What is the Role of CV Screening Tests in Medicine and Legislation? Reply

Three papers in Archives of Internal Medicine scrutinize the role of cardiovascular screening tests not only in medicine but in legislation. In the first article, Nicholas Wald and Joan Morris introduce a new interactive tool that determines the detection and false-positive rates of screening tests. The authors illustrate the value of the tool with the examples of CRP, coronary calcification, glycated hemoglobin, and the QRISK score.
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The ACC Wants You To Know That Nothing Is Rotten In The State Of Maryland Reply

For more than a year now, as most CardioBrief readers undoubtedly know, a scandal in Maryland has raised troubling questions about hundreds of stent patients treated by Mark Midei– previously considered one of the top interventional cardiologists in the state. In the wake of the scandal, some have questioned whether other interventional cardiologists, in Maryland and elsewhere, may also have routinely performed unnecessary procedures.

Of course, no one knows the true extent of the problem. But clearly something is, or was, rotten in the state of Maryland, and perhaps other states as well. (It would be interesting to know how many other cardiologists have come close to Midei’s apparent record of implanting 30 stents in one day, or have had a major device company throw them a pig roast.) But that’s not the message the ACC wants you to hear. As the official voice of the cardiology profession in the US, the ACC is making great efforts to downplay the problem and reassure anyone who might have been paying attention. Here’s the text of an audio statement from ACC president Ralph Brindis that the ACC proudly informs us was picked up by 28 radio stations:
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FDA Approves Azilsartan Medoxomil (Edarbi) for High Blood Pressure Reply

The FDA has approved azilsartan medoxomil (Edarbi, Takeda) for the treatment of high blood pressure. The new angiotensin II receptor blocker (ARB) will be available in 80 milligram and 40 mg doses. The recommended dose is 80 mg once daily. The 40 mg dose is used in combination with a diuretic.

The FDA said that in clinical studies azilsartan medoxomil was more effective than valsartan (Diovan) and olmesartan (Benicar) in lowering 24-hour blood pressure.

In a separate development, Takeda yesterday announced that it had submitted an NDA for a fixed-dose combination of azilsartan medoxomil plus chlorthalidone.
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Study Probes BMI-Associated Risk in Asia 1

The association between BMI and the risk of death in Asia is mostly similar to that seen in people of European origin, but there may be some important differences between populations, suggesting that underweight may be a more potent risk factor than overweight in Asia. In a large pooled analysis including more than 1.1 million people in 19 separate Asian cohorts, Wei Zheng and colleagues found a U-shaped curve among East Asians in which the lowest risk of death was found in people with a BMI in the range of 22.6 to 27.5. Risk was elevated by as much as 1.5 times in East Asians with a BMI over 35 and by as much as 2.8 times in those with a BMI of 15 or lower.
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Air Pollution and Cocaine Among MI Triggers Analyzed in Lancet Study Reply

Air pollution is a weak cause of MI, increasing risk by only 5%, but because so many people are exposed to polluted air the population effect is quite large. By contrast, cocaine increases MI risk by 23 times, but does not have nearly as large an effect on the population. These are two of the key results from a study published in theLancet. The authors analyzed data from 36 epidemiologic studies and calculated population attributable fractions (PAF) in order to perform a comparative risk assessment of multiple MI triggers.
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High Pacemaker Insertion Rate Observed After Corevalve TAVI Implantation Reply

One-third of patients who underwent transcatheter aortic valve implantation with the CoreValve device required a permanent pacemaker within 30 days, according to a report published online in Circulation. Researchers in the UK examined data from 243 patients who received the CoreValve device. The incidence of LBBB was 13% prior to the procedure and 61% afterward.
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Study Finds Nitroglycerin Improves Bone Density 2

A new study raises hope that nitroglycerin may help stem the rising tide of fractures in the elderly. Earlier research with nitrates had suggested the possibility of benefit in this area. Now, in a paper published in JAMA, Sophie Jamal and colleagues report the result of a single-center, double-blind, placebo-controlled trial of 243 postmenopausal women randomized to either nitroglycerin or placebo applied at bedtime.
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Study Links Stent Thrombosis to Circadian Variation Reply

Circadian patterns have long been known to influence the cardiovascular system, resulting in early morning peaks in blood pressure, heart rate, and much else, as well as an increased risk for MI and sudden cardiac death. Now, in a study published in JACC: Cardiovascular Interventions, Karim Mahmoud and colleagues have found that coronary stent thrombosis is more likely to take place in the early morning hours. Using the Mayo Clinic Percutaneous Coronary Intervention Registry, the team identified 124 patients with definite stent thrombosis and a known date and time of symptom onset.
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One Quarter of US Adults 45 and Over Taking Statins 2

One-quarter of US adults over 45 years of age are taking statins, and one-half of men 65-74 years of age are taking the drugsm according to the CDC’s annual report on trends in health statistics. In 1988-1994 only 2% of adults 45 and older were taking statins. High cholesterol levels have been declining, according to the CDC, but hypertension, diabetes and obesity have all increased. The overall prevalence of heart disease has remained stable in all groups except for an increased rate in men 75 years of age or older.

