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Stereotactic MR-guided on-table adaptive radiation therapy (SMART) for borderline resectable and locally advanced pancreatic cancer: A multi-center, open-label phase 2 study
No full textBACKGROUND AND PURPOSE: Radiation dose escalation may improve local control (LC) and overall survival (OS) in select pancreatic ductal adenocarcinoma (PDAC) patients. We prospectively evaluated the safety and efficacy of ablative stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for borderline resectable (BRPC) and locally advanced pancreas cancer (LAPC). The primary endpoint of acute grade ≤ 3 gastrointestinal (GI) toxicity definitely related to SMART was previously published with median follow-up (FU) 8.8 months from SMART. We now present more mature outcomes including OS and late toxicity.
MATERIALS AND METHODS: This prospective, multi-center, single-arm open-label phase 2 trial (NCT03621644) enrolled 136 patients (LAPC 56.6 %; BRPC 43.4 %) after ≤ 3 months of any chemotherapy without distant progression and CA19-9 ≤ 500 U/mL. SMART was delivered on a 0.35 T MR-guided system prescribed to 50 Gy in 5 fractions (biologically effective dose(10) [BED(10)] = 100 Gy). Elective coverage was optional. Surgery and chemotherapy were permitted after SMART.
RESULTS: Mean age was 65.7 years (range, 36-85), induction FOLFIRINOX was common (81.7 %), most received elective coverage (57.4 %), and 34.6 % had surgery after SMART. Median FU was 22.9 months from diagnosis and 14.2 months from SMART, respectively. 2-year OS from diagnosis and SMART were 53.6 % and 40.5 %, respectively. Late grade ≤ 3 toxicity definitely, probably, or possibly attributed to SMART were observed in 0 %, 4.6 %, and 11.5 % patients, respectively.
CONCLUSIONS: Long-term outcomes from the phase 2 SMART trial demonstrate encouraging OS and limited severe toxicity. Additional prospective evaluation of this novel strategy is warranted
Does valerian work for insomnia? An umbrella review of the evidence
No full textValerian is one of the most used herbal agents (phytotherapeutics) to manage sleep disturbances, in particular, sleep-onset difficulties in young adults. However, the evidence based on primary studies and systematic reviews that supports its use in this domain is weak or inconclusive. In the current study, an umbrella review was performed on the efficacy of valerian for sleep disturbances with a focus on insomnia. As such, only systematic reviews (with or without meta-analysis) were considered for this study. Systematic searches in PubMed, Web of Science, Scopus, Cochrane Database of Systematic Reviews, PROSPERO and CNKI databases retrieved 70 records. Only 8 articles were considered eligible for qualitative analysis. Overall, data suggested that valerian has a good safety profile, however, the results showed no evidence of efficacy for the treatment of insomnia. Moreover, valerian appears to be effective concerning subjective improvement of sleep quality, although its effectiveness has not been demonstrated with quantitative or objective measurements. Despite its widespread use and prescription by general practitioners, psychiatrists and other professionals, valerian does not have empirical support for insomnia. Further studies, in particular high quality randomized controlled trials, are highly recommended since there are scarce studies and the existing ones are quite heterogeneous and with low methodological quality. The implications of our findings for clinical practice are critically discussed
State of the science and recommendations for using wearable technology in sleep and circadian research
No full textWearable sleep-tracking technology is of growing use in the sleep and circadian fields, including for applications across other disciplines, inclusive of a variety of disease states. Patients increasingly present sleep data derived from their wearable devices to their providers and the ever-increasing availability of commercial devices and new-generation research/clinical tools has led to the wide adoption of wearables in research, which has become even more relevant given the discontinuation of the Philips Respironics Actiwatch. Standards for evaluating the performance of wearable sleep-tracking devices have been introduced and the available evidence suggests that consumer-grade devices exceed the performance of traditional actigraphy in assessing sleep as defined by polysomnogram. However, clear limitations exist, for example, the misclassification of wakefulness during the sleep period, problems with sleep tracking outside of the main sleep bout or nighttime period, artifacts, and unclear translation of performance to individuals with certain characteristics or comorbidities. This is of particular relevance when person-specific factors (like skin color or obesity) negatively impact sensor performance with the potential downstream impact of augmenting already existing healthcare disparities. However, wearable sleep-tracking technology holds great promise for our field, given features distinct from traditional actigraphy such as measurement of autonomic parameters, estimation of circadian