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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 -
BMJ Open Science 2021Bone marrow(BM)-derived cell-based therapies for critical limb ischamia showed less clinical benefit than expected. While this might be due to patient-specific factors,...
OBJECTIVE
Bone marrow(BM)-derived cell-based therapies for critical limb ischamia showed less clinical benefit than expected. While this might be due to patient-specific factors, it remains possible that important details were lost in the bench-to-clinic translation. The hindlimb ischaemia model is the golden standard to evaluate cell-based therapies aimed at promoting neovascularisation. To inform future trial design and identify potential knowledge gaps, we propose a systematic review and meta-analysis of preclinical evidence to assess the efficacy of BM-derived cell administration in restoring relative perfusion in the hind limb model and identify determinants of therapeutic efficacy.
SEARCH STRATEGY
PubMed and EMBASE were searched for prospective studies in which the hindlimb ischaemia model was used to assess BM-derived therapies.
SCREENING AND ANNOTATION
Studies with an outcome measure related to relative perfusion of the hindlimb will be included. Study characteristics which include model-related factors as well as details on BM therapy will be extracted.
DATA MANAGEMENT AND REPORTING
For the primary analysis, a random effects model will be constructed using the mean difference calculated from the maximum relative perfusion for each study arm in each study. A separate model will be constructed using the relative perfusion at the latest time point in each study. We will also assess the risk of bias using the SYRCLE tool for internal validity. Subgroup analysis will be performed on animal characteristics, administration route, dose and cell characteristics such as the cell donor.
PROSPERO REGISTRATION NUMBER
This protocol has been registered at PROSPERO (CRD2021226592).
PubMed: 35047706
DOI: 10.1136/bmjos-2021-100209 -
Reviews in Cardiovascular Medicine Dec 2021Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used as mechanical circulatory support in cardiogenic shock (CS). It restores peripheral perfusion, at the... (Meta-Analysis)
Meta-Analysis
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used as mechanical circulatory support in cardiogenic shock (CS). It restores peripheral perfusion, at the expense of increased left ventricle (LV) afterload. In this setting, Impella can be used as direct unloading strategy. Aim of this meta-analysis was to investigate efficacy and safety of LV unloading with Impella during ECMO in CS. A systematic search on Medline, Scopus and Cochrane Library was performed using as combination of keywords: extracorporeal membrane oxygenation, Impella, percutaneous micro axial pump, ECPELLA, cardiogenic shock. We aimed to include studies, which compared the use of ECMO with and without Impella (ECPELLA vs. ECMO). Primary endpoint was short-term all-cause mortality; secondary endpoints included major bleeding, haemolysis, need for renal replacement therapy (RRT) and cerebrovascular accident (CVA). Five studies met the inclusion criteria, with a total population of 972 patients. The ECPELLA cohort showed improved survival compared to the control group (RR (Risk Ratio): 0.86; 95% CI (Confidence Interval): 0.76, 0.96; = 0.009). When including in the analysis only studies with homogeneous comparator groups, LV unloading with Impella remained associated with significant reduction in mortality (RR: 0.85; 95% CI: 0.75, 0.97; = 0.01). Haemolysis (RR: 1.70; 95% CI: 1.35, 2.15; < 0.00001) and RRT (RR: 1.86; 95% CI: 1.07, 3.21; = 0.03) occurred at a higher rate in the ECPELLA group. There was no difference between the two groups in terms of major bleeding (RR: 1.37; 95% CI: 0.88, 2.13; = 0.16) and CVA (RR: 0.91; 95% CI: 0.61, 1.38; = 0.66). In conclusion, LV unloading with Impella during ECMO was associated with improved survival, despite increased haemolysis and need for RRT, without additional risk of major bleeding and CVA.
Topics: Extracorporeal Membrane Oxygenation; Heart Ventricles; Heart-Assist Devices; Humans; Shock, Cardiogenic; Stroke
PubMed: 34957789
DOI: 10.31083/j.rcm2204154 -
The Cochrane Database of Systematic... Nov 2021Acute limb ischaemia usually is caused by a blood clot blocking an artery or a bypass graft. Severe acute ischaemia will lead to irreversible damage to muscles and... (Review)
Review
BACKGROUND
Acute limb ischaemia usually is caused by a blood clot blocking an artery or a bypass graft. Severe acute ischaemia will lead to irreversible damage to muscles and nerves if blood flow is not restored in a few hours. Once irreversible damage occurs, amputation will be necessary and the condition can be life-threatening. Infusion of clot-busting drugs (thrombolysis) is a useful tool in the management of acute limb ischaemia. Fibrinolytic drugs are used to disperse blood clots (thrombi) to clear arterial occlusion and restore blood flow. Thrombolysis is less invasive than surgery. A variety of techniques are used to deliver fibrinolytic agents. This is an update of a review first published in 2004.
