1. |
- Arndt, Helene, et al.
(author)
-
A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.
- 2022
-
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
-
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.
|
|
2. |
- Baubeta Fridh, Erik, 1982, et al.
(author)
-
Editor's Choice - Impact of Comorbidity, Medication, and Gender on Amputation Rate Following Revascularisation for Chronic Limb Threatening Ischaemia
- 2018
-
In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 56:5, s. 681-688
-
Journal article (peer-reviewed)abstract
- Objective/background: Chronic limb threatening ischaemia (CLTI) has a high risk of amputation and mortality. Increased knowledge on how sex, comorbidities, and medication influence these outcomes after revascularisation may help optimise results and patient selection. Methods: This population based observational cohort study included all individuals revascularised for CLTI in Sweden during a five year period (10,617 patients in total). Data were retrieved and merged from mandatory national healthcare registries, and specifics on amputations were validated with individual medical records. Results: Mean age at revascularisation was 76.8 years. Median follow up was 2.7 years (range 0-6.6 years). Male sex (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09-1.33), renal insufficiency (HR 1.57, 95% CI 1.32-1.87), diabetes (HR 1.45, 95% CI 1.32-1.60), and heart failure (HR 1.17, 95% CI 1.05-1.31) were independently associated with an increased amputation rate, whereas the use of statins (HR 0.71, 95% CI 0.64-0.78) and low dose acetylsalicylic acid (HR 0.77, 95% CI 0.70-0.86) were associated with a reduced amputation rate. For the combined end point of amputation or death, an association with increased rates was found for male sex (HR 1.25, 95% CI 1.18-1.32), renal insufficiency (HR 1.94, 95% CI 1.75-2.14), heart failure (HR 1.50, 95% CI 1.40-1.60), and diabetes (HR 1.31, 95% CI 1.23-1.38). The use of statins (HR 0.74, 95% CI 0.67-0.82) and low dose acetylsalicylic acid (HR 0.82, 95% CI 0.77-0.881) were related to a reduced risk of amputation or death. Conclusions: Renal insufficiency is the strongest independent risk factor for both amputation and amputation/ death in revascularised CLTI patients, followed by diabetes and heart failure. Men with CLTI have worse outcomes than women. These results may help govern patient selection for revascularisation procedures. Statin and low dose acetylsalicylic acid are associated with an improved limb outcome. This underlines the importance of preventive medication to reduce general cardiovascular risk and increase limb salvage. (C) 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
|
|
3. |
- Behrendt, Christian-Alexander, et al.
(author)
-
Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia : A Delphi Consensus from the International Consortium of Vascular Registries
- 2019
-
In: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 57:6, s. 816-821
-
Journal article (peer-reviewed)abstract
- Objective: To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries. Methods: A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as >= 80% agreement among participants. Results: Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment. Conclusion: A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.
|
|
4. |
- Behrendt, Christian-Alexander, et al.
(author)
-
International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection
- 2018
-
In: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 217-237
-
Journal article (peer-reviewed)abstract
- Objective/Background: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries.Methods: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions.Results: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up.Conclusion: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.
|
|
5. |
|
|
6. |
- Behrendt, Christian-Alexander, et al.
(author)
-
International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease : A Report from VASCUNET and the International Consortium of Vascular Registries
- 2020
-
In: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 60:6, s. 873-880
-
Journal article (peer-reviewed)abstract
- Objective: The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries. Methods: Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed. Results: Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients' mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days). Conclusion: Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance.
|
|
7. |
- Behrendt, C. A., et al.
(author)
-
International Variations in Amputation Practice: A VASCUNET Report
- 2018
-
In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 56:3, s. 391-399
-
Journal article (peer-reviewed)abstract
- Objectives: To study international differences in incidence and practice patterns as well as time trends in lower limb amputations related to peripheral arterial disease and/or diabetes mellitus. Methods: Data on lower limb amputations during 2010-2014 were collected from population based administrative data from countries in Europe and Australasia participating in the VASCUNET collaboration. Amputation rates, time trends, in hospital or 30 day mortality and reimbursement systems were analysed. Results: Data from 12 countries covering 259 million inhabitants in 2014 were included. Individuals aged >= 65 years ranged from 12.9% (Slovakia) to 20.7% (Germany) and diabetes prevalence among amputees from 25.7% (Finland) to 74.3% (Slovakia). The mean incidence of major amputation varied between 7.2/100,000 (New Zealand) and 41.4/100,000 (Hungary), with an overall declining time trend with the exception of Slovakia, while minor amputations increased over time. The older age group (>= 65 years) was up to 4.9 times more likely to be amputated compared with those younger than 65 years. Reported mortality rates were lowest in Finland (6.3%) and highest in Hungary (20.3%). Countries with a fee for service reimbursement system had a lower incidence of major amputation compared with countries with a population based reimbursement system (14.3/100,000 versus 18.4/100,000, respectively, p < .001). Conclusions: This international audit showed large geographical differences in major amputation rates, by a factor of almost six, and an overall declining time trend during the 4 year observation of this study. Diabetes prevalence, age distribution, and mortality rates were also found to vary between countries. Despite limitations attributable to registry data, these findings are important, and warrant further research on how to improve limb salvage in different demographic settings. (C) 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
|
|
8. |
|
|
9. |
- Gavali, Hamid, et al.
