506 results on '"Peripheral Arterial Occlusive Disease"'
Search Results
2. Novel predictive tool for Fournier gangrene: Twenty-year experience of a tertiary institute.
- Author
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Chien, Huang-Yi, Liao, Chun-Hou, Lin, Yu-Hua, and Lu, Yu-Chuan
- Abstract
Purpose: This study aimed to identify prognostic factors and provide a novel image classification method for patients with Fournier gangrene. Materials and methods: A total of 40 consecutive patients diagnosed with Fournier gangrene between January 2003 and December 2022 were enrolled. Demographic characteristics, clinical presentations, management strategies, and outcomes were retrospectively analyzed. Results: The overall survival rate was 87.5% (35/40). Diabetic foot history, chronic kidney disease, end-stage renal disease, or peripheral arterial occlusive disease were significantly (P < 0.05) more common in nonsurvivors than in survivors. Among the parameters of the Fournier's Gangrene Severity Index, only the initial creatinine level was significantly associated with mortality (P = 0.02). Nevertheless, the Fournier's Gangrene Severity Index score with a cutoff score of 9 remained a useful indicator of death (P = 0.04). Patients with grade II (extensive) invasion determined by whole abdominal computed tomography had significantly higher mortality rates than those with grade I (nonextensive) (37.5% versus 6.3%, P = 0.04). Conclusion: Patients with a history of diabetic foot, chronic kidney disease, end-stage renal disease, and peripheral arterial occlusive disease had a higher risk of death. Early image computed tomography studies are essential for evaluating the risk and extent of the disease. More predictive tools are needed to assess this aggressively infectious disease. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
3. Case planning and execution of inframalleolar bypass for chronic limb-threatening ischemia.
- Author
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Gomez-Sanchez, Clara M and Conte, Michael S
- Subjects
Amputation ,Chronic limb-threatening ischemia ,Peripheral arterial occlusive disease ,Surgical ,Cardiovascular - Abstract
Chronic limb-threatening ischemia is challenging to treat because of the complex patient population, heterogeneity of limb presentations, and complicated arterial pathology. To meet this challenge, vascular surgeons need a broad range of skills to appropriately tailor interventions to each patient's specific needs. One tool in the armamentarium for patients with extensive arterial occlusive disease below the knee is an inframalleolar bypass. However, these procedures require a systematic approach to surgical planning and a high degree of technical competence. We describe our approach to inframalleolar bypass for limb preservation in suitable patients with advanced tibial artery disease.
- Published
- 2023
4. The value of Wound, Ischemia and foot Infection classification in patients undergoing endovascular therapy.
- Author
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Godoy, Marcos Roberto, Brochado-Neto, Francisco Cardoso, Matielo, Marcelo Fernando, Martins Cury, Marcus Vinícius, Manzioni, Renato, and Sacilotto, Roberto
- Abstract
This study aimed to evaluate the correlation between the Society for Vascular Surgery (SVS) Wound, Ischemia and foot infection (WIfI) classification system and clinical outcomes for 1-year limb amputation-free survival (AFS), freedom from reintervention, and wound healing rate in a cohort of patients affected by chronic limb-threatening ischemia treated exclusively by endovascular procedures. We analyzed a prospective, consecutive cohort of 203 patients (203 limbs) who underwent infrainguinal endovascular revascularization at a single center between March 2018 and January 2021. These patients were stratified into clinical stages 1 to 4 based on the SVS WIfI classification and categorized into two groups: WIfI 1 to 3 (n = 101 limbs) and WIfI 4 (n = 102 limbs). The SVS objective performance goals of 1-year limb AFS, freedom from reintervention, and wound healing were compared between the groups and assessed using the Kaplan-Meier method. Angiographic lesion characteristics and angioplasty details were compared. The average age was 72.4 years (44.3% male, 85.2% had hypertension, 80.3% had diabetes, and 87.7% had tissue loss). There were statistical differences between the groups in 1-year limb AFS Kaplan-Meier rate between WIfI clinical stages 1 to 3 group and WIfI clinical stage 4 group (82% vs 66%, respectively; P <.001), but there was no statistical difference in freedom from reintervention and wound healing rates between the groups (70% vs 64% [ P =.62] and 74% vs 79% [ P =.90], respectively). Owing to angiographic lesion characteristics, femoropopliteal and infrapopliteal segment distributions were similar between the groups, but there was a statistical difference in target lesion location to tibial vessels (55.4% vs 71.6%, respectively; P =.025). In this cohort of patients with chronic limb-threatening ischemia, SVS WIfI clinical stage 4 had worse results in the 1-year limb AFS rate, but there was no statistical difference in freedom from reintervention and wound healing rates between the groups. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
5. Association of Glaucoma with the Risk of Peripheral Arterial Occlusive Disease: A Retrospective Population-Based Cohort Study.
- Author
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Yeh, Han-Wei, Chung, Chi-Tzu, Chang, Chao-Kai, Yeh, Chao-Bin, Wang, Bo-Yuan, Lee, Chia-Yi, Wang, Yu-Hsun, Yeh, Liang-Tsai, and Yang, Shun-Fa
- Subjects
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ARTERIAL occlusions , *PERIPHERAL vascular diseases , *HEPATIC veno-occlusive disease , *PROPORTIONAL hazards models , *PROPENSITY score matching , *GLAUCOMA - Abstract
This study aimed to investigate the potential association between glaucoma and peripheral arterial occlusive disease. The study recruited patients, including 101,309 with glaucoma and 1,860,528 without a glaucoma diagnosis, from a population of 2 million patients in the Longitudinal Health Insurance Database. Propensity score matching was performed between the two groups, matching for age, sex, and comorbidities. In total, 95,575 patients with glaucoma and 95,575 patients without glaucoma were analyzed for their risk of developing peripheral arterial occlusive disease. The analysis of the data revealed that the glaucoma group had a higher incidence density (ID = 4.13) of peripheral arterial occlusive disease than the non-glaucoma group (ID = 3.42). The relative risk for the glaucoma group was 1.21 (95% C.I. = 1.15–1.28). Cox proportional hazard model analysis indicated that the glaucoma group had a higher risk of developing peripheral arterial occlusive disease (HR = 1.18; 95% C.I. = 1.12–1.25). The subgroup analysis of the risk of PAOD showed that the glaucoma group had a higher risk of developing peripheral arterial occlusive disease in the age group of 20 to 39 (p for interaction = 0.002). In conclusion, patients with glaucoma were associated with a higher risk of subsequent peripheral arterial occlusive disease compared with those without a diagnosis of glaucoma. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
6. Case planning and execution of inframalleolar bypass for chronic limb-threatening ischemia
- Author
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Clara M. Gomez-Sanchez, MD and Michael S. Conte, MD
- Subjects
Peripheral arterial occlusive disease ,Chronic limb-threatening ischemia ,Amputation ,Surgical ,Surgery ,RD1-811 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Chronic limb-threatening ischemia is challenging to treat because of the complex patient population, heterogeneity of limb presentations, and complicated arterial pathology. To meet this challenge, vascular surgeons need a broad range of skills to appropriately tailor interventions to each patient's specific needs. One tool in the armamentarium for patients with extensive arterial occlusive disease below the knee is an inframalleolar bypass. However, these procedures require a systematic approach to surgical planning and a high degree of technical competence. We describe our approach to inframalleolar bypass for limb preservation in suitable patients with advanced tibial artery disease.
- Published
- 2023
- Full Text
- View/download PDF
7. Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the 'SirPAD' randomized controlled trial
- Author
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Stefano Barco, Tim Sebastian, Davide Voci, Rolf Peter Engelberger, Alexandru Grigorean, Erik Holy, Claudia Leeger, Mario Münger, Daniel Périard, Eliane Probst, Rebecca Spescha, Ulrike Held, and Nils Kucher
- Subjects
Peripheral arterial occlusive disease ,Atherosclerotic disease ,Common iliac artery ,Intermittent claudication ,Critical limb ischemia ,Endovascular ,Medicine (General) ,R5-920 - Abstract
Abstract Background Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for “hard” clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability. Methods In this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective “hard” outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes. Discussion By focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative (“all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected. Trial registration ClinicalTrials.gov NCT04238546
- Published
- 2022
- Full Text
- View/download PDF
8. Sex disparities in peripheral arterial occlusive disease
- Author
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Leonor Baldaia, Luís F. Antunes, Cândida G. Silva, Miguel Silva, Eduardo Silva, Celso Nunes, Vânia Constâncio, and Manuel Fonseca
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Peripheral arterial occlusive disease ,Sex disparities ,Gender research ,Epidemiology ,Medicine ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
INTRODUCTION: Recently published studies on peripheral arterial occlusive disease (PAOD) have revealed marked sex disparities in patient selection and treatment outcomes. In a recent retrospective study with data from 11 different countries, Portugal was highlighted as one of the countries with greater sex discrepancies related to PAOD treatment. We aimed to analyze sex specific differences in the treatment of symptomatic PAOD, concerning different variables, in a single hospital center, in Portugal. METHODS: Data on treatment of symptomatic PAOD patients from October 1st, 2020, to December 31st, 2021, were retrospectively collected from clinical registries from a single hospital center in Portugal. Different variables and post-operative outcomes were analyzed dichotomized by sex, with descriptive statistics. Statistical analyses were conducted using the IBM Statistical Package for Social Sciences (SPSS) software v28. RESULTS: A total of 220 patients, 15,9% female and 84,1% male, were treated for PAOD, in the selected period, in a hospital center from Portugal. Female patients were older (mean age of 73.8 years versus 69.5 years in male); were less likely to be treated for intermittent claudication (3% versus 6% of men); more often treated at a more advanced stage of the disease with trophic lesions (91% versus 74% of men); more likely to be offered primary major amputation (14% versus 3% of male patients); less likely to be taking statins as part of PAOD medical management (65.7% versus 77.8% of male); and had a higher 90-day mortality rate (17.1% versus 6.5% in men). They were also more frequently treated with endovascular procedures (40%) than with OSR (26%). CONCLUSION: Remarkable sex discrepancies in the treatment of PAOD were found in our hospital center. This study brings awareness to the scientific medical community for sex disparities in the management of patients with PAOD.
