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Saudi Pharmaceutical Journal : SPJ :... Jul 2021Arterial catheterization is frequently performed in neonatal intensive care units with an inherent risk of peripheral ischemic injury, especially in preterm infants. The... (Review)
Review
BACKGROUND
Arterial catheterization is frequently performed in neonatal intensive care units with an inherent risk of peripheral ischemic injury, especially in preterm infants. The treatment options following vascular damage involve invasive and non-invasive modalities. The primary objective of this systematic review was to evaluate the evidence of the use of topical nitroglycerine (TNG) either alone or as adjunctive therapy. The secondary aim was to develop an approach to the treatment of catheter induced ischemia in infants based on the available evidence.
METHODS
A comprehensive search was conducted of available databases for relevant articles that involved the treatment of peripheral tissue ischemia in neonates with the use of TNG. Citations were restricted to human subjects.
RESULTS
Six hundred and eighty-nine articles were identified, and twenty-seven case reports and case series were compatible with the inclusion and exclusion criteria. Sixty-eight infants out of the 76 published cases (89%) experienced a favorable outcome and 79% (n = 60) demonstrated complete recovery with the topical application of TNG to the ischemic site.
CONCLUSION
The available evidence demonstrates that TNG is effective for the treatment of peripheral ischemia in neonates after standard conservative measures have failed. However, due to the absence of robust evidence for this therapeutic modality, there are no uniform guidelines regarding the frequency, duration, and safety of TNG use. Planning the management of peripheral ischemia in neonates with TNG should be a multidisciplinary decision that includes close surveillance of blood pressure, methemoglobin levels, and follow up cranial ultrasound.
PubMed: 34400871
DOI: 10.1016/j.jsps.2021.05.008 -
Annals of Vascular Surgery Feb 2023Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot... (Review)
Review
BACKGROUND
Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot ulcers (DFUs). The aim of this systematic review was to explore the association between frailty and outcomes from CLTI and DFUs.
METHODS
We performed a systematic literature search of electronic databases to find studies using a validated measure of frailty in individuals with CLTI and/or DFUs. The primary outcomes were the impact of frailty on the severity of initial clinical presentation and unfavorable follow-up outcomes including readmissions, major limb amputation, cardiovascular events, revascularization, and wound healing.
RESULTS
Ten cohort studies were included. Two studies had a low risk of bias, 1 was unable to be assessed, 5 had moderate risk of bias, and 2 high risk of bias. The prevalence of frailty in people presenting with CLTI ranged from 27% to 88% and was 71% in people with DFUs. The presence of frailty in both people with CLTI and DFUs was associated with substantially increased severity at presentation (severity of ischemia and tissue loss) and poorer outcomes at follow-up (risk of readmission, limb amputation, and all-cause mortality).
CONCLUSIONS
The presence of frailty in both people with CLTI and DFUs is likely associated with substantially higher complexity at presentation followed by a greater risk for readmission, amputation, and death during follow-up. Heterogeneity in the tools used to screen for frailty, poor definition of frailty, and unclear evaluation of exposure and outcomes limit further interpretation of findings.
Topics: Humans; Chronic Limb-Threatening Ischemia; Diabetic Foot; Frailty; Treatment Outcome; Peripheral Arterial Disease; Risk Factors; Chronic Disease; Ischemia; Limb Salvage; Retrospective Studies; Diabetes Mellitus
PubMed: 36332876
DOI: 10.1016/j.avsg.2022.09.057 -
Annals of Surgery Aug 2023The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus...
OBJECTIVE
The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC).
BACKGROUND
Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy.
METHODS
Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831).
RESULTS
A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis.
CONCLUSIONS
Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.
Topics: Humans; Endovascular Procedures; Exercise Therapy; Intermittent Claudication; Ischemia; Peripheral Arterial Disease; Risk Factors; Treatment Outcome; Vascular Surgical Procedures; Randomized Controlled Trials as Topic
PubMed: 36728522
DOI: 10.1097/SLA.0000000000005793 -
Journal of Vascular Surgery Nov 2023Both bypass surgery and endovascular treatment are well-recognized interventions for the treatment of peripheral artery disease; however, the effect of failed... (Review)
Review
OBJECTIVE
Both bypass surgery and endovascular treatment are well-recognized interventions for the treatment of peripheral artery disease; however, the effect of failed endovascular treatment on subsequent surgeries remains controversial. A systematic review was conducted to compare the outcomes of primary bypass and bypass surgery after endovascular treatment.
METHODS
Three academic databases (Embase, PubMed, and Scopus) were searched from their inception to August 2022. Two independent investigators searched for studies that reported the outcomes of primary bypass surgery and bypass surgery after endovascular treatment in patients with peripheral artery disease. Abstracts and full-text studies were screened independently using duplicate data abstraction. Dichotomous outcome measures were reported using a random-effects model to generate a summary odds ratio (OR) and 95% confidence interval (CI). The risk of bias was assessed using the Newcastle-Ottawa Scale.
