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Readability Analysis of the American Society of Ophthalmic Plastic & Reconstructive Surgery Patient Educational Brochures.

Semin Ophthalmol 2021 May 11:1-6. Epub 2021 May 11.

Department of Ophthalmology, George Washington University School of Medicine & Health Science, Washington DC, USA.

Introduction: Previous studies have shown patient education material (PEM) in ophthalmology has been written at levels exceeding appropriate reading levels. However, information for readability in the field of oculoplastics remains limited. The aim of this study was to evaluate the readability of patient educational brochures from the American Society of Ophthalmic Plastic & Reconstructive Surgery (ASOPRS). Read More

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Human bone marrow-derived, pooled, allogeneic mesenchymal stromal cells manufactured from multiple donors at different times show comparable biological functions in vitro, and in vivo to repair limb ischemia.

Stem Cell Res Ther 2021 May 10;12(1):279. Epub 2021 May 10.

Stempeutics Research Pvt Ltd, 3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd., #143, EPIP Industrial Area, K R Puram Hobli, Bengaluru, India.

Background: We have previously demonstrated that a pooled population of bone marrow-derived, allogeneic mesenchymal stromal cells (BMMSC), Stempeucel®-1, produced under good manufacturing practices (GMP) conditions, showed clinical efficacy and safety in patients suffering from critical limb ischemia (CLI) due to Buerger's disease. While Stempeucel®-1 is currently used for CLI and other clinical indications, we wanted to ensure that the product's continuity is addressed by developing and characterizing a second generation of pooled product (Stempeucel®-1A), manufactured identically from second BM aspirates of the same three donors after a 2-year interval.

Methods: The two versions of Stempeucel® were manufactured and subjected to gene and protein expression analysis. Read More

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Efficacy and one-year outcomes of Luminor® paclitaxel-coated drug-eluting balloon in the treatment of popliteal artery atherosclerosis lesions.

Ann Vasc Surg 2021 May 2. Epub 2021 May 2.

University of Palermo - Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), Palermo, Italy; Vascular Surgery Unit, AOUP "P. Giaccone", Palermo, Italy.

Purpose: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U. Read More

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"Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia.

Cardiovasc Intervent Radiol 2021 May 4. Epub 2021 May 4.

Université de Paris, INSERM U970, 75015, Paris, France.

Purpose: Restenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI). Read More

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A Comparison of Prognostic Scores (Mayo, UK-PBC, and GLOBE) in Primary Biliary Cholangitis.

Am J Gastroenterol 2021 May 4. Epub 2021 May 4.

Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands; Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada; Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy; Department of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University, Jena, Germany; Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany; Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece; Department of Gastroenterology and Hepatology, Ghent University Hospital, Ghent, Belgium; Arizona State University, Phoenix, Arizona, USA; Liver Unit, Hospital Cli[Combining Acute Accent]nic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain; Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy; Department of Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

Introduction: Comparative data on scores that predict outcome in primary biliary cholangitis (PBC) are scarce. We aimed to assess and compare the prognostic value of the Mayo Risk Score (MRS, 1989 and 1994), UK-PBC score, and GLOBE score in a large international cohort of patients with PBC.

Methods: Ursodeoxycholic acid-treated patients from 7 centers participating in the GLOBAL PBC Study Group were included. Read More

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Cerenkov Luminescence Imaging in prostate cancer: not the only light that shines.

J Nucl Med 2021 Apr 30. Epub 2021 Apr 30.

Netherlands Cancer Institute - Antoni van Leeuwenhoek, Netherlands.

Introduction: Cerenkov luminescence imaging (CLI) is a novel imaging technology that might have the ability to assess surgical margins intra-operatively during prostatectomy using Gallium-68 prostate-specific membrane antigen ([Ga]Ga-PSMA-11). This study evaluates the accuracy of CLI compared to histopathology and as exploratory objective investigates the characteristics of the identified chemiluminescence signal. After intravenous injection of a mean Ga-PSMA-11 activity of 69MBq intraoperatively, all excised specimens were imaged with CLI. Read More

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Trends and causes of readmission following peripheral vascular intervention in patients with peripheral vascular disease.

Catheter Cardiovasc Interv 2021 Apr 16. Epub 2021 Apr 16.

