American cardiologist/Electrofysiologist John Mandrola just issued a stern warning for the use of of left atrial appendage devices: “I am afraid. Really afraid that my colleagues will begin implanting these devices at the time of AF ablation. We do hundreds of thousands of AF ablation procedures per year in the US.
Yet the evidence from the OPTION-study does not come close to supporting placing a permanent foreign body in the heart. We could easily be wrong.
Our profession should demand stronger evidence before doing something so aggressive. Be warned. This could be one of the worse chapters in modern cardiology.”
Written by
Abbyroza
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For some time there have been doctors who question the wisdm of such devices as well as LAA removal. We really don't fully understand the role of the LAA so inerested in his reasonings.
I sometimes get the feeling that electrophysiologists are so enthusiastic about their new ‘toys’ that they tend to lose their normal caution. The marketing approach of the manufacturers of these devices -catheters, appendage closure apparatuses, stents,…- is also very agressive and they spend huge amounts of money on promotional material and conventions, making it even harder for cardiologists and electrophysiologists to keep a balanced view on things.
"The left atrial appendage (LAA), described as the “most lethal human attachment,” is responsible for >90% of embolic strokes.1 In 2020, stroke was the fifth leading cause of death in the United States after heart disease, cancer, COVID‐19, and unintentional injury.2 Atrial fibrillation (AF) is associated with a 4‐ to 5‐fold increased risk of ischemic stroke and accounts for 25% of the 700 000 cerebrovascular accidents that occur in the United States annually.3, 4 This translates to an average of $351.2 billion direct and indirect costs in the United States alone.3" CONTINUED>
Yes, and anticoagulation also also does not stop all clots. The role of both anticoagulation and LAA closure systems is not to eliminate all clots, but to reduce them significantly. Some of us either cannot take anticoagulation or choose not to take it. LAA closure devices may offer a reasonable option.
The Atriclip is also implanted, but not IN the heart. It is outside the heart and as you point out, the remark of dr. Mandrola thus has no bearing on the Atriclip.
Now I'm really worried as I had one fitted in 2017 on the NHS and thought this would be the answer to not being able to take anticoagulants. As these can't be removed I feel like I'm sitting on a time bomb.
I’m sorry if this stance of dr. Mandrola has gotten you worried. But I think it was still worth while sharing because the enthusiasm of electrophysiologists for new devices regularly obscures their view of the real world their patients live in. You’ll be fine, after 7 years.
Dr Mandrola prides himself on his medically conservative approach. He was similarly skeptical in his writing on Pulse Field Ablation when it first was being used though he has since modified his stance. The OPTION study referenced was overall positive in terms of safety on the use of left atrial appendage closure.
Do you think that a small grammatical mistake in a text written by someone who’s not English speaking (I’m from Flanders, my mother tongue is Dutch) is so important that it influences the message to a degree that makes it flawed? Strange attitude. If you don’t like the music, don’t shoot the (foreign) piano player. 😉
Why would Dr. Mandrola be afraid his "colleagues will begin implanting devices" in the LAA? Has he just now heard of this? His "colleagues" have been doing this for years with excellent results!
Which one of the implant devices is he afraid of, and why? I can't find information on that anywhere.
The OPTION Clinical Trial is one of others that shows this...
"The OPTION Clinical Trial, a breakthrough study in AFib treatment, is the first randomized, head-to-head study comparing WATCHMAN to OAC (95% DOACs) after cardiac ablation. The primary endpoints showed WATCHMAN FLX™ was equally effective to anticoagulation, with a superior safety profile, which allowed patients to eliminate continuous medication use and significantly reduce bleeding risk while maintaining stroke protection."
Look up Dr. Oussama Wazni (National Principal Investigator) discuss the OPTION Clinical Trial results.
I will add that I have personally talked with Dr. Wolf and Dr. Ohsutka (brilliant thoracic surgeons IMO) on LAA removal or occlusion and was fine with their results which includes thousands of patients over many years.
This is what dr. Mandrola writes about his concerns:
“The OPTION trial compared two strategies to reduce stroke and bleeding after catheter ablation of atrial fibrillation. The current strategy is to continue an anticoagulant medication. The alternative tested in OPTION is to implant a left atrial appendage device—abbreviated as LAAC (left atrial appendage closure.
PFablation is one of the most common procedures in my field. We ablate left atrial heart cells in attempt to reduce or eliminate episodes of AF. The success of AF ablation is debatable—and not the issue for this post.
I write today to sound a warning about a wave of implantation of devices placed into the left atrium at the same time as the ablation. CMS has already issued a special billing code for extra payment of the device.
In a Tweet from Christopher Ellis at Vanderbilt he is describing an implant at the same time as ablation. “Even dropped a FLXPRO” which is another name for a LAAC
As many readers know, I have long been skeptical regarding the evidence supporting this device. I’ve debated against LAAC on five continents. My main argument is that the device failed against warfarin in its seminal trials.
