Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines
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FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent Reply

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe:

FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response.

FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote–

 …

FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System–

Click here to read the full story on Forbes.

 

 Image representing 23andMe as depicted in Crun...

Image representing Portola Pharmaceuticals as ...

The Italian Research Scandal Grows: New Questions And More Confusion Reply

New questions are being raised about yet another published study from an embattled Italian research group. It also appears that despite attempts by some of the participants to respond to some of the previous questions and accusationst there is little likelihood that the growing scandal will be resolved anytime soon.

The new allegations are the latest episode in an ongoing saga that began last year with the arrest of 9 Italian cardiologists as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The most prominent figure arrested was Maria Grazia Modena, the former head of cardiology. Since the arrests last year I have reported about numerous errors and other problems related to 2 studies by many of the same cardiologists published in the journals Heart and the American Journal of Cardiology.

The new questions concern a paper published in Circulation Cardiovascular Inteventions. Specifically, the paper claims that the study enrolled all consecutive STEMI patients from 2002 to 2008, obtained informed consent from all patients, and achieved 100% followup at 1 year. In addition, I found 2 mathematical errors in Table 2, including the apparent paradox of a subgroup of low risk men (n = 548) being larger than the entire group of men (n = 522). (Click to enlarge the image of the Table.)

The question about the enrollment of all STEMI patients is further complicated by the fact that (at least) 2 previous papers (the Heart and  AJC papers mentioned abovehave claimed to enroll, obtain consent, and achieve complete followup of the same STEMI population from the same hospital at the same time. Do the authors claim that informed consent was obtained for each of these studies and from each of the patients?

A Weak Defense

In response to my story about the American Journal of Cardiology paper the first author of that study, Daniel Monopoli, sent a lengthy response. (I have reprinted the entire response at the bottom of this post.) Readers should of course judge for themselves, but I do not believe Monopoli has satisfactorily resolved any of the questions raised about the paper. In some instances I think he has, inadvertently, worsened his position.

Click here to read the full post on Forbes.

 

 

 

The Good, The Bad, And The Ugly: Stents In The News Reply

Three big stent stories were in the news today. You’d never know that all 3 were about the same topic.

 

The Ugly

 

The ugly side of stents is emphasized in David Armstrong’s Bloomberg News story on Mehmood Patel, the Louisiana interventional cardiologist serving a 10-year prison sentence for Medicare fraud. These days Patel “leads health-conscious inmates on a morning walk, then cracks open one of the medical journals on his prison-approved reading list. Counseling fellow convicts to keep their blood pressure down is about the extent of the doctoring done by the man who once boasted he was the busiest cardiologist in the nation.”

 

The Bad

 

Unlike Patel, Mark Midei, the poster-boy of overstenting, never faced criminal charges, but he did lose his medical license and faced an avalanche of lawsuits. Many have been settled our of court, but an important decision was reached yesterday in one very large remaining case. Jessica Anderson reports in the Baltimore Sun that a jury ruled that Midei “improperly placed three stents in the heart of a prominent businessman who didn’t need them.” The businessman is suing Midei and the former owners of his hospital, St. Joseph Medical Center, for $150 million. The businessman claims that he “lost millions of dollars after scaling back his career” after “Midei falsely led him to believe that he had serious coronary artery disease requiring stents.”

 

The Good

 

But it’s not all bad news for stents. In the New Yorker‘s Elements blog, cardiology fellow Lisa Rosenbaum adopts a much more nuanced view of stents. She writes that “stories about cardiologists behaving badly validate the conviction, common among both policymakers and the public, that misaligned financial incentives drive doctors to do things that they shouldn’t.”

 

But, she argues, the conservative view, based largely on the well known COURAGE trial, that medical therapy is just as good as a stent, “is a colossal oversimplification.”

 

Successful conservative management, however, depends on seeing patients regularly, so that you can titrate their medications and make sure that their cardiovascular risk factors are controlled. But Sun Kim didn’t come back.

 

Click here to read the full story on Forbes.

 

The Good, the Bad and the Ugly is a well-known...

 

FDA Approves First New Atherectomy Device In 20 Years Reply

The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said  it would begin a controlled launch of the device immediately, focusing initially on “a limited number of the top medical institutions in the United States.”

In separate news, Medtronic yesterday announced the launch of its Export Advance aspiration catheter for coronary thrombus removal. The device was recently approved by the FDA. The company said the device features a pre-loaded stylet that “increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site.”

Click here to read the full post on Forbes.

A Paper In The American Journal Of Cardiology About A Study That Was ‘Not Real’ Reply

New allegations about scientific misconduct have been raised about a cardiology group in a hospital in Italy. Some of the allegations come from a surprising source: Maria Grazia Modena, the former and highly prominent chief of cardiology at the hospital where the research was said to have been performed.

