Multivariate Risk Analysis Research Articles

High Preoperative Anxiety Level and the Risk of Intraoperative Hypothermia

Aim: The relationship between preoperative anxiety level and intraoperative hypothermia (<36℃) was investigated. Background: Core temperature often decreases during surgery, with an initial rapid decrease followed by a slower decrease for about 2 hours. Preoperative anxiety may influence perioperative physiological responses. The relationship between preoperative anxiety level and perioperative decrease in core temperature has not been studied closely. Design: A prospective observational study. Methods: This study enrolled 120 adult patients who underwent elective major abdominal surgery under combined epidural and general anesthesia. Tympanic membrane temperature was used to measure core temperature preoperatively and during the operation. The relationship between anxiety level according to the State-Trait Anxiety Inventory (STAI) and core temperature was examined using descriptive and multivariate risk analysis. Results: High anxiety level was found in 61 patients (51%), of which 26 (43%) developed hypothermia during the first hour and 40 (66%) developed hypothermia during the first 2 hours of anesthesia. After adjustment for covariates, patients with a high anxiety level were found to have a 2.17-fold higher risk of hypothermia during the first hour and a 1.77-fold higher risk of hypothermia during the first 2 hours than patients with a low/moderate anxiety level. Conclusions: The risk of hypothermia in the early phase of general anesthesia can be predicted by measurement of the preoperative anxiety level using the STAI. Relevance to Clinical Practice: Patients with a high anxiety level had a significantly higher risk of intraoperative hypothermia. Preoperative preventive nursing care programs should include anxiety management and thermal care.

Clinical Risk Characteristics of Upper Gastrointestinal Hemorrhage Severity: A Multivariable Risk Analysis.

BackgroundUpper gastrointestinal hemorrhage (UGIH) is one of the common clinical manifestations encountered in most emergency departments. Patient characteristics indicating UGIH severity in developing countries may be different from those in developed countries. The present study was designed to explore clinical prognostic indicators for UGIH severity.MethodsA retrospective cohort study was conducted in a university affiliated tertiary hospital in Kamphaeng Phet, Thailand. Medical folders of patients with UGIH were reviewed. Patients were grouped into 3 severity levels, based on criteria proposed by The American College of Surgeon. Pre-defined prognostic indicators were compared. The prognostic indicators for UGIH severity were analyzed by a multivariable continuation ratio ordinal logistic regression and presented with odds ratios.ResultsFrom 1,043 eligible medical folders, 984 (94.3%) complete folders were used in analysis. There were 241, 631 and 112 patients in the mild, moderate and severe UGIH groups. Six independent indicators of severe UGIH were, hemoglobin < 100 g/dL (OR = 13.82, 95% CI = 9.40 to 20.33, P < 0.001), systolic blood pressure < 100 mmHg (OR = 11.01, 95% CI = 7.41 to 16.36, P < 0.001), presence of hepatic failure (OR = 5.50, 95% CI = 1.14 to26.64, P = 0.037), presence of cirrhosis (OR = 2.03, 95% CI = 1.32 to 3.11, P = 0.001), blood urea nitrogen ≥ 35 mmol/L (OR = 1.73, 95% CI = 1.25 to 2.40, P = 0.001), and pulse rate ≥ 100 per minute (OR = 1.72, 95% CI = 1.21 to 2.45, P = 0.003).ConclusionsPulse rate ≥ 100 per minute, systolic blood pressure < 100 mmHg, hemoglobin < 10 g/dL, blood urea nitrogen ≥ 35 mmol/L, presence of cirrhosis and presence of hepatic failure are prognostic indicators for an increase in UGIH severity levels. They are potentially useful in UGIH risk stratification.

Reflex and Tonic Autonomic Markers for Risk Stratification in Patients With Type 2 Diabetes Surviving Acute Myocardial Infarction

OBJECTIVEDiabetic postinfarction patients are at increased mortality risk compared with nondiabetic postinfarction patients. In a substantial number of these patients, diabetic cardiac neuropathy already preexists at the time of the infarction. In the current study we investigated if markers of autonomic dysfunction can further discriminate diabetic postinfarction patients into low- and high-risk groups.RESEARCH DESIGN AND METHODSWe prospectively enrolled 481 patients with type 2 diabetes who survived acute myocardial infarction (MI), were aged ≤80 years, and presented in sinus rhythm. Primary end point was total mortality at 5 years of follow-up. Severe autonomic failure (SAF) was defined as coincidence of abnormal autonomic reflex function (assessed by means of heart rate turbulence) and of abnormal autonomic tonic activity (assessed by means of deceleration capacity of heart rate). Multivariable risk analyses considered SAF and standard risk predictors including history of previous MI, arrhythmia on Holter monitoring, insulin treatment, and impaired left ventricular ejection fraction (LVEF) ≤30%.RESULTSDuring follow-up, 83 of the 481 patients (17.3%) died. Of these, 24 deaths were sudden cardiac deaths and 21 nonsudden cardiac deaths. SAF identified a high-risk group of 58 patients with a 5-year mortality rate of 64.0% at a sensitivity level of 38.0%. Multivariately, SAF was the strongest predictor of mortality (hazard ratio 4.9 [95% CI 2.4–9.9]), followed by age ≥65 years (3.4 [1.9–5.8]), and LVEF ≤30% (2.6 [1.5–4.4]).CONCLUSIONSCombined abnormalities of autonomic reflex function and autonomic tonic activity identifies diabetic postinfarction patients with very poor prognoses.

