FDA Approves AliveCor Personal ECG Monitor for Apple Watch

The Food and Drug Administration has approved a wrist-worn version of the groundbreaking KardiaMobile from AliveCor, the company has announced. It's the next step in AliveCor's bid to do for the Apple Watch what it did for the iPhone: turn it into a single-channel ECG monitor.

The new AliveCor product, KardiaBand, is a wristband for the Apple Watch equipped with a sensor the user presses with a thumb. Via the company's Kardia mobile app, the ECG and heart rate are soon displayed on the watch's screen.

"This is a paradigm shift for cardiac care as well as an important advance in healthcare," Dr Ronald P Karlsberg (David Geffen School of Medicine, University of California, Los Angeles) is quoted as saying in the company announcement. "With an [ECG] device on the wrist, afib can be detected wherever the patient is, 24 hours a day." Users must subscribe to a $99/year service to use the KardiaBand system, the company notes in its announcement. That allows the user to email ECG recordings, among other things.

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Amsterdam to Host EU Drug Agency

BRUSSELS (Reuters) - Amsterdam won the right to host the EU's EMA drug agency when it leaves London after Brexit after the Dutch city tied with Milan in a vote on Monday that was then decided by the drawing of lots, diplomatic sources said.

 The Council of the European Union confirmed the choice of Amsterdam to host the European Medicines Agency (EMA) but gave no official account of the three rounds of vote which ended with disappointment for the Italian favourite in a lucky dip. The outcome was welcomed by European pharmaceuticals bodies.
 The EMA had warned that many of its staff might quit, possibly disrupting healthcare in Europe, if governments had chosen a less attractive host city, notably in the ex-communist east. Eastern governments were left empty-handed when a first round of voting among eight candidates to host the European Banking Authority (EBA) snubbed Warsaw and Prague. Paris, Frankfurt and Dublin went through to the second round, diplomats said, with Paris only slightly ahead of the other two.

Sources familiar with the meeting of national ministers from the 27 EU states other than Britain said Milan had been just two votes short of outright victory in a second round of voting for the EMA, securing 12 votes to 9 for Amsterdam and 5 for Copenhagen, which was knocked out.
But the abstention of one country -- one diplomat said it was Slovakia, whose capital Bratislava was pipped into fourth place in the first round -- saw a 13-13 result in the third-round runoff.
The Estonian minister chairing the meeting had to step in under the rules to draw lots to decide the winner -- an outcome veteran diplomats said they believed was unprecedented.

 In all, 19 cities had bid for the prestige and economic boost that the arrival of the EMA's 900 staff and many offices for international pharmaceuticals companies will bring. Slovak capital Bratislava, the leading contender in ex-communist eastern Europe, came in fourth in the first round of voting. Ministers went on to vote for one of eight cities hoping to host the smaller European Banking Authority (EBA), which sets rules used by the European Central Bank to carry out stress tests of the banking sector in the bloc. Share/Bookmark


Botox Injections to the Heart?

New research suggests epicardial botulinum toxin injections may reduce the all-too-common complication of postoperative atrial fibrillation (POAF), known to increase morbidity and affect 30% to 50% of patients after cardiac surgery.

The researchers turned to the neurotoxin, which reduces the release of acetylcholine from nerve terminals, because of the role autonomic imbalance plays in the development of AF. When injected near cardiac autonomic nerves in epicardial fat pads, botulinum toxin acts in an anticholinergic fashion on the atrium, shortening atrial effective refractory periods and blocking induction of AF, explained author and anesthesiologist Dr Nathan Waldron (Duke University School of Medicine, Durham, NC).

more: Medscape Share/Bookmark


News from American Heart Association Scientific Sessions (AHA) 2017/Hypertension

New ACC/AHA Hypertension Guidelines Make 130 the New 140

The American College of Cardiology (ACC) and the American Heart Association (AHA) have released a new guideline on hypertension with a new definition that will call 130 to 139 mm Hg systolic and or 80 to 89 mm Hg stage 1 hypertension.

"Lifestyle modification is the cornerstone of the treatment of hypertension. Specific recommendations include advice to lose weight, follow a DASH-pattern diet, reduce sodium to less than 1500 mg/day and increase potassium intake to 3500 mg/day through dietary intake, increase physical activity to a minimum of 30 minutes of exercise three times per week, and limit alcohol intake to two drinks or less per day for men and one or less for women.



Optical Coherence Tomography: Modest Benefit in PCI

ROME, ITALY — The first randomized trial to investigate the use of optical coherence tomography (OCT) in PCI has suggested that the procedure is safe and may be associated with some benefit[1].

