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Baltimore, MD


Doctors & patients are saying about 'Beat Your A-Fib'...


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"This book is incredibly complete and easy-to-understand for anybody. I certainly recommend it for patients who want to know more about atrial fibrillation than what they will learn from doctors...."

Pierre Jaïs, M.D. Professor of Cardiology, Haut-Lévêque Hospital, Bordeaux, France

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Dr. Wilber Su,
Cavanaugh Heart Center, 
Phoenix, AZ

"...masterful. You managed to combine an encyclopedic compilation of information with the simplicity of presentation that enhances the delivery of the information to the reader. This is not an easy thing to do, but you have been very, very successful at it."

Ira David Levin, heart patient, 
Rome, Italy

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Walter Kerwin, MD, Cedars-Sinai Medical Center, Los Angeles, CA


A-FIB NEWS – 2011

Check here for my take on A-Fib milestone events. Items are listed by date, most recent first. Citations to specific research studies or articles follow each entry. To find an A-Fib News item by topic, use the Search box.

DECEMBER 29, 2011

SURGICAL VERSUS CATHETER ABLATION—FLAWED STUDY, BUT IMPORTANT RESULTS FOR PATIENTS

Not that long ago, surgery was the only way to fix most heart problems including Atrial Fibrillation (the Cox-Maze operation). But thanks to new techniques and discoveries like stents and the Bordeaux Group’s discovery in 1994 that a catheter with an electrode at the end can electrically isolate the pulmonary vein openings making people A-Fib free, electrophysiologists (EPs) became more involved in fixing heart problems. Surgeons had less to do. The last fifteen years saw a tremendous growth in the number, training and quality of EPs doing Pulmonary Vein Isolations (PVIs). The author remembers when he could find and list only ten centers doing PVIs. Now there are over a thousand in the US alone. A-Fib is indeed an epidemic, but the medical field has risen to the challenge. Few medical discoveries have been introduced and received such wide-spread acceptance in such a short time as catheter ablation (PVI).

FDA Approves AtriCure Synergy Ablation System
And recently surgeons have gotten back in the game, thanks in no small part to the work of AtriCure, Inc. whose Synergy Ablation System was recently approved by the FDA (December 16, 2011). (The FDA approved the AtriCure system “in patients who have persistent or longstanding persistent Atrial Fibrillation and are also undergoing surgery for coronary artery bypass grafting or valve repair or replacement.”1The AtriCure System is and can still be used off-label for paroxysmal A-Fib. It’s probably only a matter of time before the FDA approves AtriCure’s System for paroxysmal, stand-alone operations such as the Wolf Mini-Maze.)

The FDA approval, though limited, is nevertheless a major medical breakthrough for A-Fib patients. A-Fib patients now officially have a choice of treatments.

Catheter or Surgical Ablation?
But which is better—catheter or surgical ablation? Over the years there have been many multi-center studies and data developed about the efficacy and safety of catheter ablation. But that’s not the case for the AtriCure system which is a relatively new treatment.

For what is probably the first time, a recent small study compared the two treatments head-to-head. AtriCure, Inc. provided funding for the study “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” 59 patients at St. Antonius Hopital in Nieuwegein, the Netherlands and 64 patients at the Hopital Clinic in Barcelona, Spain were randomized to receive either a catheter ablation (CA) or surgical ablation (SA). Patients were selected who had a prior failed catheter ablation (67%), had a left atrium diameter of 40 to 44 mm and hypertension (28-40 mm is normal), or a left atrium diameter greater than 45 (33%). (At first glance this seems like stacking the deck against a successful catheter ablation. These are more difficult cases usually requiring more than a simple Pulmonary Vein Isolation ablation.)

CA Ablation
At St. Antonius Hospital the Pulmonary Veins were re-isolated. No additional lines or ablation strategies were performed regardless of the type of A-Fib. A non-irrigated tip RF catheter was used. (This is surprising as non-irrigated tip catheters are outdated and considered less effective. Irrigated-tip catheters are SOP (Standard Operating Procedure) in most A-Fib centers today.)

At the Hospital Clinic an irrigated tip RF catheter was used. An additional Left Atrium roofline could be made at the discretion of the operator. Sometimes a Mitral Isthmus line was also made.

At either site no mention was made of using current mapping strategies to find and isolate activation sites, or the use of Complex Fractionated Atrial Electrograms, or Dominant Frequency, or step-wise ablation protocols typically used in more complex cases. (See 5-Step Ablation Treatment for Chronic A-Fib.) According to the study authors, “patients in the CA group may have been undertreated compared with patients in the SA group.” “More than 40% of (the CA) patients had nonparoxysmal AF and may have been undertreated by PVI alone…67% had already failed a prior CA, which may be a more serious predisposition to failure than anticipated.”2

SA Ablation
The surgical ablation arm used the AtriCure Synergy Ablation System which uses an RF clamp to ablate and isolate the pulmonary veins. In addition, 31% of patients had various additional LA ablation lines at the LA roof, aortic trigone, mitral isthmus, or box lesion around the PVs. “Part of these lines were made without verifying that conduction block had indeed been established.” (In a somewhat surprising observation, the authors concluded “efficacy tended to be a little lower in patients with such lines.3 ) The Left Atrial Appendage was also removed. And Ganglia areas on the outside of the heart were also ablated. 

