The aims of this population based study were to describe mid- to long-term amputation risk, cumulative incidence of death or amputation, and differences in pre-operative comorbidities in patients ...revascularised for lower limb peripheral artery disease (PAD).
This was an observational cohort study. Data from the Swedish National Quality Registry for Vascular Surgery (Swedvasc) were combined with mandatory national health care registries and patient medical records. All patients who underwent revascularisation in Sweden between May 2008 and May 2013 for intermittent claudication (IC) or critical limb ischaemia (CLI), aged 50 years and older, were identified through the Swedvasc database. The mandatory national health care registries and medical records provided data on comorbidities, mortality, and major amputations.
A total of 16,889 patients with PAD (IC, n = 6272; CLI, n = 10,617) were studied. The incidence of amputations in IC patients was 0.4% (range 0.3%–0.5%) per year. Among CLI patients, the amputation rate during the first 6 months following revascularisation was 12.0% (95% CI 11.3–12.6). Thereafter, the incidence declined to approximately 2% per year. The cumulative combined incidence of death or amputation 3 years after revascularisation was 12.9% (95% CI 12.0–13.9) in IC patients and 48.8% (95% CI 47.7–49.8) in CLI patients. Among CLI patients, compared with IC patients, the prevalence of diabetes, ischaemic stroke, heart failure, and atrial fibrillation was approximately doubled and renal failure was nearly tripled, even after age standardisation.
The risk of amputation is particularly high during the first 6 months following revascularisation for CLI. IC patients have a benign course in terms of limb loss. Mortality in both IC and CLI patients is substantial. Revascularised CLI patients have different comorbidities from IC patients.
The diagnosis of peripheral arterial disease (PAD) is not always evident as symptoms and signs may show great variation. As all grades of PAD are linked to both an increased risk for cardiovascular ...complications and adverse limb events, awareness of the condition and knowledge about diagnostic measures, prevention and treatment is crucial. This article presents in a condensed form information on PAD and its management.
•PAD is increasing worldwide.•Patients suffering PAD are at a great risk for cardiovascular morbidity and death.•Diagnostic procedures, such as ABPI measurement, should be used more generally.•Secondary prevention should be prescribed to all PAD patients.•Most patients with PAD, all with CLTI, should be seen by vascular specialists.
Objective
In the present case–control study, we describe the associations between leukocyte subsets in blood and early, screening‐detected AAA in men. An abdominal aortic aneurysm (AAA) may result in ...a life‐threatening rupture of the aortic wall. The trigger for AAA formation remains unknown, but the vascular adventitia of advanced AAAs is infiltrated by various leukocytes, indicating that the pathogenesis may involve inflammation.
Methods
In Sweden, all 65‐year‐old men are invited to an ultrasound examination for detection of AAA. At the Gothenburg screening site, 16 256 men were examined in 2013–2017, 1.2% of whom had an AAA (diameter of the infrarenal aorta ≥30 mm). All men with AAA at screening as well as a randomized selection of AAA‐free screened men were invited to participate in a case–control study.
Results
The median diameter of AAAs was 33 mm. Men with an AAA (n = 151) had a higher frequency of smoking, hypertension and statin use than controls (n = 224). Blood levels of neutrophils, lymphocytes, monocytes and basophils were higher in individuals with an AAA, but eosinophil count did not differ from controls. Odds ratios (95% confidence interval) for AAA were 8.6 (4.2–17.4), 3.5 (1.9–6.6) and 3.3 (1.8–6.3) for the highest versus lowest quartile of neutrophils, lymphocytes and monocytes, respectively. For neutrophils and lymphocytes, the association with AAA remained significant after adjustment for smoking and other known risk factors/markers.
Conclusion
Several, but not all, subsets of circulating leukocytes are associated with screening‐detected AAA in men, which is insufficiently explained by associations with smoking and other confounders.
Differences in comorbidity, pharmacotherapy, cardiovascular (CV) outcome, and mortality between myocardial infarction (MI) patients and peripheral arterial disease (PAD) patients are not well ...documented.
The aim of this study was to compare comorbidity, treatment patterns, CV outcome, and mortality in MI and PAD patients, focusing on sex differences.
This observational, population-based study used data retrieved from mandatory Swedish national registries. The risks of MI and death were assessed by Kaplan-Meier analysis. Secondary preventive drug use was characterized. Cox proportional risk hazard modelling was used to determine the risk of specific events.
Overall, 91,808 incident MI patients and 52,408 PAD patients were included. CV mortality for MI patients at 12, 24, and 36 months after index was 12.3%, 19.3%, and 25.4%, and for PAD patients it was 15.5%, 23.4%, and 31.0%. At index, 89% of MI patients and 65% of PAD patients used aspirin and 74% and 53%, respectively, used statins. Unlike MI women, women with PAD had a lower rate of other CV-related comorbidities and a lower risk of CV events (age-adjusted hazard ratio 0.81, 95% confidence interval 0.79‒0.84), CV death (0.78, 0.75‒0.82), and all-cause death (0.78, 0.76‒0.80) than their PAD male counterparts.
