Grading recommendations for enhanced patient safety in sentinel event analysis: the recommendation improvement matrix.

OBJECTIVES: The goal of sentinel event (SE) analysis is to prevent recurrence. However, the rate of SEs has remained constant over the past years. Research suggests this is in part due to the quality of recommendations. Currently, standards for the selection of recommendations are lacking. Developing a method to grade recommendations could help in both designing and selecting interventions most likely to improve patient safety. The aim of this study was to (1) develop a user-friendly method to grade recommendations and (2) assess its applicability in a large series of Dutch perioperative SE analysis reports. METHODS: Based on two grading methods, we developed the recommendation improvement matrix (RIM). Applicability was assessed by analysing all Dutch perioperative SE reports over a 12-month period. After which interobserver agreement was studied. RESULTS: In the RIM, two elements are crucial: whether the recommendation intervenes before or after an SE and whether it eliminates or controls the hazard. Applicability was evaluated in 115 analysis reports, encompassing 161 recommendations. Recommendation quality varied from the highest, category A, to the lowest, category D, with category A accounting for 44%, category B for 35%, category C for 2% and category D for 19% of recommendations. There was a fair interobserver agreement. CONCLUSION: The RIM can be used to grade recommendations in SE analysis and could possibly help in both designing and selecting interventions. It is relatively simple, user-friendly and has the potential to improve patient safety. The RIM can help formulate effective and sustainable recommendations, a second key objective of the RIM is to foster and facilitate constructive dialogue among those responsible for patient safety.

Incisional Wound Irrigation for the Prevention of Surgical Site Infection: A Systematic Review and Network Meta-Analysis.

Importance: Surgical site infections (SSIs) are common postoperative complications and associated with significant morbidity, mortality, and costs. Prophylactic intraoperative incisional wound irrigation is used to reduce the risk of SSIs, and there is great variation in the type of irrigation solutions and their use. Objective: To compare the outcomes of different types of incisional prophylactic intraoperative incisional wound irrigation for the prevention of SSIs in all types of surgery. Data Sources: PubMed, Embase, CENTRAL, and CINAHL databases were searched up to June 12, 2023. Study Selection: Included in this study were randomized clinical trials (RCTs) comparing incisional prophylactic intraoperative incisional wound irrigation with no irrigation or comparing irrigation using different types of solutions, with SSI as a reported outcome. Studies investigating intracavity lavage were excluded. Data Extraction and Synthesis: This systematic review and network meta-analysis is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. Two reviewers independently extracted the data and assessed the risk of bias within individual RCTs using the Cochrane Risk of Bias 2 tool and the certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation framework. A frequentist network meta-analysis was conducted, and relative risks (RRs) with corresponding 95% CIs were reported. Main Outcome and Measure: The primary study outcome was SSI. Results: A total of 1587 articles were identified, of which 41 RCTs were included in the systematic review, with 17 188 patients reporting 1328 SSIs, resulting in an overall incidence of 7.7%. Compared with no irrigation, antiseptic solutions (RR, 0.60; 95% CI, 0.44-0.81; high level of certainty) and antibiotic solutions (RR, 0.46; 95% CI, 0.29-0.73; low level of certainty) were associated with a beneficial reduction in SSIs. Saline irrigation showed no statistically significant difference compared with no irrigation (RR, 0.83; 95% CI, 0.63-1.09; moderate level of certainty). Conclusions and Relevance: This systematic review and network meta-analysis found high-certainty evidence that prophylactic intraoperative incisional wound irrigation with antiseptic solutions was associated with a reduction in SSIs. It is suggested that the use of antibiotic wound irrigation be avoided due to the inferior certainty of evidence for its outcome and global antimicrobial resistance concerns.

Introducing re-weighted range voting in clinical practice guideline prioritization: Development and testing of the re-weighted priority-setting (REPS) tool.

