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Baltimore, MD
New Anticoagulant with less Bleeding Risk―Asundexian Factor XI (Bayer)
Today’s anticoagulants (DOACs-Direct Oral Anticoagulants) have a residual risk of major bleeding of 1.5-3.6%/year. That means that after stopping a DOAC anticoagulant, the effects can continue to affect you for 1½ to 3½ years afterward.
The result is you continue to be at a higher risk of major bleeding even though you are no longer taking the anticoagulant.
Alarming, bleeding events remain a high risk for you.
These bleeding events are associated with increased mortality, high costs, and compromised adherence to treatment. Especially for patients 65 and older, anticoagulants increase the risk of hemorrhagic-type strokes. (For more about anticoagulants, see my post: Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.)
Pacific-AF clinical trials
Drug to Reduce Bleeding Event in Clinical Trial
Currently the PACIFIC-AF clinical trials is studying Asundexian, a new anticoagulant. Asundexian is an oral factor XI (FXIa inhibitor). Early clinical results indicate that FXIa inhibition works to prevent stroke with reduced bleeding risk. Clinical trials and phases are continuing.
If FXIa inhibition proves to be safer and as effective as existing DOACs, it would be a major advance in stroke-prevention therapy.
My A-Fib Update: Touch-Up Ablation and Closure of My Left Atrial Appendage
Background: I received my first catheter ablation back in 1998 at Bordeaux, France where they invented the procedure. (I was their first US patient.) After this ablation, I was A-Fib free for over 21 years. This is an update to my own A-Fib story (Story #1 under Personal A-Fib Stories of Hope.)
In 2018 my GP detected an irregular heartbeat, though I was unaware of it and had no symptoms. I had a Medtronic Reveal LINQ Insertable wireless loop recorder/monitor installed. (See Has My A-Fib Returned?)
Steve Ryan with Dr. Natale and his nurse before his ablation.
It eventually showed that my A-Fib had reoccurred−at age 80. This wasn’t surprising to me since my ablation procedure back in 1998 was primitive compared to what’s being done today. At that time, none of my Pulmonary Veins (PVs) were completely isolated.
I had a “modern” ablation in 2019 and was much improved. But my loop recorder showed Very Late Recurrence of A-Fib—I still had paroxysmal A-Fib.
Very Late Reoccurrence and the Left Atrial Appendage (LAA)
Recent research shows that the Left Atrial Appendage (LAA) is responsible for a great deal of A-Fib recurrence, (See LAA Under-Recognized Trigger).
Dr. Andrea Natale performed my re-do, touch-up ablation on August 19, 2021 at Los Robles Hospital in Thousand Oaks, CA. He isolated both my LAA and coronary sinus and other areas of my heart which had developed non-PV triggers. (See A-Fib Free Again.)
Need to Close Off My LAA
Unfortunately, the ablation work done on my LAA reduced its ability to contract properly. I was aware of this potential problem and discussed it with Dr. Natale. Because my LAA wasn’t contracting properly, there was a greater danger of forming an A-Fib clot there. But instead of going on heavy-duty anticoagulants for life, I opted fer a Watchman occlusion device to close off the LAA. So, a few weeks later I had the Watchman installed.
A-Fib Free, Once Again!
After my LAA was closed off I was on ½ dose Eliquis for a while. They also did a CT scan June 27, 2022 to make sure the Watchman was seated properly and didn’t have any leaks.
I’m now once again, A-Fib free! All is well.
My Battery Died!
LUX-Dx implantable loop monitor
My doctor continues to monitor my heart through my LINQ loop recorder (a tiny cardiac monitor implanted just under the skin near my heart). In June, the battery on my 3 year old Reveal LINQ loop recorder died. I now have a newer version (Boston Scientific LUX-Dx). It was installed by Dr. Shephal Doshi at St. John’s in Santa Monica, CA on July 7, 2022. This one should last 4½ years.
Technology marches on! My old loop record used a recording/transmitting device at my bedside. This new one seamlessly sends the daily data to my cell phone, then to Dr. Doshi for review. All has been quiet since.
Editor’s Comments
A-Fib Recurrence is Discouraging, But it Happens. It’s certainly discouraging to have A-Fib reoccur after 21 years. But on the positive side, I had 21 years of being A-Fib free! I was able to lead a normal, very active life (running, sprinting, high jumping, lifting weights, swimming, participating in track meets, etc.) I didn’t worry about A-Fib reoccurring and was surprised when it did at age 80. (In cancer research, anyone who is in remission for 5 years is considered cured. The same should hold for A-Fib.)
Why Does A-Fib Reoccur? We don’t know why A-Fib reoccurs in a small number of patients. It’s probably related to aging. But the good news is that EPs today know how to fix it and restore people to normal sinus rhythm.
