Author: Larry Husten

Larry Husten was the editor of TheHeart.Org from its inception in 1999 until December 2008. Before that he was a freelance medical journalist who wrote for The Lancet, The New York Times, Discover, and a large number of other medical and computer publications. In 1994-1995 he was a Knight Science Journalism Fellow at MIT. He received a PHD in English from the State University of New York at Buffalo and drove a taxicab in New York City before embarking on a career in medical journalism.

All Posts by Larry Husten

European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System Reply

Heart Failure, People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure.

The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent.  A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that ”although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events… The risk to benefit ratio argues against the use of dual therapy.”

Franz Messerli, senior author of the BMJ meta-analysis, applauded the EMA action and said that “as usual the FDA is dragging its feet.”

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Click here to read the full story on Forbes.

 

 

 

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Similar Cardiovascular Risk Observed With COPD Drugs Reply

Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: ,

A large observational study has found no difference in the increased risk for cardiovascular disease between the two main classes of drugs used in the first-line treatment of chronic obstructive pulmonary disease (COPD). LABAs (long-acting inhaled beta-agonists) and LAMAs (long-acting muscarinic antagonists) have a variety of beneficial effects in COPD patients, but evidence has been building that these agents may produce a small but significant increase in cardiovascular risk.

In a new study published online in JAMA Internal Medicine, Andrea Gershon and colleagues analyzed data from nearly 200,000 elderly COPD patients from Ontario, Canada. 28% of the group had a cardiovascular event.

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Click here to read the full post on Forbes.

 

Instagram for Heart Attacks: iPhone App Speeds ECG Transmission To Hospital Reply

MI/ACS, People, Places & Events • Tags: , , , , ,

In the crucial early stages of a possible heart attack, EMTs on the scene now rely on slow and unreliable proprietary technology to transmit vital ECG data to physicians at a hospital for evaluation. But a new iPhone app using standard cell phone networks may help speed the process and, ultimately,  cut delays in treatment for heart attack patients.

In a presentation earlier today at the American Heart Association’s Quality of Care and Outcomes Research Scientific Sessions 2013 meeting in Baltimore, faculty and students at the University of Virginia designed an iPhone app to overcome some of the limitations of the current system. The iPhone app takes a photo of the ECG, reduces its size, and transmits the image over a standard cell phone network to a secure server. The image can then be viewed at the receiving hospital by physicians qualified to read an ECG.

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Click here to read the full post on Forbes.

Opening Screen of the iPhone App

Salt Report From IOM Sparks Much Heat, Only A Little Light Reply

People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

An Institute of Medicine report on salt earlier this week sparked a lot of controversy. The report concludes that there’s no evidence to support current efforts to lower salt consumption to less than 2,300 mg/day. Unfortunately, the press coverage offered little insight into the science behind the issue. On the Knight Science Journalism Tracker blog, Faye Flam deftly uncovers the almost universal shallow coverage in the media.

The one exception, the one story worth reading that “dug into the science,” according to Flam, is Gina Kolata’s story in the New York Times:

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Click here to read the full post on Forbes.

 

English: A close up of salt crystals.

Study Questions Role Of Dual-Chamber ICDs For Primary Prevention Reply

Heart Rhythms • Tags: , , , , ,

Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC and HRS do not specify a single-chamber device.

In a new study published in JAMA, Pamela Peterson and colleagues analyzed data from 32,000 primary prevention patients without a pacing indication who were enrolled in the National Cardiovascular Data Registry (NCDR). 38% received a single-chamber device and 62% received a dual-chamber device. At 1 year there wereno significant differences in mortality, all-cause hospitalization, or heart failure hospitalization between the two groups. However, patients in the dual-chamber group had a higher risk of complications, including a highly significant increase in the 90 day risk of mechanical complications requiring reoperation (1.43% in the single-chamber group versus 2.02% in the dual-chamber group, p < 0.001). A very similar pattern emerged when the investigators performed an analysis that matched patients in the two groups with a propensity model. The analysis suggested “that the choice of a dual-chamber device is relatively random with respect to patient characteristics.

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Click here to read the full story on Forbes.

 

 

Novel Leadless Pacemaker Makes Debut At HRS 2013 Reply

Heart Rhythms, Interventional Cardiology & Surgery • Tags: , , ,

First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy.  Pacemaker leads are the most common source of complications associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism.  The device is manufactured by Nanostim, Inc, a small company which is being acquired by St. Jude Medical.

