Understanding delays in chronic limb-threatening ischaemia care: Application of the theoretical domains framework to identify factors affecting primary care clinicians' referral behaviours.

INTRODUCTION: Patients in the community with suspected Chronic limb-threatening ischaemia (CLTI) should be urgently referred to vascular services for investigation and management. The Theoretical Domains Framework (TDF) allows identification of influences on health professional behaviour in order to inform future interventions. Here, the TDF is used to explore primary care clinicians' behaviours with regards to recognition and referral of CLTI. METHODS: Semi-structured interviews were conducted with 20 podiatrists, nurses and general practitioners in primary care. Directed content analysis was performed according to the framework method. Utterances were coded to TDF domains, and belief statements were defined by grouping similar utterances. Relevance of domains was confirmed according to belief frequency, presence of conflicting beliefs and the content of the beliefs indicating relevance. RESULTS: Nine TDF domains were identified as relevant to primary care clinicians: Knowledge, Environmental context and resources, Memory, Decision and attention processes, Beliefs about capabilities, Skills, Emotions, Reinforcement and Behavioural regulation. Relationships across domains were identified, including how primary care clinician confidence and working in a highly pressurized environment can affect behaviour. CONCLUSION: We have identified key barriers and enablers to timely recognition and referral behaviour. These beliefs identify targets for theory-driven behaviour change interventions to reduce delays in CLTI pathways.

Outcomes Following Intact and Ruptured Aneurysm Repair across Nations: Analysis of International Registry Data from the VASCUNET Collaboration 2014 - 2019.

OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.

The symptom to assessment pathway for suspected chronic limb-threatening ischaemia (CLTI) affects quality of care: a process mapping exercise.

BACKGROUND: Delays in the pathway from first symptom to treatment of chronic limb-threatening ischaemia (CLTI) are associated with worse mortality and limb loss outcomes. This study examined the processes used by vascular services to provide urgent care to patients with suspected CLTI referred from the community. METHODS: Vascular surgery units from various regions in England were invited to participate in a process mapping exercise. Clinical and non-clinical staff at participating units were interviewed, and process maps were created that captured key staff and structures used to create processes for referral receipt, triage and assessment at the units. RESULTS: Twelve vascular units participated, and process maps were created after interviews with 45 participants. The units offered multiple points of access for urgent referrals from general practitioners and other community clinicians. Triage processes were varied, with units using different mixes of staff (including medical staff, podiatrists and s) and this led to processes of varying speed. The organisation of clinics to provide slots for 'urgent' patients was also varied, with some adopting hot clinics, while others used dedicated slots in routine clinics. Service organisation could be further complicated by separate processes for patients with and without diabetes, and because of the organisation of services regionally into vascular networks that had arterial and non-arterial centres. CONCLUSIONS: For referred patients with symptoms of CLTI, the points of access, triage and assessment processes used by vascular units are diverse. This reflects the local context and ingenuity of vascular units but can lead to complex processes. It is likely that benefits might be gained from simplification.

The Impact of Pre-Operative Anaemia on One Year Amputation Free Survival and Re-Admissions in Patients Undergoing Vascular Surgery for Peripheral Arterial Disease: a National Vascular Registry Study.

