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Item Comparison of Visual Performance and Quality of Life with A New Nondiffractive EDOF Intraocular Lens and A Trifocal Intraocular Lens(2023) Asena, Leyla; Dogan, Irem Kirci; Oto, Sibel; Altinors, Dilek Dursun; 0000-0003-0171-4200; 0000-0002-6848-203X; 0000-0002-5574-7318; 36700928; AAJ-4668-2021; E-5914-2016Purpose: To compare visual performance and quality of life (QoL) following bilateral implantation of a new nondiffractive extended depth-of-focus (EDOF) intraocular lens (IOL) and a trifocal IOL. Setting: Department of Ophthalmology, Baskent University Faculty of Medicine, Ankara, Turkey. Design: Prospective comparative interventional case series. Methods: 104 eyes of 52 patients with cataract, bilaterally implanted with a nondiffractive EDOF IOL or a trifocal IOL, were included. Outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance corrected intermediate visual acuity and distance corrected near visual acuity, defocus curves, QoL (Visual Function Index 14), quality of vision (Quality of Vision [QoV] index), contrast sensitivity (Pelli-Robson chart), and binocular reading speed. Results: Twenty-six patients were included in each group. The UDVA and CDVA were better in the EDOF group (0.05 +/- 0.04 and 0.01 +/- 0.04) than the trifocal group (0.13 +/- 0.06 and 0.11 +/- 0.07) (P=.02 and .01). Defocus curves showed that visual acuity was better with the EDOF IOL for vergences at 0.00, -0.50, and -1.00 and better with the trifocal IOL for vergences at -2.50, -3.00, -3.50, and -4.00. Contrast sensitivity scores were similar with both IOLs (P=.12). The overall mean QoL scores were lower in the EDOF group, indicating a better QoL (P=.04). The QoV was better in the EDOF group with significantly less glare, halos, and blurry vision (P<.01). Conclusions: The EDOF IOL performed better at distance, and the trifocal IOL performed better at near. Overall QoL and quality of vision were better with the EDOF IOL. Copyright (c) 2023 Published by Wolters Kluwer on behalf of ASCRS and ESCRSItem The Impact of CoronaVac Vaccination on 28-day Mortality Rate of Critically Ill Patients with COVID-19 in Turkiye(2023) Sahinturk, Helin; 37867428Background: Vaccines against coronavirus disease-19 (COVID-19) have been effective in preventing symptomatic diseases, hospitalizations, and intensive care unit (ICU) admissions. However, data regarding the effectiveness of COVID-19 vaccines in reducing mortality among critically ill patients with COVID-19 remains unclear.Aims: To determine the vaccination status and investigate the impact of the COVID-19 vaccine on the 28-day mortality in critically ill patients with COVID-19.Study Design: Multicenter prospective observational clinical study.Methods: This study was conducted in 60 hospitals with ICUs managing critically ill patients with COVID-19. Patients aged >= 18 years with confirmed COVID-19 who were admitted to the ICU were included. The present study had two phases. The first phase was designed as a one-day point prevalence study, and demographic and clinical findings were evaluated. In the second phase, the 28-day mortality was evaluated.Results: As of August 11, 2021, 921 patients were enrolled in the study. The mean age of the patients was 65.42 +/- 16.74 years, and 48.6% (n = 448) were female. Among the critically ill patients with COVID-19, 52.6% (n = 484) were unvaccinated, 7.7% (n = 71) were incompletely vaccinated, and 39.8% (n = 366) were fully vaccinated. A subgroup analysis of 817 patients who were unvaccinated (n = 484) or who had received two doses of the CoronaVac vaccine (n = 333) was performed. The 28-day mortality rate was 56.8% (n = 275) and 57.4% (n = 191) in the unvaccinated and two-dose CoronaVac groups, respectively. The 28-day mortality was associated with age, hypertension, the number of comorbidities, type of respiratory support, and APACHE II and sequential organ failure assessment scores (p < 0.05). The odds ratio for the 28-day mortality among those who had received two doses of CoronaVac was 0.591 (95% confidence