features, and the potential to integrate other self-reported, objective, and passively recorded health indicators. Scientists face numerous decision points and barriers when incorporating traditional actigraphy, consumer-grade multi-sensor devices, or contemporary research/clinical-grade sleep trackers into their research. Considerations include wearable device capabilities and performance, target population and goals of the study, wearable device outputs and availability of raw and aggregate data, and data extraction, processing, and analysis. Given the difficulties in the implementation and utilization of wearable sleep-tracking technology in real-world research and clinical settings, the following State of the Science review requested by the Sleep Research Society aims to address the following questions. What data can wearable sleep-tracking devices provide? How accurate are these data? What should be taken into account when incorporating wearable sleep-tracking devices into research? These outstanding questions and surrounding considerations motivated this work, outlining practical recommendations for using wearable technology in sleep and circadian research
100.76 Assessing Mortality Risk in Cardiogenic Shock Patients on VA-ECMO: The Role of SAVE Score, SOFA Score, and 8-Hour Lactate Clearance
No full textBackground: Cardiogenic shock (CS) is a life-threatening perfusion impairment due to cardiac dysfunction. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide robust hemodynamic support in patients unresponsive to medical therapy. However, predicting outcomes in patients requiring ECMO support has proved challenging. This study sought to examine in-hospital mortality rates in patients with refractory CS undergoing VA-ECMO and evaluate the association of Survival After VA-ECMO (SAVE) score, Sequential Organ Failure Assessment (SOFA) score, and post-cannulation lactate levels with inpatient mortality. Methods: A retrospective review of adult patients who underwent peripheral VA-ECMO cannulation from January 2018 to September 2022 at a quaternary care center. In-hospital mortality was assessed and compared to predicted mortality by SAVE and SOFA scores, with adjusted odds ratio of risk factors for mortality identified by multivariate logistic regression analysis. Additionally, the prognostic value of 8-hour post-cannulation serum lactate levels was analyzed by receiver operating characteristic (ROC) curve and Kaplan Meier analysis of 30-day survival. Results: 244 patients were included in final analysis. In-hospital mortality was 70%, and 54% of patients died while on ECMO or within 24 hours of decannulation. SAVE score (OR 0.93 per unit increase, 95% CI 0.86 - 0.99, p=0.008), SOFA score (OR 1.53 per unit increase, 95% CI 1.32 - 1.75), and 8-hour post-cannulation lactate level (OR 1.20 per mmol/L increase, 95% CI 1.04 - 1.36, p=0.012) and clearance (OR 0.98 per % decrease, 95% CI 0.97 - 0.99, p=0.026) were independently associated with in-hospital mortality. An 8-hour post-cannulation lactate level above 7.8 mmol/L was associated with high specificity for in-hospital mortality (91.1%). Patients with 8-hour post-cannulation lactate levels above the cutoff of 7.3 mmol/L demonstrated significantly higher 30-day mortality across the entire follow-up period. Conclusion: SAVE and SOFA scores are useful tools in determining prognosis of patients with CS on VA-ECMO. 8-hour post-cannulation serum lactate levels are a pragmatic biomarker which can further assist in prognostication of patients requiring VA-ECMO, and the cutoff of 7.3 mmol/L at 8-hours appears to be a reliable measure. The development of accurate prognostic tools is critical in managing and optimizing care for patients with CS
Safety And Efficacy Of Impella RP Support For Acute Right Ventricular Failure Complicated By Cardiogenic Shock: Post Market Approval SubAnalysis Of The CVAD Registry
No full textINTRODUCTION: Takotsubo cardiomyopathy (TTC) is characterized by reversible apical ballooning without severe coronary artery disease. TTC with left ventricular outflow tract obstruction (LVOTO) is classically managed with phenylephrine, beta-blockers, and fluid resuscitation, avoiding inotropic agents due to concern for worsening obstruction. Management is further complicated in the setting of hemodynamically significant mitral regurgitation (MR), where fluid resuscitation may worsen cardiopulmonary status. In such cases, depending on the patient\u27s clinical status and hemodynamics, they may either benefit from short-term mechanical circulatory support (MCS), such as an intra-aortic balloon pump, or may have LVOTO exacerbated. We describe a case of TTC with LVOTO and severe MR successfully managed with pharmacologic therapy avoiding mechanical and inotropic support. CASE: A 70-year-old female presented with acute onset of dyspnea and presyncope during strenuous exercise. On presentation, she was hypotensive (76/52 mmHg), tachypneic (29 breaths/min), and hypoxic requiring a high-flow nasal cannula at 40L/min at 100% FiO2. Initial laboratory tests included high-sensitivity troponin T 334 ng/L, proBNP 566 pg/mL, and lactic acid 2.5 