scholarly journals 2452

2017 ◽  
Vol 1 (S1) ◽  
pp. 79-79
Author(s):  
Arnav Srivastava ◽  
Gregory Joice ◽  
Madeline Manka ◽  
Nikolai Sopko ◽  
Edward Jamie Wright
Keyword(s):  
Median Time ◽  
Cox Regression ◽  
Incidence Rates ◽  
Artificial Urinary Sphincter ◽  
Surgical Revision ◽  
Time To Failure ◽  
Surgical Morbidity ◽  
Urethral Erosion ◽  
Pump Failure ◽  
Initial Placement

OBJECTIVES/SPECIFIC AIMS: Stress urinary incontinence (SUI) significantly affects quality of life and occurs in 60% of men after radical prostatectomy, with 5% requiring surgical treatment. The artificial urinary sphincter (AUS) offers these patients excellent control of their post-prostatectomy SUI. The device contains 3 parts: the pump, urethral cuff, and pressure regulating balloon. Despite the effectiveness of AUS, up to 50% of patients require surgical revision after initial placement due to recurring SUI. Thus far, literature is heterogeneous regarding the causes of mechanical AUS failure and appropriate surgical management. Our study aims to characterize the most common reasons of AUS failure requiring surgical revision and the survival of each AUS component. METHODS/STUDY POPULATION: We report a series of 48 patients who received AUS placement and/or revision by 1 surgeon from 2010 to 2013. Upon presenting for revision, intraoperatively, the surgeon systematically evaluated the device for failure of the balloon, cuff and pump as well as urethral erosion and atrophy. In patients not requiring revision all device components were presumed functional. We conducted retrospective chart review to collect baseline characteristics, intraoperative findings, and postoperative outcomes. Using Kaplan-Meier estimates, we calculated incidence rates of component failure for the cuff, pump, and balloon. To identify risk factors for AUS failure, Cox regression was performed for univariate and multivariable testing. Multivariable modeling included those variables considered biologically plausible and significant in univariate testing. RESULTS/ANTICIPATED RESULTS: In total, 48 patients were studied with median follow up of 4.25 years. All patients received an AMS 800 device with a 61–70 mL balloon filled with 27 cc of isotonic contrast. Cuff sizes ranged from 3.5 to 5.5 cm, with 4.5 cm selected in 33/48 cases (68.8%); 19 of the patients required AUS correction (41.7%). Balloon leak constituted 57.9% (11/19) of failures, followed by cuff failure/urethral atrophy (21.1%), urethral erosion (10.5%), and individual cases of infection and pump failure. Median time to mechanical failure due to balloon leak was 3.67 years (IQR 2.17, 5.33); median time to failure for nonballoon causes was 0.54 years (IQR 0.25, 1.83). Survival of the balloon, cuff, and pump was 100%, 95.7%, and 97.9% at 1 year and 76.9%, 91.0%, and 97.9% at 5 years, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study identifies fluid leakage from the balloon as the most common cause of AUS failure, particularly in patients presenting between 1 and 5 years after initial placement. For such patients, interrogating the balloon first can decrease infection risk and surgical morbidity as it can avoid manipulation of the urethral cuff. Furthermore, simply replacing lost fluid saves cost and allows for immediate reactivation of the AUS device.

scholarly journals Diabetes mellitus was not associated with lower amputation-free survival after open revascularization for chronic limb-threatening ischemia – A nationwide propensity score adjusted analysis

2021 ◽  
pp. 1358863X2110082
Author(s):  
Erika Lilja ◽  
Anders Gottsäter ◽  
Mervete Miftaraj ◽  
Jan Ekelund ◽  
Björn Eliasson ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Propensity Score ◽  
Vascular Surgery ◽  
Incidence Rate ◽  
Cox Regression ◽  
Major Amputation ◽  
Incidence Rates ◽  
Major Adverse Cardiovascular Events ◽  
Cox Regression Analysis ◽  
Number Of Patients

