545. A Retrospective Review of 30-day Mortalities in Solid-Organ Transplant Recipients (SOT) versus Non-Transplant Patients (NTP) Receiving Remdesivir (REM) and Dexamethasone (DEX) for COVID-19 Pneumonia

Abstract Background Treating COVID-19 infection in SOT is challenging due to long-term use of immunosuppressive agents. REM is the only FDA-approved anti-viral for SARS-COV-2 infection. DEX showed decrease in mortality in the Recovery Trial. COVID-19 treatment guidelines for SOT patients are the same as NTP despite limited literature on those outcomes. Our primary objective was to determine if 30-day mortality was different between SOT and NTP matched cohorts using these 2 drugs. The secondary objectives included comparisons of length of stay (LOS), days on mechanical ventilation (DMV), and the use of other treatment modalities. Methods We retrospectively collected data for hospitalized SOT and NTP, 18 years and older, with pcr-confirmed SARS-CoV-2 infection receiving REM and DEX from May 1, 2020, to October 10, 2020, at Mayo Clinic Florida. IRB approval was obtained. Descriptive statistics were used to analyze the data. Continuous variables were summarized as mean (standard deviation) or median (range) where appropriate, while categorical variables were reported as frequency (percentage). Results Of 80 patients who met the inclusion criteria, 28 were SOT, and 52 were NTP. The SOT cohort was subcategorized below: SOT patients were significantly younger than NTP (p < .001). Further, SOT patients had significantly longer LOS (p = 0.043) and more COVID-19 modalities (75% vs. 36.5%, p = 0.002) compared to NTP. Among the 28 SOT patients, 2 of them died within 30 days of admission, and among the 52 NTP patients, 7 of them died within 30 days. The 30-d survival estimate for SOT group is 92.9% (95% CI: 83.8% - 100.0%) and for NTP group is 86.5% (95% CI: 77.7% - 96.3%). The log-rank test was not significant between the groups (p=0.37), but the NTP has a worse survival curve from the figure below. SOT-NTP Survival Curve Conclusion SOT group was younger, had longer LOS, and more COVID-related modalities. The 30-d survival estimate for SOT group is 92.9% and for NTP group is 86.5%, but the survival curve for NTP was worse likely secondary to age. Use of REM & DEX in SOT recipients is a valid recommendation. Disclosures Claudia R. Libertin, MD, Gilead (Grant/Research Support)

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Epilepsy as a Comorbidity in Polymyositis and Dermatomyositis—A Cross-Sectional Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18083983 ◽

2021 ◽

Vol 18 (8) ◽

pp. 3983

Author(s):

Ella Nissan ◽

Abdulla Watad ◽

Arnon D. Cohen ◽

Kassem Sharif ◽

Johnatan Nissan ◽

...

Keyword(s):

Proportional Hazards ◽

Cross Sectional Study ◽

Cox Proportional Hazards ◽

Categorical Variables ◽

Rank Test ◽

Control Group ◽

Multivariable Logistic Regression Analysis ◽

Positive Trend ◽

Continuous Variables ◽

Cross Sectional

Polymyositis (PM) and dermatomyositis (DM) are autoimmune-mediated multisystemic myopathies, characterized mainly by proximal muscle weakness. A connection between epilepsy and PM/DM has not been reported previously. Our study aim is to evaluate this association. A case–control study was conducted, enrolling a total of 12,278 patients with 2085 cases (17.0%) and 10,193 subjects in the control group (83.0%). Student’s t-test was used to evaluate continuous variables, while the chi-square test was applied for the distribution of categorical variables. Log-rank test, Kaplan–Meier curves and multivariate Cox proportional hazards method were performed for the analysis regarding survival. Of the studied 2085 cases, 1475 subjects (70.7%) were diagnosed with DM, and 610 patients (29.3%) with PM. Participants enrolled as cases had a significantly higher rate of epilepsy (n = 48 [2.3%]) as compared to controls (n = 141 [1.4%], p < 0.0005). Using multivariable logistic regression analysis, PM was found only to be significantly associated with epilepsy (OR 2.2 [95%CI 1.36 to 3.55], p = 0.0014), whereas a non-significant positive trend was noted in DM (OR 1.51 [95%CI 0.99 to 2.30], p = 0.0547). Our data suggest that PM is associated with a higher rate of epilepsy compared to controls. Physicians should be aware of this comorbidity in patients with immune-mediated myopathies.