Distribution of cortical bone in the femoral neck and hip fracture: A prospective case-control analysis of 143 incident hip fractures; the AGES-REYKJAVIK Study

In this prospective nested case-control study we analyzed the circumferential differences in estimated cortical thickness (Est CTh) of the mid femoral neck as a risk factor for osteoporotic hip fractures in elderly women and men. Segmental QCT analysis of the mid femoral neck was applied to assess cortical thickness in anatomical quadrants. The superior region of the femoral neck was a stronger predictor for hip fracture than the inferior region, particularly in men. There were significant gender differences in Est CTh measurements in the control group but not in the case group. In multivariable analysis for risk of femoral neck (FN) fracture, Est CTh in the supero-anterior (SA) quadrant was significant in both women and men, and remained a significant predictor after adjustment for FN areal BMD (aBMD, dimensions g/cm², DXA-like), (p=0.05 and p<0.0001, respectively). In conclusion, Est CTh in the SA quadrant best discriminated cases (n=143) from controls (n=298), especially in men. Cortical thinning superiorly in the hip might be of importance in determining resistance to fracture.

Discussion: Statistical models and methods for dependence in insurance data

The paper by Haug et al. presents an overview of copulas and their use for dependence modeling in multivariate risk analysis. Various aspects of rank-based inference are covered, from pointwise and interval estimation to goodness-of-fit testing. The exposition is clearly not comprehensive and many details are glossed over but this is offset by the inclusion of newmaterial, most notably empirical likelihood methods. Readers interested in further details can refer, e.g., to Genest and Favre (2007), where additional graphical tools and inferential procedures are illustrated on a small ‘‘learning data set’’. A distinctive feature of the paper is its emphasis on extreme-value and tail copulas. These concepts are clearly relevant for risk management, as failure to account for dependence between extreme events can have disastrous financial, economic or environmental consequences; see, e.g., Chavez-Demoulin and Embrechts (2010). There is a pressing need for inference techniques tailored to extreme dependence models and the area is currently undergoing rapid development. To attempt a survey at this early stage was clearly a challenge, and the authors lived up to it. Relevant additional contributions of recent vintage include new goodness-of-fit tests for extreme-value copulas by Kojadinovic and Yan (2010) and Quessy (in press), and alternative estimators of the Pickands dependence function due to Bucher, Dette, and Volgushev (2010), Guillotte and Perron (2008), and Guillotte, Perron, and Segers (in press). In this discussion, wewould like to complement thework of Haug et al. by highlighting some of the difficulties associated with the occurrence of ties in rank-based inference for copulamodels. As illustrated in Section 2, this phenomenon is present in the Danish fire insurance data set and cannot be ignored. Unfortunately, the validity of rank-based procedures is often compromised when the margins are discontinuous (Genest & Neslehova, 2007). The Danish data are used in Sections 3 and 4 to illustrate the impact of ties on testing for extremeness and making inference for extreme-value copulas, respectively. While the problem is easily recognized, solutions are hard to come by. Some of the methodological challenges at hand are sketched in Section 5, and concluding remarks are made in Section 6.

Aortic valve replacement with bioprosthesis in patients 70 years old or older with aortic stenosis

Aortic valve stenosis is the most prevalent valvulopathy in the elderly, but it is frequently undertreated. To assess early and long term results of valve replacement with bioprostheses in patients 70 years old or older with aortic stenosis. A review of the database of the Cardiovascular Surgery Service of our hospital, for the period 1990-2007, identified 156 patients with aortic valve stenosis, aged 76.7 ± 4.5 years (67% males), that were subjected to an aortic valve replacement with bioprosthesis. Seventy eight (50%) were in functional class III-IV. Six patients had emergency surgery. In 67 patients (43%) coronary artery bypass graft were performed. Long term mortality was ascertained obtaining death records from Chilean death registry. Operative mortality was 3.2% (5 patients). Four patients (2.6%) required a reoperation due to bleeding. The mean follow up was 66 ± 41 months. The survival rate at 1, 3 and 5 years was 94%, 88% and 80%, respectively. Forty two patients (27%) were 80 years old or older. In this sub-group, 1 patient (2.3%) died during the peri operative period and the estimated survival rate at 1, 3 and 5 years was 97%, 92%, and 80%, respectively. Multivariate risk analysis, for the whole group, identified low ejection fraction and concomitant coronary artery bypass graft surgery as predictors of late mortality. Aortic valve replacement for aortic stenosis with bioprostheses in patients 70 years old or older had low perioperative mortality and morbidity and a good long term survival.

