Women and Younger Patients May Be At Higher Risk For Sprint Fidelis Failure Reply

Women, younger patients, those with hypertrophic cardiomyopathy, and those with arrhythmogenic right ventricular dysplasia or channelopathies may be more likely to develop Sprint Fidelis lead failure. Robert Hauser and colleagues at the Minneapolis Heart Institute, the Mayo Clinic, and Beth Israel Deaconess Medical Center analyzed data from 1023 patients who received Fidelis leads and 1668 patients who received Quattro leads at their institutions. At 4 years, the lead survival rate was 87% for Fidelis compared with 98.7% for Quattro. No deaths or injuries were caused by the failures, but inappropriate shocks occurred in 42% of lead fractures.The study has been published online by Circulation.
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Justice Department Files New Suit Against Boston Scientific 1

The US Department of Justice has filed another suit against Boston Scientific. The government claims that Guidant (bought by Boston Scientific in 2006) sold the Ventak Prizm 2 and the Renewal 1 and 2 devices even after the company knew they were defective.

Earlier this month Boston Scientific was convicted and sentenced in a criminal case to pay more than $296 million for withholding information from the FDA about “catastrophic failures” in these devices. The suit filed yesterday is designed to recover Medicare payments for the devices.
Click here to read the Department of Justice Press Release…

HPS Results Suggest Baseline CRP Doesn’t Predict Statin Efficacy 1

Analysis of data from the Heart Protection Study (HPS) indicates that a CRP measurement obtained at baseline does not predict the effect of statin therapy. In a paper published online in the Lancet,  the HPS Collaborative Group report the results of the more than 20,000 patient HPS study based on CRP category at baseline. As previously reported, when compared to placebo major vascular events were reduced with statins by 24% in the overall trial.

In the current report, the investigators report no significant differences in the relative effect of statins among 6 groups determined by CRP baseline levels. Even in patients with the lowest CRP concentrations statin treatment resulted in a 29% reduction in events. The same pattern was true for LDL levels and for the combination of LDL and CRP levels: a 27% reduction in risk was observed in patients with both low LDL and low CRP levels at baseline.
Click to continue reading, including a comment from Paul Ridker…

End of an Era: Eugene Braunwald Steps Down, Marc Sabatine Assumes Chair of TIMI Group 2

Marc Sabatine has replaced Eugene Braunwald as the chairman of the TIMI study group, CardioBrief has learned. Braunwald, who has been the dominant figure in cardiology for many decades, is 81. Sabatine was appointed Vice Chairman of the TIMI group last summer and he assumed the chairman’s role on January 1.
Click to continue reading, including a comment from Chris Cannon, Robert Harrington, and PK Shah…

Inappropriate ICD Shocks Linked to Increased Mortality 1

A large single-center observational study has found a link between inappropriate ICD shocks and mortality. In a report published in JACC, Johannes van Rees and colleagues from the Netherlands followed 1,544 patients who received an ICD from 1996 to 2006.

13% of patients had at least one inappropriate shock over 41 months of followup. Age below 70 and the presence of atrial fibrillation were independent predictors of inappropriate shocks. The investigators failed to find any evidence that the incidence of inappropriate shocks decreased as a result of improvements to ICDs over time.
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New Study Finds Hydrochlorothiazide Inferior To All Other BP Drugs Reply

At the doses most often used, hydrochlorothiazide (HCTZ), the most widely used antihypertensive agent in the world, is “consistently inferior” to all other drugs, according to a new meta-analysis published in JACC. Franz Messerli and colleagues performed a systematic review of studies that compared HCTZ to other drugs using 24-hour ambulatory blood pressure monitoring and found that the decrease in blood pressure with HCTZ (6.5 mm Hg systolic and 4.5 mm Hg diastolic) was significantly lower than with ACE inhibitors (12.9/7.7 mm Hg), ARBs (13.3/7.8 mm Hg), beta-blockers (11.2/8.5 mm Hg), and calcium channel blockers (11.0/8.1 mm Hg).