OBJECTIVE: Anaemia is common among patients undergoing surgery, but its association with post-operative outcomes in patients with peripheral arterial disease (PAD) is unclear. The aim of this observational population based study was to examine the association between pre-operative anaemia and one year outcomes after surgical revascularisation for PAD. METHODS: This study used data from the National Vascular Registry, linked with an administrative database (Hospital Episode Statistics), to identify patients who underwent open surgical lower limb revascularisation for PAD in English NHS hospitals between January 2016 and December 2019. The primary outcome was one year amputation free survival. Secondary outcomes were one year re-admission rate, 30 day re-intervention rate, 30 day ipsilateral major amputation rate and 30 day death. Flexible parametric survival analysis and generalised linear regression were performed to assess the effect of anaemia on one year outcomes. RESULTS: The analysis included 13 641 patients, 57.9% of whom had no anaemia, 23.8% mild, and 18.3% moderate or severe anaemia. At one year follow up, 80.6% of patients were alive and amputation free. The risk of one year amputation or death was elevated in patients with mild anaemia (adjusted HR 1.3; 95% CI 1.15 - 1.41) and moderate or severe anaemia (aHR 1.5; 1.33 - 1.67). Patients with moderate or severe anaemia experienced more re-admissions over one year (adjusted IRR 1.31; 1.26 - 1.37) and had higher odds of 30 day re-interventions (aOR 1.22; 1.04 - 1.45), 30 day ipsilateral major amputation (aOR 1.53; 1.17 - 2.01), and 30 day death (aOR 1.39; 1.03 - 1.88) compared with patients with no anaemia. CONCLUSION: Pre-operative anaemia is associated with lower one year amputation free survival and higher one year re-admission rates following surgical revascularisation in patients with PAD. Research is required to evaluate whether interventions to correct anaemia improve outcomes after lower limb revascularisation.

Outcomes after minor lower limb amputation for peripheral arterial disease and diabetes: population-based cohort study.

BACKGROUND: Patients with diabetes and peripheral arterial disease are at increased risk of minor amputation. The aim of study was to assess the rate of re-amputations and death after an initial minor amputation, and to identify associated risk factors. METHODS: Data on all patients aged 40 years and over with diabetes and/or peripheral arterial disease, who underwent minor amputation between January 2014 and December 2018, were extracted from Hospital Episode Statistics. Patients who had bilateral index procedures or an amputation in the 3 years before the study were excluded. Primary outcomes were ipsilateral major amputation and death after the index minor amputation. Secondary outcomes were ipsilateral minor re-amputations, and contralateral minor and major amputations. RESULTS: In this study of 22 118 patients, 16 808 (76.0 per cent) were men and 18 473 (83.5 per cent) had diabetes. At 1 year after minor amputation, the estimated ipsilateral major amputation rate was 10.7 (95 per cent c.i. 10.3 to 11.1) per cent. Factors associated with a higher risk of ipsilateral major amputation included male sex, severe frailty, diagnosis of gangrene, emergency admission, foot amputation (compared with toe amputation), and previous or concurrent revascularization. The estimated mortality rate was 17.2 (16.7 to 17.7) per cent at 1 year and 49.4 (48.6 to 50.1) per cent at 5 years after minor amputation. Older age, severe frailty, comorbidity, gangrene, and emergency admission were associated with a significantly higher mortality risk. CONCLUSION: Minor amputations were associated with a high risk of major amputation and death. One in 10 patients had an ipsilateral major amputation within the first year after minor amputation and half had died by 5 years.

Effectiveness of quality improvement collaboratives in UK surgical settings and barriers and facilitators influencing their implementation: a systematic review and evidence synthesis.

BACKGROUND: High-quality surgical care is vital to deliver the excellent outcomes patients deserve following surgical treatment. Quality improvement collaboratives (QICs) are based on a multicentre model for improving healthcare. They are increasingly used but their effectiveness in the context of surgical services is unclear. This review assessed effectiveness of QICs in National Health Service (NHS) surgical settings, and identified factors that influenced implementation. METHODS: A systematic search of MEDLINE and EMBASE, as well as grey literature, was conducted in January 2022 to identify evaluations of QICs in NHS surgical settings. Data were extracted on the intervention, setting, study results and factors that were identified as facilitators or barriers. These were coded using the Consolidated Framework for Implementation Research (CFIR). The quality of study reports was assessed using Quality Improvement Minimum Criteria Set. RESULTS: Fifteen reports on 10 QICs met inclusion criteria. The evaluations used study designs of different strength, with one using a stepped-wedge randomised controlled trial (RCT). Eight studies reported the QIC had been successful in achieving their principal aims, which covered a mix of patient outcomes and process indicators. The study based on the RCT found the QIC was not successful (no improvement in patient outcomes). Each article reported a range of facilitators and barriers to effectiveness of implementation of the QIC, which were spread across the CFIR domains (intervention, outer setting, inner setting, individuals and process). There were few barriers reported in the intervention domain that related to the QIC. There was no clear relationship between numbers of facilitators and barriers reported and effectiveness. CONCLUSIONS: Studies have reported QICs to be effective in increasingly complex contexts, but their results must be treated with caution. The evaluations often used weak study designs and the quality of reports was variable. Evaluation with strong study design should be integral to future QICs. PROSPERO REGISTRATION NUMBER: CRD42022324970.

