Significant Difference In Hazard Research Articles

Utility of bioselection with neoadjuvant chemotherapy for organ preservation in patients with T4 laryngeal cancer

BackgroundNeoadjuvant chemotherapy for induction selection of definitive treatment (IS) protocols have shown excellent outcomes for organ preservation and survival in patients with T3 laryngeal squamous cell carcinoma (LSCC). We seek to evaluate survival and organ preservation outcomes in T4 LSCC patients treated with IS protocols. MethodsRetrospective cohort of advanced T3 and T4 LSCC patients who underwent IS protocols based upon potential for preserving a functional larynx. Patients received one neoadjuvant cycle of platinum-based chemotherapy with either 5-fluorouracil or docetaxel or with two cycles of platinum-based chemotherapy with docetaxel and a Bcl-2 inhibitor. Patients who achieved ≥ 50 % response as determined by radiographic review and/or endoscopic evaluation received definitive chemoradiation. Patients who had < 50 % response after IS underwent total laryngectomy (TL) followed by post-operative radiation +/- chemotherapy. ResultsAmongst T4 patients, 114 met inclusion criteria including 89 who underwent IS protocols and 25 who received an upfront TL. In total, 76.0 % of T3 patients and 71.9 % of T4 patients responded to IS and underwent definitive chemoradiation. There was no significant difference in hazard of death between T4 IS and T4 TL patients (HR: 0.9, p = 0.86). Among responders, there was no significant difference in 5-year laryngectomy-free survival (T3 – 59.6 %, T4 44.3 %, p = 0.15) or laryngeal preservation by T stage (T3 – 72.8 %, T4 – 73.0 %, p = 0.84). ConclusionsSelect T4 patients may benefit from organ preservation using IS protocols with similar response rates to patients with T3 tumors, without compromising survival when compared to upfront TL.

End-Stage Kidney Disease After Partial and Radical Nephrectomy Among Patients With Severe Chronic Kidney Disease.

AUA guidelines prioritize nephron sparing in patients with preexisting chronic kidney disease (CKD). However, few studies analyze long-term renal function in patients with preoperative severe CKD who undergo extirpative renal surgery. Herein, we compare the hazard of progression to end-stage kidney disease (ESKD) following partial nephrectomy (PN) and radical nephrectomy (RN) among patients with preoperative severe CKD. Patients with stage 4 CKD who underwent PN or RN from 1970 to 2018 were identified. A multivariable Fine-Gray subdistribution hazard model was employed to assess associations with progression to ESKD accounting for the competing risk of death. A total of 186 patients with stage 4 CKD underwent PN (n = 71; 38%) or RN (n = 115; 62%) for renal neoplasms with median follow-up of 6.9 years (interquartile range 3.8-14.1). On multivariable analyses adjusting for competing risk of death, the subdistribution hazard ratio (SHR) for older age at surgery (SHR for 5-year increase 0.81; 95% CI 0.73-0.91; P < .001) and higher preoperative estimated glomerular filtration rate (SHR for 5-unit increase 0.63; 95% CI 0.47-0.84; P = .002) was associated with lower hazard of progression to ESKD. There was no significant difference in hazard of ESKD between PN and RN (SHR 0.82; 95% CI 0.50-1.33; P = .4). Among patients with preoperative severe CKD, higher preoperative estimated glomerular filtration rate was associated with lower hazard of progression to ESKD after extirpative surgery for renal neoplasms. We did not observe a significant difference in overall hazard for developing ESKD between PN and RN.

Prescription pattern and effectiveness of antihypertensive drugs in patients with aortic dissection who underwent surgery.

Background: Surgical patients with aortic dissection often require multiple antihypertensive drugs to control blood pressure. However, the prescription pattern and effectiveness of antihypertensive drugs for these patients are unclear. We aimed to investigate the prescription pattern and effectiveness of different classes of antihypertensive drugs in surgical patients with aortic dissection. Methods: Newly diagnosed aortic dissection patients who underwent surgery, aged >20years, from 1 January 2012 to 31 December 2017 were identified. Patients with missing data, in-hospital mortality, aortic aneurysms, or congenital connective tissue disorders, such as Marfan syndrome, were excluded. Prescription patterns of antihypertensive drugs were identified from medical records of outpatient visits within 90days after discharge. Antihypertensive drugs were classified into four classes: 1) β-blockers, 2) calcium channel blockers (CCBs), 3) renin-angiotensin system, and 4) other antihypertensive drugs. Patients were classified according to the number of classes of antihypertensive drugs as follows: 1) class 0, no exposure to antihypertensive drugs; 2) class 1, antihypertensive drugs of the same class; 3) class 2, antihypertensive drugs of two classes; 4) class 3, antihypertensive drugs of three classes; or 5) class 4, antihypertensive drugs of four classes. The primary composite outcomes included rehospitalization associated with aortic dissection, death due to aortic dissection, and all-cause mortality. Results: Most patients were prescribed two (28.87%) or three classes (28.01%) of antihypertensive drugs. In class 1, β-blockers were most commonly used (8.79%), followed by CCBs (5.95%). In class 2, β-blockers+CCB (10.66%) and CCB+RAS (5.18%) were the most common drug combinations. In class 3, β-blockers + CCB+RAS (14.84%) was the most prescribed combination. Class 0 had a significantly higher hazard of the composite outcome (HR, 2.1; CI, 1.46-3.02; p < 0.001) and all-cause mortality (HR, 2.34; CI, 1.56-3.51; p < 0.001) than class 1. There were no significant differences in hazards for rehospitalization associated with aortic dissection among classes. Conclusion: Among operated patients with type A aortic dissection, no specific type of antihypertensive drug was associated with a better outcome, whereas among those with type B aortic dissection, the use of β-blockers and CCBs was related to a significantly lower risk of the composite outcome.

