Examining the Influence of Historical Redlining on Firearm Injuries in Current Day Baltimore, Maryland.

Firearm injuries are a common and major public health problem in Baltimore, Maryland. The city is also one of the first U.S. cities in which the 1930s discriminatory practice of redlining first emerged. This study examines the association between current day firearm injuries and residence in these historically redlined areas at a neighborhood level using zip codes. Firearm injury outcomes in patients who presented to a hospital in Maryland from 2015 to 2020 were measured from the Health Services Cost Review Commission (HSCRC) in conjunction with both geospatial data from Richmond's Digital Scholarship Lab's Mapping Inequality project and population data from the U.S. Census. A redlining score was calculated to represent the extent of redlining in each zip code. Negative binomial regression models were utilized to measure the association between neighborhood zip codes and rate of firearm injuries. Our adjusted regression model shows that for every one-unit increase of the Home Owners' Loan Corporation (HOLC) redlining score, there is a 2.24-fold increase in the rate of firearm injuries (RR 2.24; 95% CI: 0.31, 1.31, p < 0.001). These findings suggest a strongassociation between historically redlined areas and population risk of firearm injury today. Further research is needed to investigate the underlying mechanisms that may contribute to this relationship, such as access to firearms or social and economic factors. Overall, our study highlights the potential impact of historical redlining policies on contemporary health outcomes in Baltimore.

The Two Fundamental Shapes of Sleep Heart Rate Dynamics and Their Connection to Mental Health in College Students.

Introduction: Wearable devices are rapidly improving our ability to observe health-related processes for extended durations in an unintrusive manner. In this study, we use wearable devices to understand how the shape of the heart rate curve during sleep relates to mental health. Methods: As part of the Lived Experiences Measured Using Rings Study (LEMURS), we collected heart rate measurements using the Oura ring (Gen3) for over 25,000 sleep periods and self-reported mental health indicators from roughly 600 first-year university students in the USA during the fall semester of 2022. Using clustering techniques, we find that the sleeping heart rate curves can be broadly separated into two categories that are mainly differentiated by how far along the sleep period the lowest heart rate is reached. Results: Sleep periods characterized by reaching the lowest heart rate later during sleep are also associated with shorter deep and REM sleep and longer light sleep, but not a difference in total sleep duration. Aggregating sleep periods at the individual level, we find that consistently reaching the lowest heart rate later during sleep is a significant predictor of (1) self-reported impairment due to anxiety or depression, (2) a prior mental health diagnosis, and (3) firsthand experience in traumatic events. This association is more pronounced among females. Conclusion: Our results show that the shape of the sleeping heart rate curve, which is only weakly correlated with descriptive statistics such as the average or the minimum heart rate, is a viable but mostly overlooked metric that can help quantify the relationship between sleep and mental health.

Chondroitin sulfate proteoglycan 4 (CSPG4) increases invasion of recessive dystrophic epidermolysis bullosa-associated cutaneous squamous cell carcinoma by modifying TGFß signaling.

BACKGROUND: Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genetic skin-blistering disorder often progressing to metastatic cutaneous squamous cell carcinoma (cSCC) at chronic wound sites. Chondroitin sulfate proteoglycan 4 (CSPG4) is a cell-surface proteoglycan that is an oncoantigen in multiple malignancies, where it modulates oncogenic signaling, drives epithelial-to-mesenchymal transition (EMT), and enables cell motility. OBJECTIVES: To evaluate CSPG4 expression and function in RDEB-cSCC. METHODS: RDEB-cSCC cell lines were used to assess CSPG4-dependent changes in invasive potential, TGFß1-stimulated signal activation, and clinically relevant cytopathology metrics in an in vitro full-thickness tumor model. CSPG4 expression in RDEB-cSCC and non-RDEB cSCC tumors was analyzed via immunohistochemistry and single-cell RNA sequencing (scRNA-seq), respectively. RESULTS: Inhibiting CSPG4 expression reduced invasive potential in multiple RDEB-cSCC cell lines and altered membrane-proximal TGFß signal activation through changes in SMAD3 phosphorylation. CSPG4 expression was uniformly localized to basal-layer keratinocytes in fibrotic RDEB skin and tumor cells at the tumor/stroma interface at the invasive front in RDEB-cSCC tumors in vivo. Analysis of published scRNA-seq data revealed that CSPG4 expression was correlated with an enhanced EMT transcriptomic signature in cells at the tumor/stroma interface of non-RDEB cSCC tumors. Cytopathological metrics, like nucleus:cell area ratio, were influenced by CSPG4 expression in in vitro tumor models. CONCLUSIONS: We determined that CSPG4 expression in RDEB-cSCC cell lines enhanced invasive potential. Mechanistically, CSPG4 was found to enhance membrane-proximal TGFß-stimulated signaling through SMAD3, which is a key mediator of EMT in RDEB-cSCC. The implication of these studies is that CSPG4 may represent a therapeutic target that can be leveraged for clinical management in patients with RDEB-cSCC.

