Study Follow-up Period Research Articles

Beyond conventional measures: left atrial reservoir strain as a superior prognostic marker for all-cause mortality in HFpEF

Abstract Background Considerable data are available concerning improvements in diagnostic approaches over recent years for the treatment of heart failure with reduced ejection fraction (HFrEF). Conversely, regarding heart failure with preserved ejection fraction (HFpEF), there has been relatively little change in terms of therapy and prognostic stratification. Many efforts have been made to phenotype HFpEF spectrum, aiming to identify simple and reliable tools for recognizing patients at high risk for mortality. Purpose The aim of the present study is to identify a prognostic tool for all-cause mortality in patients with HFpEF. Methods From 2013 to 2024 thirty-eight HFpEF patients who underwent both transthoracic echocardiography at rest and cardiopulmonary exercise test (CPET) combined with echocardiography have been enrolled. Patients with established cardiomyopathy, such as hypertrophic cardiomyopathy and cardiac amyloidosis, have been excluded from the analysis. Mean follow-up period was 3,7 years. Primary outcome was all-cause mortality. Results Sixteen patients (42%) died during the study's follow-up period. No statistically significant differences were found for clinical, demographic, and therapeutic variables. Among all echocardiographic parameters, both at rest and during exertion, E/e' at rest (12 [8.9-19] vs. 17 [12-33], p-value 0.023), SPAP at rest and during exertion (31 ± 7 vs. 43 ± 16, p-value 0.021 and 51 ± 10 vs. 66 ± 17, p-value 0.019), TAPSE/SPAP at rest and during exertion (0.67 ± 0.15 vs. 0.47 ± 0.20, p-value 0.005 and 0.48 ± 0.15 vs. 0.33 ± 0.12, p-value 0.019), and left atrial reservoir function (22 [15-29] vs. 9.4 [6-15], p-value 0.001) were significantly associated with all-cause mortality (Table 1). Among CPET variables, respiratory exchange rate and oxygen pulse were associated with all-cause mortality (1.1 ± 0.13 vs. 1.18 ± 0.15, p-value 0.021 and 10 [7-11] vs. 8.1 [5.4-8.7], p-value 0.008) (Table 1). In multivariate analysis, the only independent predictor of mortality was left atrial reservoir function (p-value 0.026, OR 1.17 [1.02-1.35]). The optimal cutoff was identified using the Youden Index analysis (cut-off: 16.4%, sensitivity 85%, specificity 68%; AUC 0.839 [0.710-0.969]) (Figure 1). Survival curves based on the optimal cutoff are reported in Figure 1. Conclusions In a cohort of patients with HFpEF the left atrial reservoir function remains an important prognostic determinant for all-cause mortality. These results highlight the importance of estimating left ventricular filling pressures which are higher in patients diagnosed with HFPEF due to diminished ventricular compliance. Further studies with a larger cohort are needed to confirm these preliminary data.

Shape memory polymer technology in peripheral vascular embolization.

Porous, radiolucent, shape memory polymer is a new technology available in discrete peripheral vascular embolization devices. Shape memory polymers can exist in two stable shapes; crimped for catheter delivery and expanded for vessel embolization. The expanded shape memory polymer in these new devices is hemostatic, and the porous polymeric scaffold has been shown to support tissue ingrowth and eventually bioabsorbs in preclinical animal studies. This report describes clinical experience with this novel material in vascular plug devices. a prospective, single-arm, safety study at a single center in New Zealand with longer term follow-up via retrospective imaging review. The study device was a pushable shape memory polymer vascular plug with a distal nitinol anchor coil and a proximal radiopaque marker. Ten male patients were each implanted with a single shape memory polymer vascular plug. Three inferior mesenteric arteries and an accessory renal artery were embolized during endovascular aneurysm repair. An internal iliac artery was treated prior to the open surgical repair of aorto-iliac aneurysms. An internal iliac artery and a subclavian artery were embolized to treat/prophylactically address potential endoleaks. A profunda branch was embolized prior to tumor resection, and two testicular veins were embolized to treat varicoceles. Acute technical success of target vessel embolization was achieved in all implantation cases. Patients were followed for 30days as part of the study, and no serious adverse events with a relationship to the study device occurred. No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented. There was no evidence of recanalization on retrospective review of follow-up imaging through a mean of 22.2months (range, <1-44months) post-procedure. Shape memory polymer vascular embolization devices were safe and effective over the follow-up period of this small safety study. Further experience and longer term follow-up will assess further applicability.

Economic Evaluation of a Mobile Stroke Unit Service in Germany.