Real-world comparison of triplet- versus doublet-chemotherapy with bevacizumab in patients with newly diagnosed metastatic colorectal cancer (mCRC).

3574 Background: Meta-analysis of five randomized intensification trials in mCRC demonstrated an overall survival (OS) benefit of triplet chemotherapy (5FU/leucovorin, oxaliplatin, irinotecan) plus bevacizumab (Triplet/Bev) compared to doublet chemotherapy plus bevacizumab (Doublet/Bev) (HR 0.81). Guidelines recommend first-line Triplet/Bev for patients with excellent performance status and normal organ function who can withstand increased toxicity, but such patients are less represented in the real world. In this retrospective cohort study, we examine the real-world effectiveness of Triplet/Bev compared to Doublet/Bev in the U.S. Methods: We used the nationwide Flatiron Health electronic health record-derived database, comprising de-identified patient-level structured and unstructured data curated via technology-enabled abstraction from ~ 280 cancer clinics. Included were mCRC patients treated with first-line Triplet/Bev or Doublet/Bev between 10/23/14 and 10/31/22. OS by treatment was assessed using the Kaplan Meier method and adjustment for confounding variables was performed using Cox proportional hazards modeling with stabilized inverse probability of treatment weighting (IPTW). Pre-specified confounding variables included age, gender, race/ethnicity, year of metastatic diagnosis, health insurance, practice setting, KRAS/NRAS/BRAF mutation status, MMR/MSI status, synchronous/metachronous metastases, primary tumor sidedness, CEA, renal dysfunction, hepatic dysfunction, and ECOG performance status. Missing data were imputed using multiple imputation with chained equations. Results: Among 10,016 patients, 391 (3.9%) received Triplet/Bev and 9,625 (96.1%) received Doublet/Bev. Patients who received Triplet/Bev were younger (median age 52 vs 63 years) and were more likely to be treated at academic practices (27% vs 8%), to have synchronous metastatic disease (83% vs 65%), and to have KRAS/NRAS/BRAF wild-type disease (30% vs 17%). In the univariate analysis, median OS was 30.0 months (95% CI 24.7 – 34.7) in the Triplet/Bev cohort versus 23.4 months (95% CI 22.8 – 24.1) in the Doublet/Bev cohort (HR 0.73; 95% CI 0.62 – 0.85; p &lt; 0.001). In Cox proportional hazards modeling with IPTW, there was no significant difference in hazard of death between Triplet/Bev and Doublet/Bev (HR 0.92; 95% CI 0.75 – 1.12; p = 0.4). Conclusions: In this large, national, real-world population of patients with mCRC, first-line treatment with Triplet/Bev was not associated with improved survival compared to Doublet/Bev after accounting for differences in baseline patient characteristics. The benefit to Triplet/Bev observed in randomized trials does not translate well to a more heterogeneous, real-world population. Sub-group analyses including by age, tumor sidedness, KRAS/NRAS/BRAF status, and baseline CEA level will be performed.

Idiopathic Hirsutism and Metabolic Status: A Population-based Prospective Cohort Study.

A limited number of studies have investigated the impact of idiopathic hirsutism (IH) on cardiometabolic parameters with contradictory and inconclusive results. This study aimed to explore the effect of IH on metabolic outcomes. In this population-based prospective study, 334 women with IH and 1226 women as healthy controls were selected from Tehran Lipid and Glucose Study. The generalized estimation equations method was applied to investigate the secular longitudinal trends of metabolic indices, including fasting blood sugar (FBS), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL), non-HDL, triglyceride (TG), systolic blood pressure (SBP), diastolic blood pressure (DBP), and waist circumference (WC) in both groups. Unadjusted and adjusted Cox regression models were applied to assess the hazard ratios (HR) and 95% CIs for the association between IH and metabolic disorders. Potential confounding factors such as age, body mass index, smoking, physical activity, history of hypertension (HTN), and family history of diabetes were included in the adjusted model. This study showed that compared with healthy controls, women with IH had lower SHBG and higher total testosterone (median [interquartile ratio; IQR]: 0.37 [0.16-0.70] vs 0.33 [0.14-0.58]; P = 0.01), free androgen index (median [IQR]: 0.85 [0.38-1.54] vs 0.54 [0.26-0.97]; P = 0.001), androstenedione (median [IQR]: 1.60 [1.00-2.25] vs 1.10 [0.90-1.70]; P = 0.001), and dehydroepiandrosterone sulfate (median [IQR]: 168.5 [91.1-227.8] vs 125.2 [66.3-181]; P = 0.001). Over time, mean changes of FBS, HDL-C, LDL-C, non-HDL-C, TG, SBP, DBP, and WC were not significantly different in women with IH, compared with healthy controls. According to the unadjusted Cox regression model, except for type 2 diabetes mellitus (T2DM) (HR [95% CI]: 1.45 [1.00-2.11]) P = 0.05; there was no statistically significant difference in hazard of metabolic disorders (ie, HTN, pre-HTN, pre-T2DM, and metabolic syndrome) in IH, compared with healthy controls. Besides, the adjusted Cox regression model showed no significant differences in the hazard of these outcomes. This study showed no significant difference in overtime mean changes of metabolic risk factors and cardiometabolic outcomes in women with IH, compared with the healthy control group, except marginally significant difference on T2DM, which disappeared after further adjustment for potential confounders. Accordingly, routine screening of women for these metabolic outcomes should not recommend.