Running on All Cylinders! I’m back to normal, running with no A-Fib. I may have lost some heart pumping ability when my Watchman was installed to close off my LAA. But it doesn’t seem to have much of or any effect. Curing my A-Fib was much more important. My speed isn’t what it used to be. But I am 81 years old and also had to have my left hip replaced two years ago which by itself made me seconds slower.
The bottom line is that, even though at age 81 I’m well past “my expiration date”, I’m in great health and am very active. I can’t thank enough all the EPs and researchers who made this possible.
Select an EP Who Maps and Ablates the LAA. No matter what kind of A-Fib you have, if closing off your LAA, make sure your EP knows how, is experienced at, and routinely maps and ablates the LAA. This may produce a more successful ablation and save you from a recurrence of A-Fib.
Concurrent Installation? Today, there is a trend toward closing off the LAA at the same time as your catheter ablation. If you are considering a catheter ablation, I urge you to discuss this issue with your EP.
To learn more about the Left Atrial Appendage, see my article, The Role of the Left Atrial Appendage (LAA) & Removal Issues.
2023 AF Symposium Spotlight: Ground-Breaking LAA Elimination Device
For A-Fib patients, perhaps the most innovative and potentially ground-breaking presentation at this year’s AF Symposium was by Dr. Saibal Kar of Cardiovascular Associates at Los Robles Hospital in Thousand Oaks, CA.
In a Spotlight Session on Friday, he described a new device for closing off (“eliminating”) the Left Atrial Appendage (LAA). The LAA is where 90%-95% of Atrial Fibrillation clots and strokes come from.
The Laminar LAA elimination device is a potential medical breakthrough innovation! It takes little time to insert, it could be positioned at the same time as a catheter ablation. This could revolutionize the way LAAs are closed off today.. Learn all about it in my report: Spotlight Session: Laminar LAA Closure/Elimination Device.
Study of Dementia Risk: Catheter Ablation for A-Fib Versus Drug Therapy Alone
Historically, dementia in patients with A-Fib was attributed to strokes.
Recently it has become clear that A-Fib is associated with multiple forms of dementia even in the absence of stroke.
As anyone with an aging loved one suffering from dementia can tell you, dementia is a major health problem. In the U.S., dementia is predicted to affect more than 10.5 million Americans by 2050.
Research: Risks of Ablation vs. Drug Therapy
In an observational study, researchers compared A-Fib patients who had a catheter ablation to those treated with drug therapy alone.
They used the 2010 to 2021 data from a large, nationally representative claims database (Optum Clinformatics Data) to identify 19,088 A-Fib patients. They then divided these patients into two groups: those receiving a catheter ablation vs those receiving anti-arrhythmic drug (AAD) therapy alone.
Findings: Risks of Dementia and Mortality
Dementia Risk: They found that catheter ablation for A-Fib was associated with a 41% lower risk of dementia compared to patients treated only with anti-arrhythmic drug therapy. This dementia risk reduction held across both males and females.
Mortality Risk: Though not studied as a primary outcome, researchers found patients treated with catheter ablation also had a 49% lower rick of mortality compared with anti-arrhythmic drug therapy only.
What This Means to Patients
Catheter Ablation, by reducing the risk of dementia by 41%, is a major advance in our knowledge about health care for A-Fib patients.
This is yet another reason to get a catheter ablation ASAP in order to be A-Fib free.
2023 AF Symposium: Live Case from Dublin using Pulsed Field Ablation and Multispline Catheter
LIVE live from Dublin, Ireland—it was like we were in the EP lab with Drs. Joseph Galvin and Gabor Szeplaki from Mater Private Hospital in Ireland.
They perform 800-900 ablations/year and have done 268 cases of Pulsed Field Ablation (PFA) using the Boston Scientific Farapulse system. Amazingly, these ablation average 40 minutes in length—a very short time to perform an ablation (and no complications).
The patient was a 66-year-old woman who had developed symptomatic paroxysmal A-Fib three years ago, medications were poorly tolerated.
The first thing we noticed was, instead of the typical Lead apron shields to protect against Fluoroscopy radiation, they were wearing what looked like plastic vests which were leadless (but did provide radiation protection).
As we watched from Boston… . Read my full blow-by-blow report, see Live Case Presentation from Dublin, Ireland. Pulsed Field Ablation for AF Using a Multispline Catheter.
A-Fib Patients with Sleep Apnea: Philips Respironics Recall of CPAP Devices
Background: A-Fib patients often have obstructive sleep apnea as well. Many use a Continuous Positive Airway Pressure (CPAP) device when sleeping to keep their air way open and unobstructed.
The FDA Safety Commission and NST Attorneys-at-Law report that Philips has recalled their CPAP devices because of “identified potential health risks related to the polyester-based polyurethane sound abatement foam component of these devices.” The foam in the machine can break down and then be swallowed or inhaled by the user.