Lower global disability and higher quality of life among ischemic stroke patients was found to be associated with the dispatch of mobile stroke units (MSUs) among patients eligible for recanalizing treatments in the Berlin_Prehospital Or Usual Delivery of stroke care (B_PROUD) study. The current study assessed the cost-utility and cost-effectiveness of additional MSU dispatch using data from this prospective, controlled, intervention study. Outcomes considered in the economic evaluation included quality-adjusted life years (QALYs) derived from the 3-level version of EQ-5D (EQ-5D-3L) and modified Rankin Scale (mRS) scores for functional outcomes 3-months after stroke. Costs were prospectively collected during the study by the MSU provider (Berlin Fire Brigade) and the B_PROUD research team. We focus our results on the societal perspective. As we aimed to determine the economic consequences of the intervention beyond the study's follow-up period, both care costs and QALYs were extrapolated over 5 years. The additional MSU dispatch resulted in an incremental €40,984 per QALY. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €24,470.76 and €61,690.88 per QALY. In the cost-effectiveness analysis, MSU dispatch resulted in incremental costs of €81,491 per survival without disability. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €44,455.30 and €116,491.15 per survival without disability. Among patients eligible for recanalizing treatments in ischemic stroke, MSU dispatch was associated with both higher QALYs and higher costs and is cost-effective when considering internationally accepted thresholds ranging from an additional €40,000 to €80,000 per QALY. ANN NEUROL 2023;93:942-951.

The Outcomes of Covid-19 in Patients with CLL during the Omicron Sub-Variants Surge

Introduction: Patients with chronic lymphocytic leukemia (CLL) infected with SARS-CoV-2 are at increased risk of severe Covid-19 and death, because of an impaired immune system and suboptimal immunity after vaccination. Despite recent studies, the outcomes of patients with CLL infected with the Omicron sub-variants are not fully elucidated. Methods: In this single-center retrospective study, we analyzed the clinical outcomes of CLL patients infected with SARS-CoV-2 from December 2021 through July 2022. The entire cohort was divided into three groups according to the SARS-CoV-2 variants dominating periods in Israel; period #1, since December 15th, 2021 until March 13th, 2022 (B.1.1.529, BA.1), period #2, since March 14th until June 5th, 2022 (BA.2) and period #3, since June 6th until July 24th, 2022 (BA.5). Results: A total of 90 patients were included in this study (Table 1). The median age was 72 years (range 39-93) and 66 were males (73.3%). Thirty-four patients (37.8%) were treatment naïve, 45 (50.0%) on active treatment (28 treated with Bruton's tyrosine kinase inhibitors [BTKi], 16 with venetoclax+anti-CD20 therapy, and 1 with venetoclax monotherapy), and 11 (12.2%) previously treated. Eighty-seven patients (96.7%) had Covid-19-related symptoms, most commonly fatigue (n=50, 55.6%), followed by cough (n=43, 47.8%) and fever (n=37, 41.1%). Eighty-five patients (94.4%) were vaccinated with at least 3 doses of the BNT162b2 mRNA vaccine. During the study's follow-up period (median=120 days, range 4-221), 2 patients (2.2%) were re-infected with SARS-CoV-2. The severity of Covid-19 on detection was mild in 78 patients (86.7%) and moderate/severe in 12 patients (13.3%). Forty-eight patients (53.3%) were treated with oral antiviral drugs or monoclonal antibodies (40 with paxlovid, 7 with molnupiravir and 1 with casirivimab/imdevimab) outside the hospital. Nine patients developed mild Covid-19 despite administration of pre-exposure prophylaxis with tixagevimab/cilgavimab (median=49 days [range, 7-102] prior to infection). Twenty-seven patients (30.0%) were hospitalized, 15 (55.6%) of them due to severe/critical Covid-19. The median time from SARS-CoV-2 diagnosis to hospitalization was 9 days (range, 0-36). Fifteen hospitalized patients (55.6%) required oxygen support and 2 (7.4%) eventually needed mechanical ventilation. Nine patients (33.3%, 9/27) were readmitted because of persistent SARS-CoV-2 infection, including 6 patients (66.7%) who were hospitalized twice and 3 patients (33.3%) three times. Four patients with persistent Covid-19 after a course of antiviral therapy were subsequently successfully treated with paxlovid and remdesivir. The overall 30-day mortality due to Covid-19 was 6.7% (6/90, 22.2% [6/27] of the hospitalized patients). In comparison between the 3 different time periods (Figure 1), both the hospitalization and death rates were higher in the period #1 (hospitalization rate of 42.9% [21/49] vs. 20.0% [5/25] vs. 6.3% [1/16] in period #1, #2, and #3, respectively and a mortality rate of 12.2% [6/49] in period #1 compared with 0% [0/25] in period #2 and 0% [0/16] in period #3). In univariate analysis, the independent variables associated with hospitalization included: period #1 (OR=4.4, 95% CI 1.6-12.3; p=0.007), active anti-CLL therapy (OR=3.8, 95% CI 1.3-8.9; p=0.021), and fever (OR=3.7, 95% CI 1.4-9.4; p=0.012). Conclusions: In patients with CLL, the rates of hospitalization and mortality due to Covid-19 were lower during the BA.2 and BA.5 sub-variants dominating period compared to the period dominated by the Omicron (B.1.1.529) and the BA.1 sub-variant. The improved outcomes may be attributed to better clinical management (e.g. pre-exposure prophylaxis and antiviral therapies) and viral strain properties. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Bayesian analysis for partly linear Cox model with measurement error and time-varying covariate effect.

