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“I think your site has helped a lot of patients.”Dr. Hugh G. Calkins, MD Johns Hopkins,
Baltimore, MD
2022 AF Symposium Abstract: Inhaler Can Stop A-Fib Attack in Minutes
This abstract further elaborates on an 2021 AF Symposium Spotlight session by Dr. Jeremy Ruskin of Massachusetts General Hospital. He showed safety data from the InCarda Phase 2 study (INSTANT) which he thought very promising. This abstract details a small clinical trial.
This InCarda inhaler is an incredible medical innovation for A-Fib patients! (It’s still in development.)
Imagine: A patient is having an A-Fib episode. The patient self-administers the InCarda inhaler, it produces a flecainide-containing aerosol which the patient inhales. This results in a rapid absorption of flecainide via the lungs into the heart.
It can terminate an A-Fib attack in as little as 8 minutes. (The tablet form of Flecainide takes around 1−3 hours to work.)
For more read my short report: Trial II of InCarda Orally Inhaled Flecainide.
2022 AF Symposium: Spherical Array Catheter Case with Video
Note: This was a very early, first-in-human use of this Spherical Array PFA catheter not yet approved by the FDA.
Dr. Vivek Reddy from Mount Sinai Medical Center in New York City, NY, showed a fascinating video of how the spherical PFA catheter emerged from the catheter sheath and formed itself into a spherical array, then locked itself into shape.
It was like watching a magic trick. How could they design a catheter sheath from which would emerge a complex spherical shaped catheter that would come together so smoothly?
On the video, we watched as Dr. Reddy and his team performed a Pulsed Field Ablation using the Spherical Array Catheter. The patient was a 31-year-old male diagnosed with paroxysmal A-Fib in 2020.
How the Spherical Array Catheter Works
Once fully deployed, the spherical PFA catheter has a diameter of 30 mm. It contains 122 gold-plated electrodes on 16 splines around the sphere. Continue reading about the Spherical Array catheter and the Pulsed Field Ablation for this patient.
2022 AF Symposium Spotlight: Innovation in Development to Seal the Left Atrial Appendage
The CLASS LAAO
Sometimes the method to close off the Left Atrial Appendage, doesn’t make a complete closure. It can leak. I’m very excited about this new product. Dr. Jamie Kim of the Catholic Medical Center in Manchester, NH, presented one of the most innovative and promising new developments for patients to close off their LAA.
Instead of relatively hard, rigid structures which don’t always conform perfectly to the LAA opening and thus may leak, the CLASS LAAO system from Conformal Medical, Inc. uses a different type of conformable foam-based fabric to seal off the LAA. Read this short Spotlight summary for more about this promising new device.
2022 AF Symposium: Procedural Anticoagulation with LAA Closure Devices for A-Fib Patients
In this report from the 2022 AF Symposium, Dr. Luigi Di Biase of the Albert Einstein College of Medicine, Bronx, NY gave a presentation on “Peri and Post Procedural Anticoagulation with LAA Closure Devices―An Evolving Story”.
In particular, he is talking about the Watchman occlusion device to close off an A-Fib patient’s Left Atrial Appendage. His focus is on the anticoagulation protocol following the procedure involving, that is, the drug regime for patients in the months afterward. e.g., DOACs, aspirin and clopidogrel.
This is a short report, a quick read, go to Procedural Anticoagulation with LAA Closure Devices―An Evolving A-Fib Story.
2022 AF Symposium: Challenging Cases: The Patient has the Last Say
My new report from the 2022 AF Symposium is about one of the “Challenging Cases” presentations. This is when some of the world’s leading Electrophysiologists (EPs) describe the most difficult Atrial Fibrillation cases they had to cope with through the year. Frankness prevails.
Dr. Erik Prystowsky of St. Vincent’s Hospital, Indianapolis, IN, described a 65-year-old man with Atrial Fibrillation, shortness of breath, and a critically low Ejection Fraction (10%). And a severely enlarged left atrium (5.4 cm).
The patient was offered a catheter ablation procedure but would not accept even after the most persuasive attempts to convince him—it would likely fix his A-Fib, improve his Ejection Fraction, and reduce the size of his left atrium. To learn how this patient’s health evolved over the next 5-6 years, read my full report: Challenging Cases—The Patient has the Last Say.