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Treatment Reality of Patients with Immune Thrombocytopenia (ITP) in Routine Care

Blood ◽

10.1182/blood.v124.21.5009.5009 ◽

2014 ◽

Vol 124 (21) ◽

pp. 5009-5009

Author(s):

Rudolf Weide ◽

Stefan Feiten ◽

Vera Friesenhahn ◽

Jochen Heymanns ◽

Kristina Kleboth ◽

...

Keyword(s):

Bone Marrow ◽

Bone Marrow Biopsy ◽

Treatment Guidelines ◽

Conflicts Of Interest ◽

Treatment Options ◽

Immunosuppressive Agents ◽

Routine Care ◽

Treatment Modalities ◽

Bleeding Complications ◽

Line Therapy

Abstract Introduction: New treatment options like thrombopoietin receptor agonists (TRAs) and rituximab have been introduced into the clinic which have found their way into national and international treatment guidelines. The aim of this study was to answer the following questions concerning diagnosis and treatment of patients with ITP in routine care: How are patients diagnosed and treated?Which sequences of therapy are applied?How many patients die due to bleeding complications? Methods: All patients with ITP diagnosed between 06/1995-06/2014 in a community-based oncology group practice in Germany were analyzed retrospectively. Results: 402 patients with a median age of 55 (7-90) were evaluated. 57% were female and 43% male. 357 (89%) were classified as primary ITP and 311 (77%) as having chronic ITP. In 234 patients (58%) a bone marrow biopsy was part of the diagnostic work up. Only 191 patients (48%) needed therapy. First line therapy (n=191) were steroids in 81%, intravenous immunoglobulins (ivIgG) in 12% and ivIgG plus steroids in 6%. Second line therapy (n=102) were ivIgG in 49%, steroids in 23%, ivIgG plus steroids in 17%, other immunosuppressive agents in 11% and splenectomy in 5%. Third line therapy (n=63) was splenectomy in 22%, other immunosuppressive agents in 27%, steroids in 19%, ivIgG in 16%, 11% combination therapy, rituximab in 10% and TRAs in 5%. Fourth line therapy (n=38) consisted of steroids in 26%, splenectomy in 26%, immunosuppressive agents in 34%, ivIgG in 13%, rituximab in 11% and TRAs in 3%. Patients received a median of 2 lines (1-10) of therapy. Treatment modalities most frequently used were steroids in 93%, immunoglobulins in 56%, splenectomy in 21% and other immunosuppressive agents in 21% of patients. Rituximab and TRAs were used in 10% and 5% only. 75% of patients received a durable remission (complete or partial) after their last therapy. 10% showed no response, in 15% remission couldn't be evaluated due to external treatments. 146 patients (76%) are off treatment. 1 patient (0.2%) died due to bleeding complications. Conclusions: Bone marrow biopsy is used as a diagnostic procedure in 58% of patients. Treatment modalities most frequently used are steroids, immunoglobulins, splenectomy and other immunosuppressive agents. Rituximab and TRAs are used infrequently. A high percentage of ITP-patients achieve durable remissions and ITP-related mortality is low. Disclosures No relevant conflicts of interest to declare.

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LO48: Similarities and differences between sports and recreation-related concussions and concussions from non-sport activities

CJEM ◽

10.1017/cem.2019.91 ◽

2019 ◽

Vol 21 (S1) ◽

pp. S24-S25

Author(s):

L. Gaudet ◽

L. Eliyahu ◽

M. Mrazik ◽

J. Beach ◽

G. Cummings ◽

...

Keyword(s):