The Cox proportional hazards model is commonly used to estimate the association between time-to-event and covariates. Under the proportional hazards assumption, covariate effects are assumed to be constant in the follow-up period of study. When measurement error presents, common estimation methods that adjust for an error-contaminated covariate in the Cox proportional hazards model assume that the true function on the covariate is parametric and specified. We consider a semiparametric partly linear Cox model that allows the hazard to depend on an unspecified function of an error-contaminated covariate and an error-free covariate with time-varying effect, which simultaneously relaxes the assumption on the functional form of the error-contaminated covariate and allows for nonconstant effect of the error-free covariate. We take a Bayesian approach and approximate the unspecified function by a B-spline. Simulation studies are conducted to assess the finite sample performance of the proposed approach. The results demonstrate that our proposed method has favorable statistical performance. The proposed method is also illustrated by an application to data from the AIDS Clinical Trials Group Protocol 175.

Exploring parental perceptions of psychosocial screening in paediatric emergency departments.

Objective: To explore parental perceptions of psychosocial screening in the paediatric emergency department and identify post-screening barriers to accessing mental health care. Methods: We conducted a qualitative study during the 30-day follow-up period of a larger prospective cohort study. Eligible youth and their accompanying parent/guardian first completed psychosocial self/proxy-screening using the MyHEARTSMAP tool and then received a standardized clinical mental health assessment. If the MyHEARTSMAP assessment provided youth with mental health resources recommendations, their parents were invited to a follow-up session. Thirty days (±5 days) after their ED visit, parents participated in a virtual interview to reflect and share their attitudes, perceptions and thoughts around the screening and mental health care-seeking process. Results: Of the 171 participants who received resource recommendations during their ED visit, 124 parents (72.5%; 95% CI 65.2–79.1%) completed the follow-up interview. Most parents endorsed positive perceptions of the screening process, describing it as an ‘eye-opening’ process that ‘sparked conversation’. Most participants (74.2%; 95% CI 65.6–81.6) agreed with the resource recommendations they received. In terms of resources-seeking, only 41 participants (33.1%; 95% CI 24.9–42.1) attempted to access recommended supports. Families generally felt identified concerns were mild and ‘not serious enough’ to warrant resource-seeking, though many expressed an intention to seek care if concerns escalated. Conclusion: Perceptions of psychosocial screening in the ED were favourable and encouraging among participating parents of youth screened positive for psychosocial issues. Despite positive attitudes, only a fraction of the families invited to follow-up attempted to access care. Mental health may be perceived as low priority for many families, signifying the need for improved education and awareness building on the importance of early intervention.

49 Exploring parental acceptability of universal psychosocial screening in the pediatric emergency department

Abstract Primary Subject area Mental Health Background Mental health concerns among children and adolescents presenting to the emergency department (ED) are on the rise. Universal screening can facilitate early identification and management of these concerns, mitigating significant long-term morbidity and mortality. The efficacy of psychosocial screening in the ED is not only determined by accurate identification of concerns, but by downstream resource-seeking behaviours to address these concerns. For many children and adolescents, parents hold a key role in determining their access to care. Thus, parental attitudes and perceptions of psychosocial screening may influence resource-seeking behaviours and predict a youth’s ability to access support. Objectives Given the limited understanding of parental perceptions of psychosocial screening in the ED, we aimed to qualitatively explore parents’ attitudes towards screening with MyHEARTSMAP, an electronic self/proxy administered psychosocial screening tool. We also quantified resource-seeking behaviours and explored barriers to seeking care. Design/Methods This was a nested qualitative study conducted during the 30-day follow-up period of a larger prospective cohort study. Eligible youth and their accompanying parent/guardian completed a self/proxy psychosocial screen using MyHEARTSMAP. Youth who screened positive were provided with recommendations and resources for support. 30 days (+ 5 days) after their ED visit, parents participated in semi-structured follow-up interviews to share their attitudes, perceptions, and thoughts around the screening and care-seeking process. Results Of the 171 participants requiring resources for support, 124 (72.5%; 95% CI 65.2-79.1%) completed the follow-up interview. Most parents endorsed positive perceptions of the screening process, describing it as an “eye-opening” process that “sparked conversation”.74.2% (95% CI 65.6-81.6%) of participants also agreed with the support recommendations they received during their ED visit. In terms of resource seeking, as displayed in Figure 1, only 41 participants (33.1%; 95% CI 24.9-42.1%) attempted to access support services. Other families felt identified concerns were mild and “not serious enough” to warrant resources, though many expressed an intention to seek care if the concerns escalated. Conclusion Parental perceptions of psychosocial screening in the ED were favourable and encouraging, with a majority of participants expressing an understanding and appreciation of the process. This lends support to the implementation of universal psychosocial screening in the ED. Despite positive attitudes towards screening, only a fraction actually attempted to access care. This incongruence may reflect the persisting view that mental health holds low priority and suggests a need for increased education on the importance of seeking timely mental health care.

