Wood Street Clinic Blog

Here you will find a selection of RSS feeds and blog entries

Medtronic announces FDA approval and launch of world's first app-based remote monitoring system for pacemakers

Medtronic plc has announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial availability of the MyCareLink Smart(TM) Monitor, the world's first app-based remote monitoring system for patients with implantable pacemakers. With the MyCareLink Smart Monitor, patients with a Medtronic pacemaker can use their own smartphone or tablet technology, with cellular or Wi-Fi service, to securely transmit data from their pacemakers to their physicians, who can then interpret the data to make treatment decisions.

"Remote monitoring of pacemakers and other cardiac devices is now the standard of care, as studies have established how it benefits patients - including faster diagnoses and increased survival - as well as how it helps physicians manage their pacemaker patients through increased efficiency and convenience," said George Crossley, III, M.D., associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institution in Nashville, Tennessee. "Because the MyCareLink Smart Monitor is integrated into existing mobile platforms like smartphones and tablets, it is easy for patients to transmit data from their pacemakers to their doctors via the technology that they are using every day. This innovation will serve as the foundation for future advances using smart technology to support cardiac patients."

The MyCareLink Smart Monitor is comprised of a handheld portable device reader, prescribed by a physician, and the MyCareLink Smart mobile app, available for free on both Android(TM) and Apple® platforms. When the MyCareLink Smart Monitor is connected to cellular or Wi-Fi service, patients can initiate a transmission of pacemaker data by securely uploading the information to the Medtronic CareLink® Network, the world's leading remote monitoring service for cardiac device patients, currently being used by more than 1 million patients.

In addition to sending information from their pacemakers to their physicians or clinics, patients using the MyCareLink Smart Monitor can:

Confirm the date of their most recent transmission of pacemaker information Create a personalized profile on the MyCareLink Connect Website to manage their pacemaker information and data transmissions Receive email or text reminders, confirmations and notifications of their data transmissions

By connecting patients and physicians, remote cardiac monitoring provides many clinical and economic benefits. These include faster time to treatment if the physician detects a problem with the pacemaker based on the transmitted data;i less time spent at a doctor's office or clinic for regular checks of the pacemaker;ii,iiireduced time spent in the hospital if the physician quickly detects and treats a medical problem;iv,vand a potential increase in patient survival rates.vi,vii,viii

"The use of smart technology continues to grow among people of all ages, and especially among people over 65 which is the age range of the majority of our pacemaker patients," said Darrell Johnson, vice president and general manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic. "As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement."

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Study quantifies risk of cardiac arrest in children during spine surgeries

Although the vast majority of pediatric spine surgeries are safe, a handful of neuromuscular conditions seem to fuel the risk of cardiac arrest during such operations, according to research led by investigators at the Johns Hopkins Children's Center.

A report on the findings, published in the November issue of the journal Spine, is believed to be the first to quantify the risk -- which is quite small -- of this potentially lethal complication among children. The findings, the investigators say, can help surgeons and operating room staff members better plan for such contingencies in high-risk patients.

The study results stem from an analysis of outcomes in some 2,600 spinal surgeries performed at the Johns Hopkins Children's Center and Texas Scottish Rite Hospital for Children in Dallas between 2004 and 2014.

The authors are quick to point out that the absolute risk of cardiac arrest in children during spine surgery is minuscule. Indeed, of the 2,639 patients in the study, 11 had one -- less than 0.5 percent. A single patient died. Ten of the 11 children were successfully resuscitated.

Specifically, the results showed that children with such neuromuscular disorders as cerebral palsy, spina bifida and muscular dystrophy were three times more likely to suffer cardiac arrest during surgeries that straighten the spine. Six of the 11 children who had a cardiac arrest had a neuromuscular disorder.

In eight of the 11 cases, cardiac arrest was triggered by electrolyte imbalances or circulatory problems -- not a surprising finding, the researchers say, given that young children have less blood and lower blood pressure, and are thus more vulnerable to circulatory shock. Children also tend to develop electrolyte imbalance more rapidly than adults. Other causes of cardiac arrest included allergic anaphylaxis, irregular heartbeat, and respiratory and airway problems.

"Our findings are reassuring: Spinal surgeries in children are overwhelmingly safe, but even so, some risk remains," says lead investigator Paul Sponseller, M.D., M.B.A., director of pediatric orthopaedics at the Johns Hopkins Children's Center. "Armed with this knowledge, surgeons can plan accordingly by taking a few additional preventive steps to make what is an already safe surgery even safer."

The vast majority of children with scoliosis have mild forms and don't need early corrections or surgery at all. However, children with forms of scoliosis tied to neuromuscular disease tend to have more severe spinal curvatures and often need surgery at a far younger age, when they are more vulnerable to the effects of surgery and anesthesia and are more likely to suffer serious complications.

In a cardiac arrest, the heart stops beating or begins to quiver chaotically, unable to pump out blood to the rest of the body. Always a life-threatening emergency, cardiac arrests that occur inside the hospital have dramatically higher survival rates than those that occur outside the hospital. Cardiac arrests require cardiopulmonary resuscitation or electroshock with a defibrillator to restore normal heart rhythm.

During spinal operations, surgeons position children on their stomachs, but if a cardiac arrest occurs, a child must be quickly rolled over onto the back for resuscitation.

Sponseller and colleagues say that while many of the factors that lead to cardiac arrest in these cases are not preventable, knowing who's at highest risk can improve preparedness, cut response time and reduce stress among the surgical staff should a complication occur.

"Our findings underscore the notion that any surgery can escalate from routine to super-stressful in a matter of seconds," says Sponseller. "We are hypervigilant during all surgeries, but at the same time, knowing which patients are most likely to decompensate is always a good thing."

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Are Tasers more deadly than we thought?

Billed as a "less lethal" alternative to firearms, Tasers have experienced a meteoric rise to infamy since their introduction to the US police force. This week, the BMJ publishes a new report regarding the impact of Tasers on cardiac health.
[Taser in use]
The new report highlights the danger Tasers pose to cardiac health.

Tasers are currently in use by more than 16,000 police forces in 107 countries.

Globally, Tasers have shocked people more than 1.35 million times (650,000 during arrests and stops and 700,000 during police training).

According to the main manufacturer - Taser International - one of their devices is deployed, on average, every 2 minutes.

The most common Taser is the X26, designed and manufactured by Taser International in Scottsdale, AZ. Since 1994, the company has sold more than 800,000 Taser weapons.

Tasers use compressed nitrogen to fire a pair of barbed probes into the skin of the target individual. They are capable of delivering 50,000 volts, causing intense pain and muscle contraction.

In addition to the main function, the Taser has a "drive-stun" mode. This allows the unit to be held against the skin to deliver the shock, which stimulates pain but none of the contractions.

A pull of the trigger on the gun-shaped device delivers 5 seconds of shock - and more if the trigger is held down.

Health concerns over Taser use

A recent increase in the number of Taser uses on mentally ill patients in care homes and hospitals has prompted the UK's home secretary, Teresa May, to order a review of how they are used on these types of situations.

Known risks of Tasers already include eye injuries, seizures, collapsed lung (pneumothorax), tonic-clonic seizures, seizures in people with epilepsy, skin burns, and muscle, joint, and tendon injuries, plus a short-lived decline in cognitive functioning.

The biggest safety concern is head injuries sustained from an unguarded fall.

Much of the research into the safety of Tasers has been conducted by the companies that manufacture them, and as such, their neutrality has been called into question.

In 2011, the US Department of Justice released a report on "less lethal" weapon use by US police forces:

"More than 200 Americans have died after being shocked by Tasers. Some were normal, healthy adults; others were chemically dependent or had heart disease or mental illness."

Can Tasers affect heart function?

Evidence of the Taser's ability to cause injury are well known, but one further area of concern has not yet been fully unpicked: can Tasers have a terminal effect on cardiac health?

There are concerns that a Taser attack might induce long-lasting arrhythmias caused by myocardial capture (when an external electrical stimulus changes the heart's natural rhythm).

Taser International, during trials with an experimental Taser model, did report one instance of cardiac capture. The company altered the design and, from then on, have not reported any further cases.

Ventricle fibrillation - where the ventricles of the heart quiver rather than fully contract - has never been picked up during any of Taser's official studies.

