Prevalence, Characteristics, and Reasons for Kratom Use among Psychiatrically Ill Inpatients Who Use Substances.

OBJECTIVE: Despite kratom impacting neurobiological systems involved in psychiatric disorders, little is known about the prevalence of use among patients with severe psychopathologies. Here, we investigated the prevalence of kratom use, motives for use, and the clinical associations among inpatients with severe psychiatric disorders. METHODS: A total of 578 patients, aged 18 to 65, were evaluated by New Hampshire Hospital's Addiction Services from January 1, 2020, to February 28, 2022. The study collected demographic information and used chi-square tests, multivariable logistic regression, and subgroup analyses with 95% confidence intervals to examine trends among kratom users. A receiver operating characteristic curve analysis was also conducted. All statistical tests were performed using IBM SPSS Version 28.0.1. RESULTS: Of the patients assessed, 2.2% (n = 13) reported using kratom. The reasons for kratom use were managing withdrawal symptoms (15.4%), maintaining sobriety and reducing cravings for opioids (53.8%), improving focus and concentration (30.8%), alleviating low moods (38.5%), and managing pain (15.4%). Compared to non-kratom users, the only factor with a fair to good association with kratom use is postsecondary education (Area Under Curve, AUC = 0.77). CONCLUSIONS: Prevalence of kratom use among patients with serious mental illness at our site aligns with that reported in the general population. Users often cite self-management of cravings and sobriety from opioids, as well as treatment of low mood states, as motivations for consumption. While observations suggest a possible association between kratom use and individuals with post-secondary education, multiple substance use, and experience of substance-induced psychosis or mood disorders, it is essential to interpret these links cautiously until further rigorous studies are carried out to substantiate these findings.

Green endoscopy: British Society of Gastroenterology (BSG), Joint Accreditation Group (JAG) and Centre for Sustainable Health (CSH) joint consensus on practical measures for environmental sustainability in endoscopy.

GI endoscopy is highly resource-intensive with a significant contribution to greenhouse gas (GHG) emissions and waste generation. Sustainable endoscopy in the context of climate change is now the focus of mainstream discussions between endoscopy providers, units and professional societies. In addition to broader global challenges, there are some specific measures relevant to endoscopy units and their practices, which could significantly reduce environmental impact. Awareness of these issues and guidance on practical interventions to mitigate the carbon footprint of GI endoscopy are lacking. In this consensus, we discuss practical measures to reduce the impact of endoscopy on the environment applicable to endoscopy units and practitioners. Adoption of these measures will facilitate and promote new practices and the evolution of a more sustainable specialty.

Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results.

OBJECTIVE: Adverse outcomes observed late in the Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) investigational device exemption trial prompted refinement of the anatomic instructions for use (IFU). This study aimed to investigate the association of procedural factors during Nellix endograft deployment and patient outcomes. METHODS: We retrospectively reviewed 1-month imaging of 333 patients enrolled in the prospective, multicenter EVAS investigational device exemption trial between January 2014 and September 2016. Initial observations of those patients who met revised anatomic IFU yet still experienced late adverse events suggested that inadequate seal and low graft placement were common among these patients. Key procedural variables identified from a univariate analysis were applied to construct four cohorts stratified by procedural technical performance (technically adequate [P+] or technically inadequate [P-]) and the revised anatomic indications for use (anatomically within IFU [A+] or anatomically outside of IFU [A-]) and to compare them for aneurysm-related outcomes. A logistic regression analysis was performed to identify significant predictors of sac expansion or migration. RESULTS: Proximal and distal seal zones and low graft placement were identified by logistic regression analysis as significant predictors of sac expansion or migration. Accordingly, acquisition of ≥10-mm proximal and distal seal zones and the position of the lowest stent within 10 mm of the lowest renal artery were clinically justified as thresholds for a technically adequate procedure. Patients who did not achieve these parameters were deemed to have a technically inadequate procedure. By use of the proposed procedural adequacy criteria and established anatomic criteria, patients were stratified into four cohorts: A+/P+ (n = 77), A+/P- (n = 54), A-/P+ (n = 71), and A-/P- (n = 131). Three-year estimates of freedom from migration of 10 mm were 98.6% in A+/P+, 95.9% in A+/P-, 85.8% in A-/P+, and 80.1% in A-/P-; freedom from type IA endoleak estimates were 98.6% in A+/P+, 100% in A+/P-, 96.4% in A-/ P+, and 90.3% in A-/P- cohorts. Freedom from sac expansion and secondary intervention were 96.9% and 90.6% in A+/P+, 86.0% and 93.6% in A+/P-, 87.1% and 83.1% in A-/P+, and 80.5% and 79.8% in A-/P- groups, respectively. Two early deaths (aneurysm-related mortality) on days 4 and 12 postoperatively were reported within the A+/P- group. Kaplan-Meier estimates of freedom from all-cause mortality and aneurysm-related mortality at 3 years were similar between cohorts. CONCLUSIONS: This post hoc analysis suggests that achieving a 10-mm proximal and distal seal with adequate positioning of the endograft with respect to the renal arteries is associated with improved patient outcomes.