Predicting the Prognosis of Oral Squamous Cell Carcinoma After First Recurrence

to describe the clinicopathologic features of oral squamous cell carcinoma in patients who develop locoregional recurrence of disease, to identify factors that predict prognosis in the subset of patients treated with salvage surgery, and to determine the adjusted effect of time to recurrence. cohort study. a head and neck cancer institute in Sydney, New South Wales, Australia. a total of 77 patients who underwent salvage surgery for oral squamous cell carcinoma that had been treated initially by surgery, radiotherapy, or surgery with postoperative radiotherapy. univariable and multivariable analysis of clinical and pathologic risk factors. median time to recurrence from initial treatment was 7.5 months (range, 0.9-143.9 mo), with 86% of recurrences occurring within the first 24 months. Surgical salvage was attempted in 77 patients who had experienced recurrence at the primary site (n = 39), ipsilateral neck (n = 27), and contralateral neck (n = 11). Time to recurrence, initial treatment modality, and site of failure were independent prognostic variables. the relationship of these prognostic variables displays a dynamic interaction. Initial combined-modality treatment and shorter time to recurrence were associated with worse outcome, while the effect of site of recurrence (local vs regional) was dependent on an interaction with the time to recurrence. The result of this interaction was that local recurrence was worse for those who experienced it early (eg, <6 mo after the initial treatment) and nodal recurrence was worse for those who experienced it late (eg, ≥ 6 mo after the intial treatment).

Pain as a confounding factor in postnatal depression screening

Background. Postnatal depression (PND) is one of the most serious complications following delivery in developed countries today. Thus, early screening strategies by first-line healthcare workers are of primary importance. Pain following childbirth has been proposed as a possible risk-marker for later depressive disorder. We tested this assumption and explored the possible link between pain and overestimation of PND risk in routine clinical screenings.Methods. We assessed 320 women between the third and fifth day after delivery as well as at 8 weeks post-partum (PP). Midwives were asked to evaluate the risk of later PND upon discharge from the maternity unit; additionally, pain measurements were obtained using the Visual Analogic Scale (VAS) over the same time period. A stepwise logistic regression analysis was performed to identify the risk markers linked to a positive depressive disorder diagnosis (according to the MINI-DSM-IV) at 8 weeks PP.Results and discussion. Multivariate risk analysis showed no statistical link between physical pain shortly after childbirth and subsequent PND diagnosis at 8 weeks PP. However, VAS measurements for pain were significantly higher for women that the midwives estimated to be at risk for PND (|Z| = 2.78, p = 0.005), suggesting the routine clinical screening for PND is susceptible for false-positives. Psychiatrists should encourage midwives to have an empathetic approach, to increase the detection as well as treatment of mental and physical suffering in early postpartum. At the same time, adequate education programmes for early PND screening should be proposed to non-psychiatric staffs to demonstrate that women at risk of PND often show minimal physical symptoms.

Trans-apical aortic valve implantation: univariate and multivariate analyses of the early results from the SOURCE registry☆☆☆

Trans-catheter aortic valve implantation is an alternative treatment option for patients facing high risk for aortic valve replacement. Currently, the results of trans-apical trans-catheter procedures performed outside controlled trials are unknown. The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry collects data of patients treated at European centres during the first year following commercialisation of the Edwards SAPIEN bioprosthesis. Only data from centres that could provide 100% of their consecutively treated patients (n=32) were included in the study population. This article provides the 30-day outcome data involving the trans-apical patients, including univariate and multivariate risk analyses for postoperative 30-day mortality. The interim results are based on a total number of 575 procedures performed between January 2008 and 31 January 2009. Mean age at implant was 80.7 years, and patients had a mean logistic EuroSCORE of 29.1%. Baseline characteristics included coronary artery disease 56%, prior coronary intervention 27.1%, prior coronary bypass grafting 26.9%, concomitant mitral valve disease 32.8%, porcelain aorta 11.5%, peripheral vascular disease 27.5%, prior stroke 6.3% and pulmonary disease 29.4%. Successful valve deployment was observed in 92.7% with a 3.5% conversion rate to open surgery, incidence of coronary obstruction of 0.7% and valve embolisation of 0.5%. The incidence of aortic regurgitation in excess of 2+ was 2.3% immediately following the procedure. The incidence of major postoperative complications included bleeding requiring re-operation 2.1%, dialysis 7.1%, pacemaker implantation 7.3%, stroke 2.6%, major vascular complications 2.4% and myocardial infarction 0.7%. The total 30-day mortality was 10.3%. Logistic EuroSCORE > or =30% and missing ejection fraction were found to be the only independent predictors for 30-day mortality. These results demonstrate that although trans-apical trans-catheter aortic valve implantation is a complex surgical technique, the learning curve can be minimised by appropriate training programmes. Very high logistic EuroSCOREs predict inferior survival and make it likely that in this subgroup of patients there may be some who, despite having had a successful trans-catheter aortic valve implantation procedure, do not benefit in the midterm.

