scholarly journals Chasing a rarity: a retrospective single-center evaluation of prognostic factors in primary gliosarcoma

2021 ◽  
Author(s):  
Cas S. Dejonckheere ◽  
Alexander M. C. Böhner ◽  
David Koch ◽  
Leonard C. Schmeel ◽  
Ulrich Herrlinger ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Small Sample Size ◽  
Symptom Burden ◽  
Promoter Hypermethylation ◽  
Small Sample ◽  
Single Center ◽  
Who Grade ◽  
Entire Cohort ◽  
Time To Death ◽  
Time To Recurrence

Abstract Background and purpose Primary gliosarcoma (GS) is a rare variant of IDH-wildtype glioblastoma multiforme. We performed a single-center analysis to identify prognostic factors. Patients and methods We analyzed the records of 26 patients newly diagnosed with primary WHO grade IV GS. Factors of interest were clinical and treatment data, as well as molecular markers, time to recurrence, and time to death. Results Median follow-up was 9 months (range 5–21 months). Gross total resection did not lead to improved survival, most likely due to the relatively small sample size. Low symptom burden at the time of diagnosis was associated with longer PFS (P = 0.023) and OS (P = 0.018). Median OS in the entire cohort was 12 months. Neither MGMT promoter hypermethylation nor adjuvant temozolomide therapy influenced survival, consistent with some previous reports. Conclusion In this retrospective study, patients exhibiting low symptom burden at diagnosis showed improved survival. None of the other factors analyzed were associated with an altered outcome.

scholarly journals PROGNOSTIC FACTORS IN MYELODYSPLASTIC SYNDROMES: SINGLE-CENTER EXPERIENCE

2019 ◽  
Vol 141 (7-8) ◽  
pp. 238-246
Keyword(s):  
Prognostic Factors ◽  
Small Sample Size ◽  
Risk Groups ◽  
Small Sample ◽  
World Health ◽  
Single Center ◽  
Single Center Experience ◽  
Age Of Diagnosis ◽  
Transfusion Dependency ◽  
Health Organization

Introduction: Myelodysplastic syndrome (MDS) is one of the most common myeloid neoplasms of elderly characterized by cytopenias and limited therapeutic options. The main aim of this retrospective single-center study was to examine the value of classical prognostic factors. The main outcome of the study was overall survival (OS) defined as death from MDS or any other reason. Methods: We analyzed the medical records of patients diagnosed with MDS at single centre in the period from beginning of 2013 to the end of 2016. Results: Total of 58 patients (median age of diagnosis being 69 years) were included in the study. After median of follow-up of 12 months, median OS was 17 months and estimated 3-year OS rate 25%. Classical prognostic systems such as IPSS, WPSS and R-IPSS were statistically significant prognostic factors discriminating adequately between low and high risk groups in terms of outcome. However, due to small sample size, we were not able to distinguish the most appropriate scoring system. The cytogenetics subgroups according to IPPS and R-IPSS were significant predictors of outcomes underlying its crucial role in MDS diagnosis. Despite the statistical tendency morphological features of MDS (2008 World Health Organization subtype and number of blasts in bone marrow) were not significant predictors of OS. Among clinical features, only presence and degree of anemia and transfusion dependency were significant predictors of inferior survival. Conclusion: The majority of traditional prognostic factors were significant in our cohort in concordance with literature review.

scholarly journals P0342A STUDY OF TREATMENT WITH RITUXIMAB IN REFRACTORY LUPUS NEPHRITIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Pranab Jyoti Mahanta ◽  
Manjuri Sharma ◽  
Shahzad Alam ◽  
Prodip Kumar Doley ◽  
Gayatri Pegu ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Small Sample Size ◽  
Life Time ◽  
Immunosuppressive Drugs ◽  
Small Sample ◽  
Post Treatment ◽  
Urinary Protein ◽  
Single Center ◽  
Renal Response ◽  
Stage Renal Disease