RESULTS
Seventeen retrospective observational studies were selected from 3911 articles and included 8064 patients, 6252 of whom underwent primary bypass surgery and 1812 underwent bypass surgery after endovascular treatment. The mean age was 69.0 years and 61.2% (n = 4938) were male. For perioperative outcomes, the 30-day results showed no difference in mortality (OR, 0.76; 95% CI, 0.53-1.10), or amputation (OR, 0.89; 95% CI, 0.67-1.20). For short- to mid-term outcomes, primary patency did not differ at 6 months (OR, 0.98; 95% CI, 0.81-1.19), 1 year (OR, 1.12; 95% CI, 0.97-1.30), or 2 years (OR, 1.17; 95% CI, 0.85-1.61) follow-up. Amputation-free survival did not differ at 6 months (OR, 1.03; 95% CI, 0.82-1.30), 1 year (OR, 1.09; 95% CI, 0.89-1.32), 2 years (OR, 1.18; 95% CI, 0.93-1.50), or 3 years (OR, 1.09; 95% CI, 0.84-1.40) of follow-up. No significant difference was found in overall survival or second patency.
CONCLUSIONS
This meta-analysis of retrospective, nonrandomized, observational studies suggests that prior endovascular treatment of lower extremity arterial disease does not result in worse perioperative, short-term, or mid-term clinical outcomes of subsequent infrainguinal bypass surgery compared with patients without prior endovascular treatment.
PubMed: 37453586
DOI: 10.1016/j.jvs.2023.07.003 -
Nutrition, Metabolism, and... Aug 2023The Controlling Nutritional Status (CONUT) score is a tool for assessing the risk of malnutrition (undernutrition) that can be calculated from albumin concentration,... (Meta-Analysis)
Meta-Analysis
AIMS
The Controlling Nutritional Status (CONUT) score is a tool for assessing the risk of malnutrition (undernutrition) that can be calculated from albumin concentration, total peripheral lymphocyte count, and total cholesterol concentration. CONUT score has been proposed as a promising prognostic marker in several clinical settings; however, a consensus on its prognostic value in patients with stroke is lacking. The aim of this systematic review and meta-analysis was to evaluate the relationship between CONUT score and clinical outcomes in patients with stroke based on all current available studies.
DATA SYNTHESIS
Systematic research on PubMed, Scopus and Web of Science from inception to February 2023 was performed on the association between CONUT score and clinical outcomes in patients with stroke. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were followed. Methodological quality was evaluated using the Newcastle-Ottawa Scale quality assessment tool. Pooled effect estimation was calculated by a random-effect model. Through the initial literature search, 15 studies (all high-quality) including 16 929 patients were found to be eligible and analysed in the meta-analysis. A significant risk of malnutrition (in most studies defined by a CONUT score ≥5) was directly associated with mortality, higher risk of poor functional outcome according to the modified Rankin Scale and total infection development. Evidence was consistent for acute ischaemic stroke and preliminary for acute haemorrhagic stroke.
CONCLUSION
CONUT score is an independent prognostic indicator, and it is associated with major disability and infection development during hospitalisation.
PROSPERO ID
CRD42022306560.
Topics: Humans; Nutritional Status; Brain Ischemia; Stroke; Malnutrition; Prognosis; Retrospective Studies; Nutrition Assessment
PubMed: 37336716
DOI: 10.1016/j.numecd.2023.05.012 -
Atherosclerosis Jan 2020It is unclear whether improvements in the detection/treatment of peripheral artery disease (PAD) affect overall survival and morbidity. We undertook a systematic review...
BACKGROUND AND AIMS
It is unclear whether improvements in the detection/treatment of peripheral artery disease (PAD) affect overall survival and morbidity. We undertook a systematic review to describe survival and morbidity in contemporary PAD cohorts.
METHODS
Electronic databases were searched for randomised and observational studies reporting mortality/morbidity events between 1 May 2003 and 31 December, 2017 in patients with PAD, diagnosed by intermittent claudication (IC), critical limb ischaemia (CLI), or an ankle brachial index (ABI) < 0.9. Pooled event rates for all-cause and cardiovascular (CV) mortality, non-fatal myocardial infarction (MI), non-fatal stroke, major CV events (MACE; non-fatal MI/stroke, CV death), and major amputation were calculated per 1000 person-years.
RESULTS
124 eligible studies were identified (570,856 patients; 855,894 person-years of follow-up). Statin use was reported in 67% of the overall cohort and antiplatelet use in 79%. Pooled event rates for all-cause and CV mortality, MI, stroke, MACE, and major amputation were 113, 39, 20, 12, 71, and 70 per 1000 person-years, respectively. Compared with patients with an ABI <0.9, the presence of CLI was associated with increased rates of all-cause and CV mortality, MI, MACE, and major amputation. Event rates for stroke were similar between patients with an ABI <0.9 and CLI.