(Finally) A Head-to-Head Comparison of Anticoagulants for A-Fib: Eliquis vs Xarelto
The most commonly prescribed direct-acting anticoagulants (DOACs) for A-Fib patients are Eliquis (generic name: apixaban) and Xarelto (generic name: rivaroxaban).
Direct-acting anticoagulants (DOACs) were introduced in the early 2010s, but most of the testing has been against warfarin, not against other DOACs. Finally, thanks to the researchers of two retrospective studies, A-Fib patients now have a head-to-head comparison of Eliquis versus Xarelto.
Study 1: Stroke and Bleeding Risks
A recent retrospective study (Fralick, M. et al) looked at 6 years of prescription data for atrial fibrillation patients from the Nationwide Healthcare Claims Database (NPIC). A-Fib patient group sizes were matched (39,351 each). Mean age was 69 years, 40% were women and follow up was 288–291 days.
Significant Findings
1. Eliquis patients had significantly lower rates of stroke or systemic embolism (6.6 vs 8.0 events per 1000 person-years) compared to Xarelto.
2. Eliquis patients had a significantly lower incidence of major bleeding, defined as gastrointestinal bleeding or intracranial hemorrhage (12.9 vs 21.9 events per 1000 person-years).
Researchers Conclusion (Fralick, M. et al): In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban.
Study 2: Stroke and Bleeding Risks
A second retrospective study (Ray, W. et al) looked at 581,451 atrial fibrillation patients 65 years or older who were enrolled in Medicare from 2013–2018. A-Fib patient group sizes were Rivaroxaban, 227,572 and Apixaban, 353,879. Follow up was for 4 years, through November 30, 2018. Mean age was 77.0 years; 50.2% were women (291 966).
Significant Findings
1. Xarelto patients had more hemorrhagic events including fatal extracranial bleeding (1.4 vs 1.0 per 1000 person-years)
2. Xarelto had more nonfatal extracranial bleeding (39.7 vs 18.5 per 1000 person-years)
3. Xarelto had more fatal ischemic/hemorrhagic events (4.5 vs 3.3 per 1000 person-years)
4. Xarelto had more “total mortality” (44.2 vs 41.0 per 1000 person-years)
Researchers Conclusions and Relevance (Ray, W. et al): Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.
Eliquis vs Xarelto…and the Winner is…
Eliquis (apixaban)! In routine care, Eliquis was found to be both more effective and safer than Xarelto.
As patients, we should pay particular attention to the fact that Eliquis had significantly lower incidence of major bleeding (gastrointestinal bleeding or intracranial hemorrhage) than Xarelto (12.9 vs 21.9 events). And that Xarelto had increased nonfatal extracranial bleeding (39.7 vs 18.5 events) compared to Eliquis.
These differences in bleeding weren’t just “statistically significant” but were really alarming. Major, red flag warning important. Particularly for older people who are more prone to bleeding problems.
Be Your Own Best Patient-Advocate
Whether or not to take anticoagulants and which one is one of the most difficult decisions you and your doctor must make.
All the results cited above were “significant” and should be taken into account when choosing an anticoagulant.
If you are taking Xarelto, you should talk with your doctor about switching to Eliquis.
Learn all you can about your health conditions. A well-informed patient is welcomed by your doctors and healthcare caregivers. (If not, consider changing doctors.)
• Dawwas, G.K. et al. Apixaban Versus Rivaroxaban in Patients With Atrial Fibrillation and Valvular Heart Disease—A Population-Based Study. Annals of Internal Medicine, 18 October 2022. https://www.acpjournals.org/doi/10.7326/M22-0318 https://doi.org/10.7326/M22-0318
Can You Detect Atrial Fibrillation from Your Wallet?
AliveCor KardiaMobile Card
A-Fib patients! AliveCor, Inc. has announced the launch of their most advanced single-lead personal EKG, the KardiaMobile Card. An electrocardiogram (ECG) device the size of a standard credit card.
This easy to use technology records an accurate, medical-grade EKG and can detect 6 of the most common arrhythmias anytime, anywhere. It accurately detects A-Fib, Bradycardia, Tachycardia, PVCs, Sinus Rhythm with SVE, and Sinus Rhythm with Wide QRS.
The device’s algorithm is based on AliveCor’s Artificial intelligence-enabled (AI) Kardia technology, which has been evaluated by more than 170 peer-reviewed studies.
