Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial.

AIMS: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation (RFA) vs. antiarrhythmic drug therapy (AAD) as first-line treatment for patients with PAF. In this substudy, we evaluated the effect of these treatment modalities on the Health-Related Quality of Life (HRQoL) and symptom burden of patients at 12 and 24 months. METHODS AND RESULTS: During the study period, 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD (N = 148) or RFA (N = 146). Two generic questionnaires were used to assess the HRQoL [Short Form-36 (SF-36) and EuroQol-five dimensions (EQ-5D)], and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) was used to evaluate the symptoms appearing during the trial. All comparisons were made on an intention-to-treat basis. Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D, at 24 months. Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36. The three most frequently reported symptoms were breathlessness during activity, pronounced tiredness, and worry/anxiety. In both groups, there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time. CONCLUSION: Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF. Patients randomized to RFA showed greater improvement in physical scales (SF-36) and the EQ-visual analogue scale. CLINICAL TRIAL REGISTRATION: URL http://www.clinicaltrials.gov. Unique identifier: NCT00133211.

Effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile and inflammation markers in metabolic syndrome -- a randomized study (SYSDIET).

BACKGROUND: Different healthy food patterns may modify cardiometabolic risk. We investigated the effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile, blood pressure and inflammatory markers in people with metabolic syndrome. METHODS: We conducted a randomized dietary study lasting for 18-24 weeks in individuals with features of metabolic syndrome (mean age 55 years, BMI 31.6 kg m(-2) , 67% women). Altogether 309 individuals were screened, 200 started the intervention after 4-week run-in period, and 96 (proportion of dropouts 7.9%) and 70 individuals (dropouts 27%) completed the study, in the Healthy diet and Control diet groups, respectively. Healthy diet included whole-grain products, berries, fruits and vegetables, rapeseed oil, three fish meals per week and low-fat dairy products. An average Nordic diet served as a Control diet. Compliance was monitored by repeated 4-day food diaries and fatty acid composition of serum phospholipids. RESULTS: Body weight remained stable, and no significant changes were observed in insulin sensitivity or blood pressure. Significant changes between the groups were found in non-HDL cholesterol (-0.18, mmol L(-1) 95% CI -0.35; -0.01, P = 0.04), LDL to HDL cholesterol (-0.15, -0.28; -0.00, P = 0.046) and apolipoprotein B to apolipoprotein A1 ratios (-0.04, -0.07; -0.00, P = 0.025) favouring the Healthy diet. IL-1 Ra increased during the Control diet (difference -84, -133; -37 ng L(-1) , P = 0.00053). Intakes of saturated fats (E%, beta estimate 4.28, 0.02; 8.53, P = 0.049) and magnesium (mg, -0.23, -0.41; -0.05, P = 0.012) were associated with IL-1 Ra. CONCLUSIONS: Healthy Nordic diet improved lipid profile and had a beneficial effect on low-grade inflammation.

PET hypoxia imaging with FAZA: reproducibility at baseline and during fractionated radiotherapy in tumour-bearing mice.

PURPOSE: Tumour hypoxia is linked to treatment resistance. Positron emission tomography (PET) using hypoxia tracers such as fluoroazomycin arabinoside (FAZA) may allow identification of patients with hypoxic tumours and the monitoring of the efficacy of hypoxia-targeting treatment. Since hypoxia PET is characterized by poor image contrast, and tumour hypoxia undergoes spontaneous changes and is affected by therapy, it remains unclear to what extent PET scans are reproducible. Tumour-bearing mice are valuable in the validation of hypoxia PET, but identification of a reliable reference tissue value (blood sample or image-derived muscle value) for repeated scans may be difficult due to the small size of the animal or absence of anatomical information (pure PET). Here tumour hypoxia was monitored over time using repeated PET scans in individual tumour-bearing mice before and during fractionated radiotherapy. METHODS: Mice bearing human SiHa cervix tumour xenografts underwent a PET scan 3 h following injection of FAZA on two consecutive days before initiation of treatment (baseline) and again following irradiation with four and ten fractions of 2.5 Gy. On the last scan day, mice were given an intraperitoneal injection of pimonidazole (hypoxia marker), tumours were collected and the intratumoral distribution of FAZA (autoradiography) and hypoxia (pimonidazole immunohistology) were determined in cryosections. RESULTS: Tissue section analysis revealed that the intratumoral distribution of FAZA was strongly correlated with the regional density of hypoxic (pimonidazole-positive) cells, even when necrosis was present, suggesting that FAZA PET provides a reliable measure of tumour hypoxia at the time of the scan. PET-based quantification of tumour tracer uptake relative to injected dose showed excellent reproducibility at baseline, whereas normalization using an image-derived nonhypoxic reference tissue (muscle) proved highly unreliable since a valid and reliable reference value could not be determined. The intratumoral distribution of tracer was stable at baseline as shown by a voxel-by-voxel comparison of the two scans (R = 0.82, range 0.72-0.90). During treatment, overall tracer retention changed in individual mice, but there was no evidence of general reoxygenation. CONCLUSION: Hypoxia PET scans are quantitatively correct and highly reproducible in tumour-bearing mice. Preclinical hypoxia PET is therefore a valuable and reliable tool for the development of strategies that target or modify hypoxia.

Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial.

AIMS: Postprandial triglyceridaemia is a risk factor for cardiovascular disease (CVD). This study investigated the effects of steady-state liraglutide 1.8 mg versus placebo on postprandial plasma lipid concentrations after 3 weeks of treatment in patients with type 2 diabetes mellitus (T2DM). METHODS: In a cross-over trial, patients with T2DM (n = 20, 18-75 years, BMI 18.5-40 kg/m²) were randomized to once-daily subcutaneous liraglutide (weekly dose escalation from 0.6 to 1.8 mg) and placebo. After each 3-week period, a standardized fat-rich meal was provided, and the effects of liraglutide on triglyceride (primary endpoint AUC(0-8h)), apolipoprotein B48, non-esterified fatty acids, glycaemic responses and gastric emptying were assessed. ClinicalTrials.gov ID: NCT00993304. FUNDING: Novo Nordisk A/S. RESULTS: After 3 weeks, mean postprandial triglyceride (AUC(0-8h) liraglutide/placebo treatment-ratio 0.72, 95% CI [0.62-0.83], p = 0.0004) and apolipoprotein B48 (AUC(0-8h) ratio 0.65 [0.58-0.73], p < 0.0001) significantly decreased with liraglutide 1.8 mg versus placebo, as did iAUC(0-8h) and C(max) (p < 0.001). No significant treatment differences were observed for non-esterified fatty acids. Mean postprandial glucose and glucagon AUC(0-8h) and C(max) were significantly reduced with liraglutide versus placebo. Postprandial gastric emptying rate [assessed by paracetamol absorption (liquid phase) and the ¹³C-octanoate breath test (solid phase)] displayed no treatment differences. Mean low-density lipoprotein and total cholesterol decreased significantly with liraglutide versus placebo. CONCLUSIONS: Liraglutide treatment in patients with T2DM significantly reduced postprandial excursions of triglyceride and apolipoprotein B48 after a fat-rich meal, independently of gastric emptying. Results indicate liraglutide's potential to reduce CVD risk via improvement of postprandial lipaemia.

Restorative proctocolectomy for ulcerative colitis: development and validation of a new scoring system for pouch dysfunction and quality of life.

AIM: The purpose of this study was to develop and validate a pouch dysfunction score that could identify the aspects of function which have the greatest impact on quality of life as perceived by the patient. METHOD: All (n = 1757) patients having restorative proctocolectomy in Denmark between 1980 and 2010 were identified. Of these, 1229 were available for study and were sent a questionnaire on bowel function and quality of life (QoL) designed specifically for this study. Function was correlated with QoL in a multivariate model using ordinal logistic regression with QoL as a dependent variable. The pouch dysfunction score was developed from a randomly selected half of the study population and the validity was tested on the other half. RESULTS: 1047 (85%) patients returned the questionnaire. On multivariate analysis, the symptom domains of 'incomplete emptying', 'severity of urgency', 'number of bowel movements/24 h', 'major incontinence' and 'use of anti-diarrhoeal medication' were associated with reduced QoL. The score was divided into three categories including 'none', 'minor' and 'some/major' pouch dysfunction. The corresponding coefficients gave the score a range from 0 to 7.5. There was a highly significant difference (P < 0.001) in score between the categories. The area under the receiver operating curve was 0.81. CONCLUSION: Urgency, incomplete emptying, number of bowel movements/24 h, major incontinence and use of anti-diarrhoeal medication have a major impact on QoL. There was a high accuracy for the score, demonstrating its potential clinical usefulness in relating symptoms to QoL.

