Hi George,
As you noted, afibbers who require LAA isolation to achieve long term durable freedom from all atrial arrhythmia are a class of patients that often very specifically benefit from LAA Closure. The proper perspective for decision making in such LAA-Iso patients definitely supercedes much of the rather limited short term cherry-picked data analysis Dr John and his two compatriots from Penn State (with their strong 'Big Pharma'/NOAC' support backgrounds) are trying to paint with using narrow analysis of mostly the 18 month follow top window of these two older early trials on Watchman and certainly emphasizing their view from the NOAC angle for anti-coagulation vs LAAC for folks who require OAC for an elevated CHADS2-VASC Stroke Risk score. Their discussion and assumptions have far less to do with use of the Watchman for the specific patient group with LAA-isolation who can often benefit the most from LAA closure as George was pointing to above.
Certainly, LAAC is not for all Afibbers, nor is it a universal replacement for all OAC drugs, not by any means! It is mainly targeting those who cannot or will not take OAC/NOAC drugs which represent over 40% of all Afibbers who qualify to take a blood thinner based on their stroke risk scores!! That is a LOT of people who prior to LAA closure had no good choices at all!
And LAAC preformed by expert opertors for the right patients does have very real and profound merit for a good percentage of afibbers, and especially so for those, like so many from our forum who either have already, or will eventually, benefit from LAA-isolation.
Alas, a few of the authors reasonable points get overshadowed by their focusing almost entirely on the rear view mirror using a very short term 18 month follow up window for drawing such largely highly presumptive conclusions as: the highly speculative and premature pronouncement by Dr John that "LAAC just does not work :-)" ... based on a few select data points from just the first two RCTs conducted on Watchman a good number of years ago now. And without even acknowledging much of the excellent more recent data too that has been collected since those early stage RCTs were published as well as the ver large number of successful LAA closure cases performed since theeasrly trials that strongly support the opposite presumptions promoted in their HRS article.
I welcome the article as a good point of debate which is essential in the scientific method, and congrats to Dr Mandrola for his first published peer-reviewed analysis and editorial, that is a very good and deserved feather in his cap. Nevertheless, I do very much disagree with the overriding conclusion he derives from PROTECT AF and PREVAIL pronouncing LAA closure a failure based on this still comparatively narrow window of data. Lets see what the 5 year follow up results from PREVAIL show that are due out in 2018 ... not to mention a growing list of very well done non-randomized studies from around the world over the last few years too all pointing to the signiifcant improvements in application/installation methodology and improved outcomes with significant reductions in complications as well compared to the spike in complications baked into the the early phase of PROTECT-AF.
It's all fine and good as part of the scientific debate to point out a few potential limitations of an early proof of concept study phase of an all new technology, but it is more than a bit disingenuous, in my view, to focus so narrowly on just those few metrics one can so easily over-interpret when trying to score a narrow point while missing entirely the larger forest for the trees! Especially when, to my knowledge, none of the three authors of this report have ever performed even one LAA Closure procedure themselves!
I know Dr. John means well, and I can attest that he is a very nice guy and is an outstanding writer and he is certainly entitled to his opinion. I also agree wholeheartedly with some of his writings and positions such as his support for life style risk factor management this website also has promoted for far longer than anyone in the EP world, and I very much value his views and writings own palliative care that his wife as a palliative care specialist physicians has done very good work in afield I fully support as well.
I had a nice get together with Dr John in Chicago in May where I expressed not only my appreciation and admiration for his excellent communication skills with a pen and some of our shared topics of support in common But I also noted the areas he often posits in his Medscape column that I strongly disagree with from not only my own long experience, but from that of our 19 years forums experience as well and I emphasized that none of my disagreement with these points was personal in any way. Dr Mandrole readily agreed and said he did not take any such critiques personally and that in some cases he is not as wedded to some topics as it may seem but rather is asked to stimulate controversy to some degree as well. Obviously, if all he wrote was in total agreement with the EP/Cardio world status quo, it would make for a more boring reading and stimulate less interesting and thoughtful debate and thus less success for Medscape as well.
Basically there are three main areas he often discusses that I, and many others in this field disagree with. The role and efficacy with persistent and LSPAF AFIB ablation done by expert operators, the role of LAA as a target for ablation in such advanced cases, and the potential of LAA Closure in its multiple manifestations, as an especially valuable adjunct for those who require LAA isolation to end their otherwise unending battle with persistent atrial arrhythmia.
In that light I feel he over-reaches here once again, just as with his summary and premature dismissal of The BELIEF Trial two years ago. Part of this tendency of his ... I think ... stems from his mandate from MedScape to generate controversial debate to increase the click rate and reader interest in his articles. Though I also have no doubt he truly buys into his mantra here lambasting all treatments related to the LAA and in no way am I suggesting he views this issue as simply a way to aggravate the EP world and increase reader hits alone. He does believe he is correct on this issue, while I feel he may be statistically correct in narrow areas but misses badly on the bigger picture implications and practical efficacy of LAAC in well chosen cases and when installed and followed up by highly experienced operators.
Ironically, had his stance regarding all things LAA gained universal acceptance a decade ago just before my LAA isolation way back then completely liberated me from the depths of a highly aggressive persistent AFIB. Should he have won such a stretch of an argument back then, it would have surely condemned me and so many thousands of other now long-term 'FORMER' persistent afibbers ... to a life of slow-burn misery locked into an entirely un-winnable downward spiral with the Beast! ... I shudder to think.
Thank heaven's and hallelujah for greater visionary leaders in the EP world who clearly have seen the forest while not getting side-tracked within the minutia of the trees on this complex and very important topic of the LAA.
All this will clarify itself in due time as the tidal wave of more recent data and insights in this field overwhelm those neigh-sayers who, for the most part, have had very little to do with LAA issues in their daily medical practices, if any at all.
And in the meantime, I highly suggest folks near to this topic pay attention to the many true experts in this area who have been working diligently every day for years to unlock the nuances and insights in how best to turn that knowledge into practical solutions for us all. And, most significantly, I have yet to see even just one of the many hundreds of highly intelligent and dedicated physicians working so hard with LAA-based therapies to benefit the most challenging type of AFIB patients, to suddenly decide its all been a big mistake and abandon their progress and call it quits on this important aspect of the field.
Quite the opposite, I have witnessed steadily increasing enthusiasm expressed ... and being realized ... across the board with these therapies as the months and years of progress unfold.
Cheers!
Shannon
Edited 3 time(s). Last edit at 10/15/2017 06:34PM by Shannon.