Outcomes of carotid endarterectomy in the Vascular Quality Initiative based on patch type.

OBJECTIVE: The Vascular Quality Initiative (VQI) is the largest registry of vascular surgical procedures and as such is capable of distinguishing small but important differences in outcomes. The goal of this study was to determine the outcomes of carotid endarterectomy (CEA) based on patch type, including bovine pericardium, autogenous vein, polytetrafluoroethylene (PTFE), and Dacron. METHODS: All primary CEAs performed with primary repair and patching (n = 70,987) within the VQI were retrospectively analyzed. Reoperative CEA and combined CEA and coronary artery bypass were excluded. Rates of any postoperative neurologic event, return to the operating room (bleeding, neurologic event, or wound complication), and restenosis (>50% and >80%) at 1-year follow-up were primary outcomes. Rates were compared by patch type using χ2 and Bonferroni analysis. Multivariate hierarchical logistic regression models were used to predict end points of postoperative neurologic event, return to the operating room, and 1-year restenosis. RESULTS: During the period of study, 2003 to 2017, there were 70,987 CEAs entered into the VQI registry. Bovine pericardium was the patch material with the highest frequency of use (n = 51,480), followed by Dacron (n = 12,356), vein (n = 1460), and PTFE (n = 1638). Bovine pericardium, vein, and Dacron had lower rates of postoperative neurologic events compared with PTFE or primary repair. Bovine pericardium had the lowest rate of restenosis at 1 year. By multivariate analysis, bovine pericardium (odds ratio [OR], 0.70; 95% confidence interval [CI], 0.56-0.89) and protamine use (OR, 0.74; 95% CI, 0.60-0.91) were associated with a lower incidence of return to the operating room. The use of Dacron, vein, and PTFE patches was not significantly different from the reference of primary closure. Multivariate analysis of postoperative neurologic events revealed that bovine pericardium (OR, 0.59; CI, 0.48-0.72) and Dacron (OR, 0.56; CI, 0.43-0.72) were associated with lower incidence of stroke or transient ischemic attack, whereas vein and PTFE were no different from primary closure. Bovine pericardium (OR, 0.57; CI, 0.44-0.75), Dacron (OR, 0.70; CI, 0.50-0.98), vein (OR, 0.72; CI, 0.53-0.98), and never smoking (OR, 0.87; CI, 0.78-0.96) were associated with a lower incidence of restenosis at 1 year by multivariate analysis. CONCLUSIONS: Bovine pericardium has superior outcomes both postoperatively and at 1 year compared with other patch materials. The large volume of patient data contained in the VQI makes it possible to compare outcomes that have small but meaningful differences.

Endovascular Aneurysm Sealing is Associated with Higher Medium-Term Survival than Traditional EVAR.

BACKGROUND: Endovascular aneurysm repair (EVAR) is the dominant treatment modality for abdominal aortic aneurysm (AAA). Periprocedural risks are low, and cardiovascular events are the principle determinants of long-term survival. Recently, the concept of endovascular aneurysm sealing (EVAS) has been introduced into clinical investigation. In previous cohort studies, EVAS has been associated with a lower all-cause mortality than expected despite device issues. We used a propensity weighted approach to investigate whether EVAS was associated with lower all-cause mortality after aneurysm repair. METHODS: We compared 333 patients in the Nellix United States Investigational Device Exemption trial to 15,431 controls from the Vascular Quality Initiative between 2014 and 2016 after applying the exclusion criteria from the investigational device exemption (hemodialysis, creatinine > 2.0 mg/dL, or rupture). We calculated propensity scores and applied inverse probability weighting to compare risk adjusted medium-term survival using Kaplan-Meier and Cox regression. RESULTS: After weighting, patients treated with the Nellix EVAS system experienced higher 3-year survival than controls from the Vascular Quality Initiative (93% vs. 88%, respectively). This corresponded to a 41% lower risk of mortality for EVAS compared with EVAR (HR 0.59 [0.38-0.92], P = 0.02). Subgroup analysis demonstrated that the association between EVAS and higher survival was strongest in the subgroup of patients with aneurysms over 5.5 cm (P for interaction < 0.001). In this subgroup, EVAS patients experienced half the rate of mortality as those patients treated with EVAR, with 3-year survival of 92% compared with 86% (HR 0.5 [0.3-0.9], P = 0.02). CONCLUSIONS: In this select group of patients, EVAS was associated with higher medium-term survival than traditional EVAR. Although issues with the device have recently surfaced, this exploratory analysis shows that the concept of sac sealing may hold promise. Further study is needed to confirm this finding and determine whether EVAS is associated with lower rates of cardiovascular events.

