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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 -
Circulation Research Apr 2017Critical limb ischemia is a life-threatening complication of peripheral arterial disease. In patients who are ineligible for revascularization procedures, there are few... (Meta-Analysis)
Meta-Analysis Review
RATIONALE
Critical limb ischemia is a life-threatening complication of peripheral arterial disease. In patients who are ineligible for revascularization procedures, there are few therapeutic alternatives, leading to amputations and death.
OBJECTIVE
To provide a systematic review of the literature and a meta-analysis of studies evaluating safety and efficacy of autologous cell therapy for intractable peripheral arterial disease/critical limb ischemia.
METHODS AND RESULTS
We retrieved 19 randomized controlled trials (837 patients), 7 nonrandomized trials (338 patients), and 41 noncontrolled studies (1177 patients). The primary outcome was major amputation. Heterogeneity was high, and publication bias could not be excluded. Despite these limitations, the primary analysis (all randomized controlled trials) showed that cell therapy reduced the risk of amputation by 37%, improved amputation-free survival by 18%, and improved wound healing by 59%, without affecting mortality. Cell therapy significantly increased ankle brachial index, increased transcutaneous oxygen tension, and reduced rest pain. The secondary analysis (all controlled trials; n=1175 patients) shows that there may be potential to avoid ≈1 amputation/year for every 2 patients successfully treated. The tertiary analysis (all studies; n=2332 patients) precisely estimated the changes in ankle brachial index, transcutaneous oxygen tension, rest pain, and walking capacity after cell therapy. Intramuscular implantation appeared more effective than intra-arterial infusion, and mobilized peripheral blood mononuclear cells may outperform bone marrow-mononuclear cells and mesenchymal stem cells. Amputation rate was improved more in trials wherein the prevalence of diabetes mellitus was high. Cell therapy was not associated with severe adverse events. Remarkably, efficacy of cell therapy on all end points was no longer significant in placebo-controlled randomized controlled trials and disappeared in randomized controlled trials with a low risk of bias.
CONCLUSIONS
Although this meta-analysis highlights the need for more high-quality placebo-controlled trials, equipoise may no longer be guaranteed because autologous cell therapy has the potential to modify the natural history of intractable critical limb ischemia.
Topics: Aged; Amputation, Surgical; Chi-Square Distribution; Disease-Free Survival; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Odds Ratio; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Recovery of Function; Regeneration; Risk Factors; Stem Cell Transplantation; Time Factors; Transplantation, Autologous; Treatment Outcome; Vascular Patency; Wound Healing
PubMed: 28096194
DOI: 10.1161/CIRCRESAHA.116.309045 -
The Cochrane Database of Systematic... Jan 2018Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular disease in the general population. Although numerous... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular disease in the general population. Although numerous treatments have been adopted for patients at different disease stages, no option other than amputation is available for patients presenting with critical limb ischaemia (CLI) unsuitable for rescue or reconstructive intervention. In this regard, prostanoids have been proposed as a therapeutic alternative, with the aim of increasing blood supply to the limb with occluded arteries through their vasodilatory, antithrombotic, and anti-inflammatory effects. This is an update of a review first published in 2010.
OBJECTIVES
To determine the effectiveness and safety of prostanoids in patients with CLI unsuitable for rescue or reconstructive intervention.
SEARCH METHODS
For this update, the Cochrane Vascular Information Specialist searched the Specialised Register (January 2017) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1). In addition, we searched trials registries (January 2017) and contacted pharmaceutical manufacturers, in our efforts to identify unpublished data and ongoing trials.
SELECTION CRITERIA
Randomised controlled trials describing the efficacy and safety of prostanoids compared with placebo or other pharmacological control treatments for patients presenting with CLI without chance of rescue or reconstructive intervention.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. We resolved disagreements by consensus or by consultation with a third review author.
