Should Hematopoietic Stem Cell Transplantation in First Complete Remission Be Restricted to High-Risk Patients in Childhood Acute Myeloid Leukemia?.

Abstract Hematopoietic stem cell transplantation (HSCT) has been used as an effective consolidation therapy for children with acute myeloid leukemia (AML) in first complete remission (CR). Although it is effective in relapse prevention, often it causes severe late sequelae, such as short stature and infertility. There is a recent trend to restrict the use of HSCT in first CR for high-risk patients. However, there is no study comparing which strategy is better, risk-adapted or general recommendation for HSCT in AML children in first CR. In our institutes, all such children in first CR were recommended either allogeneic or autologous HSCT until 1997. After 1998, patients were classified into three risk-groups. Low-risk patients (t(8;21) and inv(16)) were not recommended to undergo HSCT. High-risk patients (−7, 5q-, Ph1, t(16;21) and remission failure) were recommended to undergo HSCT. Intermediate-risk (other karyotypes) patients received HSCT in first CR if a suitable donor was available. In this study, we retrospectively compared the prognosis of 66 patients who were diagnosed with de novo AML between 1991 and 1997 (group A; n=37) and between 1998 and 2003 (group B; n=29). AML with Down syndrome and AML-M3 were excluded. The median (range) age was five (0–15) years. FAB classifications were M0 (n = 1), M1 (n = 10), M2 (n = 22), M4 (n = 6), M4E (n = 5), M5 (n = 14), M6 (n = 0), and M7 (n = 8). Chromosome analysis data were t(8;21) (n = 18), inv(16) (n = 4), 11q23 (n = 10), other abnormalities (n = 14), normal karyotype (n = 14), and unknown (n = 6). Induction chemotherapy comprised VP-16, cytarabine, and mitoxantrone. Sixty-three of 66 patients (95.5%) achieved CR. HSCT in first CR was done in 24 patients (64.9%) in group A and seven patients (24.1%) in group B (p = 0.0044). Age, sex, WBC count at diagnosis, FAB classification and chromosomal abnormalities did not differ between the two groups. Fourteen (five in group A and nine in group B) patients relapsed. Six (three in group A and three in group B) of them were salvaged by HSCT. Both 5-year event-free survival (EFS) and overall survival (OS) were statistically higher in group A than in group B (5-year EFS: 83.8 ± 6.1% versus 62.1 ± 9.0%, p = 0.0404; 5-year OS: 91.6 ± 4.7% versus 71.6 ± 8.5%, p = 0.0364). Although intensified chemotherapy without HSCT for low-risk AML patients is desirable to avoid the late complications of HSCT, our analysis showed that the introduction of risk-stratified treatment strategy significantly worsened the chances of EFS and OS. Our risk stratification based on chromosomal abnormalities only may be insufficient to identify low-risk AML children. Development of more sophisticated risk classification, including molecular markers, may be required to identify true low-risk patients who should avoid HSCT in first CR.

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Ultrasound Assessment of Low Risk versus High Risk Pregnancy and Perinatal Outcome

JMS SKIMS ◽

10.33883/jms.v17i1.226 ◽

2014 ◽

Vol 17 (1) ◽

pp. 6-10

Author(s):

Rita Thakur ◽

Rabia Khurshid ◽

Swarn Kanta Gupta ◽

Cimona Lynsandanha ◽

Abida Ahmad

Keyword(s):