- Published
- 2023
- Full Text
- View/download PDF
9. ACUTE ON CHRONIC LIMB-THREATENING ISCHEMIA ASSOCIATED WITH SEPTIC EMBOLISM IN PATIENT WITH INFECTIVE ENDOCARDITIS.
- Author
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Laras Ati, Nindya Sari Diajeng, Subagjo, Agus, Muhammad, Rizal, Nugraha, Ricardo Adrian, and Aditya, Muhammad
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INFECTIVE endocarditis , *MYOCARDIAL infarction , *EMBOLISMS , *Q fever , *ISCHEMIA , *ARTERIAL occlusions , *PERIPHERAL vascular diseases - Abstract
Septic embolism associated with infective endocarditis (IE) is the occlusion of a blood vessel caused by an infected thrombus traveling through the bloodstream resulting in ischemia and/or infarction. Septic embolism can result in ischemia and/or infarction due to vascular occlusion and infection, resulting in inflammation and possible abscess formation. Systemic embolization generally occurs in left-sided IE, causing stroke, blindness due to embolism or endophthalmitis, splenic or renal infarct, limb ischemia, or even acute myocardial infarction. Here, we report a case of acute on chronic limb-threatening ischemia due to septic embolism in patient with IE. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
10. Editor's Choice – Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention.
- Author
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Mao, Jialin, Sedrakyan, Art, Goodney, Philip P., Malone, Misti, Cavanaugh, Kenneth J., Marinac-Dabic, Danica, Eldrup-Jorgensen, Jens, and Bertges, Daniel J.
- Abstract
This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest. The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan–Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278). The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 – 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 – 1.04) and cohort C (HR 1.10, 95% CI 0.84 – 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 – 1.00; cohort B: HR 0.84, 95% CI 0.67 – 1.06; and cohort C: HR 1.05, 95% CI 0.51 – 2.14). No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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11. Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data.
- Author
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Peters, Frederik, Kuchenbecker, Jenny, Acar, Laura, Marschall, Ursula, L'Hoest, Helmut, Lareyre, Fabien, Spanos, Konstantinos, and Behrendt, Christian-Alexander
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ARTERIAL occlusions , *HEALTH insurance claims , *PERIPHERAL vascular diseases , *INTERMITTENT claudication , *MAJOR adverse cardiovascular events , *FIBRINOLYTIC agents - Abstract
Objectives: Patients with peripheral arterial occlusive disease (PAOD) are at risk of worsening limb symptoms, major adverse cardiovascular events and exhibit an impaired life expectancy. There is a lack of evidence on the extent of pharmacological secondary prevention in PAOD patients. This study assesses treatment patterns of antithrombotic agents in symptomatic PAOD patients. Methods: This is a retrospective cohort study using data from the second largest insurance fund in Germany, BARMER. We included symptomatic PAOD patients undergoing in-hospital treatment with an index admission between 1 January 2010 and 31 December 2017. Outcomes were proportions of single antiplatelets (SAPT), dual antiplatelets (DAPT), vitamin-K antagonists (VKA), or direct oral anticoagulants (DOAC) in the 12 months prior and 6 months after the index hospitalization. Non-parametric cumulative incidence for competing risks was estimated to account for censoring and death after discharge from hospital stay. Patient flows were visualised by alluvial diagrams. All analyses were stratified by intermittent claudication (IC) and chronic limb-threatening ischaemia (CLTI). The protocol was registered to ClinicalTrials.gov (NCT03909022). Results: A total of 80,426 unique patient encounters were identified. Mean age was 72.7 (46.3% female). Amongst all patients, 25.6% were on SAPT, 4.1% on DAPT, 9.1% on VKA, 3.9% on DOAC, 3.9% on both antiplatelets and oral anticoagulation, and 53.3% without any antithrombotic therapy during the 12 months before index stay. The estimated cumulative incidence was 37.9% SAPT, 14.8% DAPT, 7.5% VKA, 4.3% DOAC, 7.4% both, and 28.1% without any antithrombotic therapy during the 6 months after index stay. The considerable increases in antiplatelet therapy were mainly driven by the group of patients without antithrombotics before index stay. As compared with IC, patients who suffered from CLTI received less often antiplatelets but more often anticoagulants both before and after index stay. Conclusions: Utilisation rates of antithrombotic therapy increased considerably after in-hospital treatment for PAOD. Yet, remarkably high rates of symptomatic patients without any blood-thinning therapy constitute a major concern with respect to adequate secondary prevention of PAOD patients. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
12. A construction and comprehensive analysis of the immune-related core ceRNA network and infiltrating immune cells in peripheral arterial occlusive disease.
- Author
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Zhiyong Chen, Jiahui Xu, Binshan Zha, Jun Li, Yongxiang Li, and Huan Ouyang
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ARTERIAL occlusions ,PERIPHERAL vascular diseases ,IMMUNOLOGIC memory ,PLASMA cells ,GENE expression profiling ,B cells - Abstract
Background: Peripheral arterial occlusive disease (PAOD) is a peripheral artery disorder that increases with age and often leads to an elevated risk of cardiovascular events. The purposes of this study were to explore the underlying competing endogenous RNA (ceRNA)-related mechanism of PAOD and identify the corresponding immune cell infiltration patterns. Methods: An available gene expression profile (GSE57691 datasets) was downloaded from the GEO database. Differentially expressed (DE) mRNAs and lncRNAs were screened between 9 PAOD and 10 control samples. Then, the lncRNA-miRNA-mRNA ceRNA network was constructed on the basis of the interactions generated from the miRcode, TargetScan, miRDB, and miRTarBase databases. The functional enrichment and protein-protein interaction analyses of mRNAs in the ceRNA network were performed. Immune-related core mRNAs were screened out through the Venn method. The compositional patterns of the 22 types of immune cell fraction in PAOD were estimated through the CIBERSORT algorithm. The final ceRNA network and immune infiltration were validated using clinical tissue samples. Finally, the correlation between immune cells and mRNAs in the final ceRNA network was analyzed. Results: Totally, 67 DE_lncRNAs and 1197 DE_mRNAs were identified, of which 130 DE_mRNAs (91 downregulated and 39 upregulated) were lncRNA-related. The gene ontology enrichment analysis showed that those down- and upregulated genes were involved in dephosphorylation and regulation of translation, respectively. The final immune-related core ceRNA network included one lncRNA (LINC00221), two miRNAs (miR-17-5p and miR-20b-5p), and one mRNA (CREB1). Meanwhile, we found that monocytes and M1 macrophages were the main immune cell subpopulations in PAOD. After verification, these predictionswere consistentwith experimental results. Moreover, CREB1 was positively correlated with naive B cells (R = 0.55, p = 0.035) and monocytes (R = 0.52, p = 0.049) and negatively correlated with M1 macrophages (R = -0.72, p = 0.004), resting mast cells (R = -0.66, p = 0.009), memory B cells (R = -0.55, p = 0.035), and plasma cells (R = -0.52, p = 0.047). Conclusion: In general, we proposed that the immune-related core ceRNA network (LINC00221, miR-17-5p, miR-20b-5p, and CREB1) and infiltrating immune cells (monocytes and M1 macrophages) could help further explore the molecular mechanisms of PAOD. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
13. Factors affecting the outcome of lower extremity osteomyelitis treated with microvascular free flaps: an analysis of 65 patients
- Author
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Duy Quang Thai, Yeon Kyo Jung, Hyung Min Hahn, and Il Jae Lee
- Subjects
Osteomyelitis ,Free flaps ,Diabetic foot ulcer ,Peripheral arterial occlusive disease ,Orthopedic surgery ,RD701-811 ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background Free flaps have been a useful modality in the management of lower extremity osteomyelitis particularly in limb salvage. This study aimed to determine the factors affecting the outcome of free flap reconstruction in the treatment of osteomyelitis. Methods This retrospective study assessed 65 osteomyelitis patients treated with free flap transfer from 2015 to 2020. The treatment outcomes were evaluated in terms of the flap survival rate, recurrence rate of osteomyelitis, and amputation rate. The correlation between outcomes and comorbidities, causes of osteomyelitis, and treatment modalities was analyzed. The following factors were considered: smoking, peripheral artery occlusive disease, renal disease, diabetic foot ulcer, flap types, using antibiotic beads, and negative pressure wound therapy. Result Among the 65 patients, 21 had a severe peripheral arterial occlusive disease. Osteomyelitis developed from diabetic foot ulcers in 28 patients. Total flap failure was noted in six patients, and osteomyelitis recurrence was noted in eight patients, for which two patients underwent amputation surgery during the follow-up period. Only end-stage renal disease had a significant correlation with the recurrence rate (odds ratio = 16.5, p = 0.011). There was no significant relationship between outcomes and the other factors. Conclusion This study showed that free flaps could be safely used for the treatment of osteomyelitis in patients with comorbidities and those who had osteomyelitis developing from diabetic foot ulcers. However, care should be taken in patients diagnosed with end-stage renal disease.
