Watchman leak study & separately alcohol & afib study

In this study, about 10.5% of Watchman implants had a leak.

"Results
Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90 days was 3.2 ± 1.6 mm. On the basis of a median PDL of 3 mm, patients were separated into ≤3 mm (n = 73) and >3 mm (n = 35) groups. In the ≤3 mm group, PDL regressed significantly (2.2 ± 0.8 mm vs 1.6 ± 1.4 mm; P = 0.002) after 275 ± 125 days. In the >3 mm group, there was no significant change in PDL (4.9 ± 1.4 mm vs 4.0 ± 3.0 mm; P = 0.12) after 208 ± 137 days. The primary outcome occurred more frequently (69% vs 34%; P = 0.002) in the >3 mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size."

In another study

"Results:
Of 100 participants (mean age, 64 years [SD, 15]; 79% male; 85% White), 56 had at least 1 episode of AF. Results of PEth testing correlated with the number of real-time recorded drinks and with events detected by the transdermal alcohol sensor. An AF episode was associated with 2-fold higher odds of 1 alcoholic drink (odds ratio [OR], 2.02 [95% CI, 1.38 to 3.17]) and greater than 3-fold higher odds of at least 2 drinks (OR, 3.58 [CI, 1.63 to 7.89]) in the preceding 4 hours. Episodes of AF were also associated with higher odds of peak blood alcohol concentration (OR, 1.38 [CI, 1.04 to 1.83] per 0.1% increase in blood alcohol concentration) and the total area under the curve of alcohol exposure (OR, 1.14 [CI, 1.06 to 1.22] per 4.7% increase in alcohol exposure) inferred from the transdermal ethanol sensor in the preceding 12 hours."

That being said, I've personally never had alcohol be an afib trigger for me, though I've never consumed more than two drinks at time since I've had afib.

Alcohol huge trigger for me. Back in my afib days and more recently in my atypical flutter days. Perhaps more so. Being on eliquis after my 8/6 Natale ablation thus no alcohol. Ok George, please put in laymans terms that Watchman study. 10 % leaks does that mean enough for clot dislodge? If your own tissue grows over it where is the leak? My ultimate hope as for many is to get a Watchman thus eliminating Eliquis
George your just full of good news! No alcohol and Watchman leaks lol
Tom

Alcohol is an odd beast. I think it's probably (and I readily admit I have ZERO proof) related to vagal vs adrenergic AF. The latter group I would expect to be really bothered by it. I'm in the former and I can tolerate pretty much anything. I'll own up to finishing a six-pack with no ill effects other than the excessive peeing the next day. Rather a delicate problem when one is 3 miles into a 5 mile run and in front of a bunch of houses. I need to move farther into the sticks!

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Poppino
Ok George, please put in laymans terms that Watchman study. 10 % leaks does that mean enough for clot dislodge?

Hi Tom, in 10.5% of the cases in this study, there was a leak (so in 89.5% of the cases, no leak). 2/3's of the leaks were <=3 mm, 1/3 were > 3 mm. Most of the <=3 mm cases got smaller over time. The >3 mm did not. I believe these leaks can be fixed. If it were me, I'd be asking to continue anticoagulation till the leak was repaired, and making sure it was repaired (PDL closure).

"The primary outcome occurred more frequently (69% vs 34%; P = 0.002) in the >3 mm group." So the primary outcome (see below) occurred twice as often in the larger versus smaller group. In either case, there was a significant chance of the primary outcome occuring.

Here is the primary outcome definition:
"The combined primary outcome included failure to stop OAC after 45 to 90 days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure."

Wow! See im totally vagal. I drink coffee every am dark rich. My HR goes down then this morning my BP was 116/64! But a couple scotch and waters or 2 beers its over
And most nearly every episode in my 15 yr history is 9 pm to 4 ame

Thanks George. I believe ive heard the Natale Group brings you back after a period to TEE the Watchman for this exact reason. Leaks
But 90% is still decent but you’d expect a complete seal and yes staying anticoagulated until no leak is confirmed may be the protocol. Gittygirl Genie is on this path so ill look foward to her reports
George i got you down as The Professor on Gilligans Island

Here’s a study done recently that says that aerobic exercise decreases severity or the chances of events. For both paroxysmal and persistent. So maybe if we drink and it increases our chances, but we exercise and it decreases our chances, maybe they even out 😊


[www.medscape.com]

Hi Tom.....great to see your doing well......a 10% leak rate along with a bunch of natural blood thinners like Garlic, Natto + a dozen others you can take......a half a dozen or so that i take with no clotting issues at all but just for insurance with all being very healthy for us anyway.....plus a good diet which is HUGE.......should not be keeping you up at night with a watchman. As i have said many times there is more then 1 way to skin a blood thinning situation....oh.....n a t u r a l.....is always better.

