FDA Issues Warning Letter To CoreValve Investigator

The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…

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HPS2-THRIVE Coming Attraction: First Look At What Went Wrong With Niacin

In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint…

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Mixed Results For Spironolactone In Heart Failure With Preserved Ejection Fraction

Although the mineralocorticoid receptor antagonists (MRAs) spironolactone and eplerenone (Inspra, Pfizer) have been shown to be beneficial in patients with heart failure (HF) with reduced ejection fraction (EF), their role in heart failure patients with preserved EF has not been tested until now. Now the results of the Aldo-DHF (Aldosterone Receptor Blockade in Diastolic Heart Failure), published…

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The Mediterranean Diet: The New Gold Standard?

Earlier today I summarized the important new PREDIMED study published in the New England Journal of Medicine showing the cardiovascular benefits of the Mediterranean diet. This study– a rare and much welcome instance of a large randomized controlled study of a diet powered to reach conclusions about important cardiovascular endpoints– has been widely praised and will undoubtedly have a…

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Large Trial Shows Cardiovascular Benefits Of Mediterranean Diet

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A large new trial offers powerful evidence that the Mediterranean diet can reduce the risk of cardiovascular disease. Results of the PREDIMED (Prevención con Dieta Mediterránea) study were published online in the New England Journal of Medicine. Spanish investigators randomized 7,447 people at high risk for cardiovascular disease to one of three groups: a Mediterranean diet…

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Are Most People With Complex Coronary Disease Getting The Best Treatment?

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who…

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Study Casts Doubt On Value Of Genetic Testing For Familial Hypercholesterolemia

A new study published online in the Lancet suggests that one of the main screening plans that relies on genetic tests will fail to identify a substantial portion of people with familial hypercholesterolemia. Investigators from the UK and Belgium analyzed DNA from several cohorts of FH and non-FH patients. Their chief finding was that a large percentage…

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New Studies Examine Prolonged Anticoagulation For VTE Recurrence

Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). … In an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is…

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Small Study Explores Expanded Use For TAVI In Native Valve Aortic Regurgitation

As transcatheter aortic valve implantation (TAVI) gains increasing acceptance, cardiologists and surgeons are exploring additional patient populations who may benefit from the procedure. A new paper in the Journal of the American College of Cardiology provides the first look at the use of TAVI in the small but important group of patients with pure, severe native aortic…

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400 Patients Sue Kentucky Hospital and 11 Cardiologists Over Unnecessary Procedures

After undergoing more than two dozen cardiac procedures over a period of twenty years at St. Joseph Hospital in London, Kentucky, a patient was told by an outside cardiologist in Lexington that a recent procedure had been performed unnecessarily on an artery that was barely blocked. “I would have not carried out this procedure,” the…

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St. Jude Raises The Stakes In Renal Denervation With An Outcomes Study

St Jude EngligHTN Rendal Denervation System

  The already hot field of renal denervation for resistant hypertension just got a little hotter. With the announcement of a clinical trial powered to detect improvements in cardiovascular outcomes, St. Jude Medical has raised the stakes. … “To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in…

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Amid Rising Tide Of Diabetes More Patients Reach Treatment Goals

There’s a glimmer of good news amidst all the recent bad news about diabetes. Although the prevalence of diabetes has doubled over the last generation, more people today  are reaching their treatment goals than in the past. New data from the National Health and Nutrition Examination Surveys (NHANES), published online today in Diabetes Care, show that…

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FDA Approves Second Generation MRI-Friendly Pacemaker System

Medtronic Advisa

Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads.  Click here to read the full post on Forbes….

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‘Bias in choosing the question is a much bigger issue than lying about the data’

Robert Califf takes questions about conflict of interest from Harlan Krumholz. Here are a few choice quotes. Read the entire Q&A on CardioExchange. …focusing exclusively on the medical products industry and failing to consider other sources of conflict of interest is a huge mistake and leads to sensationalism that then engenders reactive rules that add to bureaucracy…

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‘Somebody has finally twigged that the heart and the lungs are joined up to each other and live in this space called the chest…’

Here are a few gems from Richard Lehman’s weekly cardiovascular literature review. Read the whole thing on CardioExchange. On a JAMA study showing that ramipril increases walking time in patients with intermittent claudication: This is the kind of trial that makes nobody millions of dollars, but which we should all be doing in our fields…

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ACC And STS Break New Ground To Test TAVR For Unapproved Uses

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In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and…

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Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk’s Long-Acting Insulin

The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But…

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Rivaroxaban Effective In Medically Ill Patients But At High Bleeding Cost

The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the…

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Should Radial Artery Access Be The Default Choice For PCI?

Over on CardioExchange six cardiologists, from fellows to senior faculty, talk about whether radial artery access should be the “default choice for PCI: Megan Coylewright, MD, MPH (interventional fellow, Mayo Clinic): …radial PCI should be a part of every interventionalist’s toolkit… Micah Eimer, MD (cardiologist, Glenview, IL): The data are pretty convincing on the lower rate of…

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Large Study Finds Genetic Links To Aortic Valve Calcification

A genetic component is believed to play an important role in valvular heart disease, but the specific genes involved have not been identified. Now an interntional group of researchers has identified genetic variations that increase the risk for valvular calcification. In a paper published in the New England Journal of Medicine, members of the Cohorts for Heart and…

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Back To The Future: Resurrected Data From 1960s Trial Might Impact Contemporary Dietary Fat Debate

In an exceedingly strange turn of events, data from a clinical trial dating from the 1960s, long thought to be lost, has now been resurrected and may contribute important new information to the very contemporary controversy over recommendations about dietary fat composition. The American Heart Association has long urged people to increase their consumption of…

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ACE Inhibitor Improves Walking In People with Peripheral Artery Disease

Giving an ACE inhibitor to people with peripheral artery disease (PAD) and intermittent claudication reduces pain and increases walking time, according to a new study published in JAMA. Currently the pharmacologic options for this patient population are few and have limited efficacy. Researchers at three Australian hospitals randomized 212 patients with PAD to receive the ACE…

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Should Physicians Be Business Partners With Medical Device Salesmen?

Should a Florida cardiologist co-own a business running frozen yogurt shops with a medical device salesman? That’s the question raised by reporter John Dorschner in a story posted by the Miami Herald yesterday:   “Mark Sabbota, a Hollywood cardiologist, regularly implants $5,000 pacemakers in patients at Memorial hospitals in South Broward — generating, last year alone,…

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European Heart Journal Retracts Main Paper Of The Kyoto Heart Study

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The editors of the European Heart Journal have retracted the 2009 paper reporting the main results of the Kyoto Heart Study, a randomized, open-labeled study testing the add-on effect of valsartan to conventional therapy in high-risk hypertension. The retraction notice gave no details about the problems that led to the retraction. Here is the full text…

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No Sunshine For Continuing Medical Education

After many long delays, CMS today released the final details of the Sunshine Act. Starting next September all pharmaceutical and device companies will be required to publicly report payments made to US physicians.   However, there is at least one very major exception to this requirement. Although the initial draft of the rules stated that…

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