Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Workflow and Patient Satisfaction in Treating Peripheral Arterial Disease in the Office-Based Setting.

Contemporary concepts in health-care reform promote a shift in the provision of care away from hospitals in favor of the more cost-effective and efficient use of outpatient facilities including ambulatory surgery centers and office-based procedure centers particularly in the care of cardiovascular disease. This article reviews the experience of patients and specialists in caring for patients with peripheral arterial disease in an office-based care setting.

Initial experience with the ambulatory management of acute iliofemoral deep vein thrombosis with May-Thurner syndrome with percutaneous mechanical thrombectomy, angioplasty and stenting.

OBJECTIVE: Patients undergoing intervention for acute iliofemoral deep vein thrombosis (IFDVT) with May-Thurner syndrome (MTS) typically require inpatient (IP) hospitalization for initial treatment with anticoagulation and management with pharmacomechanical thrombectomy. Direct oral anticoagulants and percutaneous mechanical thrombectomy (PMT) devices offer the opportunity for outpatient (OP) management. We describe our approach with these patients. METHODS: Patients receiving intervention for acute IFDVT from January 2020 through October 2022 were retrospectively reviewed. Patients undergoing unilateral thrombectomy, venous angioplasty, and stenting for IFDVT with MTS comprised the study population and were divided into two groups: (1) patients admitted to the hospital and treated as IPs and (2) patients who underwent therapy as OPs. The two groups were compared regarding demographics, risk factors, procedural success, complications, and follow-up. RESULTS: A total of 92 patients were treated for IFDVT with thrombectomy, angioplasty, and stenting of whom 58 comprised the IP group and 34 the OP group. All 92 patients underwent PMT using the Inari ClotTriever (Inari Medical), intravascular ultrasound, angioplasty, and stenting with 100% technical success. Three patients in the IP group required adjuvant thrombolysis. There was no difference in primary patency of the treated IFDVT segment at 12 months between the two groups (IP, 73.5%; OP, 86.7%; P = .21, log-rank test). CONCLUSIONS: Patients with acute IFDVT and MTS deemed appropriate for thrombectomy and iliac revascularization can be managed with initiation of ambulatory direct oral anticoagulant therapy and subsequent return for ambulatory PMT, angioplasty, and stenting. This approach avoids the expense of IP care and allows for effective use of resources at a time when staffing and supply chain shortages have led to inefficiencies in the provision of IP care for nonemergent conditions.

Severe adverse reactions after cyanoacrylate endovenous ablation.

Hypersensitivity reactions after endovenous ablation with cyanoacrylate are relatively common, mild, and self-limited. However, rare cases of severe hypersensitivity reactions have occurred. To date and to the best of our knowledge, only two other cases requiring vein excision have been reported, and we present the third. Even rarer are cases with severe reactions featuring cyanoacrylate extravasation with skin perforation. In the present report, we describe the second case of skin perforation after successful cyanoacrylate endovenous glue embolization. The mechanism of these severe hypersensitivity reactions is unknown. Clinicians should to consider this as a possible complication when using cyanoacrylate. Although rare, patients should also be advised of this adverse event when considering this alternative.

Hybrid repair of aberrant right subclavian artery using open and endovascular techniques.

An aberrant right subclavian artery, the most common anatomic variant of the aortic arch, occurs in 0.5% of the population. Symptoms generally result from compression of the esophagus and/or trachea as the aberrant vessel passes posteriorly in the mediastinum. Treatment includes revascularization of the right subclavian artery from the right common carotid artery using a cervical approach combined with occlusion of the origin of the aberrant vessel from the thoracic aorta. We describe a hybrid treatment approach for a symptomatic aberrant right subclavian artery using cervical revascularization and branched thoracic stent graft coverage of the origin of the aberrant vessel.

Acute Limb Arterial Ischemia Following Iliac Vein Stenting in the Setting of a Frozen Pelvis.

The authors report on a young patient with previous radiation to her pelvis who presented with acute limb ischemia following iliac vein stenting believed to be secondary to extrinsic iliac artery compression in the setting of a frozen pelvis. She underwent revascularization and a trans-femoral amputation, ultimately needing a femoral to femoral artery crossover bypass in order to achieve amputation stump healing. This case describes a potential arterial complication of venous stenting in a previously irradiated field.

The Use of Re-Entry Devices Through Pedal Arterial Access in the Management of Chronic Limb-Threatening Ischemia.

