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Aims Cardiovascular risk factor control is suboptimal in Europe, including Norway. The present study examined the efficacy of a multimodal primary prevention intervention programme based on the existing Norwegian health care system. Methods and results In this open-label randomized controlled trial, adult patients with elevated cardiovascular risk were randomly assigned to an intervention programme including a hospital-based lifestyle course and primary care follow-up or to a control group (CG). The participants were recruited between 2011 and 2015. Primary outcome was change in validated cardiovascular risk scores, national and international (NORRISK, NORRISK 2, Framingham, PROCAM) between baseline and follow-up. Secondary outcomes included major cardiovascular risk factors. After 36 months the NORRISK score was significantly improved in patients assigned to the intervention group (IG) compared to patients assigned to the CG; absolute difference in mean delta score in the IG (n = 305) compared to mean delta score in the CG (n = 296): −0.92, 95% CI: −1.48 to −0.36, P = 0.001. The results for NORRISK 2, Framingham and PROCAM showed similar significant effects. The secondary endpoints including total cholesterol and blood pressure were only minimally, and non-significantly, reduced in the IG, but the proportion of smokers (P = 0.0028) and with metabolic syndrome (P < 0.0001) were significantly reduced. A limited number of cardiovascular events were observed, IG (n = 9), CG (n = 16). Conclusion In subjects with elevated cardiovascular risk, a newly developed prevention programme, combining a hospital-based lifestyle course and primary care follow-up, significantly reduced cardiovascular risk scores after 36 months. This benefit appeared achievable primarily through improvements in metabolic syndrome characteristics and smoking habits. The study protocol was registered in ClinicalTrials.gov (NCT01741428).

Objective The aim was to summarise the evidence from published epidemiological studies investigating the efficacy of statin therapy on long term survival in patients after abdominal aortic aneurysm (AAA) repair. Data sources This study was a systematic review with critical appraisal and meta-analysis of observational studies. Review methods A systematic literature search was carried out throughout February 2020, revealing 14 eligible cohort studies of which 11 were judged to be of high quality. A random effects model was used to synthesise results, and heterogeneity between studies examined by subgroup and meta-regression analyses considering patient and study related variables. Small study effect was evaluated. Results The pooled estimate showed that statin treatment among 69 790 AAA patients with a median follow up of 3.1 years was associated with a 35% relative reduction in total mortality (rate ratio 0.65, 95% confidence interval 0.57–0.73) with moderate heterogeneity (I2 = 68%) and no small study effect. Conclusion Evidence from this systematic review indicates a beneficial effect of statins on long term survival in patients treated by AAA repair.

Objective To evaluate the efficacy of remote ischemic conditioning (RIC) as compared to no conditioning on clinical endpoints in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI). Design Systematic review of randomized clinical trials (RCTs). Material and methods Literature was searched up to September 13, 2019, and we identified a total of 13 RCTs. The efficacy of RIC on incidence of clinical events during follow-up was quantified by the rate ratio (RR) with its 95% confidence interval (CI), and we used fixed and random effects models to synthetize the results. Small-study effect was evaluated, and controlled for by the trim-and-fill method. Heterogeneity between studies was examined by subgroup and meta-regression analyses. The risk of false-positive results in meta-analysis was evaluated by trial sequential analysis (TSA). Results Pooled analysis of 13 trials (7183 patients) showed that RIC compared to no conditioning revealed a non-significant risk reduction on endpoint mortality (RR=0.81, 95% CI: 0.56-1.17) during a median follow-up time of 1 year (range: 0.08-3.8) with low heterogeneity (I2=16%). Controlling for small-study effect showed no efficacy of RIC (adjusted RR: 1.03, 95% CI: 0.66-1.59). Pooled effect of RIC on the incidence of myocardial infarction (MI) from 11 trials (6996 patients) was non-significant too (RR=0.85, 95% CI: 0.62-1.18), with no observed heterogeneity (I2=0%) or small-study effect. A similar lack of efficacy was found in endpoint congestive heart failure (CHF) from 6 trials including 6098 patients (RR=0.71, 95% CI: 0.44-1.15), with moderate heterogeneity (I2=30%). TSAs showed that the pooled estimates from the cumulative meta-analyses were true negative with adequate power. Conclusion Evidence from this updated systematic review demonstrates no beneficial effect of RIC on the incidence of clinical endpoint mortality, MI and CHF during a median follow-up of 1 year in ACS patients undergoing PCI.

Objective in the After Eighty study (ClinicalTrials.gov.number, NCT01255540), patients aged 80 years or more, with non-ST-elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP), were randomised to either an invasive or conservative management approach. We sought to compare the effects of these management strategies on health related quality of life (HRQOL) after 1 year. Methods the After Eighty study was a prospective randomised controlled multicenter trial. In total, 457 patients aged 80 or over, with NSTEMI or UAP, were randomised to either an invasive strategy (n = 229, mean age: 84.7 years), involving early coronary angiography, with immediate evaluation for percutaneous coronary intervention, coronary artery bypass graft, optimal medical therapy, or to a conservative strategy (n = 228, mean age: 84.9 years). The Short Form 36 health survey (SF-36) was used to assess HRQOL at baseline, and at the 1-year follow-up. Results baseline SF-36 completion was achieved for 208 and 216 patients in the invasive and conservative groups, respectively. A total of 137 in the invasive group and 136 patients in the conservative group completed the SF-36 form at follow-up. When comparing the changes from follow-up to baseline (delta) no significant changes in quality-of-life scores were observed between the two strategies in any of the domains, expect for a small but statistically significant difference in bodily pain. This difference in only one of the SF-36 subscales may not necessarily be clinically significant. Conclusion from baseline to the 1 year follow-up, only minor differences in change of HRQOL as measured by SF-36 were seen by comparing an invasive and conservative strategy. Clinicaltrials.gov identifier NCT01255540.

Aim We aimed to summarize the pooled effect of early discharge compared with ordinary discharge after percutaneous coronary intervention (PCI) on the composite endpoint of re-infarction, revascularization, stroke, death, and incidence of rehospitalization. We also aimed to compare costs for the two strategies. Methods The study was a systematic review and a meta-analysis of 12 randomized controlled trials including 2962 patients, followed by trial sequential analysis. An estimation of cost was considered. Follow-up time was 30 days. Results For early discharge, pooled effect for the composite endpoint was relative risk of efficacy (RRe)=0.65, 95% confidence interval (CI) (0.52-0.81). Rehospitalization had a pooled effect of RRe=1.10, 95% CI (0.88-1.38). Early discharge had an increasing risk of rehospitalization with increasing frequency of hypertension for all populations, except those with stable angina, where a decreasing risk was noted. Advancing age gave increased risk of revascularization. Early discharge had a cost reduction of 655 Euros per patient compared with ordinary discharge. Conclusion The pooled effect supports the safe use of early discharge after PCI in the treatment of a heterogeneous population of patients with coronary artery disease. There was an increased risk of rehospitalization for all subpopulations, except patients with stable angina. Clinical trials with homogeneous populations of acute coronary syndrome are needed to be conclusive on this issue.

