Wood Street Clinic Blog

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Heart valves made from tissue rather than metal may be better for middle-aged patients

Both valve options have similar patient survival rates, different risks.

Patients between the ages of 40 and 70 who undergo aortic valve replacement (AVR) may fare better with tissue-based valves rather than metal-based valves, according to a review article posted online by The Annals of Thoracic Surgery.

Key Points:

Middle-age patients (aged 40 to 70 years) undergoing aortic valve replacement should strongly consider tissue-based valves over metal-based valves. Patients with both valve types tend to have similar risks for survival and certain complications at 15-years post-surgery. Bioprosthetic valves wear out more quickly, but patients receiving mechanical valves need lifelong treatment with blood thinners.

Mechanical (metal) valves and bioprosthetic (tissue) valves have different benefits and risks, leading to sometimes difficult choices for patients. Mechanical valves have the potential to last longer because they don't wear out, but blood clots tend to form on them so patients must take blood thinners (anticoagulants) for the rest of their lives. Bioprosthetic valves are less likely to cause blood clots, but are less durable and may need to be replaced in the future.

"We combined the best available evidence comparing mechanical valves versus bioprosthetic valves to determine the risks and benefits to patients following surgery, depending on the type of valve they received," said James J. Wu, BMusStudies, from The University of Sydney in Australia. "We hope that our results can give future patients needing AVR more information to help them choose the appropriate replacement valve for their condition."

Wu, Paul G. Bannon, MBBS, PhD, and other colleagues in Australia evaluated 13 studies comparing mechanical valves and bioprosthetic valves in middle-age patients (age 40 to 70 years) undergoing AVR.

At 15-years post-surgery, the researchers found no difference in survival, stroke rate, or rate of endocarditis (infection of the heart lining) among patients with either valve; however, each patient group showed different complications. Patients with bioprosthetic valves were twice as likely as mechanical valve patients to need re-operation because of worn-out valves, while patients with mechanical valves were twice as likely to experience a major bleeding event or a blood clot.

Because patients with major bleeding had a significant increase of death compared to those needing reoperation, the researchers said bioprosthetic valves should strongly be considered for patients in this age group, though valve choice should be individualized for each patient.

"This is a complex decision that requires up-to-date evidence. There are options to reduce the bleeding risk of mechanical valves, so, ideally, a discussion with both the surgeon and cardiologist is warranted to take into account an individual's circumstances," said Dr. Bannon.

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Statin use before heart surgery reduces complications

A recent review, published in The Annals of Thoracic Surgery, shows that statin use before and after heart surgery might reduce complications and risk of death. The study comes as evidence mounts in favor of continued statin use around the time of surgery.
[Diagram of heart]
Statin use may increase survival rates and decrease negative outcomes in cardiac surgery.

According to the Centers for Disease Control and Prevention (CDC), cholesterol-lowering medication is used by 28% of Americans over the age of 40, and statins account for more than 90% of these drugs.

Dr. Amr F. Baraka, from the Cleveland Clinic Foundation, OH, took a look at the effects of statins on a number of cardiac surgery outcomes.

Currently, it is common practice to stop statin use before and after surgery. Dr. Baraka's team wanted to investigate whether this pause in statin use was indeed beneficial, or if a continued program of statins might improve patient outcomes.

The review is the latest in a growing line of studies investigating statin's usage around the time of surgery. The review backs up previous findings and adds additional evidence.

It seems that surgical guidelines for the safe usage of statins might soon be changed.

What are statins?

Cholesterol is an essential ingredient in the cell walls of animals, but in large amounts, it can wreak havoc on health. Statins substantially reduce cholesterol levels by interrupting its production.

Statins inhibit an enzyme called HMG-CoA reductase, the enzyme responsible for creating cholesterol in the liver. Statins are also believed to help the body break down and reabsorb existing cholesterol plaques that might be dotted around the blood vessels of the body.

Alongside statin's use as a cholesterol-reducer, it is also being investigated for its potential therapeutic uses in dementia, lung and prostate cancer, hypertension and other diseases.

Statins and surgery

Heart surgery candidates often have a number of medical issues and, consequently, use a number of prescription drugs. Some medications can interact with the anesthetic used during surgery and may have other negative interactions. For this reason, prior to an operation, it is recommended that many medications are stopped, including statins.

Dr. Baraka, in conjunction with a team from the University of Florida in Gainesville, reviewed relevant research on Medline. They examined statin use before and after coronary artery bypass grafting and evaluated the outcomes.

Coronary artery bypass grafting procedures, as with any major surgery, can cause a serious inflammatory reaction. This inflammation can lead to postoperative complications.

The present review showed that statin use before surgery was well tolerated and that the benefits, including a reduction of atrial fibrillation, outweighed any potential negative side effects.

Although statins are predominantly utilized for their cholesterol-reducing prowess, they also have anti-inflammatory activities and promote blood flow; this could be the origin of their beneficial outcomes.

Dr. Baraka says:

"Previous research has shown that discontinuation of the medication at the time of surgery is common practice. The results of our review call for proactive efforts to counsel patients and surgeons about the benefit of statins - a benefit that definitely outweighs the risk of rare potential side effects."

The research could not define what statin dosage might be optimal; more research will be necessary before full recommendations can be rolled out.

"The current evidence suggested that the benefit of statin use in reducing the risk of stroke, heart attack, or kidney problems after surgery is not well established," says Dr. Baraka. "Further research is needed to study these associations to determine if the benefits of statins expand beyond cardiac complications."

Previous investigations into pre-operative statins

This report adds further weight to previous work investigating the same question. A Cochrane review published in August 2015 found that the use of statins before cardiac surgery "resulted in a reduction in postoperative atrial fibrillation and a shorter stay both on the ICU and in the hospital."

The Cochrane team also found that pretreatment was associated with a reduction in myocardial infarction and renal failure, but these findings were not statistically significant.

Another study published in the European Heart Journal in September 2015 looked at the statin question from a slightly different angle. The trial reported on the outcomes of more than 15,000 patients undergoing non-cardiac operations.

The team concluded that, even in patients who were not having heart-based interventions, statins had a positive influence on recovery:

"Pre-operative statin therapy was independently associated with a lower risk of cardiovascular outcomes at 30 days."

The authors of the European Heart Journal study ended their paper with a call for larger studies. Dr. Baraka's work is just that; it adds another chunk of evidence supporting statin's safety and its benefits in conjunction with surgery.

Medical News Today recently reported on research showing that negative news stories about statins add to heart health risks.

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Even small reductions in kidney function may damage heart, blood vessels

Even small reductions in kidney function are associated with heart and blood vessel damage, according to new research in the American Heart Association's journal Hypertension.

"Even in very healthy people, a small reduction in kidney function from normal to just a bit below normal was associated with an increase in the mass of the left ventricle, a change that makes the heart stiffer and impairs its ability to contract," said Jonathan Townend, M.D., senior author of the paper and professor of cardiology at the Queen Elizabeth Hospital Birmingham in Edgbaston, United Kingdom.

For years, it has been known that people with long-standing kidney disease are at increased risk of heart disease.

"Mild chronic kidney disease is common, affecting over 10 percent of the U.S. population, so if kidney disease really is a cause of heart disease it may be a major public health problem," Townend said. However, since kidney disease patients commonly have other risk factors, such as high blood pressure and diabetes, the direct effect of diminishing kidney function on the heart has been uncertain.

To look for a direct link, the researchers tracked an extremely healthy group of people - living kidney donors - to see whether the decreases in kidney function that occur after donation were associated with heart and blood vessel changes.