High Risk ◽

Perinatal Mortality ◽

Perinatal Outcome ◽

Low Risk ◽

Neonatal Deaths ◽

High Risk Patients ◽

Still Births ◽

Risk Patients ◽

Group A ◽

Group B

Objective: To determine the maturational changes in the placenta by ultrasonography at various gestational ages in low risk vs. high risk pregnancies and their correlation with perinatal outcome. Subjects: Study was conducted in 100 patients with singleton pregnancies, divided into two groups: Group A (control group) having no medical or obstetrical complications in the current pregnancy and Group B (study group) having medical or obstetrical complication. All the patients were subjected to ultrasonography between 28-31 weeks, 32-37 weeks and after 37 weeks of gestation. All cases were followed till pregnancy outcome and neonates followed up to 7 days after birth. Perinatal outcome of group A and group B was compared. Results: It was observed that placental maturity increased with GA in both groups but placenta matured earlier in high risk cases. 8% patients in group A and 26% in group B showed earlier placental maturation. Patients of diabetes mellitus showed delayed maturity and lower grades were found even at termination. Incidence of LSCS was 44%in group B and 20% in group A. Good apgar score was shown when placental maturity was of higher grade. Respiratory distress syndrome was seen in only 4% neonates in group A and 8% in group B at termination with grade III placenta. 19% neonates in group A required admission to an ICU as compared to 37% in group B. Perinatal mortality was high in patients who had placental grade 0 and 1 at termination in both the groups. There was 10% perinatal mortality (4% still births and 6% neonatal deaths) in group A and 14% (4% still births and 10% neonatal deaths) in group B as high risk patients were there in group B. Conclusion: Placental grading by ultrasonography is a reliable index of foetal pulmonary maturity and it can assist the obstetrician in the management of high risk patients, thus making ultrasonography a useful tool for predicting the perinatal outcome and planning treatment modalities for termination of pregnancy. JMS 2014;17(1):6-10

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Risk-Stratification Treatment Directed by Minimal Residual Disease Improves the Outcome of Acute Myeloid Leukemia with t(8;21) in First Complete Remission: Results of the AML05 Multicentre Trial

Blood ◽

10.1182/blood.v120.21.139.139 ◽

2012 ◽

Vol 120 (21) ◽

pp. 139-139

Author(s):

Honghu Zhu ◽

Xiao-hui Zhang ◽

Yazhen Qin ◽

Hao Jiang ◽

Dai-Hong Liu ◽

...

Keyword(s):

Acute Myeloid Leukemia ◽

High Risk ◽

Complete Remission ◽

Myeloid Leukemia ◽

Hazard Ratio ◽

Low Risk ◽

Hematopoietic Stem ◽

Risk Patients ◽

First Complete Remission ◽

Acute Myeloid

Abstract Abstract 139 Background Although patients with acute myeloid leukemia (AML) and the t(8;21) translocation generally have a favorable prognosis, relapse occurs in about 40% of cases and long-term (>5years) survival less than 50%. Patients with a KIT-mutation had an even higher relapse rate up to 70% and dismal survial. Once relapse, the outcome is extremely poor, even receiving allogeneic hematopoietic stem-cell transplantation (allo-HSCT).Therefore, rapidly identifying high-risk relapse patients and preemptively treating them with more aggressive therapy, such as HSCT, may decrease the chance of relapse and improve patient survival. We sought to improve outcome in patients with t(8;21) acute myeloid leukemia(AML) in first complete remission (CR) by applying risk-directed therapy that was based on measurements of minimal residual disease (MRD) by quantitative PCR during treatment. Methods From June 1,2005, to Dec 31, 2011, 137 patients with t(8;21) AML were enrolled at three centres. MRD was detected using quantitative PCR to detect the RUNX1/RUNX1T1 transcript. High-risk was defined by not achieving major molecular remission (MMR,> 3 log reduction of RUNX1/RUNX1T1 transcript from baseline) after second consolidation therapy or loss of MMR within 6 months since achieving MMR. Low-risk was defined by achieving MMR after second consolidation therapy and maintenance of MMR within 6 months thereafter. High-risk patients were recommended to receive allogeneic hematopoietic stem-cell transplantation (allo-HSCT) and low-risk patients to high-dose cytarabine-based consolidation chemotherapy. 116 patients who achieved CR and completed second consolidation were assigned to risk-directed therapy. Finally, sixty-nine patients actually received risk-directed therapy and 47 patients received a non risk-directed treatment for patients¡ bias. Findings With a median follow-time of 36 months in patients alive, risk-directed therapy and non risk-directed therapy achieved 5 year cumulative incidence of relapse(CIR) of 15.0%±4.7% and 57.5%±8.0%(p<0.0001), disease-free survival(DFS) of 74.7%±5.8% and 37.1%±7.4%(p<0.0001) and overall survival (OS) of 82.7%±5.1% and 49.8%±8.5% (p=0.002) (Figure 1). Allo-HSCT benefited high-risk as well as KIT-mutated but impaired low-risk patients' DFS and OS (all p<0.05) (Figure 2). Multivariate analysis revealed that MRD status (high-risk vs. low-risk) and treatment (risk-directed vs. no risk-directed) were independent prognostic factor for relapse(hazard ratio 8.85, 95% CI 2.05–38.13, p=0.003; 0.26, 95% CI 0.12–0.61, p=0.002), DFS(hazard ratio 9.32, 95% CI 2.21–39.3; p=0.002; 0.36, 95% CI 0.17–0.75, p=0.007) and OS (hazard ratio10.53, 95% CI 1.41–78.83; p=0.022; 0.37, 95% CI 0.15–0.93, p=0.035).KIT-mutation was an independent prognostic factor for relapse(hazard ratio 2.12, 95% CI 1.01–4.48, p=0.049) but not for DFS and OS. Interpretation Risk-stratification treatment directed by MRD could improve the outcome of AML with t(8;21) in first complete remission. Allo-HSCT benefits high-risk as well as KIT-mutated but impairs low-risk patients¡ survival. Disclosures: No relevant conflicts of interest to declare.