Abstract Background and Aims SLE patients have 40% to 70% life time risk of developing lupus nephritis (LN). In LN patients rate of end-stage renal disease is 10%, remaining constant in the last 30 years, even after the emergence of various immunosuppressive therapy. SLE is an example of classical antibody-mediated disease and hence treatment with B cell depleting agent (like the use of Rituximab ) appears to be a promising approach for this unwinnable disease from the Roman era. The aim of this study was to analyze the outcome in terms of - no renal response (NRR), complete renal response (CRR) or partial renal response (PRR) at week 24 after rituximab treatment initiation in refractory LN. CRR considered, if serum creatinine (S Cr) level returned to baseline, with a decline in the 24 hour urinary protein to < 500 mg/day. PRR defined as stabilization (+/-25%), or improvement of S Cr, plus a 50% decrease in 24 hour urinary protein (which was < 3.5 gm/day). NRR considered, if participant did not achieve either a CRR or PRR. Method It is a single center prospective observational study, comparing short term (24 week) outcomes in resistant lupus nephritis patients of >18 year age group with weekly (total 4) dose of rituximab therapy. The study was conducted on 25 refractory lupus nephritis patients admitted in Nephrology Department (not responding to conventional immunosuppressive drugs like cyclophosphamide, MMF). Repeat renal biopsy was performed, all baseline investigations were done. Injection Rituximab 375 mg/m2 weekly 0,1,2,3 week along with premedication treatment were given to every patient. The clinical outcome was assessed monthly post-treatment. Results In the study maximum patients were of class IV, n=21 (84 %). Sustained (6 months post treatment) CRR was achieved in n=6 (24%) patients, n=7 (28%) patients achieved PRR, rest n=12 (48%) patients had NRR. Mean blood absolute CD-19 count was significantly negatively correlated with response to rituximab treatment ( p< 0.001) .Mean absolute CD-19 count was 2.33/microliter in CRR, 2.14/microliter in PRR group and 21.25 / microliter in NRR group . No significant side effects of rituximab were observed. Limitations –Small sample size, single center study, long term follow up not considered. Conclusion In refractory LN patients, 24 weeks after Rituximab treatment

ABCA3 Expression Predicts Response to Gemtuzumab Ozogamicin in AML

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3946-3946 ◽  
Author(s):  
Antony Ceraulo ◽  
Aminetou Mint-Mohamed ◽  
Delphine Maucort-Boulch ◽  
Etienne Paubelle ◽  
Xavier Thomas ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Relapse Rate ◽  
Small Sample Size ◽  
Univariate Analysis ◽  
Gemtuzumab Ozogamicin ◽  
Small Sample ◽  
Control Group ◽  
Prognostic Impact ◽  
Significant Difference