A New Prognostic Scoring System Including Transfusion Dependency and Cytogenetic Abnormalities for Patients with Chronic Myelomonocytic Leukemia.

Abstract 1750Poster Board I-776Chronic myelomonocytic leukemia (CMML) is a clonal disorder sharing features of both myelodysplastic syndromes (MDS) and chronic myeloproliferative disorders (MPD). The natural course of CMML is highly variable. Several small series have suggested the prognostic importance of different characteristics but a widely accepted prognostic scoring system for CMML is not available. The main aims of the study were to identify prognostic factors, including cytogenetic findings, for overall survival (OS) and acute leukemic (AL) transformation in a large series of patients with CMML and to develop an easily applicable prognostic scoring index for estimating outcome and planning treatment in the individual patient. Five hundred and seventy-two patients diagnosed of CMML according to FAB and WHO criteria in 25 centers belonging to the Spanish Registry of MDS were included in the study. Actuarial curves of OS and risk of AL evolution were built by Kaplan-Meier method and differences between curves compared with log-rank tests. Multivariate analyses of OS and risk of AL evolution were performed by Cox proportional hazards regression method. The weights assigned to the variables included in the final prognostic scoring system were based on the regression coefficients from the proportional hazards models. Median age was 73 yr and 397 (69%) were males. According to FAB criteria 61% of the patients had MDS-CMML (absolute WBC count '13 × 109/L) and 39% MPD-CMML and by WHO classification 86% were CMML-1 (blasts <10% in bone marrow and <5% in blood) and 14% CMML-2. Karyotype was available in 419 patients (abnormal in 113) and RBC transfusion dependency in 415 (222 transfusion-dependent). With a median follow-up of 33 months, the median OS was 25 months. Seventy-five patients evolved to AL and the cumulative risk to AL transformation was 25% at 5 yr. In univariate analyses patients with CMML-2, presence of 2–3 cytopenias, MPD-CMML, hemoglobin <10 g/L, poor-risk cytogenetics (defined as trisomy 8 or complex karyotype), and RBC transfusion dependency had both a shorter OS and higher risk of AL evolution (P<0.001 in all cases). Additionally, patients with serum LDH level >480 U/L (P<0.001), monocytes >3 × 109/L (P<0.001), platelets '100 × 109/L (P=0.001), serum ferritin level >500 ng/mL (P<0.01), and males (P=0.01) also had a poorer OS. In multivariate analyses the most relevant variables for OS were WHO (P<0.001) and FAB classifications (P<0.001), RBC transfusion dependency (P<0.001), LDH level (P<0.001), hemoglobin level (P<0.001), and cytogenetics (P=0.001). For AL transformation risk the only independent factors were WHO (P<0.001) and FAB classifications (P<0.001), RBC transfusion dependency (P<0.001), and cytogenetics (P=0.01). A prognostic scoring system using WHO (CMML-2, 1.5 points) and FAB classifications (MPD-CMML, 1 point), RBC transfusion dependency (dependent, 1 point), LDH level (>480 U/L, 1 point) and cytogenetic risk group (high-risk, 1 point) was developed (overall risk, 0 – 5.5 points). This scoring system was able to stratify patients into 4 risk groups (low, 0 points; intermediate-1, 1–1.5 points; intermediate-2, 2 points; and high, 2.5 – 5.5 points) with significantly different probabilities of death (median OS, 105, 38, 22, and 11 mo, respectively; P<0.001; Figure) and AL evolution (cumulative risk at 5 yr, 3%, 24%, 33%, and 40%, respectively; P=0.001). The results of this study confirm the prognostic impact of FAB and WHO subtypes and serum LDH level and recognize for the first time the relevance of RBC transfusion dependency and specific chromosomal abnormalities in CMML. Finally, they offer a simple and powerful index for assessing prognosis and planning therapy in CMML. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Chronic Myelomonocytic Leukemia (CMML) with More Than 15% of Ring Sideroblasts in Bone Marrow: An Overlapping Disorder Between CMML and Refractory Anemia with Ring Sideroblasts.

