Endosense Completes Enrollment In EFFICAS I Clinical Study

Endosense, a Swiss medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment completion in the EFFICAS I clinical study. EFFICAS is a study series intended to demonstrate that, in patients with paroxysmal atrial fibrillation (AF), the use of contact force control during cardiac ablation utilizing the company's TactiCath® force-sensing catheter1 results in superior outcomes as compared to ablations performed with a standard catheter.


EFFICAS I is a 45-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI) and AF treatment efficacy at three months. The endpoint for the study is the occurrence of reconduction (or "gap") areas in the PVI lines, relative to the contact forces applied during lesion formation. While investigators perform the procedure with the TactiCath, they are blinded to contact force measurements; however, the contact forces applied are recorded. Patients are re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures are then analyzed to determine the relationship with lesion formation.


"We believe that the data from EFFICAS I will greatly advance the scientific understanding of contact force and the role it plays in the catheter ablation treatment of AF, as the data will allow us to better identify those force parameters that will deliver optimal patient outcomes," said Eric Le Royer, president and chief executive officer of Endosense. "This study is yet one more proof point illustrating Endosense's leadership and commitment to clinical research of contact force in catheter ablation."


The next study in the EFFICAS series is EFFICAS II, in which investigators will take full advantage of the real-time, objective TactiCath contact force control features to improve their ablation technique during lesion creation. Endpoints for EFFICAS II will include reduction in PVI gaps as compared to EFFICAS I. Outcomes data from EFFICAS I and II will help in the design of future, larger EFFICAS randomized studies with clinical endpoints. EFFICAS II enrollment is currently underway.


"The EFFICAS studies represent a scientifically rigorous approach to quantifying the importance of contact force in catheter ablation," said Karl-Heinz Kuck, M.D., Asklepios Klinik St. Georg, Hamburg. "Never before have we looked at each ablation point with such level of detail. A preliminary analysis of the 24 patients who have completed their three-month follow-up indicates some truly groundbreaking findings. We look forward to communicating the results to our fellow electrophysiologists, as we believe these studies will result in actionable recommendations that will have a meaningful impact on catheter ablation effectiveness."


The TactiCath force-sensing ablation catheter and the TactiSys™ system are indicated for the treatment of AF and supraventricular tachycardia (SVT). BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the United States.


About the TactiCath


Endosense's TactiCath is the first and only force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has undergone considerable pre-clinical and clinical testing, the results of which have created a solid foundation of evidence supporting the feasibility, safety and value of contact force sensing during catheter ablation. The TactiCath has the potential to improve the effectiveness, safety and reproducibility of catheter ablation treatment of cardiac rhythm disorders, including AF.


1. Caution: TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

Hospitalized Seniors May Benefit From Care Programs With Exercise

Older hospital patients who participate in special care programs that include exercise may go home sooner and incur fewer medical costs than patients receiving standard care, according to a new review of evidence.


The positive effects are "small but significant" according to the review authors, led by Natalie de Morton of Monash University in Australia. However, "it is possible that the multidisciplinary intervention components other than exercise may explain improved hospital outcomes," they say. More studies are needed to determine if exercise is the key factor in producing the benefits.


Although the health benefits of physical activity are well known, senior citizens are not always encouraged to exercise during acute hospitalization. As a result, they may lose strength and mobility and require time in a rehabilitation center before returning home.


The new review is "visionary" in its exploration of "the dual burden of an acute medical condition compounded by inactivity," said Wojtek Chodzko-Zajko, Ph.D., an exercise physiologist at the University of Illinois at Urbana-Champaign.


Chodzko-Zajko, who was not involved with the review, believes hospitals should operate more like health spas, with staff focusing on "the overall health and well-being of their patients, in addition to programs that target whatever medical condition put them in the hospital."


The review appears in the most recent issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.


Nine studies with a total of 4,223 patients age 65 and older were included in the review. The programs took place in the United States, Australia, the Netherlands and Sweden. Two of the review authors conducted one of the included studies.


Three studies compared exercise-only programs to standard hospital care, while six focused on multidisciplinary care programs that included physical activity. Each of the programs began within the first few days of hospitalization and was administered by medical, nursing or allied health staff.


Most of the fitness-oriented programs encouraged a regular walking regimen, and some also incorporated other exercises. All were designed to maintain or improve patients' ability to perform their normal activities of daily living, de Morton said.


There were no clear improvements among patients in the three exercise-only programs, which included fewer than 700 participants.


Patients receiving multidisciplinary care, however, went home one day earlier than those in standard care programs. In addition, six more patients out of 100 went directly home instead of to another health care facility such as a rehabilitation center.


The bill for each patient in the team-based programs was also nearly $300 lower. Since older adults account for almost half of U.S. hospital bed days, these figures could translate into substantial health care savings, according to the review.















There was no increase in mortality of patients participating in the exercise programs.


The authors acknowledge that factors other than physical activity such as increased attention from hospital staff or better coordination of care may have led to program benefits. Nevertheless, Chodzko-Zajko continues to promote hospital-based workouts.


Even if exercise doesn't speed recovery from a specific condition, he said, "It's still valuable to keep up a regular physical activity regimen just because of the known adverse health consequences of sedentary living."


David Buchner, M.D., of the U.S. Centers for Disease Control and Prevention, concurs. He urges older adults to discuss physical activity levels with their health care providers both during and after a hospital stay. "To the extent possible, they should avoid extremely low levels of physical activity whether in the hospital or not."


Further research on the benefits of exercise for hospitalized older adults is needed, say de Morton and colleagues. They call for larger studies with more detailed reporting on exercise type and intensity, negative effects such as falls and fractures and variability among patients.


If patients at greatest risk of functional decline could be identified upon admission to the hospital, health care services could be more effectively targeted at those in greatest need, they conclude.


de Morton NA, Keating JL, Jeffs K. Exercise for acutely hospitalised older medical patients. (Review). Cochrane Database of Systematic Reviews 2007, Issue 1.


The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit cochrane for more information.


Health Behavior News Service

Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210

Washington, DC 20009

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St. Jude Medical Announces Initiation Of A Study To Evaluate The Economic Impact Of FFR In Europe And Canada

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today at EuroPCR it will evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in the UK, Germany, France, Italy, Switzerland, Belgium and Canada. The analysis will also determine FFR's potential health and budget impact for each of the seven countries.


FFR measurements indicate the severity of blood flow blockages in the coronary arteries. Using the PressureWire(TM) Aeris or PressureWire(TM) Certus, this physiological measurement helps physicians to better identify which specific lesion or lesions are responsible for a patient's ischemia, a deficiency of blood supply to the heart caused by blood restriction.


The detailed analysis will be based on the results of the FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature.


The research will reveal for each country:


- Whether there is cost savings from using an FFR-guided approach to PCI

- Whether there is a cumulative savings for the health care system annually

- Whether there is an impact on health for the population undergoing PCI


The landmark FAME study, also sponsored by St. Jude Medical, compared treatment guided by FFR to standard angiography in more than 1,000 patients with multivessel coronary artery disease and found that in addition to superior clinical outcomes (which include a 34% reduction in death or heart attack), the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14% in the U.S.


The detailed analysis will be conducted by Professor Uwe Siebert, M.D., MSc, M.P.H., ScD and a FAME study investigator. Each country will also have local clinical advisors to help validate the data modeling.


"PressureWire FFR measurement technology represents a unique opportunity in medicine in which a product not only improves clinical outcomes, but also saves money," said Frank Callaghan, president of the St. Jude Medical's Cardiovascular Division. "St. Jude Medical will continue to conduct evaluations and sponsor research to better understand the broader economic and health care impact that FFR may have."


EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.


About the FAME Trial


The FAME study is a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. The FAME study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude Medical's PressureWire Certus technology exclusively for FFR measurement. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction or repeat revascularization, were reduced by 28% for patients whose treatment was guided by FFR rather than by standard angiography alone.


Two-year results presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34% risk reduction in death or myocardial infarction (heart attack). FFR-guided treatment was also demonstrated to be cost-saving, with a difference per patient of about $2,000, or 14%, between total healthcare costs for the FFR-guided group and the group treated by angiography alone after a year. The reduced healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.


Source

St. Jude Medical

Landmark ATHENA Study With Dronedarone (Multaq(R)) Shows 24% Reduction In Cardiovascular Hospitalisation Or Death In Patients With Atrial Fibrillation

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that findings from the landmark ATHENA study showed dronedarone (Multaq®), a potential therapy for the treatment of patients with atrial fibrillation or atrial flutter, decreased the risk of cardiovascular hospitalisations or death from any cause by a statistically significant 24% (p=0.00000002), meeting the study primary endpoint. The ATHENA results will be presented at the late breaking clinical trial session of Heart Rhythm 2008, the Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco, USA.


For the first time in twenty years of clinical drug trials in atrial fibrillation, an investigational medicine, dronedarone, showed a significant decrease in the risk of cardiovascular death by 30% (p=0.03) on top of standard therapy, including rate control and antithrombotic drugs, in patients with atrial fibrillation or atrial flutter. Dronedarone also significantly decreased the risk for arrhythmic death by 45% (p=0.01) and there were numerically less deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalisation was reduced by 25% (p=0.000000009) in the dronedarone group.