OBJECTIVES
To compare the effects of infusion techniques during peripheral arterial thrombolysis for treatment of patients with acute limb ischaemia.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 20 October 2020. We undertook reference checking to identify additional studies.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing infusion techniques for fibrinolytic agents in the treatment of acute limb ischaemia.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials using the Cochrane 'Risk of bias' tool. We evaluated certainty of evidence using GRADE. For dichotomous outcomes, we calculated the odds ratio (OR) with the corresponding 95% confidence interval (CI). We were not able to carry out meta-analyses due to clinical heterogeneity, so we have reported the results and performed the comparisons narratively. The main outcomes of interest were amputation-free survival or limb salvage, amputation, mortality, vessel patency, duration of thrombolysis, and complications such as cerebrovascular accident and major and minor bleeding.
MAIN RESULTS
Nine studies with a total of 671 participants are included in this update. Trials covered a variety of infusion techniques, dosage regimens, and adjunctive agents. We grouped trials according to types of techniques assessed (e.g. intravenous and intra-arterial delivery of the agent, 'high-' and 'low-dose' regimens of the agent, continuous infusion and 'forced infusion' of the agent, use of adjunctive antiplatelet agents). We assessed the certainty of evidence as very low to low due to the limited power of individual studies to deliver clinically relevant results, small and heterogeneous study populations, use of different inclusion criteria by each study in terms of severity and duration of ischaemia, considerably different outcome measures between trials, and use of different fibrinolytic agents. This heterogeneity prevented pooling of data in meta-analyses. No regimen has been shown to confer benefit in terms of amputation-free survival (at 30 days), amputation, or death. For vessel patency, complete success was more likely with intra-arterial (IA) than with intravenous (IV) infusion (odds ratio (OR) 13.22, 95% confidence interval (CI) 2.79 to 62.67; 1 study, 40 participants; low-certainty evidence); radiological failure may be more likely with IV infusion (OR 0.02, 95% CI 0.00 to 0.38; 1 study, 40 participants; low-certainty evidence). Due to the small numbers involved in each arm and design differences between arms, it is not possible to conclude whether any technique offered any advantage over another. None of the treatment strategies clearly affected complications such as cerebrovascular accident or major bleeding requiring surgery or blood transfusion. Minor bleeding complications were more frequent in systemic (intravenous) therapy compared to intra-arterial infusion (OR 0.03, 95% CI 0.00 to 0.56; 1 study, 40 participants), and in high-dose compared to low-dose therapy (OR 0.11, 95% CI 0.01 to 0.96; 1 study, 63 participants). Limited evidence from individual trials appears to indicate that high-dose and forced-infusion regimens reduce the duration of thrombolysis. In one trial, the median duration of infusion was 4 hours (range 0.25 to 46) for the high-dose group and 20 hours (range 2 to 46) for the low-dose group. In a second trial, treatment using pulse spray was continued for a median of 120 minutes (range 40 to 310) compared with low-dose infusion for a median of 25 hours (range 2 to 60). In a third trial, the median duration of therapy was reduced with pulse spray at 195 minutes (range 90 to 1260 minutes) compared to continuous infusion at 1390 minutes (range 300 to 2400 minutes). However, none of the studies individually showed improvement in limb salvage at 30 days nor benefit for the amputation rate related to the technique of drug delivery. Similarly, no studies reported a clear difference in occurrence of cerebrovascular accident or major bleeding. Although 'high-dose' and 'forced-infusion' techniques achieved vessel patency in less time than 'low-dose' infusion, more minor bleeding complications may be associated (OR 0.11, 95% CI 0.01 to 0.96; 1 study, 72 participants; and OR 0.48, 95% CI 0.17 to 1.32; 1 study, 121 participants, respectively). Use of adjunctive platelet glycoprotein IIb/IIIa antagonists did not improve outcomes, and results were limited by inclusion of participants with non-limb-threatening ischaemia.
AUTHORS' CONCLUSIONS
There is insufficient evidence to show that any thrombolytic regimen provides a benefit over any other in terms of amputation-free survival, amputation, or 30-day mortality. The rate of CVA or major bleeding requiring surgery or blood transfusion did not clearly differ between regimens but may occur more frequently in high dose and IV regimens. This evidence was limited and of very low certainty. Minor bleeding may be more common with high-dose and IV regimens. In this context, thrombolysis may be an acceptable therapy for patients with marginally threatened limbs (Rutherford grade IIa) compared with surgery. Caution is advised for patients who do not have limb-threatening ischaemia (Rutherford grade I) because of risks of major haemorrhage, cerebrovascular accident, and death from thrombolysis.