Proponents say, no worries, John, we will use LAAC in patients not eligible for anticoagulation. But these patients were excluded from clinical trials and we have near zero RCT-level evidence to support this procedure.
The thing that saddens me most is that hundreds of thousands of these devices have been implanted worldwide. And nearly no patient has been randomized.
Things got much worse this past weekend at the AHA meeting when the results of OPTION were released. The trial delivered positive results. Of course it did. I wrote days before that the trial was designed to deliver positive results.
Then I wrote yesterday about the four huge flaws of the trial. Briefly, the trialists chose an improper primary safety endpoint. Improper because it included nonprocedural major bleeding and nonmajor clinically-relevant bleeding. It is inappropriate to exclude procedural bleeding in the primary safety endpoint because procedural bleeding is the most common adverse effect of LAAC.
The second problem was an improper efficacy endpoint. The core treatment goal after AF ablation is stroke prevention. But the authors included all-cause death to the stroke/systemic embolism composite. This is a problem because efficacy was tested with a noninferiority design. Numerous studies show that neither anticoagulation nor appendage closure affects death. By adding an endpoint not affected by either treatment, you inflate the number of events (adding noise) and make noninferiority easier to reach.
Perhaps the most notable efficacy finding in OPTION was the very low stroke rates in either arm (1.2% and 1.3%). This is far lower than our simple CHADSVASC calculator would have it. To discern any signal of noninferiority or superiority of the device with stroke rates that low would require 5x more patients randomized. To sort out noninferiority in the DOAC vs warfarin trials required more than 10,000 patients per trial. OPTION enrolled only 1600.
The third problem was missing data. Nearly 9% of data was not collected. This is higher than either the safety and efficacy endpoint, respectively. This adds even more uncertainty to an already uninformative trial.
Finally, there is the issue of incomplete closure of the appendage with the device. One in five patients had incomplete closure. This is a worrisome outcome because peri-device leaks create turbulence and a higher incidence of clots and stroke.
I am afraid. Really afraid that my colleagues will begin implanting these devices at the time of AF ablation. We do hundreds of thousands of AF ablation procedures per year in the US.
All the forces are aligned to greatly expand the number of LAAC procedures. Doctors will earn extra money for these implants. High-volume procedural docs will gain status in their employed healthcare system as well as in the profession. Patients, too, will be excited when told that if they have the device they can stop anticoagulants. It’s easier to do the implant because you are already in the left atrium.
Yet the evidence from OPTION does not come close to supporting placing a permanent foreign body in the heart. We could easily be wrong.
Our profession should demand stronger evidence before doing something so aggressive. Be warned. This could be one of the worse chapters in modern cardiology
Do not be so critical of someone’s spelling😠. So many medical words and names are very foreign to many of us!!! And so many of us were not born in an english speaking country!
What a rude comment to someone whose first language is not English.I thought we were all here to help each other about heart matters, not have pedantic folk pick over grammar and spelling.
These suppositions can only cause fear and anxiety in the many people that have already have these devices in place similar to the suppositions or opinions on the placement of stents. Well for sure stents have saved almost every persons life who had a life threatning heart attack and been stented for a blocked artery. They have also improved the lives of countless people who were suffering angina etc. As to whether or not these things will increase your life expectancy is unknown as really with serious heart issues QOL is paramount. Its just an opinion so I would tell people with these devices to just ignore it unless proven by proper clinical trials.
I have 3 stents myself, and guess what? I recently discovered from the ISCHEMIA study that there is no significant reduction in major adverse cardiovascular events (such as death or myocardial infarction) with PCI (stents) compared to OMT (optimal medical therapy) alone.
Moreover, a meta-analysis of eight trials, including over 15,000 patients, found no significant difference in all-cause mortality between OMT and OMT combined with PCI or CABG for stable CAD.
So, for patients with stable CAD, stents do not improve long-term survival or prevent heart attacks compared to medications and lifestyle changes.
Al I to be frightened now? No, I’m glad to know where I stand.
I basically said that on my post though most heart attack patients do not have stable CAD so there is a significant increase in those people who are stented in time. Also stents are given for angina relief which would seem to work fairly well. Thankfully I never had a heart attack so should live to whatever I was going to live to had I not had any stents. OMT is not suitable for a lot of people for various reasons and side effects so stents have their usefullness. Just can not see a reason to post an unproven post that will cause extreme anxiety to a lot of people especially as it could be pure claptrap anyway. Try a bit of good news for people is my motto.
I would not call the sincere concern of an experienced cardiologist/electrophysiologist ‘pure claptrap’. On the contrary, his opinion -based on figures- represents a valuable balance versus the commercial peptalk of medical hardware sellers, to which too many patients are submitted nowadays.
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Left Atrial Shunt
Left atrial appendage occlusion
Pollyanna left the building!!!
