Summary of Shannon's small stroke from LAA leak after Lariat ligation

The current Aug/Sept issue of The AFIB Report is dedicated solely to exploring my experiences over the last three months beginning with the surprise small stroke in early May up through the recent repair of my leak within the previous fully closed left atrial appendage that was the result of an initially successful LARIAT procedure performed last August 2013 exactly one year ago.

We won't repeat the full details shared within the lengthy story in the latest issue of the newsletter here, but a number of you have inquired about it and have had some questions about what happened and what I and we have learned from this latest adventure and I realize that not all readers of this forum are not also subscribers to The AFIB Report.
and
As such, this thread is mostly to provide a place for any inquiries any of you might have either after having read this latest issue of the newsletter, or even if you are not familiar at all with what this is all about.

After my LAA twice confirmed as having been well sealed, with follow-up TEE testing at 6 weeks and 10 weeks post LARIAT procedure, it came as quite an unwanted surprise to experience that small stroke, or what was called at first a TIA, until more detailed MRI/MRA scans done at Scripps Green hospital, on the second Saturday in May. My symptoms mainly included a sudden onset of a deep fatigue and feeling spacy, almost disconnected in a sense and increasingly included difficulty in taking the words in my mind and getting them off my tongue with fluid and normal speech.

As noted in the description in the newsletter my wife Magdalena was just starting her drive up from Phoenix back to our place two hours drive in the beautiful red rock country of Northern Arizona, after retuning from a short trip to San Francisco. During our conversation she could clearly hear me slurring my words and I could too feeling like my thoughts were starting in one room and getting scrambled to a degree on the long trip from there to my tongue, clearly defining the adage 'tongue-tied' . Its quite a frustrating and a bit scary feeling for those of you fortunate enough to not know this experience first hand.

She called a good friend or ours in Sedona who picked me up and whisked me to the nearest ER some 20 miles away in a modest-size country town hospital. After an urgent stroke protocol of tests including a CT scan to rule out a brain bleed, which it thankfully did, and numerous manual dexterity stroke tests which I passed with flying colors, it was determined that I had suffered a TIA (transient ischemic attack) and after a few more hours of observation I was discharged with an aspirin a day from the ER doc and a recommendation to see a neurologist on Monday.

While laying on the bed in the ER, I had phoned Dr Natale, my long time EP and who had performed the LARIAT procedure along with his colleague Dr David Burkhardt in Austin some 9 months earlier. Dr Natale called back as soon as he got the message shortly after I was discharged and my wife and I were driving home from the ER and when her learned what had happened he urged me to fly to Austin the next day as he was immediately concerned that this CVA ( cerebral vascular accident) could have been due to a late re-opening leak in my previously sealed LAA.

The next 8 weeks included my trip to St Davids in Austin as well as two separate trips to Scripps Green Hospital in La Jolla Cal where Dr Natale also does ablations a couple days a month and has some a expert interventional cardiologist colleague in DR Matthew Price as well as Scripps is home to the Magna-Safe Registry protocol for doing MRIs on patients like myself who have pacemakers, which until recently was simply out of the question!

The combination brain and heart MRI/MRA at Scripps revealed a small stroke for a couple lesions in the frontal lobe, just where one would expect embolic debris from the LAA to wind up in the brain. And the next day a high resolution 3DTEE confirmed the presence of a 4mm diameter leak in the center of my LAA that the suspicious 2DTEE from Austin also showed and that Dr Natale was sure was indeed a leak, but which was questionable at first.

The high-rez TEE at Scripps left no doubt this leak was significant and after having ruled out any other plausible cause of this stroke, it was clear the most obvious source was indeed this late leak in my LAA after an initially sealed Lariat,

A month later on July 25 Dr Price and his team repaired my left with a St Jude's Amplatzer Duct Occluder II device that looks like a small highly flexible metallic 'rivet' make from nickel and titanium by using this rivet to plug the small round hole and leak in the center of my LAA. Here is what the device looks like:

Amplatzer ADO-II occluder plug used to close LAA leaks.

The procedure, which was like a much more scaled down ablation and without any burning at all, was a big success and my LAA is now fully sealed again and it is everyone's expectation that I am now just as protected as I was when my LAA remained fully closed off after the successful LARIAT procedure as well. This time hopefully for good as this leak plugging repair is typically a very stable repair and we do not expect anymore change. Knock on wood!