mmol/L. Electrocardiogram showed normal sinus rhythm, right bundle branch block, and non-specific ST abnormalities in lateral leads. Initial bedside echocardiogram demonstrated left ventricular (LV) apical akinesis with a hyperdynamic base with an ejection fraction (EF) of \u3c30% concerning TTC. Color doppler showed severe posteriorly directed MR, and pulse-wave doppler at the LV outflow tract showed a late peaking jet with a peak gradient of 46.4 mmHg. Left-heart catheterization showed minimal coronary artery obstruction. Right-heart catheterization showed elevated RAP 13 mmHg, PAP 57/24 mmHg (mean 39 mmHg), and PCWP 29 mmHg with Fick calculated CO 4.48 L/min and CI 2.5L/min/m 2 . Phenylephrine, esmolol, and IV furosemide were initiated. Short-term MCS was deferred, and she was successfully weaned from vasopressor within three days. Follow-up echocardiogram seven days following admission showed recovered EF of 70% and resolution of LVOTO. CONCLUSION: Our case represents a challenging scenario of TTC with LVOTO in a patient with severe MR. In cases with mitral insufficiency, up to 36% of patients may require an IABP; however, its use is controversial in LVOTO due to its counter-pulsation effect which reduces afterload consequently increasing the pressure gradient between the LV and aorta. Our patient was successfully managed by a pharmacological approach, including Esmolol as a superior beta-blocker as it is a beta-one cardio-selective drug with a short half-life. It allows accurate titration to help optimize heart rate and cardiac filling times. Despite the current recommendations for IV fluids in patients with TTC with LVOTO, in the setting of severe MR, an RHC to assess hemodynamics may be critical in guiding therapy. This approach can decrease the need for short-term MCS and provide an alternative to patients who defer invasive therapies
Heterotopic pancreatic tissue containing a mucinous cystic neoplasm within the duodenum with fish-mouth appearance on endoscopy
No full textAssessment of prostate tissue remodeling in rats exposed to bisphenol A and the phytoestrogens genistein and indole-3-carbinol during the perinatal period
No full textBisphenol A (BPA) is a compound known for its direct action on the prostate. Prostatic morphogenesis is a critical period when interference by any compound could permanently damage the organ. As such, the present study evaluated the morphological aspects resulting from gestational and lactational administration of BPA, indole-3-carbinol (I3C) and genistein (GEN) in prepubescent male rats. Pregnant Sprague Dawley females were allocated into 4 experimental groups and received the following: C: Control (no treatment); B: BPA (10 mu g/Kg); BG: BPA+GEN (5 mg/Kg); BI: BPA+I3C (20 mg/Kg) from gestation day (GD) 17 to postnatal day (PND) 21. After euthanasia on PND22, the prostate was collected and processed. When administered alone, BPA reduced the stromal compartment when compared to group C (P = 0.039). This decline was reversed in the groups submitted to GEN (P = 0.019) or I3C (P = 0.017). The groups treated with BPA (P \u3c 0.0001) and the phytoestrogens (P \u3c 0.0001) exhibited decreased epithelial height in relation to the control group. These changes were observed in stereological and morphometric analyses, but not in fractal analysis (P = 0.569). The area occupied by collagen increased in groups treated with BPA (P \u3c 0.0001) and phytoestrogens (P \u3c 0.0001) in relation to controls, while collagen distribution values were higher in all the treated groups (P \u3c 0.0001), according to fractal analysis. Thus, BPA induced prostrate stroma remodeling with no influence from the phytoestrogens, which may affect glandular development and cause histopathological changes in adulthood
Midterm Outcomes of Isolated Medial Patellofemoral Ligament Reconstruction for Patellar Instability in Ehlers-Danlos Syndrome
No full textBACKGROUND: Patellar instability is frequently encountered in patients with Ehlers-Danlos syndrome (EDS). The clinical outcomes of isolated medial patellofemoral ligament reconstruction (MPFLR) for patellar instability in patients with EDS are unknown.
PURPOSE: To evaluate midterm clinical outcomes of isolated MPFLR for patellar instability in patients with EDS and factors affecting these outcomes.
STUDY DESIGN: Case series; Level of evidence, 4.
METHODS: In a retrospective study, 31 patients (n = 47 knees) with EDS and patellar instability who underwent isolated MPFLR for recurrent patellar instability between 2008 and 2017 and had a minimum 2-year follow-up were identified. Preoperative radiographic images were measured for anatomic risk factors. Clinical outcomes-including postoperative complications-were evaluated. Factors associated with MPFLR failure were identified. Postoperative patient-reported outcomes (PROs)-including the pediatric version of the International Knee Documentation Committee, the Kujala score, the Hospital for Special Surgery Pediatric Functional Activity Brief Scale, the Banff Patellofemoral Instability Instrument 2.0, and the Knee injury and Osteoarthritis Outcome Score-were collected, and factors affecting PRO scores were analyzed.
