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Stent angioplasty of patent ductus arteriosus has been shown to be a viable alternative to operative shunt placement in cyanotic neonates. With broader implementation of this strategy, novel complications are bound to arise. We present a series of cases evaluated for ductal stent angioplasty in which a dilated and torturous ductus arteriosus compressed the left mainstem bronchus. After reviewing our recent experience with ductal stenting and isolated Blalock-Taussig shunts, our best estimate of the incidence of bronchial compression by the dilated ductus is 4.6% (3/64, 95% confidence interval 1.0-12.9%). Awareness of the airway and other nonvascular contents of the thorax is an important consideration prior to ductal stenting., (© 2020 Wiley Periodicals, Inc.)

Objectives: This study aimed to evaluate the safety and efficiency of percutaneous transluminal angioplasty (PTA) with selective stenting treating Chinese patients with renal artery stenosis (RAS) due to fibromuscular dysplasia (FMD)., Background: Endovascular data of patients with RAS caused by FMD are scarce in China., Methods: Clinical data of 105 hypertensive patients with RAS caused by FMD underwent endovascular therapy at a single-site between June 2001 and October 2018 were analyzed retrospectively. Baseline blood pressure, use of antihypertensive medications, renal function, and adverse events at a 1-year follow-up were evaluated., Results: The patients were aged between 10 and 64 years (mean age 26.7 ± 8.2 years) and 52 (49.5%) were female. In total, 105 patients undergoing endovascular therapy involving 124 RASs. Thirty (24.2%), sixty-four (51.6%), and thirty (24.2%) RASs were multifocal, unifocal, and tubular types, respectively. Ninety-four (89.5%) and eleven (10.5%) patients underwent PTA alone and PTA plus stenting, respectively. The technical success rate for endovascular therapy was 95.2% (100/105) without severe complications. During 1-year follow-up (n = 100), the mean systolic and diastolic blood pressure decreased from 157.6 ± 17.5 and 102.3 ± 14.2 to 129.6 ± 12.3 and 81.3 ± 11.1 mmHg, respectively, and the number of antihypertensive medications reduced from 2.2 ± 1.2 to 0.8 ± 1.0 (all p < .001). The cure rate and improved rate of blood pressure was 49.0 and 40.0%, respectively. The serum creatinine levels remained stable. The primary and secondary restenosis rate was 13.4 and 5.8%, respectively., Conclusion: Endovascular therapy for treating RAS caused by FMD was technically safe and effective for reducing blood pressure in Chinese patients., (© 2020 Wiley Periodicals, Inc.)

Objective: To examine the impact of re-entry device (RED) use on 1- and 5-year outcomes after endovascular treatment of common iliac artery (CIA) chronic total Occlusions (CTOs)., Background: There are not enough data regarding the long-term safety and efficacy of RED., Methods: We performed a two-center retrospective study of 115 patients (140 lesions) undergoing CIA CTO endovascular intervention between 2006 and 2016. Baseline characteristics and long-term outcomes were described. A Cox proportional hazard model was developed to determine if REDs were associated with target lesion revascularization (TLR) or major adverse limb events (MALE) after 1 and 5 years., Results: Among 140 lesions, 43 (31%) required use of a RED. The mean age was 63.9 years and the majority (n = 80) of patients were male. An antegrade crossing approach and treatment of restenotic lesions were less common in the RED group (10% vs. 29%, P < .05 and 0% vs. 21%, P < .05, respectively). There were no significant differences in Rutherford class, pre-procedure ABI, or patient presentation. The procedural complication rates were similar between the two groups. The 1- and 5-year TLR rates for lesions treated with re-entry device vs. standard approaches were 11% vs. 9%; P = 0.8 and 29% vs. 29%; P = 0.9 respectively. The 1 and 5-year MALE rates for lesions treated with re-entry device were 5% vs. 6%; P = 0.8 and 11% vs. 11%; P = 0.9 respectively., Conclusions: This retrospective analysis found that recanalization of CIA occlusions using a RED is safe and is associated with long-term clinical outcomes similar to that of standard crossing techniques., (© 2018 Wiley Periodicals, Inc.)

Objectives: The objective of this meta-analysis is to evaluate clinical efficacy of double layered mesh covered carotid stent systems in the clinical practice., Background: The need for an increase plaque coverage to decrease the risk of debris dislodgement through the stent struts, following carotid artery stenting (CAS), has brought to the design of a new generation of double layered carotid stents. Several small sized clinical studies evaluating two different devices have been recently published, unfortunately these are not sufficiently powered to test for device related and clinical endpoints and no comparison, between the two available devices, has been reported yet., Methods: Ten studies, enrolling 635 patients, were included in the present meta-analysis. Our study analyzed a composite endpoint of 30-day stroke and death and the occurrence of procedural unsuccess after CAS with the use of two different double layered carotid stent systems., Results: Thirty-day stroke and death rate was quite low (patients 635, event rate 0.02, 95% CI: 0.01-0.04, P < 0.0001). The incidence of procedural unsuccess with these devices was relatively low (patients 635, event rate 0.03, 95% CI: 0.01-0.08, P < 0.0001). When a subgroup analysis was performed, according to the specific subtype of carotid stent, no differences in the occurrence of 30-day death and stroke rate and procedural unsuccess were observed (P = 0.979)., Conclusions: This meta-analysis suggests that dual layered carotid stents could be safely used for the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuccess, and allow achieving a quite low rate of postprocedural adverse events., (© 2017 Wiley Periodicals, Inc.)