I am very grateful to Dr Natale, once again, for his real dedication and care in helping to search out and find the nature of my small stroke and the need repair and for him pushing to get me to Scripps and for recommending me to Matthew Price there who was an ideal interventional cardiologist highly experienced in performing both the Lariat and Watchman LAA legation/occulsion methods and who is a real pioneer in developing the procedure and process for plugging these late LARAIT based leaks in the LAA.

It was very fortunate that he too works at Scripps, as does Dr Natale and that they have such a cutting edge imagining center there with the Magna-safe MRI protocol as well.

That is the main run down of what happened.

Here are a few bullet points some of you might have questions about?

* I have been on Eliquis since the day of the stroke when Dr Natale immediately put me on that for protection while we searched for the cause and fixed the situation if possible, and will remain on Eliquis until October 25 at 3 months post Amplatzer Occluder leak repair, after which, if all goes well as expected in the Follow up TEE on October 1st, I will be off all anti-coagulation once again.

* I was on Cardiokinase at 100mg 3x/day, which is the most potent form of Nattokinase, when I had my small stroke. While concerning, its quite possible that if my stroke was due to necrotic debris from my previously closed LAA for some months, during which obvious necrosis would have taken place, and then upon the leak opening up and re-establishing blood flow between the LAA and Left atrium some of this necrotic debris could well have washed out of the remnant LAA pouch and gone right to the brain.

If so, there is no surety that any blood thinner, including warfarin or the NOACS, would have been as effective in preventing such a necrotic debris based CVA as they generally might be with a more typical thrombi-embolic origin stroke. It is also true that my stroke could have been due to thrombi-embolic debris as well, since this origin has been confirmed as a risk from late leaks in previously surgically ligated LAAs.

In any event, while we cannot quite say for sure that Cardiokinase/Nattokinase is not helpful in such strokes, and I do think it has real merit, even if not to the level required to prevent a serious and direct stroke risk such as having an in-situ stroke generator suddenly open up inside your heart. It nevertheless needs to be said that this strong dose of Cardiokinase did not prevent my stroke, whatever the nature of the emboli.

As such, I would not recommend depending on it for anything more than mild to modest risks such as using it to reduce whole blood viscosity which is has been shown to do well with an average 20% reduction in whole blood viscosity at a 100mg dose 3x a day of Cardiokinase. And I do think from my own earlier experiences and anecdotal reports that it does indeed help make the blood more slippery and less likely for a fibrin based clot to form, I just can not recommend anyone who have a serious risk for thrombi-embolic events to go it along with Nattokinase or Cardiokinase and to strongly consider adding in a full Anti-coagulant drug such as Warfarin or Eliquis/Xeralto in such cases. At least until we better understand both the effects of Nattokinase in these kind of cases and these NOAC drugs as well. There may well be a role for combined therapy with greater knowledge of who both Nattokinase and warfarin or Eliquis work together.

* The LARIAT is still a worthwhile procedure for eht right patient meeting the specific criteria who would best be served by the electrical and structural isolation of the LARIAT as well as elimination of the need for systemic blood thinners. But only now, in light of my experience and that of a couple other LARIAT related reports of small TIAs, that the patient considering the LARIAT should demand at at follow up TEE at least each 3 to 4 months during the first year post procedure to catch any leaks that might develop and plug those few that are large enough to potentially become a problem, before any such CVA can happen.

Any of you that may have any more questions please fire away, but at least now all here who might have an interested in this topic have a general overview of these events of the last three months, belated as they are in coming.

Best wishes,
Shannon



Edited 2 time(s). Last edit at 08/16/2014 08:05PM by Shannon.

Shannon,

Thanks for the great summary and thank goodness all has worked out in your favor!

George

Thank you Shannon for the detailed report on your experience. I've read the newletter and It raised a question. If I understand the circumstance acurately the lariet suture loosened at the LAA. This rssulted in a hole in the center of the " gunny sack" thus the leak. A plug device was placed and the " gunny sack" was tightened around the plug....thus eliminating the leak? If so, why not intall the plug everytime to eliminate the potential that resulted in the situation you experienced?

