1. |
- Aivaz Ihari, Mahia, et al.
(author)
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Long-term functional consequences of cranial nerve injuries after carotid endarterectomy.
- 2022
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In: The Journal of cardiovascular surgery. - 1827-191X. ; 63:6, s. 695-699
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Journal article (peer-reviewed)abstract
- The aim of the study was to investigate long-term patient consequences of cranial nerve injury (CNI) caused by carotid endarterectomy (CEA) in patients with identified CNI at the 30-day follow-up.Consecutive patients operated for symptomatic carotid artery stenosis 2015-2019 with a documented CNI at the 30-day follow-up after CEA were recruited to this cross-sectional survey. Telephone interviews were conducted >1 year after CEA utilizing survey instruments developed to uncover CNI symptoms. Patients graded their symptoms on a 4-point scale: 1) no symptoms; 2) mild symptoms; 3) moderate symptoms; and 4) severe symptoms.Altogether, 477 patients underwent CEA, of which 82 were diagnosed with CNI; 70/82 patients remained alive at the time for the survey and 68 patients completed the interview. The mean follow-up time was 3.7 years. Severe persistent CNI symptoms were reported in 2/68 (2.9%), moderate symptoms in 1/68 (1.5%) and mild symptoms in 14/68 (21%) whereas 51/68 patients (75%) reported no residual symptoms. When extrapolating these findings to all patients, approximately 4.4% reported persistent symptoms at the long-term follow-up and only 0.8% reported moderate or severe symptoms.The long-term consequences of CNI following CEA are benign in most patients, with a high rate of symptom resolution and a very low rate of persistent clinically significant symptoms.
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3. |
- Amlani, Vishal, et al.
(author)
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The current status of drug-coated devices in lower extremity peripheral artery disease interventions
- 2021
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In: Progress in Cardiovascular Diseases. - : Elsevier BV. - 0033-0620. ; 65, s. 23-28
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Journal article (peer-reviewed)abstract
- Lower limb peripheral artery disease is a leading cause of cardiovascular disease morbidity and mortality. Endovascular revascularization is often indicated to improve walking function and to prevent limb loss but restenosis in the treated vessel segment remains a concern that limits the overall effectiveness of the treatment. The most promising technique to prevent restenosis is the use of drug-coated devices, and the most common drug used to coat lower limb balloon angioplasty balloons and stents is paclitaxel. A systematic review and meta analysis in 2018 reported a possible increase in late mortality attributable to paclitaxel-coated devices. Since then, their use has been brought into question. Here, we present an update of data focusing on the efficacy and safety of paclitaxel-coated devices in lower limb treatment applications. While paclitaxel-coated devices appear to reduce restenosis rates it is still unclear how these surrogate marker improvements translate to direct patient benefits and uncertainty remains as to whether paclitaxel-coated devices confer an increased risk of long-term mortality. Available randomized clinical data is hampered by trial heterogeneity, insufficient power, potential attrition bias and the lack of a plausible mechanistic explanation. An important step forward is that the ongoing trials that were temporarily halted due to the Katsanos et al. report have now both commenced recruitment and may ultimately resolve this clinical dilemma by virtue of their larger sample sizes. Other possible ways forward are the ongoing investigation of alternative anti-proliferative coating agents and use of new sophisticated vascular imaging techniques to more clearly identify patients at risk of restenosis already in the preoperative setting. (c) 2021 Elsevier Inc. All rights reserved.
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4. |
- Andersson, Mattias, et al.
(author)
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Editor's Choice – Structured Computed Tomography Analysis can Identify the Majority of Patients at Risk of Post-Endovascular Aortic Repair Rupture
- 2022
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 64, s. 166-174
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Journal article (peer-reviewed)abstract
- Objective: The main objective was to report mechanisms and precursors for post-endovascular aneurysm repair (EVAR) rupture. The second was to apply a structured protocol to explore whether these factors were identifiable on follow up computed tomography (CT) prior to rupture. The third objective was to study the incidence, treatment, and outcome of post-EVAR rupture. Methods: This was a multicentre, retrospective study of patients treated with standard EVAR at five Swedish hospitals from 2008 to 2018. Patients were identified from the Swedvasc registry. Medical records were reviewed up to 2020. Index EVAR and follow up data were recorded. The primary endpoint was post-EVAR rupture. CT at follow up and at post-EVAR rupture were studied, using a structured protocol, to determine rupture mechanisms and identifiable precursors. Results: In 1 805 patients treated by EVAR, 45 post-EVAR ruptures occurred in 43 patients. The cumulative incidence was 2.5% over a mean follow up of 5.2 years. The incidence rate was 4.5/1 000 person years. Median time to post-EVAR rupture was 4.1 years. A further six cases of post-EVAR rupture in five patients found outside the main cohort were included in the analysis of rupture mechanisms only. The rupture mechanism was type IA in 20 of 51 cases (39%), IB in 20 of 51 (39%) and IIIA/B in 11 of 51 (22%). One of these had type IA + IB combined. One patient had an aortoduodenal fistula without another mechanism being identified. Precursors had been noted on CT follow up prior to post-EVAR rupture in 16 of 51 (31%). Retrospectively, using the structured protocol, precursors could be identified in 43 of 51 (84%). In 17 of 27 (63%) cases missed on follow up but retrospectively identifiable, the mechanisms were type IB/III. Overall, the 30 day mortality rate after post-EVAR rupture was 47% (n = 24/51) and the post-operative mortality rate was 21% (n = 7/33). Conclusions: Most precursors of post-EVAR rupture are underdiagnosed but identifiable before rupture using a structured follow up CT protocol. Precursors of type IB and III failures caused the majority of post-EVAR ruptures.
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5. |
- Arndt, Helene, et al.
(author)
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A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.
- 2022
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 64:5, s. 526-533
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Journal article (peer-reviewed)abstract
- This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
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6. |
- Avdic, Tarik, et al.
(author)
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Non-coronary arterial outcomes in people with type 1 diabetes mellitus: a Swedish retrospective cohort study.