R-CHOEP-14 improves overall survival in young high-risk patients with diffuse large B-cell lymphoma compared with R-CHOP-14. A population-based investigation from the Danish Lymphoma Group.

BACKGROUND: Optimal treatment of young patients with high-risk diffuse large B-cell lymphoma (DLBCL) remains a matter of debate and requires improvement. The combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) with addition of etoposide (CHOEP) has in other patient groups been shown to be effective. Further improvement has been accomplished with the use of rituximab in combination with the regimens every 2 weeks (R-CHOP-14, R-CHOEP-14). The aim of the present retrospective population-based study was to compare R-CHOP-14 with R-CHOEP-14 in a cohort of high-risk patients aged 18-60 years with two or more risk factors (stage III-IV, elevated lactate dehydrogenase levels, performance status 2-4). To our knowledge, this is the first study comparing these two regimens in this patient group. METHODS: We obtained data for the period 2004-2009 from the Danish Lymphoma Database. One hundred and fifty-nine patients were eligible to enter the study. Primary end point was overall survival (OS) and secondary end points were response to treatment, progression-free survival (PFS) and safety. RESULTS: Four-year OS was superior in the R-CHOEP-14 group: 75% compared with 62% for R-CHOP-14 (P=0.04). This superiority was also seen for PFS: 4-year PFS was 70% for the R-CHOEP-14 group compared with 58% for the R-CHOP-14 group (P=0.02). CONCLUSION: R-CHOEP-14 is a promising regimen for young patients with high-risk DLBCL with improved OS and PFS compared with R-CHOP-14.

Upper-limb thrombo-embolectomy: national cohort study in Denmark.

OBJECTIVES: We investigated the incidence of thrombo-embolectomy in upper-limb and prognosis with respect to arm amputation, stroke and death. METHODS: We performed a national cohort study of individuals, aged 40-99 years, and undergoing first-time thrombo-embolectomy in the brachial, ulnar or radial artery in Denmark from 1990 to 2002. The data were retrieved from the National Vascular Registry and from the National Registry of Patients and the Civil Registration System. Patients were followed until 2006 to ascertain the occurrence of amputation and stroke and until 2007 with respect to death. RESULTS: In total, 1377 incident cases of thrombo-embolectomy were registered, comprising 504 (36.6%) males with a mean age of 72.0 (standard deviation (SD) 12.4) years and 873 (63.4%) females with a mean age of 77.2 (SD 11.7) years. Incidence was 3.3 (95% confidence interval (CI): 3.1-3.7) for males and 5.2 (95% CI: 4.9-5.6) for females per 100000 person-years. After thrombo-embolectomy, upper-limb amputation was performed in 11 (incidence 2.2%; 95% CI: 1.2-3.4) males and 31 (3.6%; 95% CI: 2.5-4.9) females. Age- and sex-specific risk of stroke was 2-16 times higher, and risk of death 3-11 times higher, than in the general population. CONCLUSIONS: Upper-limb thrombo-embolectomy is associated with an increased risk of limb amputation, stroke and death.

Non-Hodgkin's lymphoma of the gastrointestinal tract: a population-based analysis of incidence, geographic distribution, clinicopathologic presentation features, and prognosis. Danish Lymphoma Study Group.