On a much lighter note...how do you understand Dr Natale on the phone? I love the guy but his accent is so heavy I could barely understand him in person much....less on the phone. He called me in my hotel the night before my ablation to discuss using an experimental catheter during my procedure. I told Him I was having a difficult time understanding him. He slowed down a little. I think I caught about every tenth word! Actually, I made out enough to figure out his plan and approved. Heck, my wife always tells me I have selective hearing so maybe it's just me....

Craig

Speaking as someone who also had a TIA (4 weeks ago) while taking Nattokinase, I'd echp Shannon's sentiments about it as a preventative. Mine clot was probably formed either during my longest ever AF episode (26 hrs), or a subsequent 5 hr episode, 7 days after the first. Two days after the second of these episodes I suffered the TIA (which only lasted 30 seconds, after which I was fine).

It may be that taking the nattokinase actually prevented the clot from getting bigger, but my cardiologist was quite insistent, after the first episode, that I was not getting sufficient protection from Natto. Ironically, he recommended I be placed on either Rivaroxaban, Apaxiban or Dzgabitran. I agreed, but the TIA happened before I was able to start. But I'm on it now and have obviously discontinued Nattokinase. I should say that I'd had 170 episodes prior to these two, whilst taking Natto, and no problems - however my episodes were typically <2hrs length.
So, two points I'd like to underline:
1. If your episodes are lengthy,you're at higher risk of a TIA/Stroke and you might not be sufficiently protected by nattokinase;
2. Never, ever, dismiss the kind of symptoms that Shannon describes (mine were an unusually located headache and sudden, transient, weakness down my left side) as a 'funny turn'. The paramedics told me of tales of people who'd obviously been in full-blown stroke for hours before calling the emergency services. SMall strokes and TIAs are warnings that can't be ignored, and natto, in my experience, doesn't provide sufficient protection once you'd have that warning!

Shannon, that Afib report was a wonderful and detailed explanation of your LAA/LARIAT problem. Amazing and generous of you to remain as positive throughout.

Aside from being very interesting reading, the report does raise interesting questions to this ablated afibber. Ablated back in 2004 by Dr. Natale,(Cleveland) I’ve been Afib free despite the absence of any LAA isolation. I have been off of any prescription blood thinners and haven’t considered that as a danger as long as I was in NSR. To that end I carefully monitored my heart rate for 4 years, and although less vigilant now, I admit to having increased PACs especially when lying down.

With that background said, your article makes me wonder if my LAA emptying velocity is OK. I never knew to have it measured or even if that was possible to do! So is it a test that is simple enough to go through and indicate whether or not I can continue ignoring any prescription anti-coagulation? And what/where would I best proceed if needed?

Thanks for any help, Anton

Shannon, I didn't realize that your Lariat procedure failed and I am glad that it was fixed via Amplatzer. The St Jude medical site's explanation on Amplatzer is lacking in detail. I pasted a link below that shows how it is done and that device is offered in a big range of sizes. I remember when you chose the Lariat procedure with Natale/Burkhardt that it was pretty much a lead pipe cinch that the tissue would close off permanently and that they did everything according to design. I am not sure what to think now other than that Amplatzer may be the way to go since it is a simpler procedure.

It is a lengthy series of videos. Starts at about the 5 minute mark in Part I
[www.af-ablation.org]

Thanks folks for the replies and Im glad you all enjoyed the read and got something from it.

Ill try to answer the shorter topic questions from above in this post below and the couple that will need a bit longer discussion I'll address in separate posts below.

*** George many thanks and yes, we are very grateful things have worked out to date in such a great outcome and with so little stroke residual. Occasionally, when very tired I feel a slight hitch in the connection between thinking and speaking with an occasional hunt for the words, but I must admit at 62 Ive had a few of those 'senior moments' for a good while prior to the stroke from time to time as well so am not sure how much of that is just par for the course that I am more aware of now, and if any part of it is from some very minor residual from the CVA?

Normally and for the most part though things are working just fine.

****Hi David was nice speaking with you yesterday, the thing about the Nattokinase is that I have seen very definitely an effect on activated clotting time measures with the little thins short puncture they do in the forearm for testing how long it takes to clot and with Nattokinase 100mg 3x/day using at that time the Allergy Research brand it definitely made my clotting time a good degree longer than baseline.

