10 Comments
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John Rumisek MD's avatar

Good overall review but would have appreciated deeper discussion of possible selection bias in the study. Patients at higher risk of bleeding on DOAC may have gravitated to the LAAC arm, compromising results.

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One In The Pipe's avatar

Cardiologists’ lake houses and ski trips don’t pay for themselves, ya know.

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David Newman's avatar

Wonderful, important examination. LAAC should henceforth be relegated to enrollment in randomized trials by advocates who feel they can narrow the population or improve the device to show benefit. Think so? Prove it. Until then no gizmo idolatry, no smoke and mirrors, and no

LAACs. Just sober appraisal of the data. Like this.

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JDM's avatar
3hEdited

A great critique. The devil, however, is in the details. It is not enough for us to take any study at face value, but to ask questions about the results, especially unexpected ones, such as bleeding or post-procedural complications.

Letters to the editors of the journal where this paper comes out, or, better, questions of the authors days after an oral presentation or publication of a preprint should produce more information about the concerning aspects of the study. The result of this timely attention should be that we get more information to better understand the reasons for the outcomes. Increased understanding should lead to either better future studies of the device or better use of the device such as patient selection, use of accompanying therapies or operator training.

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Robird's avatar

It would be interesting to understand the peri-procedural complications as these seem a major factor in LAAC to be of value in the afib patient cohort.

Was the bleeding related to vascular access, LA perforation, or other causes? Was one device more frequently involved with complications? Presumably the operators and centers were experienced and this was not a learning curve phenomenon.

Thanks for the review, as always concise and helpful.

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Don Roth's avatar

Great analysis; do you know of any studies where anti-coagulants such as liquid compares with platelet inhibitors such as aspirin for stroke prevention? Thanks

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Benjamin Hourani's avatar

Of all the eloquent study reviews published by sensible medicine over the years,this may be the pinnacle., zenith, and apotheosis.

I don’t wear a hat, but hats off and take a bow JM and AC

Ben Hourani MD, MBA

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The Skeptical Cardiologist's avatar

Thank you for your ongoing attempts to slow the LAAO train and for bringing this particular trial to our attention.

I am on board 100% and quote you extensively in my recent Substack update on atrial fibrillation (https://theskepticalcardiologist.substack.com/p/what-is-new-in-the-world-of-atrial)

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SAMUEL POLLOCK JR's avatar

Science vs. Industry. Keep it up John.

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Globinopathy's avatar

"The patient died but the operation (oops study) was a success" —surgeons who ignore procedure endpoints

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