Management and outcome of pregnancies in women with red cell isoimmunization: a 15-year observational study from a tertiary care university hospital

Abstract Background The aims of this study were to determine the prevalence of the different anti-erythrocytic alloantibodies, to describe pregnancy outcomes according to a low-risk and high-risk classification for fetal anemia and to determine the factors that influence adverse perinatal outcomes. Methods This retrospective observational study included women referred to our center following the identification of maternal anti-erythrocytic alloantibodies between 2002 and 2017. Pregnancies were classified as high risk for fetal anemia in cases with clinically significant antibodies, no fetal-maternal compatibility and titers ≥1:16 or any titration in cases of Kell system incompatibility. In high-risk pregnancies, maternal antibody titration and the fetal middle cerebral artery peak systolic velocity (MCA-PSV) were monitored. Low-risk pregnancies underwent routine pregnancy follow-up. Results Maternal antibodies were found in 337 pregnancies, and 259 (76.9%) of these antibodies were clinically significant. The most frequent antibodies were anti-D (53%) and anti-K (19%). One hundred forty-three pregnancies were classified as low risk for fetal anemia, 65 (25%) cases were classified as no fetal-maternal incompatibility, 78 had clinically nonsignificant antibodies, 4 (2.8%) resulted in first-trimester pregnancy loss, and 139 (97.2%) resulted in livebirths. Of the 194 high-risk pregnancies, 38 had titers < 1:16 (resulting in 38 livebirths), and 156 had titers ≥1:16 or anti-K antibodies. In the last group, 6 cases miscarried before 18 weeks, 93 had a MCA-PSV < 1.5 multiples of the median (MoM), resulting in 3 perinatal deaths that were unrelated to fetal anemia, one termination and 89 livebirths; and 57 had a MCA-PSV > 1.5 MoM, resulting in 3 intrauterine deaths, 6 terminations and 48 livebirths. Ninety-two intrauterine transfusions were performed in 45 fetuses (87% anti-D). Adverse outcomes were related to a MCA-PSV > 1.5 MoM (p < 0.001), hydrops (p < 0.001) and early gestational age at first transfusion (p = 0.029) Conclusion Anti-D remains the most common antibody in fetuses requiring intrauterine transfusion. A low or high-risk classification for fetal anemia based on the type of antibody, paternal phenotype and fetal antigen allows follow-up of the pregnancy accordingly, with good perinatal outcomes in the low-risk group. In the high-risk group, adverse perinatal outcomes are related to high MCA-PSV, hydrops and early gestational age at first transfusion.

Download Full-text

Abstract WMP61: TWOACES: TIA Work-up As Outpatient, Assessment Of Clinical Efficacy And Safety

Stroke ◽

10.1161/str.44.suppl_1.awmp61 ◽

2013 ◽

Vol 44 (suppl_1) ◽

Author(s):

James Castle ◽

Jenifer Green ◽

Jean-Marc Olivot ◽

Gregory Albers

Keyword(s):

