Evaluation of basic life support interventions for foreign body airway obstructions: A population-based cohort study.

AIM: To quantify the associations of foreign body airway obstruction (FBAO) basic life support (BLS) interventions with FBAO relief and survival to discharge. METHODS: We identified prehospital FBAO patient encounters in Alberta, Canada between Jan 1, 2018 and Dec 31,2021 using the provincial emergency medical services' medical records, deterministically linked to hospital data. Two physicians reviewed encounters to determine cases and extract data. Multivariable logistic regression determined the adjusted odds ratio of FBAO relief (primary outcome) and survival to discharge for the exposure of BLS interventions (abdominal thrusts [AT], chest compressions/thrusts [CC], or combinations) relative to back blows [BB]. Intervention-associated injuries were identified using International Classification of Diseases codes, followed by health records review. RESULTS: We identified 3,677 patient encounters, including 709 FBAOs requiring intervention. Bystanders performed the initial BLS intervention in 488 cases (77.4%). Bystanders and paramedics did not relieve the FBAO in 151 (23.5%) and 11 (16.7%) cases, respectively. FBAOs not relieved before paramedic arrival had a higher proportion of deaths (n = 4[0.4%] versus n = 92[42.4%], p < 0.001). AT and CC were associated with decreased odds of FBAO relief relative to BB (adjusted odds ratio [aOR] 0.49 [95%CI 0.30-0.80] and 0.14 [95%CI 0.07-0.28], respectively). CC were associated with decreased odds of survival to discharge (aOR 0.04 [95%CI 0.01-0.32]). AT, CC, and BB were implicated in intervention-associated injuries in four, nine, and zero cases, respectively. CONCLUSIONS: Back blows are associated with improved outcomes compared to abdominal thrusts and chest compressions. These data can inform prospective studies aimed at improving response to choking emergencies.

Does the Location of Endotracheal Intubation Affect the Success of Airway Management in a Helicopter Air Ambulance Service? A Simulation Study.

OBJECTIVE: Airway management is a cornerstone of helicopter air ambulance patient management. The purpose of this study was to evaluate the overall quality of airway management of critical care crews in 3 common locations for intubation. METHODS: This was a prospective observational simulation study assessing the overall airway management of critical care providers managing simulated patients in an emergency department, helicopter, and ambulance. Composite scores were obtained and compared with respect to physical environment and provider certification level. RESULTS: Fifty-four participants completed the simulations. The median score for the emergency department was 100; for ambulance, it was 80; and for helicopter, it was 80. Ambulance scores were significantly lower than emergency department scores (median difference = -5 points, P = .002) as were helicopter scores (median difference = -10 points, P < .001). The small sample size limited the statistical power to detect differences in provider type, and no statistically significant differences were found in these groups. CONCLUSION: In this study, the physical location of airway management negatively impacted the overall airway management success as determined by a standardized composite score. This suggests that airway management may have the highest rate of success in an emergency department as opposed to ground ambulance or helicopter air ambulance settings.

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

OBJECTIVE: Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair. BACKGROUND: Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair. METHODS: The trial was registered at clinicaltrials.gov (NCT03490266). Clinical outcomes included surgical site infection, surgical site occurrence, hernia occurrence, readmission, reoperation, and mortality. RESULTS: A total of 175 consecutive patients were approached that were deemed eligible for elective minimally invasive ventral hernia repair. In all, 124 were randomized and 101 completed follow-up at 2 years. Two-year follow-up was completed in 54 patients (83%) in the robotic arm and 47 patients (80%) in the laparoscopic arm. No differences were seen in surgical site infection or surgical site occurrence. Hernia recurrence occurred in 2 patients (4%) receiving robotic repair versus in 6 patients (13%) receiving laparoscopic repair (relative risk: 0.3, 95% CI: 0.06-1.39; P =0.12). No patients (0%) required reoperation in the robotic arm whereas 5 patients (11%) underwent reoperation in the laparoscopic arm ( P =0.019, relative risk not calculatable due to null outcome). CONCLUSIONS: Robotic ventral hernia repair demonstrated at least similar if not improved outcomes at 2 years compared with laparoscopy. There is potential benefit with robotic repair; however, additional multi-center trials and longer follow-up are needed to validate the hypothesis-generating findings of this study.