Glasgow Coma Scale ◽

Scale Score ◽

Glasgow Coma Scale Score ◽

Treatment Guidelines ◽

Short Form ◽

Signs And Symptoms ◽

Categorical Variables ◽

Continuous Variables ◽

Coma Scale ◽

Injury Characteristics

Introduction: Patients with concussion often present to the emergency department (ED). Although sports and recreation (SR) activities account for less than half of all adult concussions, guidelines developed for management of SR-related concussions (SRC) are widely used for all concussion patients. This study aimed to identify whether there are clinically relevant differences in patient and injury characteristics between SRC and those occurring outside of SR activities. Methods: Adults ( >17 years) presenting from April 2013 to April 2015 with a concussion to one of three EDs with Glasgow coma scale score ≥13 were recruited by on-site research assistants. Data on patient characteristics (i.e., age, sex, employment, lifestyle, relevant medical history), ED presentation (i.e., EMS arrival, hours since injury, CTAS, Glasgow Coma Scale score) and injury characteristics (i.e., activity leading to injury, loss of consciousness [LOC], signs and symptoms [scored using the Rivermead Post-Concussion Questionnaire], and health-related quality of life [from the 12-Item Short Form Health Survey [SF-12]) were collected from structured interviews and the ED chart. Dichotomous and categorical variables were compared using Fisher's exact test; continuous variables were compared using t-tests or Mann-Whitney tests, as appropriate. Results: In total, 248 patients were enrolled (47% male, median [IQR] age: 35 [23, 49]). Patients with SRC were younger (median: 23.5 years vs 35 years; p < 0.001), more likely to be a student (31% vs 8%; p > 0.001), and more likely to exercise regularly (89% vs 66%; p = 0.001). Patients with SRC were less likely to present during the daytime (66% vs. 77%; p = 0.022), less likely to have a history of mental health issues (18% vs 33%; p = 0.011) and had significantly higher median SF-12 physical components scores (55.5 [IQR: 51.4 to 57.8] vs. 53.5 [IQR: 45.5 to 56.7]; p = 0.025). All other characteristics were similar between the two groups. Conclusion: Although differences in demographics and lifestyle have been identified between patients sustaining a SRC and those concussed during other activities, injury characteristics, such as presentation acuity, proxies for severity, and signs and symptoms, were similar in both groups. Further analysis to assess whether the demographic and lifestyle differences affect clinical outcomes, such as time to symptom resolution, between these two groups is required to assess if sport-based treatment guidelines are appropriate for all patients.

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PP54 A Cohort Case Study On Implantable Cardioverter Defibrillators

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319002083 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 47-47

Author(s):

Augusto Cesar Soares dos Santos ◽

Maria da Glória Cruvinel Horta ◽

Mariana Fernandes ◽

Luíza Rodrigues ◽

Lélia Maria de Almeida Carvalho ◽

...

Keyword(s):

Median Survival ◽

Ventricular Arrhythmias ◽

Survival Curve ◽

Cardiac Resynchronization ◽

Rank Test ◽

Implantable Cardioverter Defibrillators ◽

Continuous Variables ◽

Belo Horizonte ◽

Cardioverter Defibrillators

IntroductionMany patients presenting with arrhythmias are treated with antiarrhythmic drug therapy. However, for some patients, usually survivors of previous serious ventricular arrhythmias, treatment implies the use of implantable cardioverter defibrillators (ICDs) and/or Cardiac Resynchronization Therapy (CRT) devices.MethodsThis retrospective study evaluated a cohort of patients with arrhythmia requiring the use of ICDs, CRT or ICDs + CRT from January 2004 to March 2018. Data from a private healthcare organization in Belo Horizonte, Brazil were used to assess all-cause mortality and the need for replacement of the device. Continuous variables were expressed as mean and standard deviation. Cox proportional regression model and Log-Rank test were used to adjust the survival curve.ResultsFive hundred and ninety-three patients were included in the study (median age 67.6 years, range 23 to 89 years; male 62 percent). According to the type of device used to treat these patients, the distribution was 338 (57.0 percent), 169 (28.5 percent), 86 (14.5 percent), for ICDs, ICDs + CRT, CRT, respectively. After a mean follow-up time of 3.12 years (range 0 to 13.6 years), 283 devices were replaced (ICDs n = 140; ICDs + CRT n = 90; CRT n = 53) and 284 deaths occurred (median survival of 6.9 years). The median survival was 7.3, 5.8, 4.8, 5.5 years for ICDs single-chamber, ICDs dual-chamber, ICDs + CRT, CRT, respectively.ConclusionsRandomized trials are often criticized for their enrollment of highly selected patients. Studies on real-word data can provide reliable information regarding the use of ICDs and/or CRT devices in the treatment of patients with serious ventricular arrhythmias.