Researchers compared 68 kidney donors (average age 47) with 56 controls (average age 44) through the first year after surgery. Compared with controls, the researchers found that kidney donors had:

An expected decline in kidney function (as measured by the glomerular filtration rate and the appearance of the protein albumin in the urine). An increase in the mass of the left ventricle, a strong predictor of heart disease risk. An increase in measures of heart damage apparent in blood tests, such as troponin. No difference in blood pressure.

"This is evidence that reduction in kidney function itself leads directly to measurable adverse effects on the heart and blood vessels, even without other risk factors. More research is needed to know just what aspects of reduced kidney function are responsible for the effects," Townend said.

As for kidney donors, the researchers urge them not to worry about the new findings.

"Kidney donors are already highly selected as healthy individuals. Our paper has shown that kidney donation causes very small adverse effects on the heart and blood vessels that took careful and accurate measurements to detect. We do not yet know if these effects are maintained over the long term. Even if there is a small increase in your long-term risk of heart disease after donation, it is still likely that you will be at lower than average risk, Townend said.

Researchers suggest that all people discuss heart disease risk, and ways to lower it, with their physicians if medical tests indicate reduced kidney function.

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Exercise reduces heart disease risk in depressed patients

Symptoms of mild to minimal depression were associated with early indicators of heart disease in a research letter published today in the Journal of the American College of Cardiology, but the study found regular exercise seems to reduce the adverse cardiovascular consequences of depression.

Depression has been linked to an increased risk of heart disease and other physical ailments, and depression is commonly associated with worse outcomes for patients with heart disease and other conditions. In addition, as many as 20 percent of people hospitalized with a heart attack report symptoms of depression, while patients with heart disease have three times the risk of developing depression compared to the general population.

Researchers from Emory University Hospital in Atlanta set out to learn more about the relationship between depressive symptoms and heart disease. They studied 965 people who were free of heart disease and who had no prior diagnosis of an affective, psychotic or anxiety disorder. Researchers used questionnaires to evaluate patients for depression and levels of physical activity. They also looked a several early indicators of heart disease.

Researchers found arterial stiffening and inflammation - the early heart disease indicators - that accompany worsening depressive symptoms were more pronounced in people who were inactive. The indicators were less common in subjects engaging in regular physical activity.

"Our findings highlight the link between worsening depression and cardiovascular risk and support routinely assessing depression in patients to determine heart disease risk. This research also demonstrates the positive effects of exercise for all patients, including those with depressive symptoms," said study author Arshed A. Quyyumi, M.D., co-director of the Emory Clinical Cardiovascular Research Institute in Atlanta. "There are many patients with heart disease who also experience depression - we need to study whether encouraging them to exercise will reduce their risk of adverse outcomes."

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

Copyright Medical News Today: Excluding email/sharing services explicitly offered on this website, material published on Medical News Today may not be reproduced, or distributed without the prior written permission of Medilexicon International Ltd. Please contact us for further details.

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The impact of shift work on health

When Dolly Parton sang of working 9 to 5, she expressed concern for people barely getting by with a hard life of routine that only seems to benefit the boss. But what about all those people working less conventional hours, including night shifts? Shouldn't Ms. Parton be just as concerned about their welfare?
Doctors sleeping a corridor.
Shift workers, such as doctors, flight attendants, bartenders and police officers, have been found to be at a greater risk of certain chronic diseases.

Shift work has its own demands that set it apart from jobs with traditional working hours. Shift work has its benefits; it can be more convenient from a child care perspective, is sometimes better paid and can allow workers time for other activities, such as study.

However, the medical and scientific communities are continually reporting that shift work can increase the risk of certain disorders and have a negative impact on the overall well-being of employees.

In this article, we take a look at what has been reported recently about the effects of shift work, what reasons could possibly be behind these findings and what people working shifts can potentially do to lower their risks of various health problems.

Shift work in the US

Shift work tends to be classified as any work schedule that involves hours that are irregular or unusual in comparison with the traditional daytime work schedule that usually occurs between 6 am and 6 pm.

The term shift work can, for this reason, refer to working evenings, overnight, rotating shifts or irregular employer-arranged shift patterns.

According to an article published in 2000 by the Bureau of Labor Statistics (BLS), over 15 million (16.8 %) full-time wage and salary workers are employed working alternative shifts. Of these, the most common alternative shifts are evening shifts, with working hours usually between 2 pm and midnight, and irregular shifts with a constantly changing schedule.

In contrast, the University of California-Los Angeles (UCLA) Sleep Disorders Center reports more than 22 million Americans work evening, rotating or on-call shifts.

Recently, the BLS reported that the proportion of full-time wage and salary workers employed working alternative shifts now sits at 14.8%. This figure is supported by a poll conducted by the National Sleep Foundation (NSF) in 2005, which found 14% of Americans work shifts.

While there has been a slight drop in the number of white Americans working these hours - from 16.2% in 1997 to 13.7% in 2004 - the proportion of black, Asian and Latino Americans working alternative shifts has remained largely the same. In May 2004, the percentages for these groups were 20.8%, 15.7% and 16%, respectively.

Shift work is most commonly found within industries that provide services around the clock, such as food services, transportation, health services and protective services like the police force.

At first glance, it appears as though the main factor connecting shift workers is that they work different hours to the typical "9-to-5" routine. However, multiple studies report that there is something else that connects bar staff, long-distance truck drivers, nurses and police officers - an increased risk for certain diseases.

Previous studies reported by MNT

Medical News Today have reported on various studies associating shift work with an increased risk of certain health problems. These associations have ranged from the somewhat predictable to the surprising.

In July 2014, a meta-analysis published in Occupational and Environmental Medicine suggested that shift workers face an increased risk of type 2 diabetes. In particular, people working rotating shifts face an increased risk of 42%.

[Blood sugar test]
A 2014 study suggested shift work may raise the risk of type 2 diabetes.

The authors theorized that rotating shifts made it more difficult for workers to maintain a regular sleep-wake cycle, negatively affecting sleep quality and potentially weakening insulin resistance.

Then, in November 2014, another study published in the same journal suggested that shift work could impair the functioning of the brain.

Study participants who were currently working or had previously worked shifts scored lower in tests assessing memory, processing speed and overall brain power than participants working traditional daytime hours.

"The cognitive impairment observed in the present study may have important safety consequences not only for the individuals concerned, but also for society as a whole," wrote the study authors, "given the increasing number of jobs in high hazard situations that are performed at night."

More recently, a study published in the American Journal of Preventive Medicine reported that female nurses working rotating night shifts for 5 or more years could be at an increased risk of all-cause and cardiovascular disease mortality.

In addition, working rotating night shifts for 15 years or more was found to potentially raise the risk of lung cancer mortality.

A quick perusal of these studies indicates another factor that shift workers are likely to have in common - disruptions to the sleep-wake cycle. Shift work can lead to workers sleeping at strange or varying times of day, potentially resulting in reduced amounts of sleep.

But how much of an impact can sleep disruption have on an individual's health?

On the next page, we look at what circadian rhythms are and what can be done to protect the health of shift workers.

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New coronary congenital disease classification aids identification of secondary defects

Surgeons given heads up on further defects to look for when operating.

A new classification of coronary congenital diseases is set to help surgeons identify secondary defects in the operating theatre. The scheme is outlined in a novel European Society of Cardiology (ESC) position paper published yesterday in Cardiovascular Research. Clinical cardiologists will also know what to look for on cardiovascular images.

"It can be difficult to spot further defects in the stressful environment of the operating theatre."

"Coronary congenital diseases affect less than 1% of newborns but are an important cause of myocardial infarction and sudden death particularly in children and competitive athletes," said Professor Cristina Basso, chairperson of the ESC Development, Anatomy and Pathology Working Group. "These conditions are often forgotten in the clinical setting since atherosclerotic coronary artery disease is far more common."

Coronary arteries are the blood vessels that nourish the heart muscle. Disruption of coronary development during embryogenesis results in coronary congenital defects that change blood flow. These defects can severely affect cardiovascular health.