We aimed to develop and test a tool based on the re-weighted range voting mechanism to prioritize items (i.e. key questions) in a priority-setting assessment for clinical practice guidelines. The secondary aim was to provide methodological context of the tool. We iteratively developed the tool and used qualitative methods (i.e. think-aloud and semi-structured interviews) to test the tool's usability and make adjustments accordingly. An observational approach was used to test the tool's outcome satisfaction in a real-world priority-setting assessment within a rare-disease guideline of a European Reference Network and under four different conditions in the tool. Four guideline methodologists tested the usability of the tool. The real-world testing was performed with a guideline panel consisting of a core working group, five expertise working groups, and a working group with patient representatives. Thirty-one panel members assigned scores in the priority-setting assessment. Seventeen panel members rated the priority-setting outcome, and sixteen panel members rated the outputs generated under the four conditions. Upon initial use, guideline methodologists found the tool to be quite overwhelming. However, with some initial effort they were able to easily identify the tool's structure. Based on observations and feedback, the tool was further refined and user guidance was developed. Guideline panel members expressed (high) satisfaction with the priority-setting outcome. They particularly preferred the condition when using mean subgroup scores as input or employing aggressive penalties in the weighting method to determine the outputs. The tool generates a ranked list of items and offers flexibility for different choices in priority-setting assessments as long as its input format requirements are met. Although it is not a consensus method, the tool assists in narrowing down a set of priority items. Additional steps in the priority-setting assessment can lead to a consensus being reached regarding the final outcome.

Designing tailored maintenance strategies for systematic reviews and clinical practice guidelines using the Portfolio Maintenance by Test-Treatment (POMBYTT) framework.

BACKGROUND: Organizations face diverse contexts and requirements when updating and maintaining their portfolio, or pool, of systematic reviews or clinical practice guidelines they need to manage. We aimed to develop a comprehensive, theoretical framework that might enable the design and tailoring of maintenance strategies for portfolios containing systematic reviews and guidelines. METHODS: We employed a conceptual approach combined with a literature review. Components of the diagnostic test-treatment pathway used in clinical healthcare were transferred to develop a framework specifically for systematic review and guideline portfolio maintenance strategies. RESULTS: We developed the Portfolio Maintenance by Test-Treatment (POMBYTT) framework comprising diagnosis, staging, management, and monitoring components. To illustrate the framework's components and their elements, we provided examples from both a clinical healthcare test-treatment pathway and a clinical practice guideline maintenance scenario. Additionally, our literature review provided possible examples for the elements in the framework, such as detection variables, detection tests, and detection thresholds. We furthermore provide three example strategies using the framework, of which one was based on living recommendations strategies. CONCLUSIONS: The developed framework might support the design of maintenance strategies that could contain multiple options besides updating to manage a portfolio (e.g. withdrawing and archiving), even in the absence of the target condition. By making different choices for variables, tests, test protocols, indications, management options, and monitoring, organizations might tailor their maintenance strategy to suit specific contexts and needs. The framework's elements could potentially aid in the design by being explicit about the operational aspects of maintenance strategies. This might also be helpful for end-users and other stakeholders of systematic reviews and clinical practice guidelines.

Impact of fatigue in surgeons on performance and patient outcome: systematic review.

BACKGROUND: While fatigue is an inevitable aspect of performing surgical procedures, lack of consensus remains on its effect on surgical performance. The aim of this systematic review was to assess the effect of non-muscular fatigue on surgical outcome. METHODS: MEDLINE and Embase were searched up to 17 January 2023. Studies on students, learning, duty-hour restrictions, muscle fatigue, non-surgical or subjective outcome, the weekend effect, or time of admission were excluded. Studies were categorized based on real-life or simulated surgery. The Cochrane risk-of-bias tool was used to assess RCTs and the Newcastle-Ottawa scale was used to assess cohort studies. Due to heterogeneity among studies, data pooling was not feasible and study findings were synthesized narratively. RESULTS: From the 7251 studies identified, 134 studies (including 1 684 073 cases) were selected for analysis (110 real-life studies and 24 simulator studies). Of the simulator studies, 46% (11 studies) reported a deterioration in surgical outcome when fatigue was present, using direct measures of fatigue. In contrast, only 35.5% (39 studies) of real-life studies showed a deterioration, observed in only 12.5% of all outcome measures, specifically involving aggregated surgical outcomes. CONCLUSION: Almost half of simulator studies, along with one-third of real-life studies, consistently report negative effects of fatigue, highlighting a significant concern. The discrepancy between simulator/real-life studies may be explained by heightened motivation and effort investment in real-life studies. Currently, published fatigue and outcome measures, especially in real-life studies, are insufficient to fully define the impact of fatigue on surgical outcomes due to the absence of direct fatigue measures and crude, post-hoc outcome measures.