FAIR reporting of clinical trials for public health practice.

The number of clinical trials is rapidly growing, and automation of literature processing is becoming desirable but unresolved. Our purpose was to assess and increase the readiness of clinical trial reports for supporting automated retrieval and implementation in public health practice. We searched the Medline database for a random sample of clinical trials of HIV/AIDS management with likely relevance to public health in Africa. Five authors assessed trial reports for inclusion, extracted data, and assessed quality based on the FAIR principles of scientific data management (findable, accessible, interoperable, and reusable). Subsequently, we categorized reported results in terms of outcomes and essentials of implementation. A sample of 96 trial reports was selected. Information about the tested intervention that is essential for practical implementation was largely missing, including personnel resources needed 32·3% (.95 CI: 22·9-41·6); material/supplies needed 33·3% (.95 CI: 23·9-42·8); major equipment/building investment 42·8% (CI: 33·8-53·7); methods of educating providers 53·1% (CI: 43·1-63·4); and methods of educating the community 27·1% (CI: 18·2-36·0). Overall, 65% of studies measured health/biologic outcomes, among them, only a fraction showed any positive effects. Several specific design elements were identified that frequently make clinical trials unreal and their results unusable. To sort and interpret clinical trial results easier and faster, a new reporting structure, a practice- and retrieval-oriented trial outline with numeric outcomes (PROTON) table was developed and illustrated. Many clinical trials are either inconsequential by design or report incomprehensible results. According to the latest expectations of FAIR scientific data management, all clinical trial reports should include a consistent and practical impact-oriented table of clinical trial results.

The Cyborg Method: A Method to Identify Fraudulent Responses from Crowdsourced Data.

Crowdsourcing is an essential data collection method for psychological research. Concerns about the validity and quality of crowdsourced data persist, however. A recent documented increase in the number of invalid responses within crowdsourced data has highlighted the need for quality control measures. Although a number of approaches are recommended, few have been empirically evaluated. The present study evaluated a Cyborg Method that used automated evaluation of participant meta-data and a review of short answer responses. Two samples were recruited - in the first, the Cyborg Method was applied after data collection to gauge the extent to which invalid responses were collected when a priori quality controls were absent. In the second, the Cyborg Method was applied during data collection to determine if the method would proactively screen invalid responses. Results suggested that Cyborg Method identified a substantial portion of invalid responses and both automated and human evaluation components was necessary. Furthermore, the Cyborg Method could be applied proactively to screen invalid responses and substantially reduced the per participant cost of data collection. These results suggest that the Cyborg Method is a promising means by which to collect high quality crowdsourced data.

OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.

BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVES: The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).

Impact of heart failure hospitalizations on clinical outcomes after mitral transcatheter edge-to-edge repair: Results from the EXPAND study.

AIM: This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study. METHODS AND RESULTS: The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%. CONCLUSIONS: This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.

Pediatric Trauma Recidivism: A Statewide Risk Factor Analysis of the Maryland Health Services Cost Review Commission (HSCRC).

