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Having Surgery? Beware of Post-Operative A-Fib & Protocols to Prevent it
Updated 7/17/22 Did you know after almost any type of cardiac surgery, it’s all too common to develop Post-Operative Atrial Fibrillation (POAF)? (Other major surgeries can lead to Post-Operative A-Fib as well.)
Beware! If you or a loved one are having surgery, anticipate developing post-operative A-Fib. Some consider it an inevitable complication of surgery.
Both Short and Long-Term Consequences
Post-Operative A-Fib (POAF) is associated with prolonged hospital stays, higher healthcare-related costs, increased mortality, increased risk of cerebrovascular accidents (CVA), and re-hospitalization.
If you do develop A-Fib after cardiac surgery, both your short-term and long-term prognosis is poor. Increased short and long-term mortality is likely caused by heart failure, cerebrovascular accidents (CVA), and bleeding complications. Even after 10 years, you can develop “late recurrent A-Fib”.
The most common cardiac surgery in the U.S. is bypass surgery with more than 200,000 surgeries performed annually. And what’s the most frequent complication? If you guessed A-Fib, you’d be right. Rates of post-operative A-Fib after surgery range from 10%-to-50%. Those aren’t very good odds.
The Research: Post-Operative A-Fib is Dangerous
Post-operative A-Fib can be really nasty. (Don’t listen to people who say POAF is harmless and goes away soon.)
From Finland (Waterford and Ad), in a study of cardiac surgery, POAF produced a 36.5% occurrence of stroke.
In another study of over 2 million patients, POAF was associated with increased risk of early and late mortality. POAF is a strong predictor of long-term development of A-Fib (9-fold increase of the development of A-Fib more than 30 days after surgery).
From the Netherlands (Kuar, H. et al), in a small study, researchers used implantable loop recorders in cardiac surgery patients to record both early and late post-operative A-Fib (POAF). (Early POAF=within 5 days, POAF=after this period.) Over an average follow-up of 29 months, 34% of patients had early POAF, while 67% experienced late POAF.
From the University of Pittsburgh (Bianco et al), in a study involving 12,227 cardiac patients, 4,300 developed post-operative A-Fib (35.2%). These patients had significantly higher rates of re-operation, transfusions, sepsis, prolonged ventilation, pneumonia, renal failure and dialysis. On long-term follow-up, they had worse morbidity, lower survival, and more readmissions for heart failure.
From Weill Cornell Medicine, New York (Goyal et al)
“Post-operative A-Fib (POAF) occurs in up to 40% of patients undergoing heart surgery and 2% of patients undergoing non-cardiac surgery,” In an observational retrospective study of nearly 3 million patients at 11 acute care hospitals across the U.S.,18.8% of patients who underwent heart surgery developed post-operative A-Fib. “…and the risk of hospitalization for heart failure increased by a third compared to patients who did not develop AF.” Doctors tend to view POAF as a benign event, triggered by the stress of the surgery. But accoring to the authors of this study, “evidence is emerging that post-operative A-Fib is linked to longer term problems such as stroke and death from any cause.”
In an editorial by Melissa Middeldorp and Christine Albert (Cedars Sinai, Los Angeles), they suggest that POAF “is not just a transient response to surgery but may be reflective of underlying atrial and myocardial structural changes that not only predispose to the acute AF event but to other potentially related adverse events, such as Heart Failure hospitalization.”
The most disturbing point of this study is that A-Fib may itself contribute to heart failure, “post-operative AF is associated with future heart failure hospitalizations.”
Patients with A-Fib undergoing noncardiac surgery (NCS) were associated with higher risks of mortality, heart failure, and stroke. The study included 8,635,758 Medicare patients admitted for noncardiac surgery and focused on 16.4% of these patients who had A-Fib at the time of their surgery. “Pre-existing AF is independently associated with postoperative adverse outcomes after NCS.” (Prasadam S, et al) (Thanks to David Holzman for calling our attention to this research.)
