Real-life Cohort Of Patients Research Articles

Türkiye'de Hepatit B Virüs ve Hepatit C Virus Koenfeksiyonu Prevalansı ve Epidemiyolojik Özellikleri

Objective: We aimed to determine prevalence and epidemiological characteristics of cases coinfected with hepatitis B virus (HBV)/hepatitis C virus (HCV) in Turkey. Material and Methods: The data for this study was obtained from Turk-Hepatitis Registry (HEP-NET) Project, which includes real-life cohort of hepatitis patients from 15 centers in Turkey, and is supported by Viral Hepatitis Society. In the project, 10,165 hepatitis cases were evaluated in 10 hospitals. Results: According to initial visit results, HBV/HCV coinfection was detected in 99 patients. The ratio was 974/100 000. The mean age of the cases was 40.9+21.7 years, 56.6% of them were males and 43.4% were females,. The major risk factors were dental therapy, any surgical procedure, hemodialysis and blood transfusion. The mean alanine aminotransferase (ALT) levels were 70.9±49.1 IU/L in coinfected patients. In 12% of cases HBeAg was positive. The median HCV RNA level was found 0 IU/mL (minimum: 50-maximum: 2.18x107 IU/mL), and the median HBV DNA level was found 2.50x102 IU/mL (minimum: 12-maximum: 1.70x108 IU/mL). In 8.1% of the patients both HCV RNA and HBV DNA were positive, and in 87.5% of cases HCV infection was dominant. The most important risk factor was hemodialysis (25%) in this group. Conclusion: This is the most detailed study which evaluates the prevalence of HBV/HCV coinfection in Turkey. HBV/HCV coinfection prevalence was not higher than HBV or HCV monoinfections. In cases where both HCV RNA and HBV DNA were positive, HCV was predominant.

Quality of life monitoring in ambulatory heart failure patients: temporal changes and prognostic value

Heart failure (HF) is a chronic condition that typically affects a patient's quality of life (QoL). Little is known about long-term QoL monitoring in HF. This study aimed to evaluate the temporal changes and prognostic value of QoL assessment in a real-life cohort of HF patients. The Minnesota Living with Heart Failure Questionnaire was used to monitor QoL at baseline and at 1, 3, and 5 years for 1151 consecutive patients {71.7% men, median age 69 years [25th-75th percentiles (P(25)-P(75)) 59-76]} in an HF unit. Follow-up for prognosis assessment was extended to 6 years. The number of answered questionnaires was 1151 at baseline, 746 at 1 year, 268 at 3 years, and 240 at 5 years. QoL scores showed a steep decrease (indicating QoL improvement) during the first year [29 (P(25)-P(75) 16-43) at baseline vs. 15 (P(25)-P(75) 8-27) at 1 year, P < 0.001], which was tempered, yet significant up to 5 years [12 (P(25)-P(75) 7-23) at 3 years vs. 10 (P(25)-P(75) 5-21) at 5 years, P = 0.012]. We recorded 457 deaths during follow-up. In a comprehensive multivariable Cox regression analysis, baseline QoL remained a significant prognosticator during follow-up [hazard ratio (HR)(Cox) for death 1.012, 95% confidence interval 1.006-1.018, P < 0.001]. QoL monitoring showed that a score increase ≥10% between consecutive assessments stratified high-risk patients within the next 12 months (P = 0.008). Both baseline and follow-up QoL monitoring were useful for patient risk stratification in a real-life HF cohort. Worse QoL may warn of a worse prognosis. Widespread QoL monitoring in routine clinical practice is recommended.

Significance of sex in achieving sustained remission in the consortium of rheumatology researchers of north america cohort of rheumatoid arthritis patients