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- 2021
- Full Text
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14. Neutral effects of SGLT2 inhibitors in acute coronary syndromes, peripheral arterial occlusive disease, or ischemic stroke: a meta-analysis of randomized controlled trials
- Author
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Tsai, Pei-Chien, Chuang, Wei-Jung, Ko, Albert Min-Shan, Chen, Jui-Shuan, Chiu, Cheng-Hsun, Chen, Chun-Han, and Yeh, Yung-Hsin
- Published
- 2023
- Full Text
- View/download PDF
15. Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the "SirPAD" randomized controlled trial.
- Author
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Barco, Stefano, Sebastian, Tim, Voci, Davide, Engelberger, Rolf Peter, Grigorean, Alexandru, Holy, Erik, Leeger, Claudia, Münger, Mario, Périard, Daniel, Probst, Eliane, Spescha, Rebecca, Held, Ulrike, and Kucher, Nils
- Abstract
Background: Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for "hard" clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.Methods: In this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective "hard" outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.Discussion: By focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative ("all-comer") population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial Registration: ClinicalTrials.gov NCT04238546. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
16. Predictors of outcome in diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia.
- Author
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Yap, Trixie, Silickas, Justinas, Weerakkody, Ruwan, Lea, Talia, Santhirakumaran, Gowthanan, Bremner, Laura, Diamantopoulos, Athanasios, Biasi, Lukla, Thomas, Stephen, Zayed, Hany, and Patel, Sanjay D.
- Abstract
The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P =.015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P =.033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P =.023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P =.014). Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group. [Display omitted] [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
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17. Geographical Variation in the Management of Peripheral Arterial Occlusive Disease: A Nationwide Danish Cohort Study.
- Author
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Søgaard, Rikke, Londero, Louise S., and Lindholt, Jes
- Abstract
Equal access for equal needs is a key goal for many healthcare systems but geographical variation research has shown that this is often not the case in areas other than vascular surgery. This study assessed the variation across specialised vascular centres of an entire healthcare system in the costs and outcomes for patients having first time revascularisation for peripheral arterial occlusive disease. This was a national study of all first time revascularisations performed in the Danish healthcare system between 2009 and 2014. Episodes were identified in the Danish Vascular Registry (n = 10 300) and data on one year follow up in terms of the costs of specialised healthcare (€) and amputation status were acquired from national registers. Generalised gamma and logit regressions were used to predict margins between centres while adjusting for population heterogeneity (age, sex, education, smoking, hypertension, diabetes, use of prophylactic pharmacological therapy, indication and type of revascularisation). Cost effectiveness frontiers were used to identify efficient providers and to illustrate the cost of reducing the system level risk of amputation. For each of the indications of chronic limb threatening and acute limb ischaemia, the one year amputation risks varied from 11% to 16% across centres (p =.003, p =.006) whereas for intermittent claudication there was no significant difference across centres. The corresponding costs of care varied across centres for all indications (p =.027, p =.028, p =.030). Linking costs and outcomes, three of seven centres were observed to provide poorer quality at higher costs. Exponentially increasing costs to obtain the maximum reduction of the amputation risk were observed. The results suggest that there is substantial variation in the clinical management of peripheral arterial occlusive disease across the Danish healthcare system and that this results in very different levels of efficiency – on top of potentially unequal treatment for equal needs. Further research is warranted. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
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18. The prevalence of and risk factors for peripheral arterial occlusive disease in human immunodeficiency virus-infected omani patients: The first study in GCC
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Ahmed Al-Aufi, Khalifa Al-Wahaibi, Edwin Stephen, Abdullah Balkhair, Ibrahim Abdelhedy, and Hanan Al-Maawali
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ankle–brachial pressure index ,arterial ,asymptomatic arterial disease ,cd4 ,laudication ,gulf cooperation council ,human immunodeficiency virus ,immunodeficiency ,oman ,peripheral arterial occlusive disease ,prevalence ,vascular ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Aim: To assess the prevalence of peripheral arterial occlusive disease (PAOD) in human immunodeficiency virus (HIV)-infected Omani patients and to assess the potential risk factors in this group. Methodology: This was a single-center, cross-sectional study. All patients attending the infectious disease clinic between July 2017 and March 2018 were included in the study; their peripheral pulses were examined and pre- and postexercise ankle–brachial pressure index (ABPI) was measured. Normal ABPI was considered as being in the range of 1.0 ± 0.1, and a reduction of >15% postexercise ABPI was considered as a cutoff limit to define PAOD. The Edinburgh Claudication Questionnaire was answered by all patients, and CD4 count, viral load, albumin and Vitamin D (25-OH) levels, and glycated hemoglobin (HbA1c) were measured. The data were analyzed using IBM SPSS Statistics version 22. Results: Eighty-eight patients who were retroviral positive were enrolled in the study. Fifty-three (60.2%) patients were male and 35 (39.8%) were female, with a mean age of 43 years (24–71). The dorsalis pedis artery pulsation was absent bilaterally in 3 (3.4%) patients. None of the patients had a history of claudication; 1 (1.1%) had an abnormal ABPI; 17 (19.2%) had a reduction of >15% postexercise ABPI; 7 (8%) had CD4 count
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- 2020
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19. Increased risk of peripheral arterial occlusive diseases in patients with chronic obstructive pulmonary disease: a nationwide study in Taiwan
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Liao KM, Kuo LT, and Lu HY
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Chronic obstructive pulmonary disease ,incidence ,peripheral arterial occlusive disease ,Diseases of the respiratory system ,RC705-779 - Abstract
Kuang-Ming Liao,1 Lu-Ting Kuo,2 Hsueh-Yi Lu31Department of Internal Medicine, Chi Mei Medical Center, Chiali, Taiwan; 2Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital, Taipei 100, Taiwan; 3Department of Industrial Engineering and Management, National Yunlin University of Science and Technology, Yunlin, TaiwanObjective: Chronic obstructive pulmonary disease (COPD) is associated with atherosclerosis. Previous studies including limited sample sizes have shown the prevalence of peripheral arterial occlusive disease (PAOD) among COPD patients. We sought to investigate the incidence of PAOD among COPD patients in Taiwan using a national database.Methods: COPD patients were collected from the National Health Insurance Research Database of Taiwan from 1996 to 2010. The COPD cohort was propensity score matched according to age, sex, and comorbidities of atrial fibrillation, hypertension, diabetes, hyperlipidemia, cerebrovascular accidents, and chronic liver disease to patients without COPD (the control cohort). We evaluated the incidence of PAOD in COPD patients and the risk of PAOD associated with atrial fibrillation, hypertension, diabetes, hyperlipidemia, cerebrovascular accidents, and chronic liver disease.Results: The study included 51,869 COPD patients and 51,869 control patients without COPD. The incidence of PAOD was 1.23-fold higher (95% confidence interval [CI] =1.17–1.29) in the COPD group than in the non-COPD group. Moreover, COPD and atrial fibrillation alone (adjusted hazard ratio (aHR) 2.99; P=0.001), hypertension alone (aHR, 2.05; P
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- 2019
20. Is Toe Brachial Index a Better Tool than Ankle Brachial Index for Predicting Outcomes in Diabetic Foot Patients?
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Amit Kumar Singh and Prashant Bahirani
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ankle brachial pressure index ,diabetic mellitus ,peripheral arterial occlusive disease ,toe brachial pressure index ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Surgery ,RD1-811 - Abstract
Introduction: Diabetes accounts for more than 50% of lower extremity amputation, of which 85% of lower limb amputation in diabetic patients are preceded by foot ulcers. The increasing prevalence of ischemic ulcers has made ischemia probably the most important cause of Diabetic Foot Ulcers (DFUs) today. Modalities for assessment of vasculopathy include clinical examination of pulses, Ankle Brachial Pressure Index (ABI), Toe Brachial Pressure Index (TBI), Transcutaneous partial pressure of Oxygen (TCpO2), Duplex imaging, Magnetic Resonance (MR) and Computed Tomography Angiography (CTA). Aim: This study was aimed at evaluation of ABI and TBI in assessment of vasculopathy in DFUs and their association with the various surgical outcomes. Materials and Methods: This study was done as a cross-sectional study on 100 patients with diabetic foot, from December 2016 to April 2018, with prospective follow-up till the outcome of “ulcer healed”, “minor/major amputation” with healing of the amputation stump, was achieved. The multimodality approach for treatment of DFU was taken. Variables like age, gender, duration of present ulcer, previous history of ulcers and interventions, comorbidities, history of smoking and duration of diabetes were recorded and assessed. The examination included examination of peripheral pulses, presence of neuropathy, measurement of ABI and TBI. Investigations included HbA1c levels, swab or pus cultures from the ulcers, objective evaluation of Peripheral Arterial Disease (PAD) by Duplex Ultrasonography and CT Angiography where an intervention was contemplated. The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Results: The mean age was 62.55±9.21 years, with maximum patients belonging to the age group 61-70 years (38%) followed by 51-60 years age group (33%). Smoking as a risk factor was present in 59% of all the patients. A total of 53 patients underwent amputation among which 28 were smokers (52.8%). Neuropathy was present in 47.22% (n=51), with 60.87% of all patients with neuropathy undergoing amputation which was significant (p-value=0.005). When defined by ABI alone (ABI 0.51 with a sensitivity of 77.14 and a specificity of 56.1, which was not found to be significant (p-value=0.0796). The mean Toe Brachial index (TBI) for the diabetic feet was 0.25±0.12 for major amputation, 0.42±0.26 for minor amputation and 0.61±0.19 for ulcer healed. With a cut-off value of ≤0.3, the sensitivity and specificity for predicting amputation were 68.75 and 88.68 respectively which was found to be significant (p
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- 2021
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21. Factors affecting the outcome of lower extremity osteomyelitis treated with microvascular free flaps: an analysis of 65 patients.
