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Chronic diseases and their associated health outcomes have been known to disproportionately affect people of low socioeconomic status (SES) around the world. The authors aim to examine the association between SES and nontraumatic lower extremity amputation.

Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited.Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT).Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected.Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929).Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Contrast-associated acute kidney injury can occur after percutaneous coronary intervention (PCI). Prediction of the contrast-associated acute kidney injury risk is important for a tailored prevention and mitigation strategy. We sought to develop a simple risk score to estimate contrast-associated acute kidney injury risk based on a large contemporary PCI cohort.

Background: The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM).Methods: Patients with claudication or ischemic rest pain (Rutherford class 2–4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention.Results: A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96).Conclusions: This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months.Clinical Impact This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.

Purpose: The purpose of this review and meta-analysis is to determine the clinical outcome differences between patients with chronic limb-threatening ischemia who underwent direct versus indirect angiosome revascularization using either the surgical or endovascular approach.Materials and Methods: The data sources used for article selection included PubMed, Embase/Medline, Cochrane reviews, and Web of Science (All studies were in English and included up to September 2023). All articles included were comparative in design, including retrospective, prospective, and randomized controlled trials that compared the clinical outcomes between direct and indirect angiosome-guided revascularization in chronic limb-threatening ischemia. A random-effects model was used to determine the measure of association between direct revascularization and amputation-free survival, wound healing, and overall survival. Publication bias was assessed with both Begg’s and Egger’s test, and heterogeneity was calculated using an I2.Results: Data from 9 articles were analyzed and reported in this review. Direct revascularization was associated with improved amputation-free survival (odds ratio [OR]=2.632, confidence interval [CI]: 1.625, 4.265), binary wound healing (OR=2.262, CI: 1.518, 3.372), and overall survival (OR=1.757, CI: 1.176, 2.625). Time until wound healed was not associated with either direct or indirect revascularization (Standard Mean Difference [SMD]=−2.15, p=0.11). There was a low risk of bias across all studies according to the RoB 2.0 tool.Conclusion: Direct revascularization is associated with improved amputation-free survival, overall survival, and wound healing in chronic limb-threatening ischemic patients compared to the indirect approach.Clinical Impact Preservation of the lower extremity is critical for preventing mortality and maintaining independence. The benefit of angiosome-guided revascularization for chronic limb-threatening ischemia remains controversial. The authors of this article aim to review the current literature and compare direct and indirect angiosome-guided intervention for preserving the lower extremity. Current findings suggest direct angiosome-guided intervention reduces amputation rates and improves survival; however, many trials neglect to address the multifactorial approach needed in wound care management.

Background: Nitinol interwoven bare metal stents represent an advancement in stent technology; however, nominal deployment remains an area of focus. Intravascular ultrasound (IVUS) has been shown to improve outcomes in both the coronary and peripheral vasculature by providing the operator with greater vessel detail; however, the use of adjunctive IVUS with nitinol bare metal stents has not been widely studied. This studies aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions.Design: Retrospective study.Methods: This study included a cohort of 200 consecutive patients with peripheral artery disease. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event.Results: The patients who received IVUS had a significantly greater number of nominally deployed stents (p<0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p=0.047).Conclusion: The IVUS and angiography decreases clinically-driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents.Clinical Impact Endovascular surgones may conisder the adjuctive use of IVUS when using the Supera stent for the treatment of infra inguinal superficial femoral artery lesions. The adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultiamtely reduction in CD-TLR.

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A review of Anne Dymond’s new book, Diversity Counts: Gender, Race, and Representation in Canadian Art Galleries. In it, she takes a statistical approach to investigating gender and racial parity in large Canadian art galleries. By counting solo exhibitions shown in Canadian art galleries, Dymond reveals that they are not in fact representative of the nation’s diverse population.

INTRODUCTION: Prinzmetal angina is an unusual syndrome manifesting as rest angina with associated ST segment elevation on the EKG secondary to coronary artery spasm. Sudden death induced by Prinzmetal angina [...]