"The ATHENA results have the potential to change the face of atrial fibrillation management. For atrial fibrillation patients, who together with their physicians struggle on a daily basis to manage the dramatic consequences of this complex disease, Multaq®carries hope for patients" said Marc Cluzel, sanofi-aventisSenior Vice President, R&D. "This milestone is indicative of sanofi-aventis' commitment to bringing innovative therapies to market, and of our ongoing commitment to provide patients, physicians and public health stakeholders with breakthrough medicines in those therapeutic areas where there are major healthcare needs and limited solutions".


Atrial fibrillation is a major cause of hospitalisation and mortality and affects about 2.5 million people in the United States, as well as 4.5 million people in the European Union and is emerging as a growing public health concern because of the aging of the population. Patients suffering from atrial fibrillation have twice the risk of death, an increased risk of stroke and cardiovascular complications, including congestive heart failure. Furthermore atrial fibrillation considerably impairs patients' lives, mainly because of their inability to perform normal daily activities due to complaints of palpitations, chest pain, dyspnoea, fatigue or light-headedness, without consideration of the cumbersome and sometime serious constraints imposed by current therapies of atrial fibrillation.















"In atrial fibrillation where treatment morbidity-mortality benefit still needed to be demonstrated, ATHENA is a unique trial using clinically relevant outcomes such as cardiovascular hospitalisation or death as the primary endpoint. In this regard, the trial has clearly achieved these safety and efficacy endpoints," said Dr Stefan H. Hohnloser, J.W. from the Goethe University, Division of Clinical Electrophysiology, Frankfurt, Germany, who served as co-principal investigator of the ATHENA study. "As a consequence, dronedarone is the first treatment for atrial fibrillation which has been demonstrated to reduce cardiovascular hospitalisation or mortality in patients with AF."


The most frequently reported adverse events of dronedarone vs placebo induced gastro-intestinal effect (26% vs 22%), skin disorder (10% vs 8%, mainly rash) and increased blood creatinine (4.7% vs 1%). The mechanism of blood creatinine increase (inhibition of creatinine secretion at the renal tubular level) is well defined. Compared to placebo, dronedarone showed low risk of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuation between the two study groups.


"ATHENA is truly a landmark trial, that marks a paradigm change for the management of atrial fibrillation," said Dr Christopher Cannon, a Senior Investigator in the TIMI Study Group at Brigham and Women's Hospital, who was not involved in the study. "Atrial fibrillation is a very common disease, and our prior treatment options have been focused only on symptom relief and a hope to not do harm, which has been the problem with prior antiarrhythmic drugs. Now, with a highly significant reduction in death or hospitalisation, as well as a 45% reduction in arrhythmic death or 30% cardiovascular death, dronedarone may become a first line treatment of atrial fibrillation".


ATHENA, the largest double blind randomised study in patients with atrial fibrillation, was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients. The ATHENA landmark trial is the first morbidity-mortality study as part of the dronedaronephase III clinical development program, which also included five other multinational clinical studies, an initial study in severe cardiac heart failure and a recent decompensationpatients ANDROMEDA, and a total of 4 international studies in atrial fibrillation: EURIDIS/ADONIS, ERATO, and the ongoing DIONYSOS trial.


Based upon this new clinical data, sanofi-aventis plans to submit a registration dossier to the European Medicines Agency (EMEA), and a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) during the 3rd quarter of 2008.


About Atrial Fibrillation/Flutter


Atrial fibrillation is a major cause of hospitalisation and mortality and affects about 2.5 million people in the USA and 4.5 million people in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the next 20 years. Without appropriate management, atrial fibrillation can lead to serious complications, such as stroke and congestive heart failure.


AF is a condition in which the upper chambers of the heart beat in an uncoordinated and disorganised fashion, resulting in an irregular and fast heart rhythm (i.e. an irregular heartbeat). Atrial flutter is an abnormal fast heart rhythm that occurs in the atriaof the heart. This rhythm occurs often in individuals with other heart conditions (eg pericarditis, coronary artery disease, and cardiomyopathy). Atrial flutter frequently degenerates to atrial fibrillation. However, it may persist for months to years.


When blood is not completely pumped out of the heart's chambers, it can pool and clot. If a blood clot forms in the atria, it can exit the heart and block an artery in the brain, resulting in a stroke. Consequently, about 15 percent of all strokes result from atrial fibrillation.


The most common symptoms of atrial fibrillation include palpitations (a rapid, irregular, "flopping" movement or pounding sensation in the chest or neck), shortness of breath, dizziness and feeling of heaviness, or constriction in the chest. The disorder may even be more common than diagnosed, as patients may experience atrial fibrillation episodes that either do not cause symptoms or are not documented during their visits to the doctor.


About the ATHENA Study


The landmark ATHENA study is a randomised, placebo controlled, international metacentre study that evaluated for the first time a treatment on top of standard background therapy for the management of patients with atrial fibrillation in reducing morbidity and mortality by preventing cardiovascular hospitalisations or death from any cause. The study included 4,628 patients, which made it the largest ever outcome study of an anti-arrhythmic treatment for atrial fibrillation.


The ATHENA study objectives were to show a potential benefit of dronedarone on primary composite endpoint of all-cause mortality combined with cardiovascular hospitalisation as compared to placebo. The pre-specified secondary endpoints were death from any cause, cardiovascular death and hospitalisation for cardiovascular reasons. The pre-specified safety endpoint was the incidence of treatment emergent adverse events (time of observation for treatment emergent adverse events) including: all adverse events, serious adverse events, adverse events leading to study drug discontinuation.


The atrial fibrillation or atrial flutter patient population studied were either ?‰?75 years (with or without cardiovascular risk factor) or were 50 mm or left ventricular ejection fraction

Woman Who Regularly Fainted While Eating Sandwiches Or Fizzy Drinks - Case Explored

The unusual case of a woman who regularly fainted while eating sandwiches or fizzy drinks is explored in a Case Report in this week's edition of The Lancet, written by Dr Christopher J Boos, and Dr Howard Marshall, Department of Cardiology, University Hospital Birmingham, UK, and colleagues.



The 25-year-old woman was seen at the hospital in January this year. She presented with episodes, typically lasting 10 second or less, of feeling suddenly and alarmingly light headed, and nauseous. She had collapsed on more than one occasion, but had no movements typical of epilepsy. Sometimes she would have several episodes a week. The problem first began when she was 15 and remained unexplained despite hospital admissions between 2001 and 2007. A full battery of blood and other tests had, more than once, revealed everything to be normal. However, an electrocardiogram (ECG) test had shown a pause of 2.5 seconds. She then had external-loop ECG tests, in which she was asked to press a button to record 1-2 minutes of the ECG each time she felt faint. At times of light-headedness, she was found to have complete atrioventricular block (a slowing of intracardiac conduction), with beat-to-beat pauses lasting up to 2.5 seconds.



On questioning, the patient revealed no history of note - she did not smoke, drank little alcohol and had never used illicit drugs. Her episodes tended to occur when she ate certain types of food, particularly sandwiches and fizzy drinks - and she had last collapsed when eating a sandwich while driving (in stationary traffic). Despite weighing only 46.5 kg, she had no symptoms of anorexia and her pulse rate and blood pressure were normal. Dr Boos and colleagues offered the woman a sandwich, which caused rapid onset of atrioventricular block and an associated 'heart pause' lasting two seconds - causing her to feel light headed again. She was diagnosed with 'swallow syncope'. This is a condition caused by alterations in the vagal nervous reflex arc - whereby the action of swallowing leads to vagal hyperstimulation and abnormal feedback along these nerves causing the heart to stop temporarily, leading to light-headedness or fainting. The woman was fitted with a pacemaker to overcome this, and, when last seen in June 2008, was free of fainting.



The authors conclude: "Cardiac pacing, when necessary, has been shown to be effective in an increasing number of case reports??¦Patients with swallow syncope can languish for years because the diagnosis is little known - although a case report on it was published in The Lancet, 50 years ago."



Dr Christopher J Boos, Department of Cardiology, University Hospital Birmingham, UK



Dr Howard Marshall, Department of Cardiology, University Hospital Birmingham, bham.ac.uk



Full Case Report: press.thelancet/sandwichesfinal.pdf

Roche Diagnostics Announces Successful Resolution Of Urgent Medical Device Correction Of CoaguChek PT Test Strips Used In Anticoagulation Monitoring

Roche Diagnostics, in cooperation
with the U.S. Food and Drug Administration, announced today that the Urgent
Medical Device Correction issued for CoaguChek PT test strips (UMDC
06-266), used in anticoagulation monitoring, has been addressed and
duplicate testing is no longer required for CoaguChek PT Test Strips, lot
numbers 560A and higher (e.g., 561A, 562A, ...).




The potential for erroneous prothrombin time (PT) test results that
prompted the UMDC was a result of insufficient active ingredient
(thromboplastin) on selected test strips. Fully tested and validated
changes have been implemented within the manufacturing process to address
this concern. Every test strip is inspected to ensure that it contains the
correct amount of thromboplastin before being packaged and shipped.