Abstract 290The main diagnostic criteria for chronic myelomonocytic leukemia (CMML), a heterogeneous disorder sharing features of myelodysplastic syndromes (MDS) and chronic myeloproliferative disorders, is the existence of a sustained absolute monocyte count in peripheral blood (PB) above 1 × 109/L. On the other hand, the presence of more than 15% ring sideroblasts (RS) in bone marrow (BM) is a well recognized morphological feature of dyserithropoiesis and, in the absence of blasts in PB and less than 5% blasts in BM, is diagnostic of refractory anemia with ring sideroblasts (RARS) with or without multilineage dysplasia. In FAB as well as in WHO classification systems for myeloid neoplasms those cases presenting with both an absolute monocyte count in PB above 1 × 109/L and more than 15% RS in BM are diagnosed of CMML but the preeminence given to the monocyte count in PB over the proportion of RS in BM is not evidence-based. The main purpose of this study was to assess the clinical and biological characteristics and outcome [overall survival (OS) and acute leukemic (AL) evolution] of a series of 77 patients diagnosed of CMML by FAB and WHO criteria who had more than 15% RS in BM at presentation (CMML-RS) and to compare them with those of a series of 417 patients with CMML with less than 15% RS (classical CMML) and those of a series of 178 patients with classical RARS (38 patients with and 140 patients without multilineage dysplasia). Comparisons of proportions and ranks of variables between different groups were performed by chi square or Mann-Whitney-U tests as appropriate. Actuarial curves of OS and risk of AL evolution were built by Kaplan-Meier method and differences between curves compared with log-rank tests. Multivariate analyses of OS and risk of AL evolution were performed by Cox proportional hazards regression method. Patients with CMML-RS had lower hemoglobin level (P=0.008), lower absolute counts of leukocytes (P<0.001), neutrophils (P=0.002), and monocytes (P<0.001), higher platelet count (P<0.001), lower proportion of blasts in PB (P=0.015) and BM (P=0.035), and higher serum level of ferritin (P<0.001) and LDH (P=0.06) than patients with classical CMML. Patients with CMML-RS had significantly better OS than patients with classical CMML (median, 79 mo and 26 mo respectively; P<0.001; Figure) as well as lower risk of AL evolution (cumulative proportion at 5 yr, 7% and 20% respectively; P=0.07). Further, the beneficial prognostic relevance of the proportion of RS in BM on OS was maintained in multivariate analyses (P<0.001). In marked contrast, OS (median, 64 mo; Figure) and risk of AL evolution (cumulative proportion at 5 yr, 9%) of patients with classical RARS were closely similar to those observed in patients with CMML-RS (P>0.90). Patients with classical RARS were more anemic (P=0.001), had lower absolute counts of leukocytes (P<0.001), neutrophils (P=0.01), and monocytes (P<0.001), higher platelet count (P=0.002), lower proportion of blasts in PB (P=0.01) and BM (P<0.001), and lower serum level of ferritin (P=0.01) and LDH (P=0.11) than patients with CMML-RS. To avoid the potential interference in the analyses of disparities in the proportion of blasts in BM in the different groups of patients all the analyses were repeated excluding from all the groups those cases with 5% or more blasts in BM. Fifty-three patients with CMML-RS, 245 with classical CMML, and all 178 with classical RARS were evaluable for these sub-analyses. The results obtained were similar to those in the overall series of patients (data not showed). To sum up, all these results show that the proportion of RS in BM is a much powerful prognostic indicator than absolute monocyte count in PB in CMML and demonstrate that the presence of a proportion of RS greater than 15% in BM in patients with CMML defines a subset of patients that clearly differ in their biological characteristics from classical CMML and classical RARS. CMML-RS has a clinical course very close to that of classical RARS and markedly better than classical CMML. These data strongly suggest that CMML-RS is an overlapping syndrome between CMML and RARS. For clinical purposes patients with >1 × 109 monocytes/L in PB and >15% RS in BM should be better classified as RARS than as CMML. The WHO classification needs to be revisited to account for those findings. [Display omitted] Disclosures:No relevant conflicts of interest to declare.

GHICA — Risk analysis with GH distributions and independent components

Over recent years, a study on risk management has been prompted by the Basel committee for regular banking supervisory. There are however limitations of some widely-used risk management methods that either calculate risk measures under the Gaussian distributional assumption or involve numerical difficulty. The primary aim of this paper is to present a realistic and fast method, GHICA, which overcomes the limitations in multivariate risk analysis. The idea is to first retrieve independent components (ICs) out of the observed high-dimensional time series and then individually and adaptively fit the resulting ICs in the generalized hyperbolic (GH) distributional framework. For the volatility estimation of each IC, the local exponential smoothing technique is used to achieve the best possible accuracy of estimation. Finally, the fast Fourier transformation technique is used to approximate the density of the portfolio returns. The proposed GHICA method is applicable to covariance estimation as well. It is compared with the dynamic conditional correlation (DCC) method based on the simulated data with d = 50 GH distributed components. We further implement the GHICA method to calculate risk measures given 20-dimensional German DAX portfolios and a dynamic exchange rate portfolio. Several alternative methods are considered as well to compare the accuracy of calculation with the GHICA one.

