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Age-specific performance of the revised cardiac risk index for predicting cardiovascular risk in elective noncardiac surgery.

https://arctichealth.org/en/permalink/ahliterature266490
Source
Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):103-8
Publication Type
Article
Date
Jan-2015
Author
Charlotte Andersson
Mads Wissenberg
Mads Emil Jørgensen
Mark A Hlatky
Charlotte Mérie
Per Føge Jensen
Gunnar H Gislason
Lars Køber
Christian Torp-Pedersen
Source
Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):103-8
Date
Jan-2015
Language
English
Publication Type
Article
Keywords
Adult
Age Distribution
Age Factors
Aged
Aged, 80 and over
Brain Ischemia - etiology
Cardiovascular Diseases - diagnosis - etiology - mortality
Comorbidity
Decision Support Techniques
Denmark
Elective Surgical Procedures
Female
Humans
Logistic Models
Male
Middle Aged
Multivariate Analysis
Myocardial Infarction - etiology
Odds Ratio
Registries
Retrospective Studies
Risk assessment
Risk factors
Stroke - etiology
Surgical Procedures, Operative - adverse effects - mortality
Time Factors
Treatment Outcome
Abstract
The revised cardiac risk index (RCRI) holds a central role in preoperative cardiac risk stratification in noncardiac surgery. Its performance in unselected populations, including different age groups, has, however, not been systematically investigated. We assessed the relationship of RCRI with major adverse cardiovascular events in an unselected cohort of patients undergoing elective, noncardiac surgery overall and in different age groups.
We followed up all individuals = 25 years who underwent major elective noncardiac surgery in Denmark (January 1, 2005, to November 30, 2011) for the 30-day risk of major adverse cardiovascular events (ischemic stroke, myocardial infarction, or cardiovascular death). There were 742 of 357,396 (0.2%), 755 of 74.889 (1.0%), 521 of 11,921 (4%), and 257 of 3146 (8%) major adverse cardiovascular events occurring in RCRI classes I, II, III, and IV. Multivariable odds ratio estimates were as follows: ischemic heart disease 3.30 (95% confidence interval, 2.96-3.69), high-risk surgery 2.70 (2.46-2.96), congestive heart failure 2.65 (2.29-3.06), cerebrovascular disease 10.02 (9.08-11.05), insulin therapy 1.62 (1.37-1.93), and kidney disease 1.45 (1.33-1.59). Modeling RCRI classes as a continuous variable, C statistic was highest among age group 56 to 65 years (0.772) and lowest for those aged >85 years (0.683). Sensitivity of RCRI class >I (ie, having = 1 risk factor) for capturing major adverse cardiovascular events was 59%, 71%, 64%, 66%, and 67% in patients aged = 55, 56 to 65, 66 to 75, 76 to 85, and >85 years, respectively; the negative predictive values were >98% across all age groups.
In a nationwide unselected cohort, the performance of the RCRI was similar to that of the original cohort. Having = 1 risk factor was of moderate sensitivity, but high negative predictive value for all ages.
PubMed ID
25587095 View in PubMed
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Antiarrhythmic therapy and risk of death in patients with atrial fibrillation: a nationwide study.

https://arctichealth.org/en/permalink/ahliterature150959
Source
Europace. 2009 Jul;11(7):886-91
Publication Type
Article
Date
Jul-2009
Author
Søren Skøtt Andersen
Morten Lock Hansen
Gunnar H Gislason
Tina Ken Schramm
Fredrik Folke
Emil Fosbøl
Steen Z Abildstrøm
Mette Madsen
Lars Køber
Christian Torp-Pedersen
Author Affiliation
Department of Cardiology, Gentofte University Hospital, Niels Andersens Vej 65, Hellerup, Copenhagen DK-2900, Denmark. ssa@heart.dk
Source
Europace. 2009 Jul;11(7):886-91
Date
Jul-2009
Language
English
Publication Type
Article
Keywords
Aged
Anti-Arrhythmia Agents - therapeutic use
Atrial Fibrillation - drug therapy - mortality
Cohort Studies
Denmark - epidemiology
Female
Humans
Incidence
Male
Middle Aged
Proportional Hazards Models
Registries
Risk assessment
Risk factors
Survival Analysis
Survival Rate
Treatment Outcome
Abstract
To examine the risk of death associated with antiarrhythmic drug (AAD) therapy in a nationwide unselected cohort of patients with atrial fibrillation (AF).