The risk of major amputation is higher after urgently planned endovascular therapy for chronic limb-threatening ischemia (CLTI) in patients with diabetes mellitus (DM). The aim of this nationwide cohort study was to compare outcomes between patients with and without DM following urgently planned open revascularization for CLTI from 2010 to 2014. Out of 1537 individuals registered in the Swedish Vascular Registry, 569 were registered in the National Diabetes Register. A propensity score adjusted Cox regression analysis was conducted to compare outcome between the groups with and without DM. Median follow-up was 4.3 years and 4.5 years for patients with and without DM, respectively. Patients with DM more often had foot ulcers ( p = 0.034) and had undergone more previous amputations ( p = 0.001) at baseline. No differences in mortality, cardiovascular death, major adverse cardiovascular events (MACE), or major amputation were observed between groups. The incidence rate of stroke was 70% higher (95% CI: 1.11–2.59; p = 0.0137) and the incidence rate of acute myocardial infarction (AMI) 39% higher (95% CI: 1.00–1.92; p = 0.0472) among patients with DM in comparison to those without. Open vascular surgery remains a first-line option for a substantial number of patients with CLTI, especially for limb salvage in patients with DM. The higher incidence rates of stroke and AMI among patients with DM following open vascular surgery for infrainguinal CLTI require specific consideration preoperatively with the aim of optimizing medical treatment to improve cardiovascular outcome postoperatively.

scholarly journals Prevalence, median time, and associated factors with the likelihood of initial antidepressant change: a cross-sectional study in Qatar

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nervana Elbakary ◽  
Sami Ouanes ◽  
Sadaf Riaz ◽  
Oraib Abdallah ◽  
Islam Mahran ◽  
...  
Keyword(s):  
Median Time ◽  
Cox Regression ◽  
Cross Sectional Study ◽  
Therapeutic Interventions ◽  
Patient Treatment ◽  
Cross Sectional ◽  
Disease Outcomes ◽  
Younger Age ◽  
Risk Predictors ◽  
Subsequent Failure

Abstract Background Major Depressive Disorder (MDD) requires therapeutic interventions during the initial month after being diagnosed for better disease outcomes. International guidelines recommend a duration of 4–12 weeks for an initial antidepressant (IAD) trial at an optimized dose to get a response. If depressive symptoms persist after this duration, guidelines recommend switching, augmenting, or combining strategies as the next step. Premature discontinuation of IAD due to ineffectiveness can cause unfavorable consequences. We aimed to determine the prevalence and the patterns of strategies applied after an IAD was changed because of a suboptimal response as a primary outcome. Secondary outcomes included the median survival time on IAD before any change; and the predictors that were associated with IAD change. Methods This was a retrospective study conducted in Mental Health Services in Qatar. A dataset between January 1, 2018, and December 31, 2019, was extracted from the electronic health records. Inclusion and exclusion criteria were defined and applied. The sample size was calculated to be at least 379 patients. Descriptive statistics were reported as frequencies and percentages, in addition, to mean and standard deviation. The median time of IAD to any change strategy was calculated using survival analysis. Associated predictors were examined using several cox regression models. Results A total of 487 patients met the inclusion criteria of the study, 431 (88%) of them had an occurrence of IAD change to any strategy before end of the study. Almost half of the sample (212 (49%); 95% CI [44–53%]) had their IAD changed less than or equal to 30 days. The median time to IAD change was 43 days with 95% CI [33.2–52.7]. The factors statistically associated with higher hazard of IAD change were: younger age, un-optimization of the IAD dose before any change, and comorbid anxiety. Conclusions Because almost half of the patients in this study changed their IAD as early as within the first month, efforts to avoid treatment failure are needed to ensure patient-treatment targets are met. Our findings offered some clues to help clinicians identify the high-risk predictors of short survival and subsequent failure of IAD.

