Category Archives: Uncategorized

Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation 1

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Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not beneficial and, in fact, results in an increase in device-pocket hematoma. Results of the trial were presented today at the Heart Rhythm Society meeting in Denver and published simultaneously in the New England Journal of Medicine.

A group of mostly Canadian investigators randomized 681 patients undergoing ICD or pacemaker implantation with an annual risk for thromboembolic events greater than 5% to either heparin bridging or continued warfarin. The trial was terminated early after a prespecified interim analysis by the data and safety monitoring board. The primary outcome — clinically significant device-pocket hematoma, which the investigators defined as a hematoma that led to prolonged hospitalization, interruption of anticoagulation, or hematoma evacuation — was significantly reduced in the continued-warfarin group, as were all three components of the endpoint:

Primary outcome: 3.5% with continued warfarin versus 16% with heparin bridging (RR 0.19, CI 0.10-0.36, p<0.001).

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Click here to read the full story on Forbes.

 

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Longer Detection Time Helps Prevent Unnecessary ICD Shocks Reply

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Increasing the detection intervals in ICD programming can reduce the number of unnecessary or inappropriate shocks, according to results of the ADVANCE III study published in JAMA.

A group of Italian investigators randomized 1,902 patients receiving an ICD to programming with either long- or standard-detection intervals. After 12 months of followup, patients in the long-detection group had a significant reduction in the primary endpoint, which was the total number of antitachycardia pacing episodes and shocks:

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Click here to read the full story on Forbes.

 

Metaanalysis Finds Same Day Discharge For Low Risk PCI May Be Feasible Reply

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Although elective PCI for most low risk patients is extremely safe, overnight observation is still standard practice in the US, largely due to the lack of evidence demonstrating that same-day discharge is safe. Now a new metaanalysis, published online in the Journal of the American College of Cardiology, provides support for same-day discharge in carefully selected low-risk patients.

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Click here to read the full post on Forbes.

LONDON, ENGLAND - OCTOBER 13: Two NHS staff w...

 

 

 

 

 

 

 

Conflicting Results From Two Trials Of Cardiac Resynchronization Therapy Reply

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Two new trials have ended up reporting conflicting results regarding the expansion of the indication for cardiac resynchronization therapy (CRT) for patients without a wide QRS interval.  The positive results of the smaller trial seem likely to be undermined by the early stopping of the much larger trial.

The first trial, NARROW-CRT, published in Circulation: Arrhythmia and Electrophysiology, concluded that CRT “improved clinical status in some patients with ischemic cardiomyopathy, mild-to-moderate symptoms, narrow QRS duration, and mechanical dyssynchrony on echocardiography.” The second trial, EchoCRT, which was testing CRT in heart failure patients with narrow QRS, was terminated early due to futility.

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Click here to read the full story on Forbes.

 

Stop Sign with Divided Highway

 

Actelion Executive To Head American College of Cardiology Reply

by • People, Places & Events, Policy & Ethics, Uncategorized • Tags: , ,

Shalom “Shal” Jacobovitz will be the new chief executive officer of the American College of Cardiology, the ACC announced today. Jacobovitz is currently the president of the US division of Actelion Pharmaceuticals, best known for its pulmonary hypertension drugs.

Click here to read the complete story on Forbes.

Shalom Jacobovitz

 

Blood Sample Mismatch Leads ‘Anguished’ Authors To Retract Three Lipitor Papers 1

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Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants.

The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The trial supported the increasingly aggressive use of statins and helped to solidify the enormous commercial success of atorvastatin (Lipitor, Pfizer).

The 3 newly-retracted substudies do not appear to affect the main finding of TNT. Two papers were published in the Journal of the American College of Cardiology. The third was published in the American Heart Journal. (The AHJ retraction notice has not yet been published, but the editors have confirmed the retraction.) Here are the 3 retracted articles:

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Click here to read the full story on Forbes:

 

English: A package and pill of atorvastatin 40...

New York Area Cardiologist Admits $19 Million Fraud Reply

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Jose Katz, a 68-year-old cardiologist with offices in New York and New Jersey, has pleaded guilty to charges that he committed health care fraud, the US Attorney for New Jersey announced yesterday. Katz admitted that he billed Medicare Part B, Medicaid, and numerous private insurers “for unnecessary tests and unnecessary procedures based on false diagnoses and for medical services rendered by unlicensed practitioners.”