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The prognostic significance of white adipose tissue inflammation in advanced-stage, high-grade, and serous endometrial cancers.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.5589 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 5589-5589

Author(s):

Vance Broach ◽

Neil M. Iyengar ◽

Xi K. Zhou ◽

Hanhan Wang ◽

Dilip D. Giri ◽

...

Keyword(s):

Adipose Tissue ◽

Endometrial Cancer ◽

White Adipose Tissue ◽

Prognostic Significance ◽

Categorical Variables ◽

Rank Test ◽

Adipose Tissue Inflammation ◽

Continuous Variables ◽

Tissue Inflammation ◽

Endometrial Cancers

5589 Background: Obesity is associated with worse outcomes in endometrial cancer, but the underlying mechanisms are poorly understood. In other obesity-related cancers, white adipose tissue inflammation (WATi) is an independent predictor of shortened cancer-specific survival. We hypothesized that WATi occurs in patients with endometrial cancers and is a prognostic marker of shortened survival. Methods: We conducted a retrospective cohort study in which patients with stage III or IV grade 3 endometrioid (G3) or serous endometrial cancer were included. Eligible subjects had archived omental and/or peri-nodal adipose tissue available. WATi was detected by the presence of dead/dying adipocytes surrounded by CD68+ macrophages forming a crown-like structure (CLS). Clinicopathologic data were abstracted from medical records. For association with WATi, Wilcoxon rank sum test was used for continuous variables, Fisher’s exact test for categorical variables. Log rank test was used to assess the association of WATi and survival. Results: A total of 95 patients who underwent debulking surgery from 2001–2017 were included (median age, 67 years; range, 33-86 years). Of these, 51 (54%) had WATi. The presence of WATi was unaffected by race, tumor histology or stage. Patients with WATi had a higher median body mass index (BMI) than those without WATi (32.17 and 27.33 kg/m2, respectively; P < 0.001) and were more likely to be obese (P = 0.01). Patients with the most severe WATi (n = 20) had shorter progression-free survival (PFS) and a trend suggesting shorter overall survival (OS) than those patients with less severe or no WATi (n = 75) (median PFS 15.8 vs 59.2 months, respectively, P = 0.001; median OS 33.9 vs 59.4 months, respectively, P = 0.059). Conclusions: Visceral adipose inflammation is prevalent in obese patients with advanced G3 and serous endometrial cancer. Severe inflammation was associated with significantly worse PFS.

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Radiation and cardiotoxicity: A retrospective analysis of a midwest population.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e12616 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e12616-e12616

Author(s):

Nitin Tandan ◽

Cameron Koester ◽

Priyanka Parajuli ◽

Odalys Estefania Lara Garcia ◽

Manjari Rani Regmi ◽

...

Keyword(s):

Breast Cancer ◽

Radiation Therapy ◽

Cancer Patients ◽

Large Scale ◽

Categorical Variables ◽

Rank Test ◽

Continuous Variables ◽

Breast Cancer Patients ◽

Cardiac Events ◽

Coronary Syndrome

e12616 Background: The most common female malignancy diagnosed in the US is breast cancer. Early breast cancer therapy is often treated with radiation therapy; one of the unfortunate side effects of radiotherapy in the past has been cardiotoxicity, especially coronary artery disease. Recent usage of dose reduction techniques have helped reduce these effects. Here, we present our analysis of breast cancer patients that received radiation therapy and the likelihood of cardiotoxicity. Methods: An IRB-approved retrospective study was performed utilizing ICD codes to analyze patients diagnosed with biopsy-confirmed breast cancer between January 1, 2014 and December 31, 2017. 478 of 1618 de-identified patients qualified for this study. Statistical analysis was performed with SAS v9.4. Descriptive statistics were computed for all study variables. Continuous variables were described with measures of central tendency (mean, median) and dispersion (range, standard deviation). Categorical variables were summarized as frequencies and percentages. Comparisons between categorical variables were compared with the Chi-Square test (or Fisher’s Exact) where appropriate. Survival curves were estimated using Kaplan-Meier methodology and analyzed with a log rank test. Predictors of survival were assessed with Cox proportional hazards regression analyses. All significance is assumed at the p < 0.05 level. Results: Of the 478 eligible patients, heart failure (HF), HF hospitalizations, acute coronary syndrome and overall cardiac events were compared among breast cancer patients. Patients who received radiation experienced HF 6.02% compared to 4.61% without radiation (p = 0.574). HF hospitalization was recorded as 2.27% in radiotherapy compared to 1.23% in non-radiotherapy patients (p = 0.686). Patients who radiation experienced ACS 2.27% of the time as compared to 1.21% in patients who were not treated with radiation. Of note, 9.25% receiving radiation experienced cardiac events compared to 4.24% in patients without radiation (p = 0.068). While results were not statistically significant, the trend of elevated cardiac events in breast cancer patients receiving radiation is noteworthy. Conclusions: Per our study, although statistically insignificant, radiation therapy may result in higher incidence of cardiac events in breast cancer patients. Further large-scale, prospective studies should be performed to confirm the aforementioned trends with respect to survival outcomes in urban and rural populations.