Protocol to Prevent Post-Operative A-Fib
In the post-operative period, anticoagulants aren’t enough. Anticoagulation after cardiac surgery can be dangerous with a high risk of bleeding and thromboembolism (stroke).
A better stroke prevention strategy is to prevent the occurrence of POAF in the first place.
The researchers, Waterford and Ad, state that preoperative oral amiodarone is the single most powerful intervention to dramatically reduce rates of POAF.
Protocols to prevent POAF: They recommend a protocol of 400 mg oral amiodarone per day for 3 days prior to surgery, followed by 200 mg per day for 10 days through and following the operation regardless of whether or not POAF developed. They also recommend that a patient be on a beta-blocker or a statin whenever possible.
They also advise limiting blood transfusions. Red blood cell transfusion is associated with an increased rate of POAF. The mechanism is likely that red blood cell transfusion induces a pro-inflammatory state, which is known to underlie POAF.
They also urge the use of anti-inflammatory medicines such as colchicine (see my colchicine article: How to Reduce Post-Surgery A-Fib Inflammation? ).
Other Protocols: Some doctors use a beta blocker protocol before surgery such as propranolol and carvedilol plus N-acetyl cysteine which work by “attenuating the sympathetic tone.”
Study results showed that both amiodarone and beta blocker protocols had similar results in reducing poet-operative A-Fib, and that their combined use was more effective than just beta blockers (Tzoumas, A. et al).
Treatment of Post-Operative A-Fib: Some surgeons routinely discharge patients while they are still in A-Fib or Flutter. But others insist on discharging patients in sinus rhythm using electrical cardioversion. The authors, Waterford and Ad, state that electrical cardioversion “should be used more liberally.”
Editor’s Comments
Our Friend’s Bypass Surgery: On a personal note, a friend of ours recently had bypass surgery. We drove him to the hospital and were with him whenever we could. He had a hard time. He had to be put on a ventilator and was in a medically induced coma for 5 days. But he recovered and is now doing well!
I warned him about the chances of developing A-Fib after cardiac surgery, which is exactly what happened to him. But after the surgery, his surgeon got him on an amiodarone protocol which did help.
The surgeon did not use pre-operative amiodarone treatment to prevent him from developing A-Fib in the first place. That’s unfortunately what most cardiac surgical patients experience.
A-Fib After Surgery Not Benign and Transient: In the past, A-Fib after surgery was considered benign and transient. But we now know better. As described in the above research, post-operative A-Fib causes many health problems and even death.
Amiodarone Effective But Toxic and Dangerous: Amiodarone, though effective, is a very toxic drug that should only be used for a short time and under close monitoring.
Out friend was able to finally get off of amiodarone. See Amiodarone: Most Effective and Most Toxic and Toxic Effects of Amiodarone—What Could Have Prevented this Death?
Why Do So Few Surgeons Use Pre-Operative Protocols? Almost every surgeon knows that surgery often causes and/or predisposes patients to develop A-Fib. Then why do so few use pre-operative protocols to prevent post-operative A-Fib? Numerous studies show that post-operative A-Fib can be dramatically reduced by pre-operative oral amiodarone (53% to 25%) (Waterford and Ad)
Sending Patients Home in A-Fib: It’s shocking that surgeons often send their patients home while still in A-Fib! WHAT? How can they cause and/or be responsible for their patients developing a serious, dangerous heart illness like A-Fib and not do anything about it? Will your surgeon protect you from developing post-op A-Fib?
Are You Having Any Kind of Surgery? Before you have surgery, you have to ask your surgeons if they do anything to prevent you from developing A-Fib after the surgery. If you’re not confident or satisfied with their response, find another surgeon. Don’t hesitate to travel if necessary.
Developing Post-Operative A-Fib doesn’t
have to be a roll of the dice.
Talk to your surgeon about protocols to prevent it.
you should settle for nothing less.
A-Fib Patients Study: After Brain Hemorrhage, Back on Anticoagulation?
Sometimes I just can’t understand some of the research studies done about Atrial Fibrillation such as this one. I can not wrap my head around this recent study from the Netherlands (APACHE-AF).