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Purpose:To investigate the impact on restenosis rates of deep injury to the adventitial layer during directional atherectomy. Methods:Between 2007 and 2010, 116 consecutive patients (mean age 69.6 years; 56 men) with symptomatic femoropopliteal stenoses were treated with directional atherectomy at a single center. All patients had claudication and TASC A/B lesions in the superficial femoral or popliteal arteries. Histopathology analysis of atherectomy specimens was performed to identify adventitial injury. Clinical follow-up included physical examination and duplex ultrasound scans at 3, 6, and 12 months in all patients. The primary endpoint was the duplex-documented 1-year rate of restenosis, which was determined by a peak systolic velocity ratio <2.4. Patients were dichotomized by the presence or absence of adventitial or medial cuts as evaluated by histopathology. Results:Adventitial injury were identified in 62 (53%) of patients. There were no differences in baseline demographic and clinical features (p>0.05), lesion length (58.7±12.8 vs 56.2±13.6 mm, p=0.40), or vessel runoff (1.9±0.6 vs 2.0±0.6, p=0.37) between patients with and without adventitial injury, respectively. The overall 1-year incidence of restenosis was 57%, but the rate was significantly higher (p<0.0001) in patients with adventitial or medial injury (97%, 60/62) as compared with those without (11%, 6/54). Conclusion:Lack of adventitial injury after atherectomy for femoropopliteal stenosis is strongly related to patency at 1 year.

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Peripheral artery disease (PAD) may be silent or present with an assortment of symptoms and signs suggesting peripheral artery ischemia. Peripheral vascular disease includes PAD and disorders of the peripheral venous system and lymphatic system. Generally, PAD is synonymous with arteries of the limbs and pelvis, but it can be expanded to include the renal arteries, carotid arteries, mesenteric arteries, and the aorta. It is imperative to recognize and treat PAD early, as appropriate management of PAD can help avoid devastating complications such as limb amputation and death.

Varicose veins are a common manifestation of chronic venous disease and affect approximately 25% of adults in the western hemisphere. The historical standard treatment has been surgery, with high ligation and stripping, combined with phlebectomies. In the past decade, alternative treatments such as endovenous ablation of the great saphenous vein (GSV) with laser, radiofrequency ablation, and ultrasonography-guided foam sclerotherapy have gained popularity. Performed as office-based procedures using tumescent local anesthesia, the new minimally invasive techniques have been shown in numerous studies to obliterate the GSV, eliminate reflux, and improve symptoms safely and effectively.

Acute limb ischemia is a vascular event presenting with sudden decrease in limb perfusion (of <14 days’ duration) that threatens limb viability. Acute thrombosis of the native artery or graft makes up the bulk of etiopathogenesis. Prompt revascularization is the cornerstone of management of acute limb ischemia in limbs that have not undergone irreversible tissue and nerve damage. Amputation is performed in patients with irreversible tissue and nerve damage.

PURPOSE: Renal insufficiency is very common following lung transplantation (LT) and contributes to increased morbidity and mortality. Angiotensin receptor blockers (ARB) have emerged as antihypertensive agents (AHTN) with renal protective [...]

Statin use results in atherosclerotic plaque stabilization. We sought to determine the effects of statins on the size and number of embolic particles generated during carotid artery stenting (CAS).