interval: 0.413-0.848) (p = 0.004).Conclusion: Vaccination with at least two doses of CoronaVac within six months significantly decreased mortality in vaccinated patients than in unvaccinated patients.Item First-Line Cemiplimab Monotherapy and Continued Cemiplimab Beyond Progression Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 50% Or More (EMPOWER-Lung 1): 35-Month Follow-Up From A Multicentre, Open-Label, Randomised, Phase 3 Trial(2023) Ozguroglu, Mustafa; Kilickap, Saadettin; Sezer, Ahmet; Gumus, Mahmut; Bondarenko, Igor; Gogishvili, Miranda; Nechaeva, Marina; Schenker, Michael; Cicin, Irfan; Ho, Gwo Fuang; Kulyaba, Yaroslav; Zyuhal, Kasimova; Scheusan, Roxana-Ioana; Garassino, Marina Chiara; He, Xuanyao; Kaul, Manika; Okoye, Emmanuel; Li, Yuntong; Li, Siyu; Pouliot, Jean-Francois; Seebach, Frank; Lowy, Israel; Gullo, Giuseppe; Rietschel, Petra; 37591293Background: Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression.Methods: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged >= 18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540.Findings: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 261 months (95% CI 221-318; 149 [52%] of 284 died) versus 133 months (105-162; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 057, 95% CI 046-071; p<00001), median progression-free survival was 81 months (95% CI 62-88; 214 events occurred) in the cemiplimab group versus 53 months (43-61; 236 events occurred) in the chemotherapy group (HR 051, 95% CI 042-062; p<00001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 66 months (61-93) and overall survival of 151 months (113-187). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signalsINTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer.Copyright (c) 2023 Elsevier Ltd. All rights reserved.Item Graft-Versus-Host Disease and Relapse/Rejection-Free Survival After Allogeneic Transplantation for Idiopathic Severe Aplastic Anemia: A Comprehensive Analysis from the SAAWP of the EBMT(2023) Devillier, Raynier; Eikema, Dirk-Jan; Dufour, Carlo; Aljurf, Mahmoud; Wu, Depei; Maschan, Alexei; Kulagin, Alexander; Halkes, Constantijn J. M.; Collin, Matthew; Snowden, John; Renard, Cecile; Ganser, Arnold; Sykora, Karl-Walter; Gibson, Brenda E.; Maertens, Johan; Itala-Remes, Maija; Corti, Paola; Cornelissen, Jan; Bornhaeuser, Martin; Colorado Araujo, Mercedes; Ozdogu, Hakan; Risitano, Antonio; Socie, Gerard; de latour, Regis Peffault; 36951165Survival after allogeneic hematopoietic stem cell transplantation (allo-HSCT) for severe idiopathic aplastic anemia (SAA) has improved in recent years, approaching 75% at 5 years. However, an SAA-adapted composite endpoint, graft-versus-host disease (GvHD) and relapse/rejection-free survival (GRFS), may more accurately assess patient outcomes beyond survival. We analyzed GRFS to identify risk factors and specific causes of GRFS failure. Our retrospective analysis from the Severe Aplastic Anemia Working Party of the European Society for Blood and Marrow Transplantation included 479 patients with idiopathic SAA who underwent allo-HSCT in two conventional situations: i) upfront allo-HSCT from a matched related donor (MRD) (upfront cohort), and ii) allo-HSCT for relapsed or refractory SAA (rel/ref cohort). Relevant events for GRFS calculation included graft failure, grade 3-4 acute GvHD, extensive chronic GvHD, and death. In the upfront cohort (n=209), 5-year GRFS was 77%. Late allo-HSCT (i.e., >6 months after SAA diagnosis) was the main poor prognostic factor, specifically increasing the risk of death as the cause of GRFS failure (hazard ratio [HR]=4.08; 95% confidence interval [CI]: 1.41-11.83; P=0.010). In the rel/ref cohort (n=270), 5-year GRFS was 61%. Age was the main factor significantly increasing the risk of death (HR=1.04; 95% CI: 1.02-1.06; P<0.001), acute GvHD (HR=1.03; 95% CI: 1.00-1.07; P=0.041), and chronic GvHD (HR=1.04; 95% CI: 1.01-1.08; P=0.032) as the cause of GRFS failure. GRFS after upfront MRD allo-HSCT was very good, notably with early allo-HSCT, confirming that younger patients with an MRD should be transplanted