Prediction of major postoperative events after non-cardiac surgery for people with kidney failure: derivation and internal validation of risk models.

BACKGROUND: People with kidney failure often require surgery and experience worse postoperative outcomes compared to the general population, but existing risk prediction tools have excluded those with kidney failure during development or exhibit poor performance. Our objective was to derive, internally validate, and estimate the clinical utility of risk prediction models for people with kidney failure undergoing non-cardiac surgery. DESIGN, SETTING, PARTICIPANTS, AND MEASURES: This study involved derivation and internal validation of prognostic risk prediction models using a retrospective, population-based cohort. We identified adults from Alberta, Canada with pre-existing kidney failure (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73m2 or receipt of maintenance dialysis) undergoing non-cardiac surgery between 2005-2019. Three nested prognostic risk prediction models were assembled using clinical and logistical rationale. Model 1 included age, sex, dialysis modality, surgery type and setting. Model 2 added comorbidities, and Model 3 added preoperative hemoglobin and albumin. Death or major cardiac events (acute myocardial infarction or nonfatal ventricular arrhythmia) within 30 days after surgery were modelled using logistic regression models. RESULTS: The development cohort included 38,541 surgeries, with 1,204 outcomes (after 3.1% of surgeries); 61% were performed in males, the median age was 64 years (interquartile range [IQR]: 53, 73), and 61% were receiving hemodialysis at the time of surgery. All three internally validated models performed well, with c-statistics ranging from 0.783 (95% Confidence Interval [CI]: 0.770, 0.797) for Model 1 to 0.818 (95%CI: 0.803, 0.826) for Model 3. Calibration slopes and intercepts were excellent for all models, though Models 2 and 3 demonstrated improvement in net reclassification. Decision curve analysis estimated that use of any model to guide perioperative interventions such as cardiac monitoring would result in potential net benefit over default strategies. CONCLUSIONS: We developed and internally validated three novel models to predict major clinical events for people with kidney failure having surgery. Models including comorbidities and laboratory variables showed improved accuracy of risk stratification and provided the greatest potential net benefit for guiding perioperative decisions. Once externally validated, these models may inform perioperative shared decision making and risk-guided strategies for this population.

Preferences of Patients With Chronic Kidney Disease for Invasive Versus Conservative Treatment of Acute Coronary Syndrome: A Discrete Choice Experiment.

Background Patients with chronic kidney disease (CKD) can experience acute coronary syndromes (ACS) with high morbidity and mortality. Early invasive management of ACS is recommended for most high-risk patients; however, choosing between an early invasive versus conservative management approach may be influenced by the unique risk of kidney failure for patients with CKD. Methods and Results This discrete choice experiment measured the preferences of patients with CKD for future cardiovascular events versus acute kidney injury and kidney failure following invasive heart procedures for ACS. The discrete choice experiment, consisting of 8 choice tasks, was administered to adult patients attending 2 CKD clinics in Calgary, Alberta. The part-worth utilities of each attribute were determined using multinomial logit models, and preference heterogeneity was explored using latent class analysis. A total of 140 patients completed the discrete choice experiment. The mean age of patients was 64 years, 52% were male, and mean estimated glomerular filtration rate was 37 mL/min per 1.73 m2. Across the range of levels, risk of mortality was the most important attribute, followed by risk of end-stage kidney disease and risk of recurrent myocardial infarction. Latent class analysis identified 2 distinct preference groups. The largest group included 115 (83%) patients, who placed the greatest value on treatment benefits and expressed the strongest preference for reducing mortality. A second group of 25 (17%) patients was identified who were procedure averse and had a strong preference toward conservative management of ACS and avoiding acute kidney injury requiring dialysis. Conclusions The preferences of most patients with CKD for management of ACS were most influenced by lowering mortality. However, a distinct subgroup of patients was strongly averse to invasive management. This highlights the importance of clarifying patient preferences to ensure treatment decisions are aligned with patient values.

Preferences for COVID-19 Vaccination in People With Chronic Immune-Mediated Inflammatory Diseases.