Stem Cells as a Model of Study of SARS-CoV-2 and COVID-19: A Systematic Review of the Literature

Background The SARS-CoV-2 virus is the cause of the latest pandemic of the 21st century; it is responsible for the development of COVID-19. Within the multiple study models for both the biology and the treatment of SARS-CoV-2, the use of stem cells has been proposed because of their ability to increase the immune response and to repair tissue. Therefore, the objective of this review is to evaluate the role of stem cells against SARS-CoV-2 and COVID-19 in order to identify their potential as a study model and as a possible therapeutic source against tissue damage caused by this virus. Therefore, the following research question was established: What is the role of stem cells in the study of SARS-CoV-2 and the treatment of COVID-19? Materials and Methods A search was carried out in the electronic databases of PUBMED, Scopus, and ScienceDirect. The following keywords were used: “SARS-CoV-2,” “COVID-19,” and “STEM CELL,” plus independent search strategies with the Boolean operators “OR” and “AND.” The identified reports were those whose main objective was the study of stem cells in relation to SARS-CoV-2 or COVID-19. For the development of this study, the following inclusion criteria were taken into account: studies whose main objective was the study of stem cells in relation to SARS-CoV-2 or COVID-19 and clinical case studies, case reports, clinical trials, pilot studies, in vitro, or in vivo studies. For assessment of the risk of bias for in vitro studies, the SciRAP tool was used. The data collected for each type of study, clinical or in vitro, were analyzed with descriptive statistics using the SPSS V.22 program. Results Of the total of studies included (n = 39), 22 corresponded to in vitro investigations and 17 to human studies (clinical cases (n = 9), case series (n = 2), pilot clinical trials (n = 5), clinical trials (n = 1)). In vitro studies that induced pluripotent stem cells were the most used (n = 12), and in clinical studies, the umbilical stem cells derived were the most reported (n = 11). The mean age of the study subjects was 58.3 years. After the application of stem cell therapy, the follow-up period was 8 days minimum and 90 days maximum. Discussion. The mechanism by which the virus enters the cell is through protein “S,” located on the surface of the membrane, by recognizing the ACE2 receptor located on the target cell. The evidence that the expression of ACE2 and TMPRSS2 in stem cells indicates that stem cells from bone marrow and amniotic fluid have very little expression. This shows that stem cell has a low risk of infection with SARS-CoV-2. Conclusion The use of stem cells is a highly relevant therapeutic option. It has been shown in both in vitro studies and clinical trials that it counteracts the excessive secretion of cytokines. There are even more studies that focus on long-term follow-up; thus, the potential for major side effects can be analyzed more clearly. Finally, the ethical use of stem cells from fetal or infant origin needs to be regulated. The study was registered in PROSPERO (no. CRD42021229038). The limitations of the study were because of the methodology employed, the sample was not very large, and the follow-up period of the clinical studies was relatively short.

6. COMPARISON OF PATIENT EDUCATION USING NATIVE LANGUAGE AND BAHASA TO TREATMENT COMPLIANCE FOR HYPERTENSIVE PATIENTS IN NORTH TIWORO DISTRICT

Background: Hypertension treatment compliance at the primary care level in Indonesia was around 58%. The language barrier was known to be a potential factor of hypertension treatment non-compliance. Objective: To determine whether educating about hypertension to the patients in their native language will improve treatment compliance than educating in Bahasa. Method: This was a prospective cohort study. The research was conducted in Tondasi Health Care Center from March 2019 until April 2020. Inclusion criteria were patients with newly diagnosed hypertension and can communicate in Bahasa. The patient was excluded if he/she was reported dead during this study's follow-up period. Good treatment compliance is defined by a follow-up visit to the health care center on the follow-up date that was previously agreed upon with the patients. The data was analyzed using the test of two proportions with a chi-square test of homogeneity on SPSS 24 software. Result: We included a total number of 80 hypertensive patients in this study. Education regarding hypertension emphasizing the importance of routine control was given verbally in the patient's native language by a translator to 40 patients. The same education material was given verbally in the Bahasa to the other 40 patients. No patient was excluded from this study. In the native language education group, 22 patients (55%) had a good treatment compliance compared to 12 patients (30%) in the Bahasa education group, a statistically significant difference in the proportion of 0.25, p = 0.024. Conclusion: Educating patients in their native language results in better hypertension treatment compliance.

Effect of Bacterial Vaginosis (BV)-HIV-1 Co-existence on Maternal and Infant Health: A Secondary Data Analysis.

