Editor’s note: 86-year-old Nina Mishkin was still healthy and active when she went to Dublin, Ireland last September. After she returned home she developed atrial fibrillation, and then much more. “I never felt particularly vulnerable and fragile before,” she writes. “Now I do… It’s a different universe I inhabit.” I am grateful to Nina for giving…
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…
Guest Post: Get Ready For A Tsunami Of ECGs
December 12, 2017 by 11 Comments
Editor’s note: Ethan Weiss, a cardiologist at UCSF, reflects on a recent patient who may well be a forerunner of many more patients in the near future. I saw a man in his early 40’s. He’s super healthy. He had a Ziopatch as part of a general medical workup (not really important why). He was…
Caffeine Study Gives Heart Failure Patients Green Light To Drink Coffee
October 17, 2016 by 1 Comment
–A small but rigorous study found no arrhythmias caused by caffeine consumption. Many people with heart failure are advised to avoid coffee because of fears that caffeine might provoke an arrhythmia. Now a rare example of a randomized controlled trial in the field offers some assuring evidence that these patients can safely drink coffee. The…
FDA Reaffirms Safety And Efficacy Of Rivaroxaban
October 11, 2016 by Leave a Comment
–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…
More Bleeding Linked To Rivaroxaban In Observational Study
October 4, 2016 by 1 Comment
–Compared to dabigatran, rivaroxaban was associated with more intracranial and other serious bleeds. A new observational study finds that patients who take rivaroxaban (Xarelto, Johnson & Johnson) may be more likely to have serious bleeding events than patients who take dabigatran (Pradaxa, Boehringer Ingelheim). In a paper published in JAMA Internal Medicine, David Graham and…
Guest Post: JACC Retracts AF Ablation Trial
September 12, 2016 by Leave a Comment
Editor’s note: This guest post by Dalmeet Singh Chawla is reprinted with the permission of Retraction Watch, where it was originally published in a slightly different form. –Lead author Andrea Natale claims undue industry influence. The Journal of the American College of Cardiology (JACC) has retracted a recently published paper that questioned the effectiveness of a treatment for atrial…
FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants
August 17, 2016 by Leave a Comment
Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…
ROCKET AF Investigators Say New Analysis Supports Original Trial Results
July 6, 2016 by 1 Comment
–Test of stored blood may help answer troubling questions about the trial. A new analysis of stored blood by the ROCKET AF trial investigators may help resolve lingering questions about the trial. The questions about ROCKET AF, which compared rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation, emerged last November, when…
New Studies Seek To Allay Concerns Over The ROCKET-AF Trial
February 3, 2016 by Leave a Comment
New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…
Precision Medicine, Stuck In Second Grade, Flunks Test Of Clinical Utility
January 5, 2016 by 4 Comments
One of the great scientific achievements of the past generation has been the identification and characterization of the genetic underpinnings for many diseases. By combining genetic information with other forms of research doctors have been able to reach a much deeper understanding of many diseases. In a few cases genetic information has proved useful in screening…
New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
November 30, 2015 by 1 Comment
(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…
CMS Proposal Would Plug Up Watchman Reimbursement
November 11, 2015 by Leave a Comment
Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…
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…
New York Times: Indiana Cardiologist Accused Of Performing Unnecessary Procedures
October 18, 2015 by Leave a Comment
Just when you thought it was safe to read the paper again, along comes a New York Times report suggesting that not all cardiologists have learned the seemingly obvious lessons from the overuse scandals from the past decade. In a front page article in Sunday’s business section, Julie Creswell writes about the ongoing controversy and scandal involving cardiologist Arvind Gandhi,…
DOJ May Soon Announce Settlements With Hundreds Of Hospitals Over ICD Overuse
September 29, 2015 by Leave a Comment
The US Department of Justice may be getting ready to announce that hundreds of hospitals have settled with the government in response to a lengthy investigation over ICD (implantable cardioverter defibrillator) overuse, according to an article by Lisa Schencker in Modern Healthcare. “The U.S. Justice Department may announce in the coming weeks what may be the largest False Claims Act…
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…
FDA Approves Amgen Heart Failure Drug
April 15, 2015 by Leave a Comment
The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes. …
Gilead’s Hepatitis Drugs Tripped By Old Heart Drug
March 23, 2015 by Leave a Comment
Late last week Gilead Sciences issued a warning about a rare but potentially fatal interaction between its stellar new hepatitis C drug sofosbuvir and amiodarone, a potent but tricky antiarrhythmic agent. Sofosbuvir is marketed as Sovaldi and, in combination with another antiviral agent, as Harvoni. Amiodarone, which is used to treat dangerous heart rhythm problems, has a number of…
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…
Cardiology Drugs Of The Year: New, Old, And Not-So-Funny
December 18, 2014 by 1 Comment
New Drug Of The Year: LCZ696 from Novartis Old Drug of the Year: Ezetimibe Not-So-Funny Drug of the Year: Ivabradine … Click here to read the full post on Forbes. …
Study Suggests Epinephrine for Cardiac Arrest May Be Harmful
December 1, 2014 by Leave a Comment
Epinephrine has been a cornerstone of therapy during cardiac resuscitation after cardiac arrest because of its well-established ability to stimulate the heart and increase the probability of a return of spontaneous circulation (ROSC). In recent years, however, concerns have been raised that people treated with epinephrine may have worse neurological outcomes following their resuscitation. In a…
FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug
October 31, 2014 by Leave a Comment
On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed. … Click here to read the full post on Forbes….
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