Background: The impact of hospital volume on long-term outcome after carotid artery stenting (CAS) remains unknown., Objectives: We designed a nationwide cohort study to elucidate the impact of hospital volume on the incidence of stroke after CAS., Methods: The Taiwan National Health Insurance Research database was used to identify all patients admitted for CAS from 2008 to 2012. We defined high-volume hospitals as those performing more than 20 CAS per year. The primary outcome was new ischemic stroke after discharging from the index CAS. Propensity score-matching was performed to create two matched groups for comparison., Results: A total of 3,248 patients underwent 3,576 CAS procedures were enrolled. There were 56 hospitals performing CAS during the study period. Among these 3,248 patients, 2,226 (68.5%) were performed in high-volume hospitals. A propensity score-matching created two groups with 1,000 patients in each group. During a median of 2.06 years follow-up, 35 (3.5%) and 52 (5.2%) patients in high-volume hospitals and low-volume hospitals developed new ischemic stroke 30 days after discharging from the index CAS, respectively (for low-volume hospitals, HR 1.50, 95%CI 1.06-2.12, P = 0.023). The use of embolic protection device did not result in different periprocedural or postdischarge strokes. The periprocedural (within 30 days after CAS) ischemic stroke or all-cause mortality rates during follow-up period were similar between two groups., Conclusions: CAS performed in high-volume hospitals was associated with less new ischemic stroke after discharging from the index CAS, compared to those in low-volume hospitals. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: This study examines the outcome and procedural outcomes of percutaneous stent angioplasty for aortic coarctation in patients with Turner syndrome (TS)., Background: TS occurs in 1 in 2,500 live-born females and is associated with aortic coarctation., Methods: In this multicenter, retrospective cohort study, all patients with TS and a coarctation of the aorta, treated with percutaneous stent implantation were included. The procedural strategies were dictated by local protocols. Adverse events at short- and long-term follow-up and qualitative parameters concerning the stent implantation were assessed., Results: In the largest study to date of TS patients receiving aortic stents, a total of 19 patients from 10 centers were included. Twelve patients were treated for native and 7 for recurrent coarctation. Age at intervention was 16.9 (7-60) years (median; min-max). The coarctation diameter increased significantly from 8.0 mm (2-12) pre-intervention to 15.0 mm (10-19) post-intervention (P < 0.001). Three (15.8%) adverse events occurred within 30 days of the procedure, including two dissections despite the use of covered stents, one resulting in death. At long-term follow-up (6.5 years, min-max: 1-16), two additional deaths occurred not known to be stent-related., Conclusions: Though percutaneous treatment of aortic coarctation in TS patients is effective, it is associated with serious morbidity and mortality. These risks suggest that alternative treatment options should be carefully weighed against percutaneous stenting strategies. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Vascular thromboses are a significant cause of morbidity and mortality in children. Data in children regarding catheter-based rheolytic and aspiration thrombectomy systems are limited. We sought to review the safety and efficacy of catheter-based rheolytic and aspiration thrombectomy systems in children., Methods: Data of all children having undergone thrombectomy using specialized rheolytic or aspiration systems were reviewed., Results: Thrombectomy was performed in 50 vessels in 21 patients, median age 1.9 months (8 days-18 yrs), median weight 4.3 (1.1-67.9) kg. Thrombectomy was performed using AngioJet in 16, Helix Clot Buster in 5, Fetch catheter in 8, Pronto catheter in 1, and a combination of other systems in 20 vessels (with AngioJet in 16). Thrombectomy was successful in 47/50 (94%) vessels in 18/21 (86%) patients with additional balloon/stent therapy or tPA administration performed in 16/18 (89%) of these patients. There were 2 (9.5%) major complications (both with AngioJet) consisting of asystole when thrombectomy was performed using activation times of >5 sec. At a median follow-up of 10 months (2 weeks-7 years), all 47 successfully treated vessels are patent, with 8/18 (44%) patients requiring reintervention with angioplasty/stent placement or repeat thrombectomy., Conclusions: Catheter-based thrombectomy systems are an important adjunctive tool in the treatment of children with thrombotic vessel occlusions. Significant hemodynamic compromise seen when using AngioJet may be minimized by using activation times of ≤5 sec. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Carotid artery stenting (CAS) has become an integral part of the therapeutic armamentarium offered by cardiovascular medicine programs for the prevention of stroke. The purpose of this expert consensus statement is to provide physician training and credentialing guidance to facilitate the safe and effective incorporation of CAS into clinical practice within these programs. Since publication of the 2005 Clinical Competence Statement on Carotid Stenting, there has been substantial device innovation, publication of numerous clinical trials and observational studies, accumulation of extensive real-world clinical experience and widespread participation in robust national quality improvement initiatives [5]. Collectively, these advances have led to substantial evolution in the selection of appropriate patients, as well as in the cognitive, technical and clinical skills required to perform safe and effective CAS. Herein, we summarize published guidelines, describe training pathways, outline elements of competency, offer strategies for tracking outcomes, specify facility, equipment and personnel requirements, and propose criteria for maintenance of CAS competency., (© 2015 Wiley Periodicals, Inc.)