This lack of fibrillation and cardiac capture in Taser International's trials might be due, in part, to the use of healthy volunteers without heart problems or drug addictions of any kind. And, of course, in a real-life confrontation, heart rates are naturally elevated at baseline.

A recent report published in Circulation looked into eight cases of Taser use and concluded:

"The animal and clinical data clearly support the conclusion that a TASER X26 shock can produce ventricular fibrillation in humans"

Taser-related deaths

One death of particular note was that of 17-year-old Darryl Turner in North Carolina in March 2008. He was made redundant from his supermarket job and refused to leave the store. When a police officer arrived, Turner was "tasered" for 37 seconds and died shortly after from ventricular fibrillation.

Taser has a long history of fighting and defeating lawsuits, but in the case of Turner's death, they lost. It was established that the company had not made sufficiently clear the dangers of longer shocks and shocks to the chest area.

Taser appealed the decision, but the appeals court panel overruled them, saying that the X26:

"...had been the subject of several academic studies. (Taser International) knew about these studies, in which researchers had concluded that the device posed a risk of ventricular fibrillation, a cause of cardiac arrest, especially when the electrical current from the Taser was applied near the subject's heart.

Nevertheless, (Taser International) failed to warn Taser users to avoid deploying the Taser's electrical current in proximity to the heart."

More recently, the UK reported their first instance of death resulting from Taser. Jordon Begley, a factory worker from Greater Manchester, died just 2 hours after the police used a Taser on him in 2013.

An inquest concluded that punches he received from police officers, along with the 9-second Taser blast were to blame for his consequent cardiac arrest.

There is a clear necessity for further study into the effects of Tasers on long-term cardiac health and its implications for use on those with existing medical conditions. The author of the BMJ report, Owen Dyer, told Medical News Today:

"In both Britain and the US, firings of Tasers by police are going up quite steeply every year, even though rules of engagement have not been relaxed. So either more people are resisting arrest each year, which seems unlikely, or we are seeing Taser mission creep.

At first, Tasers are an alternative where guns might have been used. Then they're an alternative where truncheons might have been used. Finally they're an alternative where words might have been used.

Tasers were not designed to be cattle prods, and they will never be lifesavers in that role."

MNT recently covered research into how stressful situations increase police officers' risk of cardiac death.

Written by Tim Newman

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Study identifies social, practical barriers to exercise for heart failure patients

Supervised aerobic exercise can benefit many patients with heart failure. But according to new research, lack of social support and practical barriers to physical activity - such as finance and child care - reduces the amount of time such patients spend exercising, which may have negative implications for health.
[People in an exercise class]
Researchers say practical barriers to exercise - such as child care issues - and lack of social support are reducing the amount of time heart failure patients engage in exercise programs.

Lead author Dr. Lauren B. Cooper, of the Duke University School of Medicine in Durham, NC, and colleagues publish their findings in Circulation: Heart Failure - a journal of the American Heart Association (AHA).

Around 5.1 million people in the US have heart failure, which occurs when the heart is unable to pump enough blood and oxygen around the body to support other organs.

While there are a number of medications that can help treat heart failure, certain lifestyle changes can offer significant benefits.

According to the AHA, participation in a structured exercise program - with permission from a health care provider - can help alleviate some symptoms of heart failure and may even slow disease progression.

But in this latest study, Dr. Cooper and colleagues have identified a number of factors that may reduce the amount of time heart failure patients spend engaging in such programs.

To reach their findings, the team analyzed data from 2,279 patients with heart failure who were part of the study Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION).

In this trial, patients were randomly allocated to one of two groups: usual care - without a prescription of any formal exercise program - or usual care plus a supervised exercise program. The exercise program involved 36 sessions over a 3-month period, before shifting to home-based exercise for a further 2 years.

Patients were also asked to complete a survey that assessed the extent to which 10 factors - such as finance, weather, transportation and child care - interfered with their ability to participate in an exercise program. The survey also assessed patients' perception of social support.

While patients in the exercise group who had the lowest perceived social support exercised for an average of 92 minutes a week, the team found those with the highest perceived social support spent more time exercising - an average of 118 minutes weekly.

What is more, the researchers found that patients with the fewest barriers to engagement in an exercise program spent significantly more time exercising than those with the most barriers, at 169 minutes a week and 79 minutes a week, respectively.

The team believes their findings have important implications for patients and their health care providers. Dr. Cooper adds:

"Patients, family members, and health care providers should work together to find solutions to the barriers preventing a patient from participating in a structured exercise program, because exercise programs can help patients manage their condition.

[...] Assessing a patient's social support system and barriers that may interfere with their exercise program may help medical professionals to customize exercise programs that better fit individual patient needs."

Exercise does not only benefit patients with heart failure. Medical News Today recently reported on a study that suggested short bursts of exercise can lower blood pressure in people with type 2 diabetes.

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Protein biomarkers may accelerate the future of personalized medicine for CV disease

Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc., has announced that its DiscoveryMAP® platform successfully identified combinations of 15 protein biomarkers associated with cardiovascular (CV) events or death in people with pre-diabetes or early type 2 diabetes, according to a study published by the journal Circulation.

"Cardiovascular diseases are one of the leading causes of deaths globally," said Riccardo Perfetti, M.D., vice president Medical Affairs, Global Diabetes at Sanofi, which sponsored the study. "We are optimistic that as we move toward personalized medicine, cardiovascular biomarkers will help us predict future events and possibly develop tailored treatment plans for patients that will save more lives."

In the paper titled, "Identifying Novel Biomarkers for Cardiovascular Events or Death in People with Dysglycemia," researchers at the Population Health Research Institute and Sanofi used Myriad RBM's DiscoveryMAP platform to evaluate 237 cardiometabolic biomarkers in serum from 8,401 participants in the completed Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial. Results of the assays were analyzed to identify biomarkers that provided better estimates of the risk of future CV events or death than could be estimated from standard clinical and biochemical data alone. The analysis identified a novel combination of 10 biomarkers that, when added to clinical risk factors, can find people with dysglycemia who are at higher risk of heart attack, stroke or CV death. Moreover, these 10 biomarkers, plus an additional five, had the greatest impact on the ability to predict death.

"Our study is one of the largest scientific investigations in history to identify specific cardiovascular biomarkers associated with serious cardiovascular outcomes, including heart attacks, strokes and death," said Hertzel Gerstein, M.D., lead study investigator and deputy director, Population Health Research Institute. "Our results highlight the potential value of cardiovascular biomarkers for identifying people with dysglycemia at the highest risk of future events."

DiscoveryMAP is a comprehensive, quantitative, immunoassay service product that measures more than 300 human proteins. It is the culmination of 15 years of assay development for cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, cancer markers, kidney damage markers, CNS biomarkers and other important circulating proteins.

"This is another demonstration that our DiscoveryMAP technology can successfully identify panels of biomarkers with important diagnostic and prognostic applications. We believe that the protein biomarkers characterized by the PHRI and Sanofi teams may identify people at higher risk for cardiovascular events," said Ralph McDade, Ph.D., president of Myriad RBM. "Based on these very encouraging findings, we are pursuing additional research collaborations to further develop panels of protein biomarkers with application for cardiometabolic disorders."


ORIGIN (Outcome Reduction with Initial Glargine Intervention) was a seven-year landmark cardiovascular outcomes trial, evaluating insulin glargine versus standard care in over 12,500 individuals who were at high CV risk with pre-diabetes or early type 2 diabetes mellitus. ORIGIN was sponsored by Sanofi and was designed, conducted, and analyzed by the Population Health Research Institute and its international network of diabetes and cardiovascular disease experts.

About Human DiscoveryMAP®

DiscoveryMAP is for those who seek a thorough understanding of a compound's biological activity, efficacy and safety profile as well as the disease or condition being addressed. The DiscoveryMAP service products help increase the odds of identifying novel protein biomarker patterns in drug development or diagnostic discovery projects. These data can support critical go/no-go decisions or identify candidate panels for potential companion diagnostics. Once a pattern is discovered, it can be seamlessly converted into a CustomMAP for high volume sample processing resulting in better, more efficient clinical trials. For more information visit: http://rbm.myriad.com/discoverymap/

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Mount Sinai Heart director discusses population health promotion and a stratified approach for cardiovascular health

Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital joined a panel of international experts at the United Nations where he spoke about promoting cardiovascular health worldwide and how the practice of medicine will change to reflect an increase in ambulatory care. Mount Sinai Heart is ranked No. 7 in the nation by U.S. News & World Report in its 2015 "Best Hospitals" issue.

