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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.
Laminar LAA closure device
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.
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).
“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.
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.
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…
Dr. Karl-Heinz Kuck of the University of Lubeck, Lubeck, Germany described the tragic case of a 77-year-old male who was a retired Cardiologist and a personal friend of his for over 40 years. This case resonated emotionally with both the panelists and the audience who seemed to have experienced similar experiences with their patients.
Persistent A-Fib―Successful Ablation
Dr. Kuck’s patient was suffering from persistent A-Fib since 2014. He had 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 and was doing well for 6 years. But then he came back in with Tachycardia (high heart rate).
Dr. Kuck did another ablation in 2021. He found using voltage mapping that the patient had slow conduction around the scarring on the roof of the anterior wall. Among other techniques, Dr. Kuck made a roof line from the scar area to the annulus. He was able to terminate the tachycardia.
The patient was scheduled for a Left Atrial Appendage (LAA) closure procedure in 6 weeks. He was OK with that but didn’t want to come back for another ablation. He was told to continue taking anticoagulation.
Stops Taking Anticoagulation―Dies in 3 Days!
The patient stopped taking the anticoagulant apixaban (Eliquis) within a week of his ablation for fear of bleeding. He thought or was told by others or by his reading that he could substitute high dose aspirin for taking Eliquis. He was admitted at another hospital. A CT scan showed ischemia (an inadequate blood supply to the heart) and severe edema (swelling). He died 3 days later.
How to Prevent Patients Stopping Their Anticoagulation?
The audience was stunned.
An intense discussion among the panelists and the audience talked about why patients go off of anticoagulants when they shouldn’t.
People suffer a fall, develop cancer, have to have surgery, etc. and for various reasons are taken off of anticoagulants. Then they often develop a stroke.
During the discussion, some suggested closing off the LAA as soon as possible, even during an initial PVI ablation. The session’s last thought: “Should closing off the LAA be a first line procedure?”
Editor’s Comments
Nightmare of Patients Not Taking their Anticoagulant: Dr. Kuck’s case struck an emotional chord that resonated with attendees. A major nightmare EPs face is their patients not taking their anticoagulants, then having a stroke. This happens all too often and has probably occurred or will occur to every EP.
But, except for insisting that patients take their anticoagulants and other meds, there isn’t much an EP can do.
Closing Off the LAA May Be the Solution: Closing off the LAA does work and prevents stroke. It’s an effective substitute for a lifetime on anticoagulants. Then patients (and their doctors) don’t need to be preoccupied about a patient going off of anticoagulants. Instead of being a last resort procedure, many attendees seemed to think that LAA closure should be a first-line treatment for many patients.
If you find any errors on this page, email us.Y Last updated: Thursday, May 11, 2023
Live Case Presentation from Dublin, Ireland. Pulsed Field Ablation for AF Using a Multispline Catheter
The presenters of this live presentation were 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.
As we watched this live ablation, they used the optimized biphasic wave form for the PFA ablations. Dr. Szeplaki did the actual ablation while Dr. Galvin commented.
Dr. Gabor Szeplaki, Dublin, Ireland
No Lead Aprons
The first thing one noticed was that, instead of the typical Lead apron shields to protect against Fluoroscopy radiation, they were wearing what looked like plastic vests which were leadless. These transparent body shields included magnetic devices which communicated to radiation protection.
66-Year-Old Female with Common Right Atrium
The patient was a 66-year-old woman who had developed symptomatic paroxysmal A-Fib three years ago. She had been taking Sotalol but tolerated it poorly. They also had tried dronedarone, but she had symptoms.
Her CHA2DS2-VASc score was 3. She had hypertension. Her left atrium was otherwise healthy. She had a somewhat unusual pulmonary vein anatomy with what looked like a huge common right ostium. They used general anesthesia rather than conscious sedation.
Ablation Procedure
NOACs (Novel Oral Anticoagulants) were discontinued the morning of the procedure.
A TEE (Transesophageal Echocardiogram) was used to make sure there was no thrombus (clot) in the heart.
They used Ultrasound to position the catheter to puncture the vein. In the heart they used a single transseptal puncture to access the left atrium. They used the Orion catheter for 3-D mapping and paced from the Coronary Sinus.
The mapping software was integrated into the Farapulse system in real time, which is a great help to the EPs. The catheter sheaths were transparent so that they could better see and eliminate bubbles on the catheters.
Farapulse catheter Open-Basket configuration
Farapulse catheter – Five Petal Flower configuration
Each vein to be ablated received four basket and four petal ablations rotating the catheter each time for better coverage. (For a more detailed description of the Farapulse system, see my 2020 report, Pulsed Field Ablation—Emerging Tech for Atrial Fibrillation.)
They made sure that both exit and entrance block were achieved in each vein. As they ablated, the heart tissue on the screen changed from light red to dark red.
Even with the large common right ostium, they still used the 31mm catheter rather than the larger size. The patient was successfully ablated and returned to normal sinus rhythm.
Overall their results in their center are 96% vein isolation and 84% curable PVI.
Dr. Galvin commented that when they first started, PFA ablations were taking 6-7 hours. But now they are doing them in 40 minutes.
Editor’s Comments
PFA Ablation Easy, Safe and Effective: The Farapulse ablation protocol has become relatively easy and safe to do. The operators in Ireland seemed very proficient, confident, and experienced. For them this was no big deal and almost routine. This is great news for patients. 40 minutes is a very short time to perform an ablation. And with no complications.
PFA Not Yet Approved in U.S.―But Will Be Soon. PFA ablation is not yet approved in the U.S., but has been approved overseas and has been in use for some time. Panelists from Germany pointed out that PFA ablation is now done on an out-patient basis with no need to stay in a hospital overnight. This is all good news for U.S. patients with Atrial Fibrillation.
Transparent Radiation Shields Great Advance: And using these transparent shields to protect against radiation exposure is a huge advance for EPs doing ablations.
I’ve been in operating rooms and had to wear those lead aprons used today by most EPs. They are really heavy and wear you down by the end of the day. All too many EPs develop slipped disks or other back problems. And reducing or eliminating radiation exposure improves EPs health and peace of mind. Good news for EPs!
If you find any errors on this page, email us.Y Last updated: Thursday, May 11, 2023
Challenging Case―Ablates Low Voltage High Frequency Areas
Dr. John Day of the Heart Center of St. Mark’s Hospital in Salt Lake City, UT presented the case of a 56-year-old young man in otherwise good health. His BMI was normal. He had had an ablation but was still in A-Fib, according to his Apple watch. “Doc, I’m still having A-Fib. You’ve got to fix it.” 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.
Dr. Day gave the audience the following choices and asked their opinion.
1. End the case [with no further treatment]
2. Change the antiarrhythmic.
3. Ablate again.
Mapping illustration: Low-voltage high frequency areas targeted for ablation
The consensus of the audience was to ablate again. And this was indeed how Dr. Day proceeded.
Second Ablation of Hot Spots
In this patient’s second ablation, all the PVs (pulmonary veins) remained isolated. A-Fib was induced with pacing and Isoproterenol. Dr. Day used electrogram guided ablation.
When in both sinus rhythm and atrial fibrillation, the patient had low-voltage zones (suggestive of left atrial fibrosis) on the posterior wall of the left atrium.
Dr. Day targeted very high frequency signals (hot spots) appearing in low voltage areas. He remarked:
• “We only mark low voltage zones (diseased tissue) if it is low voltage in both sinus rhythm and atrial fibrillation.” • “We only treat confirmed low voltage zones with high frequency signals…basically with this approach we are only treating diseased tissue with intense abnormal electrical activity which often corresponds to atrial fibrillation driver sites.”
Dr. Day admitted this doesn’t always work. But he has done over 5,000 ablations where this technique is effective.
The patient’s A-Fib didn’t terminate during the ablation, but it did later. Sometimes these patients have to be cardioverted to get them back into normal sinus rhythm.
This patient has been A-Fib free for 18 months and is off of Flecainide.
Editor’s Comments
Dr. Day and his colleagues may have developed a new method of making patients with difficult cases A-Fib free.
Innovation approach. Instead of looking for “potentials”, he ablates areas of low voltage and high frequency. This is an innovative approach and could help many patients with difficult cases.
If you find any errors on this page, email us.Y Last updated: Thursday, May 11, 2023
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) where 90%-95% of Atrial Fibrillation clots and strokes come from.
2023 AF Symposium presentation session: Dr. Saibal Kar of Cardiovascular Associates at Los Robles Hospital in Thousand Oaks, CA.
Disappearing the LAA
In an animation by the company Laminar (Laminarlaa), Dr. Kar showed what he called a “rhythm ball”. It is inserted into the LAA, then twisted counterclockwise to the point where the LAA opening (ostium) is screwed together so tightly that the ostium disappears.
Then, this ball is locked in place to prevent it from unwinding. The closure/elimination is checked for leaks, then the catheter is released while the device remains locked in place.
Laminar LAA closure device
Dr. Kar refers to this process as not just closing off the LAA but eliminating it (in the animation, the LAA disappeared).
Quick to place:The whole process takes 16 minutes with testing taking only 60 seconds. All this can be done in real time.
Repositionable:If not satisfied with the original insertion, the device can be untwisted and repositioned.
Dr. Kar also showed implanted devices and how they look after 45 days. The LAA is closed off with only a very small ball left inside the LAA, much smaller than current LAA closure devices.
Two Years Testing, Two Centers in U.S.
The Laminar LAA Closure/Elimination device has been used in Europe for 2 years and is now in its third generation. European patients have had as many as 2 years of follow-up.
In the US, there are currently two centers performing this procedure, one at Los Robles hospital in Thousand Oaks, CA and a second in Tucson, AZ. In the U.S., 15 patients have received this device which has been 100% successful in closing off the LAA.
Editor’s Comments
Medical Breakthrough! The Laminar LAA elimination device is a potential medical breakthrough innovation!
Like many great innovations, the Laminar LAA elimination device seems remarkably simple and easy to use. It could revolutionize the way LAAs are closed off today. And because it takes so little time to insert, it could be positioned at the same time as a catheter ablation.
Most importantly, by actually eliminating the LAA rather than simply closing it off, it may be much better for patients offering fewer leaks, complications, intrusive metal devices in the heart, etc. Also, by actually eliminating the LAA, it could prevent non-PV triggers in the LAA from affecting a patient’s A-Fib.
In the future, current LAA closure devices such as the Watchman (Boston Scientific) and Amulet (Abbott) may be superseded by the Laminar device.
If you find any errors on this page, email us.Y Last updated: Friday, May 12, 2023
Ablation Combines with LAA Closure in One Procedure
Walid Saliba, MD
Dr. Walid Saliba of the Cleveland Clinic Foundation in Cleveland, OH, discussed 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. (This treatment strategy is currently in use in many countries overseas, but isn’t yet common practice in the U.S.)
Patient Selection
Dr. Saliba explained how patient selection is important in this combined procedure.
The idea patient with atrial fibrillation needing an ablation would also have a high risk of stroke but couldn’t tolerate anticoagulants because of a high risk of bleeding.
Advantages of Combining PVI with LAA Closure
While these two procedures (A-Fib ablation and LAA closure) are typically done separately, combining them in one procedure has many potential advantages. Both procedures:
• require access from the groin to the left atrium
• initiating oral anticoagulation around the time of the procedure
Dr. Saliba made the following points:
1.Combining these two procedures reduces the risk of complications. (For example, one only has to make a transseptal puncture once rather than at two different times.)
2. Patients prefer only having to have one procedure rather than the hassle of going to the hospital twice for two different steps.
3. Combining these two procedures reduces the potential risk of bleeding.
Reimbursement Problem in U.S.
Dr. Saliba described how in the beginning (2015) it was difficult to be reimbursed for combining two different procedures at the same time. But eventually he was able to convince the powers that be that this was good for certain patients and actually saved the hospital money.
Source of A-Fib Recurrences
Dr. Natale and Dr. Saliba discussed that many A-Fib recurrences come from the Left Atrial Appendage. Inserting an LAA occlusion device when performing an ablation might prevent the mapping and ablating of non-PV triggers in or around the LAA. (This is less of a problem with the Watchman than with the Amulet device which actually masks off the LAA area with a metal disc.)
High Success, Low Complication
Dr. Saliba and his colleagues at the Cleveland Clinic have performed this combined procedure on more than 240 patients with one-year follow-up. Their success rate is high with low complications. Patients stayed in the hospital for a day. Over 95% of their patients are eventually off of anticoagulants.
Half of their patients received the original Watchman, while the other half got the Watchman FlX. Leaks around the Watchman were only around 2.2% and were less than 2mm. At 90 days leaks were around 25% with less than 3mm. Dr. Saliba hasn’t noticed any problems with LAA remodeling, pressure, or scarring of the Left Atrium wall.
OPTION Trial Revelations to Come
The OPTION Trial is a clinical study of patients with non-valvular A-Fib. It compares outcomes of a combined ablation + LAA occlusion procedure versus catheter ablation alone followed with anticoagulation.
Specifically, the study is to determine if the WATCHMAN FLX occlusion device placed at the time of the ablation is a reasonable alternative to continuation of oral anticoagulation following catheter ablation. The results of this trial will be available in 2024.
Editor’s Comments
Combining PVI with LAA Closure Medical Breakthrough! Combining a catheter ablation for A-Fib (PVI) with the insertion of a Watchman occlusion device seems a major improvement for patients, as well as reducing or eliminating a major source of worry for electrophysiologists (EPs).
One day, hopefully soon, everyone getting a catheter ablation will also have an occlusion device inserted in one procedure.
Free from Most Stroke Risk: Inserting a Watchman device to close off the LAA has become a relatively simple and fast process. Combining it with a PVI doesn’t add much time to the ablation procedure. And Dr. Saliba’s research demonstrated that it works!
The Left Atrial Appendage (LAA) is where most clots and strokes come from in patients with non valvular A-Fib. Patients getting a catheter ablation generally leave the hospital A-Fib free.
Nevertheless, they are still considered at some risk of stroke. Current guidelines dictate continuation of stroke prevention with oral anticoagulation despite a successful ablation. Having the LAA closure device offers protection against stroke without the ongoing bleeding issues of oral anticoagulation.
Patients Would Choose/Prefer This Combination Procedure: If you offered the average A-Fib patient the chance to be protected from a stroke at the same time they are made A-Fib free by a catheter ablation, most patients would choose the combination procedure.
They would only have to be hospitalized once and wouldn’t have to return weeks later to have their LAA closed off, as is common practice in the U.S. today.
They would have better peace of mind and quality of life knowing they are largely protected from having an A-Fib stroke.
And their doctor wouldn’t have to worry about them going off their anticoagulant and developing a clot in their LAA.
If you find any errors on this page, email us.Y Last updated: Thursday, May 11, 2023