To determine whether men with rheumatoid arthritis (RA) are more likely to achieve remission compared to women. RA patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) cohort between October 2001 and January 2010 were selected for the present analyses. Detailed clinical, demographic, and drug utilization data were available at enrollment (baseline) and at subsequent followup visits. We examined the influence of sex on the Clinical Disease Activity Index remission score (≤2.8) using sustained remission or point remission as the primary outcome measure in multivariate stepwise logistic regression models. We stratified the data by RA duration at baseline (≤2 years or >2 years) to investigate whether RA duration had differential effects on remission in men and women. A total of 10,299 RA patients (2,406 men and 7,893 women) were available for this study. In both early and established RA, women had more severe disease at baseline with worse disease activity measures, modified Health Assessment Questionnaire disability index score, pain on a visual analog scale, and depression. Women were also more likely to have been treated with disease-modifying antirheumatic drugs and anti-tumor necrosis factor therapy compared to men. In the regression models, male sex was associated with sustained remission in early RA (odds ratio [OR] 1.38, 95% confidence interval [95% CI] 1.07-1.78, P = 0.01), but not in established RA. However, for point remission, an inverse association was observed with male sex in established RA (OR 0.65, 95% CI 0.48-0.87, P = 0.005) and not in early RA. Within the large real-life CORRONA cohort of RA patients, men were more likely to achieve sustained remission compared to women in early RA, although not in established RA.

Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Atazanavir-based regimens have established efficacy and safety in both antiretroviral (ARV)-naive and -experienced patients. However, data evaluating effectiveness beyond 2 years is sparse. Therefore, we assessed the long-term outcomes of ritonavir-boosted atazanavir (ATV/r)-containing regimens in ARV-experienced patients in a clinical setting in a noncomparative, retrospective, observational study collecting data from three European HIV databases on ARV-experienced adults with HIV-1 infection starting an ATV/r-based regimen. Data were extracted every 6 months (maximum follow-up 5 years). Primary outcome was the proportion of patients remaining on ATV/r by baseline HIV-1 RNA (<500 or ≥500 copies/ml). Secondary outcomes included time to virologic failure, reasons for discontinuation, and long-term safety profile. The duration of treatment and time to virologic failure were analyzed using the Kaplan-Meier method. Data were analyzed for 1,294 ARV-experienced patients (male 74%; mean ART exposure 5.7 years). After 3 years, 56% (95% CI: 52%, 60%) of patients with baseline HIV-1 RNA <500 copies/ml and 53% (95% CI: 49%, 58%) of those with HIV-1 RNA ≥500 copies/ml remained on ATV/r. After 3 years, 75% (95% CI: 69%, 80%) of patients with baseline HIV-1 RNA <50 copies/ml remained suppressed and 51% (95% CI: 47%, 55%) of those with baseline HIV-1 RNA ≥50 copies/ml achieved and maintained virologic suppression. Although adverse events (AEs) were the main known reason for discontinuation, no unexpected AEs were observed. In a real-life setting ATV/r-based regimens demonstrated sustained virologic suppression in ARV-experienced patients. After long-term therapy the majority of patients remained on treatment and no unexpected AEs were observed.

Response to Erythropoietin in a Multicentric Real-Life Cohort of Myelodysplastic Patients: The Grom Experience

