Major Patient Characteristics Research Articles

A cost-conscious establishment of a robotic abdominal wall reconstruction program in a publicly funded healthcare system.

Despite reports of better short-term outcomes, the main criticism for the adoption of the robotic surgery platform for abdominal wall reconstruction (AWR) has been the associated cost, especially in countries with a publicly funded healthcare system such as Canada. We describe our experience in implementation of robotic AWR while ensuring cost-effectiveness. This is a retrospective cohort analysis of all patients with ventral hernias ranging between 5 to 15cm who underwent either open or robotic AWR between January 2020 to August 2022. We reviewed patient characteristics, operative time, post-operative length of stay (LOS), and average cost of surgery. 45 patients underwent open repair and 28 underwent roboticrepair in the study period. There was no difference in major patient characteristics between the two groups. Operative time was shorter for open repairs (233.2 ± 96.6min vs. 299.3 ± 71.8min, p < 0.001). LOS was significantly longer for open repairs (5days (interquartile range = 4-6) vs. 2days (IQR = 1.75-3), p < 0.001) and there were significantly more patients who underwent robotic repair who left hospital in less than 3days (13.3 vs. 64.3%, p < 0.001). The average overall hospital-based cost for each open repair was $26,952.18 when the cost for equipment, operative time, inpatient hospital stay, and epidural use are accounted for, compared to $17,447.40 for robotic repair ($9,504.78 saving per case). With proper selection of patients based on size of hernia, we demonstrate cost conscious adaptation of the robotic technology to AWR. Our future studies will continue to explore the benefits and limits of this approach in complex hernia repair.

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Introduction: The prognosis of patients (pts) with diffuse large B-cell lymphoma (DLBCL) and involvement of the central nervous system (CNS) remains dismal. Anti-CD19 chimeric antigen receptor T-cells (CART) are considered standard treatment for pts with refractory or relapsed (r/r) DLBCL. Pts with involvement of the CNS were excluded from most CART trials; however, anecdotal reports suggest that CART might be an effective treatment option for such pts. This EBMT registry study aimed at compiling data of a larger cohort of pts with primary (PCNSL) or secondary CNS lymphoma (SCNCL) to better define the role of CART in these settings. Methods: All centres contributing to the EBMT database were asked for consecutive cases of PCNSL and SCNSL, which had been treated with any type of CART between January 2018 and December 2021. Reported pts were identified in the database and analysed for major patient characteristics, pre-treatment aspects, and major clinical endpoints. Kaplan Meier estimates were used to calculate overall survival (OS) and progression-free survival (PFS), whereas cumulative incidence was used for relapse incidence (RI), and non-relapse mortality (NRM). Results: 74 pts with PCNSL (n = 10) or SCNSL (n = 64) and complete information on major endpoints after CART and a median follow-up of 20.2 months [CI: 13.25–23.5] were analysed. Median age was 61.6 years (range 31–80), 31 pts were female. 37 of 57 pts (64.9%) had three or more prior treatment lines, 36.5% of pts had undergone autologous hematopoietic cell transplantation. 14 of 70 pts (20%) had ECOG ≥2. Disease-status at CART was complete (CR) or partial remission (PR) for 31.5% (6.8% and 24.7%, respectively) of pts, 68.5% of pts were in relapse, refractory, or had progressive disease. For one patient information on disease status was missing. 40 pts received axicabtagene ciloleucel (Yescarta®), 34 pts were treated with tisagenlecleucel (Kymriah®). OS- and PFS-rates at 12 months were 51.1% [CI: 40.2–64.8] and 33.7% [CI: 24.3–46.7] for the whole cohort. RI at 12 months was 59.4% [CI: 46.9–69.8]. NRM was 7% [CI: 2.5–14.5]. OS and PFS for pts in CR/PR were 53.0% [CI: 35.5–79.3] and 42.1% [CI: 25.9–68.7]. For the refractory cohort OS and PFS were 51.7% [CI: 38.7–69.0] and 30.6% [CI: 19.9–46.9], respectively. Conclusion: With a 51% OS-rate at 12 months CART seem to be a very effective therapeutic option in heavily pre-treated r/r PCNSL or SCNSL, particularly for pts being refractory to prior therapy. These results compare favourably with those of conventional treatment (including a minority of pts treated with autoSCT) in SCNSL with a median overall survival of 3.5 months (Schmitz et al., 2016) and 12-months OS-rate of 20% (Thieblemont et al., 2023). Pts with CNS involvement and r/r LBCL should be considered for treatment with CART. The research was funded by: Lymphoma Working Party of the EBMT GoCART coalition Keywords: Aggressive B-cell non-Hodgkin lymphoma, Cellular therapies Conflicts of interests pertinent to the abstract. S. Fuhrmann Consultant or advisory role: KiteGilead, BMS Celgene, Janssen D. Beauvais Honoraria: Merck & Co N. Kröger Consultant or advisory role: Takeda Honoraria: Takeda, Sanofi, Kite, Neovii, Amgen, BMS, Novartis, Jazz Research funding: Neovii, Riemser, DKMS, BMS, Novartis M. Stelljes Consultant or advisory role: MSD, Amgen, Novartis, Pfizer, Jazz, BMS, Kite Honoraria: MSD, Medac, Novartis, Pfizer, Jazz, BMS, Kite Research funding: Pfizer B. von Tresckow Consultant or advisory role: Allogene, BMS/Celgene, Cerus, Incyte, IQVIA, Gilead Kite, Miltenyi, Novartis, Noscendo, Pentixapharm, Roche, Amgen, Pfizer, Takeda, Merck Sharp & Dohme, Gilead Kite Honoraria: AstraZeneca, BMS, Incyte, Novartis, Roche Pharma AG, Takeda, Merck Sharp & Dohme Research funding: Novartis, Merck Sharp & Dohme, Takeda Educational grants: AbbVie, AstraZeneca, Gilead Kite, Merck Sharp & Dohme, Roche, Takeda, and Novartis P. Dreger Honoraria: Novartis, Kite, BMS, Miltenyi A. Sureda Consultant or advisory role: Takeda, BMS/Celgene, Novartis, Janssen, Gilead, Sanofi Honoraria: Takeda, BMS/Celgene, MSD, Janssen, Amgen, Novartis, Gilead, Kite, Sanofi, Roche, Alexion Research funding: Takeda, BMS/Celgene Other remuneration: Speaker’s bureau: Takeda, Non-profit organisations: Presidency of the GETH-TC, Presidency of the EBMT N. Schmitz Stock ownership: BMS Honoraria: Allogene Research funding: Astra Zeneca, Janssen, Roche Educational grants: Allogene, Miltenyi B. Glaß Honoraria: Novartis, JAZZ, Gilead, BMS, Roche, Abbvie, Miltenyi Research funding: Riemser, Roche