ObjectivesWe aimed to report the angiographic and procedural results of the After Eighty study (ClinicalTrials.gov, NCT01255540), and to identify independent predictors of revascularisation.MethodsPatients of ≥80 years old with non-ST-elevation myocardial infarction and unstable angina pectoris were randomised to an invasive or conservative strategy. Angiographic and procedural results were recorded. Univariate and multivariate analyses were performed to explore variables predicting revascularisation.ResultsAmong 229 patients in the invasive group, 220 underwent immediate coronary angiography (90% performed via the radial artery). Of these patients, 48% had three-vessel disease or left main stenosis, 18% two-vessel disease, 16% one-vessel disease, 17% minor coronary vessel wall changes and two patients had normal coronary arteries. Six patients (3%) underwent coronary artery bypass graft. Percutaneous coronary intervention (PCI) was performed in 107 patients (49%), with 57% treated with bare metal stents, 37% drug-eluting stents and 6% balloon angioplasty. On average, 1.7 lesions were treated and 2 stents delivered per patient. Complications included 1 major PCI-related bleeding (successfully treated), 2 minor access site-related bleedings, 3 side branch occlusions during PCI and 11 periprocedural myocardial infarctions (considered end points). Sex, bundle branch block and smoking were independent predictors of revascularisation.ConclusionsPCI was performed in approximately half of the patients, similar to findings in younger populations. Procedural success was high, with few complications.Trial registration numberNCT01255540

Objective. We aimed to summarize the evidence from observational studies examining the risk factors of the incidence of mediastinitis in open heart surgery. Design. The study was a systematic review and meta-analysis of cohorts and case-control studies. Material and methods. We searched the literature and 74 studies with at least one risk factor were identified. Both fixed and random effects models were used. Heterogeneity between studies was examined by subgroup and meta-regression analysis. Publication bias or small study effects were evaluated and corrected by limit meta-analysis. Results. When correcting for small study effect, presence of obesity as estimated from 43 studies had Odds Ratio OR = 2.26. (95% CI: 2.17-2.36). This risk was increasing with decreasing latitude of study place. Presence of diabetes mellitus from 63 studies carried an OR = 1.90 (95% CI: 1.59-2.27). Presence of Chronic Obstructive Pulmonary Disease (COPD) from 30 studies had an OR = 2.59 (95% CI: 2.22-2.85). Presence of bilateral intramammary graft (BIMA) from 23 studies carried an OR = 2.54 (95% CI: 2.07-3.13). This risk was increasing with increasing frequency of female patients in the study population. Conclusion. Evidence from this study showed the robustness of the risk factors in the pathogenesis of mediastinitis. Preventive measures can be implemented for reducing obesity, especially in lower latitude countries. Furthermore, it is mandatory to monitor perioperative hyperglycemias with continuous insulin infusion. Use of skeletonized BIMA carries higher risk of mediastinitis especially in female patients without evidence of beneficial effect on survival for the time being.

M Abdelnoor,1,2 Ø A Vengen,3 O Johansen,4 I Sandven,2 AM Abdelnoor5 1Centre for Clinical Heart Research, Department of Cardiology 2Oslo Centre for Biostatistics and Epidemiology, 3Department of Cardiovascular Surgery, 4Department of Cardiology, Oslo University Hospital, Oslo, Norway; 5Department of Experimental Pathology, Immunology and Microbiology, American University of Beirut, Beirut, Lebanon Objective: We aimed to summarize the pooled frequency of mediastinitis following open-heart surgery caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and Gram-negative bacteria. Design: This study was a systematic review and a meta-analysis of prospective and retrospective cohort studies. Materials and methods: We searched the literature, and a total of 97 cohort studies were identified. Random-effect model was used to synthesize the results. Heterogeneity between studies was examined by subgroup and meta-regression analyses, considering study and patient-level variables. Small-study effect was evaluated. Results: Substantial heterogeneity was present. The estimated incidence of mediastinitis evaluated from 97 studies was 1.58% (95% confidence intervals [CI] 1.42, 1.75) and that of Gram-positive bacteria, Gram-negative bacteria, and MRSA bacteria evaluated from 63 studies was 0.90% (95% CI 0.81, 1.21), 0.24% (95% CI 0.18, 0.32), and 0.08% (95% CI 0.05, 0.12), respectively. A meta-regression pinpointed negative association between the frequency of mediastinitis and latitude of study place and positive association between the frequency of mediastinitis and the age of the patient at operation. Multivariate meta-regression showed that prospective cohort design and age of the patients and latitude of study place together or in combination accounted for 17% of heterogeneity for end point frequency of mediastinitis, 16.3% for Gram-positive bacteria, 14.7% for Gram-negative bacteria, and 23.3% for MRSA bacteria. Conclusion: Evidence from this study suggests the importance of latitude of study place and advanced age as risk factors of mediastinitis. Latitude is a marker of thermally regulated bacterial virulence and other local surgical practice. There is concern of increasing risk of mediastinitis and of MRSA in elderly patients undergoing sternotomy. Keywords: mediastinitis, sternotomy, meta-analysis

Summary Background Non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris are frequent causes of hospital admission in the elderly. However, clinical trials targeting this population are scarce, and these patients are less likely to receive treatment according to guidelines. We aimed to investigate whether this population would benefit from an early invasive strategy versus a conservative strategy. Methods In this open-label randomised controlled multicentre trial, patients aged 80 years or older with NSTEMI or unstable angina admitted to 16 hospitals in the South-East Health Region of Norway were randomly assigned to an invasive strategy (including early coronary angiography with immediate assessment for percutaneous coronary intervention, coronary artery bypass graft, and optimum medical treatment) or to a conservative strategy (optimum medical treatment alone). A permuted block randomisation was generated by the Centre for Biostatistics and Epidemiology with stratification on the inclusion hospitals in opaque concealed envelopes, and sealed envelopes with consecutive inclusion numbers were made. The primary outcome was a composite of myocardial infarction, need for urgent revascularisation, stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014. An intention-to-treat analysis was used. This study is registered with ClinicalTrials.gov, number NCT01255540. Findings During a median follow-up of 1·53 years of participants recruited between Dec 10, 2010, and Feb 21, 2014, the primary outcome occurred in 93 (40·6%) of 229 patients assigned to the invasive group and 140 (61·4%) of 228 patients assigned to the conservative group (hazard ratio [HR] 0·53 [95% CI 0·41–0·69], p=0·0001). Five patients dropped out of the invasive group and one from the conservative group. HRs for the four components of the primary composite endpoint were 0·52 (0·35–0·76; p=0·0010) for myocardial infarction, 0·19 (0·07–0·52; p=0·0010) for the need for urgent revascularisation, 0·60 (0·25–1·46; p=0·2650) for stroke, and 0·89 (0·62–1·28; p=0·5340) for death from any cause. The invasive group had four (1·7%) major and 23 (10·0%) minor bleeding complications whereas the conservative group had four (1·8%) major and 16 (7·0%) minor bleeding complications. Interpretation In patients aged 80 years or more with NSTEMI or unstable angina, an invasive strategy is superior to a conservative strategy in the reduction of composite events. Efficacy of the invasive strategy was diluted with increasing age (after adjustment for creatinine and effect modification). The two strategies did not differ in terms of bleeding complications. Funding Norwegian Health Association (ExtraStiftelsen) and Inger and John Fredriksen Heart Foundation.