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Abstract 3: Association of Video- vs. Text-Based Informed Consent With Multicenter Registry Enrollment

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.11.suppl_1.3 ◽

2018 ◽

Vol 11 (suppl_1) ◽

Author(s):

Alexander C Fanaroff ◽

Shuang Li ◽

Vincent Miller ◽

Laura Webb ◽

Ann Marie Navar ◽

...

Keyword(s):

Informed Consent ◽

Management Practices ◽

Categorical Variables ◽

Rank Test ◽

Continuous Variables ◽

Chi Square ◽

Lipid Management ◽

Significant Difference ◽

Activation Times ◽

Multicenter Registry

Background: Low patient participation in clinical research undermines the generalizability of findings. Conducting informed consent by video rather than a traditional text format may enhance the appeal of research and break down barriers to participation. Methods: The Patient and Provider Assessment of Lipid Management (PALM) Registry enrolled patients at U.S. cardiology, endocrinology, and primary care clinics to evaluate cholesterol management practices. PALM investigators developed an iPad-based video informed consent tool that included video segments totaling 8 minutes which patients navigated though a “game-ified” interface. At sites whose IRB did not approve the video tool, participants read a 6-page text consent form on the iPad. Characteristics of sites and site activation times were compared between sites that did and did not use the video consent tool using Pearson’s chi-square test for categorical variables and Wilcoxon’s signed rank test for continuous variables. Results: Of 140 sites that enrolled 7904 patients in PALM, 60 (42.9%) used the video informed consent tool. Compared with sites using text consent, sites using the video consent tool were more often rural (16.7 vs. 3.8%, p = 0.01) and used a central IRB (91.7 vs. 80.0%, p = 0.06). Sites using video consent enrolled a greater proportion of patients who were ≥ 75 years old (27.5 vs. 23.6%, p < 0.001) or non-white (17.7 vs. 14.2%, p < 0.001). Sites using video consent had shorter times from site approach to first patient enrollment ( Figure ). Median (IQR) enrollment was 33 (12, 98) patients at sites using video consent versus 24 (12, 86) at sites using text consent only (p = 0.54); there was also no significant difference in median weekly enrollment rate (2.9 [1.1, 7.5] vs. 2.8 [1.3, 6.6], p = 0.73). Conclusions: In this early experience with video consent in a multicenter registry, availability of video informed consent was associated with greater enrollment of older and non-white patients, faster speed to first patient enrolled, and numerically but not significantly more rapid enrollment compared with text informed consent.

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Left atrial remodeling after Mitraclip implantation

European Heart Journal ◽

10.1093/ehjci/ehaa946.0003 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

G Neri ◽

I Aquila ◽

M Albanese ◽

G Panuccio ◽

A Polimeni ◽

...

Keyword(s):