Detroit Medical Center, Wayne State University, Detroit, Michigan, USA.

Objectives: To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD).

Background: There has been a paucity of data regarding the trend and predictors of PVI readmission.

Methods: We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. Read More

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Clinical practice patterns and ascertainment bias for cardiovascular events in a randomized trial: A survey of investigators in the BEST-CLI trial.

Vasc Med 2021 Apr;26(2):180-186

Division of Cardiology and Section of Vascular Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Ascertainment bias is a well-recognized source of bias in research, but few studies have systematically analyzed sources of ascertainment bias in randomized trials in which blinding is not possible and endpoint assessment is not protocolized. In the current study, we sought to evaluate differences in the clinical practice patterns of trial investigators with respect to bias in the ascertainment of pre-revascularization patient risk and the incidence of secondary endpoints post-revascularization. We conducted a cross-sectional survey of active investigators ( = 936) from the Best Endovascular Versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial. Read More

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End-stage renal disease patients undergoing angioplasty and bypass for critical limb ischemia have worse outcomes compared to non-ESRD patients: Systematic review and meta-analysis.

Catheter Cardiovasc Interv 2021 Apr 6. Epub 2021 Apr 6.

Department of Medicine and Center of Excellence for Cardiovascular Diseases & Sciences, Louisiana State University Health Sciences Center, Shreveport, Louisiana, USA.

Background: End-stage renal disease (ESRD) is associated with increased morbidity and mortality following lower extremity amputation for critical limb ischemia (CLI). Angioplasty and bypass are used in ESRD patients with CLI; however, the treatment of choice remains controversial. We compared the long-term outcomes in patients with CLI undergoing angioplasty or bypass to evaluate the differences between patients with ESRD and those without ESRD. Read More

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Validation of ERICVA Risk Score as a Predictor of One Year Amputation-Free Survival of Patients with Critical Limb Ischemia.

Ann Vasc Surg 2021 Apr 2. Epub 2021 Apr 2.

Department of Vascular Surgery, Galway University Hospital, Galway, Ireland; Department of Vascular Surgery, National University of Ireland Galway, Ireland.

Background: The ERICVA score was derived to predict amputation-free survival in patients with critical limb ischemia (CLI). It may be a useful tool to stratify patients in trials of novel interventions to treat CLI but, as yet, it has not been externally validated.

Methods: A prospective database of CLI patients was developed during prescreening of patients for a phase 1 stem cell therapy clinical trial. Read More

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Main Factors Predicting Nonresponders to Autologous Cell Therapy for Critical Limb Ischemia in Patients With Diabetic Foot.

Angiology 2021 Mar 30:33197211005614. Epub 2021 Mar 30.

Diabetes Centre, Tameside Hospital NHS Foundation Trust and University of Manchester, Lancashire, United Kingdom.

Autologous cell therapy (ACT) is a new treatment for patients with no-option critical limb ischemia (NO-CLI). We evaluated the factors involved in the nonresponse to ACT in patients with CLI and diabetic foot. Diabetic patients (n = 72) with NO-CLI treated using ACT in our foot clinic over a period of 8 years were divided into responders (n = 57) and nonresponders (n = 15). Read More

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The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

Angiology 2021 Mar 29:3319721997314. Epub 2021 Mar 29.

GRN Academic Teaching Hospital Weinheim, Germany.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Read More

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Analyses of the pericyte transcriptome in ischemic skeletal muscles.

Stem Cell Res Ther 2021 Mar 16;12(1):183. Epub 2021 Mar 16.

Department of Biophysics, Escola Paulista de Medicina, Federal University of São Paulo, Rua Mirassol 207, São Paulo, SP, 04044-010, Brazil.

Background: Peripheral arterial disease (PAD) affects millions of people and compromises quality of life. Critical limb ischemia (CLI), which is the most advanced stage of PAD, can cause nonhealing ulcers and strong chronic pain, and it shortens the patients' life expectancy. Cell-based angiogenic therapies are becoming a real therapeutic approach to treat CLI. Read More

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pUDK-HGF Gene Therapy to Relieve CLI Rest Pain and Ulcer: A Phase II, Double-Blind, Randomized Placebo-Controlled Trial.

Hum Gene Ther 2021 Mar 17. Epub 2021 Mar 17.

