Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass.

OBJECTIVE: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. METHODS: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. RESULTS: In the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. CONCLUSIONS: There was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.

Incidence, diagnosis, management and outcome of acute mesenteric ischaemia: a prospective, multicentre observational study (AMESI Study).

BACKGROUND: The aim of this multicentre prospective observational study was to identify the incidence, patient characteristics, diagnostic pathway, management and outcome of acute mesenteric ischaemia (AMI). METHODS: All adult patients with clinical suspicion of AMI admitted or transferred to 32 participating hospitals from 06.06.2022 to 05.04.2023 were included. Participants who were subsequently shown not to have AMI or had localized intestinal gangrene due to strangulating bowel obstruction had only baseline and outcome data collected. RESULTS: AMI occurred in 0.038% of adult admissions in participating acute care hospitals worldwide. From a total of 705 included patients, 418 patients had confirmed AMI. In 69% AMI was the primary reason for admission, while in 31% AMI occurred after having been admitted with another diagnosis. Median time from onset of symptoms to hospital admission in patients admitted due to AMI was 24 h (interquartile range 9-48h) and time from admission to diagnosis was 6h (1-12 h). Occlusive arterial AMI was diagnosed in 231 (55.3%), venous in 73 (17.5%), non-occlusive (NOMI) in 55 (13.2%), other type in 11 (2.6%) and the subtype could not be classified in 48 (11.5%) patients. Surgery was the initial management in 242 (58%) patients, of which 59 (24.4%) underwent revascularization. Endovascular revascularization alone was carried out in 54 (13%), conservative treatment in 76 (18%) and palliative care in 46 (11%) patients. From patients with occlusive arterial AMI, revascularization was undertaken in 104 (45%), with 40 (38%) of them in one site admitting selected patients. Overall in-hospital and 90-day mortality of AMI was 49% and 53.3%, respectively, and among subtypes was lowest for venous AMI (13.7% and 16.4%) and highest for NOMI (72.7% and 74.5%). There was a high variability between participating sites for most variables studied. CONCLUSIONS: The overall incidence of AMI and AMI subtypes varies worldwide, and case ascertainment is challenging. Pre-hospital delay in presentation was greater than delays after arriving at hospital. Surgery without revascularization was the most common management approach. Nearly half of the patients with AMI died during their index hospitalization. Together, these findings suggest a need for greater awareness of AMI, and better guidance in diagnosis and management. TRIAL REGISTRATION: NCT05218863 (registered 19.01.2022).

Sex differences in outcomes after revascularization for acute lower limb ischemia: Propensity score adjusted analysis.

BACKGROUND: Previous reports have suggested higher rates of mortality and amputation for female patients in acute lower limb ischemia (ALI). The aims of the present study were to investigate if there is a difference in mortality, amputation, and fasciotomy between the sexes. METHODS: A retrospective cohort study of consecutive patients undergoing index revascularization for ALI between 2001 and 2018 was conducted. A propensity score was created through a logistic regression with female/male sex as an outcome. Cox regression analyses for 90-day and 1-year mortality, combining major amputation/mortality, and logistic regression for major bleeding and fasciotomy, were performed. All analyses were performed with and without adjusting for propensity score. RESULTS: A total of 709 patients were included in the study of which 45.9% were women. Mean age was 72.1 years. Females were older and had higher rates of atrial fibrillation, embolic disease, and lower estimated glomerular filtration rate, while men more often had anemia and chronic peripheral arterial disease. Mortality at 1 year was 21.2% for women and 14.7% for men. The adjusted hazard ratio for 1-year mortality was 0.99 (95% CI 0.67-1.46). Fasciotomy was performed in 7.1% of female and 12.8% of male patients; the adjusted odds ratio was 0.52 (95% CI 0.29-0.91). CONCLUSION: Sex was not found to be an independent risk factor for mortality or combined major amputation/mortality after revascularization for acute lower limb ischemia, whereas women had lower odds of undergoing fasciotomy. Whether women are underdiagnosed or do not develop acute compartment syndrome in the lower leg as often as men should be evaluated prospectively.

Biomarkers In Prediction of Acute Mesenteric Ischaemia: a prospective multicentre study (BIPAMI study): a study protocol.