KardiaCare Membership: Purchase includes KardiaCare membership (first month free). KardiaMobile Card users have access to a cardiologist’s analyses of ECGs, monthly heart health reports, and automatic sharing of ECG recordings. Learn more at AliveCor KardiaMobile Card.
AliveCor KardiaMobile 6L
Want to Record Six-Lead EKGs?
AliveCor’s KardiaMobile 6L with KardiaCare gives you the power to record six-lead EKGs and detect 6 of the most common arrhythmias. It has two electrodes on the top for your fingers, and one on the bottom to contact the skin of your left leg and record a six-lead EKG.
KardiaMobile 6L delivers EKG leads I, II, III, aVL, aVR, and aVF. All without messy gels and wires.
Learn more at Alivecor KardiaMobile 6L with KardiaCare.
A-Fib Catheter Ablation Combined with Left Atrial Appendage (LAA) Closure
In the People’s Republic of China (and other countries) catheter ablation for Atrial Fibrillation is often combined with closure of the Left Atrial Appendage (LAA) in one procedure. This means A-Fib patients can have a Watchman occlusion device installed at the same time as their catheter ablation.
While it may be common practice in some locales, there is limited research data on this combined procedure and, in particular, with patients with prior stroke. That’s why this study in China was conducted.
Aim of this Study: To compare the safety and efficacy of combined catheter ablation with closure of the Left Atrial Appendage (LAA), especially for A-Fib patients who have had a prior stroke.
Study Design: This retrospective study enrolled 296 patients who underwent combined procedures of A-Fib catheter ablation and LAAC. Patients were divided into two groups: 81 patients with prior stroke (Stroke group) and 215 patients without prior stroke (Control group).
Combined procedures were successfully performed in all the patients.
Follow-up Findings: The researchers followed-up with patients at a mean of 20 months.
Both the Stroke group and the Control group (without prior stroke) were relatively A-Fib free after catheter ablation. (Stroke group: 64.2%, the non-stroke control group: 68.4%).
The relative risk reductions in stroke and bleeding were around 80% in the stroke group and 62% in the control non-prior stroke group.
Conclusion: The researchers wrote: “The combination of catheter ablation and LAAC (Left Atrial Appendage Closure) is safe and effective in selected AF patients with prior stroke.”
Editor’s Comments
There are several limitations to this study. This is a single-center retrospective study with a moderate sample size.
Despite the limitations of this study, for A-Fib patients the combination of catheter ablation and Left Atrial Appendage (LAA) closure appears safe and effective.
Currently, U.S. patients have to wait 3 months after a catheter ablation to have a Watchman inserted. Why must patients wait, why endure months of anticoagulants usage? But, more research is needed to confirm the conclusions of these researchers.
AF 2022 Symposium: Pulsed Field Ablation—Integrated Mapping-Ablation Spherical Array Catheter for A-Fib
2022 AF Symposium
Pulsed Field Ablation for AF Using an Integrated Mapping and Ablation Spherical Array Catheter
Note: This was a very early, first-in-human use of this Spherical Array PFA catheter not yet approved by the FDA
Dr Vivek Reddy
Dr. Vivek Reddy from Mount Sinai Medical Center in New York City, NY and Dr. Petr Neuzil of Homolka Hospital, Prague, Czech Republic presented a pre-recorded case on “Pulsed Field Ablation for AF Using an Integrated Mapping and Ablation Spherical Array Catheter.”
The patient was a 31-year-old male diagnosed with paroxysmal A-Fib in 2020. His left atrium diameter measured 39 mm (normal size). His Ejection Fraction was 65% (normal). His CHA2DS2-VASc score was zero.
Innovative Spherical Array
Dr. Reddy showed a fascinating demo of how the spherical PFA catheter emerged from the catheter sheath and formed itself into a spherical array, then locked itself into shape. It was like watching a magic trick. How could they design a catheter sheath from which would emerge a complex spherical shaped catheter that would come together so smoothly? Kudos to whomever designed this innovative system (Kardium Globe).
How the Spherical Array Catheter Works
Once fully deployed, the spherical PFA catheter has a diameter of 30 mm. It contains 122 gold-plated electrodes on 16 splines around the sphere. Behind each electrode is a thermocouple to measure heat. (The system was originally designed for RF ablation. But this spherical catheter was not irrigated.) Because of the high number of electrodes, it also produces high quality 3D activation maps of the left atrium. It can also be used for pacing.