The authors note that HCTZ is as effective as the other antihypertensive agents when blood pressure is measured in the office. They write  that this suggests that HCTZ is likely less effective at night. Although HCTZ is widely perceived to be clinically effective in improving outcomes, Messerli and colleagues write that “all outcome studies were done with higher doses than the currently used 12.5 to 25 mg or with other thiazides such as chlorthalidone or indapamide.”
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Heart Rhythm Society Advising DOJ in Investigation of ICD Implants 5

The Heart Rhythm Society has informed its members that it is “aware of an ongoing US Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants” and that it has “agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making.”

HRS explained that its role involved “reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ.”
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Guest Post: Prevention Magazine Pushes High-Tech Non-Evidence Based Heart Screening More Than Basic Prevention 5

Editor’s Note: The following post by Gary Schwitzer is reprinted with permission from his blog at HealthNewsReview.Org. HealthNewsReview has received many praises and awards, including Medgadget’s Best Medical Blog award for 2009, which wrote that “Gary has become renowned for his critique of media’s coverage of health care topics. And that’s what his blog is mostly about: checking and correcting the weak, erroneous, and misleading reporting of medical science and industry on TV and in newspapers.”

Prevention magazine pushes high-tech non-evidence based heart screening more than basic prevention

by Gary Schwitzer

The February issue of Prevention magazine has an article, “Surprising Faces of Heart Attack” profiling “three women (who) didn’t think they were at high risk. Their stories are proof that you could be in danger without even knowing it.”

Prevention mag.jpg

No, their stories are not proof of that.

The story is about three women in their 40s. The story varyingly states that the three should have had the following screening tests:

* advanced cholesterol test, carotid intimal medial thickness test ( CIMT)
* advanced cholesterol test & stress echocardiography
* cardiac calcium scoring and CIMT


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Braunwald: Vorapaxar Problem Based on Intracranial Bleeding in Patients with History of Stroke 1

Updated with additional information from TRACER chair Bob Harrington.

A key detail has now emerged about the problems encountered with vorapaxar, Merck’s thrombin receptor antagonist that suffered a large setback last week. TIMI investigators in the TRA-2P TIMI 50 trial have been informed by Eugene Braunwald that the reason vorapaxar would be discontinued in patients who experienced a stroke prior to entry or during the trial was because of an increase in intracranial hemorrhage in these patients. Merck issued a press release yesterday summarizing the TIMI chairman’s announcement (see below).

Here is Braunwald’s statement:
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Guest Post: What PROSPECT Doesn’t Tell Us Reply

Editor’s Note: The following guest post, about the recent publication of PROSPECT in the New England Journal of Medicine, is by Richard Lange and L. David Hillis. This post is reprinted with permission from CardioExchange, where Lange and Hillis write a blog about interventional cardiology. Among their many other titles, Lange is the Executive Vice Chairman of Medicine and Director of the Office of Educational Programs and Hillis is the Chair of the Department of Medicine at the University of Texas Health Science Center, San Antonio.

by Richard A. Lange, MD, MBA and L. David Hillis, MD

The PROSPECT trial provides some interesting insights about the mechanisms of thrombotic coronary artery disease, but how, if at all, should it change practice? Here are what the findings do and do not demonstrate:

What the PROSPECT study says:

In ACS patients treated with PCI, major adverse cardiovascular events that occurred during a median follow-up of 3.4 years were as likely to result from a nonculprit ( i.e., other than the originally stented) lesion as  from the culprit lesion.  These nonculprit lesions often were angiographically mild (≈30% stenosis) and were characterized (with IVUS) as having thin-cap fibroatheroma, a large plaque burden, a small luminal area, or some combination of these.

What the PROSPECT study doesn’t say:
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Review Raises Questions About Statins for Primary Prevention 1

A Cochrane Review raises troubling questions about the evidence base supporting the use of statins for primary prevention. The Cochrane reviewers analyzed 14 randomized trials including 34,272 participants and found that statins were associated with significant reductions in overall mortality, fatal and nonfatal CV endpoints, and revascularization procedures. The reviewers found no evidence of harm.