Introduction:Among patients undergoing percutaneous coronary intervention (PCI), those with chronic kidney disease (CKD) sustain poor clinical outcomes. However, there is a paucity of data on the impact of complex PCI (CPCI) on long-term prognosis, according to the presence of CKD.Objective:To determine the prognostic impact of complex procedural features in patients undergoing PCI with and without CKD.Methods:Patients undergoing PCI at a tertiary-care center between 2012 and 2019 were stratified according to the presence of CKD and procedural complexity. A CPCI was defined by the presence of ≥1 of the following: stent length >60 mm, ≥3 stents, ≥3 lesions, ≥3 target vessels, bifurcation with ≥2 stents, or chronic total occlusion. The primary outcome of interest was major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI) and target vessel revascularization (TVR) at 1 year.Results:Out of 15,071 patients, our study population consisted of 4,537 (30.1%) with CKD of whom 1,151 (25.4%) underwent CPCI, while 2,983 (28.3%) patients without CKD underwent a CPCI. The prevalence of traditional risk factors was similar among patients within the same group (CKD and no-CKD), irrespective of PCI complexity. Nonetheless, patients undergoing CPCI had more extensive coronary artery disease (i.e., higher syntax score, severe calcification, and longer lesion length). CPCI was associated with a higher risk of MACE at 1 year in both groups, though a greater risk was observed in those without concomitant CKD, mainly driven by a higher risk of MI and TVR (Figure 1). However, the risk of all-cause death was significantly higher among CKD patients undergoing a CPCI, and there was no significant difference between those with and without CPCI in non-CKD group.Conclusions:CPCI is associated with an increase in the risk of 1-year MACE among patients with or without CKD. The larger increase in the risk of MACE is observed in those without CKD, than those with CKD.

Background:Chronic obstructive pulmonary disease (COPD) is the third cause of death worldwide and often coexists with cardiovascular disease. Smoking is a common risk factor which promotes both respiratory and atherosclerotic disease. Whether COPD patients are at higher risk for cardiovascular events irrespective of smoking habit is poorly understood.Hypothesis:To investigate the additive prognostic impact of COPD and smoking in a cohort of patients undergoing percutaneous coronary intervention (PCI).Methods:Consecutive patients undergoing PCI at Mount Sinai Hospital, NY, between 2012-2019 were included and stratified by the presence of COPD at baseline. Active smoking was defined as the presence of smoking anytime during the year prior to admission. There were no formal exclusion criteria, except for the absence of information on COPD and smoking status. The primary endpoint was the composite of all-cause death or myocardial infarction at one year of follow-up.Results:Of the 16,313 patients included in the analysis, 1,295 (7.94%) had COPD. Patients with COPD were older, more often Caucasian, and had higher burden of comorbidities including hypertension, cancer, chronic kidney disease, heart failure. Active smoking was more common in COPD patients compared to those without COPD (27.3% vs. 15.4%, p<0.001). The primary endpoint occurred more frequently in COPD patients (4.6% vs. 2.0%; HR 2.3, 95% CI 1.7-3.1; p<0.001), with a graded risk by smoking status (FigureA). Findings were consistent after multivariable adjustment (FigureB).Conclusion:In a large and contemporary cohort of patients undergoing PCI, those with COPD were at higher risk of death or myocardial infarction compared to those without COPD, and this risk was further enhanced among COPD patients who smoked.

Diastolic dysfunction is a poorly understood pathophysiological entity its importance is magnified by the increasing prevalence of diastolic heart failure. Fortysix million people in the US are experiencing heart failure and 550,000 new cases are diagnosed annually. A large percentage of these patients with heart failure have a normal or nearly normal leftventricular ejection fraction. Isolated diastolic dysfunction may be associated with an increased mortality. One of the major causes of diastolic dysfunction is hypertension. Advances in diagnosis and treatment strategies may improve the clinical outcome for patients with diastolic dysfunction.