BACKGROUND: Acute mesenteric ischaemia (AMI) is a life-threatening disease where early diagnosis is critical to avoid morbidity and mortality from extensive irreversible bowel necrosis. Appropriate prediction of presence of bowel necrosis is currently not available but would help to choose the optimal method of treatment. The study aims to identify combinations of biomarkers that can reliably identify AMI and distinguish between potentially reversible and irreversible bowel ischaemia. METHODS: This is a prospective multicentre study. Adult patients with clinical suspicion of AMI (n = 250) will be included. Blood will be sampled on admission, at and after interventions, or during the first 48 h of suspicion of AMI if no intervention undertaken. Samples will be collected and the following serum or plasma biomarkers measured at Tartu University Hospital laboratory: intestinal fatty acid-binding protein (I-FABP), alpha-glutathione S-transferase (Alpha- GST), interleukin 6 (IL-6), procalcitonin (PCT), ischaemia-modified albumin (IMA), D-lactate, D-dimer, signal peptide-CUB-EGF domain-containing protein 1 (SCUBE-1) and lipopolysaccharide-binding protein (LBP). Additionally, more common laboratory markers will be measured in routine clinical practice at study sites. Diagnosis of AMI will be confirmed by computed tomography angiography, surgery, endoscopy or autopsy. Student's t or Wilcoxon rank tests will be used for comparisons between transmural vs. suspected (but not confirmed) AMI (comparison A), confirmed AMI of any stage vs suspected AMI (comparison B) and non-transmural AMI vs transmural AMI (comparison C). Optimal cut-off values for each comparison will be identified based on the AUROC analysis and likelihood ratios calculated. Positive likelihood ratio > 10 (> 5) and negative likelihood ratio < 0.1 (< 0.2) indicate high (moderate) diagnostic accuracy, respectively. All biomarkers with at least moderate accuracy will be entered as binary covariates (using the best cutoffs) into the multivariable stepwise regression analysis to identify the best combination of biomarkers for all comparisons separately. The best models for each comparison will be used to construct a practical score to distinguish between no AMI, non-transmural AMI and transmural AMI. DISCUSSION: As a result of this study, we aim to propose a score including set of biomarkers that can be used for diagnosis and decision-making in patients with suspected AMI. TRIAL REGISTRATION: NCT06212921 (Registration Date 19-01-2024).

Prophylactic and Therapeutic Fasciotomy for Acute Compartment Syndrome after Revascularization for Acute Lower Limb Ischemia-Renal and Wound Outcomes.

BACKGROUND: Acute Compartment Syndrome (ACS) is a significant complication after revascularization for acute lower limb ischemia (ALI). High risk patients sometimes undergo prophylactic fasciotomy (PF) to prevent ACS. Patients that develop ACS undergo therapeutic fasciotomy (TF). The optimal timing of fasciotomy has been debated. The aim of this study was to describe and compare renal and wound outcomes in patients undergoing PF and TF. METHODS: A retrospective cohort study including 76 patients undergoing PF (n = 40) or TF (n = 36) after revascularization for ALI between 2006 and 2018. Estimated glomerular filtration rate (e-GFR) was used to evaluate renal function and compare within (paired-samples t-test) and between (analysis of variance) groups. Wound complications and healing time were compiled from the complete wound healing period and compared between groups with Pearson's chi-squared-and log-rank test, respectively. RESULTS: E-GFR improved over the in-hospital period with 8.2 ml/min/1.73 m2 (95% confidence interval [CI] 2.4-14.1, P = 0.007) in the PF group and 4.4 ml/min/1.73 m2 (95% CI 1.2-7.7, P = 0.010) in the TF group, with no significant difference between the 2 groups (0.3 ml/min/1.73 m2, 95% CI -6.7 to 7.4, P = 0.93). The wound infection rate was higher after TF (PF = 60.6 % and TF = 82.4 %, P = 0.048), whereas rate of other wound complications (PF = 61.3 % and TF = 35.3%, P = 0.036) was higher after PF. CONCLUSIONS: Overall wound complications were high, whereas renal function improved during in-hospital stay. A more conservative approach to fasciotomy could avoid unnecessary fasciotomies and reduce wound complications, while holding the potential to sufficiently preserve renal function if fasciotomy is needed for ACS. This would be possible and safe if an early diagnosis and treatment of ACS can be ensured.