CONCLUSIONS
Our data show PAD patients have a high risk of all-cause and CV mortality, and imply the risk of stroke or MI is at least equivalent to the risk in patients with coronary artery disease. Moreover, our data underline the need for improved treatments to attenuate CV risk in PAD patients.
Topics: Ankle Brachial Index; Atherosclerosis; Global Health; Humans; Lower Extremity; Morbidity; Peripheral Arterial Disease; Survival Rate
PubMed: 31606132
DOI: 10.1016/j.atherosclerosis.2019.09.012 -
Journal of Vascular Surgery May 2022Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral... (Review)
Review
Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI.
Topics: Aged; Amputation, Surgical; Chronic Disease; Chronic Limb-Threatening Ischemia; Humans; Ischemia; Limb Salvage; Patient Reported Outcome Measures; Peripheral Arterial Disease; Quality of Life; Retrospective Studies; Risk Factors; Treatment Outcome
PubMed: 35085747
DOI: 10.1016/j.jvs.2021.11.057 -
The Cochrane Database of Systematic... Jun 2021Peripheral arterial disease (PAD) affects between 4% and 12% of people aged 55 to 70 years, and 20% of people over 70 years. A common complaint is intermittent... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Peripheral arterial disease (PAD) affects between 4% and 12% of people aged 55 to 70 years, and 20% of people over 70 years. A common complaint is intermittent claudication (exercise-induced lower limb pain relieved by rest). These patients have a three- to six-fold increase in cardiovascular mortality. Cilostazol is a drug licensed for the use of improving claudication distance and, if shown to reduce cardiovascular risk, could offer additional clinical benefits. This is an update of the review first published in 2007.
OBJECTIVES
To determine the effect of cilostazol on initial and absolute claudication distances, mortality and vascular events in patients with stable intermittent claudication.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 9 November 2020.
SELECTION CRITERIA
We considered double-blind, randomised controlled trials (RCTs) of cilostazol versus placebo, or versus other drugs used to improve claudication distance in patients with stable intermittent claudication.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trials for selection and independently extracted data. Disagreements were resolved by discussion. We assessed the risk of bias with the Cochrane risk of bias tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we used odds ratios (ORs) with corresponding 95% confidence intervals (CIs) and for continuous outcomes we used mean differences (MDs) and 95% CIs. We pooled data using a fixed-effect model, or a random-effects model when heterogeneity was identified. Primary outcomes were initial claudication distance (ICD) and quality of life (QoL). Secondary outcomes were absolute claudication distance (ACD), revascularisation, amputation, adverse events and cardiovascular events.
MAIN RESULTS
We included 16 double-blind, RCTs (3972 participants) comparing cilostazol with placebo, of which five studies also compared cilostazol with pentoxifylline. Treatment duration ranged from six to 26 weeks. All participants had intermittent claudication secondary to PAD. Cilostazol dose ranged from 100 mg to 300 mg; pentoxifylline dose ranged from 800 mg to 1200 mg. The certainty of the evidence was downgraded by one level for all studies because publication bias was strongly suspected. Other reasons for downgrading were imprecision, inconsistency and selective reporting. Cilostazol versus placebo Participants taking cilostazol had a higher ICD compared with those taking placebo (MD 26.49 metres; 95% CI 18.93 to 34.05; 1722 participants; six studies; low-certainty evidence). We reported QoL measures descriptively due to insufficient statistical detail within the studies to combine the results; there was a possible indication in improvement of QoL in the cilostazol treatment groups (low-certainty evidence). Participants taking cilostazol had a higher ACD compared with those taking placebo (39.57 metres; 95% CI 21.80 to 57.33; 2360 participants; eight studies; very-low certainty evidence). The most commonly reported adverse events were headache, diarrhoea, abnormal stools, dizziness, pain and palpitations. Participants taking cilostazol had an increased odds of experiencing headache compared to participants taking placebo (OR 2.83; 95% CI 2.26 to 3.55; 2584 participants; eight studies; moderate-certainty evidence).Very few studies reported on other outcomes so conclusions on revascularisation, amputation, or cardiovascular events could not be made. Cilostazol versus pentoxifylline There was no difference detected between cilostazol and pentoxifylline for improving walking distance, both in terms of ICD (MD 20.0 metres, 95% CI -2.57 to 42.57; 417 participants; one study; low-certainty evidence); and ACD (MD 13.4 metres, 95% CI -43.50 to 70.36; 866 participants; two studies; very low-certainty evidence). One study reported on QoL; the study authors reported no difference in QoL between the treatment groups (very low-certainty evidence). No study reported on revascularisation, amputation or cardiovascular events. Cilostazol participants had an increased odds of experiencing headache compared with participants taking pentoxifylline at 24 weeks (OR 2.20, 95% CI 1.16 to 4.17; 982 participants; two studies; low-certainty evidence).
