scholarly journals Real world experience from 1000 patients. Preprocedural DOAC interruption impacts detectable DOAC serum levels but not adverse events after catheter ablation of atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Konstantinou ◽  
S Bordignon ◽  
T Tohoku ◽  
S Chen ◽  
F Bologna ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Real World ◽  
Patient Characteristics ◽  
Af Ablation ◽  
Patient Profile ◽  
Significant Difference ◽  
Single Pill ◽  
Group A ◽  
Group B

Abstract Introduction Direct oral anticoagulation (DOAC) therapy represents the standard of care in patients with atrial fibrillation (AF) and increased stroke risk. In a real world setting withholding DOAC medication before elective AF ablation is considered to reduce procedural bleeding risks. The aim of this study was to determine the individual DOAC level prior to the ablation procedure, to identify predisposing factors affecting traceable DOAC levels and to screen for associated severe adverse events. Methods Between September 2016 and March 2019 blood samples were obtained from patients on DOAC before an elective AF ablation. Per institutional standard all patients have been instructed to pause DOAC medication prior ablation for one or two doses depending on the patient profile and type of medication. The time interval between ablation and last DOAC intake was calculated in hours. Patient characteristics, procedural data and in-hospital complications were noted from all patients. Results A total of 1000 patients (60% male, age: 68y, GFR 83.25: BMI: 28, CHADSVASC score 3) undergoing AF ablation were included. Two groups were defined. Group A (n=416, 41.6%): patients treated with “single pill” DOAC (Rivaroxaban (n=288, 28.8%) and Edoxaban (n=128, 12.8%)). Group B (n=584, 58.4%): patients treated with twice a day DOAC (Apixaban (n=505, 50.5%) and Dabigatran (n=79, 7.9%)). The only difference in patient characteristics was an increased prior bleeding history in group B. The DOAC pause was significantly longer in group A (mean 40h) compared to group B (mean 32h), p=0.026. In a total of 217 patients (21.7%) DOAC levels where traceable prior to AF ablation. Traceable DOAC levels were significantly more common in group B (n=144/584, 24.7%) compared to group A (n=73/416, 17.5%). Adverse events occurred in 5.7% of patients (0.4% stroke, 0.3% tamponade, 2.5% hematoma, 1.9% AV-fistel, 0.7% pseudoaneurysma). T-Test analysis showed no significant difference in the occurrence of adverse events between both groups. Conclusion Despite of interrupting DOACs before an elective AF ablation therapeutic substance levels can be detected in >20% of patients. The rate of adverse events was not different between “single pill” vs. twice a day DOAC intake. Funding Acknowledgement Type of funding source: None

The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Objective Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Hematological Toxicity ◽  
Significant Difference ◽  
Group A ◽  
Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

scholarly journals Feasibility of Non-Anesthesiologist-Administered Propofol Sedation for Emergency Endoscopic Retrograde Cholangiopancreatography

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Nobuhito Ikeuchi ◽  
Takao Itoi ◽  
Takuji Gotoda ◽  
Chika Kusano ◽  
Shin Kono ◽  
...  
Keyword(s):  
Adverse Events ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Acute Cholangitis ◽  
Careful Monitoring ◽  
Endoscopic Retrograde ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Technical Safety

Background. The safety of non-anesthesiologist-administered propofol (NAAP) sedation in emergent endoscopic retrograde cholangiopancreatography (ERCP) has not been fully clarified. Thus, the aim of this study was to assess the safety of NAAP sedation in emergent ERCP.Materials and Methods. We retrospectively analyzed 182 consecutive patients who had obstructive jaundice and who underwent ERCP under NAAP sedation. The patients were divided into Group A (with mild acute cholangitis or without acute cholangitis) and Group B (moderate or severe acute cholangitis). And technical safety and adverse events were assessed.Results. The adverse events were hypoxia (31 cases), hypotension (26 cases), and bradycardia (2 cases). There was no significant difference in the rate of each adverse event of hypoxia and bradycardia in either group. Although the rate of transient hypotension associated in Group B was higher than that in Group A, it was immediately improved with conservative treatment. Moreover, there were no patients who showed delayed awakening, or who developed other complications.Conclusions. In conclusion, NAAP sedation is feasible even in emergent ERCP. Although some transient adverse events (e.g., hypotension) were observed, no serious adverse events occurred. Thus, propofol can be used in emergent ERCP but careful monitoring is mandatory.

