This concise (393 word) news release from the American Heart Association on a trial that used botulinum toxin to prevent irregular heart rhythms after bypass surgery packs a lot of good information into a small frame. The novel use of botulinum toxin represented in the story is an interesting and potentially important step toward a possible solution. As noted, the research was conducted in a small sample of 60 patients and although the results are impressive, they should be viewed with an understanding that many other potential therapies have failed on subsequent examination. The news release is written in a clear and measured way, although a clarification on the type of botulinum toxin used and the potential costs would have been helpful for reporters and the public.
Atrial fibrillation after coronary bypass surgery is a vexing problem. Most patients who develop atrial fibrillation post-procedure do so within a few days of the procedure so an intraoperative or preoperative solution seems reasonable.Atrial fibrillation can cause serious complications for the patient undergoing heart bypass, extend their stay in the hospital, and substantially drive up the costs of the heart treatment.
The story rightly points out that the development of atrial fibrillation after coronary artery bypass surgery has significant financial implications: “Atrial fibrillation is also always associated with lengthened hospitalization and that means increased healthcare costs.” But we would have liked to have seen some attention paid to the cost of the intervention, namely multiple injections of botulinum toxin. We calculate the cost of one 4mls vial of Xeomin (incobotulinumtoxinA) to be approximately $1000. This cost is likely to be rather small in comparison to the cost of extended hospitalizations, antiarrhythmic therapies and lost productivity from atrial fibrillation.
The story does a good job in detailing the results of the study and the apparent benefit of botulinum toxin injections in this small sample randomized study.
Researchers found that:
The story appropriately points out that there were no additional harms seen in the group injected with the botulinum toxin compared to those who received saline other than those associated with the surgery.
“No complications from the Botox injections were reported,” according to the release. “But complications from the bypass surgery were similar in both groups, including time in intensive care and on a breathing machine, and infection rate.”
The release satisfies this criterion but a few more details would have made the release even better. We are told that 60 subjects were enrolled and were randomly assigned to receive either botulinum toxin of saline. We are also told the study was blinded. Other important details about the study are omitted including baseline differences between the two groups, number of vessels engrafted, duration of bypass or number of off bypass procedures. All are important variables in the development of atrial fibrillation post operatively.
Atrial fibrillation post coronary artery bypass grafting (CABG) can dramatically impact the patient’s quality of life as well as potentially increase morbidity. The story does not over state the impact and provides statistics concerning its prevalence.
The funding sources (The Russian State Research Institute of Circulation Pathology and the Siberian Division of Russian Academy of Medical Sciences) are noted in the release.
Given the impact of post-operative atrial fibrillation, it is reasonable to assume that other attempts have been made to reduce its incidence in this population. A variety of antiarrhythmic drugs and beta adrenergic blockers have been studied with variable results. It would have been very helpful to add a few words about the alternative pharmalogical agents.
Since the release makes no claim that this therapy is ready to be used outside of clinical trials we’ll give this a satisfactory. The story makes it clear that botulinum toxin is available and is routinely used in cosmetic dermatology. For that use it’s sold under the trade name Botox Cosmetic. However, there are four different FDA approved strains of the toxin. Various formulations of the toxin have received FDA approval for use in treating excessive sweating, migraines, dystonia, bladder control issues, and several other non-cosmetic conditions. Those formulations have been available for many years as well. Since this is the first time botulinum toxin has been tested in human hearts, it’s safe to say that it could be several years before it receives approval as a preventative for heart complications. The release is clear that larger studies are needed.
Dr. Steinberg’s comments on the study being the “first in man” establishes the novelty of the approach.
The release does not use unjustifiable language. Instead, the language is very measured and appropriate.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like