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BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.
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Angioplastia Coronária com Balão , Ocimum basilicum , Doença Arterial Periférica , Masculino , Humanos , Feminino , Idoso , Isquemia Crônica Crítica de Membro , Isquemia/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/cirurgia , Fatores de Risco , Perfusão , Dor , Resultado do TratamentoRESUMO
OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality. METHODS: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac. RESULTS: In 151/168 deaths (89.9%) the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16/77 deaths (21%) were classified as probably cardiac compared with 32/91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64/344 (18.6%), 37/344 (10.8%), and 40/342 (9%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI. CONCLUSION: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.
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AIM: There is currently an increased focus on competency-based training, in which training and assessment play a crucial role. The aim of this systematic review is to create an overview of hands-on training methods and assessment tools for appendicectomy and colon and rectal surgery procedures using either an open, laparoscopic or robot-assisted approach. METHOD: A systematic review of Medline, Embase, Cochrane and Scopus databases was conducted following the PRISMA guidelines. We conducted the last search on 9 March 2023. All published papers describing hands-on training, evaluation of performance data and development of assessment tools were eligible. The quality of studies and the validity evidence of assessment tools are reported. RESULTS: Fifty-one studies were identified. Laparoscopic assessment tools are abundant, but the literature still lacks good-quality assessment tools for open appendicectomy, robotic colectomy and open rectal surgery. Overall, there is a lack of discussion regarding the establishment of pass/fail standards and the consequences of assessment. Virtual reality simulation is used more for appendicectomy than colorectal procedures. Only a few of the studies investigating training were of acceptable quality. There is a need for high-quality studies in open and robotic-assisted colon surgery and all approaches to rectal surgery. CONCLUSION: This review provides an overview of current training methods and assessment tools and identifies where more research is needed based on the quality of the studies and the current validity evidence.
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Apendicectomia , Competência Clínica , Cirurgia Colorretal , Laparoscopia , Humanos , Apendicectomia/métodos , Apendicectomia/educação , Cirurgia Colorretal/educação , Laparoscopia/educação , Laparoscopia/métodos , Procedimentos Cirúrgicos Robóticos/educação , Procedimentos Cirúrgicos Robóticos/métodos , Colectomia/métodos , Colectomia/educação , Colectomia/normasRESUMO
BACKGROUND: Simulation-based training is increasingly used to acquire basic laparoscopic skills. Multiple factors can influence training, e.g., distributed practice is superior to massed practice in terms of efficiency. However, the optimal interval between training sessions is unclear. The objective of this trial was to investigate if shorter intervals between sessions are more efficient than longer intervals during proficiency-based laparoscopy simulator training. METHODS: A randomized simulation-based trial where medical students (n = 39) were randomized to proficiency-based training with either 1-2 days (intervention group) or 6-8 days (control group) between training sessions. Both groups practiced a series of basic tasks and a procedural module until proficiency level on the LapSim® simulator. Both groups were given instructor feedback upon request. After reaching proficiency, participants were invited back for a retention test 3-5 weeks later and practiced the same tasks to proficiency again. RESULTS: The mean time to reach proficiency during training was 291 (SD 89) and 299 (SD 89) min in the intervention and control group, respectively (p = 0.81). During the retention test, the mean time to reach proficiency was 94 (SD 53) and 96 (SD 39) minutes in the intervention and control groups, respectively (p = 0.91). CONCLUSION: We found no difference whether practicing with shorter intervals or longer intervals between training sessions when examining time to proficiency or retention.