High Risk ◽

Observational Study ◽

Risk Group ◽

High Risk Group ◽

Low Risk ◽

Stroke Rate ◽

Significant Stenosis ◽

Non Invasive ◽

Low Rate

Background: Much controversy exists as to the appropriate triage of acute TIA patients. One commonly used tool is the ABCD 2 score. This tool is helpful for patients at low risk (score of 0-3) or high risk (score of 6-7) of stroke, but leaves a large moderate risk population (score of 4-5) for whom no clear guidance can be given. As previous studies have found large artery atherosclerosis to be a potent risk factor for stroke after TIA, we attempted to further delineate low and high risk TIA populations with the addition of non-invasive arterial imaging. Methods: All patients referred to the Stanford Stroke Service for possible TIA within 72 hours of symptom onset between July 2007 and February 2010, and all patients referred to the Highland Park Stroke Service for possible TIA within 72 hours of symptom onset after October 2009 were screened for enrollment in this observational study. 406 patients were invited to enroll, 5 refused. Of the 401 enrolled, follow-up was obtained in 398 patients. Patients were placed into two groups: 1) ABCD 2 scores of 0-3 or 4-5 AND no sign of hemodynamically significant stenosis (<50%) "Low Risk Group"; and 2) those with ABCD 2 scores of 6-7 or 4-5 AND hemodynamically significant stenosis (≥50%) "High Risk Group". Non-invasive arterial imaging included CTA, MRA, and Carotid US - all chosen by the treating physician. 30 day stroke rates with 95% CIs were recorded. Results: Of the 398 patients in whom follow-up data was obtained, 340 (85.4%) fell into the “Low Risk Group”. Within that group, the stroke rate at 30 days was 1.76% (6 strokes, 95% CI 0.72-3.89%). Within the “High Risk Group”, the stroke rate at 30 days was 5.17% (3 strokes, 95% CI 1.21-14.7%). The overall stroke rate was 9/398 (2.26%, 95% CI 1.13-4.31%). Conclusions: In our observational study we continue to find that the overall 30 day stroke rate after TIA was quite low (2.26%). The percentage of all TIA patients falling into the “Low Risk Group” was quite high (85.4%), and these patients had a particularly low rate of stroke at 30 days. Given the high number of “Low Risk” patients and the low rate of stroke in that group at 30 days, the vast majority of TIA patients could likely be safely evaluated in a rapid outpatient setting provided that the treating physician is confident of the diagnosis.

Download Full-text

The effect of maternal position on fetal middle cerebral artery Doppler indices and its association with adverse perinatal outcomes: a pilot study

Journal of Perinatal Medicine ◽

10.1515/jpm-2019-0399 ◽

2020 ◽

Vol 48 (4) ◽

pp. 317-321

Author(s):

Rodney McLaren ◽

Bharati Kalgi ◽

Chima Ndubizu ◽

Peter Homel ◽

Shoshana Haberman ◽

...

Keyword(s):

High Risk ◽

Middle Cerebral Artery ◽

Cerebral Artery ◽

Repeated Measures ◽

Adverse Outcome ◽

Perinatal Outcomes ◽

Low Risk ◽

Doppler Velocity ◽

Chronic Hypertension ◽

Adverse Perinatal Outcomes

AbstractObjectiveThe aim of this study was to compare position-related changes in fetal middle cerebral artery (MCA) Doppler pulsatility indices (PI).MethodsA prospective study of 41 women with conditions associated with placental-pathology (chronic hypertension, pregestational diabetes, and abnormal analytes) and 34 women without those conditions was carried out. Fetal MCA Doppler velocity flow waveforms were obtained in maternal supine and left lateral decubitus positions. MCA PI Δ was calculated by subtracting the PI in the supine position from the PI in the left lateral position. Secondary outcomes included a composite of adverse perinatal outcomes (fetal growth restriction, oligohydramnios, and preeclampsia). χ2 and Student t-tests and repeated-measures analysis of variance were used.ResultsMCA PI Δ was significantly less for high-risk pregnant women ([P = 0.03]: high risk, left lateral PI, 1.90 ± 0.45 vs. supine PI, 1.88 ± 0.46 [Δ = 0.02]; low risk, left lateral PI, 1.90 ± 0.525 vs. supine PI, 1.68 ± 0.40 [Δ = 0.22]). MCA PI Δ was not significantly different between women who had a composite adverse outcome and women who did not have a composite adverse outcome (P = 0.843).ConclusionOur preliminary study highlights differences in position-related changes in fetal MCA PI between high-risk and low-risk pregnancies. These differences could reflect an attenuated ability of women with certain risk factors to respond to physiologic stress.

