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Postoperative fracture of the acromion is a complication uniquely more common after reverse shoulder arthroplasty (RSA) than other forms of shoulder arthroplasty. There is limited knowledge regarding the etiology of these fractures or the anatomic risk factors. The purpose of this study is to identify associations of the acromioclavicular (AC) joint and relative humeral and glenoid positioning on the occurrence of acromial fractures after RSA.A retrospective case-controlled study was performed on primary RSA patients treated by a single surgeon from September 2009 to September 2019. Patients with a postoperative acromion fracture were matched in a 3:1 ratio based on gender, indication, and age to those without a fracture and with a 2-year minimum follow-up. Preoperative and the immediate postoperative radiographs were reviewed by 2 investigators to measure critical shoulder angle, acromion-humeral interval, global lateralization, delta angle, preoperative glenoid height, and the level of inlay or onlay of the humeral stem. The morphology, width, and stigmata of osteoarthritis in the AC joint were assessed using computed tomography scans taken preoperatively.Of a total of 920 RSAs performed, 47 (5.1%) patients suffered a postoperative acromion fracture. These patients were compared with a control group of 141 patients, with a mean age of 76.4 years and similar distributions of gender and surgical indication. Patients in both groups had similar preoperative glenoid height (P = .953) and postoperative degree of inset or offset of humeral implant relative to the anatomic neck (P = .413). There were no differences in critical shoulder angle, acromion-humeral interval, global lateralization, and delta angle both preoperatively and postoperatively between the fracture and nonfracture groups. Computed tomography analysis also showed no differences in AC joint morphology (P = .760), joint space (P = .124), and stigma of osteoarthritis (P = .161).There was no relation between the features of the AC joint and the anatomic parameters of the humerus relative to the glenoid and acromion on postoperative acromion fractures after RSA.

Central sleep apnea (CSA) is a disorder defined by lack of respiratory drive from the brain stem on breathing efforts. There is a lack of established therapies for CSA and most available therapies are limited by poor patient adherence, limited randomized controlled studies, and potentially adverse cardiovascular effects. The remedē System (ZOLL Respicardia, Inc., Minnetonka, Minnesota) uses transvenous phrenic nerve stimulation to stimulate the diaphragm, thereby restoring a more normal breathing pattern throughout the sleep period.The remedē System Therapy (rēST) Study is a prospective non-randomized multicenter international study evaluating long-term safety and effectiveness of the remedē System in the post-market setting. Up to 500 adult patients with moderate to severe CSA will be enrolled and followed up to 5 years at approximately 50 sites in the United States and Europe. Safety objectives include evaluation of adverse events related to the implant procedure, device or delivered therapy, death, and hospitalizations. Effectiveness endpoints include assessment of changes in sleep-disordered breathing metrics from polysomnograms and home sleep tests, changes in daytime sleepiness using the Epworth Sleepiness Scale, and changes in QoL using the PROMIS-29 and Patient Global Assessment questionnaires. The subgroup of patients with heart failure will undergo additional assessments including echocardiography to assess cardiac reverse remodeling, 6-min walk distance, QoL assessment by Kansas City Cardiomyopathy Questionnaire and measurement of biomarkers.This will be the largest prospective study evaluating long-term safety and effectiveness of transvenous phrenic nerve stimulation for the treatment of moderate to severe CSA in adult patients.

Acromion/scapular spine fractures (ASFs) remain a challenging complication following reverse shoulder arthroplasty (RSA). Historically, nonoperative management has been the treatment of choice, with variable results. The purpose of this study is to report on both clinical and radiographic outcomes of nonoperative treatment. A new subclassification of Levy type II acromion fractures will be proposed, and outcomes will be evaluated in relation to the modified Levy classification.Forty-four patients diagnosed with ASF following RSA were matched 1:3 to a control group based on gender, age, and preoperative function. All ASF patients were treated nonoperatively. Patient-reported outcome measures, consisting of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, Simple Shoulder Test, Single Assessment Numerical Evaluation, visual analog scale pain and function scores, satisfaction, and active range of motion were gathered preoperatively and at the most recent follow-up. Outcomes were stratified based on fracture type. Radiographic findings including fracture union, scapular rotation, progressive notching, and osteolysis were reviewed from latest follow-up and compared with initial postoperative films.ASFs were identified at a median of 2 months following RSA (8 type I; 22 type II; 14 type III), followed for a median of 37 months and compared to 108 matched controls. Patients with ASF had inferior clinical outcomes with a higher rate of dissatisfaction (27.8%) when compared to controls. Lateral fracture subtypes (I and IIA) were similar to controls and had little impact on outcomes. However, medial fracture subtypes (type IIB, IIC, and III) demonstrated inferior outcomes when compared to controls, with type III fracture patients demonstrating no improvement from baseline. The overall nonunion rate was 61.4%, with high rates of scapular rotation and osteolysis in medial fracture subtypes. Nonunion was associated with a higher incidence of secondary radiographic findings, including scapular rotation, progressive notching, and osteolysis.Results of nonoperative treatment of ASF following RSA differs based on fracture location. Fractures that occur at or medial to the glenoid face (IIB, IIC, III) demonstrate high rates of unsatisfactory results and worse clinical outcomes. Concerning radiographic findings of scapular tilt, progressive scapular notching and osteolysis were seen at a higher rate with medial fracture types and fracture nonunions.

This study aimed to understand the long-term outcomes of patients with heart failure with recovered ejection fraction, identify predictors of adverse events, and develop a risk stratification model. From an academic healthcare system, we retrospectively identified 133 patients (median age 66, 38% female, 30% ischemic etiology) who had an improvement in left ventricular ejection fraction (LVEF) from40% to ≥53%. Significant predictors of all-cause mortality, hospitalization, and future reduction in LVEF were identified through Cox regression analysis. Kaplan-Meier survival was 70% at 5 years. Freedom from hospitalization was 58% at 1 year, and the risk of future LVEF reduction to40% was 28% at 3 years. Diuretic dose and B-type natriuretic peptide (BNP) at the time of LVEF recovery were the strongest predictors of mortality and hospitalization in multivariate-adjusted analysis (BNP hazard ratio 1.13 per 100 pg/ml increase [p0.01]; furosemide-equivalent dose hazard ratio 1.19 per 40 mg increase [p = 0.02]). An all-cause mortality Cox proportional hazard risk model incorporating New York Heart Association functional class, BNP and diuretic dose at the time of recovery showed excellent risk discrimination (c-statistic 0.79) and calibration. In conclusion, patients with heart failure with recovered ejection fraction have heterogenous clinical outcomes and are not "cured." A risk model using New York Heart Association functional class, BNP, and diuretic dose can accurately stratify mortality risk.