OBJECTIVE: To understand how people with chronic immune-mediated inflammatory diseases (IMIDs) trade off the benefits and risks of coronavirus disease 2019 (COVID-19) vaccine options. METHODS: We conducted an online discrete-choice experiment in people with IMIDs to quantify the relative importance (RI) of attributes relevant to COVID-19 vaccination. Participants were recruited between May and August 2021 through patient groups and clinics in Canada, and completed 10 choices where they selected 1 of 2 hypothetical vaccine options or no vaccine. The RI of each attribute was estimated and heterogeneity was explored through latent class analysis. RESULTS: The survey was completed by 551 people (89% female, mean age 46 yrs) with a range of IMIDs (inflammatory bowel disease [48%], rheumatoid arthritis [38%], systemic lupus erythematosus [16%]). Most had received 1 (94%) or 2 (64%) COVID-19 vaccinations. Across the ranges of levels considered, vaccine effectiveness was most important (RI = 66%), followed by disease flare (21%), rare but serious risks (9%), and number/timing of injections (4%). Patients would accept a risk of disease flare requiring a treatment change of ≤ 8.8% for a vaccine with a small absolute increase in effectiveness (10%). Of the 3 latent classes, the group with the greatest aversion to disease flare were more likely to be male and have lower incomes, but this group still valued effectiveness higher than other attributes. CONCLUSION: Patients perceived the benefits of COVID-19 vaccination to outweigh rare serious risks and disease flare. This supports COVID-19 vaccine strategies that maximize effectiveness, while recognizing the heterogeneity in preferences that exists.

The Impact of Community-Based Testing Sites and Gift Incentives on COVID-19 Testing Uptake in Maryland, April 29 - May 9, 2021.

PURPOSE: Information on incentives for COVID-19 testing is needed to understand effective practices that encourage testing uptake. We describe characteristics of those who received an incentive after performing a rapid antigen test. DESIGN: Cross-sectional descriptive analysis of survey data. SETTING: During April 29-May 9, 2021, COVID-19 rapid antigen testing was offered in 2 Maryland cities. SAMPLE: Convenience sample of 553 adults (≥18 years) who tested and received an incentive; 93% consented to survey. MEASURES: Survey questions assessed reasons for testing, testing history, barriers, and demographics. ANALYSIS: Robust Poisson regressions were used to determine characteristic differences based on testing history and between participants who would re-test in the future without an incentive vs participants who would not. RESULTS: The most common reasons for testing were the desire to be tested (n = 280; 54%) and convenience of location (n = 146; 28%). Those motivated by an incentive to test (n = 110; 21%) were 5.83 times as likely to state they would not test again without an incentive, compared to those with other reasons for testing (95% CI: 2.67-12.72, P < .001). CRITICAL LIMITATIONS: No comparative study group. CONCLUSION: Results indicate internal motivation and convenience were prominent factors supporting testing uptake. Incentives may increase community testing participation, particularly among people who have never tested. Keywords COVID-19, pandemic, incentives, health behavior, community testing.

Using the Revised Cardiac Risk Index to Predict Major Postoperative Events for People With Kidney Failure: An External Validation and Update.

Background: People with kidney failure have high risk of postoperative morbidity and mortality. Although the revised cardiac risk index (RCRI) is used to estimate the risk of major postoperative events, it has not been validated in this population. We aimed to externally validate the RCRI and determine whether updating the model improved predictions for people with kidney failure. Methods: We derived a retrospective, population-based cohort of adults with kidney failure (maintenance dialysis or sustained estimated glomerular filtration rate < 15 mL/min per 1.73 m2) who had surgery in Alberta, Canada between 2005 and 2019. We categorized participants based on RCRI variables and assigned risk estimates of death or major cardiac events, and then estimated predictive performance. We re-estimated the coefficients for each RCRI variable and internally validated the updated model. Net benefit was estimated with decision curve analysis. Results: After 38,541 surgeries, 1204 events (3.1%) occurred. The estimated C-statistic for the original RCRI was 0.64 (95% confidence interval: 0.62, 0.65). Examination of calibration revealed significant risk overestimation. In the re-estimated RCRI model, discrimination was marginally different (C-statistic 0.67 [95% confidence interval: 0.66, 0.69]), though calibration was improved. No net benefit was observed when the data were examined with decision curve analysis, whereas the original RCRI was associated with harm. Conclusions: The RCRI performed poorly in a Canadian kidney failure cohort and significantly overestimated risk, suggesting that RCRI use in similar kidney failure populations should be limited. A re-estimated kidney failure-specific RCRI may be promising but needs external validation. Novel perioperative models for this population are urgently needed.

