CardioExchange Archive

Healthcare Reform: American Heart Association CEO Nancy Brown issued a statement on Obama’s State of the Union Address. Brown emphasized the AHA’s “strong commitment to comprehensive reform,” noting that “nearly seven million heart disease and stroke patients do not have health insurance coverage and in many cases forgo necessary medical care to pay bills and support their families.” “Failure cannot be an option,” she said.

The American College of Cardiology has also been busy. The ACC Advocate summarizes the college’s various activities relating to healthcare reform and the college’s fierce opposition to the Medicare cuts in cardiology fees. ACC CEO Jack Lewin blogs frequently about healthcare reform, the Medicare cuts, and other activities, including a recent “fascinating meeting with Newt Gingrich.”

ACC and AHRQ Study ICDs: Separately, the ACC and the Agency for Healthcare Research and Quality (AHRQ) announced that they were supporting, in conjunction with the NHLBI, a $3.5 million research project to “study the long-term benefits and risks of implantable cardioverter defibrillators (ICDs) in patients at risk of death from ventricular fibrillation.”

In a randomized, double-blind, placebo-controlled trial, vitamin D supplements did not improve functional capacity or quality of life in older heart failure patients with vitamin D insufficiency. The Dundee, UK study appears in Circulation: Heart Failure.

New Test for LQTS: A new test to diagnose Long QT syndrome (LQTS) is surprisingly simple, fast, and cheap. In an expedited study appearing in the Journal of the American College of Cardiology, Sami Viskin and an international team of colleagues looked at the ECG of LQTS patients and normal subjects after they were asked to stand quickly after being supine. They found a highly significant 50 ms difference in the corrected QT interval and concluded that the test “should be used in addition to more accepted tests when necessary.”

MIST in the BMJ: A feature news story in BMJ by Jonathan Gornall provides a highly detailed inside look at the characters and series of events that created the public controversy and lawsuit surrounding the MIST trial, which sought to test the benefits of PFO closure to fix migraines.

ACC Preview: The late-breaking clinical trials for the ACC.10 and i2 Summit in March in Atlanta have been added to the online program planner. They’re a bit hard to locate, but you can find them by selecting the browse option.

Liraglutide Approved: Late Monday, the FDA announced that it had approved liraglutide (Victoza, Novo Nordisk) for the treatment of type 2 diabetes, but not for initial therapy. The label contains a black-box warning about thyroid cancers.

Catheter Ablation of AF: Results of the industry-funded ThermoCool AF Trial were published in JAMA. Trial investigators randomized 167 patients with paroxysmal AF unresponsive to 1 or more drugs to either catheter ablation or drug therapy. “Catheter ablation provided significantly better rhythm control and improved [quality of life] with a favorable safety profile. These findings argue for early use of catheter ablation therapy in patients with paroxysmal AF unresponsive to initial attempts with pharmacologic control,” the authors concluded.

3-D Cath Lab Images: A feasibility study in Circulation: Cardiovascular Interventions examined the first use in humans of a new system that automatically generates computer-reconstructed 3-D images in the cath lab using rotational angiography and ECG-gated iterative reconstruction.

FDA Approves Percutaneous Valve: The FDA has approved its first percutaneous heart valve. The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System was approved under the Humanitarian Device Exemption (HDE) program. “The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

Obesity & Exercise: Archives of Internal Medicine has many new studies relating to diet and exercise. Here are just a few:

The Louisiana Obese Subjects Study (LOSS), a “pragmatic clinical trial,” found that with brief training primary care practices can help some obese patients achieve a sustained modest weight loss.
A report from the Nurses’ Health Study finds that women who are more physically active at 60 years of age are more likely to be free to major chronic diseases and have no physical, cognitive, or mental limitations when they are 70.
Yancy et al. compared  a low-carbohydrate diet to a combination of orlistat and a low-fat diet and found similar improvements for weight, lipid and glycemic measures, while the low-carb diet was more effective in lowering blood pressure.
In an effort to improve the efficacy of the DASH diet in the real world, the ENCORE Study found that adding exercise and weight loss to the DASH diet “resulted in even larger BP reductions, greater improvements in vascular and autonomic function, and reduced left ventricular mass.”