Infra-inguinal arterial chronic total occlusions remain a challenging scenario for the endovascular practitioner. Retrograde access has quickly become an essential tool in approaching such lesions, increasing the chances of crossing success. When antegrade and retrograde access techniques fail in achieving lesion crossing, re-entry devices have proven to be useful. Their use is however, somewhat limited by the size of the sheaths required to accommodate their passage. As newer and slimmer profiled sheaths become available, the possibilities of interventions available from minimally invasive approaches increases. We present 2 complex arterial revascularization cases that required intravascular ultrasound-based re-entry devices utilizing a pedal retrograde access.

Acute Real-World Outcomes From the Phoenix Post-Approval Registry.

OBJECTIVES: An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD). METHODS: The Phoenix Post-Approval Registry is an all-comer study that enrolled patients with infrainguinal PAD. Patients treated with the Phoenix atherectomy system were followed for 30 days to observe device-related complications. Outcomes evaluated include procedural (final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive therapy) and technical success (defined as achieving a post-Phoenix [prior to any adjunctive therapy] residual diameter stenosis of ≤50%), target-vessel revascularization (TVR), target-lesion revascularization (TLR), target-limb amputation, ankle brachial index, Rutherford clinical category, and wound, ischemia, foot infection (WIfI) classification. RESULTS: Of the 500 patients enrolled, 259 had CLI, including 26.3% with Rutherford class 6. Procedural success rates were 97.3% for non-CLI patients and 98.2% for CLI patients. Technical success rates were 71.5% for non-CLI patients and 77.9% for CLI patients. Complication rates post Phoenix atherectomy were <1%. Through the 30-day follow-up, there were 6 patients (1.3%; 2 claudicants, 4 CLIs) who underwent TLR and 8 patients who underwent TVR. There were no major amputations in the non-CLI and CLI cohorts. In the CLI cohort, 16/235 (6.8%) underwent minor amputations. Higher stages of Rutherford class and WIfI classification were associated with amputations at 30 days. CONCLUSION: The Phoenix atherectomy system is a safe and effective treatment option in the acute setting for patients with PAD, including those with advanced Rutherford class. Randomized controlled trials are needed to confirm these results.

A case of leiomyosarcoma of the common femoral artery.

Leiomyosarcomas are rare malignant tumors of smooth muscle cell origin with those originating from blood vessels accounting for <1%. We report the unusual case of a leiomyosarcoma originating in the wall of the common femoral artery, highlighting the management decisions for vascular tumors and providing a brief literature review for these unusual malignancies.

Hybrid Approach with Angiography and Limited Open Exposure to Treat Type Ia Endoleaks after Endovascular Aortic Aneurysm Repair.

BACKGROUND: Type Ia endoleaks after endovascular aortic repair (EVAR) almost always mandate secondary percutaneous reinterventions. Several patients, however, will require conversion to open surgical repair with complete graft explant, which is associated with significant morbidity and mortality. We herein present 3 cases of hybrid surgical repair for type Ia endoleaks, using a limited open exposure for proximal stent graft edge revision to achieve graft preservation and effective aneurysm sac exclusion. METHODS: Angiography was used to confirm type Ia endoleak in 3 patients (2 males) who had previous EVAR between October 2017 and October 2019. Time to the endoleak after the index EVAR was immediate in 1 patient during repair of a ruptured aneurysm, 2 months in 1 patient and 2 years in 1 patient. The aorta was exposed through a limited transabdominal (n = 1) or retroperitoneal (n = 2) approach and circumferential aortic control was achieved below the renal arteries. A row of interrupted horizontal mattress sutures of 3-0 polypropylene reinforced with Teflon pledgets was placed along the aortic neck circumference. Multi-planar angiography was then repeated to verify the absence of sac filling and successful type Ia endoleak exclusion. Follow-up abdominal duplex was obtained for all 3 patients after discharge to monitor the stent graft and confirm endoleak resolution. Furthermore, there were no instances of acute renal failure. RESULTS: In the period of review, 77 patients underwent EVAR. In the 3 patients described, we were able to achieve complete aneurysm sac exclusion and stent graft preservation in all cases. Follow-up imaging was available on 2 patients at 4-6 weeks after surgery demonstrating sustained exclusion of the endoleak. Two patients died during follow-up: one from a myocardial infarction 7 weeks after surgery and one from metastatic lung cancer at 8 months after surgery. Follow up duplex imaging at one year on the single survivor demonstrated sac shrinkage and absence of endoleak. CONCLUSIONS: Type Ia endoleaks represent a significant source of morbidity and mortality after EVAR and typically require repair to avoid aneurysm rupture. Our use of limited proximal revision without explant provides an alternative approach to resolve the endoleaks while reducing the magnitude of physiological stress when compared to an open explant. It represents a feasible option for high-risk patients.