All healthcare professionals performing duplicate testing to confirm
results can return to a single test using CoaguChek PT Test Strips (only
from lot numbers 560A and higher) to monitor patients on warfarin
(anticoagulation) therapy. All patients previously performing patient
self-testing may now resume monitoring with CoaguChek PT Test Strips (only
from lot numbers 560A and higher).



"Patient safety is Roche Diagnostics' first priority. We are now using
an innovative detection system, combined with other measures, to improve
our test strip manufacturing process," said Randy Pritchard, Director of
Product Marketing, Near Patient Testing, Roche Diagnostics. "We are
confident that the potential for erroneous results from inadequate levels
of thromboplastin has been addressed, and we are pleased to continue
providing healthcare professionals with CoaguChek PT Test Strips and other
products that meet the highest standards of quality and patient safety."



About CoaguChek products



Physicians have been using CoaguChek instruments for PT/INR testing at
the point of care (POC) since 1994. Today, in the U.S., four out of five
POC PT/INR tests are performed using a CoaguChek system (1). The new
CoaguChek XS system represents the third generation of point-of-care
anticoagulation monitoring devices from Roche Diagnostics.



About Roche



Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. As the world's biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, a market
leader in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous system.
In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.7 billion Swiss
francs. Roche employs roughly 75,000 worldwide and has R&D agreements and
strategic alliances with numerous partners, including majority ownership
interests in Genentech and Chugai. Roche's Diagnostics Division offers a
uniquely broad product portfolio and supplies a wide array of innovative
testing products and services to researchers, physicians, patients,
hospitals and laboratories world-wide. For further information, please
visit our websites at roche-diagnostics.us and roche.



All trademarks used or mentioned in this release are legally protected
by law.



Healthcare Professional/Patient Questions: 1-800-820-0995



(1) Third quarter 2006 total market share of projected distributor unit
sales of the Point of Care Testing Coagulation Reagents and Kits product
class by HPIS Market Intelligence, a division of GHX Global Healthcare
Exchange. Total Market includes all market sectors as defined by HPIS:
Physician, Long Term Care, Treatment Centers, Clinical Laboratory,
Hospital, Home Healthcare and Other/Unspecified. Data on file.


Roche Diagnostics

roche


View drug information on Warfarin Sodium tablets.

NIH Genomic Mapping Study Finds Largest Set Of Genes Related To Major Risk Factor For Heart Disease

Scanning the genomes of more than 100,000 people from all over the world, scientists report the largest set of genes discovered underlying high cholesterol and high triglycerides - the major risk factors for coronary heart disease, the nation's number one killer. Taken together, the gene variants explain between a quarter and a third of the inherited portions of cholesterol and triglyceride measured in the blood. The research, representing scientists from 17 countries, appears in two papers in the Aug. 5 issue of Nature.


The National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) is the lead funder of the research, with additional support from the National Human Genome Research Institute (NHGRI), the National Institute on Aging (NIA), and several other NIH components. Genome-wide association studies, or GWAS, analyze DNA across populations to pinpoint hard-to-find genetic hotspots for common diseases that are thought to have many causes, both genetic and environmental. Previous gene-scanning approaches have turned up hints about the nature of inherited heart disease risk. The new results take science well beyond what was previously known, and pinpoint research directions to elucidate the molecular and cellular mechanisms by which genetic variants contribute to disease.


"Genetic studies that survey a wide variety of human populations are a powerful tool for identifying hereditary factors in health and disease," said study co-author and NIH Director Francis S. Collins, M.D., Ph.D. "These results help refine our course for preventing and treating heart disease, a health problem that affects millions of Americans and many more people worldwide."


The research team found 95 genetic variants - arrangements of the nucleic acids in DNA that differ among people - which contribute to changes in blood cholesterol and triglyceride levels in women and men of many ethnic backgrounds. Abnormal levels of blood cholesterol and of triglycerides are powerful risk factors for heart disease. Because high blood cholesterol on its own does not cause symptoms, doctors routinely do blood tests to assess individual risk, but they do not know how much risk of developing cardiovascular disease is inherited.


Of the genetic variants, 59 had not been known and thus provide new clues for developing effective medicines to combat heart disease. A significant insight from this research is that many of the variants show up in the DNA of people of widely diverse backgrounds. That is because the scientists scoured the DNA from people participating in large, population-based heart disease studies, reflecting people of European, Eastern and Southern Asian, and African-American descent.















Together, research participants from NHLBI study populations contributed about half of the 100,000 genomes scanned. Among the NIH population-based studies involved in the research were the Framingham Heart Study; the Atherosclerosis Risk in Communities Study; the Cardiovascular Health Study; the SardiNIA Study; the Ages, Gene, Environment Study; the InCHIANTI Study; the Family Heart Study; the NHLBI Candidate Gene Association Resource Program; the NIH Pharmacogenetics Research Network; the deCODE MI Study; and the Women's Genome Health Study.


"The NHLBI is a leader in supporting long-term studies, including the decades-long Framingham Heart Study, that carefully track the health outcomes of large groups of people and generations of families." said NHLBI Acting Director Susan B. Shurin, M.D. "This genome-wide association study successfully demonstrates how cutting-edge genomics research can be leveraged by our past and current research investment in population-based studies assessing long-term health and disease."


The research team's other study probed deeply into one of the genetic variants identified in the accompanying GWAS analysis.


In the group's second study, the scientists had an unusual opportunity to follow up on the findings of the GWAS to determining how one unusual gene variant trips up cholesterol and triglyceride metabolism in mice. Previous studies had identified the same genetic variant in humans who were prone to deadly heart attacks: The variant is common in people of African American, Hispanic, Asian Indian, and Chinese ancestries. Having a genetically identical mouse model enables researchers to look further into the contribution of a particular genetic variant to inherited heart disease risk.


"The new findings point us to specific genetic signposts that allow us to understand more fully why many people from all walks of life have abnormal levels of cholesterol and other blood lipids that lead to heart disease," said Christopher J. O'Donnell, M.D., associate director of the Framingham Heart Study and senior advisor for genomics to the NHLBI acting director. "What's really exciting about this work is that we are moving from discovery to understanding brand-new information about how genes alter the lipids that contribute to heart disease."


In addition to the NHLBI, the NIA and the NHGRI, other NIH funding sources include the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, the National Cancer Institute, the National Institute of General Medical Sciences, the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Research Resources.

What Are Beta-Blockers? What Are Beta-Blockers For?

Beta-blockers, also known as beta-adrenergic blocking agents, beta-adrenergic antagonists, or beta antagonists, are a type of drug that block the action of the sympathetic nervous system of the heart, resulting in a relief of stress on the heart.


A beta-blocker blocks beta-adrenergic substances, for example adrenaline (apinephrine) in the involuntary nervous system (autononomic nervous system). Beta-blockers slow down the heart beat, reduce the force of the heart muscle's contractions, and decrease blood vessel contraction in the heart, brain, and the rest of the body.



Patients with cardiac arrhythmias (abnormal heart rhythms), tachycardias (accelerated heart rates), or irregular heart rhythms (atrial fibrillation), such as premature ventricular beats may be prescribed beta-blockers. They may also be useful in treating angina because they lower the heart muscle's demand for oxygen - angina pectoris occurs when the heart's demand for oxygen is greater than the supply.


Beta-blockers are useful in the treatment of high blood pressure (hypertension) because their effects on blood vessels lowers blood pressure. They are also key drugs in improving survival rates for patients after a heart attack.


Beta-blockers are also used for preventing migraine headaches and some familial or hereditary tremors.


In other words, beta-blockers are known as beta- adrenoreceptor blocking agents and are used to treat:

Commonly

Angina
Heart failure
High blood pressure (hypertension)
irregular heart beat (atrial fibrillation)
Myocardial infarction (heart attack)


Less commonly
Prevention of migraine
Thyrotoxicosis (overactive thyroid)
Anxiety
Tremor
Glaucoma (as eye drops)

The first clinically useful beta adrenergic receptor antagonist was called Propranolol. It was invented by Sir James W. Black (born 1924), a Scottish doctor and pharmacologist. Sir James also synthesized Cimetidine (for the treatment of heartburn and peptic ulcers) and was awarded the Nobel Prize for Medicine in 1988. Propranolol revolutionized the medical management of angina pectoris - it is considered as one of the major contributions to clinical medicine and pharmacology of the 20th century.















According to Medilexicon's medical dictionary

A beta-adrenergic blocking agent is "a class of drugs that competes with ??-adrenergic agonists for available receptor sites; some compete for both Beta1 and Beta2 receptors (propranolol) whereas others are primarily either Beta1 (metoprolol) or Beta2 blockers; used in the treatment of a variety of cardiovascular diseases for which beta-adrenergic blockade is desirable."

Types of beta-blockers
There are various types of beta-blockers (beta-adrenoceptor blocking agents). Which one a patient has depends on his/her condition.