Katz spent over $6 million advertising on Spanish-language advertising. For most of his patients he performed the same battery of unnecessary diagnostic tests and falsified  records. He then gave a false diagnosis or coronary artery disease and intractable angina and prescribed EECP (enhanced external counterpulsation) to these patients. According to the government, Katz billed Medicare and Medicaid more than $15.6 million for EECP treatment from 2005 through 2012. In total, Katz billed Medicare and Medicaid more than $70 million during this period.

Some of Katz’s patients were treated by Mario Roncal, who was called “Dr. Roncal” in the office, though he did not have a valid  medical license in the United States. According to the government, “to conceal this illegal and unlicensed practice of medicine, Roncal forged Katz’s signature on paperwork associated with Roncal’s unlawful medical services, including on patient charts. During the conspiracy, Katz used his own billing numbers to bill Medicare Part B and Medicaid for the illegal services Roncal provided as though they were provided by Katz.”

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Click here to read the full story on Forbes.

Jose Katz

Jose Katz

 

 

Cuban History Offers Important Lessons For Global Health Today 1

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A large new study from Cuba shows the impressive benefits that can be achieved with weight loss and increased exercise. Much more ominously, the same study shows the dangers associated with weight gain and less exercise.

In the study, published in BMJ, researchers took advantage of a “natural” experiment that occurred in Cuba as a result of a major economic crisis in the early 1990s. Relying on 30 years of superb health statistics available in the country, the researchers analyzed the dramatic health effects associated with the economic crisis, which last from 1991 through 1995, and the subsequent recovery.

During the economic crisis caloric intake decreased and physical activity increased, resulting in a 5.5 kg reduction in weight and a very high (80%) proportion of the population classified as physically active…

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Click here to read the full story on Forbes.

 

 

English: A man fixing the tire of a "Bici...

 

 

A Closer Look At A Case Of Duplicate Publication In JACC 2

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English: http://en.wikipedia.org/wiki/Linda_an...

The Journal of the American College of Cardiology has published a Notice of Duplication about a review article written by a respected European cardiology researcher who has played a central role in the development of fractional flow reserve (FFR). The brief statement from JACC provides few details and could lead to various interpretations, but a further investigation suggests that the story may be fairly simple.

The notice states that a 2012 review article by Nico H.J. Pijls and Jan-Willem E.M. Sels, Functional Measurement of Coronary Stenosis, “duplicates to a considerable extent both the text and figures of a prior article,” Fractional flow reserve: a review” published in 2008 in Heart, by two different authors, Bernard De Bruyne and J. Sarma. Here is the JACC editors explanation:

Dr. Piljs attributes this duplication to the close collaboration that he has had over many years with Dr. De Bruyne, and the fact that both authors drew text and figures for these reviews from the same repository of material used for a joint educational program. He acknowledges his lack of care in the preparation of the manuscript and apologizes for the duplication. While the Editors accept this apology, we lament the replication of information that prevented the pages devoted to Dr. Piljs’ article from being filled with new material.

De Buyne and Pijls are longtime colleagues who have played a central role in the development of fractional flow reserve, serving as principal investigators of the seminal FAME and FAME II clinical trials. I asked them for a response to this situation. Here is their statement:

The cryptical phrasing “repository of……..” is not ours, but made by JACC.

The “repository” they mean is a keynote lecture from the bi-annual Aalst-Eindhoven-Course on Coronary Physiology, which we organize once or twice a year in Brussels since 2001. The Course is endorsed by the European Society of Cardiology and has been organized by us already 17 times.

The opening lecture of that course (keynote lecture) is always entitled: ”Practice and advanced applications of Coronary Pressure Measurement” and alternatively given by Dr de Bruyne and Dr Pijls.

That lecture has been built up by us and developed carefully over the years and has been streamlined for optimum educational content and benefit, including phrasing and slides.Not a single word is not ours.

The slides are always distributed among the participants and used by many of them for their own lectures or presentations or any educational purposes. In fact , they are public domain. Consequently, we have seen (parts of) our text and slides been used by others a myriad of times and are proud to have contributed to the dissemination of valuable medical knowledge.

When Dr De Bruyne wrote his review for HEART in 2008 , he used that keynote lecture as the basis of his paper.

