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Although palliative radiotherapy for gastric cancer may improve some symptoms, it may also have a negative impact due to its toxicity. We investigated whether symptoms improved after radiotherapy with adjustment for the Palliative Prognostic Index (PPI) considering that patients with limited survival tend to experience deterioration of symptoms.This study was an exploratory analysis of the Japanese Radiation Oncology Study Group study (JROSG 17-3). We assessed six symptom scores (nausea, anorexia, fatigue, shortness of breath, pain at the irradiated area and distress) at registration and 2, 4 and 8 weeks thereafter. We tested whether symptoms linearly improved after adjusting for the baseline PPI. Shared parameter models were used to adjust for potential bias in missing data.The present study analysed all 55 patients enrolled in JROSG 17-3. With time from registration as the only explanatory variable in the model, a significant linear decrease was observed in shortness of breath, pain and distress (slopes, -0.26, -0.22 and -0.19, respectively). Given that the interaction terms (i.e. PPI × time) were not significantly associated with symptom scores in any of the six symptoms, only PPI was included as the main effect in the final multivariable models. After adjusting for the PPI, shortness of breath, pain and distress significantly improved (slope, -0.25, -0.19 and -0.17; P0.001, 0.002 and 0.047, respectively). An improvement in fatigue and distress was observed only in patients treated with a biologically effective dose ≤14.4 Gy.Shortness of breath, pain and distress improved after radiotherapy. Moreover, a higher PPI was significantly associated with higher symptom scores at all time points, including baseline. In contrast, PPI did not seem to influence the improvement of these symptoms. Regardless of the expected survival, patients receiving radiotherapy for gastric cancer can expect an improvement in shortness of breath, pain and distress over 8 weeks. Multiple-fraction radiotherapy might hamper the improvement in fatigue and distress by its toxicity or treatment burden.

Purpose A "dead bag syndrome" has been recently described, in which the capsular bag appears to be clear many years after surgery, becoming diaphanous and floppy, and unable to support the intraocular lens (IOL) within it. The aim of this study was to describe findings of this syndrome. Setting John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. Design Case series with clinicopathological correlation. Methods Out of 10 cases suspected to be from dead bag syndrome, 8 IOLs/7 capsular bags were removed due to subluxation/dislocation. The seven capsular bags available for analysis were fixed in formalin and submitted to histopathological examination (hematoxylin/eosin and Masson's trichrome stains). The associated explanted IOLs in 5 cases were also examined microscopically. Results Histopathologic examination of the seven capsular bags showed capsular thinning and/or splitting. Lens epithelial cells (LECs) were completely absent on two specimens while the other five specimens had rare LECs on the inner surface of the capsule. Explanted IOLs were three-piece silicone lenses or single-piece hydrophobic acrylic lenses. One IOL optic showed a small amount of granular pigment deposition, but the optics of the other four lenses were unremarkable. Conclusions In this syndrome, there appears to be an absence of secondary proliferation of LECs, as well as fibrotic changes. The capsule shows some signs of degradation, such as thinning and/or splitting. Weakness of zonular attachments appears to be an associated finding, with subsequent in-the-bag IOL dislocation. Further studies are necessary to ascertain the etiology of this condition.

Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): The Japan Cardiovascular Research Foundation under a contract with Bayer Yakuhin Background The AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial demonstrated that rivaroxaban monotherapy was noninferior to combination therapy with rivaroxaban plus a single antiplatelet therapy regarding efficacy and superior for safety endpoints in patients with atrial fibrillation and stable coronary artery disease including patients not requiring revascularization [prior percutaneous coronary intervention (PCI) or bypass grafting (CABG)]. Purpose The aim of this post-hoc subgroup analysis was to investigate the efficacy and safety of rivaroxaban monotherapy compared to combination therapy in patients with and without prior revascularization. Methods Among 2,215 patients included in the modified intention-to-treat analysis in the AFIRE trial, 1445 patients (65.2%) had undergone previous PCI alone, and 252 (11.4%) had undergone previous CABG. The remaining 518 patients (23.4%) was categorized as a group without prior revascularization and then compared with a group with prior revascularization (PCI or CABG). The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis. Results In 1697 patients with prior revascularization, efficacy and safety endpoints of rivaroxaban monotherapy were superior to combination therapy (efficacy: HR 0.62, 95%CI 0.45-0.85, p=0.003; safety: HR 0.62, 95%CI 0.39-0.98, p=0.040), whereas there were no significant differences in efficacy and safety endpoints among 518 patients without prior revascularization (efficacy: HR 1.19, 95%CI 0.67-2.11, p=0.553; safety: HR 0.47, 95%CI 0.18-1.26, p=0.125). There was a borderline interaction of efficacy endpoint (P for interaction=0.055) by randomized treatment assignment (Figure 1 and Figure 2). Compared with combination therapy, the safety benefit of rivaroxaban monotherapy on any bleeding was significant in patients without prior revascularization (HR 0.59, 95%CI 0.38-0.93, p=0.022). Conclusions In patients with prior PCI or CABG, rivaroxaban monotherapy resulted in more favorable safety and efficacy outcomes than combination therapy. There was a borderline interaction for primary efficacy outcome between prior revascularization and anti-thrombotic therapy.

Objectives The aim of this AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial subgroup analysis was to examine rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment among patients after coronary stenting. Background Of 2,215 patients with atrial fibrillation and stable coronary artery disease in the AFIRE trial, rivaroxaban monotherapy was noninferior to rivaroxaban plus antiplatelet therapy (combination therapy) in terms of efficacy and superior for safety endpoints. However, thrombotic risk after antiplatelet therapy cessation remained a concern among 1,444 patients who had undergone coronary stenting >1 year before enrollment. Methods The benefits of rivaroxaban monotherapy in coronary stenting subgroups were assessed for efficacy (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death of any cause), safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria), ischemic endpoints, net adverse clinical event, and time between stenting and enrollment. Results Efficacy and safety endpoints for monotherapy were superior to combination therapy, with HRs of 0.70 for efficacy (95% CI: 0.50-0.98; P = 0.036) and 0.55 for safety (95% CI: 0.33-0.92; P = 0.019). For ischemic endpoints, the HR was 0.82 (95% CI: 0.58-1.15; P = 0.240). The HR became smaller with longer time between stenting and enrollment (efficacy, P for interaction = 0.158; safety, P = 0.097). Conclusions In patients with atrial fibrillation after coronary stenting, the benefits of rivaroxaban monotherapy for efficacy and safety endpoints were consistent with those in the whole AFIRE trial population. The benefits became apparent with longer time between stenting and enrollment. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study [AFIRE]; UMIN000016612 , NCT02642419 )

Background Chest radiography is the most common diagnostic imaging test in clinical medicine, and the cardiothoracic ratio (CTR) is a readily available and non-invasive tool with which to assess the volume status and cardiomegaly. However, it remains unknown whether CTR on chest radiography is associated with the incidence of HF hospitalization in AF patients remains unclear. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in Fushimi-ku, Kyoto, Japan. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,489 patients by the end of August 2021. In the present study, 3,727 patients with available data of CTR were examined. We divided the patients into two groups according to their CTR at baseline; Higher group (CTR ≥50.0%, n=2,696) and Lower group (CTR Results The proportion of female was grater in Higher group, and the patients in Higher group were older. The patients in Higher group had higher prevalence of HF, hypertension and chronic kidney disease. During the median follow-up of 3,033 days, in Kaplan-Meier analysis, the incidence rates of HF hospitalization were higher in Higher group (Higher group: 2.5% per person-year vs. Lower group: 1.1%; p Conclusion In Japanese AF patients, patients with higher CTR had significantly higher incidence of HF hospitalization, regardless of the prevalence of prior hospitalization for HF. Funding Acknowledgement Type of funding sources: None.