Editor's Choice - Outcomes of Surgery for Patients with Peripheral Arterial Disease During the COVID-19 Pandemic in the United Kingdom: A Population Based Study.

OBJECTIVE: There is limited information on changes in the patterns of care and outcomes for patients who had vascular procedures after the first wave of the COVID-19 pandemic. The aim of this population based study was to examine the patterns of care and outcomes for vascular lower limb procedures in the UK during the COVID-19 pandemic. METHODS: Lower limb revascularisations and major amputations performed from January 2019 to April 2021 in the UK and entered in the National Vascular Registry were included in the study. The primary outcome was in hospital post-operative death and secondary outcomes were complications and re-interventions. The study was divided into Pre-pandemic (1 January 2019 - 29 February 2020), Wave 1 (1 March - 30 June 2020), Respite (1 July - 31 October 2020), Wave 2/3 (1 November 2020 - 30 April 2021). RESULTS: The study included 36 938 procedures (7 245 major amputations, 16 712 endovascular, 12 981 open revascularisations), with 15 501 procedures after March 2020, a 27.7% reduction compared with pre-pandemic. The proportion of open surgical procedures performed under general anaesthetic was lower in Wave 1 and after compared with pre-pandemic (76.7% vs. 81.9%, p < .001). Only 4.6% of patients in the cohort had SARS-CoV-2 infection (n = 708), but their in hospital post-operative mortality rate was 25.0% (n = 177), six times higher than patients without SARS-CoV-2 (adjusted odds ratio 5.88; 95% CI 4.80 - 7.21, p < .001). The in hospital mortality rate was higher during the pandemic than pre-pandemic after elective open and endovascular revascularisation (respectively 1.6% vs. 1.1%, p = .033, and 0.9% vs. 0.5%, p = .005) and after major amputations (10.4% during Wave 2/3 vs. 7.7% pre-pandemic, p = .022). CONCLUSION: There was excess post-operative mortality rate for patients undergoing lower limb vascular procedures during the pandemic, which was associated with SARS-CoV-2 infections. Further research should be conducted on long term outcomes of patients operated on during the COVID-19 pandemic period.

Evaluation of the ICD-10 system in coding revascularisation procedures in patients with peripheral arterial disease in England: A retrospective cohort study using national administrative and clinical databases.