PURPOSE: To evaluate incidence, time trends, geographic distribution, clinicopathologic presentation features, and prognostic factors for survival and relapse in gastrointestinal (GI) non-Hodgkin's lymphomas (NHLs). PATIENTS AND METHODS: Over a 9-year period (1983 to 1991), 2,446 new NHL cases were recorded in a Danish population-based NHL registry (Danish Lymphoma Study Group [LYFO]). Of these, 306 (12.5%) were GI NHL (175 gastric, 109 intestinal, and 22 both sites). LYFO registry data were used for incidence rate (IR) assessment, and time-trend and geographic distribution analysis. Relative risk (RR) values for survival and relapse were identified by multivariate analysis. RESULTS: The mean annual, age-standardized IRs for gastric and intestinal NHL were 0.71/10(5) and 0.48/10(5) per year, respectively. Age-specific IRs for both localizations showed an exponential increase as a function of age. Time-trend analysis for the period 1983 to 1991 showed stable IRs for both localizations. Intestinal NHL was more frequent in males (male-to-female ratio, 2.0 v 1.3), and had a higher occurrence of disseminated disease, constitutional symptoms, high-grade histology, and T-cell phenotype (10% v 2%). Gastric NHL had more low-grade cases (38% v 19%), and almost all were of the mucosa-associated lymphoid tissue (MALT) type. The cause-specific 5-year survival rate was 63% for gastric NHL and 49% for intestinal NHL. The Musshoff staging system was an excellent discriminator between truly localized (stage I and II1) and disseminated cases (stage II2 to IV), particularly for gastric NHL, for which no survival difference was found between surgically and conservatively stage localized cases. CONCLUSION: (1) No increase in the incidence of GI NHL was found over a 9-year observation period; (2) nonrandom spatial distribution of new GI NHL cases was observed; (3) factors that significantly increased the risk of death in gastric cases were presence of B symptoms (RR = 3.3), clinical stage is more than II1 (RR = 3.0), age more than 72 years (RR = 2.4), and elevated serum lactate dehydrogenase (s-LDH) level (RR = 2.0); and factors that increased the risk of death in intestinal cases were presence of B symptoms (RR = 3.2), age more than 58 years (RR = 2.8), and clinical stage more than I (RR = 2.1); (4) factors that significantly increased the risk of relapse in gastric cases were male sex and no radiotherapy in primary treatment; and in intestinal cases were T-cell phenotype and no surgery in primary treatment; (5) surgical staging, as opposed to thorough noninvasive staging, did not improve staging accuracy and final outcome in localized gastric NHL.

Disrupted p53 function as predictor of treatment failure and poor prognosis in B- and T-cell non-Hodgkin's lymphoma.

Mutation of the p53 gene has been associated with treatment failure and poor outcome in various malignancies. It has been suggested that immunohistochemical analysis of p53 and p21Waf1, a downstream target, can be used to screen for p53 gene mutations. We determined the value of immunohistochemical screening for p53 gene mutations as a prognostic marker in a population-based group of B- and T-cell non-Hodgkin's lymphomas (NHLs). On the basis of p53 gene mutation status and immunohistochemically detected p53 and p21Waf1 expression in 34 lymphomas, we established an immunophenotype (delta p53) correlating with p53 gene mutation. The immunohistochemical analysis was extended to encompass 199 lymphomas from a population-based registry and was correlated with clinical parameters. Delta p53 showed 100% concordance with p53 gene mutation and was detected in 42 cases (21%). Multivariate analysis of advanced stage lymphomas showed that delta p53 was independently associated with treatment failure (relative risk, 3.8; P = 0.001). Delta p53 predicted poor survival when analyzing all patients (P = 0.0001), as well as B-cell (P = 0.04) and T-cell NHL (P = 0.000002). In multivariate analysis, delta p53 (relative risk, 2.2; P = 0.001) maintained prognostic significance. The impact on prognosis of delta p53 was highly significant in the low-intermediate-risk group (P = 0.00002). Comparing survival of the aggressive lymphoma patients in this group showed that the 8 delta p53 patients died within 1 year, whereas the median survival of the 28 non-delta p53 patients was 36 months. These results suggest that immunohistochemically assessed p53 status may predict treatment response and outcome in B- and T-cell NHL patients.

Nonsteroidal anti-inflammatory drugs after acute myocardial infarction. DAVIT Study Group. Danish Verapamil Infarction Trial.

The effect of nonsteroid anti-inflammatory drugs (NSAIDs) after acute myocardial infarction was studied in a retrospective study of 88 patients who were receiving regular NSAID treatment at randomization in the Danish Verapamil Infarction Trial II. There were no significant differences in mortality or major events between NSAID-treated patients versus controls (1,687); however, in a multivariate analysis a nonsignificant beneficial trend in favor of NSAIDs was observed.

Cardiac event rates after acute myocardial infarction in patients treated with verapamil and trandolapril versus trandolapril alone. Danish Verapamil Infarction Trial (DAVIT) Study Group.