Introduction:The predictive value of high sensitivity C-reactive protein (hsCRP) after percutaneous coronary intervention (PCI) is well described in Caucasians, but understudied in minorities.Hypothesis:We hypophesized, that there were differences in prevalence and prognostic impact of hsCRP elevation according to race/ethnicity.Methods:We included all patients undergoing PCI between 2010-2017 in a single tertiary center, excluding those with acute coronary syndrome, cancer and hsCRP >10 mg/L. Race/Ethnicity was self-reported. hsCRP ?2 mg/L during index PCI was considered elevated. The association between hsCRP elevation and 1-year major adverse cardiac events (MACE), consisting of all-cause death, myocardial infarction (MI) and target lesion revascularization was assessed using Kaplan-Meier method and Cox models, adjusting for sex, age, diabetes, prior myocardial infarction, prior coronary artery bypass graft, peripheral artery disease and hemoglobin at baseline.Results:The analysis included 2,193 Asians, 5,592 Caucasians, 2,910 Hispanics and 1,202 African-Americans (total n= 11,843). Prevalence of hsCRP elevation differed widely between subgroups (p<0.01) and was highest in African-Americans and lowest in Asians (Figure 1). Comparing patients with normal vs. elevated hsCRP, 1-year rates of MACE were 7.6% vs. 12.9% in Asians, 6.6% vs. 9.7% in Caucasians, 8.3% vs. 11.3% in Hispanics and 6.0% vs. 13.4% in African-Americans, respectively. After adjustment, the association of elevated hsCRP and MACE was not significant in Asians (HR 1.33, 0.98-1.78 95% CI), moderate in Caucasians (HR 1.4, 1.12-1.76 95% CI), higher in Hispanics (HR 1.72, 1.21-2.5 95% CI) and highest in African-Americans (HR 2.35, 1.42-3.89 95% CI).Conclusions:hsCRP elevation varies between races/ethnicities, and in Hispanics and African-Americans its prevalence and prognostic impact is the highest.

Introduction:Elevated low-density lipoprotein cholesterol (LDL-C) levels are strongly associated with coronary risk in the general population. Chronic kidney disease (CKD) is a common co-morbidity in patients undergoing percutaneous coronary intervention (PCI), but the impact of high LDL-C in these subjects remains unclear. The present study aims to investigate the relation between LDL-C and adverse events after PCI according to the presence of CKD.Hypothesis:The prognostic relevance of LDL-C on cardiovascular outcomes is influenced by the presence of concomitant CKD.Methods:Data from all PCI procedures between 2009 and 2017 in a single tertiary center was prospectively collected. CKD was defined as an estimated glomerular filtration rate <60 ml/min/1.73m2. Exclusion criteria were end-stage renal failure (requiring dialysis or estimated glomerular filtration rate <15 mL/min/1.73m2) and conditions associated with pathologically lowered LDL-C (body mass index <18.5 kg/m2, ejection fraction <30%, and neoplastic disease). Baseline LDL-C levels were classified as either high (?90 mg/dl) or low (<90 mg/dl). The primary endpoint of interest was myocardial infarction (MI) at 1 year.Results:A total of 12,823 subjects were included, of which 3,253 (25.4%) had CKD. High baseline LDL-C was present in 22.7% and 27.6% of CKD and non-CKD patients, respectively. Overall, patients with high LDL-C levels experienced higher rates of MI at 1 year (Figure). However, while the risk of MI was significantly increased in non-CKD patients with high LDL-C as compared to low LDL-C (adjusted HR: 1.78 [95% CI, 1.22-2.60]; p=0.003), no such trend was observed among CKD patients (adjusted HR: 1.40 [0.78-2.49]; p=0.26).Conclusions:The impact of LDL-C levels on the risk of MI differs between CKD and non-CKD patients. Prognostic implications of high LDL-C may be attenuated in CKD patients undergoing PCI.