The Impact of Income and Social Mobility on Colorectal Cancer Outcomes and Treatment: A Cross-sectional Study.

To determine the impact of income mobility on racial disparities in colorectal cancer. There are well-documented disparities in colorectal cancer treatment and outcomes between Black and White patients. Socioeconomic status, insurance, and other patient-level factors have been shown important, but little has been done to show the discriminatory factors that lead to these outcomes. Data were obtained from the Surveillance Epidemiology and End-Results database for Black and White patients with colorectal cancer between 2005 and 2015. County level measures of Black (BIM) and White income mobility (WIM) were obtained from the Opportunity Atlas as a measure of intergenerational poverty and social mobility. Regression models were created to assess the relative risk of advanced stage at diagnosis (Stage IV), surgery for localized disease (Stage I/II), and cancer-specific mortality. There was no significant association of BIM or WIM on advanced stage at diagnosis in Black or White patients. An increase of $10,000 of BIM was associated with a 9% decrease in hazards of death for both Black (hazard ratio 0.91, 95% confidence interval 0.86,0.95) and White (0.91, 95%CI 0.90,0.93) patients, while the same increase in WIM was associated with no significant difference in hazards among Black patients (hazard ratio 0.99, 95% confidence interval 0.97,1.02). There were no predicted racial differences in hazards of death at high levels of BIM. Increased Black income mobility significantly improves survival for both Black and White patients. Interventions aimed at increasing economic and social mobility could significantly decrease mortality in both Black and White patients while alleviating disparities in outcomes.

Low Rate of Local Salvage Therapy Following Radiation Therapy for Non-Spine Bone Metastases ― An Indication for Appropriate Patient Selection

<h3>Purpose/Objective(s)</h3> Local therapy for patients with non-spine bone metastases is evolving, with recent data suggesting that stereotactic body radiotherapy (SBRT) may improve pain response in the palliative setting. However, the rate of local salvage therapy (LST) after SBRT compared to conventional RT is unknown. We therefore characterized rates and risk factors for LST in patients with non-spine bone metastases. <h3>Materials/Methods</h3> We reviewed records of all courses of RT for non-spine bone metastases at our institution from 1/1/2016 to 12/31/2018. LST was defined as the first occurrence of either RT or surgery for progression to a bone metastasis following initial RT. Functions of the cumulative incidence of re-treatment were generated for each RT technique. We identified associations with various predictors using the Fine and Gray method for competing risk regression. <h3>Results</h3> Of the 1,754 patients included, 2,648 bone metastases were treated with RT and analyzed with a median follow up of 15 months (IQR = 6.4 – 25.0 months). 51% of episodes were multi-fraction EBRT, 10% were single fraction EBRT, and 39% were SBRT. Of the treated metastases, 120 (4.5%) episodes required LST (median time to LST = 6.2 months, range = 0.3-35.6 months), with a cumulative incidence at 6 and 12 months of 2.4% and 3.9%, respectively. Cumulative incidence of re-treatment at 6 months was 2.6% for SBRT, 3.5% for single-fraction conventional, and 2.1% for multi-fraction conventional regimens (<i>P</i> = 0.76). On multivariable analysis, younger age, higher Karnofsky performance status (KPS), and location of the metastasis in the pelvis had higher hazard of re-treatment (Table 1). There was no significant difference in hazard of LST among RT techniques (<i>P</i> = 0.44), nor was there a significant interaction between RT technique and radioresistant histology (<i>P</i> = 0.33). <h3>Conclusion</h3> In our large institutional cohort, the rate of LST was low, with no difference between RT techniques. Our results suggest that judicious selection of patients at high risk for eventual treatment failure (i.e., those with longer expected survival) for SBRT may reduce the rate of retreatment rate in the population. When patients are appropriately selected for single fraction conventional RT, such as those who are older or have poor KPS, rates of LST remain low. Further studies to validate our findings are warranted to help clinicians to select the appropriate treatment technique for patients with bone metastases.