Distal Retrograde Access for Infrainguinal Arterial Chronic Total Occlusions: A Prospective, Single Center, Observational Study in the Office-Based Laboratory Setting.

OBJECTIVE: To assess the safety and efficacy of retrograde arterial recanalization of infrainguinal CTOs in the OBL setting. METHODS: Consecutive patients who underwent interventions for lower extremity CTOs in the OBL setting by a single vascular surgeon were evaluated (January 2013-November 2017). If antegrade crossing was not possible, then a retrograde distal approach was used. Patient characteristics, CTO location, procedural time, contrast, anticoagulation and radiation doses and costs were recorded. Post-procedural complications were documented on post-procedure day 1 and 10-14 days post procedure. Three groups were compared: group 1-antegrade approach for femoropopliteal CTOs; group 2-antegrade approach for tibial CTOs, and; group 3-retrograde approach for femoropopliteal and tibial CTOs. RESULTS: Two hundred and thirty-seven patients were studied. In 39 (16.5%), the lesions could not be crossed. A successful antegrade approach was used in 185 of them, of which 69% (group 1, n = 128) patients had femoropopliteal CTOs and 31% (group 2, n = 57) had tibial CTOs. Fourteen patients (5.9%, group 3) were treated by retrograde distal approach. Group 3 patients received higher contrast doses than groups 1 and 2 (p = 0.01). However, patients in groups 1 and 2 received similar contrast doses. Group 3 patients had the highest operative time and treatment costs followed by group 1 and then group 2 (p = 0.01). Three femoral pseudoaneurysms were noted in group 1, and 2 in group 2. No complications were seen in group 3. CONCLUSIONS: Although the operative times, costs, radiation and contrast dose are higher with retrograde arterial access, it represents a safe and effective method for the crossing of CTO infrainguinal lesions in an ambulatory venue.

Retrograde deep femoral artery puncture for the treatment of an iatrogenic dissection flap of the common femoral artery bifurcation.

The authors report on a diabetic patient with tissue loss, previously treated with a femoral-tibial bypass, which occluded shortly after construction. A combination of antegrade contralateral femoral and retrograde tibial access was used for revascularization. Angiogram demonstrated a dissection flap occluding the deep femoral artery flow, which was unable to be crossed from an antegrade approach. A retrograde deep femoral artery access was used to perform "kissing" angioplasty of the origins of the superficial and deep femoral arteries, thus successfully reestablishing flow to both vessels. This represents an unconventional endovascular technique that can be safely performed as a bailout maneuver.

Capillary microbioreactors for VOC vapor treatment: Impacts of operating conditions.

Micro-capillary bioreactors (1 mm ID, 10 cm long) were investigated for the biodegradation of toluene vapors as a model volatile organic compound (VOC). The intended application is the removal of VOCs from indoor air, when such microbioreactor is coupled with a microconcentrator that intermittently delivers high concentrations of VOCs to the bioreactor for effective treatment. The effects of key operating conditions were investigated. Specifically, gas film and liquid film mass transfer coefficients were determined for different gas and liquid velocities. Both mass transfer coefficients increased with gas or liquid velocity, respectively, and the overall gas-liquid mass transfer was dominated by the liquid-side resistance. Experiments with the microbioreactors focused on the effects of gas velocity, liquid velocity and mineral medium renewal rate on the treatment of toluene vapors at different inlet concentrations. The best performance in terms of toluene removal and mineralization to CO2 was obtained when the gas and liquid velocity ratio was close to one and achieving Taylor or slug flow pattern. Sustained treatment over extended periods of time with toluene elimination capacities ranging from 4000 to over 9000 g m-3 h-1 were obtained, which is orders of magnitude greater than conventional biofilters and biotrickling filters. Biological limitations generally played a more important role than mass transfer limitation. Continuous mineral medium supply at a high rate (10 h liquid retention time) enabled pH control and provided ample nutrient supply and therefore resulted in better toluene elimination and mineralization. Overall, these studies helped select the most suitable conditions for high performance and sustained operation.

Clinical characteristics and outcomes of patients with multiple simultaneous superficial vein thrombi.