The paper launches a new classification of coronary artery anomalies that explains common points of origin between different coronary defects. By identifying the origin of the primary defect, doctors can evaluate the probability of finding specific secondary defects with an origin mechanistically related to the main anomaly.

First author Dr José María Pérez-Pomares said: "We have established links between coronary congenital diseases sharing a common mechanism. When operating a diagnosed coronary anomaly, it can be difficult for surgeons to spot further defects in the stressful environment of the operating theatre and having an idea of the anomalies you might find can be extremely helpful. The new classification will also help clinicians using imaging to diagnose coronary artery anomalies and prevent future complications."

He added: "We have been able to produce this classification because we understand more about how coronary arteries develop in the embryo and how they relate to major diseases. The paper provides basic cardiovascular research scientists with new, updated information on the complex embryonic development of coronary arteries to throw light on the aetiology of coronary congenital anomalies."

The authors give their expert opinion on the embryonic origin of the coronary endothelium, which is a controversial topic in cardiovascular developmental biology. Dr Pérez-Pomares said: "For a long time scientists have wanted to identify a single and unique source for coronary endothelial cells but we now know that they come from different sources that merge together. This appears to have an impact on what happens to coronary vessels during embryonic development but perhaps also in the adult."

Although not explicitly stated in the paper, the authors think that this heterogeneity of cell sources contributing to the endothelium may be important in the development of adult coronary disease, as endothelial cells with different origins might respond differentially to pathological stimuli.

The diverse origin of coronary smooth muscle cells and fibroblasts are also described. Remarkably, adventitial fibroblasts that cover the arteries share a common embryonic origin with adult interstitial fibroblasts located between the myocardial fibres which are responsible for fibrotic scar formation after myocardial infarction. This finding also suggests that embryonic cues related to coronary development could be relevant for understanding cardiac fibrosis in the adult ischaemic heart.

The authors say that this "mosaic-like embryonic development of the coronary vascular system" is key to understanding the complex spectrum of coronary artery anomalies. Dr Pérez-Pomares said: "The more we dig in, the more we have the impression that important events happening in the embryo, including the activation of regulatory gene networks, signalling molecular pathways and specific cellular mechanisms also have a clear function in adult responses to pathological stimuli."

Professor Basso concluded: "This is a translational paper written by basic scientists, including developmental biologists, anatomists and pathologists. It contains practical information to help clinicians diagnose coronary artery anomalies and prevent devastating complications including sudden death."

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New coronary congenital disease classification aids identification of secondary defects

A new classification of coronary congenital diseases is set to help surgeons identify secondary defects in the operating theatre. The scheme is outlined in a novel European Society of Cardiology (ESC) position paper published in Cardiovascular Research. Clinical cardiologists will also know what to look for on cardiovascular images.

"It can be difficult to spot further defects in the stressful environment of the operating theatre."

"Coronary congenital diseases affect less than 1% of newborns but are an important cause of myocardial infarction and sudden death particularly in children and competitive athletes," said Professor Cristina Basso, chairperson of the ESC Development, Anatomy and Pathology Working Group. "These conditions are often forgotten in the clinical setting since atherosclerotic coronary artery disease is far more common."

Coronary arteries are the blood vessels that nourish the heart muscle. Disruption of coronary development during embryogenesis results in coronary congenital defects that change blood flow. These defects can severely affect cardiovascular health.

The paper launches a new classification of coronary artery anomalies that explains common points of origin between different coronary defects. By identifying the origin of the primary defect, doctors can evaluate the probability of finding specific secondary defects with an origin mechanistically related to the main anomaly.

First author Dr José María Pérez-Pomares said: "We have established links between coronary congenital diseases sharing a common mechanism. When operating a diagnosed coronary anomaly, it can be difficult for surgeons to spot further defects in the stressful environment of the operating theatre and having an idea of the anomalies you might find can be extremely helpful. The new classification will also help clinicians using imaging to diagnose coronary artery anomalies and prevent future complications."

He added: "We have been able to produce this classification because we understand more about how coronary arteries develop in the embryo and how they relate to major diseases. The paper provides basic cardiovascular research scientists with new, updated information on the complex embryonic development of coronary arteries to throw light on the aetiology of coronary congenital anomalies."

The authors give their expert opinion on the embryonic origin of the coronary endothelium, which is a controversial topic in cardiovascular developmental biology. Dr Pérez-Pomares said: "For a long time scientists have wanted to identify a single and unique source for coronary endothelial cells but we now know that they come from different sources that merge together. This appears to have an impact on what happens to coronary vessels during embryonic development but perhaps also in the adult."

Although not explicitly stated in the paper, the authors think that this heterogeneity of cell sources contributing to the endothelium may be important in the development of adult coronary disease, as endothelial cells with different origins might respond differentially to pathological stimuli.

The diverse origin of coronary smooth muscle cells and fibroblasts are also described. Remarkably, adventitial fibroblasts that cover the arteries share a common embryonic origin with adult interstitial fibroblasts located between the myocardial fibres which are responsible for fibrotic scar formation after myocardial infarction. This finding also suggests that embryonic cues related to coronary development could be relevant for understanding cardiac fibrosis in the adult ischaemic heart.

The authors say that this "mosaic-like embryonic development of the coronary vascular system" is key to understanding the complex spectrum of coronary artery anomalies. Dr Pérez-Pomares said: "The more we dig in, the more we have the impression that important events happening in the embryo, including the activation of regulatory gene networks, signalling molecular pathways and specific cellular mechanisms also have a clear function in adult responses to pathological stimuli."

Professor Basso concluded: "This is a translational paper written by basic scientists, including developmental biologists, anatomists and pathologists. It contains practical information to help clinicians diagnose coronary artery anomalies and prevent devastating complications including sudden death."

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Using skin to save the heart

Following a heart attack or other heart trauma, the heart is unable to replace its dead cells. Patients are often left with little option other than heart transplants, which are rarely available, or more recently cell therapies that transplant heart cells into the patient's heart. In far too many cases, however, the transplanted heart cells do not engraft well, resulting in poor recovery.

One reason for the engraftment problem is the quality of the heart cells. For a typical cell therapy, heart cells are made from different stem cells, but the quality of the heart cells will vary. In particular, the maturation of the heart cells will be different. "Cells of different maturation will be mixed and transplanted together," said Dr. Shunsuke Funakoshi, a scientist at the Center for iPS Research and Applications (CiRA), Kyoto University, and first author of a new study that investigated the optimal maturation of heart cells for the transplant, leading him to wonder if maturation is a factor in engraftment.

Under the direction of Senior Lecturer Yoshinori Yoshida, Funakoshi took induced pluripotent stem (iPS) cells that were reprogrammed from skin cells and made them into heart cells. Heart cells differentiated from iPS cells effectively go through all stages of development. "Heart cells at different stages could behave very differently," said Fukakoshi. He therefore prepared heart cells of different maturation and transplanted them into damaged hearts of living mice. Hearts that received cells differentiated for 20 days showed much better engraftment than those that received cells differentiated for more or less, suggesting there exists an optimal maturation stage for cell therapies. However, Funakoshi cautions which day for human patients cannot be determined from this study. "We need to test animals bigger than mice," he said.

Currently, over a billion cells are needed for human heart cell therapies. Knowing which cells are best for the therapy should not only improve patient outcome, but also reduce the number of cells required, which would further reduce both the time of the preparation and invasiveness of the procedure.

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

Copyright Medical News Today: Excluding email/sharing services explicitly offered on this website, material published on Medical News Today may not be reproduced, or distributed without the prior written permission of Medilexicon International Ltd. Please contact us for further details.