scholarly journals Relationship of megakaryocyte size at diagnosis to chemotherapeutic response in children with acute nonlymphocytic leukemia

Blood ◽  
1983 ◽  
Vol 61 (5) ◽  
pp. 867-870 ◽  
Author(s):  
CW Jackson ◽  
GV Dahl
Keyword(s):  
Complete Remission ◽  
Prognostic Value ◽  
Cox Regression ◽  
Time To Failure ◽  
Acute Nonlymphocytic Leukemia ◽  
Spleen Size ◽  
Cox Regression Analysis ◽  
Biopsy Specimens ◽  
Chemotherapeutic Response ◽  
Relationship Of

Abstract Small megakaryocytes are frequently seen in patients with acute nonlymphocytic leukemia (ANLL). In this study, median megakaryocyte diameters were determined in marrow biopsy specimens of 32 children at diagnosis of ANLL and related to platelet count and chemotherapeutic response. The association between median megakaryocyte size and time-to- failure was striking. Seven of 9 patients with median megakaryocyte diameters greater than 20 microns remain in continuous complete remission for more than 3 yr, whereas 20 of 23 patients with smaller median megakaryocyte diameters failed therapy within 15 mo (p = 0.002). By Cox-regression analysis, megakaryocyte size had independent prognostic value (p less than 0.001), surpassing that of spleen size, the only other feature having significant association with time-to- failure. Megakaryocyte size at diagnosis may be useful for predicting the likelihood of prolonged complete remission in ANLL.

Kidney transplantation in the extremely elderly from extremely aged deceased donors: a kidney for each age

2020 ◽  
Vol 35 (4) ◽  
pp. 687-696
Author(s):  
Jimena Cabrera ◽  
Mario Fernández-Ruiz ◽  
Hernando Trujillo ◽  
Esther González ◽  
María Molina ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Graft Survival ◽  
Cox Regression ◽  
Patient Survival ◽  
Incidence Rates ◽  
Allocation Policy ◽  
Recipient Age ◽  
Deceased Donors ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Advances in life expectancy have led to an increase in the number of elderly people with end-stage renal disease (ESRD). Scarce information is available on the outcomes of kidney transplantation (KT) in extremely elderly patients based on an allocation policy prioritizing donor–recipient age matching. Methods We included recipients ≥75 years that underwent KT from similarly aged deceased donors at our institution between 2002 and 2015. Determinants of death-censored graft and patient survival were assessed by Cox regression. Results We included 138 recipients with a median follow-up of 38.8 months. Median (interquartile range) age of recipients and donors was 77.5 (76.3–79.7) and 77.0 years (74.7–79.0), with 22.5% of donors ≥80 years. Primary graft non-function occurred in 8.0% (11/138) of patients. Cumulative incidence rates for post-transplant infection and biopsy-proven acute rejection (BPAR) were 70.3% (97/138) and 15.2% (21/138), respectively. One- and 5-year patient survival were 82.1 and 60.1%, respectively, whereas the corresponding rates for death-censored graft survival were 95.6 and 93.1%. Infection was the leading cause of death (46.0% of fatal cases). The occurrence of BPAR was associated with lower 1-year patient survival [hazard ratio (HR) = 4.21, 95% confidence interval (CI) 1.64–10.82; P = 0.003]. Diabetic nephropathy was the only factor predicting 5-year death-censored graft survival (HR = 4.82, 95% CI 1.08–21.56; P = 0.040). Conclusions ESRD patients ≥75 years can access KT and remain dialysis free for their remaining lifespan by using grafts from extremely aged deceased donors, yielding encouraging results in terms of recipient and graft survival.

scholarly journals Urinary Artificial Sphincter ZSI 375 for Treatment of Stress Urinary Incontinence in Men: 5 and 7 Years Follow-Up Report