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Laparoscopia , Treinamento por Simulação , Humanos , Competência Clínica , Retroalimentação , Laparoscopia/educação , Simulação por ComputadorRESUMO
BACKGROUND: Preventing lower-extremity amputations (LEAs) is pivotal. In the present study, we aimed to examine the recent trends in nontraumatic LEAs seen in the Northern Danish Region. METHODS: Using data from the regional Business Intelligence unit, we identified all nontraumatic LEAs (n = 689) performed in people above 50 years of age in the Northern Danish Region between January 2016 and December 2021 (approximately 600,000 inhabitants). Persons with diabetes (n = 26,025) were identified based on International Classification of Diseases-10 codes and data from the National Health Insurance Service Registry, while preventive vascular procedures (n = 1,097) were identified using surgical codes. Major LEA was defined as any amputation above the ankle. Incidence rates were expressed as events per 1,000 person-years. Trends were described as differences between the periods 2016-2018 and 2019-2021. RESULTS: A total of 249 (36%) major LEAs were performed in people with diabetes. People with diabetes were younger (71 vs 77 years, P < 0.001) and more frequently male (70% versus 54%, P < 0.001). Between 2016-2018 and 2019-2021, the incidence of major LEA declined from 1.76 (95% CI: 1.75-1.76) to 1.39 (1.39-1.39) in people with diabetes and from 0.47 (0.47-0.47) to 0.20 (0.20-0.20) in people without diabetes (all P < 0.001). Simultaneously, the incidence of preventive vascular surgery increased from 2.26 (2.26-2.26) to 3.48 (3.48-3.48) in people with diabetes and declined slightly in people without 0.49 (0.49-0.49) to 0.47 (0.47-0.47) (all P < 0.001). CONCLUSIONS: Despite significant declines in major LEA in both people with and without diabetes, most of the decline was driven by a large reduction in major LEAs in people without diabetes.
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OBJECTIVE: General anesthesia (GA) may impair outcome after vascular surgery. The use of anticoagulant medication is often used in patients with cardiac comorbidity. Regional anesthesia (RA) requires planning of discontinuation before neuraxial blockade(s) in this subgroup. This study aimed to describe the effect of anesthesia choice on outcome after vascular surgery in patients with known cardiac comorbidity. DESIGN: Retrospective cohort study. SETTING: Danish hospitals. PARTICIPANTS: 6302 patients with known cardiac comorbidity, defined as ischemic heart disease, valve disease, pulmonary vascular disease, heart failure, and cardiac arrhythmias, undergoing lower extremity vascular surgery between 2005 and 2017. INTERVENTIONS: GA versus RA. MEASUREMENTS AND MAIN RESULTS: Data were extracted from national registries. GA was defined as anesthesia with mechanical ventilation. Multivariable regression models were used to describe the incidence of postoperative complications as well as 30-day mortality, hypothesizing that better outcomes would be seen after RA. The rate of RA decreased from 48% in 2005 to 20% in 2017. The number of patients with 1 or more complications was 9.7% vs 6.2% (p < 0.001), and 30-day mortality was 6.0% vs 3.4% (p < 0.001) after GA. After adjusting for baseline differences, the odds ratio (OR) was significantly lower for medical complications (cardiac, pulmonary, renal, new dialysis, intensive care unit and other medical complications; OR, 0.97; 95% confidence interval [CI], 0.95-0.98) and 30-day mortality (OR 0.98; 95% CI, 0.97-0.99) after RA. CONCLUSIONS: RA may be associated with a better outcome than GA after lower extremity vascular surgery in patients with a cardiac comorbidity. Prioritizing RA, despite the inconvenience of discontinuing anticoagulants, may be recommended.
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Anestesia Geral , Comorbidade , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Vasculares , Humanos , Feminino , Masculino , Dinamarca/epidemiologia , Idoso , Anestesia Geral/efeitos adversos , Anestesia Geral/tendências , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/métodos , Pessoa de Meia-Idade , Cardiopatias/epidemiologia , Cardiopatias/cirurgia , Cardiopatias/complicações , Estudos de Coortes , Sistema de Registros , Resultado do Tratamento , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Robotic-assisted complete mesocolic excision is an advanced procedure mainly because of the great variability in anatomy. Phantoms can be used for simulation-based training and assessment of competency when learning new surgical procedures. However, no phantoms for robotic complete mesocolic excision have previously been described. This study aimed to develop an anatomically true-to-life phantom, which can be used for training with a robotic system situated in the clinical setting and can be used for the assessment of surgical competency. METHODS: Established pathology and surgical assessment tools for complete mesocolic excision and specimens were used for the phantom development. Each assessment item was translated into an engineering development task and evaluated for relevance. Anatomical realism was obtained by extracting relevant organs from preoperative patient scans and 3D printing casting moulds for each organ. Each element of the phantom was evaluated by two experienced complete mesocolic excision surgeons without influencing each other's answers and their feedback was used in an iterative process of prototype development and testing. RESULTS: It was possible to integrate 35 out of 48 procedure-specific items from the surgical assessment tool and all elements from the pathological evaluation tool. By adding fluorophores to the mesocolic tissue, we developed an easy way to assess the integrity of the mesocolon using ultraviolet light. The phantom was built using silicone, is easy to store, and can be used in robotic systems designated for patient procedures as it does not contain animal-derived parts. CONCLUSIONS: The newly developed phantom could be used for training and competency assessment for robotic-assisted complete mesocolic excision surgery in a simulated setting.