Effects of FCGR3A and FCGR2A polymorphisms on outcomes of patients with diffuse large B-cell lymphoma treated with CHOP-like chemotherapy versus CHOP-rituximab

8567 Background: The addition of rituximab to cyclophosphamide/ doxorubicin/ vincristine/ prednisone (R-CHOP) therapy for diffuse large B-cell lymphoma (DLBCL) has significantly improved the outcome for many patients (pts). We evaluated the impact of single nucleotide polymorphisms (SNPs) of Fc receptor (FcR) genes FCGR3A and FCGR2A on the outcomes of patients with DLBCL treated with R-CHOP compared to a historical control patientss treated with CHOP-like chemotherapy alone. Methods: 199 patients with DLBCL who had received CHOP or CHOP-like chemo (N=99) or R-CHOP (N=100) had tissue blocks assayed for FCGR3A and FCGR2A polymorphisms. The patient characteristics, progression-free survival (PFS), and overall survivals (OS) were compared and analyzed with respect to the polymorphisms. Results: In the univariate analysis, the probability of PFS of pts according to polymorphisms in the FCGR2A gene treated with CHOP-like chemotherapy; H/H (n=25), H/R (n=39), and R/R (n=35) and those treated with R-CHOP; H/H (n=24), H/R (n=41), and R/R (n=35) were both not statistically different; log-rank p=0.47 and p=0.86, respectively. The probability of PFS in the FCGR3A gene treated with CHOP-like chemotherapy; V/V (n=10), F/V (n=40), F/F (n=49) and those treated with R-CHOP; V/V (n=12), F/V (N=40), F/F (n=48) were also not statistically different; log-rank p=0.32 and p=0.22, respectively. In a multivariate analysis for risk of progression or death: FCGR2A : H/H vs. H/R or R/R by treatment type: CHOP-like [RR 0.63 (95% CI 0.37–1.08), p=0.10] and R-CHOP [RR 0.59 (0.36–0.96), p=0.04] and for FCGR3A V/V vs. F/V or F/F by treatment arm: CHOP-like [RR 0.75 (0.36–1.54), p=0.43] and R-CHOP [RR 2.28(0.70–7.44), p=0.17]. Conclusions: Generally, the addition of rituximab to CHOP chemotherapy results in better outcomes than patients who receive CHOP-like regimen regardless of polymorphisms. However, our study also suggests that a trend toward association of certain polymorphisms with clinical outcomes. Additional, larger studies are needed to confirm this data. This information may assist in targeting additional therapies in patients with less favorable outcomes. [Table: see text]

Protective and Risk Factors for Sexually Transmitted Infections in Middle School Students

Significant numbers of adolescents are initiating sexual activity at age 13 and younger. Little is known about this younger population of adolescents. This includes risk or protective factors for sexual activity and sexually transmitted infection (STI) acquisition. To safeguard all adolescents from the consequences of risky sexual behaviors, and to insure age appropriate and effective interventions, further study is critical to address risky behaviors specific to early adolescents. This study was a retrospective chart review of 155 sexually active adolescent girls enrolled in 3 inner city school-based health centers. Students were divided into those who never had a documented STI and those who had 1 or more STIs. Data were collected from a sexual history questionnaire and the Guidelines for Adolescent Preventive Services questionnaire. These data were grouped into risk or protective Guidelines for Adolescent Preventive Services domains. Domains were made up of 5 items of protective factors, 3 items of peer risks, 2 items of family risks, and 7 items of individual risks. STI outcomes were compared to these characteristics. One hundred fifty-five sexually active black adolescents were studied. A univariate and multivariate analysis of risk and protective factors for testing positive for an STI demonstrated that high levels of protective factors reduced the risk of STIs. Increased levels of protective factors were associated with a decrease in STI risk. This suggests that STI prevention programs should focus on increasing protective factors among young adolescents in addition to reducing risk factors.

Independent Impact of Iron Overload and Transfusion Dependency on Survival and Leukemic Evolution in Patients with Myelodysplastic Syndrome