Angiotensin-converting enzyme (ACE) inhibitors improve survival in patients with congestive heart failure (CHF) after an acute myocardial infarction (AMI), but mortality may be as high as 10% to 15% after 1 year. Verapamil prevents cardiac events after an AMI in patients without CHF. We hypothesized that in postinfarct patients with CHF already prescribed diuretics and an ACE inhibitor, additional treatment with verapamil may reduce cardiac event rate. In this multicenter, double-blind study, patients with CHF receiving diuretic treatment were consecutively randomized to treatment with trandolapril 1 mg/day for 1 month and 2 mg/day the following 2 months (n = 49), or to trandolapril as mentioned plus verapamil 240 mg/day for 1 month and 360 mg/day for 2 months (n = 51). Trial medication started 3 to 10 days after AMI. All patients were followed for 3 months. End points in the trandolapril/trandolapril-verapamil groups were death 1/1, reinfarction 7/1, unstable angina 9/3, and readmission for CHF 6/2. The 3-month first cardiac event rate was 35% in trandolapril-treated patients and 14% in trandolapril-verapamil-treated patients (hazard ratio 0.35, 95% confidence interval 0.15 to 0.85, p = 0.015). These data suggest that verapamil reduces cardiac event rates in post-AMI patients with CHF when added to an ACE inhibitor and a diuretic.

Tuberous sclerosis and parathyroid adenoma.

Very little is known about the pathogenesis of tuberous sclerosis. Over the past 10 years, however, increasing numbers of reports on adenomatous diseases in association with tuberous sclerosis have been published. A case of hypercalcaemia and parathyroid adenoma in association with tuberous sclerosis is presented, of which there has been one such report published previously. This association might be another manifestation of this complex disease: it is therefore recommended that plasma calcium concentrations should be measured in such patients.

Incidence, presenting features and prognosis of low-grade B-cell non-Hodgkin's lymphomas. Population-based data from a Danish lymphoma registry.

During the period January 1983 to January 1988 1597 newly diagnosed cases of non-Hodgkin's lymphoma (NHL) were included in a Western Danish population-based NHL registry. Of these, 31% (N = 496) were low-grade NHL (LG-NHL) consisting of (Kiel): 9% lymphocytic (LY), 27% lymphoplasmacytic/-cytoid (IC), 53% follicular centroblastic/-centrocytic (CB/CCf) and 11% unclassifiable low-grade. LG-NHL (age range: 26-94 yrs, median: 64 yrs; M/F ratio: 0.8) had an age-standardised incidence rate (IR) of 2.7/10(5)/yr. Age-specific IR's showed an age-related exponential rise in all subtypes except for CB/CCf. Compared with the intermediate (IG)- and high-grade (HG) group, LG-NHL had more female cases (M/F ratio: 0.79 vs. 1.2; p = 0.0002), a higher frequency of stage III-IV disease (66% vs. 53%; p < 0.00005) and of bone marrow involvement (39% vs. 19%; p < 0.00005). A later revision of all IC cases (N = 132) distinguished 79 non-polymorphic (ICnp) from 25 polymorphic (ICp) cases; 28 cases were differently classified. In 34 LG-NHL patients histologic transformation was verified: CB/CCf to CB diffuse (22 pts) and LY to immunoblastic or CB type (6 pts). The 7-yr survival for LG-NHL was 63% (IG: 48%, HG: 38%; p < 0.00005). A Cox-regression analysis identified the following adverse prognostic factors for survival in LG-NHL: age > 50 with a relative risk (RR) of 3.2, hepatic involvement (RR = 2.1), elevated s-LDH (RR = 1.9), B-symptoms (RR = 1.8) and IC histology (ICnp+ICp) (RR = 1.7).(ABSTRACT TRUNCATED AT 250 WORDS)

Sex related differences in short and long-term prognosis after acute myocardial infarction: 10 year follow up of 3073 patients in database of first Danish Verapamil Infarction Trial.