Long-term impact of the Vascular Study Group of New England carotid patch quality initiative.

OBJECTIVE: Patch angioplasty has been shown to decrease rates of restenosis after carotid endarterectomy (CEA). In 2003, the Vascular Study Group of New England (VSGNE) implemented its first quality initiative aimed at increasing the rates of patch closure after CEA. This study reports the effects of that initiative on the rate of patch closure in the VSGNE and also postoperative and 1-year CEA outcomes. METHODS: Patients undergoing CEA (N = 14,636) within the VSGNE between 2003 and 2014 were studied. Rates of in-hospital postoperative events (death, ipsilateral stroke or transient ischemic attack [TIA], and return to the operating room for bleeding) and events during 1 year of follow-up (stroke or TIA and restenosis >70% or occlusion) were compared by repair type-patch closure, primary closure, or eversion. One-year follow-up events were also compared over time and by annualized surgeon volume. RESULTS: During the 12 years studied, patch use increased from 71% to 91% (P < .001). There was no difference in postoperative death or ipsilateral stroke or TIA between the repair types. However, there was a statistically lower rate of return to the operating room for bleeding (P < .001), 1-year stroke or TIA (P < .003), and 1-year restenosis or occlusion (P < .001) with patch closure. Overall, the rates of 1-year stroke or TIA and restenosis decreased over time in the VSGNE. The initiative affected patch closure rates and outcomes of high-volume surgeons (>47 CEAs/y) the most. High-volume surgeons increased patch use from 50% to 90% and decreased their restenosis rates from 9.0% to 1.2% and 1-year stroke or TIA from 4.9% to 1.9% (P < .001). CONCLUSIONS: The VSGNE carotid patch quality initiative successfully increased the rates of CEA patch closure. During the same time, there has been a decrease in postoperative bleeding requiring reoperation and 1-year ipsilateral neurologic events and restenosis or occlusion.

Comparison of major adverse event rates after elective endovascular aneurysm repair in New England using a novel measure of complication severity.

OBJECTIVE: Major adverse event (MAE) rates are used as an outcome measure after surgical procedures. Although MAE rates summarize the occurrences of adverse events, they do not reflect differences in severity of these events. We propose that a measure of complication severity could provide a more accurate assessment about the quality of care. We aimed to analyze and to describe the regional variation in elective endovascular aneurysm repair (EVAR) MAE rates across centers in the Vascular Study Group of New England and to create an index for describing complication severity. METHODS: Patients undergoing elective EVAR (n = 4731) at 30 Vascular Study Group of New England centers between 2003 and 2016 were studied. The MAE composite end point was defined as the occurrence of any of the following postoperative events: myocardial infarction, dysrhythmia, congestive heart failure, leg ischemia, renal insufficiency, bowel complication, reoperation, surgical site infection, stroke, respiratory complication, and no home discharge. An adjustment factor (complication severity index) was calculated as a ratio of length of stay for complicated to uncomplicated cases. Multivariate logistic regression was used to calculate predicted MAE rates. The observed and predicted MAE rates as well as complication severity index rates were compared among centers and across quintiles of center volume. RESULTS: Observed MAE rates varied widely, ranging from 0% to 39%. Multivariate predictors of MAE included abdominal aortic aneurysm diameter >6 cm (odds ratio [OR], 2.1; 95% confidence interval [CI], 2.0-2.3), female sex (OR, 2.0; 95% CI, 1.8-2.2), chronic renal insufficiency (OR, 1.9; 95% CI, 1.7-2.1), age >75 years (OR, 1.9; 95% CI, 1.8-2.1), congestive heart failure (OR, 1.7; 95% CI, 1.5-1.9), chronic obstructive pulmonary disease (OR, 1.5; 95% CI, 1.4-1.6), diabetes (OR, 1.4; 95% CI, 1.1-1.7), positive stress test result (OR, 1.2; 95% CI, 1.1-1.4), preoperative beta blocker (OR, 1.2; 95% CI, 1.1-1.3), and no preoperative statin (OR, 1.2; 95% CI, 1.1-1.3). Predicted MAE rates had little variation (range, 21%-29%). In comparing observed MAE rates and complication severity, there was an inverse relation between the two, suggesting that although certain centers had a greater number of MAEs, the complications were less severe. CONCLUSIONS: MAE rates after elective EVAR vary widely. However, centers with higher MAE rates tended to have less severe complications, suggesting that observed MAE rates may not be a good measure of outcomes assessment after elective EVARs.

Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial.

BACKGROUND: The Nellix System (Endologix, Inc, Irvine, Calif) for endovascular aneurysm sealing (EVAS) is a novel approach to abdominal aortic aneurysm treatment and conceptually different from endovascular aneurysm repair, whereby polymer is employed to fill and actively manage the abdominal aortic aneurysm sac. One-year safety and effectiveness results of the Nellix pivotal trial demonstrated encouraging outcomes with very low morbidity and mortality and high procedural and treatment success. Two-year imaging revealed a signal of migration, leading to a field safety notification issued by the manufacturer on October 21, 2016, and a dedicated root cause analysis, resulting in refinements to the instructions for use (IFU). We report the 2-year results of the investigational device exemption pivotal trial stratified according to the new and original criteria for selection of patients. METHODS: Comprehensive engineering evaluations, statistical analyses, and clinical assessments were conducted looking at patients enrolled in the pivotal trial (N = 150), roll-in cohort (N = 29), and continued access program (N = 154). All patients in all cohorts were treated on-IFU at the time of enrollment. Logistic regression models supported the mechanism that migration with Nellix is associated with a small aortic flow lumen relative to a large aneurysm thrombus burden and large aortic neck diameters. Based on these findings, refinements to the IFU criteria were applied, excluding patients with a thrombus index (maximum aneurysm sac/maximum flow lumen diameter) >1.4, aortic neck diameter >28 mm, and aortic neck conicity (>10% diameter change along the infrarenal neck) and requiring a 10-mm distal seal zone in the iliac artery. RESULTS: Freedom from all-cause mortality at 2 years was 94%. Patient outcomes were then stratified on the refined morphologic criteria and analyzed retrospectively. Two-year freedom from composite endoleak was high among both cohorts (95% on-IFU vs 92% off-IFU). Freedom from migration was 97.7% on-IFU vs 93.2% off-IFU (P = .0125). Freedom from aneurysm enlargement was 98.1% on-IFU vs 93.5% off-IFU (P value is not available because of failure of log-rank test assumptions). Composite freedom from migration, type IA endoleak, or aneurysm expansion was 95.9% among the on-IFU cohort vs 85.1% in the off-IFU cohort (P = .0017). CONCLUSIONS: Consistent with the introduction of a novel therapy, the presentation of failure modes of EVAS over time was inevitable. Using detailed imaging as well as engineering and statistical analysis, we were able to understand risk factors for adverse events specific to EVAS and defined those patients best suited for Nellix. With this EVAS-specific approach to defining IFU, on-IFU patients were identified as those with large aneurysms with little thrombus that would be prone to type II endoleaks and sac expansion with traditional devices. When treated with Nellix, these patients were predicted to experience exceptional results, especially with regard to a low composite endoleak rate and low all-cause mortality.

External Validation of a Rapid Ruptured Abdominal Aortic Aneurysm Score.

BACKGROUND: The Rapid Ruptured Abdominal Aortic Aneurysm Score (RrAAAS) was developed from Vascular Study Group of New England (VSGNE) data (649 ruptured abdominal aortic aneurysm (rAAA) patients, repaired both open and endovascularly), using preoperative age, creatinine, and blood pressure. This study validates that model using the larger National Vascular Quality Initiative (VQI) data set and compares its performance to previous models. METHODS: The VQI registry was queried for patients undergoing rAAA repair from 2006 to 2016. The performance of our original model, RrAAAS, was tested on this data set excluding VSGNE patients (VQI minus VSGNE), and its performance was then compared to the performance of the Glasgow Aneurysm Score (GAS) and Edinburgh Ruptured Aneurysm Score (ERAS). RESULTS: VQI contained 2,704 eligible patients, of which 715 had been contributed by VSGNE. The discrimination of RrAAAS was similar to GAS or ERAS (area under a receiver operator characteristic curve = 0.66). Neither GAS nor ERAS provides a direct prediction of mortality; observed mortality in the VQI minus VSGNE cohort tended to be somewhat lower than predictions of the original RrAAAS. A recalibrated equation predicting the percent mortality was Mortality (%) = 16 + 12*(age > 76) + 8*(creatinine > 1.5) + 20*(systolic blood pressure < 70). CONCLUSIONS: The previously described RrAAAS has similar discrimination as the GAS and ERAS, is easier to obtain in an emergency setting, and has been recalibrated to reflect the experience of a large national sample. The RrAAAS could be useful for clinicians caring for these patients and could be used for risk adjustment when comparing regional differences in mortality associated with rAAA repair.