Background: Many studies evaluating care in hospitals in England use the Hospital Episode Statistics (HES) administrative database. The aim of this study was to explore whether the International Classification of Diseases 10th Revision (ICD-10) system used by HES supported the evaluation of care received by patients with peripheral arterial disease (PAD) who had revascularisation. Methods: This retrospective cohort study used records on patients who had revascularisation for PAD between 1st January 2017 and 31st December 2019 in England, collected prospectively in the National Vascular Registry (NVR) and linked to HES. Patients were excluded if their NVR record did not have a match in HES, due to lack of consent or different admission and procedure dates. Agreement between different presentations of PAD recorded in the NVR and the ICD-10 diagnostic codes recorded in HES was evaluated using the unweighted Kappa statistic and sensitivity and specificity. Agreement between the NVR and HES was also assessed for gender, age, comorbidities, mode of admission, and procedure type and side. Findings: In total, 20,603 patients who had 24,621 admissions were included in the study. Agreement between NVR and HES on patient gender (Kappa = 0.98), age (Kappa = 0.98), mode of admission (Kappa = 0.80), and procedure type and side (Kappa = 0.92 and 0.87, respectively) was excellent. When all diagnostic fields in HES were explored, substantial agreement was observed for chronic ischaemia with tissue loss (Kappa = 0.63), but it was lower for chronic ischaemia without tissue loss (Kappa = 0.32) and acute limb ischaemia (Kappa = 0.15). Agreement on comorbidities was mixed; excellent for diabetes (Kappa = 0.82), moderate for chronic lung disease (Kappa = 0.56), chronic kidney disease (Kappa = 0.56), and ischaemic heart disease (Kappa = 0.45) and fair for chronic heart failure (Kappa = 0.35). Interpretation: The diagnostic ICD-10 codes currently used in HES cannot accurately differentiate between stages of PAD. Therefore, studies using HES to examine patterns of care and outcomes for patients with PAD are likely to suffer from misclassification bias. Adopting an extended ICD-10 system or the ICD-11 version released to the World Health Organisation member states in 2022, may overcome this problem. Funding: Healthcare Quality Improvement Partnership (HQIP).

Delays to revascularization for patients with chronic limb-threatening ischaemia.

BACKGROUND: Vascular services in England are organized into regional hub-and-spoke models, with hubs performing arterial surgery. This study examined time to revascularization for chronic limb-threatening ischaemia (CLTI) within and across different care pathways, and its association with postrevascularization outcomes. METHODS: Three inpatient and four outpatient care pathways were identified for patients with CLTI undergoing revascularization between April 2015 and March 2019 using Hospital Episode Statistics data. Differences in times from presentation to revascularization across care pathways were analysed using Cox regression. The relationship between postoperative outcomes and time to revascularization was evaluated by logistic regression. RESULTS: Among 16 483 patients with CLTI, 9470 had pathways starting with admission to a hub or spoke hospital, whereas 7013 (42.5 per cent) were first seen at outpatient visits. Among the inpatient pathways, patients admitted to arterial hubs had shorter times to revascularization than those admitted to spoke hospitals (median 5 (i.q.r. 2-10) versus 12 (7-19) days; P < 0.001). Shorter times to revascularization were also observed for patients presenting to outpatient clinics at arterial hubs compared with spoke hospitals (13 (6-25) versus 26 (15-35) days; P < 0.001). Within most care pathways, longer delays to revascularizsation were associated with increased risks of postoperative major amputation and in-hospital death, but the effect of delay differed across pathways. CONCLUSION: For patients with CLTI, time to revascularization was influenced by presentation to an arterial hub or spoke hospital. Generally, longer delays to revascularization were associated with worse outcomes, but the impact of delay differed across pathways.

Carotid Endarterectomy Following Intravenous Thrombolysis in the UK.

OBJECTIVE: The aim of this study was to evaluate the effect of pre-operative intravenous thrombolytic therapy (ivTT) on short term outcomes after carotid endarterectomy (CEA) among patients who presented with ischaemic stroke. METHODS: A retrospective study using a large population based dataset from the National Vascular Registry in the United Kingdom (UK-NVR). The cohort included adult patients who underwent CEA for ischaemic stroke between 1 January 2014 and 31 December 2019. NVR records provided information on patient demographics, Rankin score, medication, time from onset of symptoms to surgery and whether the patient received ivTT prior to surgery. Logistic regression was used to evaluate the relationship between ivTT and rates of any stroke at 30 days after CEA and in hospital complication rates for neck haematoma. Secondary outcomes included in hospital cardiac and respiratory complications, and cranial nerve injury. RESULTS: Between 2014 and 2019, 9 030 patients presented with a stroke and underwent CEA, of whom 1 055 (11.7%) had received pre-operative ivTT. Those receiving ivTT were younger (mean 70.6 vs. 72.0 years, p < .001). The median (IQR) time from symptom to CEA was 10 days (6 - 17) for ivTT patients and 11 days (7 - 20) for CEA patients not receiving ivTT. Post-operative rates of 30 day stroke were similar between the no ivTT (2.1%) and ivTT (1.8%) cohorts (p = .48). In hospital neck haematomas were statistically significantly more common in CEA patients receiving ivTT (3.7%) vs. no ivTT (2.3%) (p = .006). There was no statistically significant association between 30 day stroke and neck haematoma complications when stratified for delays from symptom onset to CEA, but the overall cohort contained few adverse events for analysis during the very early time period. CONCLUSION: The use of ivTT before CEA in stroke patients was not associated with an increased risk of 30 day stroke, but there was an increase in the risk of neck haematoma.