Taking Cardiokinase, which is the strongest form for Nattokinase, also lowered my tested whole blood viscosity by right at 18% which was a good reduction for only adding that in after having been off it a while prior to the first whole blood viscosity test at Meridian Valley Labs. Those are all promising indications that it should indeed help toward a less thrombo-genic hemodynamic and blood flow quality. However, we just don't have enough large scale hard data to truly compare it in terms of stroke reduction in AFIB to Warfarin of the new NOAC.

I am getting more info sent to me now by Dr. Ralph Hollsworth who is one of the leading experts on Nattokinase after having a long conversation with him about 5 weeks ago before leaving for the latest visit to Scripps to get my Amplatzer Duct Occluder II plug installed. He has some good data on its impact, but he uses it in combination with Warfarin and even now with Eliquis in more serious cases where the patients cardiologist has prescribed those and he agrees they need robust anticoagulation.

He has found evidence of superior protection with Nattokinase or Cardiokinase and the blood thinners when properly monitored and overseen by a knowledgable doctor than just the blood thinners alone, although there are no large scale studies, of course, and likely never will be, to give larger support for that combo therapy.

He has found it very save so far with both Warfarin, when doing frequent INR testing and making adjustments to stay in the therapeutic range and even in smaller Eliquis experience to date with the combined and well known anti-fibrin benefits of Nattokinase with the blood thinning attributes of the various pharmaceuticals.

Again don't try this on your own without expert guidance and full cooperation with your prescribing physician.

But Nattokinase by itself, for all its benefit for those Afibbers no longer having AFIB but who would like the added protection in the case of transient blips of arrhythmia and for general endothelial and blood flow improvement, then Nattokinase makes good sense to add and use,

You just can't expect it to reliably stop an active AFIB generated thrombus clot from the LAA, nor even more so a possible necrotic debris emboli as much hunch, and some evidence, tells me is what likely happened in my case. There is no evidence I know of that even Warfarin or NOACs can reliably prevent or break down necrotic tissue to prevent such scar tissue, once it hjas broken free, in my example. from the inside of my previously closed LAA for some months and then when it spurng a leak some of that dead tissue could easily have flaked off from the dynamic pressure of the partially restored two way blood flow from this remnant necrotic LAA pouch and my living and thriving left atrium with full venous blood supply and thus direct access to the brain for any of these tiny flakes of necrotic tissue to head straight to the brain.

The interesting thing is that even bigger leaks that can form as an eccentric arch around one side of the round Watchman device when fitted into a not perfectly round LAA osmium, compared to the generally smaller and round central holes formed in the middle of the LAA 'pucker' formed by LARIAT leading to related late leaks, those Watchman leaks do not seem to lead to any TIA or small strokes, at least so far none have been reported even with larger blood flow.

I think this might strongly favors the necrotic debris mechanism in the LARiAT over the thrombus formation method leading to subsequent emboli. Even though the thrombus clot risk and increase risk of CVA has definitely been proven a bigger risk when small leaks have formed after surgical LAA ligation which is similar to the LARIAT. So both mechanisms are possible in the Post Lariat leaks that are large enough for bi-directional blood flow to get re-established ( thankfully of the 10% to 12% of LARIAT leaks that are typical over time, only about 6% are large enough for two way blood flow and thus would require plugging for safety sake. Those holes or leaks smaller than 2mm generally can be left alone and will seal over with endothelial growth in the first month of two after the procedure.

But since with the Watchman the LAA is still intake it does not undergo necrosis and yet with the LARIAT and ATRICLIP the LAA tissue is fully ligated and does undergo necrotic withering. So far I only have heard of three CVAs from late LARIAT leaks reported and that includes mine which is the most documented and confirmed so far. It is not a major risk but its still significant for those it happens too and can be prevented with more frequent TEE testing in the first year and I would plug all leaks no matter how big just to make sure none of them open up in between scheduled TEEs and cause a problem,\

A larger solution might be to including an Amplatzer plug of that tiny central hole of the pucker formed by synching down on the outside of eht LAA osmium with a round 40mm diameter suture, and just make the plug step the last step of the original LARIAT procedure. Anyway that is worth considering though there may be some reason that isn't a great idea that I am not yet aware of.

Bottom-line Nattokinase has a good role just dont expect it to become a full fledged stroke preventative when you have a serious onboard stroke generator within your heart.

Shannon



Edited 1 time(s). Last edit at 08/17/2014 04:17PM by Shannon.