immediately. GRFS was worse in cases of salvage allo-HSCT, most notably in older patients, questioning the utility of allo-HSCT earlier in the disease course.Item Asymptomatic Lower Pole Small Renal Stones: Shock Wave Lithotripsy, Flexible Ureteroscopy, or Observation? A Prospective Randomized Trial(2015) Sener, Nevzat Can; Bas, Okan; Sener, Emine; Zengin, Kursad; Ozturk, Ufuk; Altunkol, Adem; Evliyaoglu, Yalcin; 25440816; HKN-9151-2023OBJECTIVE To present the outcomes of flexible ureteroscopy (F-URS), shock wave lithotripsy (SWL), and observation in the management of asymptomatic lower calyceal stones. METHODS A total of 150 patients with asymptomatic lower calyceal stones were randomized into F-URS (group 1), SWL (group 2), and observation (group 3) groups. The main criteria for patient enrollment were having asymptomatic single lower pole stones <1 cm. RESULTS In F-URS, the mean stone-free rate was 92% (46 of 50). The mean number of sessions for the SWL group was 1.48 +/- 0.65. Stone-free rate was 90% (45 of 50). In the observation group, patients were followed up for a mean of 21.02 +/- 3.65 months. Three stones passed spontaneously without any symptoms. Pain developed in 3 patients during follow-up, and 2 of them passed a stone and responded to analgesics without further treatment. Complication rates for groups 1 and 2 were similar, but group 2 had higher Clavien grades. CONCLUSION For asymptomatic small-sized lower calyceal stones, SWL and F-URS are established treatment modalities. However, with low auxiliary treatment rates, observation may be an option for the management of nonsymptomatic small-sized lower pole kidney stones. (C) 2015 Elsevier Inc.Item Prophylactic Red Blood Cell Exchange May Be Beneficial in the Management of Sickle Cell Disease in Pregnancy(2015) Asma, Suheyl; Kozanoglu, Ilknur; Tarim, Ebru; Sariturk, Cagla; Gereklioglu, Cigdem; Akdeniz, Aydan; Kasar, Mutlu; Turgut, Nurhilal H.; Yeral, Mahmut; Kandemir, Fatih; Boga, Can; Ozdogu, Hakan; 0000-0002-5268-1210; 0000-0002-8902-1283; 0000-0003-3856-7005; 0000-0001-5335-7976; 0000-0002-9580-628X; 0000-0002-4130-1059; 0000-0002-9680-1958; 25070465; AAE-1241-2021; AAD-5542-2021; AAL-3906-2021; AAI-7831-2021; ABC-4148-2020; AAD-6222-2021; AAS-7129-2021BackgroundSickle cell disease (SCD) is associated with chronic hemolysis and painful episodes. Pregnancy accelerates sickle cell complications, including prepartum and postpartum vasoocclusive crisis, pulmonary complications, and preeclampsia or eclampsia. Fetal complications include preterm birth and its associated risks, intrauterine growth restriction, and a high rate of perinatal mortality. The purpose of this study was to evaluate pregnancy outcomes in patients with SCD who underwent planned preventive red blood cell exchange (RBCX). Study Design and MethodsWe retrospectively evaluated the complications of SCD in 37 pregnant patients. Patients with SCD who had undergone prophylactic RBCX were compared with a control group who had not undergone RBCX during pregnancy. ResultsForty-three exchange procedures were performed in 24 patients. The control group comprised 13 patients with a mean age of 27.43.3 years who had not undergone RBCX during pregnancy. Four of the five patients who developed a vasoocclusive crisis died. There was a significant difference in maternal mortality between the study and control groups (p=0.011). There was also a significant difference in the incidence of vasoocclusive crisis between the study and control groups. One fetal death occurred in the 20th gestational week in a patient in the control group, although there were no postpartum complications in either the babies or the mothers in the control group. ConclusionThis study has demonstrated that prophylactic RBCX during pregnancy is a feasible and safe procedure for prevention of complications. Given the decrease in the risks of transfusion, RBCX warrants further study.Item Safety and Palliative Efficacy of Single-Dose 8-Gy Reirradiation for Painful Local Failure in Patients with Stage IV Non-Small Cell Lung Cancer Previously Treated