Below are some examples:

Acebutolol (Sectral)

Atenolol (Tenormin)

Betaxolol (Betoptic)

Bisoprolol (Cardicor, Emcor, Zebeta)

Carteolol (Teoptic)

Carvedilol (Coreg, Eucardic)

Celiprolol (Celectol)

Labetalol (Trandate)

Levobunolol (Betagan)

Metipranolol (Metipranolol Minims)

Metoprolol (Betaloc, Lopresor, Lopressor, Toprol XL)

Nadolol (Corgard)

Nebivolol (Bystolic, Nebilet)

Oxprenolol (Trasicor)

Pindolol (Visken)

Propranolol (Inderal LA)

Sotalol (Beta-Cardone, Sotacor)

Timolol (Betim, Nyogel, Timoptol)


What do beta-blockers do?
Beta-blockers block the release of noradrenalin in parts of the body. Noradrenalin is released by the nerves when they are stimulated - it is a chemical that conveys messages to other parts of the body, including muscles, blood vessels and the heart.

Heart problems - for a patient with heart problems beta-blockers can reduce the workload for the heart; so that it does not have to work so hard to supply all parts of the body with oxygen-rich blood. For people with angina, heart failure, or after a heart attack, reducing the heart's workload is crucial.


Beta-blockers can also block the stimulation of the heart form electrical impulses - they can control irregular heartbeats - thus lowering the activity of the heart and slowing down the heart rate.

Hypertension - beta-blockers lower blood pressure by slowing down the heart rate, as well as reducing the force of the heart. Blood still gets to all parts of the body, but at reduced pressure.

Glaucoma - pressure within the eyeball is reduced with beta-blocker eye drops. The medication lowers the production of fluid inside the eye ball (aqueous humor).

Things to bear in mind with beta-blockers


The following people should not take beta-blockers:

Patients with a history of asthma (unless the doctor says so)
Patients with a history of bronchospasm (unless the doctor says so)
Patients with second or third degree heart block
Patients with severe peripheral arterial disease (including Raynaud's syndrome)
Patients with worsening, unstable heart failure (can be used for stable heart failure)

For the following people, beta-blockers should be used with caution:

Patients with diabetes, especially those with regular episodes of low blood sugar (hypoglycemia)
Patients with MG (myasthenia gravis)
Patients with a slow heart rate (bradycardia)
Patients with low blood pressure (hypotension)
Patients with hypertension that results from an adrenal gland tumor (pheochromocytoma)
Patients with high blood acid levels (metabolic acidosis)
Patients with Prinzmetal angina

Pregnancy and breastfeeding - in some cases certain types of beta-blockers may be used.


Getting off beta-blockers - Patients must not stop taking beta-blockers suddenly without their doctor's advice and close supervision. Suddenly ceasing beta-blocker treatment may exacerbate the patient's condition, especially after a heart attack or for the treatment of angina.
What are the side effects of beta-blockers?
The most common side effects are:

Cold feet
Cold hands
Diarrhea
Fatigue
Nausea
Very slow heartbeat

The following less common side effects are also possible:

Sleeping difficulties and disturbances
Bad dreams (nightmares)
Erectile dysfunction (male inability to achieve or sustain an erection during sex)

Driving - some patients may experience dizziness or fatigue; in such cases they should not drive. However, this is rare.
Beta-blocker interactions with other drugs
Drug interaction is the extra effects two different medicines can have on the body when taken together - effects beyond their primary purposes. Beta-blockers can interact with the following medications:

Antipsychotics - these medications are commonly prescribed for patients with bipolar disorder or schizophrenia. When taken with some beta-blockers the risk of arrhythmias is greater.

Clonidine - a medication prescribed for either patients with hypertension (high blood pressure) or migraines. A patient who is taking both clonidine and beta-blockers and then suddenly stops taking clonidine has a greater risk of experiencing a sudden and sharp rise in blood pressure (rebound hypertension).

Digoxin - prescribed for patients with congestive heart failure and certain cardiac arrhythmias. When taken with beta-blockers there is a higher risk of slow heart rate (bradycardia).

Diltiazem - a medication that dilates blood vessels, prescribed for patients with angina pectoris or hypertension. When taken with beta-blockers there is a higher risk of slow heart rate (bradycardia).

Drugs to control high blood pressure (antihypertensives) - when taken with beta-blockers the patient may experience hypotension (a serious drop in blood pressure).

Drugs to control irregular heartbeats (anti-arrhythmics) - when taken with beta-blockers the risk of impaired function of the heart (myocardial depression) is greater, as is the risk of irregular heartbeats (arrhythmias).

Mefloquine - a drug for the treatment of malaria resistant to chloroquine phosphate. When taken with beta-blockers the result may be bradycardia.

Nifedipine - this drug reduces calcium ions available to heart and smooth muscle, used in the treatment of angina pectoris. When taken with beta-blockers there is a higher risk of hypotension (low blood pressure).

Nisoldipine - a calcium channel blocker used in the treatment of high blood pressure (hypertension). When taken with beta-blockers there is a higher risk of hypotension (low blood pressure).

Verapamil - used in the treatment of hypertension, angina pectoris, and certain cardiac arrhythmias. When taken with beta-blockers there is a higher risk of hypotension (low blood pressure).

Check with your pharmacist or doctor for a more comprehensive and up-to-date list of beta-blocker interactions.





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'Angiox' Licensed For Use In PCI, As Effective As More Complicated Anticoagulation Therapies

One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the bivalirudin alone treatment group had similar rates of ischemic clinical outcomes compared with more complicated standard therapy, confirming previous findings, which showed similar ischemia at 30 days, and nearly 50% fewer episodes of major bleeding.


At one year, the mortality rate of patients treated in the bivalirudin alone treatment group was 3.8%, compared to 4.4% in the control treatment group. A separate analysis found that, in patients with ACS, having a major bleeding episode within 30 days following treatment nearly triples the risk of death up to one year later, making major bleeding a more powerful predictor of mortality than even a heart attack.


The ACUITY one-year results were presented as late-breaking findings by investigators for the first time at the i2 Summit at the 56th Annual Scientific Session of the American College of Cardiology. Collectively, the data showed that ACUITY met all primary one-year endpoints and confirmed previously published 30-day findings.


"Our findings are important because compared with current standard therapy they demonstrate that in moderate and high risk patients with ACS, bivalirudin regimen, results in the overall best clinical outcomes," said ACUITY's principal investigator, Gregg W. Stone, MD, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center's Center for Interventional Vascular Therapy, and chairman of the Cardiovascular Research Foundation.


Study findings


The one-year ACUITY analysis showed that treatment in the bivalirudin alone group resulted in comparable clinical outcomes compared to standard therapy. Specifically, in patients treated in the bivalirudin alone group, the bivalirudin plus GPI group (GPIIb/IIIa inhibitors, which are intravenous anti-platelet agents) and the heparin plus GPI group, respectively:


-- Death occurred in 3.8%, 4.2% and 4.4% of patients. There was an observed numerical reduction (p=NS) in late mortality (after one month to one year) in the bivalirudin alone treatment group, and


-- Composite ischemia events occurred in 16.4%, 16.5% and 16.3% of patients. Composite ischemia was defined as death, heart attack or unplanned revascularization for ischemia.


"We have known for some time that bleeding is an important prognostic factor for patient outcomes including survival. Added to the data from the PCI (Percutaneuos Coronary Intervention) REPLACE-2 study in low and moderate risk patients, the ACUITY one year data in moderate and high risk ACS patients again shows that bivalirudin offers protection from ischaemic events whilst significantly reduces bleeding. This is important data and will further support physicians in being able to make informed treatment decisions and tailor therapy to the benefit of their patients/protect their patients from bleeding events" said Dick S?¶derberg, Executive Vice President, Marketing, Nycomed.















Additionally, the study found that major bleeding within 30 days following treatment increased the risk of death within one year even more than did a heart attack. The death rate among patients who suffered major bleeding compared to those who had a heart attack or neither was 12.5% vs. 8.6% vs. 3.4%, respectively. After adjusting for other variables, the risk of death for patients who had a major bleed or heart attack within 30 days following treatment was 2.89 and 2.47 times greater, respectively, than the risk for patients who did not experience either (p < 0.0001 for both comparisons).


"While heart attacks tend to happen in the hospital, we found the risk of death associated with major bleeding continues long-term," said Dr. Stone. "This makes major bleeding an even more powerful predictor of death than having a heart attack."


Angiox® (bivalirudin) is licensed in the UK as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).


About ACS


ACS includes a range of conditions, such as chest pain and heart attack, which are caused by insufficient blood supply to the heart due to blockages in coronary arteries, usually caused by blood clots. Patients with ACS symptoms are at significant risk for heart attack or death. Each year in the United States, 5 million people go to the emergency department with chest pain, of which about 1.4 million are identified with ACS.


The European Society of Cardiology as well as the American Heart Association and the American College of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management (e.g., various anti-clotting drugs), bypass surgery, or PCI. Heparin plus a GPI is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GPI can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed increases the risk of death.


About ACUITY


Enrolling 13,819 ACS patients in 17 countries, ACUITY is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital. ACUITY (Acute Catheterisation and Urgent Intervention Triage strategY) was designed to show that, when compared with heparins (unfractionated or enoxaparin) and routine GPIs, bivalirudin, with or without GP IIb/IIIa inhibition, reduces clinically significant bleeding and is equally effective for ischemic complications.


ACUITY evaluated the use of bivalirudin, replacing heparins, starting in the emergency department or critical care unit and continued through the cardiac catheterisation laboratory. The control arm of ACUITY comprised patients treated with the heparins combined with GPIs In the other two arms of the trial, bivalirudin is evaluated both as mono-therapy and in combination with GPIs.