Abstract Background. The ATP binding cassette transporter 3 (ABCA3) has been recently found to induce a significant reduction in cytotoxicity following exposure to anthracyclines, mitoxantrone, etoposide, Ara-C, vincristine, and rituximab. ABCA3 acts through the modulation of multivesicular bodies (MVB) and contributes to drug sequestration in late endosomal organelles, i.e. MVB and lysosomes. Studies having investigated the prognostic impact of ABCA3 expression in AML have yielded conflicting results as ABCA3 expression has both been reported to exert unfavorable or neutral effects on patient outcomes. In addition, the small sample size of these studies precluded the use of multivariate analyses. Methods. Our goal was to investigate the prognostic impact of ABCA3 expression in adult patients with AML treated with IC with or without gemtuzumab ozogamicin (GO). To this end we investigated the relationship between ABCA3 expression and EFS in a representative series of 221 AML homogeneously treated in the ALFA-0701 trial. qRTPCR amplification of conserved ABCA3 mRNA sequences, as identified with FasterDB database, was performed with GUS and ABL as reference genes. Primer sets were complementary to conserved ABCA3 exons 6-7 and exon 19-20 junctions. Patients were given a 3+7 induction course without (control group, n=110) or with fractionated intravenous GO (n=111) (Castaigne S, Lancet 2012; 379:1508-1516). Results. Among the 278 randomized patients, 221 had available bone-marrow diagnostic samples with high-quality RNA. The same benefits associated with GO were observed in the 221 patients from the present study as in the entire trial population. Overall, median age, CR rate, relapse rate, median follow-up, 3-years EFS were 62.1 years, 76.5%, 66%, 47.45 months, 28±3%, respectively. There was no significant difference in the level of ABCA3 expression between responders and non-responders. In the 169 responders, ABCA3 expression at diagnosis was more than 3-fold higher in the 111 remitters who subsequently relapsed than in the 58 patients who remained in persistent CR (p=0.033). The level of ABCA3 expression was significantly lower in ELN favorable group than in intermediate and adverse risk AML (p= 0.004) and negatively correlated with CD33 expression (R=-0.272, p<10-4). Through univariate analysis, higher ABCA3 expression was associated with shorter EFS (3-years: 22±3 vs 45±7 % p=0.002). Multivariate analysis identified age, treatment arm, and ELN risk group as independent prognostic factors for EFS. In the control group, there was no significant association between ABCA3 expression and CR rate, relapse rate, and EFS. In the 111 patients within the GO arm, there was no significant difference in the level of ABCA3 expression between responders and non-responder whereas in the 89 responders, ABCA3 expression at diagnosis was more than 7-fold higher in the 53 remitters who subsequently relapsed than in the 36 patients who remained in persistent CR (p=0.006). Through univariate analysis, higher ABCA3 expression was associated with shorter EFS (3-years: 22±5 vs 64±9 % p=0.0002). Multivariate analysis identified ABCA3 expression, cytogenetics, CD33 expression, and ECOG as independent prognostic factors for EFS (Figure 1). Conclusion. WhileABCB1 has been previously found to attenuate GO-induced cytotoxicity in AML cells (Walter RB, Blood 2003; 102:1466-1473), present results indicate that higher ABCA3 expression independently predicts poor outcome in AML patients treated with fractionated GO and intensive chemotherapy (IC). GO is an anti-CD33 antibody carrying a toxic calicheamicin derivative that, after hydrolytic release within lysosomal vesicles, induces DNA strand breaks, apoptosis, and cell death. Whether the clinical effect of ABCA3 expression relies on the modulation of CD33 internalization, calicheamicin release or combination thereof is under investigation. Finally our results encourage inhibiting ABCA3, such as with indomethacin, in order to overcome drug resistance in AML treated with GO-IC. Figure 1 Figure 1. Disclosures Thomas: Pfizer: Consultancy.

Outcomes of metastatic synovial sarcoma with doxorubicin, pazopanib, and ifosfamide therapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e23552-e23552
Author(s):  
Priscila Barreto Coelho ◽  
Philippos Apolinario Costa ◽  
Andrea P. Espejo Freire ◽  
Deukwoo Kwon ◽  
Emily Jonczak ◽  
...  
Keyword(s):  
Synovial Sarcoma ◽  
Metastatic Disease ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Small Sample ◽  
Rank Test ◽  
High Dose ◽  
Entire Cohort ◽  
Significant Difference ◽  
Localized Disease