The meeting, which focused on health and well-being and the comprehensive treatment of NCDs, was held by the United Nations NGO Committee on Mental Health, which is affiliated with the Conference of Non-Governmental Organizations (CoNGO) in Consultative Relationship with the United Nations. The event was co-sponsored by the International Council of Women, Soroptimist International, Communications Coordination Committee for the United Nations, Sigma Theta Tau International, Nightingale Initiative for Global Health, Human Rights Congress for Bangladesh Minorities, American Psychiatric Association, International Psychoanalytical Association and Nonviolence International.

According to Dr. Fuster, "We are starting to experience a significant change in the way we deliver cardiovascular medicine with a focus on promoting health over treating disease. "As a result, we should expect to see a rise in ambulatory care and shorter hospital stays. This transition will require that cardiovascular specialists and health care workers are trained in ambulatory and home-based care."

In 2010, the U.S. Institute of Medicine (IOM) formed a committee, chaired by Dr. Fuster, which produced a report, entitled "Promoting Cardiovascular Health in the Developing World". The report stressed the importance of health promotion during a person's lifetime and the significant economic burden that cardiovascular disease places on our society. The authors proposed a stratified approach at 3 different age ranges in a person's life to effectively promote cardiovascular health.

The first approach to stratified health is during the first 25 years of life, with the optimal period of time to motivate healthy behavior between 3- 5 years old. The second opportunity for stratified health is within the age range of 25 to 50 years old, when non-invasive imaging techniques can be used to detect potential future heart health issues. The third opportunity occurs at 50 years and upward, when cardiovascular disease has often begun.

"At every age range, there are scientific, psychological, and disease specific variables to consider, as well as different educational and behavioral tools to use to promote cardiovascular health globally," stated Dr. Fuster. "My years of research strongly support early education intervention and the need for a stratified approach to health promotion worldwide."

Since 2009, Dr. Fuster has worked with nearly 100,000 preschool-aged children, ages 3-5, in Madrid, Spain and Bogotá, Colombia to demonstrate that early health education can have long-lasting heart healthy effects. Under Dr. Fuster's leadership, Mount Sinai Heart of Icahn School of Medicine at Mount Sinai is launching a similar program in the United States in 8 New York City (NYC) Harlem preschools with children ages 3-5, along with their parents and caregivers, known as The FAMILIA Project.

The Project, made possible by a $3.8 million grant from the American Heart Association (AHA), is scheduled to begin this month. Mount Sinai has partnered with NYC's Administration for Children's Services (ACS), Division of Early Care and Education Head Start programs to teach young children, their parents, and caregiver's ways to reduce their risk factors of developing cardiovascular diseases, while also decreasing the growing obesity epidemic. The Project's programming will focus on child, adult, peer group, and individual health interventions.

The meeting, which was attended by members of civil society, UN staff, and government representatives, took place at the United Nations Church Center on Thursday, November 12, 2015. Welcoming remarks were delivered by Dr. Vivian B. Pender, Chair, UN NGO Committee on Mental Health. Dr. Elizabeth Carll, Founder and Convener of the Global Mental Health and NCDs Work Group of the UN NGO Committee on Mental Health, served as the moderator. The panel was comprised of Dr. Valentin Fuster; H.E. Mr. Keith Marshall, Ambassador and Permanent Representative, Mission of Barbados to the United Nations; Werner Obermeyer, Deputy Executive Director, World Health Organization in New York; Dr. Yesne Alici, Assistant Attending Psychiatrist, Memorial Sloan-Kettering Cancer Center; and Dr. Gustavo Gonzalez Canali, Senior Advisor and Focal Point for NCDs, UN Women.

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Therapeutic hypothermia can help in range of cardiac arrests

Lowering body temperature in cardiac arrest patients with "non-shockable" heart rhythms increases survival rates and brain function, according to new research in the journal Circulation.
[heart monitor]
Reducing the body's core temperature can help prevent neurologic damage after cardiac arrest.

Therapeutic hypothermia intentionally lowers the body's core temperature to a range of about 32° to 34° C (89.6° to 93.2° F) to protect the body following a period of insufficient blood flow due to such events as a cardiac arrest, blood clot or stroke.

It is typically used for patients who fail to regain consciousness after return of spontaneous circulation following a cardiac arrest. Previous studies have shown improved survival and neurological function in patients with "shockable" rhythms such as ventricular fibrillation, a condition where the lower chambers quiver and the heart is unable to pump any blood, causing cardiac arrest.

Cardiac arrest occurs when the heart malfunctions and stops beating, causing blood to stop pumping to the body. Death can result in minutes without treatment.

The risk of neurologic injury

Out-of-hospital cardiac arrest kills about 250,000 Americans yearly. Average survival rate for such cases is just 6% globally, and those who survive are at risk for neurologic injury. Of those who survive but enter a coma, only about 20% awaken with a good neurologic outcome.

Neurologic injury results when circulatory collapse impairs oxygen flow to the brain, causing mitochondrial and cellular death and cerebral edema; this is worsened by disruption to the blood-brain barrier in the initial injury.

Once circulation is restored, cell death triggers an inflammatory response in which the immune system releases neutrophils and macrophages to eliminate the dead cells, which produces free radicals that cause continued cell damage, worsening the inflammatory response and the cerebral edema in a vicious cycle.

Hypothermia counters neuroexcitation and reduces cell death by stabilizing the release of calcium and glutamate. It also stabilizes the blood-brain barrier and suppresses the inflammatory process, decreasing cerebral edema. Cerebral metabolism drops 6-10% for every degree Celsius that body temperature drops. As cerebral metabolism declines, the brain needs less oxygen.

Technique can benefit patients with non-shockable rhythms

Now, a new study shows that therapeutic hypothermia may also benefit comatose cardiac arrest patients with "non-shockable" heart rhythms - those that will not respond to the defibrillation because there is no pulse or electrical activity in the heart.

Researchers, led by Dr. Sarah Perman, assistant professor of emergency medicine at the University of Colorado in Aurora, examined data from 519 patients who had a cardiac arrest due to a non-shockable heart rhythm in the Penn Alliance for Therapeutic Hypothermia (PATH) registry between 2000-13.

Those who received therapeutic hypothermia were 2.8 times more likely to survive after cardiac arrest and 3.5 times more likely to have better neurologic recovery compared with those who were not cooled.

Dr. Perman explains that neurologic injury after cardiac arrest is devastating; the only chance doctors have to give some form of neuroprotection is immediately after the arrest.

She adds:

"Our resources right now are not extensive and our outcomes are still fairly grim. Therapeutic hypothermia is one therapy we do have in our arsenal, and if a patient is comatose after arrest, it's very important to consider applying this therapy, specifically in patients who are neurologically injured."

Although the American Heart Association (AHA) have included guidelines for the use of therapeutic hypothermia in patients who suffer cardiac arrest since 2005, adoption of this practice has been low, especially for in-hospital cardiac arrest patients and those who arrest with initial non-shockable rhythms.

Unwillingness to apply the procedure is due to the perception that there is no benefit to patients who have an initial non-shockable rhythm.

The researchers would like to see more investigation into the use of neuroprotective strategies such as therapeutic hypothermia for cardiac arrest patients with non-shockable rhythms.         

Earlier this year Medical News Today reported that therapeutic hypothermia can also help in the process of kidney transplantation.

Written by Yvette Brazier

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Moderate coffee drinking may prevent premature death

Incredible volumes of black gold are poured into our collective bodies on a daily basis, which makes the medical effects of coffee drinking a perpetual area of study. Now, new research points to some interesting positive health benefits of moderate consumption.
[Man drinking lots of coffee]
Moderate coffee intake may prevent certain types of premature death.

According to some estimates, 2.25 billion cups of coffee are consumed worldwide, daily.

Anything that humans consume on such a huge scale deserves thorough research into its health benefits, or lack thereof.