Aims Use of implantable cardioverter-defibrillators (ICD) for primary prevention of sudden cardiac death (SCD) in heart failure with reduced ejection fraction (HFrEF) is limited. We aimed to investigate barriers to ICD use in HFrEF while considering the predicted risk of mortality and SCD. Method and results Patients from the SwedeHF registered in 2011-2018 and with an indication for primary prevention ICD were analysed. The Seattle Proportional Risk and Seattle Heart Failure Models were used to predict the proportional SCD and all-cause mortality risk, respectively. A multivariable logistic regression model was fitted to identify independent predictors of ICD use/non-use; Cox regression models to evaluate the interaction between predicted SCD/mortality risk and ICD use for mortality. Of 13 475 patients, only 15.5% had an ICD. Those with higher predicted proportional SCD risk (>45%) had an similar to 80% higher likelihood to have an ICD. Other predictors of non-use were follow-up in primary versus specialty care, higher comorbidity burden and lower socioeconomic status. ICD use was associated with lower mortality only in patients with higher predicted SCD and lower mortality risk (34% and 37% relative risk reduction for 3-year all-cause and cardiovascular mortality, respectively). In this subgroup of patients, underuse of ICD was 81.8%. Conclusion In a contemporary registry, only 15.5% of patients with an indication for primary prevention ICD received the device. While a high predicted proportional SCD risk was appropriately linked to ICD use, the lack of specialized follow-up, higher comorbidity burden, and lower socioeconomic status were major unjustified impediments to implementation. Our findings suggest areas for improving ICD use for primary prevention of SCD in clinical practice. Funding Agencies|Boston Scientific; EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking BigData@Heart grant [116074]

The aim of this study was to evaluate the Social Vulnerability Index (SVI) as a predictor of long-term outcomes after injury.The SVI is a measure used in emergency preparedness to identify need for resources in the event of a disaster or hazardous event, ranking each census tract on 15 demographic/social factors.Moderate-severely injured adult patients treated at 1 of 3 level-1 trauma centers were prospectively followed 6 to 14 months post-injury. These data were matched at the census tract level with overall SVI percentile rankings. Patients were stratified based on SVI quartiles, with the lowest quartile designated as low SVI, the middle 2 quartiles as average SVI, and the highest quartile as high SVI. Multivariable adjusted regression models were used to assess whether SVI was associated with long-term outcomes after injury.A total of 3153 patients were included [54% male, mean age 61.6 (SD = 21.6)]. The median overall SVI percentile rank was 35th (IQR: 16th-65th). compared to low SVI patients, high SVI patients were more likely to have new functional limitations [odds ratio (OR), 1.51; 95% confidence interval (CI), 1.19-1.92), to not have returned to work (OR, 2.01; 95% CI, 1.40-2.89), and to screen positive for post-traumatic stress disorder (OR, 1.56; 95% CI, 1.12-2.17). Similar results were obtained when comparing average with low SVI patients, with average SVI patients having significantly worse outcomes.The SVI has potential utility in predicting individuals at higher risk for adverse long-term outcomes after injury. This measure may be a useful needs assessment tool for clinicians and researchers in identifying communities that may benefit most from targeted prevention and intervention efforts.

Climate-sensitive infectious diseases are an issue of growing concern due to global warming and the related increase in the incidence of extreme weather and climate events. Diarrhea, which is strongly associated with climatic factors, remains among the leading causes of child death globally, disproportionately affecting populations in low- and middle-income countries (LMICs). We use survey data for 51 LMICs between 2000 and 2019 in combination with gridded climate data to estimate the association between precipitation shocks and reported symptoms of diarrheal illness in young children. We account for differences in exposure risk by climate type and explore the modifying role of various social factors. We find that droughts are positively associated with diarrhea in the tropical savanna regions, particularly during the dry season and dry-to-wet and wet-to-dry transition seasons. In the humid subtropical regions, we find that heavy precipitation events are associated with increased risk of diarrhea during the dry season and the transition from dry-to-wet season. Our analysis of effect modifiers highlights certain social vulnerabilities that exacerbate these associations in the two climate zones and present opportunities for public health intervention. For example, we show that stool disposal practices, child feeding practices, and immunizing against the rotavirus modify the association between drought and diarrhea in the tropical savanna regions. In the humid subtropical regions, household’s source of water and water disinfection practices modify the association between heavy precipitation and diarrhea. The evidence of effect modification varies depending on the type and duration of the precipitation shock.

Background Cognitive behavioral therapy (CBT) is an effective treatment for youth with anxiety and related disorders, with a 59% remission rate at post-treatment. Results of reviews and meta-analyses indicate that treatment gains are maintained across long-term follow-up, at least in terms of symptom improvement. Less is known about relapse, defined as patients who initially achieve remission status but then experience a return of symptoms after a follow-up period. Method The current study used meta-analysis to determine the overall rate of relapse in CBT for children and adolescents (age 18 years or younger) with anxiety and related disorders. Potential moderating factors of relapse rates, including demographic, methodological, and clinical/intervention characteristics, were also examined. Out of a pool of 78 abstracts, 13 full-text articles were retained for meta-analysis. An additional two articles were identified from other sources (total N = 535 patients). Results Results showed an overall relapse rate of 10.5% (including comorbid autism spectrum disorder) and 8% (excluding comorbid autism spectrum disorder) across studies. Moderator analyses demonstrated that relapse rates were higher among younger and more racially diverse samples, as well as among patients with comorbid externalizing disorders and those taking psychiatric medications. There were no differences in relapse rates as a function of primary diagnosis. Conclusions Taken together, the findings indicate that relapse rates in CBT for anxious youth are relatively low, suggesting that treatment development and refinement efforts should focus on improving treatment response and remission rates for this population.

Despite the growing recognition of acromial stress fractures (ASFs) after reverse total shoulder arthroplasty (RTSA), most of the current data are derived from single-center studies with limited generalizability. This multicenter study investigated the incidence of ASFs after RTSA and identified preoperative patient characteristics associated with their occurrence.Using 2 institutional registries from different regions of the United States, we identified 1479 patients undergoing either primary or revision RTSA between 2013 and 2018 with minimum 3-month follow-up. ASFs were defined as radiographic evidence of an acromial or scapular spine fracture with clinical symptoms (eg, tenderness over the acromion or scapular spine). Multivariable logistic regression was performed to identify preoperative patient factors associated with the development of ASFs.Overall, 54 (3.7%) patients were diagnosed with an ASF after RTSA. Patient-related factors independently associated with the development of an ASF included female sex (odds ratio [OR], 2.21 reference: male; 95% confidence interval [CI], 1.03-4.74; P.05), rheumatoid arthritis (OR, 2.30; 95% CI, 1.02-5.16; P.05), osteoporosis (OR, 2.55; 95% CI, 1.24-5.21; P.05), a diagnosis of degenerative joint disease with rotator cuff tear (OR, 4.74 reference: degenerative joint disease without rotator cuff tear; 95% CI, 1.84-12.23; P .05), and fracture malunion/nonunion (OR, 5.21; 95% CI, 1.20-22.76; P.05).The non-negligible percentage of ASFs that occur after RTSA is associated with the diagnoses of rotator cuff dysfunction and chronic fracture sequelae in female patients with suboptimal bone health. This information can be used to counsel patients and set expectations about potential setbacks in recovery.

In the National Academies of Sciences, Engineering, and Medicine 2016 report on trauma care, the establishment of a National Trauma Research Action Plan to strengthen and guide future trauma research was recommended. To address this recommendation, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. We describe the gap analysis and high-priority research questions generated from the National Trauma Research Action Plan panel on long-term outcomes.Experts in long-term outcomes were recruited to identify current gaps in long-term trauma outcomes research, generate research questions, and establish the priority for these questions using a consensus-driven, Delphi survey approach from February 2021 to August 2021. Panelists were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability including both military and civilian representation. Panelists were encouraged to use a PICO format to generate research questions: Patient/Population, Intervention, Compare/Control, and Outcome model. On subsequent surveys, panelists were asked to prioritize each research question on a 9-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as ≥60% of panelists agreeing on the priority category.Thirty-two subject matter experts generated 482 questions in 17 long-term outcome topic areas. By Round 3 of the Delphi, 359 questions (75%) reached consensus, of which 107 (30%) were determined to be high priority, 252 (70%) medium priority, and 0 (0%) low priority. Substance abuse and pain was the topic area with the highest number of questions. Health services (not including mental health or rehabilitation) (64%), mental health (46%), and geriatric population (43%) were the topic areas with the highest proportion of high-priority questions.This Delphi gap analysis of long-term trauma outcomes research identified 107 high-priority research questions that will help guide investigators in future long-term outcomes research.Diagnostic Tests or Criteria; Level IV.