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Thai, Duy Quang, Jung, Yeon Kyo, Hahn, Hyung Min, and Lee, Il Jae
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CHRONIC kidney failure complications ,SURGICAL flaps ,PERIPHERAL vascular diseases ,DIABETIC foot ,PLASTIC surgery ,RETROSPECTIVE studies ,LEG ,TREATMENT effectiveness ,KIDNEY diseases ,NEGATIVE-pressure wound therapy ,DISEASE relapse ,OSTEOMYELITIS ,AMPUTATION ,SMOKING ,ODDS ratio ,COMORBIDITY ,ANTIBIOTICS ,EVALUATION ,DISEASE complications - Abstract
Background: Free flaps have been a useful modality in the management of lower extremity osteomyelitis particularly in limb salvage. This study aimed to determine the factors affecting the outcome of free flap reconstruction in the treatment of osteomyelitis. Methods: This retrospective study assessed 65 osteomyelitis patients treated with free flap transfer from 2015 to 2020. The treatment outcomes were evaluated in terms of the flap survival rate, recurrence rate of osteomyelitis, and amputation rate. The correlation between outcomes and comorbidities, causes of osteomyelitis, and treatment modalities was analyzed. The following factors were considered: smoking, peripheral artery occlusive disease, renal disease, diabetic foot ulcer, flap types, using antibiotic beads, and negative pressure wound therapy. Result: Among the 65 patients, 21 had a severe peripheral arterial occlusive disease. Osteomyelitis developed from diabetic foot ulcers in 28 patients. Total flap failure was noted in six patients, and osteomyelitis recurrence was noted in eight patients, for which two patients underwent amputation surgery during the follow-up period. Only end-stage renal disease had a significant correlation with the recurrence rate (odds ratio = 16.5, p = 0.011). There was no significant relationship between outcomes and the other factors. Conclusion: This study showed that free flaps could be safely used for the treatment of osteomyelitis in patients with comorbidities and those who had osteomyelitis developing from diabetic foot ulcers. However, care should be taken in patients diagnosed with end-stage renal disease. [ABSTRACT FROM AUTHOR]
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- 2021
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22. Clinical Impact of Stent Graft Thrombosis in Femoropopliteal Arterial Lesions.
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Ichihashi, Shigeo, Takahara, Mitsuyoshi, Iida, Osamu, Suzuki, Kenji, Yamaoka, Terutoshi, Maeda, Koji, Tobita, Kazuki, Kobayashi, Taira, Nakama, Tatsuya, Shingaki, Masami, Ozaki, Shunsuke, Akagi, Daisuke, Soga, Yoshimitsu, Iwakoshi, Shinichi, Fujimura, Naoki, and Kichikawa, Kimihiko
- Abstract
This study sought to elucidate the clinical impact and prognosis of stent graft (SG) thrombosis. The VIABAHN SG offers a favorable outcome in long peripheral artery occlusive disease (PAOD) lesions in the femoropopliteal artery. One concern after SG deployment is the incidence of stent thrombosis and consequent acute limb ischemia (ALI). In this retrospective multicenter study, we collected the clinical data of PAOD patients treated with VIABAHN SG who subsequently experienced SG thrombosis. The clinical symptoms of SG thrombosis, patency after reintervention, and predictors of loss of patency after reintervention were examined. VIABAHN SGs were used for 1,215 patients; SG thrombosis occurred in 159 (13%) patients at a median of 6.4 months (interquartile range: 2.8 to 13.5 months) after SG implantation; 21 (13%) patients presented with ALI. A total of 131 (82%) patients underwent reintervention for SG thrombosis, whereas 2 (1%) underwent primary major amputation and the remaining 26 (16%) were treated conservatively. The patency rate 1 year after reintervention, freedom from major adverse limb events, and limb salvage after reintervention were 54.9%, 73.6%, and 92.5%, respectively. Critical limb-threatening ischemia at SG implantation and ALI presentation at SG thrombosis were positively associated with an increased risk of rethrombosis, whereas distal stent diameter was negatively associated with the risk of rethrombosis. SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2021
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23. Editor's Choice – A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial.
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Gouëffic, Yann, Pin, Jean L., Sabatier, Jean, Alimi, Yves, Steinmetz, Eric, Magnan, Pierre-Edouard, Marret, Olivier, Kaladji, Adrien, Chavent, Bertrand, Kretz, Benjamin, Jobert, Alexandra, Schirr-Bonnans, Solène, Guyomarc'h, Béatrice, Riche, Valéry P., du Mont, Lucie S., and Tessier, Philippe
- Abstract
The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p =.81). Overall costs (difference: €187.83; 95% confidence interval [CI] −275.68–651.34) and QALYs (difference: 0.00277; 95% CI –0.00237 – 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold. [ABSTRACT FROM AUTHOR]
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- 2021
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24. The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions.
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Böhme, Tanja, Noory, Elias, Beschorner, Ulrich, Macharzina, Roland, and Zeller, Thomas
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PERIPHERAL vascular disease treatment ,RESEARCH ,TRANSLUMINAL angioplasty ,DRUG-eluting stents ,RESEARCH methodology ,MEDICAL cooperation ,EVALUATION research ,BIOMEDICAL materials ,TREATMENT effectiveness ,COMPARATIVE studies ,DRUGS ,MENTAL health surveys ,QUESTIONNAIRES ,POPLITEAL artery - Abstract
Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid)) that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLR DCB. [ABSTRACT FROM AUTHOR]
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- 2021
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25. Long‐Term Effectiveness and Safety of Initiating Statin Therapy After Index Revascularization In Patients With Peripheral Arterial Occlusive Disease
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Frederik Peters, Jenny Kuchenbecker, Thea Kreutzburg, Ursula Marschall, E. Sebastian Debus, and Christian‐Alexander Behrendt
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chronic limb‐threatening ischemia ,intermittent claudication ,peripheral arterial occlusive disease ,statin‐induced myopathy ,statin therapy ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background An increasing number of patients with a peripheral arterial occlusive disease were put on statins during the past years. This study assessed whether statin therapy was effective and safe for these new users. Methods and Results Using health insurance claims data from Germany’s second‐largest insurance fund, BARMER, we identified patients with peripheral arterial occlusive disease who had index revascularization between 2008 and 2018 without prior statin therapy. We compared patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers). Outcomes were all‐cause mortality, cardiovascular events, and incident major amputation for effectiveness and incident diabetes mellitus and incident myopathy for safety. Propensity score matching was used to balance the study groups. All analyses were stratified into patients with chronic limb‐threatening ischemia and intermittent claudication. A total of 22 208 patients (mean age 71.1 years and 50.3% women) were included in the study. In 10 922 matched patients, statin initiation was associated with lower all‐cause mortality (chronic limb‐threatening ischemia: hazard ratio [HR], 0.75 [95% CI, 0.68–0.84]; intermittent claudication: HR, 0.80 [95% CI, 0.70–0.92]), lower risk of major amputation in patients with chronic limb‐threatening ischemia (HR, 0.73; 95% CI, 0.58–0.93) and lower risk of cardiovascular events (hazard ratio, 0.80; 95% CI, 0.70–0.92) in patients with intermittent claudication during 5 years of follow‐up. Safety outcomes did not differ among the study groups. Conclusions Initiating statin therapy in patients with peripheral arterial occlusive disease after index revascularization is efficient and safe with an effect size comparable to earlier studies. Awareness campaigns for evidence‐based optimal pharmacological treatment among patients are recommended.