Background Atrial fibrillation (AF) increases the risk of incident heart failure (HF). Left ventricular ejection fraction (LVEF) is an important prognostic parameter in patients with HF. However, little is known regarding the association of LVEF with incident HF in patients with AF. Purpose The aim of this study is to investigate the relationship between LVEF at enrollment and incidence of HF hospitalization during follow-up period in patients with AF. Methods The Fushimi AF Registry is a community-based prospective survey of patients with AF in Fushimi-ku, Kyoto, Japan. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,489 patients by the end of August 2021. In the present study, we investigated 3,544 patients with the data of LVEF at enrollment. We divided the patients into 4 groups stratified by LVEF (reduced LVEF [LVEF Results Of 3,544 patients, the mean age was 73.6±10.7 years, 1,420 (40%) were female, 1,781 (50%) were paroxysmal AF, and 1,085 (30%) had pre-existing HF. The mean CHADS2 and CHA2DS2-VASc scores were 2.1±1.3 and 3.4±1.7, respectively. The mean LVEF at enrollment was 63±12% (reduced LVEF: 197 [6%], mildly reduced LVEF: 250 [7%], slightly reduced LVEF: 532 [15%] and normal LVEF: 2,565 [72%], respectively). Patients with lower LVEF demonstrated lower prevalence of female and paroxysmal AF, and had a higher CHADS2 and CHA2DS2-VASc scores (all P Conclusion LVEF at enrollment could stratify the incidence of HF hospitalization in patients with AF, suggesting the importance of measuring LVEF in all patients with AF. Even mildly (LVEF: 40–49%) or slightly (LVEF: 50–59%) reduced LVEF was independently associated with the risk of incident HF in patients with AF. Funding Acknowledgement Type of funding sources: None.

Background Heart failure (HF) is one of the major complications in atrial fibrillation (AF). We previously reported that not a few AF patients without pre-existing HF (defined as prior HF hospitalization, New York Heart Association functional class≥2, or left ventricular ejection fraction (LVEF) Methods In the Fushimi AF registry, 778 of 3,262 patients without pre-existing HF were receiving beta blockers at baseline. We investigated the incidence of new-onset HF defined as cardiac death or HF hospitalization, and all-cause death in a propensity-matched cohort (N=1,198; mean age, 71 years; 39% female; mean LVEF, 66%). Additionally, annual follow-up prescription data before the onset of events were collected in 294 of patients with beta blockers and 395 of those without beta blockers. We also investigated the association of starting or stopping beta blockers with the incidence of new-onset HF and all-cause death. Results During the median follow-up of 5.8 years, new-onset HF and all-cause death occurred in 77 (12.9%) and 118 (19.7%) of patients with beta blockers, and 70 (11.7%) and 131 (21.9%) of those without beta blockers, respectively. Incidence of new-onset HF was comparable between patients with and without beta blockers (Figure 1), and incidence of all-cause death was also comparable between the two groups (Figure 2). In exploratory subgroup analyses, there was no interaction in the association of beta blockers with the incidence of events, except for pulse rate for new-onset HF and left atrial size for all-cause death. Hazard ratio of beta blockers for new-onset HF tended to be lower in patients with higher pulse rates (>84 bpm) (Figure 1), and that for all-cause death was lower in those without left atrial enlargement (Figure 2). Of patients with follow-up prescription data, beta blockers were stopped in 55 (18.7%) and started in 97 (24.6%) patients, respectively. Patients with starting beta blockers had higher pulse rate (78.5±17.3 vs 74.9±13.9 bpm; p=0.03) and more symptomatic AF (58.8% vs 46.0%; p=0.03) compared to those without starting beta blockers, while there was no difference in baseline characteristics between those with and without stopping beta blockers. During the follow-up, the incidences of new-onset HF and all-cause death were also comparable between the patients with and without stopping beta blockers and those with and without starting beta blockers. Conclusion Beta blockers were not associated with the incidence of new-onset HF and all-cause death in AF patients without pre-existing HF. However, the exploratory subgroup analyses suggested the existence of subjects who may benefit from beta blockers. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boehringer Ingelheim, Bayer Healthcare, Pfizer, Bristol-Myers Squibb, Astellas Pharma, AstraZeneca, Daiichi Sankyo, Novartis Pharma, MSD, Sanofi-Aventis, and Takeda Pharmaceutical.

Background Atrial fibrillation (AF) represents the common arrhythmia and increases the risk of thromboembolism. Risk assessment for thromboembolism is important for the management of AF patients. Peripheral artery disease (PAD) is identified as a risk factor for thromboembolism in CHA2DS2-VASc score. However, there are little data on clinical characteristics and cardiovascular events of AF patients with PAD. Purpose In this study, we investigated the clinical characteristics and outcomes of AF patients with PAD. Methods The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011 and follow up data including prescription status were available in 4,464 patients from March 2011 to August 2021. Median follow-up period was 1,848 days. Results Of 4,464 patients, 183 patients had PAD (4.1%; PAD group). The mean age was higher in PAD group than no-PAD group (PAD group vs. no-PAD group: 76.7 vs. 73.5; p Conclusion AF patients with PAD had significantly higher risk for death and cardiac events, whereas the incidence of thromboembolism was similar between AF patients with and without PAD. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Japan Agency for Medical Research and Development

Background The AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial showed both noninferiority for efficacy and superiority for safety endpoints of rivaroxaban monotherapy compared to rivaroxaban plus antiplatelet therapy (combination therapy) in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD). However, no accumulating evidence regarding efficacy and safety of these fixed-dose direct oral anticoagulant therapy was available in underweight and obese patients. Purpose The aim of this post-hoc analysis of the AFIRE trial was to evaluate outcomes of rivaroxaban monotherapy (vs. combination therapy) in patients with AF and stable CAD across body mass index (BMI) categories. Methods Patients were categorized into groups 1 (underweight: BMI of Results We analyzed 2,054 patients with a median age of 75.0 (interquartile range [IQR], 69 to 80)) years old and CHA2DS2-VASc of 4 (IQR, 3 to 5). Group 1 through 4 included 72 (3.5%), 1,158 (56.4%), 680 (33.1%), 144 (7.0%) patients and 62.3%, 52.3%, 36.2%, and 30.3% were received reduced dose of rivaroxaban, respectively. Although the sample sizes for group 1 and 4 were limited, monotherapy was superior to combination therapy for efficacy in group 2 (hazard ratio [HR], 0.64; 95% CI, 0.44 to 0.95) and safety in group 3 (HR, 0.25; 95% CI, 0.10 to 0.62), whereas a significant difference in the endpoints was not observed in the other BMI categories. Impact of monotherapy on endpoints did not have a significant interaction in BMI. Conclusions Rivaroxaban monotherapy had similar effect on prognosis across all BMI categories in patients with AF and stable CAD. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The Japan Cardiovascular Research Foundation based on a contract with Bayer Yakuhin, Ltd

ObjectiveThe clinical significance of ECG abnormalities during atrial fibrillation (AF) rhythm is poorly understood. The aim of the current study was to explore the impact of inverted T wave on cardiac prognosis in patients with AF.MethodsThe current study enrolled 2709 patients with AF whose baseline ECG was available from a Japanese community-based prospective survey, the Fushimi AF Registry, and the impact of inverted T wave in baseline ECG at AF rhythm on the composite of cardiac death, myocardial infarction and hospitalisation due to heart failure was examined.ResultsIntraventricular conduction delay, ST segment depression and inverted T wave were observed in 15.8%, 24.7% and 41.4% of baseline ECG with a mean heart rate of 94.7 beats per minute. The median follow-up duration was 5.0 years. The incidence rate of the composite cardiac endpoint was significantly higher in patients with inverted T wave than those without (5.8% vs 3.3% per patient-year, log-rank pConclusionsInverted T wave was commonly observed in patients with AF and its presence during AF rhythm was associated with subsequent cardiac events.