BACKGROUND: Although unprovoked superficial venous thrombosis (SVT) has traditionally been considered a local, benign disorder, recent studies demonstrate that patients with SVT are at significant risk for deep venous thrombosis, pulmonary embolism, and other venous thromboembolism (VTE) events. Nevertheless, clinical management remains widely inconsistent. Moreover, patients with multiple, unprovoked SVTs of noncommunicating anatomic sites have not been previously described, and they may be at even increased risk for adverse outcomes. The objective of this study was to describe the clinical characteristics and outcomes of patients with multiple, unprovoked SVTs to elucidate whether this subset of patients possesses a higher risk of thrombophilia, cancer, recurrent VTE, or death compared with patients with unprovoked SVT at a single location. METHODS: Twenty-four patients with multiple, unprovoked SVTs were enrolled. Blood tests and computed tomography scans were performed to detect thrombophilia and malignant disease. Patients were followed up with duplex ultrasound and clinical examination for at least 3 months. The prevalence of recurrent VTE and clinical outcomes were compared with a control group of 39 patients with unprovoked SVT in a single vein. RESULTS: Cancer was detected in five patients (20.8%) and thrombophilia in 10 patients (41.7%). During the follow-up period, nine patients (37.5%) exhibited recurrent VTEs, and five patients (16.2%) died. The VTE recurrence rate was significantly greater than in controls (P = .03). Patients with a coexisting thrombophilia or cancer had elevated thrombotic load (4.08 vs 2.27 separate vein segments; P = .0096) and an increase in VTE recurrence (P = .038) compared with patients without any such findings. CONCLUSIONS: The results of this study warrant further investigation into this subset of patients through a larger multicenter design, as patients with multiple SVTs are at greater risk for thrombophilia, cancer, recurrent VTE events, and death compared with patients with isolated SVT.

Endovascular management of inferior vena cava filter thrombotic occlusion.

Objective Inferior vena cava occlusion is a potentially life-threatening complication related to caval filters. We present our experience with filter-induced inferior vena cava occlusion in order to assess the feasibility, safety, and effectiveness of endovascular management. Methods A retrospective review of all patients undergoing inferior vena cava filter placement over a 60-month study period was performed. From this cohort, a total of 10 cases of inferior vena cava occlusion after filter placement were identified. Demographics, clinical data, procedures, and outcomes were extracted. Patients were followed to the last clinic visit or until they died. Results One-hundred eighty filters were placed by our group practice during the study period. Of those, a total of 10 patients were identified. Overall, there were 7 males; the mean age was 57.1 years (25-78 years). The median time between inferior vena cava filter placement and filter occlusion was 105 days (range 5-4745 days). All patients were clinically symptomatic at the time of their presentation. Nine out of 10 patients were successfully managed endovascularly. Trellis™-8 thrombectomy was the most common endovascular strategy performed ( n = 9). Four patients had balloon angioplasty, two of those with stent placement for chronically occluded inferior vena cava/iliac veins. No thromboembolic complications developed during a median follow-up period of 233 days (range 4-1083 days). Conclusions Endovascular management of inferior vena cava occlusion is feasible, safe, and effective in decreasing thrombus burden in the presence of an inferior vena cava filter. Further studies evaluating long-term inferior vena cava patency and optimal surveillance regimen after endovascular management of filter-related inferior vena cava occlusion are warranted.

Endothelial vascular cell adhesion molecule 1 is a marker for high-risk carotid plaques and target for ultrasound molecular imaging.

BACKGROUND: Molecular imaging of carotid plaque vulnerability to atheroembolic events is likely to lead to improvements in selection of patients for carotid endarterectomy (CEA). The aims of this study were to assess the relative value of endothelial inflammatory markers for this application and to develop molecular ultrasound contrast agents for their imaging. METHODS: Human CEA specimens were obtained prospectively from asymptomatic (30) and symptomatic (30) patients. Plaques were assessed by semiquantitative immunohistochemistry for vascular cell adhesion molecule 1 (VCAM-1), lectin-like oxidized low-density lipoprotein receptor 1, P-selectin, and von Willebrand factor. Established small peptide ligands to each of these targets were then synthesized and covalently conjugated to the surface of lipid-shelled microbubble ultrasound contrast agents, which were then evaluated in a flow chamber for binding kinetics to activated human aortic endothelial cells under variable shear conditions. RESULTS: Expression of VCAM-1 on the endothelium of CEA specimens from symptomatic patients was 2.4-fold greater than that from asymptomatic patients (P < .01). Expression was not significantly different between groups for P-selectin (P = .43), von Willebrand factor (P = .59), or lectin-like oxidized low-density lipoprotein receptor 1 (P = .99). Although most plaques from asymptomatic patients displayed low VCAM-1 expression, approximately one in five expressed high VCAM-1 similar to plaques from symptomatic patients. In vitro flow chamber experiments demonstrated that VCAM-1-targeted microbubbles bind cells that express VCAM-1, even under high-shear conditions that approximate those found in human carotid arteries, whereas binding efficiency was lower for the other agents. CONCLUSIONS: VCAM-1 displays significantly higher expression on high-risk (symptomatic) vs low-risk (asymptomatic) carotid plaques. Ultrasound contrast agents bearing ligands for VCAM-1 can sustain high-shear attachment and may be useful for identifying patients in whom more aggressive treatment is warranted.

Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial.

BACKGROUND: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. METHODS AND RESULTS: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. CONCLUSIONS: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.

Pharmacomechanical thrombolysis in the management of acute inferior vena cava filter occlusion using the Trellis-8 device.

PURPOSE: To evaluate the performance and safety of the Trellis-8 system, a pharmacomechanical thrombolysis infusion catheter, and adjunctive therapies in the treatment of symptomatic inferior vena cava (IVC) filter-related acute thrombotic occlusion. METHODS: Eight consecutive patients (6 men; mean age 57.4 years, range 34-78 years) with acute thrombotic occlusion of the IVC in the presence of an IVC filter underwent percutaneous venous thrombectomy using the Trellis-8 thrombectomy system and adjunctive techniques between January 2009 and November 2013. Demographics, clinical data, procedures, and outcomes were retrospectively reviewed. All patients had clinical signs of lower extremity venous hypertension on presentation. The median time between IVC filter placement and occlusion was 25 months. Patients were followed for the development of thromboembolic complications to the last clinic visit or until they died. RESULTS: The procedure was technically successful in 6 patients, whereas it could not be performed in 2 due to failure to cross the occlusion. The median follow-up period was 7.8 months, at which time all patients undergoing successful Trellis-8 thrombectomy had relief of symptoms without thromboembolic or bleeding complications. CONCLUSION: In this limited performance and safety evaluation, the Trellis-8 thrombectomy system combined with adjunctive therapies, such as mechanical thrombectomy and balloon angioplasty, was effective in 75% of patients with IVC filter-related acute caval occlusion.

Aneurysmal degeneration of deep lower extremity vein conduits used for vascular reconstruction.

BACKGROUND: Successful outcomes have been reported with the use of femoropopliteal vein (FPV) grafts as arterial conduits. We identified 2 patients with a rare complication, true, nonanastomotic aneurysmal degeneration. METHODS: Patients from 1997 through 2009 that utilized FPV grafts for revascularization were analyzed. We contacted survivors by phone and conducted a literature search of FPV aneurysms. RESULTS: Of the total of 14 patients in our practice whose FPV was used as a conduit during the study period, 2 developed nonanastomotic FPV graft aneurysms. The mean follow-up time was 33.44 months. Literature review uncovered only 1 previously published case of FPV aneurysmal degeneration. CONCLUSIONS: Our experience suggests that nonanastomotic aneurysms of FPV grafts may occur more often than those suspected previously. Our study represents the first reports of aneurysmal degeneration affecting FPV grafts when used for vascular reconstructions.

Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery.

BACKGROUND: Popliteal artery stenting is not routinely performed due to concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. Open bypass is traditionally considered the gold standard for popliteal artery atherosclerotic lesions. The Supera stent (IDEV Technologies Inc, Webster, Tex) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial United States experience in the management of popliteal artery atherosclerotic disease with the Supera interwoven wire stent. METHODS: Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to Trans-Atlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis. RESULTS: A total of 39 stents were placed in 34 patients due to isolated popliteal artery occlusive disease. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0-26.8 months). Most patients had critical limb ischemia (CLI), with tissue loss (38.2%) or rest pain (35.3%) as the indication for intervention. In 20 patients (58.8%), the most distal end of the stent(s) landed in the below-the-knee popliteal segment, 12 (35.3%) landed in the above-the-knee segment, and two (5.9%) landed precisely at the knee. Other than angioplasty and stenting, 47% of patients did not receive any adjuvant concomitant therapy in the treated leg. Two patients underwent concomitant atherectomy of the popliteal segment. Primary, primary assisted, and secondary patency rates by duplex ultrasound imaging were 79.2%, 88.1% and 93%, respectively, by Kaplan-Meier estimates, with a mean stented length of 12 cm. Six instances of stent occlusion were noted, and six patients were identified with hemodynamically significant in-stent stenosis. Three patients sustained limb loss (8.8%), two related to uncontrolled infections, and one due to perioperative ischemic complications (both with patent stents at the time of limb loss). The overall mortality was 8.8% during the study period. Knee roentgenography was performed in all but one patient, and no stent fractures were identified. CONCLUSIONS: Stenting of the popliteal artery using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this highly diseased patient population justify a prospective trial in this subject.