They studied A-Fib patients who survived intracerebral hemorrhage after being treated with anticoagulation for atrial fibrillation. Their hemorrhagic stroke was “anticoagulant-associated”. Seven to 90 days after their hemorrhage, patients were either put back on anticoagulation (50 patients) or avoided anticoagulation.
WHAT?! How can you put someone back on an anticoagulant which probably caused their hemorrhagic stroke in the first place?
These researchers certainly knew the alternative options to taking anticoagulants.
This study was done at 16 hospitals in the Netherlands but was nevertheless very small. Most patients who did suffer a hemorrhagic stroke either died or were severely disabled. Few survived. That’s why there were so few patients in the study.
Further Damage From Anticoagulation
Not surprisingly, after a minimum follow-up of 6 months (a very short follow-up), 26% of the apixaban group had non-fatal strokes or vascular death. The patients on antiplatelet therapy (26) or no anticoagulation didn’t do very well either.
The researchers themselves concluded, “Patients with atrial fibrillation who had an intracerebral hemorrhage while taking anticoagulants have a high subsequent annual risk of non-fatal stroke or vascular death.”
Did I Miss Something?
How can you put someone back on an anticoagulant, even Eliquis, when anticoagulants probably caused their hemorrhagic stroke in the first place? This seems both ethically wrong and wrong-headed.
Did I miss something important? If anyone wants to share their view of this study with me, send me an email.
Exercise to Maintain Normal Heart Rhythm and Ease Symptoms―But Doesn’t Cure A-Fib
In a study from Australia (ACTIVE-AF), a six-month exercise program helped maintain normal heart rhythm and reduced the severity of symptoms in patients with atrial fibrillation.
In the ACTIVE-AF study, 120 symptomatic paroxysmal or persistent A-Fib patients were randomly assigned to a six-month exercise program or a program of usual care (control group). The average age of patients in the study was 65 years and 43% were women.
The exercise program included supervised exercise weekly for three months, then every two-weeks for three months.
The exercise group also had an individualized weekly exercise plan to follow at home. The goal was to increase aerobic exercise up to 3.5 hours a week. The six-month exercise program was followed up by another six months of observation.
Study Results
According to lead author was Dr. Adrian Elliott of the University of Adelaide, Adelaide, Australia, the A-Fib recurrence rate was significantly lower in the exercise group (60%) vs the control group (80%).
Patients in the exercise group also had a significant reduction in the severity of their symptoms at 12 months compared to the control group (less severe palpitations, shortness of breath, and fatigue).
ACTIVE-AF Conclusions
“The ACTIVE-AF trial demonstrates that some patients can control their arrhythmia through physical activity, without the need for complex interventions such as ablation or medications to keep their heart in normal rhythm,” said study author Dr. Adrian Elliott.
Recommendations for patients with symptomatic paroxysmal or persistent A-Fib:
• Aerobic exercise should part of the treatment plan, alongside the use of medications and the management of obesity, hypertension, and sleep apnea;
• Patients should strive to build up to 3.5 hours per week of aerobic exercise;
• Some higher intensity activities should be incorporated to improve cardiorespiratory fitness.
Editor’s Comments
We know from many other studies that exercise is recommended for patients with coronary heart disease and heart failure, but also for overall heart fitness and health.
This small study shows that exercise is good for A-Fib patients as well. Though sometimes it just isn’t possible with symptomatic A-Fib. (e.g., When I had A-Fib years ago, my heart rate would get very high when I’d try to jog. I’d have to stop and walk home.)
Relying on exercise to “cure” A-Fib is probably a false hope. Exercise alone won’t eliminate your A-Fib. But for those who are symptomatic, exercise can improve your A-Fib symptoms and reduce “recurrence” of your A-Fib (i.e., after being symptom-free for a period of time).
Take Away for A-Fib Patients: Aerobic exercise to improve cardiorespiratory fitness should become a regular habit. Even after one is cured of A-Fib (i.e., by catheter ablation, etc.) because exercise helps prevent recurrence of A-Fib.
