This morning STAT published an Op-Ed piece I wrote about the Apple Watch. Here’s how it starts: Set your smartwatch alarm. You’re about to be barraged by tons of hype about the health benefits of the Apple Watch. Unfortunately, it won’t include essential information and data that can put these claims in proper perspective. Last year,…
If You Look For Atrial Fibrillation You Will Find Atrial Fibrillation
July 10, 2018 by 3 Comments
If you look hard to find people who have atrial fibrillation (AF) you will in fact find people who have atrial fibrillation, a new paper published in JAMA shows. But the paper offers no evidence whatsoever that the new diagnosis improves outcomes in these people, though it does find that the diagnosis leads to increased use of…
CABANA: No Outcomes Benefit In First Big Trial Of AF Ablation
May 10, 2018 by 5 Comments
(Updated) Catheter ablation for atrial fibrillation (AF) produced no significant improvement in clinical outcomes in a large and important new clinical trial. CABANA is the first and long anticipated randomized controlled trial of AF ablation in the more than two decade long history of the procedure. The results will likely spark an intense controversy in…
Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding
November 10, 2015 by Leave a Comment
A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…
200-Year-Old Heart Drug Linked To Increased Risk Of Death
May 5, 2015 by Leave a Comment
For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin. Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there…
What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific
March 13, 2015 by Leave a Comment
Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…
FDA Approves New Oral Anticoagulant From Daiichi Sankyo
January 8, 2015 by 1 Comment
And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace… … Click here to read the full post on Forbes, including a…
AF Patients at Increased Risk for Silent Strokes
November 4, 2014 by Leave a Comment
The increased risk of stroke in people with atrial fibrillation (AF) is well known, and this stroke risk is, of course, linked to an increased risk of cognitive impairment and dementia. Less well known is that people with AF have an increased risk for cognitive impairment independent of their stroke risk. Now a new study published…
FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device
October 8, 2014 by Leave a Comment
The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. … Click here…
Novel Boston Scientific Device Headed For Another Rough FDA Panel
October 7, 2014 by Leave a Comment
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…
Study Offers Little Support for an Old Drug
August 11, 2014 by Leave a Comment
Digoxin is one of the oldest drugs in the cardiovascular arsenal, derived from the foxglove plant and first described in the 18th century by William Withering. It is frequently used in patients with heart failure (HF) and with atrial fibrillation (AF). The few trials supporting its use were performed in HF patients before newer treatments…
Yet Another Delay For Boston Scientific’s Watchman Device
June 17, 2014 by Leave a Comment
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said…
Hospitalizations For Atrial Fibrillation Are On The Rise
May 19, 2014 by Leave a Comment
In recent years there has been an explosion of interest in atrial fibrillation (AF), the most common heart rhythm disorder. Although it is sometimes thought to be relatively benign, AF increases the risk of stroke if untreated. Even if treated, it can be the source of significant discomfort and can contribute to additional complications, especially…
Exercise: Can There Be Too Much Of A Good Thing?
May 15, 2014 by Leave a Comment
In recent years researchers have developed a more complicated view of the relationship of health and exercise. Although observational studies have consistently shown that some physical activity is better than none, studies that have drilled deeper into the data suggest that these health benefits may be curtailed in people who exercise very frequently or very…
New Atrial Fibrillation Guideline Supports New Drugs And Devices
March 28, 2014 by Leave a Comment
A new guideline for atrial fibrillation (AF) was released on Friday by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. Among other features, the 2014 Guideline for the Management of Patients With Atrial Fibrillation incorporates important new information about the new oral anticoagulants and catheter ablation for the treatment…
Warfarin Benefits Extended To Patients with Chronic Kidney Disease
March 4, 2014 by Leave a Comment
Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD….
Artery Zapping Little Better Than Drugs In Atrial Fibrillation Patients
February 18, 2014 by Leave a Comment
Atrial fibrillation is the most common heart rhythm disorder. Although AF is not as lethal as some other arrhythmias, AF patients are at high risk for stroke and other serious complications. AF is also very difficult to treat. Although drugs are ineffective in a large percentage of patients, drugs are considered first line therapy in…
Problems Persist Despite Gains In Oral Anticoagulant Use
January 28, 2014 by Leave a Comment
Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk of stroke. Many elderly patients are not receiving oral anticoagulants and overall too many patients…
FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific
December 12, 2013 by Leave a Comment
The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the…
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…
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…
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…
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