MAIN RESULTS
For this update, 15 additional studies fulfilled selection criteria. We included in this review 33 randomised controlled trials with 4477 participants; 21 compared different prostanoids versus placebo, seven compared prostanoids versus other agents, and five conducted head-to-head comparisons using two different prostanoids.We found low-quality evidence that suggests no clear difference in the incidence of cardiovascular mortality between patients receiving prostanoids and those given placebo (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.41 to 1.58). We found high-quality evidence showing that prostanoids have no effect on the incidence of total amputations when compared with placebo (RR 0.97, 95% CI 0.86 to 1.09). Adverse events were more frequent with prostanoids than with placebo (RR 2.11, 95% CI 1.79 to 2.50; moderate-quality evidence). The most commonly reported adverse events were headache, nausea, vomiting, diarrhoea, flushing, and hypotension. We found moderate-quality evidence showing that prostanoids reduced rest-pain (RR 1.30, 95% CI 1.06 to 1.59) and promoted ulcer healing (RR 1.24, 95% CI 1.04 to 1.48) when compared with placebo, although these small beneficial effects were diluted when we performed a sensitivity analysis that excluded studies at high risk of bias. Additionally, we found evidence of low to very low quality suggesting the effects of prostanoids versus other active agents or versus other prostanoids because studies conducting these comparisons were few and we judged them to be at high risk of bias. None of the included studies assessed quality of life.
AUTHORS' CONCLUSIONS
We found high-quality evidence showing that prostanoids have no effect on the incidence of total amputations when compared against placebo. Moderate-quality evidence showed small beneficial effects of prostanoids for rest-pain relief and ulcer healing when compared with placebo. Additionally, moderate-quality evidence showed a greater incidence of adverse effects with the use of prostanoids, and low-quality evidence suggests that prostanoids have no effect on cardiovascular mortality when compared with placebo. None of the included studies reported quality of life measurements. The balance between benefits and harms associated with use of prostanoids in patients with critical limb ischaemia with no chance of reconstructive intervention is uncertain; therefore careful assessment of therapeutic alternatives should be considered. Main reasons for downgrading the quality of evidence were high risk of attrition bias and imprecision of effect estimates.
Topics: Alprostadil; Amputation, Surgical; Epoprostenol; Humans; Iloprost; Ischemia; Leg; Leg Ulcer; Nafronyl; Nicotinic Acids; Pentoxifylline; Peripheral Vascular Diseases; Prostaglandins; Randomized Controlled Trials as Topic; Vasodilator Agents
PubMed: 29318581
DOI: 10.1002/14651858.CD006544.pub3 -
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 -
The Cochrane Database of Systematic... May 2016People with end-stage kidney disease (ESKD) have high rates of cardiovascular events. Randomised controlled trials (RCTs) of homocysteine-lowering therapies have not... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with end-stage kidney disease (ESKD) have high rates of cardiovascular events. Randomised controlled trials (RCTs) of homocysteine-lowering therapies have not shown reductions in cardiovascular event rates in the general population. However, people with kidney disease have higher levels of homocysteine and may have different mechanisms of cardiovascular disease. We performed a systematic review of the effect of homocysteine-lowering therapies in people with ESKD.
OBJECTIVES
To evaluate the benefits and harms of established homocysteine lowering therapy (folic acid, vitamin B6, vitamin B12) on all-cause mortality and cardiovascular event rates in patients with ESKD.
SEARCH METHODS
We searched Cochrane Kidney and Transplant's Specialised Register to 25 January 2016 through contact with the Information Specialist using search terms relevant to this review.
SELECTION CRITERIA
Studies conducted in people with ESKD that reported at least 100 patient-years of follow-up and assessed the effect of therapies that are known to have homocysteine-lowering properties were included.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data using a standardised form. The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, incident cardiovascular disease (fatal and nonfatal myocardial infarction and coronary revascularisation), cerebrovascular disease (stroke and cerebrovascular revascularisation), peripheral vascular disease (lower limb amputation), venous thromboembolic disease (deep vein thrombosis and pulmonary embolism), thrombosis of dialysis access, and adverse events. The effects of homocysteine-lowering therapies on outcomes were assessed with meta-analyses using random-effects models. Prespecified subgroup and sensitivity analyses were conducted.
