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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DOJ Investigating Interventional Cardiology Services At HCA

The hospital giant HCA has disclosed that the US Attorney’s Office in Miami is investigating the company and has “requested information on reviews assessing the medical necessity of interventional cardiology services provided at any Company facility (other than peer reviews).” Following its own preliminary investigation, the company said it was aware of such reviews in about…

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RIFLE-STEACS: Radial Access Improves Outcome In Early Invasive Therapy

For early invasive therapy for  ST-segment elevation acute coronary syndrome (STEACS), the use of radial access instead of femoral access reduces bleeding complications and improves outcomes, according to the results of the first large randomized trial testing the two approaches in this population. The results of the Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary…

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TAVI: Belgian Researchers Slam Evidence Base And Overuse In Europe

The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are…

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St Jude CEO Spills The Beans On PFO Closure Trial

(Updated at bottom with statement from St. Jude Medical) Dan Starks, the CEO of St Jude Medical, stated during a quarterly earnings call last week that results of the RESPECT trial of PFO closure for crytpogenic stroke were “favorable” and that the full trial results will be presented in October at the TCT meeting in Miami. But his statement…

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Elevated Risk of Acute MI Following Total Hip And Knee Replacement Surgery

A large study reports a high increased risk for acute MI (AMI) in the first 6 weeks after total-hip replacement (THR) or total-knee replacement (TKR) surgery. Analyzing a nationwide cohort from Denmark that included 95,227 patients who underwent THR or TKR and matched controls, Arief Lalmohamed and colleagues calculated the adjusted hazard ratios (HR) for AMI. Their…

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The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?

One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI  (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR  (transcatheter aortic valve replacement) about the time when the procedure edged closer to US approval. Now,…

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Drug-Eluting Stents Often Used In Patients At Low Risk Of Restenosis

The chief advantage of drug-eluting stents (DES) over bare-metal stents is that they significantly reduce the risk of restenosis. The chief disadvantages of DES are their greater cost and the requirement for prolonged dual antiplatelet therapy after DES implantation. In a study published in Archives of Internal Medicine,  Amit Amin and colleagues analyzed data from 1.5…

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One Reader’s Negative View Of Mark Midei

A few months ago I posted a lengthy piece about Mark Midei, the interventional cardiologist from Maryland who had his medical license suspended last year following a lengthy scandal in which he became the poster-boy (or scapegoat, depending on whom you ask) for all that’s wrong with interventional cardiology in the US. Although I was highly critical…

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Severe Blood Conservation Appears Safe In Cardiac Surgery For Jehovah’s Witnesses

Severe blood conservation in conjunction with cardiac surgery is not associated with long-term adverse consequences, according to a new study published in Archives of Internal Medicine.  Investigators from the Cleveland Clinic and the NHLBI compared 322 patients who were Jehovan’s Witnesses with an equal number of matched controls. Due to their religious beliefs Witnesses…

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FDA Advisory Panel Recommends Expanded Indication For Sapien Transcatheter Heart Valve

The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device…

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Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve

Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and…

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FDA Reviewers Raise Questions About Sapien Heart Valve System

FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system…

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Troponin T Test Helps Assess Risk Following Noncardiac Surgery

A new study in JAMA finds that postoperative Troponin T (TnT) tests can independently improve 30 day mortality risk assessment among patients who have had noncardiac surgery. The VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study investigators evaluated the prognostic power of postoperative fourth-generation TnT testing in 15,133 patients. Overall mortality at 30 days was…

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No Benefit Found For Exercise Echocardiography In Asymptomatic Patients Following CABG Or PCI

Routine exercise echocardiography in asymptomatic patients after revascularization does not lead to better outcomes, according to a new study published in Archives of Internal Medicine. Although guidelines generally discourage the practice, post-revascularization stress tests are still commonly performed. Serge Harb and colleagues performed exercise echocardiography on 2,105 patients following CABG surgery or PCI and followed…

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Xience Stents Gain European Nod For Three-Month Dual Antiplatelet Therapy

The biggest drawback to drug-eluting stents has been the requirement for prolonged dual antiplatelet (DAPT) therapy following stent implantation to prevent stent thrombosis and other potential complications. The precise length of DAPT has been the subject of considerable discussion and research. Now the Xience Prime and Xience V everolimus-eluting stents have received the CE Mark…

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Returning To Detroit, William O’Neill Heads To Henry Ford Hospital

Interventional cardiology leader William O’Neill is leaving the University of Miami Miller School of Medicine to become the medical director of the new Center for Structural Heart Disease at Henry Ford Hospital in Detroit. The new center will focus on new minimally-invasive treatments for heart failure and heart valve disease. Prior to going to Miami in 2006,…

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Revascularization In New York State: High Questionable Rates For PCI But Not CABG

A large study looking at real world usage of elective coronary artery bypass surgery (CABG) and stenting (PCI) in New York State finds that nearly two-thirds of PCI procedures have inappropriate or uncertain indications. By contrast, 90% of CABG procedures were deemed appropriate and 1.1% inappropriate. In a paper published in the Journal of the…

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All Dressed Up And No Place To Go: False-Positive Activation Of The Cath Lab For Primary PCI

Primary PCI is widely recognized as the best early option for patients with  ST-segment elevation myocardial infarction (STEMI). However, efforts to deliver primary PCI to the broadest possible population inevitably result in an increased number of false-positive activations of the cardiac catheterization laboratory. Now, a new studypublished in the Archives of Internal Medicine finds that the rate of…

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Politics and Transcatheter Aortic Valve Replacement

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears: Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people. The stampede to stake a claim in a promising, highly lucrative new territory would…

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CMS Issues National Coverage Decision for TAVR

The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for  transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic…

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FDA Advisory Panel Gives Green Light To HeartWare Ventricular Assist System

The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted  8-3 that the device…

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The Medicines Company Collaborates with AstraZeneca To Sell Brilinta (ticagrelor)

The Medicines Company will collaborate with AstraZeneca to help sell Brilinta (ticagrelor), AstraZeneca’s struggling oral antiplatelet drug. The collaboration is the first stage of  “a global collaboration for acute ischemic heart disease compound” announced by the two companies today. AstraZeneca will pay $15 million per year for The Medicines Company’s Brilinta-related sales activities, scheduled to begin in May….

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Study Sheds Light on Cardiac Device Infective Endocarditis

A new study sheds light on a rare but highly dangerous complication associated with device implants: cardiac device infective endocarditis (CDIE). Approximately 10-23% of device infections result in CDIE, leading, in one estimate, to an overall rate of 1.14 cases per 1,000 device-years. In a paper published in JAMA, Eugene Athan and colleagues analyzed data from 3,284…

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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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