International audience; Objectives: To determine the predictors of a positive SARS-CoV-2 test in a pediatric ambulatory setting.Patients and methods: We performed a cross-sectional prospective study (November 2020-February 2022) of 93 ambulatory settings in France. We included symptomatic children < 15 years old tested for SARS-CoV-2. For each period corresponding to the spread of the original strain and its variants (period 1: original strain; period 2: Alpha, period 3: Delta; period 4: Omicron), we used a multivariate analysis to estimate adjusted odds ratios (aORs) associated with COVID-19 among age, signs, symptoms or contact, and 95 % confidence intervals (95CIs).Results: Of 5,336 children, 13.9 % (95CI 13.0-14.8) had a positive test. During the first three periods, the positivity rate ranged from 5.6 % (95CI 4.6-6.7) to 12.6 % (95CI 10.8-14.6). The main factors associated with a positive test were contact with an infected adult at home or outside the home (aOR 11.5 [95CI 4.9-26.9] to 38.9 [95CI 19.3-78.7]) or an infected household child (aOR 15.0 [95CI 4.8-47.1] to 28.4 [95CI 8.7-92.6]). By contrast, during period 4, aORs for these predictors were substantially lower (2.3 [95CI 1.1-4.5] to 5.5 [95CI 3.2-7.7]), but the positivity rate was 45.7 % (95CI 42.3-49.2).Conclusions: In pediatric ambulatory settings, before the Omicron period, the main predictor of a positive test was contact with an infected person. During the Omicron period, the odds of these predictors were substantially lower while the positivity rate was higher. An accurate diagnostic strategy should only rely on testing and not on age, signs, symptoms or contact.

To evaluate the laboratory long-term effect of various whitening dentifrices on the surface roughness of two brands of resin composite (TPH ST, Filtek Bulk Fill One) using a mechanical toothbrushing simulation.Thirty-two samples each of Filtek and TPH were fabricated in ring molds 10 x 1 mm. Samples were randomly grouped (n=8; four groups), according to dentifrice used; Crest 3D, Optic White, Hello (charcoal), and Aim as control. Samples were brushed in mixed solutions containing deionized water and dentifrice at 150 gf for 10,000x with rotation to ensure uniform brushing. Surface roughness was measured both before (baseline) and after the mechanical toothbrushing simulation using a stylus profilometer. Data collected was compared independently for each treatment using two-way ANOVA and SNK with α0.05 for significance.The data showed that TPH was more susceptible to the abrasive nature of three of the whitening dentifrices tested [Crest 3D, Optic White, and Hello (charcoal) ]. Filtek also exhibited significant susceptibility to the abrasive nature of Hello. Aim showed the least or minimal amount of abrasion.TPH ST composite was more susceptible to the abrasive nature of the three whitening dentifrices tested [Crest 3D, Optic White, and Hello (charcoal)]. Filtek also exhibited significant susceptibility to the abrasive nature of Hello. Aside from the data supporting the clinical efficacy of TPH compared to Filtek, clinicians should inform patients of the abrasive capacity of all whitening dentifrices, especially those that are charcoal based.

Aims Continuous‐flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end‐stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality‐of‐life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost‐effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost‐effectiveness of DT LVADs compared with medical management (MM) in the NHS England. Methods and results We developed a Markov multiple‐state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost‐effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality‐adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis. Conclusions The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost‐effective therapy in the NHS England healthcare system under the end‐of‐life willingness‐to‐pay threshold of £50 000/QALY, which applies for VAD patients.

Aims The objective of this study was to compare functional outcomes through 1 year in patients with core‐lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham‐controlled REDUCE‐FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study. Methods and results The main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow‐up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3). Conclusions REDUCE‐FMR was the first blinded sham‐controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient‐centred outcomes with the Carillon device compared with the sham procedure.

OBJECTIVES/HYPOTHESIS The primary objective of this study was to assess the safety of parathyroidectomy during pregnancy as treatment for hyperparathyroidism (HPTH) in comparison to nonsurgical management plans. Secondary outcomes involved analyzing the safety of surgery in the third trimester and the benefit of operating on asymptomatic pregnant patients. STUDY DESIGN Systematic review. METHODS PRISMA-guided systematic review of all cases of primary hyperparathyroidism during pregnancy published in peer-reviewed English journals on PubMed/MEDLINE, EMBASE, and SCOPUS from 1980 to 2020. RESULTS A total of 75 manuscripts were included in this review describing 382 cases of gestational hyperparathyroidism. The median maternal age was 31 years. Overall, 108 cases (28.3%) underwent parathyroidectomy during pregnancy while 274 cases (71.7%) were treated nonsurgically. The majority of surgeries took place during the second trimester (67.6%). Complications and/or deaths were less likely to occur after surgery in the second trimester (4.48%) as compared to surgery in the third trimester (21.1%). Nine surgically treated cases resulted in infant complications and/or death; however, none of these nine cases had any surgical complications. Despite these complications, the overall infant complication rate for patients who underwent surgical treatment remained lower than that of patients treated with conservative therapy (9.1% vs. 38.9%). CONCLUSIONS This review suggests that for all pregnant patients with diagnosed HPTH, parathyroidectomy should be considered regardless of symptomatology. Our data suggest that parathyroidectomy is associated with fewer risks than more conservative treatments and results in better fetal outcomes. Surgery during the third trimester is feasible and surgery should be considered in both symptomatic and asymptomatic patients. Laryngoscope, 131:1915-1921, 2021.

Military populations are disproportionally affected by posttraumatic stress disorder (PTSD) and may experience less benefit from first line psychotherapies for PTSD relative to civilians. We examined the efficacy of exposure therapy among Veterans and active duty military personnel across various control conditions and tested potential treatment-related, demographic, and clinical moderators. Randomized controlled trials of exposure-based therapies for PTSD in military populations were identified from a recent meta-analysis and through PsycINFO and Medline. Nineteen studies met inclusion criteria and were included in the meta-analysis (total N = 2905). Exposure therapy had medium to large effects compared to waitlist and treatment as usual, a small effect compared to non-trauma-focused therapy, and no effect relative to other trauma-focused therapy. The overall effect was similar at post-treatment and follow up. The effect size for exposure was larger in studies with younger participants, more women, fewer participants with comorbid major depression, and fewer participants taking psychiatric medication. Effect sizes were not impacted by treatment length or type, participant race or ethnicity, comorbid substance use, Veteran versus active duty status, or study risk of bias. Findings document the variable efficacy of exposure therapy in military populations across comparator types and point to several potentially important moderators of outcome that should be examined in future research.