However, the authors found “evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease.” They concluded that “only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”
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Study Supports a New Enhanced Form of CPR Reply

A study published in the Lancet lends support to a new form of CPR that uses a combination of two devices to provide three times more blood flow to the heart and brain than standard CPR. The first device is a small suction cup on the patient’s chest used to actively lift the chest and perform what is called active compression-decompression CPR. The second is an impedance-threshold device that uses a mask or tube to prevent passive air entry into the lungs.
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FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone) 4

The FDA has released a safety communication (reprinted below) about severe liver injury associated with Multaq (dronedarone). The  communication confirms and provides additional details about the 2 liver transplant cases that were first reported here on CardioBrief. (Click here for the response from Sanofi-Aventis to the CardioBrief report.) The FDA said that information about the risk of liver injury would be added to the dronedarone label.

The FDA recommended that health care professionals advise their patients “to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity while taking dronedarone.” In addition, HCPs should “consider obtaining periodic hepatic serum enzymes,” but the FDA acknowledged that there is no evidence whether this step will prevent liver injury.
Click here to continue reading, including a comment from Steve Nissen…

Sanofi-Aventis To Inform Doctors About Liver Transplants in 2 Patients Taking Multaq (Dronedarone) 3

Sanofi-Aventis is about to send a “Dear Doctor” letter to physicians informing them of two cases of fulminant hepatic failure/necrosis resulting in liver transplanation in two patients taking Multaq (dronedarone), CardioBrief has learned. The two patients were women in their 70’s with no other apparent causes of liver injury or known elevations of liver function tests (LFTs) prior to the acute liver failure. Liver failure developed after the women were taking dronedarone for four to six months.

CardioBrief has also learned that Sanofi-Aventis plans to change the drug’s label and will recommend that physicians obtain LFTs at baseline prior to prescribing the drug. The company had previously informed clinical investigators working with the drug about the liver failure cases.
Click to continue reading, including a comment from Sanjay Kaul…

Merck’s Thrombin Receptor Antagonist Suffers Major Setback 1

Merck’s thrombin receptor antagonist, vorapaxar, has suffered a major setback in its clinical trial program. In one trial, TRACER, the study drug is being discontinued and the trial will be closed out. The second trial, TRA-2P TIMI 50, is being curtailed but not stopped. The actions were based on recommendations from the combined Data and Safety Monitoring Board (DSMB) for the trials. In a letter to investigators from the study chairs no explanations were offered about the reasons for the changes. Vorapaxar is a selective PAR-1 (Protease Activated Receptor 1) thrombin receptor antagonist intended to fight clot formation.

In TRACER, 13,000 hospitalized ACS patients were randomized to placebo or vorapaxar in addition to standard care. Merck announced that TRACER had accumulated the predefined number of primary and major secondary endpoints, but not all patients had received the drug for the prespecified one-year followup.

In TRA-2P TIMI 50 more than 25,000 patients with MI, ischemic stroke, or peripheral vascular disease were randomized to either vorapaxar or placebo in addition to standard care for the secondary prevention of MI and stroke. Merck said that vorapaxar would be discontinued in patients who experienced a stroke prior to entry or during the trial. The study drug will be continued in patients with previous MI or peripheral disease, representing approximately three-quarters of the study population.
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Why Do Military Doctors Have Stricter Rules Than Other Doctors? 2

Jason Layne Davis, a US Army cardiologist, has pleaded guilty to accepting nearly $5,000 from Guidant. Last year Guidant paid $600,000 to settle claims that it had illegally paid Davis so that he would use the company’s devices at Madigan Army Hospital. Accepting a payment from an illegal source is a misdemeanor punishable by up to one year in prison and a $100,000 fine. Davis will receive his sentence on April 5.

“Military doctors must owe their allegiance to the soldiers and families they treat – not to drug companies or makers of medical devices,” said US Attorney Jenny A. Durkan, in a press release. “That is why we have a bright line rule: doctors employed by the government cannot accept payments or gratuities from an outside source – especially one that is seeking government business.”

Comment: Why only military doctors? Shouldn’t all doctors who treat patients owe their allegiance to their patients and not to industry? Shouldn’t there be “a bright line rule” for all doctors? Why should military or government doctors be subject to stricter rules than other doctors?
Click here to read the press release from the US Attorney’s office…

Researchers Shed New Light on HDL Cholesterol 1

Two papers published in the New England Journal of Medicine shed new light on the important but often mysterious role of HDL cholesterol in cardiovascular disease.