AbstractAbstract 4958Erythropoietin (EPO) have been widely employed in the treatment of patients with low-risk Myelodysplastic Syndromes (MDS) and anemia, with response rates ranging from 30 to 60%. These data, however, have been derived only from controlled clinical trials or unicentric single-arm studies; it is still lacking a wider survey evaluating the use of EPO in the real-life clinical practice. To address this issue, the Gruppo Romano Mielodisplasie (GROM) revised retrospectively 394 MDS patients (M/F 225/169, median age at diagnosis 73. 9 yrs, IR 67. 0 – 79. 3) treated with EPO from 1/2002 to 12/2010 by 11 Hematological Centers (5 university hospitals and 6 community-based hospitals) in the metropolitan area of Rome. According to WHO classification, there were 81 (20. 6%) patients with RA, 7 (1. 8 %) with SA, 160 (40. 7%) with RCMD, 17 (4. 3%) with RCMD-S, 75(19. 0%) with RAEB-1, 27 (6. 8%) with RAEB-2 and 27 (6. 8%) with isolated del5q. The IPSS score was calculated in the 307 patients with an available karyotype: 145 (47. 2%) patients were low-risk, 135 (44. 0%) int-1, 24 (7. 8%) int-2 and 3 (1. 0%) high-risk. Median interval from diagnosis to EPO start was 3. 7 months (IR 0. 9 – 12. 1). At EPO start, median age was 74. 5 yrs (IR 68. 3 – 79. 9) with a median haemoglobin level of 8. 9 g/dl (IR 8. 2 – 9. 6). Creatinine level was elevated in 64 (16. 2%) cases: 138 patients (35. 3%) had a previous transfusion requirement. Median serum EPO level was 50. 0 mU/L (IR 26. 2 – 110. 0). The initial doses of EPO were ≤ 40. 000 UI/week in 259 patients (65. 7%) (standard doses, α-EPO in 104 patients, β-EPO in 143 patients, darbepoietin in 12 patients) and 80000 UI/week in 135 patients (34. 3%) (high doses, α-EPO in 130 patients, β-EPO in 5 patients). An erythroid response was observed in 228 (57. 9%) patients, with Hb increase > 1. 5 g/dl in 210 patients (53. 3%) and disappearance of transfusion requirement in 18 (4. 6%): patients receiving initial high doses had a higher response rate compared to patients receiving standard doses [94/135 (69. 6%) vs 134/259 (51. 7%), p=0. 002]. Only 5 thrombotic events (1. 2%) were reported during the treatment. Predicting factors for erythroid response were no previous transfusion requirement (p<0. 001), serum EPO levels at baseline < 50 mU/l (p<0. 001), creatinine levels above the normal values (<0. 001), ferritin levels < 250 ng/ml (p=0. 009) and hemoglobin level at baseline > 8 g/dl (p=0. 017). Median overall survival from EPO start was 70. 7 months (CI 95% 52. 5 – 88. 8) in responders versus 41. 7 months (CI 95% 27, 6 – 55, 7) in resistant patients (p= 0. 018). Our real-life data from a single homogeneous geographic area outline that EPO treatment is safe and effective also in the current clinical practice, beyond controlled clinical trials. However, this latter type of studies is warranted to define the best initial dose of EPO in such patients. Disclosures:No relevant conflicts of interest to declare.

Therapeutic drug monitoring of imatinib in chronic myeloid leukemia: experience from 1216 patients at a centralized laboratory

This study set out to examine in a large real-life cohort of patients with chronic myeloid leukemia (CML) the impact of imatinib threshold of 1000 ng/mL on molecular response, as suggested in a small subset of patients. Patient plasma samples were submitted from around France to a central facility, free of charge under the auspices of the European Treatment and Outcome Study (EUTOS) for CML. Submitting physicians were required to complete an 'imatinib monitoring request form', including details of why therapeutic drug monitoring (TDM) was requested, dose and duration of imatinib treatment, cytogenetic and molecular response, adverse events, and concurrent medications. Imatinib trough plasma concentration (C(min)) was measured at the central facility. Among 1985 eligible plasma samples analyzed, from 1216 CML patients, imatinib C(min) correlated positively with reported imatinib dose, but interpatient variability in C(min) was high (60%). A logistic regression analysis revealed that treatment duration and imatinib C(min) > 1000 ng/mL were significantly associated with major and complete molecular responses with odds ratios of 1.69 and 2.08, respectively. These data support in real-life setting that imatinib C(min) threshold of 1000 ng/mL is associated with major and complete molecular response and that TDM could play an important role in dose optimization.

Combined use of high-sensitivity cardiac troponin T and N-terminal pro-B type natriuretic peptide improves measurements of performance over established mortality risk factors in chronic heart failure

Heart failure still maintains a high mortality. Biomarkers reflecting different pathophysiological pathways are under evaluation to better stratify the mortality risk. The objective was to assess high-sensitivity cardiac troponin T (hs-cTnT) in combination with N-terminal pro-B type natriuretic peptide (NT-proBNP) for risk stratification in a real-life cohort of ambulatory heart failure patients. We analyzed 876 consecutive patients (median age 70.3 years, median left ventricular ejection fraction 34%) treated at a heart failure unit. A combination of biomarkers reflecting myocyte injury (hs-cTnT) and myocardial stretch (NT-proBNP) was used in addition to an assessment based on established mortality risk factors (age, sex, left ventricular ejection fraction, New York Heart Association functional class, diabetes, estimated glomerular filtration rate, ischemic etiology, sodium, hemoglobin, β-blocker treatment, and angiotensin converting enzyme inhibitor or angiotensin II receptor blocker treatment). During a median follow-up of 41.4 months, 311 patients died. In the multivariable Cox proportional hazards model, hs-cTnT and NT-proBNP were independent prognosticators (P = .003 each). The combined elevation of both biomarkers above cut-off values significantly increased the risk of death (HR 7.42 [95% CI, 5.23-10.54], P < .001). When hs-cTnT and NT-proBNP were individually included in a model with established mortality risk factors, measurements of performance significantly improved. Results obtained for hs-cTnT compared with NT-proBNP were superior according to comprehensive discrimination, calibration, and reclassification analysis (net reclassification indices of 7.7% and 1.5%, respectively). hs-cTnT provides significant prognostic information in a real-life cohort of patients with chronic heart failure. Simultaneous addition of hs-cTnT and NT-proBNP into a model that includes established risk factors improves mortality risk stratification.