BACKGROUND: National estimates suggest pediatric trauma recidivism is uncommon but are limited by short follow up and narrow ascertainment. We aimed to quantify the long-term frequency of trauma recidivism in a statewide pediatric population and identify risk factors for re-injury. METHODS: The Maryland Health Services Cost Review Commission Dataset was queried for 0-19-year-old patients with emergency department or inpatient encounters for traumatic injuries between 2013 and 2019. We measured trauma recidivism by identifying patients with any subsequent presentation for a new traumatic injury. Univariate and multivariable regressions were used to estimate associations of patient and injury characteristics with any recidivism and inpatient recidivism. RESULTS: Of 574,472 patients with at least one injury encounter, 29.6% experienced trauma recidivism. Age ≤2 years, public insurance, and self-inflicted injuries were associated with recidivism regardless of index treatment setting. Of those with index emergency department presentations 0.06% represented with an injury requiring inpatient admission; unique risk factors for ED-to-inpatient recidivism were age >10 years (aOR 1.61), cyclist (aOR 1.31) or burn (aOR 1.39) mechanisms, child abuse (aOR 1.27), and assault (aOR 1.43). Among patients with at least one inpatient encounter, 6.3% experienced another inpatient trauma admission, 3.4% of which were fatal. Unique risk factors for inpatient-to-inpatient recidivism were firearm (aOR 2.48) and motor vehicle/transportation (aOR 1.62) mechanisms of injury (all p < 0.05). CONCLUSIONS: Pediatric trauma recidivism is more common and morbid than previously estimated, and risk factors for repeat injury differ by treatment setting. Demographic and injury characteristics may help develop and target setting-specific interventions. LEVEL OF EVIDENCE: III (Retrospective Comparative Study).

Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial.

Importance: Although the results of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF II) trial were neutral overall, atrial shunt therapy demonstrated potential efficacy in responders (no latent pulmonary vascular disease and no cardiac rhythm management device). Post hoc analyses were conducted to evaluate the effect of shunt vs sham stratified by responder status. Objective: To evaluate the effect of atrial shunt vs sham control on cardiac structure/function in the overall study and stratified by responder status. Design, Setting, and Participants: This was a sham-controlled randomized clinical trial of an atrial shunt device in heart failure with preserved ejection fraction (HFpEF)/HF with mildly reduced EF (HFmrEF). Trial participants with evaluable echocardiography scans were recruited from 89 international medical centers. Data were analyzed from April 2023 to January 2024. Interventions: Atrial shunt device or sham control. Main Outcome Measures: Changes in echocardiographic measures from baseline to 1, 6, 12, and 24 months after index procedure. Results: The modified intention-to-treat analysis of the REDUCE LAP-HF II trial included 621 randomized patients (median [IQR] age, 72.0 [66.0-77.0] years; 382 female [61.5%]; shunt arm, 309 [49.8%]; sham control arm, 312 [50.2%]). Through 24 months, 212 of 217 patients (98%) in the shunt arm with evaluable echocardiograms had patent shunts. In the overall trial population, the shunt reduced left ventricular (LV) end-diastolic volume (mean difference, -5.65 mL; P <.001), left atrial (LA) minimal volume (mean difference, -2.8 mL; P =.01), and improved LV systolic tissue Doppler velocity (mean difference, 0.69 cm/s; P <.001) and LA emptying fraction (mean difference, 1.88 percentage units; P =.02) compared with sham. Shunt treatment also increased right ventricular (RV; mean difference, 9.58 mL; P <.001) and right atrial (RA; mean difference, 9.71 mL; P <.001) volumes but had no effect on RV systolic function, pulmonary artery pressure, or RA pressure compared with sham. In the shunt arm, responders had smaller increases in RV end-diastolic volume (mean difference, 5.71 mL vs 15.18 mL; interaction P =.01), RV end-systolic volume (mean difference, 1.58 mL vs 7.89 mL; interaction P =.002), and RV/LV ratio (mean difference, 0.07 vs 0.20; interaction P <.001) and larger increases in transmitral A wave velocity (mean difference, 5.08 cm/s vs -1.97 cm/s; interaction P =.02) compared with nonresponders randomized to the shunt, suggesting greater ability to accommodate shunted blood through the pulmonary circulation enabling LA unloading. Conclusions and Relevance: In this post hoc analysis of the REDUCE LAP-HF II trial, over 2 years of follow-up, atrial shunting led to reverse remodeling of left-sided chambers and increases in volume of right-sided chambers consistent with the shunt flow but no change in RV systolic function compared with sham. Changes in cardiac structure/function were more favorable in responders compared with nonresponders treated with the shunt, supporting the previously identified responder group hypothesis and mechanism, although further evaluation with longer follow-up is needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03088033.