(author)
-
Outcome of Radical Surgical Treatment of Abdominal Aortic Graft and Endograft Infections Comparing Extra-anatomic Bypass with In Situ Reconstruction : A Nationwide Multicentre Study
- 2021
-
In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 62:6, s. 918-926
-
Journal article (peer-reviewed)abstract
- Objective: Abdominal aortic graft and endograft infection (AGI) is primarily treated by resection of the infected graft and restoration of distal perfusion through extra-anatomic bypass (EAB) or in situ reconstruction/repair (ISR). The aim of this study was to compare these surgical strategies in a nationwide multicentre retrospective cohort study.Methods: The Swedish Vascular Registry (Swedvasc) was used to identify surgically treated abdominal AGIs in Sweden between January 1995 and May 2017. The primary aim was to compare short and long term survival, as well as complications for EAB and ISR.Results: Some 126 radically surgically treated AGI patients were identified – 102 graft infections and 24 endograft infections – treated by EAB: 71 and ISR: 55 (23 neo-aorto-iliac systems, NAISs). No differences in early 30 day (EAB 81.7% vs. ISR 76.4%, p =.46), or long term five year survival (48.2% vs. 49.9%, p =.87) were identified. There was no survival difference comparing NAIS to other ISR strategies. The frequency of recurrent graft infection during follow up was similar: EAB 20.3% vs. ISR 17.0% (p =.56). Survival and re-infection rates of the new conduit did not differ between NAIS and other ISR strategies. Age ≥ 75 years (odds ratio [OR] 4.0, confidence interval [CI] 1.1 – 14.8), coronary artery disease (OR 4.2, CI 1.2 – 15.1) and post-operative circulatory complications (OR 5.2, CI 1.2 – 22.5) were associated with early death. Prolonged antimicrobial therapy (> 3 months) was associated with reduced long term mortality (HR 0.3, CI 0.1 – 0.9).Conclusion: In this nationwide multicentre study comparing outcomes of radically treated AGI, no differences in survival or re-infection rate could be identified comparing EAB and ISR.
|
|
10. |
- Gavali, Hamid, et al.
(author)
-
Semi-Conservative Treatment Versus Radical Surgery in Abdominal Aortic Graft and Endograft Infections
- 2023
-
In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 397-406
-
Journal article (peer-reviewed)abstract
- Objective: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort.Methods: Patients with abdominal AGI related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for the definition of AGI. Multivariable regression was performed to identify factors associated with mortality.Results: One hundred and sixty-nine patients with surgically treated abdominal AGI were identified, comprising 43 SC (14 endografts; 53% with a graft enteric fistula [GEF] in total) and 126 RS (26 endografts; 50% with a GEF in total). The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan -Meier estimated five year survival for SC vs. RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan -Meier estimated five year survival for SC patients with a GEF vs. without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC with RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in five year survival comparing SC vs. RS (HR 1.0, 95% CI 0.6 -1.5).Conclusion: In this national AGI cohort, there was no mortality difference comparing SC and RS for AGI when adjusting for comorbidities. Presence of GEF probably negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC treated patients.
|
|
11. |
- Gavali, Hamid, et al.
(author)
-
Semi-Conservative Treatment Versus Surgery in Abdominal Aortic Graft and Endograft Infections
- 2023
-
In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 66:3, s. 397-406
-
Journal article (peer-reviewed)abstract
- OBJECTIVE: Abdominal aortic graft and endograft infections (AGIs) are rare complications following aortic surgery. Radical surgery (RS) with resection of the infected graft and reconstruction with extra-anatomical bypass or in situ reconstruction is the preferred therapy. For patients unfit for RS, a semi-conservative (SC), graft-preserving strategy is possible. This paper aimed to compare survival and infection outcomes between RS and SC treatment for AGI in a nationwide cohort.METHODS: Patients with abdominal AGI-related surgery in Sweden between January 1995 and May 2017 were identified. The Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used for definition of AGI. Multivariable regression was performed to identify factors associated with mortality.RESULTS: A total of 169 patients with surgically treated abdominal AGI were identified, comprising 43 SC [14 endografts; 53% with a graft-enteric fistula (GEF) in total] and 126 RS [26 endografts; 50% with a GEF in total]. The SC cohort was older and had a higher frequency of cardiac comorbidities. There was a non-significant trend towards lower Kaplan-Meier estimated 5-year survival for SC versus RS (30.2% vs. 48.4%; p = .066). A non-significant trend was identified towards worse Kaplan-Meier estimated 5-year survival for SC patients with a GEF versus without a GEF (21.7% vs. 40.1%; p = .097). There were significantly more recurrent graft infections comparing SC versus RS (45.4% vs. 19.3%; p < .001). In a Cox regression model adjusting for confounders, there was no difference in 5-year survival comparing SC versus RS (HR 1.0, 95% CI 0.6 - 1.5).CONCLUSION: In this national AGI cohort, we could not identify any mortality difference comparing SC versus RS for AGI when adjusting for comorbidities. Presence of GEF likely negatively impacts survival outcomes of SC patients. Rates of recurrent infection remain high for SC-treated patients.
|
|
12. |
- Hasvold, Pal, et al.