Checkpoint inhibitor (CPI) experienced patients (pts) from COSMUS-1: A clinical observational study of talimogene laherparepvec (T-VEC) in United States practice.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 142-142 ◽  
Author(s):  
Matthew Perez ◽  
Thomas Amatruda ◽  
Robert Martin Conry ◽  
Charlotte Eielson Ariyan ◽  
Anupam M. Desai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Real World Data ◽  
Clinicopathologic Characteristics ◽  
Immune Mediated ◽  
Group A ◽  
Previously Treated ◽  
Group B

142 Background: T-VEC, a modified oncolytic herpes virus, is an intralesional therapy for unresectable advanced melanoma. COSMUS-1, a recently presented observational chart review study from 7 US academic sites, described metastatic melanoma treatment (tx) patterns and safety of T-VEC in the real-world setting (Perez et al, SMR 2018). In this analysis, we evaluated T-VEC use in pts after prior CPI use or with CPI from COSMUS-1. Methods: Of 76 pts treated with T-VEC (first dose 27Nov2015-15Dec2016), 33 pts had received pembrolizumab, nivolumab and/or ipilimumab (ie, CPI) prior to or with T-VEC and were analyzed for demographics, clinicopathologic characteristics, outcomes, and adverse events. Two groups were identified: Group A, CPI then T-VEC only and Group B, CPI with T-VEC. Results: There were 21 pts in A and 12 pts in B; in B, all received TVEC + CPI with (1) prior CPI, n = 5, (2) prior CPI and additional CPI after combination, n = 1, (3) as combination only, n = 4, or (4) as combination followed by CPI only, n = 2. In A and B, respectively, mean age was 72 yrs and 63 yrs; 12 (57%) and 9 (75%) were men; 17 (81%) and 9 (75%) had ECOG 0-1,10 (48%) and 4 (33%) had Stage IIIB-IVM1a, and 11 (52%) and 7 (58%) had Stage IVM1b/c. Two pts (both in B) remained on T-VEC by study end. 21 (100%) pts in A and 10 (83%) pts in B discontinued T-VEC (most common, respectively: 10 pts and 3 pts due to disease progression, 4 pts and 2 pts due to physician decision). 2 pts had no injectable lesions left (in A) and 1 pt (in A) had pathologic complete response (CR). Adverse events of interest were reported in 7 pts (33%) in A and 6 pts (50%) in B; most common events in A and B, respectively, were immune-mediated events (n = 3 and 6) which included flu-like symptoms (fever, chills, rigor; n = 2 and 5) and injection site complications (n = 5 and 2). No herpetic infections were reported in pts. Conclusions: These real-world data suggest that T-VEC is well tolerated and can be administered in pts previously treated with a CPI, both those who switched to T-VEC or those where T-VEC was added on. One pt achieved a pathologic CR.

scholarly journals Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

2021 ◽  
Vol 9 ◽  
Author(s):  
Thanan Supasiri ◽  
Nuntida Salakshna ◽  
Krit Pongpirul
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Severity Index ◽  
Tertiary Hospital ◽  
Optimal Number ◽  
Significant Difference ◽  
Patient Reported ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p &lt; 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p &lt; 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p &lt; 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p &lt; 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

Ophthalmic artery catheterization for retinoblastoma treatment: does reflux affect tumor response?

2020 ◽  
Vol 12 (9) ◽  
pp. 915-920 ◽  
Author(s):  
Ahmad Sweid ◽  
Batoul Hammoud ◽  
Joshua H Weinberg ◽  
Pavlos Texakalidis ◽  
Vivian Xu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ophthalmic Artery ◽  
Tumor Response ◽  
Retrospective Chart Review ◽  
Primary Treatment ◽  
Study Cohort ◽  
Significant Difference ◽  
Group A ◽  
Poor Outcomes ◽  
Group B

BackgroundIntra-arterial chemotherapy (IAC) for retinoblastoma (Rb) has been established as a primary treatment for the disease. To determine whether the presence of reflux into the ICA is associated with tumor response or with any other adverse events in pediatric retinoblastoma patients.MethodsA retrospective chart review was performed for patients diagnosed with Rb and managed with ophthalmic artery catheterization (OAC).ResultsThe total study cohort included 205 Rb tumors of 205 eyes in 194 consecutive patients who underwent 624 successful intra-arterial chemotherapy infusions using OAC. Of the 205 eyes, 65 eyes (32.7%) underwent 157 OAC procedures constituted group A (no reflux), 64 eyes (31.2%) underwent 236 OAC procedures constituted group B (variable pattern), and 74 eyes (36.1%) underwent 231 OAC procedures constituted group C (reflux). There was no significant difference in baseline characteristics between the three cohorts. Also, there was no significant difference in tumor characteristics between the three groups, except for genetic status. There was no significant difference between the three groups in terms of tumor response at completion of the treatment regimen. Complete tumor response was achieved at 70.2% in Group A, at 83.3% in Group B, and at 78.5% in group C (P=0.39). Similarly, eye enucleation occurred at 38.5% in group A, 31.8% in group B, and 31.5% in group C. None of the patients in both groups had any neurological adverse events or new onset of seizures.ConclusionsThe presence of reflux, which may complicate the procedure and prolong it, was not associated with poor outcomes in our analysis.