Angiotensin-converting enzyme 2 in human plasma and lung tissue

Purpose We investigated plasma angiotensin-converting enzyme 2 (ACE2) concentration in a population sample and the ACE2 expression quantitated with the diaminobenzidine mean intensity in the lung tissue in patients who underwent lung surgery. Materials and methods The study participants were recruited from a residential area in the suburb of Shanghai for the plasma ACE2 concentration study (n = 503) and the lung tissue samples were randomly selected from the storage in Ruijin Hospital (80 men and 78 age-matched women). Results In analyses adjusted for covariables, men had a significantly higher plasma ACE2 concentration (1.21 vs. 0.98 ng/mL, p = 0.027) and the mean intensity of ACE2 in the lung tissue (55.1 vs. 53.9 a.u., p = 0.037) than women. With age increasing, plasma ACE2 concentration decreased (p = 0.001), while the mean intensity of ACE2 in the lung tissue tended to increase (p = 0.087). Plasma ACE2 concentration was higher in hypertension than normotension, especially treated hypertension (1.23 vs. 0.98 ng/mL, p = 0.029 vs. normotension), with no significant difference between users of RAS inhibitors and other classes of antihypertensive drugs (p = 0.64). There was no significance of the mean intensity of ACE2 in the lung tissue between patients taking and those not taking RAS inhibitors (p = 0.14). Neither plasma ACE2 concentration nor the mean intensity of ACE2 in the lung tissue differed between normoglycemia and diabetes (p ≥ 0.20). Conclusion ACE2 in the plasma and lung tissue showed divergent changes according to several major characteristics of patients.

