Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Background: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. Methods: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation.Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. Discussion: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. Trial registration: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014

A multicentre trial of patient specific rehearsal prior to EVAR:Impact on Procedural Planning and Team Performance

\u3cp\u3eObjective Patient specific rehearsal (PsR) prior to endovascular aneurysm repair (EVAR) enables the endovascular team to practice and evaluate the procedure prior to treating the real patient. This multicentre trial aimed to evaluate the utility of PsR prior to EVAR as a pre-operative planning and briefing tool. Material and methods Patients with an aneurysm suitable for EVAR were randomised to pre-operative or post-operative PsR. Before and after the PsR, the lead implanter completed a questionnaire to identify any deviation from the initial treatment plan. All team members completed a questionnaire evaluating realism, technical issues, and human factor aspects pertinent to PsR. Technical and human factor skills, and technical and clinical success rates were compared between the randomised groups. Results 100 patients were enrolled between September 2012 and June 2014. The plan to visualise proximal and distal landing zones was adapted in 27/50 (54%) and 38/50 (76%) cases, respectively. The choice of the main body, contralateral limb, or iliac extensions was adjusted in 8/50 (16%), 17/50 (34%), and 14/50 (28%) cases, respectively. At least one of the abovementioned parameters was changed in 44/50 (88%) cases. For 100 EVAR cases, 199 subjective questionnaires post-PsR were completed. PsR was considered to be useful for selecting the optimal C-arm angulation (median 4, IQR 4-5) and was recognised as a helpful tool for team preparation (median 4, IQR 4-4), to improve communication (median 4, IQR 3-4), and encourage confidence (median 4, IQR 3-4). Technical and human factor skills and technical and initial clinical success rates were similar between the randomisation groups. Conclusion PsR prior to EVAR has a significant impact on the treatment plan and may be useful as a pre-operative planning and briefing tool. Subjective ratings indicate that this technology may facilitate planning of optimal C-arm angulation and improve non-technical skills. Trial registration: URL://www.clinicaltrials.gov. Unique identifier: NCT01632631.\u3c/p\u3

Editor's Choice – Nationwide Analysis of Patients Undergoing Iliac Artery Aneurysm Repair in the Netherlands

Objective: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR). Methods: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests. Results: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38–50) mm and 68 (IQR 58–85) mm, respectively. Mortality was 1.3% (95% CI 0.7–2.4) after eIAA repair and 25.5% (95% CI 18.0–34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively). Conclusion: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair

National Numbers of Secondary Aortic Reinterventions after Primary Abdominal Aortic Aneurysm Surgery from the Dutch Surgical Aneurysm Audit

Background: Long-term secondary aortic reinterventions (SARs) can be a sign of (lack of) effectiveness of abdominal aortic aneurysm (AAA) surgery. This study provides insight into the national number of SARs after primary AAA repair by endovascular aneurysm repair (EVAR) or by open surgical repair in the Netherlands. Methods: Observational study included all patients undergoing SAR between 2016 and 2017, registered in the compulsory Dutch Surgical Aneurysm Audit (DSAA). The DSAA started in 2013, SARs are registered from 2016. Characteristics of SAR and postoperative outcomes (mortality/complications) were analyzed, stratified by urgency of SAR. Data of SARs were merged with data of their preceded primary AAA repair, registered in the DSAA after January 2013. In these patients undergoing SAR, treatment characteristics of the preceded primary AAA repair were additionally described, with focus on differences between stent grafts. Results: Between 2016 and 2017, 691 patients underwent SAR, this concerned 9.3% of all AAA procedures (infrarenal/juxtarenal/suprarenal) in the Netherlands (77% elective/11% acute symptomatic/12% ruptured). Endoleak (60%) was the most frequent indication for SAR. SARs were performed with EVAR in 66%. Postoperative mortalities after SAR were 3.4%, 11%, and 29% in elective, acute symptomatic, and ruptured patients, respectively. In 26% (n = 181) of the patients undergoing SAR their primary AAA repair was performed after January 2013 and data of primary and SAR procedures could be merged. In 93% (n = 136), primary AAA repair was EVAR. Endografts primarily used were nitinol/polyester (62%), nitinol/polytetrafluoroethylene (8%), endovascular sealing (21%), and others (9%), compared with their national market share of 76% (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.38–0.71), 15% (OR, 0.50; CI, 0.29–0.89), 4.9% (OR, 5.04; CI, 3.44–7.38), and 4.1% (OR, 2.81; CI, 1.66–4.74), respectively. Conclusions: In the Netherlands, about one-tenth of the annual AAA procedures concerns an SAR. A quarter of this cohort had an SAR within 1–5 years after their primary AAA repair. Most SARs followed after primary EVAR procedures, in which an overrepresentation of endovascular sealing grafts was seen. Postoperative mortality after SAR is comparable with primary AAA repair