Smoking & Infants: Infants with mothers who smoke may have a permanently reprogrammed blood pressure control mechanisms that may increase their later susceptibility to hypertension. In an article appearing in Hypertension, Gary Cohen and colleagues studied the responses by babies to a tilt test. At one week, in response to being tilted semi-upright during sleep, the babies with a mother who smoked had double the blood pressure rise compared to babies with nonsmoking parents. At one year the pattern had completely reversed, and the babies with smoking mothers had only half the blood pressure increase as controls in response to tilting. Further, the smoking-exposed babies exhibited an abnormal surge in blood pressure in response to a sudden change from an upright to a horizontal position.

A recent review reports that cardiovascular devices are not subjected to nearly the same level of scrutiny as drugs, raising concern about the true safety and efficacy of approved new technologies.

Do you think this has placed patients at risk, or is it a welcome difference from the lengthy and onerous approval process that delays the implementation of potentially highly effective treatments?

Abbott Suspends Sibutramine Marketing in European Union: Following yesterday’s recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) that sibutramine be withdrawn from European markets, Abbott Laboratories announced that it was suspending its marketing of the drug in the European Union.

Generic News: A Wall Street analyst at Sanford Bernstein reports that clopidogrel besilate, which in Europe has been approved as a generic equivalent to clopidogrel bisulfate, has gained widespread acceptance and market share in Europe. In another research report the same analyst says that a generic version of enoxaparin may soon be available in the US.

Tough Day for Sibutramine– The FDA announced today that sibutramine is now contraindicated for people with cardiovascular disease. Almost simultaneously, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that sibutramine be withdrawn from European markets.

Abnormal Lipids in Youths– The CDC reported today that 20.3% of U.S. youths aged 12-19 have abnormal lipid levels. The prevalence rose with BMI: 42.9% of obese youths had at least one abnormal lipid level.

NIH Rebukes Baylor– Baylor College of Medicine (BCM) is now being closely scrutinized by the NIH following revelations that BCM failed to disclose Merck payments to Baylor cardiologist Christie Ballantyne. The story was covered in Nature News by Brendan Borrell and the Houston Chronicle by Todd Ackerman. In a  January 14 letter, NIH director Francis Collins wrote Senator Grassley that an NIH investigation “raised serious concerns regarding BCM’s compliance” with federal conflict-of-interest regulations. “As a result, the NIH has imposed special award conditions on all BCM grant awards until BCM can assure the NIH that the detected deficiencies noted in their response have been appropriately addressed and BCM can demonstrate compliance…”

Salty Stuff: Reducing dietary salt by 3 g per day would cut the annual number of new cases of CHD in the U.S. by 60,000 to 120,000, stroke by 32,000 to 66,000, and MI by 54,000 to 99,000, according to a report released early online in the NEJM by researchers from UCSF, Stanford, and Columbia University. Even smaller reductions would be beneficial, write the authors: “The population-wide benefits of salt reduction are similar in magnitude to the benefits that would accrue from other public health and clinical interventions and would reduce costs even if only a more modest reduction of 1 g of salt per day were achieved gradually over time.” In an accompanying editorial, Lawrence Appel and Cheryl Anderson call on the US “to swiftly implement public health interventions that result in population-wide reduction in salt intake.”

AHA’s Life’s Simple 7: As part of an effort to improve the nation’s cardiovascular health, the American Heart Association has developed seven simple measures of cardiovascular health for adults. Here are the measures, which the AHA is calling Life’s Simple 7:

Never smoked or quit more than one year ago;
Body mass index less than 25 kg/m2;
Physical activity of at least 150 minutes (moderate intensity) or 75 minutes (vigorous intensity) each week;
Four to five of the key components of a healthy diet consistent with current American Heart Association guideline recommendations;
Total cholesterol of less than 200 mg/dL;
Blood pressure below 120/80 mm Hg;
Fasting blood glucose less than 100 mg/dL.

HeartMate II Gains New Indication: The FDA announced today that Thoratec’s HeartMate II continuous flow left ventricular assist system (LVAS) had been approved for use as destination therapy for patients not eligible for a heart transplant. The device had been previous approved as a bridge-to-transplant.