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Allogeneic hematopoietic stem cell transplantation can improve the prognosis of high-risk pediatric t (8;21) acute myeloid leukemia in first remission based on MRD-guided treatment

10.21203/rs.3.rs-19480/v1 ◽

2020 ◽

Author(s):

Guan-hua Hu ◽

Yi-fei Cheng ◽

Ai-dong Lu ◽

Yu Wang ◽

Ying-xi Zuo ◽

...

Keyword(s):

High Risk ◽

Myeloid Leukemia ◽

Risk Group ◽

Low Risk ◽

Hematopoietic Stem ◽

High Risk Patients ◽

Risk Patients ◽

The Difference ◽

Acute Myeloid ◽

Better Than

Abstract Background Pediatric acute myeloid leukemia (AML) with t (8;21) (q22;q22) or RUNX1-RUNX1T1 rearrangement is classified as a low-risk group. However, relapse is still the main factor affecting survival. The purpose of this study was to investigate the effect of allogeneic hematopoietic stem cell transplantation (allo-HSCT) on reducing recurrence and improving the survival of high-risk pediatric t (8;21) AML based on MRD-guided treatment, and to further explore the prognostic factors to guide risk stratification treatment and define who will benefit from allo-HSCT. Methods Overall, 129 newly diagnosed pediatric patients with AML with t (8;21) were included in this study. The patients were divided into a high-risk and low-risk group according to RUNX1-RUNX1T1 transcript levels after two cycles of consolidation chemotherapy. We recommended allo-HSCT for the high-risk group and chemotherapy for the low-risk group. The characteristics and outcomes of 125 patients were analyzed.Results For the high-risk patients, allo-HSCT improved event-free survival (EFS) compared to chemotherapy (87.4% [95% CI, 86%–108.7%]) vs. 61.9% [95% CI, 51.96%–80.41%]; P = 0.026). Overall survival (OS) of the high-risk HSCT group was better than that of the high-risk-chemo group but the difference was not statistically significant (82.8% [95% CI, 78.6%–101.7%]) vs. 71.4% [95% CI, 62.09%–87.6%]; P = 0.26). The EFS of the C-KIT+ high-risk-HSCT group was better than that of the C-KIT+ high-risk-chemo group but the difference was not statistically significant (82.9% [95% CI, 59.3%–84.8%]) vs. 75% [95% CI, 49.3%–85.6%]; P = 0.4). Extramedullary infiltration (EI) at diagnosis was associated with high cumulative incidence of relapse for high-risk patients (50% [95% CI, 17.2%–66.5%]) vs. 18.4% [95% CI, 3.0%–18.9%]; P = 0.004); allo-HSCT can improve survival (P = 0.009). Conclusions allo-HSCT can improve the prognosis of high-risk pediatric t (8;21) AML based on MRD-guided treatment. Patients with KIT mutation may benefit from allo-HSCT, but this result was not statistically significant. EI is an independent prognostic factor for high-risk patients and allo-HSCT can improve the prognosis.

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P–671 Dual Trigger(low adjuvant HCG4h after GnRHagonist trigger)have positive impact of overall embryo’s quality, implantation ,clinical pregnancy and live birth rates in high-risk patients for OHSS

Human Reproduction ◽

10.1093/humrep/deab130.670 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

E Petanovsk. Kostova

Keyword(s):