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New touchless device makes earlier detection of heart problems possible

Researchers at the University of Waterloo have developed a revolutionary system for monitoring vital signs that could lead to improved detection and prevention of some cardiovascular issues, as well as greater independence for older adults.

Using patent-pending technology called Coded Hemodynamic Imaging, the device is the first portable system that monitors a patient's blood flow at multiple arterial points simultaneously and without direct contact with the skin. It is ideal for assessing patients with painful burns, highly contagious diseases, or infants in neonatal intensive care whose tiny fingers make traditional monitoring difficult.

"Traditional systems in wide use now take one blood-pulse reading at one spot on the body. This device acts like many virtual sensors that measure blood-flow behaviour on various parts of the body. The device relays measurements from all of these pulse points to a computer for continuous monitoring," said Robert Amelard, a PhD candidate in systems design engineering at Waterloo and recipient of the prestigious Alexander Graham Bell Canada Graduate Scholarship from the Natural Sciences and Engineering Research Council of Canada. "By way of comparison, think of measuring the traffic flow across an entire city rather than through one intersection."

Continuous data collection at different parts of the body provides a more complete picture of what's happening in the body. Whole-body imaging opens doors for advanced monitoring that can't be done with the traditional, single-point methods.

"Since the device can also scan multiple patients individually at once and from a distance, consider the potential in mass emergency scenarios or long-term care homes," said Professor Alexander Wong, of the Faculty of Engineering at Waterloo and Canada Research Chair in Medical Imaging Systems. "This technology provides for a more predictive approach to monitor vitals and the potential for its use is extensive, such as indicating arterial blockages that might otherwise go undetected, or warning older adults who risk falling as a result of getting dizzy when they stand."

Amelard won an AGE-WELL award in Technology and Aging earlier this year to support the development of his system to help enhance or maintain older adults' independence. He is the lead author of the recent paper in Nature's Scientific Reports that details part of the technology behind the device.

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

Copyright Medical News Today: Excluding email/sharing services explicitly offered on this website, material published on Medical News Today may not be reproduced, or distributed without the prior written permission of Medilexicon International Ltd. Please contact us for further details.

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New guidelines for heart transplantation candidacy issued

For the first time in a decade, the International Society for Heart and Lung Transplantation have issued updated guidelines to help physicians determine which patients may be suitable candidates for heart transplantation.
[A doctor holding a heart]
The ISHLT have updated their heart transplant candidacy guidelines for the first time in 10 years.

Published in The Journal of Heart and Lung Transplantation, the updated guidelines are a result of a collaboration between the International Society for Heart and Lung Transplantation (ISHLT) Heart Failure and Transplantation, Pediatric and Infectious Disease Councils.

Chaired by Dr. Mandeep R. Mehra, professor of medicine at Harvard Medical School, and medical director of the Heart and Vascular Center at Brigham and Women's Hospital - both in Boston, MA - the revised guidelines for heart transplantation candidacy address some of the issues that have arisen since such guidelines were first put in place in 2006.

One key issue has been heart transplantation eligibility for patients with certain medical conditions; the 2006 guidelines stated that patients with particular illnesses should not be considered for the procedure.

However, based on recent scientific evidence, the ISHLT now state that patients with human immunodeficiency virus (HIV), hepatitis, Chagas disease or tuberculosis can now be considered suitable transplant candidates, provided they meet other criteria.

Additionally, the 2006 guidelines stated that for heart failure patients who are overweight, a body mass index (BMI) of 35 or less must be achieved before they can be considered for a heart transplant.

However, the revised guidelines now stipulate that doctors must ensure such patients reach a BMI of 30 or less, based on new evidence showing that more patients are likely to qualify for heart transplantation if they reach this goal.

Another notable change to the 2006 guidelines involves the Heart Failure Survival Score (HFSS) - a system that is used to estimate all-cause mortality for patients with heart failure. The HFSS is used to judge a patient's eligibility for heart transplantation.

Fast facts about heart transplants

More than 4,100 people in the US are currently on the waiting list for a heart transplant More than 62,000 heart transplants have been conducted in the US since 1988 The majority of heart transplants have occurred among adults aged 50-64.

Learn more about organ transplants

However, recent studies have raised concerns about the accuracy of the HFSS. As such, the updated guidelines state that listing patients for heart transplantation based solely on HFSS criteria should only occur if a patient's prognosis is unclear.

The ISHLT have also updated recommendations for the use of right-heart catheterization (RHC) - a test that determines how well the heart is pumping. The Society now recommend that all adult heart transplant candidates undergo RHC testing before being listed for the procedure, and such patients should be tested regularly up until the date of transplantation.

For heart failure patients with potentially reversible or treatable co-existing conditions - such as renal failure, cancer or obesity - and those who have pharmacologically irreversible pulmonary hypertension or engage in tobacco use, the ISHLT now recommend that mechanical circulatory support be considered to determine heart transplantation candidacy, with re-evaluation recommended before a decision is reached.

The updated guidelines also take patients' social support into account, noting that for individuals who are unlikely to comply with outpatient care requirements, heart transplantation may be considered a major risk.

The ISHLT also recommend against heart transplantation for patients with severe cognitive disabilities, noting that this may impact their ability to understand the procedure, adhere to medical recommendations or engage in self-injury; the benefits of heart transplantation have not been determined in such patients.

Commenting on the updated guidelines, Dr. Mehra says:

"There are many controversial issues in the guidelines that we have tackled head on, including heart transplantation in previously denied conditions (HIV, hepatitis amyloidosis, certain congenital heart diseases) that we now allow or recommend more lenient listing.

The 2006 guidelines were particularly important in that we recommended against an age limit for transplantation or time dependency for patients with previously healed cancers (e.g. waiting a minimum of 5 years for freedom from cancers). The new guidelines not only update several of these prior issues, but also tackle the most controversial topics of our times."

In November 2015, Medical News Today reported on the issue of the first ever guidelines for diagnosis and treatment of children with pulmonary hypertension, developed by the American Heart Association and the American Thoracic Society.

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ACE study evaluates health benefits of aerial yoga

Aerial Yoga, one of the latest evolutions of yoga practice, involves the use of circus hammocks to lift participants off the floor and enable them to achieve traditional yoga poses and align the body midair. But does it offer a good workout? The American Council on Exercise (ACE) commissioned an independent study from researchers at Western State Colorado University to evaluate the health effects of both a single Aerial Yoga session and a six-week Aerial Yoga intervention.

"We are pleased to announce that even though Aerial Yoga does not include traditional cardio exercises, a single session of Aerial Yoga offered participants many of the benefits associated with low- to moderate-intensity aerobic exercise like brisk walking or leisurely cycling," said ACE Chief Science Officer Cedric X. Bryant, Ph.D. "After the six week program, participants displayed measurable reductions in some common risk factors for cardiovascular heart disease."

In a study led by Lance C. Dalleck, Ph.D., researchers recruited 16 apparently healthy and physically active female volunteers between the ages of 18 and 45 to participate in a six-week intervention with three 50-minute Aerial Yoga sessions per week. Before the study, common indicators of cardiovascular and metabolic health of participants were measured, including body weight, body-fat percentage, resting and maximal heart rate and oxygen uptake, blood pressure and waist circumference. The study evaluated participants' physiological responses to a single session, as well as the broader health effects of the six-week intervention.

The study revealed that a single 50-minute session of Aerial Yoga burned an average of 320 calories and yielded cardiovascular effects in the range of low- to moderate-intensity exercise. Both of these findings suggest Aerial Yoga is an effective form of exercise for promoting good health. After the six-week long Aerial Yoga program, participants experienced significant improvements in several health risk factors such as body weight, body-fat percentage and blood pressure. The combined improvements in these risk factors suggest that participants reduced their risk for a cardiovascular heart disease event, such as a heart attack, by approximately 10 percent over the course of the six-week intervention.

