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Nick Freemantle

Publications and source records attributed to Nick Freemantle.

At least 19 recordsLinked to original sources
PubMed2007

Prevalence of ECG abnormalities in an international survey of patients with suspected or confirmed heart failure at death or discharge.

BACKGROUND: Most patients suspected of having heart failure (HF) will get a 12-lead electrocardiogram (ECG) but its utility for excluding HF or assisting in its management has rarely been investigated. METHODS: The EuroHeart Failure survey identified 11,327 patients hospitalised with a suspected diagnosis of HF from 115 hospitals in 24 countries. ECGs were obtained from 9315 patients, of whom 5934 had cardiac imaging tests. The utility of the ECG was assessed for excluding or diagnosing major structural heart disease (MSHD) or major left ventricular systolic dysfunction (MLVSD) and for therapeutic decision making. FINDINGS: MSHD was present in 70% and MLVSD in 54% of patients overall but in only 21% and 5%, respectively, if the ECG was entirely normal. However, <2% of patients had a normal ECG. No single ECG characteristic identified a probability <25% of MSHD or <20% of MLVSD. Patients with QRS width >or=120 ms or anterior pathological Q-waves had a probability >80% of MSHD and >70% of MLVSD. Diagnostic models suggested that electrocardiographic criteria alone were not accurate for the diagnosis or exclusion of important heart disease in this population. However, 2468 patients (42%) had an electrocardiographic finding that should be used to guide the choice of therapy. CONCLUSIONS: A normal ECG is rare in patients with suspected HF but has limited diagnostic value in this setting. The ECG has an important role in guiding therapy.

Adolescent↗
PubMed2006

Clinical trials update from the American Heart Association 2006: OAT, SALT 1 and 2, MAGIC, ABCD, PABA-CHF, IMPROVE-CHF, and percutaneous mitral annuloplasty.

This article provides information and a commentary on trials presented at the American Heart Association meeting held in November 2006, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. The OAT study failed to show a benefit of PCI over optimal medical therapy in patients with persistent total occlusion of the infarct related artery following a myocardial infarction. In SALT 1 and 2, tolvaptan was found to correct hyponatraemia of various aetiologies; however, whether this has an impact on heart failure prognosis requires further evaluation. A placebo controlled study of myocardial implantation of skeletal myoblasts in patients with moderate to severe LVSD (MAGIC) showed equivocal/uncertain effects, long term follow-up data are awaited. The ABCD study which compared the ability of an invasive and a non-invasive test to identify patients at risk of arrhythmic events prior to ICD implantation, suggested that the two strategies were comparable, although the practical value of either test remains uncertain and the study had many major flaws. The PABA-CHF study hinted that pulmonary vein antrum isolation might be more effective than AV node ablation with bi-ventricular pacing for the treatment of patients with heart failure in atrial fibrillation. In IMPROVE-CHF, an NT-pro BNP guided treatment strategy was found to reduce the cost of managing patients with acute breathlessness.

American Hospital Association↗
PubMed2006

The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator.

AIMS: Cardiac resynchronization therapy (CRT-P) is an effective treatment for patients with heart failure and cardiac dyssynchrony with moderate or severe symptoms despite pharmacological therapy. The addition of an implantable cardioverter-defibrillator (ICD) function may further reduce the risk of sudden death. We assessed the cost-effectiveness of CRT-P compared with medical therapy (MT) alone, and the cost-effectiveness of CRT-ICD + MT compared with CRT-P + MT, on incremental cost per quality adjusted life year (QALY) and life year using data from two landmark clinical trials. METHODS AND RESULTS: A Markov model with Monte Carlo simulation to assess costs, life years, and QALYs associated with CRT (+/- ICD) and MT in patients with heart failure and cardiac dyssynchrony, on the basis of a UK healthcare perspective was constructed. NYHA class distribution and transitions, associated health utilities, rates and cause of hospitalization and death were estimated from individual patient data from the CArdiac REsychronization in Heart Failure (CARE-HF trial). The estimated additional benefit on survival of an ICD was based on results from COMPANION. The base case analysis used 10 000 individual life-time simulations assuming a battery life of 6 years for CRT-P and 7 years for CRT-ICD. From a life-time perspective in a 65-year-old patient, the incremental cost-effectiveness of CRT-P compared with MT is 7538 euros (95% CI 5325-11,784 euros) per QALY gained and 7011euros (95% CI 5346-10,003 euros) per life year gained. The incremental cost-effectiveness of CRT-ICD compared with CRT-P is 47,909 euros (95% CI 35,703-79,438 euros) per QALY gained, and 35,864 euros (95% CI 26,709-56,353 euros) per life year gained. CONCLUSION: Long-term treatment with CRT-P appears cost-effective compared with MT alone. From a life-time perspective, assuming a reasonable life expectancy when receiving effective treatment for heart failure, CRT-ICD may also be considered cost-effective when compared with CRT-P + MT.