Editor's Choice - Variation in Intact Abdominal Aortic Aneurysm Repair Outcomes by Country: Analysis of International Consortium of Vascular Registries 2010 - 2016.

OBJECTIVE: Outcomes for intact abdominal aortic aneurysm (AAA) repair vary over time and by healthcare system, country, and surgeon. The aim of this study was to analyse peri-operative mortality for intact AAA repair in 11 countries over time and compare outcomes by gender, age, and geographical location. METHODS: Prospective data on primary repair of intact AAA were collected from 11 countries through the International Consortium of Vascular Registries (ICVR) and analysed for two time periods, 2010 - 2013 and 2014 - 2016. The primary outcome was peri-operative mortality after endovascular aneurysm repair (EVAR) and open surgical repair (OSR). Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: A total of 103 715 patients were included. The percentage of patients undergoing EVAR increased from 63.6% to 71.2% (p < .001) over the study period. This proportion varied by country from 35% in Hungary to 81% in the United States. Overall peri-operative mortality decreased from 2.1% to 1.6 % (p < .001). Mortality also declined significantly over time for both OSR 4.2% to 3.6 % (p = .002) and EVAR 1.0% to 0.7% (p = .002). Mortality was significantly higher for female than male patients (3.0% vs. 1.6% p < .001). The percentage of patients > 80 years old undergoing AAA repair remained constant at 23.6% (p = .91). Peri-operative mortality was higher for patients > 80 years than for those < 80 years old (2.7% vs. 1.6% p < .001). Forty-six per cent (n = 275) of all EVAR deaths occurred in the over 80s. CONCLUSION: The proportion of AAA repairs performed using EVAR has increased over time. Peri-operative mortality continues to decline for both OSR and EVAR. Outcomes however were significantly worse for both women and those aged over 80, so efforts should be focused on these patient groups to further reduce elective AAA mortality rates.

Association of neighbourhood deprivation with risks of major amputation and death following lower limb revascularisation.

BACKGROUND AND AIMS: Individual-level socioeconomic deprivation is associated with an increased risk of adverse patient outcomes following cardiovascular disease interventions, but the role of area-level socioeconomic circumstances as a predictor for treatment outcomes is unclear. We have examined the association of neighbourhood socioeconomic deprivation with risks of major lower limb amputation and death following surgical and endovascular lower limb revascularisation due to peripheral artery disease (PAD). METHODS: Patients aged 50+ years who underwent surgical or endovascular lower limb revascularisation for PAD were identified from Hospital Episode Statistics, a nationwide hospital data warehouse in England. Major amputations and deaths within a year of revascularisation were ascertained from HES and national mortality register, respectively. Index of Multiple Deprivation (IMD) was used to measure neighbourhood deprivation. Flexible parametric competing risks models were used to estimate sub-distribution hazard ratios (SHRs) for amputation and death. RESULTS: In all, 65,806 patients underwent endovascular and 20,072 underwent surgical revascularisation. The covariate-adjusted 1-year risk of major amputation was higher among patients from the most deprived compared to least deprived neighbourhoods following endovascular revascularisation (SHR: 1.24, 95% confidence interval, CI:1.10 to 1.38) and surgical revascularisation (SHR:1.28, 95% CI: 1.09 to 1.51). The risk of death was higher in most deprived compared to the least deprived neighbourhoods following both procedures. CONCLUSIONS: We found a consistent association between neighbourhood deprivation and amputation and death outcomes following lower limb revascularisation for PAD. These findings suggest there may be opportunities for targeted interventions to improve care of PAD patients in deprived neighbourhoods.