Craigh Wrote:
-------------------------------------------------------
> Thank you Shannon for the detailed report on your
> experience. I've read the newletter and It raised
> a question. If I understand the circumstance
> acurately the lariet suture loosened at the LAA.
> This rssulted in a hole in the center of the "
> gunny sack" thus the leak. A plug device was
> placed and the " gunny sack" was tightened around
> the plug....thus eliminating the leak? If so, why
> not intall the plug everytime to eliminate the
> potential that resulted in the situation you
> experienced?
> .................................................
> Craig

Thanks Craig and Researcher, Im very glad to hear things are going so well with you Craig too after leaving the blanking period from your Natale ablation and Researcher this answer below overlaps some to your comments as well.

Its not so much that the Lariat suture loosens. its more a function of the gradual necrosis and shrinking of the LAA tissue being pinched down by the synched down round suture from the outside of the LAA mouth .. like a string tied tightly around the mouth of a burlap 'gunnysack'. The suture knot is robust and not supposed to loosen directly but when the living tissue that is still filled with blood flow and collagen etc when it is squeezed down originally helps form that tight initial seal.

But overtime that tissue immediately distal to the suture and including the entire remnant of the LAA tissue starts to undergo necrosis and partial resorption by left atrium itself and as that happens that tissue right in the center forming the 'puckered' folded center by the LARIAT closure, then starts to wither and desiccate and shrivel up some as it is denied blood flow. And its easy to envision then how that central folded pucker will start to loosen and retract some from its own center point and thus forming a small round hole located right smack dab in the center of the previously sealed LAA osmium.

This is how these relatively small LARIAT leaks form. Luckily that is a good thing, assuming you are going to have to have a hole to begin with, as the small round and centered nature of such leaks make them nearly ideally suited for plugging with readily available and well-understood vascular occlusion plugging devices such as the Amplatzer Duct Occluder II now installing in my LAA plugging things up good.

And your insight Craig, asking why not use the plug from the beginning is a very good one. Researcher suggests a similar thing below and I do feel that potentially adding such a small occluder plug as the last step of future LARIATs might an make excellent revision to the procedure.

They could just do the full LARIAT and as they synch down the suture they could place that plug right in the center and then finish fully tightening it such that it should remain sealed even with the expected necrosis happening to that distal LAA tissue.

To me that seems a rather elegant and straightforward modification to every LARIAT, even though around 94 to 95%% of existing LARIATS work out perfectly fine with either no leak at all for the vast majority but for many more that do have leaks they are too small to worry about and will never cause a problem. Its really only those 5% to 6% of the total 10 to 12% that do show a late leak large enough to re-establish bi-directional blood flow and thus that small thin jet of blood flow with each heart beat will slowly form a small remnant LAA pouch as that pressure and flow start to reconstitute a portion of the old LAA. These are obviously the relatively few that really require plugging and could potentially lead to a leak.. So some cost/benefit analysis will surely be run to see if it makes sense both anatomically and in terms of efficacy in adding in a final plug for every LARIAT procedure, or perhaps they feel its better to just do more frequent first year testing to actually discover those few number of leaks that really demand plugging and then doing so with a separate procedure,

The main thing is establishing a protocol that will almost totally prevent the kind of very rude and unwanted surprise as I had to experience. Its just ironic .. at least from my point of view ... that I would up one of only a tiny handful so far who have actually had an embolic event related to the LARIAT.

Im sure that was not a welcomed thing to hear for Sentreheart either, (the makers of the LARIAT) that a recipient of one of their suture ligation systems who is on a forum and publishes an AFIB newsletter had to be one of the vanishingly few so far to have experienced such a relatively rare late complication related to the LARIAT. I can symphatize with them as well, but I trust also that my experience, and that of the few others reported so far, will inspire some creative engineering solutions, in addition to increasing the testing frequency in the first year towards eliminating the chances of such an event to happen going forward to any existing or future LARIAT recipients.

I think the LARIAT is a very good concept, with some real assets for the right patient, and when done with skill and now we know with more frequent first year follow-up.

Also Craig and Researcher, just using a plug to begin with in place of a LARIAT is basically what the WATCHMAN device is. The original AMPLATZER LAA Occluder device that researcher mentions was shelved after some pretty successful European trials some years ago, as I think St Jude who makes the many various Amplatzer vascular occluding devices looked at the up and coming Watchman and felt it wasn't worth dumping so much money there toward a direct Watchman competitor when the Watchman had such good funding and a good head of steam behind it.