"This study indicates that Aerial Yoga offers people another effective option for achieving enhanced health and wellness," Bryant added. "The more forms of exercise we can validate through research, the better the chances that people can find an effective form of exercise they enjoy, which improves adherence and leads to improved overall health."

To view the study, visit: https://www.acefitness.org/prosourcearticle/5757/ace-sponsored-research-can-aerial-yoga-take.

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

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VIB researchers discover possible strategy against stroke

Scientists at VIB and KU Leuven have identified the oxygen sensor PHD1 as a potential target for the treatment of brain infarction (ischemic stroke). Despite (minor) improvements in stroke treatment, stroke remains the fourth leading cause of death and the most common reason of severe disability. The impact of stroke is overwhelming for the patient, family and society - representing one of the largest unmet medical needs. Research led by Prof. Peter Carmeliet and Dr. Annelies Quaegebeur (VIB/KU Leuven) indicates that inhibition of PHD1 offers protection against stroke, via an unexpected mechanism, raising hope for future stroke treatment. The study was published in the leading medical journal Cell Metabolism.

The importance of PHD1 in the brain

Of all organs in our body, the brain is unique because it needs the highest levels of oxygen and glucose to function and to survive. The simple reason herefore is that brain cells absolutely rely on oxygen and glucose to generate energy, necessary to function normally. In stroke, reduced blood supply therefore threatens this energy balance, causing neurons to die. The Carmeliet lab discovered that brain cells sense and adapt to a shortage of oxygen and nutrients via PHD1.

The Peter Carmeliet lab observed that mice lacking the oxygen sensor PHD1 were protected against stroke induced by an obstruction of a main blood vessel supplying oxygen and glucose to the brain. Not only was their infarct size reduced by more than 70 % (which is an unusually large beneficial effect), but mice lacking PHD1 also performed much better in functional tests after stroke.

Peter Carmeliet (VIB/KU Leuven): "These results established for the first time that blocking PHD1 offered large protection against irreparable brain damage when blood vessels can no longer supply vital nutrients to brain cells".

Reprogramming of glucose metabolism - a first in class mechanism

A critical problem when brain cells are deprived of oxygen is that they generate damaging side-products, "oxygen radicals", which kill brain cells. Most previous stroke treatments are unsucessful, because they are based on the principle to target the consequences rather than the cause of these oxygen radicals. The Peter Carmeliet lab focused on a completely new concept, i.e. utilizing the endogenous power of brain cells to enhance the neutralization of these toxic side-products. The researchers now discovered that inhibition of the oxygen sensor PHD1 protects brain cells against these toxic side-products by reprogramming the use of sugar in low-oxygen conditions.

Dr. Annelies Quaegebeur (VIB/KU Leuven): "By reprogramming glucose utilization, neurons lacking PHD1 have an improved capacity to detoxify damaging oxygen radicals, protecting the brain against stroke. This is a paradigm-shifting concept in the field of stroke protection."

Translational potential of PHD1 inhibition for stroke

While further study is necessary, this research identifies PHD1 as a potential therapeutic target for stroke. Prof. Peter Carmeliet (VIB/KU Leuven): "Similar to genetic loss of PHD1, treating mice with a pharmacological PHD1 blocker protected mice against stroke. This raises the possibility that PHD1 inhibition might be clinically useful, but future research will be necessary to unveil the therapeutic potential in this debilitating disorder.

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

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ISHLT issues updated candidacy criteria for heart transplantation

To determine patient eligibility for heart transplant, the International Society for Heart Lung Transplantation (ISHLT) maintains a list of criteria, first issued in 2006, that acts as a guideline for physicians. A major 10-year update has now been issued and published in The Journal of Heart and Lung Transplantation, which is freely available at http://www.jhltonline.org/.

"The 2016 ISHLT Listing Criteria for Heart Transplantation: A 10-Year Update," focuses on evolving areas of importance not fully addressed previously, including infectious diseases such as the candidate with HIV and hepatitis, congenital heart disease, and restrictive cardiomyopathies. In addition, all of the original 2006 guidelines have been updated to incorporate newly available information and instances in which evolution in clinical practice demanded significant changes. For practitioners, the update includes 145 references to the recent literature concerning heart transplantation.

This multi-disciplinary effort between the ISHLT Heart Failure and Transplantation, Pediatric and Infectious Disease Councils included 15 task force members from eight nations, and was chaired by Mandeep R. Mehra, MD, Professor of Medicine, Harvard Medical School and Medical Director, Heart and Vascular Center, Brigham and Women's Hospital, Boston MA, and Editor-in-Chief of The Journal of Heart and Lung Transplantation.

"There are many controversial issues in the guidelines that we have tackled head on including heart transplantation in previously denied conditions (HIV, hepatitis amyloidosis, certain congenital heart diseases) that we now allow or recommend more lenient listing," noted Dr. Mehra. "The 2006 guidelines were particularly important in that we recommended against an age limit for transplantation or time dependency for patients with previously healed cancers (e.g. waiting a minimum of five years for freedom from cancers). The new guidelines not only update several of these prior issues, but also tackle the most controversial topics of our times."

Notable changes to the 2006 guidelines include:

For overweight patients with heart failure, the criteria now stipulate that physicians should recommend a weight loss program to reduce body mass index (BMI) to less than 35, rather than the previous target of 30. This somewhat relaxed goal was changed in response to new evidence-based information and may result in more patients qualifying for transplantation. Because new evidence has questioned the predictive accuracy of the Heart Failure Survival Score (HFSS), the ISHLT now recommends that listing patients solely on HFSS criteria should occur, only in situations of indeterminate prognosis. Right heart catheterization (RHC) is recommended for all adult candidates in preparation for listing for cardiac transplantation and periodically up to the date of transplantation. The committee now agrees that this periodic RHC is not advocated for routine surveillance in children. Use of mechanical circulatory support should be considered for patients with potentially reversible or treatable co-morbidities such as cancer, obesity, renal failure, tobacco use and pharmacologically irreversible pulmonary hypertension with subsequent re-evaluation to establish candidacy. Any patient for whom social supports are deemed insufficient to achieve compliant care in the outpatient setting may be regarded as having a relative contraindication to transplant. The benefit of heart transplantation in patients with severe cognitive-behavioral disabilities or dementia (e.g. self-injurious behavior, inability to ever understand and cooperate with medical care) has not been established, has the potential for harm and therefore heart transplantation cannot be recommended for this subgroup of patients. Patients with HIV infection, hepatitis, Chagas disease, or even tuberculosis can now be considered as suitable candidates provided certain strict management principles are adhered to by the teams.

For any corrections of factual information, or to contact our editorial team, please see our contact page.

Please note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms of use.

Copyright Medical News Today: Excluding email/sharing services explicitly offered on this website, material published on Medical News Today may not be reproduced, or distributed without the prior written permission of Medilexicon International Ltd. Please contact us for further details.

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Using nanoparticles to combat arteriosclerosis

In industrialized countries, a particularly high number of people suffer from arteriosclerosis -- with fatal consequences: Deposits in the arteries lead to strokes and heart attacks. A team of researchers under the leadership of the University of Bonn has now developed a method for guiding replacement cells to diseased vascular segments using nanoparticles. The scientists demonstrated in mice that the fresh cells actually exert their curative effect in these segments. However, much research remains to be done prior to use in humans. The results are now being published in the renowned journal ACS NANO.

In arterial calcification (arteriosclerosis), pathological deposits form in the arteries and this leads to vascular stenosis. Strokes and heart attacks are a frequent outcome due to the resultant insufficient blood flow. Endothelial cells which line the blood vessels play an important role here. "They produce nitric oxide and also regulate the expansion of the vessels and the blood pressure," explains junior professor Dr. med. Daniela Wenzel from the Institute of Physiology I of the University of Bonn. Damage to the endothelial cells is generally the insidious onset of arteriosclerosis.