A 47-year-old male underwent surgery for functional bicuspid aortic valve severe regurgitation with a fused right and left coronary cusp. The patient presents nine years after surgical bicuspid aortic valve repair with symptomatic severe aortic regurgitation, diagnosed by TEE and MRI, caused primarily from a perforation located at the base of the surgically fused coronary cusps. The patient had a minimally dilated aortic root that did not yet necessitate surgical intervention. We present a novel percutaneous bicuspid aortic valve perforation repair that potentially decreases the number of surgical operations the patient must undergo during his lifetime., (© 2015 Wiley Periodicals, Inc.)

Percutaneous carotid artery stenting (CAS) has emerged as a less invasive alternative to carotid endarterectomy for the treatment of carotid atherosclerotic disease. The main risk of CAS is the occurrence of neuro-vascular complications; however, carotid artery stenting-related dysautonomia (CAS-D) (hypertension, hypotension, and bradycardia) is the most frequently reported problem occurring in the periprocedural period. Alterations in autonomic homeostasis result from baroreceptor stimulation, which occurs particularly at the time of balloon inflation in the region of the carotid sinus. The response can be profound enough to induce asystole or even complete cessation of postganglionic sympathetic nerve activity. Frequency and factors predisposing a patient to CAS-D have been investigated in several studies; however, there are significant discrepancies in results among reports. Lack of consistent findings may arise from using different methods and definitions, as well as other factors discussed in detail in this review. Furthermore, a correlation of CAS-D with short and long-term outcomes has been investigated only in small and mostly retrospective studies, explaining why its prognostic significance remains uncertain. In this manuscript, we have focused on risk factors, pathophysiology and management of periprocedural autonomic dysfunction. As there is no standardized approach to the treatment of CAS-D, we present an algorithm for the periprocedural management of patients undergoing CAS. The proposed algorithm was developed based on our procedural experience as well as data from the available literature. The Yale Algorithm was successfully implemented at our institution and we are currently collecting data for short- and long-term safety. © 2014 Wiley Periodicals, Inc., (© 2014 Wiley Periodicals, Inc.)

Objectives: The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians., Background: There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels., Methods: The study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience while individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events [MAEs; including stroke, death, and myocardial infarction (MI)]. Individual event rates were evaluated across the overall study, and by center experience and physician training tier., Results: Of 1,097 enrolled patients, 1,025 were evaluable for 30-day MAE rate. The stroke rate (3.3%) was a major contributing factor in the overall MAE rate (4.6%). Mortality was 1.3% and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers (P = 0.61) nor among the operator training categories (P = 0.26)., Conclusions: CAS with the Carotid WALLSTENT and FilterWire EZ yielded a low 30-day MAE rate that did not differ significantly across operator experience and training levels. Clinicaltrials.gov identifier: NCT00741091., (© 2014 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.)

Objective: The aim of this study was to assess the association of kidney function with carotid artery revascularization outcomes in a large contemporary database., Background: Chronic kidney disease (CKD) is associated with increased mortality and adverse cardiovascular events after coronary intervention. There are limited data evaluating the association between CKD and adverse events among patients undergoing carotid artery revascularization procedures., Methods: The Carotid Artery Revascularization and Endarterectomy (CARE) Registry is a voluntary registry of 168 hospitals. Using data from the CARE Registry, we examined registry patients undergoing carotid artery revascularization by either carotid endarterectomy (CEA) or carotid artery stenting (CAS) from May 2005 through March 2010. Patients were divided into four groups according to their glomerular filtration rate (GFR), as estimated by the Modification of Diet in Renal Disease Study Group equation using preprocedural serum creatinine levels., Results: The analysis included 11,832 patients who underwent carotid revascularization (6,899 CAS and 4,933 CEA). Patients with lower GFR were older, more frequently female, had more comorbidities, including hypertension, dyslipidemia, peripheral arterial disease, diabetes mellitus, chronic lung disease, ischemic heart disease, heart failure, and reduced left ventricular function, and were more likely to undergo CAS than CEA. In the overall population, CKD was associated with higher unadjusted in-hospital and 30-day rates of the combined endpoint of death, stroke, and myocardial infarction and the individual endpoint of stroke. After adjustment for baseline and preprocedural characteristics, CKD was not an independent predictor of adverse events in either CAS or CEA., Conclusions: Patients with CKD have a greater number of comorbidities and worse unadjusted in-hospital and 30-day outcomes; CKD was not, however, an independent predictor of in-hospital and 30-day outcomes after carotid artery revascularization., (© 2013 Wiley Periodicals, Inc.)