According to Philips’ lab results, degraded polyurethane foam produced potentially harmful chemicals. These chemicals may then enter one’s body, reach the bloodstream, and travel to any body tissue and organ. Most of these harmful chemicals from the degraded foam can cause cancer.
All CPAP Users
If you use a different brand of CPAP device, check the tubing. Or talk to your supplier about how safe your device is in light of the Phillips recall.
If You Have a Philips CPAP Device
For detailed information about this recall, go the NST Attorneys-at-Law web site or Philips Voluntary Recall Information to:
- Determine if your product is listed in the Philips recall notification
- Learn how to Register Your Device For Recall and What To Expect Next
Talk to Your Doctor: The U.S. Food and Drug Administration (FDA) advises consumers to talk to their doctor to weigh the risks of continued use and decide on a suitable way to move forward.
A-Fib, Sleep Apnea and CPAP: What You Need to Know
If you have a Phillips CPAP device, learn if you have a model that has been recalled. If so, stop using it and talk with your doctor on how to proceed.
If you model has been officially recalled, Philips should give you a new one. But you may be safer switching to another CPAP manufacturer.
Visit the Philips Voluntary Recall Information website to stay current on your claim.
2023 AF Symposium Challenging Case―“Doc, I’m still having A-Fib. You’ve got to fix it.”
“According to my Apple watch, Doc, I’m still having A-Fib. You’ve got to fix it.”
That’s how Dr. John Day began relaying this challenging case at the 2023 AF Symposium. The patient was a 56-year-old young man in otherwise good health.
Dr. Day, from the Heart Center of St. Mark’s Hospital in Salt Lake City, UT, describes the patient’s BMI as normal. He had had an ablation but was still in A-Fib. He had mild or moderate left atrium enlargement but no clear A-Fib triggers. He didn’t want to be on drugs. He had tried Flecainide which lowered his heart rate too much. He couldn’t exercise on Flecainide. How did Dr. Day proceed?
Dr. Day and his colleagues may have developed a new method of making patients with difficult cases A-Fib free.
To learn more, read my report, Challenging Case―Ablates Low Voltage High Frequency Areas.
2023 AF Symposium: Challenging Case―An EP’s Nightmare
This is a tragic case of a 77-year-old male, a retired Cardiologist and a personal friend of the speaker for over 40 years. This case resonated emotionally with both the doctors, panelists and the audience who seemed to have experienced similar experiences with their patients.
Dr. Karl-Heinz Kuck of the University of Lubeck, Lubeck, Germany, described what lead up to a fatal climax.
The story starts in 2014 when his patient developed Persistent Atrial Fibrillation. He had a successful PVI (Pulmonary Vein Isolation/ablation) and roof line ablation in 2015.
A couple of weeks later, the patent had a repeat ablation including an isthmus line. He was doing well for 6 years. But then he came back with… Read the whole story at Challenging Case―An EP’s Nightmare.
2023 AF Symposium: Innovative A-Fib Ablation Plus LAA Closure in One Procedure
This report from the 2023 AF Symposium is about an innovative treatment for A-Fib patients―combining A-Fib ablation with the insertion of a Left Atrial Appendage (LAA) occlusion device in a combined procedure.
Closing off the Left Atrial Appendage has become an important topic for patients looking to be A-Fib free.
Many A-Fib stokes originate in the Left Atrial Appendage. And many recurrences of A-Fib come from the Left Atrial Appendage, too.
Inserting a Watchman occlusion device to close off the LAA has become a relatively simple and fast process. Combining it with a catheter ablation doesn’t add much time to the ablation procedure.
This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.
Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH explained how patient selection is important in this combined procedure. To learn more read my report…
2023 AF Symposium: My First Report for Atrial Fibrillation Patients
The 28th Annual International AF Symposium took place Feb. 2-4, 2023 at the new Omni Hotel at the Seaport in Boston. Featured were presentations by 82+ leaders in Atrial Fibrillation research and clinical practice from all over the world. These stellar medical scientists, clinicians, and researchers share recent developments in the A-Fib field in a major scientific forum unmatched by any other conference.
It’s a jam packed 2 1/2 days and affords me a unique opportunity to talk with and learn directly from many of the most eminent investigators in the field.
As always, I do this to offer A-Fib.com readers the most up-to-date research and developments that may impact their treatment choices. All my reports are written in plain language for A-Fib patients and their families.
Conference Snapshot: We might call this year’s Symposium “The Pulse Field Ablation” meeting.”
Most Noteworthy Quote: Dr. Daniel Singer of Massachusetts General Hospital in Boston, MA commented: “CHA2DS2-VASc is an embarrassment.”
Read my 2023 AF Symposium Overview and Introduction for highlights on this year’s conference. Other reports will follow shortly and will be announced here first.
You might want to visit and review my 2022 AF Symposium Reports.