Effect of Adjuvant Chemotherapy After SBRT for Node Negative, Non-Metastatic Non-Small Cell Lung Cancer

Administration of adjuvant chemotherapy (ACT) after surgical resection of a tumor ≥4cm is standard of care based on studies demonstrating improved overall survival. No such standard exists for tumors ≥ 4cm treated with stereotactic body radiation therapy (SBRT), and thus, administration of ACT remains variable across institutions. Using the National Cancer Database (NCDB), we aim to analyze overall survival (OS) in patients who undergo SBRT followed by ACT for localized non-small cell lung cancer (NSCLC). Additionally, we seek to identify predictors for receipt of ACT.Patients with node negative, non-metastatic NSCLC treated with definitive SBRT between 2004-2017 were identified from the NCDB. Patients were grouped into tumor size < 4cm or ≥4cm, and by use of ACT within 30 days of SBRT. Demographics were described by treatment. Logistic regression was used to assess the association between tumor size and treatment, adjusting for age, gender, race and comorbidities. Overall survival was calculated from date of end of radiation to date of death or last follow up. Multivariable Cox proportional regression was used to investigate the association between tumor size, treatment type, and OS, adjusting for the factors above.Of the 17441 patients identified meeting the inclusion criteria, 195 received ACT after SBRT (1.1%). Forty-nine percent of these patients were male, and 91% were white. The median age of patients who received ACT was 69. Twenty-six percent of the patients who received ACT had tumors ≥ 4cm (n = 51). There was a significant difference in hazard of death; patients with tumors ≥ 4cm without ACT (n = 1310) had worse OS as compared to those with tumors < 4cm without ACT (n = 15936) (HR 1.45; 95% CI 1.34-1.56, P < 0.0001). This difference became non-significant when comparing ≥4cm with ACT versus < 4cm without ACT (HR 1.17; P = 0.40). On pairwise comparison, there was no difference in hazard of death when comparing tumors ≥ 4cm with ACT versus ≥4cm without ACT (HR 0.81; P = 0.26). On multivariate analysis, tumor size ≥ 4cm was a significant predictor for receipt of ACT (OR 5.08; 95% CI 3.64-7.07, P < 0.0001). Older patients (OR 0.93 per 10yr increase; 95% CI 0.92-0.95, P < 0.0001) and those with comorbidities (OR 0.73 any vs no comorbidities; 95% CI 0.54-0.97, P = 0.032) were less likely to receive ACT. Notably, there was no difference between sex and race, white versus non-white, in administration of ACT.Patients with tumors ≥4cm treated with SBRT without ACT have decreased OS as compared to those with tumors < 4cm who are similarly treated without ACT. This survival decrement disappears when comparing tumors ≥4cm with ACT to tumors < 4cm without ACT suggesting a benefit to ACT. While there was no difference in OS between patients with tumors ≥4cm with or without ACT, this could be due to the small number of patients with tumors ≥4cm who received ACT. These findings identify a need to further study the roll of systemic therapy after SBRT.

Malaria Is Associated With Kaposi Sarcoma-Associated Herpesvirus Seroconversion in a Cohort of Western Kenyan Children.

We aimed to determine whether Plasmodium falciparum infection affects age of Kaposi sarcoma-associated herpesvirus (KSHV) seroconversion in Kenyan children. Kenyan children (n = 144) enrolled at age 1 month, from 2 sites with different levels of malaria transmission (stable/high vs unstable/low) were followed to age 24 months. Plasma was tested for KSHV antibodies using enzyme-linked immunosorbent assay (ELISA; K8.1 and LANA) and a multiplex bead-based assay (K8.1, K10.5, ORF38, ORF50, and LANA) and whole blood tested for P. falciparum DNA using quantitative PCR. Cox proportional hazards models were used to assess associations between P. falciparum DNA detection, malaria annualized rate (P. falciparum detections/person-years), and enrollment site (malaria-high vs malaria-low) with time to KSHV seroconversion. KSHV seroprevalence was 63% by age 2 years when assessed by multiplex assay. Children with P. falciparum were at increased hazards of earlier KSHV seroconversion and, among children with malaria, the hazard of becoming KSHV seropositive increased significantly with increasing malaria annualized rate. Children from the malaria-high transmission region had no significant difference in hazards of KSHV seroconversion at 12 months but were more likely to become KSHV seropositive by age 24 months. Malaria exposure increases the risk for KSHV seroconversion early in life.

Abstract 14418: Association Between 2018 Unos Heart Transplant Policy Changes and Likelihood of Transplant for Patients in Rural versus Urban Settings