Adolescent↗
PubMed2006

The perindopril in elderly people with chronic heart failure (PEP-CHF) study.

AIMS: Many patients who receive a diagnosis of heart failure have neither a low left ventricular (LV) ejection fraction nor valve disease. Few substantial randomized controlled trials have been conducted in this population, none has focussed on patients with evidence of diastolic dysfunction and none has shown clear benefit on symptoms, morbidity, or mortality. METHODS AND RESULTS: This was a randomized double-blind trial, comparing placebo with perindopril, 4 mg/day in patients aged > or =70 years with a diagnosis of heart failure, treated with diuretics and an echocardiogram suggesting diastolic dysfunction and excluding substantial LV systolic dysfunction or valve disease. The primary endpoint was a composite of all-cause mortality and unplanned heart failure related hospitalization with a minimum follow-up of 1 year. A total of 850 patients were randomized. Their mean age was 76 (SD 5) years and 55% were women. Median follow-up was 2.1 (IQR 1.5-2.8) years. Enrollment and event rates were lower than anticipated, reducing the power of the study to show a difference in the primary endpoint to 35%. Many patients withdrew from perindopril (28%) and placebo (26%) after 1 year and started taking open-label ACE-inhibitors. Overall, 107 patients assigned to placebo and 100 assigned to perindopril reached the primary endpoint (HR 0.919: 95% CI 0.700-1.208; P = 0.545). By 1 year, reductions in the primary outcome (HR 0.692: 95% CI 0.474-1.010; P = 0.055) and hospitalization for heart failure (HR 0.628: 95% CI 0.408-0.966; P = 0.033) were observed and functional class (P < 0.030) and 6-min corridor walk distance (P = 0.011) had improved in those assigned to perindopril. CONCLUSION: Uncertainty remains about the effects of perindopril on long-term morbidity and mortality in this clinical setting since this study had insufficient power for its primary endpoint. However, improved symptoms and exercise capacity and fewer hospitalizations for heart failure in the first year were observed on perindopril, during which most patients were on assigned therapy, suggesting that it may be of benefit in this patient population.

Aged↗
PubMed2006

Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial.

OBJECTIVE: to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. DESIGN: randomised controlled trial of clinical medication review by a pharmacist against usual care. SETTING: sixty-five care homes for the elderly in Leeds, UK. PARTICIPANTS: a total of 661 residents aged 65+ years on one or more medicines. INTERVENTION: clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. MAIN OUTCOME MEASURES: primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). RESULTS: the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. CONCLUSIONS: general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.

Accidental Falls↗
PubMed2006

Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial.

BACKGROUND: Common deterrents to insulin therapy for both physicians and patients are the complexity and burden of daily injections. In January 2006, the first inhaled human insulin (INH, Exubera (insulinhuman [rDNA origin])InhalationPowder) was approved for use in adult patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the United States and European Union. Results from the INH clinical trial program have shown comparable efficacy of INH to subcutaneous (s.c.) insulin and superior efficacy versus oral antidiabetic agents; thus providing effective glycemic control in adult patients with T2DM without the requirement for preprandial injections. However, because subjects in those trials were randomized to either INH or an alternative, the studies could not estimate the effect of INH on patient acceptance of insulin therapy. Therefore, traditional study designs cannot provide answers to important and practical questions regarding real world effectiveness, which is influenced by psychological and other access barriers. METHODS: To overcome these limitations, the Real World Trial was designed to estimate the effect of the availability of INH as a treatment option for glycemic control. A total of approximately 700 patients from Canada, France, Germany, Italy, Spain, United Kingdom, and the United States with T2DM poorly controlled by oral agent therapy will be randomized to two different treatment settings. Patients and clinicians in both groups (A & B) may choose from all licensed therapies for diabetes including SC insulin delivered by pens; INH will be an additional treatment option only available in Group A. The Real World Trial (Protocol A2171018) has been registered with ClincalTrials.gov, registration id NCT00134147. RESULTS: The primary outcome for the trial will be the difference in mean glycosylated hemoglobin (HbA1c) at 6 months between groups. The design was based on a preceding feasibility study examining the theoretical effects of inhaled insulin availability on treatment choice in 779 patients. In that study, patients were three times more likely to choose insulin therapy when inhaled insulin was available. CONCLUSION: Innovations in study designs may provide an opportunity to reveal unbiased answers to important treatment questions that are more relevant to prescribers, funding agencies, and healthcare policymakers.