Association of bevacizumab-free interval with efficacy of anti-EGFR therapy in patients with metastatic colorectal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 610-610
Author(s):  
Azusa Komori ◽  
Hiroya Taniguchi ◽  
Yukiya Narita ◽  
Shiori Uegaki ◽  
Sohhei Nitta ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Short Interval ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Free Interval ◽  
Significant Difference ◽  
Group A ◽  
Group B

610 Background: Both bevacizumab (Bev) and anti-EGFR agents are sequentially used for metastatic colorectal cancer (mCRC). Some basic studies reported the interaction between Bev and anti-EGFR agents in vivo. Therefore we hypothesized the shorter Bev-free interval may lead to poor outcome of anti-EGFR therapy. The aim of this study is to examine the association of the interval between last Bev administration and initial anti-EGFR agents with efficacy of anti-EGFR therapy. Methods: We retrospectively reviewed consecutive mCRC patients who underwent combination therapy of anti-EGFR agents and irinotecan after failure of fluoropyrimidines, oxaliplatin, irinotecan, and Bev at a single institution. We divided patients in two groups (group A: the interval between Bev and anti-EGFR agents <6M, group B: ≥6M). Results: A total of 114 patients constituted the cohort of analysis. The median age was 63; 78 (68%) patients were male. Most patients (N=100, 88%) were treated with cetuximab, and 14 patients were panitumumab. Seventy-four patients were group A and 40 patients group B, respectively. There was no significant difference in patient characteristics. Response rate was 24.7% in group A, and 50.0% in group B (p=0.0072). The patients in group B have significantly longer progression free survival (4.2 vs. 6.6 M, HR 0.65, 95% CI 0.43- 0.98, p=0.042) and longer overall survival (11.6 vs. 14.3 M, HR 0.62, 95% CI 0.39- 0.97, p=0.038). Conclusions: The short interval (<6M) between last Bev and anti-EGFR agents may interfere with the efficacy of anti-EGFR therapy.

Abstract T MP60: Impact of Aortic Arch Atheroma for Stroke Recurrence in Patients With or Without Atrial Fibrillation

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Shigeru Fujimoto ◽  
Masato Osaki ◽  
Masaya Kumamoto ◽  
Makoto Kanazawa ◽  
Naoki Tagawa ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Aortic Arch ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
Stroke Recurrence ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
The Impact

Background & Purpose: In patients with embolic stroke of undetermined source, aortic arch atheroma evaluated using transesophageal echocardiography (TEE) is a possible embolic source. We investigated the impact of embolic sources including aortic arch atheroma for a stroke recurrences and death. Methods: Among the consecutive 1545 acute stroke patients, 542 patients who were admitted within 24 hours after the symptom onset, with ischemic lesions in the cortex or cerebellum on the diffusion-weighted image, NIH stroke scale of 7 or less, and prior modified Rankin scale (mRS) of 0 or 1 were included in the present study. All 542 patients underwent TEE to search for embolic sources. According to the categories of embolic sources, patients were classified into 4 groups: patients with severe aortic arch atheroma of 4mm or more in diameter (group A; n=167), patients with cardiogenic embolic sources such as atrial fibrillation or intracardiac thrombus (group C; n=93), patients with both factors as described above (group B; n=88), and other patients (group O; n=194). We followed them up for average period of 3.2 years, and investigated the frequency of stroke recurrences and death from any cause according to embolic sources. Results: Stroke recurrences were observed in 12.0% patients in group A, 11.8% patients in group C, 18.2% patients in group B, and 6.7% patients in group O respectively (p=0.0371). Stroke recurrences and death from any cause occurred in 14.4%, 15.1%, 21.6% and 6.7% patients respectively (p=0.0041). Kaplan-Meier curve analysis revealed a significant difference in the recurrence-free survival among the four groups (p=0.0076, log-rank test). Stroke recurrence was more frequent in group B than group C patients especially in the early phase from the onset. On COX proportional-hazards model analysis and diabetes mellitus (HR 1.73, p=0.0264) and aortic arch atheroma of 4mm or more (HR 1.86, p=0.0146) were significant predictors for stroke recurrences and death from any cause. Conclusions: Severe aortic arch atheroma can independently be associated with stroke recurrences and death, furthermore, a combination of aortic arch atheroma and cardiogenic embolic sources showed more frequent events than each of them alone.