Short-Term Complications and Outcomes in Pharmaco-Mechanical Thrombolysis First and Catheter-Directed Thrombolysis First in Patients with Acute Lower Limb Ischemia.

BACKGROUND: Pharmaco-mechanical thrombolysis (PMT) has emerged as a treatment option in patients with acute lower limb ischemia (ALI), especially Rutherford IIb (motor deficit) for rapid revascularization, but supportive data is scarce. The aim of the present study was to compare the effects of thrombolysis, complications, and outcomes of PMT first versus catheter-directed thrombolysis (CDT) first in a large cohort of patients with ALI. METHODS: All endovascular thrombolytic/thrombectomy events in patients with ALI performed between January 1st, 2009, and December 31st, 2018 (n = 347) were included. Successful thrombolysis/thrombectomy was defined as complete or partial lysis. Reasons for using PMT were described. Complications such as major bleeding, distal embolization, and new onset of renal impairment, and major amputation and mortality at 30 days were compared between PMT (AngioJet) first and CDT first groups in a multivariable logistic regression model with adjustment for age, gender, atrial fibrillation, and Rutherford IIb. RESULTS: The most common reason for initial use of PMT was the need for rapid revascularization, and the most common reason for use of PMT after CDT was the insufficient effect of CDT. Presentation of Rutherford IIb ALI was more common in the PMT first group (36.2% vs. 22.5%, respectively, P = 0.027). Among the 58 patients receiving PMT first, 36 (62.1%) were terminated within a single session of therapy without need of CDT. The median duration of thrombolysis was shorter (P < 0.001) for the PMT first group (n = 58) compared to the CDT first group (n = 289) (4.0 hr vs. 23.0 hr, respectively). There was no significant difference in amount of tissue plasminogen activator given, successful thrombolysis/thrombectomy (86.2% and 84.8%), major bleeding (15.5% and 18.7%), distal embolization (25.9% and 16.6%), major amputation or mortality at 30-days (13.8% and 7.7%) in the PMT first compared to the CDT first group, respectively. The proportion of new onset of renal impairment was higher in the PMT first compared to the CDT first group (10.3% vs. 3.8%, respectively), and the increased odds (odds ratio 3.57, 95% confidence interval 1.22-10.41) were maintained in the adjusted model. In Rutherford IIb ALI, no difference in rate of successful thrombolysis/thrombectomy (76.2% and 73.8%), complications or 30-day outcomes was found between PMT first (n = 21) and CDT (n = 65) first group. CONCLUSIONS: PMT first appears to be a good treatment alternative to CDT in patients with ALI, including Rutherford IIb. The found renal function deterioration in the PMT first group needs to be evaluated in a prospective, preferably randomized trial.

Prospective Comparison of Wound Complication Rates after Elective Open Peripheral Vascular Surgery - Endovascular Versus Open Vascular Surgeons.

BACKGROUND: Skill and experience of surgeons are likely to influence the incidence of surgical wound complications (SWC) after open lower limb revascularization. Differences in SWC between surgeons with predominantly endovascular or open vascular surgical profiles could be expected. The aim of this study was to compare SWC rates after elective open vascular surgery between primarily endovascular and primarily open vascular surgeons. METHODS: Prospective data from patients undergoing elective surgery for peripheral artery disease (PAD) was collected between 2013 and 2019. Senior surgeons were assigned to the open-surgeon or the endo-surgeon group based on the percentage of their open surgical case load during the 6 year study period. SWC was measured by their clinical impact scale (grade 1-outpatient treatment to grade 6-death). Surgical site infection was defined by Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) criteria. Propensity score adjusted analysis (PSAA) was used to account for differences in baseline and perioperative characteristics and expressed as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: The proportion of chronic limb-threatening ischemia (P = 0.001), ipsilateral foot wound (P = 0.012) and femoro-popliteal bypass procedures (P < 0.001) were higher in the open-surgeon group. A lower incidence of SWC according to ASEPSIS criteria (25.6% vs. 38.6%, respectively, P = 0.042) and SWC grade ≥1 (33.7% vs. 51.0%, respectively, P = 0.010) was found in the endo-surgeon group (n = 86) compared to the open-surgeon group (n = 153). These differences disappeared after PSAA (OR 0.63, 95% CI 0.27-1.44, and OR 0.60, 95% CI 0.27-1.33, respectively). CONCLUSIONS: Patients operated by endo-surgeons had less advanced PAD and lower incidence of SWC compared to those treated by open-surgeons. No difference in SWC remained after PSAA.