Download Full-text

Abstract 2126: Twoaces (tia Work-up Asoutpatient: Assessment Of Clincal Efficacy And Safety)

Stroke ◽

10.1161/str.43.suppl_1.a2126 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Jenifer Green ◽

Connie Wolford ◽

Jean Marc Olivot ◽

Gregory Albers ◽

James Castle

Keyword(s):

High Risk ◽

Observational Study ◽

Risk Group ◽

High Risk Group ◽

Low Risk ◽

Stroke Rate ◽

Significant Stenosis ◽

Non Invasive ◽

Low Rate ◽

Arterial Imaging

Background: Much controversy exists as to which TIA patients need to be admitted to the hospital for evaluation and treatment and which can be sent home. One commonly used trigae tool is the ABCD 2 score (Age, presenting Blood Pressure, Clinical symptoms and Duration, and Diabetes). Although this tool gives good information for determining populations at low risk (score of 0-3) and high risk (score of 6-7) of stroke after TIA, it leaves a large moderate risk population (score of 4-5) for whom no clear triage guidance can be given. As previous studies have found large artery atherosclerosis to be a potent risk factor for stroke after TIA, we attempted to further delineate low and high risk TIA populations with the addition of non-invasive arterial imaging to the ABCD 2 score. Methods: All patients referred to the Stanford Stroke Service for possible TIA within 72 hrs of symptom onset between July 2007 and February 2010, and all patients referred to the Highland Park Stroke Service for possible TIA within 72 hrs of symptom onset after October 2009 were screened for enrollment in this observational study. Exclusion criteria included age <18 years, use of TPA at initial presentation, and symptoms lasting >24 hours. 352 patients were invited to enroll, 3 refused. Of the 349 enrolled, follow-up was obtained in 346 patients at 30 days. Patients were placed into two groups: 1) those with ABCD 2 scores of 0-3 or scores of 4-5 AND no sign of hemodynamically significant stenosis in an artery within the distribution of the TIA (Low Risk Group); and 2) those with ABCD 2 scores of 6-7 or scores of 4-5 AND a hemodynamically significant stenosis in an artery within the distribution of the TIA (High Risk Group). Non-invasive arterial imaging included CT angiogram, MR angiogram, and carotid ultrasound - all used at the discretion of the treating physician. 30 day stroke rates with 95% confidence intervals were recorded. Results: Of the 346 patients enrolled, 295 (85.3%) fell into the "Low Risk Group" based on ABCD 2 scoring and non-invasive arterial imaging. Within that group, the stroke rate at 30 days was 1.0% (3 strokes, 95% CI 0.2-3.1%). Within the "High Risk Group", the stroke rate at 30 days was 5.9% (3 strokes, 95% CI 1.4-16.5%). Within the "Low Risk Group", all 3 of the strokes occurred in patients with ABCD 2 scores of 4-5 (3/133 patients - 2.3% stroke rate with 95% CI 0.5-6.7%). The overall stroke rate was 6/346 (1.7%, 95% CI 0.7-3.8%). Conclusions: In our observational study we found that the overall 30 day stroke rate after TIA was quite low. The percentage of all TIA patients falling into the “Low Risk Group” was quite high, and these patients had a particularly low rate of stroke at 30 days. Given the high number of "Low Risk" patients and the low rate of stroke in that group at 30 days, the vast majority of TIA patients could likely be safely evaluated in an rapid outpatient setting provided that the treating physician is confident of the diagnosis.

Download Full-text

Abstract 19763: Role of HAS-BLED Score on Major Bleeding in Atrial Fibrillation Undergoing Percutaneous Coronary Intervention With Drug-eluting Stents

Circulation ◽

10.1161/circ.132.suppl_3.19763 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Yoshitaka Ito ◽

Kazuhiro Naito ◽

Katsuhisa Waseda ◽

Hiroaki Takashima ◽

Akiyoshi Kurita ◽

...