(author)
-
Long-term cardiovascular outcome, use of resources, and healthcare costs in patients with peripheral artery disease : results from a nationwide Swedish study
- 2018
-
In: European Heart Journal - Quality of Care and Clinical Outcomes. - : OXFORD UNIV PRESS. - 2058-5225 .- 2058-1742. ; 4:1, s. 10-17
-
Journal article (peer-reviewed)abstract
- Aims: Data on long-term healthcare costs of patients with peripheral artery disease (PAD) is limited, and the aim of this study was to investigate healthcare costs for PAD patients at a nationwide level.Methods and results: A cohort study including all incident patients diagnosed with PAD in the Swedish National Patient Register between 2006-2014, and linked to cause of death-and prescribed drug registers. Mean per-patient annual healthcare costs (2015 Euros (sic)) (hospitalisations and out-patient visits) were divided into cardiovascular (CV), lower limb and non-CV related cost. Results were stratified by high and low CV risk. The study included 66,189 patients, with 221,953 observation-years. Mean total healthcare costs were (sic)6,577, of which 26% was CV-related ((sic)1,710), during the year prior to the PAD diagnosis. First year after PAD diagnosis, healthcare costs were (sic)12,549, of which (sic)3,824 (30%) was CV-related and (sic)3,201 (26%) lower limb related. Highrisk CV patients had a higher annual total healthcare and CV related costs compared to low risk CV patients during follow-up ((sic)7,439 and (sic)1,442 versus (sic)4,063 and (sic)838). Annual lower limb procedure costs were (sic)728 in the PAD population, with lower limb revascularisations as key cost driver ((sic)474).Conclusion: Non-CV related hospitalizations and outpatient visits were the largest cost contributors for PAD patients. There is a substantial increase in healthcare costs in the first year after being diagnosed with PAD, driven by PAD follow-up and lower limb related procedures. Among the CV-related costs, hospitalisations and outpatient visits related to PAD represented the largest costs.
|
|
13. |
- Hayderi, Assim, 1990-, et al.
(author)
-
RSAD2 is abundant in atherosclerotic plaques and promotes interferon-induced CXCR3-chemokines in human smooth muscle cells
- 2024
-
In: Scientific Reports. - : Nature Publishing Group. - 2045-2322. ; 14:1
-
Journal article (peer-reviewed)abstract
- In atherosclerotic lesions, monocyte-derived macrophages are major source of interferon gamma (IFN-γ), a pleotropic cytokine known to regulate the expression of numerous genes, including the antiviral gene RSAD2. While RSAD2 was reported to be expressed in endothelial cells of human carotid lesions, its significance for the development of atherosclerosis remains utterly unknown. Here, we harnessed publicly available human carotid atherosclerotic data to explore RSAD2 in lesions and employed siRNA-mediated gene-knockdown to investigate its function in IFN-γ-stimulated human aortic smooth muscle cells (hAoSMCs). Silencing RSAD2 in IFN-γ-stimulated hAoSMCs resulted in reduced expression and secretion of key CXCR3-chemokines, CXCL9, CXCL10, and CXCL11. Conditioned medium from RSAD2-deficient hAoSMCs exhibited diminished monocyte attraction in vitro compared to conditioned medium from control cells. Furthermore, RSAD2 transcript was elevated in carotid lesions where it was expressed by several different cell types, including endothelial cells, macrophages and smooth muscle cells. Interestingly, RSAD2 displayed significant correlations with CXCL10 (r = 0.45, p = 0.010) and CXCL11 (r = 0.53, p = 0.002) in human carotid lesions. Combining our findings, we uncover a novel role for RSAD2 in hAoSMCs, which could potentially contribute to monocyte recruitment in the context of atherosclerosis.
|
|
14. |
- Laboyrie, Suzanne L., et al.