Combined treatment with iodine-125 (125I) seed strand and transarterial chemoembolization (TACE) plus lenvatinib with anti-PD-1 antibodies in patients with unresectable hepatocellular carcinoma (uHCC) and portal vein tumor thrombus (PVTT): Real-world experience in China.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16152-e16152
Author(s):  
Zi-Han Zhang ◽  
Wen Zhang ◽  
Qing-Xin Liu ◽  
Ling-Xiao Liu ◽  
Jian-Jun Luo ◽  
...  
Keyword(s):  
Propensity Score ◽  
Adverse Events ◽  
Real World ◽  
Stent Implantation ◽  
Interventional Procedure ◽  
Locoregional Therapy ◽  
Survival Outcomes ◽  
125I Seed ◽  
Group A ◽  
Group B

e16152 Background: We reviewed real-world outcomes for patients with uHCC and PVTT receiving TACE with 125I seed and stent implantation combined with lenvatinib plus anti-PD-1 antibodies. Methods: We retrospectively reviewed medical records from 62 consecutive adult (≥18 to ≤75 years) patients with HBV-related HCC and type III and IV PVTT with Child-Pugh class A or B liver function and ECOG performance status of 0-2 who received 125I seed strand and stent implantation combined with TACE at our center between November 2018 and May 2020. Patients were divided into two groups; those who had received adjuvant lenvatinib plus anti-PD-1 inhibitors, initiated 3 days after the first interventional procedure (Group A; n=18), and those who only received locoregional therapy (Group B; n=44). Propensity score matching (PSM) with a 1:1 ratio was used to reduce selection bias. Tumor response, progression-free survival (PFS, time from the first interventional procedure to progression or death for both Group A and Group B) and time-to-progression (TTP) were assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Time to untreatable progression (TTUP) and overall survival (OS) were also assessed. Adverse events (AEs) were graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. Results: PSM resulted in 15 matched pairs of patients, and baseline demographic parameters were comparable between the two groups. The median follow-up time was 12.4 ± 4.6 and 9.4 ± 4.8 months for patients in Groups A (n=15) and B (n=15) after PSM, respectively. Compared with patients in Group B, those in Group A had a higher overall response rate (66.7 vs. 18.2%; p=0.001) and disease control rate (72.2 vs. 43.2%; p=.038) and a longer median PFS, TTP, TTUP and OS (Table). No serious complications related to locoregional procedures were reported in either group. In Group A, 13% (n=2) of patients experienced ≥1 AE but the majority were Grade <3; one patient had Grade 2 hyperthyroidism and one had Grade 2 enteritis, which were both considered related to immunotherapy. Conclusions: These real-world data show that 125I seed strand and stent implantation combined with TACE plus adjuvant lenvatinib and anti-PD-1 antibodies led to better treatment responses and survival outcomes compared with locoregional treatment alone in patients with uHCC and PVTT, with an acceptable safety profile. Summary of survival outcomes in propensity score matched groups.[Table: see text]