Journal Article↗
PubMed2006

Effect of cardiac resynchronization on the incidence of atrial fibrillation in patients with severe heart failure.

BACKGROUND: Atrial fibrillation/flutter (AF) and heart failure often coexist; however, the effect of cardiac resynchronization therapy (CRT) on the incidence of AF and on the outcome of patients with new-onset AF remains undefined. METHODS AND RESULTS: In the CArdiac REsynchronisation in Heart Failure (CARE-HF) trial, 813 patients with moderate or severe heart failure were randomly assigned to pharmacological therapy alone or with the addition of CRT. The incidence of AF was assessed by adverse event reporting and by ECGs during follow-up, and the impact of new-onset AF on the outcome and efficacy of CRT was evaluated. By the end of the study (mean duration of follow-up 29.4 months), AF had been documented in 66 patients in the CRT group compared with 58 who received medical therapy only (16.1% versus 14.4%; hazard ratio 1.05; 95% confidence interval, 0.73 to 1.50; P=0.79). There was no difference in the time until first onset of AF between groups. Mortality was higher in patients who developed AF, but AF was not a predictor in the multivariable model (hazard ratio 1.17; 95% confidence interval, 0.82 to 1.67; P=0.37). In patients with new-onset AF, CRT significantly reduced the risk for all-cause mortality and all other predefined end points and improved ejection fraction and symptoms (no interaction between AF and CRT; all P>0.2). CONCLUSIONS: Although CRT did not reduce the incidence of AF, CRT improved the outcome regardless of whether AF developed.

Aged↗
PubMed2006

Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase].

AIMS: The CArdiac REsynchronization-Heart Failure study randomized patients with left ventricular ejection fraction < or =35%, markers of cardiac dyssynchrony, and persistent moderate or severe symptoms of heart failure despite pharmacological therapy, to implantation of a cardiac resynchronization therapy (CRT) device or not. The main study observed substantial benefits on morbidity and mortality during a mean follow-up of 29.4 months [median 29.6, interquartile range (IQR) 23.6-34.6]. Prior to study closure, an extension phase lasting a further 8 months (allowing time for data analysis and presentation) was declared during which cross-over was discouraged. METHODS AND RESULTS: This was an extension of the already reported open-label randomized trial described above. The primary outcome of the extension phase was all-cause mortality from the time of randomization to completion of the extension phase. The secondary outcome was mode of death. The mean follow-up was 37.4 months (median 37.6, IQR 31.5-42.5, range 26.1-52.6 months). There were 154 deaths (38.1%) in 404 patients assigned to medical therapy and 101 deaths (24.7%) in 409 patients assigned to CRT (hazard ratio 0.60, 95% CI 0.47-0.77, P<0.0001) without evidence of heterogeneity in pre-specified subgroups. A reduction in the risk of death due to heart failure (64 vs. 38 deaths; hazard ratio 0.55, 95% CI 0.37-0.82, P=0.003) and sudden death was observed (55 vs. 32; hazard ratio 0.54, 95% CI 0.35-0.84, P=0.005). CONCLUSION: The benefits of CRT observed in the main trial persist or increase with longer follow-up. Reduction in mortality was due to fewer deaths both from worsening heart failure and from sudden death.

Aged↗
PubMed2006

PROactive study.

Explore the source record for details and available documents.

Cardiovascular Diseases↗
PubMed2006

Early onset of selective serotonin reuptake inhibitor antidepressant action: systematic review and meta-analysis.