Mitral Regurgitation ◽

Left Atrial ◽

Global Longitudinal Strain ◽

Matched Pair ◽

Categorical Variables ◽

Rank Test ◽

Atrial Remodeling ◽

Continuous Variables ◽

Paired Data ◽

Systolic Volume

Abstract Objective Changes in left atrial (LA) size and function are associated with major adverse cardiovascular outcomes such as atrial fibrillation, heart failure, stroke, and death. Reverse LA remodelling occurs after successful surgical mitral valve repair for severe MR. Changes in LA volumes after MV repair have reported in several studies. However, LA data are limited in the setting of transcatheter repair. Materials an methods From November 2016 to July 2018, clinical and echocardiographic data of 42 patients with mitral regurgitation who underwent Mitraclip implantation in our division were evaluated for LA function: LA global longitudinal strain (LA GLS); LAESV (Left atrial end-systolic volume), LAEDV (Left atrial end-diastolic volume); LA emptying Fraction at baseline, at 1 month, at 6 months and 1 year of follow up were assessed. The variation of continuous variables was evaluated using a student T test for paired data or the Wilcoxon matched-pair signed rank test when appropriate. The categorical variables between two groups were evaluated using the chi-square test (χ2). P values <0.05 were considered significant. Results The etiology of the mitral regurgitation was primary in 33,3% and secondary in 66,7% of the included patients. The MR degree was 3+ in 21,4% of patients and 4+ in 78,6%. When compared to baseline at 6 months and 1 year a statistically significant reduction was observed for both LAESV (p<0.001) and LAEDV (p<0.001). At 6 months, compared to baseline, the LA GLS reached statistic relevance (p 0.05) with a significant improvement at 1 year (p 0.001). Finally, we did not find significant differences in LA emptying fraction at different time point analyzed. Conclusions A successful MitraClip procedure can reverse the process of LA remodeling within 12 months, and this can be detected by Two-dimensional speckle tracking echocardiography (2D STE) through an improvement in the LA reservoir function. These data generate the hypothesis that the GLS, compared to conventional echocardiographic parameters, represents an advanced method that quantify atrial function in Mitraclip implanted patients. Funding Acknowledgement Type of funding source: Public hospital(s)

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Haploidentical Allogeneic Transplantation Provides Comparable Outcomes to HLA-Matched or Mismatched Unrelated Donor Grafts in Hematological Malignancies

Blood ◽

10.1182/blood.v124.21.1226.1226 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1226-1226

Author(s):

Melissa F Baker ◽

Daniel Kim ◽

Michele L Donato ◽

Andrew L Pecora ◽

David H. Vesole ◽

...

Keyword(s):

Conflicts Of Interest ◽

Allogeneic Transplantation ◽

Outcome Data ◽

Categorical Variables ◽

Rank Test ◽

Control Group ◽

Unrelated Donor ◽

Continuous Variables ◽

Exact Test ◽

Post Transplant

Abstract Haploidentical (HAPLO) and unrelated donors (URD) are established cell sources for patients (pts) who lack HLA-matched siblings. Limited data are available comparing transplant (TP) outcomes using cells from HAPLO vs URD donors. We performed a retrospective analysis of sequential pts (n=54) undergoing HAPLO transplants with post-transplant cyclophosphamide (Cy). A control group of HLA 7/8 or 8/8 matched URD recipients (n=59) matched by diagnosis, transplant date, and cell source (PBSC or marrow) was identified (Table). Most HAPLO pts received cycles of pre-TP fludarabine (Flu) for lymphodepletion to achieve CD4 <0.2x109/l. HAPLO pts received Flu 30 mg/m2 qd x 5 with Cy 14.5 mg/kg qd x 2, followed by TBI, 200-400 cGy in 1 or 2 fractions (physician discretion). PB (n= 30) or BM (n= 24) was infused from 1st or 2nddegree related HAPLO donors. Post-transplant immunosuppression was Cy 50-60 mg/kg on days +3 and +4, followed by tacrolimus (tacro) and mycophenolate (MMF) starting on day +5. Pts received filgrastim daily starting at day +5. URD recipients were conditioned with a variety of standard myeloablative (n=23) or reduced intensity (n=36) regimens, and received PB (n= 40) or BM (n= 19), with daily filgrastim starting on day +9. GvHD prophylaxis was tacro and short-course methotrexate (n= 53) or tacro/MMF (n=6). CD3+ and CD15+ cell chimerisms were assessed at 4 week intervals commencing at day +28. Bone marrow staging and CD34+ cell chimerism were assessed at day +84. GvHD was staged per standard guidelines. Analysis of categorical variables was performed using the Fisher's exact test. Non-parametric analysis of median values was used for continuous variables. Survival was assessed using the log-rank test. Informed consent for analysis of transplant outcome data was obtained before transplantation for all patients and donors. Engraftment kinetics in the HAPLO cohort was slightly slower compared to the URD cohort, ANC >0.5x109/l at a median of 16 days (range: 13-45) vs 13 days (range: 9-25, p<0.001); PLT >20x109/l median 24 days (range: 13-109) vs 15 days (range: 8-216, p= 0.02). ANC and PLT recoveries were faster for URD PB compared to BM recipients. However, engraftment kinetics did not differ for HAPLO PB or BM recipients, (ANC median days 16.5 vs. 16, p=0.38; PLT median 24 vs 26 days p=0.80). HAPLO donor CD3 engraftment was robust, with 44 of 48 (92%) HAPLO compared to 37 of 52 (71%) URD recipients achieving >95% CD3+ chimerism at day +28 (p=0.01). Engraftment failure defined by failure to achieve ANC recovery and day +28 donor CD3 chimerism >5% was reported in 4 (7.4%) HAPLO and 2 (3%) URD recipients (p=0.42). The cumulative incidence of grade II-IV aGVHD by day 100 was similar for both groups (61% vs 47%, p=0.19). The cumulative incidences of cGVHD in the HAPLO vs URD cohorts were comparable (39% vs 36%, p=0.84) and the incidence of moderate or severe cGVHD was 15% and 22%, respectively (p=0.34). At time of analysis, relapse occurred for 37% HAPLO pts (n=20) compared to 33% (n=20) in the URD group (p=0.84). 23 pts died (43%) in the HAPLO group: 12 from relapse, 5 from infection, 6 from other causes. In the URD group, 23 (39%) died: 13 from relapse, 3 from infection, 7 from other causes. The one-yr survival probabilities were 56% HAPLO and 66% URD, with median OS probabilities 18 mo and 22 mo (p=0.85). OS was lower for recipients of 7/8 vs 8/8 matched URD grafts, but the difference was not significant (not shown). These results show similar outcomes after HAPLO and URD transplant for engraftment, GvHD, relapse and OS. Almost all HAPLO pts achieved full donor CD3+ chimerism by day +28. In conclusion, HAPLO transplant with post transplant Cy is an option for pts lacking HLA matched siblings; prospective studies are needed to validate these findings. Figure 1 Figure 1. ; Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.

