Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands:Study protocol for the retrospective ODYSSEUS study

Introduction Strict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as 'low risk' for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance. Methods and analysis The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient's medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients. Ethics and dissemination The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal. Trial registration number The Netherlands Trial Registry, NL6953 (old: NTR28773)

Development of three different decision support tools to support shared decision-making in vascular surgery

Background: Shared decision-making (SDM) is known to improve quality of care. Particularly in vascular surgery treatment options are often preference-sensitive. Unfortunately, vascular surgeons infrequently apply SDM. Decision support tools (DSTs) have been shown to be helpful in SDM. Objective: This article describes the development process of three different DSTs to help vascular surgeons and patients apply SDM. Patient involvement: Patients’ information needs were obtained via focus group meetings. Fifty-two patients and eighteen vascular surgeons not involved in the development process evaluated the comprehensibility and usability of the DST-prototypes. Methods: A multidisciplinary steering group commissioned the development of the three DSTs according to international standards. Results: Digital decision aids and paper-based consultation cards and decision cards were developed for patients with an abdominal aortic aneurysm, carotid artery disease, intermittent claudication or varicose veins. Patients preferred the use of the decision aids followed by consultation cards, whereas vascular surgeons preferred to use decision cards followed by decision aids. Discussion: Decision aids, consultation cards and decision cards for four vascular diseases are now available to all vascular surgeons and patients in the Netherlands. The DSTs were well received by both surgeons and patients. English versions are also available

Best–Worst Scaling Study to Identify Complications Patients Want to Be Informed About Prior to Abdominal Aortic Aneurysm Surgery

Background: Surgeons must discuss the most severe surgical complications with their patients while making a treatment decision. However, it is unclear which complications patients deem most severe. This study aimed to have patients classify potential complications following abdominal aortic aneurysm surgery based on severity using best–worst scaling. Methods: Dutch patients with an abdominal aortic aneurysm, either under surveillance or following surgery, received a survey with 33 potential surgical complications. The survey presented these complications in sets of three. Patients had to classify one of three complications as most severe and one as least severe. After all participants had completed the survey, the number of times a complication was classified as most severe was subtracted from the number of times that the complication was classified as least severe, thus resulting in a best–worse scaling score. Complications with the lowest scores were ranked as more severe. Results: Fifty out of 79 participating patients completed the survey in full. Patients classified the following ten complications as most severe: Below-ankle amputation, aneurysm rupture, stroke, renal failure, type 1 endoleak, spinal cord ischaemia, peripheral bypass surgery, bowel lesion, myocardial infarction and heart failure. Haematoma was ranked as the least severe complication. Conclusion: This best–worst scaling study enabled patients to classify complications following abdominal aortic aneurysm surgery based on severity. Vascular surgeons should discuss the ten complications deemed most severe with their patients and help their patients to effectively weigh the benefits of surgery against the harms patients themselves deem important, thereby improving shared decision making

Effect of Imaging Surveillance After Endovascular Aneurysm Repair on Reinterventions and Mortality: A Systematic Review and Meta-analysis

Purpose: To study the effects of imaging surveillance after endovascular aortic repair (EVAR) on reintervention and mortality. Materials and Methods: A systematic review was conducted comparing complication rates in EVAR patients compliant with the imaging surveillance protocol vs partially or noncompliant patients. Two authors independently selected articles and performed quality assessment and data extraction. Risk differences for reintervention and mortality between compliant and partially/noncompliant patients were meta-analyzed. The pooled risk difference (RD) is reported with the 95% confidence interval (CI). The review protocol is registered at Prospero (CRD42017080494). Results: A total of 11 cohort studies involving 21,838 patients were included. Studies differed in imaging, their surveillance protocols, and definitions of compliance subgroups. Median follow-up was 31.7 months (interquartile range 29.8, 49.3). The overall reintervention rate was 5%, while the overall mortality was 31%. The RD for the reintervention rate was 4% (95% CI 1% to 7%) in favor of partial/noncompliance [number needed to harm 25 (95% CI 14 to 100)], while mortality showed a nonsignificant RD of 12% (95% CI −2% to 26%) in favor of partial/noncompliance. Two studies reported that 41% to 53% of reinterventions were performed for complications detected through imaging surveillance; the other events were detected through patient symptoms. Conclusion: Patients who are compliant with imaging surveillance appear to undergo more reinterventions than those who are partially or noncompliant. However, imaging surveillance does not seem to protect against mortality. This suggests that the recommended yearly imaging surveillance may not be beneficial for all EVAR patients