Topics: Amputation, Surgical; Arteries; Fibrinolytic Agents; Humans; Ischemia; Thrombolytic Therapy
PubMed: 34786692
DOI: 10.1002/14651858.CD000985.pub3 -
European Journal of Vascular and... Dec 2021Many techniques have been introduced to enable quantification of tissue perfusion in patients with peripheral arterial disease (PAD). Currently, none of these techniques...
OBJECTIVE
Many techniques have been introduced to enable quantification of tissue perfusion in patients with peripheral arterial disease (PAD). Currently, none of these techniques is widely used to analyse real time tissue perfusion changes during endovascular or surgical revascularisation procedures. The aim of this systematic review was to provide an up to date overview of the peri-procedural applicability of currently available techniques, diagnostic accuracy of assessing tissue perfusion and the relationship with clinical outcomes.
DATA SOURCES
MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials.
REVIEW METHODS
This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. Four electronic databases were searched up to 31 12 2020 for eligible articles: MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials. Eligible articles describing a perfusion measurement technique, used in a peri-procedural setting before and within 24 hours after the revascularisation procedure, with the aim of determining the effect of intervention in patients with PAD, were assessed for inclusion. The QUADAS-2 tool was used to assess the risk of bias and applicability of the studies.
RESULTS
An overview of 10 techniques found in 26 eligible articles focused on study protocols, research goals, and clinical outcomes is provided. Non-invasive techniques included laser speckle contrast imaging, micro-lightguide spectrophotometry, magnetic resonance imaging perfusion, near infrared spectroscopy, skin perfusion pressure, and plantar thermography. Invasive techniques included two dimensional perfusion angiography, contrast enhanced ultrasound, computed tomography perfusion imaging, and indocyanine green angiography. The results of the 26 eligible studies, which were mostly of poor quality according to QUADAS-2, were without exception, not sufficient to substantiate implementation in daily clinical practice.
CONCLUSION
This systematic review provides an overview of 10 tissue perfusion assessment techniques for patients with PAD. It seems too early to appoint one of them as a reference standard. The scope of future research in this domain should therefore focus on clinical accuracy, reliability, and validation of the techniques.
Topics: Diagnostic Techniques, Cardiovascular; Endovascular Procedures; Humans; Perfusion Imaging; Peripheral Arterial Disease; Predictive Value of Tests; Regional Blood Flow; Reproducibility of Results; Treatment Outcome; Vascular Surgical Procedures
PubMed: 34674935
DOI: 10.1016/j.ejvs.2021.08.017 -
Journal of Endovascular Therapy : An... Jun 2022To perform a systematic review assessing the safety and efficacy of percutaneous transluminal angioplasty (PTA) for treatment of critical hand ischemia (CHI) due to...
PURPOSE
To perform a systematic review assessing the safety and efficacy of percutaneous transluminal angioplasty (PTA) for treatment of critical hand ischemia (CHI) due to below-the-elbow (BTE) obstructive arterial disease.
MATERIALS AND METHODS
MEDLINE and EMBASE systematic searches were performed from inception to December 2020 to identify studies assessing PTA for management of BTE obstructive arterial disease. Three independent reviewers performed abstract selection, data extraction, and quality assessment. The Newcastle-Ottawa Scale was used to assess individual study bias for non-randomized controlled trials.
RESULTS
Eight studies comprising 176 patients with obstructive BTE vessel disease were included. All studies had a score >5 on the Newcastle-Ottawa Scale, indicative of high quality. All studies used low-profile balloons (1.5-4 mm) for PTA of stenotic lesions or chronic total occlusions (CTOs). The weighted average technical success and clinical success rates were 89.3% (range = 82%-100%) and 69.9% (range = 19%-100%), respectively, at a mean follow-up of 29.7 ± 17.1 months. The short-term (<30 days) complication rate was low at 4.7% and most commonly included access site hematomas, pseudoaneurysms, and radial artery perforation or re-thrombosis. Nearly 20% of patients required an amputation, and most (96%) were minor (either distal phalanges or digits). Only 2 patients required above-wrist amputations. The primary and secondary patency rate at 5 years were 38% and 54%, respectively. The cumulative 5-year mortality rate was 33.1%.
CONCLUSIONS
PTA for CHI due to BTE obstructive arterial disease is feasible with a high technical success rate and a low short-term complication rate. Additional long-term comparative studies are required to unequivocally establish the clinical benefit of endovascular treatment compared with conservative management or surgical bypass.
