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Previous studies imply a profound residual mortality risk following successful abdominal aorta aneurysm (AAA) repair. This excess mortality is generally attributed to increased cardiovascular risk. The aim of this study was (I) to quantify the excess residual mortality for AAA patients, (II) to evaluate the cross-sectional level of cardiovascular risk management, and (III) to estimate the potential of optimized cardiovascular risk-management to reduce the excess mortality in these patients.Excess mortality was estimated through a systematic review and meta-analysis, and through data from the Swedish National Health Registry. Cardiovascular risk-profiles were individually assessed during eligibility screening of AAA patients for two multi-center pharmaceutical AAA-stabilization trials. The potential of full implementation of cardiovascular risk management was estimated through the validated SMART risk-scores algorithm.The meta-analysis showed a similarly impaired survival for patients who received early repair (small AAA) or regular repair (≥55mm), and a further impaired survival for patients under surveillance for a small AAA. Excess mortality was further quantified using Swedish population data. The data revealed a, respectively more than quadrupled and doubled 5-years mortality rate for women and men who had their AAA repaired. Evaluation of the level of risk-management of 358 patients under surveillance in 16 Dutch hospitals showed that the majority of AAA patients did not meet therapeutic targets set for risk-management in high risk populations, and indicated a more pronounced prevention-gap in women. Application of the SMART risk-score algorithm predicted that optimal implementation of risk-management guidelines would reduce the 10-years risk of major adverse cardiovascular events from 43% to 14%.Independent of the rupture risk, AAA associates with a worryingly compromised life-expectancy with a particular poor prognosis for women. Optimal implementation of cardiovascular risk prevention guidelines is predicted to profoundly reduce cardiovascular risk. However, the prediction tool estimate changes in life expectancy.

Routinely reported structured data from the electronic health record (EHR) are frequently used for secondary purposes. However, it is unknown how valid routinely reported data are for reuse.This study aimed to assess the validity of routinely reported Rutherford scores by clinicians as an indicator for the validity of structured data in the EHR.This observational study compared clinician-reported Rutherford scores with medical record review Rutherford scores for all visits at the vascular surgery department between April 1, 2016 and December 31, 2018. Free-text fields with clinical information for all visits were extracted for the assignment of the medical record review Rutherford score, after which the agreement with the clinician-reported Rutherford score was assessed using Fleiss' Kappa.A total of 6,633 visits were included for medical record review. Substantial agreement was shown between clinician-reported Rutherford scores and medical record review Rutherford scores for the left (k = 0.62, confidence interval [CI]: 0.60–0.63) and right leg (k = 0.62, CI: 0.60–0.64). This increased to the almost perfect agreement for left (k = 0.84, CI: 0.82–0.86) and right leg (k = 0.85, CI: 0.83–0.87), when excluding missing clinician-reported Rutherford scores. Expert's judgment was rarely required to be the deciding factor (11 out of 6,633).Substantial agreement between clinician-reported Rutherford scores and medical record review Rutherford scores was found, which could be an indicator for the validity of routinely reported data. Depending on its purpose, the secondary use of routinely collected Rutherford scores is a viable option.

Objective To discuss practical strategies to consider for morbidity and mortality conferences (M&M). Materials and Methods This article reflects on (i) insights that can be drawn from the M&M literature, (ii) practical aspects to consider when organizing M&M, and (iii) possible future directions for development for this long-standing practice for routine reflection. Results M&M offers the opportunity to learn from past cases in order to improve the care delivered to future patients, thereby serving both educational and quality improvement purposes. For departments seeking to implement or improve local M&M practice, it is difficult that a golden standard or best practice for M&M is nonexistent. This is partly because comparative research on different formats is hampered by the lack of objective outcome measures to evaluate the effectiveness of M&M. Common practical suggestions include the use of (i) a skillful and active moderator; (ii) structured formats for case presentation and discussion; and (iii) a dedicated committee to guide improvement plans that ensue from the meeting. M&M practice is affected by various sociological factors, for which qualitative research methods seem most suitable, but in the M&M literature these are sparsely used. Moreover, aspects influencing an open and blame-free atmosphere underline how local teams should tailor the format to best fit the local context and culture. Conclusion This article presents practice guidance on how to organize and carry out M&M This practice for routine reflection needs to be tailored to the local setting, with attention for various sociological factors that are at play.

In a time of exponential growth of medical scientific knowledge medical specialists need all the help they can get in translating the vast amount of information to the best treatment for their patients. Evidence based guidelines in essence seem a useful tool in promoting this translation as they report an extensive evaluation of available evidence. In daily practice however, guidelines do not always find their way to the clinical encounter with patients. But how do the end users of clinical practice guidelines, the medical specialists, utilize these instruments and how can this potentially be improved?