(author)
-
Vascular Access Outcomes in Patients with Autosomal Dominant Polycystic Kidney Disease
- 2024
-
In: KIDNEY360. - : Wolters Kluwer. - 2641-7650. ; 5:6, s. 877-885
-
Journal article (peer-reviewed)abstract
- Key Points More patients with autosomal dominant polycystic kidney disease received their first intervention to re-establish vascular access patency.Patients with autosomal dominant polycystic kidney disease do not require differential monitoring and treatment of hemodialysis vascular access.Background Autosomal dominant polycystic kidney disease (ADPKD) is a leading hereditary cause of ESKD, often using hemodialysis as a form of RRT. Patients with ADPKD may also present with extrarenal manifestations, including arterial aneurysms. The gold standard for hemodialysis access is an arteriovenous vascular access (VA), such as arteriovenous fistulas (AVFs) or arteriovenous grafts (AVGs). However, limitations, such as low VA flow and inadequate AVF outward remodeling, affect VA utilization. This study aimed to explore whether ADPKD affects patency rates of AVFs/AVGs in comparison with other underlying ESKD causes.Methods We conducted a retrospective cohort study using data from the Swedish Renal Registry from 2011 to 2020, with follow-up until 2022. We included 496 patients with ADPKD and 4321 propensity score–matched controls. VA patency rates of patients with ADPKD were compared with those of non-ADPKD patients using Kaplan–Meier survival curves and Mantel–Cox log-rank test. Interventions to maintain or restore patency were also analyzed.Results Patients with ADPKD constituted 8.0% of all patients, with a higher proportion in the pre-ESKD phase during VA creation (51.6% versus 40.6%). No significant differences were observed in primary, postcannulation primary, secondary, or functional patency between patients with ADPKD and non-ADPKD patients. However, more VAs were ligated in patients with ADPKD (10.5% versus 7.7%, P = 0.03), and they underwent more first interventions to re-establish flow (49.4% versus 41.9%, P = 0.02).Conclusions These findings suggest that AVF/AVG patency remains comparable in patients with ESKD with or without ADPKD, and VA monitoring and treatment strategies for patients with ADPKD should align with those for individuals with other ESKD causes.
|
|
15. |
|
|
16. |
- Nordanstig, Joakim, et al.
(author)
-
Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.
- 2020
-
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.).
|
|
17. |
- Pereira Filho, Antonio J. G., et al.
(author)
-
Impact of Ankle Brachial Index Calculations on Peripheral Arterial Disease Prevalence and as a Predictor of Cardiovascular Risk
- 2022
-
In: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 64:2-3, s. 217-224
-
Journal article (peer-reviewed)abstract
- Objective: The aim of this study was to estimate the prevalence and predictive accuracy for cardiovascular (CV) morbidity by using different ankle brachial index (ABI) calculation methods in the general population.Methods: ABI measurements and questionnaire data were collected from 5 080 randomly selected citizens aged 60 - 90 years. A 10 year follow up with data from Swedish national health registries was carried out. ABI was calculated using as numerator the highest (ABI-HI) or the lowest (ABI-LO) ankle BP obtained in each leg. Subjects were defined as references or having peripheral arterial disease (PAD) based on ABI-LO (Group 1) or ABI-HI (Group 2). Prevalence, mortality, CV events and risk were then analysed for these three groups, and their predictive power by using the area under the curve (AUC).Results: A total of 4 909 inhabitants were included in the cohort (References: 83.8%, Group 1: 6.7% and Group 2: 9.6%). The prevalence of PAD was 16% using ABI-LO, and 9.6% using ABI-HI. The 10 year all cause mortality for references and Groups 1 and 2 was 27.6%, 48.8%, and 67.2%, respectively. The overall age adjusted hazard ratio (95% confidence interval) for the composite outcome of CV mortality and a non-fatal CV event was 1.25 (1.06 - 1.49) for Group 1 and 2.11 (1.85 - 2.39) for Group 2. The prediction accuracy for ABI < 0.9 in predicting CV event measured with AUC was 0.60 for ABI-HI and 0.62 for ABI-LO.Conclusion: An ABI < 0.9 should be considered a strong risk marker for future CV morbidity. Applying the traditional ABI calculation method of using the highest measured ankle BP, a group of subjects with high CV risk may be overlooked for intervention, and this why the lowest ankle BP should be the preferred for risk stratification. However, as a single predictive tool an ABI < 0.9 cannot adequately discriminate which individual will have a future CV event regardless of calculation method used.
|
|
18. |
- Sandberg, Anna, et al.
(author)
-
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
-
In: European Journal of Cardiovascular Nursing. - : Oxford University Press (OUP). - 1474-5151 .- 1873-1953. ; 22:4400-411
-
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.
|
|
19. |
- Sandberg, Anna, et al.
(author)
-
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
-
In: Health and Quality of Life Outcomes. - : BioMed Central (BMC). - 1477-7525. ; 21:1
-
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.
|
|
20. |
- Sartipy, Fredrik, et al.