'When you're it': a qualitative study exploring the rural nurse experience of managing acute mental health presentations.

INTRODUCTION: A higher proportion of chronic mental illness is reported for populations residing in inner and outer regional (IOR) areas when compared to major cities in Australia. Conversely, fewer mental health professionals work in IOR areas when compared to major cities indicating poorer access to services for rural populations. Rural emergency departments (EDs) and urgent care centres (UCCs) deliver a broad range of services. Often they are the first point of care for consumers experiencing acute mental health issues. Rural nurses working in EDs and UCCs require a diverse clinical skill set to manage complex presentations, often with limited support and resources. Developments in telehealth services have reportedly improved access for rural consumers. It is known that nurses report a lack of skills and confidence when managing mental health presentations. Despite these challenges, there is little documented regarding the experience of generalist nurses managing acute mental health presentations in rural hospitals that have limited support of community mental health teams and no onsite inpatient mental health facilities. METHODS: A qualitative study was conducted to explore the experience of rural nurses in managing acute mental health presentations within an emergency context. An interview guide developed from the literature was used to explore issues of experience, safety, knowledge and clinical confidence. Thirteen rural generalist nurses from one rural emergency department and two rural UCCs located in south-west Victoria participated in a semi-structured interview. Interviews were audio-recorded and transcribed verbatim. Transcriptions were thematically analysed by applying an inductive descriptive approach. RESULTS: The majority of participants were experienced generalist registered nurses with no formal qualifications in mental health. Two participants had some clinical experience in mental health and drug and alcohol. Themes elicited from data analysis and discussion between the researchers were (1) 'we are the frontline', (2) 'doing our best to provide care', (3) 'complexities of navigating the system', and (4) 'thinking about change'. Findings indicated that rural generalist nurses deliver the majority of care to mental health consumers in EDs and UCCs. Local mental health clinicians and emergency service providers offer limited support, with a reliance on telephone triage for after-hours assessment. Multiple challenges were cited including coordinating the transfer of consumers to inpatient facilities and feeling inadequately supported. Irrespective of these challenges, nurses reported delivering the best possible care to consumers despite reporting a lack of knowledge and skills. Recommendations for improving the delivery of care included increasing access to emergency mental health training and receiving more support from local mental health teams. The need for more rural mental health facilities was also discussed. CONCLUSIONS: The findings from this study suggest generalist nurses are the frontline providers of care for mental health consumers in rural EDs and UCCs. Nurses feel ill-equipped for assessing and managing mental health presentations, relying heavily on local mental health teams and telephone triage who provide limited onsite support. The need to support nurses through training and mentoring relationships with community mental health teams is highlighted by this study in conjunction with improving the delivery of mental health services in rural areas.

One-year pivotal trial outcomes of the Nellix system for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial. METHODS: Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect. RESULTS: Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness end point (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention. CONCLUSIONS: Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress.

Effect of adjunct femoral endarterectomy in lower extremity bypass on perioperative and 1-year outcomes.