Purpose: To describe the concept of aortic elastic deformation (ED) measurement using duplex ultrasonography (DUS) as a tool for detection of high aneurysm sac pressure following endovascular aortic repair (EVAR). Technique: High aneurysm sac pressure, with or without proven endoleak, will result in a less compressible aneurysm. Using the dual image function in B-mode of the DUS device and a standardized amount of applied probe pressure, ED can be measured. It is defined as the percentage of deformation of the aneurysm sac on probe pressure application. We hypothesize that less ED of the aneurysm sac can be related with high aneurysm sac pressure and possibly the presence of clinically relevant endoleak. In this note, we describe the technical details of the procedure and report on the applicability and results of ED measurements in the framework of aortic aneurysm and EVAR follow-up in a cohort of 109 patients. Conclusion: ED measurement is the first noninvasive pressure-based method in the quest to find a practical and reliable diagnostic tool to exclude high aneurysm sac pressure. In our patient cohort, patients with proven endoleak showed a smaller ED (less compressible), implying the presence of high aneurysm sac pressure. Further research should confirm whether ED measurement using DUS could reliably exclude endoleak after EVAR and further explore its potential for clinical application in EVAR follow-up. Clinical Impact For the first time, a simple, fast, and inexpensive diagnostic tool is presented in this study for detecting high sac pressure following EVAR. High sac pressure is typically caused by clinically significant endoleaks, which can have significant consequences. Currently, computed tomography scanning is the most common method used to identify and characterize endoleaks. However, measuring elastic deformation may potentially replace more invasive and expensive modalities, such as the computed tomography in the future.

Objective Two consensus histopathological classifications for thoracic aortic aneurysms (TAAs) and inflammatory aortic diseases have been issued to facilitate clinical decision-making and inter-study comparison. However, these consensus classifications do not specifically encompass abdominal aortic aneurysms (AAAs). Given its high prevalence and the existing profound pathophysiologic knowledge gaps, extension of the consensus classification scheme to AAAs would be highly instrumental. The aim of this study was to test the applicability of, and if necessary to adapt, the issued consensus classification schemes for AAAs. Methods Seventy-two AAA anterolateral wall samples were collected during elective and emergency open aneurysm repair performed between 2002 and 2013. Histologic analysis (hematoxylin and eosin and Movat Pentachrome) and (semi-quantitative and qualitative) grading were performed in order to map the histological aspects of AAA. Immunohistochemistry was performed for visualization of aspects of the adaptive and innate immune system, and for a more detailed analysis of atherosclerotic lesions in AAA. Results Because the existing consensus classification schemes do not adequately capture the aspects of AAA disease, an AAA-specific 11-point histopathological consensus classification was devised. Systematic application of this classification indicated several universal features for AAA (eg, [almost] complete elastolysis), but considerable variation for other aspects (eg, inflammation and atherosclerotic lesions). Conclusions This first multiparameter histopathological AAA consensus classification illustrates the sharp histological contrasts between thoracic and abdominal aneurysms. The value of the proposed scoring system for AAA disease is illustrated by its discriminatory capacity to identify samples from patients with a nonclassical (genetic) variant of AAA disease., Clinical Relevance The pathophysiology of abdominal aortic aneurysm (AAA) disease remains an enigma. Histological evaluation is critical for appreciation of the tissue remodeling and spatial aspects of AAA disease. Histopathological classification schemes have been devised for aortic pathology. Unfortunately, these schemes do not specifically address the most common aortic pathology, AAA disease. In order to facilitate interstudy comparisons and pathophysiologic understanding of AAA disease, we here present a multiparameter consensus histopathological AAA classification scheme. The scheme clearly discriminates AAA disease from thoracic aortic aneurysm disease. Systematic implementation of this AAA classification system indicates a substantial biological variation for AAA disease, and stresses the need for adequate group sizes in order to adequately cover the natural variability. Examples illustrating the diagnostic value of the classification system are provided.

Objective Efforts to study morbidity and mortality conferences (M&MC) are hampered by the lack of rigorous instruments to assess the effectiveness of the conferences for the purpose of quality improvement and medical education. This might limit further advancement of the practice. The aim of this scoping review was to determine commonly used effectiveness measures of M&MC in the literature. Method A scoping review was performed of quantitative, qualitative, and mixed methods studies of M&MC, using databases from PubMed, Emcare, Embase, Web of Science, and the Cochrane library. Studies were included if an outcome was described after a general evaluation or an intervention to M&MC. Study quality was assessed with the Quality Assessment Tool for Studies with Diverse Designs. Results A total of 43 articles were included in the review. The majority used a quantitative (n = 23) or mixed (n = 17) design, with surveys as the most frequent method used for data collection (n = 29). The overall Quality Assessment Tool for Studies with Diverse Designs scores were modest (64%). Outcome measures used to evaluate the effectiveness of M&MC were clustered in the following categories: "participant experiences," "characteristics of the meeting," "medical knowledge," "actions for improvement," and "clinical outcomes." Conclusions This review found a wide variety of effectiveness measures for M&MC. Rather than using isolated measures, approaches that combine multiple effectiveness measures could offer a more comprehensive assessment of M&MC. Although there was a preference for quantitative metrics, this fails to seize the opportunity of qualitative methods to yield insights into sociological purposes of M&MC, such as building professional identities and safety culture.