Background Digoxin reduces the risk of heart failure hospitalization in patients with heart failure with reduced ejection fraction. Less is known about this association in patients with heart failure with preserved ejection fraction (HFpEF), the examination of which was the objective of the current study. Methods In the Medicare-linked OPTIMIZE-HF registry, 7374 patients hospitalized for HF had ejection fraction ≥50% and were not receiving digoxin prior to admission. Of these, 5675 had a heart rate ≥50 beats per minute, an estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or did not receive inpatient dialysis, and digoxin was initiated in 524 of these patients. Using propensity scores for digoxin initiation, calculated for each of the 5675 patients, we assembled a matched cohort of 513 pairs of patients initiated and not initiated on digoxin, balanced on 58 baseline characteristics (mean age, 80 years; 66% women; 8% African American). Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes associated with digoxin initiation were estimated in the matched cohort. Results Among the 1026 matched patients with HFpEF, 30-day heart failure readmission occurred in 6% and 9% of patients initiated and not initiated on digoxin, respectively (HR 0.70; 95% CI, 0.45-1.10; P = .124). HRs (95% CIs) for 30-day all-cause readmission and all-cause mortality associated with digoxin initiation were 0.95 (0.73-1.23; P = .689) and 0.93 (0.55-1.56; P = .773), respectively. Digoxin initiation had no association with 6-year outcomes. Conclusion Digoxin initiation prior to hospital discharge was not associated with 30-day or 6-year outcomes in older hospitalized patients with HFpEF.

Supplemental Digital Content is available in the text., This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation via thoracotomy. Cost-effectiveness of LVADs implanted via the traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD via this less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs via a less invasive approach as being cost-effective.

Objective Assess the prevalence of anxiety, depression, and posttraumatic stress disorder (PTSD) after injury and their association with long-term functional outcomes. Background Mental health disorders (MHD) after injury have been associated with worse long-term outcomes. However, prior studies almost exclusively focused on PTSD. Methods Trauma patients with an injury severity score ≥9 treated at 3 Level-I trauma centers were contacted 6-12 months post-injury to screen for anxiety (generalized anxiety disorder-7), depression (patient health questionnaire-8), PTSD (8Q-PCL-5), pain, and functional outcomes (trauma quality of life instrument, and short-form health survey)). Associations between mental and physical outcomes were established using adjusted multivariable logistic regression models. Results Of the 531 patients followed, 108 (20%) screened positive for any MHD: of those who screened positive for PTSD (7.9%, N = 42), all had co-morbid depression and/or anxiety. In contrast, 66 patients (12.4%) screened negative for PTSD but positive for depression and/or anxiety. Compared to patients with no MHD, patients who screened positive for PTSD were more likely to have chronic pain {odds ratio (OR): 8.79 [95% confidence interval (CI): 3.21, 24.08]}, functional limitations [OR: 7.99 (95% CI: 3.50, 18.25)] and reduced physical health [β: -9.3 (95% CI: -13.2, -5.3)]. Similarly, patients who screened positive for depression/anxiety (without PTSD) were more likely to have chronic pain [OR: 5.06 (95% CI: 2.49, 10.46)], functional limitations [OR: 2.20 (95% CI: 1.12, 4.32)] and reduced physical health [β: -5.1 (95% CI: -8.2, -2.0)] compared to those with no MHD. Conclusions The mental health burden after injury is significant and not limited to PTSD. Distinguishing among MHD and identifying symptom-clusters that overlap among these diagnoses, may help stratify risk of poor outcomes, and provide opportunities for more focused screening and treatment interventions.

Exposure to outdoor fine particulate matter (PM2.5) is a leading risk factor for mortality. We develop global estimates of annual PM2.5 concentrations and trends for 1998-2018 using advances in satellite observations, chemical transport modeling, and ground-based monitoring. Aerosol optical depths (AODs) from advanced satellite products including finer resolution, increased global coverage, and improved long-term stability are combined and related to surface PM2.5 concentrations using geophysical relationships between surface PM2.5 and AOD simulated by the GEOS-Chem chemical transport model with updated algorithms. The resultant annual mean geophysical PM2.5 estimates are highly consistent with globally distributed ground monitors (R2 = 0.81; slope = 0.90). Geographically weighted regression is applied to the geophysical PM2.5 estimates to predict and account for the residual bias with PM2.5 monitors, yielding even higher cross validated agreement (R2 = 0.90-0.92; slope = 0.90-0.97) with ground monitors and improved agreement compared to all earlier global estimates. The consistent long-term satellite AOD and simulation enable trend assessment over a 21 year period, identifying significant trends for eastern North America (-0.28 ± 0.03 μg/m3/yr), Europe (-0.15 ± 0.03 μg/m3/yr), India (1.13 ± 0.15 μg/m3/yr), and globally (0.04 ± 0.02 μg/m3/yr). The positive trend (2.44 ± 0.44 μg/m3/yr) for India over 2005-2013 and the negative trend (-3.37 ± 0.38 μg/m3/yr) for China over 2011-2018 are remarkable, with implications for the health of billions of people.

This study sought to determine if combining the Seattle Heart Failure Model (SHFM-D) and cardiac magnetic resonance (CMR) provides complementary prognostic data for patients with cardiac resynchronization therapy (CRT) defibrillators.The SHFM-D is among the most widely used risk stratification models for overall survival in patients with heart failure and implantable cardioverter-defibrillators (ICDs), and CMR provides highly detailed information regarding cardiac structure and function.CMR Displacement Encoding with Stimulated Echoes (DENSE) strain imaging was used to generate the circumferential uniformity ratio estimate with singular value decomposition (CURE-SVD) circumferential strain dyssynchrony parameter, and the SHFM-D was determined from clinical parameters. Multivariable Cox proportional hazards regression was used to determine adjusted hazard ratios and time-dependent areas under the curve for the primary endpoint of death, heart transplantation, left ventricular assist device, or appropriate ICD therapies.The cohort consisted of 100 patients (65.5 [interquartile range 57.7 to 72.7] years; 29% female), of whom 47% had the primary clinical endpoint and 18% had appropriate ICD therapies during a median follow-up of 5.3 years. CURE-SVD and the SHFM-D were independently associated with the primary endpoint (SHFM-D: hazard ratio: 1.47/SD; 95% confidence interval: 1.06 to 2.03; p = 0.02) (CURE-SVD: hazard ratio: 1.54/SD; 95% confidence interval: 1.12 to 2.11; p = 0.009). Furthermore, a favorable prognostic group (Group A, with CURE-SVD 0.60 and SHFM-D 0.70) comprising approximately one-third of the patients had a very low rate of appropriate ICD therapies (1.5% per year) and a greater (90%) 4-year survival compared with Group B (CURE-SVD ≥0.60 or SHFM-D ≥0.70) patients (p = 0.02). CURE-SVD with DENSE had a stronger correlation with CRT response (r = -0.57; p 0.0001) than CURE-SVD with feature tracking (r = -0.28; p = 0.004).A combined approach to risk stratification using CMR DENSE strain imaging and a widely used clinical risk model, the SHFM-D, proved to be effective in this cohort of patients referred for CRT defibrillators. The combined use of CMR and clinical risk models represents a promising and novel paradigm to inform prognosis and device selection in the future.