A-Fib Catheter Ablation Combined with Left Atrial Appendage (LAA) Closure
In the People’s Republic of China (and other countries) catheter ablation for Atrial Fibrillation is often combined with closure of the Left Atrial Appendage (LAA) in one procedure. This means A-Fib patients can have a Watchman occlusion device installed at the same time as their catheter ablation.
While it may be common practice in some locales, there is limited research data on this combined procedure and, in particular, with patients with prior stroke. That’s why this study in China was conducted.
Aim of this Study: To compare the safety and efficacy of combined catheter ablation with closure of the Left Atrial Appendage (LAA), especially for A-Fib patients who have had a prior stroke.
Study Design: This retrospective study enrolled 296 patients who underwent combined procedures of A-Fib catheter ablation and LAAC. Patients were divided into two groups: 81 patients with prior stroke (Stroke group) and 215 patients without prior stroke (Control group).
Combined procedures were successfully performed in all the patients.
Follow-up Findings: The researchers followed-up with patients at a mean of 20 months.
Both the Stroke group and the Control group (without prior stroke) were relatively A-Fib free after catheter ablation. (Stroke group: 64.2%, the non-stroke control group: 68.4%).
The relative risk reductions in stroke and bleeding were around 80% in the stroke group and 62% in the control non-prior stroke group.
Conclusion: The researchers wrote: “The combination of catheter ablation and LAAC (Left Atrial Appendage Closure) is safe and effective in selected AF patients with prior stroke.”
Editor’s Comments
There are several limitations to this study. This is a single-center retrospective study with a moderate sample size.
Despite the limitations of this study, for A-Fib patients the combination of catheter ablation and Left Atrial Appendage (LAA) closure appears safe and effective.
Currently, U.S. patients have to wait 3 months after a catheter ablation to have a Watchman inserted. Why must patients wait, why endure months of anticoagulants usage? But, more research is needed to confirm the conclusions of these researchers.
What is the Annual International AF Symposium and Why is it Important to A-Fib Patients?
The past two decades have witnessed dramatic advances in all areas of A-Fib research with major progress in our understanding of atrial fibrillation and the development of safer and more effective strategies for the treating and curing of atrial fibrillation.
The annual International AF Symposium (formerly called the Boston AF Symposium) is one of the most important conferences on A-Fib in the world. The Symposium is a major scientific forum at which health care professionals have a unique opportunity to learn about advances in research and therapeutics directly from many of the most eminent investigators in the field.
AF Symposium presentation hall equipped with huge video monitors for panelists and via steaming video procedures.
This intensive and highly focused three-day symposium brings together the world’s leading medical scientists to share the most recent advances in the field of atrial fibrillation.
Why I Attend the Symposium Every Year
Each year I attend the Symposium to learn and ‘absorb’ the presentations and research findings.
Attending the annual AF Symposium gives me a thorough and practical view of the current state of the art in the field of A-Fib. I then apply this newly acquired knowledge and understanding to the publishing of A-Fib.com.
Prof. Michel Häissaguerre (who invented the PV ablation) and Steve Ryan AF Symposium
Writing My Reports
On the plane ride home I start writing summaries of significant presentations and important research findings that are relevant to A-Fib patients and their families.
I strive to ‘translate’ as much of the medical jargon into everyday language. (My wife, Patti, keeps an eye out for this). I add my own comments and insights to help interpret the information for A-Fib.com readers.
In the months following the Symposium, I write and post three or four reports each month usually ending up with about 12–20 articles. 
(Why does it take so long? I send each of my summaries to the presenter inviting their feedback, so it takes some time to get each article written, reviewed, and posted.)
I announce each posting on my A-Fib News Blog with a link to each article.
For the Readers of A-Fib.com
My goal is to offer the most up-to-date A-Fib research findings and developments that may impact the treatment choices of patients seeking their A-Fib cure or best outcome.