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Anticoagulant Therapy ◽

Major Bleeding ◽

Stent Implantation ◽

Risk Group ◽

High Risk Group ◽

Low Risk

Background: While anticoagulant therapy is standard management for atrial fibrillation (Af), dual antiplatelet therapy (DAPT) is needed after stent implantation for coronary artery disease. HAS-BLED score estimates risk of major bleeding for patients on anticoagulation to assess risk-benefit in Af care. However, it is little known about usefulness of HAS-BLED score in Af patient treated with coronary stents requiring DAPT or DAPT plus warfarin (triple therapy: TT). The aim of this study was to evaluate the role of HAS-BLED score on major bleeding in Af patients undergoing DAPT or TT. Methods: A total of 837 consecutive patients were received PCI in our hospital from Jan. 2007 to Dec. 2010, and 66 patients had Af or paroxysmal Af at the time of PCI. Clinical events including major bleeding (cerebral or gastrointestinal bleeding) were investigated up to 3 years. Patients were divided into 2 groups based on HAS-BLED score (High-risk group: HAS-BLED score≥4, n=19 and Low-risk group: HAS-BLED score<4, n=47). DAPT therapy was required for a minimum 12 months after stent implantation and warfarin was prescribed based on physicians’ discretion. Management/change of antiplatelet and anticoagulant therapy during follow-up periods were also up to physicians’ discretion. Results: Baseline characteristics were not different between High-risk and Low-risk group except for age. Overall incidence of major bleeding was observed in 8 cases (12.1%) at 3 years follow-up. Major bleeding event was significantly higher in High-risk group compared with Low-risk group (31.6% vs. 4.3%, p=0.002). However, management of DAPT and TT was not different between the 2 groups. Among component of HAS-BLED score, renal dysfunction and bleeding contributed with increased number of the score. Conclusion: High-risk group was more frequently observed major bleeding events compared with Low-risk group in patients with Af following DES implantation regardless of antiplatelet/anticoagulant therapy.

Download Full-text

P9 Novel use of CHA2DS2VASC score to select patients to undergo repeat atrial fibrillation screening

European Heart Journal ◽

10.1093/ehjci/ehz872.015 ◽

2020 ◽

Vol 41 (Supplement_1) ◽

Author(s):

W Sun ◽

B P Y Yan

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Clinical Outcomes ◽

Cross Validation ◽

Risk Group ◽

Curve Analysis ◽

Low Risk ◽

Decision Curve Analysis ◽

Risk Patients

Abstract Background We have previously demonstrated unselected screening for atrial fibrillation (AF) in patients ≥65 years old in an out-patient setting yielded 1-2% new AF each time screen-negative patients underwent repeated screening at 12 to 18 month interval. Selection criteria to identify high-risk patients for repeated AF screening may be more efficient than repeat screening on all patients. Aims This study aimed to validate CHA2DS2VASC score as a predictive model to select target population for repeat AF screening. Methods 17,745 consecutive patients underwent 24,363 index AF screening (26.9% patients underwent repeated screening) using a handheld single-lead ECG (AliveCor) from Dec 2014 to Dec 2017 (NCT02409654). Adverse clinical outcomes to be predicted included (i) new AF detection by repeated screening; (ii) new AF clinically diagnosed during follow-up and (ii) ischemic stroke/transient ischemic attack (TIA) during follow-up. Performance evaluation and validation of CHA2DS2VASC score as a prediction model was based on 15,732 subjects, 35,643 person-years of follow-up and 765 outcomes. Internal validation was conducted by method of k-fold cross-validation (k = n = 15,732, i.e., Leave-One-Out cross-validation). Performance measures included c-index for discriminatory ability and decision curve analysis for clinical utility. Risk groups were defined as ≤1, 2-3, or ≥4 for CHA2DS2VASC scores. Calibration was assessed by comparing proportions of actual observed events. Results CHA2DS2VASC scores achieved acceptable discrimination with c-index of 0.762 (95%CI: 0.746-0.777) for derivation and 0.703 for cross-validation. Decision curve analysis showed the use of CHA2DS2VASC to select patients for rescreening was superior to rescreening all or no patients in terms of net benefit across all reasonable threshold probability (Figure 1, left). Predicted and observed probabilities of adverse clinical outcomes progressively increased with increasing CHA2DS2VASC score (Figure 1, right): 0.7% outcome events in low-risk group (CHA2DS2VASC ≤1, predicted prob. ≤0.86%), 3.5% intermediate-risk group (CHA2DS2VASC 2-3, predicted prob. 2.62%-4.43%) and 11.3% in high-risk group (CHA2DS2VASC ≥4, predicted prob. ≥8.50%). The odds ratio for outcome events were 4.88 (95%CI: 3.43-6.96) for intermediate-versus-low risk group, and 17.37 (95%CI: 12.36-24.42) for high-versus-low risk group. Conclusion Repeat AF screening on high-risk population may be more efficient than rescreening all screen-negative individuals. CHA2DS2VASC scores may be used as a selection tool to identify high-risk patients to undergo repeat AF screening. Abstract P9 Figure 1

