RESUMEN
OBJECTIVE: Complex abdominal aortic aneurysms (cAAA) pose a clinical challenge. The aim of this study was to assess the 30 day mortality and morbidity rates for open aneurysm repair (OAR) and fenestrated or branched endovascular aortic repair (F/B-EVAR), and the effect of hospital volume in patients with asymptomatic cAAA in Switzerland. METHODS: Retrospective, cohort study using data from Switzerland's national registry for vascular surgery, Swissvasc, including patients treated from 1 January 2019 to 31 December 2022. All patients with asymptomatic, true, non-infected cAAA were identified. The primary outcome was 30 day mortality and morbidity rates reported using the Clavien-Dindo classification. Outcomes were compared between OAR and F/B-EVAR after propensity score weighting. RESULTS: Of the 461 patients identified, 333 underwent OAR and 128 underwent F/B-EVAR for cAAA. At 30 days, the overall mortality rate was 3.3% after OAR and 3.1% after F/B-EVAR (p = .76). Propensity score weighted analysis indicated similar morbidity rates for both approaches: F/B-EVAR (OR 0.69, 95% CI 0.45 - 1.05, p = .055); intestinal ischaemia (1.8% after OAR, 3.1% after F/B-EVAR, p = .47) and renal failure requiring dialysis (1.5% after OAR, 5.5% after F/B-EVAR, p = .024) were associated with highest morbidity and mortality rates. Treatment specific complications with high morbidity were abdominal compartment syndrome and lower limb compartment syndrome following F/B-EVAR. Overall treatment volume was low for most of the hospitals treating cAAA in Switzerland; outliers with increased mortality rates were identified among low volume hospitals. CONCLUSION: Comparable 30 day mortality and morbidity rates were found between OAR and F/B-EVAR for cAAA in Switzerland; lack of centralisation was also highlighted. Organ specific complications driving death were renal failure, intestinal ischaemia, and limb ischaemia, specifically after F/B-EVAR. Treatment in specialised high volume centres, alongside efforts to reduce peri-procedural kidney injury and mesenteric ischaemia, offers potential to lower morbidity and mortality rates in elective cAAA treatment.
RESUMEN
OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.
RESUMEN
OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.
RESUMEN
BACKGROUND: Reliable prediction of the preoperative risk is of crucial importance for patients undergoing aortic repair. In this retrospective cohort study, we evaluated the metabolic equivalent of task (MET) in the preoperative risk assessment with clinical outcome in a cohort of consecutive patients. METHODS: Retrospective analysis of prospectively collected data in a single center unit of 296 patients undergoing open or endovascular aortic repair from 2009 to 2016. The patients were divided into four anatomic main groups (infrarenal (endo: n = 94; open: n = 88), juxta- and para-renal (open n = 84), thoraco-abdominal (open n = 13) and thoracic (endo: n = 11; open: n = 6). Out of these, 276 patients had a preoperative statement of their functional capacity in metabolic units and were evaluated concerning their postoperative outcome including survival, in-hospital mortality, postoperative complications, myocardial infarction and stroke, and the need of later cardiovascular interventions. RESULTS: The median follow-up of the cohort was 10.8 months. Patients with < 4MET had a higher incidence of diabetes mellitus (p = 0.0002), peripheral arterial disease (p < 0.0001), history of smoking (p = 0.003), obesity (p = 0.03) and chronic obstructive pulmonary disease (p = 0.05). Overall in-hospital mortality was 4.4% (13 patients). There was no significant difference in the survival between patients with a functional capacity of more than 4 MET (220 patients, mean survival: 74.5 months) and patients with less than 4 MET (56 patients, mean survival: 65.4 months) (p = 0.64). The mean survival of the infrarenal cohort (n = 169) was 74.3 months with no significant differences between both MET groups (> 4 MET: 131 patients, mean survival 75.5 months; < 4 MET: 38 patients, mean survival 63.6 months. p = 0.35). The subgroup after open surgical technique with less than 4 MET had the lowest mean survival of 38.8 months. In 46 patients with > 4MET (20.9%) perioperative complications occurred compared to the group with < 4MET with 18 patients (32.1%) (p = 0.075). There were no significant differences in both groups in the late cardiovascular interventions (p = 0.91) and major events including stroke and myocardial infarction (p = 0.4) monitored during the follow up period. The risk to miss a potential need for cardiac optimization in patients > 4MET was 7%. CONCLUSION: The functional preoperative evaluation by MET in patients undergoing aortic surgery is a useful surrogate marker of perioperative performance but cannot be seen as a substitute for preoperative cardiopulmonary testing in selected individuals. Trial registration clinicaltrials.gov, registration number NCT03617601 (retrospectively registered).
Asunto(s)
Aorta , Equivalente Metabólico , Cuidados Preoperatorios , Aorta/cirugía , Humanos , Estudios Retrospectivos , Medición de Riesgo/métodosRESUMEN
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
Asunto(s)
Cardiología/normas , Medicina Basada en la Evidencia/normas , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Técnicas de Imagen Cardíaca/normas , Enfermedad Crónica , Consenso , Pruebas de Función Cardíaca/normas , Humanos , Isquemia/diagnóstico , Isquemia/mortalidad , Isquemia/fisiopatología , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Valor Predictivo de las Pruebas , Factores de Riesgo , Terminología como Asunto , Resultado del TratamientoRESUMEN
GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.