with Radical Chemoradiation Therapy(2015) Topkan, Erkan; Yildirim, Berna Akkus; Guler, Ozan Cem; Parlak, Cem; Pehlivan, Berrin; Selek, Ugur; 0000-0001-8120-7123; 0000-0001-6170-0383; 0000-0001-6661-4185; 0000-0001-6908-3412; 0000-0001-8087-3140; 25752391; AAG-2213-2021; B-3671-2014; V-5717-2017; AAC-5654-2020; O-5474-2014Purpose: To investigate the safety and efficacy of single-dose 8-Gy palliative chest reirradiation (CRI) in metastatic non-small cell lung cancer (M-NSCLC) patients with painful thoracic failures (TF) within the previous radiation portal. Patients and Methods: We retrospectively analyzed the clinical data of 78 M-NSCLC patients who received single-dose 8-Gy CRI for painful TF after concurrent chemoradiation therapy to a total radiation dose of 52 to 66 Gy between 2007 and 2012. Primary endpoints included significant pain relief (SPR) defined as a >= 2 point decrement in the Visual Analogue Scale for Pain inventory (VAS-P), time to pain relief, and duration of pain control. Secondary objectives were survival and prognostic factors. Results: Treatment was well tolerated, with only 5.1% grade 3 pneumonitis and 1.3% grade 2 esophagitis. Pre-CRI median and post-CRI minimum VAS-P were 7 and 3 (P < .001), respectively. SPR was noted in 67 (85.9%) patients, and only 3 (3.9%) scored progressive pain. Median time to lowest VAS-P and duration of pain control were 27 days and 6.1 months, respectively. Median overall survival (OS) was 7.7 months, and the 1-year OS rate was 26.5%. On multivariate analyses, lower Eastern Cooperative Oncology group score (1-2; P < .001), absence of anemia (P = .001), and fewer metastatic sites (1-2; P < .001) were found to be associated with longer OS. Conclusions: Single-dose 8-Gy CRI provides safe, effective, and durable pain palliation for TF in radically irradiated M-NSCLC patients. Because of its convenience, lower cost, and higher comfort, the present protocol can be considered an appropriate option for patients with limited life spans. (C) 2015 Elsevier Inc.Item Effect of Post-Transplant Cardiac Angiographic Procedures on Post-Transplant Renal Function(2022) Keskin, Suzan; Ciftci, Orcun; Soy, Ebru Ayvazoglu; Muderrisoglu, Haldun; Haberal, Mehmet; 0000-0002-0993-9917; 0000-0002-3462-7632; 35918191; AAC-5566-2019; AAJ-8097-2021Background. Cardiac interventions often are performed before and after renal transplant for coronary artery disease. The aim of this study was to investigate whether post-transplant cardiac coronary procedures affect post-transplant renal function. Method. We retrospectively included renal transplant recipients who underwent renal transplant procedures at Baskent University between April 28, 1997 and January 20, 2020. We analyzed the effect of cardiac catheterization in renal transplant recipients between 6 and 12 months post-transplant with post-transplant renal function assessed by glomerular filtration rate (GFR). We compared the effect of the type of coronary intervention on GFR change in group 1, whereby group 1 was divided into 2 subgroups (coronary artery bypass grafting [CABG] and stenting). Group 1 included patients who underwent cardiac intervention, whereas group 2 included those who had not undergone cardiac intervention. Results. In all, 108 patients underwent coronary angiography; 45 (41.7%) had normal coronaries or minimal coronary artery disease (CAD); 37 (34.3%) underwent stent implantation; 26 (24.1%) underwent CABG. The mean post- transplantation GFR of all patients after cardiac catheterization was 84.26+25.91 (mL/min/1.73 m(2)). The final, after 12 months mean GFR of all patients was 69.55+27.05. The final GFR was significantly lower than the initial post-renal GFR value in patients who underwent cardiac intervention but not in non-intervened patients. Conclusion. Invasive cardiac revascularization procedures showed a negative effect on posttransplant renal function in renal transplant recipients. All renal transplant recipients who underwent cardiac intervention survived the intervention, and there was no mortality. The reason for this outcome