(author)
-
Cardiovascular long-term outcome and prophylactic treatment patterns in peripheral arterial disease in a population-based cohort
- 2019
-
In: European Heart Journal - Quality of Care and Clinical Outcomes. - : OXFORD UNIV PRESS. - 2058-5225 .- 2058-1742. ; 5:4, s. 310-320
-
Journal article (peer-reviewed)abstract
- Aims: This study evaluates 10-year follow-up data on associated comorbidity, mortality, and pharmacological treatment patterns for men and women with different stages of peripheral arterial disease (PAD) in a population-based setting.Methods and results: This was a prospective observational population-based cohort study, based on physical examinations and questionnaires at baseline supplemented with national register data between 2005 and 2015. Subjects were placed in subgroups defined by ankle-brachial index levels and reported symptoms; asymptomatic PAD (APAD), intermittent claudication (IC), severe limb ischaemia (SLI), or references (Ref). Cox proportional hazards regression models were used for analysis with adjustments for sex and baseline age and comorbidity. The cohort consisted of 5080 subjects (45% males). At baseline, APAD, IC, and SLI were prevalent in 559 (11%), 320 (6.3%), and 78 (1.5%) subjects, respectively. A significant increased risk for cardiovascular (CV) death, even when adjusted for age and baseline morbidity, were noted in all PAD stages as compared with reference group with a small difference between APAD and IC, an adjusted hazard ratio 1.80 (confidence interval 1.45-2.22) and 1.95 (1.50-2.53), respectively. Only about 60% of PAD subjects received medical prophylactic treatment as recommended in guidelines.Conclusion: Peripheral arterial disease subjects had significantly increased CV morbidity and mortality risks, especially males. Asymptomatic PAD subjects confer similar risk for CV events as symptomatic patients. Our findings motivate enhanced preventive efforts of all PAD stages, including in asymptomatic disease.
|
|
21. |
- Sartipy, Fredrik, et al.
(author)
-
Presence of asymptomatic Peripheral Arterial Disease in combination with common risk factors elevates the cardiovascular risk Substantially
- 2022
-
In: INTERNATIONAL JOURNAL OF CARDIOLOGY CARDIOVASCULAR RISK AND PREVENTION. - Philadelphia, PA, United States : Elsevier. - 2772-4875. ; 13
-
Journal article (peer-reviewed)abstract
- Background and aims: This study evaluates the risks for adverse cardiovascular (CV) events in Asymptomatic Peripheral Arterial Disease (APAD) combined with different traditional CV risk factors. Methods: A population-based observational study of 8000 subjects, identified 559 subjects as having APAD through ankle-brachial index (ABI) measurements and questionnaires regarding limb symptoms. This cohort and subgroups classified by presence of different traditional CV risk factors at baseline were assessed for 10 years on CV outcome. The recorded endpoints were all-cause mortality, CV mortality and non-fatal CV events. Results: Before subdividing the APAD subjects, the CV mortality incidence was 28.5 deaths per 1000 person-years as compared to 8.7 deaths for references without APAD. For subjects with hypertension at baseline the CV mortality incidence was 35.4 when combined with APAD and 11.7 without. In women with hypertension but without other risk factors, presence of APAD increased the age-adjusted Hazard Ratio (HR) for fatal and non-fatal CV events by 1.86 [CI 1.54,2.24, p < 0.001]. Conclusions: ABI measurements should be considered an important indication for aggressive multifactorial risk factor reduction in populations with any other prevalent CV risk factor. In hypertension, diabetes mellitus and a smoking history, coexisting APAD contributes significantly to the increased age-adjusted CV risk.
|
|
22. |
- Sartipy, Fredrik, et al.
(author)
-
Ten Year Mortality in Different Peripheral Arterial Disease Stages : A Population Based Observational Study on Outcome
- 2018
-
In: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 55:4, s. 529-536
-
Journal article (peer-reviewed)abstract
- Objective: The aim was to determine long-term mortality rates and the underlying cause of death for subjects with different peripheral arterial disease (PAD) stages in a population based setting. Methods: A randomly selected population sample of 5080 subjects was enrolled in the study in 2004-2005. Participants completed health state questionnaires and underwent ankle brachial index (ABI) measurements for classification into PAD severity stages and reference subjects. A follow-up was conducted by the end of 2015 using data from Swedish governmental national registers for cause of death, which was then compared with PAD stage determined at baseline in 2005. Results: The 10 year all cause mortality was 27% for reference cases, 56% for asymptomatic PAD (APAD), 63% for intermittent claudication (IC), and 75% for severe limb ischaemia (SLI). Among all PAD subjects, cardiovascular (CV) causes were the most common main cause of death (45%) and a CV event was present as either the main or one of the three most common contributing causes of death in 64% of the cases. The age adjusted hazard ratios for a main cause of death by a CV event were 1.9 (95% CI 1.5-2.3) for APAD, 2.6 (95% CI 2.1-3.4) for IC, and 3.5 (95% CI 2.3-5.2) for SLI. Conclusion: PAD subjects, including the APAD subjects, are still at high risk of CV death. The mortality risks are more than doubled in symptomatic PAD patients compared with reference subjects and increase by severity of PAD stage. Awareness and improved risk reduction management of PAD are still warranted.
|
|
23. |
|
|
24. |
- Sigvant, Birgitta, et al.