The proximity of the iris to the instruments and currents of cataract surgery makes iatrogenic damage to the iris a common complication of cataract surgery. This article discusses techniques to prevent or minimize this damage. When damage does occur, the surgeon must decide if, when, and how to repair the damage. Principles governing these decisions and techniques for repair are discussed. Figures and videos, included as online Supplemental Data files, illustrate cases of iatrogenic damage and repair techniques.

We can catch all sorts of falling objects like eggs or balls. We must predict the dynamical properties of objects to interact with them, but doing so precisely is difficult. The CNS is suggested to...

Background Controversy exists as to whether the threshold for blood pressure-lowering treatment should differ between people with and without type 2 diabetes. We aimed to investigate the effects of blood pressure-lowering treatment on the risk of major cardiovascular events by type 2 diabetes status, as well as by baseline levels of systolic blood pressure. Methods We conducted a one-stage individual participant-level data meta-analysis of major randomised controlled trials using the Blood Pressure Lowering Treatment Trialists' Collaboration dataset. Trials with information on type 2 diabetes status at baseline were eligible if they compared blood pressure-lowering medications versus placebo or other classes of blood pressure-lowering medications, or an intensive versus a standard blood pressure-lowering strategy, and reported at least 1000 persons-years of follow-up in each group. Trials exclusively on participants with heart failure or with short-term therapies and acute myocardial infarction or other acute settings were excluded. We expressed treatment effect per 5 mm Hg reduction in systolic blood pressure on the risk of developing a major cardiovascular event as the primary outcome, defined as the first occurrence of fatal or non-fatal stroke or cerebrovascular disease, fatal or non-fatal ischaemic heart disease, or heart failure causing death or requiring hospitalisation. Cox proportional hazard models, stratified by trial, were used to estimate hazard ratios (HRs) separately by type 2 diabetes status at baseline, with further stratification by baseline categories of systolic blood pressure (in 10 mm Hg increments from Findings We included data from 51 randomised clinical trials published between 1981 and 2014 involving 358 533 participants (58% men), among whom 103 325 (29%) had known type 2 diabetes at baseline. The baseline mean systolic/diastolic blood pressure of those with and without type 2 diabetes was 149/84 mm Hg (SD 19/11) and 153/88 mm Hg (SD 21/12), respectively. Over 4·2 years median follow-up (IQR 3·0–5·0), a 5 mm Hg reduction in systolic blood pressure decreased the risk of major cardiovascular events in both groups, but with a weaker relative treatment effect in participants with type 2 diabetes (HR 0·94 [95% CI 0·91–0·98]) compared with those without type 2 diabetes (0·89 [0·87–0·92]; pinteraction=0·0013). However, absolute risk reductions did not differ substantially between people with and without type 2 diabetes because of the higher absolute cardiovascular risk among participants with type 2 diabetes. We found no reliable evidence for heterogeneity of treatment effects by baseline systolic blood pressure in either group. In keeping with the primary findings, analysis using stratified network meta-analysis showed no evidence that relative treatment effects differed substantially between participants with type 2 diabetes and those without for any of the drug classes investigated. Interpretation Although the relative beneficial effects of blood pressure reduction on major cardiovascular events were weaker in participants with type 2 diabetes than in those without, absolute effects were similar. The difference in relative risk reduction was not related to the baseline blood pressure or allocation to different drug classes. Therefore, the adoption of differential blood pressure thresholds, intensities of blood pressure lowering, or drug classes used in people with and without type 2 diabetes is not warranted. Funding British Heart Foundation, UK National Institute for Health Research, and Oxford Martin School.

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