All patients admitted with AF in Denmark from 1995 to 2004 and their subsequent use of AADs were identified by individual-level linkage of nationwide registries. Multivariable Cox proportional-hazard models with time-dependent covariates were used to analyse the risk of death associated with AAD therapy. A total of 141,500 patients were included in the study; of these 3356 (2.4%) patients received treatment with flecainide, 3745 (2.6%) propafenone, 23,346 (16.5%) sotalol, and 10,376 (7.3%) amiodarone. Annualized mortality rates were 2.54, 4.25, 5.29, and 7.42 per year per 100 person years for flecainide, propafenone, sotalol, and amiodarone, respectively. Multivariable Cox proportional-hazard models did not show increased risk of death associated with any of the AADs. Hazard ratio (95% confidence interval) for flecainide 0.38 (0.32-0.44), propafenone 0.65 (0.58-0.71), sotalol 0.65 (0.63-0.67), and amiodarone 0.94 (0.89-1.00).
In an unselected cohort of patients with AF, antiarrhythmic treatment with flecainide, propafenone, sotalol, or amiodarone was not associated with increased risk of death. From a safety perspective, this indicates appropriate selection of patients for AAD therapy.
Notes
Comment In: Europace. 2009 Jul;11(7):840-119546183
Comment In: Europace. 2009 Jul;11(7):837-919546182
PubMed ID
19443433 View in PubMed
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Antithrombotic treatment in patients with heart failure and associated atrial fibrillation and vascular disease: a nationwide cohort study.

https://arctichealth.org/en/permalink/ahliterature104350
Source
J Am Coll Cardiol. 2014 Jun 24;63(24):2689-98
Publication Type
Article
Date
Jun-24-2014
Author
Morten Lamberts
Gregory Y H Lip
Martin H Ruwald
Morten Lock Hansen
Cengiz Özcan
Søren L Kristensen
Lars Køber
Christian Torp-Pedersen
Gunnar H Gislason
Author Affiliation
Department of Cardiology, Gentofte University Hospital, Hellerup, Copenhagen, Denmark. Electronic address: mortenlamberts@gmail.com.
Source
J Am Coll Cardiol. 2014 Jun 24;63(24):2689-98
Date
Jun-24-2014
Language
English
Publication Type
Article
Keywords
Aged
Aged, 80 and over
Atrial Fibrillation - diagnosis - drug therapy - epidemiology
Cohort Studies
Denmark - epidemiology
Female
Fibrinolytic Agents - therapeutic use
Follow-Up Studies
Heart Failure - diagnosis - drug therapy - epidemiology
Hospitalization - trends
Humans
Male
Middle Aged
Registries
Retrospective Studies
Treatment Outcome
Vascular Diseases - diagnosis - drug therapy - epidemiology
Abstract
The aim of this study was to investigate the impact of atrial fibrillation (AF) and antithrombotic treatment on the prognosis in patients with heart failure (HF) as well as vascular disease.
HF, vascular disease, and AF are pathophysiologically related, and understanding antithrombotic treatment for these conditions is crucial.
In hospitalized patients with HF and coexisting vascular disease (coronary artery disease or peripheral arterial disease) followed from 1997 to 2009, AF status was categorized as prevalent AF, incident AF, or no AF. Risk of thromboembolism (TE), myocardial infarction (MI), and serious bleeding was assessed by Cox regression models (hazard ratio [HR] with 95% confidence interval [CI]) with antithrombotic therapy and AF as time-dependent variables.