In the first paper, researchers at the University of Pennsylvania studied 1,000 healthy volunteers and patients with coronary artery disease and observed a strong inverse relationship between cholesterol efflux from macrophages (a key element in reverse cholesterol transport, which is thought to have a protective effect against atherosclerosis) and carotid intima-media thickness.
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Large Meta-Analysis Explores Cardiovascular Safety of NSAIDs Reply

A large network meta-analysis has found “little evidence” to suggest that any of the commonly used NSAIDs or COX 2 inhibitors are safe in terms of cardiovascular risk. In a paper published in BMJ, Sven Trelle and colleagues analyzed data from 31 trials in which patients receiving an NSAID were compared to another NSAID or placebo. Rofecoxib was associated with the highest risk of MI while naproxen appeared to be the safest of the agents studied. The authors concluded that “options for the treatment of chronic musculoskeletal pain are limited and patients and clinicians need to be aware that cardiovascular risk needs to be taken into account when prescribing.”
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Candesartan Beats Losartan in Swedish HF Registry Reply

The Swedish Heart Failure Registry followed more than 5,000 patients treated with the angiotensin II receptor blockers (ARBs) candsartan or losartan between 2000 and 2009. According to a paper published in JAMA, survival at one year was 90% in the candesartan group compared to 83% in the losartan group. Five-year survival was 61% and 44%. After adjustment for clinical differences and propensity scores, the hazard ratio for losartan compared to candesartan was 1.43.
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World’s First Drug Eluting Bioresorbable Stent Gains CE Mark Approval Reply

Abbott announced today that it had received CE Mark approval for Absorb, its bioresorbable vascular scaffold (BVS) device.  The device props a narrowed coronary artery open but then dissolves within 2 years, leaving the patient without a permanent implant. One hope for the device is that it will allow stent patients to safely discontinue dual antiplatelet therapy at an earlier time.

“Abbott’s Absorb has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug eluting coronary device has been able to do before –completely dissolve and potentially restore natural vessel function in a way not possible with permanent metallic implants,” said Patrick Serruys, in an Abbott press release.

Abbott said that the new device will be available “in select sizes to a limited number of centers in Europe later this year and into 2012.” A full commercial launch in Europe will not take place until late 2012. Abbott also announced plans for a 500 patient European study comparing Absorb to Abbott’s Xience Prime. A global trial is also planned for later in the year.

Click here to read the Abbott press release…

ACC and HRS Downplay Data From Their Own Registry Reply

[Updated]– A study in JAMA earlier this week received a lot of attention when it reported that 22.5% of ICD implantations in the US did not have a firm basis in evidence. The study was derived from a very large dataset taken from the NCDR ICD registry, which was established by the American College of Cardiology and the Heart Rhythm Society in 2004 and 2005 as a condition of coverage of ICDs for primary prevention” by CMS.

John Spertus wrote a very thoughtful commentary in CardioExchange and concluded:

I believe that the key challenge raised by this article is that we need to develop improved methods for using these data about our selection practices. Do we need to start reporting at an individual operator level? Do we need to start holding physicians accountable? Should there be a prospective worksheet to document why a physician chooses to defy the evidence and treat a patient? Should there be mandatory “secondary opinions” prior to treatment to minimize this practice in the future? These are key issues facing our profession and we need to start addressing them.

A very different response to the study was issued by the ACC and HRS. Despite the fact that these groups run the NCDR ICD registry, they sought to downplay the significance of the findings, and to absolve implanting physicians of any guilt or responsibility for unnecessary implantations:
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Bevacizumab in Breast Cancer Linked to Increase in Heart Failure Risk Reply

A meta-analysis in the Journal of Clinical Oncology suggests that bevacizumab (Avastin) significantly raises the risk for heart failure when given to patients with breast cancer. Toni Choueiri and colleagues analyzed data from 3,784 patients and found a significant increase in the incidence of heart failure among those taking bevacizumab compared with those taking placebo (1.6% versus 0.4%).
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