Periprosthetic proximal humerus fractures (PPHFs) are a detrimental complication of shoulder arthroplasty, yet their characterization and management have been poorly studied. We aimed to determine the intra- and interobserver reliability of 4 previously described PPHF classification systems to evaluate which classifications are the most consistent.We retrospectively reviewed 32 patients (34 fractures) that were diagnosed with a PPHF between 1990 and 2017. Patient electronic medical records and research electronic data capture (REDCap) were used for data collection. Post-PPHF radiographs in multiple views for all 34 cases were organized into an encrypted, randomized Qualtrics survey. Four blinded fellowship-trained shoulder and elbow surgeons graded each fracture using previously reported classification systems by (1) Wright and Cofield (1995), (2) Campbell et al (1998), (3) Worland et al (1999), and (4) Groh et al (2008), along with selecting a preferred management strategy for each fracture. Grading was performed twice with at least 2 weeks between each randomized attempt. Intraobserver reliability was calculated as an unweighted Cohen kappa coefficient between attempt 1 and attempt 2 for each surgeon. Interobserver reliability and agreeability between surgeons' preferred management strategies were calculated for each classification system using Fleiss kappa coefficient. The kappa coefficients were interpreted using the Landis and Koch criteria.The average intraobserver kappa coefficient for each classification was as follows: Wright and Cofield = 0.703, Campbell = 0.527, Worland = 0.637, Groh = 0.699. The overall Fleiss kappa coefficient for interobserver reliability for each classification was as follows: Wright and Cofield = 0.583, Campbell = 0.488, Worland = 0.496, Groh = 0.483. Interobserver reliability was significantly greater with the Wright and Cofield classification. Using Landis and Koch criteria, all the classification systems assessed demonstrated only moderate interobserver agreement. Additionally, the mean interobserver agreeability kappa coefficient for preferred management strategy was 0.490, indicating only moderate interobserver agreement.There is only moderate interobserver reliability among the 4 PPHF classification systems and the preferred management strategy for the fractures assessed. Of the 4 PPHF classification systems, Wright and Cofield demonstrated the greatest mean intraobserver reliability and overall interobserver reliability. Our study highlights a need for the development of a PPHF classification system that can achieve high intra- and interobserver reliability and that can allow for a standardized treatment algorithm in the management of PPHFs.

Effective communication and collaboration with patients, carers and between healthcare professionals improves patient management. This study aimed to explore essential communication and collaboration skills training (CCST) for a radiation oncologist (RO) to inform competencies, learning outcomes and enhance curriculum training methods.Eight focus group discussions with 10 fellows and 14 trainees of the Faculty of Radiation Oncology, Royal Australian and New Zealand College of Radiologists (FRO RANZCR) were conducted face to face between October 2018 and March 2019. Participants included doctors from culturally and linguistically diverse backgrounds, working in public and private, metropolitan, and rural sectors. Data were recorded, transcribed verbatim, managed in Excel, and coded using a qualitative content analysis framework. The study was approved by South Eastern Sydney Local Health District HREC (18/186). Participants provided informed written consent.After achieving thematic saturation, four predominant themes emerged. These were as follows: (1) Enablers and barriers to effective communication and collaboration; (2) written communication; (3) communicating bad news; and (4) multidisciplinary team meeting collaboration. Managing uncertainty and workplace culture emerged as interconnected sub-themes.There is a current lack of CCST in radiation oncology in Australia and New Zealand. The most common theme that emerged to improve CCST focused on increasing the exposure to a variety of communication and collaboration clinical scenarios, which are observed and upon which immediate structured feedback is given. Consultants and trainees offered tangible suggestions on how to improve the curriculum. These findings underscore the importance of using a combination of structured teaching methods and work-based assessments. CCST templates are recommended.

Lesser tuberosity osteotomy (LTO) and subscapularis peel (Peel) are 2 common techniques used to mobilize the subscapularis tendon during anatomic total shoulder arthroplasty (TSA). The literature is inconclusive over which technique is optimal; thus, controversy exists over which technique should be performed. The purpose of this study was to compare specific functional internal rotation tasks and general outcome scores in TSA patients who received either an LTO or Peel.A retrospective review of 563 patients treated with primary TSA using either an LTO (n = 358) or Peel (n = 205) with a minimum 2-year follow-up was performed. Subjective internal rotation, active internal rotation, and specific questions related to functional internal rotation isolated from the Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons functional questionnaires were reviewed. Other outcome scores including visual analog scale pain and function, Single Assessment Numerical Evaluation, SST, American Shoulder and Elbow Surgeons, and revision rates were compared between the 2 groups.The study found no difference in postoperative functional internal rotation and range of motion between LTO and Peel. Patients who received a Peel were shown to have a slightly greater improvement in the ability to perform toileting and a higher average change in SST score that did not reach clinical significance. There was no difference in the percentage of maximal improvement, revision rate, or need for revision between the 2 groups.No difference was found between the LTO and Peel techniques in regard to functional tasks of internal rotation at short-term follow-up.

Advanced chronic kidney disease (CKD) frequently aggravates heart failure (HF). However, these patients have inherently been excluded from most HF trials. We aim to provide updated estimates of the representation of patients with advanced CKD and the provision of baseline renal function indices in HF trials with a focused interest on the landmark trials. Updated systematic review was performed from the inception of MEDLINE to 31 December 2019 to identify all chronic HF randomized trials published in the three major cardiology and medical journals, respectively, which included mortality endpoint. The included studies were analysed based on the representativeness of the advanced CKD population and the reporting of baseline renal function. A total of 187 eligible randomized trials with 322,374 participants were included in our analysis. One hundred and six trials (56.7%) had exclusion criteria related to renal function, which remained a continuing trend-55.1% (27/49) from inception-2000, 53.4% (39/73) from 2001-2010 and 61.5% (40/65) from 2011 (P = 0.64). The exclusion criteria, however, have become less restrictive. There was a temporal improvement in the likelihood of HF trials in providing baseline renal function indices (28.6% from inception-2000 versus 53.4% from 2001-2010 and 83.1% from 2011, P 0.001). Concordant findings were observed in the landmark trials. Patients with advanced CKD remain underrepresented in HF trials in the contemporary era, even though the exclusion criteria have become less restrictive, and the quality of renal function monitoring has improved. The continued underrepresentation of patients with advanced CKD in HF trials merits measured broadening of eligibility in further trial studies.

Background As patients derive variable benefit from generator changes (GCs) of implantable cardioverter‐defibrillators (ICDs) with an original primary prevention (PP) indication, better predictors of outcomes are needed. Methods and Results In the National Cardiovascular Data Registry ICD Registry, patients undergoing GCs of initial non‐cardiac resynchronization therapy PP ICDs in 2012 to 2016, predictors of post‐GC survival and survival benefit versus control heart failure patients without ICDs were assessed. These included predicted annual mortality based on the Seattle Heart Failure Model, left ventricular ejection fraction (LVEF) >35%, and the probability that a patient's death would be arrhythmic (proportional risk of arrhythmic death [PRAD]). In 40 933 patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs (age 67.7±12.0 years, 24.5% women, 34.1% with LVEF >35%), Seattle Heart Failure Model–predicted annual mortality had the greatest effect size for decreased post‐GC survival ( P 35% had a lower Seattle Heart Failure Model–adjusted survival versus 23 472 control heart failure patients without ICDs (model interaction hazard ratio, 1.21 [95% CI, 1.11–1.31]). In patients undergoing GCs of initial noncardiac resynchonization therapy PP ICDs with LVEF ≤35%, the model indicated worse survival versus controls in the 21% of patients with a PRAD 65%. The association of the PRAD with survival benefit or harm was similar in patients with or without pre‐GC ICD therapies. Conclusions Patients who received replacement of an ICD originally implanted for primary prevention and had at the time of GC either LVEF >35% alone or both LVEF ≤35% and PRAD