Introduction: United Network for Organ Sharing (UNOS) recently extended the radius for which a heart transplant candidate can be matched with a donor in order to improve transplantation access for the most critically-ill patients. However, this means that smaller transplant centers serving rural populations may not retain the hearts that were donated within their geographic area. It is unknown whether the UNOS policy change of 2018 was associated with differences in likelihood of heart transplantation or death on the waiting list for patients from rural versus urban (metropolitan or micropolitan) settings. Methods: Using the Scientific Registry of Transplant Recipients, we analyzed U.S. adult patients who were listed for heart transplant from January 2017 through January 2020. Patients were stratified by home zipcodes to either metropolitan, micropolitan, or rural settings. Fine and Gray proportional hazard regression models were used to estimate the sub-distribution hazard ratio (SHR) of heart transplantation with death or removal from transplant list as a competing event according to geographic residence with date of UNOS policy change October 18 2018 as a time-varying covariate. Interaction (p-int) tests were performed between geographic setting and time of policy change. Results: Among 8756 patients, 82% were from metropolitan, 9% micropolitan, and 9% rural settings. The 2018 UNOS policy change was associated with increased receipt of heart transplantation within each geographic setting [metropolitan SHR 1.41 (95%CI: 1.33-1.50); micropolitan SHR 1.30 (95%CI: 1.08-1.56); rural SHR 1.33 (95%CI: 1.10-1.62); p-int=0.60]. Policy changes were not significantly associated with death on the transplant list for any geographic setting [metropolitan SHR 0.97 (95%CI: 0.82-1.14); micropolitan SHR 1.25 (95%CI: 0.80-1.96); rural SHR 0.89 (95%CI: 0.55-1.46); p-int=0.52]. Conclusions: Independent of geographic location, the 2018 UNOS policy change for heart transplantation was associated with increased heart transplantation and no significant difference in hazard of death. Additional follow-up is needed to determine whether improvements are sustained.

Cardiovascular toxicity in patients treated with immunotherapy for metastatic non-small cell lung cancer: A SEER-medicare study: CVD outcomes with the use of ICI in mNSCLC

ObjectivesIn recent years immunotherapy has escalated to frontline treatment options for metastatic non-small cell lung cancer. Cardiovascular toxicity from chemotherapeutic agents is well described in this patient population with common underlying risk factors like smoking. We explored cardiovascular toxicity form the addition of immune checkpoint inhibitors to traditional chemotherapy. Materials and MethodsThis is a retrospective study from SEER-Medicare datasets which represents 34 % of the US population. This study included patients age ≥ 65 years-old with newly diagnosed metastatic non-small cell lung cancer between the years 2013 and 2015. Patients were divided into 2 cohorts, one who received traditional chemotherapy only (control arm) and the others who received immune checkpoint inhibitors in addition to traditional chemotherapy (study arm). The primary endpoint was the hazards of new cardiovascular toxicity in the study versus the control arm. ResultsWe identified 6405 patients who met our study criteria. Of these, 5730 patients received chemotherapy only while 675 patients received chemotherapy and immune checkpoint inhibitors. Results showed that the hazard ratio for all cardiovascular toxicity was 0.81 (95 % CI:0.72−0.91, p = 0.0003) in patients who received immune checkpoint inhibitors with chemotherapy. Among the subgroups, hazards ratio for acute coronary syndrome was 0.82 (95 % CI: 0.64–1.05, p = 0.10), hazards ratio for heart failure was 0.74 (95 % CI: 0.62−0.88, p = 0.0007), hazards ratio for cardiac arrhythmia was 0.72 (95 % CI: 0.63−0.82, p < 0.0001) and hazards ratio for heart blocks was 0.48 (95 % CI: 0.30−0.76, p < 0.0001). There was no significant difference in hazards for cardiomyopathy, pericarditis, and myocarditis between the two cohorts. Patients above 75 years, with comorbidities and pre-existing heart disease, were at higher risk. ConclusionsResults from this study are reassuring that adding immune checkpoint inhibitors to chemotherapy is safe and does not result in increased cardiovascular toxicity but instead showed lower hazards.

Risk of cardiovascular disease in women with and without a history of breast cancer: The Pathways Heart Study.

12016 Background: Breast cancer (BC) survivors are at increased risk of cardiovascular disease (CVD) following diagnosis, as compared to women without BC. To provide a population-based estimate of CVD risk in BC survivors, we compared risk of CVD events in women with and without BC history enrolled in the Kaiser Permanente Northern California (KPNC) integrated health system. Methods: Data were extracted from KPNC electronic health records. All invasive BC cases diagnosed between 2005-2013 were identified and matched 1:5 with non-BC controls on birth year, race/ethnicity and KPNC membership at date of BC diagnosis. Cox regression models were used to assess differences in the hazard of four major CVD events (ischemic heart disease (IHD), heart failure (HF), cardiomyopathy, and stroke). Models were adjusted for factors known to influence risk of breast cancer or CVD.Other CVD events included arrhythmia, cardiac arrest, carotid disease, myocarditis/pericarditis, transient ischemic attack, valvular disease, and venous thromboembolism (VTE). We additionally examined subgroups of cases who received chemotherapy, radiation, and endocrine therapy, and their controls. Results: A total of 14,942 women with a new diagnosis of invasive BC were identified and matched to 74,702 women without BC history. On average, women were 62.0 years, 28.3 kg/m2BMI, 64.9% non-Hispanic white. Among all cases and controls, there were no significant differences in hazard of developing IHD, cardiomyopathy, and stroke; there was a borderline difference in HF (HR: 1.08, 95% CI: 0.99, 1.19). Cases were more likely to have a cardiac arrest (HR: 1.39, 95% CI: 1.09, 1.78) and develop VTE (HR: 1.97, 95% CI: 1.74, 2.23). Women treated with chemotherapy were more likely than controls to develop HF (HR: 1.44, 95% CI: 1.21, 1.72), cardiomyopathy (HR: 2.01, 95% CI: 1.02, 3.98), and VTE (HR: 3.15, 95% CI: 2.62, 3.79). Women who received radiation therapy were more likely to develop carotid disease (HR: 5.49, 95% CI: 1.22, 24.66) and VTE (HR: 1.65, 95% CI: 1.35, 2.03) than controls. Women who received endocrine therapy were more likely to experience a cardiac arrest (HR: 1.49, 95% CI: 1.07, 2.09) and develop VTE (HR: 1.70, 95% CI: 1.42, 2.03) than controls. Conclusions: Women with BC were at increased risk of heart failure, cardiomyopathy, cardiac arrest, VTE and carotid disease. These risks varied by cancer treatment, with higher risk in those who received chemotherapy. Future studies should explore the effects of chemotherapy class and radiation dose exposure on diverse CVD endpoints in BC survivors.