Objective The aim was to summarise the evidence from published epidemiological studies investigating the efficacy of statin therapy on long term survival in patients after abdominal aortic aneurysm (AAA) repair. Data sources This study was a systematic review with critical appraisal and meta-analysis of observational studies. Review methods A systematic literature search was carried out throughout February 2020, revealing 14 eligible cohort studies of which 11 were judged to be of high quality. A random effects model was used to synthesise results, and heterogeneity between studies examined by subgroup and meta-regression analyses considering patient and study related variables. Small study effect was evaluated. Results The pooled estimate showed that statin treatment among 69 790 AAA patients with a median follow up of 3.1 years was associated with a 35% relative reduction in total mortality (rate ratio 0.65, 95% confidence interval 0.57-0.73) with moderate heterogeneity (I2 = 68%) and no small study effect. Conclusion Evidence from this systematic review indicates a beneficial effect of statins on long term survival in patients treated by AAA repair.

Objective The aim of the study was to summarize the pooled incidence rate of sudden unexpected death in epilepsy (SUDEP) in patients. Meta-regression analysis was applied to identify factors influencing the incidence rate. Design The study was a systematic review and critical appraisal with a meta-analysis of cohort studies, both prospective and retrospective. Material and method In a literature search, a total of 45 cohort studies were identified. A random effect model was used to synthesize the results. Heterogeneity between studies was examined by subgroup and meta-regression analysis. The small-study effect was evaluated and not corrected for by the “trim and fill” method because of great heterogeneity. Results A substantial heterogeneity was present. The pooled estimated incidence rate for SUDEP was 1.4/1000 patient years. A meta-regression pinpointed a negative association between the incidence rate of SUDEP and the mean follow-up time and a positive association with the mean age of the patient. The definition of epilepsy showed statistical significance, with a higher incidence rate of SUDEP in studies where the definition of epilepsy was described and clear (p = 0.019) compared with studies having an inadequate or failing epilepsy definition. Conclusion Evidence from this study suggests a high incidence rate of sudden death in epilepsy. Its incidence rate was 23 times the incidence rate of sudden death in the total population of the same age. There was heterogeneity and variability of incidence rate depending on the quality of the study and on the definition of epilepsy and the mean age of the patients.

AIMS Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) usually restores TIMI 3 flow in the occluded artery, but microvascular impairment may persist in >30% of patients. Less is known about microvascular reperfusion in STEMI patients treated with thrombolysis followed by early PCI. We aimed to assess the association between TIMI myocardial perfusion (TMP) at the end of the PCI procedure and left ventricular function (LVEF) and infarct size after three months in such patients. METHODS AND RESULTS Patients with STEMI treated with thrombolysis and early PCI were included. TMP grade was assessed at the end of the PCI procedure, and MRI was performed after three months. Of the 89 patients included, 92% (n=82) had TIMI 3 flow at the end of the PCI procedure, while only 62% (n=55) had TMP grade 2 or 3. Patients with TMP grade 2-3 had significantly higher LVEF (59% [53-67] vs. 50% [41-56], p

We aimed to study in-hospital mortality and long-term survival in elderly compared to younger patients with ST-segment elevation myocardial infarction (STEMI) in the era of primary angioplasty.This was a prospective cohort study. All consecutive STEMI-patients admitted to our hospital between September 2005-December 2011 were included in a local registry. Predefined variables were registered during hospital admission. Vital status was obtained from the Norwegian Cause of Death Registry with censoring date 31 December 2011. Adjusted effects of age ⩾80 years on in-hospital- and long-term mortality were determined using propensity score analysis. Of 4525 registered STEMI patients, 600 (13%) were octogenarians or older. In-hospital mortality was 17% in patients ⩾80 years and 4% in patients80 years. In invasively treated patients (83% of patients ⩾80 years; 98% of patients80 years), in-hospital mortality was 13% and 3.4%, respectively. Median follow-up time was 2.5 years. Three-year cumulative survival was 52% in patients ⩾80 years vs 89% in patients80 years. In invasively treated patients ⩾80 years, three-year survival was 58%. The adjusted odds ratio of in-hospital mortality was 2.61 (1.94-3.52) and adjusted incidence rate ratio of long-term mortality was 4.07 (3.43-4.84) in very elderly compared to younger patients.Short-term prognosis was acceptable in very elderly STEMI patients, especially in the invasively treated subgroup. However, only 52% of STEMI patients ⩾80 years were alive after three years of follow-up. Very elderly patients had 2.6 times higher risk of in-hospital mortality and 4.1 times the risk of not surviving during long-term follow-up compared to patients80 years, after adjustment for confounding factors and selection bias.

This is the pre-print version of an article published by Taylor & Francis in Scandinavian Cardiovascular Journal on 12 December 2017, available online: http://www.tandfonline.com/10.1080/14017431.2017.1416157. Objectives. The inflammatory response to on-pump cardiac surgery is well known. Systemic inflammatory response syndrome after transcatheter valve implantation (TAVI) has been reported. The objective of this study was to study the inflammatory response during TAVI, and compare with the response during surgical aortic valve replacement. Methods. Eighteen patients undergoing transcatheter implantation, either by a transfemoral (n = 9) or transaortal (n = 9) approach were compared with eighteen patients admitted for surgical replacement. Blood samples per- and postoperatively were analysed for C3bc, terminal complement complex, myeloperoxidase, macrophage inflammatory protein-1β, monocyte chemo-attractant peptide-1, eotaxin, IL-6 and troponin-T. All markers were measured at defined time points and the areas under the curve were compared. Results. Activation of complement, granulocytes, monocytes and eosinophils were significantly lower in the transcatheter group as compared to the surgical group (Discussion. Activation and release of inflammatory markers was significantly less during with TAVI as compared to SAVR, particularly for markers associated with extracorporeal circulation. TAVI and SAVR generated the same degree of IL-6 and troponin T, indicating that the burden on the myocardial tissue was the same.

In this single center, retrospective cohort study we wished to compare early and total mortality for all patients treated for abdominal aortic aneurysms (AAA) with open surgery who were taking statins compared to those who were not. A cohort of 640 patients with AAA was treated with open surgery between 1999 and 2012. Patients were consecutively recruited from a source population of 390,000; 21.3% were female, and the median age was 73 years. The median follow-up was 3.93 years, with an interquartile range of 1.79–6.58 years. The total follow-up was 2855 patient-years. An explanatory strategy was used. The propensity score (PS) was implemented to control for selection bias and confounders. The crude effect of statin use showed a 78% reduction of the 30-day mortality. A stratified analysis using the Mantel–Haenszel method on quintiles of the PS gave an adjusted effect of the odds ratio equal to 0.43 (95% CI: 0.18–0.96), indicating a 57% reduction of the 30-day mortality for statin users. The adjusted rate ratio was 0.62 (95% CI: 0.45–0.83), indicating a reduction of long-term mortality of 38% for statin users compared to non-users for a median follow-up of 3.93 years. This retrospective cohort study showed a significant beneficial effect of statin use on early and long-term survival for patients treated with open surgery. To be conclusive, our results need to be replicated by a randomized clinical trial.