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- 2020
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26. Automated Muscle Segmentation from Dynamic Computed Tomographic Angiography Images for Diagnosis of Peripheral Arterial Occlusive Disease
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Zehong Lin, He Xu, and Daming Zhang
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Curve-based Fuzzy C-means ,dynamic computed tomographic angiography ,lower leg muscle ischemia ,peripheral arterial occlusive disease ,standard computed tomographic angiography ,Electrical engineering. Electronics. Nuclear engineering ,TK1-9971 - Abstract
The purpose of this study was to quantitatively evaluating lower leg muscle ischemia measured from dynamic computed tomographic angiography (dyn-CTA) for patients with peripheral arterial occlusive disease (PAOD). A total of 35 patients with known PAOD underwent a dyn-CTA of the lower leg first with 70 kV tube voltage and 30 mL iodinated contrast media. Five minutes later, a standard CTA (s-CTA) of the peripheral runoff from the diaphragm to the toes was scanned. For each of four lower leg artery segments, a runoff score was given by a radiologist according to s-CTA images as a reference standard. The muscle enhancement measured from the dyn-CTA was analyzed by automated muscle segmentation using curve-based Fuzzy C-means (CBFCM) algorithms with three classes for bone, two classes for muscle and one class for fat and background. The muscle enhancement ratio (MER) was calculated for (i) higher enhanced area over total area; and (ii) corresponding average signal value at higher enhanced are over total area. Lower extremities were diagnosed as a normal group (n = 22) with each vessel segment score ≤ 1 and runoff score ≤ 7, and otherwise as an ischemia group (n = 48). The MER for the ischemia group was significantly different (p
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- 2019
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27. Predictors for Amputation in Patients with Diabetic Foot Wound
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Se-Young Kim, Tae Hoon Kim, Jun-Young Choi, Yu-Jin Kwon, Dong Hui Choi, Ki Chun Kim, Min Ji Kim, Ho Kyung Hwang, and Kyung-Bok Lee
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Diabetic foot wound ,Amputation ,Peripheral arterial occlusive disease ,Risk factors ,Diseases of the blood and blood-forming organs ,RC633-647.5 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Purpose: Diabetic foot wound (DFW) is known as a major contributor of nontraumatic lower extremity amputation. We aimed to evaluate overall amputation rates and risk factors for amputation in patients with DFW. Materials and Methods: From January 2014 to December 2017, 141 patients with DFW were enrolled. We determined rates and risk factors of major amputation in DFW and in DFW with peripheral arterial occlusive disease (PAOD). In addition, we investigated rates and predictors for amputation in diabetic foot ulcer (DFU). Results: The overall rate of major amputation was 26.2% in patients with DFW. Among 141 DFWs, 76 patients (53.9%) had PAOD and 29 patients (38.2%) of 76 DFWs with PAOD underwent major amputation. Wound state according to Wagner classification, congestive heart failure, leukocytosis, dementia, and PAOD were the significant risk factors for major amputation. In DFW with PAOD, Wagner classification grades and leukocytosis were the predictors for major amputation. In addition, amputation was performed for 28 patients (38.4%) while major amputation was performed for 5 patients (6.8%) of 73 DFUs. Only the presence of osteomyelitis (OM) showed significant difference for amputation in DFU. Conclusion: This study represented that approximately a quarter of DFWs underwent major amputation. Moreover, over half of DFW patients had PAOD and about 38.2% of them underwent major amputation. Wound state and PAOD was major predictors for major amputation in DFW. Systemic factors, such as CHF, leukocytosis, and dementia were identified as risk factors for major amputation. In terms of DFU, 38.4% underwent amputation and the presence of OM was a determinant for amputation.
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- 2018
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28. Editor's Choice – The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease.
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Kreutzburg, Thea, Peters, Frederik, Kuchenbecker, Jenny, Marschall, Ursula, Lee, Regent, Kriston, Levente, Debus, E. Sebastian, and Behrendt, Christian-Alexander
- Abstract
Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent. [ABSTRACT FROM AUTHOR]
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- 2021
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29. Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis.
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Heidemann, Franziska, Peters, Frederik, Kuchenbecker, Jenny, Kreutzburg, Thea, Sedrakyan, Art, Marschall, Ursula, L'Hoest, Helmut, Debus, Eike S., and Behrendt, Christian-Alexander
- Abstract
Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan–Meier method and Cox regression. There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p <.001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78–0.91), amputation or death (HR 0.87, 95% CI 0.81–0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80–0.92) were observed. In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia. [ABSTRACT FROM AUTHOR]
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- 2020
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30. Editor's Choice – Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data.
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Peters, Frederik, Kreutzburg, Thea, Rieß, Henrik C., Heidemann, Franziska, Marschall, Ursula, L'Hoest, Helmut, Debus, Eike S., Sedrakyan, Art, and Behrendt, Christian-Alexander
- Abstract
Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs. [ABSTRACT FROM AUTHOR]
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- 2020
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31. Decrease of peripheral resistance after intraoperative administration of iloprost in patients with and without type 2 diabetes mellitus and with peripheral arterial occlusive disease.
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Hirsch, Kornelia, Säemann, Marcus, Walter, Corinna, Taher, Fadi, Edda, Skrinjar, Mlekusch, Irene, Jäger, Heidrun, Assadian, Afshin, and Falkensammer, Jürgen
- Abstract
Background: In many cases, Ilomedin
® infusions are applied as part of a perioperative measure in patients with peripheral arterial occlusive disease because it makes a relevant vasodilatatory effect in patients with type 2 diabetes mellitus and with/without peripheral neuropathy. Aims: A prospective case–control study was performed to investigate the effect of prostanoids on peripheral resistance in patients with type 2 diabetes mellitus and patients without type 2 diabetes mellitus, as well as the role of peripheral neuropathy in patients undergoing arterial reconstruction. Methods: Sixty patients undergoing arterial reconstruction were enrolled. Sufficient data were collected on 38 patients. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow volume at the common femoral artery was assessed intraoperatively using a Doppler flowmeter at four time points: at baseline before arterial reconstruction (T0), after reconstruction (T1), after 5 (T2) and 10 min (T3) after intra-arterial application of 3000 ng of Ilomedin. Peripheral resistance units were calculated as a function of mean arterial pressure and flow volume using the following formula: peripheral resistance unit = mean arterial pressure (mm Hg) / flow volume (mL/min). Results: Ilomedin produced an immediate and significant drop of peripheral resistance in patients without type 2 diabetes mellitus as well as in patients with type 2 diabetes mellitus. Patients with peripheral neuropathy showed a less pronounced effect to Ilomedin compared to individuals with normal nerve conduction velocity. [ABSTRACT FROM AUTHOR]- Published
- 2020
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32. Evaluation of superficial femoral artery-lesions after percutaneous transluminal angioplasty: color-coded summation images vs. monochromatic digital subtraction angiography.
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Augustin, Anne Marie, Thein, Irina, Rickert, Nicole, Klink, Thorsten, Bley, Thorsten Alexander, and Kickuth, Ralph
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DIGITAL subtraction angiography ,TRANSLUMINAL angioplasty ,RECEIVER operating characteristic curves ,FEMORAL artery ,ARTERIAL occlusions ,ENDOVASCULAR surgery ,PERIPHERAL vascular diseases - Abstract
Background: Percutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses. Methods: During a period of 18 months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77 years (range, 35–96 years). Median length of the treated lesions was 10.5 cm (range, 1.0–50 cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis. Results: ROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p > 0.05). Results of reader C were significantly better in the assessment of monochromatic images (p = 0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (κ = 0.486 vs. κ = 0.459). Conclusions: In this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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33. Editor's Choice – Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis.
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Behrendt, Christian-Alexander, Sedrakyan, Art, Peters, Frederik, Kreutzburg, Thea, Schermerhorn, Marc, Bertges, Daniel J., Larena-Avellaneda, Axel, L'Hoest, Helmut, Kölbel, Tilo, and Debus, Eike Sebastian
- Abstract
The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan–Meier method and Cox regression. There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p <.001). Paclitaxel coated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77–0.90), amputation free survival (HR 0.85, 95% CI 0.78–0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77–0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76–0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80–0.98). In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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34. Association of Lipoproteins with Neutrophil Extracellular Traps in Patients with Abdominal Aortic Aneurysm
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Annika Brandau, Nahla Ibrahim, Johannes Klopf, Hubert Hayden, Maria Ozsvar-Kozma, Taras Afonyushkin, Sonja Bleichert, Lukas Fuchs, Viktoria Watzinger, Verena Nairz, Emely Manville, Veronika Kessler, Herbert Stangl, Wolf Eilenberg, Christoph Neumayer, and Christine Brostjan
- Subjects
abdominal aortic aneurysm ,citrullinated histones ,lipoproteins ,neutrophil extracellular traps ,peripheral arterial occlusive disease ,Biology (General) ,QH301-705.5 - Abstract
Neutrophil extracellular traps (NETs) are DNA–protein structures released by neutrophils in response to various stimuli, including oxidized, low-density lipoprotein (oxLDL). Accumulating evidence suggests a role for NETs in the pathogenesis of abdominal aortic aneurysm (AAA). In this study, we investigated the potential association of lipoprotein particles and NETs in AAA in comparison to non-AAA control groups. The concentrations of neutrophil myeloperoxidase (MPO), the NET parameters citrullinated histone H3 (citH3) and circulating cell-free DNA (cfDNA), as well as of blood lipids were determined in plasma or serum of patients with AAA (n = 40), peripheral artery occlusive disease (PAD; n = 40) and healthy donors (n = 29). A sandwich ELISA detecting oxidized phosphatidylcholine in association with apolipoprotein B-100 (oxPL/apoB) was applied to measure oxidized phospholipids in circulation. The effect of lipoparticles on NET formation was tested using a DNA release assay with isolated human neutrophils. Plasma MPO, citH3 and cfDNA levels were significantly increased in AAA patients in comparison to healthy donors and PAD patients. Plasma concentrations of citH3 positively correlated with serum oxPL/apoB in AAA patients. In functional in vitro assays, the addition of oxLDL induced NET formation in pre-stimulated neutrophils. In conclusion, our data suggest a promoting role of oxLDL on NET formation in AAA patients.