Objective: Doppler ultrasonography (DUS) is used as initial measurement to diagnose and classify carotid artery stenosis. Local distorting factors such as vascular calcification can influence the ability to obtain DUS measurements. The DUS derived maximal systolic acceleration (ACCmax) provides a different way to determine the degree of stenosis. While conventional DUS parameters are measured at the stenosis itself, ACCmax is measured distal to the internal carotid artery (ICA) stenosis. The value of ACCmax in ICA stenosis was investigated in this study. Material and Methods: All carotid artery DUS studies of a tertiary academic center were reviewed from October 2007 until December 2017. Every ICA was included once. The ACCmax was compared to conventional DUS parameters: ICA peak systolic velocity (PSV), and PSV ratio (ICA PSV/CCA PSV). ROC-curve analysis was used to evaluate accuracy of ACCmax, ICA PSV and PSV ratio as compared to CT-angiography (CTA) derived stenosis measurement as reference test. Results: The study population consisted of 947 carotid arteries and was divided into 3 groups: = 70% (128/947). Between these groups ACCmax was significantly different. Strong correlations between ACCmax and ICA PSV (R-2 0.88) and PSV ratio (R-2 0.87) were found. In ROC subanalysis, the ACCmax had a sensitivity of 90% and a specificity of 89% to diagnose a >= 70% ICA stenosis, and a sensitivity of 82% and a specificity of 88% to diagnose a >= 50% ICA stenosis. For diagnosing a >= 50% ICA stenosis the area under the curve (AUC) of ACCmax (0.88) was significantly lower than the AUC of PSV ratio (0.94) and ICA PSV (0.94). To diagnose a >= 70% ICA stenosis there were no significant differences in AUC between ACCmax (0.89), PSV ratio (0.93) and ICA PSV (0.94). Conclusions: ACCmax is an interesting additional DUS measurement in determining the degree of ICA stenosis. ACCmax is measured distal to the stenosis and is not hampered by local distorting factors at the site of the stenosis. ACCmax can accurately diagnose an ICA stenosis, but was somewhat inferior compared to ICA PSV and PSV ratio to diagnose a >= 50% ICA stenosis.

Objective The suggested high costs of endovascular aneurysm repair (EVAR) hamper the choice of insurance companies and financial regulators for EVAR as the primary option for elective abdominal aortic aneurysm (AAA) repair. However, arguments used in this debate are impeded by time related aspects such as effect modification and the introduction of confounding by indication, and by asymmetric evaluation of outcomes. Therefore, a re-evaluation minimising the impact of these interferences was considered. Methods A comparative analysis was performed evaluating a period of exclusive open repair (OR; 1998–2000) and a period of established EVAR (2010–2012). Data from four hospitals in The Netherlands were collected to estimate resource use. Actual costs were estimated by benchmark cost prices and a literature review. Costs are reported at 2019 prices. A break even approach, defining the costs for an endovascular device at which cost equivalence for EVAR and OR is achieved, was applied to cope with the large variation in endovascular device costs. Results One hundred and eighty-six patients who underwent elective AAA repair between 1998 and 2000 (OR period) and 195 patients between 2010 and 2012 (EVAR period) were compared. Cost equivalence for OR and EVAR was reached at a break even price for an endovascular device of €13 190. The main cost difference reflected the longer duration of hospital stay (ward and Intensive Care Unit) of OR (€11 644). Re-intervention rates were similar for OR (24.2%) and EVAR (24.6%) (p = .92). Conclusion Cost equivalence for EVAR and OR occurs at a device cost of €13 000 for EVAR. Hence, for most routine repairs, EVAR is not costlier than OR until at least the five year follow up.

The aim of this study was to validate a Dutch translation of the Cardiff wound impact schedule (CWIS), a disease‐specific instrument to measure the health‐related quality of life (HRQoL) in patients with chronic leg ulcers. To achieve this, the original instrument was translated. A total of 83 patients with chronic lower leg ulcers were included and completed the translated instrument and SF36 at baseline after assessment of their wound severity. Follow‐up was performed 1 week after inclusion. The psychometric properties of the instrument were assessed. Construct validity was positively evaluated by an expert panel. Face validity was positively evaluated in a cognitive debriefing of a pilot group. Discriminant validity was assessed by correlating 1‐year amputation risk according to the Wound, Ischaemia, foot Infection classification system with the instrument scores. Significant correlation could not be proven. Criterion validity was assessed by correlating domain scores of the instrument with domain scores of the gold standard: SF36. Moderate to high correlation was calculated for most domains of the instrument. Test‐retest reliability and internal consistency were evaluated as acceptable. In conclusion, the Dutch translation of the CWIS is a valid and reliable disease‐specific instrument to assess the HRQoL in patients with chronic lower leg ulcers.