BACKGROUND: Isolated common femoral endarterectomy was recently reported to have a 30-day mortality of 3.4%. The effect of adjunctive femoral endarterectomy at the time of lower extremity bypass is not well described, and therefore, the purpose of this study was to determine its associated perioperative and long-term risk. METHODS: Vascular Study Group of New England registry data were used to identify patients undergoing initial lower extremity bypass from 2003 to 2015. After univariate analysis, multivariable logistic regression was used to identify the independent association of endarterectomy with adverse perioperative events. Kaplan-Meier and Cox hazard models were used for the 1-year analysis. RESULTS: After exclusions, 4496 patients were identified as undergoing infrainguinal bypass (33% with endarterectomy). There was no difference in the proportion with chronic limb-threatening ischemia (CLI; 68% vs 67%; P = .24) or tissue loss of those with CLI (65% vs 63%; P = .34) between the adjunctive endarterectomy group and bypass alone, respectively. Patients undergoing adjunctive endarterectomy were older (mean 68 years vs 67 years; P = .02), more likely white (95% vs 93%; P = .02), smokers (91% vs 87%; P = .001), and more often had prior coronary artery bypass grafting/percutaneous coronary intervention (34% vs 31%; P = .02). The endarterectomy cohort had similar 30-day mortality (CLI: 2.6% vs 2.9%; P = .60; claudication: 0.2% vs 0.4%; P = 1.0) despite a longer operative time (median, 268 minutes vs 210 minutes; P < .001) and increased blood loss (median, 250 mL vs 180 mL; P < .001). Patients with CLI undergoing adjunctive endarterectomy had more in-hospital myocardial infarctions (MIs; 6.2% vs 3.8%; P = .003) and transfusions (11% vs 6.8%; P < .001). At 1-year, this group had a suggestion of improved freedom from major amputation (91% vs 87%; P = .049) and amputation-free survival (80% vs 76%; P = .03) that did not reach significance after adjustment. For patients with claudication and adjunctive endarterectomy, rates of MI (2.4% vs 0.9%; P = .02), renal dysfunction (3.6% vs 1.4%; P = .01), surgical site infection (SSI; 5.0% vs 2.6%; P = .02), and transfusion (4.6% vs 1.8%; P = .002) were higher. After adjustment, all patients undergoing adjunctive endarterectomy were at increased risk of MI (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.2), SSI (OR, 1.5; 95% CI, 1.1-2.0), and bleeding requiring transfusion (OR, 1.8; 95% CI, 1.4-2.3). There were no differences in 1-year survival for CLI or claudication groups and no difference in all 1-year end points for patients with claudication. CONCLUSIONS: Adjunctive femoral endarterectomy with bypass is safe, with no difference in perioperative or 1-year mortality compared with bypass. However, surgeons should be aware that adjunctive endarterectomy is associated with an increased risk of bleeding, SSI, and MI, likely from these patients' disease burden and presumed more extensive atherosclerosis.

Predicting Mortality of Ruptured Abdominal Aortic Aneurysms in the Era of Endovascular Repair.

BACKGROUND: Previous risk prediction models of mortality after ruptured abdominal aortic aneurysm (rAAA) repair have been limited by imprecision, complexity, or inclusion of variables not available in the preoperative setting. Most importantly, these prediction models have been derived and validated before the adoption of endovascular aneurysm repair (EVAR) as a treatment for rAAA. We sought to derive and validate a new risk-prediction tool using only easily obtainable preoperative variables in patients with rAAA who are being considered for repair in the endovascular era. METHODS: We used the Vascular Study Group of New England (VSGNE) database to identify all patients who underwent repair of RAAA (2006-2015). Variables were entered into a multivariable logistic regression model to identify independent predictors of 30-day mortality. Linear regression was then used to develop an equation to predict risk of 30-day mortality. RESULTS: During the study period, 649 patients underwent repair of rAAA; of these, 247 (38.1%) underwent EVAR and 402 (61.9%) underwent an open repair. The overall mortality associated with rAAA was 30.7% (open, 33.4% and EVAR, 26.2%). On multivariate modeling, the primary determinants of 30-day mortality were advanced age (>76 vs. ≤76 years, odds ratio [OR] = 2.91 and CI: 2.0-4.24), elevated creatinine (>1.5 mg/dL vs. ≤1.5 mg/dL, OR = 1.57 and CI: 1.05-2.34), and lowest systolic blood pressure (SBP) (BP <70 mm Hg vs. ≥70 mm Hg, OR = 2.65 and CI: 1.79-3.92). The logistic regression model had an area under a c-statistic of 0.69. The corresponding linear model used to provide a point estimate of 30-day mortality (%) was % mortality = 14 + 22 * (age >76) + 9 * (creatinine >1.5) + 20 * (bp <70) Using this model, patients can be stratified into different groups, each with a specific estimated risk of 30-day mortality ranging from a low of 14% to a high of 65%. CONCLUSIONS: In the endovascular era where both open and endovascular treatment are offered for the treatment of rAAA three variables, easily obtained in an emergency setting, accurately predict 30-day mortality for patients operated on for rAAA. This simple risk prediction tool could be used as a point of care decision aid to help the clinician in counseling patients and their families on treatment of those presenting with rAAA.

Determinants of Follow-Up Failure in Patients Undergoing Vascular Surgery Procedures.