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- 2022
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35. Usefulness of the platelet-to-lymphocyte ratio in predicting long-term cardiovascular mortality in patients with peripheral arterial occlusive disease
- Author
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Fatih Uzun, Mehmet Erturk, Huseyin Altug Cakmak, Ali Kemal Kalkan, Ibrahim Faruk Akturk, Ahmet Arif Yalcin, Begum Uygur, Umit Bulut, and Kursat Oz
- Subjects
platelet-to-lymphocyte ratio ,peripheral arterial occlusive disease ,cardiovascular mortality ,Medicine - Abstract
Introduction: Inflammation and increased platelet activation play a crucial role in the initiation and progression of atherosclerosis. Platelet-to-lymphocyte ratio (PLR) has recently been reported as a new independent predictor for major adverse cardiovascular events in cardiovascular diseases. Aim: To investigate the relation between PLR and cardiovascular mortality in patients with intermittent claudication or critical limb ischemia (CLI) or both. Material and methods : In our retrospective study, 602 consecutive patients who were admitted to a large tertiary hospital with the diagnosis of symptomatic peripheral arterial occlusive disease (PAOD) were included. Patients were divided into two groups according to their PLR as follows: high PLR (PLR > 142) and low PLR (PLR ≤ 142) groups. Results : During the follow-up period (median: 33.8 months (interquartile range: 21–45)), 131 deaths occurred out of 602 (21.8%) patients. Cardiovascular mortality was found to be significantly higher in the high PLR group compared to the low PLR group (31.6% vs. 17.2 %; p 142 and age were found to be independent predictors of long-term cardiovascular mortality in Cox regression analysis (hazard ratios (95% confidence interval): 1.03 (1.01–1.04) and 1.04 (1.02–1.06), p < 0.001 and p < 0.001, respectively). Conclusions : Platelet-to-lymphocyte ratio, which is one of the parameters of routine complete blood count, reflects increased inflammatory status, platelet activation and aggregation. PLR is a cheap and readily available marker that has the ability to improve risk stratification provided by conventional risk scores in predicting long-term cardiovascular mortality in PAOD.
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- 2017
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36. Antiproliferative Device Coatings: Efficacy Without Adverse Drug Effect?
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Zeller, Thomas and Böhme, Tanja
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- *
ARTERIAL occlusions , *PERIPHERAL vascular diseases , *SURFACE coatings , *FEMORAL artery , *TRANSLUMINAL angioplasty , *DRUGS - Abstract
[Display omitted] [ABSTRACT FROM AUTHOR]
- Published
- 2021
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37. Smart Anklet Use to Measure Vascular Health Benefits of Preventive Intervention in a Nature-Based Environment-A Pilot Study.
- Author
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Stosic MB, Kaljevic J, Nikolic B, Tanaskovic M, and Kolarov A
- Subjects
- Humans, Pilot Projects, Male, Female, Middle Aged, Aged, Exercise, Longitudinal Studies, Walking, Ecuador, Peripheral Arterial Disease
- Abstract
The present study aimed to investigate the associations between nature-based intervention and peripheral pulse characteristics of patients with PAOD using new smart technology specifically designed for this purpose. A longitudinal panel study performed between 1 January 2022 and 31 December 2022 included 32 patients diagnosed with peripheral arterial occlusive disease (PAOD) who were treated in the vascular surgeons' hospital "Dobb" in Valjevo. These patients were exposed for six months to moderate-intensity physical activity (MPA) in a nature-based environment. They practiced 150 to 300 min of walking 6 km/h and cycling activities (16-20 km/h) weekly as recommended for patients with chronic conditions and those living with disability. Univariate logistic regression analysis was used to identify factors associated with major improvements in peripheral pulse characteristics of patients with PAOD. After six months of MPA, half of the patients (50%, 16/32) achieved minor, and half of them major improvements in peripheral pulse characteristics. The major improvements were associated with current smoking (OR = 9.53; 95%CI = 1.85-49.20), diabetes (OR = 4.84; 95%CI = 1.09-21.58) and cardiac failure, and concurrent pulmonary disease and diabetes (OR = 2.03; 95%CI = 1.01-4.11). Our pilot study showed that patients with PAOD along with other chronic conditions and risk factors benefited more from continuous physical activity in a nature-based environment.
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- 2024
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38. Feasible Evaluation of PQ Bypass Results with Duplex Ultrasound.
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Lācis, Aigars, Ezīte, Natālija, Šavlovskis, Jānis, Kukulis, Indulis, Rumba, Roberts, Strīķe, Eva, Zellāns, Edgars, Ļūļaka, Inguna, and Krieviņš, Dainis
- Subjects
- *
DUPLEX ultrasonography , *PERIPHERAL vascular diseases , *FEMORAL vein , *ANKLE brachial index , *ARTERIAL occlusions , *POSTOPERATIVE period - Abstract
Patients with peripheral arterial disease (PAD) have substantially impaired health-related quality of life (HR-QoL). Chronic lower limb ischaemia due to the atherosclerotic occlusion of infra-inguinal arteries is one of the most important causes of invalidity among smokers over the age of fifty. Historically, these lesions were treated by open bypass surgery. Less invasive endovascular revascularisation methods are available to treat short lesions, while treatment of long lesions are lacking. Fully endovascular trans-venous femoro-popliteal bypass (PQ Bypass, Inc., Sunnyvale, CA, USA) to treat long femoral lesions has been developed recently. The objective of the study was to evaluate duplex ultrasound (DUS) as a tool to follow up patients after PQ bypass procedure. A prospective clinical study was conducted at one clinical site. DUS of treated arteries and femoral vein was performed before the procedure, 30 days, 6 months, and 12 months in follow-up period by 2 independent radiologists. Ankle-brachial index (ABI) evaluation was performed at all visits. Thirty-five patients (35 limbs) treated with PQ bypass were enrolled in the study. Median age was 63.6 years (ranged 50 to 87 years). There was 100% successful evaluation of all patients at all clinical visits available. Deviation of the DUS results was found within the accepted standard limit between two radiologists. Twelve months after the PQ procedure, 28 (80.0%) PQ stent-grafts were still functioning without DUS signs of stenosis, while seven (20.0%) limbs experienced varying degrees of stent malfunction. PQ stent-graft occlusion was detected in five (14.3%) – 1 (2.9%) patients at one-month follow-up, 3 (8.6%) at six months and 1 (2.9%) at twelve months follow-up period, respectively. PQ stent-graft proximal junction stenosis was detected in one patient (2.9%) at six months and distal junction stenosis in one patient (2.9%) at twelve months follow-up, respectively. Despite of graft occlusion found with DUS, two patients had no severe worsening of post-operative ABI. DUS is a reliable method to evaluate patients after PQ bypass procedure and has higher sensitivity than ABI to follow-up patients after PQ procedure, especially in asymptomatic stent stenosis. Regular and timely use of DUS during the postoperative period may help to recognise potential complications and provide effective treatment.. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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39. The Role of Oxidative Stress Markers in Predicting Acute Thrombotic Occlusion of Haemodialysis Vascular Access and Progressive Stenotic Dysfunction Demanding Angioplasty
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Jenq-Shyong Chan, Po-Jen Hsiao, Wen-Fang Chiang, and Prabir Roy-Chaudhury
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haemodialysis vascular access ,vascular access dysfunction ,oxidative stress markers ,asymmetrical dimethylarginine (ADMA) ,peripheral arterial occlusive disease ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Haemodialysis vascular access (VA) dysfunction is a major cause of morbidity in haemodialysis (HD) patients. Primary venous outflow occlusion and restenosis after percutaneous transluminal angioplasty (PTA) are two major obstacles for the long-term use of dialysis VA. It remains unclear whether oxidative stress markers can be used as predictors for thrombotic occlusion of VA and progressive stenosis dysfunction demanding PTA. All routine HD patients at one teaching hospital participated in this study including ankle-brachial index (ABI) examinations and serum oxidative stress markers. The serum oxidative stress markers (high-sensitivity C-reactive protein (hs-CRP), matrix metalloproteinase-2 (MMP-2), MMP-9, homocysteine, asymmetrical dimethylarginine (ADMA), nitrate oxidase (NO), tumour necrosis factor-α (TNF-α), monocyte chemotactic protein 1 (MCP-1), interleukin-1β (IL-1β), and transforming growth factor-β (TGF-β)) were measured using immunosorbent assays in 159 HD patients (83 men and 76 women; mean age: 65 ± 12 years). The participants met the following criteria: (1) received regular HD treatment for at least 6 months, without clinical evidence of acute or chronic inflammation, recent myocardial infarction, unstable angina or circulatory congestion; and (2) received an arteriovenous fistula (AVF)/arteriovenous graft (AVG: polytetrafluoroethylene, PTFE) as the current VA for more than 6 months, without interventions within the last 6 months. All the participants were followed up clinically for up to 12 months to estimate the amount of primary thrombotic occlusion and VA dysfunction demanding PTA. During the 12-month observation, 24 patients (15.1%) had primary thrombotic occlusion of VAs. Another 24 patients (15.1%) required PTA because of clinical dysfunction of access. Additionally, during the follow-up period, restenosis occurred in 12 patients (50% of 24 patients). The access types of arteriovenous grafts (AVGs) and a diagnosis of peripheral arterial occlusive disease (PAOD) were two strong predictors for acute thrombotic events of VA (hazard ratio (HR): 16.93 vs. 2.35; p < 0.001 vs. 0.047). Comparing dysfunctional with non-dysfunctional VAs, up to 27.7% of patients with high levels of ADMA (>0.6207 μM, N = 65) received required PTA compared with 4.4% of those with low levels (≤0.6207 μM; N = 90; p < 0.001). In multivariate analysis, the plasma baseline levels of ADMA independently conferred nearly 4.55 times the risk of primary stenotic dysfunction of HD VA (HR: 4.55; 95% confidence interval: 1.20 to 17.26; p = 0.026). In conclusion, our findings suggest the role of ADMA in the development of symptomatic VA dysfunction. Additionally, PAOD severity can be used in clinical practice to predict whether acute thrombotic occlusion of VA will easily occur in HD patients.