At some point, surgeons become tired, just like anyone else. While in other jobs, people start to perform worse as they get tired, it is not known whether this is also true for surgeons. It is important to know this because patients may be worse off if their surgeon is tired. The aim of this study was to find out if being tired affects how surgeons do their work. Medical databases were searched through for studies on tired surgeons and the impact of fatigue on their work. Some studies looked at tired surgeons during real surgery and other studies looked at tired surgeons during sessions on surgery simulators. More than 7000 studies were examined and 134 of them were selected. They included over 1.6 million surgeries. Among these studies, 110 investigated real surgeries and 24 looked at simulated surgical sessions. Interestingly, almost half of the studies looking at simulated surgeries found that being tired had a negative effect on the simulated surgery. However, in real surgeries, this happened in only one-third of studies. The difference between real surgery and simulator surgery could be because in real surgeries surgeons always try to do their best, even when fatigued, because they are dealing with real patients. Another reason could be that the tools used to check whether surgeons are tired or whether the surgery went well are not very good. To help both surgeons and patients, there is a need to find better ways to determine if surgeons are truly tired and to make sure the tests are better.

Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis.

Background: The evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and ambiguous. Implementation in daily practice is impaired by inconsistent recommendations in current international guidelines and published meta-analyses. More recently, multiple new randomised controlled trials (RCTs) have been published. We aimed to provide an overview of all meta-analyses and their characteristics; to conduct a new and up-to-date systematic review and meta-analysis and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment; and to explore the additive value of new RCTs with a trial sequential analysis (TSA). Methods: PubMed, Embase and Cochrane CENTRAL databases were searched from database inception to October 24, 2022. We identified existing meta-analyses covering all surgical specialties and RCTs studying the effect of iNPWT compared with standard dressings in all types of surgery on the incidence of SSI, wound dehiscence, reoperation, seroma, hematoma, mortality, readmission rate, skin blistering, skin necrosis, pain, and adverse effects of the intervention. We calculated relative risks (RR) with corresponding 95% confidence intervals (CI) using a Mantel-Haenszel random-effects model. We assessed publication bias with a comparison-adjusted funnel plot. TSA was used to assess the risk of random error. The certainty of evidence was evaluated using the Cochrane Risk of Bias-2 (RoB2) tool and GRADE approach. This study is registered with PROSPERO, CRD42022312995. Findings: We identified eight previously published general meta-analyses investigating iNPWT and compared their results to present meta-analysis. For the updated systematic review, 57 RCTs with 13,744 patients were included in the quantitative analysis for SSI, yielding a RR of 0.67 (95% CI: 0.59-0.76, I2 = 21%) for iNPWT compared with standard dressing. Certainty of evidence was high. Compared with previous meta-analyses, the RR stabilised, and the confidence interval narrowed. In the TSA, the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate from the meta-analysis. Interpretation: In this up-to-date meta-analysis, GRADE assessment shows high-certainty evidence that iNPWT is effective in reducing SSI, and uncertainty is less than in previous meta-analyses. TSA indicated that further trials are unlikely to change the effect estimate for the outcome SSI; therefore, if future research is to be conducted on iNPWT, it is crucial to consider what the findings will contribute to the existing robust evidence. Funding: Dutch Association for Quality Funds Medical Specialists.

What are Effective Strategies to Reduce Low-Value Care? An Analysis of 121 Randomized Deimplementation Studies.

BACKGROUND: Low-value care is healthcare leading to no or little clinical benefit for the patient. The best (combinations of) interventions to reduce low-value care are unclear. PURPOSE: To provide an overview of randomized controlled trials (RCTs) evaluating deimplementation strategies, to quantify the effectiveness and describe different combinations of strategies. METHODS: Analysis of 121 RCTs (1990-2019) evaluating a strategy to reduce low-value care, identified by a systematic review. Deimplementation strategies were described and associations between strategy characteristics and effectiveness explored. RESULTS: Of 109 trials comparing deimplementation to usual care, 75 (69%) reported a significant reduction of low-value healthcare practices. Seventy-three trials included in a quantitative analysis showed a median relative reduction of 17% (IQR 7%-42%). The effectiveness of deimplementation strategies was not associated with the number and types of interventions applied. CONCLUSIONS AND IMPLICATIONS: Most deimplementation strategies achieved a considerable reduction of low-value care. We found no signs that a particular type or number of interventions works best for deimplementation. Future deimplementation studies should map relevant contextual factors, such as the workplace culture or economic factors. Interventions should be tailored to these factors and provide details regarding sustainability of the effect.