2017 ◽  
Vol 84 (4) ◽  
pp. 263-266 ◽  
Author(s):  
Christophe Llorens ◽  
Tobias Pottek
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Artificial Urinary Sphincter ◽  
Minimal Period ◽  
Artificial Sphincter ◽  
Urethral Erosion ◽  
Randomised Study ◽  
Urinary Sphincter ◽  
Male Patients

Study Design This is a retrospective, non-randomised study. Objectives The aim of this study was to evaluate safety and efficacy of artificial urinary sphincter ZSI 375 inserted in male patients with stress urinary incontinence (SUI). Methods Between May 2009 and January 2017, 45 men with SUI underwent ZSI 375 device insertion. Operations were performed in two French centres by one surgeon. Complications and pad used to manage continence were recorded. Results From May 2009 to January 2012, 45 patients with a mean age of 70.42 years underwent placement of the ZSI 375 device in France. The most common cause for incontinence was radical prostatectomy (RP, 33/45 ­patients, 73.33%). The minimal period of incontinence was 6 months. Twenty-seven out of 45 patients (60.00%) had a severe incontinence (at least four pads per day), 13 patients (28.89%) had moderate incontinence (three pads per day) and five patients (11.11%) had two pads per day. With a long follow-up, the ZSI 375 device was considered to be successful in 73.33% patients after 5 years (60 months) and 72% of patients after 7 years (84 months). The infection rate was 2.2 % affecting one in 45 patients. Six out of 45 patients presented a urethral erosion (13.33%). Mechanical failure with a revision occurred in three patients (6.67%). Conclusions The ZSI 375 device is a safe and effective device to treat severe SUI in men.

scholarly journals Role of Disease Modifying Treatment in the Risk of Alloimmunization in Transfused Patients with Myelodysplastic Syndromes: A Population-Based Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4253-4253
Author(s):  
Hanne Rozema ◽  
Robby Kibbelaar ◽  
Nic Veeger ◽  
Mels Hoogendoorn ◽  
Eric van Roon
Keyword(s):  
Risk Factors ◽  
Regression Analysis ◽  
Cox Regression ◽  
Population Based ◽  
Incidence Rates ◽  
Blood Products ◽  
Cox Regression Analysis ◽  
In The Beginning ◽  
Observation Period

The majority of patients with myelodysplastic syndromes (MDS) require regular red blood cell (RBC) transfusions. Alloimmunization (AI) against blood products is an adverse event, causing time-consuming RBC compatibility testing. The reported incidence of AI in MDS patients varies greatly. Even though different studies on AI in MDS patients have been performed, there are still knowledge gaps. Current literature has not yet fully identified the risk factors and dynamics of AI in individual patients, nor has the influence of disease modifying treatment (DMT) been explored. Therefore, we performed this study to evaluate the effect of DMT on AI. An observational, population-based study, using the HemoBase registry, was performed including all newly diagnosed MDS patients between 2005 and 2017 in Friesland, a province of the Netherlands. All available information about treatment and transfusions, including transfusion dates, types, and treatment regimens, was collected from the electronic health records and laboratory systems. Follow-up occurred through March 2019. For our patient cohort, blood products were matched for AB0 and RhD, and transfused per the 'type and screen' policy (i.e. electronic matching of blood group phenotype between patient and donor). After a positive antibody screening, antibody identification and Rh/K phenotyping was performed and subsequent blood products were (cross)matched accordingly. The observation period was counted from first transfusion until last transfusion or first AI event. Univariate analyses and cumulative frequency distributions were performed to study possible risk factors and dynamics of AI. DMT was defined as hypomethylating agents, lenalidomide, chemotherapy and monoclonal antibodies. The effect of DMT as a temporary risk period on the risk of AI was estimated with incidence rates, relative risks (RR) and hazard ratios (HR) using a cox regression analysis. Follow-up was limited to 24 months for the cox regression analysis to avoid possible bias by survival differences. Statistical analyses were performed using IBM SPSS 24 and SAS 9.4. Out of 292 MDS patients, 236 patients received transfusions and were included in this study, covering 463 years of follow-up. AI occurred in 24 patients (10%). AI occurred mostly in the beginning of the observation period: Eighteen patients (75%) were alloimmunized after receiving 20 units of RBCs, whereas 22 patients (92%) showed AI after 45 units of RBCs (Figure 1). We found no significant risk factors for AI in MDS patients at baseline. DMT was given to 67 patients (28%) during the observation period. Patients on DMT received more RBC transfusions than patients that did not receive DMT (median of 33 (range: 3-154) and 11 (range: 0-322) RBC units respectively, p<0,001). Four AI events (6%) occurred in patients on DMT and 20 AI events (12%) occurred in patients not on DMT. Cox regression analysis of the first 24 months of follow-up showed an HR of 0.30 (95% CI: 0.07-1.31; p=0.11). The incidence rates per 100 person-years were 3.19 and 5.92 respectively. The corresponding RR was 0.54 (95% CI: 0.16-1.48; p=0.26). Based on our results, we conclude that the incidence of AI in an unselected, real world MDS population receiving RBC transfusions is 10% and predominantly occurred in the beginning of follow-up. Risk factors for AI at baseline could not be identified. Our data showed that patients on DMT received significantly more RBC transfusions but were less susceptible to AI. Therefore, extensive matching of blood products may not be necessary for patients on DMT. Larger studies are needed to confirm the protective effect of DMT on AI. Disclosures Rozema: Celgene: Other: Financial support for visiting MDS Foundation conference.