Toward Optimizing Risk Adjustment in the Dutch Surgical Aneurysm Audit

Background: To compare hospital outcomes of aortic aneurysm surgery, casemix correction for preoperative variables is essential. Most of these variables can be deduced from mortality risk prediction models. Our aim was to identify the optimal set of preoperative variables associated with mortality to establish a relevant and efficient casemix model. Methods: All patients prospectively registered between 2013 and 2016 in the Dutch Surgical Aneurysm Audit (DSAA) were included for the analysis. After multiple imputation for missing variables, predictors for mortality following univariable logistic regression were analyzed in a manual backward multivariable logistic regression model and compared with three standard mortality risk prediction models: Glasgow Aneurysm Score (GAS, mainly clinical parameters), Vascular Biochemical and Haematological Outcome Model (VBHOM, mainly laboratory parameters), and Dutch Aneurysm Score (DAS, both clinical and laboratory parameters). Discrimination and calibration were tested and considered good with a C-statistic > 0.8 and Hosmer-Lemeshow (H-L) P > 0.05. Results: There were 12,401 patients: 9,537 (76.9%) elective patients (EAAA), 913 (7.4%) acute symptomatic patients (SAAA), and 1,951 (15.7%) patients with acute rupture (RAAA). Overall postoperative mortality was 6.5%; 1.8% after EAAA surgery, 6.6% after SAAA, and 29.6% after RAAA surgery. The optimal set of independent variables associated with mortality was a mix of clinical and laboratory parameters: gender, age, pulmonary comorbidity, operative setting, creatinine, aneurysm size, hemoglobin, Glasgow coma scale, electrocardiography, and systolic blood pressure (C-statistic 0.871). External validation overall of VBHOM, DAS, and GAS revealed C-statistics of 0.836, 0.782, and 0.761, with an H-L of 0.028, 0.00, and 0.128, respectively. Conclusions: The optimal set of variables for casemix correction in the DSAA comprises both clinical and laboratory parameters, which can be collected easily from electronic patient files and will lead to an efficient casemix model

Nationwide study of the treatment of mycotic abdominal aortic aneurysms comparing open and endovascular repair in The Netherlands

Objective: Mycotic aneurysms of the abdominal aorta (MAAA) can be treated by open repair (OR) or endovascular aneurysm repair (EVAR). This nationwide study provides an overview of the situation of MAAA treatment in The Netherlands in 2016. Methods: A retrospective cohort study was conducted with all centers that registered aortic abdominal aneurysms in the Dutch Surgical Aneurysm Audit in 2016. Questionnaires on 1-year outcomes were sent to all centers that treated patients with MAAA. The primary aim was to determine 30-day and 1-year mortality and morbidity of OR- and EVAR-treated patients. Morbidity was determined by the need for reoperations and the number of readmissions to the hospital. Results: Twenty-six MAAA were detected in the Dutch Surgical Aneurysm Audit database of 2016, resulting in an incidence of 0.7% of all registered abdominal aortic aneurysms. The 30-day mortality for OR and EVAR treated patients was 1 in 13 and 0 in 13, respectively. Major and minor reinterventions within 30 days were needed for two (one OR and one EVAR) and two (one OR and one EVAR) patients, respectively. Two patients (15.4%) in the OR group and one patient (7.7%) in the EVAR group were readmitted to hospital within 30 days. In total, 1-year outcomes of 23 patients were available. In the OR group, one patient (9.1%) died in the first postoperative year. There was one major reintervention (removal of endoprosthesis and spiralvein reconstruction) in the EVAR group. Two patients (18.2%) treated with OR and two (16.7%) treated with EVAR required a minor reintervention. In both groups, four patients (OR, 36.4%; EVAR, 33.3%) were readmitted to hospital within 1 year postoperatively. Conclusions: Both OR- and EVAR-treated patients show acceptable clinical outcomes after 30 days and at the 1-year follow-up. Depending on the clinical course of the patient, EVAR may be considered in the management of this disease

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study

Objective: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. Summary of Background Data: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volumeoutcome association exists in endovascular treatment of complex AAs (complex EVAR). Methods: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. Results: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/ yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and 23 procedures/yr. The highest volume hospitals treated significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of <9, and 2.5% in hospitals with a volume of 13 (P = 0.008). After adjustment for confounders, an annual volume of 13 was associated with less perioperative mortality compared to hospitals with a volume of <9. Conclusions: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates

Intravenous NPA for the treatment of infarcting myocardium early: InTIME-II, a double-blind comparison on of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction

Aims to compare the efficacy and safety of lanoteplase, a single-bolus thrombolytic drug derived from alteplase tissue plasminogen activator, with the established accelerated alteplase regimen in patients presenting within 6 h of onset of ST elevation acute myocardial infarction. Methods and Results 15 078 patients were recruited from 855 hospitals worldwide and randomized in a 2:1 ratio to receive either lanoteplase 120 KU. kg-1 as a single intravenous bolus, or up to 100 mg accelerated alteplase given over 90 min. The primary end-point was all-cause mortality at 30 days and the hypothesis was that the two treatments would be equivalent. By 30 days, 6.61% of alteplase-treated patients and 6.75% lanoteplase-treated patients had died (relative risk 1.02). Total stroke occurred in 1.53% alteplase- and 1.87% lanoteplase-treated patients (ns); haemorrhagic stroke rates were 0.64% alteplase and 1.12% lanoteplase (P=0.004). The net clinical deficit of 30-day death or non-fatal disabling stroke was 7.0% and 7.2%, respectively. By 6 months, 8.8% of alteplase-treated patients and 8.7% of lanoteplase-treated patients had died. Conclusion Single-bolus weight-adjusted lanoteplase is an effective thrombolytic agent, equivalent to alteplase in terms of its impact on survival and with a comparable risk-benefit profile. The single-bolus regimen should shorten symptoms to treatment times and be especially convenient for emergency department or out-of-hospital administration. (C) 2000 The European Society of Cardiology

Evolocumab and clinical outcomes in patients with cardiovascular disease

peer reviewedBACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets. © 2017 Massachusetts Medical Society