Peter Andreas Claussen,1,2 Michael Abdelnoor,3 Kristin M Kvakkestad,1,2 Jan Eritsland,1 Sigrun Halvorsen1 1Department of Cardiology, Oslo University Hospital, Ullevaal, Norway; 2Faculty of Medicine, University of Oslo, Oslo, Norway; 3Centre of Clinical Research: Unit of Epidemiology and Biostatistics, Oslo University Hospital, Ullevaal, Norway Background: Elderly patients with ST-segment elevation myocardial infarction (STEMI) are at high risk for complications and early mortality; still, they are underrepresented in clinical trials and observational studies. We studied the risk profiles at presentation and early mortality in elderly (≥80 years) versus younger (

OBJECTIVE We aimed to summarize the evidence from randomized clinical trials studies examining the efficacy of ischemic postconditioning (IPost) in ST-elevation myocardial infarction. DESIGN The study was a systematic review and critical appraisal, with meta-analysis of randomized clinical trials. MATERIALS AND METHODS We searched the literature. A total of 21 randomized clinical trials were identified. Both fixed effect and random effects models were used to synthesize the results of individual studies. Heterogeneity between studies was examined by subgroup and random effects meta-regression analyses, considering ptient-related and study-level variables. Publication bias, or "small-study effect", was evaluated. RESULTS Substantial heterogeneity was present. The random effects model pooled estimate for the outcome infarct size assessed by cardiac magnetic resonance was estimated by the standardized mean difference (SMD) =-0.06, 95% confidence interval (CI): -0.34 to 0.21, ie, no effect of IPost. For the end point infarct size, estimated by biomarkers of myocardial necrosis, an overall pooled effect was SMD =-0.58, 95% CI: -0.96 to -0.19. This effect disappeared in powered and nonbiased studies (SMD =0.03, 95% CI: -0.48 to 0.55). Finally, for the outcome left ventricular ejection fraction, SMD =0.47 95% CI: 0.20 to 0.74. Unfortunately, selection bias (small-study effect) was present. For this outcome, the meta-regression showed that both presence of hypertension and the inclusion of nonbiased studies explained 28.3% of the heterogeneity among the studies. Simulation by the "trim and fill" method, which controlled for selection bias using random effects model, diluted the effect (SMD =0.17 95% CI: -0.13 to 0.48). No effects by IPost on ST-segment resolution or on the majority of adverse clinical events were observed during follow up, except the incidence of congestive heart failure was found. CONCLUSION Evidence from this study suggests no cardioprotection from IPost, on surrogate and the majority of clinical end points. A possible beneficial effect on the incidence of congestive heart failure needs to be replicated by a large clinical trial.

Aims Rate control of atrial fibrillation (AF) has become a main treatment modality, but we need more knowledge regarding the different drugs used for this purpose. In this study, we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with permanent AF. Methods and results We included 60 patients (mean age 71 ± 9 years, 18 women) with permanent AF and normal left ventricular function in a randomized, cross-over, investigator-blind study. Diltiazem 360 mg, verapamil 240 mg, metoprolol 100 mg, and carvedilol 25 mg were administered o.d. for 3 weeks. At baseline and on the last day of each treatment period, the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise. The exercise capacity (peak VO2) was significantly lower during treatment with metoprolol and carvedilol compared with baseline (no treatment) or treatment with diltiazem and verapamil ( P < 0.001 for all). Compared with baseline, treatment with diltiazem and verapamil significantly reduced the NT-proBNP levels both at rest and at peak exercise, whereas treatment with metoprolol and carvedilol increased the levels ( P < 0.05 for all). Conclusion Rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of NT-proBNP compared with baseline, whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of NT-proBNP.

To determine the prevalence of otitis media with effusion (OME) in children with Down syndrome (DS), and the associated to hearing loss at the age of 8 years.A national population based clinical study of all children with DS born in Norway in 2002.OME was found in 20 out of 52 (38%) children. Those with OME had a significant lower hearing level with a mean pure tone average (PTA) of 33.4 dB HL compared to children with no OME whose mean PTA was 21.7 dB HL (p0.0001). Verified hearing loss above 25 dB HL in the better hearing ear was found in 12 out of the 20 with OME, compared to 5 out 31 without OME.The findings of this present study uncover the increased risk of OME in eight year old children with DS as current otitis media was found in one of three. This reduced hearing ability in children with DS due to OME at age of 8 strongly emphasizes the need for optimal treatment and follow up to optimize hearing rehabilitation. The findings are further supported by the population based study design, the focus on the narrow age band and the high response rate.

To investigate X-linked adrenoleukodystrophy in an unselected population, we performed a population based, cross-sectional prevalence study, supplemented by a retrospective study of deceased subjects. Sixty-three subjects (34 males, 29 females) belonging to 22 kindreds were included. Thirty-nine subjects (13 males, 26 females) were alive, and 24 (21 males, 3 females) were deceased on the prevalence day. The point prevalence of X-linked adrenoleukodystrophy in Norway on July 1, 2011, was 0.8 per 100,000 inhabitants. The incidence at birth in the period 1956-1995 was 1.6 per 100,000 inhabitants. An age-dependent penetrance was observed among males and females, with more severe phenotypes appearing with rising age. Only 5% of deceased males had not developed cerebral leukodystrophy. No female older than 50 years was neurologically intact. Sixteen mutations in the ABCD1 gene were identified. De novo mutations were found in 19% of probands. The frequency of X-linked adrenoleukodystrophy was lower in Norway than reported in the literature. A more severe natural course than previously reported was observed, indicating a need for better follow-up of both male and female patients. Given the high rate of de novo mutations, identification programs such as newborn screening may be required to offer timely treatment to all patients.

Mediastinitis after coronary artery bypass grafting (CABG) gives a longstanding chronic inflammation and has a detrimental negative effect on long-term survival. For this reason, we aimed to study the effect of mediastinitis on graft patency after CABG. The epidemiologic design was of an exposed (mediastinitis, n = 41) versus non-exposed (non-mediastinitis, controls, n = 41) cohort with two endpoints: (i) obstruction of saphenous vein grafts (SVG) and (ii) obstruction of the internal mammary artery (IMA) grafts. The graft patency was evaluated with coronary CT-angiography examination at a median follow-up of 2·7 years. The number of occluded SVG in the mediastinitis group was 18·9% versus 15·5% in the control group. Using generalized estimating equations model with exchangeable matrix, and confounding effect of ischaemic time and patients age, we found no significant association between presence of mediastinitis and SVG obstruction [rate ratio (RR) = 0·96, 95% CI (0·52-2·67), P = 0·697]. The number of occluded IMA grafts was 10·5% in the mediastinitis group and 2·4% in the control group. Using the Poisson regression model, we estimated RR = 5·48, 95% CI (1·43-21·0) and P = 0·013. There was a significant association between mediastinitis and IMA graft obstruction, when controlling for the confounding effect of ischaemic time, body mass index, presence of diabetes mellitus and the number of diseased vessels. Presence of mediastinitis increases the risk of IMA graft obstruction. This may confirm the importance of inflammation as a major contributor to the pathogenesis of atherosclerosis and explain the negative effect of mediastinitis on a long-term survival.