A total of 37,464 patients were included (age, 74.5 ± 10.7 years; 36.3% females) with a mean follow-up of 3 years during which 20.7% were categorized as prevalent AF and 17.2% as incident AF. Compared with vitamin K antagonist (VKA) in prevalent AF, VKA plus antiplatelet was not associated with a decreased risk of TE (HR: 0.91; 95% CI: 0.73 to 1.12) or MI (HR: 1.11; 95% CI: 0.96 to 1.28), whereas bleeding risk was significantly increased (HR: 1.31; 95% CI: 1.09 to 1.57). Corresponding estimates for incident AF were HRs of 0.77 (95% CI: 0.56 to 1.06), 1.07 (95% CI: 0.89 to 1.28), and 2.71 (95% CI: 1.33 to 2.21) for TE, MI, and bleeding, respectively. In no AF patients, no statistical differences were seen between antithrombotic therapies in TE or MI risk, whereas bleeding risk was significantly increased for VKA with and without single-antiplatelet therapy.
In AF patients with coexisting HF and vascular disease, adding single-antiplatelet therapy to VKA therapy is not associated with additional benefit in thromboembolic or coronary risk, but notably increased bleeding risk.
Notes
Comment In: J Am Coll Cardiol. 2014 Jun 24;63(24):2699-70124794117
PubMed ID
24794118 View in PubMed
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Comparison of the clinical outcome of different beta-blockers in heart failure patients: a retrospective nationwide cohort study.

https://arctichealth.org/en/permalink/ahliterature260851
Source
Eur J Heart Fail. 2014 Jun;16(6):678-84
Publication Type
Article
Date
Jun-2014
Author
Rasmus Bølling
Nikolai Madrid Scheller
Lars Køber
Henrik Enghusen Poulsen
Gunnar H Gislason
Christian Torp-Pedersen
Source
Eur J Heart Fail. 2014 Jun;16(6):678-84
Date
Jun-2014
Language
English
Publication Type
Article
Keywords
Adrenergic beta-Antagonists - therapeutic use
Aged
Cohort Studies
Denmark
Female
Follow-Up Studies
Heart Failure - drug therapy - mortality
Hospitalization - statistics & numerical data
Humans
Male
Middle Aged
Proportional Hazards Models
Retrospective Studies
Survival Analysis
Treatment Outcome
Abstract
To compare survival on different beta-blockers in heart failure.
We identified all Danish patients =35?years of age who were hospitalized with a first admission for heart failure and who initiated treatment with a beta-blocker within 60?days of discharge. The study period was 1995-2011. The main outcome was all-cause mortality and all-cause hospitalization. Cox proportional hazard models were used to compare survival. The study included 58?634 patients of whom 30.121 (51.4%) died and 46.990 (80.1%) were hospitalized during follow-up. The mean follow-up time was 4.1?years. In an unadjusted model carvedilol was associated with a lower mortality [hazard ratio (HR) 0.737, 0.714-0.761] compared with metoprolol (reference) while bisoprolol was not associated with an increased mortality (HR 1.020, 0.973-1.069). In a model adjusted for possible confounders and stratified according to beta-blocker dosages, patients that received high-dose carvedilol (=50?mg daily) had a lower all-cause mortality risk (HR 0.873, 0.789-0.966) than patients receiving high-dose (=200?mg daily) metoprolol (reference). High-dose bisoprolol (=10?mg daily) was associated with a greater risk of death (HR 1.125, 1.004-1.261). High-dose carvedilol was associated with significantly lower all-cause hospitalization risk (HR 0.842, 0.774-0.915) than high-dose metoprolol (reference), while high-dose bisoprolol had insignificantly lower risk than high-dose metoprolol (HR 0.948, 0.850-1.057).
Heart failure patients receiving high-dose carvedilol (=50?mg daily) showed significantly lower all-cause mortality risk and hospitalization risk, compared with other beta-blockers.
Notes
Comment In: Eur J Heart Fail. 2014 Jun;16(6):595-724863629
PubMed ID
24706485 View in PubMed
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Driveline infections in patients supported with a HeartMate II: incidence, aetiology and outcome.