e23552 Background: Synovial sarcoma (SS) accounts for 5-10% of all soft tissue sarcoma. SS are aggressive tumors with a median 5-year survival of 60-70% when localized disease but also a propensity for metastatic spread with 40-45% of patients developing metastasis within 5 years. It is considered a chemotherapy-sensitive sarcoma and treatment options are increasing. Herein, we present the outcomes of SS patients by systemic regimen and multimodality approach. Methods: This is a single institution, retrospective cohort of 79 patients with histopathologically confirmed SS treated at from 2004 to 2019. Clinical characteristics, treatment, response and survival were analyzed. We estimated medians of progression-free survival (PFS) and overall survival (OS) using the method of Kaplan-Meier along with the Log-Rank test. All tests were two-sided and statistical significance was considered when p<0.05. Results: Median follow-up was 3.7 years (range 3.13 to 4.33), 59.5% were women and median age at diagnosis was 41 (range 5-77). At presentation, 60 patients (75.9%) had localized disease and 19 (24.1%) presented with metastatic disease. Among the entire cohort the three-year OS rate was 78.9% (95%CI = 66.3-87.3) and five-year OS rate 68.7% (95%CI = 53.5-79.9). OS between localized disease (N = 45) and metastatic (N = 12) was not statistically significant (log-rank p = 0.098). When comparing different regimens, doxorubicin-based regimens (DBR) showed longest median PFS of 10.1 months (95%CI = 3.97-21.16), while pazopanib had a median PFS of 7.45 (95%CI = 2.63-12.3), high dose ifosfamide (HDI) 6.4 months (95%CI = 2.79-15.5) and trabectedin 3.12 months (95%CI = 0.99-6.97). Conversely, patients with metastatic disease treated with pazopanib experienced a median PFS of 11.47 months (95%CI = 2.63-32.9) while those treated with a DBR 8.15 months (95%CI = 1.08-35.8). Conclusions: SS is highly aggressive and, in our cohort, patients with local presentation had non-significant difference in OS to the metastatic disease, this could be due to a small sample size or the high probability for relapse this tumor has. Chemotherapy with DBRs showed superiority to other regimens and pazopanib showed to be slightly superior when evaluating only metastatic disease. Addition of pazopanib maintenance therapy may improve PFS and OS. Continuous evaluation of these patients with further inclusion of SS on immunotherapy is warranted.

scholarly journals Predicting prognosis and IDH mutation status for patients with lower-grade gliomas using whole slide images

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Shuai Jiang ◽  
George J. Zanazzi ◽  
Saeed Hassanpour
Keyword(s):  
Performance Metrics ◽  
Small Sample Size ◽  
Small Sample ◽  
The Cancer Genome Atlas ◽  
World Health ◽  
Lower Grade ◽  
Who Grade ◽  
Mutation Status ◽  
Idh Mutations ◽  
Whole Slide Images

AbstractWe developed end-to-end deep learning models using whole slide images of adults diagnosed with diffusely infiltrating, World Health Organization (WHO) grade 2 gliomas to predict prognosis and the mutation status of a somatic biomarker, isocitrate dehydrogenase (IDH) 1/2. The models, which utilize ResNet-18 as a backbone, were developed and validated on 296 patients from The Cancer Genome Atlas (TCGA) database. To account for the small sample size, repeated random train/test splits were performed for hyperparameter tuning, and the out-of-sample predictions were pooled for evaluation. Our models achieved a concordance- (C-) index of 0.715 (95% CI: 0.569, 0.830) for predicting prognosis and an area under the curve (AUC) of 0.667 (0.532, 0.784) for predicting IDH mutations. When combined with additional clinical information, the performance metrics increased to 0.784 (95% CI: 0.655, 0.880) and 0.739 (95% CI: 0.613, 0.856), respectively. When evaluated on the WHO grade 3 gliomas from the TCGA dataset, which were not used for training, our models predicted survival with a C-index of 0.654 (95% CI: 0.537, 0.768) and IDH mutations with an AUC of 0.814 (95% CI: 0.721, 0.897). If validated in a prospective study, our method could potentially assist clinicians in managing and treating patients with diffusely infiltrating gliomas.

scholarly journals Retrospective study of prognostic factors in pediatric invasive pneumococcal disease

