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Leadless pacemaker study assesses safety and efficacy

( LONDON, UK - A leadless cardiac pacemaker showed "good safety and reliable function" during the initial six months of follow-up in the LEADLESS II study, investigators reported during a Hot Line presentation at the ESC congress 2015. The findings, published simultaneously in the New England Journal of Medicine, suggest the device is effective and safe, and can serve as an alternative to conventional transvenous pacemakers in patients with indications for permanent pacing, said principal investigator Vivek Reddy, MD. "Leadless cardiac pacemakers have the potential to overcome many of the complications of conventional transvenous pacemakers," said Dr. Reddy, from Icahn School of Medicine at Mount Sinai in New York, NY, USA. "Transvenous leads are considered the Achilles' heel of conventional pacemakers because they are particularly susceptible to complications." LEADLESS II was a prospective, non-randomized, pre-marketing study that included 526 patients (mean age 75.8 years) from 56 sites in 3 countries. All patients had indications for permanent, single-chamber, ventricular pacing and were implanted non-surgically with an active fixation, rate-adaptive pacemaker using a steerable delivery catheter. The primary effectiveness endpoint was clinically acceptable pacing capture thresholds (? 2.0 V at 0.4 ms) and sensing (R-wave ? 5.0 mV or ? implant value) at six months, and the primary safety endpoint was freedom from serious adverse device effects (SADEs) over the same time frame. Among 300 subjects in the intention-to-treat primary analysis, the primary effectiveness and safety endpoints were met in 90.0% and 93.3% respectively, and effectiveness was met in 93.4% of successfully implanted patients. There was a 6.7% rate of SADEs over 6 months, including cardiac perforation (1.3%), device dislodgement with successful percutaneous retrieval (1.7%), and capture threshold elevation requiring percutaneous retrieval and placement of a new leadless pacemaker (1.3%). There were no device-related infections or chronic electrical failure. Among the five device dislodgements observed, device embolisation to the lung occurred in three subjects and migration to the right femoral vein in two subjects. A sub-analysis looking at complications and operator experience suggests the SADE rate "would be expected to improve with increased operator experience," noted Dr. Reddy. "With the exception of one operator, none of the other operators in this trial had any prior clinical experience with implantation of the device." When cases were stratified according to the first 10 devices implanted versus subsequent implants by the same operator, the procedural SADE, device dislodgement, and cardiac perforation rates changed from 6.8% to 3.6% (P=0.6), 1.3% to 0.0% (P=0.9), and 1.5% to 1.8% (P=0.6), respectively. "These multicenter data represent the largest population of patients to receive a leadless pacemaker system and as such provide unique insight into their efficacy and safety," concluded Dr. Reddy. "When interpreted in the context of limited prior experience of the majority of operators with this new technology, these results provide support for the applicability of this technology in routine clinical practice."



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LONDON, UK - In patients with atrial fibrillation (AF) treated with radiofrequency catheter ablation, the addition of antiarrhythmic drugs (AADs) for 90 days after the procedure did not reduce arrhythmia recurrence rates at one year, according to results of the Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) trial. Results of the study, presented as a Hot Line at ESC Congress 2015 The study did show a temporary benefit of AAD, but the effect disappeared as soon as medication was stopped, suggesting no benefit to ...

Multiple risk factors cancel impact of atrial fibrillation on ischemic stroke risk

London, UK - 30 Aug 2015: The impact of atrial fibrillation on ischaemic stroke risk in elderly patients is eliminated with multiple risk factors, according to an 11 year study in more than 425 000 patients presented at ESC Congress today.1 The findings suggest that stroke prevention in the elderly may need to focus on the concomitant effects of multiple risk factors rather than on a specific risk factor such as atrial fibrillation (AF). "The incidence of ischaemic stroke increases with greater numbers of cardiovascular risk factors," said principal investigator Dr Yutao ...

Rapid, more sensitive test speeds up chest pain triage

LONDON, England - 30 August, 2015: Patients arriving at the emergency department with chest pain suggestive of acute myocardial infarction (AMI) can be triaged more quickly and more safely using a new rapid assay with refined cut-offs, German research suggests. The Biomarkers in Acute Cardiovascular Care (BACC) study, presented as a Hot Line at ESC Congress 2015, suggests this new algorithm can reduce mortality and cut triage times to one hour, compared to the standard three-hour approach. "There is an urgent need for fast decision-making for this growing patient population," ...