High Risk ◽

Live Birth ◽

Clinical Pregnancy ◽

Birth Rates ◽

High Risk Patients ◽

Live Birth Rates ◽

Significant Difference ◽

Risk Patients ◽

Group A ◽

Group B

Abstract Study question Study aim is to compare implantation,clinical pregnancy and livebirth rates between giving1500IU of hCG4hours after GnRHagonist,on trigger day or GnRHagonist as alone trigger with luteal support withHCG1500IU.35h later on OPUday. Summary answer Adjuvant doze of1500IUhCG4h after bolus of GnRHagonist on trigger day significantly improve quality of blastocyst,implantation,clinical pregnancy and live birth rates without increasing the risk ofOHSS. What is known already The use of GnRHagonist for final oocyte maturation in antagonist cycle significantly decrease the incidence of OHSS,but there have been studies showing lower pregnancy rates in patients triggered with GnRHagonist compared with hCG in autologous cycles,attributed to a defective luteal phase, especially in high–risk patients despite intensive luteal phase support.To improve the results of IVF,an alternative approach is adding a small bolus dose of hCG(1500IU)35h later,on the OPU day after GnRHagonist trigger which provides more sustained support for the corpus luteum.The question is does low doses of hCGgiven on the same day with GnRHagonist trigger is making better quality oocytes. Study design, size, duration Single center prospective longitudinal cohort study fromJanuary2017 to Decembar2019.The initial inclusion criteria were:women age≥18and≤39years,AMH≥3,3ng/ml and ≥12 antral follicles on basal ultrasound.Patients with history of OHSS and PCO are also included in the study.Patients with applied “freeze-all” technique with peak estradiol≥4000pg/ml on trigger day>18oocytes on the OPU day,and recognized significant risk for developing OHSS were also included.The cumulative implantation,clinical pregnancy and live birth rates were analyzed,only in embryos from the same COS protocol in every patient. Participants/materials, setting, methods A total of 231 patients were entered for final analysis,who underwent a flexible antagonist protocol,ICSI and fresh or thawed ET on 3th(38.53%) or 5th( 61.47%)day in women’s autologous cycles.Patients were randomized in one of two groups: GroupA-Dual trigger group 1500IUof hCG 4h after GnRH agonist application on trigger day and GroupB –1500IU of HCG 35h later,on the OPU day.We used nonparametric and parametric statistical tests.Significant differences were considered all values of p < 0.05 Main results and the role of chance Both groups are homogenous regarding several variables:age,BMI,type of sterility,smoking status,AMH,PCO, spermogram.There is no significant difference between the two(AvsB)groups according to average number of retrieved oocytes(13.6 vs 14.6 p > 0,05),M II oocytes(11.03 vs 11.99 p > 0.05).The dual trigger group(A)had a higher fertility rate(69.99% vs 64.11% p < 0,05)compared with GnRHagonist trigger group(B).There are no significant difference between groups(AvsB)according to cumulative average number of:transferred embryos(2.4vs2.5 p > 0.05)TQE transfered on 3th day(1.5.vs 1.3.p>0.05);transferred blastocyst(2.6 vs2.7 >0.05);cryo embryos(2.5vs1.9 p > 0.05),but there are significant difference according to cumulative implantation rate of transferred blastocyst in favor of group A(48.18% vs 33.89%p<0.05).Analyzes of morphological characteristics of transferred blastocyst depicted in the order of degree of blastocyst expansion,inner cellular mass(ICM)and trofoectoderm(TE) and ranking overall blastocysts quality from“excellent”,“good”,“average” and “pore” ,shows that there are significantly more percentage of patient with embryo transfer of “excellent” or even one “excellent” blastocyst in group A (30.56%,31.94% vs 21.54%,23.08% p < 0.05) in opposite of percentage of patients with embryo transfer with “poore “” blastocyst in group B (37.5% vs 46.15.%p<0.05). Clinical pregnanacy rate (71.68% vs 50.84% p < 0.05) , and live birth rate (60,18% vs 42,58% ), were significantly higher in group A. There were no cases of moderate or severe OHSS in both groups. Limitations, reasons for caution Dual trigger in GnRH antagonist protocols should be advocated as a safe approach but undetected high risk patients are reasons for caution for developing clinically significant OHSS. Wider implications of the findings: Adjuvant low dose of hCG on GnRHagonist trigger day improve clinical pregnancy and live birth rates without increasing the risk of clinically significant OHSS.Protocol of dual trigger and freezing all oocytes or embryos in patients with high risk of developing OHSS is promising technique in everyday practice. Trial registration number 8698

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What is the impact of a previously failed Robicsek repair in the subsequent treatment of sternal dehiscence with thermoreactive nitinol clips?