Beijing Institute of Radiation Medicine, 96702, Beijing, Beijing, China;

This phase II clinical trial investigated the efficacy and safety of intramuscular injection of plasmid pUDK-HGF which encodes the human hepatocyte growth factor gene in patients with critical limb ischemia (CLI). Resting pain patients (n=119) and patients with leg ulcers (n=121) were enrolled as two cohorts and randomized to receive pUDK-HGF treatment on days 0, 14, and 28. In the resting pain cohort, the proportion of patients with complete pain relief on day 180 after receiving pUDK-HGF injection, as the primary outcome, was significantly higher than that of the placebo group on the same day (p = 0. Read More

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Online educational materials for appendectomy patients have good quality but poor readability.

Am J Surg 2021 Mar 3. Epub 2021 Mar 3.

Department of Surgery, University of British Columbia & Paul's Hospital, C303 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada. Electronic address:

Background: Guidelines recommend patient health-related information be written at or below the sixth-grade level. This study evaluates the readability level and quality of online appendectomy patient education materials.

Methods: Webpages were evaluated using seven readability formulae: Flesh-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI), Coleman-Liau Index (CLI), Automated Readability Index (ARI), Simple Measure of Gobbledygook (SMOG), Flesch Reading Ease (FRE), and New Dale-Chall (NDC). Read More

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Low admission blood pressure as a marker of poor 1-year survival in patients with revascularized critical limb ischemia.

J Hypertens 2021 Mar 11. Epub 2021 Mar 11.

ESH Excellence Center, Vascular Medicine Department Medical Information Department Clinical Research Center ESH Excellence Center, Internal Medicine Department, Groupe Hospitalier Paris St Joseph Inserm UMR 1153-CRESS, Paris, France.

Objective: To contrast the association between blood pressure (BP) level and antihypertensive medications at hospital admission with 1-year mortality in patients undergoing revascularization for critical limb ischemia (CLI).

Methods: From November 2013 to May 2019, 315 consecutive patients were retrospectively included. A median of seven (IQR 3-13) separate readings were recorded for each patient before revascularization procedure and the average represented patient's mean BP. Read More

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Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review - revival of a promising therapeutic option?

Br J Neurosurg 2021 Mar 11:1-9. Epub 2021 Mar 11.

Department of Stereotactic and Functional Neurosurgery, University Cologne Hospital, Cologne, Germany.

Introduction: Peripheral vascular disease (PVD) is caused by a blood circulation disorder of the arteries and Critical Limb Ischemia (CLI) is the advanced state of PVD. For patients with surgically non-reconstructable CLI, Spinal Cord Stimulation (SCS) appears to be an alternative therapeutic option.

Objective: The aim of our study was to investigate the efficacy of SCS in non-reconstructable CLI compared with the conservative treatment and re-appraise the existing literature in light of the recent advances in neuromodulation. Read More

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Rationale and Design of Therapeutic Angiogenesis by Cell Transplantation Using Adipose-Derived Regenerative Cells in Patients With Critical Limb Ischemia - TACT-ADRC Multicenter Trial.

Circ Rep 2020 Aug 8;2(9):531-535. Epub 2020 Aug 8.

Department of Cardiology, Nagoya University Graduate School of Medicine Nagoya Japan.

Despite the growing knowledge regarding optimal treatments for critical limb ischemia (CLI), there are still a considerable number of patients who have to undergo major limb amputation. Intramuscular injection of autologous adipose-derived regenerative cells (ADRCs) in these patients has shown therapeutic potential in improving tissue ischemia, in both preclinical and initial pilot studies. Here, we present a clinical protocol for ADRCs use in a multicenter trial. Read More

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Rationale and Design of a Prospective, Multicenter, Single-Arm Clinical Trial to Investigate the Safety and Effectiveness of Rotablator Atherectomy System as an Adjunctive Device for Endovascular Treatment of Occlusive Atherosclerotic Lesions in Below-the-Knee Arteries With Critical Limb Ischemia (RESCUE-BTK).

Circ Rep 2020 Jun 16;2(8):449-454. Epub 2020 Jun 16.

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center Suita Japan.