Download Full-text

Long-Term Outcome of Iron-Induced Cardiac Disease in Patients with Thalassemia Major Treated with Combined DFP/DFO or DFO Alone.

Blood ◽

10.1182/blood.v108.11.1764.1764 ◽

2006 ◽

Vol 108 (11) ◽

pp. 1764-1764

Author(s):

Maria Eliana Lai ◽

Stefania Vacquer ◽

Alessia Pepe ◽

Aurelio Maggio ◽

Maria P. Carta ◽

...

Keyword(s):

High Risk ◽

Cardiac Disease ◽

Risk Group ◽

Thalassemia Major ◽

Left Ventricular ◽

Low Risk ◽

Left Ventricular Ejection ◽

Ventricular Ejection Fraction

Abstract We conducted a 4-yr prospective trial to evaluate the long-term effects of combined deferiprone (DFP)/deferoxamine (DFO) on reversal of cardiac complications in thalassemia major compared to those of DFO alone. Twenty-eight patients (pts) with cardiac disease requiring medication were stratified according to their risk for cardiac death. Fourteen pts were high risk, serum ferritin (SF) > 2500 ug/L on two-thirds of occasions since the onset of cardiac disease. Of those with a SF < 2500 ug/L (low risk), six had progressive decrements of left ventricular ejection fraction (LVEF). Nine high-risk pts and six low-risk pts were placed on DFP/DFO (DFP, 75 mg/kg/d divided t.i.d.; DFO, 40 – 50 mg/kg over 8 – 12 h at night 5 – 7 d/wk. The others infused DFO alone. If SF fell below 500 ug/L, DFO infusions were reduced to 2 d/wk. Cardiac follow-up (including blood work and ECG) was done at 4-m intervals. M-mode and two-dimensional echocardiograms were done at 4- to 6-m intervals. Cardiac T2* was not available at the beginning of the study. All but eight patients (3 death, 1 refusal, 2 claustrophobic, 2 pacemaker) subsequently had at least one T2* assessment. Routine lab tests were done at 1- to 6-m intervals. Blood counts were done at 7- to 10-d intervals for those taking DFP. Mean follow-up was approximately 40 m. Compliance with DFO was significantly better among low-risk pts in both treatment groups (DFP/DFO, 82% vs 61%; DFO alone, 83% vs 52%) as was that with DFP (94% vs 76%). At baseline, no statistically significant differences were observed between the SF levels, LVEFs or left ventricular shortening fractions (LVSFs) of pts on DFP/DFO or DFO alone in either risk group except for the LVEFs of the low-risk group (DFP/DFO, 56.5% +/− 5.5%; DFO alone, 65.4% +/− 5.0%; p = 0.032). In the high-risk group, four cardiac events (3 deaths, 1 worsening of CHF) occurred in the group getting DFO alone vs none in the DFP/DFO-treated group. The latter pts showed a decrease in SF and an increase in both LVEF and LVSF at the end of study (EOS). The three pts who died (at 17 to 35 m) had increased SFs. These pts were not rescued by IV DFO (98 +/− 12 mg/kg/d). The two DFO-treated pts who survived had marginally improved T2*s (1.5 to 3.0 ms and 7.6 to 8.8 ms) over the year prior to EOS. Only one of the seven evaluable pts on DFP/DFO had a T2* < 10 ms, the others averaging 19.4 +/− 6.7 ms. Among the low-risk pts, those on DFP/DFO showed a reduction in SF and an improvement in both LVEF and LVSF. Those on DFO alone had increased SF but essentially no change in LVEFs or LVSFs. Five pts on DFP/DFO had T2* evaluations. In two pts, T2* rose from 9.0 to 37 ms (38 m) and from 9.3 to 11.8 ms (17 m). The remaining three had T2* values > 20 ms at EOS. Similar results were seen in low-risk pts on DFO alone. These finding clearly support the notion that DFP/DFO has a beneficial effect upon the heart, even in well established disease. Moreover, our finding of low T2* values associated with low SF levels indicates the importance of tailoring treatment to each individual.

