I have two questions. The first has to do with the Watchman implant. Has anyone here had any experience with this device? I was recently diagnosed with AF and am not tolerating Eliquis well. I contacted Boston Scientific and they sent me some information. I've also seen a TV ad touting its benefits but I would like to get a first hand report from someone who has one.
My other question has to do with gabapentin. I went to the ER because I was having jerky movements and feeling quite weak in the legs and the ER doctor prescribed a low dose of gabapentin. She said it might be helpful for the seizures and when I googled it, it does say that gabapentin is prescribed for that. The side effects sound quite scary. My question is, should I take it or should I wait until I see my cardiologist and neurologist? As always, thanks for your helpful advice.
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Calypso76
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I'm about to leave home in an hour or so to have an Occlusion device fitted. This may be either Watchman or Amulet. I suspect the latter. I'll keep you informed how I get on!
Regarding Gabapentin, I've had this prescribed fir nerve pain in the past. It can be very effective. All drugs have side effects which we have to be warned of. Its really up to you to decide if you can wait to see your cardiologist etc
I had the LAAO procedure yesterday and it went all to plan.
I went down to the Cath lab at 9am and was back in the ward at 11am. The procedure was under local anaesthesia ( with sedation) . I was concerned that I would have to have assistance with TOE ....not my favourite procedure 😬.Thank goodness nothing had to be poked down my throat. The echcardiograohy necessary was carried out by Intracardiac Echocardiography..... ICE ( through the groin) I felt very little discomfort, much to my surprise. The device fitted was an Amulet.
I had to lie still for 4 hours afterwards and then wait to have an echo. I was home early evening and had an early night. Great night's sleep as I hardly slept at all the night before. I have to take small aspirin for one month , speak to my EP in 3 months and then wait to hear about stopping my Warfarin.
I feel fine this morning , just have to take it easy for a few days. Good excuse to be a bit lazy so will probably catch up on some admin work ! (....probably!)
I would also research the risks associated with the Watchman device implantation as an important counterbalance to the positive glow of a TV advertisement designed to sell such devices.
Then there's a device called an Atriclip which clamps on the atrial appendage outside the heart, rather than inside the heart as with the Watchman. I have neither device, but my interest arose from investigating alternatives to DOACs (due to personal intracranial bleed fears).
I am not supposed to post links to devices. However a simple Google search will give you all the information you need ... the device, the insertion procedure by a cardiac surgeon, the risks, and comparisons with other devices.
The Atriclip was invented by the famous Dr Wolf who works at Houston Methodist DeBakey Heart Centre. Houston Methodist DeBakey also have a YouTube education channel on which Dr Wolf gives live monthly (on a break at the moment) discussions about all things AF, particularly the Wolf minimaze procedure which he invented 20 years ago now. I recommend you check out his catalogue of AF related videos. You will learn a lot. The mini maze is performed by a cardiac surgeon and scars the outside of the heart, not the inside as with a catheter ablation. Dr Wolf then uses the Atriclip to close the left atrial appendage as part of his minimaze procedure. (See his website wolfminimaze(.com) ... address doctored so as not to create a link)
My left atrial appendage was isolated and EP strongly recommends Watchman. He tells me I am higher stroke risk because of LAA isolation. This was two years ago, but I have since read about some problems with Watchman. Eliquis doesn't bother me. I take Gabapentin 500 mg total daily down from 900 mg total daily. Gabapentin made me dizzy at first.
This is the professional opinion of cardiologist dr. Anthony Pearson:
The Watchman device I was grasping has been approved for preventing stroke in patients with atrial fibrillation who are at high risk and can’t, or won’t, take blood thinners. Boston Scientific has been flying cardiologists to various cities for the last year to wine and dine them and fill them full of reasons to send their patients for the device.
I also agreed with John Mandrola’s early skeptical take on Watchman. John updated his arguments against LAAO in a Substack post (subtitled “percutaneous closure of the left atrial appendage may become one of cardiology’s biggest errors”) in 2021 and provided a link to his excellent lecture on the topic.
Beware The Leaky Watchman
Unfortunately, the device is being implanted willy-nilly in patients with atrial fibrillation and patients need to understand it is not the panacea (eliminate stroke risk without having to take a blood thinner!) they are being promised.
On his most recent publication, Dr. Mandrola does a great job of summarizing some of the issues surrounding LAAO and discussing a new paper that should raise further concerns. If you are interested in critical analysis of current cardiology studies and practice I can’t recommend TWIC highly enough. I tell every trainee who gets within a few feet of me on hospital rounds that listening if they can spend 20 minutes listening to TWIC that time will be the most densely educational part of their week.
I’m going to alternate text from the Medscape transcript of John’s podcast with my own observations:
Last week, authors from Athens Greece, first author, Athanasios Samaras, published a meta-analysis, including randomized controlled trials [RCTs] and observational studies) looking at the incidence and prognosis of residual leaks following percutaneous LAAO.