OBJECTIVE: To re-examine the prevailing hypothesis that women fare worse than men after acute myocardial infarction. DESIGN: 10 year follow up of all patients with confirmed acute myocardial infarction registered in the database of the Danish verapamil infarction trial in 1979-81. SETTING: 16 coronary care units, covering a fifth of the total Danish population. PATIENTS: 3073 consecutive patients with acute myocardial infarction, 738 (24%) women and 2335 (76%) men. MAIN OUTCOME MEASURES: Early mortality (before day 15). For patients alive on day 15: mortality, cause of death, admission with recurrent infarction, and mortality after reinfarction. RESULTS: Early mortality increased significantly with age (P < 0.0001) but was not significantly related to sex, with a 15 day mortality of 17% in women and 16% in men. Adjustment for age and sex simultaneously revealed a significant interaction (P = 0.02) between these variables, with a greater increase with age in early mortality for men than for women (early mortality was equal for the two sexes at age 64 years). Ten year mortality in patients alive on day 15 was 58.8%. The overall age adjusted hazard ratio (95% confidence interval) for women versus men was 0.90 (0.80 to 1.01); 0.90 (0.78 to 1.04) for 10 year reinfarction (48.8%); and 0.98 (0.82 to 1.16) for 10 year mortality after reinfarction (82.3%). No difference in cause of death was found between the sexes. With a follow up of up to 10 years for patients alive on day 15 mortality, rate of reinfarction, and mortality after reinfarction increased with increasing age (P < 0.0001). CONCLUSION: Sex by itself is not a risk factor after acute myocardial infarction.

Ten year mortality in patients with suspected acute myocardial infarction.

OBJECTIVE: To describe the 10 year mortality in patients with suspected acute myocardial infarction. DESIGN: Follow up of all patients below 76 years of age admitted with acute chest pain to 16 coronary care units participating in the Danish verapamil infarction trial in 1979-81. SUBJECTS: Of the 5993 patients included, 2586 had definite infarction, 402 had probable infarction, and 3005 did not have infarction. MAIN OUTCOME MEASURES: Death and cause of death. Standardised mortality ratio (observed mortality/expected mortality in background population). RESULTS: The estimated 10 year mortalities were 58.8%, 55.5%, and 42.8% in patients with definite, probable, and no infarction, respectively (P < 0.0001). Stratified Cox's analysis identified a hazard ratio for mortality of 1.25 (95% confidence interval 1.08 to 1.44) for probable infarction compared with no infarction and of 1.15 (1.00 to 1.32) for definite compared with probable infarction. The standardised mortality ratio in the first year was 7.1 (6.5 to 7.8) for definite infarction, 5.0 (3.6 to 6.3) for probable infarction, and 4.7 (4.2 to 5.2) for no infarction. From the second year and onwards the annual standardised mortality ratio in the three groups did not differ significantly. Cardiac causes of deaths were recorded in 89%, 84%, and 71% of the deaths in patients with definite, probable, and no infarction, respectively. CONCLUSIONS: The 10 year mortality of patients with and without infarction is significantly higher than in the background population. Most deaths are caused by coronary heart disease, and these patients should consequently be further evaluated at the time of discharge and followed up closely.

[Prognosis after late versus early nonfatal myocardial infarction]. / Prognosen efter sent versus tidligt ikkedødeligt myokardiereinfarkt. DAVIT Study Group.

Many recent studies have identified nonfatal recurrent myocardial infarction (RNMI) as the most significant predictor for later outcome. Almost all of these studies have been based on the studies of RNMI in the first year after the index infarction. The prognosis after late RNMI has not been studied properly. In 3,867 nonselected patients below 76 years of age with an acute myocardial infarction we studied the prognosis after a first RNMI depending on the year of its occurrence after the index infarction. Mortality was estimated by the method of Kaplan-Meier and the differences were evaluated by means of the Tarone-Ware test. Four hundred and ninety-three (13.6%) patients had a first RNMI in the first, 151 (5.4%) in the second, 105 (4.2%) in the third, and 71 (3.8%) in the fourth year after the index infarction (group 1-4). One-year mortality rate after RNMI was 23.7% in the first group, 24.1% in the second, 17.5% in the third, and 22.8 in the fourth group. When all the groups were compared with each other no significant difference was found between the mortality rates (p = 0.12) or Standardised Mortality Rates. We concluded that late and early RNMIs have almost the same grave prognosis.

[Thrombocyte concentrate infusions--a study of the frequency of contamination and its clinical significance]. / Trombocytkoncentratinfusioner--en undersøgelse af kontamineringshyppigheden og dennes kliniske relevans.