Background: Though distal filter protection during carotid stenting reduces the risk of cerebrovascular events, periprocedural stroke remains a risk despite their broad usage. This observation may be related to the pore size of common filters. The FiberNet distal filter system is unique by its very small pore size (40 µm) as well as its low profile and flexibility. Little data is available regarding the clinical performance and safety of this device., Purpose: The aim was the evaluation of the safety of the FiberNet embolic protection system during carotid artery stenting., Methods: All consecutive patients treated with carotid stenting at our institution using the FiberNet device were systematically followed. Primary endpoint was the rate of all death and stroke within 30 days of the procedure., Results: Carotid artery stenting using the FiberNet embolic protection system was performed in 54 patients. The procedure was technical successful in all patients. Three patients (5.5%) had a TIA. Amauosis fugax occurred in two patients (3.7%). One patient (1.9%) had a minor stroke with hemiparesis of the left arm and face which resolved completely within 48 hr after the procedure. No patient died or suffered a major stroke., Conclusion: The safety and feasibility of the FiberNet distal protection system appears to be at least equivalent to that reported in studies using conventional distal filter protection., (Copyright © 2013 Wiley Periodicals, Inc.)

Background & Purpose: Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS., Methods: We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses., Results: Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87)., Conclusions: Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients., (Copyright © 2013 Wiley Periodicals, Inc.)

Retroperitoneal fibrosis is a rare condition characterized by the presence of inflammatory and fibrous retroperitoneal tissue that surrounds and often encases abdominal structures. In this report we describe an unusual presentation of retroperitoneal fibrosis and inferior vena cava (IVC) obstruction that was unidentified by noninvasive testing and ultimately diagnosed using exercise right heart catheterization and venography. Exercise hemodynamic catheterization revealed a high pressure gradient across the IVC obstruction during exercise that resulted in reduced preload and inappropriately low cardiac output reserve. The patient ultimately underwent angioplasty and stenting of the obstruction resulting in resolution of his symptoms., (Copyright © 2013 Wiley Periodicals, Inc.)

Objective: To identify the specific caseload to overcome learning curve effect based on data from consecutive patients treated with Intracranial Angioplasty and Stenting (IAS) in our center., Background: The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke and Intracranial Stenosis trial was prematurely terminated owing to the high rate of periprocedural complications in the endovascular arm. To date, there are no data available for determining the essential caseload sufficient to overcome the learning effect and perform IAS with an acceptable level of complications., Methods: Between March 2004 and May 2012, 188 consecutive patients with 194 lesions who underwent IAS were analyzed retrospectively. The outcome variables used to assess the learning curve were periprocedural complications (included transient ischemic attack, ischemic stroke, vessel rupture, cerebral hyperperfusion syndrome, and vessel perforation). Multivariable logistic regression analysis was employed to illustrate the existence of learning curve effect on IAS. A risk-adjusted cumulative sum chart was performed to identify the specific caseload to overcome learning curve effect., Results: The overall rate of 30-days periprocedural complications was 12.4% (24/194). After adjusting for case-mix, multivariate logistic regression analysis showed that operator experience was an independent predictor for periprocedural complications. The learning curve of IAS to overcome complications in a risk-adjusted manner was 21 cases., Conclusions: Operator's level of experience significantly affected the outcome of IAS. Moreover, we observed that the amount of experience sufficient for performing IAS in our center was 21 cases., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: To evaluate initial and long-term results of endovascular therapy (EVT) for symptomatic subclavian artery (SCA) disease., Background: EVT for SCA disease has a similar success rate as open surgery, but the long-term patency of EVT alone is uncertain., Methods: We retrospectively studied 59 consecutive patients (42 males and 17 females) with 60 lesions. Mean patient age was 68 ± 10 years. Clinical symptoms were vertebrobasilar insufficiency in 21 patients (35.0%), arm claudication in 20 patients (33.3%), angina pectoris in 12 patients (20%), severe arm ischemia in 3 patients (5.0%), vascular access insufficiency in 3 patients (5.0%), and leg ischemia in 1 patient (1.7%). A total of 57 stents were implanted. All patients were followed up at 1, 3, 6, and 12 months after the procedure and annually thereafter., Results: The technical success rate was 93.3%. All patients for whom technical success was obtained received stents. There were four technical failures, all of which were owing to the failure of crossing the wire in occluded lesions. There were no procedure-related deaths. There were two stroke events (3.4%) and one embolic event (1.7%). Primary patency rates were 94.9, 90.8, and 85.8% at 1, 3, and 5 years, respectively., Conclusions: EVT for SCA disease is an effective treatment with regard to initial success rate, clinical efficacy, and long-term primary patency. This minimally invasive procedure is appropriate as the treatment of first choice for proximal subclavian arterial obstructive disease., (Copyright © 2013 Wiley Periodicals, Inc.)