Coffee is a complex cocktail of chemicals, including, of course, naturally occurring caffeine. Alongside this much-studied and consumed stimulant are a whole host of interesting chemicals.

Coffee includes more than 1,000 distinct and exotic sounding compounds, including caffeoylquinic acids, chlorogenic acids, diterpenes, feruloylquinic acids, 4-methylimidazole and p-coumaroylquinic acids, to name but a few.

The highly abbreviated list above makes coffee's complex range of physiological effects less surprising. Is it good or bad for the heart? Positive or negative for liver function? Does it help or hinder Alzheimer's, or worsen the effects of diabetes?

New research reported in the American Heart Association's journal Circulation brings together data from a number of longitudinal trials to investigate coffee's potential health effects over a substantial period of time.

The investigation utilizes data from 74,890 women in the Nurses' Health Study and 93,054 from the Nurses' Health Study 2, plus 40,557 men from the Health Professionals Follow-up Study.

Information regarding dietary habits was collected from questionnaires every 4 years, with participants being followed up for a maximum of 30 years.

Coffee's health benefits

The study found that people who drank a moderate amount of coffee (fewer than five cups per day) experienced a lower risk of death from cardiovascular disease, neurological diseases, type 2 diabetes and suicide.

The study's lead author, Dr. Ming Ding, says:

"Bioactive compounds in coffee reduce insulin resistance and systematic inflammation. They might be responsible for the inverse association between coffee and mortality."

Interestingly, the study included caffeinated and decaffeinated coffee, so at least some of the measured benefits of coffee appear to be secondary to the caffeine content.

The group also made sure to control for alcohol and tobacco consumption, as these were both relatively high in coffee drinkers, compared with non-coffee drinkers.

The authors make it clear that the study was not designed to show a direct causation between coffee drinking and illness, so drawing conclusions at this stage would be premature. Another drawback, mentioned by the research team, was their reliance on participants accurately reporting their own level of coffee consumption.

Previous results of similar studies have produced inconsistent results in regard to coffee's effects on various illnesses, so the results of this study cannot be taken as definitive evidence, but they are a significant addition to the literature.

Previous research into coffee's health benefits

In recent years, there has been a wide range of experimentation into the consequences of high coffee intake. Results seem to show coffee as having a positive role in type 2 diabetes, Parkinson's and some liver diseases.

On the other side of the coin, coffee appears to negatively impact blood pressure and plasma homocysteine, both of which increase cardiovascular risk, contrary to the current study's findings.

In addition, some sections of society are likely to be more vulnerable to adverse effects. Another of the study's authors, Dr. Frank Hu, adds another word of caution:

"Regular consumption of coffee can be included as part of a healthy, balanced diet. However, certain populations such as pregnant women and children should be cautious about high caffeine intake from coffee or other beverages."

The current study's results certainly are intriguing. Dr. Ding and his team hope that further research, over the years to come, will tease apart the roles of some of the individual ingredients within coffee.

As part of the ever-growing tapestry of information on coffee's health effects, Medical News Today recently covered research into how an evening coffee can disrupt our body clock.

Written by Tim Newman

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Snake venom could make surgery safer for patients on blood thinners

Preventing blood clots with drugs such as heparin has become a common practice for fighting some heart and lung conditions, and for certain surgeries. But patients who take them also need their blood to clot to heal incisions made during operations. Researchers are developing a new way to tackle this problem - by pairing snake venom with nanofibers. Their study using the therapy on rats appears in the journal ACS Biomaterials Science & Engineering.

Currently, doctors can take several approaches to reduce bleeding in surgical patients on heparin and other blood thinners, including applying pressure, sutures, foams and adhesives. But these options can come with potentially serious risks. Some can introduce toxic byproducts into a patient, spark an allergic reaction or cause tissue to die. To come up with a better alternative, Jeffrey D. Hartgerink and colleagues turned to an enzyme from snake venom that causes blood to coagulate even if it contains heparin. Called batroxobin, the enzyme is already in clinical use for another condition. But using it to control bleeding is problematic because it dissolves quickly and moves away from where it's originally introduced - a problem when trying to heal surgical incisions.

To override batroxobin's tendency to disperse, the researchers paired it with "sticky" nanofibers to make the enzyme stay put. The therapy, which was tested on rats treated with heparin, promoted localized blood clotting at a wound site within 20 seconds. The researchers say with further testing, the approach could eventually help make surgery safer for human patients taking heparin.

The authors acknowledge funding from the National Institutes of Health and the Welch Foundation.

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Myocardial infarction: PEGASUS-TIMI 54 sub-analysis outlines long-term tolerability data for BRILINTA

AstraZeneca has announced results of a sub-analysis of the PEGASUS-TIMI 54 study, which evaluated reasons and rates for discontinuation of BRILINTA® (ticagrelor) in patients with a history of myocardial infarction (MI) (one to three years prior to study randomization) and the efficacy in those patients who stayed on therapy. The data were presented during a Late-Breaking Clinical Trials session at the 2015 American Heart Association (AHA) Scientific Sessions.

The pooled analysis of the results showed that in patients who stayed on therapy, BRILINTA reduced the rate of the composite efficacy endpoint of cardiovascular (CV) death, MI, or stroke at three years (HR 0.79, 95% CI 0.70-0.88), consistent with the results of the overall population of the PEGASUS study. Discontinuation resulting from an Adverse Event (AE) was 8.9% in the placebo arm, 19% and 16.4% in the BRILINTA 90 mg and 60 mg arms, respectively, and was most frequently due to bleeding and dyspnea. Rates of AEs leading to discontinuation were highest in the first year at 16% in the 90 mg arm, 13% in the 60 mg arm, and 6% in the placebo arm. In those patients who stayed on therapy, discontinuation rates over the subsequent two years were 6.5% in the 90 mg arm, 6.0% in the 60 mg arm, 4.6% in the placebo arm.

Marc Bonaca, MD, Thrombolysis in Myocardial Infarction [TIMI] Study Group, Brigham and Women's Hospital, Boston, MA and lead investigator for the sub-analysis study, said: "This analysis pointed to important patterns with regards to common AEs associated with ticagrelor in the context of clinical benefit. Physicians must consider the overall risks, including higher rates of bleeding and dyspnea particularly within the first year. For patients at increased risk for recurrent cardiovascular events in the long-term, ticagrelor can provide an important benefit."

"This sub-group analysis provides additional insight into the clinical profile of ticagrelor and reinforces its role in the reduction of the composite of CV death, MI, and stroke for these patients studied in PEGASUS," Bonaca added.

Steven Zelenkofske, D.O., FACC, Vice President, US Medical Affairs, AstraZeneca said: "We welcome the results of this sub-analysis, which lends insights regarding the tolerability and efficacy of BRILINTA long-term during a time when questions remain regarding the appropriate length of dual antiplatelet therapy."

On September 3, 2015, the US Food and Drug Administration (FDA) approved a new 60-mg tablet dosage strength for BRILINTA to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

The PEGASUS-TIMI 54 study investigated the efficacy and safety of ticagrelor at both 60 mg and 90 mg twice daily, plus low dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of atherothrombotic events in patients >50 years of age who had suffered a heart attack one to three years prior to study enrollment and had one additional risk factor for thrombotic CV events. Only the 60-mg dosage strength is approved for use in patients with a history of MI. BRILINTA 60 mg tablets are now available in US pharmacies.

BRILINTA has been studied in multiple clinical trials, including the PLATO and PEGASUS trials. In PLATO and PEGASUS alone, nearly 40,000 patients have been studied with BRILINTA.

For patients who have been prescribed BRILINTA, AstraZeneca offers the BRILINTA Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey. To help loved ones, the program offers important patient education and coaching in addition to savings offers, refill reminders, personal pharmacy locator, co-pay calculator, and coverage verification and information. To enroll in BPSS, call 1-888-512-7454 or enroll online at www.BRILINTA.com. Health care professionals can visit www.BRILINTAtouchpoints.com.

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New study supports localised services for cardiac rehab

New research at the University of York has found that smaller, more localised cardiac rehabilitation (CR) centres are equally as effective as their larger counterparts.

The study, funded by the British Heart Foundation (BHF) and published in Open Heart, found that similar patient outcomes were achieved at smaller, more localised CR schemes when compared with larger, centralised centres.