Research priorities to prevent and treat diabetic foot ulcers-A digital James Lind Alliance Priority Setting Partnership.

AIM: To establish outcomes of a priority setting partnership between participants with diabetes mellitus and clinicians to identify the top 10 research priorities for preventing and treating diabetic foot ulcers (DFUs). METHODS: Due to the COVID-19 pandemic, the James Lind Alliance Priority Setting Partnership process was adapted into a digital format which involved a pilot survey to identify understandable uncertainties with high relevance for participants tested by calculating the content validity index; a main survey answered by 53 participants living with diabetes and 49 clinicians; and a final digital workshop to process and prioritise the final top 10 research priorities. RESULTS: The content validity index was satisfactory for 20 out of 25 uncertainties followed by minor changes and one additional uncertainty. After we processed the 26 uncertainties from the main survey and seven current guidelines, a list of 28 research uncertainties remained for review and discussion in the digital workshop. The final top 10 research priorities included the organisation of diabetes care; screening of diabetes, impaired blood circulation, neuropathy, and skin properties; vascular surgical treatment; importance of self-care; help from significant others; pressure relief; and prevention of infection. CONCLUSION: The top 10 research priorities for preventing and treating DFUs represent consensus areas from persons living with diabetes and clinicians to guide future research. These research priorities can justify and inform strategic allocation of research funding. The digitalisation of James Lind Alliance methodology was feasible.

Circulating Biomarkers Predict Symptomatic but Not Asymptomatic Carotid Artery Stenosis.

BACKGROUND: Subjects exposed to risk factors such as age, gender, hypertension, diabetes mellitus, and smoking are prone to atherosclerotic events. AIMS: The main aim of this longitudinal cohort study was to determine whether the role of novel plasma biomarkers for atherosclerotic carotid artery disease is different in subjects developing symptomatic carotid artery stenosis (CAS), as opposed to those with incident asymptomatic CAS. METHODS: The following biomarkers were measured in 5,550 middle-aged subjects in a population-based cohort study: C-reactive protein (CRP), lipoprotein-associated phospholipase A2 mass and activity, proneurotensin, midregional proadrenomedullin (MR-proADM), midregional proatrial natriuretic peptide (MR-proANP), N-terminal pro-B-type natriuretic peptide (NT pro-BNP), copeptin, and cystatin C. After exclusion of those with prevalent CAS, subjects were thereafter followed in national patient registers for 23.4 (interquartile range 19.5-24.3) years regarding incident symptomatic and asymptomatic CAS. RESULTS: Among 110 patients with confirmed incident CAS, 56 were symptomatic and 54 were asymptomatic. When including conventional risk markers in a Cox regression analysis, NT pro-BNP (hazard ratio [HR] 1.59; 95% confidence interval [CI]: 1.20-2.11), MR-proADM (HR 1.40; CI: 1.13-1.73), cystatin C (HR 1.21; CI: 1.02-1.43), and CRP (HR 1.53; CI: 1.13-1.73) were independently associated with incident symptomatic CAS, whereas no plasma biomarker was associated with incident asymptomatic CAS. CONCLUSION: Plasma biomarkers NT pro-BNP, MR-proADM, cystatin C, and CRP were independently associated with incident symptomatic CAS, whereas no such association could be demonstrated with incident asymptomatic CAS. As these biomarkers indicate future development of clinically relevant atherosclerotic CAS, their potential utility in relation to intensified preventive measures and selection of potential candidates for carotid surgery should be further evaluated.

Epidemiology and Prognostic Factors in Acute Lower Limb Ischaemia: A Population Based Study.