OUR MISSION: At A-Fib.com, we offer hope & guidance to empower patients to find their A-Fib cure or best outcome. A-Fib.com is the patient’s unbiased source of well-researched information on current & emerging Atrial Fibrillation treatments.
Go to my list of 2022 AF Symposium Reports
or my AF Symposium Archives by Year
How Does LAA Closure for Atrial Fibrillation Affect Heart Pumping Ability?
Left Arial Appendage (LAA) closure is the cornerstone of stroke prevention in surgical treatment of A-Fib. The Left Atrial Appendage is closed off, cut out, stapled shut, or shut off with a clip. How does this affect the heart’s ability to pump blood?
Small Study to Directly Measure Pumping Effect of LAA Closure
In a very small study of the hybrid operation/ablation, seven patients were measured for cardiac output and left ventricular stroke volume just before the hybrid operation, directly after, then ten minutes later.
The researchers pointed out that “the LAA also has a contractile function and takes part in the LA contraction process, especially in patients in SR (sinus rhythm)”.
But five of the seven patients were in A-Fib and already had reduced ejection fraction (EF) (26%). (Normal EF is 50% to 75%.) Even in the patients in SR, their EF was only 46%.
Ejection fraction (EF) is a percentage of blood that is pumped out of the heart during each beat. A range of 50%-75% indicates your heart is pumping well, delivering an adequate amount of blood to the body and brain.
LAA Closure Lowers Pumping Pressure Long Term
The researchers pointed out that LAA closure “can result in lower systolic blood pressure on the long term” according to previous research. (“Systolic” is the top number in your blood pressure measurement and is the pumping force your heart exerts.)
The researchers also pointed out that the LAA is the predominant site of atrial natriuretic peptide (ANP) in the heart which can affect heart pumping “volume overload”.
No Significant Difference
The researchers found no significant differences in various pumping measurements, but the Left Ventricular Stroke Volume (LSCI) was affected (28 mLm² to 24 mLm², P-value 0.066).
Editor’s Comments
Patients with Poor EF: In patients with poor heart pumping and contracting ability (EF below 50%) to begin with, this study suggests they aren’t affected much by losing their LAA. They probably wouldn’t even notice it was gone. But the jury is still out on how losing the LAA affects even A-Fib patients with poor Ejection Fraction (EF) long term.
Patients with Normal EF: However, this may not be the case with A-Fib patients with a normal EF. The LAA does have a contractile function, particularly in patients with larger size LAAs. (Do athletes have larger size LAAs due to their exercise?) This small study did not address the cases of A-Fib patients with normal EFs.
What This Means for A-Fib Patients
This small study didn’t measure patients with a normal Ejection Fraction (EF) who had their Left Atrial Appendage (LAA) closed off or removed. Most likely the heart’s pumping ability is affected by losing one’s LAA. (In dogs, the LAA provides 17.2% of the volume of blood pumped by the left atrium.)
If you are an active exerciser or athlete, you may want to consider keeping your LAA if possible. But for most people, losing your LAA probably won’t affect you very much. You may not even notice your LAA is gone.
What this Means to Me: A Watchman in my Future
Personally, I love to run, do sprints, etc. But after two recent ablations (after 21 years of being A-Fib free), my Medtronic Reveal LINQ loop recorder recently picked up a full day of Silent A-Fib signals. (Reports are sent wirelessly to my EP each night by the bedside transmitter.)
This wasn’t a big surprise. In my last ablation, my LAA was ablated to stop A-Fib signals, but it also electrically affected the LAA from pumping out properly. My EPs warned me that I would likely need to close-off my LAA sometime in the future.
With this recent data, my two EPs (Drs. Doshi and Natale) recommended I close-off my LAA with a Watchman device.
Even though it might affect my pumping ability, at age 81, stopping my A-Fib signals is more important to me. After my Watchman implant, I’ll write more.