Cardiac rehabilitation offers behavioural advice and support, including diet and exercise, to help people living with heart disease to manage their condition and reduce the risk of associated heart events.

In the first study of its kind, researchers in our Cardiovascular Health Research Group based in the University's Department of Health Sciences looked at factors such as smoking rates, cholesterol levels and physical activity levels for patients and found measured improvements were regardless of the size of the CR scheme where the patient attended.

Previous research has shown that CR can improve patients' mortality rates and reduce the chance of a further heart event. Yet less than half of eligible heart patients attend CR following a major heart event.

The BHF says that accessibility to schemes is one of the main issues for the low uptake numbers of CR and more localised services could help improve patient uptake.

There has been pressure for localised CR services to merge into centralised schemes to reduce costs and it was thought that better patient outcomes could be achieved with larger volumes of patients using the same scheme.

The study's author Professor Patrick Doherty, from the Department of Health Sciences at York, said: "This study is important as it is based on routinely collected data, within the NHS, which means this is a real world effect that directly relates to patient care.

"One of the arguments for merging cardiac rehabilitation services was improved outcomes, but our study shows that the same outcomes are achieved at smaller, more localised rehabilitation centres."

Dr Mike Knapton, Associate Medical Director at the BHF, added: "Less than half of eligible patients receive cardiac rehabilitation following a heart attack or other serious heart problems, despite the clear benefits and better outcomes for patients.

"Cardiac rehabilitation schemes need to be made more accessible to patients if we are to see increases in the number of people benefitting from them.

"This evidence suggests that improving access through more localised services can be achieved without diminishing the outcomes for patients."

Health and Wellbeing is one of the major Research Themes at University of York which strives to improve health service delivery and outcomes.

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'Personalized medicine' drives better outcomes for certain heart patients

In the weeks and months after a patient gets a heart stent, blood clots can pose a major threat to recovery. Now, University of Florida Health researchers have found that a quick genetic test can tell doctors early on whether a crucial anti-clotting drug will work, they reported at the American Heart Association's Scientific Sessions in Orlando.

They also are hailing the finding as a significant gain for personalized medicine, which tailors medical decisions based on individual patients' genetic information and other unique characteristics.

Their research focused on clopidogrel, a drug that can prevent blood clots after a heart artery is propped open with a coronary stent. Yet the drug doesn't work on everyone: About 30 percent of all patients have a genetic deficiency that prevents them from activating it. Treating those patients with a drug their bodies can't use is akin to providing no medication, said associate professor Larisa Cavallari, Pharm.D., director of the Center for Pharmacogenomics at the UF College of Pharmacy and associate director of the UF Health Personalized Medicine Program.

That's where the genetic testing made available through UF Health pathology laboratories and studied by UF Health researchers comes into play.

A patient's genetic information is analyzed quickly and economically using a process known as genotyping. That tells a physician if clopidogrel will work effectively, allowing doctors to more precisely personalize treatment by prescribing a different medication. The genotyping also has lifesaving implications: Every patient gets the best possible drug at the right time, Cavallari said.

"This is tailoring therapy based on the patient's genetic makeup, and recognizing that not everyone is going to respond well to one drug," she said.

The study is among the first to examine the effect of genotype-guided treatment on cardiovascular outcomes after a heart procedure known as percutaneous coronary intervention, or PCI, researchers said.

During the two-year study, researchers tracked 408 patients who had genotyping and had a PCI to open narrow or clogged heart arteries. Of that group, 126 patients had the genetic deficiency that prevents clopidogrel from working effectively. Fifty-eight of them were treated with clopidogrel and 68 received an alternative medication.

After six months, the risk of major cardiovascular problems such as death, heart attack, stroke and having a stent become blocked by blood clots was significantly reduced among patients with the genetic deficiency who were prescribed an alternative drug, researchers found. None of those patients had a major cardiovascular problem within 30 days of the PCI procedure. In contrast, 12.5 percent of patients who got clopidogrel but could not activate it had problems such as a heart attack or blood clot.

That shows exactly how genetic analysis can be used for a more effective and personalized health care experience, said Julie A. Johnson, Pharm. D., dean of the UF College of Pharmacy, the project's principal investigator and the director of the UF Health Personalized Medicine Program.

"This is a way to identify a medication that isn't going to be very good for some patients and choose an alternative that's better for them," she said.

In addition to saving lives and preventing medical problems, genotyping has significant implications for the business side of health care. Simple genotyping that costs several hundred dollars can prevent a heart attack by getting a patient on the correct antiplatelet medication early on.

"You don't have to prevent a lot of heart attacks to achieve a cost savings," Johnson said.

The Personalized Medicine Program is expanding genotype-guided therapy at UF Health to include additional medications for which genetic variations are known to influence effectiveness. Genotyping patients to determine the best drug dose or the most effective medication can also be used for other diseases such as hepatitis C, some pediatric cancers, inflammatory bowel disease and pain management, Johnson said.

Personalized medicine, also known as precision medicine, is already delivering benefits for PCI patients at UF Health Shands Hospital because genotyping is standard practice for most of these patients, Cavallari said.

Next, researchers want to make cardiologists and other health systems aware of the benefits of genotyping PCI patients. No randomized, controlled trial with PCI patients has been done and Cavallari doesn't believe it is necessary.

"We believe the current data are strong enough to support using genotyping in a clinical setting. It provides data to support the idea that other health care institutions should do this," she said.

The Personalized Medicine Program is collaborating with other institutions to study outcomes of genotype-guided anti-clotting therapy in a larger group of PCI patients. To help spur broader adoption, the UF Health team also is evaluating education and implementation strategies so others can build on the program's experience.

UF Health's Personalized Medicine Program is a multidisciplinary initiative created in 2011 within the Clinical and Translational Science Institute. Led by College of Pharmacy faculty, researchers work with health professionals and patients at UF Health and across the state to study and implement methods that allow genetic information to be used as a routine part of patient care.

Funding and other support for the PCI research was provided by UF Health, its Clinical and Translational Science Institute and National Institutes of Health grants U01 HG007269, U01 GM074492, U01 HL105198 and UL1 TR000064.

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Are mechanical heart valves better than biological ones?

Increasingly, biological heart valves are being used preferentially to mechanical valves in surgical replacement procedures. New research at Sweden's Karolinska Institutet might turn this preference on its head.
[Heart with trace reading]
A new study shows that biological valves might not be the best choice for replacement procedures.

Aortic valve replacements have been carried out since the 1960s, and since those early days, the procedure has been repeatedly and significantly improved.

Today's aortic valve replacement procedures can often be minimally invasive; around 280,000 aortic valves are replaced globally each year.

There are a number of reasons why a heart valve may need replacing. The most common of which is aortic stenosis, a narrowing of the aortic valve.

This narrowing restricts blood flow from the left ventricle to the aorta and increases the eventual risk of heart failure.

Aortic regurgitation is another of the most common reasons for valve replacement. In this case, the valve is leaky and allows blood to move back into the heart rather than exit and move through the body.

As with aortic stenosis, the excess work required to pump blood around the body can eventually lead to complications, including heart failure.

Mechanical or biological valves?

Surgeons completing modern valve replacement operations must choose between mechanical and biological valves, both of which have their own pros and cons.

Mechanical versions are constructed from sturdy man-made materials like carbon and titanium; these valves are stress tested for durability, and some are capable of remaining viable for an estimated 50,000 years.

Biological valves are made either from strong, flexible animal tissue or, rarely, human donor tissue. They are expected to last 10-20 years.

Biological heart valves are used in the majority of replacements and are generally considered, across all age groups, to be the best option.

Mechanical valves are much more durable, but they are also more likely to succumb to clotting problems. These clotting issues can lead to serious consequences. As such, patients with mechanical valves are required to take blood thinning medication, like warfarin, for the rest of their lives.

This clotting risk and lifelong medication is clearly not ideal for younger heart surgery candidates with decades left to live.

Which valve is best for younger patients?

Whether mechanical or biological valves are preferable in relatively young patients is a question that has sparked lively debate among researchers and doctors.

New research, carried out by Dr. Ulrik Sartipy, associate professor at the Department of Molecular Medicine and Surgery at the Karolinska Institutet, looked at the mechanical-biological question in depth.