Estimated Glomerular Filtration Rate and Prognosis in Heart Failure: Value of the Modification of Diet in Renal Disease Study-4, Chronic Kidney Disease Epidemiology Collaboration, and Cockroft-Gault Formulas

The purpose of this study was to assess the value of estimated glomerular filtration rate (eGFR) calculated by different formulas for predicting the risk of death in heart failure (HF) outpatients. Patients with both HF and renal insufficiency have a poor prognosis. Three formulas are mostly used to assess renal function: Cockroft-Gault formula, MDRD-4 (Modification of Diet in Renal Disease Study) formula, and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The prognostic values of these formulas have not been adequately compared in HF patients. A total of 925 patients (72% men; age 69 years; interquartile range: 59 to 75.5 years) with a left ventricular ejection fraction of 31% (interquartile range: 23.5% to 39%) were studied. Follow-up was 1,202 days (interquartile range: 627.5 to 2,156.5 days). Measures of performance were evaluated using continuous data and by dividing patients into 4 subgroups according to the eGFR: ≥90, 89 to 60, <60 to 30, and <30 ml/min/1.73 m(2). The 3 formulas correlated significantly, with the best correlation found between the MDRD-4 and CKD-EPI formulas. The 3 formulas afforded independent prognostic information over long-term follow-up. However, risk prediction was most accurate using the Cockroft-Gault formula as evaluated by Cox proportional hazards models (hazard ratio: 0.75 vs. 0.81 with the MDRD-4 formula and 0.80 with the CKD-EPI equation), area under the curve (0.67 vs. 0.62 and 0.64, respectively), and Bayesian information criterion (both analyzing eGFR as a continuous or categorical variable). Indeed, net reclassification improvement and integrated discrimination improvement using the Cockroft-Gault formula were 21% and 5.04, respectively, versus the MDRD-4 formula (the most used) and 13.1% and 3.77 respectively versus CKD-EPI equation (the more recent) (all p values <0.001). In this ambulatory, real-life cohort of HF patients, the Cockroft-Gault formula was the most accurate of the 3 used eGFR formulas to improve the risk stratification for death.

Combined use of high‐sensitivity ST2 and NTproBNP to improve the prediction of death in heart failure

To address the incremental usefulness of biomarkers from different disease pathways for predicting risk of death in heart failure (HF). We used data from consecutive patients treated at a structured multidisciplinary HF unit to investigate whether a combination of biomarkers reflecting ventricular fibrosis, remodelling, and stretch [ST2 and N-terminal pro brain natriuretic peptide (NTproBNP)] improved the risk stratification of a HF patient beyond an assessment based on established mortality risk factors (age, sex, ischaemic aetiology, left ventricular ejection fraction, New York Heart Association functional class, diabetes, glomerular filtration rate, sodium, haemoglobin, and beta-blocker and angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker treatments). ST2 was measured with a novel high-sensitivity immunoassay. During a median follow-up time of 33.4 months, 244 of the 891 participants in the study (mean age 70.2 years at baseline) died. In the multivariable Cox proportional hazards model, both ST2 and NTproBNP significantly predicted the risk of death. The individual inclusion of ST2 and NTproBNP in the model with established mortality risk factors significantly improved the C statistic for predicting death [0.79 (0.76-0.81); P < 0.001]. The net improvement in reclassification after the separate addition of ST2 to the model with established risk factors and NTproBNP was estimated at 9.90% [95% confidence interval (CI) 4.34-15.46; P < 0.001] and the integrated discrimination improvement at 1.54 (95% CI 0.29-2.78); P = 0.015). Our data suggest that in a real-life cohort of HF patients, the addition of ST2 and NTproBNP substantially improves the risk stratification for death beyond that of a model that is based only on established mortality risk factors.