Antimineralocorticoids offer no benefit in heart attack patients without heart failure

LONDON, UK - 30 August, 2015: Heart attack patients without heart failure derive no benefit from the addition of mineralocortoid receptor antagonists (MRA), to standard therapy, results of the ALBATROSS study show. The Hot Line findings, reported at ESC Congress 2015, "do not warrant the extension of MRA use" to such patients, said the study's principal investigator Gilles Montalescot, MD, PhD. MRAs, also known as aldosterone antagonists, inhibit sodium retention and excretion of potassium and magnesium, and therefore "there is an indication for MRA therapy in MI ...

Peri-infarct pacing does not improve outcomes in patients with large myocardial infarction

LONDON, UK - In patients with a large myocardical infarction (MI), pacing, with the left ventricular (LV) lead placed in the area of the lesion (peri-infarct) did not prevent further enlargement of the heart (remodeling), nor did it improve functional or clinical outcomes after 18 months, according to results of the Pacing Remodeling Prevention Therapy trial (PRomPT) trial. In MI patients with large infarcts, medical therapy and rapid restoration of blood flow to the area is not always enough to prevent cardiac remodeling. One reason for remodeling may be the response ...

Cyclosporine does not improve outcomes after PCI

LONDON, UK - 30 August, 2015: The immunosuppressant drug cyclosporine did not improve clinical outcomes compared to placebo in patients receiving percutaneous coronary intervention (PCI) for the more severe form of heart attack known as ST-segment elevation myocardial infarction (STEMI). Results of the CIRCUS trial, presented today in a Hot Line session at ESC Congress 2015, and published simultaneously in the New England Journal of Medicine. showed that the drug, administered prior to PCI, had no impact on a composite of all-cause death, hospitalisation for - or worsening ...

Surprise cardiac finding predicts future risk

LONDON, UK - In patients with chronic ischemic heart disease, a small left ventricle with thick walls, is the strongest predictor of morphologic remodelling, which is generally considered a first step towards heart failure, according to unexpected findings presented today at ESC Congress 2015. Results of the DOPPLER-CIP (which stands for "Determining Optimal non-invasive Parameters for the Prediction of Left vEntricular morphologic and functional Remodeling in Chronic Ischemic Patients") study were not expected and, if confirmed by other studies, "could completely change ...

How can we prevent suicide? Major study shows risk factors associated with depression

A major multi-national study of suicides has identified the behaviour patterns which precede many suicide attempts. This may lead to changes in clinical practice in the care of patients affected with depression, as it shows the clinical factors which confer major risk of suicide attempts. The statistics for suicide are frightening. According to the WHO, more than 800,000 people commit suicide every year, with perhaps 20 times that number attempting suicide. Suicide is one of the leading causes of death in the young (in the UK for example, it is the leading cause of death ...

Scientists show how magnetic pulses change the brain in treatment for depressed patients

A group of UK scientists have found a way of understanding how transcranial magnetic stimulation (TMS) can give relief to severely depressed patients. TMS is used as an alternative to Electro-Convulsive Therapy (ECT)*, but it is not known how it achieves its therapeutic effect. Understanding how it works may open the door to better, more targeted treatment for depression and other conditions. Transcranial magnetic stimulation works by applying a magnetic pulse to the frontal part of the brain of depressed patients. Like ECT, it seems to 'reset' the brain, but is easier ...

A single cocaine dose lowers perceptions of sadness and anger

A single dose of cocaine can interfere with the ability to recognise negative emotions, according to new research presented at the ECNP conference in Amsterdam. In a placebo-controlled within subject study, researchers from the Netherlands and Germany took 24 students (aged 19 to 27) with light to moderate cocaine use, and gave them either 300mg of oral cocaine, or a placebo. After 1 to 2 hours, each participant was then subject to a series of biochemical tests, as well as the facial emotion recognition test to measure response to a series of basic emotions, such ...


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