Transfusion dependency seems to have a major prognostic impact in patients with myelodysplastic syndrome (MDS) (Malcovati L et al. J Clin Oncol 2007; 25:3503). Preliminary data also suggest that the development of iron overload could influence outcome (Malcovati L et al. J Clin Oncol 2005; 23:7594 and Garcia-Manero G et al. Leukemia 2008; 22:538), but small numbers have precluded a meaningful analysis of the prognostic value of this characteristic. The main aim of this study was to evaluate the independent prognostic value of transfusion dependency (as defined in WHO-based Prognostic Scoring System [WPSS]) and iron overload (defined as serum ferritin level >1,000 ng/mL) in a large series of 2,994 patients (median age, 74 yr) with de novo MDS according to FAB criteria (2,107 MDS according to WHO criteria). Complete transfusional history was available in 2,241 patients (835 transfusion dependent [TD] at diagnosis, 526 TD during follow-up, and 880 non-TD) and serum ferritin levels in 1,634. Karyotyping was successfully performed in 2,074 patients, who could then be classified by the International Prognostic Scoring System (IPSS) as low (861 patients), intermediate-1 (748), intermediate-2 (311), and high-risk (154). The numbers of patients in the five risk categories defined by the WPSS (available for 1,228 patients) were 257 (21%) in very low, 385 (31%) in low, 217 (18%) in intermediate, 271 (22%) in high, and 98 (8%) in very high, closely similar to those reported in the original WPSS series. Actuarial curves of overall survival (OS) and risk of evolution to acute myeloblastic leukemia (AML) were built by Kaplan-Meier method and differences between curves compared with log-rank tests. Multivariate analyses of OS and risk of evolution to AML were performed by Cox proportional hazards regression method, with development of transfusion dependency and iron overload entered as time-dependent covariates. Other variables included in the prognostic factor analyses were age, gender, hemoglobin level, absolute WBC, PMN, and platelet counts, proportion of blasts in blood and marrow, percentage of dysplastic features in the three different hematopoietic cell lines, cytogenetics according to IPSS cytogenetic risk subgroups, FAB and WHO classifications, ferritin, beta-2 microglobulin, erythropoietin, and LDH levels at diagnosis, and IPSS and WPSS risk categories. All the previous variables showed a statistically significant relationship with OS and/or AML risk on univariante analyses. Median OS for TD patients at diagnosis, TD patients during evolution, and non-TD patients was 19, 60, and 96 months, respectively (P<.0001). Multivariate analyses in a set of 902 cases with complete data confirmed that development of iron overload (1st variable selected to enter the model; hazard ratio [HR], 52.4; P<.0001) and transfusion dependency (2nd to enter; HR, 8.8; P<.0001) were strongly associated with OS and added significant independent prognostic information to that afforded by the IPSS and WPSS scores or by other characteristics with universally recognized prognostic value. Further, multivariate analyses of AML transformation risk showed that iron overload (1st to enter; HR, 6.6; P<.0001) and transfusion dependency (2nd to enter; HR, 3.5; P=.003) had also independent impact on that endpoint. These results demonstrate for the first time the independent prognostic value of development of iron overload on OS and AML risk in MDS, confirm the impact of transfusion dependency on those outcomes, and support that the inclusion of both variables in a new prognostic scoring system would add clinically relevant information. They also suggest that avoiding or reducing iron overload by an appropriate chelation therapy could improve OS and reduce the risk of AML transformation in MDS patients.

Predictors of Difficult Intubation in Patients With Cervical Spine Limitations

Cervical spine function is of paramount importance to the management of the airway. What has not been reported in the literature is a systematic analysis of airway management in patients with cervical spine limitation (CSL) compared with their normal counterparts or a predictive model of difficult intubation (DI) in patients with CSL. We reviewed the electronic charts of 14,053 patients and identified those with CSL based on the preoperative airway evaluation. We then compared various airway parameters in patients with CSL to those without CSL and further assessed risk factors for DI in patients with CSL. We develop a predictive model on the basis of multivariate analysis of such risk factors. Of the cohort studied, 1145 or 8.1% of patients were documented as having some form of CSL, with an average age of 60. In the <60 population, CSL was associated with a statistically significant increase in difficult and impossible mask ventilation, difficult laryngoscopy, and DI. In the population > or =60 years old, CSL was associated with a statistically significant increase in difficult laryngoscopy and DI. There were no significant differences in mask ventilation between normal and CSL patients in the population > or =60. Multivariate modeling revealed age > or =48, Mallampati 3 or 4, and thyromental distance <6 cm as independent preoperative risk factors of DI in patients with CSL. A predictive model is developed on the basis of these findings. Limitations of cervical spine mobility are relatively common and increase the incidence of difficulty throughout the spectrum of airway management. DI should be anticipated in CSL patients who are > or =48 years old, have a Mallampati class 3 or 4, and a thyromental distance of <6 cm.

Autosomal Dominant Polycystic Kidney Disease Is Not a Risk Factor for Post-transplant Diabetes Mellitus. Matched-pair Design Multicenter Study

Post-transplant diabetes mellitus (PTDM) is a relatively common complication of kidney transplantation. The aim of our work was to compare the incidence of PTDM in kidney transplant recipients with and without autosomal dominant polycystic kidney disease (ADPKD) in a matched-pair design study. In total, 98 pairs of graft recipients, all of Caucasian origin and who received a kidney from the same cadaveric donor, were included in the study. The following clinical data were collected for statistical analysis: age, body mass index (BMI) before transplant, length and type of dialysis treatment, residual diuresis, and cold and warm graft ischemia time. Diabetes was diagnosed based on American Diabetes Association (ADA) criteria. Incidence of PTDM was 19.4% in the ADPKD group and 18.4% in the non-ADPKD group, with no significant differences between groups. Multivariate logistic regression analysis of the PTDM risk in the ADPKD group including age, gender, BMI, and dialysis time as independent variables indicated that only higher residual diuresis is a significant independent risk factor (OR = 5.64 per every L/24 h, 95% CI = 1.31-24.33, p = 0.017). Similarly, logistic regression analysis adjusted for age and gender in the non-ADPKD group has shown that significant independent risk factors are BMI (OR = 1.30 per every kg/m(2), 95% CI = 1.06-1.59, p = 0.0094), longer dialysis time prior to transplant (OR = 1.036 per each month, 95% CI = 1.004-1.070, p = 0.025), and a history of arterial hypertension (OR = 9.09, 95% CI = 1.20-68.66, p = 0.030). In this paired analysis, our results suggest that diagnosis of ADPKD does not increase risk of PTDM.