Outcomes after ruptured abdominal aortic aneurysm repair in the era of centralized care

ObjectiveLittle is known about the relationship between case volume and patient outcomes of those treated for ruptured abdominal aortic aneurysm (rAAA) after either endovascular aneurysm repair (EVAR) or open aneurysm repair (OAR). This study evaluated the impact of hospital case volume on outcomes after rAAA. MethodsPatients with rAAA were identified in the Society for Vascular Surgery Vascular Quality Initiative database from 2003 to 2017, excluding patients from years in which a limited number of hospitals were included (2003-2009, 2017). Patients were stratified according to type of aneurysm repair and further stratified according to aortic surgical volume of the treating facility. Univariate and multivariable analyses were performed. ResultsBetween 2010 and 2016, of 2895 patients who presented emergently with rAAA, 1246 underwent ruptured OAR (rOAR) and 1649 underwent ruptured EVAR (rEVAR). Before adjustment for demographics, comorbidities, and clinical characteristics, there were no differences in 1-year patient survival based on hospital OAR or EVAR volumes among patients undergoing rOAR or rEVAR. After adjustment for confounding variables, patients treated with rOAR at the highest volume OAR hospitals had a 33% lower hazard of mortality at 1 year relative to patients treated with rOAR at the lowest volume OAR hospitals. Preoperative interfacility transfer was associated with a 27% lower hazard of mortality after rOAR. There was no significant difference in hazard of mortality among patients undergoing rEVAR when they were stratified according to hospital EVAR volumes after adjustment for all other covariates. ConclusionsOutcomes after rAAA repair are associated with hospital volume among patients undergoing rOAR but not among patients undergoing rEVAR. Thus, centralization of care may have an important impact on outcomes when OAR is indicated, suggesting a benefit for preoperative interfacility transfer of care when it is feasible.

No Gender Differences in Long-Term Survival after Brachytherapy of 1,541 Patients with Uveal Melanoma

Background: In several malignancies, gender-based survival differences after specific therapeutic interventions have been demonstrated. It is not known whether such differences exist after plaque brachytherapy of uveal melanoma. Methods: All patients who received brachytherapy for uveal melanoma at St. Erik Eye Hospital from November 1, 1979 through November 20, 2017 were included (n = 1,541). Retrospective data were retrieved including baseline patient and tumor characteristics, brachytherapy nuclide (ruthenium-106 or iodine-125), radiation dose, treatment duration, tumor relapses, date of metastasis, and cause of death. Results: A total of 775 men and 766 women were treated with plaque brachytherapy. There were no significant differences between the genders in baseline characteristics, treatment, or follow-up. Men and women had similar rates of tumor relapses, hazard for repeated brachytherapy (men vs. women 0.8, p = 0.47), enucleation-free survival, and survival after detection of metastasis. Five-, 10-, and 15-year melanoma-related mortality was 14, 24, and 27% for men and 15, 26, and 32% for women, respectively. There were no significant differences in hazard for melanoma-related mortality (men vs. women 0.9, p = 0.32), median Kaplan-Meier disease-specific survival (men 18.2 years, women 15.5 years, p = 0.22), or median overall survival (men 13.5 years, women 12.6 years, p = 0.60). Conclusion: There are no relevant differences between men and women in ocular or patient survival after brachytherapy for uveal melanoma.

Real-world presentation with heart failure in primary care: do patients selected to follow diagnostic and management guidelines have better outcomes?

ObjectiveTo describe associations between initial management of people presenting with heart failure (HF) symptoms in primary care, including compliance with the recommendations of the National Institute for Health and Care...

Safety and Clinical Outcomes of Catheter Ablation of Atrial Fibrillation in Patients With Chronic Kidney Disease.