Topics: Humans; Amputation, Surgical; Angioplasty; Angioplasty, Balloon; Arterial Occlusive Diseases; Elbow; Ischemia; Limb Salvage; Retrospective Studies; Treatment Outcome; Vascular Patency; Controlled Clinical Trials as Topic
PubMed: 34623191
DOI: 10.1177/15266028211050309 -
The Journal of Cardiovascular Surgery Dec 2021The main goal of this systematic review was to analyze the outcomes of acute limb ischemia (ALI) in patients suffering from the novel Coronavirus: COVID-19 (SARS-CoV-2).
INTRODUCTION
The main goal of this systematic review was to analyze the outcomes of acute limb ischemia (ALI) in patients suffering from the novel Coronavirus: COVID-19 (SARS-CoV-2).
EVIDENCE ACQUISITION
A systematic review on Medline and Embase was conducted up to May 15, 2021. All papers were sorted by abstract and full text by two independent authors. Systematic reviews, commentaries, and studies that did not distinguish status of COVID-19 infection were excluded from review. Patient demographics were recorded along with modality of treatment (endovascular and/or surgical). We analyzed 30-day outcomes, including mortality. Primary outcome was to evaluate clinical characteristic of ALI in patients affected by SARS-CoV-2 in term of location of ischemia, treatment options and 30-day outcomes.
EVINDENCE SYNTHESIS
We selected 36 articles with a total of 194 patients. Most patients were male (80%) with a median age of 60 years old. The treatment most used was thromboembolectomy (31% of all surgical interventions). A total of 32 patients (19%) were not submitted to revascularization due to critical status. The rate of technical success was low (68%), and mortality rate was high (35%).
CONCLUSIONS
This review confirms that SARS-CoV-2 is associated with a high risk of ALI. Further studies are needed to investigate the association and elucidate potential mechanisms, which may include a hypercoagulable state and hyperactivation of the immune response. Furthermore, management of ALI is not standardized and depends on patient condition and extension of the thrombosed segment. ALI in COVID-19 patients is associated with high risk of failure of revascularization and perioperative mortality.
Topics: Acute Disease; Anticoagulants; Blood Coagulation; COVID-19; Female; Humans; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Postoperative Complications; Risk Assessment; Risk Factors; Thrombophilia; Treatment Outcome; Vascular Surgical Procedures
PubMed: 34581552
DOI: 10.23736/S0021-9509.21.12017-8 -
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 -
European Journal of Vascular and... Jan 2022There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised... (Meta-Analysis)
Meta-Analysis
Editor's Choice - Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
OBJECTIVE
There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD).
METHOD
This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed.
RESULTS
In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies.
CONCLUSION
There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.
Topics: Humans; Amputation, Surgical; Angioplasty, Balloon; Femoral Artery; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 34326002
DOI: 10.1016/j.ejvs.2021.05.027 -
The British Journal of Radiology Aug 2021With the increasing recognition of gastrointestinal (GI) manifestation of coronavirus disease-19 (COVID-19), various abdominal imaging findings are increasingly being...
OBJECTIVES
With the increasing recognition of gastrointestinal (GI) manifestation of coronavirus disease-19 (COVID-19), various abdominal imaging findings are increasingly being noted. We scoped the existing literature on the abdominal imaging findings in COVID-19.
METHODS
A systematic literature search was performed on PubMed, Embase, Google scholar and World Health Organization COVID-19 database.
RESULTS
35 studies were included in the final descriptive synthesis. Among the studies reporting positive abdominal imaging findings in patients with COVID-19, majority described imaging abnormalities of the GI tract (16 studies), of which bowel wall thickening was most frequently reported. Other findings noted were abdominal imaging manifestations of bowel ischemia with thrombosis of the splanchnic vasculature, and imaging features suggestive of pancreatitis. Imaging findings suggestive of solid organ infarction were reported in nine studies. An association between imaging evidence of hepatic steatosis and COVID-19 was noted in three studies. Incidental lung base findings on abdominal imaging were noted in 18 studies, where patients presented with predominant GI symptoms. The most common finding was bilateral ground glass opacities (90.7%) with predominant multilobar (91.1%) and peripheral (64.4%) distribution.
CONCLUSION
This systematic review provides insight into the abdominal imaging findings in patients with COVID-19. Knowledge of these imaging manifestations will not only help in further research but also will aid in curtailing transmission of the SARS-CoV-2. Further prospective studies are needed to gain better insight into the pathophysiology of these imaging manifestations.
ADVANCES IN KNOWLEDGE
This review highlights the abdominal imaging findings in patients with COVID-19, to gain insight into the disease pathophysiology and gear the abdominal radiologist through the pandemic.
Topics: Abdomen; COVID-19; Gastrointestinal Diseases; Humans
PubMed: 34260323
DOI: 10.1259/bjr.20201220