OBJECTIVE: The aim of this study was to evaluate the contemporary population based incidence of acute lower limb ischaemia (ALI) and factors associated with major amputation/death at one year. METHODS: In this retrospective observational study, in hospital, operation, radiological, and autopsy registries were scrutinised to capture 161 citizens of Malmö, Sweden, with ALI between 2015 and 2018. Age and sex specific incidence rates were calculated in the population of Malmö between 2015 and 2018, expressed as number of patients per 100 000 person years (PY). Independent risk factors for major amputation/death at one year were identified by multivariable logistic regression analysis and expressed as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: One hundred and sixty-one patients with ALI gave an overall incidence of 12.2/100 000 PY (95% CI 10.3 - 14.1), with no sex related differences. Embolism (42.2%) was the most common cause of ALI. Among 52 patients with atrial fibrillation, 38.5% were on anticoagulant medication. Endovascular or open vascular revascularisation was performed in 54.7% of patients. The total cause specific mortality ratio was 2.63 (95% CI 1.66 - 3.61)/1 000 deaths, without no sex related differences. The combined major amputation/mortality rate at one year for the whole cohort was 46.6%. Rutherford ≥ IIb ALI (OR 4.19, 95% CI 1.94 - 9.02; p < .001), age (OR 1.03/year, 95% CI 1.00 - 1.06; p = .036), female sex (OR 2.37, 95% 1.07 - 5.26; p = .034), and anaemia (OR 2.46, 95% CI 1.08 - 5.62; p = .033) were associated with an increased risk of major amputation/death at one year. The major amputation/mortality rate at one year was 100% (n = 14/14) for patients living in a nursing home on admission. CONCLUSION: The incidence of ALI appears to be unchanged, and major amputation and mortality at one year remain high. It is necessary to include the substantial proportion of patients with ALI that do not undergo revascularisation in epidemiological studies. There is room for improvement in anticoagulation therapy in patients with atrial fibrillation to prevent ALI due to embolism. Research on gender inequalities in patients with ALI is warranted.

Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR-A Randomized Trial.

BACKGROUND: Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR). METHODS: A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132). RESULTS: The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up. CONCLUSIONS: No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure. CLINICAL TRIALS: NCT01913132.

High versus low-added sugar consumption for the primary prevention of cardiovascular disease.

BACKGROUND: High intake of added sugar have been suggested to impact the risk for cardiovascular disease (CVD). Knowledge on the subject can contribute to preventing CVD. OBJECTIVES: To assess the effects of a high versus low-added sugar consumption for primary prevention of CVD in the general population. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, Conference Proceedings Citation Index-Science (CPCI-S) on 2 July 2021. We also conducted a search of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal for ongoing or unpublished trials. The search was performed together with reference checking, citation searching and contact with study authors to identify additional studies. We imposed no restriction on language of publication or publication status. SELECTION CRITERIA: We included randomised controlled trials (RCTs), including cross-over trials, that compared different levels of added sugar intake. Exclusion criteria were: participants aged below 18 years; diabetes mellitus (type 1 and 2); and previous CVD. Primary outcomes were incident cardiovascular events (coronary, carotid, cerebral and peripheral arterial disease) and all-cause mortality. Secondary outcomes were changes in systolic and diastolic blood pressure, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting plasma glucose and adverse events (gastrointestinal symptoms and impaired dental health). DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 21 RCTs (1110 participants completing the interventions) examining the effects of different levels of added sugar intake with a mean duration of 14 weeks. The study participants were generally described as healthy and the mean age ranged from 22 to 57 years. No studies reported on cardiovascular events or all-cause mortality. There was minimal effect of low intake of added sugar on total cholesterol levels (MD 0.11, 95% CI 0.01 to 0.21; I² = 0%; 16 studies; 763 participants; low certainty of evidence) and triglycerides (MD 0.10, 95% CI 0.03 to 0.17; I² = 3%; 14 studies; 725 participants) but no evidence of effect on LDL-cholesterol and HDL-cholesterol. There was minimal effect on diastolic blood pressure (MD 1.52, 95% CI 0.67 to 2.37; I² = 0%; 13 studies; 873 participants) and on systolic blood pressure (MD 1.44, 95% 0.08 to 2.80; I² = 27%, 14 studies; 873 participants; low certainty of evidence), but no evidence of effect on fasting plasma glucose. Only one study reported on dental health, with no events. No other trials reported adverse events (impaired dental health or gastrointestinal symptoms). All results were judged as low-quality evidence according to GRADE. The risk of bias was generally unclear, five studies were classified at an overall low risk of bias (low risk in at least four domains, not including other bias). AUTHORS' CONCLUSIONS: No trials investigating the effect of added sugar on cardiovascular events or all-cause mortality were identified in our searches. Evidence is uncertain whether low intake of added sugar has an effect on risk factors for CVD; the effect was small and the clinical relevance is, therefore, uncertain. Practical ways to achieve reductions in dietary added sugar includes following current dietary recommendations. Future trials should have longer follow-up time and report on all-cause mortality and cardiovascular events in order to clarify the effect of added sugar on these outcomes. Future trials should also aim for more direct interventions and preferably be more independent of industry funding.