Contexte: Les personnes atteintes d'insuffisance rénale présentent un risque élevé de mortalité et de morbidité postopératoires. L'indice de risque cardiaque révisé (IRCR) est utilisé pour estimer le risque d'événements postopératoires majeurs, mais il n'a pas été validé au sein de cette po-pulation. Nous avons cherché à réaliser une validation externe de l'IRCR et à déterminer si une modification du modèle pourrait permettre une meilleure valeur prédictive pour les patients atteints d'insuffisance rénale. Méthodologie: Nous avons étudié rétrospectivement une cohorte populationnelle d'adultes atteints d'insuffisance rénale (sous dialyse d'entretien ou avec un débit de filtration glomérulaire estimé < 15 ml/min/1,73 m2, de façon soutenue) ayant subi une intervention chirurgicale en Alberta (Canada) entre 2005 et 2019. Les participants ont été classifiés selon les variables de l'IRCR, et une estimation du risque de décès ou d'événement cardiovasculaire majeur leur a été attribuée; la performance prédictive a ensuite été évaluée. Nous avons réestimé les coefficients pour chacune des variables de l'IRCR et nous avons validé de manière interne le modèle modifié. Le bénéfice net a été estimé avec une analyse de la courbe décisionnelle. Résultats: Après 38 541 interventions chirurgicales, des événements cardiovasculaires sont survenus dans 1 204 cas (3,1 %). La statistique C estimée obtenue avec l'IRCR initial était de 0,64 (intervalle de confiance [IC] à 95 %, de 0,62 à 0,65). Un examen de la calibration de l'indice a révélé une surestimation significative du risque. Avec le modèle d'IRCR modifié, la discrimination présentait une légère différence (statistique C de 0,67 [IC à 95 %, de 0,66 à 0,69]), bien que la calibration ait été améliorée. Pour l'indice modifié, aucun bénéfice net n'a été observé lors de l'examen des données par une analyse décisionnelle, alors qu'un préjudice était associé à l'IRCR initial. Conclusions: L'IRCR s'est révélé peu concluant dans une cohorte populationnelle de patients canadiens atteints d'insuffisance rénale et il a significativement surestimé les risques pour ces patients, ce qui suggère que l'utilisation de l'IRCR dans des populations similaires atteintes d'insuffisance rénale devrait être limitée. Un IRCR réestimé, propre à la population des patients atteints d'insuffisance rénale, pourrait être prometteur, mais requiert une validation externe. De nouveaux modèles périopératoires sont indispensables pour cette population.

Reconstructive Surgeons as Essential Operative Consultants: Quantifying the True Value of Plastic Surgeons to an Academic Medical Center.

BACKGROUND: The revenue generated by plastic surgeons assisting other surgical services is poorly captured by hospital accounting systems, which categorize solely by attending physician of record. The financial impact of reconstructive surgery is thus systematically underestimated. The authors sought to quantify the overlooked value of plastic surgeons as consultants who facilitate complex and profitable operations. METHODS: Hospital billing data were reviewed for inpatient operations over a 3-year fiscal period (2015 to 2017). Cases in which a plastic surgeon assisted were identified. Case mix index, a measure of complexity that correlates with profit, and contribution margin, defined as revenue minus cost, were obtained for each case. RESULTS: Five hundred fifty-four cases required a reconstructive surgeon; 18,904 nonconsultation cases were identified for comparison. Average net revenue per case involving a consultation was 1.79 times greater than for control cases (p < 0.0001). Average contribution margin was 1.73 times greater (p < 0.005). The highest contribution margins stemmed from joint cases with cardiothoracic surgery and neurosurgery. Case mix index was significantly higher for consultation cases than for controls (4.5 versus 3.9; p < 0.0001). In 434 cases (78 percent), plastic surgery assisted with an integral aspect of the operation, meaning the surgery could not have been technically performed without reconstructive assistance. CONCLUSIONS: The authors' findings demonstrate that cases involving plastic surgeons have a higher profit margin than those performed by any department alone. However, this revenue is not appropriately attributed because of oversimplified financial metrics. The skill set of reconstructive surgeons is an undervalued resource for both patient care and hospital economics.