Download Full-text

Application of a Validated Predictive Model for Venous Thromboembolism in Cancer to Patients with Multiple Myeloma

Blood ◽

10.1182/blood.v128.22.534.534 ◽

2016 ◽

Vol 128 (22) ◽

pp. 534-534

Author(s):

Natasha Catherine Edwin ◽

Jesse Keller ◽

Suhong Luo ◽

Kenneth R Carson ◽

Brian F. Gage ◽

...

Keyword(s):

High Risk ◽

Research Funding ◽

Risk Group ◽

High Risk Group ◽

Low Risk ◽

Intermediate Risk ◽

Discriminative Ability ◽

Blood Institute ◽

C Statistic

Abstract Background Patients with multiple myeloma (MM) have a 9-fold increased risk of developing venous thromboembolism (VTE). Current guidelines recommend pharmacologic thromboprophylaxis in patients with MM receiving an immunomodulatory agent in the presence of additional VTE risk factors (NCCN 2015, ASCO 2014, ACCP 2012). However, putative risk factors vary across guidelines and no validated VTE risk tool exists for MM. Khorana et al. developed a VTE risk score in patients with solid organ malignancies and lymphoma (Blood, 2008). We sought to apply the Khorana et al. score in a population with MM. Methods We identified patients diagnosed with MM within the Veterans Health Administration (VHA) between September 1, 1999 and December 31, 2009 using the International Classification of Diseases (ICD)-03 code 9732/3. We followed the cohort through October 2014. To eliminate patients with monoclonal gammopathy of undetermined significance and smoldering myeloma, we excluded patients who did not receive MM-directed therapy within 6 months of diagnosis. We also excluded patients who did not have data for hemoglobin (HGB), platelet (PLT) count, white blood count (WBC), height and weight, as these are all variables included in the Khorana et al. risk model. Height and weight were assessed within one month of diagnosis and used to calculate body mass index (BMI). We measured HGB, PLT count, and WBC count prior to treatment initiation: within two months of MM diagnosis. A previously validated algorithm, using a combination of ICD-9 code for VTE plus pharmacologic treatment for VTE or IVC filter placement, identified patients with incident VTE after MM diagnosis (Thromb Res, 2015). The study was approved by the Saint Louis VHA Medical Center and Washington University School of Medicine institutional review boards. We calculated VTE risk using the Khorana et al. score: We assigned 1 point each for: PLT ≥ 350,000/μl, HGB < 10 g/dl, WBC > 11,000/μl, and BMI ≥ 35 kg/m2. Patients with 0 points were at low-risk, 1-2 points were considered intermediate-risk and ≥3 points were termed high-risk for VTE. We assessed the relationship between risk-group and development of VTE using logistic regression at 3- and 6-months. We tested model discrimination using the area under the receiver operating characteristic curve (concordance statistic, c) with a c-statistic range of 0.5 (no discriminative ability) to 1.0 (perfect discriminative ability). Results We identified 1,520 patients with MM: 16 were high-risk, 802 intermediate-risk, and 702 low-risk for VTE using the scoring system in the Khorana et al. score. At 3-months of follow-up, a total of 76 patients developed VTE: 27 in the low-risk group, 48 in the intermediate-risk group, and 1 in the high-risk group. At 6-months of follow-up there were 103 incident VTEs: 41 in the low-risk group, 61 in the intermediate-risk group, and 1 in the high-risk group. There was no significant difference between risk of VTE in the high- or intermediate-risk groups versus the low-risk group (Table 1). The c-statistic was 0.56 at 3-months and 0.53 at 6-months (Figure 1). Conclusion Previously, the Khorana score was developed and validated to predict VTE in patients with solid tumors. It was not a strong predictor of VTE risk in MM. There is a need for development of a risk prediction model in patients with MM. Figure 1. Figure 1. Disclosures Carson: American Cancer Society: Research Funding. Gage:National Heart, Lung and Blood Institute: Research Funding. Kuderer:Janssen Scientific Affairs, LLC: Consultancy, Honoraria. Sanfilippo:National Heart, Lung and Blood Institute: Research Funding.