Inadequacies of Physical Examination in Patients with Acute Lower Limb Ischemia Are Associated with Dreadful Consequences.

BACKGROUND: Acute lower limb ischemia (ALI) is limb and life-threatening. The aim of this study was to explore the association between adherence to guidelines on clinical diagnosis of ALI and outcome at 1 year. The hypothesis was that that better examination was associated with favorable outcome in ALI patients. METHODS: Retrospective cohort study between 2015 and 2018. In-hospital, operation, radiological and autopsy registries captured 161 citizens of Malmö with ALI. The initial bedside evaluation was performed by an emergency physician. Scoring was based on evaluation of the 6 "Ps" and 1 point was given for pain, pallor, pulselessness, perishing cold, paresthesia, paralysis or ankle-brachial pressure index (ABI). The performance was scored (range 0-7), and a score ≥5 was defined as a satisfactory vascular leg status. A multivariate logistic regression was performed to adjust for confounders and expressed in Odds Ratios (OR) with 95% confidence intervals (CI). RESULTS: A satisfactory first clinical examination was performed in 55.3% of the patients. Measurement of ABI (OR 0.25, 95% CI 0.11-0.55), performing complete pulse status (OR 0.41, 95% CI 0.20-0.85), evaluating paralysis (OR 0.43, 95% CI 0.20-0.89), and a bedside score ≥5 points (OR 0.48, 95% CI 0.23-0.97) were independently associated with reduced risk of major amputation/mortality at 1-year follow up. CONCLUSIONS: Quality of initial bedside evaluation in patients with ALI was unsatisfactory to a large extent and better clinical examinations were associated with favorable outcome at 1 year. Skills in clinical diagnostics in ALI needs to be much improved.

Influence of diabetes on diagnostic performance of computed tomography angiography of the calf arteries in acute limb ischemia.

BACKGROUND: Patients with diabetes mellitus (DM) have a more extensive distal arterial occlusive disease compared to non-diabetic patients. Diagnostic imaging is a necessity to identify the location and extent of the arterial occlusion in acute limb ischemia (ALI). Computed tomography angiography (CTA) is the most commonly used modality and the diagnostic performance with CTA of calf arteries may be questioned. PURPOSE: To evaluate diagnostic performance of CTA of calf arteries in ALI and to compare patients with and without DM. MATERIAL AND METHODS: All thrombolytic treatments performed during 2001-2018 in patients with ALI were included. Initial digital subtraction angiography (DSA) and CTA of all patients were classified according to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) below-the-knee arteries and compared to CTA. Two raters assessed the CTA images independently. Inter-rater reliability was expressed as intraclass correlation (ICC) with 95% confidence intervals (CI). RESULTS: Patients with (n = 23) and without (n = 85) DM had lower (P = 0.006) glomerular filtration rate. ICC between CTA and DSA was 0.33 (95% CI -0.22 to 0.56) and 0.71 (95% CI 0.38-0.68) in patients with and without DM, respectively. Sensitivity with CTA for TASC D lesions in patients with and without DM was 0.14 (95% CI -0.12 to 0.40) and 0.64 (95% CI 0.48-0.80), respectively. CONCLUSION: The sensitivity of CTA for assessment of infra-popliteal TASC D lesions in patients with ALI was not acceptable in patients with DM in contrast to those without DM. Another imaging option at present times should be considered for patients with DM.

Extravascular incidental findings in computed tomography angiography are associated with lower amputation-free survival in patients with acute lower limb ischaemia.