All the best.

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Brian_og
Here’s a study done recently that says that aerobic exercise decreases severity or the chances of events. For both paroxysmal and persistent. So maybe if we drink and it increases our chances, but we exercise and it decreases our chances, maybe they even out 😊

Exercise is a double edged sword. If you are inactive, then adding exercise may help, if you are part of the smaller group (who tend to be overrepresented on this forum) who do a lot of long duration, high intensity endurance exercise, then moderation is likely a better choice.

Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation: A Scientific Statement From the American Heart Association

"PHYSICAL ACTIVITY AND AF
Not only does physical inactivity contributes to AF burden through its association with established AF risk factors, but there is increasing evidence that inactivity represents an independent AF risk factor.38–42
Effects of Regular Moderate-Intensity Aerobic Exercise on AF Incidence and Burden
The 2018 Physical Activity Guidelines Advisory Committee Report recommends 150 min/wk of moderate-intensity or 75 min/wk of vigorous-intensity aerobic exercise (Table 4) for all adults because this exercise volume improves cardiovascular health..."

"...Exercise Dose and AF Risk
Participation in extreme endurance exercise races has grown in popularity. In parallel, there is growing concern that excessive exercise (such as that undertaken by endurance athletes) may be deleterious to cardiovascular health, including paradoxically increasing AF risk...."

My path to afib was in the latter category 17 years ago. Subsequently I empirically determined that limiting my intensity on long duration activity to what is described as Zone 2 by Iñigo San Míllan (University of Colorado Health Sciences researcher and head coach of the winning Tour de France team in 2020 and 2021), which can be approximated by Phil Maffetone's MAF protocol or just nasal breathing mitigated the exercise trigger risk. I can still do very short duration sprint interval or high intensity interval training, but long duration, higher intensity is a known trigger for me.

Thread on this topic and The Haywire Heart book.



Edited 1 time(s). Last edit at 09/01/2021 10:42PM by GeorgeN.

Enjoy this thread : yes id love to someday in the next year be able to use a natural approach vs potential clots should a future Watchman give me that opportunity
I was an afib experiment. Excessive sports for many many yrs. running lifting cycling men’s basketball leagues etc etc. all the while downing 2-3 scotches a night. Then i got pneumonia then i took levaquin then 3 months later my first afib episode Jan 2006

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Poppino
Thanks George. I believe ive heard the Natale Group brings you back after a period to TEE the Watchman for this exact reason. Leaks
But 90% is still decent but you’d expect a complete seal and yes staying anticoagulated until no leak is confirmed may be the protocol.

Doing a TEE at 9 weeks post-procedure is the standard FDA protocol. The protocol is aspirin plus anticoagulant for 45 days. A TEE is done then to confirm placement and lack of leaks. If no leaks are found, you stop the anticoagulant and begin clopidogrel instead (an anti-platelet drug like aspirin). You then continue that for 6 months when another TEE is done and you stop the clopidogrel. You remain on aspirin thereafter.

As with all things medical, the EP can modify that protocol. I never took clopidogrel, for example. Natale had me on aspirin + Eliquis for the 45 days followed by aspirin + half-dose Eliquis instead of clopidogrel for the 6 months. I then stopped the aspirin and continued the half-dose Eliquis on Natale's recommendation. Continuing Eliquis wasn't anything to do with the Watchman. It serves the same purpose that taking a daily baby aspirin does, but it's safer and more effective.

As for that 10% leaks figure, keep in mind that's across all EPs of all experience levels, including the ones doing their first Watchman. I'm sure that EPs well experienced in placing Watchman devices don't have numbers anywhere near that high. In any case, most leaks are inconsequential and will seal themselves. Those that are larger can be plugged with a small device made for plugging vascular holes.

Appreciate that clarification Carey. Im not good at living in the moment anymore. Trying with some therapy to get back to it
Im always projecting into the future i knew the Watchman deal took some time before all said and done. Yes the 10% may include lesser volume installers!
Tom