- 2024
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In: The Lancet regional health - Europe. - 2666-7762. ; 39
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Journal article (peer-reviewed)abstract
- Observational studies on long-term trends, risk factor association and importance are scarce for type 1 diabetes mellitus and peripheral arterial outcomes. We set out to investigate trends in non-coronary complications and their relationships with cardiovascular risk factors in persons with type 1 diabetes mellitus compared to matched controls.34,263 persons with type 1 diabetes mellitus from the Swedish National Diabetes Register and 164,063 matched controls were included. Incidence rates of extracranial large artery disease, aortic aneurysm, aortic dissection, lower extremity artery disease, and diabetic foot syndrome were analyzed using standardized incidence rates and Cox regression.Between 2001 and 2019, type 1 diabetes mellitus incidence rates per 100,000 person-years were as follows: extracranial large artery disease 296.5-84.3, aortic aneurysm 0-9.2, aortic dissection remained at 0, lower extremity artery disease 456.6-311.1, and diabetic foot disease 814.7-77.6. Persons with type 1 diabetes mellitus with cardiometabolic risk factors at target range did not exhibit excess risk of extracranial large artery disease [HR 0.83 (95% CI, 0.20-3.36)] or lower extremity artery disease [HR 0.94 (95% CI, 0.30-2.93)], compared to controls. Persons with type 1 diabetes with all risk factors at baseline, had substantially elevated risk for diabetic foot disease [HR 29.44 (95% CI, 3.83-226.04)], compared to persons with type 1 diabetes with no risk factors. Persons with type 1 diabetes mellitus continued to display a lower risk for aortic aneurysm, even with three cardiovascular risk factors at baseline [HR 0.31 (95% CI, 0.15-0.67)]. Relative importance analyses demonstrated that education, glycated hemoglobin (HbA1c), duration of diabetes and lipids explained 54% of extracranial large artery disease, while HbA1c, smoking and systolic blood pressure explained 50% of lower extremity artery disease and HbA1c alone contributed to 41% of diabetic foot disease. Income, duration of diabetes and body mass index explained 66% of the contribution to aortic aneurysm.Peripheral arterial complications decreased in persons with type 1 diabetes mellitus, except for aortic aneurysm which remained low. Besides glycemic control, traditional cardiovascular risk factors were associated with incident outcomes. Risk of these outcomes increased with additional risk factors present. Persons with type 1 diabetes mellitus exhibited a lower risk of aortic aneurysm compared to controls, despite presence of cardiovascular risk factors.Swedish Governmental and the county support of research and education of doctors, the Swedish Heart and Lung Foundation, Sweden and Åke-Wibergs grant.
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7. |
- Baubeta Fridh, Erik, et al.
(author)
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Comparison of Magnetic Resonance Angiography and Digital Subtraction Angiography for the Assessment of Infrapopliteal Arterial Occlusive Lesions, Based on the TASC II Classification Criteria
- 2020
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In: Diagnostics (Basel). - : MDPI. - 2075-4418. ; 10:11
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Journal article (peer-reviewed)abstract
- This paper aimed to study the agreement and repeatability, both intra- and interobserver, of infrapopliteal lesion assessment with magnetic resonance angiography (MRA), using the TransAtlantic Inter-Society Consensus (TASC) II criteria, with perioperative digital subtraction angiography (DSA) as a reference. Sixty-eight patients with an MRA preceding an endovascular infrapopliteal revascularization were included. Preoperative MRAs and perioperative DSAs were evaluated in random order by three independent observers using the TASC II classification. The results were analyzed using visual grading characteristics (VGC) analysis and Krippendorffs alpha. No systematic difference was found between modalities: area under the VGC curve (AUC(VGC)) = 0.48 (p = 0.58) or intraobserver; AUC(VGC) for Observer 1 and 2 respectively, 0.49 (p = 0.85) and 0.53 (p = 0.52) for MRA compared with 0.54 (p = 0.30) and 0.49 (p = 0.81) for DSA. Interobserver differences were seen: AUC(VGC) of 0.63 (p < 0.01) for DSA and 0.80 (p < 0.01) for MRA. These results were confirmed using Krippendorffs alpha for the three observers showing 0.13 (95% confidence interval (CI) -0.07-0.31) for MRA and 0.39 (95% CI 0.23-0.53) for DSA. Poor interobserver agreement was also found in the choice of a target vessel on preoperative MRA: Krippendorffs alpha = 0.19 (95% CI 0.01-0.36). In conclusion, infrapopliteal lesions can be reliably determined on preoperative MRA, but interobserver variability regarding the choice of a target vessel is a major concern that appears to affect the overall TASC II grade.
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8. |
- Behrendt, Christian-Alexander, et al.
(author)
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Do We Need a War on Amputations? A Call to Arms!
- 2022
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 63:1
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Journal article (peer-reviewed)
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9. |
- Behrendt, C. A., et al.
(author)
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Sex disparities in long-term mortality after paclitaxel exposure in patients with peripheral artery disease: A nationwide claims-based cohort study
- 2021
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In: Journal of Clinical Medicine. - : MDPI AG. - 2077-0383. ; 10:13
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Journal article (peer-reviewed)abstract
- Background: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes. Methods: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively. Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64–0.95), while no statistically significant differences were observed in males. Conclusions: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.
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10. |
- Behrendt, C. A., et al.
(author)
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The OAC3-PAD Risk Score Predicts Major Bleeding Events one Year after Hospitalisation for Peripheral Artery Disease
- 2022
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 63:3, s. 503-510
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Journal article (peer-reviewed)abstract
- Objective: There is a paucity of evidence concerning the risk of bleeding after hospitalisation for symptomatic peripheral artery disease (PAD) in everyday clinical practice, as randomised clinical trials commonly exclude patients with heightened risk. The current study aimed to develop a pragmatic risk score that enables prediction of major bleeding during the first year after index discharge. Methods: Unselected retrospective data from the second largest insurance fund in Germany, BARMER, were used to identify patients with a first hospitalisation for PAD registered between 1 January 2010 and 31 December 2018. Within a separate training cohort, final predictors were selected using penalised Cox regression (least absolute shrinkage and selection operator with ten fold cross validation) with one year major bleeding requiring hospitalisation as outcome. The risk score was internally validated. Four different risk groups were constructed. Results: A total of 81 930 patients (47.2% female, 72.3 years) underwent hospitalisation for symptomatic PAD. After one year, 1 831 (2.2%) of the patients had a major bleeding event. Independent predictors were previous oral anticoagulation, age over 80, chronic limb threatening ischaemia, congestive heart failure, severe chronic kidney disease, previous bleeding event, anaemia, and dementia. The OAC3-PAD risk score exhibited adequate calibration and discrimination between four risk groups (c 1/4 0.69, 95% confidence interval 0.67 - 0.71) from low risk (1.3%) to high risk (6.4%). Conclusion: A pragmatic risk score was developed to predict the individual major bleeding risk classifying a fifth of the cohort as high risk patients. Individual prediction scores such as the one proposed here may help to inform the risk and benefit of intensified antithrombotic strategies.