Clinical Decision Making by Medical Marijuana Physicians in Florida: A Qualitative Assessment

Medical marijuana (MMJ) was legalized in November 2016 with the passing of Amendment 2 in the state of Florida. Since the legalization, many studies have been conducted to understand the direct effect medical marijuana has on specific medical conditions. Unlike most allopathic drugs, medical marijuana does not target single ailments or specific conditions and does not follow precise recommending guidelines. There is scarce knowledge on how patient characteristics, including medical conditions, affect a physician’s direct recommendations and registry limits. To obtain insight on the effect patient characteristics have on the clinical decision-making process, we conducted ten qualitative interviews of medical marijuana physicians who are certified to order medical marijuana for patients in Florida. Interview topics ranged from typical daily practice to specific recommendations for patient histories. Each interview was transcribed and thematically analyzed. Five major patient characteristics that influence a physician’s recommendation emerged from the interviews: patient medical history, co-medications, lifestyle, marijuana experience level and counter-indications. Each category was analyzed further to understand how the characteristics influenced the practice of recommending and ordering product. Physicians emphasized the equivalent importance of reviewing a patient’s medical history, lifestyle, and past marijuana experiences while also expressing the need to look holistically at the individual patient. Instead of the characteristics determining what the physician recommends for the patient and orders through the registry, the characteristics dictate the education given to the patient so that the patient may lead and determine their own individual care.

Abstract PS13-31: Prospective observational study to explore the effectiveness of eribulin as first- or second- line chemotherapy in patients with HER2-negative hormone-resistant advanced or metastatic breast cancer (KBCRN A001: E-SPEC study)

Abstract BackgroundEribulin (E) is a chemotherapeutic drug that prolongs overall survival (OS) of patients with HER2-negative advanced or metastatic breast cancer (AMBC), mainly in multi-line chemotherapy (ChT) or later. However, the effectiveness and optimal scheduling of E remain unclear. We prospectively investigated the impact of E use in 1st- and 2nd-line ChT (early E) for patients with endocrine-resistant AMBC. Methods In this multi-institutional prospective cohort study, we registered patients with hormone receptor-positive AMBC who relapsed during or within 6 months after ending adjuvant endocrine therapy, were refractory to at least one previous endocrine therapy, or patients with triple negative AMBC. The endpoints were 1st-line OS (OS1), 2nd-line OS (OS2), and 3rd-line OS (OS3), defined as the time from the start of treatment to death. In addition, the time from the start of 1st-line ChT to death was also analyzed for 2nd-line and 3rd-line ChT groups. In addition to E therapy, oral FU-based therapies (FU) and anthracycline or taxane-based therapies (A/T) were also analyzed (ClinicalTrial.gov number, NCT02551263). Results Between June 2015 and July 2017, a total of 201 patients were enrolled, and full analysis was conducted for 180 patients. The median OS1, OS2, and OS3 of all patients was 2.69, 1.74, and 1.13 years, respectively. Major patient characteristics are described in the Table. Concurrent or maintenance endocrine therapy was used by 14.9%, 31.6%, and 12.9% of patients receiving E, FU and A/T in 1st-line ChT, respectively. The median OS of patients using E was OS1: 2.25 years (N=47), OS2: 1.75 years (N=70) and OS3: 0.94 years (N=16). The median OS of patients using A/T was OS1: 2.60 years (N=70), OS2: 1.69 years (N=44) and OS3: 0.96 years (N=49). The median OS of patients using FU was OS1: 3.49 years (N=57), OS2: 2.33 years (N=27), and OS3: 1.45 years (N=24). The time from the start of 1st-line ChT to death was 2.58 and 3.18 years among patients who received E in 2nd- and 3rd-line ChT, respectively. Multivariate analysis of patients who used 1st-line and 2nd-line E demonstrated that higher LDH (≥300) (HR 3.50, 95% CI 1.78-6.73; p&amp;lt;0.001), brain metastasis (HR 2.64, 95% CI 1.02-6.83; p=0.045) and smoker (HR 2.33, 95% CI 1.20-4.53; p=0.013) were associated with shorter OS. Overall, OS data for E were comparable to those for A/T. While OS tended to be better for FU, patient characteristics for 1st-line ChT showed that FU was often used for patients with less aggressive AMBC. We also present data on second progression-free survival and new metastasis-free survival, prognostic factor analysis and prognostic factor-adjusted comparison, and predictive factor analysis for early E. Conclusions This prospective observational study of AMBC patients showed that E and A/T had similar survival outcomes in each treatment line. While FU led to relatively longer survival, it was often used for patients with less aggressive AMBC. Analysis data on survival outcomes will also be presented. Patient characteristics according to 1st-line therapyE (n=47)Oral FU based (n=57)A/T based (n=70)Median age (IQR)61(54-71)64(51-68)59(48-66)Triple negative, n (%)15(31.9)11(19.3)23(32.9)Disease-free interval, n (%)&amp;lt;2 years15(31.9)9(15.8)12(17.1)2-5 years12(25.5)18(31.6)15(21.4)5-8 years4(8.5)9(15.8)9(12.9)&amp;gt;8years3(6.4)10(17.5)8(11.4)Stage49(19.1)9(15.8)23(32.9)(neo) Adjuvant chemotherapy, n (%)30(63.8)36(63.2)32(45.7)Metastatic sites at 1st-line ChT, n (%)Liver16(34.0)12(21.1)22(31.4)Lung15(31.9)17(29.8)25(35.7)Bone24(51.1)27(47.3)36(51.4)Brain6(12.8)1(1.8)2(2.9) Citation Format: Yuri Fujimoto, Yuichiro Kikawa, Takeshi Kotake, Shigeru Tsuyuki, Sachiko Takahara, Hiroyasu Yamashiro, Hiroshi Yoshibayashi, Masahiro Takada, Rie Yasuoka, Kazuhiko Yamagami, Hirofumi Suwa, Toshitaka Okuno, Ichiro Nakayama, Tatsuji Kato, Nobuko Ogura, Yoshio Moriguchi, Hiroshi Ishiguro, Tatsuo Kagimura, Tetsuya Taguchi, Tomoharu Sugie, Masakazu Toi. Prospective observational study to explore the effectiveness of eribulin as first- or second- line chemotherapy in patients with HER2-negative hormone-resistant advanced or metastatic breast cancer (KBCRN A001: E-SPEC study) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-31.