When Dr Pijls wrote his State-of-the-Art paper ( i.e also a review) on the invitation of JACC in 2012, he also used text and slides of that keynote lecture (extended in the meantime) without realizing that Dr De Bruyne had done the same some years earlier. As a result, the first part of Dr Pijls paper is very close to Dr De Bruyne’s review, wheras the second part of Dr Pijls paper reflects the new data and insights obtained in those last 4 years.

So, there is nothing mysterious about that “repository” and we explained this to JACC in a similar way as we do now to you.

And by the way, when Dr Pijls submitted his paper to JACC, he mentioned explicitely in the submission letter that – as the nature of this paper was a State-of-the-Art paper – it was a concise reflection of the knowledge in the field and not original data.

Answering your last question: Neither Dr De Bruyne nor Dr Pijls ever received any financial or other compensation from whoever or in whatsoever way for writing any of these papers.

Writing these papers was on the strict invitation of the editors of Heart and JACC respectively and except the authors and staff of the Journals, nobody was even aware of it before they were published.

And as stated above: any single word or figure in any of these papers is completely our own work to which we equally contributed.

Comment: When I first read the notice it seemed to me like the case was an indication of a larger wrongdoing. I’m glad my initial suspicions were proven wrong. This is a great example of why editor’s notes should be much more detailed. The truth needs to come out no matter which way it falls.

Quinidine Unavailable In Most Of The World 1

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Quinidine– the only drug known to be effective in preventing lethal ventricular arrhythmias in people with several rare conditions, including Brugada syndrome, idiopathic ventricular fibrillation, and early repolarization syndrome– is no longer available in much of the world.

In a study published online in the Journal of the American College of Cardiology, Sami Viskin and colleagues surveyed physicians around the world about the availability of quinidine in their country and received responses from 273 physicians in 131 countries. In 76% of the countries quinidine was not available at all. In another 10% quinidine was available only through a regulatory process that can take several days to several months to obtain the drug. Quinidine was easily obtained in only 14% of countries.

Click here to read the full post on Forbes.

 

World map of quinidine availability.

World map of quinidine availability.
Color code: green = quinidine is readily available; red = quinidine is not available;
yellow = available with restrictions; white = no data
(Reproduced with permission from the Journal of the American College of Cardiology)

Lifelong Statin Sentence Now Includes Furloughs 1

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Although the benefits of statins are among the best documented in all of medicine, continuous lifelong statin therapy is not always easy to achieve in clinical practice. Now a new retrospective study suggests that although clinical events causing temporary cessation of statin therapy occur often, most of these patients are later able to resume statin therapy.

In a paper published in Annals of Internal Medicine, researchers analyzed data from 107,835 patients with a statin prescription treated by physicians associated with Massachusetts General Hospital and Brigham and Women’s Hospital. 18,778 of these patients had documented events that were statin related, resulting in 11,124 patients who stopped taking statins. Within a year more than half of these (6,579) were rechallenged with a statin, and most of these (92.2%) were taking a statin a year after the initial statin-related event.

Click here to read the full story on Forbes.

 

 

A Guide To The Raging Debate Over The NIH’s TACT Chelation Trial 7

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(Updated) The publication in JAMA of the NIH’s Trial To Assess Chelation Therapy (TACT) trial has provoked a fascinating debate in the blogosphere. The vast majority of responsible physicians and healthcare professionals have little interest in chelation therapy per se, but the TACT trial has raised many important questions about the nature of medical evidence. Here’s a brief guide with links to some of the more interesting discussions (let me know if you are aware of other worthwhile discussions):

In the first of two accompanying editorials, the JAMA editors discuss some of the complex issues relating to TACT and explain why they decided to publish the TACT paper.

In a second accompanying editorial, Steve Nissen, while agreeing in principle with the idea that randomized controlled trials should be published, argues that the TACT investigators “fell short of the minimum level of quality necessary to adequately answer the question they sought to investigate.”

TACT investigator Daniel Mark provided CardioBrief with a  detailed response to Nissen’s criticism. (Nissen declined to respond to Mark.)

Harlan Krumholz, in a blog post on Forbes, asked “what to do with inconvenient evidence”? He agrees with just about everyone else that TACT does not provide a reason to administer chelation therapy, but he argues forcefully that the results of the trial should not be simply dismissed.