Therapeutic Superiority and Safety of Combined Hydroxyurea with Recombinant Human Erythropoietin Over Hydroxyurea in B-Thalassemia Intermedia Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 252-252
Author(s):  
Mohsen Saleh Elalfy ◽  
Amira Adly ◽  
Yassmine Elhanawy
Keyword(s):  
Adverse Events ◽  
Short Form ◽  
Single Agent ◽  
Random Allocation ◽  
Thalassemia Intermedia ◽  
Transfusion Requirements ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract Abstract 252 Background: Both Hydroxyurea (HU) as a single agent or in combination with Erythropoietin (rHuEPO) became a therapeutic option for β-Thalassemia intermedia(TI) over last 2 decades. However superiority and safety of combination therapy over HU alone needs further evaluation. Aim: to assess the increase of hemoglobin levels in TI patients by at least 1g/dl above baseline during therapy using combined HUO and rHuEPO compared to single HUO therapy, also to report decline in transfusion requirements, quality of life (QoL), and any drug related adverse events. Patients and methods: An interventional prospective randomized open-labeled study; was approved from the local ethical committee and was registered in the Clinical Trials. Goverment (NCT01624038 ). Eighty Patients 18 years or less will be assigned into one of 2 groups using a random allocation method. Group A: Forty TI patients (age range: 5–18 years) considered as interventional arm 1 and received combined daily HUO (25 mg/kg/day orally) and rHuEPO (1000 IU/kg/week subcutaneously divided in three times/week). Group B: Forty TI patients (age range: 4–18 years) considered as arm 2 (control arm) and received daily single HUO therapy of 25 mg/kg/day. Both groups were followed up both clinically and laboratory for a mean period of one year with assessment of transfusion requirements, blood pressure weekly, liver and renal functions, Hemoglobin (Hb), HbF monthly, basal serum erythropiotin levels and QoL was assessed at study entry and end using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Diagnosis of TI was based on both genetic mutations and absence of transfusion during the 1st 2 years of life. Exclusion criteria were: evidence of active hepatitis (ALT>5 times) or renal impairment. Results: There were a significant improvement in the QoL in 80% and 60% of patients on combined compared to single therapy(p<0.05). There was a significant increase in both Hb and HbF (p <0.001), and the increments were strongly correlated (r =0.84; p <0.001) in both groups more in group A patients. The median Hb level in groups A and B during the study was 9.1 and 7.9 g/dL, respectively (p=0.03). In 68% (n=27) of TI patients group (A) were responded by a 0.5–3 g/dl increase in Hb level. There was significant difference between the 2 groups as only 20% (n=8) of patients in group B show intended improvement in their hemoglobin levels (p<0.01). In studied thalassemics 40%(n=16) of group A compared to 15%(n=6) of group B (p=0.01) became transfusion independent with 20% in group A showed decrease in their transfusion requirements with significant decrease in transfusion index compared to group B thalassemics (p<0.001). There was no significant change in absolute Hb-F, and serum ferritin levels during treatment. splenectomized patients and those with serum EPO less than 500 mU/mL, and intial HbF% > 40% had best response to combined therapy. Side effects from rHuEPO included bone pain in 2 patients, headache in 4 patients, however no uncontrolled hypertension was reported. Gastrointestinal irritation was observed in 3 patients and resolved when the dose was given at bedtime. No renal or hepatic toxicity were reported. A single case of mild neutropenia was reported and recovered within one week of temporary discontinuation Conclusions: Hu was effective in management of TI however combination with erythropiotin had an additive therapeutic effect and was well tolerated with no further serious adverse events. Disclosures: No relevant conflicts of interest to declare.

Pentraxin 3 and other inflammatory biomarkers related to atrial fibrillation in cardiac surgery

Perfusion ◽  
2016 ◽  
Vol 32 (4) ◽  
pp. 269-278 ◽  
Author(s):  
Zdenka Holubcova ◽  
Pavel Kunes ◽  
Jiri Mandak ◽  
Dana Vlaskova ◽  
Martina Kolackova ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Serum Levels ◽  
Inflammatory Biomarkers ◽  
Surgical Patients ◽  
Significant Difference ◽  
History Of ◽  
Group A ◽  
Group B ◽  
New Onset

Objectives: The aim was to evaluate the association between perioperative inflammatory biomarkers and atrial fibrillation (AF) in cardiac surgical patients. Methods: Forty-two patients undergoing cardiac surgery were divided into three groups according to the occurrence of AF: Group A (n = 22) – patients with no AF, Group B (n = 11) – patients with new onset AF postoperatively and Group C (n = 9) – patients with preoperative history of atrial fibrillation. The serum levels of PTX3, CRP, TLR2, IL-8, IL-18, sFas, MMP-7 and MMP-8 were measured at the following time points: before surgery, immediately and 6 h after surgery and on the 1st, 3rd and 7th postoperative days (POD). Results: Serum levels of PTX3 showed a significant difference between Groups A and C on the 3rd POD (p<0.05) and on the 7th POD (p<0.0001). IL-8 levels were different between Groups A and C immediately after surgery (p<0.05), 6 hours after surgery (p<0.05) and on the 3rd POD (p<0.05). There was a difference between Groups B and C on the 1st POD in IL-8 levels (p<0.05). The sFas levels differed between Groups A and C on the 3rd POD (p<0.01) and the 7th POD (p<0.05). There was also a difference on the 7th POD (p<0.05) between the Groups B and C. No significant differences between the groups was seen for other biomarkers. Conclusion: This study demonstrates significantly different dynamics of PTX3, IL-8 and sFas levels after cardiac surgery in relation to AF.

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