Background Despite the belief that heart failure therapies are not effective in transthyretin cardiac amyloidosis, data are limited. We tested the association of neurohormonal blockade use with survival. Methods and Results A total of 309 consecutive patients with transthyretin cardiac amyloidosis were identified. Medication inventory was obtained at baseline and subsequent visits. Exposure included a neurohormonal blockade class (β‐blocker [βB], angiotensin‐converting enzyme inhibitor/angiotensin receptor blocker, and mineralocorticoid antagonist) at baseline and subsequent visits. βB was modeled as baseline use, time‐varying use, and in an inverse probability treatment weighted model. Primary outcome was all‐cause mortality analyzed with adjusted Cox proportional hazards models. Continuing compared with stopping βB during follow‐up was tested. Mean age was 73.2 years, 84.1% were men, and 17.2% had atrial fibrillation/flutter at baseline. At the time of study entry, 49.8% were on βBs, 35.0% were on angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers, and 23.9% were on mineralocorticoid antagonists. For the total cohort, there was a trend toward harm in the unadjusted model for baseline βB use, but this was neutral after adjustment. When βB use was analyzed as a time‐varying exposure, there was no association with mortality. βB discontinuation was associated with decreased mortality for the total cohort. Findings were consistent in inverse probability treatment weighted models. For angiotensin‐converting enzyme inhibitor/angiotensin receptor blocker or mineralocorticoid antagonist use, there was no association with mortality after adjustment for the total cohort. Conclusions There was no association of neurohormonal blockade use with survival in transthyretin cardiac amyloidosis. For the total cohort, deprescribing βB may be associated with improved survival. Additional studies are needed to confirm these findings.

Altres ajuts: acords transformatius de la UAB Aims: Several heart failure (HF) web-based risk scores are currently used in clinical practice. Currently, we lack head-to-head comparison of the accuracy of risk scores. This study aimed to assess correlation and mortality prediction performance of Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC-HF) risk score, which includes clinical variables + medications; Seattle Heart Failure Model (SHFM), which includes clinical variables + treatments + analytes; PARADIGM Risk of Events and Death in the Contemporary Treatment of Heart Failure (PREDICT-HF) and Barcelona Bio-Heart Failure (BCN-Bio-HF) risk calculator, which also include biomarkers, like N-terminal pro B-type natriuretic peptide (NT-proBNP). Methods and results: A total of 1166 consecutive patients with HF from different aetiologies that had NT-proBNP measurement at first visit were included. Discrimination for all-cause mortality was compared by Harrell's C-statistic from 1 to 5 years, when possible. Calibration was assessed by calibration plots and Hosmer-Lemeshow test and global performance by Nagelkerke's R. Correlation between scores was assessed by Spearman rank test. Correlation between the scores was relatively poor (rho value from 0.66 to 0.79). Discrimination analyses showed better results for 1-year mortality than for longer follow-up (SHFM 0.817, MAGGIC-HF 0.801, PREDICT-HF 0.799, BCN-Bio-HF 0.830). MAGGIC-HF showed the best calibration, BCN-Bio-HF overestimated risk while SHFM and PREDICT-HF underestimated it. BCN-Bio-HF provided the best discrimination and overall performance at every time-point. Conclusions: None of the contemporary risk scores examined showed a clear superiority over the rest. BCN-Bio-HF calculator provided the best discrimination and overall performance with overestimation of risk. MAGGIC-HF showed the best calibration, and SHFM and PREDICT-HF tended to underestimate risk. Regular updating and recalibration of online web calculators seems necessary to improve their accuracy as HF management evolves at unprecedented pace.

Prior research suggests that estradiol may moderate fear extinction in animal models and humans. Based on these findings, estradiol may also moderate cognitive reappraisal, which is theorized to be an important mechanism of change in extinction-based therapy (exposure therapy). We compared cognitive restructuring (CR) skills acquisition and outcome between women with primary anxiety disorders who had high versus low estradiol using a standardized CR task that closely resembles clinical practice. As a proxy of CR outcome, we assessed subjective distress ratings before and after the task and psychophysiological arousal (heart rate and electrodermal activity) throughout the task. Contrary to predictions, results showed that CR skills acquisition and outcome did not differ between the high and low estradiol groups. Although both groups demonstrated reductions in negative affect and skin conductance responses during the CR task, suggesting that participants were able to acquire CR skills and use them effectively to regulate distress, the groups did not differ with respect to CR ability or outcome. The findings suggest that estradiol may not moderate cognitive reappraisal, and may have more of an effect on basic habituation and extinction processes instead.

Determine the proportion and characteristics of traumatic injury survivors who perceive a negative impact of the COVID-19 pandemic on their recovery and to define post-injury outcomes for this cohort.The COVID-19 pandemic has precipitated physical, psychological, and social stressors that may create a uniquely difficult recovery and reintegration environment for injured patients.Adult (≥18 years) survivors of moderate-to-severe injury completed a survey 6 to 14 months post-injury during the COVID-19 pandemic. This survey queried individuals about the perceived impact of the COVID-19 pandemic on injury recovery and assessed post-injury functional and mental health outcomes. Regression models were built to identify factors associated with a perceived negative impact of the pandemic on injury recovery, and to define the relationship between these perceptions and long-term outcomes.Of 597 eligible trauma survivors who were contacted, 403 (67.5%) completed the survey. Twenty-nine percent reported that the COVID-19 pandemic negatively impacted their recovery and 24% reported difficulty accessing needed healthcare. Younger age, lower perceived-socioeconomic status, extremity injury, and prior psychiatric illness were independently associated with negative perceived impact of the COVID-19 pandemic on injury recovery. In adjusted analyses, patients who reported a negative impact of the pandemic on their recovery were more likely to have new functional limitations, daily pain, lower physical and mental component scores of the Short-Form-12 and to screen positive for PTSD and depression.The COVID-19 pandemic is negatively impacting the recovery of trauma survivors. It is essential that we recognize the impact of the pandemic on injured patients while focusing on directed efforts to improve the long-term outcomes of this already at-risk population.

Posttraumatic stress disorder (PTSD) is associated with high morbidity and functional impairment in the absence of effective treatment. Exposure therapy for PTSD is a trauma-focused treatment that typically includes in vivo and/or imaginal exposure. The goal of this meta-analysis was to examine the overall efficacy of exposure therapy for PTSD compared to various control conditions. We also assessed the efficacy of individual exposure-based treatments and the potentially moderating impact of various demographic, clinical, and treatment-related factors. PsycINFO and Medline were searched for randomized controlled trials of exposure-based therapies for adult PTSD. A total of 934 abstracts were screened for initial eligibility; of these, 65 articles met inclusion criteria and were included in the meta-analysis (total N = 4929 patients). Exposure therapy showed large effects relative to waitlist and treatment-as-usual, a small effect relative to non-trauma-focused comparators and a negligible effect relative to other trauma-focused treatments or medication. At follow-up most effects sizes were stable, except for a medium effect favoring exposure over medication. The individual exposure-based therapies examined were similarly effective. Moderator analyses revealed larger effect sizes in studies with fewer sessions, younger samples, fewer participants diagnosed with substance use disorder, and fewer participants on psychiatric medication. Effect sizes were also larger in studies of refugees and civilians compared to military samples, studies of PTSD related to natural disasters and transportation accidents vs. other traumatic events, and studies of individual vs. group therapy. Findings support the overall efficacy of exposure therapy and highlight that there are a number of efficacious exposure-based therapies available.