https://arctichealth.org/en/permalink/ahliterature134820
Source
Scand Cardiovasc J. 2011 Oct;45(5):273-8
Publication Type
Article
Date
Oct-2011
Author
Tobias Bomholt
Claus Moser
Kaare Sander
Søren Boesgaard
Lars Køber
Peter Skov Olsen
Peter Bo Hansen
Svend-Aage Mortensen
Finn Gustafsson
Author Affiliation
Rigshospitalet, Department of Cardiology, University Hospital of Copenhagen, Denmark.
Source
Scand Cardiovasc J. 2011 Oct;45(5):273-8
Date
Oct-2011
Language
English
Publication Type
Article
Keywords
Adult
Anti-Bacterial Agents - therapeutic use
Biological Markers - blood
C-Reactive Protein - analysis
Chi-Square Distribution
Denmark - epidemiology
Escherichia coli - isolation & purification
Escherichia coli Infections - blood - drug therapy - epidemiology - microbiology
Female
Heart Failure - therapy
Heart-Assist Devices - adverse effects
Humans
Incidence
Kaplan-Meier Estimate
Leukocyte Count
Male
Middle Aged
Predictive value of tests
Prosthesis Design
Prosthesis-Related Infections - blood - epidemiology - microbiology - therapy
Retrospective Studies
Risk assessment
Risk factors
Sensitivity and specificity
Staphylococcal Infections - blood - drug therapy - epidemiology - microbiology
Staphylococcus aureus - isolation & purification
Treatment Outcome
Young Adult
Abstract
To investigate the incidence and outcome of driveline infections in patients supported with a continuous flow left ventricular assist device (HeartMate II (HMII)) and to study the microbiological aetiology.
Retrospective analysis of 31 patients who received an implantation of a HMII. Follow-up was from implantation to either device explantation, death or closure of the study. Clinical signs of infections were divided into superficial, deep or systemic and compared to culture and gram stain, the clinical course and infectious parameters.
The incidence of driveline infections was 1.65 episodes per patient per year. Staphylococcus aureus and Escherichia coli were the most common bacterial aetiology. More than two weeks of treatment was required in 81% of the patients. In terms of detecting superficial driveline infections, leucocyte count demonstrated a sensitivity of 27% and C-reactive protein (CRP) a sensitivity of 28%. In 22 cases of driveline infections plasma pro-calcitonin was found to be normal.
Driveline infections are common in HMII recipients but primarily remain superficial and are reasonably easy to manage. Infectious agents mostly originate from the skin and gastrointestinal tract. Blood biomarkers did not appear to be helpful in detecting driveline infections.
PubMed ID
21539474 View in PubMed
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Duration of clopidogrel treatment and risk of mortality and recurrent myocardial infarction among 11 680 patients with myocardial infarction treated with percutaneous coronary intervention: a cohort study.

https://arctichealth.org/en/permalink/ahliterature145748
Source
BMC Cardiovasc Disord. 2010;10:6
Publication Type
Article
Date
2010
Author
Rikke Sørensen
Steen Z Abildstrom
Peter Weeke
Emil L Fosbøl
Fredrik Folke
Morten L Hansen
Peter R Hansen
Jan K Madsen
Ulrik Abildgaard
Lars Køber
Henrik E Poulsen
Christian Torp-Pedersen
Gunnar H Gislason
Author Affiliation
Department of Cardiology, Copenhagen University Hospital Gentofte, Niels Andersens Vej 65, 2900 Hellerup, Denmark. rs@heart.dk
Source
BMC Cardiovasc Disord. 2010;10:6
Date
2010
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary - mortality - trends
Cohort Studies
Denmark - epidemiology
Female
Follow-Up Studies
Humans
Male
Middle Aged
Myocardial Infarction - drug therapy - mortality - prevention & control
Recurrence - prevention & control
Registries
Retrospective Studies
Risk factors
Ticlopidine - administration & dosage - analogs & derivatives
Time Factors
Treatment Outcome
Abstract
The optimal duration of clopidogrel treatment after percutaneous coronary intervention (PCI) is unclear. We studied the risk of death or recurrent myocardial infarction (MI) in relation to 6- and 12-months clopidogrel treatment among MI patients treated with PCI.