Data regarding catheter ablation of atrial fibrillation (AF) in patients with chronic kidney disease (CKD) is limited. We therefore assessed the association of CKD with common safety and clinical outcomes in a nationwide sample of ablation recipients. Using MarketScan® Commercial Claims and Medicare Supplemental Databases, we evaluated 30-day safety and 1-year clinical outcomes in patients who underwent a first AF ablation procedure between 2007 and 2011. We calculated frequency of common 30-day complications and calculated frequencies, incidence rates, and Cox proportional hazards for outcomes at 1-year postablation. Of 21,091 patients included, 1,593 (7.6%) had CKD. Patients with CKD were older (64 years vs. 59 years, P < 0.001) with higher CHA2 DS2 -VASc scores (3.2 vs. 1.8, P < 0.001). At 30 days postablation, patients with CKD had similar rates of stroke/TIA (0.13% vs. 0.13%, P = 0.99), perforation/tamponade (3.2% vs. 3.1%, P = 0.83), and vascular complications (2.4% vs. 2.2%, P = 0.59) as patients without CKD, but were more likely to be hospitalized for heart failure (2.1% vs. 0.4%, P < 0.001). In multivariate analysis, there were no significant differences in hazards of AF hospitalization (adjusted HR: 1.02, 95%CI: 0.87-1.20), cardioversion (adjusted HR: 0.99, 95%CI: 0.87-1.12), or repeat AF ablation (adjusted HR: 0.89, 95%CI: 0.76-1.06) at 1 year. Among patients selected for AF ablation, those with and without CKD had similar rates of postprocedural complications although they were more likely to be re-admitted for heart failure. CKD was not independently associated with AF hospitalization, cardioversion, and repeat ablation. These findings can inform clinical decision-making in patients with AF and CKD.

Comparing First- and Second-Season Palivizumab Prophylaxis in Patients with Hemodynamically Significant Congenital Heart Disease (HSCHD) in the ‘Caress’ Database (2005-2014)

Abstract BACKGROUND: Compared with normal children, RSV-related hospi-talization (RSVH) rates in children with HSCHD are 2-4 fold higher even up to 2 years of age with an overall weighted mean mortality rate of 5.2%. Pediatric advisory guidelines recommend prophylaxis against respiratory syncytial virus (RSV) for infants with HSCHD. However, current recommendations cast doubt as to whether prophylaxis is beneficial beyond 1 year of age. OBJECTIVES: To determine whether there are differences in RSVH in HSCHD infants receiving palivizumab during the first versus second RSV season in the Canadian Registry of palivizumab (CARESS). DESIGN/METHODS: CARESS is a prospective registry of infants who received ≥1 dose of palivizumab at one of 32 sites across Canada during the 2005-2014 RSV seasons. Demographic data were collected at enrollment and respiratory-illness-related hospitalization events recorded monthly. In the event of a hospitalization, the relevant hospital records were reviewed by the site’s research nurse for detailed information on criteria for hospital-ization, length of stay (regular ward vs. ICU), days on respiratory support and/or intubation, and RSV test type and diagnosis. Infants aged &amp;lt;24 months with cyanotic or acyanotic HSCHD were recruited. RESULTS: 1306 (64.9%) of 2013 infants received prophylaxis only for the first season. 707 (35.1%) were prophylaxed during the second season (average age in months: 4.7 [first season] vs 14.7 [second season]). Baseline demographics for both seasons were similar. However, infants aged &amp;gt;1year had a more complicated neonatal course, with significantly longer neonatal length of stay (46.7 versus 25.6 days). Infants received: 4.5±1.4 injections; 90.5% of their expected injections and 88.2% of their injections within the appropriate time intervals. 26 infants in the first year (RSVH rate: 2.26%) and 11 infants in the second year (RSVH rate: 2.09%) were hospitalized. Cox regression analysis showed no significant differences in hazards between infants in their first or second year of prophylaxis in the time to first RSVH (Hazard ratio: 1.4, 95%CI 0.5-4.0, p=0.52) CONCLUSION: Infants enrolled in the CARESS database in the second RSV season had a similar hazard of RSVH as those in the first year of life. These findings suggest that infants aged &amp;gt;1 year with HSCHD who remain unstable, are equally at risk for RSVH and merit palivizumab prophylaxis.

Persistence, adherence, and all-cause healthcare costs in atazanavir- and darunavir-treated patients with human immunodeficiency virus in a real-world setting

Objectives:Atazanavir (ATV) and darunavir (DRV) are protease inhibitors approved for HIV treatment in combination with ritonavir (/r). The objectives of this study were to compare persistence (time to treatment discontinuation/modification), adherence, and healthcare costs among patients with human immunodeficiency virus (HIV) initiating ATV/r or DRV/r.Methods:This retrospective cohort study used commercial and Medicaid administrative insurance claims data. Patients initiating ATV/r or DRV/r from 2006–2013 with continuous enrollment for ≥6 months before and ≥3 months after initiation were included. Patients were followed from initiation until discontinuation/modification (≥30 day gap in ATV or DRV or initiation of a new antiretroviral medication), during which time adherence (proportion of days covered [PDC], with PDC ≥80% or 95% considered adherent) and per-patient per-month (PPPM) total healthcare costs were measured. DRV/r patients were propensity score matched to ATV/r patients at a 1:1 ratio to achieve balance on potentially confounding demographic and clinical factors. Commercial and Medicaid samples were analyzed separately, as were antiretroviral (ART)-naïve and experienced patients.Results:The final samples comprised 2988 commercially-insured and 1158 Medicaid-insured patients. There were no significant differences in hazards of discontinuation/modification between the ATV/r or DRV/r cohorts. With respect to odds of being adherent, the only marginally significant result was comparing odds of achieving PDC ≥80% among ART-naïve Medicaid patients, which favored ATV/r. All other adherence comparisons were not significant. Although ATV/r cohorts tended to have lower PPPM costs, the majority of these differences were not statistically significant.Conclusions:Patients with HIV treated with either ATV/r or DRV/r had similar time to treatment discontinuation/modification, adherence, and monthly healthcare costs. Results were similar across the pre-specified sub-groups. These findings are useful not only as an insight into clinical practice, but also as a resource for healthcare providers and payers evaluating treatment options for HIV+ individuals.