Background: The lactobacillus-rich microbiome forms a defense system against infections. Babies are born sterile and acquire their microbiome from exposure to the mothers' vaginal and rectal microbiota. Bacterial vaginosis (BV), which is characterized by a deficit of the Lactobacilli genera, may predispose women and their babies to an increased frequency of illness.Objective: To determine the effect of BV on HIV-infected women's post-delivery health as well as the morbidity and mortality of the exposed infant at birth, 6 months, and at 12 months of life.Study Design: A retrospective cohort study was conducted using previously collected data to investigate whether there was an association between BV-HIV-1 infected mothers and subsequent infant morbidity and mortality over a 12-month period.Methods: Data for this analysis were extracted from the original data set. Women were categorized into two groups according to whether they had a positive or negative laboratory-based diagnosis of BV using the Nugent method. The two groups were compared for socio-demographic characteristics, prior to the pregnancy experience in their current pregnancy outcome and at post-delivery morbidity, and for the duration of hospital stay. BV-exposed and unexposed infants were compared in terms of morbidity and mortality at birth, and in the periods between birth and 6 months, and between 6 and 12 months, respectively, based on prospectively collected data of the mother's past and present illness, and clinical examination at scheduled and unscheduled visits during the follow-up period of the original study. The generalized estimating equation (GEE) was used to analyze the longitudinally collected data. We used the Kaplan-Meier (KM) method to generate the cumulative hazard curve and compared the mortality in the first year of life between the two groups.Results: In total, 365 patients were included in the study. Exposure to BV was associated with an adverse maternal condition (Relative Risk [RR], 2.45; 95% confidence interval [CI], 1.04–5.81, P = 0.04) and maternal hospital admission (RR, 1.99; 95% CI, 1.14–3.48, P = 0.02) but was not linked to any neonatal morbidity at birth. There was a higher frequency of gastro-intestinal morbidity among BV-exposed infants. At 6 months, infants of BV-exposed mothers had higher odds of bloody stool (Odds Ratio [OR], 3.08; 95% CI, 1.11–10.00, P = 0.04), dehydration (OR, 2.94; 95% CI, 1.44–6.37, P = 0.01), vomiting (OR, 1.64; 95% CI, 1.06–2.56, P = 0.03), and mouth ulcers (OR, 12.8; 95% CI, 2.27–241.21, P = 0.02). At 12 months, exposure to BV was associated with dehydration (OR, 1.81; 95% CI, 1.05–3.19, P = 0.03) and vomiting (OR, 1.39; 95% CI, 1.01–1.92, P = 0.04). KM survival analysis showed non-significant higher trends of deaths among BV-exposed infants (P = 0.65).Conclusion: This study demonstrates differences in maternal and infant morbidity outcomes associated with exposure to BV. Further research is required to determine whether treatment for maternal BV mitigates maternal and infant morbidity.

Role of Core/Capsid Inhibitors in Functional Cure Strategies for Chronic Hepatitis B

Functional cure of chronic hepatitis B (CHB), defined as sustained hepatitis B surface antigen (HBsAg) seroclearance, is associated with favourable clinical outcomes. Nonetheless, the functional cure is rarely achievable by current treatment modalities. Core/capsid inhibitors (core protein allosteric modulators, CpAMs) are a novel drug class that targets the hepatitis B core protein and may have a potential impact on the functional cure. This article reviews the preclinical and clinical results of CpAMs. CpAMs interfere with the hepatitis B virus (HBV) nucleocapsid assembly and also exert a secondary action on covalently closed circular DNA replenishment. CpAMs are able to sustainably suppress hepatitis B viral load and viral antigens in in vivo studies. In phase I/II clinical trials, CpAMs are well tolerated and are efficacious in suppressing viral replication. CpAMs also have synergistic antiviral effects when combined with nucleoside analogues or pegylated interferon. The clinical data has yet to demonstrate the capability of CpAMs in inducing HBsAg seroclearance, possibly due to the short follow-up period of current studies. There is emerging data showing initial viral antigen reduction with the continuation of CpAMs for more than 24 weeks. CpAMs have shown promising preclinical and phase I/II clinical data. Data from long-term phase III trials and from combination therapies with other antiviral agents are keenly anticipated.

Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction: An Assessment From the TRIUMPH Study.

Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction. The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting. Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies.

Comparison of clinical efficacy between dexamethasone and triamcinolone for transforaminal epidural steroid injections in the management of low back pain

The objective of this study was to compare the clinical efficacy of transforaminal epidural injection of dexamethasone and triamcinolone in the management of chronic low back pain with or without radiculopathy due to herniated intervertebral disc. It was a prospective, randomized, single-blind study, conducted in eighty patients of either sex suffering from low back pain of more than 3 months duration due to herniated intervertebral disc. The patients were allocated into two groups to receive either injection dexamethasone 8 mg or injection triamcinolone acetonide 40 mg as 2 ml solution through transforaminal epidural route. Each patient underwent unilateral lumbar transforaminal epidural steroid injections (TFESIs) at one level only depending on predominant involvement of nerve root on magnetic resonance imaging computed tomography of the spine and consistent with a clinical presentation of patients. Patients in both the groups were assessed prior to epidural injection and at the 2nd, 6th, and 12th weeks following epidural injection for the intensity of pain using a numerical rating scale of 0–10 and requirement of analgesics on weekly basis. Any adverse event following epidural injection was also noted during the follow-up period of the study. Improvement in pain score was significantly better with transforaminal epidural injection of triamcinolone acetonide compared to dexamethasone, in patients with chronic low back pain due to herniated intervertebral disc. No major adverse event was reported during the follow-up period in patients of either group.