Derivation and External Validation of a Risk Index for Predicting Acute Kidney Injury Requiring Kidney Replacement Therapy After Noncardiac Surgery.

Importance: Severe acute kidney injury (AKI) is a serious postoperative complication. A tool for predicting the risk of AKI requiring kidney replacement therapy (KRT) after major noncardiac surgery might assist with patient counseling and targeted use of measures to reduce this risk. Objective: To derive and validate a predictive model for AKI requiring KRT after major noncardiac surgery. Design, Setting, and Participants: In this prognostic study, 5 risk prediction models were derived and internally validated in a population-based cohort of adults without preexisting kidney failure who underwent noncardiac surgery in Alberta, Canada, between January 1, 2004, and December 31, 2013. The best performing model and corresponding risk index were externally validated in a population-based cohort of adults without preexisting kidney failure who underwent noncardiac surgery in Ontario, Canada, between January 1, 2007, and December 31, 2017. Data analysis was conducted from September 1, 2019, to May 31, 2021. Exposures: Demographic characteristics, surgery type, laboratory measures, and comorbidities before surgery. Main Outcomes and Measures: Acute kidney injury requiring KRT within 14 days after surgery. Discrimination was assessed using the C statistic; calibration was assessed using calibration intercept and slope. Logistic recalibration was used to optimize model calibration in the external validation cohort. Results: The derivation cohort included 92 114 patients (52.2% female; mean [SD] age, 62.3 [18.0] years), and the external validation cohort included 709 086 patients (50.8% female; mean [SD] age, 61.0 [16.0] years). A total of 529 patients (0.6%) developed postoperative AKI requiring KRT in the derivation cohort, and 2956 (0.4%) developed postoperative AKI requiring KRT in the external validation cohort. The following factors were consistently associated with the risk of AKI requiring KRT: younger age (40-69 years: odds ratio [OR], 2.07 [95% CI, 1.69-2.53]; <40 years: OR, 3.73 [95% CI, 2.61-5.33]), male sex (OR, 1.55; 95% CI, 1.28-1.87), surgery type (colorectal: OR, 4.86 [95% CI, 3.28-7.18]; liver or pancreatic: OR, 6.46 [95% CI, 3.85-10.83]; other abdominal: OR, 2.19 [95% CI, 1.66-2.89]; abdominal aortic aneurysm repair: OR, 19.34 [95% CI, 14.31-26.14]; other vascular: OR, 7.30 [95% CI, 5.48-9.73]; thoracic: OR, 3.41 [95% CI, 2.07-5.59]), lower estimated glomerular filtration rate (OR, 0.97; 95% CI, 0.97-0.97 per 1 mL/min/1.73 m2 increase), lower hemoglobin concentration (OR, 0.99; 95% CI, 0.98-0.99 per 0.1 g/dL increase), albuminuria (mild: OR, 1.88 [95% CI, 1.52-2.33]; heavy: OR, 3.74 [95% CI, 2.98-4.69]), history of myocardial infarction (OR, 1.63; 95% CI, 1.32-2.03), and liver disease (mild: OR, 2.32 [95% CI, 1.66-3.24]; moderate or severe: OR, 4.96 [95% CI, 3.58-6.85]). In external validation, a final model including these variables showed excellent discrimination (C statistic, 0.95; 95% CI, 0.95-0.96), with sensitivity of 21.2%, specificity of 99.9%, positive predictive value of 38.1%, and negative predictive value of 99.7% at a predicted risk threshold of 10% or greater. Conclusions and Relevance: The findings suggest that this risk model can predict AKI requiring KRT after noncardiac surgery using routine preoperative data. The model may be feasible for implementation in clinical perioperative risk stratification for severe AKI.

Sex chromosome transformation and the origin of a male-specific X chromosome in the creeping vole.