Introduction:Contrast-induced acute kidney injury (CI-AKI) after PCI predicts worse cardiovascular outcomes. Physiologic mechanisms, genetic predisposition and socioeconomic disparities related to ethnicity may contribute to the occurrence of CI-AKI.Hypothesis:We evaluated the risk of CI-AKI after PCI according to ethnicity and its subsequent impact on 1-year mortality.Methods:Patients undergoing PCI at our Institution from 2009-2018 were grouped by ethnicity into White (n=7,942), Asian (n=2,604), Hispanic (n=1,431) and African American (n=1,748). CI-AKI was defined as a peri-procedural creatinine increase of >0.3 mg/dL or >50% compared to baseline. The association between ethnicity and CI-AKI was assessed using logistic regression. A sensitivity analysis was performed by including only patients with baseline CKD, defined as eGFR <60 mL/min/1.73m2. The risk of 1-year mortality after CI-AKI was evaluated with multivariate Cox model.Results:The rate of CI-AKI was 5.8% in the overall population. Compared to White patients, the risk of CI-AKI was higher in African Americans (OR 1.45, 95% CI 1.19-1.76; p<0.001), lower in Asians (OR 0.78, 95% CI 0.65-0.98; p=0.03) and similar in Hispanics (OR 0.93, 95% CI 0.73-1.19; p=0.57). However, after adjustment for confounders, the association between ethnicity and CI-AKI was largely attenuated (Figure). Findings of sensitivity analysis in CKD patients were consistent with those in the general population. Overall, 1-year mortality was increased in patients who experienced CI-AKI (adjusted HR 1.92, 95% CI 1.39-2.66; p<0.001), but this risk was not uniform among the different subgroups (White: p<0.001, African American: p=0.05, Hispanic: p=0.06, Asian: p=0.37) (Figure).Conclusions:The risk of CI-AKI after PCI varies according to ethnicity, however, this might be explained by differences in risk factors observed in each group. The occurrence of CI-AKI is associated with an increased risk of mortality at 1 year.

Introduction:Efficacy of drug-eluting stent has been assessed in several trials with consistent effect between genders. However, patients undergoing PCI for left main (LM) stenosis tend to experience high rates of recurrent events, especially in anatomically complex cases. As women are generally underrepresented in most trials, gender differences in this high-risk population undergoing LM PCI are not well established.Hypothesis:We sought to evaluate predictors of patient- and device-oriented outcomes at 1 year in men and women receiving unprotected LM PCI.Methods:We included patients undergoing LM PCI at our institution from 2009 to 2017. Those with prior CABG, STEMI on presentation, or treated with bare metal stents were excluded. We assessed the predictors of major adverse cardiac and cerebrovascular events (MACCE; the composite of death, myocardial infarction or stroke) and target vessel revascularization (TVR) at 1 year separately for men and women, using multivariate Cox regression model.Results:Of the 641 patients undergoing unprotected LM PCI, 216 (34%) were female. Among women, the strongest predictor of MACCE was chronic kidney disease, followed by atrial fibrillation, NSTEMI on presentation and reduced left ventricular ejection fraction (by decrease of 10%). In men, NSTEMI on presentation was the strongest predictor of MACCE followed by bifurcation lesions, anemia, and reduced left ventricular ejection fraction (Table). In stent restenosis was the only predictor of 1-year TVR in both men (HR 2.22, 95% CI 1.10-4.48; p=0.026) and women (HR 7.47, 95% CI 2.18-25.57; p=0.001).Conclusions:Men and women undergoing unprotected LM PCI with drug-eluting stent present common as well as distinctive predictors of MACCE at 1 year. In-stent restenosis constitutes the only independent predictor of TVR after LM PCI in both genders.

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A wild fungal strain of Aspergillus terreus, labeled as PM3, was isolated by using the Candida albicansbioassay and confirmed by 18S r DNA analyses. Lovastatin was produced by submerged and solid state fermentations. Of the 30 isolated fungal strains, 11 showed lovastatin production with Aspergillus terreusPM3 being the best with a yield of 240 mg/L at the 10thday of submerged fermentation. Carboxymethylcellulose had a stimulatory effect on lovastatin production. It restricted uncontrolled filamentous growth, induced pellet formation and, thereby, improved lovastatin yield. In solid state fermentation (SSF), of the agro wastes from five crops (bran of wheat and rice, husks of red gram and soybean, and green gram straw), wheat bran showed maximum lovastatin production (12.5 mg/g of dry substrate) at pH 7.1 and a temperature of 30±2°C. Development of a lovastatin production process based on wheat bran as a substrate in SSF is economically attractive as it is a cheap and readily available raw material in agriculture-based countries.