Using nationwide registers of hospitalizations and drug dispensing from pharmacies we identified 11 680 patients admitted with MI, treated with PCI and clopidogrel. Clopidogrel treatment was categorized in a 6-months and a 12-months regimen. Rates of death, recurrent MI or a combination of both were analyzed by the Kaplan Meier method and Cox proportional hazards models. Bleedings were compared between treatment regimens.
The Kaplan Meier analysis indicated no benefit of the 12-months regimen compared with the 6-months in all endpoints. The Cox proportional hazards analysis confirmed these findings with hazard ratios for the 12-months regimen (the 6-months regimen used as reference) for the composite endpoint of 1.01 (confidence intervals 0.81-1.26) and 1.24 (confidence intervals 0.95-1.62) for Day 0-179 and Day 180-540 after discharge. Bleedings occurred in 3.5% and 4.1% of the patients in the 6-months and 12-months regimen (p = 0.06).
We found comparable rates of death and recurrent MI in patients treated with 6- and 12-months' clopidogrel. The potential benefit of prolonged clopidogrel treatment in a real-life setting remains uncertain.
Notes
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PubMed ID
20113477 View in PubMed
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Early echocardiographic deformation analysis for the prediction of sudden cardiac death and life-threatening arrhythmias after myocardial infarction.

https://arctichealth.org/en/permalink/ahliterature108735
Source
JACC Cardiovasc Imaging. 2013 Aug;6(8):851-60
Publication Type
Article
Date
Aug-2013
Author
Mads Ersbøll
Nana Valeur
Mads Jønsson Andersen
Ulrik M Mogensen
Michael Vinther
Jesper Hastrup Svendsen
Jacob Eifer Møller
Joseph Kisslo
Eric J Velazquez
Christian Hassager
Peter Søgaard
Lars Køber
Author Affiliation
The Heart Centre, Department of Cardiology, Rigshospitalet, Copenhagen University, Copenhagen, Denmark. mads.ersboell@gmail.com
Source
JACC Cardiovasc Imaging. 2013 Aug;6(8):851-60
Date
Aug-2013
Language
English
Publication Type
Article
Keywords
Aged
Arrhythmias, Cardiac - etiology - mortality - physiopathology - prevention & control
Death, Sudden, Cardiac - etiology - prevention & control
Defibrillators, Implantable
Denmark
Echocardiography - methods
Electric Countershock - instrumentation
Female
Humans
Male
Middle Aged
Multivariate Analysis
Myocardial Infarction - complications - mortality - physiopathology - therapy - ultrasonography
Predictive value of tests
Primary Prevention
Proportional Hazards Models
Prospective Studies
Risk factors
Stroke Volume
Treatment Outcome
Ventricular Function, Left
Abstract
This study sought to hypothesize that global longitudinal strain (GLS) as a measure of infarct size, and mechanical dispersion (MD) as a measure of myocardial deformation heterogeneity, would be of incremental importance for the prediction of sudden cardiac death (SCD) or malignant ventricular arrhythmias (VA) after acute myocardial infarction (MI).
SCD after acute MI is a rare but potentially preventable late complication predominantly caused by malignant VA. Novel echocardiographic parameters such as GLS and MD have previously been shown to identify patients with chronic ischemic heart failure at increased risk for arrhythmic events. Risk prediction during admission for acute MI is important because a majority of SCD events occur in the early period after hospital discharge.
We prospectively included patients with acute MI and performed echocardiography, with measurements of GLS and MD defined as the standard deviation of time to peak negative strain in all myocardial segments. The primary composite endpoint (SCD, admission with VA, or appropriate therapy from a primary prophylactic implantable cardioverter-defibrillator [ICD]) was analyzed with Cox models.
A total of 988 patients (mean age: 62.6 ± 12.1 years; 72% male) were included, of whom 34 (3.4%) experienced the primary composite outcome (median follow-up: 29.7 months). GLS (hazard ratio [HR]: 1.38; 95% confidence interval [CI]: 1.25 to 1.53; p
Notes
Comment In: JACC Cardiovasc Imaging. 2013 Aug;6(8):861-323948377
PubMed ID
23850252 View in PubMed
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Echocardiographic and clinical findings in patients with Fabry disease during long-term enzyme replacement therapy: a nationwide Danish cohort study.