Patients with psychiatric illness feel the brunt of the intersection of many of our society's and our health care system's disparities, and the vulnerability of this population during the Covid‐19 pandemic cannot be overstated. Patients with psychiatric illness often suffer from the stigma of mental illness and receive poor medical care. Many patients with severe and persistent mental illness face additional barriers, including poverty, marginal housing, and food insecurity. Patients who require psychiatric hospitalization now face the risk of transmission of Covid‐19 due to the inherent difficulties of social distancing within a psychiatric hospital. Patients whose freedom and self‐determination have been temporarily overruled as they receive involuntary psychiatric treatment deserve a setting that maintains their health and safety. While tele‐mental health has been rapidly expanded to provide new ways to access psychiatric treatment, some patients may have limitations in technological literacy or access to devices. The social isolation, economic fallout, and potential traumatization related to the current pandemic will disproportionately affect this vulnerable population, and society's duties to them must be considered.

Aims While data from randomized trials suggest a declining incidence of sudden cardiac death (SCD) among heart failure patients, the extent to which such a trend is present among patients with cardiac resynchronization therapy (CRT) has not been evaluated. We therefore assessed changes in SCD incidence, and associated factors, in CRT recipients over the last 20 years. Methods and results Literature search from inception to 30 April 2018 for observational and randomized studies involving CRT patients, with or without defibrillator, providing specific cause-of-death data. Sudden cardiac death was the primary endpoint. For each study, rate of SCD per 1000 patient-years of follow-up was calculated. Trend line graphs were subsequently constructed to assess change in SCD rates over time, which were further analysed by device type, patient characteristics, and medical therapy. Fifty-three studies, comprising 22 351 patients with 60 879 patient-years of follow-up and a total of 585 SCD, were included. There was a gradual decrease in SCD rates since the early 2000s in both randomized and observational studies, with rates falling more than four-fold. The rate of decline in SCD was steeper than that of all-cause mortality, and accordingly, the proportion of deaths which were due to SCD declined over the years. The magnitude of absolute decline in SCD was more prominent among CRT-pacemaker (CRT-P) patients compared to those receiving CRT-defibrillator (CRT-D), with the difference in SCD rates between CRT-P and CRT-D decreasing considerably over time. There was a progressive increase in age, use of beta-blockers, and left ventricular ejection fraction, and conversely, a decrease in QRS duration and antiarrhythmic drug use. Conclusion Sudden cardiac death rates have progressively declined in the CRT heart failure population over time, with the difference between CRT-D vs. CRT-P recipients narrowing considerably.

Strokes remain a leading cause of morbidity and mortality in patients with ventricular assist devices (VADs). Varying study populations, event definitions, and reporting methods make direct comparison of neurologic event risk across clinical trials and registries challenging. We aim to highlight important differences among major VAD studies and standardize rates of neurologic events to facilitate a comprehensive and objective comparison. We systematically identified and analyzed key clinical trials and registries evaluating the HeartMate II (HMII), HeartMate 3 (HM3), and HVAD devices. Reported neurologic events were nonexclusively categorized into ischemic stroke, hemorrhagic stroke, disabling stroke, fatal stroke, and other neurologic events per the studies' definitions. Event rates were standardized to events per patient-year (EPPY) and freedom from event formats. Seven key clinical trials and registries were included in our analysis. There is significant variation and overlap in neurologic event rates for the three VAD platforms across clinical trials (all neurologic events [EPPY]: HM3 0.17-0.21; HMII 0.19-0.26; HVAD 0.16-0.28). None performs consistently better for all types of neurologic events. Furthermore, stroke rates among VAD trials correlated with baseline stroke risk factors including ischemic etiology, history of atrial fibrillation, and history of prior stroke.

Background Ideal management of severe glenoid retroversion during anatomic total shoulder arthroplasty (TSA) remains controversial, as previous reports have suggested that severe retroversion may negatively impact clinical outcomes. The purpose of this study was to evaluate the impact of severe glenoid retroversion on clinical and radiographic TSA outcomes using a standard glenoid component, as well as to compare outcomes among patients with less severe retroversion. Methods A case-control study was performed comparing 40 patients treated with TSA with more than 20° of glenoid retroversion preoperatively (average follow-up, 53 months) vs. a matched cohort of 80 patients with less than 20° of retroversion (average follow-up, 49 months). In all patients, the surgical technique, implant design, and postoperative rehabilitation protocol were identical. Patients were matched based on sex, age, indication, and prosthetic size. Comparisons were made regarding patient-reported outcome measures (PROMs), motion, postoperative radiographic loosening, and the presence of medial calcar resorption. Results Preoperatively, both groups demonstrated similar PROMs and measured motion, except for preoperative Single Assessment Numeric Evaluation scores and American Shoulder and Elbow Surgeons total scores, which were higher for the severe retroversion group (44.4 vs. 31.3 [P = .012] and 34.9 vs. 29.4 [P = .048], respectively). Postoperative PROMs and motion were also similar between the 2 cohorts. No significant differences were observed for postoperative radiographic findings. Medial calcar resorption was identified in 74 patients (61.7%). Calcar resorption and individual resorption grades were not found to differ significantly. Conclusion At midterm follow-up, preoperative severe glenoid retroversion does not appear to influence clinical or radiographic outcomes of TSA using a standard glenoid component.

Background Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Aims Accurate blood pressure (BP) measurement in continuous‐flow ventricular assist device (CF‐VAD) patients is imperative to reduce stroke risk. This study assesses the accuracy of the Doppler opening pressure method compared with the gold standard arterial line method in CF‐VAD patients. Methods and results In a longitudinal cohort of HeartMate II and HVAD patients, arterial line BP and simultaneously measured Doppler opening pressure were obtained. Overall correlation, agreement between Doppler opening pressure and arterial line mean vs. systolic pressure, and the effect of arterial pulsatility on the accuracy of Doppler opening pressure were analysed. A total of 1933 pairs of Doppler opening pressure and arterial line pressure readings within 1 min of each other were identified in 154 patients (20% women, mean age 55 ± 15, 50% HeartMate II and 50% HVAD). Doppler opening pressure had good correlation with invasive mean arterial pressure (r = 0.742, P

The purpose of this study was to determine whether thresholds regarding the percentage of maximal improvement in the Simple Shoulder Test (SST) score and American Shoulder and Elbow Surgeons (ASES) score exist that predict excellent patient satisfaction after reverse shoulder arthroplasty (RSA).Patients undergoing RSA with a single implant system were evaluated preoperatively and at a minimum 2-year follow-up. Receiver operating characteristic curve analysis determined thresholds to predict excellent patient satisfaction by evaluating the percentage of maximal improvement for SST and ASES scores. Preoperative factors were analyzed as independent predictors for achieving SST and ASES score thresholds.There were 198 (SST score) and 196 (ASES score) patients who met inclusion criteria. For SST and ASES scores, receiver operating characteristic curve analysis identified 61.3% (P.001) and 68.2% (P.001) maximal improvement as the threshold for maximal predictability of excellent satisfaction, respectively. Significant positive correlation between the percentage of maximum score achieved and excellent patient satisfaction for both groups was found (r = 0.440 [P.001] for SST score; r = 0.417 [P.001] for ASES score). Surgery on the dominant hand, greater baseline visual analog scale pain score, and cuff arthropathy were independent predictors for achieving the SST and ASES score threshold.Thresholds for the achievement of excellent satisfaction after RSA were 61.3% of maximal SST score improvement and 68.3% of maximal ASES score improvement. Independent predictors of achieving these thresholds were dominant-sided surgery and higher baseline visual analog scale pain scores for the SST score and rotator cuff arthropathy for the ASES score.