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Age is not the only risk factor in COVID-19: the role of comorbidities and of long staying in residential care homes.

10.21203/rs.3.rs-42681/v1 ◽

2020 ◽

Author(s):

Michela D'Ascanio ◽

Marta Innammorato ◽

Lara Pasquariello ◽

Dario Pizzirusso ◽

Giulio Guerrieri ◽

...

Keyword(s):

Elderly Patients ◽

Residential Care ◽

Pneumonia Severity Index ◽

University Hospital ◽

Care Homes ◽

Categorical Variables ◽

Rank Test ◽

Continuous Variables ◽

Very Elderly ◽

Arterial Blood

Abstract Background: The actual SARS-CoV-2 outbreak caused a highly transmissible disease with a tremendous impact on elderly people. So far, few studies focused on very elderly patients (over 80 years old). In this study we examined the clinical presentation and the evolution of the disease in this group of patients, admitted to our Hospital in RomeMethods: This is a single-center, retrospective study performed in the Sant’Andrea University Hospital of Rome. We included patients older than 65 years of age with a diagnosis of COVID-19, from March 2020 to may 2020, divided in two groups according to their age (G1 65-80 years old; G2 >80 years old). Data extracted from the each patient record included age, sex, comorbidities, symptoms at onset, the Pneumonia Severity Index (PSI), the ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2) (P/F) on admission, laboratory tests, radiological findings on computer tomography (CT), length of hospital stay (LOS), mortality rate and the viral shedding. The differences between the two groups were analyzed by the Fisher’s exact test or the Wilcoxon signed-rank test for categorical variables and the Mann-Whitney U test for continuous variables. The survival time was estimated by Kaplan-Meier method and Log Rank Test. Univariable Cox proportional hazard regression and ordinal logistic regression were performed to estimate associations between age, comorbidities and provenance from residential care homes and clinical outcomes.Results: We found that G2 patients had an increased mortaliy rate, also due to (the frequent prevalence of) multiple comorbidities. Moreover we found that patients coming from long-stay residential care homes appeared to be highly susceptible and vulnerable to develop severe manifestations of the disease.Conclusion: We demonstrate that there were considerable differences between Elderly and Very Elderly patients in terms of inflammatory activity, severity of disease, adverse clinical outcomes; moreover, to establish a correct risk stratification, comorbidities and information about provenience from residential care homes should be considered.

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