CONTEXT: Selective serotonin reuptake inhibitors (SSRIs) are often described as having a delayed onset of effect in the treatment of depression. However, some trials have reported clinical improvement as early as the first week of treatment. OBJECTIVE: To test the alternative hypotheses of delayed vs early onset of antidepressant action with SSRIs in patients with unipolar depression. DATA SOURCES: Trials identified by searching CENTRAL, The Cochrane Collaboration database of controlled trials (2005), and the reference lists of identified trials and other systematic reviews. STUDY SELECTION: Randomized controlled trials of SSRIs vs placebo for the treatment of unipolar depression in adults that reported outcomes for at least 2 time points in the first 4 weeks of treatment (50 trials from >500 citations identified). Trials were excluded if limited to participants older than 65 years or specific comorbidities. DATA EXTRACTION: Data were extracted on trial design, participant characteristics, and outcomes by a single reviewer. DATA SYNTHESIS: Pooled estimates of treatment effect on depressive symptom rating scales were calculated for weeks 1 through 6 of treatment. In the primary analysis, the pattern of response seen was tested against alternative models of onset of response. The primary analysis incorporated data from 28 randomized controlled trials (n=5872). A model of early treatment response best fit the experimental data. Treatment with SSRIs rather than placebo was associated with clinical improvement by the end of the first week of use. A secondary analysis indicated an increased chance of achieving a 50% reduction in Hamilton Depression Rating Scale scores by 1 week (relative risk, 1.64; 95% confidence interval, 1.2-2.25) with SSRI treatment compared with placebo. CONCLUSIONS: Treatment with SSRIs is associated with symptomatic improvement in depression by the end of the first week of use, and the improvement continues at a decreasing rate for at least 6 weeks.

Adult↗
PubMed2006

Clinical trials update from the American Heart Association: REPAIR-AMI, ASTAMI, JELIS, MEGA, REVIVE-II, SURVIVE, and PROACTIVE.

This article provides information and a commentary on trials presented at the American Heart Association meeting held in November 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. In REPAIR-AMI an improvement in ejection fraction was observed in post-MI patients following infusion of bone marrow stem cells. However, the ASTAMI study showed no benefit of stem cell implantation in a similar patient cohort. The JELIS study reported a reduction in major coronary events in patients receiving statins plus fish oil compared to statins alone. MEGA showed that low dose statins in a low risk population reduce the incidence of major cardiovascular events. Two studies of levosimendan in acute heart failure gave conflicting results, in the REVIVE-II study levosimendan was reported to have a superior effect on the composite primary outcome compared to placebo, however, in SURVIVE despite a trend to early benefit with levosimendan, there was no difference in effect on long-term outcome versus dobutamine. The PROACTIVE study showed encouraging results for the use of pioglitazone in post-myocardial infarction patients with concomitant type 2 diabetes.

Clinical Trials as Topic↗
PubMed2006

Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis.

BACKGROUND: The duration and cost of cancer clinical trials could be reduced if a surrogate endpoint were used in place of survival. We did a meta-analysis to assess the extent to which two surrogates, tumour response and time to progression, are predictive of mortality in metastatic colorectal cancer and non-small-cell lung cancer. METHODS: Summary data (median time to progression, proportion of patients responding to treatment, and median overall survival) from randomised trials of first-line treatment in colorectal cancer (146 trials) and lung cancer (191 trials) were identified. Data were extracted and analysed by linear regression. We used prediction bands for trials with 250, 500, and 750 patients to identify the surrogate threshold effect that would predict a significant difference in survival. FINDINGS: Response to treatment and time to progression correlated with improvement in survival for both lung cancer (p<0.0001 and p=0.0003, respectively) and colorectal cancer (p<0.0001 for both). To predict a significant survival gain in colorectal cancer trials, an improvement of 20% in the number of patients responding to treatment was required in trials with 750 patients, increasing to 26% in trials with 500 patients and 38% in trials with 250 patients. In lung cancer trials, the same prediction required differences in response of 18% for 750 patients, 21% for 500 patients, and 30% for 250 patients. For time to progression for both cancer types, the incremental gain needed to predict a survival improvement was a median of 1.8 months for trials with 750 patients, 2.2 months for 500 patients, and 3.3 months for 250 patients. INTERPRETATION: Irrespective of trial size, large differences in tumour response rate are needed to predict a significant survival benefit. If surrogates are chosen as the primary endpoint in a clinical trial, time to progression is the preferred measure because more modest and achievable differences are needed for a significant survival benefit. Trials in metastatic lung cancer and colorectal cancer should measure survival as their primary outcome unless the surrogate outcome difference is anticipated to exceed the threshold effect size.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Development and validation of the Economic Assessment of Glycemic Control and Long-Term Effects of diabetes (EAGLE) model.