Emerging research suggests that hoarding disorder (HD) is associated with abnormal hemodynamic activity in frontal brain regions. Prior studies have not examined intrinsic network connectivity in HD during unstructured “resting state” fMRI. Furthermore, it remains unclear whether previously observed HD abnormalities might be better explained by the presence of other disorders frequently comorbid with HD, such as major depressive disorder (MDD). The current study compared resting state functional connectivity in HD-only patients (n = 17), MDD-only patients (n = 8), patients with co-occurring HD and MDD (n = 10), and healthy control participants (n = 18). Using independent component analysis, we found that HD-only patients exhibited lower functional connectivity in a “task positive” cognitive control network, compared to the other three groups. The HD group also had greater connectivity in regions of the “task negative” default mode network than did the other groups. Findings suggest that HD is associated with a unique neurobiological profile, and are discussed in terms of recent neurological and neuropsychological findings and models in HD and related disorders.

Background Delirium commonly affects critically ill patients and is associated with high morbidity and mortality. Some studies have suggested that ramelteon may prevent delirium, but ramelteon's impact on treating delirium is unknown. Objective To compare outcomes of critically ill delirious patients treated with ramelteon versus those who were not. Methods Retrospective cohort study of 322 intensive care unit patients stratified based on ramelteon exposure after a nonnegative Confusion Assessment Method-ICU score. Main outcomes Primary outcomes were hours alive without delirium or coma and likelihood of delirium-coma resolution. Secondary outcomes were ventilator-free hours, likelihood of extubation, and mortality. Results Hazard ratios for delirium-coma resolution, extubation, and 10-day mortality were 1.05 (95% confidence interval 0.54–2.01), 1.20 (95% confidence interval 0.47–3.03), and 0.31 (95% confidence interval 0.07–1.32), respectively. Median delirium-coma free hours did not differ between ramelteon exposed and unexposed patients. Median ventilator-free hours were higher in the ramelteon group, however, ramelteon was administered postextubation in 92% of cases. Conclusions Ramelteon was not associated with increased likelihood of delirium-coma resolution, extubation, or changes in mortality.

Previous studies have demonstrated that proactive psychiatric consultation reduces hospital length of stay (LOS) in the general medical setting; however this model has not been studied in the intensive care unit (ICU).To compare outcomes between a conventional consultation model and a proactive psychiatric consultation model.Two medical ICUs (MICUs) were randomized to proactive psychiatric consultation vs conventional consultation psychiatric models. Proactive consultation included embedding a psychiatrist into daily MICU team rounds on all patients. In the conventional consultation MICU, psychiatric consultations were activated when deemed necessary. Primary outcomes were hospital LOS and MICU LOS. Secondary outcomes included delirium-coma-free hours and ventilator-free hours.A total of 429 patients were admitted to the proactive consultation MICU; 393 patients were admitted to the conventional consultation MICU. The consultation rate for the intervention group was 24.2% vs 6.1% in the control group (p0.001). Time to psychiatric consultation was shorter in the intervention group. Median hospital LOS was 6.92 days, interquartile range 3.70-14.31 in the intervention group vs 7.69 days, interquartile range 3.95-16.21 in the control group (p = 0.113). MICU LOS, delirium-coma-free hours, and ventilator-free hours were not significantly different between the 2 groups. Among the respiratory failure subgroup, hospital LOS was shorter in the intervention vs control group (median 9.46 days, interquartile range 4.95-17.56 vs 12.29 days, interquartile range 6.58-21.10, p = 0.011).Proactive psychiatric consultation in a MICU was associated with decreased time to consultation among all patients and shorter hospital LOS among patients with respiratory failure.

Background Anatomic total shoulder arthroplasty (TSA) provides reliable, reproducible, and durable results; however, outcomes of many modern TSA systems are lacking. The present study reports early to midterm results of a third-generation TSA system using a traditional-length press-fit humeral stem and cemented glenoid. Methods A retrospective review was conducted of TSA patients with minimum 2-year clinical follow-up. Patient-reported outcome measures, including Simple Shoulder Test, American Shoulder and Elbow Surgeons Total, visual analog scale for pain, 12-Item Short Form Health Survey, and Single Assessment Numeric Evaluation, as well as measured active motion (forward elevation, external and internal rotation), were recorded at preoperative and postoperative intervals. Preoperative midglenoid axial computed tomography scans were used to evaluate eccentric glenoid wear, humeral head subluxation, and glenoid version. Most recent postoperative radiographs were used to evaluate glenoid loosening, humeral loosening, lesser tuberosity union, and medial calcar resorption. Patient satisfaction at final follow-up was reported as excellent, good, satisfied, or unsatisfied. Results There were 267 patients who met inclusion criteria, with a mean age of 70.9 years and mean clinical follow-up of 47 months. Average glenoid retroversion was 9.7°, and 27% had eccentric glenoid wear. At final follow-up, measured motion and nearly all patient-reported outcome measures showed significant improvements, with 75.6% of patients rating their satisfaction as excellent. No patient was considered “at risk” for humeral stem loosening. Glenoid radiolucencies were seen in 13.5% of shoulders (7 gross loosening). Five patients were revised to reverse TSA. Conclusion TSA using a third-generation traditional-length press-fit stem and cemented glenoid provides excellent early to midterm outcomes with low rates of loosening and high rates of excellent satisfaction.

Trauma-informed care has emerged as an important model to address the pervasiveness of traumatic experiences across the life cycle and their association with significant adverse medical and psychiatric consequences. To achieve health equity, in which all people have the opportunity for health, it is crucial for physicians to become comfortable with a neurobiopsychosocial understanding of trauma and how to provide optimal trauma-informed care. Given the pervasiveness of trauma exposure, and its impact on individual and community health, this paradigm shift in adult health care delivery systems requires physician engagement at every stage of development and implementation.

BACKGROUND: Press-fit humeral fixation for reverse shoulder arthroplasty (RSA) has been shown to have loosening rates and outcomes similar to a cemented technique; however, increased value has not been reported. The purpose of this study was to determine whether the press-fit technique could improve the value of RSA using the procedure value index (PVI). METHODS: Primary RSA patients with complete hospitalization cost data, preoperative and minimum 2-year postoperative Simple Shoulder Test (SST) scores, and postoperative satisfaction were included. The PVI was calculated as improvement in the SST score (in units of minimal clinically important difference) divided by total cost and normalized. Itemized cost data were obtained from hospital financial records and categorized. Radiographic complications, infections, and revisions were noted. Comparisons were made between the press-fit and cemented RSA cohorts. RESULTS: A total of 176 primary RSA patients (83 cemented and 93 press fit) met the inclusion criteria (mean follow-up period, 44.6 months). Surgical indications (except failed rotator cuff repair), baseline SST scores, and demographic characteristics were similar. The calculated minimal clinically important difference for the SST score was 3.98. The average PVI was significantly greater in the press-fit cohort (1.51 vs 1.03, P