(author)
-
Cardiovascular outcomes in patients with peripheral arterial disease as an initial or subsequent manifestation of atherosclerotic disease : Results from a Swedish nationwide study
- 2017
-
In: Journal of Vascular Surgery. - : MOSBY-ELSEVIER. - 0741-5214 .- 1097-6809. ; 66:2, s. 507-514e1
-
Journal article (peer-reviewed)abstract
- Objective: Long-term progression of peripheral arterial disease (PAD) as initial manifestation of atherosclerotic arterial disease is not well described. Cardiovascular (CV) risk was examined in different PAD populations diagnosed in a hospital setting in Sweden. Methods: Data for this retrospective cohort study were retrieved by linking data on morbidity, medication use, and mortality from Swedish national registries. Primary CV outcome was a composite of myocardial infarction, ischemic stroke (IS), and CV death. Kaplan-Meier analysis and Cox proportional hazards modeling was used for describing risk and relative risk. Results: Of 66,189 patients with an incident PAD diagnosis (2006-2013), 40,136 had primary PAD, 16,786 had PAD _ coronary heart disease (CHD), 5803 had PAD _IS, and 3464 had PAD _IS _CHD. One-year cumulative incidence rates of major CV events for the groups were 12%, 21%, 29%, and 34%, respectively. Corresponding numbers for 1-year all-cause death were 16%, 22%, 33%, and 35%. Compared with the primary PAD population, the relative risk increase for CV events was highest in patients with PAD _IS _CHD (hazard ratio [HR], 2.01), followed by PAD _IS (HR, 1.87) and PAD _ CHD (HR, 1.42). Despite being younger, the primary PAD population was less intensively treated with secondary preventive drug therapy. Conclusions: PAD as initial manifestation of atherosclerotic disease diagnosed in a hospital-based setting conferred a high risk: one in eight patients experienced a major CV event and one in six patients died within 1 year. Despite younger age and substantial risk of future major CV events, patients with primary PAD received less intensive secondary preventive drug therapy.
|
|
25. |
- Sigvant, Birgitta, et al.
(author)
-
Contemporary cardiovascular risk and secondary preventive drug treatment patterns in peripheral artery disease patients undergoing revascularization.
- 2016
-
In: Journal of vascular surgery. - : Elsevier BV. - 1097-6809 .- 0741-5214. ; 64:4
-
Journal article (peer-reviewed)abstract
- Peripheral artery disease (PAD) is common worldwide, and PAD patients are increasingly offered lower limb revascularization procedures. The aim of this population-based study was to describe the current risk for cardiovascular (CV) events and mortality and also to elucidate the current pharmacologic treatment patterns in revascularized lower limb PAD patients.This observational, retrospective cohort study analyzed prospectively collected linked data retrieved from mandatory Swedish national health care registries. The Swedish National Registry for Vascular Surgery database was used to identify revascularized PAD patients. Current risk for CV events and death was analyzed, as were prescribed drugs aimed for secondary prevention. A Cox proportional hazard regression model was used to explore risk factors for suffering a CV event.Between May 2008 and December 2013, there were 18,742 revascularized PAD patients identified. Mean age was 70.0years among patients with intermittent claudication (IC; n= 6959) and 76.8years among patients with critical limb ischemia (CLI; n= 11,783). Antiplatelet therapy, statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and beta-blockers were used by 73%, 60%, 57%, and 49% at admission for revascularization. CV event rate (a composite of myocardial infarction, ischemic stroke, or CV death) at 12, 24, and 36months was 5.1% (95% confidence interval [CI], 4.5-5.6), 9.5% (95% CI, 8.7-10.3), and 13.8% (95% CI, 12.8-14.8) in patients with IC and 16.8% (95% CI, 16.1-17.6), 25.9% (95% CI, 25.0-26.8), and 34.3% (95% CI, 33.2-35.4) in patients with CLI. Best medical treatment, defined as any antiplatelet or anticoagulant therapy along with statin treatment, was offered to 65% of IC patients and 45% of CLI patients with little change during the study period. Statin therapy was associated with reduced CV events (hazard ratio, 0.76; 95% CI, 0.71-0.81; P< .001), whereas treatment with low-dose aspirin was not.Revascularized PAD patients are still at a high risk for CV events without a declining time trend. A large proportion of both IC and CLI patients were not offered best medical treatment. The most commonly used agent was aspirin, which was not associated with CV event reduction. This study calls for improved medical management and highlights an important and partly unmet medical need among revascularized PAD patients.
|
|
26. |
- Sigvant, Birgitta, et al.