PAD patients were less intensively treated and had a higher CV mortality than MI patients. Women with PAD were less likely than men to present with established polyvascular disease, whereas the opposite was true of women with MI. This result indicates that the lower-limb vasculature may more often be the index site for atherosclerosis in women.
Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) ...instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation.
This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation.
A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients.
The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following different interventions in PAD and in the design of clinical trials.
Background
Revascularization is a treatment option for patients with intermittent claudication. However, there is a lack of evidence to support its long‐term benefits and cost‐effectiveness. The aim ...of this study was to compare the cost‐effectiveness of revascularization and best medical therapy (BMT) with that of BMT alone.
Methods
Data were used from the IRONIC (Invasive Revascularization Or Not in Intermittent Claudication) RCT where consecutive patients with mild‐to‐severe intermittent claudication owing to aortoiliac or femoropopliteal disease were allocated to either BMT alone (including a structured, non‐supervised exercise programme) or to revascularization together with BMT. Inpatient and outpatient costs were obtained prospectively over 24 months of follow‐up. Mean improvement in quality‐adjusted life‐years (QALYs) was calculated based on responses to the EuroQol Five Dimensions EQ‐5D‐3 L™ questionnaire. Cost‐effectiveness was assessed as the cost per QALY gained.
Results
A total of 158 patients were randomized, 79 to each group. The mean cost per patient in the BMT group was €1901, whereas it was €8280 in the group treated with revascularization in addition to BMT, with a cost difference of €6379 (95 per cent c.i. €4229 to 8728) per patient. Revascularization in addition to BMT resulted in a mean gain in QALYs of 0·16 (95 per cent c.i. 0·06 to 0·24) per patient, giving an incremental cost‐effectiveness ratio of €42 881 per QALY.
Conclusion
The costs associated with revascularization together with BMT in patients with intermittent claudication were about four times higher than those of BMT alone. The incremental cost‐effectiveness ratio of revascularization was within the accepted threshold for public willingness to pay according to the Swedish National Guidelines, but exceeded that of the UK National Institute for Health and Care Excellence guidelines.
Revascularization effective but pricey
Objective/Background To investigate the frequency of initial misdiagnosis and the clinical consequences of an initial misdiagnosis of ruptured abdominal aortic aneurysms (rAAA). Methods This was a ...retrospective cohort study. Data from the Swedish National Registry for Vascular Surgery (Swedvasc) and medical charts were extracted for patients treated for rAAA in the West of Sweden in the period 2008–14. Initially misdiagnosed patients were compared with correctly diagnosed patients. Results In all, 261 patients were included in the study. Patients with rAAA were initially misdiagnosed in 33% ( n = 86) of the cases and this caused a 4.8 hour (median time) additional delay to surgical intervention. There were no differences in 30 day mortality between initially misdiagnosed patients and correctly diagnosed patients (27.9% vs. 28.0%; p = 1.00). The adjusted odds ratio for mortality in initially misdiagnosed patients compared with correctly diagnosed patients was 0.78 (95% confidence interval 0.38–1.60). No difference was observed between the groups regarding 90 day mortality, length of intensive care, need for post-operative ventilator support, need of haemodialysis support, and length of hospital stay. Conclusion Misdiagnosis is common in patients with rAAA, and treatment is significantly delayed in misdiagnosed patients. The study did not show any survival disadvantage or increased frequency of post-operative complications in misdiagnosed patients despite the delayed treatment. However, only patients who reached surgical intervention were included in the analysis.
Background
Intermittent claudication is associated with significant impairment of health‐related quality of life. The use of revascularization techniques to improve health‐related quality of life ...remains controversial.
Methods
Patients with intermittent claudication due to iliac or femoropopliteal peripheral artery disease were enrolled in the IRONIC trial. They were randomized to either best medical therapy (BMT), including a structured, non‐supervised exercise programme, or revascularization with either endovascular or open techniques in addition to BMT. The primary outcome was health‐related quality of life at 2 years assessed using the Short Form 36 (SF‐36®) questionnaire. Secondary outcomes included VascuQoL questionnaire results, treadmill walking distances and achievement of patient‐specified treatment goals.
Results
Both randomized groups had improved health‐related quality of life and treadmill walking distance at 2‐year follow‐up. Overall SF‐36® physical component summary score, three SF‐36® physical domain scores, overall VascuQoL score, and three of five VascuQoL domain scores showed significantly greater improvement in the group that also received invasive treatment. Intermittent claudication distance on a graded treadmill improved more in the revascularization + BMT group (117 versus 55 m; P = 0·003) whereas maximum walking distance and 6‐min walk test distance were similar. Some 44 per cent of patients in the revascularization + BMT group reported they had fully achieved their treatment goal versus 10 per cent in the BMT group.
Conclusion
A revascularization strategy with unsupervised exercise improved health‐related quality of life and intermittent claudication distance more than standard BMT and an unsupervised exercise programme in patients with lifestyle‐limiting claudication. Registration number: NCT01219842 (http://www.clinicaltrials.gov).
Revascularization better than unsupervised exercise alone
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