Mediastinitis is treated with either vacuum-assisted closure (VAC) or traditional closed drainage (TCD) with irrigation. The aim of the study was to determine the effect of the two treatments on mortality and re-infection rate in a source population, using 21 314 consecutive patients undergoing isolated coronary artery bypass grafting (CABG) from January 1997 to October 2010. Median observation time was 2·9 years in the VAC group and 8·0 years in the TCD group. The epidemiological design was of an exposed (VAC, n = 64) versus non-exposed (TCD, n = 66) cohort with two endpoints: (1) mortality and (2) failure of sternal wound healing or re-infection. The crude effect of treatment technique versus endpoint was estimated by univariate analysis. Stratification analysis by the Mantel-Haenszel method was performed to quantify confounders and to pinpoint effect modifiers. Adjustment for confounders was performed using Cox regression analysis. Mediastinitis was diagnosed 6-105 (median 14) days after primary operation in the VAC group and 13 (5-29) days in the TCD group. There was no difference between groups in long-term survival. Failure of sternal wound healing or re-infection occurred less frequently in the VAC group (6%) than in the TCD group (21%; relative risk = 0·29, 95% CI = 0·06-0·88, P = 0·01). There are concerns for increase in right ventricle rupture in VAC compared with TCD. There was no difference in survival after VAC therapy and TCD therapy of post-CABG mediastinitis. Failure of sternal wound healing or re-infection was more common after TCD therapy.

Reduced forced expiratory volume in one second (FEV(1)) has been associated with new-onset atrial fibrillation (AF), and AF patients often complain of dyspnea. We hypothesized that patients with permanent AF had reduced lung function compared to subjects in sinus rhythm.The participants were 75year-olds from the general population. FEV(1), forced vital capacity (FVC), maximal voluntary ventilation (MVV), total lung capacity by single breath (TLC(SB)), single-breath diffusing capacity of the lung for carbon monoxide (DLCO(SB)) and exercise testing with peak oxygen uptake (VO(2) peak) were assessed. The slope of minute ventilation over carbon dioxide output defined ventilatory efficiency. The Symptom Checklist-frequency and severity questionnaire assessed dyspnea.AF patients had significantly higher number (%) of subjects below the 5th percentile of predicted FEV(1) (7 (27) versus 3 (4), p=0.005), FVC (6 (23) versus 2 (3), p=0.006) and TLC(SB) (11 (42) versus 12 (18), p=0.014) compared to control subjects, also after adjustment for smoking and obesity, or if disregarding subjects with chronic heart failure. The dyspnea frequency and severity scores correlated with VO(2) peak (r=-0.6, p0.01) in AF patients, and in control subjects with % predicted FEV(1), MVV and TLC(SB) (r=-0.3, p0.05).More patients with permanent AF had lung function below normal range than control subjects in sinus rhythm, irrespective of smoking, obesity or chronic heart failure. Dyspnea, however, was related to exercise capacity rather than to lung function in AF patients.

Background Epistaxis is usually the first and most common symptom in hereditary hemorrhagic telangiectasia (HHT), which is known also as Rendu-Osler-Weber syndrome. The severity of HHT-associated epistaxis is highly variable and can affect the patient's quality of life. In the literature, the natural history of epistaxis in HHT patients has been described in a few countries but not from the Norwegian population. Objective This work focused on the natural history of epistaxis in the Norwegian population in a cross-sectional study. Material and Methods Ninety-eight patients with three or four Curaçao criteria were included. The severity of epistaxis was graded depending on epistaxis intensity, frequency, and the amount of blood transfusion during a period of 4 weeks. The epistaxis grades were studied in association with age, gender, gene mutation, age of onset, and whether the patient had or had not been treated for epistaxis during the last 2 years. Results Most of the HHT patients (90%) complained of mild-to-moderate epistaxis. Seventy-seven percent of the patients started epistaxis by or before the age of 20 years. The progression of HHT-associated epistaxis with age could not be proved statistically in this study. There was no statistically significant difference in the grades of epistaxis between HHT1 and HHT2 type, neither between female and male patients. Most of the patients started epistaxis by or before the age of 20 years. There was a significant difference in the grade of epistaxis between non-ENG, non-ALK1 carrier patients, and ENG or ALK1 carrier patients. Conclusion Compared with other populations, the grading of epistaxis in Norwegian patients with HHT gave generally similar results. A multicenter epidemiological study is required to get a larger study population. A common internationally accepted grading or classification system for epistaxis in HHT is highly recommended.

In patients with the metabolic syndrome, the prevalence of cardiovascular disease, disease-related morbidity and mortality are reported to be significantly higher than in a population without the metabolic syndrome. We investigated the role of metabolic syndrome and related biomarkers as predictors of infarct size in patients with their first myocardial infarction.This was a cross-sectional sub-study from the 3 months follow-up in the NORwegian Study of DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI), including 152 consecutive patients, all initially treated with thrombolysis. Infarct size after 3 months was determined by late gadolinium enhanced magnetic resonance imaging, measuring ventricular infarct volume in absolute and relative terms.At 3 months, 33 patients (22%) were categorized as having metabolic syndrome. There was no significant difference in median infarct size between those presenting with and without the metabolic syndrome [relative infarct volume 9.0 (4.8, 15.1) % vs. 8.3 (2.9, 13.6)%, p = 0.34]. Adjusting for possible confounders did not alter the results essentially. Circulating levels of IL-18, CRP and PAI-I activity were significantly higher in patients with the metabolic syndrome while adiponectin concentrations were significantly lower (por = 0.01 for all). None of these variables were associated with myocardial infarct size.No association between the presence of metabolic syndrome and related biomarkers, and the size of the myocardial infarction was apparent in this study population.

Background/objective Progressive encephalopathy (PE) is a heterogeneous group of individually rare diseases, many with an autosomal recessive mode of inheritance. We estimated the increased risk of PE associated with consanguinity. Patients and methods Using a historic cohort study design, the exposures were country of origin (Pakistan versus Norway) and consanguinity. We included children living in Oslo, born between 1985 and 2003. PE cases were retrieved from an electronic registry of diagnoses coded according to the International Classification of Diseases. Incidence rates were calculated for country of origin. We also estimated population attributable risks caused by consanguinity. Results We identified 30 cases per 79 704 person years with Pakistani origin and 35 cases per 658 932 person years with Norwegian origin. This gave incidence rates of 37.6 and 5.3 per 100 000 person years, whereas the incidence rate ratio was 7.1 (95% CI: 4.2–11.9). The incidence rates of consanguineous versus non-consanguineous of Pakistani origin were 59.6 and 18.7 per 100 000 person years. The incidence rate ratio was 3.2 (95% CI: 1.4–7.2), whereas the incidence rate ratio of non-consanguineous Pakistani versus non-consanguineous Norwegian origin was 3.5 (95% CI: 1.6–7.6). The incidence rate ratio between consanguineous Pakistanis and Norwegians was 11.2. The population attributable risk due to parental consanguinity was 50.3% in the Pakistani sub-population. Conclusions We found a seven-fold increased risk of PE in the general Pakistani population, and an eleven-fold increased risk in consanguineous Pakistanis. Pakistani origin by itself was also an independent risk factor. Avoidance of consanguinity in the Pakistani population would result in at least 50% reduction of PE in that group.