Long-Term Survival and Quality of Life After Fenestrated Endovascular Repair for Complex Abdominal Aortic Aneurysms.

OBJECTIVES: Fenestrated endovascular repair (FEVAR) has become a widely used treatment option for complex abdominal aortic aneurysms (AAA) but long-term survival and quality of life (QoL) outcomes are scarce. This single center cohort study aims to evaluate both long-term survival and QoL after FEVAR. METHODS: All juxtarenal and suprarenal AAA patients treated with FEVAR in a single-center between 2002 and 2016 were included. QoL scores, measured by the RAND 36-Item Short Form Survey (SF-36), were compared with baseline data of the SF-36 provided by RAND. RESULTS: A total of 172 patients were included at a median follow-up of 5.9 years (IQR 3.0-8.8). Follow-up at 5 and 10 years post-FEVAR yielded survival rates of 59.9% and 18%, respectively. Younger patient age at surgery had a positive influence on 10-year survival and most patients died due to cardiovascular pathology. Emotional well-being was better in the research group as compared to baseline RAND SF-36 1.0 data (79.2 ± 12.4 vs 70.4 ± 22.0; P < 0.001). Physical functioning (50 (IQR 30-85) vs 70.6 ± 27.4; P = 0.007) and health change (51.6 ± 17.0 vs 59.1 ± 23.1; P = 0.020) were worse in the research group as compared to reference values. CONCLUSIONS: Long-term survival was 60% at 5-years follow-up, which is lower than reported in recent literature. An adjusted positive influence of younger age at surgery was found on long-term survival. This could have consequences for future treatment indication in complex AAA surgery but further large-scale validation is necessary.

Efficacy of different preoperative skin antiseptics on the incidence of surgical site infections: a systematic review, GRADE assessment, and network meta-analysis.

BACKGROUND: Surgical site infection (SSI) is the most common postoperative complication and substantially increases health-care costs. Published meta-analyses and international guidelines differ with regard to which preoperative skin antiseptic solution and concentration has the highest efficacy. We aimed to compare the efficacy of different skin preparation solutions and concentrations for the prevention of SSIs, and to provide an overview of current guidelines. METHODS: This systematic review and network meta-analysis compared different preoperative skin antiseptics in the prevention of SSIs in adult patients undergoing surgery of any wound classification. We searched for randomised controlled trials (RCTs) in MEDLINE, Embase, and Cochrane CENTRAL, published up to Nov 23, 2021, that directly compared two or more antiseptic agents (ie, chlorhexidine, iodine, or olanexidine) or concentrations in aqueous and alcohol-based solutions. We excluded paediatric, animal, and non-randomised studies, and studies not providing standard preoperative intravenous antibiotic prophylaxis. Studies with no SSIs in both groups were excluded from the quantitative analysis. Two reviewers screened and reviewed eligible full texts and extracted data. The primary outcome was the occurrence of SSI (ie, superficial, deep, and organ space). We conducted a frequentist random effects network meta-analysis to estimate the network effects of the skin preparation solutions on the prevention of SSIs. A risk-of-bias and Grading of Recommendations, Assessment, Development, and Evaluation assessment were done to determine the certainty of the evidence. This study is registered with PROSPERO, CRD42021293554. FINDINGS: Overall, 2326 articles were identified, 33 studies were eligible for the systematic review, and 27 studies with 17 735 patients reporting 2144 SSIs (overall incidence of 12·1%) were included in the quantitative analysis. Only 2·0-2·5% chlorhexidine in alcohol (relative risk 0·75, 95% CI 0·61-0·92) and 1·5% olanexidine (0·49, 0·26-0·92) significantly reduced the rate of SSIs compared with aqueous iodine. For clean surgery, we found no difference in efficacy between different concentrations of chlorhexidine in alcohol. Seven RCTs were at high risk of bias, 24 had some concerns, and two had low risk of bias. Heterogeneity across the studies was moderate (I2=27·5%), and netsplitting did not show inconsistencies between direct and indirect comparisons. Five of ten studies that mentioned adverse events related to the skin preparation solutions reported no adverse events, and five reported a total of 56 mild events (mainly erythema, pruritus, dermatitis, skin irritation, or mild allergic symptoms); none reported a substantial difference in adverse events between groups. INTERPRETATION: For adult patients undergoing a surgical procedure of any wound classification, skin preparation using either 2·0-2·5% chlorhexidine in alcohol or 1·5% olanexidine is most effective in the prevention of SSIs. For clean surgery, no specific concentration of chlorhexidine in alcohol can be recommended. The efficacy of olanexidine was established by a single randomised trial and further investigation is needed. FUNDING: Dutch Association for Quality Funds Medical Specialists.