Researcher, below is the link to my exact Amplatzer Duct Occluder II device which is the newest one and is really well suited for this specific application for plugging late LARIAT leaks.

Please look at this device used in me and videos on its deployment, in order to get a good idea of what it looks like before viewing the angiogram photos linked to as well in the second link below, of my procedure inside my left atrium and LAA so that you can better make out the faint Xray outline of the ADOII device as deployed and plugging the leak in my LAA.

Amplatzer Duct Occluder II plug device used to repair LAA leaks

And for all here is a link I just posted on my Google Plus 'afibbers.org' link that shows three anggiogram photos of my Amplazter Duct Occluder II leak repair on July 25 by Dr Matthew Price at Scripps Green Hospital in La Jolla.

Here: Angiogram photos of Shannon's Amplatzer Duct Occluder II LAA leak repair

As noted, the first of the three black and white pix shows contrast dye being injected from the larger catheter sheath from inside my left atrium towards the previously sealed LAA osmium or mouth, You can clearly see the edge of my LAA sealed seam as the clearly defines line above the dark cloud of contrast dye. If you look at the faint arrow that is annotated "Pre-Amplatzer Plug' that arrow points to the top of the contrast dye jet plume through the small 4mm diameter leak in the center of my otherwise well sealed LAA osmium or LAA mouth.

Other angiogram pix I have on CD movies of the procedure leak show the residual LAA pouch and the contrast and blood jet plume even more clearly and as a larger pouch than is seen in this view in which is is rather faint simple;y due to the timing on when this shot was captured during a given heart beat, but you can still easily make out the thin stalk of the leak jetting up into the remnant LAA space and then culminating as a mushroom shaped head.

Angiogram pix 2 shows an faint outline of the Amplatzer ADOII occluder plug with two black radio-opague dots on the top and bottom of the upper and lower discs defining the body of the plug device and you can make out the center thicker waist or gasket portion between the two discs and this gasket or waist is plugging the exact hole. and spans the hole in the LAA tissue with the two discs acting like tight caps sealing the inner and outer spaces in the LAA space and within the left atrium.

The final pix 3 of 3 shows the same ADOII device in place and they are injecting more contrast dye from within the left atrium directly at the bottom of the lower disc sealing the leak into the LAA and it clearly shows all dye being deflected off the bottom of that disc bouncing off harmlessly into the left atrium with none making it into the LAA space for a prefect repair of the leak.

Finally, a big advantage of the LARIAT and Atriclip ligation devices over a Watchman or original Amplatzer LAA occluder is that these ligation devices achieve full LAA electrical and structural isolation. So for those who have confirmed triggering from the LAA, even if it has been successfully isolated with an endocardial ablation such as LAA isolation ablation, adding a LARIAT closure , for example, can reinforce that isolation and make needing a touch up to the isolation no longer a possible issue. This in addition to allowing one to get off blood thinner as well with a well sealed ligation.



Edited 1 time(s). Last edit at 08/17/2014 05:17PM by Shannon.

Thank you Shannon. I expect that my 4th ablation in November, second by Dr. Natale, could result in an isolated LAA. So I am anticipating the possibility of a next step. I have wondered about the Watchman and why you didn't have one installed. Of course I will discuss this with Dr. Natale and hope for the best, i.e. a functioning LAA and no afib after my ablation.

Nick

Hi afjune14

The LARIAT was a better fit for me than the Watchman as I not only wanted to get off blood thinners, which for me was the second most important attribute I was seeking, but a successful LAA closure via full ligation of the LARIAT also confirms the LAA electrical isolation I mentioned above and reinforces the LAA isolation ablation I had in 2012, giving me the best overall odds of being arrhythmia free for life, inspite of having such a progressive and highly symptomatic case of persistent AFIB before starting my whole ablation process with Dr Natale in 2008.

And that is exactly what has happened, the small leak and small stroke from that leak in my LAA not withstanding. Also, getting a Watchman is still more difficult to qualify for as you need to be at least CHADS2 score of 2 before you would be considered for a Watchman, where as when I was in line for the LARIAT I was still a CHADS-0.