The mammalian sex chromosome system (XX female/XY male) is ancient and highly conserved. The sex chromosome karyotype of the creeping vole (Microtus oregoni) represents a long-standing anomaly, with an X chromosome that is unpaired in females (X0) and exclusively maternally transmitted. We produced a highly contiguous male genome assembly, together with short-read genomes and transcriptomes for both sexes. We show that M. oregoni has lost an independently segregating Y chromosome and that the male-specific sex chromosome is a second X chromosome that is largely homologous to the maternally transmitted X. Both maternally inherited and male-specific sex chromosomes carry fragments of the ancestral Y chromosome. Consequences of this recently transformed sex chromosome system include Y-like degeneration and gene amplification on the male-specific X, expression of ancestral Y-linked genes in females, and X inactivation of the male-specific chromosome in male somatic cells. The genome of M. oregoni elucidates the processes that shape the gene content and dosage of mammalian sex chromosomes and exemplifies a rare case of plasticity in an ancient sex chromosome system.

Thromboelastography-Based Profiling of Coagulation Status in Patients Undergoing Bariatric Surgery: Analysis of 422 Patients.

INTRODUCTION/PURPOSE: Some clinical indicators suggest hypercoagulability/hyperaggregability in patients with morbid obesity. Thromboelastography (TEG®) has been used to profile coagulation status in surgical patients. We aimed to assess coagulation profiles in patients with morbid obesity undergoing bariatric surgery by correlating demographic and patient characteristics to pre-operative TEG® values. MATERIALS AND METHODS: Pre-operative TEG® values from 422 patients undergoing bariatric surgery were evaluated. TEG® results were analyzed by gender, use of medications known to alter the coagulation profile, and body mass index (BMI). RESULTS: Patients have a mean of 45.03 ± 11.8 years, female (76.3%), and with a mean BMI of 42 kg/m 1. The overall coagulation profile of female patients was significantly different from males, even in the sub-cohort without use of medications known to alter coagulation. The majority of patients (94%) with a G value > 15 dynes/cm 1 (clot strength) were female. In females, there was no association between BMI and TEG® values; however, in men, there was a statistically significant difference in TEG® values for those with BMI < 40 kg/m 1 compared to those with BMI > 50 kg/m2. CONCLUSIONS: TEG®-based analysis of coagulation profiles offers unique insights. Compared to laboratory normal values (R time, angle, maximal amplitude, and G values), patients with morbid obesity may have a tendency for hypercoagulability/hyperaggregability, with mean values at the higher limit. A significant hypercoagulable difference in TEG® values was identified in female as compared to male patients. Male patients with a BMI greater than 50 kg/m2 were also found to be increasingly hypercoagulable.

Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcomes of robotic versus laparoscopic ventral hernia repair (LVHR) at 1-year postoperative. SUMMARY OF BACKGROUND DATA: Despite a relative lack of research at low risk for bias assessing robotic ventral hernia repair (RVHR), the growth of RVHR has been rapid. We previously reported short-term results of the first randomized control trial comparing RVHR versus LVHR; there was no clear difference in clinical outcomes but increased operative time and cost with robotic repair. METHODS: Patients from a multicenter, blinded randomized control trial comparing RVHR versus LVHR were followed at 1 year. Outcomes included wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis). RESULTS: A total of 124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed 1-year follow-up. Baseline demographics were similar in both groups. No differences were seen in wound complication (15% vs 15%; P = 0.899), hernia recurrence (7% vs 9%; P = 0.576), or readmission (2% vs 6%; P = 0.251). No patients underwent reoperation in the robotic arm, whereas 5 (9%) did in the laparoscopic arm (P = 0.020). No differences were seen in patient-reported outcomes. Both arms reported clinically significant improvements in functional status, low pain scores, and high satisfaction scores at 1-year post repair. CONCLUSION: This study confirms that robotic ventral hernia repair is safe when compared to laparoscopy. Further studies are needed to confirm these findings.

Outcomes of primary versus revisional robotically assisted laparoscopic Roux-en-Y gastric bypass: a multicenter analysis of ten-year experience.