PeerJ ◽  
2017 ◽  
Vol 5 ◽  
pp. e2941 ◽  
Author(s):  
Nan-Chang Chiu ◽  
Hsin Chi ◽  
Chun-Chih Peng ◽  
Hung-Yang Chang ◽  
Daniel Tsung-Ning Huang ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Mortality Rate ◽  
Invasive Pneumococcal Disease ◽  
Pneumococcal Disease ◽  
Large Scale ◽  
Small Sample Size ◽  
Laboratory Data ◽  
Clinical Manifestations ◽  
Small Sample ◽  
Significant Prognostic Factor

Streptococcus pneumoniaeremains the leading causative pathogen in pediatric pneumonia and bacteremia throughout the world. The invasive pneumococcal disease (IPD) is known as isolation ofS. pneumoniaefrom a normally sterile site (e.g., blood, cerebrospinal fluid, synovial fluid, pericardial fluid, pleural fluid, or peritoneal fluid). The aim of this study is to survey the clinical manifestations and laboratory results of IPD and identify the prognostic factors of mortality. From January 2001 to December 2006, a retrospective review of chart was performed in a teaching hospital in Taipei. The hospitalized pediatric patients with the diagnosis of pneumonia, arthritis, infectious endocarditis, meningitis or sepsis were recruited. Among them, 50 patients were pneumococcal infections proved by positive culture results or antigen tests. Clinical manifestations, laboratory data and hospitalization courses were analyzed. The median age was 3.5-year-old and there were 30 male patients (60%). Eight patients (16%) had underlying disease such as leukemia or congenital heart disease. Hemolytic uremic syndrome (HUS) was observed in ten patients and extracorporeal membrane oxygenation (ECMO) was performed in three patients. Leukocytosis, elevated C-reactive protein and AST level were noted in most of the patients. The overall mortality rate was 10%. We found that leukopenia, thrombocytopenia and high CRP level were significant predictors for mortality. In conclusion,S. pneumoniaeremains an important health threat worldwide and IPD is life-threatening with high mortality rate. We found leukopenia, thrombocytopenia, and high CRP levels to be associated with mortality in pediatric IPD, and these factors are worthy of special attention at admission. Although we failed to identify a statistically significant prognostic factor in multivariate analysis due to relatively small sample size, we suggest an aggressive antibiotic treatment in patients with these factors at admission. Further large-scale studies are warranted.

scholarly journals 213. Assessment of Compliance with Order Set and Bundle for Management of Staphylococcus aureus Bacteremia

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S214-S215
Author(s):  
Ryan R Flynn ◽  
Marilee Obritsch ◽  
Veronica Lesselyoung ◽  
Joe Strain ◽  
John Kappes
Keyword(s):  
Staphylococcus Aureus ◽  
Statistical Difference ◽  
Small Sample Size ◽  
Small Sample ◽  
Single Center ◽  
Recurrence Rates ◽  
Adequate Treatment ◽  
Single Center Study ◽  
Center Study ◽  
Order Set

Abstract Background Staphylococcus aureus (S. aureus) is an aerobic gram-positive coccus that causes a variety of infections. S. aureus bloodstream infections, also known as bacteremias, have significant morbidity and mortality and are difficult to eradicate. A single-center study showed a 9.4% recurrence rate for S. aureus bacteremia, despite adequate treatment. The Infectious Disease Society of America (IDSA) recognizes the seriousness of S. aureus infections, particularly methicillin-resistant S. aureus (MRSA), and has released guidance for treatment of these infections. Guidance for S. aureus bacteremias include identification and removal of the source and early optimization of antibiotics. Serial imaging and laboratory monitoring, including repeat blood cultures, are also necessary to establish the duration of therapy, ensure microbiologic eradication, and reduce the risk of long-term complications. Due to the complexity of S. aureus bacteremia, early involvement of infectious diseases (ID) specialists is strongly recommended. Methods This retrospective, single-center study was designed to evaluate the current management of S. aureus bacteremias, including compliance to the elements of the S. aureus order set and bundle. Patients 18 years and older who had a positive blood culture for S. aureus were included in this study. Recurrence of S. aureus infection was assessed at 6 months. Data was analyzed to compare patients with and without ID consults. Results Eighty-four patients met inclusion criteria. ID consultation resulted in a higher percentage of patients achieving 100% compliance with the bundle elements compared to patients without ID consults (73% vs 25%, respectively; p=0.009). For further breakdown of compliance see Table 1. No statistical difference was detected in recurrence rates (11% vs 33%, respectively; p=0.18) or mortality (8% vs 25%, respectively; p= 0.17) possibly due to the small sample size. Table 1. Outcomes Conclusion ID specialist involvement for the treatment of S. aureus bacteremia resulted in greater compliance with the S. aureus bacteremia bundle. No statistical difference in recurrence or mortality rates was detected. Disclosures All Authors: No reported disclosures