Expecting the Unexpected: Predicting Panic Attacks From Mood, Twitter, and Apple Watch Data.

OBJECTIVE: Panic attacks are an impairing mental health problem that affects 11% of adults every year. Current criteria describe them as occurring without warning, despite evidence suggesting individuals can often identify attack triggers. We aimed to prospectively explore qualitative and quantitative factors associated with the onset of panic attacks. RESULTS: Of 87 participants, 95% retrospectively identified a trigger for their panic attacks. Worse individually reported mood and state-level mood, as indicated by Twitter ratings, were related to greater likelihood of next-day panic attack. In a subsample of participants who uploaded their wearable sensor data (n = 32), louder ambient noise and higher resting heart rate were related to greater likelihood of next-day panic attack. CONCLUSIONS: These promising results suggest that individuals who experience panic attacks may be able to anticipate their next attack which could be used to inform future prevention and intervention efforts.

Intracellular Lactate Dynamics Reveal the Metabolic Diversity of Drosophila Glutamatergic Neurons.

Lactate, an intermediary between glycolysis and mitochondrial oxidative phosphorylation, reflects the metabolic state of neurons. Here, we utilized a genetically-encoded lactate FRET biosensor to uncover subpopulations of distinct metabolic states among Drosophila glutamatergic neurons. Neurons within specific subpopulations exhibited correlated lactate flux patterns that stemmed from inherent cellular properties rather than neuronal interconnectivity. Further, individual neurons exhibited consistent patterns of lactate flux over time such that stimulus-evoked changes in lactate were correlated with pre-treatment fluctuations. Leveraging these temporal autocorrelations, deep-learning models accurately predicted post-stimulus responses from pre-stimulus fluctuations. These findings point to the existence of distinct neuronal subpopulations, each characterized by unique lactate dynamics, and raise the possibility that neurons with correlated metabolic activities might synchronize across different neural circuits. Such synchronization, rooted in neuronal metabolic states, could influence information processing in the brain.

Availability and Geographic Access to Hospital-Based Breast Cancer Diagnostic Services in Ghana.

PURPOSE: Breast cancer is the most frequent cancer and second most common cause of cancer-related death in Ghana. Early detection and access to diagnostic services are vital for early treatment initiation and improved survival. This study characterizes the geographic access to hospital-based breast cancer diagnostic services in Ghana as a framework for expansion. METHODS: A cross-sectional hospital-based survey was completed in Ghana from November 2020 to October 2021. Early diagnostic services, as defined by the National Comprehensive Cancer Network (NCCN) Framework for Resource Stratification, was assessed at each hospital. Services were characterized as available >80% of the time in the previous year, <80%, or not available. ArcGIS was used to identify the proportion of the population within 20 and 45 km of services. RESULTS: Most hospitals in Ghana participated in this survey (95%; 328 of 346). Of these, 12 met full NCCN Basic criteria >80% of the time, with 43% of the population living within 45 km. Ten of the 12 met full NCCN Core criteria, and none met full NCCN Enhanced criteria. An additional 12 hospitals were identified that provide the majority of NCCN Basic services but lack select services necessary to meet this criterion. Expansion of services in these hospitals could result in an additional 20% of the population having access to NCCN Basic-level early diagnostic services within 45 km. CONCLUSION: Hospital-based services for breast cancer early diagnosis in Ghana are available but sparse. Many hospitals offer fragmented aspects of care, but only a limited number of hospitals offer the full NCCN Basic or Core level of care. Understanding current availability and geographical distribution of services provides a framework for potential targeted expansion of services.