A team of researchers working with Jun.-Prof. Wenzel, together with the Technische Universität München, the Institute of Pharmacology and Toxicology at the University of Bonn Hospital and the Physikalisch-Technische Bundesanstalt Berlin, developed a method with which damaged endothelial cells can regenerate and which they successfully tested in mice. The scientists transferred the gene for the enzyme eNOS into cultured cells with the aid of viruses. This enzyme stimulates nitic oxide production in the endothelium like a turboloader. "The enzyme is an essential precondition for the full restoration of the original function of the endothelial cells," reports Dr. Sarah Vosen from Jun.-Prof. Wenzel's team.

A magnet delivers the nanoparticles to the desired site

Together with the gene, the scientists also introduced tiny nanoparticles, measuring a few hundred nanometers (one-millionth of a millimeter), with an iron core. "The iron changes the properties of the endothelial cells: They become magnetic," explains Dr. Sarah Rieck from the Institute of Physiology I of the University of Bonn. The nanoparticles ensure that the endothelial cells equipped with the 'turbo' gene can be delivered to the desired site in the blood vessel using a magnet where they exert their curative effect. Researchers at the Technische Universität München have developed a special ring-shaped magnet configuration for this which ensures that the replacement cells equipped with nanoparticles line the blood vessel evenly.

The researchers tested this combination method in mice whose carotid artery endothelial cells were injured. They injected the replacement cells into the artery and were able to position them at the correct site using the magnet. "After half an hour, the endothelial cells adhered so securely to the vascular wall that they could no longer be flushed away by the bloodstream," says Jun.-Prof. Wenzel. The scientists then removed the magnets and tested whether the fresh cells had fully regained their function. As desired, the new endothelial cells produced nitric oxide and thus expanded the vessel, as is usual in the case of healthy arteries. "The mouse woke up from the anesthesia and ate and drank normally," reported the physiologist.

Transfer to humans requires additional research

Normally, doctors surgically remove vascular deposits from the carotid artery and in some cases place a vascular support (stent) to correct the bottleneck in the crucial blood supply. "However, these areas frequently become blocked with deposits once again," reports Jun.-Prof. Wenzel. "In contrast, we are getting to the root of the problem and are restoring the original condition of healthy endothelial cells." The researchers hope that what works in mice is also possible in humans, in principle. However, there are still many challenges to overcome. Jun.-Prof. Wenzel: "There is still a considerable need for research."

Fluorescence-Labeled Cells with Nanoparticles
On the left are fluorescence-labeled cells with nanoparticles: The cellular nuclei are shown in blue, the fluorescence labeling is shown in green and the nanoparticles in the cells are identified by arrows. The middle photo shows a blood vessel populated with these cells (green). On the right is a detailed image of a vascular wall with the eNOS protein identified (red).
Credit: Photo: Dr. Sarah Rieck/Dr. Sarah Vosen/University of Bonn
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E-cigarette adverts target susceptible youth

Advertisements for electronic cigarettes are seen by around 70% of middle and high school students in stores, online, in newspapers and magazines or on television and in movies, says a new report published in the Centers for Disease Control and Prevention report, Vital Signs.
[e-cigarette]
Independence and rebellion: e-cigarette adverts echo conventional themes to encourage teen smoking.

Advertising strategies include many of the themes traditionally used in cigarette and conventional tobacco product sales: independence, rebellion and sex.

E-cigarettes and conventional tobacco products entail similar risks: a higher chance of heart disease, stroke and early death; at a young age, they can affect brain development. Both products also promote addiction and can lead to sustained tobacco use.

Advertising of tobacco products has been proven to promote tobacco use among young people. There are concerns now that decades of progress in preventing tobacco use among youths could be reversed as a result of the unrestricted marketing of e-cigarettes and dramatic rise in their use.

Dr. Tom Frieden, director of the Centers for Disease Control and Prevention (CDC), explains, "The same advertising tactics the tobacco industry used years ago to get kids addicted to nicotine are now being used to entice a new generation of young people to use e-cigarettes."

Dr. Frieden calls on everyone to agree that children should not use e-cigarettes.

As spending on advertising soars, so does teen use of e-cigarettes

In 2014, e-cigarettes became the most commonly used tobacco product among young people, more commonly used than conventional cigarettes.

From 2011-14, e-cigarette use among high school students rose from 1.5% to 13.4%, and among middle school students it increased from 0.6% to 3.9%. At the same time, spending on e-cigarette advertising rose from $6.4 million in 2011 to an estimated $115 million in 2014.

Data from the 2014 National Youth Tobacco Survey (NYTS) show that 68.9% of middle and high school students see e-cigarette ads from one or more media sources.

The adverts are seen in retail stores by 54.8% of young people; 39.8% of youth see them online; 36.5% see advertisements on TV or at the movies and 30.4% see e-cigarettes advertised in newspapers and magazines. Some 15% of all students see the advertisements from all four sources: retail stores, the Internet, TV/movies and magazines/newspapers.

To prevent the use of e-cigarettes, a number of strategies are proposed:

Limiting tobacco product sales to facilities not frequented by youths Reducing the number of stores that sell tobacco and their proximity to schools Restricting e-cigarettes sales to face-to-face transactions, not through the Internet Requiring age verification to enter websites selling e-cigarettes, to make purchases and to accept deliveries of e-cigarettes.

Dr. Corinne Graffunder, director of the CDC's Office on Smoking and Health, calls on states and communities to fund tobacco prevention and control programs to help reduce youth tobacco use by raising awareness of the different tobacco products available, including e-cigarettes.

'It is unacceptable that e-cigarette ads remain unrestricted'

Dr. Graffunder points out that since we already know how to reduce youth tobacco use, we should be investing in these strategies in order to reduce the "staggering" effect of tobacco on families and communities.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to regulate the manufacture, marketing and sale of certain tobacco products.

FDA intentions to regulate e-cigarettes and other currently unregulated tobacco products as part of this Act are currently under review at the Office of Management and Budget.

Commenting on the report, the American Heart Association (AHA) support the call for tighter regulations to protect the susceptible youth audience and for lessons learned in the past regarding tobacco use to be applied to e-cigarettes.

The organization says:

"It is unacceptable that e-cigarette advertising remains unrestricted. More and more money is being poured into targeting kids at every turn. As the report shows, kids are encountering these ads virtually everywhere: in stores, online, in newspapers and magazines, and on television and in movies. And the sad truth is, it's working. The 2014 NYTS survey revealed e-cigarette use has tripled among US teens."

Medical News Today recently reported on a study linking e-cigarettes with cancer-related cell damage.

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Rapid uptake of heart attack treatment gives nine in ten patients fighting chance of survival

A ten year study of 300,000 heart attack patients, part funded by the British Heart Foundation (BHF) and led by the University of Leeds, has found rapid rates in the uptake of a treatment which improves a patient's chances of survival after they have suffered a major heart attack1.

The research, also part funded by the National Institute of Health Research (NIHR), showed the use of emergency stenting treatment (PPCI) increased from 0.1% in 2003 to 86% in 2013 for patients with STEMI - a heart attack caused by a complete blockage of a coronary artery which accounts for 25-40% of all heart attack cases in Europe2.

Despite such rapid uptake, the study found vast differences in the provision of PPCI treatment between hospitals, ranging from a 4 - 300% increase from 2003 to 2013. Recipients of the procedure are 37% less likely to die compared to those treated with clot busting drugs3.

The BHF says all patients having a STEMI should be taken to a designated heart attack centre with the facilities and staff to deliver round the clock PPCI, 7 days a week. And to ensure people do not miss out on the best available treatment, the emergency services need to improve their ability to identify heart attacks in patients who are chronically ill with multiple symptoms.