Spiral Array Catheter at opening to Pulmonary Vein
As we watched, Dr. Reddy easily rotated and moved the Spherical Array catheter. It can map and ablate anywhere is the left atrium and produce continuous lesions. It doesn’t have to be manipulated as much as a point-by-point RF catheter. The next generation catheter will be smaller.
The system is bi-polar and biphasic in that the PFA signal is delivered using an electrode on one spline along with another electrode on an adjacent spline. Usually, Dr. Reddy said, he only required a 3-second PFA ablation to isolate a PV.
They used general anesthesia, but acknowledged that this system could work under simple conscious sedation.
Single-Shot, Omni-Directional, Needs Tissue Contact
Dr. Reddy described it as a single shot system in that one PFA application should isolate an area. It is omni-directional in that the sphere can be positioned in any direction as long as there is contact, and the sphere is touching tissue. The system seemed to easily produce a voltage map of the left atrium. The system uses GPS 3D navigation and mapping to track the precise location of the Globe catheter inside the atrium.
“Flow” and “Contact” Mapping: Where to Apply the PFA Pulse
Dr. Reddy described the system as using two types of contact mapping: “Flow” Map and “Contact” Mapping.
The Flow Map gets contact info relatively fast by sensing how quickly the electrodes cool when electricity is applied to them, while Contact Mapping takes 10-15 seconds and calculates how high the temperature rises. If it touches tissue, the temperature should become higher. “Contact” mapping provides more high-fidelity info than “Flow” mapping.
Dr. Reddy would use both systems one after the other to determine where the actual PFA pulse should be applied. Dr. Reddy said that the Spherical Array catheter is in one sense a large focal catheter while also more forgiving in terms of precise positioning. When a green area appeared, this meant contact. While white represented areas not yet ablated. Blue areas represented completed PFA lesions.
We watched as the PVs were isolated. He showed both pre and post voltage maps side-by-side to document that the PVs were isolated. Some microbubbles were produced, but previous RF ablations using this system didn’t produce any problems. Dr. Reddy said that they haven’t seen any reconnection. In this case they only isolated the PVs and made no attempt to isolate the posterior left atrium wall or other areas of the heart.
Removing the Spherical Array Catheter
At the end we watched as Dr. Reddy forced the catheter shaft back over the Spherical Array which collapsed back into a linear form and was easily removed (another fascinating technical achievement).
Editor’s Comments
Though this Spherical Array catheter is in very early stages of development, it seems to me to have the potential to challenge current leaders in the PFA field.
A streaming video-on-demand of Dr. Reddy’s case and presentation is available at https://player.vimeo.com/video/676797282. 28:48 min. (Published by the 2022 AF Symposium.)
Spotlight Session: Clinical Experience with the CLASS LAAO System
2022 AF Symposium
Spotlight Sessions: Features products or devices usually still in development or not yet FDA approved. They give us a glimpse into what the future of A-Fib treatment may look like.
Spotlight Session: Clinical Experience with the CLASS LAAO System
Dr. Jamie Kim
Dr. Jamie Kim of the Catholic Medical Center in Manchester, NH, presented one of the most innovative and promising new developments for patients to close off their Left Atrial Appendage (LAA).
The CLASS LAAO
Instead of relatively hard, rigid structures which don’t always conform perfectly to the LAA opening and thus may leak, the CLASS LAAO system from Conformal Medical, Inc. uses a different type of conformable foam-based fabric to seal off the LAA.
Complete Seal
The CLASS is designed to conform to a broader range of LAA sizes and shapes.
In the animation we saw, the foam-like material expanded from the insertion catheter to fill the interior of the irregularly shaped LAA. Dr. Kim says the seal made by the CLASS is complete.
Easier To Use, Wider Applicability
The CLASS LAAO system catheter
The CLASS device is soft which allows for both easier positioning when inserted and greater conformability. It also didn’t seem to have any metal protrusions as one sees in the Watchman.
It comes in only two sizes. It also uses rows of anchors to lock the device in place in the LAA. It’s designed with a flexible Nitinol under skeleton. It can be re-captured, if necessary.
To compare the Watchman with the CLASS, see my report: The Watchman Device. There’s also a brief animation of how the Watchman is installed: The Watchman FLXTM Device: Closure of the Left Atrial Appendage.