10.22541/au.161780059.97703123/v1 ◽

2021 ◽

Author(s):

Yunus Seyrek ◽

Murat Akkuş

Keyword(s):

Treatment Group ◽

High Risk ◽

Complication Rate ◽

Median Sternotomy ◽

Sternal Dehiscence ◽

High Risk Patients ◽

Risk Patients ◽

Group A ◽

Group B ◽

The Impact

Background: In this study, we conducted a retrospective review of patients at our institution with noninfectious sternal dehiscence (NISD) after median sternotomy who received thermoreactive nitinol clips (TRNC) treatment during a 10-year period. We compared TRNC patients with and without history of failed Robicsek repair. The purpose of the study was to analyze the impact of previous Robicsek repair on the treatment of sternal dehiscence with TRCN. Methods: Between December 2009 and January 2020, out of 283 patients with NISD who underwent refixation, we studied 34 cases who received TRNC treatment. We divided these 34 cases into two groups: patients who had a previously failed Robicsek procedure before TRNC treatment (group A, n=11) and patients who had been directly referred to TRCN treatment (group B, n= 23). Results: Postoperative complication rate was significantly higher in group A (p=0.026). Hospitalization duration was significantly longer in group A due to the higher complication rate (p=0.001). Operative time was significantly shorter and blood loss was significantly lower in group B (p=0.001). Conclusion: The Robicsek procedure is considered an effective method in the treatment of NISD but, in case of its failure, subsequent TRNC treatment might become cumbersome in high-risk patients. In our study, a previously failed Robicsek procedure caused significantly higher morbidity and additional operative risk in later TRNC treatment of high-risk cases. Ultimately, we speculate that a direct TRNC treatment for NISD is favorable in high-risk patients.

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Allogeneic Hematopoietic Stem Cell Transplantation (allo HSCT) in Patients with IPSS Low or Intermediate-1 Myelodysplastic Syndrome (MDS): A Prospective Multicenter Phase II Study Based on Donor Availability By the GFM & SFGM-TC "MDS-ALLO-Risk"

Blood ◽

10.1182/blood-2021-146846 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 1842-1842

Author(s):

Marie Sebert ◽

Cendrine Chaffaut ◽

Sylvain Thepot ◽

Corentin Orvain ◽

Thomas Cluzeau ◽

...

Keyword(s):