Extra-Anatomical Reconstruction in the Case of an Inaccessible Groin: The Axillopopliteal Bypass

Axillopopliteal bypass is a relatively unknown and uncommon therapeutic option for patients with critical limb ischemia in the presence of an inaccessible groin due to infection or excessive scar formation. In our center, this procedure is performed several times a year. The results of all axillopopliteal bypass reconstructions over an 11-year period were analyzed. Thirty axillopopliteal bypass grafts were performed on 24 patients (16 men, mean age 67 years). In 23 limbs, the indication was persistent groin infection after previous vascular surgery and a threatened limb. In seven limbs, the possibility to anastomose in the groin was absent. There were eight patients (27%) with diabetes mellitus, hypertension was present in 43% (n = 13), and 90% (n = 27) were current or previous smokers. During 5 years of follow-up, 11 patients died, eight during the first year after operation. The primary patency after 1 year was 64% (n = 9). The secondary patency after 1 year was 77%. Seven amputations (23%) were needed: six for ischemia and one for persistent infection. Limb salvage after 1 year was 84%. A limitation of the study is the small number of patients, which was not enough for uni- and multivariate risk analyses with sufficient statistical power. The results of axillopopliteal bypass surgery in patients with critical limb ischemia and an inaccessible groin demonstrate a high mortality rate of 29% after 1 year. However, surviving patients may benefit from the operation in terms of limb salvage because the primary patency was 64% and the secondary patency 77% at 1-year follow-up. We conclude that extra-anatomical axillopopliteal bypass is a valuable therapeutic option for limb salvage in this specific patient population.

Carotid endarterectomy in patients with acute neurological symptoms: a case-control study

The aim of this study was to retrospectively evaluate our experience in urgent carotid endarterectomy (CEA) in patients with acute neurological symptoms comparing them with results obtained in stable symptomatic patients in a case-control study. From January 1996 to December 2005, 3336 consecutive CEAs were performed at our department. In 70 cases CEA was carried out in patients with acute neurological deficit; in all these patients, clinical presentations were recent (<24 h) or crescendo (defined as two or more episodes in 24 h, with complete recovery after each episode) TIAs (group 1). The control group was randomly obtained from our historical database and consisted of 352 stable symptomatic patients operated on in the same period (group 2). Early (30-day) results in the two groups were compared by chi(2) and Fisher exact tests; follow-up data were analysed by life-table analysis (Kaplan-Meier test) and results in subgroups were compared by means of log-rank test. Considering mortality and any neurological morbidity, the patients of group 1 showed a cumulative rate of death and neurological complication significantly higher than those in group 2 (5.4% and 0.3%, respectively; P=0.005); however, when analysing 30-day disabling strokes and deaths, the patients of group 1 had a cumulative complication rate of 1.4%, whereas in group 2 the corresponding figure was 0.3% (P=n.s.). In patients of group 1, univariate analysis and logistic regression for multivariate analysis for 30-day risk of stroke and death did not show any influence of comorbidities, clinical status, anatomical and surgical features. Estimated cumulative 36-month survival was significantly better in group 2 than in group 1. Considering the absence of ipsilateral stroke at 36 months, there were no differences between the two groups; however, analysing the estimated absence of any neurological events, both ipsilateral and contralateral, at 36 months, patients of group 1 had a higher risk than those of group 2. Urgent CEA in patients with recent/crescendo TIA and appropriate carotid artery lesion, carries good early and long-term results, which, however, remain slightly poorer than those obtained in symptomatic patients with a stable neurological status.

Perioperative Morbidity Using Transvaginal Mesh in Pelvic Organ Prolapse Repair

To describe the perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse. During a 6-month time period, 25 centers registered all surgical procedures using a commercially available mesh. The frequency and type of perioperative complications, during surgery and the associated hospital stay, were documented using a standardized protocol. During the inclusion period, 248 women underwent transvaginal mesh surgery: anterior repair in 106 patients (43%), posterior repair in 71 (29%), combined anterior and posterior repair in 20 (8%), and total repair in 51 (21%). Mean age was 67.8 years (+/-10.3 standard deviation) and median parity was 2 (range 0-6). Surgery for prolapse recurrence was performed in 56% of the patients (n=140), and 91% (n=225) had undergone at least one previous pelvic floor surgical procedure. Serious complications occurred in 4.4% of patients (n=11) and were dominated by visceral injury (10 of 11 cases). One case of bleeding in excess of 1,000 mL occurred. Minor complications occurred in 14.5% of patients (n=36), and the majority were urinary tract infections, urinary retention, and postoperative fever. A multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications, odds ratio 2.8 (95% confidence interval 1.1-6.9). There were no other predictors of outcomes when assessing the association with age, parity, weight, previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy. Perioperative serious complications are uncommon after transvaginal mesh procedures although particular care should be taken to detect visceral injury at the time of surgery. III.