PPCI involves opening a blocked artery to restore blood flow to the oxygen-starved part of the heart and has helped save thousands of lives since becoming available in the early 2000's. Introduction of PPCI followed a ten-year action plan for heart disease (National Service Framework for Coronary Heart Disease) which prompted system-wide change and led to an increase in the number of hospitals able to deliver this lifesaving treatment.

However the research, published in the journal Heart, also found vast differences in the provision of PPCI treatment between hospitals, ranging from a 4 - 300% increase over the ten years. Patients suffering from diabetes, angina or having previously had a heart attack were less likely to receive the treatment (3%, 4% and 5% respectively), with chronic illness increasing the difficultly of diagnosis.

Living more than 30 kilometres from a hospital also lead to lower PPCI rates, but guidelines state that patients whose treatment with PPCI cannot be provided within 2 hours of arrival of the emergency services should receive clot busting drugs as an alternative. Other factors including the number of suitably trained cardiologists and an absence of round the clock availability of PPCI helped to explain 50% of the variation between hospitals.

However, the researchers say the remaining variation indicates differing standards of care across England and they believe all heart attack centres should have the facilities and infrastructure to be able to deliver this routine treatment round the clock.

Dr Chris Gale, BHF-funded researcher of the School of Medicine at the University of Leeds, said: "Emergency stenting has revolutionised the way we now treat heart attack patients and our research highlighted just how far we have come over the past ten years, with the vast majority of patients now receiving the best care.

"However it's clear that opportunities are being missed and in some cases treatment is simply not being offered. This is unacceptable and undoubtedly lives are being lost as a result.

"We need to ensure that services are adapted so doctors are able to recognise patients who need this potentially life saving treatment and hospitals are geared up to deliver it."

Professor Peter Weissberg, Medical Director of the BHF, said: "BHF-funded researchers first showed that a heart attack is caused by a blood clot blocking a coronary artery and that the sooner the blockage is opened, the greater the chances of survival.

"It is a testament to the NHS and its investment through the National Service Framework for Coronary Heart Disease that today nine in ten people who suffer a major heart attack in the UK are treated by PPCI. But clearly we need to do even better to guarantee all patients across the UK receive the best possible treatment.

"We need to ensure that the NHS provides enough, sufficiently resourced heart attack centres providing round the clock PPCI, to avoid needless loss of life."

The BHF continues to fund research to improve heart attack diagnosis and treatment, including a study which could reduce complications from stenting. Research like this is only possible thanks to donations from the public. At the BHF around 78p of every pound we raise is used to fight heart disease.

The BHF is calling on people to join the nation to Wear it. Beat it. on Friday 5th February. By wearing red and holding your own fundraising event you can help power life saving research to revolutionise the way we prevent and treat cardiovascular disease. Sign up online at www.bhf.org.uk/red.

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Actelion announces US commercial availability of UPTRAVI (selexipag) for the treatment of pulmonary arterial hypertension

Actelion has announced the commercial availability of the oral, selective, IP prostacyclin receptor agonist, UPTRAVI® (selexipag) for the treatment of pulmonary arterial hypertension (PAH) in the US.

UPTRAVI is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%).

Richard Channick, MD, Director, Pulmonary Hypertension and Thromboendarterectomy Program, Massachusetts General Hospital, Boston commented: "After 20 years of prostacyclin therapy I am very excited to have UPTRAVI, an oral treatment that targets the prostacyclin pathway and is proven to improve long-term outcomes for patients. Furthermore, with UPTRAVI we can now use oral combination therapy regimens that target the three established treatment pathways for PAH, an option that could change the way we treat PAH in the long-term."

Bill Fairey, President of Actelion Pharmaceuticals US, commented: "Today's announcement represents a milestone for PAH treatment in the US - the availability of a new oral medication that effectively targets the prostacyclin pathway. We are proud to bring an oral treatment to patients which is supported by robust outcome-based evidence in combination with an ERA, or a PDE-5 inhibitor, and even in combination with both an ERA and a PDE-5 inhibitor. "

Rino Aldrighetti, President and CEO of the Pulmonary Hypertension Association spoke of the impact of the availability of UPTRAVI on the PAH community: "We at the Pulmonary Hypertension Association welcome new treatment options that help patients and their families affected by this devastating disease. We hope that UPTRAVI, will enable physicians to impact the long-term outcome for many of their PAH patients."

The safety of UPTRAVI has been evaluated in a long-term, placebo-controlled study enrolling 1,156 patients with symptomatic PAH (GRIPHON study). The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Adverse reactions occurring more frequently on UPTRAVI compared to placebo - greater than or equal to 3% - over the course of the study, were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite and rash. These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI and in none of the patients on placebo.

UPTRAVI is available in the following strengths: 200 mcg [Light yellow tablet debossed with 2], 400 mcg [Red tablet debossed with 4], 600 mcg [Light violet tablet debossed with 6], 800 mcg [Green tablet debossed with 8], 1000 mcg [Orange tablet debossed with 10], 1200 mcg [Dark violet tablet debossed with 12], 1400 mcg [Dark yellow tablet debossed with 14], 1600 mcg [Brown tablet debossed with 16]. Full prescribing information can be found on www.uptravi.com.

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Exercise and diet improves ability to exercise for patients with common type of heart failure

Among obese older patients with a common type of heart failure, calorie restriction or aerobic exercise training improved their ability to exercise without experiencing shortness of breath, although neither intervention had a significant effect on a measure of quality of life, according to a study in JAMA.

Heart failure with preserved ejection fraction (a measure of how well the left ventricle of the heart pumps with each contraction) is the most rapidly increasing form of heart failure, occurs primarily in older women, and is associated with high rates of illness, death, and health care expenditures. More than 80 percent of patients with heart failure with preserved ejection fraction (HFPEF) are overweight or obese. Exercise intolerance is the primary symptom of chronic HFPEF and a major determinant of reduced quality of life (QOL).

Dalane W. Kitzman, M.D., of the Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues randomly assigned 100 older obese participants (average age, 67 years) with chronic, stable HFPEF to 20 weeks of diet, exercise, or both, or a control group. The researchers measured exercise capacity (peak oxygen consumption [Vo2]) and QOL (with the Minnesota Living with Heart Failure Questionnaire; MLHF).

Of the study participants, 26 were assigned to exercise; 24 to diet; 25 to exercise + diet; 25 to control. Of these, 92 completed the trial. The authors found that peak Vo2 was increased significantly by both exercise and diet, and the combination of diet with exercise produced an even greater increase in exercise capacity. The change in peak Vo2 was positively correlated with the change in percent lean body mass. Body weight decreased by 7 percent in the diet group, 3 percent in the exercise group, 10 percent in the exercise + diet group, and 1 percent in the control group.

There was no significant change in the MLHF score with exercise or diet.

The researchers note that because of the reported "heart failure obesity paradox" (lower mortality observed in overweight or obese individuals), before diet can be recommended for obese patients with HFPEF, further studies likely are needed to determine whether these favorable changes are associated with reduced clinical events.

Editorial: Lifestyle Interventions to Improve Exercise Tolerance in Obese Older Patients With Heart Failure and Preserved Ejection Fraction

"This innovative report by Kitzman et al provides applicable evidence that dietary intervention (caloric restriction) alone or complemented by aerobic exercise training improves peak Vo2, increasing exercise capacity," writes Nanette K. Wenger, M.D., of the Emory University School of Medicine, Atlanta, in an accompanying editorial.