BACKGROUND: Emergency computed tomography angiography (CTA) is the most important imaging modality to visualize arterial occlusions in patients with acute lower limb ischaemia (ALI). Extravascular incidental findings (EVIFs) have received less attention. PURPOSE: The aims of this study were to evaluate the incidence of EVIFs of immediate clinical relevance in patients with ALI undergoing CTA and evaluate the association between EVIFs and emergency revascularization and amputation-free survival at 1 year. METHODS: Retrospective cohort study. Emergency CTA in patients with ALI between 2015 and 2018 were independently scrutinized by two senior radiologists. EVIFs were classified into immediate (category I), potential (category II) or no clinical relevance (category III). Multi-variable binary logistic regression analysis was expressed in Odds ratios (OR) with 95% confidence intervals (CI). RESULTS: The intra-class correlation (ICC) coefficient for EVIF category I between the raters was 0.94 (95% CI 0.92-0.96). Among 118 patients with ALI, 78 patients underwent emergency revascularization. Forty-six EVIFs (34 patients) were category I, of which 63% were found in the chest, including pleural effusion (n = 12), pneumonia (n = 8) and cardiac thrombus (n = 4). Ascites (n = 4) and cancer disease (n = 4) were other category I findings. Category I EVIFs were associated with reduced rate of emergency revascularization (OR 0.26, 95% CI 0.10-0.66) and increased rate of combined major amputation/mortality at 1 year (OR 2.9, 95% CI 1.1-8.2) in adjusted analysis. CONCLUSION: It is important to evaluate EVIFs in emergency CTA in patients with ALI since these findings are both common and associated with reduced emergency revascularization and amputation-free survival at 1 year.

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm.

OBJECTIVES: Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. METHODS: The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. RESULTS: The two groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing >20% was the most frequent deviation against IFU (n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference >1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17-2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018-2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. CONCLUSION: The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference >1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.

A clinical approach to acute mesenteric ischemia.

PURPOSE OF REVIEW: To summarize current evidence on acute mesenteric ischemia (AMI) in critically ill patients, addressing pathophysiology, definition, diagnosis and management. RECENT FINDINGS: A few recent studies showed that a multidiscipliary approach in specialized centers can improve the outcome of AMI. Such approach incorporates current knowledge in pathophysiology, early diagnosis with triphasic computed tomography (CT)-angiography, immediate endovascular or surgical restoration of mesenteric perfusion, and damage control surgery if transmural bowel infarction is present. No specific biomarkers are available to detect early mucosal injury in clinical setting. Nonocclusive mesenteric ischemia presents particular challenges, as the diagnosis based on CT-findings as well as vascular management is more difficult; some recent evidence suggests a possible role of potentially treatable stenosis of superior mesenteric artery and beneficial effect of vasodilator therapy (intravenous or local intra-arterial). Medical management of AMI is supportive, including aiming of euvolemia and balanced systemic oxygen demand/delivery. Enteral nutrition should be withheld during ongoing ischemia-reperfusion injury and be started at low rate after revascularization of the (remaining) bowel is convincingly achieved. SUMMARY: Clinical suspicion leading to tri-phasic CT-angiography is a mainstay for diagnosis. Diagnosis of nonocclusive mesenteric ischemia and early intestinal injury remains challenging. Multidisciplinary team effort may improve the outcome of AMI.

Results After Open and Endovascular Repair of Popliteal Aneurysm: A Matched Comparison Within a Population Based Cohort.

OBJECTIVE: To identify factors affecting the outcome after open surgical (OSR) and endovascular (ER) repair of popliteal artery aneurysm (PA) in comparable cohorts. METHODS: A matched comparison in a national, population based cohort of 592 legs treated for PA (2008 - 2012), with long term follow up. Registry data from 899 PA patients treated in 2014 - 2018 were analysed for time trends. The 77 legs treated by ER were matched, by indication, with 154 legs treated with OSR. Medical records and imaging were collected. Analysed risk factors were anatomy, comorbidities, and medication. Elongation and angulations were examined in a core lab. The main outcome was occlusion. RESULTS: Patients in the ER group were older (73 vs. 68 years, p = .001), had more lung disease (p = .012), and were treated with dual antiplatelet therapy or anticoagulants more often (p < .001). The hazard ratio (HR with 95% confidence intervals) for occlusion was 2.69 (1.60 - 4.55, p < .001) for ER, but 3.03 (1.26 - 7.27, p = .013) for poor outflow. For permanent occlusion, the HR after ER was 2.47 (1.35 - 4.50, p = .003), but 4.68 (1.89 - 11.62, p < .001) for poor outflow. In the ER subgroup, occlusion was more common after acute ischaemia (HR 2.94 [1.45 - 5.97], p = .003; and poor outflow HR 14.39 [3.46 - 59.92], p < .001). Larger stent graft diameter reduced the risk (HR 0.71 [0.54 - 0.93], p = .014). In Cox regression analysis adjusted for indication and stent graft diameter, elongation increased the risk (HR 1.020 per degree [1.002 - 1.033], p = .030). PAs treated for acute ischaemia had a median stent graft diameter of 6.5 mm, with those for elective procedures being 8 mm (p < .001). Indications and outcomes were similar during both time periods (2008 - 2012 and 2014 - 2018). CONCLUSION: In comparable groups, ER had a 2.7 fold increased risk of any occlusion, and 2.4 fold increased risk of permanent occlusion, despite more aggressive medical therapy. Risk factors associated with occlusion in ER were poor outflow, smaller stent graft diameter, acute ischaemia, and angulation/elongation. An association between indication, acute ischaemia, and small stent graft diameter was identified.