Endovascular Ablation of the Right Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: Rationale, Design and Lead-in Phase Results of the REBALANCE-HF Trial.

OBJECTIVE: Splanchnic vasoconstriction augments transfer of blood volume from the abdomen into the thorax, which may increase filling pressures and hemodynamic congestion in patients with noncompliant hearts. Therapeutic interruption of splanchnic nerve activity holds promise to reduce hemodynamic congestion in patients with heart failure with preserved ejection fraction (HFpEF). Here we describe (1) the rationale and design of the first sham-controlled, randomized clinical trial of splanchnic nerve ablation for HFpEF and (2) the 12-month results of the lead-in (open-label) trial's participants. METHODS: REBALANCE-HF is a prospective, multicenter, randomized, double-blinded, sham-controlled clinical trial of endovascular, transcatheter, right-sided greater splanchnic nerve ablation for volume management (SAVM) in patients with HFpEF. The primary objectives are to evaluate the safety and efficacy of SAVM and identify responder characteristics to inform future studies. The trial consists of an open-label lead-in phase followed by the randomized, sham-controlled phase. The primary efficacy endpoint is the reduction in pulmonary capillary wedge pressure (PCWP) at 1-month follow-up compared to baseline during passive leg raise and 20W exercise. Secondary and exploratory endpoints include health status (Kansas City Cardiomyopathy Questionnaire), 6-minute walk test distance, New York Heart Association class, and NTproBNP levels at 3, 6 and 12 months. The primary safety endpoint is device- or procedure-related serious adverse events at the 1-month follow-up. RESULTS: The lead-in phase of the study, which enrolled 26 patients with HFpEF who underwent SAVM, demonstrated favorable safety outcomes and reduction in exercise PCWP at 1 month post-procedure and improvements in all secondary endpoints at 6 and 12 months of follow-up. The randomized phase of the trial (n = 44 SAVM; n = 46 sham) has completed enrollment, and follow-up is ongoing. CONCLUSION: REBALANCE-HF is the first sham-controlled randomized clinical trial of greater splanchnic nerve ablation in HFpEF. Initial 12-month open-label results are promising, and the results of the randomized portion of the trial will inform the design of a future pivotal clinical trial. SAVM may offer a promising therapeutic option for patients with HFpEF. TRIAL REGISTRATION: NCT04592445.

Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.

BACKGROUND: Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging. METHODS: The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups. RESULTS: Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar. CONCLUSION: Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653). NON-STANDARD ABBREVIATIONS AND ACRONYMS: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.

Behavioral activation is associated with post-disaster mental health: Secondary longitudinal analysis from a population-based study.

OBJECTIVE: Interventions in post-disaster environments may be accelerated by identifying protective behavioral factors adding incremental value to models of psychopathology using longitudinal methods. One protective behavior applicable to post-disaster contexts is behavioral activation (BA). BA is defined here as a behavioral pattern involving presence of valued activity engagement. While relevant post-disaster, the incremental value of BA behaviors in predicting longitudinal post-disaster outcomes is not well understood. We hypothesized that higher baseline engagement in behaviors consistent with a BA framework would predict decreased posttraumatic stress disorder (PTSD) symptom severity, depression symptom severity, and sleep disturbance approximately 3, 6, and 12 months after hurricane survivors completed baseline measures. METHODS: The current study is a secondary analysis from a randomized controlled trial of a disaster mental health digital intervention. Participants completed surveys at baseline and approximately 3, 6, and 12 months post-enrollment. Correlations and hierarchical regression analyses were calculated following data screening to predict PTSD symptom severity, depression symptom severity, and sleep disturbances. RESULTS: Controlling for alcohol use, prior trauma, displacement, and intervention condition, higher baseline BA consistently predicted less PTSD symptom severity, depression symptom severity, and sleep disturbances. CONCLUSION: Results suggest that post-disaster interventions should consider addressing BA. The study provides evidence that BA is potentially an important protective factor longitudinally predicting sleep disturbances and psychopathology after natural disasters.