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- 2021
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40. Assessment of occlusive disease of lower extremity arteries on the basis of anatomic region: Value of 128-slice multidetector CT angiography in comparison with digital subtraction angiography
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Roshan Pangeni, Ping Han, Feng Pan, Laxmi Pangeni Lamsal, Zhen Zhang, Jie Yu, and Rajiv Rizal
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Digital Subtraction Angiography ,Multidetector CT Angiography ,Peripheral Arterial Occlusive Disease ,Medicine (General) ,R5-920 - Abstract
Background & Objectives: The Previous studies of multidetector CT (MDCT) of the lower extremities for the detection of peripheral vascular disease showed high diagnostic accuracy but were performed with older generation systems. Our study aimed at assessing the diagnostic value of 128 MDCTA compared with that of digital subtraction angiography (DSA) in the grading of focal arterial disease of lower extremity arteries on the basis of anatomic regions.Materials & Methods: Forty-two patients with peripheral arterial occlusive diseases underwent both MDCTA and DSA. Lower extremity arteries depicted at MDCTA and DSA were graded separately for the degree of stenosis into 3 anatomic regions and 33 segments. Grading by MDCTA and DSA was done independently. Homogeneity analysis was used between MDCTA and DSA measurements in each patient. The sensitivity, specificity, positive predictive value and negative predictive value for detection of stenotic lesions were calculated for all anatomic regions, with findings at DSA used as the reference standard. Results: No statistically significant difference (P>.05) between DSA and MDCTA was present in Aorto-iliac and poplitiofemoral regions while there was statistically significant difference (PConclusion: MDCTA is excellent alternative in diagnosing lower extremity arterial occlusive diseases above the knee. DSA remains better on illustrating distal runoff vessels.
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- 2017
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41. Diagnostic accuracy of three-dimensional contrast-enhanced automatic moving-table MR angiography in patients with peripheral arterial occlusive disease in comparison with digital subtraction angiography
- Author
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Hazem Soliman
- Subjects
MRA ,Automatic moving table ,Angiography ,Peripheral arterial occlusive disease ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 - Abstract
Objective: The aim of this study was to compare the diagnostic accuracy of contrast-enhanced (CE) three-dimensional (3D) moving-table magnetic resonance (MR) angiography with that of selective digital subtraction angiography (DSA) for routine clinical investigation in patients with peripheral arterial occlusive disease. Methods: Between April 2012 and May 2013, the lower extremities of 30 patients with suspected peripheral vascular disease performed both conventional digital subtraction angiography and three-dimensional contrast-enhanced MR angiography MRA with the automatic table movement technique (MoBI-trak). DSA and MR angiographic images were interpreted prospectively, one vascular radiologist interpreted the digital subtraction angiographic images and the second vascular radiologist interpreted the MR angiographic images; both interpreters were unaware of the clinical history and the results of the other examination. Results: The MRA and DSA studies in the 30 study patients produced 870 arterial segments for interpretation. The sensitivity of MRA for the detection of mild stenotic, hemodynamically severe stenotic and occlusions were 86.1%, 90.5% and 93.9%, respectively. Corresponding specificity was 90.1%, 96.1% and 97.5%, respectively. Conclusion: Our prospective comparison shows that three-dimensional contrast-enhanced automatic moving-table MRA is a noninvasive imaging modality that has a diagnostic accuracy comparable to DSA for the assessment of peripheral arterial occlusive disease.
- Published
- 2015
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42. Impact of pre-operative glycated haemoglobin A1C level on 1-year outcomes of endovascular treatment in patients with critical limb ischemia in the course of diabetes mellitus.
- Author
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WACHSMANN, AGNIESZKA, MAGA, MIKOŁAJ, SCHÖNBORN, MARTYNA, OLSZEWSKA, MARTA, BLUKACZ, MATEUSZ, CEBEŃKO, MAŁGORZATA, TRYNKIEWICZ, AGNIESZKA, and MAGA, PAWEŁ
- Subjects
PEOPLE with diabetes ,HEMOGLOBINS ,PERIPHERAL vascular disease treatment ,TREATMENT effectiveness ,ANGIOPLASTY - Abstract
Introduction: Peripheral arterial occlusive disease (PAOD) is a disease with worldwide increasing occurrence. Diabetic patients are greatly exposed on the risk of PAOD and its complications. The aim of the study was to check the influence of preoperative HbA1C on the outcomes of patients with diabetes undergoing PAOD related endovascular treatment. Material and Methods: The study was conducted among 59 patients with PAOD referred from the diabetic foot outpatient for endovascular treatment. They were included in one-year observation based on follow-up visits in 1, 3, 6 and 12 months aft er angioplasty and divided into 2 groups basing on their preoperative glycaemia. The clinical condition of the lower limbs was assessed by use of the Rutherford classification, ankle-brachial index (ABI) and toe-brachial index (TBI). Changes in patients' quality of life (QoL) were also evaluated. Results: Reintervention within 12 months were less frequent in patients with HbA1C =8.0% than in HbA1C >8.0% patients (9.09% vs. 35.48%, p = 0.03). TBI of the treated limb was lower in patients with elevated than in patients with proper glycaemia at 6 month [0.2 (0.0-0.38) vs. 0.38 (0.31-0.46); p <0.008] and 12 month follow-up [0.17 (0.0-0.27) vs. 0.32 (0.25-0.38); p <0,001]. The rate of healed ulcerations aft er 6 months was higher in patients HbA1C =8.0% (45.0% vs. 16.13%; p = 0.02) and they had significantly greater improvement of QoL. Conclusion: Results of this study shows that preoperative level of glycaemia is an important factor for long-term prognosis in diabetic patients with PAOD. Elevated HbA1C level decreases significantly long-term improvement of QoL in DM patients undergoing endovascular treatment. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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43. Diabetic foot ulcers—comparison of performance of ankle-brachial index and transcutaneous partial oxygen pressure in predicting outcome.
- Author
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Rajagopalan, Chithra, Viswanathan, Vijay, Rajsekar, Seena, Selvaraj, Bamila, and Daniel, Linu
- Subjects
- *
DIABETIC foot , *ANKLE brachial index , *HOSPITAL admission & discharge , *LEG amputation , *FOOT ulcers - Abstract
Diabetic foot ulcer (DFU) is the commonest condition for hospital admission and usually the starting point of most diabetic related lower limb amputations. Considering the significant role played by vascularity in the outcome of ulcer healing, we undertook this study to find out the comparative utility of commonly used vascular assessment methods. This study was a single center prospective non-randomized observational study, conducted for a period of 6 months, in diabetic patients presenting with foot ulcers of Wagner Grade II and III. The aim of our study was to compare the performances of ankle-brachial index (ABI) and transcutaneous partial pressure of oxygen (tcPO2) measurement in predicting wound healing in diabetic ulcers and to define the optimal cut-off value for Indian patients. Five hundred sixty-four patients were included in this study, with the mean age of 58 years. Eighty-seven patients (15%) had peripheral arterial occlusive disease. Four hundred seventy ulcers (83%) healed with the mean healing days of 42.6 days. Age, duration of diabetes, serum creatinine level, and presence of infection were the factors with negative impact in wound healing. In our study, ABI value of 0.6 was found to have 100% sensitivity and 70% specificity, and tcPO2 value of 22.5 was found to have 75% sensitivity and 100% specificity in predicting wound healing. Both ABI and tcPO2 are complementary, but tcPO2 is a better predictor for amputation while ABI is a better predictor for ulcer healing. While assessing the ischemic status of foot ulcer, the cut-off values should be higher in diabetics than non-diabetics. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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44. Plasma levels of resistin predict cardiovascular events
- Author
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Vida-Simiti Luminița, Todor Irina, Stoia Mirela, Gherman Claudia, and Goidescu Cerasela
- Subjects
resistin ,leptin ,coronary artery disease ,peripheral arterial occlusive disease ,resistina ,leptina ,cardiopatie ischemică ,arteriopatie cronică obliterantă a membrelor inferioare ,Medicine - Abstract
Introducere: Un număr de citokine şi adipokine secretate de ţesutul adipos pot influenţa direct peretele vascular. Adiponectina exercită efecte anti-inflamatorii şi ateroprotective. Resistina este exprimată în cantităţi crescute în celulele inflamatorii. Resistina activează direct endoteliul prin suprareglarea moleculelor de adeziune, induce producţia de TNF-α în macrofage, efecte antagonizate de adiponectină. Leptina are multe efecte asupra celulelor din peretele arterial, unele similare cu efectele resistinei. Rolul prognostic al adipokinelor în ateroscleroză nu este bine precizat. Metode: Nivelele bazale ale adiponectinei, resistinei, leptinei şi TNF-α (ELISA) la pacienţi cu cardiopatie ischemică au fost comparate cu cele ale pacienţilor cu arteriopatie cronică obliterantă aterosclerotică a membrelor inferioare. Am investigat impactul nivelelor bazale asupra incidenţei evenimentelor ischemice nou apărute în evoluţia de durată. Rezultate: Au fost luaţi în studiu 91 pacienţi cu manifestări clinice ale aterosclerozei, 59 cu cardiopatie ischemică şi 32 cu arteriopatie cronică obliterantă a membrelor inferioare. În grupul pacienţilor cu cardiopatie ischemică, comparativ cu cel al pacienţilor cu arteriopatie cronică obliterantă a membrelor inferioare, nivelele plasmatice ale leptinei au fost semnificativ mai crescute (2882.02 ± 368.57pg/ml vs 1025.56 ± 232.28 pg/ml; p < 0.001), cele ale resistinei semnificativ mai scăzute (13.15 ± 0.83ng/ml vs 17.76 ± 2.13 ng/ml; p = 0.02) şi nu s-au constatat diferenţe privind nivelele adiponectinei şi ale TNF-α. Nivele plasmatice ale leptinei s-au corelat cu indicele de masă corporală în ambele grupe de pacienţi. 45 pacienţi (49,5%) au fost reinternaţi în următorii 2 ani. Într-o analiză multivariabilă numai resistina ≥ 15 ng/ml, HR =1.8829, 95% CI 1.0490- 3.3797, p = 0.034 şi presiunea arterială diastolică ≥ 85 mmHg, HR =2.0927, 95% CI 1.0782- 4.0616, p=0.0299 au fost independent asociate cu noi evenimente cardiovasculare. Concluzii: La pacienţi cu ateroscleroză clinic manifestă nivelele plasmatice ale resistinei pot prezice noi evenimente ischemice.