Objective: To report the efficacy and safety of the Outback(®) LTD(®) Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER)., Background: Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable., Methods: A retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied., Results: A total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication., Conclusion: Use of Outback(®) LTD(®) Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown., (Copyright © 2012 Wiley Periodicals, Inc.)

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure., (Copyright © 2013 Wiley Periodicals, Inc.)

Landmark trials comparing carotid endarterectomy (CEA) with medical therapy in patients with symptomatic or asymptomatic atherosclerotic stenosis of extracranial carotid arteries have favored carotid revascularization. Carotid artery stenting (CAS) has emerged as a minimally invasive option for revascularization of carotid artery stenoses and has been shown to be noninferior to CEA, regardless of patient symptom status. Debate continues regarding the importance of periprocedural myocardial infarction (PMI) as an endpoint in carotid revascularization trials. Recent randomized comparisons of CEA and CAS pre-specify PMI as an endpoint. Understanding PMI in CEA and CAS, the need for routine biomarker assessment surrounding both revascularization strategies, the effect of PMI on long-term morbidity and mortality, and the groups most at risk for PMI are of critical importance when choosing a carotid revascularization strategy for symptomatic and asymptomatic patients, since decreasing the incidence of PMI will make revascularization safer. This review examines available data regarding the relevance of PMI in vascular and carotid-specific outcomes., (Copyright © 2013 Wiley Periodicals, Inc.)

The role of endovascular therapy is expanding in the treatment of acute limb ischemia (ALI). In addition to catheter-based thrombolysis, there are multiple devices which allow for clot disruption and aspiration. The Trellis catheter system provides mechanical agitation of thrombus coupled with chemical thrombolysis. We present two cases of native arterial occlusions in which the Trellis catheter was used for thrombolysis. Procedural tips and challenges associated with the use of this device in native vessels are discussed., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting., Methods: Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days., Results: The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors., Conclusions: A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for revascularization of the internal carotid artery (ICA). CAS from the femoral approach may be problematic due to peripheral vascular disease, anatomical variations of the aortic arch, and access site complications. The purpose of this study was to evaluate the right radial approach (RRA) for CAS., Methods: A retrospective analysis of all patients who had undergone transradial (TR) CAS at two centers was performed. Demographics, the technique used to deploy the sheath in the common carotid, procedural details, results, and complications were evaluated., Results: CAS was attempted from TR in 382 patients (mean age 68, 70% male). CAS was successful in 347/382 (91%) patients; 201/216 (93%) right CA, 14/16 (88%) bovine left CA, 132/150 (88%) left CA. The specific technique varied with the anatomy. Seven different carotid artery stents (51% Xact) and seven different distal embolic protection devices were used. Adverse events included two major strokes (0.6%) one of whom died, three minor strokes (1%), and no myocardial infarction at 30 days. No bleeding complications occurred although 23 (6%) of patients had asymptomatic postprocedure radial occlusion. Inadequate catheter support at the origin of the CCA was the technical cause of failure in the unsuccessful cases which were then completed from femoral access as part of the same procedure., Conclusion: The transradial approach is an alternative for CAS in the presence of factors that increase the risk or difficulty of femoral access., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Bi-plane angiography is the gold standard for imaging the pulmonary arteries (PAs) after cavo-pulmonary connection (CPC). Three-dimensional rotational angiography (3DRA) is emerging technology that we hypothesized may enhance diagnostic capabilities in this patient group., Methods: Retrospective review of patients who underwent 3DRA to assess the PAs after CPC. 3DRA images were examined for diagnostic quality and compared, both qualitatively and quantitatively with corresponding 2D images., Results: Between 1/2010 and 12/2010, 37 3DRAs were obtained in 32 pts with prior CPC. Median age and weight were 4.3 years (0.3-19) and 15.7 kg (4.3-114). Previous surgery included: bi-directional Glenn (16), bilateral bi-directional Glenn (2), and Fontan (14). Thirty-three (89%) acquisitions in 28 pts were of diagnostic quality. In 19/28 pts (68%) 3DRA provided significant additional information pertaining to 22 lesions when compared with bi-plane angiography. These included delineating the mechanism of PA stenosis in 13 (aortic compression: 7, PA torsion: 6), demonstrating a discrete PA stenosis not seen or under appreciated on corresponding 2D images in 9. This additional information led to the performance of 9 interventions (stent implantation 8, angioplasty 1). Corresponding 2D and 3DRA images of the right and left PA were compared using quantitative analysis with a correlation coefficient of 0.94 (P < 0.001) and 0.97 (P < 0.001), for the right and left PAs respectively., Conclusions: 3DRA can be performed safely and effectively following CPC and may be more sensitive in diagnosing PA stenoses than 2D angiography. Quantitative measurements of PA diameter using 3DRA correlates well with 2D angiography., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers., Methods: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events., Results: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%., Conclusions: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: The purpose of this study was to analyze the debris captured in the distal protection filters used during carotid artery stenting (CAS)., Background: CAS is an option available to high-risk patients requiring revascularization. Filters are suggested for optimal stroke prevention during CAS., Methods: From May 2005 to June 2007, filters from 59 asymptomatic patients who underwent CAS were collected and sent to a specialized laboratory for light-microscope and histological analysis. Peri- and postprocedural outcomes were assessed during 1-year follow-up., Results: On the basis of biomedical imaging of the filter debris, the captured material could not be identified as embolized particles from the carotid plaque. On histological analysis the debris consisted mainly of red blood cell aggregates and/ or platelets, occasionally accompanied by granulocytes. We found no consistent histological evidence of embolized particles originating from atherosclerotic plaques. Post-procedure, three neurological events were reported: two (3.4%) transient ischemic attacks (TIA) and one (1.7%) ipsilateral minor stroke., Conclusion: The filters used during CAS in asymptomatic patients planned for cardiac surgery often remained empty. These findings may be explained by assuming that asymptomatic patients feature a different atherosclerotic plaque composition or stabilization through antiplatelet medication. Larger, randomized trials are clearly warranted, especially in the asymptomatic population., (Copyright © 2011 Wiley Periodicals, Inc.)