P47 De-novo antiviral therapy with nucleos(t)ide analogues in ‘real-life’ patients with chronic hepatitis B infection: comparison of virological responses between lamivudine + adefovir vs entecavir vs tenofovir therapy

IntroductionSeveral nucleos(t)ide analogues (NA) are approved for the treatment of chronic hepatitis B (CH-B); all aim to control HBV replication with minimal risk of drug-resistance and toxicity. Limited comparative data...

Long-term efficacy and safety of atazanavir/ritonavir treatment in a real-life cohort of treatment-experienced HIV patients

7-11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

SECONDARY STROKE PREVENTION IN THE VERY ELDERLY IN REAL LIFE: PP.4.139

Objective: People over the age of 80 years is increasing, representing a population at particularly high cardiovascular risk. Studies suggest that primary and secondary prevention interventions among the very elderly is much less aggressive, leading to poorer outcomes. Our objective was to assess clinical characteristics and outcomes in very elderly stroke patients treated to similar goals than younger population. Design and Method: Ambulatory stroke patients were included in PROTEGE-ACV, a stroke secondary prevention program. Patients with severe functional impairment (Rankin > 3) or life expectancy less than three years were excluded. We compared premorbid risk factors, their management after stroke, and all-cause mortality and recurrence in > 80 years vs. < 80 years after three years of PROTEGE-ACV starting-up. Results: Among 413 patients included between December 2006 and December 2009, 154 (37%) were aged over 80 years (59% women). The only difference between older than 80 years and younger patients in major cardiovascular RF profile was the smoking status (34% vs 51%, p 0.01). Pre and post-stroke use of antihypertensives, statins and antithrombotics was similar in both groups, with a significant increase in all prescriptions after the event for the entire cohort. The only difference was less use of aspirin in > 80 years (58% vs 70%, p 0.009) with higher use of anticoagulants (24% vs 15%, p 0.02). Table shows the comparison of evaluated variables between groups, including recurrence and all-cause mortality (bad outcome). Kaplan-Meier analysis with log-rank test shows no difference in three-year survival probability between groups (92% vs 89%).Conclusion: In a real-life cohort of stroke patients, intensive treatment of major vascular risk factors to secondary prevention goals was safe and effective in our population of very elderly patients.

Increased of overall survival (OS) and malignancies (K) during tyrosine kinase inhibitors (TKI) in a real life cohort of patients (pts) with a chronic myeloid leukemia (CML).

6602 Background: Management of CML has been transformed by targeted therapies like TKI. It has been described in clinical trial that an increased OS of pts giving hope but also opportunity to observe late effects of TKI treatment (Tt) as an increased occur of K. Our objective was to evaluate in a real life cohort of CML pts the impact of TKI on OS and to report new diagnosed K occurring during Tt. Methods: We conducted a retrospective, observational study from the CML database including all consecutive pts with CML into a French regional network. Included criteria were cytogenetic (Cg) or molecular (MB) proved CML. Clinical and biological data, Tt response and outcome including other K were collected and statistically analyzed. Results: We identified 176 pts with CML diagnosed since 1978, SR 1.2, median age 59 (22-84), regional incidence 1.08 vs 1 in France. At diagnosis, pts were in CML-CP 92% (n = 162), CML-AP 5.7% (n = 10), CML-BC 0.6% (n = 1), missing (ND) 1.7% (n = 3). Sokal < 0.8 for 61% (n = 108), 0.8-1.2 for 24% (n = 42), > 1.2 for 11% (n = 19), ND for 4% (n = 7). t(9,22) or Bcr-Abl expressing in MB was 100% with another Cg abnormality in 8%.Tt was non TKI 28% (n = 49), TKIs for 72% (127/176) with 54% (n = 68) in first line, 20% (n = 26) second line and 26% (n = 33) third line or more. In TKI cohort: RCC at 6, 12 and 24 months (m) were respectively 57%, 66%, 83% and MMR/CMR at 6, 12 and 24 m were 14%, 23%, 37%. K occurred during TKI in 12 pts (9.6%), SR 1.4, median age 76 (59-86), median follow up of CML 40.5 m (28-137), median duration TKI: 37 m (26-77). Histologic type of K : 3 prostate, 2 colon, 1 breast, 1 pancreas, 1 lung, 1 parotid, 1 melanoma, 1 renal and 1 bladder. 92% (n = 11) were treated for K, 75% (n = 9) still alive with TKI. Median OS of pts never receiving TKI: 4 y, receiving TKI in second line or more: 18 y, TKI in first line: not reached (p < 0.0001). Conclusions: In real life,TKI Tt with monitored response according to the guidelineshad improved median OS of pts non included in clinical trial, even if they already received several lines of Tt. The occurence of K diagnosed during TKI in our study was 9.6% vs. 4.07% reported in another study (Verma ASH 2008). The older median age in our series (76 y vs. 67 y) may explain the higher rate of K. No significant financial relationships to disclose.