BACKGROUND: The Economic Assessment of Glycemic control and Long-term Effects of diabetes (EAGLE) model was developed to provide a flexible and comprehensive tool for the simulation of the long-term effects of diabetes treatment and related costs in type 1 and type 2 diabetes. METHODS: EAGLE simulations are based on risk equations, which were developed using published data from several large studies including the Diabetes Control and Complications Trial, the United Kingdom Prospective Diabetes Study, and the Wisconsin Epidemiological Study of Diabetic Retinopathy. Risk equations for the probability of complications (including hypoglycemia, retinopathy, macular edema, end-stage renal disease, neuropathy, diabetic foot syndrome, myocardial infarction, and stroke) were based on regression analyses, using linear, exponential, and quadratic regression formulae. Subsequent cost calculations are made from the simulated event rates. Internal validation of the EAGLE model was completed by comparing simulated event rates with the published event rates used as the basis for the model. RESULTS: EAGLE provides microsimulations of virtual patient cohorts for type 1 and type 2 diabetes over n years in 1-year cycles. Complications include microvascular and macrovascular events and death, which are calculated over time as cumulative incidences. Glycosylated hemoglobin levels over time are simulated in relation to treatment regimen. Internal validation demonstrated that each mean event rate simulated by EAGLE overlapped with the published mean event (within a range of +/-10%). CONCLUSIONS: The EAGLE model is an evidence-based, internally valid tool for the assessment of the long-term effects of diabetes treatment and related costs.

Diabetes Complications↗
PubMed2006

Pharmacokinetics of a single bolus of propofol in chinese children of different ages.

BACKGROUND: There is no information about the pharmacokinetic profile of propofol in Chinese children younger than 3 yr. This study was designed to determine a complete pharmacokinetic profile of a single dose of propofol in Chinese children of different ages. METHODS: Arterial blood samples were obtained from 35 children with an American Society of Anesthesiologist physical status of I or II at 2, 4, 6, 8, 10, 20, 30, 45, 60, 90, 120, and 180 min after a single bolus intravenous injection of propofol (3 mg/kg). The plasma concentrations of propofol were measured using high-performance liquid chromatography with an ultraviolet detector. A population model was used to estimate the pharmacokinetics of propofol. RESULTS: A three-compartment pharmacokinetic model best described the pharmacokinetics of propofol. Clearance was 0.185 l/min, the volume of distribution of the central compartment was 7.41 l, the peripheral volumes of distribution were 54.6 and 7.2 l, and the intercompartmental clearances were 0.614 and 0.692 l/min for a child of the average weight of 13.7 kg. The half-lives were 2.67, 14.89, and 310.60 min. Covariate models were applied, and weight was found to be significant covariate for the clearance and volume of distribution parameters. No significant age effect could be demonstrated on clearance or volume of distribution parameters after weight was taken into account. CONCLUSIONS: This study supports the case that the pharmacokinetic properties of propofol do not differ substantially across Chinese children of different ages after weight has been accounted for.

Aging↗
PubMed2006

Do shock absorbing insoles in recruits undertaking high levels of physical activity reduce lower limb injury? A randomized controlled trial.