Background: Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self-expandable nitinol stent., Methods: The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(-)) after procedure. Propensity-score analyses matched 281 cilostazol(+) with 281 cilostazol (-) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all-cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex., Results: Mean follow-up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5-year, P = 0.02). In-stent re-occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5-year, P = 0.09) compared with control. No significant difference of all-cause mortality (21.4% vs. 18.3% at 5-year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5-year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis., Conclusions: Cilostazol reduced restenosis after SFA stenting with self-expandable nitinol stent and it seems to be more effective in high-risk patients for restenosis., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: To evaluate the procedural safety and filter efficiency of Lumen Biomedical FiberNet® embolic protection system in conjunction with primary stenting of ostial atherosclerotic renal artery lesions., Background: There is limited data regarding the utility of distal embolic protection devices in renal artery angioplasty and stenting., Methods: Patients with angiographically severe (≥70%) renal artery stenosis were prospectively enrolled if one or more inclusion criteria met: resistant hypertension, progressive chronic kidney disease, unexplained heart failure, or flash pulmonary edema. Patients underwent renal artery angioplasty and stenting with utilization of the Lumen Biomedical FiberNet® EPS. The protection devices and aspirate were analyzed for degree of atheromatous particles. Procedural safety and clinical outcomes were assessed through 6 months., Results: Twenty patients were prospectively enrolled at five centers; average age 73.8 (±9.5) years, mean baseline eGFR 60.8 cm(3) min(-1). Twenty-five renal artery stenting procedures were performed. Device and procedural success were achieved in 100% of cases. All patients tolerated the procedure without any adverse events. Embolic debris was captured in all cases. Debris analysis of the distal protection system displayed an average post procedure atheroma area of 51.31 mm(2). There was no clinical evidence of peripheral atheroembolization through 30-days follow-up. No subjects progressed to temporary or permanent renal replacement therapy. Favorable trends in blood pressure control were observed at 6 months., Conclusion: The Lumen Biomedical FiberNet® embolic protection system is a safe and feasible method to prevent atheroembolization associated with angioplasty and stenting of renal artery ostial lesions., (Copyright © 2011 Wiley Periodicals, Inc.)

Background: Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types., Methods: This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier., Discussion: The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: To report on early and mid-term outcomes of carotid artery stenting (CAS) in patients with angiographic string sign (SS)., Background: Little is known about the prognosis of patients with carotid SS treated by CAS., Methods: We retrospectively evaluated early and mid-term outcomes, together with ultrasound findings, in patients with SS treated by CAS at our institution., Results: Of 308 CAS procedures, SS was diagnosed in 6.2% (19 patients, 58% symptomatic). Carotid stent implantation was successful in 18 patients (success rate 95%). There were no peri-procedural adverse events. One patient suffered from a transient ischemic attack during hospitalization and died of pneumonia. All remaining patients completed a 30-day follow-up, and no complications were reported (asymptomatic restenosis was diagnosed in 1 patient and successfully redilated). Six patients died of causes unrelated to CAS (pneumonia, decompensated heart failure, and contralateral stroke) before completing a 6-month follow-up. However, these patients presented with more pronounced, unfavorable clinical and angiographic characteristics compared to the rest of the patients., Conclusions: We suggest that CAS might be performed with acceptable procedural risk in patients presenting with SS, which is unsuitable for surgery. However, patients' clinical and angiographic characteristics must be carefully evaluated when considering interventional therapy, regardless of the favorable procedural outcomes., (Copyright © 2011 Wiley Periodicals, Inc.)