BACKGROUND: Postoperative morbidity after laparoscopic bariatric surgery is considered higher for patients undergoing revisional versus primary procedures. The objective of this retrospective cohort study was to compare outcomes between patients undergoing primary versus revisional robotically assisted laparoscopic (RAL) Roux-en-Y gastric bypass (RYGB). METHODS: Data of all patients who underwent RAL primary and revisional RYGB between 2009 and 2019 at two accredited, high-volume bariatric surgery centers-the Memorial Hermann - Texas Medical Center, Houston, TX, and the Tower Health, Reading Hospital, Reading, PA, were analyzed. Primary outcomes were early (< 30 days) and overall postoperative complications. Secondary outcomes included intraoperative complications, operative times, conversions to laparotomy, length of hospital stay, early (< 30 days) postoperative readmissions and deaths. RESULTS: Data of 1072 patients were analyzed, including 806 primary and 266 revisional RAL RYGB procedures. Longer operative times (203 versus 154 min, P < 0.001), increased number of readmissions for oral intolerance (10.5% versus 6.7%, P = 0.046) and higher rate of gastrojejunal stricture (6.4% versus 2.7%, P = 0.013) were found in the revisional group. Gastrointestinal leak rates were 0.2% for the primary versus 1.1% for the revisional group (P = 0.101). Early (< 30 days) reoperations rates were 2.2% for the primary versus 1.1% for the revisional group (P = 0.318). There were no statistically significant differences between groups in overall and severe complication rates. CONCLUSION: Patients undergoing RAL primary and revisional RYGB had comparable overall outcomes, with a non-significant higher early complication rate in the revisional group. Despite the study being underpowered to detect differences in specific complication rates, the morbidity seen in the revisional RYGB group remains markedly below literature reports of revisional laparoscopic RYGB and might suggest a benefit of robotic assistance. Further prospective studies are needed to confirm these results.

Patient and physician perspectives on shared decision-making for coronary procedures in people with chronic kidney disease: a patient-oriented qualitative study.

BACKGROUND: Patients with chronic kidney disease (CKD) and heart disease face challenging treatment decisions. We sought to explore the perceptions of patients and physicians about shared decision-making for coronary procedures for people with CKD, as well as opinions about strategies and tools to improve these decisions. METHODS: We partnered with 4 patients with CKD and 1 caregiver to design and conduct a qualitative descriptive study using semi-structured interviews and content analysis. Patient participants with CKD and either acute coronary syndrome or cardiac catheterization in the preceding year were recruited from a provincial cardiac registry, cardiology wards and clinics in Calgary between March and September 2018. Cardiologists from the region also participated in the study. Data analysis emphasized identifying, organizing and describing themes found within the data. RESULTS: Twenty patients with CKD and 10 cardiologists identified several complexities related to bidirectional information exchange needed for shared decision-making. Themes identified by both patients and physicians included challenges synthesizing best evidence, variable patient knowledge seeking, timeliness in the acute care setting and influence of roles on decision-making. Themes identified by physicians related to processes and tools to help support shared decision-making in this setting included personalization to reflect the variability of risks and heterogeneity of patient preferences as well as allowing for physicians to share their clinical judgment. INTERPRETATION: There are complexities related to bidirectional information exchange between patients with CKD and their physicians for shared decision-making about coronary procedures. Processes and tools to facilitate shared decision-making in this setting require personalization and need to be time sensitive.

Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial.

OBJECTIVE: To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair. DESIGN: Pragmatic, blinded randomized controlled trial. SETTING: Multidisciplinary hernia clinics in Houston, USA. PARTICIPANTS: 124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019. INTERVENTIONS: Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59). MAIN OUTCOME MEASURES: The primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat. RESULTS: Patients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair. CONCLUSION: This study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs. TRIAL REGISTRATION: Clinicaltrials.gov NCT03490266.

Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.

Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 µg/serotype/dose adjuvanted with aluminum, AS01E or AS03B, or aluminum-adjuvanted 4 µg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03B). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03B: 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.

Impact of a care delivery redesign initiative for vascular surgery.

