Magnetic Resonance Imaging as a Diagnostic Tool for Ilio-Femoro-Caval Deep Venous Thrombosis.

This study aimed to test the accuracy of a magnetic resonance imaging (MRI)-based method to detect and characterise deep venous thrombosis (DVT) in the ilio-femoro-caval veins. Patients with verified DVT in the lower extremities with extension of the thrombi to the iliac veins, who were suitable for catheter-based venous thrombolysis, were included in this study. Before the intervention, magnetic resonance venography (MRV) was performed, and the ilio-femoro-caval veins were independently evaluated for normal appearance, stenosis, and occlusion by two single-blinded observers. The same procedure was used to evaluate digital subtraction phlebography (DSP), considered to be the gold standard, which made it possible to compare the results. A total of 123 patients were included for MRV and DSP, resulting in 246 image sets to be analysed. In total, 496 segments were analysed for occlusion, stenosis, or normal appearance. The highest sensitivity compared occlusion with either normal or stenosis (0.98) in MRV, while the lowest was found between stenosis and normal (0.84). Specificity varied from 0.59 (stenosis >< occlusion) to 0.94 (occlusion >< normal). The Kappa statistic was calculated as a measure of inter-observer agreement. The kappa value for MRV was 0.91 and for DSP, 0.80. In conclusion, MRV represents a sensitive method to analyse DVT in the pelvis veins with advantages such as no radiation and contrast and the possibility to investigate the anatomical relationship in the area.

Developing a phantom for simulating robotic-assisted complete mesocolic excision using 3D printing and medical imaging.

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.

Training and assessment for colorectal surgery and appendectomy- a systematic review.

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 appendectomy 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 appendectomy, 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 appendectomy 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.

No difference between using short and long intervals for distributed proficiency-based laparoscopy simulator training: a randomized trial.

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.

A vein bypass first versus a best endovascular treatment first revascularisation strategy for 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 (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

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.

Incidence of myocardial infarction, heart failure, and cardiovascular mortality in patients with peripheral artery disease: trends between 1997 and 2016.

AIMS: Over the past decades, there have been improvements in the management of cardiovascular (CV) disease and risk factors. Long-term contemporary data on the population-level incidence of myocardial infarction (MI), heart failure (HF), and CV mortality in patients with peripheral artery disease (PAD) are sparse, which we aim to investigate in this study. METHODS AND RESULTS: Danish nationwide registers were used to identify all patients aged ≥18 years, with first diagnosis of PAD between 1997 and 2016. Age-standardized incidence rates (IRs) per 1000 person-years were calculated to estimate trends of MI, HF, and CV mortality. The risk of MI, HF, and CV mortality was estimated by 1-year cumulative incidence with death as the competing risk. A total of 131 568 patients with PAD were identified [median age 70.67 (interquartile range, IQR, 61-78) years and 53.05% males]. The IRs showed increasing trends of MI until 2002, with an estimated annual percentage change (APC) of + 0.6 [95% confidence interval (CI) 3.3-16.1, P-value 0.2]. After the year 2002, MI incidence persistently decreased until the study end with an estimated APC of -5.0 (95% CI 3.7-6.3, P < 0.0001), HF declined with an estimated APC of -3.3 (95% CI 2.0-4.6, P < 0.0001); and CV mortality declined, with an APC of -3.5 (95% CI 3.0-4.0, P < 0.0001). CONCLUSION: The incidence of MI (since 2002) and HF in patients with PAD has significantly decreased over time, together with a decline in CV mortality. Our results suggest that preventive strategies have overall improved, most likely due to improvements in the application of guidelines in clinical care.

Identifying curriculum content for a cross-specialty robotic-assisted surgery training program: a Delphi study.

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.

Life-style counseling program and supervised exercise improves walking distance and quality of life in patients with intermittent claudication.

INTRODUCTION: There are many barriers for patients with intermittent claudication (IC) to complete and maintain the supervised exercise therapy (SET) programs. SET combined with life-style counseling was, therefore, investigated. OBJECTIVE: This study aimed to report the experience of a single center where SET and life-style counseling targeting the modification of risk factors to treat IC, improved walking distance and quality of life. METHODS: Thirty-five patients out of 62 referred patients with IC completed the full program of 12 weeks SET and 12 weeks self-training combined with counseling focusing in modifying the risk factors. The pain free walking distance (PFWD) and maximum walking distance (MWD) were measured as primary outcomes. Vascular Quality of Life Questionnaire 6 (VascuQoL-6) and 6-min walk test (6-MWT) were measured as secondary outcomes. Analysis of variance and last value carried forward method was used to compare the outcomes. RESULTS: Fifteen females and 20 males with mean age of 71.5 years completed the program. PFWD and MWD increased by 116% (P < .001) and 120% (P < .001), respectively, at 24 weeks follow-up. Similarly, there was 14% increase in 6-MWT and VascuQoL-6 overall score increased from 13.1 to 15.9 at 24 week follow-up (P < .001). CONCLUSION: SET along with life-style counseling can be considered as a package in the treatment of patients with IC.

Trends in Use of Cardioprotective Medication in Peripheral Artery Disease: A Nationwide Study.