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Click here to read the full story on Forbes.

 

 

Leadless

 

Our Limitless Capacity For Self-Deception 10

Policy & Ethics • Tags: , , ,

I want to share with my readers a recent post and accompanying comment published on CardioExchange. The original post is by Eric Lindley, a cardiology fellow at the University of Utah:

Journal X: Not so Subtle Marketing Messages

I was the rare resident who thought that conflict of interest issues in medicine were a bit overblown. I did not find (or ignored) the evidence that pharma played a role in prescribing habits very persuasive, at least not when it came to my personal prescribing habits. I was not alone among the house staff, however, in appreciating an occasional “free” lunch, and the much rarer sponsored dinners at places I couldn’t afford as a physician-in-training.

Now I’m a fellow, and my attitudes about the pervasiveness of pharma influence have changed. Am I older and wiser? I’d like to think so. But I owe most of my conversion to the fresh perspective of my three-year-old daughter. She refers to most things by their color, including a majority of my medical journals. For instance, my JACC journals: blue for the mother journal, red for heart failure, green for interventions, etc. But then she started calling the original JACC the “X” journal. When I asked her why, she pointed to the “X” in Xarelto (rivaroxaban). I realized that every issue of JACC is covered front to back with the “X”. The message was subliminal to me, but quite obvious to her.

How do you think all of our pharma marketing looks with naive eyes?

This post prompted the following response from Siqin Ye, a cardiology fellow at Columbia University:

A story that I heard at ACC a few years ago goes something like this:

In a roomful of interventional cardiologists, the speaker asks, “How many of you have ever put in a stent that was unnecessary?”

Two or three hands went up.

The speaker then asks, “How many of you have seen someone in this room put in a stent that was unnecessary?”

About half the room raised their hands.

I think there is something similar with respect to our attitude towards pharma ads and gifts. I know plenty of residents and fellows who firmly believe that ads and dinners do not affect their personal practice patterns. Whether or not this is true for any given individual, the fact that pharma continue to spend so much on these activities suggest that as a whole, we are probably more susceptible than we believe.

 Thanks to Drs. Lindley and Ye for permission to reprint their words.

 

Suspicions Raised About Another Japanese Cardiovascular Researcher Reply

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

Significant questions about research misconduct have been raised about a prominent Japanese cardiovascular researcher, Issei Komuro.

Last year a Nature paper on which Komuro served as a co-author was corrected because “several images were mistakenly switched or duplicated during preparation of the artwork.” The Nature correction states that the “corrections do not alter any of the conclusions” of the paper. Now, however, a Japanese blog, entitled Issei Komuro – image manipulation -, raises questions about 13 additional papers. The papers were all published in well-known journals, including a second Nature paper, Nature Medicine, and 4 separate papers in Circulation. On many of the papers Komuro served as the senior author.

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Click here to read the full post on Forbes.

 

 

Encouraging 4 Year Results For Watchman Device In AF Patients Reply

Heart Rhythms, Interventional Cardiology & Surgery, Policy & Ethics • Tags: , , , , ,

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.

Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.

Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in  2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).

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Click here to read the full story on Forbes.

 

 

 

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

Uncategorized • Tags: , , , ,

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.

 

Another Disappointing Study For Fish Oil Supplements 3

Heart Failure, Heart Rhythms, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Another large study has failed to find any benefits  for  fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement (1 gram daily of n-3 fatty acids) or placebo.

After 5 years of followup, the primary endpoint– the time to death from cardiovascular causes or admission to the hospital for cardiovascular causes– had occurred in 11.7% of the fish oil group versus 11.9% of the placebo group (adjusted hazard ratio 0.97, CI 0.88-1.08, p=0.58). There were no significant differences in any of the prespecified secondary endpoints.

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Click here to read the full post on Forbes, including comments from James Stein and Dariush Mozaffarian

A typical softgel

Longer Detection Time Helps Prevent Unnecessary ICD Shocks Reply

Uncategorized

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.

 

Burton Sobel, Towering Cardiologist, Dead At 75 Reply

People, Places & Events • Tags: , , , , ,

Burton Sobel, a towering scientist and cardiologist, died at home on May 3 at the age of 75. Sobel had been treated in the past for prostate cancer and had suffered a recurrence, but it is not known if this was the immediate cause of his death.

