18 Comments
User's avatar
Markus S's avatar

Thanks! re. "We exactly matched the length between the base and study cohort entry date" does it concern you that some DOAC patients were stable on treatment prior to starting in the study - prevalent user bias apparently is the term here? I'm no advocate for LAA devices but could be a valid critique??

Mohammed Ruzieh's avatar

That’s a reasonable concern. We also included patients who had prior bleeding so we didn’t only enroll low-risk patients. In addition, the trials of pLAAO included patients who were able to tolerate DOACs and we sought to do similar comparison.

Aussie Med Student's avatar

So... If I'm planning on refusing anticoagulation if I ever get Afib (no way am I going to have a CT Brain if I fall over and hit my head) it sounds like a Watchman is not on the table either. Especially as it requires an anti platelet forever and a day... I'm not Trump, I don't want nice thin blood...

Rod Rodriguez's avatar

This was a very sobering post. It’s possible to glean important insights from observational studies while also acknowledging their limitations. The study seems important enough to have not have been rejected so much.

Steve Cheung's avatar

Obviously no way to establish causation from this.

But I would view the confounders from the other direction. Even for people in whom, for one reason or another, the clinician actively decided to pursue LAAO implant, these pts bled more and had no embolic benefit. So either these clinicians were really lousy at what they do in terms of cherry-picking appropriate patients, and/or the procedure as a whole (including upfront procedural complications and early need for antiplatelet or anticoagulation) simply does not do any good and probably leads to net harm.

Andrew M's avatar

This is a great review and summary. Cost of watchman is over $30k for higher mortality?

Adam Cifu, MD's avatar

Thank you, Dr. Ruzieh. Excellent.

One After 909's avatar

I’m old and out of the game (ICU/ID) for 8 years but articles like this are invaluable because, sooner or later I will be a patient considering choices such as these.

So, the depiction is the catheter enters the RA traverses to the LA through interatrial septum, correct?

Matt Phillips's avatar

Translation- journals get support from industry ?

Gail Pickens Barger's avatar

Thank you. I could not be on blood thinners as it created a gastric bleed in my stomach. I had to find an alternative to the watchman. So I chose the minimally invasive outside of the heart maze procedure with a clipping of the left atrial appendage. No more afib! Gail

Anita Mitchell's avatar

My favorite part of the Hippocratic Oath. The premier portion...

The Tox Nurse's avatar

This was a really well written summary of a really fascinating study.

Sheila Crook-Lockwood's avatar

Thank you for writing this using "layman's" terms. I share so many items from Sensible Medicine with my nursing students. Still, they do complain that they don't understand much of the terminology, which doesn't elicit much sympathy from me! I am adding this article to the fall research class.

Running Burning Man's avatar

Disclaimer: I am not a Dr. and I did not stay at a Holiday Inn last night. However, I read quite a few Sensible Medicine articles, as well as other medical Substacks and sometimes even underlying studies. I don't have AF, but am fascinated by the condition, including why the LAA even exists ...

First, Dr Ruzieh: Wonderful article and your ability to write in terms that are easy to comprehend by mere mortals is greatly appreciated. Write more!

Second, Dr. Mandrola: Your note at the end is also really appreciated. It is a depressing reality that so much of what constitutes "the literature" is corrupted by publishing house bias. From a potential patient perspective for any medical intervention, it is just a tad unnerving.

Epaminondas's avatar

Fantastic points. The combination of a knowledgeable expert and excellent communicator is all too rare in medicine and science, so Dr. Ruzieh definitely deserves his kudos.

And Dr. Mandrola's addendum just reinforces my increasing belief that peer reviewed journals are mostly useless. Unfortunately, this isn't limited to medicine, but in all academic endeavors where journals act more like gatekeepers for their preferred perspectives rather than objective sources for quality research.

Anita Mitchell's avatar

Agree. Where $ is involved science becomes bendable

Robert H Lopez-Santini's avatar

That speaks volumes of the human condition. Perfection is a great target but an impossible to reach destination. Still, striving to do the best should be the way forward. Guess the atrial appendage clipping has not been included in these studies?