For my first-hand account of having a Medtronic Reveal LINQ loop recorder, go to Has My A-Fib Returned? I Get an Insertable Wireless Monitor
Catheter Ablation: Long-Term A-Fib Symptom Reduction and Improved Quality of Life
In an observational study from Sweden, researchers examined the long-term effects of catheter ablation after 5 years. They wanted to know if undergoing a catheter ablation would affect both A-Fib symptoms and health-related Quality of Life (HRQoL).
Catheter Ablation: Eliminated or Reduced A-Fib Symptoms
From 2011 through 2019, 1521 A-Fib patients had RF PVI catheter ablations at Swedish hospitals using primarily the Carto system. After 5 years, 52% reported freedom from symptoms, 18% reported a greater than 50% symptom reduction, 14% had a minor reduction, while 18% reported no effect or a worsening of symptoms. Over half of the patients who had a catheter ablation were free from arrhythmia-related symptoms.
Symptom Reduction: Of those A-Fib patients still reporting symptoms, more than 80% experienced a symptom reduction. Altogether, more than 80% of the study participants experienced an improved arrhythmia-related situation. Researchers wrote: “The positive effect of CA [catheter ablation] on symptoms is long-lasting.”
Re-Ablation Option: Some of those who did not improve or whose symptoms worsened were accepted for re-ablation at follow-up. After five years, the most commonly reported symptoms were: breathlessness during activity, weakness/fatigue, and tiredness.
Independent predictors: Of those who reported no or worse A-Fib effects at follow-up, independent predictors were:
• Female gender
• Obesity (Body mass index ≥ 35)
• Ischemic Heart Disease (IHD) (narrowed arteries).
At follow-up in the study, the researchers didn’t find any gender differences.
More About Women with A-Fib: In my article, Women with A-Fib: Mother Nature and Gender Bias, I discuss how women have a higher symptom burden and often experience a more negative Quality of Life.
Dramatic Improvement in Quality of Life After Catheter Ablation
Quality of life (HRQoL) was evaluated both before the catheter ablation and after 5 years.
I found the Quality of Life questionnaire (ASTA) to be comprehensive, well written, and easy for patients to fill out.
Patients reported Quality of Life by using a 13-item scale divided into a 7-item physical subscale and a 6-item mental subscale. (HRQoL scale score values ranged from 0 to 100. Higher scores reflected both a higher symptom burden and a worse effect on Quality of Life.)
Quality of Life score was significantly lower [better] 5 years after catheter ablation (36.7 vs 13.1).
Quality of Life was obviously influenced by A-Fib symptoms which can cause psychological and emotional effects. At baseline at the beginning of the study, the most commonly reported negative influences on Quality of Life (HRQoL) were physically related: impaired physical ability, deteriorated life situation, and feeling unable to carry out daily activities.
Patients also reported worry, uncertainty about potential side-effects of medication, risk of recurrence, and the possible need for repeat procedures.
These negative effects improved dramatically over five years. The negative influences on HRQoL were primarily in those still reporting the presence of arrhythmia.
The Elderly had the Same Improvement as Younger Patients
Older A-Fib patients (over age 75) reported the same significant improvement in the symptoms scale score as younger ones. Quality of Life (HRQoL) improved significantly over 5 years, without any differences found between gender or age group.
Editor’s Comments:
Being “Elderly” Shouldn’t Stop You from Having a Catheter Ablation: Unfortunately, some centers have an age cutoff for catheter ablation at age 75 or 80. This Swedish study instead found that “patients with AF should not be excluded from CA solely because of age.” To learn more see my FAQs A-Fib Ablations: Is 82 Too Old for a PVA?
Catheter Ablation Produces Better Results Today: A-Fib is one of the easiest heart diseases to “cure”. Catheter Ablation (CA) today is one of the safest, most effective, life-transforming procedures you can have in a hospital (CA isn’t surgery, there is no cutting involved.)
Today’s advanced catheter ablation treatments and mapping would probably produce greater symptom reduction than in this study.
Important Study on Quality of Life: The authors are to be commended for studying how catheter ablation influences Quality of Life (HRQoL). (Anyone who has become A-Fib free can testify how transformative and life-changing it is to go from A-Fib to normal sinus rhythm, such as myself.)