Changing Patterns of Carotid Endarterectomy Between 2011 and 2017 in England.

Background and Purpose- Carotid endarterectomy (CEA) reduces the risk of stroke in recently symptomatic patients and less so in asymptomatic patients. Recent evidence suggests that the number of CEAs may be declining. The aim of this study was to investigate annual patterns of CEA in asymptomatic and symptomatic patients in England from 2011 to 2017. Methods- Data from the National Vascular Registry were used to describe (1) the number of CEA procedures in England and its 9 geographic regions from 2011 to 2017, (2) the characteristics of patients undergoing CEA, and (3) whether rates of CEA correlated with the number of vascular arterial units within each region. Annual stroke incidence for each region was derived from official population figures and the number of index stroke admissions per year. Results- The overall number of CEAs performed in England fell from 4992 in 2011 to 3482 in 2017, a 30% decline. Among symptomatic patients, there was a 25% decline, the number of CEAs falling from 4270 to 3217. In asymptomatic patients, there were 722 CEAs performed in 2011 and 265 in 2017, a 63% decline. CEAs per 100 000 adults within all regions declined over time but the size of change varied across the regions (range, 1.7-5.5 per 100 000). The regional numbers of CEAs per year were associated with changes in the regional stroke incidence, the proportion of CEAs performed in asymptomatic patients, and the number of hospitals performing CEA. Conclusions- This population-based study revealed a 63% decline in CEAs among asymptomatic patients between 2011 and 2017, possibly because of changing attitudes in the role of CEA. Reasons for the 25% decline in CEAs among symptomatic patients are unclear as UK guidelines on CEA have not changed for these patients. Whether the proportion of symptomatic patients with 50% to 99% ipsilateral stenosis has changed requires investigation.

Improving 1-Year Outcomes of Infrainguinal Limb Revascularization: Population-Based Cohort Study of 104 000 Patients in England.

BACKGROUND: The availability and diversity of lower limb revascularization procedures have increased in England in the past decade. We investigated whether these developments in care have translated to improvements in patient pathways and outcomes. METHODS: Individual-patient records from Hospital Episode Statistics were used to identify 103 934 patients who underwent endovascular (angioplasty) or surgical (endarterectomy, profundaplasty, or bypass) lower limb revascularization for infrainguinal peripheral artery disease in England between January 2006 and December 2015. Major lower limb amputations and deaths within 1 year after revascularization were ascertained from Hospital Episode Statistics and Office for National Statistics mortality records. Competing risks regression was used to estimate the cumulative incidence of major amputation and death, adjusted for patient age, sex, comorbidity score, indication for the intervention (intermittent claudication, severe limb ischemia without record of tissue loss, severe limb ischemia with a record of ulceration, severe limb ischemia with a record of gangrene/osteomyelitis), and comorbid diabetes mellitus. RESULTS: The estimated 1-year risk of major amputation decreased from 5.7% (in 2006-2007) to 3.9% (in 2014-2015) following endovascular revascularization, and from 11.2% (2006-2007) to 6.6% (2014-2015) following surgical procedures. The risk of death after both types of revascularization also decreased. These trends were observed for all indication categories, with the largest reductions found in patients with severe limb ischemia with ulceration or gangrene. Overall, morbidity increased over the study period, and a larger proportion of patients was treated for the severe end of the peripheral artery disease spectrum using less invasive procedures. CONCLUSIONS: Our findings show that from 2006 to 2015, the overall survival increased and the risk of major lower limb amputation decreased following revascularization. These observations suggest that patient outcomes after lower limb revascularization have improved during a period of centralization and specialization of vascular services in the United Kingdom.