BACKGROUND: The Vascular Study Group of New England (VSGNE) requires documentation of follow-up for >80% of patients at least 9 months postprocedure. However, many participating groups fall short of this goal. We sought to identify factors independently associated with loss to long-term follow-up (LTF). METHODS: The VSGNE was queried from 2008 to 2012, for all carotid endarterectomy (CEA), endovascular aneurysm repair (EVAR), open abdominal aortic aneurysm repair (OPEN), infrainguinal bypass (INFRA), and suprainguinal bypass (SUPRA) procedures in patients who survived greater than 9 months postprocedure. Our primary endpoint was loss to LTF, with LTF defined as documentation of a phone call or office visit ≥9 months postprocedure. Multivariable logistic regression was used to identify independent predictors of loss to LTF. Covariates included patient and procedural characteristics, and treatment center/physician. Relative contributions of covariates to the model were assessed by evaluation of the relative model Wald chi-squared values. RESULTS: We identified 14,452 procedures (6567 CEA, 2391 EVAR, 3356 INFRA, 979 OPEN, and 1159 SUPRA). Of those, 4669 (32%) were lost to LTF. Rates of loss to LTF varied by center, and ranged from 9.8% to 100%. Independent predictors of loss to LTF were history of coronary artery disease or percutaneous coronary artery intervention (odds ratio [OR] 1.4, 95% confidence interval [CI] 1.1-1.7), procedure type (OPEN, OR 1.4, 95% CI: 1.2-1.7; CEA, OR 1.2, 95% CI: 1.1-1.4; referent, EVAR), and discharge to rehab (OR 1.2, 95% CI: 1.1-1.4; referent, home). Center variation was the strongest determinant of loss to LTF with a model χ2 over 40 times as large as the second strongest determinant. CONCLUSIONS: LTF is central to outcome reporting and is vital to the success of any registry effort. In the VSGNE experience, center variation is the strongest predictor of loss to LTF, outweighing patient and procedural factors. Other predictors of loss to LTF included history of coronary revascularization, procedure type, no prior history of congestive heart failure, and discharge location. High performing centers likely have specific process measures that decrease loss to LTF. As the Society for Vascular Surgery Vascular Quality Initiative continues to roll out nationally, high performing centers in VSGNE should be studied to document and propagate best practices for minimizing loss to LTF.

Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. METHODS: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). RESULTS: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). CONCLUSIONS: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.

Effect of chronic oral anticoagulation with warfarin on the durability and outcomes of endovascular aortic aneurysm repair.

OBJECTIVE: Endoleak after endovascular aortic aneurysm repair (EVAR) can affect the durability of the repair and lead to continued sac expansion, rupture, and the need for further endovascular or open surgical interventions. The purpose of this study was to determine whether chronic anticoagulation therapy with warfarin is associated with an increased incidence of endoleak and thus increased need for reintervention after EVAR. METHODS: We reviewed the records of 401 consecutive patients who underwent EVAR at a single institution from 2003 until 2011. Patients on warfarin were compared with a control group not on warfarin. Primary endpoints included reintervention, defined as rupture, explant, or angiography; death from any cause; and a composite outcome of reintervention or death. The presence of an endoleak at last follow-up, identified by computed tomography or ultrasound scan, and increase of more than 5 mm in aneurysm sac size were secondary endpoints. Cox proportional hazards models were used to estimate the effect of warfarin use on the primary and secondary outcomes, controlling for age, gender, obesity, specific comorbidities, antiplatelet drugs, statin use, and urgency of EVAR. RESULTS: Three hundred sixty-three patients with a median follow-up period of 29 months had sufficient data for analysis. Warfarin use was not associated with an increased risk of any of the primary endpoints. Controlling for covariates and length of observation via proportional hazards models, the effect of warfarin remained insignificant. It was found, however, on regression analysis, that adverse outcomes were more prevalent after emergency EVAR and in patients deemed unfit for open surgical repair. CONCLUSIONS: Chronic oral anticoagulation does not appear to affect the incidence of endoleak after EVAR, nor does it impact the need for reintervention or degree of sac regression. We feel that warfarin may be safely used in post-EVAR patients. It appears that adverse long-term outcomes are more likely after emergency EVAR and in patients deemed unfit for open surgery.

The New Hampshire Hospital Screening and Referral Algorithm (NHHSRA) for Substance Use in People With Serious Mental Illness.