For many A-Fib patients, the impact on Quality of Life is just as important as their symptoms.
When doctors talk with patients about catheter ablation, they usually concentrate on A-Fib symptoms.
Instead, more emphasis should be put on how catheter ablation can radically improve Quality of Life. In this Swedish study, the strongest, most dramatic results for patients were in improved Quality of Life.
For many A-Fib patients, the challenges and impact on Quality of Life are just as important as their symptoms.
Considering a catheter ablation for your Atrial Fibrillation? Learn more on our Treatments for A-Fib page: Catheter Ablation: Pulmonary Vein Ablation (Isolation)
2022 AF Symposium: The LOOP Study–Implications for Clinical Practice
Last week, I published my Overview of the 2022 AF Symposium held in January in New York City. You can find it on my page, My Summary Reports Written for Atrial Fibrillation Patients.
“The LOOP Study – Implications for Clinical Practice and Future Trials” was presented by Dr. Andrea Russo of Cooper University Hospital in Camden, New Jersey.
Dr. Andrea Russo
A-Fib Strokes More Dangerous: Dr. Russo described how one-third of strokes are due to A-Fib. And these strokes are more severe and debilitating than those not associated with A-Fib. Many were not diagnosed with Atrial Fibrillation until after they had a stroke or heart attack.
The LOOP Study Research: The researchers posed the questions: Is all A-Fib is worth seeing or worrying over? “Does all detected A-Fib require anticoagulation?” Is A-Fib lasting more than 6 minutes but less than 24 hours duration, really a threat?
From 4 centers in Denmark, study patients received the Medtronic Reveal LINQ LOOP Implantable Recorders (ILR), the Reveal LINQ to investigate…. continue reading The Loop Study.
A-Fib Stroke Risk: The LOOP Study–Implications for Clinical Practice and Future Trials
2022 AF Symposium
The LOOP Study–Implications for Clinical Practice and Future Trials
Dr. Andrea Russo of Cooper University Hospital in Camden, New Jersey gave a talk on “The LOOP Study – Implications for Clinical Practice and Future Trials”.
Dr. Andrea Russo
A-Fib Strokes More Dangerous
She described how one-third of strokes are due to A-Fib. And these strokes are more severe and debilitating than those not associated with A-Fib.
Asymptomatic A-Fib may not be diagnosed until after someone has a stroke or heart attack. Dr. Russo described how previous studies defined “device detected A-Fib” as lasting more than 6 minutes but less than 24 hours duration without a prior diagnosis of A-Fib.
The LOOP Study Research
From 4 centers in Denmark, the LOOP Implantable Recorder Study investigated whether anticoagulation can prevent stroke in patients with high risk of stroke.
Participants: In the study, 318 patients, with no prior A-Fib, were over 70 years old (average age was 75 or over) and had at least one risk factor for stroke. They each received an implantable loop recorder (ILR), the Reveal LINQ (by Medtronic).
The control group received standard care (an annual interview with a study nurse and typical interactions with the participant’s general practitioner.)
Patients were monitored and followed for 2-3 years (medium follow-up 64 months).
Study Results
For both groups, the primary outcome was stroke or systemic embolism. Anticoagulation was recommended if someone had A-Fib for 6 minutes or longer.
A-Fib was detected in 32% of the implanted loop recorder group while in only 13% of the control group who received usual care.
There was no significant difference between the groups in major bleeding and hemorrhagic stroke.
Of the LOOP group, 4.5% suffered a primary outcome (stroke or embolism) compared to 5.6% of the control group.
Short Duration A-Fib Not a Risk
The researchers posed the question: Is all A-Fib worth seeing or worrying over? “Does all detected A-Fib require anticoagulation?” Is 6 minutes of A-Fib really a threat?
Dr. Russo cited other studies such as ASSERT where 6-24 hours of A-Fib wasn’t significant as a risk of stroke, whereas over 24 hours duration was. (See my report: How Long Does It Take for an A-Fib Clot to Form? The ASSERT Clinical Trial )
Researchers also asked: What other considerations should be examined? What about A-Fib burden?
