Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing…

Click here to continue reading…

ARCTIC Blows A Cold Wind On Platelet Function Tests

The use of platelet-function tests to monitor and guide antiplatelet therapy in PCI patients has sparked heated debate. Cardiologists have sought to reconcile biological plausibility with the absence of clinical evidence. Now the ARCTIC (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy versus a Monitoring-guided Strategy for Drug-Eluting Stent Implantation versus Continuation One…

Click here to continue reading…

FREEDOM Lends Strong Support To CABG For Diabetics With Multivessel Disease

Editor’s note: The embargo on FREEDOM was lifted early after a press release was published by mistake.) Diabetics with multivessel disease do better with CABG than PCI, according to FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease), a large NIH-sponsored study presented at the American Heart Assocation in Los…

Click here to continue reading…

DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System

Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26….

Click here to continue reading…

Research And Denial At St Jude Medical

Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…

Click here to continue reading…

TCT: Two PFO Closure Trials Miss Primary Endpoints

Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant  benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients  to PFO closure…

Click here to continue reading…

TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years

At the TCT meeting in Miami  Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At three years the mortality advantage continued to grow for TAVR over standard therapy in patients who are…

Click here to continue reading…

Setback For Trial Studying Dabigatran After Mechanical Valve Surgery

Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…

Click here to continue reading…

Jeffrey Moses Accused Of Cocaine Use And Domestic Violence (Updated)

Update– December 21, 2012:The New York Post has substantially disavowed significant portions of an October 22 news story about Jeffrey Moses. The story contained allegations that the well-known interventional cardiologist had tested positive for cocaine but was allowed to continue performing procedures at New York-Presbyterian Hospital. Now, the Post says, allegations of cocaine use were “subsequently proven to be conclusively false…

Click here to continue reading…

FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients

The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not…

Click here to continue reading…

Free Cardiac And Spine Surgery For Walmart Employees At Six Hospitals

Starting next year 1.1 million US Walmart employees and their dependents will be eligible for free heart, spine, and transplant surgery at 6 highly regarded health care organizations. Walmart employees will have no out-of-pocket costs, including travel, lodging and food for the patient and a caregiver. On Thursday the company announced that its “Centers of Excellence”…

Click here to continue reading…

PCI Utilization Lower In States With Public Reporting Of Outcomes

In patients with acute MI, utilization of percutaneous coronary intervention (PCI) is lower in states that publicly report outcomes data, according to a new study published in JAMA. Despite the difference in utilization, however, there was no difference in mortality between reporting and nonreporting states. Karen Joynt and colleagues used Medicare data to analyze PCI utilization and mortality…

Click here to continue reading…

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…

Click here to continue reading…

Screening For AAA Comes Under Renewed Scrutiny And Criticism

A 2007 Medicare initiative to increase AAA (abdominal aortic aneurysm) screening in appropriate patients failed to prevent AAA rupture or reduce all-cause mortality, according to a new study published in Archives of Internal Medicine. The larger implications of the study are unclear, but two accompanying papers, an invited commentary and a perspective, emphasize the darker side of…

Click here to continue reading…

News Flash! Company Issues Incredibly Boring Press Release

Last week Abiomed issued a press release (reprinted below) that was about as dull as a press release can get. The main news of the press release was that the PROTECT II study testing the company’s Impella 2.5  circulatory support device had been published online in Circulation. The press release provides no details or information about…

Click here to continue reading…

News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD

Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…

Click here to continue reading…

Danish Survey Finds Clopidogrel Less Effective In Diabetics

A large nationwide survey of MI survivors in Denmark provides new information about the efficacy of antiplatelet therapy with clopdiogrel in patients with diabetes. In a paper published in JAMA, Charlotte Andersson reports on 58,851 MI patients, 12% of whom had diabetes and 60% of whom received clopidogrel. As expected, diabetics had a worse outcome than nondiabetics: the…

Click here to continue reading…

ESC Trials: The Best And The Worst

Two trials presented at the ESC this year– WOEST and IABP-SHOCK II— are great examples of the way medicine is supposed to work. Another trial, FAME 2, is an example of so many of the things that can go wrong. WOEST and IABP-SHOCK II are remarkably similar. Both trials tested conventional wisdom and found it lacking. WOEST…

Click here to continue reading…

Pilot Study Demonstrates Feasibility Of MRI-Guided Catheterization

A small pilot study has demonstrated that it may one day be possible to replace x-rays with MRI to guide some cardiac catheterization procedures. As reported in the European Heart Journal, researchers at the National Heart Lung and Blood institute (NHLBI) performed x-ray and MRI-guided transfemoral right heart catheterization in 16 patients (four with shunt, nine…

Click here to continue reading…

WOEST: Get Rid Of The Aspirin In Triple Therapy

According to current guidelines and clinical practice, PCI patients already taking an oral anticoagulant generally end up on triple therapy comprising the anticoagulant plus clopidogrel and aspirin. However, there is no supporting evidence base for this approach and the triple therapy regimen is known to increase bleeding complications. Now a new study– the first randomized…

Click here to continue reading…

FAME 2: Can FFR Save PCI From Medical Therapy?

Two sharply divergent views have developed about the value of fractional flow reserve (FFR) in PCI. FFR advocates think the new technology can help identify ischemic lesions that will benefit from PCI, thereby helping to salvage or enhance the reputation of PCI. FFR skeptics think that optimal medical therapy is still the preferred option for most…

Click here to continue reading…

ESC: Trial Finds No Benefit For Intraaortic Balloon Counterpulsation In Cardiogenic Shock

Despite a lack of evidence, circulatory support with intraaortic balloon counterpulsation (IABP) has a class 1 recommendation in the guidelines and is often used in patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. That situation may change soon, as no benefit was found for the use of IABP in the…

Click here to continue reading…

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…

Click here to continue reading…

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…

Click here to continue reading…

Risks and Benefits Of Pediatric Ventricular Assist Device Explored

Few options besides extracorporeal membrane oxygenation (ECMO) have been available for children with systolic heart failure awaiting transplantation. Now a new report by Charles Fraser, Jr and colleagues published in the New England Journal of Medicine provides important new information about a ventricular assist device (VAD) designed for children. Trial investigators implanted 48 patients with the Excor…

Click here to continue reading…