The study, reported in the European Heart Journal, followed 4,500 Swedish aortic valve replacement patients aged 50-69. The research team collated survival rates, incidents of stroke and re-operation rates.

Their investigation reconfirmed a previous study's findings in relation to the reduced bleeding risks attributed to biological valves. However, the team's other findings bucked the trend significantly.

Dr. Ulrik Sartipy says:

"We show that patients who had received a mechanical prosthesis had better survival rates than those who had received a biological prosthesis."

Another of the study's findings, which might help sway the pro-biological lobby, was that patients with a biological valve had a higher chance of needing further operations on the valve.

Additionally, stroke risk was found to be the same in both mechanical and biological valve replacements. Natalie Glaser, PhD student and part of the research team, says:

"Our research shows that mechanical valve prostheses should be the preferred option for young patients."

The research certainly adds weight to the argument for using mechanical valves in younger patients. The debate, however, is likely to continue as weight is added to either side through further investigation.

Medical News Today recently reported that cardiovascular risk falls in patients with rheumatoid arthritis.

Written by Tim Newman

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Interim results support the clinical utility of the Corus CAD test in the assessment of obstructive coronary artery disease

CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, has announced results from a multi-center, community-based patient registry called the PRESET Registry which found that patients with symptoms of obstructive coronary artery disease (CAD)* and who had low Corus® CAD test scores had an 82% decreased odds of referral for further cardiac evaluation versus patients with elevated Corus CAD test scores.[1]

The Corus CAD test is a blood-based test that integrates age, sex, and gene expression levels into a single score indicating the current likelihood of a significant narrowing or blockage of the coronary arteries. The data was presented at American Heart Association Scientific Sessions 2015 in Orlando, Fl. on November 7-11, 2015.

"Challenges associated with diagnosing obstructive CAD in symptomatic patients can lead to repeat and unnecessary tests and procedures," said Joseph A. Ladapo, M.D., Ph.D., Assistant Professor of Medicine, Department of Population Health and Medicine, NYU School of Medicine and lead author of the study. "The PRESET Registry analysis reinforces the benefits of implementing the age/sex/gene expression score (ASGES) test in the primary care setting for patients and clinicians. With the ASGES test, clinicians are able to safely and efficiently rule-out low-risk patients suspected of having CAD."

The registry study, "Primary Endpoint Results from a Community-Based Registry Evaluating the Use of a Blood-Based Age/Sex/Gene Expression Test in Patients Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease: the PRESET Registry (A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings)," evaluated 718 stable, non-acute and non-diabetic adult patients without a history of obstructive CAD from 21 primary care practices from September 2012 to August 2014.

The interim results of the primary efficacy endpoint demonstrated that the use of the Corus CAD test in the primary care setting was associated with a clinically relevant and statistically significant impact on medical decision making in patients presenting with typical or atypical symptoms suggestive of obstructive CAD. The median test score was 18 (range: 1-40), and 310 of the 718 (43%) patients had low scores ( ≤ 15). In a 30-day follow up, 27 of 310 (9%) patients with low Corus CAD scores were referred for further cardiac evaluation (OR 0.18, p

"With approximately $5.9 billion spent annually on non-invasive and invasive cardiac testing among non-diabetic patients in the U.S. we are faced with the challenge to better and more confidently diagnose patients presenting with symptoms suggestive of obstructive CAD," said Mark Monane, M.D., FACP, Chief Medical Officer of CardioDx. "The large number of community-based office practices included in the PRESET registry helps to address the generalizability of the study findings. The results of the primary endpoint showing a low rate of further cardiac referral reinforce results from previous studies showing the clinical utility of Corus CAD on clinical decision making."

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Sanofi and Regeneron announce new Praluent (alirocumab) injection analyses

Sanofi and Regeneron Pharmaceuticals, Inc. have announced a new post-hoc analysis of six Phase 3 clinical trials showing that approximately three quarters (74 percent) of patients reached their pre-specified LDL cholesterol targets within 8 weeks of adding Praluent® (alirocumab) Injection 75 mg to their standard-of-care, which included statins. In the 26 percent of patients whose dose was increased to 150 mg, most were able to achieve their pre-specified LDL cholesterol target, with an average additional 14 percent reduction in LDL cholesterol. The results from this and other analyses, which evaluated Praluent every two weeks, were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, FL.

"In this analysis of patients who required further improvement of their LDL cholesterol levels, adding Praluent 75 mg to their standard-of-care allowed the majority of patients to achieve their LDL cholesterol goals. For those who required further LDL cholesterol lowering, increasing Praluent to 150 mg provided additional efficacy," said Harold Bays, M.D., from the Louisville Metabolic & Atherosclerosis Research Center, Kentucky, U.S. "Data such as these provide clinicians practical insight as to how the two Praluent doses may better allow patients to achieve their LDL cholesterol goals."

These results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol (heterozygous familial hypercholesterolemia, or HeFH) which found 74 percent of patients who added Praluent 75 mg achieved their LDL cholesterol-lowering goals at week 8, and the remaining 26 percent had their dose adjusted to 150 mg at week 12. In other results:

By week 24, 61 percent of patients who switched to 150 mg achieved their goal, with a mean additional LDL cholesterol reduction of 14 percent. Comparable adverse event (AE) rates were observed in patients whose Praluent dose was increased, versus those whose dose was not (66 percent in both arms in placebo-controlled trials; and 55 percent versus 56 percent respectively in ezetimibe-controlled trials). About the data: The pooled analysis included results from six Phase 3 ODYSSEY trials where patients added Praluent 75 mg to standard-of-care, and had their dose adjusted at week 12 to 150 mg if they did not reach their LDL cholesterol goals by week 8. Cholesterol goals were either less than 70 mg/dL or less than 100 mg/dL, dependent on CV risk. All patients across the six trials received background statin therapy. In three trials Praluent was compared to placebo (ODYSSEY FH I, FH II, COMBO I), and in three it was compared to ezetimibe (ODYSSEY COMBO II, OPTIONS I, OPTIONS II).

In a separate pooled post-hoc analysis of 3,499 patients, individuals with diabetes (n=1,051) who initially received Praluent 75 mg or 150 mg every two weeks had a mean percent difference in LDL cholesterol of 44 percent and 58 percent, respectively, versus placebo at week 24 (p

Praluent was generally well tolerated, with the most common adverse events among people with diabetes being nasopharyngitis (11 percent Praluent, 10 percent placebo) and upper respiratory tract infection (8 percent Praluent, 9 percent placebo). About the data: The pooled analysis included results from five placebo-controlled trials of individuals with diabetes (1,051), and without diabetes (2,448) with inadequately controlled hypercholesterolemia receiving standard-of-care, which included maximally-tolerated statins. In two of the trials, patients initially received Praluent 150 mg (ODYSSEY LONG TERM, HIGH FH). In three of the trials, patients initially received Praluent 75 mg and had their dose adjusted to 150 mg at week 12 if they required additional lipid-lowering to meet their LDL cholesterol goals (ODYSSEY COMBO I, FH I, FH II).

A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related AEs among those who didn't have diabetes when they entered the trials, regardless of whether they were taking Praluent or were in a control group (placebo or ezetimibe). There was also no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes. The ongoing ODYSSEY OUTCOMES trial will provide further data on the impact of Praluent on glycemic measures.

About the data: The pooled analysis included results from 10 Phase 3 ODYSSEY trials of patients with inadequately controlled hypercholesterolemia, ranging from 24 to 78 weeks (ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II, MONO, ALTERNATIVE). In total, 1,526 (31 percent) had a medical history of diabetes upon entering the trials, 1,969 (40 percent) were identified as having pre-diabetes, and 1,479 (30 percent) did not have diabetes (e.g., had a normal concentration of glucose in the blood).
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New vaccine could offer 'cheaper, more effective' treatment for high cholesterol

Around 73.5 million adults in the US have high levels of "bad" cholesterol, but only 1 in 3 have the condition under control. In a new study, researchers reveal the development of a vaccine they say could offer a cheaper and more effective alternative to current cholesterol-lowering treatments.
The new vaccine was found to dramatically reduce cholesterol in mice and monkeys, suggesting it could do the same for humans.