(author)
-
Differences in presentation of symptoms between women and men with intermittent claudication
- 2011
-
In: BMC Cardiovascular Disorders. - : BioMed Central. - 1471-2261 .- 1471-2261. ; 11:39
-
Journal article (peer-reviewed)abstract
- Background: More women than men have PAD with exception for the stage intermittent claudication (IC). The purpose of this study was to evaluate differences in disease characteristics between men and women when using current diagnostic criteria for making the diagnosis IC, defined as ABI less than 0.9 and walking problems. Study Design: Cohort study Methods: 5040 elderly (median age 71) subjects participated in a point-prevalence study 2004. They had their ABI measured and filled out questionnaires covering medical history, current medication, PAD symptoms and walking ability. The prevalence of IC was 6.5% for women and 7.2% for men (P = 0.09). A subset of subjects with IC (N = 56) was followed up four years later with the same procedures. They also performed additional tests aiming to determine all factors influencing walking ability. Results: Men with IC had more concomitant cardiovascular disease and a more profound smoking history than women. Women, on the other hand, reported a lower walking speed (P less than 0.01) and more joint problems (P = 0.018). In the follow up cohort ABI, walking ability and amount of atherosclerosis were similar among the sexes, but women more often reported atypical IC symptoms. Conclusion: Sex differences in the description of IC symptoms may influence diagnosis even if objective features of PAD are similar. This may influence accuracy of prevalence estimates and selection to treatment.
|
|
27. |
- Sigvant, Birgitta
(author)
-
Epidemiological aspects of peripheral arterial disease
- 2009
-
Doctoral thesis (other academic/artistic)abstract
- Peripheral arterial disease (PAD) is defined as atherosclerosis in the arteries distal to the aortic bifurcation, with or without symptoms in the legs. It is diagnosed by ankle brachial pressure index (ABI) measurements and symptoms, and a confirmed diagnosis is associated with an increased cardiovascular (CV) mortality reaching the same levels as in patients with symptomatic coronary disease. The overall aim of this study was to describe PAD epidemiology and its consequences from a societal perspective with special focus on sex differences. Eight-thousand subjects, aged 60-90 years, were selected at random and invited to participate in a survey performed in 2004. Of those 63% participated and had their ABI measured and they also completed questionnaires covering medical history, current medication, PAD symptoms and walking ability. A subset of subjects with intermittent claudication (IC) at inclusion was followed up 2008 with the same procedures. A walking test and duplex scanning of leg arteries, echocardiography and an interview were added to gain further insight of disease specifics. Survey data and published studies were finally used to estimate cost-effectiveness of CV risk prevention with drugs in subclinical PAD. PAD prevalence was 18% and varied with stage of disease, geographic region and patients' sex. Women dominated when diagnosis was based on ABI only, but for diagnosis of IC, it was more frequent among men. The prevalence of critical limb ischemia was around one percent. Risk factor profiles differed among PAD stages and sexes. Men, for example, reported having diabetes mellitus and stroke more often than women, who in turn reported hypertension more frequently. Smoking for 10 years was associated with having PAD in women, but for men this relationship occurred first after 30 years of smoking. Women also reported use of less CV preventive medication. Women with IC had a lower walking speed and more joint problems than men, and in the follow up cohort most IC disease specifics were similar. Another difference was that women reported atypical symptoms more often than men. The cost-effectiveness modelling revealed that of the evaluated drugs, ACE-inhibitors (ACE-i), statins, aspirin and clopidogrel, there were differences. ACE-i displayed the largest reduction of CV events leading to the highest mean gain in quality-adjusted life-years compared with the other treatments. It was far below willingness to pay thresholds. Aspirin treatment did not appear to be cost-effective due to low rate of event reduction. In conclusion, the studies performed in this thesis points out that PAD is common among elderly, and especially so in women. Risk factors occurring simultaneously with PAD are the known ones and many subjects with this disease have only PAD and do not report smoking habits. A majority is not medicating to reduce their high CV disease risk. Diagnosis of IC is a particular problem for epidemiological studies, and the prevalence of this PAD stage may therefore be underestimated in women. ACE-i may be the drug of choice for early prevention of CV risk in PAD and the benefits of aspirin may be overrated.
|
|
28. |
- Sigvant, Birgitta, et al.
(author)
-
Myocardial infarction and peripheral arterial disease : Treatment patterns and long-term outcome in men and women results from a Swedish nationwide study
- 2021
-
In: European Journal of Preventive Cardiology. - : Oxford University Press. - 2047-4873 .- 2047-4881. ; 28:13, s. 1426-1434
-
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.
|
|
29. |
- Sigvant, Birgitta, et al.
