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Total 307 results found since Jan 2013.

First Drug-Coated Balloon Approved By FDA For Leg Blockages
The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012. … Click here to read the full post on Forbes.  
Source: CardioBrief - October 10, 2014 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics CR Bard FDA Lutonix PAD peripheral artery disease Source Type: blogs

Novel Boston Scientific Device Headed For Another Rough FDA Panel
On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe th...
Source: CardioBrief - October 7, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Interventional Cardiology & Surgery People, Places & Events Policy & Ethics atrial fibrillation Boston Scientific FDA stroke Watchman Source Type: blogs

Nissen Urges Prompt Revision Of Cardiovascular Guidelines
Sparked by a new study that once again finds serious flaws in the cardiovascular risk calculator at the heart of the American College of Cardiology/American Heart Association cardiovascular guidelines, Steve Nissen states that “the ACC and AHA should promptly revise the guidelines to address the criticisms offered by independent authorities.” The CV risk calculator is a key component of the guidelines, since people are generally considered candidates for statins if they have a 10-year estimated risk of CV disease of 7.5% or higher according to the equations used by the calculator. In a study published in JA...
Source: CardioBrief - October 6, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes American Heart Assocation risk guidelines statins Source Type: blogs

A ‘Disappeared’ Article, Finally Published, Finds A Desultory Response To Scientific Misconduct
Back in January an article in the European Heart Journal raising the disturbing possibility that guidelines based on fraudulent research may have been responsible for as many as 800,000 deaths was “disappeared” from the journal’s website only minutes after being published. The journal’s editor claimed the article had not been properly peer reviewed. In its place the editors published an editorial refuting the claims of the article, though of course they were responding to an article that no one could then actually read. Now, eight months later, a revised version of the original article, byÂ...
Source: CardioBrief - September 23, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Bax guidelines Poldermans scientific misconduct Source Type: blogs

Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation
In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign.  In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all nonculprit lesions in heart attack patients should be performed. The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmfu...
Source: CardioBrief - September 22, 2014 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics American College of Cardiology Choosing Wisely guidelines primary PCI stents Source Type: blogs

Counterintuitive Advice About Staying Alive After A Heart Attack
… An interventional cardiologist– the cardiologists who put in stents and usually treat heart attack patients in the first few hours– asked an electrophysiologist– the cardiologists who treat arrhythmias– whether wearable defibrillators should be used post-MI. Here’s what that electrophysiologist, Edward J. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, replied. It is a good example of how sometimes a procedure or a therapy that seems, intuitively, to be worthwhile and beneficial, may actually not be beneficial at all. Here’s his r...
Source: CardioBrief - September 21, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms MI/ACS Policy & Ethics defibrillator ICD SCD wearable defibrillator Source Type: blogs

ACC And AHA Don’t Recommend Routine ECG Screening Of Young People
In a new scientific statement the American Heart Association and the American College of Cardiology do not recommend the routine initial use of ECGs to screen young people for underlying congenital or genetic heart disease. More aggressive screening for heart disease in young people is often advocated in response to pressure resulting from the rare but tragic cases of sudden death in young people. But a detailed examination of the evidence led the AHA/ACC group to conclude that routine initial ECG screening “in healthy people 12-25 years old without positive findings on the history and physical examination has not More…
Source: CardioBrief - September 15, 2014 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes ECG screening screening athletes sudden cardiac death Source Type: blogs

Japanese Research Scandal Involving Novartis Blood Pressure Drug Widens
The Japanese scandal over research using the Novartis blockbuster hypertension drug Diovan (valsartan) continues to widen. The first major figure brought down in the scandal was Hiroaki Matsubara, a prominent cardiologist and researcher at Kyoto Prefectural University in Japan, who  resigned from his position after numerous retractions and investigations. Then last year accusations surfaced about another prominent researcher, Issei Komuro, a professor at Chiba University. Chiba University has now completed an investigation of one of Komuro’s most important papers, the 2011 report of the Valsartan Amlodipin...
Source: CardioBrief - September 11, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Diovan Komuro Matsubara Novartis valsartan Source Type: blogs

FDA Advisory Panel Offers Cautious Support For Polypill
The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for more than a decade and has attracted considerable doses of support as well as skepticism. An all-star group of cardiology leaders– including Sir Nicholas Wald, Salim Yusuf, Suzanne Oparil, Sidney Smith, and Clyde Yancy– helped provide the spoonful ...
Source: CardioBrief - September 10, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes Uncategorized aspirin blood pressure FDA polypill statins Source Type: blogs

Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI
In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the interventional cardiology community. Bernard De Bruyne presented 2-year results from the FAME 2 (Fractional flow reserve versus Angiography for Multivessel Evaluation 2) study (simultaneously published in the New England Journal of Medicine). FAME 2 was de...
Source: CardioBrief - September 2, 2014 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery MI/ACS angina FFR NSTEMI st jude medical stents Volcano Corporation Source Type: blogs

Newly Elected European Society Of Cardiology President Co-Authored Hundreds Of Papers With Don Poldermans
The ESC today announced that Jeroen Bax, a Dutch cardiologist, will serve as the group’s President Elect for the next two years before becoming President starting in 2016. Bax is a professor of cardiology at Leiden University Medical Center. Bax is also known for his very close collaboration with Don Poldermans, the disgraced Dutch researcher who has been accused of significant and multiple examples of scientific misconduct. … Click here to read the full post on Forbes.      
Source: CardioBrief - September 1, 2014 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Bax European Society of Cardiology Poldermans Source Type: blogs

Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug
The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart failure indication. Now a very large new study presented at the European Society of Cardiology meeting in Barcelona and published simultaneously in the New England Journal of Medicine has found no evidence of benefit in a stable angina population and found more advers...
Source: CardioBrief - August 31, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Heart Rhythms People, Places & Events Policy & Ethics Amgen angina heart rate ivabradine Servier Source Type: blogs

SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug
The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart failure indication. Now a very large new study presented at the European Society of Cardiology meeting in Barcelona and published simultaneously in the New England Journal of Medicine has found no evidence of benefit in a stable angina population and found more advers...
Source: CardioBrief - August 31, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Heart Rhythms People, Places & Events Policy & Ethics Amgen angina heart rate ivabradine Servier Source Type: blogs

Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference
Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon. According to the ESC, the SIGNIFY investigators, who include Kim Fox, Ian Ford, Philippe Gabriel Steg, Jean-Claude Tardif, Michal Tendera, and Roberto Ferrari, told the ESC leadership that regulators at the European Medicines Authority (EMA) had told the inv...
Source: CardioBrief - August 30, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Heart Rhythms People, Places & Events Policy & Ethics Amgen EMA ivabradine Servier SIGNIFY Source Type: blogs

PARADIGM-HF Establishes a New Paradigm for Heart Failure Treatment
So far as I can tell the only problem with PARADIGM-HF is that the results are so good that it’s boring. Anyone interested can reasonably assume that what they hear or read about PARADIGM-HF — and cardiologists will be seeing and hearing an awful lot about it —  will be overwhelmingly positive. Briefly, the trial did everything its sponsor (Novartis) and its investigators (led by Milton Packer and John McMurray) hoped. It met all its major endpoints in all the subgroups without raising any sort of a safety signal. If the findings are confirmed after a More…
Source: CardioBrief - August 30, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics LCZ696 Milton Packer Novartis Source Type: blogs