Some background: The idea of LAAO is that if you completely occlude the appendage, clots cannot form there, and you reduce a substantial nidus for cerebral embolism and stroke. The added benefit, proponents say, is that after occlusion, the device endothelizes and you can stop oral anticoagulation, thereby reducing bleeding risk.
I have to admit, it’s a great story, and I am sure it’s easy to explain to patients.
It is remarkably easy to convince patients to get the device if you don’t share with them inconvenient truths about the lack of efficacy and the possibility of device-related thrombus. But typically patients don’t get all the information they need to make an informed decision before signing up for having the foreign body inserted inside their heart.
Dr M goes on to describe the problem of inadequate closure in the LAAO world:
One major problem is that our LAAs come in lots of different shapes and sizes, and it’s hard to get complete closure. What’s more, and this is a whopper of a barrier, if the device leaves a little leak, blood can more easily pool and clot. Surgical data has shown that incomplete LAA closure carries a serious risk of stroke.
Many studies have documented peri-device leaks (PDL) after percutaneous closure. The nice thing about the current paper is that it brings together and sums up the incidence and prognosis of these leaks.
The results:
All but four of the 48 included studies were observational. Total patients studied was nearly 62,000.
The main finding was the most sobering: PDL by transesophageal (TEE) were found in 26% of patients. One in four. Wow.
Two notes on this: a) This incidence comes from centers that actually report things; you might expect that these centers are better at implantation than lower volume centers that don’t report data. b) This incidence is by the standard TEE.
The authors also report incidence of PDL by CT scanning — a more sensitive technique. PDL were noted in 57% of patients. I find this quite sobering, but proponents will argue that prognostic data is based on TEE, and we don’t know what finding leaks by CT means.
The PDL ranged from 1 mm to > 5 mm and the larger the leak the greater the chance of experiencing thromboembolism. A PDL of 3 mm was found in 10% of the patients and was associated with a fourfold increase in stroke or systemic embolism.
Comparison to Surgical Obliteration of the LAA
“the word occlusion is in the name of LAAO. It’s not LAApO for partial occlusion. I can’t help but think this discovery, nearly 10 years after the seminal trials, is one of the explanations for higher ischemic stroke rates in the seminal trials, PROTECT and PREVAIL.
Of course, the other reason was the decision to stop oral anticoagulation (OAC) after occlusion. Recall that one of the best studies in the entire cardiology space involved surgical LAAO at the time of cardiac surgery. Surgical LAAO reduced stroke significantly compared with no occlusion, but OAC was not discontinued.
Why did LAAOS 3 authors not stop OAC? Because atrial fibrillation (AF) is a systemic disease, and the appendage is only one source of stroke. Also, the entire evidence base of stroke and AF have shown the necessity of OAC to reduce AF-related stroke.
I wrote about LAAOS3. That post includes a TEE video of an LAA clot. Back then I bemoaned the lack of evidence preceding LAAOS3: “as one who visualizes the LAA routinely by transesophageal echocardiography I see how important the pump function of this appendage is to overall atrial function and how its pump function is essentially eliminated in postoperative patients. What damage was removing or obliterating the LAA doing to overall cardiac function? I even created a website with the URL “I am Joe’s Left Atrial Appendage”, attempting to drum up sympathy for this abused portion of the heart.”
Even Biased Authors Acknowledge Many Challenges with LAAO
I remain concerned about Joe’s left atrial appendage and, like Dr. M, wish we had good RCT data that deploying a nitinol frame structure with fixation anchors and a permeable polyester (PET) fabric cover is a good long-term solution to afib-related stroke:
I remain totally pessimistic about this preventive approach to stroke reduction, and I am truly saddened by the fact that our field embraced this technique without proper studies. Hundreds of thousands of procedures have been done, and if only a fraction of these patients had been enrolled in RCTs, we would know if this procedure worked.
A recent review notes all the issues John outlined in 2017: lack of efficacy data (“A key issue with these data is the lack of convincing evidence that supports the mechanism of action of LAAO; reducing cardiac thromboembolism due to exclusion of the LAA cavity from systemic circulation. Indeed, ischemic events were higher in the device arm in PROTECT AF and PREVAIL”), the high prevalence of device-related thrombus and device leaks. Despite these huge issues (“remaining challenges”) there was no call to put a halt on implantation”.
Thanks for posting that article. You have given me a lot to think about. I was already leery about having surgery, unless it's absolutely necessary. I'll go over this piece of information more thoroughly before I meet with my cardiologist .
One of my best friends is a retired cardiologist and he shares dr. Mandrola’s opinion wholeheartedly. Same stance about ablations, by the way. ‘Sold’ much too often and too soon, according to him.
I had a Watchman implanted in May. The worst part was having to take Placix for 3 months, it seemed I only had to look at my arm and it bruised. Really, I moved during the time so lots bumps. The Watchman is well seated and no more Eliquist!
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