scholarly journals Baseline Quantitative Hepatitis B Core Antibody Titer Is a Predictor for Hepatitis B Virus Infection Recurrence After Orthotopic Liver Transplantation

2021 ◽  
Vol 12 ◽  
Author(s):  
Bin Lou ◽  
Guanghua Ma ◽  
Feifei LV ◽  
Quan Yuan ◽  
Fanjie Xu ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Median Time ◽  
Orthotopic Liver Transplantation ◽  
Cox Regression ◽  
Hbv Infection ◽  
Hbsag Loss ◽  
Kaplan Meier ◽  
B Virus

ObjectiveHepatitis B virus (HBV) reinfection is a serious complication that arise in patients who undergo hepatitis B virus related liver transplantation. We aimed to use biomarkers to evaluate the HBV reinfection in patients after orthotopic liver transplantation.MethodsSeventy-nine patients who underwent liver transplantation between 2009 and 2015 were enrolled, and levels of biomarkers were analyzed at different time points. Cox regression and receiver operating characteristic (ROC) curves of different markers at baseline were used to analyze sustained hepatitis B surface antigen (HBsAg) loss. The Kaplan-Meier method was used to compare the levels of the biomarkers.ResultsAmong the 79 patients, 42 sustained HBsAg loss with a median time of 65.2 months (12.0-114.5, IQR 19.5) after liver transplantation and 37 patients exhibited HBsAg recurrence with a median time of 8.8 (0.47-59.53, IQR 19.47) months. In the ROC curve analysis, at baseline, 4.25 log10 IU/mL qHBcAb and 2.82 log10 IU/mL qHBsAg showed the maximum Youden’s index values with area under the curves (AUCs) of 0.685and 0.651, respectively. The Kaplan-Meier method indicated that qHBsAg and quantitative antibody against hepatitis B core antigen (qHBcAb) levels in the two groups were significantly different (p = 0.031 and 0.006, respectively). Furthermore, the Cox regression model confirmed the predictive ability of qHBcAb at baseline (AUC = 0.685).ConclusionLower pretransplantation qHBcAb is associated with HBV infection. The baseline concentration of qHBcAb is a promising predictor for the recurrence of HBV in patients undergoing liver transplantation and can be used to guide antiviral treatment for HBV infection.

scholarly journals Incidence of inpatient venous thromboembolism in treated patients with rheumatoid arthritis and the association with switching biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in the real-world setting

