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Source: CardioBrief
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Total 307 results found since Jan 2013.
Using Registry Data, FDA Expands Indication For Edwards’ Sapien Transcatheter Heart Valves
Relying on an important new source of information. the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points and therefore allows for alternative access points such as the subclavian. The most significant part of the FDA’s announcement may be not the label change itself but the source of the data supporting the claim, the Transcatheter Valve Therapy Registry More…
Source: CardioBrief - September 23, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics Source Type: blogs
Both Overuse And Underuse Explain Disparities In Heart Procedures
A new study finds that groups who have often been found to receive less medical care– non-whites, women, and people without private insurance or who are from urban and rural areas– are less likely to undergo coronary revascularization. But the same study finds that this disparity may be in no small part due to the fact that these same groups are less likely to receive inappropriate procedures. The study, published online in the Journal of the American College of Cardiology, suggests, therefore, that the apparent underuse of healthcare in some groups may be partly counterbalanced by overuse in other grou...
Source: CardioBrief - September 18, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery American College of Cardiology appropriate use criteria NCDR PCI Source Type: blogs
Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology
Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology, have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some experts have proclaimed renal denervation a potential “cure” for resistant hypertension, perhaps enabling a significant number of patients to eliminate all drug therapy. Other expanded uses of the technology in more moderate forms of hypertension and other...
Source: CardioBrief - September 10, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Policy & Ethics Prevention, Epidemiology & Outcomes blood pressure Clinical trial hypertension Medtronic renal denervation st jude medical Source Type: blogs
New Test Could Speed Heart Attack Treatment In The Emergency Department
Only 1 in 10 patients with acute chest pain in the emergency department turn out to have an actual heart attack (myocardial infarction), yet many are not released from the hospital until after 6-12 hours of cardiac monitoring and multiple ECG and troponin tests. The search for a test that can rule out MI early in the process has proved elusive. The Biomarkers in Cardiology-8 (BIC-8) trial, presented at the European Society of Cardiology meeting in Amsterdam, was designed to determine the utility of the combination of troponin and copeptin testing. Copeptin is a marker of severe hemodynamic More…
Source: CardioBrief - September 4, 2013 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Acute coronary syndrome Biomarker European Society of Cardiology health myocardial infarction Source Type: blogs
Study Fails To Support Broader Patient Population For Cardiac-Resynchronization Therapy
Cardiac-resynchronization therapy (CRT) has been shown to be beneficial in heart failure (HF) patients with a wide QRS interval. These benefits have not been reproduced so far in patients with narrow QRS intervals, though many such patients have ventricular dyssynchrony. Now a new study, presented at the European Society of Cardiology in Amsterdam and published simultaneously in the New England Journal of Medicine, once again has failed to find benefits for CRT in a broader patient population. The EchoCRT Study Group randomized HF patients with a QRS duration < 130 msec and left ventricular dyssnchrony upon echocardiography. More…
Source: CardioBrief - September 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Heart Rhythms Amsterdam CRT European Society of Cardiology QRS complex Source Type: blogs
Automatic Wireless Monitoring Shows Benefits in Chronic Heart Failure
Following in the wake of studies that failed to find benefits associated with remote wireless monitoring of heart failure (HF) patients, the In-Time trial, presented at the European Society of Cardiology meeting in Amsterdam, is the first trial to show that home monitoring of HF patients may be beneficial. Gerhard Hindricks, the coordinating investigator of the trial, said that In-Time was designed to test whether automatic remote home monitoring can detect events that precede clinical events and thereby spark interventions to help reduce hospitalizations for HF. In the trial, 664 chronic HF patients with an indication for More…
Source: CardioBrief - September 2, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Prevention, Epidemiology & Outcomes Amsterdam European Society of Cardiology Forbes Gerhard Hindricks Source Type: blogs
Cardiovascular Outcome Studies in Diabetes Drugs Finally Arrive
For many years critics have bemoaned the absence of outcome studies for the many diabetes drugs used to lower blood glucose levels. Now, finally, two large trials with different drugs have been presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in The New England Journal of Medicine. The good news is that the drugs appear safe. Both trials turned up no evidence for the adverse cardiovascular events that some had feared. The bad news is that neither drug appeared to improve cardiovascular outcomes, though cardiovascular disease is the cause of death in More…
Source: CardioBrief - September 2, 2013 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes Alogliptin Anti-diabetic medication AstraZeneca Bristol Myers Squibb European Society of Cardiology food and drug administration Nesina new england journal of medicine Onglyza Taked Source Type: blogs
Pretreatment with Prasugrel Not Indicated in NSTEMI
Although current guidelines strongly recommend that dual antiplatelet therapy be administered early in treating patients with non-ST-segment-elevation acute myocardial infarction (NSTEMI), it is unclear whether pretreatment is beneficial,especially with the newer, more potent and more rapidly acting antiplatelet agents prasugrel (Effient, Lilly) and ticagrelor (Brilinta, AstraZeneca). Now a large new study, ACCOAST, presented at the European Society of Cardiology in Amsterdam and published simultaneously in the New England Journal of Medicine, offers strong evidence that pretreatment with prasugrel should not be perfo...
