gaps in the multidisciplinary care of patients with CLI, with a goal toward increasing disease recognition and timely referral, defining important components of CLI treatment teams, establishing options for revascularization strategies, and identifying best practices for wound care post-revascularization.

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.

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.

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.

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.

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.

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.

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

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

Extreme below-the-knee interventions: retrograde transmetatarsal or transplantar arch access for foot salvage in challenging cases of critical limb ischemia.

PURPOSE: To describe advanced retrograde access (transmetatarsal or transplantar arch) for endovascular treatment of critical limb ischemia (CLI) and foot salvage. METHODS: From September 2011 to March 2012, 28 CLI patients (24 men; mean age 71.9 ± 10.6 years) being treated for foot salvage had failed antegrade recanalization, and percutaneous retrograde access at the pedal or plantar artery was unavailable. Advanced retrograde access techniques were required to recanalize the target vessel to restore blood flow to the compromised tissue. After local administration of verapamil to control spasm, the first dorsal metatarsal artery was preferentially accessed with a 21-G needle. When the first metatarsal artery was occluded and not fluoroscopically viewable, the plantar arch was punctured directly. After puncture, a 0.018- or 0.014-inch guidewire and microsheath were inserted for retrograde recanalization of the foot and tibial arteries with balloons sized to the target vessels. RESULTS: Retrograde transmetatarsal artery access was performed in 25 cases and direct transplantar arch access in 3. Technical success (ability to deliver the balloon across the lesion and inflate it at nominal pressure) was achieved in 24 (86%) cases, with <50% residual stenosis and no complications. The 4 technical failures were due to spasm or no true lumen re-entry after successful transmetatarsal (n=3) and transplantar arch access. During a mean 5-month follow-up (range 1-8), clinical improvement was obtained in the patients having technically successful tibial and foot artery recanalization; the transcutaneous pressure improved from 12.5 ± 6.7 to 49.8 ± 9.5 mmHg. There were no major and only 8 minor amputations. Amputation-free survival estimated by Kaplan-Meier analysis was 71% at 6 months. In patients with failed advanced access, the clinical condition did not improve. CONCLUSION: The advanced retrograde access technique appears feasible and beneficial as a rescue strategy in challenging patients with a failed antegrade approach who are unsuitable for retrograde pedal/plantar access.

Below-the-Ankle Orbital Atherectomy in Chronic Limb-Threatening Ischemia Patients as a Bailout Strategy for Limb Salvage: Early Clinical Experience.

PURPOSE: To evaluate the feasibility and early outcomes of below the ankle orbital atherectomy in chronic limb-threatening ischemia in patients with calcified foot arteries. METHODS: 12 patients (mean age 69.4 ± 14.7; range 57 to 85 years) who were affected by diabetes underwent orbital atherectomy below the knee and ankle arterial segments. Technical success was defined as orbital atherectomy passage and debulked the calcified lesion, delivery of adjunctive therapy, and < 30% residual stenosis at final angiogram. The procedural outcome included complications, amputation-free survival, and freedom from clinically-driven target lesion revascularization at 30-days and 6-months of follow-up. RESULTS: Orbital atherectomy was performed in 3 cases in Anterior tibial (AT) and dorsalis pedis (Ped) arteries + Posterior tibial (PT) and Lateral Plantar (Lat Plan), 5 cases in PT and Lat Plan arteries, 1 case of PT and Medial Plantar, 1 case of Peroneal and Plan Lat, and 2 cases of AT and Ped. After atherectomy, we used a drug-coated balloon (DCB) angioplasty. Technical success was achieved in 11 (91.6%) cases. No deaths were registered during the follow-up. The limb salvage rate was 100%, and no major amputations were registered. Amputation-free survival was 50%. Freedom from CD-TLR was 100% at 30 days and 91.7% at 6-months. One patient underwent a TLR at three months. No major cardiovascular events, limb events, or significant procedure-related complications were registered. CONCLUSIONS: CSI orbital atherectomy and DCB angioplasty appear a feasible and promissor treatment options in diabetic CLTI patients.

Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial.

BACKGROUND: B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. METHODS: EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. RESULTS: A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ±â€¯43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ±â€¯12.2 (femoro-popliteal 85.6 ±â€¯12.8%; tibials 86.0 ±â€¯9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ±â€¯14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ±â€¯0.18), Rutherford category (-1.79 ±â€¯1.22) and WIQ (0.26 ±â€¯0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. CONCLUSION: The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization.

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.

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.

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.

Endovascular treatment of in-stent occlusion: new technique for recanalization of long superficial femoral artery occlusion (direct stent puncture technique).

In-stent reocclusion is a frequent complication of endovascular treatment and stenting, especially in the superficial femoral artery. Neointimal hyperplasia is the main cause of this problem, but in many cases, it occurs as a result of the presence of stent strut fractures. The two treatment options are endovascular and surgical intervention. The effectiveness of endovascular interventions in patients with critical limb ischemia has been well established, but in some cases, crossing the occluded stent is difficult. We describe a new technique to recanalize long in-stent superficial femoral artery occlusions characterized by direct stent puncture, followed by retrograde-antegrade recanalization after antegrade failures.