Background: Because of the presence of medial calcific sclerosis, both ankle-branchial index and toe pressure measures can yield misleading results when attempting to diagnose peripheral artery disease (PAD). A new ultrasound parameter, maximal systolic acceleration (ACC(max)), can be an accurate tool for diagnosing PAD, including in diabetic patients. However, it has not been evaluated thoroughly. The aim of this study was to assess the feasibility of using ACC(max) to diagnose and assess the severity of PAD.Methods: The human circulatory system was simulated using an in vitro circulatory system driven by a pulsatile pneumatic pump. Arterial stenosis of various degrees (50%, 70%, 80%, and 90%) was simulated in order to investigate the change in several ultrasound parameters (including ACC(max)), as well as the intraluminal mean arterial pressure gradient. In a separate set of measurements, interobserver variability was measured using two investigators who were unaware of the degree of stenosis.Results: ACC(max) significantly decreased (P < .001), and the pressure gradient increased (P < .001) as the degree of stenosis increased. Moreover, we found a strong correlation between ACC(max) and the pressure gradient (R-2 = 0.937). Finally, interobserver variability with respect to ACC(max) was extremely low, with an intraclass correlation coefficient of 0.99.Conclusions: The results of this flow model study suggest that ACC(max) can be a valid, noninvasive tool for diagnosing PAD. Moreover, our finding that ACC(max) decreases as the severity of stenosis increases, together with the strong correlation between ACC(max) and the pressure gradient, suggests that ACC(max) may be useful as an alternative diagnostic tool for assessing the severity of PAD. These promising in vitro data warrant further study in a clinical setting.

Calamity investigations often lead to recommendations that are difficult to implement and that are of little relevance, because the analysis is carried out according to a cause and effect system. The complexity of care provision requires a different method that respects the complexity of day-to-day care and is able to assess it correctly. Research according to the Safety-II philosophy clearly shows the variable interactions and dependencies present in daily work. These investigations require more effort and time, but lead to better recommendations, better recognition among professionals and an appreciative way of interviewing. This is to the satisfaction of calamity investigators, involved professionals and patients and family. This method of investigation requires an investment in time and people of the healthcare institution.

Objective: The aim of this study was to identify risk factors for 90 day death after elective open surgical repair (OSR) of abdominal aortic aneurysms (AAAs) in women.Methods: This was a multicentre case control study. The nationwide Dutch Surgical Aneurysm Audit registry (2013–2019) was solely used to identify women who underwent elective OSR as eligible patients. Data for this study were subsequently collected from the patients’ medical files. Women with AAA were included and those who died (cases) were compared with those who survived (controls) 90 days after surgery. Inflammatory, mycotic, or symptomatic or ruptured AAA were excluded. The association between pre- and peri-operative risk factors and death was assessed by logistic regression analysis in the whole sample and after matching cases to controls of the same age at the time of repair. Mesenteric artery patency was also assessed on pre-operative computed tomography and used in the analysis.Results: In total, 266 patients (30 cases and 236 controls) from 21 hospitals were included. Cases were older (median [interquartile range; IQR] 75 years [71, 78.3] vs. 71 years [66, 77]; p =.002) and more often had symptomatic peripheral arterial disease (PAD) (14/29 [48%] vs. 49/227 [22%]; p =.002). Intra-operative blood loss (median [IQR] 1.6 L [1.1, 3.0] vs. 1.2 L [0.7, 1.8]), acute myocardial infarction (AMI) (10/30 [33%] vs. 8/236 [3%]), renal failure (17/30 [57%] vs. 33/236 [14%]), and bowel ischaemia (BI) (17/29 [59%] vs. 12/236 [5%]) were more prevalent among cases. Older age (odds ratio [OR] 1.11, 95% confidence interval [CI] 1.03–1.19) and PAD (OR 3.91, 95% CI 1.57–9.74) were associated with death. Multivariable analysis demonstrated that, after adjustment for age, AMI (OR 9.34, 95% CI 1.66–52.4) and BI (OR 35.6, 95% CI 3.41–370) were associated with death. Superior mesenteric artery stenosis of >70% had a clinically relevant association with BI (OR 5.23, 95% CI 1.43–19.13; p =.012).Conclusion: Age, symptomatic PAD, AMI, and BI were risk factors for death after elective OSR in women. The association between a >70% SMA stenosis and BI may call for action in selected cases.