The DOCTORS study was presented today at the European Society of Cardiology (ESC) 2016 Congress and simultaneously published online in Circulation.
The OCT technology visualizes the artery and stent placements, allowing the operator to make alterations on stent expansions and positioning. The intravascular procedure allows improved plaque characterization and can lead to improvements in lesion coverage, stent expansion, or apposition, explained lead investigator Dr Nicolas Meneveau (University Hospital Jean Minjoz, Besançon, France). Downsides of its use include prolonged procedural time and higher exposure to contrast media, as well as the cost issue.
The main result of DOCTORS study showed a modest 2-point improvement in fractional flow reserve (FFR) in NSTEMI patients undergoing PCI guided by OCT compared with those undergoing PCI guided by fluoroscopy alone.
Meneveau said: "This is a small absolute benefit in FFR, but it was statistically significant." Asked whether this would be clinically relevant, he said couldn't comment on that, although it is known that an increase in FFR is associated with a reduction in clinical outcomes. "We obviously need a clinical end-point study to look at clinical benefit," he commented
He added: "But we did show that OCT affected physician decision making, leading to a change in procedural strategy in half of cases, most commonly optimization of stent expansion. The benefit was obtained at the cost of a longer procedure with higher fluoroscopy time and more contrast medium, but without an increase in periprocedural MI or kidney dysfunction."
Meneveau said he also could not comment on whether the benefit shown in this study was worth the additional exposure to contrast media.

"Important Milestone "
In an accompanying editorial in Circulation[2], Dr William Wijns (National University of Ireland, Galway) and Dr Stylianos A Pyxaras (Medizinische Klinik, Coburg, Germany) note that invasive imaging such as OCT or intravascular ultrasound (IVUS) is used extensively in Japan and a little in the US and Asia but is almost nonexistent in Europe. They say that the intracoronary images obtained with these approaches give the physician significant information, but their use is restricted by reimbursement issues, as they have not been shown to affect patient outcomes. They therefore describe the DOCTORS study as an "important milestone" to accumulate global evidence to support the role of OCT guidance during complex PCI and to extend the guidelines supporting its use.

"Safety Encouraging" Senior author of the study, Dr François Schiele (University Hospital Jean Minjoz, Besançon, France), told heartwire from Medscape that he was encouraged by the safety results in the study. "When the DOCTORS study was conceived, I was concerned about possibility of side effects, as this is a very invasive intervention and prolongs the PCI procedure. But we didn't show any harm. The safety side actually looks good. This is valuable information, as OCT is widely used in many centers and we need to know that it is safe." On the benefit, Schiele said: "Although the overall benefit was only two units in FFR, which is a modest amount, it could have an impact. We know that an increase in FFR is linked to reduced outcomes. But for some patients the FFR increase was much higher and would be likely linked to a clinical benefit." He explained that at present OCT is often used before PCI if information is missing on angiography, particularly if it is an important artery such as the left main that is being stented. "But actually we found that it gave us much more useful information after stenting to identify incomplete expansion or malapposition . . . so we can fix those problems."

For the study, 240 NSTEMI patients were randomized to OCT-guided PCI (use of OCT pre- and post-PCI) or to standard fluoroscopy-guided PCI.

Results showed that OCT use led to a change in procedural strategy in 50% of patients. Post-PCI OCT revealed stent underexpansion in 42% of patients, stent malapposition in 32%, incomplete lesion coverage in 20%, and edge dissection in 37.5%. This led to the more frequent use of poststent overdilation in the OCT-guided group vs the angiography-guided group (43% vs 12.5%, P

With thanks to heart.org and European Society of Cardiology (ESC) Congress 2016Share/Bookmark


Gene discovery points to new treatments for heart disease

The findings could also lead to new treatments for other common diseases.

A gene discovery could pave the way for the development of new treatments for heart disease, after researchers found that it is responsible for blood vessel formation, or angiogenesis. The findings have resulted from an international research collaboration part-funded by the British Heart Foundation (BHF). The paper was published in the journal Nature Communications.

Researchers found that when they turned off the gene, called Wars2, in rats and zebrafish, there was reduced blood vessel growth both in the heart and throughout the rest of the body. This has confirmed the vital role of the Wars2 gene in blood vessel formation.

The Wars2 gene has previously been linked to obesity and cancer in large genetic studies, known as Genome Wide Association Studies (GWAS), which look for versions of genes which are common among people with a disease. Researchers are able to see if a gene is associated with a particular condition.

The heart muscle relies on a constant supply of blood, to keep blood pumping around the body. Coronary heart disease is just one of the diseases where this supply of blood is implicated, and the heart muscle has a reduced blood supply. The discovery of the Wars2 gene will allow scientists to test new molecules to find ways of enhancing the effect of the gene to increase the blood supply to the heart.

In contrast, diseases such as breast cancer, could be targeted with treatments aimed at blocking the function of the gene. Cancerous tumours rely on a blood supply which provides them with nutrients and oxygen in order to grow and proliferate. Blocking Wars2 and reducing blood vessel formation could starve tumour cells from the outside in.