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Neoplasias do Colo , Laparoscopia , Mesocolo , Procedimentos Cirúrgicos Robóticos , Humanos , Mesocolo/diagnóstico por imagem , Mesocolo/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Neoplasias do Colo/cirurgia , Colectomia/métodos , Excisão de Linfonodo/métodos , Diagnóstico por Imagem , Impressão Tridimensional , Laparoscopia/métodosRESUMO
BACKGROUND: Robotic-assisted surgery is increasing and there is a need for a structured and evidence-based curriculum to learn basic robotic competencies. Relevant training tasks, eligible trainees, realistic learning goals, and suitable training methods must be identified. We sought to develop a common curriculum that can ensure basic competencies across specialties. METHODS: Two robotic surgeons from all departments in Denmark conducting robotic-assisted surgery within gynecology, urology, and gastrointestinal surgery, were invited to participate in a three-round Delphi study to identify learning goals and rank them according to relevance for a basic curriculum. An additional survey was conducted after the Delphi rounds on what training methods were considered best for each learning goal and who (console surgeon/patient-side assistant) should master each learning goal. RESULTS: Fifty-six robotic surgeons participated and the response rates were 86%, 89%, and 77%, for rounds 1, 2 and 3, respectively. The Delphi study identified 40 potential learning goals, of which 29 were ranked as essential, e.g., Understand the link between arm placement and freedom of movement or Be able to perform emergency un-docking. In the additional survey, the response rate was 70%. Twenty-two (55%) of the identified learning goals were found relevant for the patient-side assistant and twenty-four (60%) were linked to a specific suitable learning method with > 75% agreement. CONCLUSIONS: Our findings can help training centers plan their training programs concerning educational content and methods for training/learning. Furthermore, patient-side assistants should also receive basic skills training in robotic surgery.
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Procedimentos Cirúrgicos Robóticos , Robótica , Cirurgiões , Competência Clínica , Currículo , Técnica Delphi , Humanos , Procedimentos Cirúrgicos Robóticos/educaçãoRESUMO
OBJECTIVE: Cardiopulmonary comorbidity is common in vascular surgery. General anaesthesia (GA) may impair perfusion and induce respiratory depression. Regional anaesthesia (RA), including neuraxial or peripheral nerve blocks, may therefore be associated with a better outcome. METHODS: This was a nationwide retrospective cohort study. All open inguinal and infra-inguinal arterial surgical reconstructions from 2005 to 2017 were included. Data were extracted from national registries. Multivariable linear and logistic regression models and propensity score matching were used. The propensity score was derived by developing a model that predicted the probability that a given patient would receive GA based on age, comorbidity, anticoagulant medication, procedure type, and the urgency of surgery. Matching was performed in four groups based on American Society of Anesthesiologists' score I - II, score III - V, and gender. Outcome parameters included surgical and general complications (bleeding, thrombosis/embolus, cardiac, pulmonary, renal, cerebral, and >3 days intensive care therapy), length of stay, and 30 day mortality, hypothesising a better outcome after RA. RESULTS: There were 10 509 procedures in the GA group and 6 850 in the RA group. After propensity score matching, 6 267 procedures were included in each group. Surgical and general complications were significantly more common after GA in both matched (3.8 vs. 2.5%, p < .001 and 6.5 vs. 4.2%, p < .001) and unmatched analyses (3.8 vs. 2.5%, p < .001 and 6.5 vs. 4.2%, p < .001). The 30 day mortality rate was significantly higher after GA, in matched and un matched analyses (3.1 vs. 2.4%, p = .019 and 4.1 vs. 2.4%, p < .001). There was no difference in length of stay. CONCLUSION: RA may be associated with a better outcome, compared with GA, after open inguinal and infra-inguinal peripheral vascular surgery. In the clinical context when RA is not feasible, GA can still be considered safe.