https://arctichealth.org/en/permalink/ahliterature285496
Source
Scand Cardiovasc J. 2017 Aug;51(4):207-216
Publication Type
Article
Date
Aug-2017
Author
Christoffer Valdorff Madsen
Henning Bundgaard
Åse Krogh Rasmussen
Søren Schwartz Sørensen
Jørgen Holm Petersen
Lars Køber
Ulla Feldt-Rasmussen
Helle Petri
Source
Scand Cardiovasc J. 2017 Aug;51(4):207-216
Date
Aug-2017
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Arrhythmias, Cardiac - diagnosis - etiology
Denmark
Disease Progression
Echocardiography
Electrocardiography, Ambulatory
Enzyme Replacement Therapy
Fabry Disease - complications - diagnostic imaging - drug therapy
Female
Humans
Hypertrophy, Left Ventricular - diagnostic imaging - etiology
Isoenzymes - therapeutic use
Male
Middle Aged
Predictive value of tests
Retrospective Studies
Time Factors
Treatment Outcome
Young Adult
alpha-Galactosidase - therapeutic use
Abstract
In patients with Fabry disease (FD), left ventricular hypertrophy and arrhythmias are frequently observed and cardiac involvement is the leading cause of death. Long-term efficacy of enzyme replacement therapy (ERT) on cardiac involvement is unclear. We assessed and compared long-term progression of cardiac involvement according to ERT and non-ERT.
We retrospectively assessed and compared long-term progression of cardiac involvement in adult patients with FD in the nationwide Danish cohort. We followed clinical signs, symptoms and findings by echocardiography, electrocardiography and Holter-monitoring.
We included 66 patients; 47 patients (27 women) received ERT (ERT group) and 19 patients (15 women) did not (non-ERT group). The groups were followed for a median of 8 [0-12] years and 6 [0-13] years, respectively. Comparison between ERT and non-ERT receiving patients by left ventricular mass (echocardiographic assessment) and Sokolow-Lyon voltage- and Cornell product criteria (electrocardiographic assessment) revealed no significant differences. In the ERT group, we observed no change in left ventricular mass but a decrease in Sokolow-Lyon voltage- and Cornell product criteria from baseline to follow-up; 30?mm [15-53] vs. 25?mm [3-44], p?
PubMed ID
28545342 View in PubMed
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Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

https://arctichealth.org/en/permalink/ahliterature112942
Source
Trials. 2013;14:104
Publication Type
Article
Date
2013
Author
Kirstine Laerum Sibilitz
Selina Kikkenborg Berg
Tina Birgitte Hansen
Signe Stelling Risom
Trine Bernholdt Rasmussen
Christian Hassager
Lars Køber
Daniel Steinbrüchel
Christian Gluud
Per Winkel
Lau Caspar Thygesen
Jane Lindschou Hansen
Jean Paul Schmid
Viviane Conraads
Barbara Christina Brocki
Ann-Dorthe Zwisler
Author Affiliation
The Heart Centre, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. kirstine.laerum.sibilitz@rh.regionh.dk
Source
Trials. 2013;14:104
Date
2013
Language
English
Publication Type
Article
Keywords
Cardiac Surgical Procedures - adverse effects - economics - mortality - psychology - rehabilitation
Clinical Protocols
Combined Modality Therapy
Cost-Benefit Analysis
Denmark
Exercise Test
Exercise Therapy - economics
Health Care Costs
Health Knowledge, Attitudes, Practice
Heart Valve Diseases - economics - mortality - physiopathology - psychology - rehabilitation - surgery
Humans
Mental health
Oxygen consumption
Patient Education as Topic - economics
Postoperative Care
Questionnaires
Recovery of Function
Referral and Consultation - economics
Research Design
Time Factors
Treatment Outcome
Abstract
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery.
A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study.
The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).
ClinicalTrials.gov (http://NCT01558765).
Notes
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PubMed ID
23782510 View in PubMed
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Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: randomised trial.