High Risk ◽

Lower Risk ◽

Research Funding ◽

Low Risk ◽

Donor Group ◽

Hematopoietic Stem ◽

The Past ◽

Group A ◽

Group B

Abstract Background: Allo HSCT is a potentially curative treatment in MDS which, in higher risk (IPSS high and int 2) MDS demonstrated an overall survival (OS) advantage over conventional treatment (especially HMAs) in retrospective (Koreth et al., JCO 2013) and prospective (Robin et al. leukemia 2015) studies. Retrospective studies, on the other hand, suggested no OS advantage for allo HSCT in lower risk MDS (IPSS low and int 1), except possibly in the "poorest" lower risk MDS subsets, as classified by the WPSS (Alessandrino et al. AMJH 2013) However, about 25% of lower risk MDS patients are reclassified as higher risk by the R-IPSS and a proportion of other lower risk MDS can also harbor some higher risk features that compromise their outcome. MDS-ALLO-RISK trial (clinicaltrial.gov NCT02757989), was designed to assess outcome of lower risk MDS patients with some high-risk features after HLA-matched donor HSCT. Method: The primary objective of this study was to demonstrate an OS improvement in lower risk MDS patients with some high risk features with a donor compared with those without a donor (with a 3 year OS of 70% versus 40%, respectively) . Inclusion criteria were: IPSS low or int1 MDS with at least one of the following characteristics: 1) R-IPSS intermediate or higher 2) RBC transfusion dependent anemia and failure to two or more treatments (including EPO, Lenalidomide or HMA ); 3) platelets < 20 G/L requiring transfusions 4) ANC < 0.5 G/L with severe infection 5) no contra indication to allo HSCT 6) age <70 years 7) HLA identical donor (sibling or 10/10 unrelated) 105 inclusions were planned: 62 in group with a donor (group A) and 43 in group without a donor (group B). Recruitment began in June 2016 and stopped in March 2021 due to futility on the interim analysis. Median follow-up was 20 months. Data cut off analysis was June 2021. Results: 79 patients were included, 64 in group A and 15 in group B. Median age was 62.4 (IQR: 58-65) years in group A and 66 (IQR: 60.5-68) years in group B. Patients in group A were more frequently males (73 vs 40%, p=0.029), WHO was CMML in 8 (10%), MDS-SLD in 5 (8%), MDS-MLD in 9 (11%), MDS-EB1 in 41 (52%), MDS-RS in 12 (15%), unclassified in 4 (6%) without significant differences between the two groups. IPSS /IPSS-R was similar in both groups: IPSS low in 10% (11% in group A and 7% in group B) and Int-1 in 90%. IPSS-R: very low risk (6% vs 0%); low risk (25% vs 27%); intermediate (50% vs 47%); high (19% vs 27%); no very high risk. Among the 64 patients with a donor, 58 (92%) received HSCT, 2 died before HSCT; 2 had progressive disease and 2 are planned for HSCT. Transplanted patients received reduced intensity conditioning regimen with busulfan 6.4mg/kg, fludarabine 150mg/m2 and ATG (rabbit antithymocyte globulin therapy, grafalon®) 30mg/kg and cyclosporine-mycophenolate mofetil as GVHD prophylaxis. In group A, 21/64 had died, including 13 died from a non-relapse cause. In group B, 4/15 patients had died, 3 from MDS progression and one from CNS bleeding. Three-year OS was 60% (95%CI: 46.9-76.8) in group A and 64.2% (41.3-99.6) in group B (p=NS). At the time of analysis, 20 and 5 patients had progressed/relapsed in group A and B respectively. with a cumulative incidence of relapse/progression (from inclusion) of 27.4% (IC95%: 15;39.8) in group A and 41.7% (IC95%:9.2;74.2) in group B (p=0.71). Among the 58 transplanted patients, 11 (19%) died without disease progression, including one death from a solid tumor. 3 years non-relapse mortality in transplanted patients was 23.4% (IC95%:9.7;37). 3 years Incidence of grade 2 to 4 acute GVHD was 40.8% and 3 years chronic GVHD was 24.9%. Conclusion: In this, to our knowledge, first prospective study in IPSS lower risk patients with some unfavorable clinical or biological features, HLA identical donor (sibling or 10/10 unrelated) HSCT yielded a 3-year OS of 60%. Non relapse mortality was however 23%, and OS somewhat lower than expected (70% at 3 years) and similar to that observed in patients without a donor. Long-term follow-up is needed to better define subgroups of IPSS lower risk MDS that may benefit from allo HSCT. Disclosures Sebert: Abbvie: Consultancy; BMS: Consultancy. Cluzeau: Pfizer: Other: travel, accommodations, expenses; Astellas: Speakers Bureau; Amgen: Speakers Bureau; Agios: Honoraria; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses, Speakers Bureau; Roche: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria, Speakers Bureau; Takeda: Other: travel, accommodations, expenses; Jazz Pharma: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria, Speakers Bureau. Loschi: AbbVie: Ended employment in the past 24 months, Honoraria; CELGENE/BMS: Honoraria; Gilead: Ended employment in the past 24 months, Honoraria; Novartis: Ended employment in the past 24 months, Honoraria; Servier: Ended employment in the past 24 months, Honoraria; MSD: Honoraria. Huynh: Jazz Pharmaceuticals: Honoraria. Ades: ABBVIE: Honoraria; NOVARTIS: Honoraria; CELGENE/BMS: Honoraria; CELGENE: Research Funding; JAZZ: Honoraria, Research Funding; TAKEDA: Honoraria. Fenaux: JAZZ: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Celgene/BMS: Honoraria, Research Funding; Syros Pharmaceuticals: Honoraria. Robin: NEOVII MEDAC NOVARTIS: Research Funding.

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The Prophylactic Effect of Proton Pump Inhibitors Combined with Enteral Nutrition for Preventing Gastrointestinal Hemorrhage after Cardiovascular Surgery in High-Risk Patients

The Heart Surgery Forum ◽

10.1532/hsf.2279 ◽

2019 ◽

Vol 22 (3) ◽

pp. E183-E190

Author(s):

Mei-Fang Chen ◽

Yong Lin ◽

Liang-Wan Chen

Keyword(s):