Reporting of Complications and Mortality in Relation to Risk Communication in Patients with an Abdominal Aortic Aneurysm: A Systematic Review

OBJECTIVES: High-quality reporting of surgical risks is necessary for evidence-based risk communication in clinical practice. Risk communication is defined as the process of discussing benefits and harms of treatment options with patients. This review addressed the current quality of reporting of complications and mortality in publications on abdominal aortic aneurysm treatment, with a focus on items relevant to risk communication. DESIGN: A systematic review. MATERIALS: Randomised clinical trials, comparative observational studies and registries from 2010 onwards were eligible if they reported complications and/or mortality in patients with an asymptomatic abdominal aortic aneurysms who received primary treatment. METHODS: Quality of reporting was assessed by scoring items relevant to risk communication from the reporting standards of the Society for Vascular Surgery (SVS) and the Consolidated Standards of Reporting Trials (CONSORT) statement. Screening, quality assessment and data extraction were independently undertaken by two authors. RESULTS: Forty-seven publications were included. Nine of 47 publications (19%) provided no definition of complications. In 14 of 47 publications (30%), it was unclear whether the number of adverse events or the number of patients with adverse events were presented. Absolute risk differences were provided in 1 of 32 publications (3.1%) that compared complications between two treatment options. Forty-six of 47 publications reported mortality, of which 42 reported overall mortality rates (91%). Absolute risk differences were given in 2 of the 31 publications (6.5%) that compared mortality between two treatment options. CONCLUSIONS: The quality of reporting of complications and mortality following primary abdominal aortic aneurysm treatment varied considerably. Better adherence to the SVS reporting standards and the CONSORT statement, as well as stating absolute risk differences may improve the quality of reporting and facilitate evidence-based risk communication

Pathophysiology and treatment of focal segmental glomerulosclerosis:the role of animal models

<p>Focal segmental glomerulosclerosis (FSGS) is a kidney disease with progressive glomerular scarring and a clinical presentation of nephrotic syndrome. FSGS is a common primary glomerular disorder that causes renal dysfunction which progresses slowly over time to end-stage renal disease. Most cases of FSGS are idiopathic Although kidney transplantation is a potentially curative treatment, 40% of patients have recurrence of FSGS after transplantation. In this review a brief summary of the pathogenesis causing FSGS in humans is given, and a variety of animal models used to study FSGS is discussed. These animal models include the reduction of renal mass by resecting 5/6 of the kidney, reduction of renal mass due to systemic diseases such as hypertension, hyperlipidemia or SLE, drug-induced FSGS using adriamycin, puromycin or streptozotocin, virus-induced FSGS, genetically-induced FSGS such as via Mpv-17 inactivation and alpha-actinin 4 and podocin knockouts, and a model for circulating permeability factors. In addition, an animal model that spontaneously develops FSGS is discussed. To date, there is no exact understanding of the pathogenesis of idiopathic FSGS, and there is no definite curative treatment. One requirement facilitating FSGS research is an animal model that resembles human FSGS. Most animal models induce secondary forms of FSGS in an acute manner. The ideal animal model for primary FSGS, however, should mimic the human primary form in that it develops spontaneously and has a slow chronic progression. Such models are currently not available. We conclude that there is a need for a better animal model to investigate the pathogenesis and potential treatment options of FSGS.</p>

Treatment of varicose veins, international consensus on which major complications to discuss with the patient: A Delphi study

Objective: To reach consensus on which complications of varicose vein treatments physicians consider major or minor, in order to standardize the informed consent procedure and improve shared decision-making. Methods: Using the e-Delphi method, expert physicians from 10 countries were asked to rate complications as “major” or “minor” on a 5-point Likert scale. Reference articles from a Cochrane review on varicose veins were used to compose the list of complications. Results: Participating experts reached consensus on 12 major complications: allergic reaction, cellulitis requiring intravenous antibiotics/intensive care, wound infection requiring debridement, hemorrhage requiring blood transfusion/surgical intervention, pulmonary embolism, skin necrosis requiring surgery, arteriovenous fistula requiring repair, deep venous thrombosis, lymphocele, thermal injury, transient ischemic attack/stroke, and permanent discoloration. Conclusion: An international consensus was reached about what physicians consider to be major complications of varicose vein treatments. This consensus may assist in standardizing the information physicians discuss with patients prior to varicose vein treatment