Responding to Krumholz, Peter Lipson, also on Forbes, takes a position similar to Nissen’s that the trial was poorly performed and the results are highly questionable. The important things here are the responses to Lipson from Krumholz himself, Forbes pharma reporter Matt Herper, and Sanjay Kaul.

The most sustained assault on TACT, and on Krumholz’s position, comes from the highly-regarded skeptic blog Respectful Insolence written by Orac (the pseudonym of David Gorski, a surgical oncologist). In his take-no-prisoners assault on TACT, JAMA, and Krumholz, Orac writes “that JAMA is every bit as guilty as The Lancet was in 1998 when it published Andrew Wakefield’s antivaccine nonsense…. If published at all, TACT should have been published in some crappy, bottom-feeding journal, because that’s all that it deserves.” The comments section includes worthwhile exchanges between Orac and Sanjay Kaul and Matt Herper.

Finally (for now), Sanjay Kaul today summarized his defense of TACT (though he does not, of course, endorse chelation) in a blog post on CardioExchange. ”Bottom line,” he writes, “in my opinion, the arguments that the TACT results are dubious or not valid are overstated. While the debate surrounding TACT is clearly warranted and welcome, I hope it generates more light than heat.”

Update:

Responding to the attacks on TACT from Orac and other members of the skeptical community, TACT investigator Dan Mark sent me the following comment on email, which he has agreed to share with my readers. The comment moves the debate in an entirely new and philosophical direction:

Although skepticism has an important role to play in critical debates, it is easy to overplay that hand. The people you mention seem to have a very naïve view of science, very far removed from the messy realities of daily work of people doing science. It is also important to remember that even the most hard core scientists can have some pretty eccentric views when they venture outside their narrow field of expertise. What does that imply about science and the people who wish to guard its borders?

There has been a project in philosophy to identify firm demarcation criteria that will allow for a distinction between science and pseudoscience. While some useful work has resulted, the overall attempt failed. Gets into some deep waters, but the harder the philosophers tried to find that electrified fence that marked off “real science” from the rest of human thought, the more they undermined the borders of science itself. Interestingly, “real scientists” rarely worry about whether they are doing science. They consider the question uninteresting, leaving it for the philosophers, sociologists and (now) the bloggers!

Emerging Biomarkers: How Reliable Is The Evidence? Reply

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Novel biomarkers are the subject of intense controversy, with a bewildering variety of factions and perspectives seeking to elevate or dismiss any of a large number of proposed new measures. Now a new examination of the literature published online in JAMA Internal Medicine suggests that the evidence base used to evaluate novel biomarkers may be seriously compromised by selective reporting bias.

John Ioannidis led a team of researchers who analyzed 56 meta-analyses of new candidate cardiovascular biomarkers. 49 of the studies had statistically significant results, but 9 studies were compromised by very large heterogeneity, 13 studies were compromised by small-study effects, and 29 studies had an excess of studies with statistically significant results. Only 13 studies had more than 1,000 cases, achieved statistical significance, and had none of the other deficiencies listed above. The meta-analyses that emerged unscathed examined the associations of  glomerular filtration rate and albumin to creatinine ratio in general and high-risk populations with cardiovascular disease mortality and of non–high-density lipoprotein cholesterol, serum albumin, Chlamydia pneumoniae IgG, glycosylated hemoglobin, nonfasting insulin, apolipoprotein B/AI ratio, erythrocyte sedimentation rate, and lipoprotein- associated phospholipase mass or activity with coronary heart disease.

The authors summarized their finding as suggesting that “the effect of biomarkers is exaggerated because the largest studies— which one would expect to produce the most stable estimates— consistently showed smaller effects. In most meta-analyses, too many single studies had reported ‘positive’ results compared with what would be expected on the basis of the results of the largest studies. This suggests that small studies with ‘negative’ results remain unpublished or that their results are distorted during analysis and reporting to seem more prominent.”

In an invited commentary, Steve Nissen writes that evidence-based medicine has been put on a “golden pedestal” but publication basis “is a dark secret that corrupts nearly every aspect of our profession and undermines societal efforts to promote evidence-based medicine.” He cites carotid intima-medial thickness and apolipoprotein B as just two biomarkers in which “the magnitude of the association is probably much smaller than suggested by the definitive meta-analysis.”