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11. |
- Casian, Dumitru, et al.
(author)
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Romanian Translation and Validation of Vascular Quality of Life Questionnaire “VascuQOL-6” in Patients with Lower Extremity Arterial Disease
- 2023
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In: Surgery, Gastroenterology and Oncology. - 2559-723X .- 2601-1700. ; 28:3, s. 167-173
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Journal article (peer-reviewed)abstract
- Background: Patient reported outcomes are valuable components in the assessment of results of treatment for peripheral arterial disease (PAD). The aim of the study was to translate the six item Vascular Quality of Life Questionnaire (VascuQoL-6) survey into Romanian, and to validate the psychometric performance of the questionnaire in a representative cohort of patients with lower extremity arterial disease. Material and Methods: Translation of the VascuQoL-6 questionnaire was performed following accepted methodology. The overall validation cohort included 100 patients with PAD (86% with chronic limb-threatening ischemia) undergoing lower limb revascularization. In 20 patients with stable PAD two questionnaires were offered preoperatively with a median interval of 15 days. Another 22 patients were re-tested after revascularization at a median interval of 30 days. Results: The median time required for completion of the VascuQoL-6 survey was 2 (IQR 2-3) minutes. The translated version demonstrated high internal consistency (Cronbach’s alpha – 0.81) and there was no difference in the preoperative median VascuQoL-6 scoring during the test re-test assessment. Area under the ROC curve for ability to discriminate intermittent claudication from chronic limb-threatening ischemia was 0.897. The median VascuQoL-6 score increased from 10 (IQR 8-12) points preoperatively to 18.5 (IQR 14.7-20) points postoperatively (p < 0.0001) with a standardized response mean of 2.94. Conclusion: The Romanian version of the VascuQoL-6 survey demonstrated good reliability, validity and responsiveness and can thus be recommended for use in patients with lower limb PAD.
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12. |
- Chuter, Vivienne, et al.
(author)
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Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.
- 2023
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In: Diabetes/metabolism research and reviews. - 1520-7560.
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Research review (peer-reviewed)abstract
- As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.
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13. |
- Chuter, V., et al.
(author)
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Effectiveness of revascularisation for the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review
- 2024
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In: Diabetes-Metabolism Research and Reviews. - 1520-7552. ; 40:3
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Journal article (peer-reviewed)abstract
- Introduction: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality. Methods: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided. Results: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions. Conclusions: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.
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14. |
- Chuter, Vivienne, et al.
(author)
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Performance of non-invasive bedside vascular testing in the prediction of wound healing or amputation among people with foot ulcers in diabetes: A systematic review.
- 2023
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In: Diabetes/metabolism research and reviews. - 1520-7560.
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Research review (peer-reviewed)abstract
- The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene.A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool.From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10).Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations.
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15. |
- Djerf, Henrik, et al.
(author)
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Absence of Long-Term Benefit of Revascularization in Patients with Intermittent Claudication: Five-Year Results from the IRONIC Randomized Controlled Trial
- 2020
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In: Circulation: Cardiovascular Interventions. - 1941-7640 .- 1941-7632. ; 13:1
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Journal article (peer-reviewed)abstract
- © 2020 Lippincott Williams and Wilkins. All rights reserved. Background: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. Methods: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. Results: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). Conclusions: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.
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16. |
- Djerf, Henrik, et al.
(author)
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Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial
- 2021
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 62:4, s. 576-582
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Journal article (peer-reviewed)abstract
- Objective: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms aremainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aimof this studywas to investigate its cost effectiveness vs. noninvasive treatment. Methods: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ5D 3L (TM) questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. Results: The mean cost per patient was (SIC)11 060 in the stent group and (SIC)4 787 in the control group, resulting in a difference of (SIC)6 273 per patient between the groups.The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of (SIC)23 785 per QALY. Conclusion: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < (SIC)50 000 - (SIC)70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < 20 pound 000 - 30 pound 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.
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17. |
- Djerf, Henrik, et al.
(author)
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Low Risk of Procedure Related Major Amputation Following Revascularisation for Intermittent Claudication: A Population Based Study.
- 2020
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 59:5, s. 817-822
-
Journal article (peer-reviewed)abstract
- To investigate the risk of procedure-related major amputation attributable to revascularization for intermittent claudication (IC) in a population-based observational cohort study.All patients who underwent open or endovascular lower limb revascularisation for IC in Sweden between 12 May 2008 and 31 December 2012 were identified from the Swedish National Quality Registry for Vascular Surgery (Swedvasc) and data on above ankle amputations were extracted from the National Patient Registry. Any uncertainty regarding amputation level and laterality was resolved by reviewing medical charts. For the final analysis, complete medical records of all patients with IC, having ipsilateral amputation after the revascularisation procedure, were reviewed. Patients wrongly classified as having IC were excluded. Ipsilateral amputations within one year of the revascularisation were defined as procedure related.Altogether, 5 860 patients revascularised for IC were identified of whom 109 were registered to have undergone a post-operative ipsilateral lower limb amputation during a median follow up of 3.9 years (standard deviation 1.5y). Seventeen were duplicate registrations and 51 were patients with chronic limb threatening ischaemia, misclassified as IC in the registry. One patient had not undergone any revascularisation, one was revascularised for a popliteal artery aneurysm, one was revascularised for acute limb ischaemia, one had a minor amputation only, and one patient was not amputated at all. Twenty-seven were amputated more than one year after the procedure. Thus, the major amputation rate within one year of revascularisation for IC was 0.2% (n=9/5 860).Revascularisation for IC in a contemporary setting confers a low but existing risk of procedure related major amputation within the first post-procedural year.
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18. |
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19. |
- Fitridge, Robert, et al.
(author)
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The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.
- 2023
-
In: Diabetes/metabolism research and reviews. - 1520-7560.
-
Journal article (peer-reviewed)abstract
- Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
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20. |
- Koeckerling, D., et al.
(author)
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Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis
- 2023
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In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 44:11, s. 935-950
-
Journal article (peer-reviewed)abstract
- Aims Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. Methods and results Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (>= 2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints. Conclusion Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.
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21. |
- Langenskiöld, Marcus, 1972, et al.
(author)
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Deep Femoral Vein Reconstruction for Abdominal Aortic Graft Infections is Associated with Low Aneurysm Related Mortality and a High Rate of Permanent Discontinuation of Antimicrobial Treatment
- 2021
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 927-934
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Journal article (peer-reviewed)abstract
- Objective: Aortic prosthesis infection is a devastating complication of aortic surgery. In situ reconstruction with the neo-aorto-iliac system (NAIS) bypass technique has become increasingly used and is recommended in recent treatment guidelines. The main aim was to evaluate NAIS procedural outcomes when undertaken after previous open or endovascular aortic repair in Sweden.Methods: In this retrospective study, The National Quality Registry for Vascular Surgery (Swedvasc) was used to identify Swedish centres that offered the NAIS bypass procedure for aortic prosthesis infection between 2008 and 2018. Variables of special interest were procedural details, short and long term survival, renal and other complications, and the durtion of antimicrobial treatment.Results: Forty patients (36 males, four females [mean age 69 years], 32 open repairs, seven endovascular aortic repairs [EVAR] and one fenestrated EVAR; 21 presented with aorto-enteric fistula) operated on with NAIS bypass were reviewed. The median time from the primary aortic intervention to the NAIS bypass procedure was 32 months (range 0 – 252 months). Mean ± standard deviation operating time was 645 ± 160 minutes, mean blood loss was 6 277 ± 6 525 mL, mean length of intensive care unit stay was 5.3 ± 3.7 days, and mean length of overall hospital stay was 21.2 ± 11.4 days. Thirty-five patients (88%) had a positive microbial culture; the most commonly isolated pathogen was Candida spp. The majority of patients survived for 30 days (n = 35 [88%]), and 33 (83%) and 32 (80%) patients survived for 90 days and one year, respectively. The number of surviving patients free from antimicrobial treatment at 90 days, six months, and one year was 19 (58%), 29 (88%), and 30 (94%). After a mean long term follow up of 69.9 ± 44.7 months, 20 patients were still alive.Conclusion: The NAIS bypass procedure offered reasonable survival and functional outcomes, and was associated with a high cure rate, defined as freedom from any antimicrobial treatment.
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22. |
- Langenskiöld, Marcus, 1972, et al.
(author)
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Leukocyte subsets and abdominal aortic aneurysms detected by screening in men
- 2020
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In: Journal of Internal Medicine. - : Wiley. - 0954-6820 .- 1365-2796. ; 288:3, s. 345-355
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Journal article (peer-reviewed)abstract
- 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, 16256 men were examined in 2013–2017, 1.2% of whom had an AAA (diameter of the infrarenal aorta ≥30mm). 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 33mm. 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. © 2020 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine
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23. |
- Ludwigs, Karin, et al.
(author)
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Poor inter-observer agreement in anatomical classifications of infrapopliteal arterial disease due to mandatory selection of only one target artery
- 2023
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In: Acta Radiologica. - : SAGE Publications. - 0284-1851 .- 1600-0455. ; 64:3, s. 1298-1306
-
Journal article (peer-reviewed)abstract
- Background Established anatomical classifications of infrapopliteal arterial lesion severity are based on assessment of only one target artery, not including all infrapopliteal arteries although multivessel revascularization is common. Purpose To investigate the reproducibility of one of these classifications and a new aggregated score. Material and Methods A total of 68 patients undergoing endovascular infrapopliteal revascularization at Sahlgrenska University Hospital during 2008-2016 were included. Preoperative magnetic resonance angiographies (MRA) and digital subtraction angiographies (DSA) were evaluated by three blinded observers in random order, using the infrapopliteal TransAtlantic Inter-Society Consensus (TASC) II classification. An aggregated score, the Infrapopliteal Total Atherosclerotic Burden (I-TAB) score, including all infrapopliteal arteries, was constructed and used for comparison. Results Inter-observer agreement on lesion severity for each evaluated artery was good; Krippendorff's alpha for MRA 0.64-0.79 and DSA 0.66-0.84. Inter-observer agreement on TASC II grade, based on the selected target artery as stipulated, was poor; Krippendorff's alpha 0.14 (95% confidence interval [CI]=-0.05 to 0.30) for MRA and 0.48 (95% CI=0.33-0.61) for DSA. Inter-observer agreement for the new I-TAB score was good; Krippendorff's alpha 0.76 (95% CI=0.70-0.81) for MRA and 0.79 (95% CI=0.74-0.84) for DSA. Conclusion Reproducible assessment of infrapopliteal lesion severity can be achieved for separate arteries with both MRA and DSA using the TASC II definitions. However, poor inter-observer agreement in selecting the target artery results in low reproducibility of the overall infrapopliteal TASC II grade. An aggregated score, such as I-TAB, results in less variability and may provide a more robust evaluation tool of atherosclerotic disease severity.
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24. |
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25. |
- Millinger, Johan, 1978, et al.
(author)
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Arterial Blood Flow and Effects on Limb Tissue Perfusion During Endoshunting of the Common Iliac Artery in an Experimental Porcine Model
- 2024
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In: EJVES VASCULAR FORUM. - 2666-688X. ; 61, s. 54-61
-
Journal article (peer-reviewed)abstract
- Objective: Temporary arterial shunting is an established method to prevent tissue ischaemia. Although less well established, shunting might also be achieved through endovascular and hybrid techniques, known as endoshunting. Endoshunting offers advantages, for example, enabling minimally invasive access and avoiding complete occlusion of the donor artery. In an ex vivo bench test, volume flow in various interconnected endoshunt systems has been tested previously. This study aimed to investigate the capacity of the best performing endoshunt system in vivo. Methods: Six anaesthetised pigs had their common iliac arteries (CIAs) explored, with the left CIA serving as the experimental and the right CIA as the control. Mean arterial pressure, regional blood flow, endoshunt flow, and regional oxygen extraction and lactate production were recorded. Distal muscle perfusion was monitored using near infrared spectroscopy (NIRS). Each experiment involved baseline registration, cross clamping of the left CIA, a 120 minute endoshunt session, and restoration of native flow. Results: During cross clamping, NIRS values on the experimental side reached the lowest measurable value. Following endoshunt activation, there were no NIRS value differences between the experimental and control extremities whereas the average arterial flow decreased in both the experimental (270-140 mL/min, p = .028) and control extremities (245-190 mL/min, p = .25), with a greater drop on the endoshunted side (48% vs. 22%, respectively). Lactate levels temporarily increased by 42% in the endoshunted limb on endoshunt activation but were normalised within an hour. Oxygen extraction remained constant at 55% on the control side but increased to 70% on the endoshunted side (p = .068). Conclusion: In this animal model, a flow optimised endoshunt system appeared to provide sufficient blood flow and restored stable tissue perfusion. Although arterial flow was slightly lower and oxygen extraction slightly higher on the endoshunted side, the endoshunt seemed to deliver adequate perfusion to prevent significant ischaemia.
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26. |
- Millinger, Johan, 1978, et al.
(author)
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Optimisation of Volume Flow Rates when Using Endovascular Shunting Techniques: An Experimental Study in Different Bench Flow Circuits
- 2023
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In: EJVES Vascular Forum. - : Elsevier BV. - 2666-688X. ; 58, s. 5-10
-
Journal article (peer-reviewed)abstract
- Objective: Acute tissue ischaemia may arise due to arterial emergencies or during more complex vascular procedures and may be mitigated by temporary shunting techniques. Endovascular shunting (ES) techniques enable percutaneous access and shunting from the donor artery without the need to completely interrupt the arterial flow in the donor artery. An endoshunt system may also cover longer distances than most conventional shunts. The aim was to investigate and optimise the flow rates in different endovascular shunt systems.Methods: Step 1: The flow capacity of different ES configurations was compared with the flow capacity of a 9 Fr Pruitt-Inahara shunt (PIS). An intravenous bag with 0.9% NaCl, pressurised to 90 mmHg, was connected simultaneously to a PIS and to one of the tested ES configurations. The two shunt systems were then opened at the same time. The delivered fluid volumes from the shunt systems were collected and measured. The volume flow rate was subsequently calculated. Steps 2 and 3: Within a heart lung machine circuit, pressure -flow charts were constructed for the individual ES components and for the fully connected optimised endoshunt systems. The flow rate was increased in steps of 40-50 mL/min while monitoring the driving pressure, enabling the creation and comparison of the pressure -flow charts for the individually tested components. In total, seven individual inflow and outflow potential ES components were investigated with inflow and outflow diameters ranging from 6 to 15 Fr.Results: ES systems based on standard donor introducers led to substantially lower volume flow than the corresponding PIS volume flow, whereas ES systems based on dedicated 6 or 8 Fr dialysis access introducers (Prelude Short Sheet, Merit Medical) matched PIS flow rates. The introduction of 30 cm long 1/400 perfusion tubing within the ES system did not affect volume flow for any of the tested ES configurations.Conclusion: Endoshunting techniques can match PIS volume flow rates over short and long distances. The achieved ES flow rate is highly dependent on the components used within the ES system.
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27. |
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28. |
- Nordanstig, Joakim, et al.
(author)
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Are These Pills Made for Walking?
- 2021
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 61:3
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Journal article (peer-reviewed)
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29. |
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30. |
- Nordanstig, Joakim, et al.
(author)
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Game, SET, and Match?
- 2020
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 60:6
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Journal article (other academic/artistic)
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31. |
- Nordanstig, Joakim
(author)
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Hope for the Best, Prepare for the Worst.
- 2020
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165. ; 60:1
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Journal article (other academic/artistic)
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32. |
- Nordanstig, Joakim, et al.
(author)
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Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.
- 2020
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In: The New England journal of medicine. - : Massachusetts Medical Society. - 1533-4406 .- 0028-4793. ; 383, s. 2538-46
-
Journal article (peer-reviewed)abstract
- The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality.No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively).In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
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33. |
- Nordanstig, Joakim, et al.
(author)
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Not Everything That Glitters is Gold, Even When Randomised.
- 2023
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - 1078-5884 .- 1532-2165. ; 66:3, s. 369-370
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Journal article (peer-reviewed)
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34. |
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35. |
- Nordanstig, Joakim, et al.
(author)
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Peripheral arterial disease (PAD)-A challenging manifestation of atherosclerosis
- 2023
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In: Preventive Medicine. - : Academic Press. - 0091-7435 .- 1096-0260. ; 171
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Journal article (peer-reviewed)abstract
- 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.
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36. |
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37. |
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38. |
- Ohlsson, Claes, 1965, et al.
(author)
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Low Progesterone and Low Estradiol Levels Associate with Abdominal Aortic Aneurysms in Men.
- 2022
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In: The Journal of clinical endocrinology and metabolism. - : The Endocrine Society. - 1945-7197 .- 0021-972X. ; 107:4
-
Journal article (peer-reviewed)abstract
- Male sex is a major risk factor for abdominal aortic aneurysms (AAA) but few studies have addressed associations between sex hormone levels and AAA.To describe the associations between serum sex steroids and early, screening-detected AAA in men.We validated a high-sensitivity liquid chromatography-tandem mass spectrometry assay for comprehensive serum sex hormone profiling. This assay was then employed in a case-control study including 147 men with AAA (infrarenal aorta ≥30mm) and 251 AAA-free controls recruited at the general population-based ultrasound screening for AAA in 65-year-old Swedish men.Associations between dehydroepiandrosterone, progesterone, 17α-hydroxyprogesterone, androstenedione, estrone, testosterone, dihydrotestosterone, and estradiol and AAA presence.Dehydroepiandrosterone, progesterone, 17α-hydroxyprogesterone, testosterone, and estradiol, but not the other hormones, were lower in men with AAA. In models with adjustments for known AAA risk factors and comorbidity, only progesterone (odds ratio per SD decrease 1.62 [95% CI 1.18-2.22]) and estradiol (1.40 [95% CI 1.04-1.87]) remained inversely associated with the presence of AAA. Progesterone and estradiol contributed with independent additive information for prediction of AAA presence; compared with men with high (above median) levels, men with low (below median) levels of both hormones had a 4-fold increased odds ratio for AAA (4.06 [95% CI 2.25-7.31]).Measured by a high-performance sex steroid assay, progesterone and estradiol are inversely associated with AAA in men, independently of known risk factors. Future studies should explore whether progesterone and estradiol, which are important reproductive hormones in women, are protective in human AAA.
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39. |
- Perlander, Angelica, et al.
(author)
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Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia
- 2020
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In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214. ; 72:6, s. 1987-1995
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Journal article (peer-reviewed)abstract
- Background: The optimal strategy for revascularization in chronic limb-threatening ischemia (CLTI) is not yet completely known and is still under debate. Endovascular treatment methods predominate despite limited evidence for their advantage. In this concurrent, prospective observational cohort study, we investigated outcomes after open and endovascular revascularization in the femoropopliteal segment for CLTI. Methods: Between March 2011 and January 2015, there were 190 patients presenting with CLTI with the principal target lesion in the superficial femoral or popliteal segment who underwent endovascular intervention (n = 117) or bypass surgery (n = 73) and were observed prospectively. The choice of revascularization technique was based on international and local guidelines. All patients were observed for 2 years. The primary end point was amputation-free survival (AFS) assessed with Kaplan-Meier estimates; secondary end points included CLTI symptom alleviation rates and reintervention rates. A Cox proportional hazards regression model was used to investigate risk factors for amputation and death. Results: AFS at 2 years was 59% in the endovascular group and 76% in the bypass group (P =.020). Kaplan-Meier survival analysis confirmed a significant difference in AFS, with mortality rate as the main driver for the observed intergroup AFS difference. In sequential multivariable regression analysis, the observed difference in AFS between the groups favored bypass surgery and remained significant after controlling for covariates of known prognostic importance (hazard ratio, 2.38; 95% confidence interval, 1.14-4.96). At 2 years, a higher proportion of patients subjected to bypass surgery remained free from ischemic rest pain, wounds, and gangrene (65% vs 45%; P =.009). The proportions of patients who underwent reintervention within 2 years were similar in the two groups (38% vs 39%; P =.90), but repeated reinterventions were more frequent in the bypass group. Conclusions: At 2 years, bypass surgery was associated with higher AFS than endovascular intervention, a finding that could not be explained only by differences in case mix. More patients who had bypass surgery were free from CLTI symptoms at both 1 year and 2 years after revascularization. Reinterventions to maintain patency were equally common after bypass and endovascular intervention. © 2020 Society for Vascular Surgery
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40. |
- Perlander, Angelica, et al.
(author)
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Cost-Effectiveness of Endovascular Intervention Versus Bypass Surgery in Patients With Chronic Limb-Threatening Ischemia and Principal Target Lesion in the Femoropopliteal Segment
- 2022
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In: Journal of Critical Limb Ischemia. - 2694-3026. ; 2:1
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Journal article (peer-reviewed)abstract
- Background. Chronic limb-threatening ischemia (CLTI) commonly requires revascularization to alleviate symptoms and prevent amputation. This study investigates the cost-effectiveness of bypass surgery vs endovascular intervention in CLTI with femoropopliteal lesions. Methods. Between March 2011 and January 2015, a total of 160 CLTI patients, undergoing bypass surgery (n = 55) or endovascular intervention (n = 105), were included in a prospective cohort study. The main study endpoint was quality-adjusted life years (QALYs) based on self-registered EQ-5D-3L questionnaires. Costs were retrieved from the hospi-tal’s cost-per-patient system. The incremental cost-effectiveness ratio (ICER) was calculated as costs per gained QALY and per avoided amputation. Results. QALYs during 2 years of follow-up were 1.04 years (95% CI, 0.89-1.18) in the bypass group and 0.95 years (95% CI, 0.84-1.07) in the endovascular group, with no significant intergroup difference. Amputation-free survival was 78% in the bypass group and 59% in the endovascular group (P<.05). The mean total cost per patient was $42,900 (95% CI, 32,400-53,500) for bypass surgery and $22,200 (95% CI, 17,800-26,600) for endovascular treatment. The cost per gained QALY and per avoided amputation with bypass surgery vs endovascular intervention was $730,000 and $104,000, respec-tively. Conclusion. At 2 years, the mean total hospital cost post bypass surgery was almost twice the cost post endovascular intervention. Although amputation-free survival was higher after bypass surgery, there was no corresponding gain in generic health status. This led to a high additional cost per QALY gained and per amputation avoided with bypass surgery compared with endovascular intervention.
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41. |
- Perlander, Angelica, et al.
(author)
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Disease Specific Health Related Quality of Life in Patients With Chronic Limb Threatening Ischaemia Undergoing Revascularisation of Femoropopliteal Lesions.
- 2023
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In: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - 1078-5884 .- 1532-2165. ; 66:2, s. 245-251
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Journal article (peer-reviewed)abstract
- Patients with chronic limb threatening ischaemia (CLTI) suffer from pain and non-healing ulcers, which impact negatively on both their physical and mental health. While maintaining and improving quality of life is a principal aim with all treatments, little is known about the health related quality of life (HRQoL) of CLTI patients and how revascularisation procedures impact on HRQoL endpoints. The aim of this study was to investigate disease specific HRQoL before and after revascularisation in patients with CLTI undergoing femoropopliteal revascularisation.HRQoL was prospectively analysed in 190 CLTI patients with main atherosclerotic target lesions in the femoropopliteal segment, who were planned for endovascular or open revascularisation. The choice of revascularisation method was made by the vascular team, represented by both open and endovascular expertise. The Vascular Quality of Life (VascuQoL) questionnaire was used to assess disease specific HRQoL before revascularisation and one month, one year, and two years after the procedure. Main endpoints were mean VascuQoL score changes, effect sizes of observed changes and the proportion reaching a minimally important difference (half a standard deviation change from baseline) during two years after revascularisation.Patient reported VascuQoL scores were low at baseline (mean 2.68, 95% CI 1.18 - 4.17). After revascularisation, the mean VascuQoL score improved statistically significantly over time, with the largest improvement observed after one year (difference from baseline 2.02, 95% CI 1.75 - 2.29; p < .001). No differences in HRQoL change over time were observed between patients treated with endovascular approaches compared with bypass surgery. Approximately half the patients reached the minimally important threshold at one year (53%), which was largely maintained also at two years (41%).While CLTI profoundly affected HRQoL, a large and clinically meaningful HRQoL increase was observed after revascularisation. This confirms the value of CLTI revascularisation on HRQoL and underlines the importance of including patient reported outcomes when evaluating revascularisation procedures in CLTI patients.