Download Full-text

The Glasgow whipple risk score to predict pancreas-specific complications after pancreaticoduodenectomy.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.394 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 394-394

Author(s):

Lavanniya Kumar Palani Velu ◽

Vishnuvardhan Chandrabalan ◽

Ross Carter ◽

Colin McKay ◽

Donald McMillan ◽

...

Keyword(s):

High Risk ◽

Serum Amylase ◽

Risk Group ◽

Risk Groups ◽

High Risk Group ◽

Low Risk ◽

Prolonged Stay ◽

Increased Risk ◽

Clinically Significant ◽

Serum Crp

394 Background: Pancreas-specific complications (PSC), comprising postoperative pancreatic fistula, post-pancreatectomy haemorrhage, and intra-abdominal collections, are drivers of morbidity following pancreaticoduodenectomy (PD). Intra-operatively derived pancreatic gland texture is a major determinant of postoperative PSC. We have previously demonstrated that a postoperative day 0 (PoD0) serum amylase ≥ 130 IU/L is an objective surrogate of pancreatic texture, and is associated with PSC. We sought to refine the PSC risk prediction model by including serial measurements of serum C-reactive protein (CRP). Methods: 230 consecutive patients undergoing PD between 2008 and 2014 were included in the study. Routine serum investigations, including amylase and CRP were performed from the pre-operative day. Receiver operating characteristic (ROC) curve analysis was used to identify a threshold value of serum CRP associated with clinically significant PSC. Results: 95 (41.3%) patients experienced a clinically significant PSC. ROC analysis identified post-operative day 2 (PoD2) serum CRP of 180 mg/L as the optimal threshold (P=0.005) associated with clinically significant PSC, a prolonged stay in critical care (P =0.032), and a relaparotomy (P = 0.045). Patients with a PoD0 serum amylase ≥ 130 IU/L who then developed a PoD2 serum CRP ≥ 180 mg/L had a higher incidence of postoperative complications. Patients were categorised into high, intermediate and low risk groups based on PoD0 serum amylase and PoD2 serum CRP. Patients in the high risk group (PoD0 serum amylase ≥ 130 IU/L and PoD2 serum CRP ≥ 180 mg/l) had significantly higher incidence of PSC, a return to theatre, prolonged lengths stay (all P≤ 0.05) and a four-fold increase in perioperative mortality compared patients in the intermediate and low risk groups (7 deaths in the high risk group versus 2 and nil in the intermediate and low risk groups respectively). Conclusions: A high risk profile, defined as PoD0 serum amylase ≥ 130 IU/L and PoD2 serum CRP ≥ 180 mg/l, should raise the clinician’s awareness of the increased risk of clinically significant PSC and a complicated postoperative course following pancreaticoduodenectomy.