Now that Ive had a small stroke ironically I could likely qualify for a Watchman which is a viable alternate for those who either have confirmed that there is no arrhythmia-genetic substrate triggering mischief within their LAAs, or who have a solid confirmed LAA isolation already and feel confident its all done and no need for any more touchups are likely.

The LARIAT still can work just as advertised for the large majority of recipients and even for me, it has been restored to full functionality now after this little detour through CVA land for a few months and now back in the saddle with what should be robust stroke prevention from here on out, and shortly should be off all NOAC drugs as well once again for the long term, just as intended with the LARIAT.

Yes there can be this issue of leaks to deal with in a relatively small number of LARIAT cases, but now that everyone is fully aware of this fact, I trust early and frequent first year testing will catch any such leaks that are large enough to cause possible trouble well before they do so in the future.

Alas, I would up picking the short straw as one of the vanishing few with an actual embolic event actually due to such a leak, in order to play the 'canary in the coal mine' for present and future LARIAT patients to hopefully help pave the road toward an even safer procedure and long term process.

Shannon

researcher Wrote:
-------------------------------------------------------
> Shannon, I didn't realize that your Lariat
> procedure failed and I am glad that it was fixed
> via Amplatzer. The St Jude medical site's
> explanation on Amplatzer is lacking in detail. I
> pasted a link below that shows how it is done and
> that device is offered in a big range of sizes. I
> remember when you chose the Lariat procedure with
> Natale/Burkhardt that it was pretty much a lead
> pipe cinch that the tissue would close off
> permanently and that they did everything according
> to design. I am not sure what to think now other
> than that Amplatzer may be the way to go since it
> is a simpler procedure.
...............................................

Hi researcher, I hope I answered most of your questions above, and if not, there is a lot more in this issue of The AFIB Report that goes into a fair bit of more detail on the subject.

Its not really that the LARIAT failed, per se, it might be closer to the mark to say that I experienced a small leak in what remained an otherwise mostly sealed LAA and suffered a very rare small embolic event as a result, thus making the leak necessary to plug with the Amplatzer ADOII plug. So far so good, with the glaring exception of actually having had this small stroke in spite of the Lariat procedure which is certainly unfortunate and a bit of a pinch for sure! At least now it seems the good graces provided by a fully ligated and well-sealed LAA should now working full time for me, so that is surely a big plus.

And researcher, as far as performing the Lariat procedure itself goes, Drs Burkhardt and Natale did a first class job with no complications and a perfect seating and seal confirmed not only at the end of the procedure, but also during follow up TEE scans at 6 weeks and 10 weeks post procedure. The late re-opening leak issue has nothing to do with the installing operator or installation, provided the install was fully successful to begin with. Once the Lariat suture is properly positioned around the mouth of the LAA every operator can only synch it down a specific and consistent degree based on a define number of clicks on the epicardial Lariat control handle so the tightness of the suture is uniform for all cases. the possibility of late leaks is just an inherent risk in the nature of the 'gunnysack effect' tying a round string around the outside of the LAA mouth and synching it down as explained in the more details version of the story in the current issue of the newsletter.

As you noted too researcher, there are many sizes and shapes of St Jude's Amplatzer vascular occluding devices to plug all sorts of cardiac and vascular holes and leaks but mine is the newest model in their range called the ADO-II.

Dr. Natale and I were discussing when I saw him last at Scripps after all the MRI imaging and 3DTEE defined just what was going on, and with a little light gallows humor, how this surely ought to be my last direct first hand experience of an interventional cardio or EP procedure, and that he and I are both counting on all my dues now being paid in full to what ever AFIB gods there may be lurking about. And that from here on, I can learn about all this stuff strictly vicariously and just through the experiences of others, second hand!

Best,
Shannon



Edited 2 time(s). Last edit at 08/19/2014 10:11AM by Shannon.

S -- So happy to hear this recent event didn't cause much damage.

Wishing you remain issue-free from here on out. With all the help you provide everyone here, there's no question that you certainly merit this outcome.

Best regards,

/L

Shannon, No question at all that your Lariat job is as good as it can get as far as executing the procedure as envisioned. You had the two most competent pairings in the world working on you. In your case the Lariat solution wasn't enough and I am no longer confident that the Lariat will not be prone to repeat occurrences like yours without further understanding and improvements. Watchman or atriclip maybe the way to go for now. I don't know if the FDA has cleared the Watchman or not.