I have never seen such enthusiasm and adoption of a device with such low-quality data. In my practice, it has also been disappointing to see the fervor with which colleagues I respect adopted this procedure. Hopefully, this new trial will take some steam out of the referrals. Will need to see the results of upcoming trials, but am certainly concerned that these are industry-sponsored.
As you’ve noted in the past, it is a travesty that this procedure received regulatory and payer approval based on such dismal prior data.
And now, after 500k devices in the US….oops, it actually doesn’t work as well as DOAC. Well golly if they’d only figured that out before foisting it upon so many unsuspecting buyers (patients).
You’ve often spoke of “medical reversal” when it comes to previously well-founded/ evidence-based therapies that no longer pass muster in contemporary care (such as BB post MI with preserved LV function). This current scenario is more akin to a “medical correction”, when loads of people were doing the wrong thing based on dubious evidence, and need to stop perpetuating insanity immediately.
Probably the numbers are too small to reach any conclusion but I can't help but wonder how the 10% that received no anticoagulants compared with the other groups.
Such an astute question b/c I for one would want a NO anticoagulant arm of a LAAC trial in super high risk older pts. Proponents argue it’s not ethical to do nothing, but in CLOSURE, a pt randomized to that arm would avoid risk of serious complications from the procedure: bleeding requiring transfusion, embolization of device, tamponade, even death. A pt randomized to No Rx goes to lunch w their family rather than a procedure room where a device is placed into their heart.
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.
JR. it’s an RCT. As in randomized. There should be no “gravitating” to a group. Interesting also was that one of the inclusion criteria was major bleeding episode.
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.
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.
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.
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
Update: I just noticed that “skeptic” suggests everyone should get a COVID vax this year, including children. Under “What Fall Vaccinations Should You Get?” I find:
“Do we really need a Covid-19 vaccine every year—or would skipping a year be better? An annual dose continues to provide additional protection to everyone, including children.” That tells me everything I need to know about Dr Skeptic.
I have never seen such enthusiasm and adoption of a device with such low-quality data. In my practice, it has also been disappointing to see the fervor with which colleagues I respect adopted this procedure. Hopefully, this new trial will take some steam out of the referrals. Will need to see the results of upcoming trials, but am certainly concerned that these are industry-sponsored.
So I should have my Boston device removed and return to OACs?
As you’ve noted in the past, it is a travesty that this procedure received regulatory and payer approval based on such dismal prior data.
And now, after 500k devices in the US….oops, it actually doesn’t work as well as DOAC. Well golly if they’d only figured that out before foisting it upon so many unsuspecting buyers (patients).
You’ve often spoke of “medical reversal” when it comes to previously well-founded/ evidence-based therapies that no longer pass muster in contemporary care (such as BB post MI with preserved LV function). This current scenario is more akin to a “medical correction”, when loads of people were doing the wrong thing based on dubious evidence, and need to stop perpetuating insanity immediately.
SC — I would not call it a reversal yet. There are still two large trials to be reported.
Probably the numbers are too small to reach any conclusion but I can't help but wonder how the 10% that received no anticoagulants compared with the other groups.
Such an astute question b/c I for one would want a NO anticoagulant arm of a LAAC trial in super high risk older pts. Proponents argue it’s not ethical to do nothing, but in CLOSURE, a pt randomized to that arm would avoid risk of serious complications from the procedure: bleeding requiring transfusion, embolization of device, tamponade, even death. A pt randomized to No Rx goes to lunch w their family rather than a procedure room where a device is placed into their heart.
Thank you for the response. I would see it the same way.
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.
JR. it’s an RCT. As in randomized. There should be no “gravitating” to a group. Interesting also was that one of the inclusion criteria was major bleeding episode.
Cardiologists’ lake houses and ski trips don’t pay for themselves, ya know.
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.
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.
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.
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
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
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)
Paywalled.
Update: I just noticed that “skeptic” suggests everyone should get a COVID vax this year, including children. Under “What Fall Vaccinations Should You Get?” I find:
“Do we really need a Covid-19 vaccine every year—or would skipping a year be better? An annual dose continues to provide additional protection to everyone, including children.” That tells me everything I need to know about Dr Skeptic.
https://substack.com/@theskepticalcardiologist/p-175628171
Science vs. Industry. Keep it up John.