Ischemic hepatitis, also known as hypoxic hepatitis or shock liver is defined as an acute, transient elevation of aminotransferase levels in the absence of any known causes. The pathogenesis is multifactorial. Many studies have suggested systemic hypotension as a major contributor to the pathogenesis of ischemic hepatitis but that alone is not enough to cause it. Celiac artery stenosis does not commonly cause clinically significant hepatic ischemia because of its rich collaterals. We present a case of a 78-year-old male with a background of severe orthostatic hypotension, who presented with elevation of liver enzymes due to hepatic artery steal precipitated by celiac artery stenosis. Clinical investigations showed elevated transaminases and unremarkable CT scan. Invasive celiac artery angiography showed a critical ostial lesion and it was stented. The liver enzymes peaked the day following stenting and normalized over the next 9 days. This confirmed clinically significant hepatic artery steal due to an ostial celiac artery stenosis. Relieving the celiac artery stenosis normalized the liver enzymes confirming the interdependence of the two components of this rare syndrome. Our report is the only report to our knowledge where classic hepatic artery steal and shock liver was demonstrated due to the rare combination of severe orthostatic hypotension and celiac artery ostial stenosis., (Copyright © 2011 Wiley-Liss, Inc.)

Subintimal recanalization is beneficial in selected patients with peripheral chronic total occlusions (CTO). However, in complex cases, re-entry into the true arterial lumen may prove to be unsuccessful with a conventional guidewire or a re-entry catheter when using standard femoral artery access. Our case series describes these technical dilemmas along with strategies that can be utilized to overcome these challenges., (Copyright © 2011 Wiley-Liss, Inc.)

Fibromuscular dysplasia (FMD) is a noninflammatory, nonatherosclerotic disorder resulting in arterial stenosis. Here, a unique case of renal artery FMD (RA FMD) is presented. With the use of angiograpic and intravascular ultrasound (IVUS) imaging modalities, a patient was diagnosed with two distinct types of FMD. Until now, the prevalence of FMD has been underestimated due to limitations in diagnostic modalities. Clinically, the correct identification of RA FMD is essential because these patients have been shown to respond to revascularization therapy with significant improvement in blood pressure whereas renal artery lesions secondary to other etiologies such as atherosclerosis have yet to show the same consistent response. Further, the presence of two subtypes of FMD in a single patient may suggest the possibility of genetic factors that predispose certain vessels to certain subtypes of FMD., (Copyright © 2011 Wiley-Liss, Inc.)

In transradial renal intervention, the long distance between the vascular access and the target lesion represents a major issue. The 100 cm guiding catheter (GC) may be too short to engage the renal artery particularly in tall patients or with excessive aortic turtousity. On the other hand, with the use of 125 cm long GC, only few premounted dedicated renal stents can be used. The shaft of the stent delivery system must be 140 cm or more to be compatible with the 125 GC. However, in many renal interventions, only few more centimeters are required to give the GC the sufficient working length needed for proper engagement and back up support. For this purpose, we used the Terumo "five-in-six" system to provide the necessary extra length through the protruding part of the 5 Fr GC out of the tip of the 6 Fr GC. With the super soft distal segment of the 5 FR GC deeply intubated into the right renal artery, we had the sufficient backup support to do renal stenting with IVUS guidance. This case illustrates that the "five-in-six" system can be an alternative strategy whenever extra length or strong backup support is needed during transradial renal artery intervention., (Copyright © 2010 Wiley-Liss, Inc.)

Background: Engagement of the brachiocephalic vessels during carotid angiography is performed using a JR-4, Vitek, or other catheters with variable success. These catheters require additional training for safe manipulation. In this study, we evaluated the feasibility of using the 3D RCA catheter which requires less manipulation in the aorta, and less training, to engage the brachiocephalic vessels., Methods: We prospectively studied consecutive high-risk patients undergoing carotid angiography and stenting from August 2005 to March 2009 at our institution. A baseline aortogram was performed to define the arch type in all patients. Engagement of the brachiocephalic vessels was initially attempted using the 3D RCA catheter using the following approach: The 3D RCA catheter is positioned in the ascending aorta beyond the brachiocephalic vessels take off. The natural curve of the catheter usually makes it point cephalad spontaneously in most patients and as it is gently withdrawn it engages the aortic arch vessels without much manipulation. Clinical follow-up with a neurological exam was performed at one month and six months., Results: A total of 52 patients were enrolled in this study. Baseline demographics and aortic arch types encountered are listed in Table I. The 3D RCA catheter readily engaged the brachiocephalic vessels in 50/52 patients (96.0 %) in our cohort of patients undergoing carotid angiography. Of the 52 patients, 43 subsequently underwent carotid stenting and shuttle sheath placement was facilitated by initial engagement of the relevant common carotid artery with the 3D RCA catheter. There was one transient neurologic complication that resolved by 5 days in a patient that underwent carotid stenting., Conclusions: The 3D RCA catheter can be used with a high success rate to engage the brachiocephalic vessels in all 3 arch types, including a bovine arch during carotid angiography and facilitates shuttle sheath placement for carotid stenting. It requires less manipulation and therefore may be a more operator friendly approach. © 2010 Wiley-Liss, Inc., (Copyright © 2010 Wiley-Liss, Inc.)