Secondary spontaneous pneumothorax in cancer patients.

Malignancy-associated secondary spontaneous pneumothorax (MSSP) poses significant challenges due to limited survival. By assessing risk factors associated with a MSSP recurrence, there is potential to identify patients who could benefit from early intervention intended to prevent recurrence. We performed a retrospective cohort study of patients with MSSP. The primary outcome was time to MSSP recurrence. We used a competing risk model to identify risk factors associated with MSSP recurrence. A total of 2,532 patients were diagnosed with pneumothorax, with 114 having MSSP but only 96 were evaluable for the time-to-recurrence analysis. Of the 96 patients, 9 (9.4%) patients experienced recurrent MSSP, and 58 (60.4%) patients died during the study's follow-up period. The estimated cumulative incidence (CI) of MSSP considering death as a competing risk was 10.1% at 15 months. The univariable model identified the following covariates as associated with MSSP recurrence: mediastinal shift (HR 12.30, 95% CI: 3.44-43.91, P<0.001), distance from lung apex to thoracic cupola (HR 1.02, 95% CI: 1.00-1.03, P=0.003), and distance between visceral and chest wall at the hilum (HR 1.02, 95% CI: 1.00-1.03, P=0.026). Although the incidence of MSSP recurrence was found to be low, clinical factors such as sarcoma, the associated mediastinal shift, greater distance from lung apex to thoracic cupola, greater distance between visceral and chest wall at the hilum were found to be risk factors for MSSP recurrence.

The impact of SPARC expression on the survival of pancreatic ductal adenocarcinoma patients after curative resection.

Background: The predictive roles of secreted protein acidic and rich in cysteine (SPARC) in pancreatic ductal adenocarcinoma (PDAC) patients after curative resection have not been clarified. We investigated the correlations between the SPARC expression and the postoperative prognosis.Methods: We retrospectively analyzed the clinical data from consecutive patients who underwent curative resection for pancreatic cancer in our institution from 2005 to 2014. Stromal SPARC expression was analyzed by immunohistochemistry on tumor tissue microarrays (TMAs) from the patients.Results: A total of 179 patients were enrolled to this study. The median follow-up period of the present study was 62.1 months. Seventy patients had positive SPARC expression (39.1%). There were no significant differences between the positive SPARC-positive group and the SPARC-negative group. In the survival analysis, there was a significant difference between the SPARC-positive and SPARC-negative groups in the 5-year overall survival (OS) rates after surgery, which were 8.1% and 19.8%, respectively (p=0.0316). A univariate analysis showed that the SPARC expression, size of tumor, lymph node metastasis, and residual tumor were possible prognostic factors. A multivariate analysis showed that the SPARC expression (hazard ratio [HR]: 1.44, 95% confidence interval [CI]: 1.017-2.051), lymph node metastasis (HR: 2.019, 95% CI: 1.318-3.091), and residual tumor (HR: 1.648, 95% CI: 1.132-2.401) were independent prognostic factors.Conclusions: The stromal SPARC expression in resectable pancreatic cancer patients might be useful as a prognostic marker.

Hearing preservation after cyberknife stereotactic radiosurgery for vestibular schwannomas

Background: The aim of this study is to evaluate retrospectively prognosis and auditory function after CyberKnife (CK) stereotactic radiosurgery (SRS) for vestibular schwannomas (VS) and to determine the radiation effects on hearing loss/preservation. Materials and Methods: The records of forty-one41 patients (24 males, 17 females) with VS who had received CK-SRS treatment were enrolled and retrospectively analyzsed. All patients underwent SRS (18 Gy in 3 sessions) between 2007 and 2012 at Tri-Service General Hospital, Taipei, Taiwan. Audiograms had been obtained before and after radiosurgery, and magnetic resonance imagingMRI and computed tomographyCT had been repeated to evaluate the tumour control rate. Age, percent tumour coverage, conformality index, new conformality index, cochlear dose, and audiometric test results were collected and analyzsed for all patients. Results: There were 41 patients enrolled in this study. The mean follow-up period of imaging studies was 56.6 ± 15.5 mo. At the postoperative assessment, there are 13 patients (76%) of Gardner–Robertson (GR) hearing maintained in Grade I and four4 patients (23%) of GR hearing changed to Grade II within those levels after treatment. There are 15 patients (62%) of GR hearing had been maintained in Grade II, and 9 patients (37%) of GR hearing changed to Ggrade I within those levels after treatment. After CK-SRS radiotherapy, 22 patients (22/41, 53%) had GR Ggrade I hearing, and 19 patients (19/41, 46%) had GR Ggrade II hearing. The patients with hearing deterioration had larger tumour volumes, lower cochlear volumes, higher cochlear radiation doses, and poorer hearing beforeprior to radiosurgery. Conclusions: Excellent tumour control and hearing preservation rates were observed for VS patients treated by CK SRS, with rates consistent with those reported in the literature. Compared with therapeutic alternatives, CK SRS is an effective tool for VS treatment and preserves hearing well.