Outcomes of prechemotherapy (pCHT) abiraterone (AA) or enzalutamide (E) for metastatic castration-resistant prostate cancer (mCRPC) after androgen deprivation therapy (ADT) + docetaxel (D) or ADT alone for metastatic hormone sensitive prostate cancer (mHSPC) in a hospital-based registry.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16515-e16515
Author(s):  
Edoardo Francini ◽  
Kathryn P. Gray ◽  
Carolyn Evan ◽  
Marina D. Kaymakcalan ◽  
Grace Katherine Shaw ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
De Novo ◽  
Small Sample Size ◽  
Small Sample ◽  
Castration Resistant Prostate Cancer ◽  
Start Time ◽  
Time To Death ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Hormone Sensitive

e16515 Background: The E3805: CHAARTED trial noted use of D at time of commencing ADT for mHSPC was associated with an improvement in time to CRPC (PSA rise or clinical progression [CP]) or time to CP and resulted in a prolongation of overall survival (OS). Therefore, we postulated that pCHT AA or E maintained activity after ADT+D. Methods: A cohort of CRPC patients (pts) treated with pCHT AA or E for CRPC between 2010 and 2016 was selected from the Dana-Farber Cancer Institute IRB approved database. Patients were grouped by use of D and whether they had prior localized therapy (PLT) or de novo (DN) metastatic disease, at time of ADT start for mHSPC. The analysis endpoints included OS (time to death from all causes) from ADT start, time to AA/E start from ADT start, OS from AA/E start. Kaplan-Meier method estimated the time to events distribution with median (95% CI). Results: Of the 147 pts selected, 134 (91.2%) had previously received ADT alone, while 13 (8.8%) had ADT+D. Once stratified by PLT or DN, the distributions of the 4 groups are 33.3% (ADT/PLT), 57.8% (ADT/DN), 0.7% (ADT+D/PLT), and 8.2% (ADT+D/DN). In the ADT alone group, the median OS with pCHT AA or E for CRPC was approximately 3 years from the AA/E start, regardless of PLT or DN. In the smaller cohort of pts selected for treatment with ADT+D, both the OS from ADT start and from AA/E start were shorter than the ADT alone cohort. However, even in this group with shorter time to AA/E start, the median OS from AA/E start was still 1.5 years despite prior chemotherapy. Conclusions: Within limitations of a hospital-based registry, small sample size for ADT+D and lack of volume of metastases data, pts selected for ADT+D show poorer outcomes but still have an OS of 1.5 yrs from AA/E start. [Table: see text]

Subgroups of survivors with distinct aggravating factors associated with chemotherapy-induced neuropathy (CIN) in the hands.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 157-157
Author(s):  
Grace Mausisa ◽  
Judy Mastick ◽  
Melissa Mazor ◽  
Steven M. Paul ◽  
Bruce A. Cooper ◽  
...  
Keyword(s):  
Latent Class ◽  
Small Sample Size ◽  
Symptom Burden ◽  
Individual Variability ◽  
Small Sample ◽  
Neurologic Complication ◽  
Platinum Compound ◽  
Temperature Group ◽  
Motor Tests ◽  
Activity Groups