Professor Stuart Cook, who led the study, is head of the Cardiovascular Genetics and Genomics group within Genetics & Imaging at the National Heart and Lung Institute (NHLI). He said:

"Angiogenesis is vital for supporting life and providing nutrients to all parts of the body.

"Finding a way to control angiogenesis not only provides a target for the development of anti-cancer therapies, but may also prove useful in similarly starving abnormal blood vessel growth elsewhere in the body, like in diabetic eye disease."

Dr Rizwan Ahmed, at Royal Brompton & Harefield NHS Foundation Trust, who worked on the study, said: "We are now one step closer to improving heart function in people with an obstructed or reduced blood flow to the heart muscle. Our findings could lead to new treatments to stimulate blood vessel production in the heart. "The next step is to find medications to activate blood vessel production specifically in the heart muscle, using this gene. This research was an important step forward to help us target a gene known to be important in a range of conditions."

Professor Jeremy Pearson, Associate Medical Director at the British Heart Foundation, which helped fund the research, said: "This careful genetic study has found a new gene that controls cardiac blood vessel growth, opening up the potential for new therapies to enhance blood supply to the failing heart. "This new insight into the role of Wars2 in blood vessel growth will allow researchers around the world to explore a fresh new target to treat diseases which are characterised by impaired blood vessel formation."

The research was also supported by the Medical Research Council (MRC), Leducq Foundation, Tanoto Foundation Singapore, NMRC Singapore, Goh Foundation Singapore, Ministry of Education, Youth and Sports of the Czech Republic, The Czech Science Foundation, NIHR Cardiovascular Biomedical Research Unit at Royal Brompton & Harefield NHS Foundation Trust, London, UK. European Union EURATRANS award, Helmholtz Alliance ICEMED, Deutsche Forschungsgemeinschaft from Grant Agency of the Ministry of Health of the Czech Republic.
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Virtual heart reveals new clues to heart failure

Scientists have produced a detailed computer model of a heart that shows the electrophysiology of congestive heart failure, according to a study published in PLOS Computational Biology.

Congestive heart failure (CHF) is a leading cause of death in the United States.
According to the Centers for Disease Control and Prevention (CDC), around 5.7 million Americans have heart failure.

About half of the people who are diagnosed with this condition die within 5 years of diagnosis.

Heart failure does not mean that the heart has stopped, or will stop, completely. It refers to a condition in which the heart is not able to pump enough blood for the body to function properly. As a result of heart failure, fluid and blood can back up into the lungs, the person may experience tiredness, breathlessness, and edema, or a buildup of fluid in the legs, ankles, and feet.

Heart failure can happen as a result of coronary artery disease, high blood pressure, and diabetes.
It is more likely to affect people over the age of 65 years, and especially those who are overweight. People who have previously had a heart attack are more at risk. It tends to affect men more than women. However, the mechanisms that cause it, including its electrophysiological (EP) mechanisms, are not well understood. It is hoped that the new "virtual heart" could benefit the development of new drugs to treat the disease.

Tweaking an existing model gives insight into heart's workings The researchers, from the University of California-San Diego, CA, modified an existing model of a healthy rabbit heart to create their simulation.

The model is able to simulate small changes in the heart, from the cellular and tissue levels, up to the whole heart.

An electrocardiogram (ECG) is a tool commonly used by doctors use to diagnose heart abnormalities.

The team hopes to use the numerical model they have created to link changes that occur at the cellular and tissue level when a heart fails to a numerically computed ECG. This, they hope, will help to pinpoint what it is that triggers ventricular fibrillation (VF), and to identify the risk of VF.

At the cellular and tissue levels, the model can replicate the heart's reactions to changes in the levels and flow of calcium, sodium, and potassium. It also can take into account the speed at which the ion channels - which take in those ions - function. At the whole-heart level, it can also show what happens in a healthy, working heart as a result of variations in the different critical chemicals and electrophysiologic components.

New insight into VF VF is a common cause of sudden death. During VF, the electrical waves that occur in the heart break up chaotically. When this happens, it affects the timing of the heart's pumping action. The heart can no longer contract and pump blood to the rest of the body.

Using the new model, researchers in the current study found that this fragmentation and loss of coordination can be caused by a slowdown in cellular processes at the top of the heart. This can lead to heart failure. To learn more about the causes of VF in a person with heart failure, the team set up a test that would simulate a person with heart failure performing physical exercise.
The results suggest that a patient with heart failure who experiences a fast heart rate and variable pacing will be more susceptible to VF. This, they say, is because of a newly identified mechanism that blocks conduction.

The researchers have shown that the model can be used to plan a new drug strategy to prevent the type of fibrillation that is associated with heart failure.
With thanks to MNTShare/Bookmark
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