Critical appraisal of published case-control studies examining the etiology or risk factors of Hyperemesis gravidarum (HG).We searched the Medline/PubMed database from 1966 to February 12, 2009. A total of 48 case-control studies were retrieved and each article was evaluated using a structured assessment devised for the purpose.The case-control studies were published between 1978 and 2008. The majority investigated hormonal, gastrointestinal, and metabolic risk factors associated with hyperemesis gravidarum (37 studies). Selection bias and non-response received insufficient attention in many articles. Sample size varied widely with a median number of 40 cases and 42 controls. Association uncommonly was expressed by odds ratios and confidence intervals (9 studies), confounding rarely controlled for (10 studies) and few examined effect modification (2 studies).We are concerned as far the inadequacies in the design, analysis, and reporting of case-control studies examining the etiology of HG. It is mandatory to follow adequate clinical research methodology in executing and reporting such studies.

Objectives The goal of this study was to compare a strategy of immediate transfer for percutaneous coronary intervention (PCI) with an ischemia-guided approach after thrombolysis in patients with very long transfer distances to PCI. Background Thrombolysis remains the treatment of choice in ST-segment elevation myocardial infarction (STEMI) when primary PCI cannot be performed within 90 to 120 min. The optimal treatment after thrombolysis is still unclear. Methods A total of 266 patients with acute STEMI living in rural areas with more than 90-min transfer delays to PCI were treated with tenecteplase, aspirin, enoxaparin, and clopidogrel and randomized to immediate transfer for PCI or to standard management in the local hospitals with early transfer, only if indicated for rescue or clinical deterioration. The primary outcome was a composite of death, reinfarction, stroke, or new ischemia at 12 months, and analysis was by intention to treat. Results The primary end point was reached in 28 patients (21%) in the early invasive group compared with 36 (27%) in the conservative group (hazard ratio: 0.72, 95% confidence interval: 0.44 to 1.18, p = 0.19). The composite of death, reinfarction, or stroke at 12 months was significantly reduced in the early invasive compared with the conservative group (6% vs. 16%, hazard ratio: 0.36, 95% confidence interval: 0.16 to 0.81, p = 0.01). No significant differences in bleeding or infarct size were observed. Conclusions Immediate transfer for PCI did not improve the primary outcome significantly, but reduced the rate of death, reinfarction, or stroke at 12 months in patients with STEMI, treated with thrombolysis and clopidogrel in areas with long transfer distances. (Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction; NCT00161005 ).

Rapid reperfusion of the infarct-related coronary artery is essential in the treatment of acute ST-elevation myocardial infarction (STEMI). Paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium. This phenomenon is described as ‘ischemia/reperfusion injury’ and the pathophysiological mechanisms are not fully elucidated. A cardioprotective effect of ischemic postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute STEMI treated with primary percutaneous coronary intervention. We present the study design of the Postconditioning in ST-Elevation Myocardial Infarction (POSTEMI) study, which is a prospective, randomized, open-label clinical trial with blinded endpoint evaluation designed to evaluate the effect of postconditioning on final infarct size. Patients with acute STEMI with symptoms of less than 6 h and proximal or mid-coronary artery occlusion will be included. The primary endpoint is infarct size, assessed by cardiac MRI after 4 months. The secondary endpoints are to evaluate the effect of postconditioning on TIMI myocardial perfusion grade, resolution of ST-segment elevation, release of markers of ischemia, left ventricular function and final infarct size related to the area at risk. A total of 260 patients will be included in the study.

This study aims to compare the result of an incontinence procedure performed at the time of prolapse repair or 3 months later in women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In a multicenter prospective randomized trial, women with POP and SUI were randomized to have a tension-free vaginal tape (TVT) at the time of prolapse repair (n = 87; group I) or 3 months later (n = 94; group II). Women in group II were evaluated for SUI 3 months after the prolapse repair. Those with confirmed SUI had a TVT performed (n = 53). The main evaluation of all women was 1 year after the last surgery. On-treatment analysis resulted in 95% cure of SUI in group I and 89% in group II (p = 0.12). Twenty-seven percent were cured after prolapse surgery alone. No differences were found between the two treatment strategies, but almost one third of women were cured of SUI by prolapse surgery alone.

Objectives: The evaluation of infarct size and left ventricular function after acute myocardial infarction is important for predicting the subsequent clinical course. This assessment can be achieved by non-invasive imaging methods, but biochemical assays are frequently used as an alternative. We investigated the ability of a single measurement of cardiac troponin T (cTnT) the third morning after onset of ST-segment elevation myocardial infarction (STEMI) to predict infarct size and left ventricular ejection fraction (LVEF). Methods: The study population consisted of 103 patients with their first STEMI treated with thrombolysis. Blood samples for determination of cTnT were drawn the third morning after onset of symptoms. Infarct size and LVEF were assessed by magnetic resonance imaging 3 months later. Results: Linear regression analysis showed a strong, significant correlation between third-day cTnT and infarct size at 3 months (r = 0.84, p < 0.0001). A significant but inverse and weaker correlation was obtained between third-day cTnT and LVEF (r = –0.63, p < 0.0001). Adjusting for age, gender, infarct location and medication changed the results marginally. Conclusions: A single cTnT value the third morning after onset of STEMI predicted the final infarct size in this group of patients with their first STEMI, and might be useful for ruling out impaired LVEF.

Serious pulmonary failure may be treated with extracorporeal membrane oxygenation (ECMO) when other treatment has failed. The aim of this study was to analyze pre-operative risk factors of early mortality in patients who underwent either veno-arterial (VA) ECMO or veno-venous (VV) ECMO for pulmonary failure. We studied a total of 26 risk factors in 72 patients with severe pulmonary insufficiency treated with ECMO. All consecutive cases treated at our institution between Sept 1990 and Aug 2007 were included. Univariate analysis and multiple logistic regression analysis were performed on 26 risk factors. The end point was early mortality (any death within 30 days of ECMO treatment). Thirty-six (50%) of the patients died within 30 days of treatment. Age, gender, body mass index(BMI)(adults), cause of pulmonary failure, pre-ECMO treatment with nitric oxide(NO), intra-aortic balloon pump(IABP), and type of ventilation did not significantly influence early mortality. Neither pre-operative blood gas results, oxygenation index or pre-operative PaO2/FiO2ratio, nor mean ventilator days prior to ECMO gave any indications on early mortality. Liver function did not predict early mortality, but pre-ECMO serum creatinine levels were significantly lower in patients who survived. Treatment with ECMO in patients with severe pulmonary failure may save lives. It is, however, difficult to predict outcome when initiating ECMO. In this analysis, only pre-operative serum creatinine levels correlated with survival. None of the other parameters, including those which were used to select patients for ECMO treatment, could significantly predict the outcome.