- Published
- 2014
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45. Innovativ: geriatrische Konzepte für die Gefäßmedizin und Gefäßchirurgie
- Author
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Konstantinos Chondros, Björn G. Maassen, and Leo Cornelius Bollheimer
- Subjects
Polypharmacy ,Geriatrics ,medicine.medical_specialty ,business.industry ,Biological age ,Vascular surgery ,medicine.disease ,Abdominal aortic aneurysm ,Peripheral arterial occlusive disease ,medicine ,Surgery ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business ,Neurocognitive ,Vascular Medicine - Abstract
So far, advances in vascular surgery and geriatrics have developed largely independent of each other, and there are - unlike orthogeriatrics - hardly any overlaps in daily clinical practice. Yet in an interdisciplinary setting, geriatric concepts might be helpful in individualized indication, choice of therapy and prognosis in vascular surgery, especially in terms of old(est)-old patients (85+). Geriatric notions, such as biological age and functionality, are not sufficiently reflected by the vascular status, but have to consider other organ-specific components (e.g., immunology, musculoskeletal system) as well as psychological/neurocognitive issues and social contextual factors. Limitations to chronological age, the vascular status or paraphrasing geriatric surrogate parameters like "frailty" do not properly characterize the functional health status of old people. In the present article we follow this train of thought at the interface between vascular surgery and geriatrics using the examples of abdominal aortic aneurysm (AAA) and peripheral arterial occlusive disease (PAOD).
- Published
- 2021
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46. Severe Type of Minocycline-Induced Hyperpigmentation Mimicking Peripheral Arterial Occlusive Disease in a Bullous Pemphigoid Patient
- Author
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Meng-Yu Wu, Yueh-Tseng Hou, Giou-Teng Yiang, Andy Po-Yi Tsai, and Ching-Hsiang Lin
- Subjects
hyperpigmentation ,minocycline ,peripheral arterial occlusive disease ,bullous pemphigoid ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Minocycline is a tetracycline group antibiotic that is known to cause significant antibacterial and anti-inflammatory effects. Minocycline has been widely used to treat systemic infection, acne, dermatitis, and rosacea. However, various dose-related side effects of hyperpigmentation in whole body tissues have been reported. Three main types of minocycline-induced hyperpigmentation have been identified. In rare severe hyperpigmentation cases, drug-induced hyperpigmentation can mimic local cellulitis or peripheral arterial occlusive disease (PAOD). These processes require different therapeutic strategies. Therefore, early diagnosis is extremely important for physicians to determine the etiology of the hyperpigmentation, and subsequently discontinue the minocycline if indicated. We describe a rare case presenting a severe form of type III minocycline-induced hyperpigmentation mimicking peripheral arterial occlusive disease in a bullous pemphigoid patient.
- Published
- 2019
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47. Efficacy and Safety of Alprostadil in Patients with Peripheral Arterial Occlusive Disease Fontaine Stage IV: Results of a Placebo Controlled Randomised Multicentre Trial (ESPECIAL).
- Author
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Lawall, H., Pokrovsky, A., Checinski, P., Ratushnyuk, A., Hamm, G., Randerath, O., Grieger, F., and Bentz, J.W.G.
- Abstract
Objectives The aim was to assess the efficacy and safety of alprostadil in patients with peripheral arterial occlusive disease (PAOD) Fontaine Stage IV. Methods This was a multinational, prospective, randomised, double blind, placebo controlled, parallel group trial. Patients with Stage IV PAOD were equally randomised to either 4 weeks of alprostadil treatment twice daily or to placebo treatment twice daily. The primary efficacy variables were the rate of complete healing of all necrosis and ulceration 12 weeks after the end of treatment and the frequency of major amputations 24 weeks after the end of treatment. Results A total of 840 patients were randomised between 2004 and 2013. At baseline, no major differences between treatment groups were found. The rate of “complete healing” was 18.4% in patients on alprostadil and 17.2% in patients on placebo. The rates of “major amputations” were 12.6% in patients on alprostadil and 14.6% in patients on placebo. The adjusted difference between alprostadil and placebo including their 95% confidence intervals was 1.1 (−4.0 to 6.3) for “complete healing” and −2.1 (−6.7 to 2.5) for “major amputations.” In the subgroup of diabetic patients the rates of major amputations were numerically lower in the alprostadil than placebo group (10.6% vs. 17.4%). Within the total cohort a non-significant difference in “decrease in ulcer area ≥50%” was reached in 30.2% of patients on alprostadil and in 24.3% of patients on placebo at end of treatment. Conclusions In this study, superiority of alprostadil over placebo could not be shown. Nevertheless, a slight numerical but not clinically relevant advantage for alprostadil emerged from the “area decrease of ulcers by ≥ 50%,” indicating that a healing effect may have started. The results have to be considered in the light of several limitations in study design and conduct. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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48. Editor's Choice – The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease
- Author
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E. Sebastian Debus, Ursula Marschall, Thea Kreutzburg, Regent Lee, Jenny Kuchenbecker, Frederik Peters, Christian-Alexander Behrendt, and Levente Kriston
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Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,030230 surgery ,Risk Assessment ,Amputation, Surgical ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Peripheral arterial occlusive disease ,Clinical Decision Rules ,Internal medicine ,medicine ,Humans ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Aged, 80 and over ,Framingham Risk Score ,business.industry ,Proportional hazards model ,Reproducibility of Results ,Retrospective cohort study ,Middle Aged ,Prognosis ,Intermittent claudication ,Confidence interval ,Amputation ,Female ,Surgery ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Risk assessment - Abstract
Objective Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). Methods In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). Results In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. Conclusion The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.
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- 2021
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49. Editor's Choice – International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease: A Report from VASCUNET and the International Consortium of Vascular Registries
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Ian Thomson, Christian-Alexander Behrendt, Eric A. Secemsky, Adam W. Beck, E. Sebastian Debus, Daniel J. Bertges, Alexei Svetlikov, Birgitta Sigvant, Barry Beiles, Matthew J. Grima, Frederico Bastos Gonçalves, E. Laxdal, Marc L. Schermerhorn, Kevin Cassar, Martin Altreuther, Kevin Mani, Carlo Setacci, and Jenny Kuchenbecker
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medicine.medical_specialty ,Peripheral vascular diseases ,Epidemiology ,Administrative data ,MEDLINE ,Diabetes -- Complications ,030204 cardiovascular system & hematology ,030230 surgery ,Article ,03 medical and health sciences ,0302 clinical medicine ,Peripheral arterial occlusive disease ,Evidence-based medicine -- Data processing ,Internal medicine ,medicine ,Cardiac and Cardiovascular Systems ,Registries ,Peripheral arterial occlusive disease (PAOD) ,Kardiologi ,business.industry ,Kirurgi ,Member states ,Lower extremity artery disease ,Sex specific ,Arterial occlusions ,Diabetic foot syndrome (DFS) ,Surgery ,Foot -- Ulcers ,Cardiology and Cardiovascular Medicine ,business ,Arteries -- Diseases - Abstract
Objective: The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries., Methods: Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed., Results: Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients’ mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days)., Conclusion: Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance., peer-reviewed
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- 2020
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50. Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products—The example of paclitaxel
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U. Rother, H. Görtz, Christian-Alexander Behrendt, G. Rümenapf, C. Uhl, and Dittmar Böckler
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medicine.medical_specialty ,Medical device ,business.industry ,Market access ,Vascular surgery ,Real world evidence ,law.invention ,Clinical Practice ,Randomized controlled trial ,Peripheral arterial occlusive disease ,law ,medicine ,Surgery ,Observational study ,ddc:610 ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business - Abstract
In 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validity of this association, while various observational studies using clinical and administrative registries proved the safety of coated devices. This article aimed to summarize the development and adoption of paclitaxel-coated balloons and stents for the treatment of peripheral arterial occlusive disease in clinical practice, research, and practice guidelines. It especially focusses on the European Unionʼs medical device regulation, which has far-reaching implications for the market approval and monitoring of high-risk medical devices.
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- 2020
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