The new allegations are the latest episode in an ongoing saga that began last year involving many of the same researchers, including Maria Grazia Modena herself. As I first reported last November, nine Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The charges included conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. The most prominent person arrested was Maria Grazia Modena, who is also a former president of the Italian Society of Cardiology. (The fact that she shares her last name with the city and the hospital where she works appears to be a coincidence.)

The suspicion that there might be problems with the paper  first emerged when Maria Grazia Modena, who was originally listed as a co-author, publicly distanced herself from the paper and said that she was not an author of the paper and had had nothing to do with the study. To date the only public acknowledgement that there might be problems with the paper is an erratum published in AJC stating that Modena “was not associated with this manuscript” and that “the authors apologize for this error.”

I personally asked the physicians and fellows who were working in the department (except the authors of the manuscript) if anyone have ever heard about the study. Nobody had ever seen informed consents or appointments for study-related peripheral echo in 8 years.

 In the methods section of their manuscript, the authors stated that echo examinations  were made with [a GE Healthcare transducer]… That echocardiography machine was bought around 2005-2006 (the authors  report they started the study  in 2002).

Click here to read the full post on Forbes.

 

Could Terrorists Have Hacked Dick Cheney’s ICD? 3

It happened in Homeland. Could it happen in real life?

In a 60 Minutes segment scheduled for broadcast tomorrow, Dick Cheney says that his doctors turned off the wireless function of his implanted cardiac defibrillator (ICD) “in case a terrorist tried to send his heart a fatal shock,” according to the Associated Press.

Years later, Cheney watched an episode of the Showtime series “Homeland” in which such a scenario was part of the plot.

“I found it credible,” Cheney tells “60 Minutes” in a segment to be aired Sunday. “I know from the experience we had, and the necessity for adjusting my own device, that it was an accurate portrayal of what was possible.”

I asked three experienced electrophysiologists– the cardiologists who devote a good part of their professional life implanting ICDs– whether this was a realistic concern…

Click here to read the full story on Forbes.

 

Former ACC CEO Takes Reins Of Cardiovascular Research Foundation Reply

The Cardiovascular Research Foundation (CRF) announced today that it had appointed Jack Lewin as its next President and Chief Executive Officer.

Lewin is the former CEO of the American College of Cardiology. In April 2012 the ACC announced his abrupt departure from the college. No explanation was ever given for the sudden change.

Click here to read the full story on Forbes.

 

 

A Vision Unfulfilled: Reflections On The Death Of TheHeart.Org (1999-2013) Reply

(Updated, October 25–) On Friday, September 20 the cardiology website TheHeart.Org died. It lost its separate and unique identity and became a part of Medscape (which is owned by WebMD). I played a part in the founding and development of TheHeart.Org (THO) and I mourn its loss. What follows is some of that story and why I think the loss of THO is sad.

(For those of you who don’t know, THO is, or was, an extremely popular website for cardiologists. It has been widely regarded as the most reliable and authoritative source for news about cardiology. In 2005 it was bought by WebMD for nearly $20 million. In 2008 it had about $30 million in annual revenue.)

I was the editor of the TheHeart.Org from its launch in 1999 until December 2008. I believe the success of THO was largely due to the way it improved the state of medical journalism, which was in a pitiful state at that time. The creation of THO was without doubt the professional highlight of my career. But that feeling was always tempered by my recognition that there was still much more that remained to be done. I am still proud of what we achieved, and want to acknowledge that the new THO/Medscape retains value, but it no longer represents the future of medical journalism, or aspires to create something new and different.

Click here to read the full story on Forbes.

 

 

Update (October 25)– Since the announcement of the change I have watched with concern as significant amounts of Medscape-generated content have appeared on TheHeart.Org. Although the news generated by the Heartwire team continues to be valuable, the avalanche of additional so-called editorial content has had an unfortunate effect on the editorial balance, and it is harder to tell whether an individual item comes from the Heartwire editorial team or somewhere else.

This update was prompted by this tweet that came out a little while ago on TheHeart.Org twitter feed:

 

It’s hard to figure out how to respond to this sort of despicable clickbait. It demonstrates the complete rejection of any commitment to editorial excellence in favor of the cynical pursuit of page views. In this brave new world mindless content is king, as long as it contains nothing to which the sponsors might object.

Can Inflating A Blood Pressure Cuff Improve Outcomes Following Bypass Surgery? Reply

http://www.forbes.com/sites/larryhusten/2013/08/15/can-inflating-a-blood-pressure-cuff-improve-outcomes-following-bypass-surgery/

 

For several decades cardiologists have been intrigued by the concept of ischemic preconditioning. A small body of research has consistently found that brief episodes of ischemia (in which reduced blood flow results in damage to tissue) appeared to somehow prepare the body to better handle a major episode of ischemia. Now a new study from Germany published in the Lancet holds out the promise that deliberate ischemic preconditioning prior to bypass surgery might prevent ischemic injury caused by the surgery and may even improve long-term survival. But the investigators themselves say that the results need to be confirmed in a larger study.