MAIN RESULTS
We included six studies that reported data on 2452 participants with ESKD. Interventions investigated were folic acid with or without other vitamins (vitamin B6, vitamin B12). Participants' mean age was 48 to 65 years, and proportions of male participants ranged from 50% to 98%.Homocysteine-lowering therapy probably leads to little or no effect on cardiovascular mortality (4 studies, 1186 participants: RR 0.93, 95% CI 0.70 to 1.22). There was no evidence of heterogeneity among the included studies (I² = 0%). Homocysteine-lowering therapy had little or no effect on all-cause mortality or any other of this review's secondary outcomes. All prespecified subgroup and sensitivity analyses demonstrated little or no difference. Reported adverse events were mild and there was no increase in the incidence of adverse events from homocysteine-lowering therapies (3 studies, 1248 participants: RR 1.12, 95% CI 0.51 to 2.47; I(2) = 0%). Overall, studies were assessed as being at low risk of bias and there was no evidence of publication bias.
AUTHORS' CONCLUSIONS
Homocysteine-lowering therapies were not found to reduce mortality (cardiovascular and all-cause) or cardiovascular events among people with ESKD.
Topics: Aged; Cardiovascular Diseases; Cause of Death; Female; Folic Acid; Homocysteine; Humans; Hyperhomocysteinemia; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Renal Dialysis; Stroke; Venous Thrombosis; Vitamin B 12; Vitamin B 6; Vitamin B Complex
PubMed: 27243372
DOI: 10.1002/14651858.CD004683.pub4 -
The Cochrane Database of Systematic... Dec 2014Venous thromboembolism (VTE) is common in clinical practice. The efficacy of statins in the primary prevention of VTE remains unproven. This is an update of the review... (Review)
Review
BACKGROUND
Venous thromboembolism (VTE) is common in clinical practice. The efficacy of statins in the primary prevention of VTE remains unproven. This is an update of the review first published in 2011.
OBJECTIVES
To assess the efficacy of statins in the primary prevention of VTE.
SEARCH METHODS
For this update the Cochrane Peripheral Vascular Diseases (PVD) Group Trials Search Co-ordinator searched the Specialised Register (last searched February 2014) and CENTRAL (2014, Issue 1).
SELECTION CRITERIA
Randomised controlled trials (RCTs) that assessed statins in the primary prevention of VTE were considered. The outcomes we evaluated were the rates of VTE, cardiovascular and cerebrovascular events, death and adverse events. Two authors (L Li, JH Tian) independently selected RCTs against the inclusion criteria. Disagreements were resolved by discussion with a third author (KH Yang).
DATA COLLECTION AND ANALYSIS
Data extraction was independently carried out by two authors (L Li, JH Tian). Disagreements were resolved by discussion with a third author (PZ Zhang). Two authors (L Li, JH Tian) independently assessed the risk of bias according to a standard quality checklist provided by the PVD Group.
MAIN RESULTS
For this update we included one RCT with 17,802 participants that assessed rosuvastatin compared with placebo for the prevention of VTE. The quality of the evidence was moderate because of imprecision, as the required sample size for the outcomes of this review was not achieved. Analysis showed that when compared with placebo rosuvastatin reduced the incidence of VTE (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.37 to 0.86) and deep vein thrombosis (DVT) (OR 0.45, 95% CI 0.25 to 0.79), the risk of any (fatal and non-fatal) myocardial infarction (MI) (OR 0.45, 95% CI 0.30 to 0.69), and any (fatal and non-fatal) stroke (OR 0.51, 95% CI 0.34 to 0.78). There was no difference in the incidence of pulmonary embolism (PE) (OR 0.77, 95% CI 0.41 to 1.46), fatal MI (OR 1.50, 95% CI 0.53 to 4.22), fatal stroke (OR 0.30, 95% CI 0.08 to 1.09) or death after VTE (OR 0.50, 95% CI 0.20 to 1.24). The incidence of any serious adverse events was no different between the rosuvastatin and placebo groups (OR 1.07, 95% CI 0.95 to 1.20).