[Safer surgery for abdominal aortic aneurysm]. / Opereren van abdominaal aorta aneurysma kan nog veiliger.

Since 2013 it is mandatory for all centers in the Netherlands to register outcomes of all aortic aneurysm repairs in the Dutch Surgical Aneurysm Audit (DSAA). Analysis of DSAA data shows a reduction in mortality and complications after endovascular and open surgery for infrarenal abdominal aortic aneurysm (AAA) from 2015-2019. The question is however whether a quality registry alone is sufficient to improve the quality of care, since it is up to the individual hospital to act on DSAA information. This commentary discusses targets for further improvement of outcomes of AAA surgery such as structural and transparent feedback on results, opportunities to learn from "best practices" and to look beyond quality scores and act instead. It further highlights the call for action to reduce the high mortality in females after open AAA repair and to avoid unnecessary operations under the threshold for AAA repair.

Multicenter experience of upper extremity access in complex endovascular aortic aneurysm repair.

PURPOSE: Upper extremity access (UEA) for antegrade cannulation of aortic side branches is a relevant part of endovascular treatment of complex aortic aneurysms and can be achieved using several techniques, sites, and sides. The purpose of this study was to evaluate different UEA strategies in a multicenter registry of complex endovascular aortic aneurysm repair (EVAR). METHODS: In six aortic centers in the Netherlands, all endovascular aortic procedures from 2006 to 2019 were retrospectively reviewed. Patients who received UEA during complex EVAR were included. The primary outcome was a composite end point of any access complication, excluding minor hematomas. Secondary outcomes were access characteristics, access complications considered individually, access reinterventions, and incidence of ischemic cerebrovascular events. RESULTS: A total of 417 patients underwent 437 UEA for 303 fenestrated/branched EVARs and 114 chimney EVARs. Twenty patients had bilateral, 295 left-sided, and 102 right-sided UEA. A total of 413 approaches were performed surgically and 24 percutaneously. Distal brachial access (DBA) was used in 89 cases, medial brachial access (MBA) in 149, proximal brachial access (PBA) in 140, and axillary access (AA) in 59 cases. No significant differences regarding the composite end point of access complications were seen (DBA: 11.3% vs MBA: 6.7% vs PBA: 13.6% vs AA: 10.2%; P = .29). Postoperative neuropathy occurred most after PBA (DBA: 1.1% vs MBA: 1.3% vs PBA: 9.3% vs AA: 5.1%; P = .003). There were no differences in cerebrovascular complications between access sides (right: 5.9% vs left: 4.1% vs bilateral: 5%; P = .75). Significantly more overall access complications were seen after a percutaneous approach (29.2% vs 6.8%; P = .002). In multivariate analysis, the risk for access complications after an open approach was decreased by male sex (odds ratio [OR]: 0.27; 95% confidence interval [CI]: 0.10-0.72; P = .009), whereas an increase in age per year (OR: 1.08; 95% CI: 1.004-1.179; P = .039) and diabetes mellitus type 2 (OR: 3.70; 95% CI: 1.20-11.41; P = .023) increased the risk. CONCLUSIONS: Between the four access localizations, there were no differences in overall access complications. Female sex, diabetes mellitus type 2, and aging increased the risk for access complications after a surgical approach. Furthermore, a percutaneous UEA resulted in higher complication rates than a surgical approach.

Brachial and Axillary Artery Vascular Access for Endovascular Interventions.