OBJECTIVES: To assess the benefits, if any, of the use of shock absorbing insoles in reducing lower limb injury among Air Force recruits, and to assess the differences, if any, in the efficacy of two commonly available shock absorbing insoles. DESIGN: Randomized controlled trial. SETTING: RAF Halton, UK. Site of all basic training for RAF personnel. PARTICIPANTS: 1205 recruits participating in basic training between 17 September 2003 and 7 April 2004. INTERVENTIONS: Participants were randomized to receive either standard issue Saran non-shock absorbing insoles, or shock absorbing Sorbothane or Poron insoles, on a 1:1:1 basis. MAIN OUTCOME MEASURES: The primary outcome measure was withdrawal from training for lower limb injury. The two primary comparisons were shock absorbing insole versus non-shock absorbing insole, and Sorbothane versus Poron (comparison of different shock absorbing insoles). Secondary outcomes were medical withdrawals for reasons other than those qualifying for the primary outcome measure. RESULTS: When comparing the non-shock absorbing insole to the shock absorbing insoles 72/401 participants (18.0%) allocated to Saran insoles were removed from training because of a qualifying lower limb injury, compared with 149/804 (18.5%) allocated to the shock absorbing insole (Sorbothane or Poron), odds ratio 1.04 (95% CI 0.75 to 1.44; P=0.87). When comparing the two shock absorbing insole 73/421 participants (17.3%) randomized to Sorbothane were removed from training because of a qualifying lower limb injury, compared with 76/383 for Poron (19.8%), odds ratio 0.85 (95% CI 0.58 to 1.23; P=0.37). CONCLUSIONS: Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial. The trial provides no support for a change in policy to the use of shock absorbing insoles for military recruits.

Adolescent↗
PubMed2005

Baseline echocardiographic characteristics of heart failure patients enrolled in a large European multicentre trial (CArdiac REsynchronisation Heart Failure study).

AIMS: Information on the prevalence and clinical, electrocardiographic and echocardiographic inter-relationships of mechanical dyssynchrony among patients with heart failure (HF) and left ventricular systolic dysfunction derives mainly from relatively small studies. The CARE-HF trial provides the opportunity to address these issues in a large population of patients with advanced HF. METHODS AND RESULTS: The CARE-HF trial enrolled patients with New York Heart Association (NYHA) class III or IV HF, with a QRS duration > or =120 ms, left ventricular (LV) ejection fraction (EF) < or =35% and LV end diastolic diameter > or =30 mm/m (height in m). Patients underwent a thorough echocardiographic evaluation, which included assessment of LV structure, systolic function, mitral inflow pattern, right ventricular (RV) dimensions and function, and interventricular mechanical delay (IVMD) as an index of interventricular dyssynchrony. Echocardiographic measurements were made in a Core Laboratory to ensure consistent quantitative analysis. Of the 813 patients enrolled, 735 had a baseline echocardiographic examination suitable for measurement. Overall patients had advanced LV dysfunction (mean EF 25.5%) but few had a restrictive mitral filling pattern (18%) and both the mean RV diameter and RV function were within normal limits. Interventricular dyssynchrony defined as IVMD >40 ms was present in 455 patients (62%). Clinical, electrocardiographic and standard echocardiographic variables were only loosely associated with IVMD. CONCLUSIONS: Interventricular dyssynchrony appears to be an independent characteristic of patients with advanced HF, and is poorly related to clinical, electrocardiographic or standard echocardiographic variable.

Aged↗
PubMed2005

The clinical impact of implantable loop recorders in patients with syncope.

AIMS: Implantable loop recorders (ILR) provide an opportunity to record ECG data from a spontaneous syncopal event. We conducted a randomized study to investigate the impact of the Reveal Plus ILR on an unselected population of patients with recurrent syncope. Initial follow-up (at least 6 months) did not demonstrate a reduction in syncopal events or an improvement in quality of life. We report the planned extension of follow-up to 18 months. METHODS AND RESULTS: All patients presenting acutely with recurrent unexplained syncope over a 16-month period, following a basic clinical work-up, were randomized to receive the ILR or conventional investigation and management. A total of 421 patients presented, 201 were eligible, median age 74, (IQ range 61-81) 54% female, with median syncopes 3 (IQ range 2-6). Median follow-up 17 months (IQ range 9-23). 42 (43%) of ILR patients and 8 (6%) of conventional patients received an ECG diagnosis (hazard ratio 6.53, 95% CI 3.73-11.4, P<0.001). Time to second syncope was significantly longer for ILR patients, although of borderline significance (P=0.04). A greater variety of diagnoses and treatments were seen in ILR patients. ILR patients had fewer post-randomization investigations and fewer days in hospital; however, cost savings were not statistically significant. There was improved quality of life in the ILR group (visual analogue scales, P=0.03) for general wellbeing. Overall mortality was 12% with no difference between the two groups. CONCLUSION: Investigation by the ILR significantly increases the diagnostic rate and ECG directed treatments in a typical unselected syncopal population. Long-term follow-up has demonstrated a significant subsequent reduction in syncopal events with improved quality of life.

Aged↗