OBJECTIVE: A hospital-wide quality improvement process through a care delivery redesign (CDR) was initiated to improve patient care efficiency, clinical documentation, and length of stay (LOS). The impact of CDR was assessed through LOS, unplanned readmission rates, and hospital financial metrics. METHODS: The CDR team consisted of the Chief of Vascular Surgery, inpatient nurse practitioner, dedicated case manager, clinical documentation improvement specialist, and vascular surgery residents and faculty. The nurse practitioner facilitated patient care coordination, resident system-based education, and multidisciplinary collaboration. Tools created to track performance and to ensure sustainability included daily discussions of patient care barriers and solutions; standardized order sets; a mobile app for residents containing resident service expectations, disease-specific resources, and vascular surgery journal links; and a weekly inpatient tracker showing real-time patient care data. Outcome measures included LOS, case mix index, contribution margin, and unplanned readmissions. Each outcome was determined for all inpatient admissions the year before and the 12 months after CDR was initiated. Outcomes were compared between the two groups. RESULTS: Implementation of CDR resulted in a 23% decrease in LOS (P = .003), reducing the gap to the Centers for Medicare and Medicaid Services geometric mean LOS from 2.1 days to 0.5 day (P < .001). Clinical documentation resulted in an increase in case mix index of 10% (P = .011). The 30-day unplanned readmission rates did not change in the 12 months after CDR was initiated compared with the year before (P = .92). Financial data demonstrated decreased variable cost and increased revenue resulting in a $1.89 million increase in contribution margin. CONCLUSIONS: A CDR predicated on a dedicated service line advanced practitioner, clinical documentation education, weekly service tracker review, and real-time management of system-related barriers to patient care is described. Implementation of the CDR reduced hospital LOS with no change in unplanned readmissions and provided significant financial benefit to the hospital by increasing revenue and decreasing variable cost.

Trocar site closure with a novel anchor-based (neoClose®) system versus standard suture closure: a prospective randomized controlled trial.

BACKGROUND: Patients with obesity have a higher risk of trocar site hernia. The objective of the present study was to compare a standard suture passer versus the neoClose® device for port site fascial closure in patients with obesity undergoing laparoscopic bariatric surgery. METHODS: This is a randomized, controlled trial with two parallel arms. Thirty five patients with BMI ≥ 35 kg/m2 and undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass were randomized to each group. Port site fascial closure for trocars ≥ 10 mm was performed with the neoClose® device in the study group and the standard suture passer in the control group. Primary outcomes were time required to complete closure and intensity of postoperative pain at the fascial closure sites. Secondary outcomes were intraabdominal needle depth and incidence of trocar site hernia. RESULTS: The use of the neoClose® device resulted in shorter closure times (20.2 vs 30.0 s, p = 0.0002), less pain (0.3 vs 0.9, p = 0.002) at port closure sites, and decreased needle depth (3.3 cm vs 5.2 cm, p < 0.0001) compared to the standard suture passer. There was no trocar site hernia at the one-year follow-up in either group. CONCLUSIONS: Use of the neoClose® device resulted in faster fascial closure times, decreased intraoperative needle depth, and decreased postoperative abdominal pain at 1 week as compared to the standard suture passer. These data need to be confirmed on larger cohorts of patients with longer follow-up.

Safety of robotic assisted laparoscopic recurrent paraesophageal hernia repair: insights from a large single institution experience.

BACKGROUND: Laparoscopic repair of recurrent as opposed to primary paraesophageal hernias (PEHs) are historically associated with increased peri-operative complication rates, worsened outcomes, and increased conversion rates. The robotic platform may aid surgeons in these complex revision procedures. The aim of this study was to compare the outcomes of patients undergoing robotic assisted laparoscopic (RAL) repair of recurrent as opposed to primary PEHs. METHODS: Patients undergoing RAL primary and recurrent PEH repairs from 2009 to 2017 at a single institution were reviewed. Demographics, use of mesh, estimated blood loss, intra-operative complications, conversion rates, operative time, rates of esophageal/gastric injury, hospital length of stay, re-admission/re-operation rates, recurrence, dysphagia, gas bloat, and pre- and post-operative proton pump inhibitor (PPI) use were analyzed. Analysis was accomplished using Chi-square test/Fischer's exact test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: There were 298 patients who underwent RAL PEH repairs (247 primary, 51 recurrent). They were followed for a median (interquartile range) of 120 (44, 470) days. There were no significant differences in baseline demographics between groups. Patients in the recurrent PEH group had longer operative times, increased use of mesh, and increased length of hospital stay. They were also less likely to undergo fundoplication. There were no significant differences in estimated blood loss, incidence of intra-operative complications, re-admission rates, incidence of post-operative dysphagia and gas bloat, and incidence of post-operative PPI use. There were no conversions to open operative intervention or gastric/esophageal injury/leaks. CONCLUSIONS: Although repair of recurrent PEHs are historically associated with worse outcomes, in this series, RAL recurrent PEH repairs have similar peri-operative and post-operative outcomes as compared to primary PEH repairs. Whether this is secondary to the potential advantages afforded by the robotic platform deserves further study.