Objectives: The recurrence rate of atrial fibrillation after electrical cardioversion is disappointingly high. The aim of the present study was to prospectively investigate if standard echocardiographic variables at the day of cardioversion could predict sinus rhythm maintenance. Methods: Transthoracic echocardiographic examination was performed within 4 h after cardioversion for all the patients in the CAPRAF (Candesartan in the Prevention of Relapsing Atrial Fibrillation) study. Results: Cardioversion was successful for 137 patients not given specific antiarrhythmic therapy, and only 41 (30%) maintained sinus rhythm at 6-month follow-up. There were significant (p = 0.05) lower transmitral A wave velocities in the group with relapsing atrial fibrillation compared with the group with sinus rhythm at 6-month follow-up. All patients with the lowest A wave velocities had an early recurrence of atrial fibrillation. There were no differences between the groups regarding atrial dimensions or left ventricular function. The use of the angiotensin II receptor antagonist candesartan had no influence on the echocardiographic variables, nor on the recurrence rate of atrial fibrillation after cardioversion. Conclusions: Transthoracic echocardiographic examination performed a short time after electrical cardioversion of atrial fibrillation showed that only A wave peak velocities were significantly predictive of sinus rhythm maintenance 6 months after the procedure.

Aims: To find the true prevalence of diagnosed and undiagnosed atrial fibrillation (AF) in a population aged 75 years in 2 municipalities in Norway, and to study the use of antithrombotic therapy in this group. Methods: All 1,117 citizens in Asker and Baerum municipalities in eastern Norway born in 1930 were invited to participate in a prevalence study of AF. Nine hundred and sixteen subjects (82%) were examined by electrocardiogram, and blood pressure and pulse rate were measured. Comorbidity and current medication were recorded. Results: AF was present in 92 subjects (10%; 95% CI 8.2–12.1%), including 33 with ECG-documented, paroxysmal AF. In addition, 8 subjects had a history of a single, transient episode of AF. AF was previously undiagnosed in 10 out of 916 (1.1%). In 77 of 82 patients with previously diagnosed AF (93.9%), antithrombotic therapy was compliant with international guidelines. Conclusion: Ten percent (95% CI 8.2–12.2%) in this 75-year-old population had AF. Compliance with international guidelines regarding antithrombotic therapy was high. Previously undiagnosed AF was found in only 10 out of 916 (1.1%).

Background Several studies have indicated that treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin II type 1 receptor blockers (ARBs) may reduce the incidence of atrial fibrillation (AF) in hypertensive patients and patients with left ventricular dysfunction. However, there is limited data on the effect of ACE-inhibitors and ARBs in patients undergoing electrical cardioversion for persistent AF. We hypothesized that treatment with the ARB candesartan, without adjunct antiarrhythmic therapy, would reduce the recurrence rate of AF after successful cardioversion. Methods In a double blind, placebo-controlled study, 171 patients with persistent AF were randomized to receive candesartan 8 mg once daily ( n =86) or placebo ( n =85) for 3–6 weeks before and candesartan 16 mg once daily or placebo for 6 months after electrical cardioversion. Primary endpoint was recurrence of AF. Results A total of 68 patients in the candesartan group and 69 patients in the placebo group were successfully cardioverted. Forty-eight patients (71%) in the candesartan group and 45 (65%) in the placebo group had a recurrence of AF during 6 months follow-up. Median time to recurrence was 8 and 9 days in the candesartan and placebo groups, respectively. The differences between the groups were not statistically significant. Conclusion Treatment with the ARB candesartan for 3–6 weeks before and 6 months after electrical cardioversion had no effect on the recurrence rate of AF.

Background. Serious heart failure may be treated with extracorporeal membrane oxygenation (ECMO) when other treatment fails. The aim of the present study was to analyse preoperative risk factors of early mortality in patients treated with veno-arterial (VA)-ECMO. Methods. We studied a total of 18 possible risk factors in 80 patients with severe cardiac insufficiency treated with VA-ECMO. All consecutive cases treated at our institution between Sept.1990 and May 2006 were included. Univariate analysis and multiple logistic regression analysis were performed on 16 risk factors. The endpoint was early mortality (any death within 30 days of ECMO treatment). Results. Thirty patients (37.5%) died within 30 days. Age, gender, cause of cardiac failure, pre-ECMO treatment (ventilator, NO, IABP) did not significantly influence early mortality. A higher SvO2 was associated with survival and remained significant in the multivariate analysis. Conclusion. Treatment with VA-ECMO in patients with severe cardiac failure may save lives. It is, however, difficult to predict outcome. In this study, only SvO2 values prior to ECMO were positively associated with survival. Perfusion (2007) 22, 225—229.

Oxidative stress might exert deleterious cardiovascular effects. The aim of the present study was to compare the antioxidative effects of carvedilol and atenolol. Levels of oxidized low-density lipoprotein cholesterol (ox-LDL), vitamin E, and thiobarbituric acid reactive substances (TBARS) were measured. In a prospective, open, and end-point-blinded study, 232 patients with an acute myocardial infarction (AMI) were randomized to receive either carvedilol or atenolol at equipotent doses, and the previously mentioned 3 parameters were measured at baseline and after 12 months of active treatment, with changes during the study period being compared both within and between the groups. Ox-LDL decreased in both treatment modalities, from 40.5 +/- 15.6 to 35.0 +/- 13.8 U/L, P = 0.0001, in the carvedilol group and from 40.3 +/- 16.5 to 37.4 +/- 13.1 U/L, P = 0.044, in the atenolol group, with a significant between-group difference in the changes (P = 0.036). The levels of vitamin E did not change during carvedilol treatment (31.0 +/- 10.2 vs 31.7 +/- 11.1 micromol/L), but it decreased marginally in the atenolol group (30.8 +/- 12.1 vs 27.2 +/- 9.1 micromol/L, P = 0.056), with a significant between-group difference (P = 0.008). No significant change in TBARS was observed between the carvedilol and atenolol groups (P = 0.454). These results indicate that carvedilol has a more pronounced antioxidative effect than atenolol in post-AMI patients, which might be of clinical importance.

Thrombolysis is the treatment of choice for patients with ST-elevation myocardial infarction (STEMI) living in rural areas with long transfer delays to percutaneous coronary intervention (PCI). This trial compares two different strategies following thrombolysis: to transfer all patients for immediate coronary angiography and intervention, or to manage the patients more conservatively.The NORwegian study on DIstrict treatment of STEMI (NORDISTEMI) is an open, prospective, randomized controlled trial in patients with STEMI of less than 6 hours of duration and more than 90 minutes expected time delay to PCI. A total of 266 patients will receive full-dose thrombolysis, preferably pre-hospital, and then be randomized to either strategy. Our primary endpoint is the one year combined incidence of death, reinfarction, stroke or new myocardial ischaemia. The study is registered with ClinicalTrials.gov, number NCT00161005.By April 2006, 109 patients have been randomized. Thrombolysis has been given pre-hospital to 52% of patients. The median transport distance from first medical contact to catheterization laboratory was 155 km (range 90-396 km). Results of the study are expected in 2008.

Syed SH Kazmi,1 Jørgen Junkichi Jørgensen,1,2 Jon Otto Sundhagen,1 Anne Helene Krog,1,2 Tor L Flørenes,1 Dagfinn Kollerøs,3 Michael Abdelnoor2,4,5 1Department of Vascular Surgery, Heart, Lung and Vascular Disease Clinic, Oslo University Hospital, 2Faculty of Medicine, Oslo University, 3Department of Anaesthesiology, Oslo University Hospital, 4Unit of Epidemiology and Biological Statistics, 5Centre for Clinical Heart Research, Faculty of Medicine, Oslo University, Oslo, Norway Background: Totally laparoscopic aortobifemoral bypass (LABF) procedure has been shown to be feasible for the treatment of advanced aortoiliac occlusive disease (AIOD). This study compares the LABF with the open aortobifemoral bypass (OABF) operation. Methods: In this prospective comparative cohort study, 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with an LABF operation. The group was compared with 30 patients who were operated on with the OABF procedure for the same disease and time period. We had an explanatory strategy, and our research hypothesis was to compare the two surgical procedures based on a composite event (all-cause mortality, graft occlusion, and systemic morbidity). Stratification analysis was performed by using the Mantel–Haenszel method with the patient–time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoint. Results: There was a higher frequency of comorbidity in the OABF group. A significant reduction of composite event, 82% (hazard ratio 0.18; 95% CI 0.08–0.42, P=0.0001) was found in the LABF group when compared with OABF group, during a median follow-up time period of 4.12 years (range from 1 day to 9.32 years). In addition, less operative bleeding and shorter length of hospital stay were observed in the LABF group when compared with the OABF group. All components of the composite event showed the same positive effect in favor of LABF procedure. Conclusion: LABF for the treatment of AIOD, Trans-Atlantic Inter-Society Consensus II type D lesions, seems to result in a less composite event when compared with the OABF procedure. To conclude, our results need to be replicated by a randomized clinical trial. Keywords: aortic surgery, laparoscopy, atherosclerosis, aortoiliac atherosclerosis, aortobifemoral bypass, competing risk analysis, minimally invasive surgery

The aim was to evaluate the importance of the osmolarity of different oral agents for bowel distension and the level of related adverse events. The longitudinal design included the exposition of different oral MR agents on two separate occasions. Four groups of volunteers were randomly given 350 ml gastrografin of three different concentrations and water. On the second occasion they received mannitol, iohexol or iodixanol with equivalent osmolarities, but the control group (water) received mannitol. We recorded the outcomes as the degree of bowel distension determined as the mean bowel section area and the total level of discomfort recorded from a visual analogue scale (VAS). The statistical analysis included scatter plots with the best-fitted line with linear regression to study the association between osmolarity and section area and the association between osmolarity and adverse events. A dose-response association was found between increasing osmolarity levels and bowel area in square centimeters (P = 0.00001). A similar dose-response association existed between increasing levels of osmolarity and adverse events (P = 0.001). Osmolarity appears to be more important for bowel distension than the physico-chemical characteristics of the nonabsorbable oral agents. The optimum osmolarity level is determined by the patient's tolerance of the adverse events.

Intracoronary transplantation of different cell populations has been used in acute myocardial infarction (AMI) with promising results. The primary objective of the Autologous Stem cell Transplantation in Acute Myocardial Infarction (ASTAMI) study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improves left ventricular ejection fraction (LVEF) after anterior wall AMI.The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute percutaneous coronary intervention (PCI) are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 d after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow-up.By August 2004, out of 1004 patients with STEMI, 49 patients have been included in the study. Twenty-four patients have been randomized to intracoronary mBMC transplantation. Twenty patients had chest pain and 16 patients had ischemic ECG changes during the mBMC transplantation procedure. One patient had ventricular fibrillation 24 h after transplantation.Intracoronary transplantation of autologous mBMC in the acute phase after AMI is feasible and seems safe in the short term.

Background: β-Blockers have been found to reduce mortality and morbidity in postmyocardial infarction patients. However, it is not fully understood whether all β-blockers have similar favourable cardiovascular effects. The aim of this study was to compare the effects of carvedilol and atenolol on global and regional left ventricular ejection fraction (LVEF) and on predefined cardiovascular endpoints. Methods: In a single-centre, randomized, open, endpoint-blinded, parallel group study, 232 patients with acute myocardial infarction were randomized to treatment with carvedilol or atenolol. LVEF was measured by gated blood pool scintigraphy during the first week and after 12 months. The treatment was given orally within 24 h. The mean dose was 36.2 and 72.1 mg in the carvedilol and atenolol groups, respectively. Results: No significant difference was found between the two study groups in the mean global and regional LVEF. There tended to be fewer first serious cardiovascular events in the carvedilol compared with the atenolol group (RR = 0.83, 95% CI 0.56–1.23, p = 0.39). Cold hands and feet were observed less frequently in the carvedilol group (20 vs. 33%, p = 0.025). Conclusion: In patients following an acute myocardial infarction, no difference in either global or regional LVEF was observed between baseline and 12 months when treatment with carvedilol was compared with atenolol.

Objective Simple linear resection and endoventricular patch plasty are alternative techniques to repair postinfarction left ventricular aneurysm. The aim of the study was to compare these 2 methods with regard to early mortality and long-term survival. Methods We retrospectively reviewed 159 patients undergoing operations between 1989 and 2003. The epidemiologic design was of an exposed (simple linear repair, n=74) versus nonexposed (endoventricular patch plasty, n=85) cohort with 2 endpoints: early mortality and long-term survival. The crude effect of aneurysm repair technique versus endpoint was estimated by odds ratio, rate ratio, or relative risk and their 95% confidence intervals. Stratification analysis by using the Mantel-Haenszel method was done to quantify confounders and pinpoint effect modifiers. Adjustment for multiconfounders was performed by using logistic regression and Cox regression analysis. Survival curves were analyzed with the Breslow test and the log-rank test. Results Early mortality was 8.2% for all patients, 13.5% after linear repair and 3.5% after endoventricular patch plasty. When adjusted for multiconfounders, the risk of early mortality was significantly higher after simple linear repair than after endoventricular patch plasty (odds ratio, 4.4; 95% confidence interval, 1.1-17.8). Mean follow-up was 5.8 ± 3.8 years (range, 0-14.0 years). Overall 5-year cumulative survival was 78%, 70.1% after linear repair and 91.4% after endoventricular patch plasty. The risk of total mortality was significantly higher after linear repair than after endoventricular patch plasty when controlled for multiconfounders (relative risk, 4.5; 95% confidence interval, 2.0-9.7). Linear repair dominated early in the series and patch plasty dominated later, giving a possible learning-curve bias in favor of patch plasty that could not be adjusted for in the regression analysis. Conclusions Postinfarction left ventricular aneurysm can be repaired with satisfactory early and late results. Surgical risk was lower and long-term survival was higher after endoventricular patch plasty than simple linear repair. Differences in outcome should be interpreted with care because of the retrospective study design and the chronology of the 2 repair methods.