"The largest increase in exercise capacity was associated with a combination of the exercise + diet interventions. The hypothesis tested is intriguing, and worthy of further investigation in a community population, with longer follow-up, either with or without specific provision of meals to effect caloric restriction, although translation of this type of intervention to the community will be challenging. Whether nonprofessionally administered diet and nonmedically supervised exercise could safely attain similar benefit is uncertain but worthy of exploration."

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Findings raise questions about the implications of notifying patients of incidental genetic findings

A review of medical records of patients with genetic variations linked with cardiac disorders found that patients often did not have any symptoms or signs of the conditions, questioning the validity of some genetic variations thought to be related to serious disorders, according to a study in JAMA.

Sequencing of selected gene sets, whole exomes, and whole genomes is increasingly used for research and clinical care. These approaches also identify incidental findings (also called secondary findings) of potential clinical relevance. Driven by the prospect for preclinical diagnosis and risk factor mitigation, the American College of Medical Genetics and Genomics has supported the return of medically actionable incidental findings and generated a list of genes in which known or predicted pathogenic (pertaining to genetic cause of a disease or condition) variants should be returned to patients who undergo clinical sequencing. These recommendations have been controversial because the frequency of clinical manifestations of these variants and their implications for diagnosis and management are poorly defined. Phenotype (an appearance or characteristic of an individual, which results from the interaction of the person's genetic makeup and his or her environment) data from electronic medical records (EMRs) may provide a resource to assess the clinical relevance of rare variants, according to background information in the article.

Dan M. Roden, M.D., and Sara Van Driest, M.D., Ph.D., of the Vanderbilt University Medical Center, Nashville, Tenn., and colleagues determined the clinical phenotypes from EMRs for individuals with variants designated as pathogenic by expert review in arrhythmia susceptibility genes. The study included 2,022 individuals recruited for nonantiarrhythmic drug exposure phenotypes for the Electronic Medical Records and Genomics Network Pharmacogenomics project from 7 U.S. academic medical centers. Variants in SCN5A and KCNH2, disease genes for long QT and Brugada syndromes (potentially fatal cardiac conditions), were assessed for potential pathogenicity by 3 laboratories and by comparison with the database ClinVar. Relevant phenotypes were determined from EMRs, with data available from 2002 (or earlier for some sites) through September 10, 2014.

Among the 2,022 study participants, a total of 122 rare variants in 2 arrhythmia susceptibility genes were identified in 223 individuals (11 percent of the study cohort). Expert laboratory review of these variants designated 42 as potentially pathogenic, and these classifications were discordant across the laboratories. Review of EMR and electrocardiographic (ECG) data revealed no difference in prevalence of arrhythmia diagnoses or ECG phenotypes among participants with the designated variants compared with those without.

After the researchers performed a manual review of EMR data and an ECG review, the majority of participants with a designated variant in either SCN5A or KCNH2 had no identifiable arrhythmia or ECG phenotype. Among patients with designated variants, 35 percent had evidence of any arrhythmia or ECG phenotype.

The authors write that there are several potential explanations for the paucity of clinical manifestations among participants with these variants, including that some participants may have clinically manifest disease that was not documented in the EMR; these variants may have low penetrance or cause subclinical disease except in the setting of additional genetic or environmental influences; this cohort may not represent individuals at risk for the phenotype; and some of these designated variants may confer little or no increased risk for either arrhythmias or ECG abnormalities.

Editorial: Establishing the Clinical Validity of Arrhythmia-Related Genetic Variations Using the Electronic Medical Record

"Establishing the clinical validity of genetic variations proposed as biomarkers for important health conditions can be technically challenging, time-consuming, and expensive. The success of precision medicine ultimately depends on the availability of biomarkers in which the clinical community has confidence," writes William Gregory Feero, M.D., Ph.D., of Maine Dartmouth Family Medicine Residency, Fairfield, Maine, and Associate Editor, JAMA, in an accompanying editorial.

"The report by Van Driest et al provides a glimpse of a potential future in which EMR data might be used to define the clinical validity of biomarkers, genetic or otherwise, more rapidly, and at potentially lower cost, than is possible via traditional approaches. However, the study also exposes some shortcomings in the existing ability to meaningfully predict the consequences of at least some genetic variations currently thought to be causally related to serious disorders. For now, caution should be exercised when considering clinical interventions informed by the presence of 'pathogenic' variations in healthy individuals, families, and populations."

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High blood sugar levels could lead to heart attack complications

Scientists at the University of Leicester have demonstrated for the first time the mechanism by which the level of sugar in your blood can affect the contraction of blood vessels, with potentially dangerous effects on the heart and blood pressure.

Researchers led by Dr Richard Rainbow from the University's Department of Cardiovascular Sciences have shown that blood vessels contract more strongly at raised glucose levels than at 'normal physiological' levels.

Blood vessels contract and relax to control blood pressure. In general, the more contracted the blood vessels are, the higher the blood pressure. Using electrophysiology and myography techniques to examine the impact of glucose on arterial myocytes, cells that make up the tissue of our blood vessels, the team has identified a mechanism that controls the narrowing of blood vessels.

The research comes as MPs and health experts debate proposals for a 'sugar tax' and highlights the potential health risks of consuming large amounts of rich, sugary foods regularly in your diet. With healthy eating among the most common New Year's resolutions, it adds another incentive to reduce our intake of these foods all year round.

Heart attacks occur when a coronary artery, which provides the blood to the heart muscle to give the required nutrients and oxygen, are blocked. High glucose at the time of heart attack could make this block more severe by causing the blood vessel to contract, leading to a higher risk of complications.

Dr Richard Rainbow, Lecturer in Cardiovascular Cell Physiology, said: "We have shown that the amount of sugar, or glucose, in the blood changes the behaviour of blood vessels making them contract more than normal. This could result in higher blood pressure, or could reduce the amount of blood that flows through vital organs.

"This was an experimental lab study which means that we can draw conclusions about cause and effect in a controlled environment. Here, we have identified a known signalling protein family, protein kinase C, is a key part of this enhanced contractile response, and have also shown in our experiments that we can restore the normal level of contractile response, and reverse the effects on the heart, with inhibitors of these proteins.

"This is the first study to show direct evidence of blood vessel contraction to glucose, and the potential mechanism behind this contractile response. In the experimental models we used in this study, including human blood vessels, increasing glucose to the levels that could be reached after a large meal altered vascular contraction.

"A large number of people who suffer a heart attack will have high glucose due to the 'stress response'. This means that even people who are not diabetic may become hyperglycaemic during a heart attack."

The research team that worked on this study has a history of investigating the effects of glucose on the cardiovascular system, diabetes and heart function. Previous research in 20101 showed that high glucose from any cause, not just diabetes, was an indicator of a 'worse outcome' following a heart attack. Further research in 20142 by the Leicester group showed that glucose has potentially damaging effects on the normal function of the heart, such as arrhythmia and abolishing the built-in protective mechanisms that the heart can activate on stress.

Dr Rainbow added: "Our studies show that glucose has an important physiological effect on the normal functioning of the cardiovascular system. Increases in blood sugar to pathophysiological levels cause marked changes in normal blood vessel and cardiac muscle behaviour that could be life-threatening if left untreated.

"Our data show a clear glucose-induced potentiation of contraction in blood vessels. Targeting the specific types of protein kinase C that we've shown to be involved in this can provide a novel therapeutic route for improving outcome in ischaemic diseases, such as heart attack or stroke."

Professor Jeremy Pearson, Associate Medical Director at the British Heart Foundation, said: "This team have shown that, in multiple species, it is possible to use PKC as a target to block blood vessel constriction caused by high levels of glucose in the blood. This opens up the possibility for improved treatment for patients where recovery from heart attack is complicated by raised glucose levels."

The study 'Distinct and complementary roles for α and β isoenzymes of protein kinase C in mediating vasoconstrictor responses to acutely elevated glucose' is published in the British Journal of Pharmacology.

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