Editor’s Comments
Dr. Russo is going against the grain of conventional A-Fib thought by suggesting that 6 minutes of A-Fib is not a serious threat or risk of developing an A-Fib stroke.
If you only have an occasional, short episode of A-Fib, you may not need an anticoagulant. If your doctor insists that you take an anticoagulant, it might be time to get a second opinion.
Remember that anticoagulants are considered high risk drugs. They should only be prescribed if there is a real risk of stroke.
If you find any errors on this page, email us. Y Last updated: Friday, February 25, 2022
Return to 2022 AF Symposium Reports
Closure of the Left Atrial Appendage (LAA) vs Anticoagulants
The Left Atrial Appendage (LAA) is the source of many non-pulmonary vein A-Fib signals. So, when irregular heart rhythm signals persist after a catheter ablation, Atrial Fibrillation patients (like myself) look to closure or removal of the Left Atrial Appendage (LAA) rather than spending a lifetime on anticoagulants. Is this the wiser choice?
The term “non-inferior” is used in a study to mean the new treatment is not worse than an active treatment.
Prague Research Study
A four-year study from Prague (PRAGUE-17) determined that Left Atrial Appendage (LAA) closure was “non-inferior” (i.e., not worse in comparison) to Novel Oral Anticoagulants (NOACs) for preventing major neurological, cardiovascular, or bleeding events in high-risk patients with A-Fib.
Two LAA occlusion devices
The anticoagulant most used in the study was apixaban (Eliquis) in 95% of cases. To close off the Left Atrial Appendage (LAA), electrophysiologists (EPs) used either the Amplatzer™ Amulet™ LAA Occluder or the Boston Scientific Watchman occlusion device.
The study also examined device-related complications finding “significant procedure/device-related complication was similar between the two treatment groups” (NOAC vs LAA Closure).
Bleeding risks: Furthermore, subsequent non-procedural bleeding was significantly reduced with LAA closure.
Anticoagulant risks: Patients taking anticoagulants for four years had a significantly greater risk of bleeding complications.
Danish Study Confirms Prague Results
NOACs vs DOAC? The term Novel oral anticoagulants (NOACs) is no longer “novel”; Preferred term is “DOAC,” which stands for direct oral anticoagulant.
In a study from Denmark using the Danish National Patient Registries, patients receiving the Amulet Left atrial appendage (LAA) closure device with a history of ischemic stroke were compared to similar patients receiving DOACs.
Risk of major bleeding events: The risk of major bleeding and all-cause mortality was significantly lower in the Amulet group. This study indicated similar stroke prevention effectiveness but significantly lower risk of major bleeding events with Left atrial appendage occlusion (LAAO) therapy compared with DOAC.
Editor’s Comments
LAA Closure as Effective as Anticoagulants…Studies show that LAA Closure is just as effective as anticoagulants in preventing A-Fib stroke and other cardiovascular problems (stroke, transient ischemic attack, cardiovascular death, and clinically-relevant bleeding).
…But Anticoagulants Increase Bleeding: As one would expect, having to take anticoagulants for four years did increase bleeding. For more, see Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.
The Bottom Line: If you have a choice, this research indicates a Left Atrial Appendage closure device like the Watchman is better than having to take anticoagulants for the rest of your life.
Many people hate taking anticoagulants. Now you don’t have to! LAA occlusion devices like the Watchman are a most welcome alternative to having to take anticoagulants for life.
Steve Ryan with Dr. Natale and surgical nurse, before ablation August 2021.
On a Personal Note: A Watchman is in my future.
As many readers know after 21 years, my A-Fib returned. Not to worry. I’m once again A-Fib free after two catheter ablations by Dr. Shephal Doshi and Dr. Andrea Natale.
But Dr. Natale and Dr. Doshi both recommended I close off my Left Atrial Appendage (LAA). So in a few months, I’ll be getting the Watchman FLX occlusion device. I’ll write about the experience.