Endovascular treatment with balloon angioplasty plays a major role in revascularization of below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI). However, with severely calcified lesions, achieving optimal revascularization with balloon angioplasty alone is difficult. Therefore, we are evaluating the safety and effectiveness of the Rotablator atherectomy system as an adjunctive device in the treatment of severely calcified lesions in BTK arteries in the RESCUE-BTK trial, a multicenter, single-arm, open-label, exploratory investigator-initiated clinical study of medical devices. Read More

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Zinc Deficiency and Clinical Outcome After Infrainguinal Bypass Grafting for Critical Limb Ischemia.

Circ Rep 2020 Feb 26;2(3):167-173. Epub 2020 Feb 26.

Division of Vascular Surgery, Departments of Surgery, Nagoya University Graduate School of Medicine Nagoya Japan.

The aim of this study was to identify a relationship between zinc (Zn) deficiency and clinical outcome in patients with critical limb ischemia (CLI). Forty-five limbs from 44 patients with CLI who underwent de novo infrainguinal bypass grafting (IBG) were retrospectively reviewed. The patients were divided into a Zn deficiency group (ZD group: Zn <60 µg/dL) and a Zn sufficiency group (ZS group: Zn ≥60 µg/dL). Read More

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February 2020

Endovascular Treatment for Critical Limb Ischemia in Type II Diabetes Mellitus Involving Femoropopliteal and Infrapopliteal Segments: Revascularization Strategy.

Vasc Health Risk Manag 2021 4;17:69-76. Epub 2021 Mar 4.

Department of Surgery, Vascular Surgery, Jordan University of Science and Technology, Irbid, 22110, Jordan.

Purpose: To determine if further endovascular infrapopliteal angioplasty in combination with femoropopliteal revascularization improves the clinical outcomes regarding major amputation rate, rate of secondary interventions, and mortality in diabetic type-II patients presented with critical lower limb ischemia (CLI).

Patients And Methods: This is a retrospective study in which all type-II diabetic patients with CLI at King Abdullah University Hospital between October 2015 and September 2019 were identified. Patients with concomitant femoropopliteal and infrapopliteal vessels atherosclerotic lesions (total occlusion or more than 50% stenosis) who received successful endovascular treatment were included. Read More

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Autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene as graft materials for below-the-knee femoro-popliteal bypass in patients with critical limb ischemia: A propensity score-matched analysis.

Surgeon 2021 Mar 6. Epub 2021 Mar 6.

Department of Vascular Surgery, University of Florence, Italy.

Objective: To compare the outcomes of heparin bonded expanded polytetrafluoroethylene (HePTFE) and autologous saphenous vein (ASV) in patients undergoing below-knee (BK) femoro-popliteal bypass for critical limb ischemia (CLI).

Design: Retrospective single-centre matched case-control study.

Methods: From 2003 to 2019, 275 consecutive BK bypasses for CLI were performed, 109 with the ASV and 166 with a HePTFE graft. Read More

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Racial differences in the limb skeletal muscle transcriptional programs of patients with critical limb ischemia.

Vasc Med 2021 Mar 8:1358863X20983918. Epub 2021 Mar 8.

Diabetes and Obesity Institute, East Carolina University, Brody Medical Center, Greenville, NC, USA.

Critical limb ischemia (CLI) is the most severe manifestation of peripheral artery disease (PAD) and is characterized by high rates of morbidity and mortality. As with most severe cardiovascular disease manifestations, Black individuals disproportionately present with CLI. Accordingly, there remains a clear need to better understand the reasons for this discrepancy and to facilitate personalized therapeutic options specific for this population. Read More

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Therapeutic angiogenesis using zinc oxide nanoflowers for the treatment of hind limb ischemia in rat model.

Biomed Mater 2021 Mar 3. Epub 2021 Mar 3.

Biomaterials Group, LST Division, CSIR-Indian Institute of Chemical Technology, Uppal Road, Tarnaka, Hyderabad 500007, AP, Hyderabad, Andhra Pradesh, 500007, INDIA.

Critical limb ischemia (CLI) is considered as a severe type of peripheral artery diseases (PADs) which occurs due to the inadequate supply of blood to the limb extremities. CLI patients often suffer from extreme cramping pain, impaired wound healing, immobility, cardiovascular complications, amputation of the affected limb and even death. The conventional therapy for the treatment of CLI includes surgical revascularization as well as restoring angiogenesis using growth factor therapy. Read More

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Current Status of Angiogenic Cell Therapy and Related Strategies Applied in Critical Limb Ischemia.