In the journal Vaccine, study coauthor Dr. Bryce Chackerian - of the Department of Molecular Genetics and Microbiology at the University of New Mexico - and colleagues reveal how the new vaccine significantly reduced low-density lipoprotein (LDL) cholesterol in both mice and rhesus macaque monkeys.

LDL cholesterol is commonly referred to as "bad" cholesterol; high levels of LDL cholesterol can cause a build-up of plaque in the arteries, increasing the risk of heart attack, stroke and heart disease - the leading cause of death in the US.

According to the Centers for Disease Control and Prevention (CDC), people with high LDL cholesterol are twice as likely to develop heart disease than those with normal levels.

While lifestyle changes, such as adopting a healthy diet and increasing physical activity, are key for maintaining normal cholesterol levels, many people take statins to lower LDL cholesterol. Statins work by blocking an enzyme needed by the liver to produce cholesterol.

Though statins can be effective, Dr. Chackerian and colleagues note that they do not work for everyone and may cause severe side effects, including muscle pain, liver damage, digestive problems and increased diabetes risk.

But the team says their vaccine - which works by inhibiting a cholesterol-regulating protein in the blood called PCSK9 (proprotein convertase subtilisin/kexin type 9) - may provide a more effective alternative to statins.

For their study, the researchers created a bacteriophage virus-like particle (VLP) vaccine that produces strong antibody responses against PCSK9.

PCSK9 works by binding to the LDL cholesterol receptor in the blood. In the liver, the LDL receptor effectively removes LDL cholesterol from the blood, but when PCSK9 binds to it, it no longer has this ability. By blocking PCSK9 - which the new vaccine does - the LDL receptor can do its job.

Fast facts about cholesterol

Less than half of adults in the US with high LDL cholesterol are receiving treatment for it However, the percentage of Americans receiving treatment for high LDL cholesterol has increased, from only 28.4% in 1999-2002 to 48.1% in 2005-08 All adults should have their cholesterol levels checked every 5 years.

Learn more about cholesterol

On testing a single dose of the vaccine in 4-6-week-old mice, the team found it significantly reduced LDL cholesterol levels. When combined with statins, the team found the vaccine produced an even greater reduction in LDL cholesterol among 9-17-year-old rhesus macaques. The findings suggest the vaccine may also lower cholesterol in humans, according to the researchers.

"One of the most exciting things about this new vaccine is it seems to be much more effective than statins alone," notes Dr. Chackerian.

The new vaccine is the not the first cholesterol-lowering treatment to be developed that targets PCSK9. In August, the US Food and Drug Administration (FDA) approved a drug called evolocumab (brand name Repatha) that uses monoclonal antibodies to block PCSK9 and lower LDL cholesterol.

The FDA approved the drug to be used alongside a healthy diet and maximally-tolerated statin therapy for adults with a genetic predisposition for high cholesterol, as well as heart attack and heart disease patients who require further lowering of LDL cholesterol.

However, Dr. Chackerian and colleagues believe their vaccine may not only be more effective than such treatments, but it may also be a much cheaper alternative, noting that monoclonal antibody-based therapies can cost a patient more than $10,000 annually.

"While the developed world may be able to sustain these costs, expense is likely to be a major impediment to the use of such drugs in the developing world," say the authors. "In contrast, vaccination for a wide variety of mostly infectious communicable diseases has been proven to be compatible with the health care infrastructure in the developed and developing world."

Commenting on their overall findings, the researchers say:

"The data reported here, in both mice and macaques, provides proof-of-principle evidence that a vaccine targeting PCSK9 can effectively lower lipid levels and work synergistically with statins.

Thus, the use of VLP-based vaccines targeting PCSK9 peptide could serve as a cost-effective alternative to other therapies and could lead to a widely applicable vaccine-based approach for controlling hypercholesteremia [high cholesterol] and cardiovascular disease. If successful, this approach could obviously have a major impact on human health worldwide."

The researchers plan to conduct further testing of the vaccine in macaques, and they hope to move forward with vaccine development by teaming up with commercial partners.

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Low-income, elderly, women less likely to complete cardiac rehab after bypass

Bypass patients who are older, female and/or from lower-income neighbourhoods are more likely to face delays in beginning cardiac rehabilitation (CR), making them less likely to complete CR, which can lead to a higher mortality risk, suggests a new study.

The study, led by Dr. Susan Marzolini, exercise physiologist, Toronto Rehabilitation Institute (TR), UHN, examined nearly 6,500 coronary artery bypass graft surgery patients enrolled in the Cardiovascular Prevention and Rehabilitation program at Toronto Rehab over the course of 16 years.

Published in the November issue of Circulation: Cardiovascular Quality and Outcomes, the study found that bypass patients who waited longer than 60 days after their surgery to start CR were more likely to drop out of the program, attended fewer classes, and saw less improvement in their fat percentage and fitness, the Toronto study suggests.

"We know cardiac rehabilitation saves lives," says Dr. Paul Oh, Medical Director of the Cardiovascular Prevention and Rehabilitation Program at TR and co-author of the study. "Our past research has found that those who participate in cardiac rehabilitation after experiencing a major heart event cut the risk of dying from a subsequent heart event in half."

The study found that bypass patients are more likely to experience longer wait times, and subsequently poorer participation, if they are women, older, from a lower socioeconomic neighbourhood, employed, or had less social support. Any one of these factors is associated with longer wait times.

"We have now pinpointed a specific profile of bypass surgery patients most vulnerable to these delays and this study offers evidence that these wait times are problematic for the health of bypass patients," Dr. Marzolini notes.

In Ontario, cardiac rehabilitation services are reimbursed by the province's Ministry of Health. However, socioeconomic barriers exist that prevent some from accessing cardiac rehabilitation soon after bypass, she says.

"Women tend to experience heart events when they're older, and are more likely to be single," Dr. Marzolini explains. "With a lack of social support in place, they may have less access to transportation or be unable to overcome the cost associated with travel to the CR program, limiting their participation.

"Now that we've identified a gap with socially vulnerable bypass patients, this is a group we - as CR programs - can focus on and be equipped to reach out and help them."

Dr. Marzolini suggests the system could increase timely CR participation by ensuring surgical teams inform and refer patients to CR before hospital discharge. CR patients should be informed of the program options available in CR programs such as home program (off-site) models, evening classes, classes specifically for women; social support services; and help identifying transportation alternatives.

This study is specific to Toronto, ON, and similar research across Ontario and in the United States has also shown wait times to start CR after a heart event tend to exceed the suggested 60 days.

"While we cannot generalize the findings of this study yet, it gives us a great starting point to explore the impact of CR delays on a larger scale, find methods to integrate the socially vulnerable earlier, and continue to examine CR wait times for other cardiac patient populations," says Dr. Oh.

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Highly sensitive sensors successfully map electrical patterns of embryonic heart

Highly sensitive sensors have been successfully used to map the electrical activity of the developing heart in embryos, in a University of Sussex study published today (10 November 2015).

Zebrafish Embryo
This is an example of the electrocardiogram mapped from the embryonic zebrafish heart three days after fertilization.
Credit: Dr. Elizabeth Rendon-Morales

The study could lead to new insight into how heart rhythm abnormalities develop, the researchers say.

The team fine-tuned patented Electric Potential Sensing (EPS) technology, developed at the University, to detect the electrical signals of zebrafish embryos from just three days after fertilization. The findings have been published in the scientific journal Applied Physics Letters.

This is the first time that scientists have been able to see the full picture of the electrical activity in the developing heart of such a small organism, given that currently electrocardiography (ECGs) methods only measure the heartbeat.

Zebrafish hearts are remarkably similar to those of humans, making them a good model organism for scientific research. These latest results "push the frontiers" of the EPS sensor technology and could help scientists better understand how the heart develops - particularly during the early stages of life - and how defects originate.

Professor Robert Prance, head of the Sensor Technology Research Centre at the University of Sussex, said: "The EPS is a sensor technology that measures changes in an electric field in a similar way to a 'perfect voltmeter', drawing no current into the sample, making it non-invasive and safe to use. The sensor has already been used to carry out human ECG heart scans -- or their cranial equivalent, electroencephalographs -- saving patients from uncomfortable electrodes.