AUTHORS' CONCLUSIONS
Available evidence showed that rosuvastatin was associated with a reduced incidence of VTE, but the evidence was limited to a single RCT and any firm conclusions and suggestions could be not drawn. Randomised controlled trials of statins (including rosuvastatin) are needed to evaluate their efficacy in the prevention of VTE.
Topics: Female; Fluorobenzenes; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Pyrimidines; Randomized Controlled Trials as Topic; Rosuvastatin Calcium; Stroke; Sulfonamides; Venous Thromboembolism; Venous Thrombosis
PubMed: 25518837
DOI: 10.1002/14651858.CD008203.pub3 -
Journal of Vascular Surgery May 2023Postoperative morbidity in patients undergoing lower extremity amputation (LEA) has remained high. Studies investigating the influence of the anesthetic modality on the... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Postoperative morbidity in patients undergoing lower extremity amputation (LEA) has remained high. Studies investigating the influence of the anesthetic modality on the postoperative outcomes have yielded conflicting results. The aim of our study was to assess the effects of regional anesthesia vs general anesthesia on postoperative complications for patients undergoing LEA.
METHODS
We systematically searched PubMed, Embase, MEDLINE, Web of Science, and Google Scholar from 1990 to 2022 for studies investigating the effect of the anesthetic modality on the postoperative outcomes after LEA. Regional anesthesia (RA) included neuraxial anesthesia and peripheral nerve blocks. The outcomes included 30-day mortality, respiratory failure (unplanned postoperative intubation, failure to wean, mechanical ventilation >24 hours), surgical site infection, cardiac complications, urinary tract infection, renal failure, sepsis, venous thrombosis, pneumonia, and myocardial infarction.
RESULTS
Of the 25 studies identified, we included 10 retrospective observational studies with 81,736 patients, of whom 69,754 (85.3%) had received general anesthesia (GA) and 11,980 (14.7%) had received RA. In the GA group, 50,468 patients were men (63.8%), and in the RA group, 7813 patients were men (62.3%). The results of the meta-analyses revealed that GA was associated with a higher rate of respiratory failure (odds ratio, 1.38; 95% confidence interval, 1.06-1.80; P = .02) and sepsis (odds ratio, 1.21; 95% confidence interval, 1.11-1.33; P < .0001) compared with RA. No differences were found in postoperative 30-day mortality, surgical site infection, cardiac complications, urinary tract infection, renal failure, venous thrombosis, pneumonia, and myocardial infarction between the GA and RA groups.
CONCLUSIONS
The results of our meta-analysis have shown that GA could be associated with a higher rate of respiratory failure and sepsis compared with RA for LEA.
Topics: Male; Humans; Female; Surgical Wound Infection; Retrospective Studies; Treatment Outcome; Anesthesia, Conduction; Amputation, Surgical; Pneumonia; Myocardial Infarction; Anesthesia, General; Lower Extremity; Respiratory Insufficiency; Postoperative Complications
PubMed: 36243265
DOI: 10.1016/j.jvs.2022.10.005 -
Journal of Vascular Surgery Mar 2023The objective of this study was to evaluate the application of the Global Anatomic Staging System (GLASS) in the endovascular treatment of chronic limb-threatening... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The objective of this study was to evaluate the application of the Global Anatomic Staging System (GLASS) in the endovascular treatment of chronic limb-threatening ischemia (CLTI).
METHODS
We performed systematic research between June 2019 and February 2022, including articles investigating the relationship of GLASS classification with the outcomes of endovascular interventions in the treatment of CLTI. Data from the included studies were pooled and meta-analyzed. The primary endpoints were limb-based patency (LBP) at 1-year follow-up and immediate technical failure (ITF). Secondary endpoints included major amputation. We performed subgroup analysis between studies that reported on calcium modifier inclusion during GLASS classification and studies that did not.