In-Hospital Safety and Effectiveness of Bivalirudin in Percutaneous Peripheral Interventions: Data From a Real-World Registry

To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%). Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.

Do gender differences exist in pacemaker implantation?--results of an obligatory external quality control program

The aim of the study was to evaluate the effects of patient gender onto primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany. The database of the obligatory external quality control program for the years 2003-2006 was evaluated retrospectively. In 72 centres, 17 826 patients undergoing stationary primary pacemaker implantation have been registered. Male patients had more AV blocks when compared with women and less sick sinus syndrome and atrial fibrillation with bradycardia. In patients being 80 years and older, men received significantly more dual-chamber devices than women for the indications: AV block and sick sinus syndrome. In women, atrial pacing thresholds were significantly higher and P-wave amplitudes were significantly lower. Women had, independent from age or pacing system implanted, significantly more acute complications than men, with significant differences for pneumothorax and pocket haematoma. This large-scale real-life patient cohort of primary stationary pacemaker implantation showed that gender has an impact onto pacemaker implantation, with less favourable outcomes for women.

The MUSIC Risk score: a simple method for predicting mortality in ambulatory patients with chronic heart failure

The prognosis of chronic heart failure (CHF) is extremely variable, although generally poor. The purpose of this study was to develop prognostic models for CHF patients. A cohort of 992 consecutive ambulatory CHF patients was prospectively followed for a median of 44 months. Multivariable Cox models were developed to predict all-cause mortality (n = 267), cardiac mortality (primary end-point, n = 213), pump-failure death (n = 123), and sudden death (n = 90). The four final models included several combinations of the same 10 independent predictors: prior atherosclerotic vascular event, left atrial size >26 mm/m(2), ejection fraction < or =35%, atrial fibrillation, left bundle-branch block or intraventricular conduction delay, non-sustained ventricular tachycardia and frequent ventricular premature beats, estimated glomerular filtration rate <60 mL/min/1.73 m(2), hyponatremia < or =138 mEq/L, NT-proBNP >1.000 ng/L, and troponin-positive. On the basis of Cox models, the MUSIC Risk scores were calculated. A cardiac mortality score >20 points identified a high-risk subgroup with a four-fold cardiac mortality risk. A simple score with a limited number of non-invasive variables successfully predicted cardiac mortality in a real-life cohort of CHF patients. The use of this model in clinical practice identifies a subgroup of high-risk patients that should be closely managed.

Effects of increasing age onto procedural parameters in pacemaker implantation: results of an obligatory external quality control program

The aim of the study was to evaluate the effects of increasing patients' age onto procedural parameters, especially complications, during primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany. The database of the obligatory external quality control program was evaluated retrospectively for the years 2003-2006. A total of 17 826 patients undergoing stationary primary pacemaker implantation have been registered in 72 centres. In single-chamber implants, the implant duration is shortest in non-agenarians. For dual-chamber implants, the implant duration shortens with increasing age. Thus, as well as fluoroscopy time is significantly shorter in the oldest patients. Atrial and ventricular pacing thresholds as well as R-wave amplitudes do not change with age. P-wave amplitudes showed a small but steady decline with increasing ages. Complications do not increase with advanced age. In this large-scale real-life patient cohort of primary stationary pacemaker implantation, increasing age resulted only in reduced P-wave amplitudes. Higher age was not associated with an increased risk of complications. Thus, pacemaker implantations in the elderly can be performed with the same reliability as in younger patients.