Discovering Digital Biomarkers of Panic Attack Risk in Consumer Wearables Data.

Panic attacks are an impairing mental health problem that impacts more than one out of every 10 adults in the United States (US). Clinical guidelines suggest panic attacks occur without warning and their unexpected nature worsens their impact on quality of life. Individuals who experience panic attacks would benefit from advance warning of when an attack is likely to occur so that appropriate steps could be taken to manage or prevent it. Our recent work suggests that an individual's likelihood of experiencing a panic attack can be predicted by self-reported mood and community-level Twitter-derived mood the previous day. Prior work also suggests that physiological markers may indicate a pending panic attack. However, the ability of objective physiological, behavioral, and environmental measures collected via consumer wearable sensors (referred to as digital biomarkers) to predict next-day panic attacks has not yet been explored. To address this question, we consider data from 38 individuals who regularly experienced panic attacks recruited from across the US. Participants responded to daily questions about their panic attacks for 28 days and provided access to data from their Apple Watches. Mixed Regressions, with an autoregressive covariance structure were used to estimate the prevalence of a next-day panic attack Results indicate that digital biomarkers of ambient noise (louder) and resting heart rate (higher) are indicative of experiencing a panic attack the next day. These preliminary results suggest, for the first time, that panic attacks may be predictable from digital biomarkers, opening the door to improvements in how panic attacks are managed and to the development of new preventative interventions.Clinical Relevance- Objective data from consumer wearables may predict when an individual is at high risk for experiencing a next-day panic attack. This information could guide treatment decisions, help individuals manage their panic, and inform the development of new preventative interventions.

One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX: A National Registry Analysis.

BACKGROUND: Left atrial appendage occlusion (LAAO) is an approved alternative for stroke prevention in atrial fibrillation for patients with an "appropriate rationale" to avoid long-term oral anticoagulation (OAC). Many patients undergoing LAAO are at high risk of bleeding. OBJECTIVES: This study sought to investigate whether dual antiplatelet therapy (DAPT) is a safe alternative to OAC (direct oral anticoagulation [DOAC] or warfarin) with aspirin after LAAO. METHODS: Using National Cardiovascular Data Registry LAAO registry data, patients undergoing Watchman FLX (Boston Scientific) implantation (August 5, 2020-September 30, 2021) were included in 1:1 propensity-matched analyses comparing discharge medication regimens (DAPT, DOAC/aspirin, or warfarin/aspirin). A composite endpoint (death, stroke, major bleeding, and systemic embolism), its components, and device-related thrombus between discharge and 45 days were evaluated. RESULTS: In 49,968 patients implanted with the Watchman FLX during the study period, the mean age was 77 years, and 40% were women. Postimplant DOAC/aspirin was prescribed in 24,497 patients, warfarin/aspirin in 3,913, and DAPT in 4,155. DAPT patients had more comorbid conditions than patients receiving OAC/aspirin. After propensity score matching, the 45-day composite endpoint rates were similar among the groups (DAPT = 3.44% vs DOAC/aspirin: 4.06%; P = 0.13 and DAPT = 3.23% vs warfarin/aspirin: 3.08%; P = 0.75). Death, stroke, and device-related thrombus were also similar; major bleeding was slightly increased in DOAC/aspirin patients (DAPT = 2.48% vs DOAC/aspirin = 3.25%; P = 0.04 and DAPT = 2.25% vs warfarin/aspirin = 2.22%; P = 0.93). CONCLUSIONS: In a large registry, DAPT had a similar safety profile compared with current Food and Drug Administration-approved postimplant drug regimens of OAC with aspirin following LAAO with the Watchman FLX. Shared decision making for nonpharmacologic stroke prevention should include a discussion of postprocedure medical therapy options.