157 Background: CIN is the most prevalent neurologic complication of cancer treatment. Inter-individual variability exists in survivors’ reports of the factors that aggravate CIN in their hands. The purpose of this study was to identify groups of survivors with CIN in their hands based on distinct aggravating factors and evaluate for differences in demographic, clinical, symptom characteristics and quality of life (QOL) based on group membership. Methods: Cancer survivors (n = 307) who received a platinum and/or a taxane and rated their altered sensation/pain in their hands at > 3 on 0-10 scale were enrolled and completed study questionnaires, including a list of 22 factors that could make pain worse. Medical records were reviewed and sensory and motor tests were done. Latent class analysis was used to identify groups of survivors based on the occurrence rates for aggravating factors. Differences among the groups were evaluated using parametric and nonparametric statistics. Results: Three groups were identified based on occurrence rates for aggravating factors in the hands (i.e., Activity and Temperature (41.0%), Activity (8.7%), Few Factors (52.2%)). No differences were found among the groups in demographic characteristics, or sensory (light touch, temperature, pain, vibration) and motor (grip strength, pegboard) tests. Compared to the Few Factors group, the Activity and Temperature group had more comorbidities, poorer sleep, greater fatigue, and more anxious and depressive symptoms. Survivors who received a platinum compound were more likely to be in the Activity and Temperature group. Those who received a taxane compound were more likely to be in the Few Factors or Activity groups. Conclusions: Survivors who reported a higher occurrence of aggravating factors had a higher symptom burden and poorer QOL. Most differences were found between the Few Factors group and the Activity and Temperature group which may be due to the small sample size of the Activity group. Objective measures did not differ among the groups. Findings suggest that subgroups of survivors can be identified based on their reports of CIN aggravating factors.

Anticoagulation Management for Impella Percutaneous Ventricular Assist Devices: An Analysis of a Single-Center Experience

2020 ◽  
Vol 54 (11) ◽  
pp. 1073-1082
Author(s):  
Ethan Wood ◽  
Charles Hayes ◽  
Anthony Hart
Keyword(s):  
Therapeutic Range ◽  
Major Bleeding ◽  
Small Sample Size ◽  
Small Sample ◽  
Ventricular Assist Devices ◽  
Patient Specific ◽  
Circulatory Support ◽  
Single Center ◽  
Bleeding Events ◽  
Anticoagulation Management

Background: Impella devices offer temporary mechanical circulatory support for cardiogenic shock. The manufacturer recommends systemic anticoagulation with a target activated clotting time of 160 to 180 s but provides no guidance on how to manage both the heparinized purge solution and the additional intravenous heparin needed to reach this therapeutic range. Previous publications demonstrated a lack of standardization in heparin management for Impella devices. Objective: The purpose of this study was to compare the effectiveness and safety of 2 different heparin protocols for long-term Impella support. Methods: This single-center, retrospective study included adult patients on Impella support for greater than 24 hours. The primary end point was time to therapeutic range measured in hours, from time of implantation to the first of 2 consecutive measurements within the therapeutic range. Secondary end points included percentage of time in therapeutic range, rates of major bleeding, pump thrombosis, hemolysis, and nursing satisfaction. Results: There were 19 patients identified, with 7 using the original protocol and 12 using the revised protocol. Time to therapeutic range was similar between protocols (15.5 vs 12 hours, P = NS). Another 14 patients were managed with patient-specific protocols as a result of bleeding or physician preference. In total, 42% of all patients in this study experienced major bleeding. There were no confirmed thrombosis events. This study was limited by a small sample size. Conclusion and Relevance: Despite using different heparin protocols, outcomes and bleeding events were similar between groups. Future studies are needed to determine the optimal degree of anticoagulation necessary to reduce bleeding risk.

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