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Anestesia por Condução , Anestesia Geral , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Dinamarca , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Resultado do TratamentoRESUMO
OBJECTIVE: The risk of ipsilateral neurological recurrence (NR) was assessed in patients awaiting carotid endarterectomy (CEA) due to symptomatic carotid artery stenosis and whether current national guidelines of performing CEA within 14 days are adequate in present day practice. METHODS: This was a retrospective multicentre observational cohort study. Patients scheduled for CEA due to symptomatic carotid artery stenosis in a five year period, 1 January 2014 to 31 December 2018, from four centres were included. Data from the Danish Vascular Registry (www.karbase.dk), operative managing systems, and electronic medical records were reviewed. RESULTS: In total, 1 125 patients scheduled for CEA were included and 1 095 (97%) underwent the planned surgery. During a median delay from index event to CEA of 11 days (interquartile range 8-16 days), 40 patients (3.6%; 95% confidence interval [CI] 2.5%-5%) experienced a NR. One third were minor strokes (n = 12, 30%); half were transient ischaemic attacks (TIA) (n = 22, 55%); and amaurosis fugax accounted for 15% (n = 6). Twenty-six (2%) CEA procedures was cancelled, of which one was due to a disabling recurrent ischaemic event (aphasia). There were no deaths or major strokes in the waiting time for CEA. Best medical treatment (BMT) with platelet inhibitory or anticoagulation drugs and a statin was initiated in nearly all patients (98%) at first assessment. The overall 30 day risk of a post-operative major event (death or stroke) was (Kaplan-Meier [KM] estimate) 2.7% (95% CI 1.8-3.8), and not significantly correlated with the timing of surgery. Most (69%) occurred within the first three days. One, two, and three year mortality rate for CEA patients was (KM estimate) 4.8%, 7.8%, and 11.5% respectively. CONCLUSION: In symptomatic carotid artery stenosis patients awaiting CEA, very few NRs occurred within 14 days. Institution of immediate BMT in specialised TIA/stroke units followed by early, but not necessarily urgent, CEA is a reasonable course of action in patients with high grade symptomatic carotid artery stenosis.
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Estenose das Carótidas/complicações , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Tempo para o Tratamento , Idoso , Idoso de 80 Anos ou mais , Amaurose Fugaz/tratamento farmacológico , Amaurose Fugaz/etiologia , Anticoagulantes/uso terapêutico , Dinamarca , Quimioterapia Combinada , Endarterectomia das Carótidas/mortalidade , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Ataque Isquêmico Transitório/etiologia , AVC Isquêmico/etiologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêutico , Complicações Pós-Operatórias/etiologia , Recidiva , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Taxa de SobrevidaRESUMO
BACKGROUND: The utilisation of laparoscopic fundoplication peaked internationally around 2000. Perioperative morbidity, mortality, and length of stay initially declined as the use of laparoscopic technique increased. Studies indicate that complication rates have increased over time, probably as a consequence of rising age and level of comorbidity. None of these previous studies is nationwide. Therefore, this study aimed to investigate trends in the utilisation of anti-reflux surgery in the entire Danish population from 2000 to 2017. METHODS: Nationwide Danish health registries were utilised to include all Danish patients undergoing anti-reflux surgery 2000-2017. The utilisation of anti-reflux surgery in procedures per 100.000 inhabitants was compared to the utilisation of proton-pump inhibitors for each year. Postoperative complications, mortality, and length of stay per year, including yearly changes, were also calculated. RESULTS: The use of anti-reflux surgery peaked in 2001 with 5.9 procedures per 100,000 inhabitants and reached its lowest point in 2008 with 2.8 procedures per 100,000 inhabitants. The use of proton-pump inhibitors increased from 3,370 users per 100,000 inhabitants in 2000 to 10,284 users per 100,000 inhabitants in 2017. The 30-day and 90-day mortality ranged from 0 to 1.2%. The 30-day hospital-registered complications were 1.3-6.1%, and the 90-day hospital-registered complications were 2.4-8.3%. Length of stay was consistently low, with a median of 2 days in 2000 reduced to a median of 1 day by 2017. CONCLUSION: The utilisation of anti-reflux surgery in Denmark from 2000 to 2017 declined, and the use of PPI increased dramatically. Age, comorbidity, and postoperative complications increased, while the use of laparoscopic technique remained high, and mortality was consistently low.