Modality of RRT and Recovery of Kidney Function after AKI in Patients Surviving to Hospital Discharge.

Observational evidence has suggested that RRT modality may affect recovery after AKI. It is unclear whether initial choice of intermittent hemodialysis or continuous RRT affects renal recovery, survival, or development of ESRD in critically ill patients when modality choice is made primarily on hemodynamics. We performed a retrospective cohort study examining adults (≥18 years old) admitted to intensive care units from 2000 to 2008 who received RRT for AKI and survived to hospital discharge or 90 days. We analyzed renal recovery (alive and not requiring RRT) and reasons for nonrecovery (death or ESRD) at 90 and 365 days. Conditional multivariable logistic regression was used to assess differences in renal recovery at 90 and 365 days between continuous RRT and intermittent hemodialysis. Models were stratified by propensity for continuous RRT and adjusted for age and reference creatinine. Of 4738 patients with Kidney Disease Improving Global Outcomes stage 3 AKI, 1338 (28.2%) received RRT, and 638 (47.7%) survived to hospital discharge (353 intermittent hemodialysis and 285 continuous RRT). Recovery from AKI was lower for intermittent hemodialysis versus continuous RRT at 90 days (66.6% intermittent hemodialysis versus 75.4% continuous RRT; P=0.02) but similar at 365 days (54.1% intermittent hemodialysis versus 59.6% continuous RRT; P=0.17). In multivariable analysis, there was no difference in odds of recovery at 90 or 365 days for patients initially treated with continuous RRT versus intermittent hemodialysis (90 days: odds ratio, 1.19; 95% confidence interval, 0.91 to 1.55; P=0.20; 365 days: odds ratio, 0.93; 95% confidence interval, 0.72 to 1.2; P=0.55). We found no significant difference in hazards for nonrecovery or reasons for nonrecovery (mortality or ESRD) with intermittent hemodialysis versus continuous RRT. These results suggest that, when initial RRT modality is chosen primarily on hemodynamics, renal recovery and clinical outcomes in survivors are similar between intermittent hemodialysis and continuous RRT.

Effect of surgical treatment on mortality after acetabular fracture in the elderly: a multicenter study of 454 patients.

Controversy exists regarding the effect of operative treatment on mortality after acetabular fracture in elderly patients. Our hypothesis was that operative treatment would confer a mortality benefit compared with nonoperative treatment even after adjusting for comorbidities associated with death. Retrospective study. Three University Level I Trauma Centers. All patients aged 60 years and older with acetabular fractures treated from 2002 to 2009 were included in the study. Four hundred fifty-four patients were identified with an average age of 74 years. Sixty-seven percent of the study group was male and 33% female. One of 4 treatments: nonoperative management with early mobilization, percutaneous reduction and fixation, open reduction and internal fixation, acute total hip arthroplasty. Kaplan-Meier survival curves were created, and Cox proportional hazards models were used to calculate unadjusted and adjusted hazard ratios (HRs) for covariates of interest. In contrast to previous smaller studies, the overall mortality was relatively low at 16% at 1 year [95% confidence interval (CI), 13-19]. Unadjusted survivorship curves suggested higher 1-year mortality rates for nonoperatively treated patients (21% vs. 13%, P < 0.001); however, nonoperative treatment was associated with other risk factors for higher mortality. By accounting for these patient risk factors, our final multivariate model of survival demonstrated no significant difference in hazard of death for nonoperative treatment (0.92, P = 0.6) nor for any of the 3 operative treatment subgroups (P range, 0.4-0.8). As expected, we did find a significantly increased hazard for factors such as the Charlson comorbidity index [HR, 1.25 per point (95% CI, 1.16-1.34)] and age [HR, 1.08 per year of age more than 70 years (95% CI, 1.05-1.11)]. In addition, associated fracture patterns (compared with elementary patterns) significantly increased the hazard of death with a ratio of 1.51 (95% CI, 1.10-2.06). The operative treatment of acetabular fractures does not increase or decrease mortality, once comorbidities are taken into account. The reasons for this are unknown. Regardless of the causes, the decision for operative versus nonoperative treatment of geriatric acetabular fractures should not be justified based on the concern for increased or decreased mortality alone. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.