Keeping you up-to-date on recent headlines in cardiovascular healthcare:

Snapshot from ACC Scientific Session presentations

• Interim study results from critical limb ischemia trial in India .... Harvest Technologies (Plymouth, Massachusetts) reported announced that the interim study report was completed for the first 30 patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to Buerger's Disease. Harvest's SmartPReP System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in about 15 minutes. The most important finding from the trial was that 87.5% of patients were able to save their legs. (

• Combination therapy benefits those with AF .... A new study by McMaster University researchers at Hamilton Health Sciences (Hamilton, Ontario) indicates that people with atrial fibrillation (AF) who are unsuitable for warfarin therapy have another alternative to reduce their risk of complications taking clopidogrel (Plavix) in addition to aspirin, further decreasing their risk of stroke and heart attack without facing an unreasonable risk of bleeding. The study, ACTIVE A, was led by Dr. Stuart Connolly, a professor of medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences, who presented the findings.

• Need for pediatric cardiovascular devices emphasized .... Nearly two-thirds of children who undergo routine interventional cardiology procedures those involving a catheter to treat structural disorders of the heart may be receiving treatment with a device in an off-label use. The finding underscores the need for regulatory agencies to include pediatric applications when reviewing and approving cardiac device processes in the U.S., according to Robert Beekman, MD, a pediatric cardiologist at the Heart Institute, Cincinnati Children's Hospital Medical Center.

Coronary angiography may improve outcomes in cardiac arrest .... People who suffer cardiac arrests and then receive coronary angiography are twice as likely to survive without significant brain damage, compared with those who don't have the procedure, according to a study by researchers at the University of Pittsburgh School of Medicine. The study, published in the May/June issue of the Journal of Intensive Care Medicine, found no significant differences between those who received angiography and those who did not with respect to age, history of cardiac disease and use of therapeutic hypothermia. (

Validation of ABC heart failure risk model .... Researchers at Emory University School of Medicine (Atlanta), creators of the Health ABC Heart Failure Model for predicting risk of new onset heart failure in the elderly, have now validated the model in a separate library of patient data from an earlier cardiovascular study. The results indicate that the Health ABC risk model can be used to identify high-risk individuals for whom interventions can be targeted cost-effectively to prevent heart failure. The Health ABC model uses nine clinical measures age, coronary heart disease history, smoking, blood pressure, heart rate, left ventricular hypertrophy measured by EKG, and glucose blood levels, creatinine and albumin to estimate the risk of heart failure in patients who haven't necessarily been seen by doctors for coronary heart disease before. (Reference: Circulation Heart Failure 2008,1:125-133)

Discontinuing Plavix due to allergy can be fatal for stent patients .... Stent-implanted patients who stop using the required regimen of anti-platelet drug Plavix, because of an allergy to the drug and therefore putting them at risk for thrombosis may have life-threatening complications. Now, a clinical study of cardiac patients who suffered this allergic reaction had this reaction alleviated with a combination of steroids and antihistamines, thereby allowing them to remain on the drug, according to a study by doctors at Thomas Jefferson University Hospital (Philadelphia).

New approach a possible path to artificial blood .... A team of biochemists from the University of Pennsylvania School of Medicine (Philadelphia) say they have built from scratch a completely new type of protein that can transport oxygen, akin to human neuroglobin, a molecule that carries oxygen in the brain and peripheral nervous system. They say this approach might be the basis for making artificial blood. The findings appear in the most recent issue of Nature.

Market for invasive pressure and hemodynamic monitoring expanding in Europe .... The higher incidence of chronic illnesses in Europe, and the consequent increase of patient populations in intensive care units, has expanded the need for equipment that measure vital signs such as blood pressure during surgeries. The new analysis from Frost & Sullivan, "European Market for Invasive Pressure Monitoring and Hemodynamic Monitoring," finds that the market earned revenues of $336.4 million in 2007 and is estimated to reach $520.6 million by 2014. (

New stem cell therapy to treat heart tissue in Phase II trial .... The Heart Hospital of Austin (Austin, Texas) reported that on March 30 it was the first hospital in the world to treat a patient enrolled in a Phase II study designed to test the effectiveness/safety of administering adult stem cells intravenously to repair damaged heart tissue after a heart attack. Roger Gammon, MD, with Austin Heart cardiology group treated a 58-year-old Central Texas man with the experimental adult stem cell treatment, using Prochymal, a product from Osiris Therapeutics (Columbia, Maryland), just days after his first heart attack and said that Austin Heart and the Heart Hospital of Austin were selected because of their proven history of excellence in cardiovascular research and strong performance in the earlier Phase I trial." (

Study looks at effect of heart surgery on employment .... A study appearing in the current issue of Congenital Heart Disease compares the careers and long-term occupational successes of men and women who underwent surgery for congenital heart disease to those of the general population. Lead researcher is Siegfried Geyer, MD, a professor and director of the Medical Sociology Unit at Hannover Medical School (Hannover, Germany). The findings shoed that male patients were less likely to be employed full-time than part-time and this was largely dependent on disease severity.

Missing enzyme conveys major heart protection .... A new study finds that mice born without the enzyme GNSOR (or S-nitrosoglutathione reductase) can resist the normal effects of a heart attack and retain nearly normal function in the heart's ventricles and still-oxygenated heart tissue, according to a study by researchers at Duke University Medical Center (Durham, North Carolina). The findings raise the possibility of a therapy that could stimulate the growth of blood vessels and limit damage from a heart attack as well as prevent an attack from occurring at all, the scientists said. The study was published in the Proceedings of the National Academy of Sciences online on March 27.

Cardiovascular and orthopedic content added to Materials for Medical Devices Database .... In an extension to its Cardiovascular Module, the Materials for Medical Devices Database has added information for all FDA classifications of catheters and other related interventional devices. Records for these devices have been organized into the following database folders: Diagnostic Devices: Catheter Cannula (870.1300), Continuous Flush Catheter (870.1210), Electrode Recording (870.1220), Guide Wires (870.1330), and Percutaneous Catheter (870.1250). Surgical Devices: Vascular Clamps (870.4450). Therapeutic Devices: Embolectomy (870.5150) and Septostomy (870.5175).

— Compiled by Don Long, Medical Device Daily National Editor

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