was assumed to be because of the short follow-up period.Item Comparison of Anteromedial and Transtibial ACL Reconstruction Using Expandable Fixation(2017) Ozel, Omer; Yucel, Bulent; Orman, Osman; Demircay, Emre; Mutlu, Serhat; 0000-0002-2753-426X; 0000-0002-9177-2457; 0000-0003-1274-4288; 0000-0002-2062-991X; 28399324; AAG-3009-2020; HKW-6873-2023; AAL-2368-2021; J-9611-2014The influence of anatomical or nonanatomical femoral tunnel position on tunnel widening and clinical outcomes in patients undergoing anterior cruciate ligament (ACL) reconstruction is not fully understood. This retrospective study examined the influence of tunnel width and placement on anterior knee stability and clinical outcomes after ACL reconstruction using the AperFix System (Cayenne Medical Inc, Scottsdale, Arizona), a direct expandable fixation technique with autologous hamstring grafts. The records of 80 patients (79 men and 1 woman) who underwent ACL reconstruction were evaluated. In 38 patients, anatomical femoral tunnel placement was performed via an accessory medial portal (anteromedial group); in the remaining 42 patients, the femoral tunnel was positioned nonanatomically using a transtibial technique (transtibial group). Mean follow-up was 40.7 months (range, 27-60 months). Postoperative knee kinetics were measured, and clinical outcomes were assessed using International Knee Documentation Committee, Lysholm, and Tegner scores. Femoral tunnel widening was measured by comparing postoperative radiographs with final follow-up radiographs. Femoral tunnel width was significantly greater (P<.001) and anterior knee translation was significantly higher (P=.01) in the transtibial group. Lysholm and Tegner scores were not significantly different (P>.05) between the 2 groups. These findings suggest that femoral tunnel widening is associated with increased anterior joint laxity when a direct fixation technique is used for ACL reconstruction, particularly in nonanatomically positioned femoral tunnels. Anatomical femoral tunnel placement provides better anterior stability and less tunnel widening than transtibial tunnel placement; however, these benefits did not produce a detectable advantage in clinical outcomes measures.Item A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae(2016) Azap, Ozlem Kurt; 27712635Objective: To develop a score to predict mortality in patients with bloodstream infections (BSIs) due to carbapenemase-producing Enterobacteriaceae (CPE). Patients and Methods: A multinational retrospective cohort study (INCREMENT project) was performed from January 1, 2004, through December 31, 2013. Patients with clinically relevant monomicrobial BSIs due to CPE were included and randomly assigned to either a derivation cohort (DC) or a validation cohort (VC). The variables were assessed on the day the susceptibility results were available, and the predictive score was developed using hierarchical logistic regression. The main outcome variable was 14-day all-cause mortality. The predictive ability of the model and scores were measured by calculating the area under the receiver operating characteristic curve. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for different cutoffs of the score. Results: The DC and VC included 314 and 154 patients, respectively. The final logistic regression model of the DC included the following variables: severe sepsis or shock at presentation (5 points); Pitt score of 6 or more (4 points); Charlson comorbidity index of 2 or more (3 points); source of BSI other than urinary or biliary tract (3 points); inappropriate empirical therapy and inappropriate early targeted therapy (2 points). The score exhibited an area under the receiver operating characteristic curve of 0.80 (95% CI, 0.74-0.85) in the DC and 0.80 (95% CI, 0.73-0.88) in the VC. The results for 30-day all-cause mortality were similar. Conclusion: A validated score predictive of early mortality in patients with BSIs due to CPE was developed. (C) 2016 Mayo Foundation for Medical Education and Research
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