RESULTS
Eleven studies, including 1816 patients (1975 limbs) met the inclusion criteria. The pooled ITF rates for GLASS stages I, II, and III are 5.52% (95% confidence interval [CI], 3.74%-8.07%), 7.39% (95% CI, 5.32%-10.18%), and 21.07% (95% CI, 13.48%-31.39%) respectively. The pooled LBP for GLASS stages I, II, and III are 68.43% (95% CI, 53.44%-80.37%), 41.52% (95% CI, 18.91%-68.37%), and 38.64% (95% CI, 19.83%-61.57%). The relative risk (RR) for ITF regarding composite GLASS I and II stages vs GLASS III is 3.96 (95% CI, 1.96-7.98). The RR for LBP of GLASS I and II versus GLASS stage III is 1.51 (95% CI, 0.86-2.64). Pooled major amputation rates for the composite GLASS I, II and GLASS III stages are 7.62% (95% CI, 5.44%-10.58%) and 15.43% (95% CI, 11.72%-20.05%) respectively, whereas the RR between GLASS I, II, and GLASS III stages is 1.84 (95% CI, 1.18-2.87).
CONCLUSIONS
Our study demonstrated that patients with CLTI undergoing endovascular interventions classified as GLASS stage III had almost a four-fold risk increase for ITF and 1.84 times the risk of major amputation compared with stages I and II. Additionally, GLASS classification correctly predicted ITF for all three stages, whereas it failed to predict stage I and II LBP outcomes. Safe conclusions regarding LBP cannot be drawn due to the low quality and small number of the included studies, necessitating further research. Furthermore, we displayed the importance of calcium moderator inclusion in the accurate classification of GLASS.
Topics: Humans; Chronic Limb-Threatening Ischemia; Endovascular Procedures; Treatment Outcome; Calcium; Risk Factors; Limb Salvage; Ischemia; Peripheral Arterial Disease; Retrospective Studies; Chronic Disease
PubMed: 35953002
DOI: 10.1016/j.jvs.2022.07.183 -
International Wound Journal Feb 2020Early reliable, valid screening, diagnosis, and treatment improve peripheral arterial disease outcomes, yet screening and diagnostic practices vary across settings and...
Early reliable, valid screening, diagnosis, and treatment improve peripheral arterial disease outcomes, yet screening and diagnostic practices vary across settings and specialties. A scoping literature review described reliability and validity of peripheral ischaemia diagnosis or screening tools. Clinical studies in the PUBMED database January 1, 1970, to August 13, 2018, were reviewed summarising ranges of reliability and validity of peripheral ischaemia diagnostic and screening tools for patients with non-neuropathic lower leg ischaemia. Peripheral ischaemia screening and diagnostic practices varied in parameters measured such as timing, frequency, setting, ordering clinicians, degree of invasiveness, costs, definitions, and cut-off points informing clinical and referral decisions. Traditional ankle/brachial systolic blood pressure index <0.9 was a reliable, valid lower leg ischaemia screening test to trigger specialist referral for detailed diagnosis. For patients with advanced peripheral ischaemia or calcified arteries, toe-brachial index, claudication, or invasive angiographic imaging techniques that can have complications were reliable, valid screening, and diagnostic tools to inform management decisions. Ankle/brachial index testing is sufficiently reliable and valid for use during routine examinations to improve timing and consistency of peripheral ischaemia screening, triggering prompt specialist referral for more reliable, accurate Doppler, or other diagnosis to inform treatment decisions.
Topics: Adult; Aged; Aged, 80 and over; Diagnostic Techniques and Procedures; Female; Humans; Male; Mass Screening; Middle Aged; Peripheral Arterial Disease; Practice Guidelines as Topic; Reproducibility of Results
PubMed: 31680419
DOI: 10.1111/iwj.13223