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42. |
- Rawshani, Araz, 1986, et al.
(author)
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Non-coronary peripheral arterial complications in people with type 2 diabetes: a Swedish retrospective cohort study
- 2024
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In: LANCET REGIONAL HEALTH-EUROPE. - 2666-7762. ; 39
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Journal article (peer-reviewed)abstract
- Background Few studies have explored long-term trends and risk factors for peripheral arterial complications in type 2 diabetes compared to the general population. Our research focuses on identifying optimal risk factors, their significance, risk associated with multifactorial risk factor control, and trends for these complications in diabetic patients versus general controls. Methods This study included persons with type 2 diabetes mellitus entered into the Swedish National Diabetes Register 2001 - 2019 and controls matched for age-, sex- and county of residence. Outcomes comprised of extracranial large artery disease, aortic aneurysm, aortic dissection, lower extremity arterial disease and diabetes foot disease. Standardized incidence rates and Cox regression were used for analyses. Findings The study comprises 655,250 persons with type 2 diabetes mellitus; average age 64.2; 43.8% women. Among persons with type 2 diabetes mellitus, the incidence rates per 100,000 person years for each non-coronary peripheral arterial complication event changed between 2001 and 2019 as follows: extracranial large artery disease 170.0 - 84.9; aortic aneurysm 40.6 - 69.2; aortic dissection 9.3 to 5.6; lower extremity artery disease from 338.8 to 190.8; and diabetic foot disease from 309.8 to 226.8. Baseline hemoglobin A1c (HbA1c), systolic blood pressure (SBP), smoking status and lipid levels were independently associated with all outcomes in the type 2 diabetes mellitus cohort. Within the cohort with type 2 diabetes mellitus, the risk for extracranial large artery disease and lower extremity artery disease increased in a stepwise fashion for each risk factor not within target. Excess risk for non -coronary peripheral arterial complications in the entire cohort for persons with type 2 diabetes mellitus, compared to matched controls, were as follows: extracranial large artery disease adjusted hazard ratio (HR) 1.69 (95% confidence interval (CI), 1.65 - 1.73), aortic aneurysm HR 0.89 (95% CI, 0.87 - 0.92), aortic dissection HR 0.51 (95% CI, 0.46 - 0.57) and lower extremity artery disease HR 2.59 (95% CI, 2.55 - 2.64). Interpretation The incidence of non-coronary peripheral arterial complications has declined significantly among persons with type 2 diabetes mellitus, with the exception of aortic aneurysm. HbA1c, smoking and blood pressure demonstrated greatest relative contribution for outcomes and lower levels of cardiometabolic risk factors are associated with reduced relative risk of outcomes.
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43. |
- Sandberg, Anna, et al.
(author)
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Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial
- 2023
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In: European Journal of Cardiovascular Nursing. - : Oxford University Press (OUP). - 1474-5151 .- 1873-1953. ; 22:4400-411
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Journal article (peer-reviewed)abstract
- Aims Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. Methods and results This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was -11.6 m, 95% confidence interval: -36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin). Conclusion The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year. Registration ClinicialTrials.gov: NCT02341716.
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44. |
- Sandberg, Anna, et al.
(author)
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Impact of walk advice alone or in combination with supervised or home-based structured exercise on patient-reported physical function and generic and disease-specific health related quality of life in patients with intermittent claudication, a secondary analysis in a randomized clinical trial
- 2023
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In: Health and Quality of Life Outcomes. - : BioMed Central (BMC). - 1477-7525. ; 21:1
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Journal article (peer-reviewed)abstract
- BackgroundSupervised exercise is an integral part of the recommended first-line treatment for patients with intermittent claudication (IC). By reflecting the patients’ perspectives, patient-reported outcome measurements provide additional knowledge to the biomedical endpoints and are important outcomes to include when evaluating exercise interventions in patients with IC. We aimed to evaluate the one-year impact of three strategies: unsupervised Nordic pole walk advice (WA), WA + six months of home-based structured exercise (HSEP) or WA + six months of hospital-based supervised exercise (SEP) on health-related quality of life and patient-reported physical function in patients with IC.MethodsThis secondary exploratory analysis of a multi-center, randomized clinical trial compared three exercise strategies. The primary outcome of the secondary analysis was the one-year change in the 36-Item Short-Form (SF-36). Secondary outcomes were three- and six-months SF-36 changes alongside three, six- and 12-months changes in the disease-specific Vascular Quality of Life instrument (VascuQoL) and the Patient-Specific Functional Scale (PSFS). The Kruskal–Wallis test with Bonferroni-adjusted post-hoc tests were used for between-group comparisons. Effect size calculations were used to describe the size of observed treatment effects, and the clinical meaningfulness of observed changes in the VascuQoL summary score at one year was studied using established minimally important difference (MID) thresholds.ResultsA total of 166 patients with IC, mean age: 72.1 (SD 7.4) years, 41% women, were randomized. No significant between-group differences were observed over time for the SF-36 or the PSFS scores whereas some significant between-group differences were observed in the VascuQoL domain and summary scores over time, favoring SEP and/or HSEP over WA. The observed SF-36 and VascuQoL domain and summary score effect sizes were small to moderate, and many domain score effect sizes also remained unchanged over time. A significantly higher proportion of the patients in the SEP group reached the VascuQoL summary score MID of improvement in one year.ConclusionClinically important improvements were observed in SEP using the VascuQoL, while we did not observe any significant between-group differences using the SF-36. Whereas effect sizes for the observed changes over time were generally small, a significantly higher proportion of patients in SEP reached the VascuQoL MID of improvement.
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45. |
- Sandberg, Anna, et al.
(author)
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Test-retest reliability, agreement, and minimal detectable change in the 6-minute walk test in patients with intermittent claudication.