Download Full-text

Is safety of childhood growth hormone therapy related to dose? Data from a large observational study

Acta Endocrinologica ◽

10.1530/eje-15-1017 ◽

2016 ◽

Vol 174 (5) ◽

pp. 681-691 ◽

Cited By ~ 10

Author(s):

Lars Sävendahl ◽

Effie Pournara ◽

Birgitte Tønnes Pedersen ◽

Oliver Blankenstein

Keyword(s):

Growth Hormone ◽

High Risk ◽

Observational Study ◽

Mortality Risk ◽

Growth Hormone Treatment ◽

Risk Group ◽

Safety Data ◽

Hormone Treatment ◽

Low Risk ◽

Intermediate Risk

AbstractObjectiveConcerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice.DesignNordiNet®International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin®(somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark).MethodsLong-term safety data (1998–2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group.ResultsWe found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk—ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure;P< 0.0001 for all). Except for SAEs in the intermediate-risk group (P= 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported.ConclusionsWe conclude that safety data from NordiNet®IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found.

Download Full-text

The predictive role of Ki-67 protein in determining the aggressiveness of primary malignant bone tumors. A retrospective study

Romanian Journal of Orthopaedic Surgery and Traumatology ◽

10.2478/rojost-2019-0018 ◽

2019 ◽

Vol 2 (2) ◽

pp. 91-95

Author(s):

Ioan-Mihai Japie ◽

Dragoș Rădulescu ◽

Adrian Bădilă ◽

Alexandru Papuc ◽

Traian Ciobanu ◽

...

Keyword(s):

High Risk ◽

Ewing Sarcoma ◽

Bone Tumors ◽

Risk Group ◽

High Risk Group ◽

Low Risk ◽

The Other ◽

Malignant Bone Tumors ◽

Ki 67

AbstractIntroduction: In order to diagnose and stage malignant bone tumors, the pathologic examination of harvested pieces with immunohistochemistry test is necessary; they also provide information regarding the prognosis on a medium to long term. Among tissular biomarkers with potential predictive value, a raised Ki-67 protein level is used to determine the risk of local recurrence or metastasis.Material and method: This study was performed on 50 patients with primary malignant bone tumors admitted in the Traumatology and Orthopedy Department of University Emergency Hospital, Bucharest. Patients repartition according to diagnosis was the following: 21 patients with osteosarcoma, 18 patients with chondrosarcoma, 6 patients with Ewing sarcoma, 3 patients with malignant fibrous histiocytoma, and 2 with fibrosarcoma. The follow-up period was between 12 and 72 months with a mean of 26 months.Results: Patients were aged between 18 and 77 years old, with a mean age of 41,36. There were 22 women and 28 men. No sex or age difference was notable for the tumor outcome. After calculating the Ki-67 LI, 36 patients were included in the high-risk group (Ki-67 LI > 25%), while 14 had a low risk for metastasis and local relapse (Ki-67 < 25%). The low-risk patients had chondrosarcoma (8 patients), osteosarcoma (5 patients), and fibrosarcoma (1 patient). During the follow-up, 8 patients, all belonging to the high risk group, developed metastasis, while 5 patients developed local recurrences; 4 patients who relapsed belonged to the high risk group and 1 to the low risk group. Metastases developed in 3 patients with osteosarcoma, 2 with Ewing sarcoma, 2 with chondrosarcoma and 1 patient with fibrosarcoma. Most metastases occurred within one year after surgery. The other fibrosarcoma patient developed local recurrence after 6 months, while the other local recurrences occurred in osteosarcoma patients (2 cases) and 1 in a Ewing sarcoma patient and chondrosarcoma patient.Conclusions: Our study concluded that while Ki-67 LI values are useful in determining the aggressivity of primary malignant bone tumors, it should always be used in conjunction with the clinical, imaging and anatomopathological diagnosis methods in order to accurately predict the patients’ outcome.

Download Full-text