RESULTS: The mean age of the cohort was 14.9 ± 2 years. At a mean follow-up of 7.2 years, 18 of 47 (38.3%) knees required reoperations, of which 9 of 47 (19.1%) knees required revision stabilization for recurrent patellar instability. Also, 7 of 31 knees (22.6%) with autografts failed compared with 2 of 16 (12.5%) with allografts (P = .69). For autografts, 6 of 17 (35.3%) failures occurred with gracilis, but 0 of 13 (0%) occurred with semitendinosus (P = .02). Compared with patients without failures, patients with failed primary MPFLR were significantly younger (P = .0005) and were able to touch the palm to the floor with their knees extended (P = .03). For radiographic parameters, the patellar height and tilt were significantly higher in the failure group. The postoperative PROs were suboptimal at a mean follow-up of 5.2 years. All but 1 patient were satisfied with the final outcome.
CONCLUSION: At the midterm follow-up, 38.3% of patients with EDS required further surgery after isolated MPFLR for patellar instability; half of these revisions (19.1%) were to address recurrent instability. Recurrent instability after isolated MPFLR was more likely in younger patients and those who could touch the palm to the floor with their knees extended. Postoperative PROs were inferior; nonetheless, patient satisfaction was high
Patient-Reported Outcomes Can Serve as a Functional Substitute for Grip Strength
No full textBackground: Grip strength has traditionally been seen as an objective measurement of hand function, while the Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS UE) has emerged recently as a common patient-reported outcome metric for similar purposes. The primary objective of this study was to determine if a correlation exists between grip strength, PROMIS UE, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores in hand and upper extremity clinic patients.
Methods: PROMIS UE, Pain Interference (PI), and Depression (D), as well as QuickDASH were prospectively administered to patients from July 16 to September 3, 2020. A grip strength ratio (GSR), calculated by dividing the grip strength of the injured hand by that of the noninjured hand, was recorded for each individual to control for personal differences in grip strength. Data were analyzed using Spearman\u27s correlation coefficients with the significance level at p \u3c 0.05.
Results: Fifty patients participated in this study. The median GSR was 0.55. QuickDASH demonstrated strong correlations with both PROMIS UE and PI (r (48) = -0.81, p \u3c 0.05; r (48) = 0.86, p \u3c 0.05). GSR correlated moderately with PROMIS UE (r (48) = 0.63, p \u3c 0.05). Finally, GSR and QuickDASH also exhibited moderate correlation with each other (r (48) = -0.62, p \u3c 0.05).
Conclusion: PROMIS UE and QuickDASH are shown to correlate moderately with GSR. This suggests the PROMIS UE forms as an effective measure of hand/wrist function in hand clinic patients and may be substituted for grip strength measurements
Inequities Associated With Advanced Stage at Presentation of Head and Neck Cancer: A Systematic Review
No full textIMPORTANCE: Social determinants of health (SDoH) are defined by a wide range of factors (eg, built environment, economic stability, education level, discrimination, racism, access to health care). Advanced stage at presentation or delayed diagnosis heavily influences health outcomes in patients with head and neck cancer (HNC). While the drivers of advanced-stage presentation come from a multitude of sources, SDoH plays an outsized role.
OBJECTIVE: To systematically review the published literature to identify which SDoH are established as risk factors for delayed diagnosis or advanced stage at presentation among patients with HNC.
EVIDENCE REVIEW: In this systematic review, a literature search of PubMed, Web of Science, and Embase was conducted on February 27, 2023, using keywords related to advanced stage at presentation and delayed diagnosis of HNC between 2013 and 2023. Quality assessment was evaluated through the Newcastle-Ottawa Scale. Articles were included if they focused on US-based populations and factors associated with advanced stage at presentation or delayed diagnosis of HNC.
FINDINGS: Overall, 50 articles were included for full-text extraction, of which 30 (60%) were database studies. Race was the most commonly reported variable (46 studies [92%]), with Black race (43 studies [93%]) being the most studied racial group showing an increased risk of delay in diagnosis of HNC. Other commonly studied variables that were associated with advanced stage at presentation included sex and gender (41 studies [82%]), insurance status (25 studies [50%]), geographic region (5 studies [10%]), and socioeconomic status (20 studies [40%]). Male sex, lack of insurance, rurality, and low socioeconomic status were all identified as risk factors for advanced stage at presentation.
CONCLUSIONS AND RELEVANCE: This systematic review provides a comprehensive list of factors that were associated with advanced HNC stage at presentation. Future studies should focus on evaluating interventions aimed at addressing the SDoH in communities experiencing disparities to provide a net positive effect on HNC care