High Risk ◽

Enteral Nutrition ◽

Intravenous Infusion ◽

Cardiovascular Surgery ◽

Early Enteral Nutrition ◽

Continuous Intravenous Infusion ◽

High Risk Patients ◽

Risk Patients ◽

Group A ◽

Group B

Background: Gastrointestinal hemorrhage (GH) is one of the most serious complications after cardiovascular surgery. The aim of the study was to provide an optimal therapeutic strategy for preventing postoperative GH in high-risk patients. Methods: This retrospective case-control study included 188 adult patients at high risk of postoperative GH. These patients were divided into two groups based on a strategy for preventing postoperative GH: Group A (n = 97) received continuous intravenous infusion of proton-pump inhibitor (PPI) combined with early enteral nutrition, and Group B (n = 91) received a bolus intravenous infusion of PPI combined with late enteral nutrition. The clinical features of the groups were examined. Results: The incidence of postoperative GH in the patients of group A was significantly lower than the patients in group B. The duration from the end of surgery to eating for the first time in the patients of group A was significantly shorter than in the patients of group B. A descending trend in 30-day mortality was observed in the patients of group A compared with group B, but no significant difference was found between the two groups. Conclusion: Continuous intravenous infusion of PPI combined with early enteral nutrition could effectively prevent GH and reduce 30-day mortality after cardiovascular surgery in high-risk patients.

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Is Percutaneous Cholecystostomy a Good Alternative Treatment for Acute Cholecystitis in High-Risk Patients?

The American Surgeon ◽

10.1177/000313481708300628 ◽

2017 ◽

Vol 83 (6) ◽

pp. 623-627 ◽

Cited By ~ 5

Author(s):

Davide Papis ◽

Eiman Khalifa ◽

Ricky Bhogal ◽

Amit Nair ◽

Saboor Khan ◽

...

Keyword(s):

High Risk ◽

Acute Cholecystitis ◽

Long Term Results ◽

Definitive Treatment ◽

Percutaneous Cholecystostomy ◽

Record System ◽

High Risk Patients ◽

Risk Patients ◽

Group A ◽

Group B

Cholecystectomy is the treatment of choice for acute cholecystitis but the management of high-risk surgical patients is a difficult dilemma. Percutaneous cholecystostomy (PC) could represent a safer and less invasive option. The aim of the study was to assess the outcomes of PC in high-risk patients. This is a retrospective single-center study; data were collected from our hospital electronic record system. From February 2009 to March 2014, there were 753 patients admitted with acute cholecystitis. Of these 39 were considered high risk for surgery and underwent PC during their hospital stay. The radiological approach was transperitoneal in 29 patients and transhepatic in 10 patients. Median follow-up was 19 months. There were 27 males (69.2%) and 12 females (30.8%) with a mean age of 72 years (range 41–90 years). Twenty-seven patients had PC as definitive treatment (group A) and 12 patients as a bridge to cholecystectomy (group B). There were no postprocedure complications. Five patients in group A were readmitted once with another episode of cholecystitis after PC (18.5%), one patient in group B was readmitted with cholecystitis after two years before proceeding to cholecystectomy, and two patients were readmitted after cholecystectomy (16.6%) for intra-abdominal collections treated with percutaneous radiological drainage. Seven patients died (17.9%) as a result of severe biliary sepsis during their index hospital admission. PC is a safe approach in high-risk patients with acute cholecystitis and can provide satisfactory long-term results when cholecystectomy is not a viable option.

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Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial

Endoscopy ◽

10.1055/a-0977-3119 ◽

2019 ◽

Vol 51 (10) ◽

pp. 915-921 ◽

Cited By ~ 1

Author(s):

Rasoul Sotoudehmanesh ◽

Ali Ali-Asgari ◽

Morteza Khatibian ◽

Mehdi Mohamadnejad ◽

Shahin Merat ◽

...

Keyword(s):

High Risk ◽

Hospital Stay ◽

Pancreatic Duct ◽

Length Of Hospital Stay ◽

Pharmacological Prophylaxis ◽

High Risk Patients ◽

Pancreatic Duct Stenting ◽

Risk Patients ◽

Group A ◽

Group B

Abstract Background Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. Methods In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer’s lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. Results During 21 months, a total of 414 patients (mean age 55.5 ± 17.0 years; 60.2 % female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3 %, 95 % confidence interval [CI] 11.1 % – 17.9 %: 26 patients [12.6 %, 95 %CI 8.6 % – 17.6 %] in group A and 33 [15.9 %, 95 %CI 11.4 % – 21.4 %] in group B). There was no significant difference between the two groups in PEP severity (P = 0.59), amylase levels after 2 hours (P = 0.31) or 24 hours (P = 0.08), and length of hospital stay (P = 0.07). Conclusions The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.

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