Background: Patients with chronic limb threatening ischemia have a risk of undergoing a major amputation within 1 year of nearly 30% with a substantial risk of re-amputation since wound healing is often impaired. Quantitative assessment of regional tissue viability following amputation surgery can identify patients at risk for impaired wound healing. In quantification of regional tissue perfusion, near-infrared (NIR) fluorescence imaging using Indocyanine Green (ICG) seems promising. Methods: This pilot study included adult patients undergoing lower extremity amputation surgery due to peripheral artery disease or diabetes mellitus. ICG NIR fluorescence imaging was performed within 5 days following amputation surgery using the Quest Spectrum Platform (R). Following intravenous administration of ICG, the NIR fluorescence intensity of the amputation wound was recorded for 10 minutes. The NIR fluorescence intensity videos were analyzed and if a fluorescence deficit was observed, this region was marked as "low fluorescence." All other regions were marked as "normal fluorescence." Results: Successful ICG NIR fluorescence imaging was performed in 10 patients undergoing a total of 15 amputations. No "low fluorescence" regions were observed in 11 out of 15 amputation wounds. In 10 out of these 11 amputations, no wound healing problems occurred during followup. Regions with "low fluorescence" were observed in 4 amputation wounds. Impaired wound healing corresponding to these regions was observed in all wounds and a re-amputation was necessary in 3 out of 4. When observing time-related parameters, regions with low fluorescence had a significantly longer time to maximum intensity (113 seconds vs. 32 seconds, P = 0.003) and a significantly lesser decline in outflow after five minutes (80.3% vs. 57.0%, P = 0.003). Conclusions: ICG NIR fluorescence imaging was able to predict postoperative skin necrosis in all four cases. Quantitative assessment of regional perfusion remains challenging due to influencing factors on the NIR fluorescence intensity signal, including camera angle, camera distance and ICG dosage. This was also observed in this study, contributing to a large variety in fluorescence intensity parameters among patients. To provide surgeons with reliable NIR fluorescence cut-off values for prediction of wound healing, prospective studies on the intraoperative use of this technique are required. The potential prediction of wound healing using ICG NIR fluorescence imaging will have a huge impact on patient mortality, morbidity as well as the burden of amputation surgery on health care.

Purpose: Post-EVAR (endovascular aneurysm repair) aneurysm sac growth can be seen as therapy failure as it is a risk factor for post-EVAR aneurysm rupture. This study sought to identify preoperative patient predictors for developing post-EVAR aneurysm sac growth. Material and Methods: A systematic review was conducted to select potential predictive preoperative factors for post-EVAR sac growth (including a total of 34.886 patients), which were evaluated by a retrospective single-center analysis of patients undergoing EVAR between 2009 and 2019 (N=247) with pre-EVAR computed tomography scans and at least 1 year follow-up. The primary study outcome was post-EVAR abdominal aortic aneurysm (AAA) sac enlargement (≥5 mm diameter increase). Multivariate Cox regression and Kaplan-Meier survival curves were constructed. Results: Potential correlative factors for post-EVAR sac growth included in the cohort analysis were age, sex, anticoagulants, antiplatelets, renal insufficiency, anemia, low thrombocyte count, pulmonary comorbidities, aneurysm diameter, neck diameter, neck angle, neck length, configuration of intraluminal thrombus, common iliac artery diameter, the number of patent lumbar arteries, and a patent inferior mesenteric artery. Multivariate analysis showed that infrarenal neck angulation (hazard ratio, 1.014; confidence interval (CI), 1.001–1.026; p=0.034) and the number of patent lumbar arteries (hazard ratio, 1.340; CI, 1.131–1.588; pConclusions: This study showed that having 4 or more patent lumbar arteries is an important predictive factor for postoperative sac growth in patients undergoing EVAR. Clinical Impact This study strongly suggests that having 4 or more patent lumbar arteries should be included in preoperative counseling for EVAR, in conjunction to the instructions for use (IFU).

We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR.Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR).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.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 performed9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of9, 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 of9.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.

Objectives: The aim of this retrospective study was to assess the predictive performance of the American College of Surgeons (ACS) risk calculator for aortic aneurysm repair for the patient population of a Dutch tertiary referral hospital. Methods: This retrospective study included all patients who underwent elective endovascular or open aortic aneurysm repair at our institution between the years 2013 and 2019. Preoperative patient demographics and postoperative complication data were collected, and individual risk assessments were generated using five different current procedural terminology (CPT) codes. Receiver operating characteristic (ROC) curves, calibration plots, Brier scores, and Index of Prediction Accuracy (IPA) values were generated to evaluate the predictive performance of the ACS risk calculator in terms of discrimination and calibration. Results: Two hundred thirty-four patients who underwent elective endovascular or open aortic aneurysm repair were identified. Only five out of thirteen risk predictions were found to be sufficiently discriminative. Furthermore, the ACS risk calculator showed a structurally insufficient calibration. Most Brier scores were close to 0, however, comparison to a null model though IPA-scores showed the predictions generated by the ACS risk calculator to be inaccurate. Overall, the ACS risk calculator showed a consistent underestimation of the risk of complications. Conclusions: The ACS risk calculator proved to be inaccurate within the framework of endovascular and open aortic aneurysm repair in our medical center. To minimize the effects of patient selection and cultural differences, multicenter collaboration is necessary to assess the performance of the ACS risk calculator in aortic surgery.

Objective In order to better incorporate the patient’s perspective in medical decision making, core outcome sets (COS) are being defined. In the field of abdominal aortic aneurysm (AAA), efforts to capture the patient’s perspective focus on generic quantitative quality of life (QoL) scales. The question arises whether these quantitative scales adequately reflect the patient’s perspective on QoL, and whether they can be included in the QoL aspect of COS. A scoping review of QoL assessment in the context of elective AAA repair was undertaken. Data Sources PubMed, Embase, Web of Science, and the Cochrane Library. Review Methods A scoping review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. Articles reporting QoL assessment in the context of elective AAA repair were identified. Quantitative studies (i.e., traditional QoL scales) were aligned (triangulation approach) with qualitative studies (i.e., patient perspective) to identify parallels and discrepancies. Mean Short Form 36 item survey (SF-36) scores were pooled using a random effects model to evaluate sensitivity to change. Results Thirty-three studies were identified, of which 29 (88%) were quantitative and four (12%) qualitative. The 33 studies reported a total of 54 quantitative QoL scales; the most frequently used were the generic SF-36 (16 studies) and five dimension EuroQol (EQ-5D; eight studies). Aneurysm specific scales were reported by one study. The generic quantitative scales showed poor alignment with the patient’s perspective. The aneurysm specific scales better aligned but missed “concerns regarding symptoms” and “the impact of possible outcomes/complications”. “Self control and decision making”, which was brought forward by patients in qualitative studies, was not captured in any of the current scales. Conclusion There is no established tool that fully captures all aspects of the patient’s perspective appropriate for a COS for elective AAA repair. In order to fulfil the need for a COS for the management of, AAA disease, a more comprehensive overview of the patient’s perspective is required.

In assessing the severity of lower extremity arterial disease (LEAD), physicians rely on clinical judgements supported by conventional measurements of macrovascular blood flow. However, current diagnostic techniques provide no information about regional tissue perfusion and are of limited value in patients with chronic limb-threatening ischemia (CLTI). Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used extensively in perfusion studies and is a possible modality for tissue perfusion measurement in patients with CLTI. In this prospective cohort study, ICG NIR fluorescence imaging was performed in patients with CLTI and control patients using the Quest Spectrum Platform® (Middenmeer, The Netherlands). The time–intensity curves were analyzed using the Quest Research Framework. Fourteen parameters were extracted. Successful ICG NIR fluorescence imaging was performed in 19 patients with CLTI and in 16 control patients. The time to maximum intensity (seconds) was lower for CLTI patients (90.5 vs. 143.3, p = 0.002). For the inflow parameters, the maximum slope, the normalized maximum slope and the ingress rate were all significantly higher in the CLTI group. The inflow parameters observed in patients with CLTI were superior to the control group. Possible explanations for the increased inflow include damage to the regulatory mechanisms of the microcirculation, arterial stiffness, and transcapillary leakage.

Objectives Current diagnostic modalities for patients with peripheral artery disease (PAD) mainly focus on the macrovascular level. For assessment of tissue perfusion, near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) seems promising. In this prospective cohort study, ICG NIR fluorescence imaging was performed pre- and post-revascularization to assess changes in foot perfusion. Methods ICG NIR fluorescence imaging was performed in 36 patients with PAD pre- and post-intervention. After intravenous bolus injection of 0.1 mg/kg ICG, the camera registered the NIR fluorescence intensity over time on the dorsum of the feet for 15 min using the Quest Spectrum Platform®. Time-intensity curves were plotted for three regions of interest (ROI): (1) the dorsum of the foot, (2) the forefoot, and (3) the hallux. Time-intensity curves were normalized for maximum fluorescence intensity. Extracted parameters were the maximum slope, area under the curve (AUC) for the ingress, and the AUC for the egress. The non-treated contralateral leg was used as a control group. Results Successful revascularization was performed in 32 patients. There was a significant increase for the maximum slope and AUC egress in all three ROIs. The most significant difference was seen for the maximum slope in ROI 3 (3.7%/s to 6.6%/s, p < 0.001). In the control group, no significant differences were seen for the maximum slope and AUC egress in all ROIs. Conclusions This study shows the potential of ICG NIR fluorescence imaging in assessing the effect of revascularization procedures on foot perfusion. Future studies should focus on the use of this technique in predicting favorable outcome of revascularization procedures.

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.

ObjectivesLinkage of safety data to patient experience data may provide information to improve surgical care. This retrospective observational study aimed to assess associations between complications, incidents, patient-reported problems, and overall patient experience. MethodsRoutinely collected data from safety reporting on complications and incidents, as well as patient-reported problems and experience on the Picker Patient Experience Questionnaire 15, covering seven experience dimensions, were linked for 4236 surgical inpatients from an academic center (April 2014-December 2015, 41% response). Associations between complication and/or incident occurrence and patient-reported problems, regarding risk of nonpositive experience (i.e., grade of 1-5 of 10), were studied using multivariable logistic regression. ResultsPatient-reported problems were associated with occurrence of complications/incidents among patients with nonpositive experiences (odds ratio [OR] = 2.8, 95% confidence interval [CI] = 1.6-4.9), but not among patients with positive experiences (OR = 1.0, 95% CI = 0.6-1.5). For each experience dimension, presence of patient-reported problems increased risk of nonpositive experience (OR range = 2.7-4.4). Patients with complications or incidents without patient-reported problems were at lower risk of a nonpositive experience than patients with neither complications/incidents nor reported problems (OR = 0.5; 95% CI = 0.3-0.9). Occurrence of complications/incidents only increased risk of nonpositive experience when patients also had problems on "continuity and transition" or "respect for patient preferences" dimensions. ConclusionsLinking safety data to patient experience data can reveal ways to optimize care. Staff seem able to ensure positive patient experiences despite complications or incidents. Increased attention should be paid to respecting patient preferences, continuity, and transition, particularly when complications or incidents occur.