"Zebrafish embryo hearts are 2,500 times smaller than the human heart, so we needed to enhance the EPS design to make possible the detection of such cardiac activity.

"This could provide the biomedical research community with a novel instrumentation tool for performing cardio-electrophysiological studies at early developmental stages."

Dr Elizabeth Rendon-Morales, a Research Fellow at the University of Sussex and lead author of the study, said: "With this research we wanted to push the frontiers of the EPS sensor design towards its performance limits.

"Currently heart-related diseases such as congenital cardiac arrhythmias and long/short QT syndrome cost the EU economy almost 196 million euros a year. It is vital for us to develop tools that help our professionals understand as much as possible. This research could potentially generate new insights into the origins of such heart abnormalities.

"Using our technique based on electric field detection, we were able to obtain electrophysiological signals from living zebrafish embryos starting at three days post-fertilization. This is an excellent demonstration of the high sensitivity provided by the EPS sensor, which is also non-invasive and completely biocompatible."

Although the technique has not yet been tested on human embryos, the study nevertheless provides a solid 'proof of principle' to underpin further research.

The team is now designing a multiplatform based on EPS arrays for the recording of electrophysiological signals simultaneously, which could potentially be used for applications in drug screening studies and neuroscience.

The EPS sensor was developed out of research led by Professor Prance, in collaboration with the University's business incubation network Sussex Innovation. A licensing agreement was signed in 2010 with Plessey Semiconductors to bring new applications to market and it was shortlisted in the 2011 Times Higher Educations Awards for technological innovation of the year.

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'Post-hospital syndrome' found to be a risk factor for elective surgery

A condition known as "post hospital syndrome" (PHS) is a significant risk factor for patients who undergo elective outpatient surgery, a Loyola study has found.

PHS is defined as having been hospitalized during the previous 90 days. The first-of-its-kind study found that among patients with PHS, 7.6 percent had to be readmitted to the hospital within 30 days of undergoing elective outpatient hernia surgery. By comparison, only 1.6 percent of non-PHS patients had to be readmitted following hernia surgery.

Also, 8.3 percent of PHS patients were admitted to the emergency department within 30 days of hernia surgery, compared with 4.3 percent of non-PHS hernia surgery patients.

The study by senior author Paul Kuo, MD, first author Anai Kothari, MD, and colleagues was presented at the annual meeting of the Western Surgical Association in Napa Valley, Ca. Dr. Kuo is chair of the Department of Surgery of Loyola University Medical Center and Loyola University Chicago Stritch School of Medicine. Dr. Kothari is a resident in the Department of Surgery.

"Surgeons must consider all recent inpatient admissions when risk-stratifying patients for ambulatory, elective surgery," researchers concluded.

PHS was first identified in an article in the New England Journal of Medicine by Harlan Krumholz, MD of Yale University School of Medicine. Dr. Krumholz defined PHS as "an acquired condition of vulnerability."

During hospitalization, patients often are sleep deprived and in pain or discomfort. They receive medications that can alter their mental and physical abilities. They become deconditioned (loss of muscle mass, reduced cardiac output, etc.). And patients may not get sufficient nutrition if, for example, they are on a ventilator or have to fast before surgery or tests. These problems can impair their recovery and make them more prone to disease and mental errors, Dr. Krumholz wrote.

The Loyola researchers analyzed records of 57,988 California patients who underwent hernia repair in 2011, including 1,332 patients who had PHS. Data sets came from the U.S. Agency for Healthcare Research and Quality. Researchers focused on hernia repair because it is a common surgery performed at ambulatory surgery centers, community hospitals and academic medical centers.

Among the PHS patients, the most common reason for their previous hospitalization was gastrointestinal problems (25.1 percent), followed by cardiovascular problems (12.3 percent), hip fractures and other injuries (8.2 percent) and pregnancy-related complications (7.1 percent). The average length of time between their previous hospitalization and their elective hernia surgery was 48.7 days.

The study is titled "Impact of the Post-Hospital Syndrome on Outcomes Following Elective Outpatient Surgery". In addition to Drs. Kuo and Kothari, co-authors are Robert Blackwell, MD; Ryan Yau; Matthew Zapf; Matthew Arffa; and Gerard Abood, MD.

Loyola researchers are doing a follow-up study to determine what measures hospitals could take to reduce the negative impact of PHS.

The PHS study was conducted by Loyola's predictive analytics program, which mines large data sets to predict health outcomes. In addition to the PHS study, researchers are studying, for example, how hospitals can reduce the negative effects of having surgery on the weekend and whether having a trauma department confers a beneficial "halo effect" on patient outcomes across the board.

Large new databases, electronic medical records and more powerful computing capabilities are enabling researchers to conduct such studies. "We're now able to ask and answer a broad range of questions that could significantly help improve patient care and reduce costs," Dr. Kuo said. Dr. Kuo heads Loyola's analytics group, One to Map Analytics. (One-to-map is a common computer command in analytics research.)

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Obese 8-year-olds found with signs of heart disease

The obesity epidemic is never far from the news desk, and for good reason. Today, around 1 in 3 American kids and teens are overweight, which is three times the rate it was in 1963.
[Overweight baby with stethoscope]
Researchers found significant heart defects in MRI scans of obese children.

This relatively new plague of juvenile obesity is, of course, a huge concern.

Science has already uncovered a barrage of negative health implications tied to obesity. Even more worrying, perhaps, are the things we are yet to find out about obesity.

This range of unknowns is particularly obvious in children, because, since the birth of humanity, children have not been witnessed at such large sizes and in such high numbers.

Children who are overweight already display similar reactions to excess weight as adults. Issues such as high blood pressure, type 2 diabetes and elevated blood cholesterol levels, once the reserve of adults, are now known to strike at any age.

Added to the worrying barrage of physical woes, overweight kids and teens face additional psychological issues such as depression and low self-esteem - both epidemics in their own right.

New research presented at the American Heart Association's Scientific Sessions 2015 by lead study author Linyuan Jing, PhD, adds another worrying finding to the tsunami of weight-related health news.

Jing and colleagues took MRI scans of 20 overweight children and compared the function and dimensions of their hearts with 20 children within the normal weight range. The results make somber reading.

MRI scans produce sobering results

The overweight children did display negative health impacts due to their size and weight, such as asthma and depression, but none directly attributed to heart malfunction.

The scans, however, told a different story:

The team found that the obese youths had 27% more muscle mass in the left ventricle of their hearts and 12% thicker heart muscles, which are both signs of heart disease.

The study also considered 40% of the children to be "high-risk" because the type of thickening seen in their heart wall is associated with a reduced ability to pump blood.

Of the 20 obese children, seven were teenagers, but the younger participants yielded the most shocking results. The researchers were particularly surprised to see signs of heart disease in children as young as 8 years old: "This was alarming to us."

Jing hopes this study might spur parents on to spend a little more time and thought on their child's diet:

"Ultimately we hope that the effects we see in the hearts of these children are reversible; however, it is possible that there could be permanent damage. This should be further motivation for parents to help children lead a healthy lifestyle."

Childhood obesity

As mentioned above, 1 in 3 children in America are overweight. Even worse, perhaps, is that 70-80% of those children are likely to remain overweight for their entire lives.

In adulthood, 7 out of 10 Americans are overweight or obese. In other words, they outnumber people who are in a healthy weight range.

Surgeon General Richard Carmona spoke of the epidemic in chilling terms:

"Because of the increasing rates of obesity, unhealthy eating habits and physical inactivity, we may see the first generation that will be less healthy and have a shorter life expectancy than their parents."

The effects of childhood obesity can be complex, but in most cases, the causes are much less so. The bottom line is that children are taking on more calories than they are burning off.

Underlying this simple equation are a multitude of personal and societal causes. Factors include increased portion sizes, hours spent staring at screens rather than playing outdoors, eating the wrong kinds of foods and eating out more regularly.

A second sting in the tail

Jing and his team chose their candidates by measuring the children's height and weight. If they were in the 95th percentile - heavier than 95% of other children at that age and sex - they could be included.

During the process of selecting candidates, however, children with existing diabetes or who were too large to fit in the MRI scanner were rejected. Worryingly, if these children had been included, the overall picture might have been substantially worse.

Medical News Today recently covered news of the discovery of an obesity gene.

Written by Tim Newman

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