Long-term clinical and radiographic evaluation of the effectiveness of direct pulp-capping materials.

The aim of this review was to assess the effectiveness of different direct pulp-capping (DPC) materials for human pulp-exposed teeth. An electronic search was performed on 20 February 2018. Long-term clinical and radiographic evaluations of the effectiveness of different DPC materials for use on human pulp-exposed teeth were included. Risk-of-bias assessment and data extraction were performed. From the 496 identified articles, 15 met the eligibility criteria. Among the studies included in those articles, a total of 1,322 teeth were treated with 12 types of DPC materials, and 1,136 teeth were evaluated at a final follow-up examination. For mineral trioxide aggregate (MTA) and calcium hydroxide (CH), the number of included studies, the number of treated teeth, and the mean follow-up period of studies were almost equal, and the success rates of MTA was superior to CH. Therefore, MTA is likely to be a more effective and predictable material for DPC compared to CH. However, the results were based on the included studies, which were all judged to have a high risk of bias. Therefore, more long-term clinical and radiographic studies designed with lower risk of bias are needed. Moreover, the other 10 materials were only investigated by a small number of studies; therefore, further studies are required.

Effect of Postablation Statin Treatment on Arrhythmia Recurrence in Patients With Paroxysmal Atrial Fibrillation.

Statins have been proposed as a means to prevent postablation atrial fibrillation (AF) recurrences, mainly on the basis of their pleiotropic effects. The objective of this subanalysis of a prospectively randomized controlled study population of patients undergoing radiofrequency ablation for paroxysmal AF was to test the hypothesis that statin treatment is associated with longer time to recurrence. This is a subanalysis over an extended follow-up period of a prospective randomized study (ClinicalTrials.gov Identifier NCT01791699). Among 291 patients, 2 propensity score-matched subgroups of patients who received or did not receive statins after pulmonary vein isolation were created. In the unmatched cohort, there was no difference in the rate of recurrence between statin-treated and not treated patients, with a 1-year recurrence estimate of 19% and 23%, respectively (Gehan statistic 0.59, P = 0.443). In the propensity-matched cohort (N = 166, 83 per group), recurrence-free survival did not differ significantly between groups (839 days, 95% confidence interval 755-922 days, in the no statin group vs. 904 days, 95% confidence interval 826-983 in the statin group; P = 0.301). The 1-year recurrence rate estimate was 30% in the no statin group versus 27% in the statin group (Gehan statistic 0.56, P = 0.455). Statin treatment does not seem to affect AF recurrence in following radiofrequency ablation for paroxysmal AF, over a follow-up time of about 2.5 years.

Decreased Survival and Increased Rate of Fibrotic Progression in Essential Thrombocythemia Chronicled after the FDA Approval Date of Anagrelide

