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

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,”…

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Surgery Preferable To Stents In Elderly People With Carotid Disease

Age should play an important role in choosing a revascularization procedure for people with blocked carotid arteries, according to a new paper published in JAMA Surgery.  Carotid endarterectomy surgery (CEA) is preferable to carotid artery stenting (CAS) in elderly people; for younger patients the two revascularization procedures are broadly similar. George Antoniou and colleagues analyzed data from 44…

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

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…

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Are Cardiologists Worried About Being Accused Of Unnecessary PCI?

In the last week two cases highlighted, yet again, the continuing shift in standards regarding PCI. In his interventional cardiology blog on CardioExchange, Rick Lange asks cardiologists: Could You Be Accused of Doing Unnecessary PCI? “Public confidence is eroding as the number of reports of physician suspensions and monetary penalties for unnecessary PCIs grow. Accordingly, patients…

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Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs

In 2006, Reed Abelson in the New York Times reported that the PCI rate in Elyria, Ohio was four times the national average. Now, six-and-a-half years later, the local hospital and cardiology group have agreed to pay $4.4 million to settle US allegations “that the hospital and the physicians “performed angioplasty and stent placement procedures on patients who had heart disease…

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Missouri Board Issues Emergency Suspension Of Cardiologist Accused Of Implanting Unnecessary Stents

A Missouri cardiologist who has been accused of unnecessarily implanting stents in six patients has been temporarily barred from seeing patients. The Missouri State Board of Registration for the Healing Arts, which licenses physicians and investigates and disciplines physicians in cases of accused misconduct, issued an emergency suspension of the cardiologist’s license to practice, according to…

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Studies Examine Less Burdensome Dual Antiplatelet Regimens

Two new studies published in the Journal of the American College of Cardiology offer hope but not, yet, compelling evidence to support less burdensome requirements for dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. In the first study, Spanish investigators followed 1,622 consecutive patients who received a drug-eluting stent (DES) for one year. They found…

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Guest Post: Is It The Right Time To Introduce Real Supervision Into Medical Practice?

Editor’s Note: Dr. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, originally submitted the following post as a comment on my previous post in which I compared HCA to Barclays and JP Morgan. I’d be very eager to hear responses from other physicians about this subject. Is It The Right Time To…

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Why HCA Is Like Barclays And JP Morgan

Earlier this week the New York Times reported on a pattern of seriously deficient cardiac care at a number of hospitals owned by HCA. Understandably, the most common reaction is simple disgust over more bad cardiology behavior. After the Mark Midei case, after subsequent and even worse cases in Maryland, Pennsylvania, and elsewhere, the easy thing is to…

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NY Times: HCA Concealed Significant Problems At Lucrative Cardiac Centers

Despite numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of its hospitals, the giant HCA corporation did little to rein in the problem or to inform regulators, payers, or patients about the problem, according to an investigative report in the New York Times by Reed Abelson and…

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Meta-Analysis Compares Drug-Eluting and Bare-Metal Stents for Primary Angioplasty

A new meta-analysis comparing drug-eluting stents (DES) and bare-metal stents (BMS) in patients with myocardial infarction has provoked opposing take-away messages from an author of the study and an editorialist. The authors emphasize the reduction in target-vessel revascularization (TVR) associated with DES, but the editorialist focuses on several potential DES weaknesses suggested by the study….

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Large Meta-Analysis Finds Very Low Thrombosis Rates for Xience Stent

A large new meta-analysis published in the Lancet provides the best evidence yet that the cobalt-chromium everolimus eluting (CoCr-EES) stents  (Xience and Promus) have a significantly lower rate of stent thrombosis than bare-metal stents BMS) and other drug-eluting stents (DES). Tullio Palmerini and colleagues analyzed data from 49 randomized trials comparing different stents in more than 50,000 patients….

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FDA Approves Medtronic’s Resolute Drug-Eluting Stent for Treatment of CAD, Including Diabetics

The FDA has approved the Medtronic Resolute zotarolimus-eluting stent for the treatment of coronary artery disease. The Resolute DES is approved for use in a wide variety of patients, including diabetics. The new stent uses the same drug-and-polymer combination as the popular Resolute Integrity DES. The Resolute clinical trial program enrolled more than 5,000 patients worldwide, a…

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