About Angiox®


Angiox® (bivalirudin) - US trade name Angiomax® - is a thrombin-specific anti-coagulant currently indicated for use in patients undergoing PCI. In clinical trials, bivalirudin has demonstrated reductions in both ischaemic events and bleeding complications. Reductions that remain evident even in high-risk patients.


Developed and owned by US-based The Medicines Company, bivalirudin was in-licensed by Nycomed with the exclusive right to market the product in 33 countries in Europe and Russia-CIS. Following the approval by the European Medicines Agency (EMEA) in September 2004, bivalirudin is now marketed in Europe by Nycomed under the trade name Angiox®.


About Nycomed


Nycomed provides products for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets. The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners.


Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.


Privately owned, the combined group employs about 12,000 and had non-audited estimated annual sales of approximately ?‚¬ 3.4 billion and an EBITDA of approximately ?‚¬ 927 million (2006 results). In connection with the acquisition of ALTANA Pharma AG, effective 1 January 2007, Nycomed is relocating its group headquarters from Roskilde (Denmark) to Zurich (Switzerland).


For more information visit nycomed or acc07.acc


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A Step Toward Tissue-Engineered Heart Valves For Children

Infants and children who receive replacements for missing or malformed heart valves face a high frequency of re operations, since the prosthetic replacements cannot grow along with the child. Researchers Virna Sales, MD, and John Mayer, MD, in Children's Hospital Boston's Department of Cardiac Surgery, have developed a tissue engineering technique for creating biological replacements for pulmonary valves (those between the right ventricle and the pulmonary artery). They isolated cells from the blood, known as endothelial progenitor cells, and "seeded" them onto tiny biodegradable molds that were pre-coated with proteins found in the natural "matrix" that surrounds and supports cells. Using this technique, recently reported at the American Heart Association meeting, they were able to make pulmonary valve leaflets (flaps) with the desired cellular characteristics and mechanical flexibility.


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Call For Post-Mortem Genetic Testing To Become Routine In Cases Of Sudden Death

At a meeting on Sudden Cardiac Death (SCD) at the Royal Society of Medicine, sponsored by Cardiac Risk in the Young (CRY), doctors have called for coroners to routinely request consent from relatives to allow small amounts of tissue to be retained from young people (under 35 year olds) who die suddenly from heart disease or without explanation. DNA extracted from the retained tissue may then be tested to provide information about possible genetic conditions that might explain that person's death, and which may therefore affect their relatives.



Dr Mary Sheppard, of the Royal Society of Medicine's Pathology Section and a leading expert in SCD, argued "A DNA sample from a person who has died suddenly could provide a whole genome picture which might benefit relatives potentially at risk from genetic conditions, such as certain inherited heart problems that cause SCD*. If coroners routinely requested consent from the family to retain material for DNA testing at autopsies we would be able to find out far more about how the person died and possibly prevent other deaths in the same family."



It is currently illegal to retain tissue for DNA testing without consent of the deceased's relatives except in forensic cases. Dr Paul Brennan, a Clinical Geneticist and Clinical Lead for Cardiac Genetics for the Northern Genetics Service, argued for a change to the current situation in his presentation at the meeting. He said,



"The coroner's remit is to establish cause of death. This does not currently involve DNA analysis so there is no imperative for the coroner to request storage of DNA from the deceased person. There is, however, a need to alert surviving relatives to the possibility that their relative may have died from an inherited heart problem, in which case genetic testing in the deceased is often necessary. Ideally, there should be one part of a coroner's form which deals specifically with consent for the pathologist to retain tissue for DNA extraction and storage. Until then, I would urge pathologists who haven't had the opportunity to obtain consent, to think about taking these tiny tissue samples - usually a spoonful of blood or a cubic centimetre of spleen tissue - and then ask the relatives for consent. If consent is not given, the tissue must, by law, be destroyed. But if it is not even taken in the first place, a huge potential benefit is lost."



The tissue required for DNA extraction and genetic testing needs to be taken at autopsy in order to provide the information needed. Delay can mean that the specimen cannot provide the important information needed. "There's only a short window of opportunity after a person has died. Once that time has passed a perfect - perhaps life-saving - opportunity is missed," said Dr Brennan.



At present, all close relatives of a victim of SCD should be offered medical screening tests to see if they display signs of an inherited heart problem. This approach can, however, fail to detect problems that a genetic test can help to reveal. The whole idea is to detect these conditions before they cause serious complications - including sudden death. Dr Brennan argued that routine retention and subsequent analysis of the specimens would have negligible cost implications as the cost of genetic testing was usually provided for under specialist commissioning arrangements.



He added, "There has been a lot of discussion about DNA being retained in criminal cases. It seems ridiculous that we don't retain tissue in a situation where it could actually save lives."



* Conditions such as: Long QT Syndrome; Brugada Syndrome; inherited cardiomyopathies



Source
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Secrets Of The Heart Revealed By Molecular Imaging

The extraordinary action of a new cellular therapy came to light as a result of powerful PET and SPECT imaging in a recent study reported in the April issue of the Journal of Nuclear Medicine. Researchers in Germany were able to observe the repair action of circulating progenitor cells (CPCs), immature blood-derived cells capable of developing into adult stem cells, as they successfully preserved healthy heart tissue and corrected blood flow imbalance within the heart.



Twenty-six patients took part in the randomized, placebo-controlled and double-blinded study. Following the recanalization of blocked coronary arteries (the surgical reopening or formation of new paths for blood flow), one group received an infusion of progenitor cells. FDG PET and 99mTc-tetrofosmine-SPECT were then used to image relative changes in myocardial perfusion (blood flow through the middle and thickest part of the heart) and glucose metabolism.



The results were compared with a control group that had undergone recanalization but did not receive CPCs. In the CPC group, normalization of glucose metabolism and coronary blood flow was seen in nearly 50 percent of the repaired artery segments.



"PET and SPECT are the only techniques capable of validating the metabolic changes we needed to observe in the heart once we had administered the progenitor cells," said Kai Kendziorra, M.D., a specialist in Nuclear Medicine at the University of Leipzig in Leipzig, Germany. "The results shown by these imaging modalities provide the evidence needed to expand the use of CPC treatment."



Earlier research has shown that when a patient's progenitor cells are activated by growth factors, the result is increased cell division, which is vital to the tissue repair process. In this study, progenitor cells developed from circulating blood were also found to be capable of repairing dysfunctional - yet viable - myocardial tissue, a condition referred to as "hibernating myocardium."



Kendziorra said he believes that in addition to assisting in monitoring and guiding treatment of heart patients, PET scans may also be helpful in selecting those who would profit the most from CPC administration.



"Early detection of hibernating myocardial tissue via noninvasive imaging modalities such as PET and SPECT will help us to assess a patient's myocardial metabolism and blood flow," he said. "Subsequent early coronary recanalization and CPC administration may lead to treatment-specific normalization and reduce the risk of cardiac events over longer periods."



"For decades, nuclear medicine imaging has contributed functional assessment to the anatomical definition of the presence or absence of disease," said Alexander J. McEwan, M.D., president of SNM. "Today molecular imaging is on the way to revolutionizing patient care - by integrating information about location, structure, function and biology - leading to a package of non-invasive imaging tools with enormous potential for improving patient care and outcomes."



Co-authors of "Effect of Progenitor Cells on Myocardial Perfusion and Metabolism in Patients After Recanalizatoin of a Chronically Occluded Coronary Artery" include Henryk Barthel, Osama Sabri and Regine Kluge, Department of Nuclear Medicine; Sandra Erbs and Gerhard Schuler, Heart Center Leipzig GmbH; and Frank Emmrich, Institute of Clinical Immunology and Transfusion Medicine, all with the University of Leipzig, Leipzig, Germany; and Rainer Hambrecht, Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany and Heart Center Bremen, Bremen, Germany.



About SNM - Advancing Molecular Imaging and Therapy


SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose, manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (The Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced - and continue to explore - biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at snm/.

Acute Coronary Syndrome Carries High Costs For Employers

Employees with myocardial infarction (heart attack) and other types of acute coronary syndrome (ACS) are a major source of direct and indirect health costs, reports a study in the January Journal of Occupational and Environmental Medicine, official publication of the American College of Occupational and Environmental Medicine (ACOEM).


"Acute coronary syndrome is more costly to employers and payers than other health conditions that are common among employed persons," according to the new research, led by Stephen S. Johnston, M.A., of Thomson Reuters, Washington, D.C.


Based on an analysis of medical insurance claims, the researchers estimated the costs of ACS for employers and health care payers. 'Acute coronary syndrome' refers to a range of heart conditions, including different types of myocardial infarction as well as unstable angina. Nearly half of all ACS patients are of working age, previous studies have found.


The results confirmed the high direct costs (that is, costs for medical care) for workers with ACS- $40,000 higher, on average, than for other workers. The initial hospitalization accounted for about one-half of these costs. Thirty percent of workers with ACS had at least one more heart disease hospitalization within the next year.


Acute coronary syndromes were also associated with higher indirect costs for short-term disability: about $1,000 per year. Costs due to absence from work were not significantly increased, but this was based on a small number of cases.


The findings show that ACS is even more costly than other conditions common in working-age adults, such as asthma, high blood pressure, and diabetes.


"Patients with ACS represent a substantial direct and indirect cost burden for employers and payers and incur productivity losses that may greatly affect employers," the researchers conclude. They believe that their data on comparative costs will be useful in prioritizing resources for the treatment and prevention of ACS.

Managing Your Moods Can Benefit Your Health

Learning how to deal with negative emotions and create positive ones may help you avoid many health problems.


Your emotions may originate in your brain, but they don't confine themselves to your mind. They express themselves in your body as well in your heartbeat, your respiratory rate, your blood pressure and many other physical functions.


Usually, strong emotions come and go, and normal physiological equilibrium is restored. But when emotional stressors endure for long periods of time, they can tip the balance of chemicals in brain and body and affect your health, often for the worse. Learning to recognize the physiological consequences of your emotions, and finding ways to establish emotional balance in your life, can help you avoid many health problems that may result from the way you react to the world around you. Consider susceptibility to the common cold, for example. A study published in the November/December 2006 issue of the journal Psychosomatic Medicine suggests emotional factors can affect resistance to cold and flu symptoms. Researchers interviewed 193 healthy volunteers daily for two weeks about the positive and negative emotions they had experienced each day, recording the results. They then exposed subjects to a cold or flu virus. Fewer positive-thinkers became infected, and positive thinkers who did become infected had less pronounced symptoms than subjects with more negative emotions. Only 28 percent of infected individuals who often reported positive emotions developed symptoms such as cough or congestion, compared to 41 percent of those who rarely reported positive emotions. "Positive emotions are thought to be beneficial to health," said Darin D. Dougherty, MD, Massachusetts General Hospital. "But when we experience negative emotions in excess, they can be physically and psychologically harmful. Chronic excess anger, for example, is linked to a higher risk of hypertension, diabetes and heart disease. For this reason, it's important to strive to stabilize your emotions. "The good news is that we can minimize health problems associated with emotional stressors by seeking out circumstances that make us feel positive, avoiding as much as possible situations that cause us distress, and by using stress reduction techniques to address the stresses that we can't control."


The mind/body interface Emotions are conscious mental states that arise spontaneously in reaction to situations (or memories of situations) in the environment, and usually manifest themselves in behavioral and physiological changes. Emotions have evolved to help us defend ourselves (anger), bond with others (joy and love), and avoid danger (fear), among other things, and are important for human survival. Responses to emotion-evoking events that involve conscious thought are generated within the cortex, a region of the brain responsible for reasoning, voluntary muscle movement, and memory. Even more rapid reactions occur without conscious control. This is the work of the limbic system, a network of brain regions involved in many primary emotions. It responds to emotional triggers by activating the autonomic nervous system, which controls the automatic functions of the body, such as circulation, digestion and respiration. The autonomic nervous system physically prepares the body for action when necessary, and helps restore a normal, relaxed state when the need for action passes. The limbic system generates physiological and behavioral responses to emotions that are stereotypic patterns displayed by every human being. These responses often involve outward manifestations of emotion, such as facial expressions and muscle tightening. The patterns such as the downcast facial expression of sadness are so universal we recognize them in others. But many physical and behavioral effects generated by the limbic system may be hidden from view inside our bodies. These include responses to emotion such as increases in heart rate and blood pressure, constriction of blood vessels, and gastrointestinal disturbances.















Physical fallout The intensity of emotional responses and their effects on the body can be influenced by a number of physiological factors, including patterns of brain activation, levels of hormones, levels of brain chemicals called neurotransmitters, and patterns of autonomic nervous system activity. Research suggests that each emotion is associated with a characteristic set of physiological responses. Here are examples of common emotions, along with some observed physical consequences:


Anger: Increase in diastolic blood pressure, heart rate and cardiac output; changes in respiration; dilation of blood vessels (flushing); dilation of pupils and tearing of eyes; tensing of muscles; hyperactivity (pacing, tapping feet, etc.); focused vision; sweating; stimulation of upper gastrointestinal (GI) contractions and acid secretion; suppression of immune response.


Fear/anxiety: Increase in systolic blood pressure, heart rate, and cardiac output; constriction of blood vessels (pale skin); increased muscle tension; changes in respiration; tightening of throat; trembling; light-headedness; shortness of breath; sweating; nausea; inhibition of contractions and secretions of the upper GI tract (feelings of lack of appetite and fullness); stimulation of the motility and secretions of the lower GI (abdominal pain and diarrhea); suppression of immune response.


Shame/guilt: Flushing or warmth in the upper chest and face; irregular breathing; increased pro-inflammatory activity; increased vulnerability to stress


Joy/pleasure: Slowing of heart rate and respiration, lower blood pressure. Sadness/grief: Tightness in throat and eyes; relaxation of arm and leg muscles; increased heart rate and elevated blood pressure; shortness of breath; insomnia; pain; gastrointestinal symptoms; fatigue;headache; chest pressure; backache; dizziness; suppression of immune response.


Disgust: Slowed heart rate; nausea; increased salivation.


Loneliness: Sleep disturbance; lack of appetite; reduced energy; headaches or stomach pain; high blood pressure; elevated stress hormones.


Love/desire: Slowed heart and respiration rate; muscle relaxation; enhanced immune response. When intense (love sickness), can be associated with dry throat, increased respiration; changes in appetite, and sleep disturbance.


Humor/laughter: Release of tension; lowered blood pressure, heart rate and respiration rate; elevated immune response; improved pain tolerance; increased levels of endorphins resulting in improved mood.


Emotional Damage Control When emotional stressors such as anger or loneliness affect the body repeatedly, or over a long period of time, they can compromise the health of vulnerable individuals. Such prolonged stress is associated with a variety of disorders, including metabolic syndrome (a precursor to type 2 diabetes characterized by insulin resistance, hypertension and elevated levels of unhealthy LDL cholesterol), cardiovascular problems, confusion, poor memory, allergies, ulcers, functional bowel disorders, insomnia and rapid aging. Fortunately, you can reduce your risk of health problems associated with emotional wear and tear by paying attention to your emotional reactions and taking steps to establish emotional balance. Minimize emotional stress by buffering yourself from upsetting situations as much as possible. Adopt a positive attitude toward life. Pursue activities that you enjoy, and seek out people with whom you can be yourself. To build up resilience, eat a nutritious diet, avoid drugs, limit alcohol, exercise, get adequate sleep, and take time to relax. "If you find you can't manage your emotions on your own, it's important to get help," Dr. Dougherty says. "There are effective therapies available that can help you reduce unhealthy stress and restore a sense of calm and control to your life."


What you can do when emotions seem overwhelming, try these techniques for rapidly establishing more emotional balance:


Learn relaxation techniques. Yoga, deep-breathing exercises, meditation and visualization can help you reduce emotional stress.


Do things that relax your senses. Play soothing music, go somewhere where you can see or walk in peaceful natural Surroundings; get a massage.


Release energy. Take out your anxiety or anger through vigorous physical activity such as raking leaves, doing housework or going for a brisk walk.


Talk about it. Make a date with a loved one or trusted friend and vent your feelings. Talking about what bothers you can be a good way to diffuse pent up emotions.


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Greater Risk Of Death For African-Americans With Depression And Heart Attack

African-American patients with acute myocardial infarction (MI) and previously treated depression that persists at their MI hospitalization have an increased risk of post-MI death, according to Emory researcher Susmita Parashar, MD, MPH.



Parashar, a member of the cardiology division, Emory University School of Medicine, presented findings Nov. 12 at the American Heart Association Scientific Sessions conference in New Orleans.



"Our study shows that prior depression that persists at the time of MI may indicate a more severe, enduring or recurrent depression," says Parashar. "Thus, it is important to screen and identify persistent depressive symptoms at the time of hospitalization for MI because targeting of interventions regarding persistent depression may improve outcomes."



Often referred to as a heart attack, MI occurs when the blood supply to part of the heart is interrupted. This decreased blood supply is commonly due to blockage of a coronary artery and if left untreated can cause damage and/or death (infarction) of heart muscle tissue.



Classical symptoms of acute MI include sudden chest pain, shortness of breath, nausea, vomiting, palpatations, sweating and anxiety. Heart attacks are the leading cause of death for both men and women in the U.S. Risk factors include cardiovascular disease, older age, tobacco use, diabetes, high blood pressure, obesity, chronic kidney disease, heart failure, excessive alcohol consumption and chronic high level of stress.



Using the Patient Health Questionnaire as part of a prospective myocardial infraction registry, Parashar and her team measured depressive symptoms in 397 African-American MI patients at Grady Memorial Hospital in metro Atlanta.



Patients were assessed and categorized as past, new, persistent or never depressed. Patients were followed up for a maximum of 58 months after MI. Researchers examined the relative prognostic importance of current, past versus persistent depression on mortality among African Americans with acute MI adjusting for demographic, clinical and quality of care variables.



Preliminary results show patients with persistent depression were almost three times as likely to die after MI compared with never depressed patients.

Costs of Coronary Artery Bypass Graft Surgery in U.S. More Than Canada

Although there are no differences in clinical outcome, the in-hospital cost of coronary artery bypass graft surgery (CABG) in the U.S. is 82.5 percent higher in the U.S. than in Canada, according to a study in the July 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.


Cardiovascular disease is a leading cause of illness and death in the U.S. and Canada, with an estimated direct cost in the U.S. of $209.3 billion in 2003, including $94.1 billion in in-hospital costs alone, according to background information in the article. In 2000, more than 500,000 CABGs were performed in the U.S.


Mark J. Eisenberg, M.D., M.P.H., of Jewish General Hospital, Montreal, and colleagues compared the outcomes and costs of treatment of 12,017 consecutive patients (4,698 U.S. and 7,319 Canadian patients) undergoing CABG at five U.S. and four Canadian hospitals.


"In-hospital costs of treatment were substantially higher in the United States than in Canada [an average cost of $20,673 vs. $10,373]," the authors report. "After controlling for demographic and clinical differences, length of stay in Canada was 16.8 percent longer than in the United States; there was no difference in in-hospital mortality [death]; and the cost in the United States was 82.5 percent higher than in Canada."


"Coronary artery bypass graft surgery requires substantial resources in Canada and the United States," the authors conclude. "However, patients undergoing CABG at U.S. hospitals incur approximately twice as much cost compared with those at Canadian hospitals, with little difference in clinical outcome and despite shorter average LOS [length of stay]. The difference in total in-hospital costs is almost equally attributable to differences in direct and overhead costs between the Canadian and U.S. hospitals. This cost differential primarily reflects higher resource prices for products and labor and higher overhead costs in the United States resulting from a nonsocialized medical system. However, U.S. hospitals also appear to streamline services better to reduce LOS, a strategy Canadian hospitals might emulate to further reduce treatment costs."


(Arch Intern Med. 2005; 165:1506-1513. Available pre-embargo to the media at jamamedia.)


Editor's Note: This study was supported by an unrestricted research grant from Pfizer, Inc., Groton/New London, Conn. Dr. Eisenberg is a Senior Physician-Scientist of the Quebec Foundation for Health Research, Montreal. Co-author Kristian B. Filion, B. Sc., was supported by a Canadian Cardiovascular Outcomes Research Team Summer Studentship. Co-author Louise Pilote, M.D., M.P.H., Ph.D., is a Physician-Scientist of the Canadian Institutes of Health Research, Ottawa, Ontario.


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Boston Scientific Begins International Clinical Trial Enrollment For INNOVA&trade; Self-Expanding Bare-Metal Stent System

Boston Scientific Corporation (NYSE: BSX) announced the start of patient enrollment in the SuperNOVA clinical trial, an international, prospective, single-arm, non-randomized trial evaluating the safety and effectiveness of the INNOVA™ Self-Expanding Bare-Metal Stent System in patients with stenosis of the superficial femoral artery (SFA) or proximal popliteal artery (PPA). Enrollment is planned for up to 300 patients at 50 sites in the U.S., Canada and Europe. The first patient was enrolled in the trial last week by Subhash Banerjee, M.D., Associate Professor of Medicine and Chief of Cardiology at the VA Medical Center in Dallas, TX.


The INNOVA Stent System is designed to treat peripheral vascular lesions in arteries above the knee, specifically the SFA and PPA. It consists of a nitinol, self-expanding bare-metal stent loaded on an advanced low-profile delivery system. The innovative architecture features a closed cell design at each end of the stent for improved radial force and fracture resistance, and an open cell design along the stent body that doesn't compromise flexibility. Stent deliverability is enhanced with a tri-axial catheter shaft designed to provide added support and placement accuracy as well as dual deployment options and radiopaque markers to enhance ease of use. The INNOVA Stent is 6F compatible and ranges from 5 mm to 8 mm in diameter and 20 mm to 200 mm in length.


"Treating arteries above the knee is difficult because the challenging anatomy can lead to stent fractures and higher restenosis rates," said Richard J. Powell, M.D., Section Chief of Vascular Surgery at Dartmouth-Hitchcock Medical Center in Lebanon, NH, and Global Principal Investigator of the SuperNOVA trial. "I believe the INNOVA Stent offers a unique design that provides excellent radial strength while remaining flexible and durable, which is critical to sustaining patency in treated SFA and PPA lesions."


"The INNOVA Stent is engineered to offer an advanced solution in treating blockages within these critical arteries," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Endovascular Unit. "Its design is intended to improve blood flow and provide greater long-term stent durability, ultimately improving the overall quality of life for patients with peripheral artery disease."

High Heart Rate Is A Factor For Heart Disease, Says BHF

In response to a study published in the British Medical Journal which investigates a resting heart rate as a low tech predictor of coronary events in women, Professor Peter Weissberg, Medical Director at the British Heart Foundation, said:


"This study shows that having a high heart rate is a risk factor for future heart disease in women, a finding that has been known for some time in men.
"It adds heart rate to the numerous other risk factors known to influence the chances of having a heart attack.


"However, one's heart rate changes minute by minute in response to things like activity and emotion, so people shouldn't automatically assume that if their heart rate happens to be high at a particular time it is putting them at risk of a heart attack."


Issued in response to 'Resting heart rate as a low tech predictor of coronary events in women: prospective cohort study' by Husia et al published by British Medical Journal. DOI:10.1136/bmj.b219


The British Heart Foundation (BHF) is the nation's heart charity, dedicated to saving lives through pioneering research, patient care, campaigning for change and by providing vital information. But we urgently need help. We rely on donations of time and money to continue our life-saving work. Because together we can beat heart disease.


British Heart Foundation, Greater London House 180 Hampstead Road, London, London NW1 7AW United Kingdom


British Heart Foundation

Anthera Pharmaceuticals Advances Global Development Strategy For Varespladib In Patients With Acute Coronary Syndrome

Anthera Pharmaceuticals
Inc., a privately held biopharmaceutical company developing
anti-inflammatory drugs, announced the initiation of the FRANCIS
(Fewer Recurrent Acute coronary events with Near-term Cardiovascular
Inflammation Suppression) clinical trial designed to examine the impact of
varespladib when administered to patients within 96 hours of an Acute
Coronary Syndrome (ACS) event.



The FRANCIS trial is designed to assess the impact of oral varespladib
on known biological markers of cardiovascular risk. It will enroll up to
500 patients that will be treated for a minimum of six months. The study
will be conducted at sites in North America and Europe. FRANCIS will
provide insight into the prevention of secondary Major Adverse
Cardiovascular Events (MACE) over the duration of the trial. In this study,
MACE is defined as a composite endpoint consisting of cardiovascular death,
non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a
subset of revascularization following the initial event. During the course
of the study, patients will receive therapeutic standard of care in
addition to high dose Lipitor(R) (atorvastatin). In previous clinical
trials, varespladib, a potent and highly selective inhibitor of secretory
phospholipase A2 (sPLA2), has demonstrated marked improvements in
independent markers of cardiovascular risk including, a near complete
suppression of the target enzyme sPLA2, a clinically meaningful and
statistically significant reduction in "bad" LDL cholesterol, and a
reduction in C-reactive protein, a known marker of inflammation.



"We are pleased with the continued progress of our varespladib
cardiovascular program targeting secretory phospholipase A2," said Paul
Truex, President and Chief Executive Officer of Anthera Pharmaceuticals,
Inc. "The FRANCIS trial was designed with input from global regulatory
agencies and industry experts and represents the next key component of our
international cardiovascular development program. The multiple therapeutic
impact of varespladib's mechanism of action provides us with a unique
opportunity to develop a first-in-class product targeting a
life-threatening coronary event for which there are limited therapeutic
options."



"Based upon the success of varespladib in two previous Phase II
clinical trials in patients with cardiovascular disease in which it
demonstrated lipid-lowering and anti-inflammatory benefits, we look forward
to further evaluating the impact of varespladib on the hyper-inflammatory
state presented by ACS patients," said Dr. James Pennington, Executive Vice
President and Chief Medical Officer of Anthera Pharmaceuticals, Inc.



About Acute Coronary Syndrome



Acute coronary syndrome is a heart condition characterized by chest
pain occurring at rest or upon minimal exertion. This condition is also
referred to as unstable angina. If the chest pain is associated with heart
muscle damage and heart tracing abnormalities, it is typically classified
as a heart attack or myocardial infarction.



About Anthera Pharmaceuticals



Anthera Pharmaceuticals is a privately-held company committed to
developing and commercializing clinical pharmaceutical products that
address unmet medical needs of patients with life-threatening, chronic and
acute inflammatory diseases and autoimmune disorders.


Anthera Pharmaceuticals Inc.

anthera

First Total Artificial Heart Implanted In California

On January 7, 2011, UC San Diego Medical Center performed the West Coast's first implant of the world's only FDA-approved total artificial heart. During the four-hour procedure, the patient's diseased heart was completely removed and replaced by a lifesaving device that rapidly restored blood flow to his entire body. The patient, who suffered from a near-fatal heart virus in his 20s, recently underwent heart transplant surgery and is now recovering.


"The total artificial heart is a good device for people who are just beginning to lose the function of their kidneys, liver, intestines, lungs and brain. Patients may be near the point of organ failure but the damage is still reversible," said Jack Copeland, MD, professor of surgery and director of cardiac transplantation and mechanical circulatory support at UC San Diego Health System. "The total artificial heart goes in and, in most cases, the patients can recover from metabolic disaster, provided they are not too advanced in age, weak, or suffering from other chronic organ disease."