Objectives: To evaluate the cost-effectiveness of carotid stenting vs. carotid endarterectomy using data from the SAPPHIRE trial., Background: Carotid stenting with embolic protection has been introduced as an alternative to carotid endarterectomy for prevention of cerebrovascular and cardiovascular events among patients at increased surgical risk., Methods: Between August 2000 and July 2002, 310 patients with an accepted indication for carotid endarterectomy but at high risk of complications were randomized to and subsequently underwent either carotid stenting (n = 159) or endarterectomy (n = 151). Clinical outcomes, resource use, costs, and quality of life were assessed prospectively for all patients over a 1-year period. Life expectancy, quality-adjusted life expectancy, and health care costs beyond the follow-up period were estimated for patients alive at 1 year, based on observed clinical events during the first year of follow-up., Results: Although initial procedural costs were significantly higher for stenting than for endarterectomy (mean difference: $4,081/patient; 95% CI, $3,849-$4,355), mean post-procedure length of stay was shorter for stenting (1.9 vs. 2.9 days; P < 0.001) with significant associated cost offsets. As a result, initial hospital costs were just $559/patient higher with stenting (95% CI, $3,470 less to $2,289 more). Neither follow-up costs after discharge nor total 1-year costs differed significantly. The incremental cost-effectiveness ratio for stenting compared with endarterectomy was $6,555 per quality-adjusted life year (QALY) gained, with over 98 percent of bootstrap estimates < $50,000/QALY gained., Conclusions: Although carotid stenting with embolic protection is more costly than carotid endarterectomy, by commonly accepted standards, stenting is an economically attractive alternative to endarterectomy for patients at high surgical risk., (Copyright © 2011 Wiley-Liss, Inc.)

Background: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain., Methods: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection., Results: The MAE rate was 4.5% (11 patients; P=0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy., Conclusion: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population., (Copyright © 2010 Wiley-Liss, Inc.)

Background: Pulmonary artery (PA) stents are utilized to treat branch pulmonary stenosis (BPS). Often patients with PA stents undergo subsequent cardiac surgery for other indications, and the stents can be manipulated during the procedure., Objective: The purpose of this study was to evaluate the outcome of branch PA stenoses following surgical manipulation of previously implanted PA stents and to determine factors associated with future reintervention., Methods: Catheterization data, operative reports, and clinical summaries were reviewed on patients with PA stents placed between September 1989 and December 2006 undergoing subsequent cardiac surgery. Surgical manipulation was recorded as removed, trimmed, or longitudinally transected, and patched. Those that were not manipulated were defined as untouched., Results: 459 patients had branch PA stents placed. About 54 patients, with 70 stents in branch PA's. subsequently had further cardiac surgery. The median age of stent placement was 7.5 (0.5-32.4) years with a median age of surgery of 12.7 (5.1-39.6) years. Surgical manipulation was performed in 23 (33%) PA's and 47 (66%) stents were untouched. Stent removal occurred in 11 (16%), with transecting longitudinally and patching in 5 (7%), and trimming in 7 (10%). Comparing the surgical manipulation and the untouched groups, there was no difference in median age of stent placement [7.2 (0.5-30.2) versus 7.6 (1.8-32.4) years, p=0.40], wt [21.0 (5.3-86.5) versus 24.7 (9.0-96.0) kg, p=0.42], or residual catheterization gradient across the stent [3 (0-59) versus 4 (0-50) mmHg, p=0.81]. Catheter reintervention (stent n=6 or balloon dilation n=14) on the previously stented PAs was similar between the surgically manipulated (median 7.5 years) and untouched groups (median 11.5 years) (p=0.31). In multivariate analysis, the factors associated with future catheter reintervention were having the stent transected longitudinally and patched (p=0.003) and a lower weight (p=0.006) at the time of stent placement., Conclusions: Surgical stent manipulation is often performed in patients who have PA stents. Surgical manipulation does not alter the need for future reintervention and catheter re-intervention may be more likely when the stents are transected longitudinally and patched., (Copyright © 2010 Wiley-Liss, Inc.)