Three hundred and twenty-four samples from platelet concentrate bags were examined for bacterial contamination. Blood cultures were made when platelet transfusion was followed by pyrexia to examine the frequency of platelet transfusion-induced septicemia. 6.5% of samples showed bacterial growth, mostly ordinary skin flora, but other bacteria were also demonstrated. Pyrexia followed 14% of the transfusion episodes, and in 58% of the febrile episodes this was associated with bacterial contamination of the bag. In one episode of post-transfusion pyrexia the same bacteria were found in cultures from both bag and blood. The case is presented here. Sources of bacterial contamination of platelet preparations are discussed. The use of platelet concentrates in treatment of thrombocytopenic patients is so important that the demonstrated rate of contamination does not alter the indication for platelet transfusion. Nevertheless, when platelet transfusion is followed by pyrexia, cultures from the bag and patient's blood should be performed to establish etiology and relevant antibiotic treatment.

[Prognosis after AMI--are there gender differences?]. / Prognosen efter AMI--er der en kønsforskel?

To examine the prevailing hypothesis that females fare worse than males after acute myocardial infarction, we compared short-term (15 days) and long-term (ten year) prognosis after acute myocardial infarction for the two sexes. Three thousand and seventy-three consecutive patients with acute myocardial infarction were followed for 10 years after a first registration in the Danish Verapamil Infarction Trial database in 1979-81. Early mortality increased significantly with age (p < 0.0001), but was not significantly related to sex, with a 15 days mortality of 17% in females and 16% in males. Ten year mortality in patients alive day 15 was 58.8%. Hazard ratio for females versus males after adjustment for age was 0.90 (0.80-1.01). Ten year reinfarction rate was 48.8% with age adjusted hazard ratio for females versus males of 0.90 (0.78-1.04) and ten year mortality after reinfarction was 82.3%, with age adjusted hazard ratio in females versus males of 0.98 (0.82-1.16). No difference in cause of death was found between the two sexes. We conclude that sex by itself is not a risk indicator after acute myocardial infarction.

[Effect of specific physiotherapy on chronic pain, functional level and quality of life in osteoporosis. A prospective randomized single-blind placebo-controlled study]. / Effekt af specifik fysioterapi på kroniske smerter, funktionsniveau og livskvalitet ved osteoporose. En prospektiv randomiseret enkeltblindet placebokontrolleret undersøgelse.

Patients suffering from osteoporotic vertebral fractures are handicapped by pain and reduced quality of life. Our aim was to investigate the effect of a short training program for osteoporotic patients with regard to pain level, use of analgetics and quality of life. We performed a prospective randomized single-blinded placebo-controlled study. The training program included general training of balance and muscle strength and stabilization of the back. The participants were randomised to 10 weeks of ambulatory training. Controls and training participants were tested weekly by registration of pain level and analgetic intake. Questionnaires on daily level of function and quality of life were given at the start and after five and 10 weeks. After three months both groups filled out the questionnaires at home. The training group had a significant reduction in pain score and use of analgetics. The distribution of functional score improved during training. Quality of life score improved significantly throughout the study and after three months. In conclusion, this ambulatory training program is effective for training osteoporotic patients with moderately severe pain and the training should be continued.

[10-year mortality of patients admitted to coronary units with or without confirmed diagnosis of myocardial infarction. A relation to anamnesis and diagnosis at discharge]. / Tiårsmortalitet for patienter indlagt på koronarafsnit med og uden bekaeftet akut myokardieinfarkt. Relation til anamnese og udskrivelsesdiagnose.

The ten-year mortality in patients with suspected myocardial infarction with (AMI) and without (non-AMI) confirmed diagnosis was evaluated in 1897 non-AMI patients and 1401 AMI patients who were consecutively admitted to hospital during The Danish Verapamil Infarction Study. The following risk factors contained independent prognostic information about mortality for non-AMI patients: age, previous AMI, sex and diabetes. In patients with AMI the risk factors were: age, previous AMI, clinical heart failure, diabetes and angina pectoris. When the diagnosis at discharge for non-AMI patients was included in the Cox-analysis, only the diagnoses of bronchopneumonia, musculoskeletal disorders and observation only of added prognostic information. We conclude that non-AMI patients are at high risk for mortal events in the long-term. High risk patients can be identified from the medical history and should be carefully evaluated regarding coronary artery disease at the time of discharge in order to improve the risk stratification, treatment and prognosis.