Abstract 688: Risk of Radiation Induced Cancer from Cardiac CT in a Real-Life Clinical Patient Population

Previous studies on lifetime cancer risks from radiation at cardiac CT are based on extrapolation of data unrelated to medical imaging and on presumptive scan protocols but not on actual patient cohorts. We aimed to determine the realistic risk of radiation induced cancer based on a real-life clinical patient population undergoing cardiac CT. We studied 104 consecutive patients undergoing 64-slice cardiac CT (Siemens). Data were obtained on patient demographics (sex, age, weight) as well as CT technique (kV, mAs, scan length, DLP) which were used to determine median values and the 10th and 90th percentiles. Organ dose estimates were obtained using the ImPACT dosimetry spreadsheet. Organ doses were converted into patient lifetime risk of developing radiation induced fatal and non-fatal cancer using the BEIR VII approach. Patient cancer risks were adjusted taking into account patient sex, age and weight, the latter being an often neglected factor influencing radiation risk. The majority of patients (62%) were males, with a median patient age of 59 years (41–72) and a median weight of 92 kg (69–116). All scans were performed at 120 kV, and the median DLP was 1124 mGy-cm (940–1500). In normal sized patients, the organs receiving the highest radiation doses were the lung (76 mGy) and the female breasts (92 mGy). The average patient lifetime risk for developing a radiation induced cancer was 0.12%, of which 90% would be fatal. Approximately 85% of the radiation risk arises from the irradiation of the lung. Patients with an age and weight at the 10th percentile, who receive a DLP at the 90th percentile would have a cancer risk double the average value. In a typical clinical population undergoing cardiac CT patients are predominantly male, heavier set, and in their 5th–7th decade of life. In such a patient population the realistic risk of radiation induced cancer from cardiac CT is 0.12%, with the risk to the most sensitive patients being about twice this value. Thus, in a real-life clinical patient cohort the realistic risk of radiation induced cancer from cardiac CT is substantially lower than previously reported for general populations. Appropriate patient selection and indication remain the most important means for radiation protection.

Long-term outcome of treatment with infliximab in 614 patients with Crohn’s disease: results from a single-centre cohort

Background and aims:This observational study assessed the long-term clinical benefit of infliximab (IFX) in 614 consecutive patients with Crohn’s disease (CD) from a single centre during a median follow-up of...

Pre-hospital thrombolysis delivered by paramedics is associated with reduced time delay and mortality in ambulance-transported real-life patients with ST-elevation myocardial infarction

There are sparse data on the impact of pre-hospital thrombolysis (PHT) in real-life patients. We therefore evaluated treatment delays and outcome in a large cohort of ambulance-transported real-life patients with ST-elevation myocardial infarction (STEMI) according to PHT delivered by paramedics or in-hospital thrombolysis. Prospective cohort study used data from the Swedish Register of Cardiac intensive care on patients admitted to the coronary care units of 75 Swedish hospitals in 2001-2004. Ambulance-transported thrombolytic-treated patients younger than age 80 with a diagnosis of acute myocardial infarction were included. Patients with PHT (n=1690) were younger, had a lower prevalence of co-morbid conditions, fewer complications, and a higher ejection fraction (EF) than in-hospital-treated patients (n=3685). Median time from symptom onset to treatment was 113 min for PHT and 165 min for in-hospital thrombolysis. One-year mortality was 7.2 vs. 11.8% for PHT and in-hospital thrombolysis, respectively. In a multivariable analysis, after adjusting for baseline characteristics and rescue angioplasty, PHT was associated with lower 1-year mortality (odds ratio 0.71, 0.55-0.92, P=0.008). When compared with regular in-hospital thrombolysis, pre-hospital diagnosis and thrombolysis with trained paramedics in the ambulances are associated with reduced time to thrombolysis by almost 1 h and reduced adjusted 1-year mortality by 30% in real-life STEMI patients.