An article in Medpage Today includes comments from Christopher Cannon, James Stein, Robert Califf and Harlan Krumholz.
Click here to view several slides from the CDC report…

Ron Waksman Paper on Novel CAD Test Retracted Reply

Trouble continues to mount for the noninvasive CAD test from Spirocor. Last week, in a guest post on CardioBrief, Ivan Oransky and Adam Marcus reported the retraction of a paper with authors from Israel (where Spirocor is located) in the the American Journal of the Medical Sciences. Oransky and Marcus also noted that prominent US cardiologist Ron Waksman was the author of a second paper on the Spirocor test. In fact, Waksman was the editor-in-chief of the journal, Cardiovascular and Revascularization Medicine and also served as a consultant to Spirocor and as a co-principal investigator along with William Weintraub of the SPIROCOR Coronary Outcome by Respiratory Stress Examination (SCORE) trial, which according to ClinicalTrials.Gov has been terminated.

Now Oransky and Marcus report on Retraction Watch that Waksman’s paper in his own journal has also been withdrawn. Here is the current citation for the paper:
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Study Sheds Light on Racial Disparities in Hospital Readmissions Reply

Although many studies in recent years have explored the issue of racial disparities in health care, a new study scrutinizes the effect of race on hospital readmissions, an area that has not been previously examined. In a report appearing in JAMA, Karen Joynt and colleagues examined Medicare data to study readmissions after hospitalizations for acute MI, congestive heart failure, and pneumonia.
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AHA Releases Updated Guidelines for the Prevention of CV Disease in Women Reply

Newly published online in Circulation, updated guidelines for the prevention of cardiovascular disease in women emphasize practical medical advice. “These recommendations underscore the fact that benefits of preventive measures seen day-to-day in doctors’ offices often fall short of those reported for patients in research settings,” said Lori Mosca, chair of the guidelines writing committee, in an AHA press release. “Many women seen in provider practices are older, sicker, and experience more side effects than patients in research studies. Factors such as poverty, low literacy level, psychiatric illness, poor English skills, and vision and hearing problems can also challenge clinicians trying to improve their patients’ cardiovascular health.”

The guidelines state that some once-common therapies are not effective and may be harmful when used for the prevention of cardiovascular disease in women, including:
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CRT Found Beneficial in Less Severe Heart Failure Patients Reply

Cardiac resynchronization therapy (CRT) appears to be beneficial in patients with less severe heart failure (NYHA class I and II), according to a new systematic review published online in Annals of Internal Medicine. In a previous analysis, Nawaf Al-Majed and colleagues had found that CRT was highly beneficial in HF patients with NYHA class III and IV symptoms. The new analysis incorporates the results of recent trials, including less symptomatic HF patients.
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AF Guidelines Updated to Incorporate Dabigatran Reply

Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation:

Class I: Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance 15 mL/min), or advanced liver disease (impaired baseline clotting function). (Level of Evidence: B)

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SCAST Trial Provides No Support for Blood Pressure Lowering in Acute Stroke 1

Lowering blood pressure with an angiotensin-receptor blocker in patients with acute stroke and hypertension produces no benefits, according to a new study presented at the International Stroke Conference and published simultaneously online in the Lancet. In the Scandinavian Candesartan Acute Stroke Trial (SCAST), investigators randomized 2029 acute stroke patients in 9 north European countries who had a systolic blood pressure of 140 mm Hg or higher to candesartan or placebo.
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Apixaban Better Than Aspirin for Stroke Prevention in AF Patients Unable to Take Warfarin 1