Objective: Substance use is a common co-occurrence among psychiatrically hospitalized adults, yet it is especially difficult to identify in those with serious mental illness. Existing screening instruments are not feasible for individuals with serious mental illness, as they rely heavily on subjective self-report. This study aimed to develop and validate an objective substance use screening instrument for use in seriously mentally ill patient populations.Methods: Objective elements were extracted from existing substance use screening instruments and used to develop a new, data-driven referral tool, the New Hampshire Hospital screening and referral algorithm (NHHSRA). Descriptive statistics were employed to compare NHHSRA summed score and individual patient data elements in a convenience sample of patients who were referred to the Addiction Services by expert addiction psychiatrist evaluation to those who were not referred. Pearson correlation coefficients and logistic regression models assessed the association between patient referral and the overall NHHSRA score and individual items. The NHHSRA was then piloted in a smaller convenience sample of patients against the standard clinical-based identification for substance use treatment needs.Results: The instrument consists of 5 objective items. These were tested in a sample of 302 sequentially admitted adults with serious mental illness. Three of the items were significantly associated with likelihood of benefitting from referral for substance use interventions (maximum likelihood estimate and standard deviation [SD] for positive non-tetrahydrocannabinol [non-THC] toxicology screen or > 0% blood alcohol level = 3.61 [0.6]; diagnosis of a substance use disorder = 4.89 [0.73]; and medication-assisted treatment or relapse prevention = 2.78 [0.67]), and these were prioritized in building a decision tree algorithm. The area under the receiver operating characteristic (ROC) curve for the NHHSRA was 0.96, indicating that the NHHSRA has high overall sensitivity and the algorithm was capable of distinguishing between patients needing substance use intervention versus those who do not with 96% accuracy. In the pilot implementation study of another 20 patient admissions, the NHHSRA accurately identified 100% (n = 6) of patients deemed to benefit from substance use interventions by expert addiction psychiatric evaluation. The standard clinical-based referral process identified only 33% (n = 2) and erroneously identified another 4 for referral to substance use intervention that would not have been warranted.Conclusions: The NHHSRA holds promise in its ability to improve objective and timely identification of substance use in a seriously mentally ill inpatient population, helping to facilitate treatment.

Visual Analytics for the Coronavirus COVID-19 Pandemic.

The coronavirus disease COVID-19 was first reported in Wuhan, China, on December 31, 2019. The disease has since spread throughout the world, affecting 227.2 million individuals and resulting in 4,672,629 deaths as of September 9, 2021, according to the Johns Hopkins University Center for Systems Science and Engineering. Numerous sources track and report information on the disease, including Johns Hopkins itself, with its well-known Novel Coronavirus Dashboard. We were also interested in providing information on the pandemic. However, rather than duplicating existing resources, we focused on integrating sophisticated data analytics and visualization for region-to-region comparison, trend prediction, and testing and vaccination analysis. Our high-level goal is to provide visualizations of predictive analytics that offer policymakers and the general public insight into the current pandemic state and how it may progress into the future. Data are visualized using a web-based jQuery+Tableau dashboard. The dashboard allows both novice viewers and domain experts to gain useful insights into COVID-19's current and predicted future state for different countries and regions of interest throughout the world.

An Efficient and Smooth Methadone-to-Buprenorphine Transition Protocol Utilizing a Transdermal Fentanyl Bridge and a Pharmacokinetic Inducer: The Stanciu Method.

The traditional method of transitioning from methadone to buprenorphine requires a gradual dose reduction to a low dose of 30 mg daily, followed by cessation, and addressing withdrawal symptoms prior to the initiation of buprenorphine. This process can be time-consuming and is also associated with tremendous patient suffering and adverse outcomes. In recent years, several protocols have emerged based on the notion of blunting the shift from full receptor activation to partial receptor activation via an intermediate "bridge". This typically is required for the time period needed for the acting full agonist, methadone, to undergo biotransformation and clearance. In this report, we present an inadvertent case where transdermal fentanyl as a transitional bridge was utilized along with an inducer of methadone's metabolism to speed up the course, and urine acidification to enhance clearance. Our patient was transitioned from moderate-dose methadone, without encountering any withdrawal symptoms in the process, in three days. This method presents yet another option for select candidates, and it allows physicians to individualize methadone-to-buprenorphine transitions.

The life history of human foraging: Cross-cultural and individual variation.

Human adaptation depends on the integration of slow life history, complex production skills, and extensive sociality. Refining and testing models of the evolution of human life history and cultural learning benefit from increasingly accurate measurement of knowledge, skills, and rates of production with age. We pursue this goal by inferring hunters' increases and declines of skill from approximately 23,000 hunting records generated by more than 1800 individuals at 40 locations. The data reveal an average age of peak productivity between 30 and 35 years of age, although high skill is maintained throughout much of adulthood. In addition, there is substantial variation both among individuals and sites. Within study sites, variation among individuals depends more on heterogeneity in rates of decline than in rates of increase. This analysis sharpens questions about the coevolution of human life history and cultural adaptation.