Sobel was among the most powerful and influential cardiologists in the 1980s when he played a key early role in the development of fibrinolysis and the first major biotechnology product, TPA. From his perch as the chief of cardiology at Washington University in Saint Louis and as the editor of Circulation, Sobel was a member of a small group of cardiologists who set the agenda for cardiology and moved the field forward. The group, which also included James Willerson, Myron Weisfeldt, and Eugene Braunwald, was “innovative” and “visionary,” said Allan Jaffe, who worked closely with Sobel at Washington University for many years. “It was a very exciting time in cardiology,” he said.

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Click here to read the full post on Forbes.

 

 

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

Uncategorized

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...

 

 

 

 

 

 

 

FDA Approves Combination Of Ezetimibe And Atorvastatin Reply

People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , , ,

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.

Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol from 53% to 61%, depending on dosage.

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Click here to read the full post on Forbes.

 

Scrutiny Of Sodium Meta-Analysis In Heart Uncovers Duplicated And Missing Data Reply

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

A meta-analysis published in the journal Heart has been retracted. As Adam Marcus writes in Retraction Watch, the retraction occurred when the journal editors learned “that two of the six studies included in the review contained duplicated data.  Those studies, it so happens, were conducted by one of the co-authors [of the meta-analysis].”

The article, “Low sodium versus normal sodium diets in systolic heart failure: systematic review and meta-analysis,” was published online in August 2012. In their attempt to investigate the duplicate data, the Heart editors reported “that the raw data are no longer available having been lost as a result of computer failure.”

The authors of the meta-analysis were James J DiNicolantonio (Wegmans Pharmacy, Ithaca, NY), Pietro Di Pasquale (Chief Division of Cardiology, “Paolo Borsellino”, G.F. Ingrassia Hospital, Palermo, Italy),  Rod S Taylor (Peninsula Medical School, University of Exeter, Exeter, UK), and Daniel G Hackam (University of Western Ontario and the London Health Sciences Centre, London, Ontario, Canada).

It was the second author, De Pasquale, who was the co-author of the duplicated papers that also contained the missing data.

You can read the entire story in Retraction Watch. Don’t miss the comments. Here’s one:

“computer failure” is the scientist’s version of “the dog ate my homework”

 

heart cover may13

Japanese Research Scandal Expands To A Second Trial And A Novartis Employee Reply

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

A Japanese research scandal, which has so far centered on actions taken by the once-prominent cardiologist Hiroaki Matsubara, has now expanded. As has been previously reported, several papers authored by Matsubara have been retracted, including, most notably, the main publication of the Kyoto Heart Study in the European Heart Journal.

Now, however, questions have been raised about  another clinical trial, the Jikei Heart Trial, which was published in the Lancet in 2007.  (Matsubara was not involved in this trial.) Novartis, which manufactures valsartan (Diovan), the drug studied in both trials, has announced that it is investigating both trials in response to new allegations that a Novartis employee worked on the trials without any disclosure of his company affiliation.

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Click here to read the full story on Forbes.

Danish Study Finds No Increased CV Risk With Azithromycin In General Population Reply

People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published  in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls who took no antibiotics and with matched controls who took penicillin V for similar indications.

Although there was a significant increase in the risk of death from cardiovascular causes in people taking azithromycin compared with people taking no antibiotics (RR 2.85, CI 1.13 – 7.24), there was no increase in risk when compared to people taking penicillin V (RR 0.93, CI 0.56 to 1.55). The findings, write the authors, indicate “that the increased risk that was observed in the comparison with no antibiotic use was entirely attributable to the risk of death associated with acute infection (or some other adverse health characteristic in persons receiving antibiotic treatment, as compared with those not treated with antibiotics) rather than with its treatment.”

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Click here to read the full story on Forbes.

FDA Warns That Tolvaptan Can Lead To Serious Liver Injury Reply

Heart Failure, People, Places & Events, Policy & Ethics • Tags: , ,

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. “

The liver injury risk was discovered in clinical trials testing tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). The drug label has been updated and now states that use of the drug should be limited to 30 days and that it is no longer indicated in patients with cirrhosis. The FDA recommended that tolvaptan should be discontinued in patients with liver disease who are currently taking the drug.