Background Guideline-based cardioprotective medical therapy is intended to reduce the burden of adverse cardiovascular and limb outcomes in patients with peripheral artery disease (PAD). However, contemporary data describing trends in use of medication remains limited. The present study, therefore, aims to investigate changes in use of cardioprotective medication in PAD. Methods and Results By using Danish national healthcare registries, we identified all patients with first-time diagnosis of PAD (1997-2016) and classified them into two groups: (1) PAD+ that includes all patients with PAD with a history of cardiovascular disease, ie, myocardial infarction, atrial fibrillation, and stroke (n=162 627); and (2) PAD (n=87 935) that comprise patients without a history of cardiovascular disease. We determined the use of medication in the first 12 months after the incident diagnosis of PAD and estimated age standardized 1-year mortality rates. Our results showed increase in use of cardioprotective medication throughout the study period in both groups. However, PAD+ had a higher use of medication (acetylsalicylic acid, 3.5%-48.4%; Clopidogrel, 0%-17.6%; vitamin K antagonists, 0.9%-7.8%; new oral anticoagulants, 0.0%-10.1%; Statins, 1.9%-58.1%; angiotensin-converting enzyme inhibitors, 1.2%-20.6%), compared with PAD (acetylsalicylic acid, 2.9%-54.4%; Clopidogrel, 0%-11.9%; vitamin K antagonists, 0.9%-2.4%; new oral anticoagulants, 0.0%-3.4%; Statins, 1.5%-56.9%; angiotensin-converting enzyme, 0.9%-17.2%), respectively. Furthermore, 1-year mortality rates in PAD declined with increased use of medications during study. Conclusions In this nationwide study, use of cardioprotective medication increased considerably with time, but compared to patients with other atherosclerotic diseases, there remains an underuse of guideline-based medical therapy in patients with PAD.

Low Risk of Neurological Recurrence while Awaiting Carotid Endarterectomy: Results From a Danish Multicentre Study.

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.

[Intermittent claudication].

Intermittent claudication is a manifestation of peripheral arterial occlusive disease. Multiple large international guidelines state that besides cardiovascular risk management, supervised exercise therapy (SET) should be offered to all patients with intermittent claudication. As described in this review, The Netherlands have already established a systemic rehabilitation program, ClaudicatioNet, where SET has been included and have shown positive outcomes. Despite all large national guidelines and the successful experience from the Netherlands, Denmark still fails to include SET to patients with intermittent claudication.

Editor's Choice - Regional Versus General Anaesthesia in Peripheral Vascular Surgery: a Propensity Score Matched Nationwide Cohort Study of 17 359 Procedures in Denmark.

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.

Trends of anti-reflux surgery in Denmark 2000-2017: a nationwide registry-based cohort study.

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.

Time trends in the risk of atrial fibrillation and ischaemic stroke in patients with peripheral artery disease between 1997 and 2015.

OBJECTIVE: The risk of atrial fibrillation (AF) and stroke in patients with peripheral artery disease (PAD) is an important issue that has not been investigated adequately. Our aim with the present study was to explore trends in the incidence of AF and stroke in patients with PAD. METHODS: We employed Danish nationwide registers to identify all patients with first-time diagnosis of PAD (aged ≥18 years) between 1997 and 2015. Age-standardised incidence rates per 1 000 person-years were calculated to estimate trends of AF and stroke. Risk of AF and stroke was estimated by 1 year cumulative incidence. RESULTS: A total of 121.241 patients with first-time diagnosis of PAD were identified. The 1-year cumulative incidence of AF in patients with PAD were 1.97% for year 1997-2000, 2.63% for year 2001-2005, 2.66% for year 2006-2010 and 2.78% for year 2011-2015, respectively. The 1-year cumulative incidence of stroke in patients with PAD were 2.71%, 2.71%, 1.95% and 1.81%, for the 1997-2000, 2001-2005, 2006-2010 and 2011-2015 year groups, respectively. Likewise, the age-standardised incidence rates showed increasing trends of AF during the study period, whereas trends of stroke demonstrated a decline. During study, the initiation of cholesterol-lowering agents and clopidogrel increased markedly from 7.0% to 51.3% and 0.1% to 5.9%, whereas use of warfarin slightly dropped from 4.29% to 3.21%. CONCLUSIONS: The incidence of AF in patients with PAD has significantly increased over time, whereas a marked decline has occurred in the incidence of stroke. This may suggest that the secondary prevention strategies aimed at reducing risk of stroke are broadly effective.

Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection.

INTRODUCTION: Laparoscopic anti-reflux surgery is standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, including disruption of the fundoplication and postfundoplication dysphagia, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression influence postoperative satisfaction and symptom relief. Previous studies have focused on a short-term follow-up or only certain aspects of disease, such as reoperation or postoperative quality of life. The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using a comprehensive multimodal follow-up, and to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery. METHODS AND ANALYSIS: The study is a retrospective cohort study utilising data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease-specific quality of life and dysphagia will be collected from a patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up. ETHICS AND DISSEMINATION: Study approval has been obtained from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU legislation. Inclusion in the study will require informed consent from participating subjects. The results of the study will be published in peer-reviewed medical journals regardless of whether these are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03959020).

Faster Detection of Ischemia in Free Muscle Transfer When Using Microdialysis.

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.

Surgical revascularization and reconstruction procedures in diabetic foot ulceration.

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.

Diabetes and risk of peripheral artery disease in patients undergoing first-time coronary angiography between 2000 and 2012 - a nationwide study.

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.