Nissen urges investigators to register their studies with ClinicalTrials.Gov, but points out that the site does not support large data sets. “Therefore,” he argues, “society must consider funding the National Library of Medicine to create a public website where authors can post the detailed results of findings that they were unable to publish despite submitting to multiple journals. Finally, we must emphasize to colleagues and trainees that all studies contribute to scientific understanding. We have a moral obligation to our patients to make all research findings available to the broader scientific community.”

 

FDA Panel Gives Tepid Endorsement To Abbott’s MitraClip Reply

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The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

At the end of the day, after a long and torturous discussion, the panel voted 5-3 in favor of the device, saying that the benefits outweighed the risks. The panel agreed unanimously that the device was safe (8-0) but by a narrow margin (5-4) said there was not a “reasonable assurance” that it was effective. The panel struggled over how to use the available data to identify patient groups that could benefit from the device.

Click here to read the full story on Forbes.

 

Mitraclip

Controversial PFO Closure Trials Published In NEJM Reply

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Two controversial trials testing PFO closure with the Amplatzer PFO Occluder (St. Jude Medical) in patients with cryptogenic stroke, first presented last fall at the TCT meeting, have now been published in the New England Journal of Medicine. Both trials missed their primary endpoints but contained suggestions of possible benefit. The results appear unlikely to resolve the ongoing controversy over the value, or lack of value, of this procedure, but, as an accompanying editorial states, both advocates and critics of PFO closure will find source material for their arguments in these papers.

…

In the accompanying editorial, Steven Messé and David Kent write that both trials suffered from slow enrollment, “which was probably due to widespread off-label use of atrial septal closure devices.” They note that RESPECT and PC, like the only other randomized trial in the field, CLOSURE 1, did not show significant benefits in the main intention-to-treat analysis, but did present some evidence of possible benefit.

They conclude:

…we are left for the moment to make decisions under conditions of uncertainty. In such circumstances, evidentiary standards vary among decision makers — patients, clinicians, authors of practice guidelines, and regulatory authorities — depending not only on the interpretation of the results, but also on the potential consequences of their decisions. Some of them may interpret the data as supporting closure of a patent foramen ovale as a viable therapeutic option, even while conceding the failure of trials to show the superiority of closure over medical therapy. Yet given the prevalence of patent foramen ovale in the general population, the enormous potential for overuse of percutaneous closure of a patent foramen ovale, and the relatively low risk of stroke in patients who are treated medically, the routine use of this therapy seems unwise without a clearer view of who, if anyone, is likely to benefit…. Randomized studies of closure may come to an end, however, if the Amplatzer device is approved. Thus, all eyes will be on the regulatory agencies to see how they will interpret these results in light of their own evidentiary standards.

Click here to read the entire story on Forbes.

 

Amplatzer

 

 

 

Radiotherapy For Breast Cancer Increases Heart Disease Risk 1

by • Prevention, Epidemiology & Outcomes, Uncategorized • Tags: , , , , ,

A new study published in the New England Journal of Medicine offers the best look yet at the increased risk for heart disease produced by radiotherapy for breast cancer. Further, this increased risk may just be the tip of the iceberg of more radiation-related problems, warns a cardio-oncologist in an accompanying editorial.

The new study, based on data from Sweden and Denmark of women treated with radiotherapy for invasive breast cancer, found a linear increase in the rate of heart disease associated with the dose of radiation received by the heart. Starting 5 years after radiotherapy, and with no sign of a threshold,  the risk for major coronary events increased by 7.4% per gray. The mean dose of radiation was 4 Gy. Although the relative risk was consistent throughout the study, the increase in absolute risk was greatest in women with cardiac risk factors or established heart disease.

Findings from the study, according to the authors, “make it possible to estimate” a patient’s risk for heart disease related to radiation. “This absolute risk can be weighed against the probable absolute reduction in her risk of recurrence or death from breast cancer that would be achieved with radiotherapy.” The authors estimated that for a 50-year-old woman without preexisting risk factors and with a mean radiation exposure of 3 Gy, her risk for death from ischemic heart disease by age 80 would rise from 1.9% to 2.4% and her risk for an acute coronary event would rise from 4.5% to 5.4%. The risk for death by age 80 for an otherwise similar woman with existing risk factors would rise from 3.4% to 4.1%. Women exposed to larger doses of radiation would be exposed to even greater risks.