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Refluxo Gastroesofágico , Laparoscopia , Estudos de Coortes , Dinamarca/epidemiologia , Fundoplicatura , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/cirurgia , Humanos , Sistema de RegistrosRESUMO
This article summarizes surgical procedures for preservation of the foot in diabetic patients with peripheral artery disease. Distal bypass surgery performed to perigeniculate arteries and to an isolated 'blind' popliteal segment with visible collaterals can be performed with limb salvage rates close to what can be achieved with standard bypass to crural arteries. This is also the case when performing bypass to the dorsalis pedis artery. Bypass to the medial or lateral plantar artery or to the lateral tarsal artery is associated with a relatively high rate of early occlusion, but in the patients who have persistently open grafts, limb salvage is common. The use of an arteriovenous fistula as an adjunct to distal bypass surgery does not improve prognosis. Venous arterialization, either creating retrograde perfusion of the superficial or of the deep veins of the foot has been successful in several cases although it is difficult to predict which patients will benefit. Reconstructive surgery is often performed in a multidisciplinary team including plastic surgeons. In patients with need of more extensive cover of defects, the transplant of muscular or fasciocutaneous free flaps has provided good results in the few centres that have applied this technique. This procedure can be combined with a revascularization in the same session or at a later stage. A majority of the described techniques can be implemented in most vascular centres and they should be considered in complicated cases when standard methods of revascularization and reconstruction do not suffice.
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Diabetes Mellitus/fisiopatologia , Pé Diabético/cirurgia , Procedimentos Endovasculares/métodos , Pé/irrigação sanguínea , Pé/cirurgia , Doença Arterial Periférica/complicações , Procedimentos de Cirurgia Plástica/métodos , Pé Diabético/etiologia , HumanosRESUMO
BACKGROUND: Microdialysis is a clinical method used to detect ischemia after microvascular surgery. Microdialysis is easy to use and reliable, but its value in most clinical settings is hampered by a 1- to 2-h delay in the delivery of patient data. This study evaluated the effectiveness of an increase in the microdialysis perfusion rate from 0.3 to 1.0 µL/min on the diagnostic delay in the detection of ischemia. METHODS: In eight pigs, two symmetric pure muscle transfers were dissected based on one vascular pedicle each. In each muscle, two microdialysis catheters were placed. The two microdialysis catheters were randomized to a perfusion rate of 0.3 or 1.0 µL/min, and the two muscle transfers were randomized to arterial or venous ischemia, respectively. After baseline monitoring, arterial and venous ischemia was introduced by the application of vessel clamps. Microdialysis sampling was performed throughout the experiment. The ischemic cutoff values were based on clinical experience set as follows: CGlucose < 0.2 mmol/L, CLactate > 7 mmol/L, and the lactate/pyruvate ratio > 50. RESULTS: The delay for the detection of 50% of arterial ischemia was reduced from 60 to 25 minutes, and for the detection of all cases of arterial ischemia, the delay was reduced from 75 to 40 minutes when the perfusion rate was increased from 0.3 to 1.0 µL/min. After the same increase in perfusion, the detection of 50% of venous ischemia was reduced from 75 to 40 minutes, and for all cases of venous ischemia, a reduction from 135 to 95 minutes was found. CONCLUSION: When using microdialysis for the detection of ischemia in pure muscle transfers, an increase in the perfusion rate from 0.3 to 1.0 µL/min can reduce the detection delay of ischemia.