For patients who receive the total artificial heart, and stay in the hospital, approximately 80 percent are transplanted in six months. Almost all are transplanted at the one-year mark.


During total artificial heart surgery, the patient's chest wall is opened. Medicines are used to stop the heart to allow the team to operate while the heart is not beating. A heart-lung machine keeps oxygen-rich blood moving through the body. Copeland then begins the process of removing the dying heart. Both ventricles are removed, leaving the upper chambers of the heart to connect to the device. When the device is attached, the heart-lung machine is switched off and the total artificial heart starts pumping about eight liters of blood per minute.


"All of a sudden the organs are pinking up and working again. It all happens before your eyes, right in the operating room," said Copeland. "It's amazing to see these patients rescued from death and brought back to life. Within days, many patients are breathing on their own. In less than two weeks, they are out of bed and walking more than 100 feet, and getting re-nourished in preparation for a heart transplant."


Each year, more than 5 million Americans are diagnosed with heart failure. For some, medical therapies such as beta blockers are a lifesaver. For others with end-stage heart disease, the only option for survival is one of 2,500 donated hearts. The total artificial heart extends the life of the patient until a match can be found.


"Heart failure is a slow insidious way to die. Basically the patient suffocates as time passes," said Copeland. "Some patients have to take small triple breaths just to take in the equivalent of one normal breath. They become malnourished because they cannot exercise. They consume their calories just trying to breathe."


For more than 30 years, Copeland has pioneered the field of heart transplantation and device therapy. In 1979, he performed Arizona's first heart transplant and in 1985 became the first surgeon in the world to successfully use the total artificial heart as a bridge to transplant. During his career, Copeland has performed more than 850 heart transplants and 100 implants of the total artificial heart, which is manufactured by SynCardia. Copeland helped found Syncardia in 2002 and serves on their board with no compensation.


Implanting the total artificial heart is not without risks. The two major complications which may arise are clotting and slow healing of the chest.


Copeland says that in the next year Americans may begin pushing for the total artificial heart as a permanent replacement and that more studies need to be done to prove the viability of this assertion. To date, the longest anyone has ever been on the total artificial heart is more than 1,100 days.


Under the leadership of Dr. Stuart Jamieson, chief of heart surgery, the surgery team includes Jack Copeland, MD, Victor Pretorius, MD, Michael Madani, MD, David Garcia, NP, and Amanda Topik, RN.


In April 2011, UC San Diego Health System will open the doors to the Sulpizio Cardiovascular Center. This new 128,000-square-foot facility will unify UC San Diego Health System's ambulatory, clinical, and inpatient heart and stroke care in one convenient location.

An International First At The CHUM Promising Treatment In Regeneration Of The Myocardium Through The Use Of Stem Cells

The Centre hospitalier de l'Universite
de Montreal (CHUM) announces the beginning of a phase II randomized
double blind trial with the potential of providing a therapeutic
alternative after a first acute myocardial infarction. One patient has
already undergone this technique, which consists of implanting immature
stem cells from the bone marrow to regenerate heart muscle. The procedure
went smoothly and the patient is doing well. This worldwide first,
conducted in collaboration with Hopital Maisonneuve-Rosemont (Montreal,
Canada) follows in the footsteps of successful phase I clinical trials
carried out in Europe. To date, these preliminary studies have revealed no
complications in the subjects treated, after five years of follow-up. These
encouraging findings confirm the results of many preliminary experiments
carried out on animal models.


Some facts


- Did you know that cardiovascular disease is the primary cause of death
in Western countries?


- Did you know that one hospital bed in five is occupied by someone
suffering from heart disease?


- Did you know that myocardial infarction (heart attack), the most
frequent cause of heart failure, affects over 250,000 patients in
Quebec?



"Drug treatment and heart transplant are among the various techniques
that can improve heart function. But because the paucity of organs
available remains a major problem, CHUM researchers have worked together to
set up this innovative research protocol," states Dr. Samer Mansour,
cardiologist at the CHUM, and principal investigator for the trial. One of
the aims of this trial is to understand the effect of immature stem cells
(CD133+), extracted from the patient's bone marrow in the iliac crest, on
the healing process of the heart after a first heart attack. The experiment
protocol involves intracoronary injection of CD133+ cells against placebo,
in addition to standard medical treatment. The entire process takes place
during the same period of hospitalization.



"The study of cell therapy in the case of myocardial lesions is
relatively recent and we still have a great deal to learn in this trial,"
adds Dr Guy Leclerc, head of the CHUM's cardiology service. "Previous
studies have demonstrated significant improvement of 7 to 10 % in heart
function after implanting several types of bone marrow stem cells. In this
trial, we will study these immature cells using the most advanced
technologies and state-of-the-art imaging techniques to prepare and
transplant these cells into the patient."



Bone marrow cells extracted at the CHUM are transferred to the
Laboratoire de therapie cellulaire at Hopital Maisonneuve-Rosemont (HMR) to
isolate the most immature stem cells. According to Dr. Denis-Claude Roy,
director of the hospital's research centre, "The fact that the stem cells
that have been isolated are immature should improve their capacity to
repair the heart muscle."
















This clinical trial is one of a body of research projects in
regenerative medicine and cell therapy currently being carried out at the
CHUM. In these studies, Dr. Mansour and Dr. Nicolas Noiseux,
co-investigator for the trial and cardiac surgeon, are attempting to better
characterize the mechanisms behind the beneficial effects of stem cells
used for the treatment of cardiovascular diseases.



Anticipated impact of the procedure



Currently, this procedure applies to patients who have suffered a first
extensive infarction and are at risk for complications such as heart
failure. The target population could be broadened once the technique has
been further refined and the laboratory protocols perfected. The ultimate
goal of this minimally invasive and inexpensive technique, compared to
heart transplant, is for it to become more commonly performed in hospitals,
in the medium term.



The research team includes the following investigators: Drs. Samer
Mansour, Denis-Claude Roy, hematologist (HMR), Guy Leclerc, Nicolas
Noiseux, cardiac surgeon, and Francois Reeves, cardiologist (CHUM). Stem
cell preparation is carried out at the cell therapy laboratory of HMR under
the supervision of Dr Roy. "The contribution of HMR is another good example
of complementarity and cooperation in research between the institutions of
the RUIS de l'Universite de Montreal (UdeM)," states Dr. Denis R. Roy,
Director General of the CHUM and president of the UdeM RUIS.



This research protocol was made possible through the collaboration of
the Laboratoire de therapie cellulaire of the Hopital Maisonneuve-Rosemont,
Miltenyi Biotec, the CHUM Research Centre, its radiology and nuclear
medicine departments and its cardiology service, notably through its
interventional hemodynamics development fund. Health Canada, Fonds de la
recherche en sante du Quebec, and Boston Scientific also contributed to the
trial.


CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
chumontreal.qc.ca

Barts And The London Heart Expert Recognised For His Innovation, UK

A leading heart expert at Barts and The London NHS Trust has been honoured for pioneering a host of breakthrough treatments for heart disease.



Professor Martin Rothman received the inaugural award for "outstanding contribution to innovation" at NHS Innovations London's annual awards dinner last week.



Presenting it, Olympic Gold Medallist Tessa Sanderson said: "This award goes to an outstanding innovator, who, by his own admission has said the roots of his success as a cardiologist and cardiac interventionist have been firmly laid in innovation.



"He recognised early on the need to kiss a lot of frogs in order to find the princes of ideas, something which has pushed him further and kept him at the leading edge of research."



"He's a great advocate of innovation, building a research inheritance to encourage and promote entrepreneurship as clinical activity."



Throughout his career Consultant Interventional Cardiologist, Professor Rothman has been behind a number of key innovations and is currently the inventor on 25 patent families*.



In 1982 Professor Rothman was one of the first doctors in the UK to use angioplasty ** on heart attack patients, a now-common technique used to unblock arteries without the need for surgery.



In 1987 he also introduced the coronary stent in the UK, a tiny scaffold-like device inserted into a patient's artery to stop it from closing.



At the time, both innovations were deemed novel and dangerous, yet both are now mainstream procedures.



Professor Rothman said: "I was honoured and surprised to receive this award and would like to acknowledge NHS Innovations London for their continuing support and funding which has enabled me to develop some of my more recent inventions.



"There are some exciting things in the pipeline in terms of innovative treatments for heart disease which kills one in three people in the UK."



One such product is Professor Rothman's ascending thoracic aorta graft (ATAG) innovation. The ATAG is a prosthetic blood vessel that can be inserted into the body using a catheter to re-establish blood flow around a diseased or damaged vessel section. The new system aims to replace the current high-cost, high-risk procedure, open heart surgery, used to treat this condition. A prototype for use in animal trials is near completion.



Professor Martin Rothman and his team also picked up an award from NHS Innovations London in 2008 for their work on another innovative device, Percutaneous Implantable Cardiac Support (PICS). The device, used to treat end stage heart failure, is small enough to be implanted without the need for major surgery. Development of this product continues and testing in animals is expected to begin in 2010.



Source
Barts and The London NHS Trust