▪Background:Anagrelide clinical trials in myeloproliferative neoplasms (MPN) were pioneered by the late Murray N. Silverstein M.D.(1928-1998) of the Mayo Clinic and the first publication involving 20 patients, including 17 with essential thrombocythemia (ET), appeared in 1988 (study launched in October 1985) (N Engl J Med 1988;318:1292). A larger study involving 577 patients, including 335 with ET, was subsequently published in 1992 and led to FDA approval in March 1997 (Am J Med 1992;92:69). Anagrelide has also been evaluated, in controlled studies, for its efficacy and safety as first-line therapy for ET; the results of these studies suggested that anagrelide was not inferior to hydroxyurea, in one study (Blood 2013;121:1720), but might have been harmful to patients in, the second study (N Engl J Med 2005;353:33); in the latter study, patients receiving anagrelide experienced higher incidences of arterial thrombosis, bleeding complications and fibrotic progression. These observations raised significant concern regarding an adverse survival impact of anagrelide in ET; unfortunately, the follow-up period of formal controlled studies were too short to accurately address the particular concern.Methods:The current study represents a retrospective examination of the potential impact of anagrelide therapy on survival and disease complication rates in ET. The study population was recruited from a consecutive cohort of adult patients (age ≥18 years) with MPN seen at the Mayo Clinic from 10/27/1967 through 12/29/2017. Diagnosis and determinations of fibrotic and/or leukemic transformations, were in strict accordance with the 2016 World Health Organization criteria (Blood 2016;127:2391). Statistical analyses were based on clinical and laboratory parameters obtained at the time of first referral to the Mayo Clinic which, in the majority of cases, coincided with initial diagnosis. All patients were followed from diagnosis until death or date of last follow-up or contact. Follow-up was until April 2018 and data collected via medical records or in certain cases, by directly contacting patients or their physicians. Survival and time-to-event curves were prepared using the Kaplan-Meier method and compared by the log-rank test. The JMP® Pro 13.0.0 software package was used for all analyses (SAS Institute, Cary, NC, USA).Results:1,076 patients with ET were considered (median age 58 years; females 63%); international prognostic scoring system for ET (IPSET; Blood 2012;120:1197) risk distribution was 28% high, 42% intermediate and 30% low; driver mutational status was JAK2 61%, CALR 25%, triple-negative 11% and MPL 3%. Comparison of cases diagnosed before (n=433) and after (n=643) the FDA approval date of anagrelide (1997) revealed the former cohort to be younger (median 57 vs 60 years; p=0.003), although the difference in IPSET risk distribution was not significant (p=0.14).Figures 1a, 1b, 1c and 1d illustrate overall (OS), myelofibrosis-free (MFFS), leukemia-free (LFS) and thrombosis-free survival data comparing ET patients diagnosed before and after the 1997 FDA approval date for anagrelide; a significant difference was apparent for OS (p=0.006; HR 1.4, 95% CI 1.1-1.7) and MFFS (p<0.001; HR 4.2, 95% CI 2.7-6.5), in favor of patients diagnosed prior to 1997; during multivariable analysis that included IPSET and sex, the significant difference in both OS and MFFS were sustained; the difference in OS was most apparent after the first decade of diagnosis with 10- and 20-year survival rates of 75% and 50% for diagnosis prior to 1997 vs 72% and 21% for diagnosis between 1997 and 2017 (figure 1a); the 10- and 20-year risk of fibrotic progression was 3% and 15% for diagnosis prior to 1997 and 14% and 46% for diagnosis after 1997 (figure 1b); there was no impact on LFS (p=0.32; Figure 1c) or TFS (p=0.18; Figure 1d). Similarly stratified survival data in polycythemia vera (n=665) and primary myelofibrosis (n=1,282) showed no impact on survival (p=0.3 and 0.17, respectively).Conclusions:In a retrospective, but otherwise unbiased comparative analysis, we show significantly decreased OS and MFFS in ET patients diagnosed after the FDA approval date of anagrelide (1997); the increased risk of fibrotic progression noted is consistent with results of earlier prospective data (N Engl J Med 2005;353:33). Our observations regarding OS requires confirmation in a prospective controlled setting. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

PS01.053: GASTRO-ESOPHAGEAL REFLUX TEST DECIDING SURGICAL INDICATION AND RESULTS OF LAPAROSCOPIC NISSEN FUNDOPLICATION FOR GERD PATIENTS

Abstract Background The indication of laparoscopic anti-reflux surgery for GERD patients is difficult to be judged fairly. We have established ‘Reflux Test‘ as the tool for the decision in the surgical indication for GERD patients. Methods Reflux Test At the standing position a patient swallows 300 ml barium solution. After total solution goes into stomach, a patient lies down at the flat position. Then a patient changes the position to left lateral decubitus position, flat position, right lateral decubitus position and flat position again every 10 seconds in the order. During this procedure, gastro-esophageal reflux was evaluated and assigned to severe, moderate and slight category. If the reflux was observed slightly up to cervical esophagus, the case was assigned to moderate category. If the reflux was observed intensely up to cervical esophagus, the position was returned to head high position for the safety and the case was assigned to severe category. The anti-reflux surgery was considered in the moderate and severe categories. Results We have performed laparoscopic Nissen procedure in 90 cases. The mean operation time of recent 20 cases was 90 min. The outcome was assessed by Reflux Test performed on 4–5 postoperative day, and the results showed no reflux in every cases. Median follow-up period of this study was 48 months (0–99 months). In 11 cases (12.6%) PPI was restarted before 6 months after the anti-reflux surgery. In 23 cases (25.6%) PPI was restarted after the anti-reflux surgery during the whole follow-up period of this study. The BMI of the patients had no relationship to the needed PPI restart. To evaluate the degree of esophagitis objectively before and after the anti-reflux surgery we designed ‘the esophagitis score’. In this scoring method, a number from 0–5 was assigned according to the degree of esophagitis along with the LA classification. The results of the study have shown that the reflux esophagitis was improved obviously after the anti-reflux surgery even in the PPI restarted group (P &lt; 0.001). Conclusion Reflux Test is feasible because of its convenience and visual effects for the patients. The results of the laparoscopic Nissen fundoplication were good and satisfied by the patients mostly. Disclosure All authors have declared no conflicts of interest.