In the accompanying editorial, Javid Moslehi writes that results of the study suggest that “cardiac risk factors should be assessed and aggressively managed — starting at the time of radiation treatment (or even before) and continuing throughout survivorship.” To make matters worse, the findings “may represent just the tip of the iceberg.” Radiation may also cause increases in pericardial disease, peripheral vascular disease, cardiomyopathy, valvular dysfunction, and arrhythmias, according to Moslehi, and other breast cancer therapies, such as anthracyclines and hormonal therapies, may have “additional cardiotoxic effects.”

Moslehi, who is in the Cardio-Oncology Program at the Dana–Farber Cancer Institute, writes about the emerging new discipline of “cardio-oncology”:

Given the widespread use of radiation therapy in the treatment of breast cancer, and the continually expanding arsenal of novel therapies, the current study calls for greater collaboration between oncologists and cardiologists. An important lesson for the oncologist may be that the time to address concerns about cardiovascular “survivorship” is at the time of cancer diagnosis and before treatment rather than after completion of therapy. Similarly, cardiologists need to assess prior exposure to radiation therapy as a significant cardiovascular risk factor in survivors of breast cancer.

Was Atherosclerosis The Real Curse Of The Mummy? 2

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From a growing evidence base of mummies, researchers are now concluding that atherosclerosis may have been common in people who lived in premodern times. A new study presented at the ACC in San Francisco and published simultaneously in the Lancet appears likely to challenge the common belief that atherosclerosis is largely a phenomenon of the modern era.

MummySeveral years ago investigators first reported finding evidence of atherosclerosis in 20 of 44 Egyptian mummies. Now an international group of researchers has extended this research and performed whole body CT scans on 137 mummies from four different places and times– ancient Egypt, ancient Peru, southwest America, and the Aleutian Islands.

Probable or definite atherosclerosis was observed in 34% (47) of the 137 mummies:

  • 38% (29 of 76) from ancient Egypt.
  • 25% (13 of 51) from ancient Peru
  • 40% (2 of 5) from Ancestral Puebloans
  • 60% (3 of 5) from Unangan hunter gatherers

Atherosclerosis was found in a variety of vascular beds and was correlated with the age of the mummy at the time of death. The authors wrote:

“Our findings greatly increase the number of ancient people known to have atherosclerosis and show for the first time that the disease was common in several ancient cultures with varying lifestyles, diets, and genetics, across a wide geographical distance and over a very long span of human history. These findings suggest that our understanding of the causative factors of atherosclerosis is incomplete, and that atherosclerosis could be inherent to the process of human ageing.”

Although the populations from which the mummies came did not smoke cigarettes, the authors point out that “the need for fire and thus smoke inhalation could have played a part in the development of atherosclerosis.” They also speculate that high levels of infections might have contributed to the development of atherosclerosis in this population.

Late-Breaking News: Confusion Over ACC Late-Breaker Trial Reply

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In an extremely unusual move, only days before the scheduled presentation of the main results of a highly-anticipated late-breaking clinical trial, the trial’s sponsor announced that the full results of the trial would not be presented. Instead, the company said the principal investigator would present only one of three of the trial’s primary endpoints, the acute procedural safety results. But, it appears, there is still a chance that the full results of the trial will end up being presented.

In 2010 the FDA refused to approve the Watchman, Boston Scientific’s left atrial appendage closure device for patients with nonvalvular atrial fibrillation. Although the  earlier pivotal PROTECT AF trial received a positive, though lukewarm endorsement from the FDA’s Circulatory System Devices Panel, the FDA ultimately said Boston Scientific needed to perform an additional trial. The PREVAIL trial was intended to confirm the safety and efficacy of the Watchman left atrial appendage closure device.

PREVAIL was arguably the most high-profile trial scheduled for presentation at the American College of Cardiology scientific sessions starting this Saturday in San Francisco. On Monday, however, Boston Scientific, in a press release listing its presentations at the ACC, announced that the principal investigator of the trial, David Holmes, would only “present the acute procedural safety results.”

…

Click here to read the full story on Forbes.

How much data will David Holmes present on Saturday?

How much data will David Holmes present on Saturday?