BACKGROUND: Endovascular access is usually achieved through the common femoral artery due to its large size and accessibility. Access through the upper extremity can however be necessary due to anatomic reasons, obesity, or peripheral arterial disease. The 2 main methods of access are surgical cutdown and percutaneous puncture. In this single-centre retrospective cohort study we compared complication risks for both surgical cutdown and percutaneous puncture of an upper arm approach. MATERIALS AND METHODS: Data was obtained from patients receiving endovascular access through the brachial or axillary artery between 2005 and 2018. A total of 109 patients were included. Patient demographics including age, sex, medical history, smoking status, and actual medication were registered, as well as postoperative complications including hematoma, thrombosis, dissection, infection, pseudoaneurysm, nerve injury, reoperation, and readmission. RESULTS: Access was achieved through surgical cutdown in 53% (n = 58) and through percutaneous puncture in 47% (n = 51) of patients. Fifty-eight percent (n = 63) received access via the brachial artery (BA) and 42% (n = 46) via the axillary artery. Complication rate was 25.0% (3 of 12) for surgical cutdown via the BA, 29.4% (15 of 51) for percutaneous puncture via the BA, and 10.9% (5 of 46) for surgical cutdown via the axillary artery. Major complication rate was 8.3% (1 of 12) for surgical cutdown via the BA, 13.7% (7 of 51) for percutaneous puncture via the BA, and 4.3% (2 of 46) for surgical cutdown via the axillary artery. There was no association between baseline patient characteristics and complication rate. CONCLUSIONS: In this nonrandomized retrospective study, surgical cutdown via the axillary artery was the safest option with fewest complications, but selection of patients may have blurred the results. Surgical cutdown and percutaneous puncture seem equally safe in terms of complication rate in the BA.

Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair.

INTRODUCTION: The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). METHODS: A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. RESULTS: A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%. CONCLUSION: There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.

Results from a nationwide prospective registry on open surgical or endovascular repair of juxtarenal abdominal aortic aneurysms.

BACKGROUND: Juxtarenal abdominal aortic aneurysms (JRAAAs) can be treated either with open surgical repair (OSR) including suprarenal clamping or by complex endovascular aneurysm repair (cEVAR). In this study, we present the comparison between the short-term mortality and complications of the elective JRAAA treatment modalities from a national database reflecting daily practice in The Netherlands. METHODS: All patients undergoing elective JRAAA open repair or cEVAR (fenestrated EVAR or chimney EVAR) between January 2016 and December 2018 registered in the Dutch Surgical Aneurysm Audit (DSAA) were eligible for inclusion. Descriptive perioperative variables and outcomes were compared between patients treated with open surgery or endovascularly. Adjusted odds ratios for short-term outcomes were calculated by logistic regression analysis. RESULTS: In all, 455 primary treated patients with JRAAAs could be included (258 OSR, 197 cEVAR). Younger patients and female patients were treated more often with OSR vs cEVAR (72 ± 6.1 vs 76 ± 6.0; P < .001 and 22% vs 15%; P = .047, respectively). Patients treated with OSR had significantly more major and minor complications as well as a higher chance of early mortality (OSR vs cEVAR, 45% vs 21%; P < .001; 34% vs 23%; P = .011; and 6.6% vs 2.5%; P = .046, respectively). After logistic regression with adjustment for confounders, patients who were treated with OSR showed an odds ratio of 3.64 (95% confidence interval [CI], 2.25-5.89; P < .001) for major complications compared with patients treated with cEVAR, and for minor complications, the odds ratios were 2.17 (95% CI, 1.34-3.53; P = .002) higher. For early mortality, the odds ratios were 3.79 (95% CI, 1.26-11.34; P = .017) higher after OSR compared with cEVAR. CONCLUSIONS: In this study, after primary elective OSR for JRAAA, the odds for major complications, minor complications, and short-term mortality were significantly higher compared with cEVAR.

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 volume-outcome 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 the 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.

Criteria for recommendations after perioperative sentinel events.

BACKGROUND: The recurrence of sentinel events (SEs) is a persistent problem worldwide, despite repeated analyses and recommendations formulated to prevent recurrence. Research suggests this is partly attributable to the quality of the recommendations, and determining if a recommendation will be effective is not yet covered by an adequate guideline. Our objectives were to (1) develop and validate criteria for high-quality recommendations, and (2) evaluate recommendations using the criteria developed. METHODS: (1) Criteria were developed by experts using the bowtie method. Medical doctors then determined if the recommendations of Dutch in-hospital SE analysis reports met the criteria, after which interobserver variability was tested. (2) Researchers determined which recommendations of Dutch perioperative SE analysis reports produced from 2017 to 2018 met the criteria. RESULTS: The criteria were: (1) a recommendation needs to be well defined and clear, (2) it needs to specifically describe the intended changes, and (3) it needs to describe how it will reduce the risk or limit the consequences of a similar SE. Validation of criteria showed substantial interobserver agreement. The SE analysis reports (n=115) contained 442 recommendations, of which 64% failed to meet all criteria, and 28% of reports did not contain a single recommendation that met the criteria. CONCLUSION: We developed and validated criteria for high-quality recommendations. The majority of recommendations did not meet our criteria. It was disconcerting to find that over a quarter of the investigations did not produce a single recommendation that met the criteria, not even in SEs with a fatal outcome. Healthcare providers have an obligation to prevent SEs, and certainly their recurrence. We anticipate that using these criteria to determine the potential of recommendations will aid in this endeavour.