Click here to read the full post on Forbes.

 

New Trend? Free Tablet Computers For All Registrants At TCT Meeting Reply

Cardiologists and others who attend this year’s TCT meeting in San Francisco will receive a free tablet computer. TCT is the highly influential interventional cardiology meeting run by the Cardiovascular Research Foundation. This year it will take place in San Francisco from October 27 through November 1.

Heavily promoted in emails and on the site’s webpage, TCT is promising that paid registrants for the entire meeting “will receive a free tablet computer loaded with the official conference app and other interactive tools to optimize the TCT experience.” Attendees will get to keep their tablets. Here’s how TCT is saying the tablets can be used:

Another very important question: what sort of information about the user will the device send to TCT and/or sponsors? What sort of privacy controls will be available to the user, and will these controls be understood (see Facebook)? Concerns have been raised in the past about the presence of RFID tags embedded in conference badges. The potential for invasion of privacy is much greater with a tablet computer, I imagine.

Click here to read the full post on Forbes.

 

 

Dramatic Increase in Use of Radial Artery Access for PCI in the U.S. Reply

In the last six years interventional cardiologists have dramatically increased their use of radial access for PCI, according to a retrospective study published in Circulation. Using data from the CathPCI registry on more than 2.8 million procedures between January 2007 and September 2012, Dmitriy Feldman and colleagues found that radial access PCI increased 13-fold, from a negligible 1.2% at the beginning of the study to 16.1% at the end.

Click here to read the full story in Forbes.

 

Infographic from the American Heart Association

Scientific Misconduct: From Darwin And Mendel To Poldermans And Matsubara Reply

Responding to recent episodes of scientific misconduct in cardiovascular research involving once prominent cardiovascular researchers, the editor of the European Heart Journal, Thomas Lüscherhas written an editorial discussing the significance of the new cases and placing them in a historical context that includes allegations of scientific misconduct by Mendel and Darwin, among many others.

Poldermans was the first or the senior author in 7 papers published in EHJ. Lüscher writes that the chairman of the Poldermans investigative committee “made it clear that the vast amount of publications led by Poldermans over the last decades made it impossible to assess their scientific validity in all cases.” As a result, Poldermans announces that “the editors of the European Heart Journal therefore would like to make an expression of concern related to the papers where Poldermans was the responsible author.”

Comment: Without more information there will continue to be a large cloud of uncertainty hanging over the cardiovascular literature. The statement of the chairman of the Poldermans committee bears repeating: “the vast amount of publications led by Poldermans over the last decades made it impossible to assess their scientific validity in all cases.”

 Click here to read the full story on Forbes.

 

Gregor Mendel
Gregor Mendel

 

Don Poldermans

 

 

 

 

Are Most People With Complex Coronary Disease Getting The Best Treatment? 1

angiogram

The relative value of PCI (stents) and bypass surgery for the treatment of people with blocked coronary arteries has been a topic of intense interest and debate for more than a generation now. Over time, the less invasive and more patient-friendly (and less scary) PCI has become the more popular procedure, but the surgeons (who perform bypass surgery) and cardiologists (who perform the less invasive PCI) have argued furiously about which procedure is safest and will deliver the most benefit in specific patient populations. In general, the most complex cases require the more thorough revascularization provided by surgery, while the more simple cases do well with PCI and can therefore avoid the trauma of surgery. But the specific criteria have remained murky, and interventional cardiologists have aggressively sought to take on increasingly more complex cases.

Now, long term results from a highly influential trial comparing the two procedures offer what is likely the most definitive solution we are likely to have for a very long time. Five year results from the SYNTAX trial have now been published in the Lancet.

Here’s some of the perspective on this study from two very savvy cardiologists, Rick Lange and L. David Hillis. (These comments are extracted from their original publication in CardioExchange. Note that I work on CardioExchange, which is published by the New England Journal of Medicine.)

…The “bottom line” conclusions are:

  1. CABG should remain the standard of care for patients with complex lesions…
  2. For patients with 3-vessel disease considered to be less complex… PCI is an acceptable alternative.
  3. All the data from patients with complex multivessel CAD should be reviewed and discussed by a cardiac surgeon and an interventional cardiologist, after which consensus on optimal treatment can be reached.

But Lange and Hillis, while they seem to largely agree with the study findings, also cast doubt on whether most physicians are likely to pay attention to the study details. They wonder whether most hospitals actually live up to the standards in the study, which requires, for each patient, a review of each patient by the multidisciplinary heart team, and the calculation of a complex SYNTAX score to establish the precise degree of risk.

Okay, let’s be honest….