A new trial presented at the American Stroke Association’s International Stroke Conference and published online in the New England Journal of Medicine demonstrates that the novel factor Xa inhibitor apixaban is better than aspirin for the prevention of stroke in AF patients who don’t take warfarin. Stuart Connolly and investigators in the AVERROES (Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Strokes) trial randomized 5599 AF patients who were deemed by their physicians to be unsuitable for vitamin K antagonist therapy to either apixaban (5 mg twice daily) or aspirin (81-324 mg per day). Results of the trial were first presented last year at the ESC.
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Trial Finds Benefit in Wireless Pulmonary Artery Monitoring in HF 1

Results of a new trial suggest that an implanted device that provides continuous wireless sensing of pulmonary artery pressures can reduce hospitalizations in patients with heart failure (HF). In a report published online in the Lancet, William Abraham and members of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) Trial Study Group randomized 550 patients with NYHA class III HF to receive either the CardioMEMS heart sensor or conventional therapy.

After six months, there were 83 HF-related hospitalizations in the treatment group versus 120 in the control group — a 30% reduction. At 15 months, the reduction in HF-related hospitalizations reached 39%. There were no pressure-sensor failures and 8 patients had a complication related to the device.
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Guest Post: Retraction Reveals Downfall of Company Where Ron Waksman Consulted Reply

Editor’s Note: CardioBrief is pleased to publish this guest post by Adam Marcus and Ivan Oransky. A different version of this story appeared on their blog, Retraction Watch, which has been called “required reading for anyone interested in scientific journalism or the issue of accuracy” by the Columbia Journalism Review.

Spirocor is an Israeli company that until last year was developing a new point-of-care test for coronary artery disease. The firm’s advisors and consultants included Ron Waksman, the prominent Washington, D.C. cardiologist, who was a co-PI on what was going to be a major study to demonstrate the utility of the test, called respiratory status response, or RSR.

Waksman has published at least one paper and one abstract on RSR, but it’s a third article that tells the full story. The American Journal of the Medical Sciences (AJSM), not exactly a top-drawer cardiology title, has retracted a May 2010 paper by Waksman’s Israeli collaborators (and a few other authors, although not Waksman himself) about the test.

The notice speaks for itself, but what it has to say can make the head spin:
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Biomarker Levels Post-CABG Strongly Linked to Mortality Reply

Creatine kinase (CK-MB) and troponin levels obtained in the first day after CABG are a strong predictor of long-term mortality, according to a new report appearing in JAMA. Michael Domanski and colleagues analyzed data from 7 studies that included 18,908 patients who underwent CABG and for whom data on biomarkers and mortality were available. Mortality was closely correlated with peak CK-MB levels: the 30-day death rate ranged from 0.63% for those with a CK-MB ratio below 1 to 7.06% for those with a CK-MB ratio over 20. In a multivariate model, CK-MB was the strongest predictor of mortality and persisted out to 1 year.
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FDA Approves First Pacemaker Designed For Use with MRI Reply

The FDA has approved Medtronic’s Revo MRI SureScan Pacing System, the first pacemaker designed for safe use during MRI exams. Here is Medtronic’s description of how the pacemaker differs from traditional pacemakers:

The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, since MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment.

“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.”

According to Medtronic, every year about 200,000 pacemaker patients in the US are forced to skip a medically indicated MRI exam.

Click here to read the FDA and the Medtronic press releases…

WebMD: the 800 Pound Gorilla in the Room 2

There’s been a lot of discussion in the blogosphere and twittersphere about Virginia Heffernan’s column in the New York Times magazine on Sunday comparing WebMD very unfavorably to MayoClinic.Com. Heffernan makes a fairly simple point: because of WebMD’s “(admitted) connections to pharmaceutical and other companies,” the site is “permeated with pseudomedicine and subtle misinformation.”

Because of the way WebMD frames health information commercially, using the meretricious voice of a pharmaceutical rep, I now recommend that anyone except advertising executives whose job entails monitoring product placement actually blockWebMD. It’s not only a waste of time, but it’s also a disorder in and of itself — one that preys on the fear and vulnerability of its users to sell them half-truths and, eventually, pills.

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FDA Sets July Deadline for Decision on Ticagrelor (Brilinta) 1

AstraZeneca said today that the FDA had accepted its resubmission of the ticagrelor (Brilinta) NDA and had set a deadline of July 20, 2011 to reach a decision. As previously reported, on December 16 the FDA issued a Complete Response Letter to the initial ticagrelor NDA. Although ticagrelor received a favorable response from the FDA Cardiovascular and Renal Advisory last summer, the lack of benefit seen in patients treated in the US in the PLATO trial has remained a stumbling block for the drug’s approval.
Click here to read the AstraZeneca press release…