Clinical importance of testing for clopidogrel resistance in patients undergoing carotid artery stenting-a systematic review.

Dual antiplatelet therapy is frequently prescribed for patients undergoing carotid artery stenting (CAS), however clopidogrel resistance might cause thromboembolic complications. The role of testing for clopidogrel resistance in patients undergoing CAS is unclear. In this study, we aimed to review the periprocedural thromboembolic outcomes in clopidogrel resistant patients who underwent CAS. We conducted a review of PubMed, EMBASE, and the Cochrane Library up to October 7, 2020. Studies were included that investigated at least ten patients aged 18 years or older with a symptomatic carotid artery stenosis requiring CAS. Studies were excluded that investigated patients with a carotid artery dissection, case reports, case series of less than ten patients, reviews, commentaries, letters to the editors, and conference abstracts. The primary endpoint was the incidence of thromboembolic events. One hundred seventy-seven unique articles were identified of which three studies were included in our systematic review. The sample sizes ranged from 76 to 449 patients and the follow-up duration from 24 hours to 2 years postprocedural. Two retrospective observational studies determined clopidogrel resistance using measurement of P2Y12 reaction units, and one historical cohort study used genetic testing. Two studies concluded that clopidogrel resistance was a risk factor for thromboembolic complications, the other found higher values of P2Y12 reaction units in patients with thromboembolic events compared to those without. In conclusion, current literature supports a possible relationship between clopidogrel resistance and thromboembolic complications in patients who underwent CAS. Preprocedural testing for clopidogrel resistance might therefore be of additional value. Randomized studies using a valid, reliable clopidogrel resistance test and clinical endpoints, are however required to make a definitive statement and to determine the impact of the thromboembolic complications. This study was registered within PROSPERO (CRD42020197318).

Treatment of patch infection after carotid endarterectomy: a systematic review.

Carotid endarterectomy (CEA) with patch angioplasty is a widely used method for treating carotid artery stenosis. Patch infections are extremely rare, but the consequences may be serious. The current gold standard for treatment is patch excision and reconstruction with autologous material. However, no consensus has been reached and other options may be valuable as well in certain cases. The objective of this study was to evaluate the various treatment options for carotid patch infection after CEA with patch angioplasty on the basis of their outcomes (reinfection, ischemic stroke, and infection-related mortality). This systematic review was conducted in accordance with the PRISMA statement. The electronic bibliographic databases PubMed, Cochrane, and EMBASE were searched. Case series and case reports were included. Studies in languages other than English were excluded. Patients who developed a post-operative patch infection of CEA with patch angioplasty were included. Angioplasty could be performed with any type of patch. Patch infection needed to be confirmed by clinical presentation in combination with imaging, culture, or during the operation. The primary outcome measures were reinfection, ischemic stroke, and infection-related mortality. Eleven retrospective case series, two prospective case series, and seventeen case reports were included. The study size was 165 patients (mean age 69.7 years, M/F ratio 1.75:1). One hundred and seventy-one patches developed a patch infection after CEA with patch angioplasty and needed treatment. Treatment strategies included conservative treatment (14.0%), endovascular treatment (4.7%), and open surgery (81.4%). Mean follow-up was 34.8 months and extended up to 180 months. Reinfection rate was 4.7%, ischemic stroke rate 5.8%, and infection-related mortality rate 2.3%. No statistical comparison between treatment options could be performed, because of the heterogeneity of the included studies. Autologous material should be the primary choice of treatment if patch infection is diagnosed after CEA with patch angioplasty. In emergency situations, endovascular treatment, carotid ligation, or abscess drainage could be considered. Endovascular treatment and abscess drainage are temporary solutions. After the patient has recovered sufficiently, a more durable treatment i.e., open surgery is advised. Endo vacuum assisted closure (EndoVAC) seems to be promising. Further research is needed to determine the applicability of each treatment option.