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Isquemia/diagnóstico , Microdiálise/métodos , Músculos/irrigação sanguínea , Músculos/transplante , Retalhos Cirúrgicos/irrigação sanguínea , Retalhos Cirúrgicos/transplante , Animais , Biomarcadores/sangue , Modelos Animais de Doenças , Distribuição Aleatória , SuínosRESUMO
OBJECTIVE: The aim of this nationwide study was to provide insight into the incidence and geographical distribution of vascular services and major amputations in patients with peripheral arterial disease (PAD) in Denmark. METHODS: The incidence of major amputation caused by PAD was investigated by linking data from population based healthcare and administrative databases. The study period was divided into three parts, i.e. 1997-2002, 2003-2008, and 2009-2014. Amputation rates and revascularisation rates per 100 000 inhabitants ≥ 50 years of age were calculated and the association was displayed using scatter plots. The association between amputation rates and revascularisation rates was explored using a mixed effect model. Multivariable logistic regression was used to identify risk factors for having amputation without prior revascularisation relative to having amputation with prior revascularisation. RESULTS: During 1997-2014, 13 075 first time major amputations were performed. The proportions of patients with diabetes as well as atherosclerotic comorbidity increased through the decades. The incidence rate decreased from 41.67 per 100 000 citizens ≥ 50 years of age in 1997-2002, to 32.53 in 2009-2014 (r = -0.88, p < .001), but with municipal differences. In parallel, revascularisations increased from 166.63 per 100 000 citizens ≥ 50 years of age in 1997-2002, to 239.05 in 2009-2014 (r = 0.83, p < .001). The percentage of patients evaluated by a vascular surgeon within a year prior to amputation increased from 23.7% to 31.3% (p < .001), while no increase in the proportion having revascularisation within a year prior to amputation was seen. Multivariable logistic regression analysis showed that diabetes mellitus (OR 1.28; CI 1.17-1.40), stroke (OR 1.66; CI 1.52-1.81), coronary heart disease (OR 1.25; CI 1.14-1.37), and renal disease (OR 1.31; CI 1.15-1.48) were associated with a higher risk of undergoing amputation without prior revascularisation. CONCLUSIONS: The incidence of major amputations decreased, while general cardiovascular prevention and revascularisation rates increased. Despite that, few patients had revascularisation prior to amputation, leaving room for improvements.
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Amputação Cirúrgica/estatística & dados numéricos , Aterosclerose/epidemiologia , Diabetes Mellitus/epidemiologia , Doença Arterial Periférica , Procedimentos Cirúrgicos Vasculares , Idoso , Comorbidade , Dinamarca/epidemiologia , Procedimentos Endovasculares/estatística & dados numéricos , Feminino , Humanos , Incidência , Extremidade Inferior/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/cirurgia , Melhoria de Qualidade , Fatores de Risco , Procedimentos Cirúrgicos Vasculares/métodos , Procedimentos Cirúrgicos Vasculares/estatística & dados numéricosRESUMO
OBJECTIVE: Contemporary information on major amputations after revascularisation in Denmark is sparse. This population based national study aimed to determine outcomes following revascularisation for PAD and to identify predictors of major amputation after revascularisation, including geographical variation. METHODS: Data on patients with PAD undergoing revascularisation (endovascular, open, and hybrid procedures) from 2002 to 2014 were obtained from the Danish Vascular Registry and linked with information from population based healthcare and administrative databases. Cox proportional hazards regression was used to assess the relationship between major amputation and the various associated factors. RESULTS: In all 25,982 first time vascular reconstructions for PAD were performed between 2002 and 2014 and major amputations were performed in 2883 (11.1%) of the patients. The total number of revascularisations increased up to 2010 and thereafter numbers decreased slightly. A trend towards endovascular revascularisation as first time revascularisation was seen (36.6% in 2002 vs. 59.0% in 2014, p < .001). Median time from first revascularisation to major amputation was 4.66 months (range 0.03-146.88 months), and 63.1% of major amputations were performed within one year following revascularisation. No change in the number of amputations performed within one year after revascularisation was found during the study (p = .251). The strongest predictor for major amputations was ulcers/gangrene (HR 8.06, CI 7.11-9.13, p < .001) at the time of revascularisation. Geographic variation for intensity of revascularisation was observed and geographic differences in amputation free survival for patients with intermittent claudication and ulcers/gangrene were found. CONCLUSION: Although more patients with PAD undergo revascularisation, one in 10 still ends up with a major amputation of the lower limb. The risk of amputation was highly associated with the severity of the vascular disease at the time of revascularisation, with ulcers/gangrene as the strongest predictor. Geographic differences in vascular treatment intensity were found, but these failed to explain the differences in risk of major amputation after revascularisation across catchment areas.