(author)
-
Risk factor profile and use of cardiovascular drugprevention in women and men with peripheral artery disease
- 2009
-
In: European Journal of Cardiovascular Prevention & Rehabilitation. - 1741-8267 .- 1741-8275. ; 16:1, s. 39-46
-
Journal article (peer-reviewed)abstract
- Objective To determine cardiovascular comorbidities and use of cardiovascular disease preventive drugs in patients with peripheral arterial disease (PAD), with special attention to sex differences. Design A cross-sectional point-prevalence study. Patients A population sample of patients that are 60-90 years old. Setting Primary care areas in four Swedish regions. Main outcome measures Prevalence of PAD stages, comorbidities and medication use. Results The prevalence of any type of PAD was 18.0% (range 16-20), of asymptomatic peripheral arterial disease (APAD) was 11.1% (range 9-13), intermittent claudication was 6.8% (range 6.5-7.1), and of critical limb ischemia (CLI) was 1.2% (range 1.0-1.5). APAD and CLI were more common in women. Statins were used by 17.5% (range 16.9-18.2), 29.4% (range 29.0-30.1), and 30.3% (range 29.9-30.8) of the patients with APAD, intermittent claudication, and CLI, respectively, and antiplatelet therapy was reported by 34.1% (range 33.7-34.3), 47.6% (range 47.3-47.9), and 60.2% (range 59.1-60.7). The odds ratio for having APAD was 1.7 (range 1.2-2.4) for women with a smoking history of 10 years in relation to nonsmokers. This association was observed only in men who had smoked for at least 30 years or more. Preventive drug use was more common in men with PAD. Compared with women they had an odds ratio of 1.3 (range 1.1-1.5) for lipid-lowering therapy, 1.3 (range 1.0-1.7) for β-blockers or angiotensin-converting enzyme inhibitors, and 1.5 (range 1.2-1.9) for antiplatelet therapy. Conclusion The patients' risk factor profiles differed among the PAD stages. Smoking duration already seemed to be a risk factor for women with PAD after 10 years of smoking, as compared with 30 years for men, and fewer women reported use of preventive medication. These observations may partly explain the sex differences in prevalence that were observed.
|
|
30. |
- Sigvant, Birgitta, et al.
(author)
-
The Swedish vascular registry Swedvasc 1987-2018 : 31years of quality improvement and research
- 2019
-
In: Gefässchirurgie. - : SPRINGER HEIDELBERG. - 0948-7034 .- 1434-3932. ; 24:1, s. 21-26
-
Journal article (peer-reviewed)abstract
- The Swedish vascular registry, Swedvasc, was created in 1987 as aregional registry and achieved national coverage in 1994. This article describes how the registry developed during those 31years. The aims of the registry were to enhance quality improvement and research within the field of vascular surgery. The registry was validated on several occasions and in 2015 an independent international validation took place, showing both excellent external (no missing cases) and internal validity (comparing the variables in the registry with case records). The Swedvasc was instrumental in the creation of Vascunet in 1997, the international collaboration of vascular registries in Europe, Australia and New Zealand. Enabling international comparisons of indications, techniques and outcomes has proven to be agreat force in quality improvement. This collaboration is now turning global, including the North American registry the Society for Vascular Surgery Vascular Quality Initiative (SVS-VQI) and hopefully soon also including the Japanese registry. The Swedvasc is used as an integral part of routine healthcare and over 10,000 procedures are registered annually. This provides clinicians, clinics, health authorities and researchers with real-world data from an unselected nationwide population. Registry data have been used to describe patterns of treatment and outcomes over time and for monitoring quality of care locally, nationally and internationally and for quality improvement projects. The clinical data available in Swedvasc provide an important source not only for assessment and development of healthcare but also for research and over 100 original articles based on Swedvasc data have been published. Arandomization module has been included in the registry since 2014 and opens up anew clinical trial paradigm; registry-based randomized clinical trials.
|
|
31. |
- Welander, Gunilla, et al.
(author)
-
Validating vascular access data in the Swedish Renal Registry SRR
- 2021
-
In: Journal of Vascular Access. - : Sage Publications. - 1129-7298 .- 1724-6032. ; 22:4, s. 629-634
-
Journal article (peer-reviewed)abstract
- Background: All Swedish dialysis units register data on vascular access in the Swedish Renal Registry (SRR). This study assessed external and internal validity of vascular access data in the SRR and its use as a tool in clinical practice. Methods: For external validation, all procedures for placed fistulas, open and endovascular reinterventions registered in the SRR in 2011 to 2017 were cross-matched with data from the Swedish National Patient Registry. A two-stage sampling selected 12/60 dialysis units for internal validation. Data on current vascular access for 10 randomly selected patients at each unit were compared with medical record data. SRR data on placed fistulas from 2017 were cross-checked with data from local surgical units. Registrations of central venous catheters (CVCs) as temporary or permanent were used as a proxy for clinical utilization of the registry and analyzed separately. Results: External validity increased from 74% to 83% during the observation period. In all, 1037 datapoints were used in internal validation, with a 95% match between SRR registrations and medical records. Registrations of CVCs, fistulas, and interventions were reliable, with few missing data or mismatches. Vascular access type initiating hemodialysis was missing or incorrect in either the SRR or medical records for 14/120 patients. Registrations of placed fistulas in 2017 matched in all but four (pre-dialysis stage) of 135 cases. Some 35% of the CVCs validated (n = 49) at 7/12 units were not categorized as temporary or permanent. Conclusion: The SRR provides a reliable resource on current vascular access care.
|
|