AUTHORS' CONCLUSIONS
Cilostazol has been shown to improve walking distance in people with intermittent claudication. However, participants taking cilostazol had higher odds of experiencing headache. There is insufficient evidence about the effectiveness of cilostazol for serious events such as amputation, revascularisation, and cardiovascular events. Despite the importance of QoL to patients, meta-analysis could not be undertaken because of differences in measures used and reporting. Very limited data indicated no difference between cilostazol and pentoxifylline for improving walking distance and data were too limited for any conclusions on other outcomes.
Topics: Aged; Bias; Cilostazol; Humans; Intermittent Claudication; Middle Aged; Myocardial Infarction; Pentoxifylline; Peripheral Vascular Diseases; Placebos; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Stroke; Tetrazoles; Walking
PubMed: 34192807
DOI: 10.1002/14651858.CD003748.pub5 -
Heliyon Mar 2024Many clinical management strategies have been proposed to deal with diabetic foot ulcers. However, the occurrence and recurrence of foot ulcers remain the major problems...
Many clinical management strategies have been proposed to deal with diabetic foot ulcers. However, the occurrence and recurrence of foot ulcers remain the major problems for diabetics. This study aims to identify, visualize, and characterize the meta-analyses on diabetic foot ulcer research. Articles published online were retrieved from the Web of Science core collection database using a search query incorporating MeSH terms and topics related to diabetic foot ulcers and meta-analysis. The publications were then analyzed for basic characteristics, including publication year, countries, topics covered, references, and keywords discussed in the articles. Data visualization was performed using CiteSpace. 334 meta-analyses and systematic reviews on diabetic foot ulcers were identified. The number of publications has experienced rapid growth in recent years (nearly 6-fold since 2016). The United States, China, Netherlands, England, and Australia had a strong collaboration in the contribution of publication. 7 primary topics were summarized from the top 100 highly cited publications: #1 Interventions (proportion: 59%), #2 Risk factors and Prevention (22%), #3 Epidemiology analysis (6%), #4 Cost-effectiveness of interventions (5%), #5 Long-term prognosis (3%), #6 Quality of life analysis (3%), and #7 Economic burden analysis (2%). Footwear and offloading interventions, multidisciplinary care, hyperbaric oxygen, platelet-rich plasma, and negative pressure wound therapies are highly regarded in terms of intervention. Diabetic foot osteomyelitis, peripheral diabetic neuropathy, chronic limb-threatening ischemia, and infections are the main comorbidities. In recent years, offloading interventions, debridement, telemedicine, long-term prognosis, and economic burden analyses have gradually received attention. Individualized treatment, multidisciplinary collaboration, quality of life considerations, and economic burden analyses are the long-term concerns.
PubMed: 38496839
DOI: 10.1016/j.heliyon.2024.e27534 -
BMJ Open Diabetes Research & Care Aug 2020The aims of this systematic review were to assess the clinical relevance and quality of previously published animal models of ischemic ulceration and examine the... (Meta-Analysis)
Meta-Analysis Review
The aims of this systematic review were to assess the clinical relevance and quality of previously published animal models of ischemic ulceration and examine the available evidence for interventions improving ulcer healing in these models. Publicly available databases were searched for original studies investigating the effect of limb ischemia on wound healing in animal models. The quality of studies was assessed using two tools based on the Animal research: Reporting of In Vivo Experiments (ARRIVE) guidelines and the clinical relevance of the models. A total of 640 wounds (ischemic=314; non-ischemic=326) were assessed in 252 animals (92 mice, 140 rats, 20 rabbits) from 7 studies. Meta-analyses showed that wound healing was consistently delayed by ischemia at all time-points examined (day-7 standard median difference (SMD) 5.36, 95% CI 3.67 to 7.05; day-14 SMD 4.50, 95% CI 2.90 to 6.10 and day-21 SMD 2.53, 95% CI 1.25 to 3.80). No significant difference in wound healing was observed between 32 diabetic and 32 non-diabetic animals with ischemic wounds. Many studies lacked methods to reduce bias, such as outcome assessors blinded to group allocation and sample size calculations and clinically relevant model characteristics, such as use of older animals and a peripheral location of the wound. Five different interventions were reported to improve wound healing in these models. The impaired wound healing associated with limb ischemia can be modeled in a variety of different animals. Improvements in study design could increase clinical relevance, reduce bias and aid the discovery of translatable therapies.
Topics: Animals; Diabetic Foot; Mice; Models, Animal; Rabbits; Rats; Ulcer; Wound Healing
PubMed: 32847840
DOI: 10.1136/bmjdrc-2020-001676