Diabetes mellitus was not associated with lower amputation-free survival after open revascularization for chronic limb-threatening ischemia - A nationwide propensity score adjusted analysis.

The risk of major amputation is higher after urgently planned endovascular therapy for chronic limb-threatening ischemia (CLTI) in patients with diabetes mellitus (DM). The aim of this nationwide cohort study was to compare outcomes between patients with and without DM following urgently planned open revascularization for CLTI from 2010 to 2014. Out of 1537 individuals registered in the Swedish Vascular Registry, 569 were registered in the National Diabetes Register. A propensity score adjusted Cox regression analysis was conducted to compare outcome between the groups with and without DM. Median follow-up was 4.3 years and 4.5 years for patients with and without DM, respectively. Patients with DM more often had foot ulcers (p = 0.034) and had undergone more previous amputations (p = 0.001) at baseline. No differences in mortality, cardiovascular death, major adverse cardiovascular events (MACE), or major amputation were observed between groups. The incidence rate of stroke was 70% higher (95% CI: 1.11-2.59; p = 0.0137) and the incidence rate of acute myocardial infarction (AMI) 39% higher (95% CI: 1.00-1.92; p = 0.0472) among patients with DM in comparison to those without. Open vascular surgery remains a first-line option for a substantial number of patients with CLTI, especially for limb salvage in patients with DM. The higher incidence rates of stroke and AMI among patients with DM following open vascular surgery for infrainguinal CLTI require specific consideration preoperatively with the aim of optimizing medical treatment to improve cardiovascular outcome postoperatively.

Healthcare professionals' experiences of being observed regarding hygiene routines: the Hawthorne effect in vascular surgery.

BACKGROUND: The Hawthorne Effect is the change in behaviour by subjects due to their awareness of being observed and is evident in both research and clinical settings as a result of various forms of observation. When the Hawthorne effect exists, it is short-lived, and likely leads to increased productivity, compliance, or adherence to standard protocols. This study is a qualitative component of an ongoing multicentre study, examining the role of Incisional Negative Pressure Wound Therapy after vascular surgery (INVIPS Trial). Here we examine the factors that influence hygiene and the role of the Hawthorne effect on the adherence of healthcare professionals to standard hygiene precautions. METHODS: This is a qualitative interview study, investigating how healthcare professionals perceive the observation regarding hygiene routines and their compliance with them. Seven semi-structured focus group interviews were conducted, each interview included a different staff category and one individual interview with a nurse from the Department for Communicable Disease Control. Additionally, a structured questionnaire interview was performed with environmental services staff. The results were analysed based on the inductive qualitative content analysis approach. RESULTS: The analysis revealed four themes and 12 subthemes. Communication and hindering hierarchy were found to be crucial. Healthcare professionals sought more personal and direct feedback. All participants believed that there were routines that should be adhered to but did not know where to find information on them. Staff in the operating theatre were most meticulous in adhering to standard hygiene precautions. The need to give observers a clear mandate and support their work was identified. The staff had different opinions concerning the patient's awareness of the importance of hygiene following surgery. The INVIPS Trial had mediated the Hawthorne effect. CONCLUSION: The results of this study indicate that the themes identified, encompassing communication, behaviour, rules and routines, and work environment, influence the adherence of healthcare professionals to standard precautions to a considerable extent of which many factors could be mediated by a Hawthorne effect. It is important that managers within the healthcare system put into place an improved and sustainable hygiene care to reduce the rate of surgical site infections after vascular surgery.