- 2020
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In: Journal of vascular surgery. - : Elsevier BV. - 1097-6809 .- 0741-5214. ; 71:1, s. 197-203
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Journal article (peer-reviewed)abstract
- Standardized walk tests are important for objective assessment of walking distance in patients with intermittent claudication (IC). The 6-minute walk test (6MWT) has been suggested to correlate more closely than testing on a treadmill with everyday ambulatory function, but its measurement properties have hardly been studied in IC. The aim of this study was to determine the test-retest reliability, agreement, standard error of measurement (SEM), and minimal detectable change of the 6MWT in patients with IC.This reliability and agreement study recruited 102 patients with stable IC (mean age, 72± 7.4years; 43 women) from the vascular surgery outpatient clinic at Sahlgrenska University Hospital in Sweden. The patients performed the 6MWT twice, with at least 30minutes of rest between tests. To determine test-retest reliability, the intraclass correlation coefficient was calculated. Bland-Altman plots were used to measure agreement.The mean walking distance in both test and retest was 397.8m (standard deviation, 81.2m; N= 100), and the individual walking distance varied from 175 to 600m. Excellent test-retest reliability for the 6MWT (intraclass correlation coefficient, 0.95; 95% confidence interval, 0.9-0.97) was observed. The SEM was 16.6m (95% confidence interval, 14.6-19.3), the SEM percentage was 4.2%, and the minimal detectable change was 46m. Five observations (5%) were positioned outside the limits of agreement; there was a small proportional bias, and the scatter of values for differences decreased as the average values increased.The excellent test-retest reliability implies that it is sufficient for a patient with IC to perform the 6MWT once, at every test occasion. For the individual, an improvement or deterioration in maximum walking distance of >46m after an intervention would be required to be 95% confident that the change is significant. Being a simple and clinically useful test, the 6MWT can be widely used to evaluate the effects of different interventions in patients with IC.
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46. |
- Sandberg, Anna, et al.
(author)
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The Impact of Nordic Pole Walk Advice Alone or in Combination With Exercise Strategies on Daily Physical Activity in Patients With Intermittent Claudication: A Randomized Clinical Trial.
- 2023
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In: Physical therapy. - 1538-6724. ; 103:11
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Journal article (peer-reviewed)abstract
- The impact of exercise interventions on physical activity (PA) remains undetermined in intermittent claudication, which is why it is important to include objectively measured PA as an additional endpoint. The aim of this prespecified secondary analysis of a randomized clinical trial was to investigate the impact of unsupervised Nordic pole walk advice (WA) alone or in combination with hospital-based supervised exercise (SEP) or home-based structured exercise (HSEP) on PA in patients with intermittent claudication.In total, 166 patients with intermittent claudication (mean age=72 [SD=7.4] y; 41% women) were randomized to 3 intermittent claudication-treatment strategies: WA, WA+SEP, or WA+HSEP. All patients received Nordic poles and standardized WA (≥30min, 3 times weekly). Patients randomized to HSEP and SEP accepted participation in an additional 6-months exercise program. PA was measured with an accelerometer-based activPAL3 monitor for 7days at baseline and at 3, 6, and 12months. PA outcomes were steps per day, time spent within a stepping cadence ≥100 steps per minute, time spent upright, number of body transitions from sitting to standing, and number of sitting bouts of >30minutes and>60minutes.At 1year, no intergroup differences were observed in any of the PA variables, whereas significant intergroup differences were observed at 3months regarding time spent within a stepping time cadence ≥100 steps per minute. The mean change for HSEP (2.47 [SD=10.85] min) was significantly different from the mean change for WA (-3.20 [SD=6.24] min). At 6months, the number of sitting bouts (>60min) for SEP was significantly different from WA (mean change=0.24 [SD=0.69] vs -0.23 [SD=0.81]).This study indicates that the addition of 6months of HSEP or SEP does not improve PA at 1year, as compared to unsupervised WA alone. Factors of importance for increasing PA in patients with intermittent claudication require further investigation.At the 1-year follow-up, the addition of intermittent claudication-tailored additional exercise strategies did not improve daily PA in patients with intermittent claudication compared with unsupervised Nordic pole WA alone. Future studies may explore the role of behavior change techniques to increase PA in this patient group.
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47. |
- Sigvant, Birgitta, et al.
(author)
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Myocardial infarction and peripheral arterial disease : Treatment patterns and long-term outcome in men and women results from a Swedish nationwide study
- 2021
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In: European Journal of Preventive Cardiology. - : Oxford University Press. - 2047-4873 .- 2047-4881. ; 28:13, s. 1426-1434
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Journal article (peer-reviewed)abstract
- Background Differences in comorbidity, pharmacotherapy, cardiovascular (CV) outcome, and mortality between myocardial infarction (MI) patients and peripheral arterial disease (PAD) patients are not well documented. Aim The aim of this study was to compare comorbidity, treatment patterns, CV outcome, and mortality in MI and PAD patients, focusing on sex differences. Methods 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. Results 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. Conclusion 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.
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48. |
- Smidfelt, Kristian, et al.
(author)
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Misdiagnosis of ruptured abdominal aortic aneurysms is common and is associated with increased mortality.
- 2021
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In: Journal of vascular surgery. - : Elsevier BV. - 1097-6809 .- 0741-5214. ; 73:2
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Journal article (peer-reviewed)abstract
- To investigate the rate of misdiagnosis in the emergency department in patients with ruptured abdominal aortic aneurysms (rAAAs), and to investigate how misdiagnosis affects rAAA mortality.Data were extracted from the Swedish Cause of Death Registry and the Swedish National Registry for Vascular Surgery from 2010 to 2015. All rAAA patients registered in the health care system in the west of Sweden were identified. Medical charts for rAAA patients were reviewed, and patients who were correctly diagnosed at the first assessment in the emergency department were compared with patients who were misdiagnosed.Altogether, 455 patients with rAAA were identified, including both patients who underwent surgery and those who did not. One hundred seventy-seven (38.9%) were initially misdiagnosed. The mortality rate was 74.6% in patients who were misdiagnosed, as compared with 62.9% in correctly diagnosed patients (P= .01). The adjusted odds ratio for mortality in misdiagnosed patients relative to correctly diagnosed patients was 1.83 (95% confidence interval, 1.13-2.96) (P= .01). When excluding patients offered palliative care (n= 134) after detection of the rAAA, the mortality in initially misdiagnosed patients was 65.1% as compared with 46.4% in correctly diagnosed patients (P= .001). In patients reaching surgical intervention, 37 (45.1%) of the primarily misdiagnosed patients died (30-day or in-hospital mortality) as compared with 63 (38.0%) of the correctly diagnosed (P= .34).Misdiagnosis is common in patients with rAAA, and it is associated with a substantially higher risk of dying from the ruptured aneurysm.
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