Perhaps I’m being overdramatic but I think the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball. The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable. But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing…
New Trial Confirms Role For Pradaxa In Venous Thromboembolism
December 18, 2013 by Leave a Comment
A new study helps support a role for the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE). The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for…
Boston Scientific May Face A Tough FDA Panel
December 10, 2013 by Leave a Comment
On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response…
Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
December 5, 2013 by Leave a Comment
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of…
Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug?
December 4, 2013 by Leave a Comment
Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the…
New Anticoagulant From Daiichi Sankyo Works Well In AF Patients
November 19, 2013 by Leave a Comment
Edoxaban, a direct oral factor Xa inhibitor under development by Daiichi Sankyo, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. The results of the trial were…
First Leadless Pacemaker Gains Approval In Europe
October 15, 2013 by Leave a Comment
St. Jude Medical announced on Monday that the world’s first leadless pacemaker had gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude…
Study Fails To Support Broader Patient Population For Cardiac-Resynchronization Therapy
September 3, 2013 by Leave a Comment
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…
American Heart Association Announces Late-Breaking Clinical Trials
August 27, 2013 by Leave a Comment
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 –…
New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
August 26, 2013 by Leave a Comment
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…
Observational Study Lends Support to CRT Guidelines
August 13, 2013 by Leave a Comment
A large observational study published in JAMA suggests that patients with left bundle-branch block (LBBB) and longer QRS duration derive the most benefit from a cardiac resynchronization therapy defibrillator (CRT-D). The findings appear to support current, but often criticized, guidelines from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society, in which a class I recommendation…
Too Much, Too Fast? Cross-Country Skiing And Heart Arrhythmias
June 12, 2013 by 1 Comment
When it comes to exercise it may be true that you can do too much or go too fast. It may seem counterintuitive but a new study finds that among cross-country skiers the risk of having a cardiac arrhythmia was highest in those who raced the fastest or most often. … In a paper published in…
People With Sleep Apnea At Increased Risk For Sudden Cardiac Death
June 11, 2013 by Leave a Comment
Although people with obstructive sleep apnea (OSA) have an increased risk for death and cardiovascular disease, the relationship between OSA and sudden cardiac death (SCD) has not been clear. Now a new study published in the Journal of the American College of Cardiology provides evidence that OSA is in fact associated with an increase in the risk…
Athletes With Defibrillators Don’t Need To Quit Sports
May 21, 2013 by Leave a Comment
Although the American College of Cardiology and the European Society of Cardiology now advise people with ICDs not to participate in vigorous sports, a new study offers strong support for people with ICDs who want to take part in sports. Although a large number of people with ICDs are elderly heart failure patients who are unlikely…
Study Questions Role Of Dual-Chamber ICDs For Primary Prevention
May 14, 2013 by Leave a Comment
Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC…
Novel Leadless Pacemaker Makes Debut At HRS 2013
May 13, 2013 by Leave a Comment
First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy. Pacemaker leads are the most common source of complications associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism. The device…
Encouraging 4 Year Results For Watchman Device In AF Patients
May 10, 2013 by Leave a Comment
Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver. Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events…
Another Disappointing Study For Fish Oil Supplements
May 8, 2013 by 3 Comments
Another large study has failed to find any benefits for fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement…
BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block
April 24, 2013 by Leave a Comment
Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may…
Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran
April 4, 2013 by Leave a Comment
As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American…
Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns
March 27, 2013 by Leave a Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Case Report Of Durata Lead Failure Raises Fresh Concerns by Edward J. Schloss, MD A case report of a failed St. Jude Medical Durata…
FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators
March 22, 2013 by Leave a Comment
Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist…
CHMP And FDA Diverge On Mipomersen And Rivaroxaban
March 22, 2013 by Leave a Comment
The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected— for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…
FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran
March 13, 2013 by 1 Comment
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…
Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC
March 9, 2013 by 2 Comments
UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that…
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