https://arctichealth.org/en/permalink/ahliterature120014
Source
BMJ. 2012;345:e6409
Publication Type
Article
Date
2012
Author
Louise Lind Schierbeck
Lars Rejnmark
Charlotte Landbo Tofteng
Lis Stilgren
Pia Eiken
Leif Mosekilde
Lars Køber
Jens-Erik Beck Jensen
Author Affiliation
Department of Endocrinology, Hvidovre Hospital, Kettegård alle 30, 2650 Hvidovre, Denmark. louise.schierbeck@gmail.com
Source
BMJ. 2012;345:e6409
Date
2012
Language
English
Publication Type
Article
Keywords
Breast Neoplasms - mortality
Contraceptives, Oral, Synthetic - therapeutic use
Denmark - epidemiology
Estradiol - therapeutic use
Estrogens - therapeutic use
Female
Follicle Stimulating Hormone - blood
Follow-Up Studies
Heart Failure - mortality
Hormone Replacement Therapy - adverse effects - methods - mortality
Hospitalization
Humans
Middle Aged
Myocardial Infarction - mortality
Neoplasms - mortality
Norethindrone - analogs & derivatives - therapeutic use
Postmenopause
Prospective Studies
Risk
Stroke - epidemiology
Time Factors
Treatment Outcome
Venous Thrombosis - mortality
Abstract
To investigate the long term effect of hormone replacement therapy on cardiovascular outcomes in recently postmenopausal women.
Open label, randomised controlled trial.
Denmark, 1990-93.
1006 healthy women aged 45-58 who were recently postmenopausal or had perimenopausal symptoms in combination with recorded postmenopausal serum follicle stimulating hormone values. 502 women were randomly allocated to receive hormone replacement therapy and 504 to receive no treatment (control). Women who had undergone hysterectomy were included if they were aged 45-52 and had recorded values for postmenopausal serum follicle stimulating hormone.
In the treatment group, women with an intact uterus were treated with triphasic estradiol and norethisterone acetate and women who had undergone hysterectomy received 2 mg estradiol a day. Intervention was stopped after about 11 years owing to adverse reports from other trials, but participants were followed for death, cardiovascular disease, and cancer for up to 16 years. Sensitivity analyses were carried out on women who took more than 80% of the prescribed treatment for five years.
The primary endpoint was a composite of death, admission to hospital for heart failure, and myocardial infarction.
At inclusion the women on average were aged 50 and had been postmenopausal for seven months. After 10 years of intervention, 16 women in the treatment group experienced the primary composite endpoint compared with 33 in the control group (hazard ratio 0.48, 95% confidence interval 0.26 to 0.87; P=0.015) and 15 died compared with 26 (0.57, 0.30 to 1.08; P=0.084). The reduction in cardiovascular events was not associated with an increase in any cancer (36 in treated group v 39 in control group, 0.92, 0.58 to 1.45; P=0.71) or in breast cancer (10 in treated group v 17 in control group, 0.58, 0.27 to 1.27; P=0.17). The hazard ratio for deep vein thrombosis (2 in treated group v 1 in control group) was 2.01 (0.18 to 22.16) and for stroke (11 in treated group v 14 in control group) was 0.77 (0.35 to 1.70). After 16 years the reduction in the primary composite outcome was still present and not associated with an increase in any cancer.
After 10 years of randomised treatment, women receiving hormone replacement therapy early after menopause had a significantly reduced risk of mortality, heart failure, or myocardial infarction, without any apparent increase in risk of cancer, venous thromboembolism, or stroke.
ClinicalTrials.gov NCT00252408.
Notes
Comment In: Evid Based Med. 2013 Oct;18(5):176-723328969
Comment In: BMJ. 2012;345:e8141; author reply e816423208255
Comment In: Ann Intern Med. 2013 Feb 19;158(4):JC223420251
Comment In: BMJ. 2012;345:e8149; author reply e816423208258
Comment In: BMJ. 2012;345:e8146; author reply e816423208257
Comment In: BMJ. 2012;345:e8144; author reply e816423208256
PubMed ID
23048011 View in PubMed
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