Medial arterial calcification (MAC), frequently associated with diabetes mellitus (DM) and chronic kidney disease (CKD), is a systemic vascular disorder leading to stiffness and incompressible arteries. These changes impede the accuracy of bedside tests to diagnose peripheral arterial disease (PAD). This review aimed to evaluate the reliability of bedside tests for the detection of PAD in patients prone to MAC.A systematic search (Pubmed, Embase, Web of Science, Cochrane, and Emcare) was performed according to the PRISMA guidelines to identify relevant studies providing data on the performance of bedside tests for the detection of PAD in patients prone to MAC. Studies were included when bedside test were compared to a reference standard. Primary endpoints were the positive and negative likelihood ratios (PLR, NLR). Methodological quality and risk of bias were evaluated using the QUADAS-2 tool.In total, 23 studies were included in this review. The most commonly evaluated test was the ankle-brachial index (ABI), followed by toe-brachial index (TBI), toe pressure (TP) measurements, and continuous wave Doppler (CWD). The majority of patients were older, male, and had DM. We found that ABI0·9 was helpful to diagnose PAD, but failed to rule out PAD (NLR0·2). The same applied for TP (NLR0·3) and TBI (5 out of 6 studies revealed an NLR0·2). CWD (loss of triphasic pattern) is reliable to exclude PAD (NLR 0-0·09), but was only validated in two studies. Overall, methodological quality was poor which led to risk of bias in 20 studies.The diagnosis of PAD in patients prone to MAC remains challenging. The ABI performed reasonably in the diagnosis of PAD, while the CWD (loss of triphasic signal) can be used to rule out PAD. This systematic review showed that test performances were generally poor with serious concerns in methodological quality of the included studies. We therefore counsel against the use of a single bedside test.None to declare.

Purpose Complex endovascular aortic repair (EVAR) procedures provide a treatment option for patients with aortic aneurysms involving visceral branches. Good technical results and short-term outcomes have been reported. Whether complex EVAR provides acceptable functional outcomes is not clear. The current study aims to describe postoperative functional outcomes in complex EVAR patients—an older and relatively frail patient group. Materials and Methods A single-center retrospective cohort study was performed, using data from a computerized database of consecutive patients who underwent complex EVAR in the Leiden University Medical Center (LUMC, The Netherlands) between July 2013 and September 2020. As of May 2017, patients scheduled for complex EVAR were referred to a geriatric care pathway to determine (Instrumental) Activities of Daily Living ((I)ADL) scores at baseline and, if informed consent was given, after 12 months. For the total patient group, adverse functional performance outcomes were: discharge to a nursing home and 12-month mortality. For the patients included in geriatric follow-up, the additional outcome was the incidence of functional decline (defined by a ≥2 point increase in (I)ADL-score) at 12-month follow-up Results Eighty-two patients underwent complex EVAR, of which 68 (82.9%) were male. Mean age was 73.3 years (SD=6.3). Within 30 days postsurgery, 6 patients (7.3%) died. Mortality within 12 months for the total patient group was 14.6% (n=12). After surgery, no patients had to be discharged to a nursing home. Fifteen patients (18.3%) were discharged to a rehabilitation center. Twenty-three patients gave informed consent and were included in geriatric follow-up. Five patients (21.7%) presented functional decline 12 months postsurgery and 4 patients had died (17.4%) by that time. This means that 39.1% of the patients in the care pathway suffered an adverse outcome. Conclusion To our knowledge, this is the only study that examined functional performance after complex EVAR, using a prospectively maintained database. No patients were newly discharged to a nursing home and functional performance results at 12 months are promising. Future multidisciplinary research should focus on determining which patients are most prone to deterioration of function, so that efforts can be directed toward preventing postoperative functional decline.