Source: CardioBrief - September 1, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Antiplatelet drug AstraZeneca European Society of Cardiology myocardial infarction prasugrel Source Type: blogs
A Disruptive TASTE of the Future? Getting the Best of Randomized Trials AND Observational Studies
A new study from Scandanavia may influence the treatment of acute myocardial infarction. But it also may end up having a much bigger impact on the entire field of medicine by pointing the way to an entirely new way of performing randomized clinical trials rapidly and inexpensively. One expert said the trial design may represent “a new paradigm,” and for once the use of the p-word may actually be appropriate. Thrombus aspiration for ST-segment elevation myocardial infarction (STEMI) has been kicking around for a long time, but its utility has never been definitively evaluated. The More…
Source: CardioBrief - September 1, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery MI/ACS Policy & Ethics Conventional PCI European Society of Cardiology myocardial infarction new england journal of medicine Randomized controlled trial SCAAR Thrombus Source Type: blogs
Disappointing Results with Dabigatran for Mechanical Valves
Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer serious interactions with other drugs and food. So far, however, there has been no convincing demonstration that the the newer agents are as safe and effective as warfarin for this indication. RE-ALIGN was a phase 2 dose-valid...
Source: CardioBrief - September 1, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Anticoagulant Artificial heart valve dabigatran European Society of Cardiology new england journal of medicine RE-ALIGN warfarin Source Type: blogs
Positive Results for New Anticoagulant From Daiichi Sankyo
A new entrant in the growing oral anticoagulant field shows promise for the treatment of venous thromboembolism (VTE) and pulmonary embolism (PE). The drug, edoxaban, is a new, once-daily Factor Xa inhibitor with a rapid onset of action that is under development by Daiichi Sankyo. Results of the Hokusai-VTE trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine. The Hokusai-VTE investigators randomized 4921 patients with VTE and 3319 patients with PE to either warfarin or edoxaban. The trial differed from some earlier trials w...
Source: CardioBrief - September 1, 2013 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Anticoagulant Daiichi Sankyo European Society of Cardiology new england journal of medicine pulmonary embolism VTE Source Type: blogs
American Heart Association Announces Late-Breaking Clinical Trials
There are still a few days left in August and the European Society of Cardiology meeting doesn’t start until this weekend in Amsterdam. Nevertheless, the American Heart Association has released the list of late-breaking clinical trials for the annual meeting in November. Late-Breaking Clinical Trials 1: Acute Cardiovascular and Cerebrovascular Care Sunday, Nov 17, 2013, 4:00 PM – 5:19 PM Moderators: Lance Becker, Philadelphia, PA Stephen Bernard, Melbourne, Australia 4:00 PM: Nitrites in Acute Myocardial Infarction Nishat Siddiqi, Univ of Aberdeen, Aberdeen, United Kingdom Discussant: Kenneth Bloch, Boston...
Source: CardioBrief - August 27, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Heart Rhythms Interventional Cardiology & Surgery MI/ACS People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes american heart association Clinical trial Source Type: blogs
New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized incidents, have forced the FDA and ICD companies to initiate recalls. Now a prominent cardiologist writes that the S-ICD poses an “existential crisis” for previous generations of ICDs. FDA approval of the S-ICD was based on a pivotal trial designed More…
Source: CardioBrief - August 26, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Policy & Ethics Boston Scientific Defibrillation FDA food and drug administration implantable cardioverter defibrillator Ventricular fibrillation Source Type: blogs
Can Inflating A Blood Pressure Cuff Improve Outcomes Following Bypass Surgery?
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 c...
Source: CardioBrief - August 15, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Blood flow Coronary artery bypass surgery ischemia Lancet preconditioning Source Type: blogs
Fuster To Succeed DeMaria As Editor Of JACC
The American College of Cardiology has announced that Valentin Fuster will be the next editor-in-chief of the Journal of the American College of Cardiology. Fuster will succeed the current editor, Anthony DeMaria, beginning in 2014. … Click here to read the full post on Forbes.
Source: CardioBrief - August 15, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events American College of Cardiology Elsevier Fuster journal of the american college of cardiology Valentin Fuster Source Type: blogs