The Prevalence and Impact of Arrhythmias in Hospitalized Patients with Sickle Cell Disorders: A Large Database Analysis

Introduction: Sickle cell disorders (SCD) is associated with progressive dysfunction of vital organs, including the cardiovascular system. While the development of pulmonary hypertension and left ventricular dysfunction have been previously studied, the burden of arrhythmias in SCD patients remains largely unknown. Thus, we aim to describe and analyze the prevalence and impact of arrhythmias in hospitalized adult patients with SCD and their impact in patient-oriented outcomes. Methods: We identified incident arrhythmias in patients with SCD in the National Inpatient Sample (NIS) database in 2 years (2016-2017), using ICD-10 codes. We compared major patient characteristics, outcomes, and economic impact between groups of SCD patients with and without documented arrhythmias. A logistic regression model was used to control for age, sex, race, admission type, hospital characteristics, and relevant comorbidities. To increase statistical robustness, propensity-score matching for age, sex, income, and comorbidities was used to match 1144 SCD patients with arrhythmia and 1144 patients without. Results: Among inpatients with SCD in the database, 5,930 of 174,450 patients with SCD had documented arrhythmias (3.4%). The arrhythmia group consisted mostly of patients' sickle cell disease (5,650; 95%), while 245 had sickle cell trait, and 35 were classified as having other sickle cell disorders. Individuals in the arrhythmia group were significantly older (mean age 41.3, SD 14.1) than those with no arrhythmia (mean age 31.5, SD 10.3). Further, arrhythmia group had higher prevalence of hypertension (44.2% vs 19.1%, p&amp;lt;0.001), congestive heart failure (25.8% vs 4.1%, p&amp;lt;0.001), chronic kidney disease (24.0% vs 5.6%, p&amp;lt;0.001), valvular heart disease (9.3% vs 1.5%, p&amp;lt;0.001), myocardial infarction (4.1% vs 1.25%, p&amp;lt;0.001), type 2 diabetes mellitus (3.5% vs 1.7%, p&amp;lt;0.001), and pulmonary hypertension (3.5% vs 1.2%, p&amp;lt;0.001). When looking at major outcomes, after adjusting for confounders, arrhythmias were positively associated with all cause in-hospital mortality with an adjusted OR of 53.6 (95% CI 44.3, 65.1). After propensity-matching (Table 1), the arrhythmia group had a higher rate of all-cause in-hospital mortality (6.12% vs 0.35%, p&amp;lt;0.001), higher median length of stay (6.8 days vs 5.8 days, p&amp;lt;0.001), and mean total hospital charges ($13,441 vs $10,255, p&amp;lt;0.001). There was no statistically significant difference in the rate of stroke between both groups. Conclusions: The presence of arrhythmias in patients with SCD was associated with markedly increased all cause in-hospital mortality, even after adjusting for confounders via logistic regression and propensity-score matching analyses. Despite a relatively low overall prevalence of 3.4% among this large inpatient cohort, this data suggests that arrhythmias may confer an important excess disease burden in SCD patients, including higher mortality. Intuitively, arrythmias confer higher mortality in patients with chronic disorders and multiple cardiovascular risks, whether this is specific to SCD deserves further study. Also, studies are needed to better understand the occurrence particularly in relation to active vaso-occlusive crisis and to evaluate whether SCD individuals with arrhythmias could potentially benefit from more intensive monitoring and/or better cardiovascular disease control. Disclosures No relevant conflicts of interest to declare.

How to prevent in-hospital COVID-19 infection and reassure women about the safety of pregnancy: Experience from an obstetric center in China.

ObjectiveThis study aimed to describe the emergency responses to coronavirus disease 2019 (COVID-19) for pregnant patients at our hospital and their effect on hospital operations and patients’ outcomes.MethodsWe developed strategies to prevent hospital-associated transmission of COVID-19 in obstetric care. Infrastructure, including the fever clinic and wards, were modified. Outpatient volume was controlled and screening processes were strictly performed. Verification of the virus was compulsory for non-surgery and non-emergency patients. Emergency operations were performed in a negative pressure theater with surgeons fully protected. Outcomes were analyzed and the patients’ characteristics were evaluated. The effect of intervention on depressed and anxious patients was assessed. Data from the first 2 months of 2019 and 2020 were compared.ResultsNo in-hospital COVID-19 infections occurred in our unit. During the epidemic, patient volume significantly decreased. While major characteristics of patients were similar, a higher prevalence of gestational hypertension was found in 2020 than in 2019. Psychological interventions showed optimistic effects in ameliorating depression and anxiety at the beginning of the COVID-19 pandemic.ConclusionsOur strategies were effective in preventing in-hospital infection of COVID-19 and reassuring women about the safety of pregnancy. Monitoring and managing psychological issues were necessary during this critical period.

Optimization of Antimicrobial Prophylaxis in Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing an Absolute Neutrophil Count Driven Approach

Background Hematopoietic stem cell transplantation (HSCT) recipients often develop profound neutropenia and are ultimately at an increased risk of developing life-threatening infections peri-engraftment. There is discordance in the current guidelines for antibacterial prophylaxis (AP) in patients undergoing HSCT. While ASTCT, formerly ASBMT, guidelines suggest beginning antibacterial prophylaxis on the day of stem cell infusion, NCCN and ASCO/IDSA guidelines recommend beginning at time of neutropenia. These recommendations for timing of antimicrobials are unsubstantiated by any comparative analyses. Methods A retrospective study was conducted across two cohorts over a two-year period (November 2016-2018). The pre-intervention cohort called for initiation of AP on Day -1 while the post-intervention cohort initiated AP when patients' absolute neutrophil count (ANC) was ≤500 cells/mm3. The preferred AP agent used was levofloxacin, which was discontinued in both cohorts when patients attained a post-nadir ANC of ≥500 cells/mm3. The primary outcome was frequency of febrile occurrences, defined as a temperature of ≥38°C. Secondary outcomes included days of AP, positive blood cultures, all-cause mortality, length of stay (LOS), acute graft-versus-host disease (GvHD) through Day +100, and Clostridiodies difficile infection rates. Patients were excluded if they received a haploidentical transplant or inappropriately initiated AP per cohort approach. Results A total of 248 patients were included in the final analysis with 130 and 118 patients in the pre- and post-intervention cohorts, respectively. The majority of patients included were male (60%) and autologous transplant recipients (83%), with no clinically significant difference in major patient characteristics between both cohorts. There were lower rates of fever occurrences for autologous HSCT recipients (83 pre- vs 69% post-intervention; p=0.019), but no difference in allogeneic (64 vs 73%; p=0.542) HSCT patients. A significant reduction in the mean AP days per patient was identified (10.3 vs 4.9 days; p Conclusion Delaying AP until severe neutropenia showed a reduction in primary outcome of fever in autologous patients, and no difference in allogeneic patients or other significant clinical outcomes regarding patient safety. This approach is associated with a drastic reduction in antimicrobial exposure.

Prognostic impact of tumoral and/or peri-tumoral stromal SPARC expressions after surgery in patients with biliary tract cancer.

SPARC (secreted protein acidic and rich in cysteine) is a matricellular glycoprotein that modulates interactions between tumoral cells and the peri-tumoralstroma. SPARC induces proliferation and invasion in vitro, and is a poor prognostic factor in several gastrointestinal cancers. Herein, we evaluated the prognostic value of tumoral and stromal SPARC expression in patients with biliary tract cancer (BTC) after surgery. We examined immunohistochemical patterns of SPARC expression in 110 resected BTC specimens and evaluated the prognostic value using prospectively collected data. SPARC was expressed in tumoral cells in 46 samples (42%) and inperi-tumoralstromain 65 samples (59%). Tumoral SPARC expression was not related to major patient characteristics. Stromal SPARC expression was related to lymph node metastasis, stage, margin status, and tumor location. Overall survival at 5 years after surgery was 34.2%. Stromal SPARC (P < 0.001) and tumoral SPARC (P = 0.048) were associated with poor prognosis. Multivariate analysis revealed invasion into lymphatic system, residual tumor, and stromal SPARC as independent prognostic factors. The hazard ratio for patients with positive stromal SPARC was 3.20 (P < 0.001). SPARC expression inperi-tumoralstroma predicts a poor prognosis for patients with BTC after surgery.

Competing risks and prognostic stages of cirrhosis: a 25‐year inception cohort study of 494 patients

Morphological, haemodynamic and clinical stages of cirrhosis have been proposed, although no definite staging system is yet accepted for clinical practice. To investigate whether clinical complications of cirrhosis may define different prognostic disease stages. Analysis of the database from a prospective inception cohort of 494 patients. Decompensation was defined by ascites, bleeding, jaundice or encephalopathy. Explored potential prognostic stages: 1, compensated cirrhosis without oesophago-gastric varices; 2, compensated cirrhosis with varices; 3, bleeding without other complications; 4, first nonbleeding decompensation; 5, any second decompensating event. Patient flow across stages was assessed by a competing risks analysis. Major patient characteristics were: 199 females, 295 males, 404 HCV+, 377 compensated, 117 decompensated cirrhosis. The mean follow-up was 145 ± 109 months without dropouts. Major events: 380 deaths, 326 oesophago-gastric varices, 283 ascites, 158 bleeding, 146 encephalopathy, 113 jaundice, 126 hepatocellular carcinoma and 19 liver transplantation. Patients entering each prognostic stage along the disease course were: 202, stage 1; 216, stage 2; 75 stage 3; 206 stage 4; 213 stage 5. Five-year transition rate towards a different stage, for stages 1-4 was 34.5%, 42%, 65% and 78%, respectively (P < 0.0001); 5-year mortality for stages 1-5 was 1.5%, 10%, 20%, 30% and 88% respectively (P < 0.0001). An exploratory analysis showed that this patient stratification may configure a prognostic system independent of the Child-Pugh score, Model for End Stage Liver Disease and comorbidity. The development of oesophago-gastric varices and decompensating events in cirrhosis identify five prognostic stages with significantly increasing mortality risks.

Are we ready for a randomized trial of valproic acid in newly diagnosed glioblastoma?

Are we ready for a randomized trial of valproic acid in newly diagnosed glioblastoma?

Long‐term clinical effects of epalrestat, an aldose reductase inhibitor, on progression of diabetic neuropathy and other microvascular complications: multivariate epidemiological analysis based on patient background factors and severity of diabetic neuropathy

AimsThe goal of the study was to evaluate the efficacy of epalrestat, an aldose reductase inhibitor, on diabetic retinopathy and diabetic nephropathy, based on analysis of the results of the Aldose Reductase Inhibitor–Diabetes Complications Trial, a 3-year multicentre comparative clinical trial of conventional therapy (control group) and epalrestat therapy (epalrestat group) in Japanese patients with mild diabetic neuropathy.MethodsThe subjects of the study were patients enrolled in the Aldose Reductase Inhibitor–Diabetes Complications Trial for whom data for major patient characteristics, severity of diabetic neuropathy at the end of the study and time-courses of diabetic retinopathy and diabetic nephropathy were available (57 and 52 patients from the control and epalrestat groups, respectively). Progression of diabetic retinopathy/nephropathy (a primary endpoint) in relation to major patient characteristics, severity of diabetic neuropathy at the end of the study (assessed from the mean of z-scores in four neurological function tests) and epalrestat treatment were analysed using univariate analysis and multiple logistic regression analysis.ResultsProgression of diabetic retinopathy/nephropathy was significantly inhibited in the epalrestat group compared with the control group (odds ratio = 0.323, P = 0.014) and was dependent on the severity of diabetic neuropathy at the end of the study (odds ratio = 2.131, P = 0.025).ConclusionsEpalrestat prevented progression of diabetic neuropathy and retinopathy/nephropathy. The effect on diabetic retinopathy/nephropathy may have occurred indirectly because of the prevention of progression of diabetic neuropathy, in addition to the inhibitory action of epalrestat on aldose reductase.

991 Noninvasive Ventilation in Children, Can we Predict its Failure?

Background and AimsNoninvasive ventilation (NIV) constitutes an alternative treatment for pediatric acute respiratory failure. However, tracheal intubation should not be delayed when considered necessary. Our main objective is to identify...

Die repetitive thermische Selbstverletzung im Rahmen der Borderline-Persönlichkeitsstörung

Self-mutilations are one of the major characteristics of patients with borderline personality disorder (BPD). Thermal injuries of BPD should be treated by a plastic surgeon who is faced to a challenge in the plastic-reconstructive strategy because of the most complex psychiatric disease. This means the need of a multidisciplinary strategy. Based on 3 case reports such conflict between best plastic reconstructive treatment of the burns wound and the psychiatric limit with the appropriate therapy options are presented.

Postoperative wound manipulation after self-mutilation in borderline personality disorder—a plastic reconstructive challenge

Borderline personality disorder (BPD) is a mental illness with a prevalence of 1.5% in Western countries. One of the major characteristics of patients with BPD is self-mutilation of any kind. These patients are especially often seen in our clinic since our institution is collaborating with the department of psychiatry that offers supra-regional specialist inpatient hospital treatment of BPD. Types of self-manipulation are various and include slashing and cutting, burning or freezing, bonebreaking, hitting or incorporation of foreign objects. Due to the difficult-to-treat primary disorder, more wound manipulation or self-injury may occur when tensions continue, even after adequate plastic reconstructive surgical treatment and during hospitalization, which represents a challenge for the plastic reconstructive strategy. We describe special problems associated with plasticreconstructive surgery in the light of BPD and self-mutilation and present our algorithm with a series of recommendations for the treatment of such patients as well as three illustrative case reports.

Virus shedding and environmental deposition of novel A (H1N1) pandemic influenza virus: interim findings

Background The relative importance of different routes of influenza transmission, including the role of bioaerosols, and ability of masks and/or hand hygiene to prevent transmission, remains poorly understood. Current evidence suggests that infectious virus is not typically released from adults after 5 days of illness, however, little is known about the extent to which virus is deposited by infected individuals into the environment and whether deposited virus has the ability to infect new hosts. Further information about the deposition of viable influenza virus in the immediate vicinity of patients with pandemic influenza is fundamental to our understanding of the routes and mechanisms of transmission. Objectives To collect data on patients infected with pandemic H1N1 2009 (swine flu). Primary objectives were to correlate the amount of virus detected in a patient’s nose with that recovered from his/her immediate environment, and with symptom duration and severity. Secondary objectives were to describe virus shedding and duration according to major patient characteristics: adults versus children, and those with mild illness (community patients) versus those with more severe disease (hospitalised patients). Methods Adults and children, both in hospital and from the community, who had symptoms of pandemic H1N1 infection, were enrolled and visited every day during follow-up for a maximum of 12 days. Symptom data was collected and samples were taken, including nose swabs and swabs from surfaces and objects around patients. Samples of air were obtained using validated sampling equipment. The samples were tested for the presence of pandemic H1N1 virus, using polymerase chain reaction (PCR) to detect virus genome and an immunofluorescence technique to detect viable virus. Results Forty-three subjects were followed up, and 19 of them were subsequently proven to be infected with pandemic H1N1 virus. The median duration of virus shedding from the 19 infected cases was 6 days when detection was performed by PCR, and 3 days when detection was performed by a culture technique. Over 30% of cases remained potentially infectious for at least 5 days. Only 0.5% of all community and none of the hospital swabs taken revealed virus on surfaces. Five subjects had samples of the air around them collected and virus was detected by PCR from four; some of the air particles in which virus was detected were small enough to be inhaled and deposited deep in the lungs. Limitation Small number of subjects recruited. Conclusions The finding that over 30% of infected individuals have infectious virus in their noses for 5 days or more has infection control implications. The data suggest that contact transmission of pandemic influenza via fomites may be less important than previously thought, but transmission via bioaerosols at short range may be possible, meaning that high-level personal protective equipment may be needed by health-care workers when attending patients with pandemic influenza. Further work is being undertaken to consolidate these findings, as they have important potential implications for the protection of health-care workers and the formulation of advice to households, nationally and internationally.

Racial differences in long-term survival among patients with coronary artery disease

Cardiovascular disease is the leading cause of death among blacks and whites in the United States. Despite this, there are insufficient data on the long-term prognosis of black patients with coronary artery disease (CAD) as well as the major clinical related determinants of outcome. We studied 22,618 patients (3,314 black) having significant CAD findings at cardiac catheterization performed at Duke from January 1986 to December 2004 with follow-up through June 2006. Using Kaplan-Meier and Cox modeling, we compared unadjusted and adjusted long-term survival by patient race and gender (median follow-up 7.6 years, interquartile range 3.5-13.0) as well as identified major patient characteristics associated with survival. Blacks with CAD were younger; were more often female; had lower median household incomes; and had more hypertension, diabetes mellitus, and heart failure. The number of coronary vessels with significant disease was similar by race. At 15-year follow-up, black women had the lowest survival and white men had the highest (41.5% vs 45.8%, P < .0001). Blacks were less likely to receive initial therapy with coronary revascularization (odds ratio 0.66, 95% CI 0.60-0.72, P < .0001). After adjusting for baseline clinical and demographic characteristics and initial treatment selection, black race remained an independent predictor of lower survival (hazard ratio 2.54, 95% CI 1.60-4.04, P < .0001). Among patients with CAD, blacks have lower long-term survival compared with whites. The difference may be partially, but not fully, explained by differences in cardiovascular risk factors and 30-day revascularization rates.

Randomized phase II study (EORTC 08062) of amrubicin as single agent or in combination with cisplatin versus etoposide-cisplatin as first-line treatment in patients (pts) with extensive disease small cell lung cancer (ED SCLC).

7052 Background: Outcome for pts with ED SCLC remains poor, despite standard treatment with platinum and etoposide (E). Amrubicin (A) is a synthetic anthracycline and a potent topoisomerase II inhibitor, with less cardiotoxicity than doxorubicin, approved in Japan for the treatment of NSCLC and SCLC. Methods: Eligible pts had previously untreated, histologically confirmed ED SCLC,WHO performance status (PS) 0-2and measurable disease according to RECIST. Pts were randomized to 3 weekly cycles of either (1) A alone 45 mg/m2 d1-3, (2) cisplatin (C) 60 mg/m2 d1 and A 40 mg/m2 d1-3 or (3) E 100 mg/ m2 d1, d2-3 i.v/po and C 75 mg/m2 d1. The primary endpoint was overall response rate (ORR) aiming at ORR = 80% and powered to rule out an ORR < 55% in any experimental arm. Patients were stratified by center, gender and PS. To declare success, 19 responses out of 27 eligible pts who started treatment (ORR of at least 70%) were needed in each arm using a Fleming design. Results: The number of randomized/eligible pts who started treatment was 33/28 in Arm 1, 33/30 in arm 2 and 33/30 in arm 3, respectively. Major patient characteristics including age, sex and PS were well balanced between the arms. The median number of chemotherapy cycles received was 5, 6 and 6. Primary prophylaxis with pegfilgrastim was added in the later part of the trial in arms 1-3 (57%, 43%, 37%); grade (G) 3-4 hematological toxicity in arms 1-3 was neutropenia (73%, 73%, 69%); thrombocytopenia (17%, 15%, 9.4%), anemia (10%, 15%, 3.1%) and febrile neutropenia (17%,15%,14%). Early deaths including treatment related were 1, 3 and 3 pts respectively. Cardiac toxicity did not differ among the 3 arms. Out of 88 eligible pts who started treatment, the response rate assessed by investigators was 17 (61%), 23 (77%) and 19 (63%) for arm 1, 2 and 3, respectively. Conclusions: A + C was associated with the highest response rate and further evaluation of this combination is warranted. Independent central review is still on-going. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, AstraZeneca, Celgene, sanofi-aventis Celgene, Lilly Celgene, Lilly

Factors associated with noninvasive ventilation failure in postoperative acute respiratory insufficiency: an observational study

Few data are available on the efficacy of noninvasive ventilation (NIV) in postoperative patients with acute respiratory failure (ARF). Seventy-two patients coming from the surgical wards with postoperative ARF were retrospectively evaluated. The major characteristics of patients who were intubated were compared with the characteristics of those who were not after a trial of NIV. Predictive factors for failure of NIV were analysed. Out of 72 patients with ARF after surgery who were treated with NIV, 42 avoided intubation (58%). On a univariate analysis, a decrease in the paO2/FiO2 ratio after 1 h of NIV (223 +/- 84 to 160 +/- 68 mmHg, P < 0.05) was associated with NIV failure and need for tracheal intubation because of nosocomial pneumonia and an increased simplified acute physiology score (SAPS) 2. In a multivariate analysis, nosocomial pneumonia [odds ratio (OR) 4.189; 95% confidence interval (CI) 1.383-12.687] and SAPS 2 higher than 35 (OR 4.969; 95% CI 1.627-15.172) were independent predictive factors of NIV failure. NIV success was associated with a reduced ICU stay (16.8 vs. 26.1 days, P < 0.001). NIV could be considered in postoperative patients who presented with ARF. Nosocomial pneumonia is predictive of NIV failure.

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