Jelle A Nieuwstraten,1 Louk P van Doorn,1 Winifred A Gebhardt,2 Jaap F Hamming1 1Department of Vascular Surgery, Leiden University Medical Center, Leiden, the Netherlands; 2Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, the NetherlandsCorrespondence: Jelle A NieuwstratenDepartment of Vascular Surgery, Leiden University Medical Center, Postzone K6-R, Postbus 9600, Leiden, RC, 2300, the NetherlandsTel +31 618849873Email Jellenieuwstraten@gmail.comPurpose: This study focusses on identifying values and preferences of patients, caregivers and healthcare professionals who have dealt with lower limb amputation for no-option chronic limb threatening ischemia. No-option chronic limb threatening ischemia is defined as limb ischemia for which no treatment options exist and where lower limb amputation is necessary in the short term. The values and preferences identified in this study can help improve decision-making processes.Patients and Methods: This was a qualitative study, using semi-structured interviews to gather data from patients, caregivers and healthcare professionals. Participants were selected from the patient and employee population of an academic medical center in The Netherlands. Nine patients and seven caregivers who dealt with lower limb amputation for no-option chronic limb threatening ischemia six to twelve months prior to the interview and were not cognitively impaired were selected. Nine healthcare professionals dealing with patients with no-option chronic limb threatening ischemia and lower limb amputation were selected.Results: Lower limb amputation was explicitly discussed late in the disease process, sometimes during an emergency setting. Patients stated goals were never discussed, healthcare professionals stated they were. The most important goal for patients was to live independently after lower limb amputation. Patients and caregivers feel healthcare professionals should be upfront about the possible necessity of lower limb amputation. Reasons to undergo lower limb amputation were absence of treatment options, pain and wanting to enjoy life again. Participants indicated accelerating lower limb amputation was not a viable option.Conclusion: All stakeholders reported overlapping values and preferences regarding main reasons for lower limb amputation, the primary goals after lower limb amputation, and the absence of a desire to accelerate lower limb amputation. The main difference in values and preferences is the preferred timing of discussing lower limb amputation.Keywords: vascular surgery, shared decision-making, SDM, communication

(1) Background: Near-infrared fluorescence imaging is a technique capable of assessing tissue perfusion and has been adopted in various fields including plastic surgery, vascular surgery, coronary arterial disease, and gastrointestinal surgery. While the usefulness of this technique has been broadly explored, there is a large variety in the calculation of perfusion parameters. In this systematic review, we aim to provide a detailed overview of current perfusion parameters, and determine the perfusion parameters with the most potential for application in near-infrared fluorescence imaging. (2) Methods: A comprehensive search of the literature was performed in Pubmed, Embase, Medline, and Cochrane Review. We included all clinical studies referencing near-infrared perfusion parameters. (3) Results: A total of 1511 articles were found, of which, 113 were suitable for review, with a final selection of 59 articles. Near-infrared fluorescence imaging parameters are heterogeneous in their correlation to perfusion. Time-related parameters appear superior to absolute intensity parameters in a clinical setting. (4) Conclusions: This literature review demonstrates the variety of parameters selected for the quantification of perfusion in near-infrared fluorescence imaging.

Objectives Preoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to study how complex processes usually go right at the frontline (labeled Safety-II) and how this relates to predefined procedures. This study aimed to assess PAM in everyday practice and explore the usability and utility of FRAM. Methods The study was conducted at an Australian and European Cardiothoracic Surgery Department. A FRAM model of work-as-imagined was developed using (inter)national guidelines. Semistructured interviews with 18 involved professionals were used to develop models reflecting work-as-done at both sites, which were presented to staff for validation. Workload in hours was estimated per process step. Results In both centers, work-as-done differed from work-as-imagined, such as in the division of tasks among disciplines (e.g., nurses/registrars rather than medical specialists), but control mechanisms had been developed locally to ensure safe care (e.g., crosschecking with other clinicians). Centers had organized the process differently, revealing opportunities for improvement regarding patient information and clustering of clinic visits. Presenting FRAM models to staff initiated discussion on improvement of functions in the model that are vital for success. Overall workload was estimated at 47 hours per site. Conclusions This FRAM analysis provided insight into PAM from the perspective of frontline clinicians, revealing essential functions, interdependencies and variability, and the relation with guidelines. Future studies are warranted to study the potential of FRAM, such as for guiding improvements in complex systems.

This chapter explores how currently available safety data in hospitals, such as adverse events, incidents and patient complaints, could be used with a Safety-II approach. While each data system captures different important signals from a patient’s journey, current use of these data in isolation of each other risks oversimplification and obscures complex relations between events. Connecting these data sources at the patient level produces a comprehensive dataset that can be used to help reveal the bigger picture of hospital performance, including both unsuccessful and successful outcomes. Moreover, assessing these data in relation to each other, offers a perspective that is closer to the messy reality of everyday clinical practice, helping to trace resilient behaviour and situations in which staff are muddling through with purpose.An increasing number of hospitals around the world are interested in adopting the Safety-II approach. Yet, quality and safety officers, clinicians, as well as policymakers, regulators and accreditation agencies may worry that implementing this novel approach means that they would have to start anew, wasting previous investments in patient safety using the ‘Safety-I’ approach. First, it is important to mention that Safety-II is not meant to replace Safety-I but to complement and enhance it. But would it be possible to apply Safety-II principles to the currently available systems and processes that hospitals have implemented over the past 20 years? This chapter will explore this central question and discuss the new opportunities that would be created by looking at currently available hospital data through a Safety-II lens.