Int J Mol Sci 2021 Feb 26;22(5). Epub 2021 Feb 26.

Biomedicine, Biotechnology and Public Health Department, Cádiz University, 11519 Cadiz, Spain.

Critical limb ischemia (CLI) constitutes the most severe form of peripheral arterial disease (PAD), it is characterized by progressive blockade of arterial vessels, commonly correlated to atherosclerosis. Currently, revascularization strategies (bypass grafting, angioplasty) remain the first option for CLI patients, although less than 45% of them are eligible for surgical intervention mainly due to associated comorbidities. Moreover, patients usually require amputation in the short-term. Read More

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February 2021

Contemporary Revascularization Strategies and Outcomes Among Patients With Diabetes With Critical Limb Ischemia: Insights From the National Inpatient Sample.

JACC Cardiovasc Interv 2021 Mar 24;14(6):664-674. Epub 2021 Feb 24.

Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA. Electronic address:

Objectives: The purpose of this study was to evaluate temporal trends in the frequency of revascularization and associated outcomes in patients with diabetes mellitus and critical limb ischemia (CLI).

Background: Little is known about outcomes following revascularization for CLI in patients with diabetes mellitus.

Methods: Temporal trends in hospitalization for CLI among patients with diabetes were determined using the 2002-2015 National Inpatient Sample database. Read More

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Potential of an Approach Based on the Identification and Treatment of Vulnerable Coronary Plaques.

JACC Cardiovasc Interv 2021 Feb;14(4):468-473

Department of Cardiology, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain.

In this viewpoint paper, the authors are tackling criticism to the limits of invasive imaging modalities for identification and treatment of vulnerable plaques. They believe in the clinical usefulness of invasive imaging modalities for identification of vulnerable plaques, and are suggesting an explanation for the suboptimal results of past studies, that failed to demonstrate a correlation between interventional treatment of vulnerable plaques, and reduction of hard clinical endpoints. Vulnerability studies have been based, so far, on the detection and measurement of plaques lipid content, because of its ease. Read More

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February 2021

Calcifying characteristics of peripheral vascular smooth muscle cells of chronic kidney disease patients with critical limb ischemia.

Vasc Med 2021 Apr 16;26(2):139-146. Epub 2021 Feb 16.

Department of Orthopedic Surgery, Seoul National University Hospital, Jongno-gu, Seoul, Korea.

The role of vascular smooth muscle cells (VSMCs) in vascular calcification, which is related to chronic kidney disease (CKD), has been studied in greater detail in the major arteries relative to the peripheral arteries. We compared the calcifying characteristics of peripheral VSMCs relative to non-pathologic major VSMCs in patients with severe peripheral artery disease (PAD). We isolated peripheral VSMCs from the posterior tibial artery of 10 patients with CKD who underwent below-knee amputation for critical limb ischemia (CLI). Read More

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Medical therapy for cardiovascular and limb-related risk reduction in critical limb ischemia.

Vasc Med 2021 Apr 15;26(2):210-224. Epub 2021 Feb 15.

Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA.

Critical limb ischemia (CLI) constitutes the most advanced form of peripheral artery disease (PAD) and is characterized by ischemic rest pain, tissue loss and/or gangrene. Optimized medical care and risk factor modification in addition to revascularization could reduce the incidence of cardiovascular events and major adverse limb events, improving patients' quality of life and promising higher survival rates. Adequate adherence to cardioprotective medications, including antithrombotic therapy (e. Read More

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[Pharmacotherapy for obesity].

Ned Tijdschr Geneeskd 2021 01 19;165. Epub 2021 Jan 19.

Erasmus MC, afd. Kindergeneeskunde,Rotterdam.

Obesity is a complex endocrine disease, mainly caused by environmental, behavioral and biological factors. Maintaining weight loss is extremely difficult due to the neuro-endocrine dysregulations that stimulate the body to return to the previous, increased, weight. Identifying underlying weight-gaining factors is needed, including medication-related, psychological and endocrine factors, as well as monogenic obesity. Read More

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January 2021