  1. In your hospital, in what percentage of patients with left main or 3 vessel CAD are all the data systematically reviewed and discussed by a “Heart Team”?
  2. Do you calculate SYNTAX on all patients with left main or 3 vessel disease, or do you usually just “guestimate” lesion complexity?

If Lange and Hillis’s suspicions are correct, many people with complex coronary lesions are not receiving the best possible care. Hmmm.

400 Patients Sue Kentucky Hospital and 11 Cardiologists Over Unnecessary Procedures Reply

After undergoing more than two dozen cardiac procedures over a period of twenty years at St. Joseph Hospital in London, Kentucky, a patient was told by an outside cardiologist in Lexington that a recent procedure had been performed unnecessarily on an artery that was barely blocked.

“I would have not carried out this procedure,” the cardiologist, Michael R. Jones, wrote in a letter to the patient. The story is recounted  in an article published on Sunday in USA Today and the Louisville Courier-Journal, about the latest and perhaps the biggest case yet to surface over unnecessary cardiac procedures.

Comment: By sheer coincidence, on the same day, the New York Times published a news analysis by Barry Meier about the scandal over Johnson & Johnson’s hip implant. “Doctors Who Don’t Speak Out” focuses on the failure of physicians to report problems with devices and drugs, but clearly the issue has even larger implications. A quote from Harlan Krumholz in the story– “Questioning the status quo in medicine is not easy”– could easily apply to the many recent cases of egregious overuse of cardiac procedures and devices. Imagine how recent history might have been different if colleagues of  Sandesh Patil and Mark Midei had raised earlier questions about borderline procedures. Cardiologists and other physicians complain about the intrusive and burdensome role played by the legal system, regulators, and insurance companies, but they have only themselves to blame if they refuse to police their own ranks, and indeed tacitly participate in a system that provides lucrative compensation to high-volume proceduralists.

Click here to read the entire post on Forbes.

Kentucky

Should Radial Artery Access Be The Default Choice For PCI? Reply

Over on CardioExchange six cardiologists, from fellows to senior faculty, talk about whether radial artery access should be the “default choice for PCI:

Megan Coylewright, MD, MPH (interventional fellow, Mayo Clinic): …radial PCI should be a part of every interventionalist’s toolkit…

Micah Eimer, MD (cardiologist, Glenview, IL): The data are pretty convincing on the lower rate of complications, and my clinicial experience confirms that. Patients who have undergone both radial and femoral approaches consistently and strongly prefer the radial approach…

L. David Hillis, MD, (Chair, Department of Internal Medicine) and Richard Lange, MD (Professor, University of Texas Southwestern Medical School): As old dogs (admittedly late in learning new tricks), we’re a part of “Gen-S” (“S” for Sones)… In Texas, where everything is bigger and better, we don’t feel a need to abandon the femoral approach.

Click here to read the entire discussion on CardioExchange.

2012 In Review: Social Media In Cardiology 5

For a whole variety of reasons most cardiologists are not really comfortable diving into social media. For some reason they’re more comfortable remaining poolside, reading Braunwald or the latest mini JACC or Circulation than writing a blog or interacting with each other or their patients on Facebook or Twitter. Most cardiologists who do get their feet wet send out a few isolated tweets or posts and then disappear into the great digital void. So here’s a special shout out to a few brave cardiologists who are at least making an effort (feel free to add to this list in the comments section):

twitter

Cardiologists Chris Cannon and Herb Aronow,  and cardiology fellow Michael Katz, regularly tweet about cardiology. Some big names like Harlan Krumholz and Bob Harrington are sporadic tweeters, providing behind the scene glimpses at events like a PCORI meeting or an ACC Board of Governors meeting. Electrophysiologist John Mandrola didn’t just get his feet wet but took a big belly dive into the social media pool, actively tweeting, blogging on his own and over at that other cardiology website, and contributing to newspapers and big sites like KevinMD. Eric Topol is a prolific tweeter, but he rarely seems interested in cardiology these days.

Jay Schloss deserves special mention for live-tweeting a closed Riata symposium and then keeping CardioBrief readers fully informed about each major development of this important case as it slowly unfolded this past year. Westby Fisher is the great grandfather of all cardiologists in the blogosphere and twitterverse, though lately he’s pulled back a bit, foolishly deciding that his medical practice and family life are somehow more important than his social media standing.

Finally, though he’s not a cardiologist, Lancet editor Richard Horton deserves special mention. He took to Twitter like a duck to water, though not everyone was so pleased by all his preening. As I wrote earlier this year, it was impossible not to be fascinated by the occasional glimpses he provided of the dark underside of medical publishing. He’s toned this down a lot lately, but on occasion he still has some amusing comments on the rivalry (real or imagined?) between his journal and the New England Journal of Medicine. But if you’re not interested in the politcs of the World Health Organization or the British medical establishment you may not want to follow him these days.

Late entries: