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2020 AF Symposium Abstract: High Hemorrhagic Risk Factors from NOACs
2020 AF Symposium Abstract
High Hemorrhagic Risk Factors from NOACs
by Steve S. Ryan
NOAC Hemorrhagic Stroke Risk
When I read in this abstract from Massachusetts General Hospital in Boston, these NOAC findings almost jumped off the page at me! We know that NOACs are high risk meds (though they are certainly better than having an A-Fib stroke). But, add to that, also a high risk of Hemorrhagic risk factors, too?
This is a most important and relevant study for A-Fib patients.
Brain MRI to Detect NOAC Hemorrhagic Stroke Risk
Researchers from Massachusetts General Hospital in Boston used MRI to identify markers of increased intracerebral hemorrhage risk (ICH).
This was a single center study conducted from January 2011 to May 2019. In the study were 282 patients of which 76% had Atrial Fibrillation; Of the 282 patients, 49 were taking NOACs and 233 were taking warfarin. All demographic variables, vascular risk factors, etc. were similar between the two groups.
Study Findings
Analyzing the MRI data of the 282 participants revealed:
• cerebral microbleeds (67%)
• moderate-to-severe white matter hyperintensities (76%)
• cortical superficial siderosis (excess iron in body tissue) (18%)
In particular, of the 49 patients taking NOACs:
• 97% had at least one of these markers
• 60% had two
• 4% had all three
Conclusion
Established MRI markers of increased ICH (intracerebral hemorrhage) were common in the NOAC study group.
High hemorrhagic risk markers were present in an overwhelming 97% of NOAC patients.
Editor’s Comments:
Does taking a NOAC long-term mean you’ll eventually develop a hemorrhagic stroke?
No, the researchers didn’t go that far. This was a limited study as the number of patients who were on NOACs was 49 compared to those on warfarin which was 233.
Red Flag Warning: This study should raise a red flag for anyone taking NOACs long term. Almost all patients on NOACs (97% in this study) had “evidence of neuroimaging markers of high ICH risk.”
The authors recommended that prescribers (and patients) look at nonpharmacological stroke prevention methods. Eliminating the need for lifelong NOAC anticoagulation “may decrease the incidence of fatal/disabling hemorrhages in A-Fib patients.”
For more on NOACs and stroke, see my article Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.
If you find any errors on this page, email us. Y Last updated: Friday, May 1, 2020
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2020 AF Symposium: Terminate Persistent A-Fib by Ablating Higher Frequency Modulation Areas
2020 AF Symposium
Terminate Persistent A-Fib by Ablating Higher Frequency Modulation Areas
by Steve S. Ryan
Background: Previous studies by Dr. Jose Jalife, University of Michigan, Ann Arbor, MI.:
• A-Fib Produces Fibrosis—Experimental and Real-World Data: Dr. Jose Jalife’s ground-breaking research studies with sheep demonstrated conclusively that A-Fib produces fibrosis;
• Experiments in Atrial Remodeling in Sheep and the Transition From Paroxysmal to Persistent A-Fib: Dr. Jalife’s later research showed how A-Fib progresses in time from paroxysmal to persistent A-Fib.
Jose Jalife MD
At this year’s AF symposium, Dr. Jalife presented findings by research colleagues showing how leading-driver regions of A-Fib have higher frequency modulation (iFM) areas which, when ablated, usually terminate persistent A-Fib.
His presentation was entitled “Using Instantaneous Amplitude and Frequency Modulation to Detect the Footprint of Stable Driver Regions as Targets for Ablation of Persistent AF.” Dr. Jose Jalife, University of Michigan, Ann Arbor, MI.
Clinical Study
Researchers have used sheep and pigs in previous studies. This time to detect rotors in sheep, researchers developed algorithms based on amplitude modulation (iAM) and frequency modulation (iFM).
They then switched to pigs who underwent high-rate atrial pacing to develop persistent A-Fib.
Frequency modulation (iFM) /instantaneous amplitude modulation (iAM) approach to patients with persistent atrial fibrillation
Using the PentaRay Catheter (Biosense Webster) to produce high-density electroanatomical atrial mapping, they found that regions of higher than surrounding average iFM were considered leading-drivers.
These iFM areas also had the highest dominant frequency. “They are the footprints of rotors.”
Not all rotors are drivers. Only those with the highest frequency and greater stability are A-Fib drivers. “IFM helps identify the regions with the highest frequency drivers.”
Researchers constructed two leading-driver + rotational-footprint maps (rotors) 2.6 hours apart from each other to test for stability and to guide ablation. Leading-driver regions remained in approximately the same spots in each map.
The trial showed high iFM areas are responsible for maintaining persistent A-Fib
The trial showed high iFM areas are responsible for maintaining persistent A-Fib
Study Results
When these areas were ablated, persistent A-Fib terminated in 12 of the 13 cases (92.3%). Rotational-footprints (rotors) were found at every leading-driver region, but not all rotors had higher iFM. “In pigs, ablation of leading-driver regions usually terminates persistent A-Fib and prevents its sustainability.”
Conclusion
Dr. Jalife concluded that high iFM areas are responsible for maintaining persistent A-Fib. And using iFM results in higher sensitivity and specificity without the need for high resolution and costly panoramic mapping.
Editor’s Comments:
(I had never heard of the term “frequency modulation” (iFM) applied to A-Fib before.)
High Areas of iFM a New Discovery in A-Fib: The researchers have re-defined the field of mapping and catheter ablation.
This research shows that higher regions of iFM help identify the regions with the highest frequency drivers (rotors) and are more easily mapped in persistent A-Fib.
Dr. Jalife and his colleagues have given EPs and researchers a new tool to better ablate persistent A-Fib, the most difficult arrhythmia to fix.
If you find any errors on this page, email us. Y Last updated: Friday, May 1, 2020
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2020 AF Symposium: Protecting the Esophagus by Cooling It
2020 AF Symposium
Protecting the Esophagus by Cooling It
Mark Gallagher. MD
“We know that most strategies (to prevent fistula) don’t work,” Says Dr. Mark Gallagher from St. George’s University Hospital in London, United Kingdom.
At the 2020 AF Symposium, he described an innovative strategy he and his colleagues developed to prevent fistula. He presented the completed IMPACT study which investigated whether Attune Medical’s ensoETM esophageal cooling system could effectively reduce the incidence and severity of thermal injuries to the esophagus during cardiac ablation.
IMPACT Double Blind Randomised Controlled Trial
In their clinical trial, Dr. Mark Gallagher and colleagues divided 120 patients into two groups: a control group and a experimental group.
IMPACT stands for Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation.
The Control Group: The control group received only standard care, in this case a temperature probe in the esophagus. If the temperature in the esophagus went too high, they would stop the ablation till the temperature went back down (current practice).
This would often lead to the EP not being able to effectively isolate all A-Fib signal areas in the heart which were too close to the esophagus. And often, by the time the temperature went up, damage had already been done to the esophagus.
The Experimental Group: Patients in the second (experimental) group instead received a 3-foot long silicone soft tube in their esophagus connected to what was basically a refrigerator. This closed loop system pumped cooled water (25 ͦ F) down one loop of the tube, then back through another loop to the console whenever the EP worked near the esophagus. The EP controls the temperature.
Double-Blind for Both Operators and Evaluators
This was a double-blind study. The EP doing the ablation didn’t know if they were working on a Control or Experimental patient. And the doctors evaluating the procedure for possible esophagus damage also were blinded.
After 7 days, an endoscopy was performed on each patient’s esophagus (an endoscopy examines the inside of an organ). They were looking for lesions and for gastroparesis (delayed emptying of the stomach).
IMPACT Study Results
The Control group who received the standard temperature probe had multiple epithelial lesions, while the Experimental group who experienced the closed loop cooling system had only one minor lesion.
The Experimental group also needed less fluoroscopy (X-ray) time. And, more importantly, the EP was able to ablate longer in areas near the esophagus (such as the posterior wall of the left atrium). That improved the success rate of the ablation and ablation efficacy.
Editor’s Comments
Most fistula patients die. And for those who live through the emergency treatment, they are often compromised for life. But with the esophageal cooling system, patients and doctors may never again have to worry about the dreaded complication Atrial-Esophageal Fistula!
Cooling the Esophagus, a Major Medical Breakthrough! Cooling the esophagus is simple and relatively easy to do. And, barring future research findings, it seems full proof.
The Attune Medical’s ensoETM esophageal cooling system is certainly cheaper than having to care for patients with a fistula.The Attune Medical ensoETM esophageal cooling system can provide both cooling during RF ablation, and heating during Cryo ablation.
The Attune Medical ensoETM esophageal cooling system can provide both cooling during RF ablation, and heating during Cryo ablation.
Probably among the major proponents of the esophagus cooling system will be hospital administrators. Treating patients with a fistula is a huge expense and a nightmare for hospital staff.
A fistula is an all-hands-on-deck emergency involving not just the EP department but surgeons and many hospital staffers. A surgeon may have to perform emergency surgery to insert stents in the esophagus in order to close off the fistula, or the surgeon may have to cut out part of the damaged esophagus, which is particularly risky
(I remember one EP describing how he and his staff were running down a hospital corridor with their fistula patient close to dying, in order to get the patient to an operating surgeon.).
Esophageal Cooling Means Better Ablations: And as a bonus, using the esophageal cooling system enables EPs to do a more thorough better job. They can ablate all areas of the heart rather than avoiding areas too close to the esophagus or using lower power with shorter duration or less contact force.
When Will Esophageal Cooling be Available? For catheter ablation application, probably not soon. In the U.S and probably worldwide, Attune Medical’s ensoETM esophageal cooling system is already in use and approved for specific purposes, for example, in cases of brain damage where a patient needs to have their whole body cooled down. But not for catheter ablation
In the United Kingdom, it will first have to be approved by NHS. In the U.S., it may not need to go through the FDA approval process again. (But this is a very speculative observation.)
Will Ablation Centers Implement? It will probably require a great deal of marketing to make EPs and ablation centers aware of and actually start using the esophageal cooling system. And because Atrial-Esophageal Fistula is such a rare complication, centers may not be willing to invest in an esophageal cooling system.
If you find any errors on this page, email us. Y Last updated: Wednesday, April 29, 2020
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2020 AF Symposium: After Diagnosis, How Soon Should an A-Fib Patient Get an Ablation?
2020 AF Symposium
After Diagnosis, How Soon Should an A-Fib Patient Get an Ablation?
by Steve S. Ryan
When you were diagnosed with A-Fib, did your doctor say, “Let’s wait a year or two and try different drugs before we send you for a catheter ablation.” Is this attitude justified by current research?
Karl-Heinz Kuck, MD
Dr. Karl-Heinz Kuck of St. Georg Hospital in Hamburg, Germany discussed this most important topic for patients in his presentation “ATTEST Trial―Impact of Catheter Ablation on Progression from Paroxysmal to Persistent AF.”
Heavy Decision for Electrophysiologists (EPs): When to Ablate
Dr. Kuck started by describing how he personally is affected by the strategic decisions he has to make every day. As an EP, “when should we ablate a patient with A-Fib?” Should we just look at symptoms (not considering anything that is caused by A-Fib).
Will this decision contribute to a patient moving into persistent forms of A-Fib?
This happens all too often―within one year, 4% to 15% of paroxysmal A-Fib patients become persistent.
Persistent A-Fib Patients at Higher Risk
Patients who progress to persistent A-Fib are at a higher risk of dying, they have more risk of stroke, it’s more difficult to restore them to normal sinus rhythm.
In the Rocket AF trial, the mortality rate of persistent A-Fib was triple that of paroxysmal patients.
ATTEST stands for “Atrial Fibrillation progression randomized control trial“
ATTEST stands for “Atrial Fibrillation progression randomized control trial“
ATTEST: RF Ablation vs Antiarrhythmic Drugs
The ATTEST clinical trial included 255 paroxysmal patients in 36 different study locations. They were older than 60 years and had to have been in A-Fib for at least 2 years (mean age 68). They had failed up to 2 antiarrhythmic drugs (either rate or rhythm control).
Patients were randomized to two groups: radiofrequency ablation (RF) (128) or antiarrhythmic drugs (127). They were followed for 3 years (ending in 2018).
ATTEST Findings: RF Ablation vs Antiarrhythmic Drugs
At 3 years, the rate of persistent A-Fib or atrial tachycardia was lower (2.4% ) in the RF group vs the antiarrhythmic drug group (17.5%).
The RF group was approximately 10 times less likely to develop persistent A-Fib compared to the antiarrhythmic drug group.
For patients in the antiarrhythmic drug group, 20.6% progressed to persistent A-Fib or atrial tachycardia compared to only 2.2% in the RF group.
Recurrences occurred in 49% of the ablation group vs. 84% in the drug group. Repeat ablations were done on 17.1% of the ablation group.
Dr. Kuck’s Conclusion
Early radiofrequency ablation was superior to antiarrhythmic drugs to delay the progression to persistent atrial fibrillation among patients with paroxysmal A-Fib.
His advice: “Ablate as early as possible.”
Editor’s Comments
Don’t Leave Someone in A-Fib―Ablate as Early as Possible: Dr. Kuck’s ingenious research answers once and for all whether or not A-Fib patients should be left in A-Fib, whether seriously symptomatic or not (e.g., leaving A-Fib patients on rate control drugs but still in A-Fib.)
These patients are 10 times more likely to progress to persistent A-Fib. That’s why today’s Management of A-Fib Guidelines list catheter ablation as a first-line choice. That is, A-Fib patients have the option of going directly to a catheter ablation.
Know Your Rights—Be Assertive: I occasionally hear of Cardiologists who refuse to refer patients for a catheter ablation, who tell patients a catheter ablation is unproven and dangerous.
When you hear something like that, it’s time to get a second opinion and/or change doctors.
As an A-Fib patient, you should know your rights and be assertive—that according to the guidelines, you have a right to choose catheter ablation as your first choice.
Your doctor may try to talk you into first trying antiarrhythmic meds before offering you the option of a catheter ablation. That is so wrong!
Why risk progressing into persistent A-Fib? There are so many bad things that can happen to you when left in A-Fib. As Dr. Kuck points out, you’re at a higher risk of dying, there’s more risk of stroke, it’s more difficult to restore you to sinus.
And we haven’t even talked about heart damage from fibrosis, the risk of electrical remodeling of the heart and, the all-too-real dangers of taking antiarrhythmic drugs over time.
Thanks for Sharing, Dr. Kuck! I am particularly grateful to Dr. Kuck for sharing his own anxieties and decision-making strategies when trying to determine when a patient should get a catheter ablation, how this affects him personally.
Making decisions about patients whom one cares about isn’t always easy. But Dr. Kuck’s research should now make these decisions easier both for EPs and for patients.
The Bottom Line for Patients: It’s safer to have an ablation than to not have one. For more see my article Live Longer―Have a Catheter Ablation!
If you find any errors on this page, email us. Y Last updated: Tuesday, April 28, 2020
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2020 AF Symposium Live Case: Ultra-Low Temperature Cryoablation
AF Symposium 2020
Live Case: Ultra-Low Temperature Cryoablation
Background: The Adagio Medical iCLAS catheter is a Cryo catheter that uses ultra-low temperatures and is unlike anything currently on the market. To learn more about the iCLAS catheter, see my earlier report from the 2018 AF Symposium: Innovative iCLAS Cyro Catheter by Adagio Medical.
Note: The Adagio Medical iCLAS is not yet FDA approved. The U.S. IDE study trial is active and enrolling. The clinical trial started in December 2019. https://clinicaltrials.gov/ct2/show/NCT04061603.
Live Ablation Via Streaming Video
Tom DePottee, MD
Live from Belgium, Dr. Tom De Potter and his colleagues from OLV Hospital performed an ablation using Adagio Medical’s ultra-low temperature cryoablation catheter.
When the Symposium audience joined the live ablation via streaming video, Dr. De Potter and his colleagues had already performed a single transseptal puncture and were working in the left atrium.
Several catheter configurations possible with the Adagio Medical system.
To produce temperatures as low as (minus) –196° Celsius, Adagio Medical uses what they call Near Critical Nitrogen (NCN) which is far lower than current CryoBalloon technologies.
Producing Continuous Linear Ablations
Adagio catheters produce continuous linear ablations and can also be configured to do focal (single point) catheter lesions. Dr. De Potter also showed how the same Adagio Medical catheter can also do cryo mapping.
As we watched, Dr. De Potter encircled the Left Superior Pulmonary Vein (PV) with a double loop catheter. Then applied the cryo energy and froze the ostium area to isolate the PV. The catheter stylus included a loop of the freezing section and a loop with electrodes which recorded/mapped the A-Fib signals.
Freezing Isolated the Vein
We could see the ice formation on the catheter itself and how the freezing isolated the vein.
Adagio catheter encircles PV and freezes to isolate the PV area.
It only took 30 seconds to isolate that vein, but Dr. De Potter continued the freeze for one minute. Then performed what he called a bonus freeze.
On the catheter monitor, we could see how that vein had PV potentials which were then isolated.
Then Dr. De Potter moved to the Right Pulmonary Veins. The phrenic nerve usually runs close to the ostia of the right PVs. He said they perform phrenic nerve pacing to prevent damage to the phrenic nerve. We saw how they performed phrenic nerve capture.
Monitoring the Phrenic Nerve
If they do find they might be damaging the phrenic nerve, they don’t ablate there or insert a different catheter stylus configuration which doesn’t affect that area.
They didn’t achieve isolation of the Right Interior PV, so they did a second ablation while slightly changing the stylus loop position. Dr. De Potter said that he usually achieves isolation with one pass, except for, as in this case, with the Right Interior PV which is more challenging.
Protecting the esophagus with the Adagio Medical Warming Balloon (right of heart)
CryoAblation is Reversible. Dr. De Potter showed how they first used low energy cryo in a 30 second ablation to see if the phrenic nerve was affected (if affected, the tissue can be de-frosted and returned to normal or reversed.) Then they applied the full cryo energy at the ultra-low temperature which is permanent. The speed of decrease in cooling is very fast at 300°C/sec.
Protecting the Esophagus
To protect the esophagus, Dr. De Potter showed how they insert a warming balloon with constantly circulating warm saline into the esophagus which prevents excessive cooling and damage to the esophagus.
He stated that the next generation of the warming balloon will also have temperature sensing. They can then have a much better idea of what the freezing will do to the esophagus, how much temperature affects will be seen in the esophagus.
Ablating the Posterior Wall
Dr. De Potter also showed the Adagio Medical system ablating the posterior wall. “It’s very simple. We will make overlapping rings.”
We saw him make those overlapping ring ablations in three passes which blocked conduction over the posterior wall. But with a larger atria, he may use 6 applications. He mentioned that at this stage he hasn’t achieved consistent success making a Mitral Isthmus line.
The Key Benefit of Ultra-Low Temperature Cryoablation
According to Dr. De Potter:
“The key benefit of this technology is a different energy source in contrast to the CryoBalloon which uses a theoretical minimum of –80°C.
This system (Adagio Medical) uses liquid nitrogen which has a theoretical minimum of –196°C. When you consider that this –80°C is at the center of the balloon and not necessarily at the tissue, we think we have a far better margin for efficient energy delivery while providing for patient safety.”
Editor’s Comments:
When I visited the Adagio booth at the Symposium exhibit hall, I was fascinated to see how easily the catheter can be manipulated into many different configurations depending on the lesions which need to be made.
Using its full length, the catheter can produce ultra-low temperatures along its whole span (110mm). Its 20 electrodes can also produce cryo-mapping of the atria.
Why is the iCLAS Cryo catheter special and innovative? The iCLAS catheter produces ablation lesions like current CryoBalloon catheters but at lower temperatures (colder). One would expect that such ultra-low Cryo lesions would be deeper, more transmural, and more lasting.
In addition, the ability to produce unlimited shapes gives the iCLAS catheter a unique ability to position Cryo lesions in a variety of locations in the heart.
The Adagio Medical iCLAS cyro system will make ablations much simpler and easier for EPs. It may eventually supersede normal CryoBalloon ablation (which is already a very effective ablation strategy).
If you find any errors on this page, email us. Y Last updated: Saturday, May 23, 2020
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2020 AF Symposium Abstract: Using MRI to Check Pulsed Field Ablations (PFA)
2020 AF Symposium Abstract
Using MRI to Check Pulsed Field Ablations (PFA)
by Steve S. Ryan
Background: Pulsed Field Ablation (PFA) is a new treatment for Atrial Fibrillation with some unique features. First, the ablations are tissue-specific, only affecting heart tissue and not the surrounding organs. Second, instead of direct contact to make lesions, as with RF ablation, all that’s necessary is proximity to the targeted tissue to make the ablation.
Pierre Jaïs, MD, The Bordeaux Group
In a remarkable statement that would strike terror in the heart of most Electrophysiologists (EPs), the French Bordeaux group stated about Pulsed Field Ablations:
“Measures to alter lesion placement based on proximity of the esophagus and phrenic nerve were not taken.”
Normally, during a RF or cryo ablation, doctors move the esophagus as far away as possible from where they are ablating. In this study they took no such precautions.
Pulsed Field Ablation (PFA) study
Farapulse catheter – Five Petal Flower configuration
At this year’s AF Symposium, the French Bordeaux group presented an abstract of their study using Pulsed Field Ablation (PFA) with MRI.
Study Technique: With the Pulsed Field Ablation (PFA) waveform generator, they used a 5-spline 12F catheter to isolate the Pulmonary Veins (PVs). Then, they used MRI to check the PFA lesions to assess any extra-cardiac damage.
Study Results
NO DAMAGE TO THE ESOPHAGUS
Position of Esophagus behind the heart
In 17 patients, the esophagus was located directly behind and adjacent to PFA lesions at a distance of 0.5 to 2 mm. Post PFA ablation and using MRI imaging, they found no esophageal lesions.
They also found no discontinuities (gaps) in any isolated PV.
(With other energy ablation sources such as RF, the esophagus would be scarred, have ulcer-like damage, and fistula.)
NO PHRENIC NERVE DAMAGE
Phrenic nerve near heart
When they ablated the right PVs, they knew that they were right next to or close to the phrenic nerve.
Upon examination, PFA lesions were found in the area of the phrenic nerve but no damage was seen (despite the fact that there was consistent phrenic nerve capture during PFA delivery).
LESS THAN 60 SECONDS PER PATIENT
And even more remarkably, the total energy delivery time per patient was less than 60 seconds. This is much less time than with other types of ablation.
Editor’s Comments:
I expect Pulsed Field Ablation (PFA) will revolutionize catheter ablation for A-Fib. This is incredibly good news for patients and will make the EP’s job much easier requiring less time in the EP lab.
Better for Patients
Atrial-Esophageal Fistula No Longer a Threat: These are remarkable results! When using Pulsed Field Ablation (PFA), EPs don’t have to worry about damaging the esophagus, even though the PFA catheter may be very close to the esophagus. The dreaded complication Atrial-Esophageal Fistula will become a thing of the past! The same holds for Phrenic Nerve damage.
PFA is Tissue Selective: Instead of direct tissue contact as with RF ablation, all that’s necessary with PFA is to position the catheter in proximity to the targeted tissue. Because PFA is tissue selective, it’s easier and faster to make lesions without gaps.
Better for EPs
PFA Allows More A-Fib Patients to be Treated: Because PFA takes so little time, patients won’t have to wait for months to schedule an ablation. EPs will be better able to handle today’s epidemic of A-Fib cases. (One wonders how many PFA ablations a skilled EP will be able to do during a day?)
Better for Health of EPs: PFA may add years to an EP’s career and health. EPs no longer will have to wear those heavy lead shields for long periods of time to prevent fluoroscopy radiation damage.
But Not Ready Yet
It will probably take 3-5 years for PFA to be available for most A-Fib patients.
If you find any errors on this page, email us. Y Last updated: Saturday, May 2, 2020
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COVID-19: White House Pushes Unproven Drugs—Risk of Arrhythmias and Sudden Death
by Steve S. Ryan
Note: I have already written about the risk of COVID-19 for patients with A-Fib (and other cardiovascular diseases). See my post: COVID-19 Virus: Higher Risk for A-Fib Patients.
In recent coronavirus pandemic press conferences, President Donald Trump has repeatedly advocated the use of the drugs hydroxychloroquine (HCQ) and azithromycin (Z-Pak) to treat the COVID-19 virus.
He often says, “What have you got to lose?” About treating patients, he also said these drugs can “help them, but it’s not going to hurt them.” (Really?)
COVID-19 stands for Coronavirus Disease 2019
Hydroxychloroquine & Azithromycin Danger―“What Have You Got to Lose?”
The drugs hydroxychloroquine and azithromycin are currently gaining attention as potential treatments for COVID-19. Hydroxychloroquine sulphate (Plaquenil) is an antimalarial medication. Azithromycin (Z-Pak) is an antibiotic. (Antibiotics in general are ineffective against viruses.)
Each has potential serious implications for people with existing cardiovascular disease.
Contrary to Mr. Trump’s statements, you do have a lot to lose. Medical groups warn that it’s dangerous to be hawking unproven remedies.
Recently, three U.S. heart societies published a joint statement to detail critical cardiovascular considerations in the use of hydroxychloroquine and azithromycin for the treatment of COVID-19.
According to the “Guidance from the American Heart Association, the American College of Cardiology and the Heart Rhythm Society”:
Complications include severe electrical irregularities in the heart such as arrythmia (irregular heartbeat), polymorphic ventricular tachycardia (including Torsade de Pointes) and long QT syndrome, and increased risk of sudden death.
The effect on QT or arrhythmia of these two medications combined has not been studied.
With these increased dangers in mind, we must not take unnecessary (or foolish) risks in the rush to find a treatment or cure for COVID-19.
What We Know So Far About These Drugs and COVID-19
COVID-19 Virus: Higher Risk for A-Fib Patients
COVID-19, the disease caused by the new coronavirus SARS-CoV-2, has sickened hundreds of thousands and continues to kill large numbers of people worldwide.
Typically, it’s considered a threat to the lungs, but COVID-19 also presents a significant threat to heart health, according to recently published research.
“But It’s Just the Flu, Right?”
“During most flu epidemics, more people die of heart problems than respiratory issues like pneumonia,” according to Dr. Mohammad Madjid, McGovern Medical School at UTHealth. He expects similar cardiac problems among severe COVID-19 cases.
In addition, COVID-19 can worsen existing cardiovascular disease. For example, Atrial Fibrillation patients may develop myocarditis, an inflammation of the heart muscle. If left untreated, myocarditis may lead to symptoms of heart failure.
And for otherwise healthy people, COVID-19 can cause new heart problems.
Comorbid Conditions Increase Fatality Rate
Many A-Fib patients also suffer from other chronic conditions such as diabetes and hypertension. With comorbid conditions, COVID-19 can increase the severity and fatality of the virus.
According to research from the Chinese Center for Disease Control and Prevention (CCDC), COVID-19 patients from mainland China who reported no comorbid conditions had a case fatality rate of 0.9%.
While patients with the following comorbid conditions had much higher rates:
+ 10.5% for those with cardiovascular disease
+ 7.3% for diabetes
+ 6.3% for chronic respiratory disease
+ 6.0% for hypertension
+ 5.6% for cancer.
Among critical cases, the case fatality rate is unsurprisingly highest at 49%.
Take Away: A-Fib Patients at Higher Risk for COVID-19
Patients with underlying cardiovascular disease (i.e., A-Fib) are at higher risk for developing COVID-19 and have a worse outlook. Prior heart disease is a risk factor for higher mortality from COVID-19. Cardiovascular patients are encouraged to take additional, reasonable precautions to avoid contact with the COVID-19 virus. And to stay current with vaccinations, especially for influenza and pneumonia. Since people can spread the COVID-19 virus before they know they are sick, it is important to stay away from others when possible, even if you or they have no symptoms. • Stay at least 6 feet (2 meters) from other people Social distancing is especially important for people who are at higher risk of getting very sick including older adults and people of any age who have serious underlying medical conditions. For more information: see the article “How to Protect Yourself & Others” from the Centers for Disease Control and Prevention (CDC).A-Fib Patients: Practice Social Distancing and Stay Safe at Home
• Do not gather in groups
• Stay out of crowded places and avoid mass gatherings
Update: A-Fib and Dementia & My Top 5 Articles
This article was first published on Apr 26, 2017. Last updated: March 14, 2019
There’s a growing body of evidence linking atrial fibrillation with early onset of dementia. New cases of dementia are diagnosed every four seconds. The number of people with dementia is also expected to triple worldwide to an estimated 140 million by 2050.
Most Feared: When 65+ year olds were asked what disease or condition they were most afraid of getting, 56 percent cited memory-robbing dementia.
Good News: A bit of good news is that the prevalence rate of dementia has declined in some countries, including in the US. And researchers think it may in part be due to increases in levels of education, which seems to protect people from getting dementia.
For a disease many of us fear, the message is hopeful: Dementia is not necessarily inevitable.
While both Atrial fibrillation and dementia have been linked to aging, neither is a normal part of growing older.
Reducing Your Risk of Developing Dementia
You CAN influence or avoid developing dementia. Review these articles to learn more about the link between Atrial Fibrillation and dementia:
1. Anticoagulants, Dementia and Atrial Fibrillation
2. Increased Dementia Risk Caused by A-Fib: 20 Year Study Findings
3. FAQ: “I’m scared of getting dementia. Can the right minerals help? I’ve read about the link with A-Fib. What does research reveal about this risk?”
4. Leaving Patients in A-Fib Doubles Risk of Dementia—The Case for Catheter Ablation
5. FAQ: I’m concerned because Vitamin D deficiency has been tied to both A-Fib and Dementia. What is a normal level of Vitamin D
A-Fib Patients & Strategies to Prevent Dementia
Atrial Fibrillation and Dementia: Neither is a normal part of growing older.
What doesn’t work: current drugs, even statins, don’t work or have mixed results in preventing dementia.
What does work: Catheter ablation to eliminate your Atrial Fibrillation. Patients who get a catheter ablation have long-term rates of dementia similar to people without A-Fib. (This result holds regardless of their initial CHADS2 score.)
Don’t Settle. Seek your A-Fib cure: To decrease your increased risk of dementia, your goal should be to get your A-Fib fixed and get your heart beating normally again. We can’t say it enough:
Do not settle for a lifetime on meds. Seek your A-Fib cure.
Eye Disease: The Atrial Fibrillation Link to Glaucoma
This article was first published May 26, 2017 ♥ Last updated: March 15, 2019
Atrial Fibrillation patients are at high risk for developing Glaucoma. You may have Glaucoma right now and not know it because Glaucoma is often asymptomatic. Patients often have no eye complaints and have a normal range of intraocular pressure (IOP).
Glaucoma is a group of diseases that damage the eye’s optic nerve and can result in vision loss and blindness.
Like Atrial Fibrillation, Glaucoma is a progressive disease. It usually happens when fluid builds up in the front part of your eye. That extra fluid increases the pressure in your eye, damaging the optic nerve. Glaucoma is a leading cause of blindness for people over 60 years old.
Glaucoma: damage to the optic nerve
However, with early detection and treatment, you can often protect your eyes against serious vision loss. (See VIDEO below.)
Atrial Fibrillation Linked with Glaucoma
Research shows a connection between cardiac arrhythmias and Glaucoma. Glaucoma may be related to “ischemia” (when your heart muscle doesn’t get enough oxygen) and has been linked with Atrial Fibrillation
A 2017 research study at Medical University of Warsaw (Zaleska-Zmijewska) looked at the rate of Glaucoma in patients with Atrial Fibrillation.
Though it was a relatively small sample size of 117 patients (79 with A-Fib and a control group of 38 with sinus rhythm), participants were matched for age and sex. Ophthalmic examinations were conducted between October 2014 and December 2015.
Normal-tension glaucoma (NTG) is a form of glaucoma in which damage occurs to the optic nerve without eye pressure exceeding the normal range.
Study findings: Normal-tension glaucoma was diagnosed almost 3 times more often in patients with A-Fib than in the control group. Just like an A-Fib diagnosis, normal-tension glaucoma is highly dependent on age. The older the patient, the greater the risk of glaucoma.
A-Fib increases risk of Glaucoma: Independent of other known cardiovascular risk factors, this research study and others have found that A-Fib increases the risk of developing normal-tension glaucoma.
Among A-Fib patients, glaucoma is found especially among those who are female, 60+ years old, take the medication Warfarin and have high blood pressure.
What Patients Need to Know
What Glaucoma looks like during eye exam.
While there are no known ways of preventing glaucoma, blindness or significant vision loss from glaucoma can be prevented if the disease is recognized in the early stages.
Know your risk: As a patient with Atrial Fibrillation, you’re at increased risk of glaucoma. If Glaucoma runs in your family, you are also at increased risk.
More frequent eye exams: When at higher risk of Glaucoma, the American Academy of Ophthalmology recommends having regular eye examinations. If you’re 55 to 64 years old, that would be every one to three years; if you’re older than 65, then every one to two years. Ask your doctor to recommend the right screening schedule for you.
Most ophthalmologists will include a glaucoma test as part of your regular eye care. Make sure to have your eyes examined through dilated pupils.
With early detection and treatment, you can often protect your eyes against serious vision loss.
VIDEO: Glaucoma Animation: The causes of glaucoma, a group of diseases that damage the eye’s optic nerve. National Eye Institute, NIH. (40 sec.)
YouTube video playback: Click center arrow icon to watch.
How Wide-Spread is Silent Brain Damage in A-Fib Patients?
A-Fib patients are at increased risk for cognitive problems and dementia, even in the absence of stroke. But why?
Swiss researchers devised a study to determine what causes A-Fib patients to experience more cognitive dysfunction.
Mechanisms of A-Fib Cognitive Decline
The Swiss-AF research is an observational study designed to identify the mechanisms of cognitive decline in A-Fib patients. The study enrolled A-Fib patients between 2014 and 2017 from 14 centers in Switzerland.
Analyzed were 1,389 A-Fib patients with no history of stroke or transient ischemic attack (TIA)
All patients had standardized brain magnetic resonance imaging (MRI). Analyzed were 1,389 A-Fib patients with no history of stroke or transient ischemic attack (TIA). The average age of the A-Fib patients was 72 years. Most (89%) were being treated with oral anticoagulants.
Study Findings: Types of Silent Brain Damage
The MRI scans showed that 569 (41%) had at least one type of previously unknown (silent) brain damage.
• 15% (207) had a cerebral infarct (dead tissue resulting from a failure of blood supply)
• 19% (269) had small bleeds in the brain (microbleeds)
• 16% (222) had small brain lesions
41% had at least one type of previously unknown (silent) brain damage
Oral Anticoagulants and Silent Brain Damage: In this study the researchers couldn’t determine if the cerebral infarcts and other brain lesions occurred before or after patients started taking oral anticoagulants. But the researchers did state:
“The findings nevertheless raise the issue that oral anticoagulation might not prevent all brain damage in patients with atrial fibrillation.”
Additional analysis incomplete: The patients in this study underwent extensive cognitive testing to determine if patients with silent brain damage also have impaired cognitive function. But this analysis hasn’t been completed.
What A-Fib Patients Need to Know
The Swiss-AF research was a small study in one country over four years with 1,389 A-Fib patients. The risk of silent brain damage was found in 4 of 10 A-Fib patients. But the findings are alarming and worth continued research.
For A-Fib patients these findings can be frightening―especially for older patients. On top of that, it’s likely further analysis will show ‘cognitive decline’ as well in patients with these types of brain damage.
So, what can you do?
• Aim to get cured of A-Fib as soon as practical, such as by a catheter ablation. (Don’t let anyone tell you that you’re too old to have an ablation. People in their 90s have successful ablations.)
• Seek ways to avoid taking oral anticoagulants, if possible. Intuitively one suspects that anything that causes or increases bleeding in the brain like anticoagulants can be risky and dangerous for older patients. Consider installing a device to close off the Left Atrial Appendage (LAA) where 90%-95% of A-Fib clots originate.
Learn More About Risks for Cognitive Problems and Dementia
To learn more about how A-Fib patients are at increased risk for cognitive problems and dementia, see my articles: Anticoagulants, Dementia and Atrial Fibrillation and Increased Dementia Risk Caused by A-Fib: 20 Year Study Findings.
Also see my answer to this FAQ: “I’m scared of getting dementia. Can the right minerals help? I’ve read about the link with A-Fib. What does research reveal about this risk?”
Part II Framingham Study: Research Milestones in Heart Disease and Atrial Fibrillation
Now celebrating its 70th year, the Framingham Heart Study (FHS) is a long-term, ongoing cardiovascular study of residents of the city of Framingham, MA, a small, middle-class community 23 miles west of Boston.
Starting in 1948, the objective of the Framingham Heart Study was to identify the common factors that contribute to cardiovascular disease by following its development over a long period of time. Participants would have no overt symptoms of heart disease and not suffered a heart attack or stroke. Today 15,447 people of varying ages, backgrounds and heritage are enrolled including second and third generations.
Findings Integral to Scientific Understanding A-Fib
The Framingham study has contributed greatly to our understanding of Atrial Fibrillation and to the risk of stroke, heart attack and heart failure. A few important milestones about A-Fib include:
1957 High blood pressure and high cholesterol levels increase likelihood of heart disease
1960 Cigarette smoking found to increase the risk of heart disease
1970 Atrial fibrillation increases stroke risk 5-fold
1982 Chronic atrial fibrillation associated with a doubling of overall mortality and of mortality from cardiovascular disease
1991 Atrial fibrillation as an independent risk factor for stroke
1994 Diabetes and hypertension risk factors for atrial fibrillation
2002 Obesity is a risk factor for heart failure
2009 New genetic variant associated with increased risk for atrial fibrillation
2010 Sleep apnea tied to increased risk of stroke
2010 Having first-degree relative with atrial fibrillation associated with increased risk
Framingham Research: Expect More Findings About Atrial Fibrillation
Framingham scientists circa 1948
Framingham data resources are available for researchers to use, and those data continue to spur new scientific discoveries. The study data has spawned over 3,600 published studies in medical, peer-reviewed journals.
As A-Fib patients, we owe a huge debt to the Framingham participants, doctors, scientists and researchers. With continuation of the Framingham Heart Study, we can expect more research findings about Atrial Fibrillation for years to come.
Celebrating 70 Years of the Framingham Heart Study: Solving Mysteries of Heart Disease
When I first started researching my A-Fib back in 1998, I kept coming across research studies that credited its data to the Framingham Heart Study. I had no idea how influential the study has been to expanding our understanding of cardiovascular health.
The Framingham Heart Study (FHS) is a long-term, ongoing cardiovascular study of residents of the city of Framingham, MA, now celebrating its 70th year. The study was commissioned by the U.S. Congress and had been intended to last for only 20 years.
The Lifesaving Power of Scientific Research
Much of the now-common knowledge concerning heart disease, such as the effects of diet, exercise, smoking, good and bad cholesterol and high blood pressure is based on this longitudinal study. As well as far-reaching programs in stroke and Alzheimer’s.
Before the FHS, doctors had little sense of prevention.
“It’s no coincidence that deaths from heart disease have declined over the 70 years of this groundbreaking study.”
–Nancy Brown, CEO, AHA
American Heart Association CEO Nancy Brown said new approaches and therapies have sprung from Framingham’s work. “Framingham is living proof of the lifesaving power of scientific research. It’s no coincidence that deaths from heart disease have declined over the 70 years of this groundbreaking study.”
The study has huge repositories of data, from cell lines and gene sequences to scanned images of the heart, brain, bone and liver.
“Every part of the body that can be measured, imaged or assessed, we’ve done so over the last 70 years,” said Dr. Vasan S. Ramachandran, principal investigator and director of the study for Boston University. “It’s a remarkable human experiment. It’s with humility I say that. It’s unbelievable, and to be part of it is a gift, a privilege and an honor.”
Framingham: The Study and the Town that Changed the Health of a Generation
Framingham doctors in 1948
The study began in 1948 with 5,209 adult subjects (mostly white women and men) from Framingham, (about two-thirds of the town) and now has over 14,000 people from three generations.
Participants, and their children and grandchildren, voluntarily consented to undergo a detailed medical history, physical examination, and medical tests every two years, creating a wealth of data about physical and mental health, especially about cardiovascular disease.
Judie Saltonstall is one of them. She’s a second-generation participant who moved to Arizona 29 years ago and still faithfully logs on to her computer every three months to answer questionnaires and memory quizzes.
FHS participants live all over the country and travel back to Framingham whenever needed for exams and tests.
The 75-year-old is part of a contingent of FHS participants living all over the country who travel back to Framingham whenever needed for exams and tests. She reels off a list: retina photographs, bone density tests, and MRIs of the brain, heart and abdomen.
“It’s kind of exciting to do,” said Saltonstall, a mother of four and a former teacher. “It’s important for me personally, but also for them to know what’s going on with me and to learn from that, whatever good it does.”
Adding Different Segments (“Cohorts”)
In 1968, despite the recommendation to end the study as scheduled, Congress voted to continue it. Over the decades, the study had been split into different segments, or “cohorts”:
To study race and heritage in heart factors, The Omni Cohort (1994) asked people of color to volunteer; The Omni Two Cohort (2003) is the 2nd generation.
• The Original Cohort (1948)
• Offspring Cohort, the second generation (1971)
• The Omni Cohort asked people of color to volunteer to study race and heritage in heart factors (1994)
• The Generation Three Cohort (2002)
• The Omni Two Cohort, the second generation of Omni Cohort participants (as young as 13 years of age, 2003).
Landmark Study: Inspiring Thousands of Published Studies
Framingham, MA, circa 1948
It’s been 70 years since a small, middle-class community 23 miles west of Boston became the linchpin in helping to solve the mysteries of heart disease.
Framingham data resources are available for researchers to use, and those data continue to spur new scientific discoveries. FHS data has spawned over 3,600 published studies in medical, peer-reviewed journals. (Including many studies about Atrial Fibrillation, heart arrhythmias, and prevention of strokes).
The Framingham Heart Study is a joint project of the U.S. National Heart, Lung, and Blood Institute (NHLBI) and Boston University. Learn more at News on Framingham Heart Study.
As A-Fib patients, we owe a huge debt to the Framingham participants, doctors, scientists and researchers.
VIDEO: Framingham Heart Study: The First 70 Years
Learn about the legacy of the Framingham Heart Study. Includes interviews with participants; current and historical photos and footage. 12:17 min. Go to video.
Early-Onset A-Fib linked With Family History
Blacks and Hispanics/Latinos with A-Fib have higher rates of complications and even death as a result of A-Fib. This is despite research which shows that Blacks and Hispanics/Latinos are less likely than Whites to develop Atrial Fibrillation.
Although research of A-Fib in minority populations has been limited, researchers think they have unlocked one bit of the mystery.
Thanks to the development of a large, diverse registry of patients at the University of Illinois at Chicago, researchers have been studying A-Fib in minority populations.
This study is unique because most prior studies on family history and A-Fib relied on data from mostly White populations, leaving doctors with little research to guide personalized treatment in minority communities.
A-Fib Registry of Blacks, Hispanics/Latinos and Whites: Of the 664 patients enrolled in UIC’s A-Fib registry at the time of the study, 40 percent were white, 39 percent were black and 21 percent were Latino, according to Dr. Dawood Darbar, professor of medicine and head of cardiology at the UIC College of Medicine.
Early-onset A-Fib refers to those younger than 60 years old when diagnosed.
Early-onset A-Fib refers to those younger than 60 years old when diagnosed.
Link with Early-Onset A-Fib diagnosis: The researchers found that there was a family history of A-Fib in 49 percent of patients who were diagnosed with early-onset A-Fib (EOAF), that is, in patients younger than 60 years of age―compared with only 22 percent of patients diagnosed with A-Fib later in life.
Monitoring First-Degree Relatives: This is the first research-based evidence that supports increased monitoring (even including genetic testing) of families who have first-degree relatives with early-onset A-Fib (EOAF) as a preventive measure against complications including strokes.
When broken down by race, the chance of a patient with early-onset A-Fib having a first-degree relative with the condition was more than two-and-a-half times more likely for Blacks and almost 10 times more likely for Latinos, compared with only two-and-a-half times more likely for Whites.
While more research is needed, these findings have important implications for identifying family members at risk for atrial fibrillation
“Many people with A-Fib do not know they have the condition until they present to the emergency room with a stroke,” said Dr. Darbar.
Hispanics/Latinos with early-onset A-Fib are almost 10 times more likely to have a first-degree relative with A-Fib.
Hispanics/Latinos with early-onset A-Fib are almost 10 times more likely to have a first-degree relative with A-Fib.
What this Means to Patients
For patients diagnosed with early-onset A-Fib, a family history of A-Fib was found in 49 percent of patients. This research holds true across all three races, Whites, Blacks and Hispanics/Latinos.
If you have early-onset A-Fib (EOAF), that is, if younger than 60 years old when diagnosed, your family members should be monitored for A-Fib as a preventive measure against complications including stroke. This is especially true for Hispanics/Latinos.
More Research on Coffee (& Caffeine)! Could it Actually Help Prevent A-Fib?
Yes—another study about coffee and Atrial Fibrillation.
A retrospective study from Australia included 228,465 subjects. Researchers found that drinking coffee lowered atrial fibrillation occurrence. Regular coffee drinkers had a 6% average reduction in A-Fib. While heavy coffee drinkers had a 16% reduction. How do they explain this? Caffeine blocks the effects of adenosine, a compound that can facilitate A-Fib.
Conclusion: In this one study, researchers found that coffee doesn’t increase abnormal heart rhythms—but helps prevent them.
Coffee and the Bottom Line for A-Fib Patients
Needless to say, the caffeine in coffee is a stimulant. And we don’t all react to stimulants the same way.
Caffeine is the most popular drug in the United States and the least regulated one.
Remember, A-Fib is not a “one-size fits all” disease. Contrary to this research, coffee or caffeine may trigger or worsen your A-Fib. So, you may want to start (or continue) avoiding caffeinated beverages until your A-Fib is cured.
For some, drinking coffee regularly (including me) may have no ill effects. This research suggests coffee and caffeine may actually help prevent A-Fib.
How Much Caffeine is There in the Food and Beverages you Consume?
Caffeine is not a nutrient but a drug that is a mild stimulant of the central nervous system. Like any drug, the effects of caffeine on the body are not wholly good or bad. For an extensive list of how much caffeine there is in the food and beverages you consume, go to Caffeine Effects, Half-Life, Overdose, Withdrawal
Illustration credit: NutritionsReview.com
More Bad News for Warfarin: Older A-Fib Patients Risk Severe Brain Bleeds
Researchers looked at 31,951 veterans with A-Fib. All were over age 75 and newly taking warfarin. The study found that one in 50 of these veterans developed severe bleeding inside the skull. The rate of traumatic intracranial bleeding in this group was higher than previously reported in clinical trials, researchers noted.
Dementia in particular doubled the risk of intracranial bleeding.
Dementia in particular doubled the risk of intracranial bleeding.
Comorbidities may be a factor: These patients often had other illnesses (comorbidities) such as hypertension 82.5%, coronary artery disease 42.6%, diabetes 33.8% and chronic obstructive pulmonary disease 25.5%. Many of these patients also had dementia and depression.
Dementia, in particular, doubled the risk of intracranial bleeding (possibly because cerebral amyloid angiopathy increases bleeding risk).
Rates of Ischemic Stroke vs. Brain Bleeds
There’s one bit of good news. While the rates of ischemic stroke and intracranial bleeding in this study were similar, not all intracranial bleeds were traumatic.
But there’s no good news if you have a low CHAD2DS2-VASc score (low score = low risk of stroke). Intracranial bleeding remained relatively constant over the range of CHAD2DS2-VASc scores. (For more, see The CHADS2 & CHA2DS-VASc Stroke-Risk Grading Systems.)
What Patients Need To Know: Possible Options
Warfarin (brand name Coumadin)
Older patients with A-Fib are between a rock and a hard place. On one hand, if you take warfarin, you reduce your risk of an ischemic stroke. But on the other hand, if taking warfarin, you may get brain bleeds which can kill you or cause dementia.
While we don’t have a guaranteed method of preventing A-Fib-related strokes, here are two options to avoid a lifetime of taking warfarin (or another anticoagulant).
• Close off your Left Atrial Appendage (LAA). This is the origin of 90%-95% of ischemic clots. LAA closure is a recognized alternative to having to take anticoagulants. Some say it’s an improvement rather than an alternative to anticoagulants.
• Have a catheter ablation to stop your A-Fib. If you no longer have A-Fib, you can no longer have an A-Fib-related stroke. Your stroke risk drops down to that of someone without A-Fib. (But, of course, people without A-Fib also have strokes.)
Warning: Anticoagulation is No Guarantee Against Stroke
Be advised that warfarin greatly reduces but doesn’t totally eliminate stroke risk in A-Fib.
On a personal note, a close friend of ours with A-Fib was in the correct range of her INR testing (2.5) when she had a massive ischemic stroke that paralyzed her left side.
It breaks our hearts when we visit and have dinner with her to see food dripping from the left side of her mouth. But happily, her thinking and communication skills are still good.
For additional readings, see Watchman Better Than Warfarin and Anticoagulants Increase Hemorrhagic Stroke Risk.
The Watchman Occlusion Device and Risk of Device-Related Blood Clot
The Watchman is an occlusion device that closes off the Left Atrial Appendage (LAA) to prevent clots from getting into the heart. For those with A-Fib, 90%–95% of clots and strokes come from the LAA.
The Watchman device is considered an alternative or an improvement to a lifetime of taking anticoagulants including warfarin and the NOACs. See Watchman Alternative to Coumadin and Watchman Better Than Warfarin.
2018 HRS Report: Clots Can Form on the Watchman
A new meta-analysis of clinical trials and registries of the Watchman device is believed to be the largest to date of Device-Related Thrombi (blood clot) following left atrial appendage closure.
Size comparison of the Watchman occlusion device
The study shows that in about 3.7 percent of patients a blood clot forms on a metal screw on the face of the device. The clot can form many months, even a year after installation.
“While not frequent, when present, thrombus on the face of an LAA occluder is associated with a high rate of ischemic stroke,” said study presenter Vivek Y. Reddy of Mount Sinai Hospital in New York City. (Dr. Reddy was one of the original investigators of the Watchman clinical trials.) These findings were presented at the 2018 Heart Rhythm Society meeting.
Device-related thrombi (DRTs) are troublesome because they increase the risk of ischemic stroke by over 3 fold. However, no significant association with mortality emerged.
This risk, Dr. Reddy said, calls for aggressive management of patients at risk for device-related blood clots.
The Study: Finds Device-Related Thrombi (DRTs)
To better understand the mechanism of stroke after LAA closure, Dr. Vivek Reddy and his colleagues, looked at the incidence, predictors and clinical outcomes of device-related thrombus (DRT).
Watchman device: inserted (L) and progression of proper tissue growth (R)
The meta-analysis study looked at data on 1,739 patients who were successfully implanted with the Watchman device as part of four prior clinical studies. Patient follow-ups included a transesophageal echocardiography (TEE).
Findings: Among those patients receiving a Watchman, the investigators found 65 patients (3.74%) had DRT. Most were detected after anticoagulation had been discontinued at 45 days post-insertion. Some DRTs first showed up at the 1-year TEE.
“A majority of Watchman patients with an identified DRT (74% of the 65 patients) did not have a stroke.” Dr. Vivek Reddy
Dr. Reddy reported that despite these findings, a majority of Watchman patients with an identified DRT (74% of the 65 patients) did not have a stroke. And in Watchman patients who did have stroke, 87% occurred in the absence of a DRT.
Implications: There is a strong case for rethinking the timing of planned follow-up TEE examinations of Watchman patients. The standard protocol is a TEE at 45 days after placement, when routine anticoagulation usually stops, and then a second TEE 12 months after placement.
Dr. Reddy suggests a better schedule might be to perform the first TEE at 3-4 months after placement when oral anticoagulant therapy stops. This gives time for a potential DRT to form.
What this Means For Those Patients With a Watchman
“Prevention and management of DRT may require that each [Watchman] patient receive a tailored regimen of anticoagulation and surveillance,” said B. De Lurgio, MD, a cardiac electrophysiologist at Emory Healthcare commenting on Reddy’s report.
If you have a Watchman device, you and your EP should discuss “aggressive surveillance” to find any clots on the face of your Watchman. Usually these can be resolved by taking a course of anticoagulants.
If Closing the LAA: An Alternative Occlusion Device
Lariat placement: lasso around opening to LAA
With no metal involved, another occlusion device is the Lariat II noose-like device which is slipped around the LAA. This ‘lasso’ is then tightened, and eventually the tissue dies and shrivels up (like a grape into a raisin).
But there has been a reported problem with the Lariat, too. For more on the Lariat see my article: Alert: Patients with Lariat Device for Left Atrial Appendage Closure.
A Challenge to Install: Compared to the Watchman, the Lariat is more challenging to install and is currently used less often than the Watchman. Not all EPs install and have experience with the Lariat II. You may need to do research to find an EP experienced and good at installing the Lariat. For more about the Lariat, see Lariat II Suture to Close the Left Atrial Appendage.
Watchman Still As Effective As Warfarin
Regarding this DRT data, Dr. Reddy said he didn’t think this data takes away from the argument that the Watchman is a reasonable strategy. “It doesn’t add or detract from the previous data.”
Clots can form on any foreign body as well as inside the heart.
Comparing stroke risks: In cases where no treatment was applied (neither anticoagulants nor the Watchman), the overall ischemic stroke rate is 6.0% per year.
Contrast that 6% rate to the stroke rates of 1.77% per year in people with the Watchman device and 1.71% per year for those on oral anticoagulation.
The Watchman is still a viable option against stroke risk.
Calling All A-Fib Patients: Participate in On-Line Research Survey on Anxiety and A-Fib
Many of us know how debilitating the emotional component of A-Fib can be and the impact on our quality of life. We often say that Atrial Fibrillation wreaks havoc with our heads as well as with our hearts.
This is what doctoral student Sevinc E. Uzumcu is investigating—the anxiety and depression often associated with Atrial Fibrillation. She has asked all our A-Fib.com readers to help with her research.
This survey is part of her doctoral applied research project at A.T. Still University’s Arizona School of Health Sciences. She is seeking all A-Fib patients to answer her online questionnaire whether or not suffering with anxiety or depression.
This aspect of Atrial Fibrillation is seldom investigated.
Give Just 7 Minutes for A-Fib Research
We strongly encourage all A-Fib patients to take this online survey. I answered the questions, and it only takes about 7 minutes. Your responses are anonymous.
To participate, go to the survey “Invitation”.
Submissions will be accepted through September 30, 2018. As part of her doctoral studies, she hopes to publish the results of her research.
A-Fib Doctors Need to Treat the Emotional Effects
The A-Fib patient community really needs this research study and needs to share the findings with doctors treating A-Fib patients. Raising doctors’ awareness of the psychological aspects may encourage them to develop treatment protocols.
Kudos to doctoral student Sevinc E. Uzumcu for undertaking this research.
(In all my years of attending A-Fib conferences, I’ve never seen doctors discuss this topic. But I did! As a patient advocate, I talked on this topic to 200 cardiologists in Zurich, Switzerland at MAM 2016.)
For dealing with the anxiety associated with A-Fib, see my article: Coping With A-Fib Anxiety and the PODCAST: 15 Ways to Manage the Fear & Anxiety of Atrial Fibrillation.
Click here to go the survey Invitation (link is at the bottom of the page).
Polypharmacy: A Cautionary Tale of Taking Too Many Prescription Drugs
Tracking prescription drug use from 1999 to 2012 through a large national survey, Harvard researchers reported that 39 percent of those over age 65 now use five or more medications— a 70 percent increase over the 12 years tracking period.
“Polypharmacy” is the term for prescribing patients five or more medications at the same time (even if all are given for legitimate reasons).
This often happens when a person has many chronic diseases, such as diabetes, high blood pressure and heart disease, each requiring long-term treatment with medications.
What’s the Problem?
First, drugs are chemicals that can interact with one another with the potential to cause all kinds of complications (versus if you take just one medication).
Polypharmacy contributes to higher rates of hospitalizations and death, and higher costs.
For example, an anti-inflammatory medication like Ibuprofen (Advil, Motrin, Midol, Nuprin), may increase blood pressure and worsen kidney function. Therefore they should not be used by persons with high blood pressure or kidney problems.
Next, as we age, the kidneys and liver become less efficient in passing medications out of the body. The lingering drugs can magnifying their effects as well as have side effects.
Polypharmacy contributes to higher rates of hospitalizations and death, and higher costs.
Should You Be Prescribed Fewer Drugs?
Some people outgrow their medication. They change their lifestyle (ex. diet, physical activity, and weight loss) and subsequently may no longer need medications for diabetes, cholesterol or high blood pressure.
But they keep taking them, because no one told them to stop.
To ‘deprescribe’ a drug is not as simple as saying “stop”. It’s a process requiring caution and skill by your doctor.
Simple errors can occur, too. Dr. Michael A. Steinman, a geriatrician at the University of California, San Francisco, recalled asking a patient to bring in every pill he took for a so-called ‘brown bag review’. He learned that the man had accumulated four or five bottles of the same drug without realizing it, and was ingesting several times the recommended dose.
De-Prescribing: A Brown Bag Review
Always keep an accurate and updated list of medications you are taking including over-the-counter drugs, herbal products, and supplements. Give your doctors each a copy. (See our free download form below.)
Periodically ask your physicians or pharmacist for your own ‘brown bag review’. Discuss whether to continue or change any of your regimens. Ask about:
▪ any medicines you no longer need?
▪ any medications you can do without?
▪ if a lower dose would work for any of your medicines?
▪ if any of your medications might interact with another?
▪ any non-pharmacologic alternatives?
If your doctor agrees to ‘de-subscribe’ a medication, realize it isn’t as simple as saying “stop” taking it. It’s a process requiring caution and skill by your doctor. (Afterwards, remember to update your list of medications.)
“We spend an awful lot of money and effort trying to figure out when to start medications and shockingly little on when to stop.”
Dr. Caleb Alexander, Johns Hopkins Center for Drug Safety and Effectiveness
Free Download: Keep an Inventory List of Your Medications
As a service to atrial fibrillation patients, we offer Free Reports, Worksheets and Downloads of our own worksheets and articles and useful free services or downloads from others serving the atrial fibrillation community.
Inventory List of Your Medications: We want to help you keep your doctor and other healthcare providers up-to-date on all the medications you are taking by using this Medications List from Alere.
Download and use to help you keep track of everything (including over-the-counter drugs, vitamins, herbs and mineral supplements, too). Remember to save the PDF to your hard drive.
Because your medications will change over time, print several copies of the blank form so you will always have a clean copy ready to use. (Keep in your A-Fib file or binder.) Give a copy to each of your doctors or other medical healthcare providers.
The Impact of Race on Stroke Risk Among Atrial Fibrillation Patients
It’s well reported that African Americans have a lower risk of developing A-Fib as compared to Caucasians.
But it’s a different story regarding strokes. A new study has found that compared with whites, blacks are at increased risk of developing an ischemic stroke either before or after a diagnosis of atrial fibrillation (A-Fib).
A new University of Pennsylvania study found that such strokes may occur even before the patient is aware of having the heart-rhythm problem, and that this risk is higher for black patients. In many cases, the stroke was the red flag that led to the patient’s A-Fib diagnosis.
African Americans and Heart Disease
Heart disease tends to occur earlier in African American patients than in white counterparts.
The death rate from heart-related causes is higher, too, largely due to a higher rate of heart attacks, sudden cardiac arrest, heart failure, and stroke, according to the American Heart Association.
The Penn Study: Looking Back and Monitoring Forward
Researchers used a centralized pool of patient data from across the University of Pennsylvania Health System, which was comprised of 56,835 patients without a history of atrial fibrillation or a remote history of stroke.
Of these patients, the authors identified 3,507 patients who developed A-Fib. Upon diagnosis, they checked each patient’s medical history for the prior six months to document any history of stroke.
Going forward, the authors monitored these A-Fib patients for strokes for a median of 3.6 years.
Unique Design: The study design was unique in that researchers had a time point that represented the initial diagnosis of atrial fibrillation.
This approach provided an opportunity to examine the risk of stroke during a six-month period prior to a formal, clinical diagnosis of atrial fibrillation. Until now, no prior study has examined stroke risk in this period prior to a diagnosis of atrial fibrillation.
Study Findings
Out of 538 strokes occurring in the study periods, nearly half, 254, occurred before diagnosis with atrial fibrillation.
The authors suspect that in many of those 254 cases, the patients already had A-Fib but were undiagnosed.
Blacks had an independently higher risk of stroke both before and after being diagnosed with A-Fib, as compared with whites.
Prior Six Months Findings: For the strokes that occurred in the six months before A-Fib diagnosis, the rate in black patients was about one-third higher than the rate in white patients.
Findings after A-Fib Diagnosis: For the strokes that occurred in the years following an A-Fib diagnosis, the rate in black patients was two-thirds higher than in white patients — a 2.5 percent chance of stroke per year in black patients compared with a 1.5 percent chance for whites.
Blood-Thinning Medicines: The increased stroke risk for black patients (with A-Fib) was especially high among those who did not have prescriptions for blood-thinning medicines (i.e., warfarin or NOACs).
But even the black patients with prescriptions had a somewhat higher risk of stroke than their white counterparts. (Note: The study authors did not examine whether patients took the medicines, only if they had been given a prescription.)
Editor’s Comments
It’s well reported that African Americans have a lower risk of developing A-Fib as compared to Caucasians. But until now, there was little data on the additional risks that come with A-Fib for each race.
The new findings build on previous studies examining the impact of race on the risk of developing atrial fibrillation.
More Facts About Strokes in African Americans: On his website, Dr. Greg Hall, who specializes in urban health and the clinical care of African Americans shared these sobering facts about strokes in African Americans:
“Most strokes in African Americans occur due to high blood pressure, and a much higher number of African Americans have uncontrolled blood pressure.
A quarter of all strokes occur in the presence of atrial fibrillation (a fib). And while representing 13 percent of the US population, African Americans experience almost twice that percentage of all strokes (26%).
Strokes are worse in Blacks. And when a stroke occurs, African Americans have them earlier in life and present with more severe and disabling conditions. “
To learn more, see Dr. Hall’s post: Atrial Fibrillation in African Americans
A-Fib Stroke Risk Greater for Blacks: This is obviously a very important study for black patients. If you’re African American, you have less chance of developing A-Fib.
Blacks have almost twice the percentage of all strokes (26%) while making up only 13% of the U.S. population.
“Silent” A-Fib Stroke Risk Greater for Blacks: An even more disturbing fact is that in this study, half of the strokes occurred before an African American patient was diagnosed with A-Fib. Silent A-Fib is a danger for all A-Fib patients, but the stroke risk was nearly one-third higher in black patients.
Blacks Urgently Need Monitoring for Silent A-Fib: Most strokes in African Americans occur because of high blood pressure which is more prevalent in blacks. But from a public health aspect, it’s even more important to test black patients for silent A-Fib. Monitoring for silent A-Fib needs to become Standard Operating Procedure for blacks reaching middle age.
If you are African American, you should be monitored or get yourself a DIY A-Fib monitor to make sure you don’t have silent A-Fib.
(For recommended DIY heart monitors, see my article, Do-It-Yourself ECG: A Review of Consumer Handheld ECG Monitors.)
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