 

 

WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children Reply

Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

There’s probably no greater public health issue than the long-term  consequences of the childhood obesity epidemic. So the Wall Street Journal should be commended for digging into some of the important science behind this problem in a feature article in today’s paper. The author, Ron Winslow, is widely regarded as the best working journalist who regularly covers cardiovascular medicine. But I’m afraid the article fails to raise several key questions about the topic and therefore misses an opportunity to educate people about its complexities.

The article deals with the “growing concerns about the cardiovascular health of millions of children in the U.S. who are considered obese or overweight” and then focuses on one recent study published in Pediatrics that “suggests there is a simple way to assess a child’s arterial health with a calculation based on an often-overlooked component of cholesterol: triglycerides.” Winslow faithfully reports the main finding of the study, which is that the triglyceride to HDL ratio corresponds closely with arterial stiffness. A stiff vessel is a sign of “accelerated aging” and “likely raises the risk of dangerous outcomes relatively early in adult life,” writes Winslow.

Winslow notes that an NHLBI panel now recommends universal cholesterol screening for children between 9 and 11, but there is no mention that some experts disagree with this recommendation.  Further, these screening tests focus on the measurement of LDL cholesterol. Winslow doesn’t discuss whether  LDL would be equally effective as triglycerides and HDL at identifying children with stiff arteries. Winslow writes, reasonably, that high triglycerides and low HDL “are a hallmark reflection of the poor diets and sedentary lifestyles that researchers say are behind the wide prevalence of obesity among both children and adults,” but there’s a big gap between that association and concrete recommendations to measure HDL and triglycerides in children and, more importantly, to take actions based on these measurements.

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Click here to read the full story on Forbes.

scale_zero

Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised 1

People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , ,

Here are two small but important changes in the anticoagulation field:

FDA approves new product for urgent reversal of anticoagulation. 

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Pradaxa label gains boxed warning.

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Click here to read the full story on Forbes.

 

English: Logo of the .

 

Unconventional Analysis Finds Threshold For LDL Reduction With Statins Reply

Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

Using an unconventional mathematical approach, a group of Japanese researchers say there may be no good reason to reduce LDL cholesterol more than 40 mg/dl. Their research letter has been published online in JAMA Internal Medicine.

According to the authors, members of the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group, most meta-analyses use linear models that assume “a constantly increasing or decreasing risk as the exposure increases or decreases.” Linear models, however, can be “misleading,” they write, because they assume a specific dose-response relationship. By contrast, their new analysis utilizes “flexible” models that can more readily uncover “threshold effects.”

Click here to read the full post on Forbes.

 

Edwards CEO Sold Stock 2 Weeks Before It Tanked 2

Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics • Tags: , ,

(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed at 65 on Thursday.

But Edwards chairman and CEO Michael Mussallem didn’t suffer along with his shareholders. As reported by GuruFocus, Mussallem sold 35,000 shares of his stock on April 10 at 83.37 per share netting him nearly $3 million. Another executive, the corporate VP of Japan and Intercontinental, Huimin Wang, sold 4,850 shares at $81.74 per share.

The dramatic drop in Edwards’ stock is another sign that the market for transcatheter heart valves has not grown as rapidly as many had expected. “Edward’s initial 2013 guidance clearly proved to be overly aggressive on U.S. TAVR sales as capacity constraints and the complexities of bringing a 20+ person team up the learning curve clearly tempered the adoption curve more than expected,” said a Leerink Swann analyst quoted by Bloomberg.

Update: I have been informed by Edwards that the recent sale was part of a predetermined plan to sell shares. Mussallem has sold 35,000 shares each month since June of 2012.

Conflicting Results From Two Trials Of Cardiac Resynchronization Therapy Reply

Uncategorized

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

 

Another Cleveland Clinic Study Links TMAO To Atherosclerosis Reply

People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

A new study from the Cleveland Clinic research group headed by Stanley Hazen offers more evidence in support of the hypothesis that TMAO (trimethylamine-N-oxide) may play a role in the development of heart disease. The new research, published in the New England Journal of Medicine, follows closely on a related study published recently in Nature Medicine that received broad public attention.

The Nature Medicine paper demonstrated that digestive tract bacteria metabolize carnitine into trimethylamine-N-oxide (TMAO), which had previously been linked to atherosclerosis in animals. The new research in NEJM focuses on another pathway that leads to TMAO production and provides for the first time a credible association between TMAO and cardiovascular disease in humans.

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Click here to read the full story on Forbes.

Stanley Hazen