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Amputação Cirúrgica/tendências , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgia , Doença Arterial Periférica/cirurgia , Idoso , Idoso de 80 Anos ou mais , Área Programática de Saúde , Dinamarca , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Complicações Pós-Operatórias/cirurgia , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/tendênciasRESUMO
Objective: The aim of this study was to describe short-term treatment of gastroesophageal reflux disease (GERD) in patients registered with a GERD-diagnosis as part of evaluation with endoscopy using national Danish registers. Methods: The study population included all adults undergoing upper gastrointestinal endoscopy in Denmark from 1 January 2000 to 31 December 2015, who within 90 days received a diagnosis of GERD. We obtained nationwide data from The National Patient Registry on procedures (endoscopy and anti-reflux surgery) and diagnosis (GERD diagnosis and comorbidity), The Danish National Prescription Registry on the use of anti-reflux medication and ulcerogenic drugs, and The National Civil Registry on death and civil status. The primary outcome was a type of treatment of GERD within two years of primary endoscopy defined as either no treatment, medical treatment alone, surgical treatment alone or both medical and surgical treatment. Results: A total of 36,292 patients were included in the study. Endoscopies were performed without biopsies in 67.5% (n = 24,479) of cases. The majority (66.3%, n = 24,077) was registered as GERD with esophagitis. After initial endoscopy, 10.6% (n = 3862) received no pharmacological or surgical treatment for GERD within two years of follow-up, 87.5% (n = 31,761) received only pharmacological treatment, 0.1% (n = 50) received only surgical treatment and 1.7% (n = 619) received a combination of pharmacological and surgical treatment. Conclusion: Patients referred to investigation with endoscopy and diagnosed with GERD in Denmark are primarily treated with pharmacological anti-reflux treatment within the first two years with PPI being the primary agent. Only a small fraction of patients is treated surgically.
Assuntos
Esofagite/epidemiologia , Refluxo Gastroesofágico/epidemiologia , Refluxo Gastroesofágico/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Dinamarca/epidemiologia , Endoscopia do Sistema Digestório , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/uso terapêutico , Sistema de Registros , Procedimentos Cirúrgicos Operatórios , Adulto JovemRESUMO
BACKGROUND: The risk of peripheral artery disease (PAD) in patients with diabetes mellitus (DM) and coronary artery disease (CAD) is an important and inadequately addressed issue. Our aim is to examine the impact of DM on risk of PAD in patients with different degrees of CAD characterized by coronary angiography (CAG). METHODS: Using nationwide registers we identified all patients aged ≥18 years, undergoing first time CAG between 2000 and 2012. Patients were categorized into DM/Non-DM group, and further classified into categories according to the degree of CAD i.e., no-vessel disease, single-vessel disease, double-vessel disease, triple-vessel disease, and diffuse disease. Risk of PAD was estimated by 5-year cumulative-incidence and adjusted multivariable Cox-regression models. RESULTS: We identified 116,491 patients undergoing first-time CAG. Among these, a total of 23.969 (20.58%) had DM. Cumulative-incidence of PAD among DM patients vs. non-DM were 8.8% vs. 4.9% for no-vessel disease, 8.2% vs. 4.8% for single-vessel disease, 10.2% vs. 6.0% for double-vessel disease, 13.0% vs. 8.4% for triple-vessel disease, and 6.8% vs. 6.1% for diffuse disease, respectively. For all patients with DM, the cox-regression analysis yielded significantly higher hazards of PAD compared with non-DM patients with HR 1.70 (no-vessel disease), 1.96 (single-vessel disease), 2.35 (double-vessel disease), 2.87 (triple-vessel disease), and 1.46 (diffuse disease), respectively (interaction-p 0.042). CONCLUSION: DM appears to be associated with increased risk of PAD in patients with and without established CAD, with increasing risk in more extensive CAD. This observation indicates awareness on PAD risk in patients with DM, especially among patients with advanced CAD.
Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Diabetes Mellitus/epidemiologia , Doença Arterial Periférica/epidemiologia , Idoso , Doença da Artéria Coronariana/epidemiologia , Dinamarca/epidemiologia , Diabetes Mellitus/diagnóstico , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Valor Preditivo dos Testes , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de TempoRESUMO
Objective. International guidelines recommend rehabilitation including supervised exercise therapy in patients with Intermittent Claudication (IC), but knowledge of the implementation in clinical practice is limited. This study aims to investigate current practice and opinions on rehabilitation for patients with IC among vascular surgeons and rehabilitation departments in the municipalities and hospitals. Design. Three electronic cross-sectional surveys were distributed nationally to the Danish vascular surgeons (n = 131) and to rehabilitation departments in the municipalities (n = 92) and hospitals (n = 33). Results. The response rates were 70% among the vascular surgeons, 98% among the municipalities and 94% among the hospitals. Vascular surgeons utilize oral advice to exercise by self-administered walking, pharmacological treatment, and revascularization to improve walking distance in patients with IC. Currently, only 12% of the vascular surgeons referred to rehabilitation to improve walking distance, while almost all vascular surgeons (96%) would refer their patients to IC rehabilitation, if it was available. Only 14% of municipalities and none of the hospitals, who treat patients with IC, have a rehabilitation program designed specifically for patients with IC. However, 59% of the rehabilitation departments in the municipalities and 26% in the hospitals included patients with IC in rehabilitation program designed for other patient groups - mostly cardiac patients. There was consensus among the groups of respondents that future IC specific rehabilitation should include an initial conversation, supervised exercise therapy, smoking cessation, and patient education according to guidelines. Conclusion. Vascular surgeons support referral and participation in IC rehabilitation to improve walking distance in patients with IC. Despite some hospitals and municipalities included patients with IC in rehabilitation nearly all services fail to meet current guideline as specific services tailored to patient with IC is almost non-existent in Denmark. Our findings call for action for services to comply with current recommendations of structured, systematic rehabilitation for patients with IC.
Assuntos
Terapia por Exercício/tendências , Claudicação Intermitente/reabilitação , Educação de Pacientes como Assunto/tendências , Padrões de Prática Médica/tendências , Encaminhamento e Consulta/tendências , Abandono do Hábito de Fumar , Medicina Estatal/tendências , Cirurgiões/tendências , Adulto , Atitude do Pessoal de Saúde , Estudos Transversais , Dinamarca/epidemiologia , Tolerância ao Exercício , Feminino , Pesquisas sobre Atenção à Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/epidemiologia , Claudicação Intermitente/fisiopatologia , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Cirurgiões/psicologia , Resultado do Tratamento , CaminhadaRESUMO
BACKGROUND: Failure to keep medical appointments results in inefficiencies and, potentially, in poor outcomes for patients. The aim of this study is to describe non-attendance rate and to investigate predictors of non-attendance among patients receiving hospital outpatient treatment for chronic diseases. METHODS: We conducted a historic, register-based cohort study using data from a regional hospital and included patients aged 18 years or over who were registered in ongoing outpatient treatment courses for seven selected chronic diseases on July 1, 2013. A total of 5895 patients were included and information about their appointments was extracted from the period between July 1, 2013 and June 30, 2015. The outcome measure was occurrence of non-attendance. The associations between non-attendance and covariates (age, gender, marital status, education level, occupational status, specific chronic disease and number of outpatient treatment courses) were investigated using multivariate logistic regression models, including mixed effect. RESULTS: During the two-year period, 35% of all patients (2057 of 5895 patients) had one or more occurrences of non-attendance and 5% of all appointments (4393 of 82,989 appointments) resulted in non-attendance. Significant predictors for non-attendance were younger age (OR 4.17 for 18 ≤ 29 years as opposed to 80+ years), male gender (OR 1.35), unmarried status (OR 1.39), low educational level (OR 1.18) and receipt of long-term welfare payments (OR 1.48). Neither specific diseases nor number of treatment courses were associated with a higher non-attendance rate. CONCLUSIONS: Patients undergoing hospital outpatient treatments for chronic diseases had a non-attendance rate of 5%. We found several predictors for non-attendance but undergoing treatment for several chronic diseases simultaneously was not a predictor. To reduce non-attendance, initiatives could target the groups at risk. TRIAL REGISTRATION: This study was approved by the Danish Data Protection Agency (Project ID 18/35695 ).