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001013 ◽  
Author(s):  
Huifang Liang ◽  
Raghava Danwada ◽  
Dianlin Guo ◽  
Jeffrey R Curtis ◽  
Ryan D Kilpatrick ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cox Regression ◽  
Incidence Rates ◽  
Disease Modifying Antirheumatic Drugs ◽  
Vein Thrombosis ◽  
Real World Setting ◽  
Increased Risk ◽  
Safety Studies ◽  
Unbiased Estimates ◽  
Deep Vein

ObjectivesTo assess incidence rates (IRs) of VTE in patients with rheumatoid arthritis (RA) on different DMARDs and DMARD switchers.MethodsAdults with RA on a DMARD between 2007 and 2017 were studied in a US claims database. Conventional synthetic DMARD (csDMARD) users, first biologic/targeted synthetic DMARD (b/tsDMARD) users and b/tsDMARD switchers (from a b/tsDMARD to another b/tsDMARD) were followed for inpatient VTE (pulmonary embolism (PE)/deep vein thrombosis (DVT)). Crude and adjusted IR and 95% CIs of VTE were estimated. HRs for VTE were estimated via Cox regression. VTE risk was also evaluated by number of switches between b/tsDMARDs and in patients without a VTE history.ResultsThe age and sex standardised IR (95% CI) of VTE (per 100 person-years) was 0.86 (0.70 to 1.03), 0.60 (0.52 to 0.68) and 0.58 (0.51 to 0.65) for b/tsDMARD switchers, first b/tsDMARD users and csDMARD users, respectively. After adjustment, b/tsDMARD switchers had an increased risk of VTE, compared with csDMARD users, HRadj (95% CI) being 1.36 (1.16 to 1.58), 1.36 (1.13 to 1.63) and 1.47 (1.18 to 1.83) for VTE, DVT and PE, respectively. Compared with first b/tsDMARD users, the HRadj (95% CI) for VTE was 1.35 (1.15 to 1.60) for first b/tsDMARD switchers and 1.48 (1.19 to 1.85) for second b/tsDMARD switchers.ConclusionsIn RA, b/tsDMARD switchers have a higher VTE risk compared with csDMARD users and first b/tsDMARD users. Switching b/tsDMARDs may be a proxy for higher disease severity or poorly controlled RA and an important confounder to consider in obtaining unbiased estimates of VTE risk in observational RA safety studies.

scholarly journals Risk factors for developing cardiac toxicities in cancer patients treated with panitumumab combination therapy

2020 ◽  
Vol 16 (19) ◽  
pp. 1359-1370
Author(s):  
Wei-xiang Qi ◽  
Shengguang Zhao ◽  
Jiayi Chen
Keyword(s):  
Risk Factors ◽  
Cardiac Arrhythmia ◽  
Cardiac Arrhythmias ◽  
Cardiac Toxicity ◽  
Cox Regression ◽  
Incidence Rates ◽  
Ischemic Event ◽  
History Of ◽  
Caucasian Patients ◽  
Ischemic Events

Aim: To evaluate the incidence and risk of cardiac toxicities associated with panitumumab in advanced cancer of Caucasian patients. Materials & methods: The incidence of cardiac toxicity was assessed by simple incidence rates and rates per 100 person-years. Univariate and multivariate Cox regression was conducted. Results: Panitumumab-containing therapy significantly increased the risk of developing cardiac arrhythmias (p = 0.036), but not for any cardiac event (p = 0.24) or ischemic event (p = 0.087). The absolute rate of developing cardiac arrhythmia was 10.0 events versus 7.5 events per 100 person-years. Pre-existing hypertension (p = 0.033), history of cardiac disease (p = 0.055) or panitumumab usage (p = 0.046) were risk factors for cardiac arrhythmias. Conclusion: The addition of panitumumab to chemotherapy increases the risk of developing cardiac arrhythmia, but not for any cardiac toxicity or ischemic events.

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