YORK: Researchers from the Center for Health Economics at the University of York have analysed results from the CE-MARC study to assess the most cost effective ways to diagnose heart disease. Cost effectiveness wsa measured as the cost per life year benefit, adjusted for quality of life.

Five different strategies were tested, out of which the most cost effective two included the use of cardiac MRI (cardiac magnetic resonance, also known as CMR). These both had a better accuracy than SPECT in terms of obtaining diagnosis and suggest a greater role of cardiac MRI in assessing those with the symptoms of angina pectoris.

The second most cost effective strategy, coming in at around £30,000 per quality adjusted life year (QALY), was the use of cardiac MRI early in the diagnostic process, to be followed by cardiac angiography if the scan results are positive or inconclusive. However, the most cost effective, at £20,000 per QALY, was to administer a treadmill test, then cardiac MRI if the treadmill test is positive or inconclusive, and only then cardiac angiography if the cardiac MRI is also positive or inconclusive.

Measures of cost effectiveness take into account both the costs of the procedure and the benefits the procedure bring. Through this form of analysis it is possible to ensure that limited resources are used wisely through the establishment of normative practice guidelines. In a private healthcare setting, such studies help to avoid unnecessary costs to patients or their insurance companies.  The results of this study are reported in the journal Heart (doi:10.1136/heartjnl-2013-303624) and are based upon costs and outcomes from the United Kingdom; variation to the effectiveness of diagnostic procedures and their relative costs in other countries may limit the direct application of this study elsewhere.

In this month’s volume of BMC Medicine, the latest results from the Million Women Study analyse the relationship between age, BMI, and coronary heart disease. In the study by the University of Oxford, some 1.2 million women from England and Scotland were monitored for around ten years.

Just under 10% of lean women of middle age (BMI 21 on average) will have one or more hospital admission for coronary heart disease between the age of 54 and 74. Those with a higher BMI have a higher risk, reaching 16% for those with a BMI of 34 (classified obsese).

The incidence of coronary heart disease increases with age and BMI

Commenting on the study he led, Dr. Dexter Canoy explains that “The risk of developing CHD increases even with small incremental increases in BMI, and this is seen not only in the heaviest but also in women who are not usually considered obese. Small changes in BMI, together with leading a healthy lifestyle by not smoking, avoiding excess alcohol consumption, and being physically active could potentially prevent the occurrence of CHD for a large number of people in the population”.

The study, which concludes that CHD incidence in women increases progressively with BMI, being an association consistently seen in different subgroups, is published here:

http://www.biomedcentral.com/1741-7015/11/87/abstract

ARDSLEY, N.Y. & NASHVILLE, Tenn.–Mar. 7, 2013– Acorda Therapeutics, Inc. (Nasdaq: ACOR) and collaborator Vanderbilt University Medical Center today announced data from a Phase 1 clinical trial of Glial Growth Factor 2 (GGF2) designed to study safety, tolerability and exploratory measures of efficacy in people with heart failure who were already on optimized regimens of currently available therapies. The study evaluated the effects of a range of doses, with each participant receiving a single dose. Data from this trial, which enrolled patients at Vanderbilt and St. Joseph’s Hospital in Atlanta, GA, are being presented on Sunday, March 10 at the American College of Cardiology 62nd Annual Scientific Session in San Francisco, CA.

GGF2 is the leading development candidate from Acorda’s neuregulin program.

“We have completed the first in human trial with GGF2 in patients with heart failure, and especially want to thank our patients who volunteered for this important study. We are very encouraged by the results,” said Daniel Lenihan, M.D., Professor of Medicine and Director, Clinical Research at the Vanderbilt University Medical Center, Division of Cardiovascular Medicine. “It is notable that trends of long-lasting and dose-related improvement in cardiac function were seen following a single dose in patients who were already optimized on standard therapies. GGF2 warrants further investigation as a treatment for heart failure.”

“Preclinical studies have suggested that GGF2 may improve heart function through direct repair of cardiac muscle, a novel mechanism of action. This first clinical trial in patients with heart failure identified a maximally tolerated GGF2 dose and key safety parameters to be monitored in future studies. This information supports continued development of the compound as a potential treatment for heart failure,” said Anthony Caggiano, M.D., Ph.D., Vice President of Research and Development at Acorda.

This was a double-blind, placebo controlled, escalating single dose clinical trial that included 40 patients with advanced heart failure. Safety and exploratory efficacy were monitored for 90 days in patients randomized to receive various doses of GGF2 or placebo.

Safety Findings
In this study, a single dose of GGF2 in patients with heart failure was generally well tolerated up to 0.75 mg/kg. Among participants receiving GGF2, the most commonly observed adverse events were headache, site injection reaction and gastrointestinal symptoms. There were no notable effects of treatment on hematology or electrocardiogram, and no adverse events led to withdrawal from the study.
A dose-limiting adverse event of hepatotoxicity (liver injury) meeting Hy’s Law criteria (elevated ALT, AST and bilirubin) occurred in the highest-dose cohort. The patient’s liver function tests and bilirubin had returned to normal by two weeks after dosing. There was also one reported case of uroepithelial carcinoma, a form of cancer in the cells that line the bladder, which was diagnosed three months after dosing in the highest-dose cohort. The patient’s baseline urinalysis showed the presence of red blood cells, indicating that the tumor was likely present prior to dosing.

Ejection Fraction Findings
A left ventricle ejection fraction of 55% or higher is considered normal; all participants in the Phase 1 GGF2 trial had left ventricle ejection fraction of less than 40%. Trial participants receiving GGF2 showed a consistent and dose-responsive trend towards improving left ventricular ejection fraction over 28 and 90 days compared to placebo.

Mean ejection fractions at screening in the treatment and placebo groups were 27% and 29%, respectively. For the cohort receiving the maximally tolerated dose (0.75 mg/kg) of GGF2, the mean ejection fraction at screening was 28% and the absolute mean changes in ejection fraction at day 8, day 14, day 28, and day 90 were 5%, 12%, 12.0% and 9.0%, compared to absolute mean changes of -1%, -1%, 0% and 2% for the placebo group; thus, the mean ejection fraction for this GGF2 group at day 28 was 40%, versus 29% for placebo.

Acorda has discussed the findings from this initial study with the U.S. Food and Drug Administration (FDA) and has reached agreement on the next clinical study of GGF2 in heart failure. This study will primarily investigate further the safety profile of GGF2 across a range of doses, and will continue to explore efficacy outcomes.

The FDA has granted Fast Track designation for GGF2 for the treatment of heart failure.

The compartmentation of ion channels in the adult ventricular cardiomyocyte is a key feature that allows electrical propogation and coupling via specialsed ion channels and receptors. However, the correlation between the channel protein location and the channel functions has remained mostly a mystery – until now.

In a study published in the Journal of Circulation Research, Anamika Bargava and colleagues from the National Heart and Lung Institute of Imperial College (London), report the validation of a method that allows the imaging of the topography of a cardiomyocyte whilst it is still living, and then to study the way in which these ion channels are clustered from a specific microdomain.

The new method combines scanning ion conductance microscopy with conventional cell-attached patch-clamp methods, along with specialised software to gradually increase the pipette tip diameter.

The paper is entitled Super-Resolution Scanning Patch-Clamp Reveals Clustering of Functional Ion Channels in the Adult Ventricular Myocyte and is published as doi: 10.1161/​CIRCRESAHA.111.300445

VIRGINIA – In a development that will shock many in the medical profession, a church in Suffolk, Virginia, has started advertising healing for all forms of heart disease – by faith.

Dr. Princella Johnson, of the Master’s House COGIC (TMHC) is bringing in ‘international healing ministers’ William and Lucille Lau between the 22nd and 24th February for an ‘Evangelistic Healing and Miracles Crusade’.

Those suffering from heart disease are ‘challenged’ to come and ‘be healed’ by these persons who have already held similar events in Asia, Africa, Europe, and other parts of North and South America.

Why can they confidently promise that which the best in the medical profession cannot? According to Dr. Johnson, “God is not dead, and the church is still relevant today because Jesus’ power still saves souls, heals the sick and delivers us from sin and Hell!”

Heartzine asks whether this is morally responsible, and should it be legal? Have your say – write to the editor via our contact feature, and we will publish a representative selection of your letters.

DUBAI: The First American Diabetes Association Middle East congress in Dubai yesterday points to an increased risk of heart disease in women who suffer from diabetes. Heart disease is the most common complication of this condition.

Diabetic women at a higher risk of heart disease: shown here, blood sugar level testing

In the UAE itself, diabetes is particularly common, at more than 20 percent (another 18 percent are considered of ‘high risk’).

Although heart disease is perceived as a male disease, the impact of diabetes is significant and warrants careful monitoring. (Usually, a woman has protective hormones, however with diabetes, this outweighs that benefit).

The implication is that medical health practitioners should engage in patient education of female diabetic patients to highlight the risk of heart disease, and inform governmental level messages that seek to reduce the kind of high-sugar diet that leads to the development of diabetes.

ST. LOUIS – The manufacturers of the Taser police defence system are being taken to court as a result of a man who suffered brain damage subsequent to cardiac arrest apparently caused by the use of the Taser against him. The man, one Colin Fahy, was shot twice in the chest using the Taser whilst under the influence of alcohol and narcotics. Following the use of the Taser, he fell to the floor and was handcuffed. According to claims made in court filings, the Taser use caused him to go into “ventricular fibrillation and cardiac arrest”.  He was to spend some thirty minutes in cardiac arrest, followed by a long recovery period in ICU. Permanent brain damage still remains.

Could the Taser trigger cardiac arrest?

This is not the only allegation of cardiac arrest triggered by Taser use and professional opinions vary about the risks involved. The case, which dates back to 1997, may predate knowledge or suspicion of such risks. The company in this case will argue that the handcuffing of Colin Fahy was instrumental in causing the health complications. Further, they will claim that it would take some 15 times the power of a Taser to trigger cardiac arrest, according to their trials.

Discussion over this case and related issues is likely to focus upon risk:benefit analysis rather than scientific observation, however it is important that medical facilities are prepared for this form of case and those who use Tasers consider the availability of critical care facilities in close proximity before discharging their weapons.

PHILADEPHIA – Researchers at the Institute for Translational Medicine and Therapeutics, U Penn, have shed doubt upon the generally accepted view that some people are genetically ‘resistant’ to the use of Aspirin for protecting their hearts. Instead, their study suggests, it is coatings added to the tablets which may be to blame. The coatings on some tablets have been introduced in order to make Aspirin less of a problem to the gastric tract – particularly following a greater awareness of the involvement of aspirin and some ulcers.

The study suggests that the coating actually slows the absorption of the active ingredient, stopping it from having its full desired effect. In fact, the authors report that they could not find anyone out of a pool of 400 volunteers who was actually resistant to the beneficial effects of the medicine.

A daily dose of aspirin is given for many reasons, including:

• Following cardiac stenting
• To those with a history of heart disease
• In the presence of some arrythmias
• Prophylatically in at-risk populations

The study did indicate that coated Aspirin was functional in many persons, which by no means rules out its continued use. However, it may be that some people will need to avoid this particular form of the medicine to obtain the greatest effect.