Veterans Study Finds HIV To Be An Independent Risk Factor For MI Reply

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Although it has long been suspected that people with the HIV virus are at increased risk for cardiovascular (CV) disease, reliable data has not been available. Now a new study published online in JAMA Internal Medicine provides a much clearer picture of the relationship between CV disease and HIV.

…

In an accompanying editorial, Patrick Mallon writes that “the results demonstrate a clear and consistent excess risk of MI (approximately 50% increase) in HIV-positive people across a range of age groups, with the association between HIV status and MI remaining significant when controlled for a number of covariates…” Since the cause of this increased risk is not understood, he argues, “presuming that interventions used in the general population to reduce the risk of MI will translate into similar reductions in MI incidence in HIV-positive populations is arguably naive.”

Click here to read the full story on Forbes.

Bad Pharma And The Statin Wars 4

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It’s been amusing to watch former Pfizer executive John LaMattina try to pick apart Ben Goldacre’s new book, Bad Pharma,  a powerful indictment of the industry in which LaMattina used to work. This is not the occasion to get into the details of this battle, but as an aside let me just say that I would advise any representatives of the pharmaceutical industry to think very carefully before choosing to take on Goldacre.

What I want to focus on here is an assertion, accepted by both Goldacre and LaMattina, that is simply mistaken. LaMattina’s latest post is a response to a brief statement by Goldacre in his book that there has never been a head-to-head clinical trial comparing statins. Both writers accept this statement as a fact.

I think it is very curious that neither Goldacre not LaMattina remember the PROVE-IT TIMI 22 trial published in NEJM in 2004.

Click here to read the full post on Forbes.

John LaMattina

John LaMattina

Dr Ben Goldacre, author of the Bad Science col...

Ben Goldacre

Mixed Results For Spironolactone In Heart Failure With Preserved Ejection Fraction Reply

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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 in the Journal of the American Medical Association, demonstrate that although the treatment works as expected to improve diastolic function in this patient population, no clinical benefits were observed in association with these changes.

422 patients in Germany and Austria with NYHA class II or III heart failure with preserved LVEF were randomized to spironolactone or placebo for one year.  Compared with placebo, spironolactone was associated with improvements in LV end-diastolic filling, LV remodeling, and neurohumoral activation. However, there were no significant differences in maximal exercise capacity or quality of life between the groups.

Click here to read the full post on Forbes.

 

Whistleblower Lawsuit Yields $2.4 Million For New Jersey Cardiologist 2

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A New Jersey cardiologist will receive $2.4 million for his role in a whistleblower lawsuit against Cooper Health System and Cooper University Hospital. Following an investigation by the US Department of Justice and the New Jersey Attorney General’s Office, Cooper agreed last week to pay $12.6 million to settle Medicare and Medicaid fraud allegations. The federal qui tam lawsuit was originally filed by Delaware Valley cardiologist Nicholas L. DePace, who claimed that Cooper paid illegal kickbacks to physicians for patient referrals.

Click here to read the full story on Forbes.

English: By Richard Wheeler (Zephyris) 2007.

Small Study Suggests Yoga May Benefit AF Patients Reply

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A small study published online in the Journal of the American College of Cardiology suggests that yoga may benefit people who have atrial fibrillation. The study, which the authors describe as “a small, proof-of-concept study,” is the first of its kind. The findings raise the possibility that yoga may reduce AF symptoms and arrhythmia burden. Other physiological and quality of life benefits were also observed. But, the authors caution, large randomized trials will be required to confirm the finding.

 

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A yoga class.

 

Popular Antidepressants May Put Patients At Risk For Serious Arrhythmias 1

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In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that other antidepressants may also prolong the QT interval.

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The Big Gamble of CETP Inhibitors 2

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Merck has invested a substantial amount of money on the CETP inhibitor anacetrapib. Chemist and veteran pharma blogger Derek Lowe suspects that the company might as well have plunked the money down in a casino.

In a provocative new post, Lowe wonders if big pharma, in its desperation, has abandoned rational research in favor of, essentially, gambling. He notes that CETP is “a drug target that has incinerated a lot of money over the years” and wonders whether any of the compounds will “ever make it as a drug?” The failure of past CETP inhibitors, torcetrapib (Pfizer) and dalceptrapib (Roche), along with the recent failure of Tredaptive (Merck), “illustrate how little we know about this area [HDL].”

Read the rest of the post on Forbes.