Editor’s comment: Ganglia Ablation is a subject of some controversy that deserves its own report. There are over 1000 neurons (nerve signal pathways) in the Ganglia areas. They affect other areas than just A-Fib, such as the ventricles and the GI tract.) See Merits of GP [Ganglionated Plexi] Ablation.) According to the authors of this study, “So far, no randomized clinical trials have quantified the added effect of surgical ganglia ablation to achieve freedom from AF.4

Results
Efficacy: [As one would expect], the efficacy of catheter ablation was low—44.4%. What was more surprising was that the efficacy of Surgical Ablation was only 67.2%, far less than the over 90% success rates often reported (in unpublished, self-reported, or single-center, non-controlled series with short duration and lax follow-up). This is all the more surprising in that the surgical arm, in addition to isolating the pulmonary veins, often employed additional extensive lesion sets and burns in the left atrium and elsewhere on the heart. Whereas the catheter ablation arm was limited in ablation strategies it used.

Safety: The procedural adverse event rate for surgery was 23% (approximately 1 out of 4 patients) which was significantly higher than catheter ablation 3.2% (in line with previously published data). The main procedural complications in surgery were pneumothorax (collapsed lung), major bleeding, and the need for a pacemaker. (In surgical ablation the lungs have to be alternately deflated and re-inflated to fit the clamp around the pulmonary veins. Especially in older people whose lungs are no longer as elastic, this may be hard on the lungs.) These complications were caused “mostly from direct mechanical injury during the procedure. About half required additional intervention and/or prolonged hospitalization.”5

“The events reported with CA seemed more transient and did not require intervention.”They seemed to center around anticoagulation, with bleeding on the one hand and transient ischemic attack, stroke and hemorrhage stroke on the other. (One of the CA patients died of a hemorrhagic stroke a month after the ablation.)

Catheter Ablation procedure time was shorter, on average 163 minutes versus a Surgical Ablation average of 188 minutes. CA patients tended to stay in the hospital 2.0 days, versus 5.5 days for surgery.

Unlike catheter ablation, “there are no large registries for minimally invasive surgical ablation that provide good insight into safety.”6

Editor’s Comments: Though not the fault of the study’s investigators, the deck was obviously stacked against catheter ablation. The success rates were far lower than previously published and documented data. (For example, the Bordeaux Group reports a 95% success rate after two ablations using their step-wise ablation protocol for Persistent A-Fib patients. (See 95% Success Rate in Curing Persistent A-Fib.)
But what was more surprising was the moderate success rate for the surgical arm which seemed to pull out all the stops and use the newest, most advanced extensive lesion sets and burns to achieve success.
In terms of safety, a 1-in-4 major adverse event rate is huge when one considers that the surgeons were probably under intense scrutiny to perform their best and not make any mistakes, since so much was riding on this study.

What the FAST Study means for Patients
This was probably the first study to provide documented, verifiable, non-self reporting data on the safety of Surgical Ablation (Mini-Maze). The results for patients were not good. A 1-in-4 chance of a major adverse event is not acceptable for most patients.

This study did not address simpler cases of Paroxysmal A-Fib. But the surgical Mini-Maze operations are generally the same for Paroxysmal as for more complex cases. Until we get verifiable data to the contrary, anyone going for a Mini-Maze operation should expect a 1-in-4 chance of a major adverse event.

“But what if I’ve had a failed catheter ablation? Shouldn’t I get one of the more advanced types of Mini-Maze ablations?” A 67% success rate is certainly acceptable and is better odds than you’d get in Las Vegas. But one of the more disturbing findings in this study is that with the more advanced surgical approaches using ablation lines on the left atrium and burns on other areas of the heart, “efficacy tended to be a little lower in patients with such lines.”7 The Mini-Maze operations featuring extensive ablation lines and burns didn’t seem to work, at least in this study.

And according to the numbers, you have a better (and much safer) chance of being A-Fib free if you go to catheter ablation centers specializing in advanced activation mapping, step-wise protocols, etc. Unfortunately those centers are relatively few and far between. The Bordeaux protocol, for example, is currently used in only a few centers around the world. And catheter ablation strategies for complex cases currently have not been standardized, though most centers’ strategies are very similar (See Comparison of Dr. Pappone’s, Haïssaguerre’s, and Reddy’s Stepwise Approaches in Ablating for Chronic A-Fib)

The FAST study, though probably the first of its kind, was a relatively small study. A-Fib patients shouldn’t rely entirely on the results of this study for their medical decisions. While the efficacy results for catheter ablation should probably be discounted because of the design bias of the study, the FAST study does raise red flags particularly about the safety, but also about the efficacy, of surgical ablation (Mini-Maze) operations.

Most reports of the FAST study tout the higher success rate of surgical versus catheter ablation, but these results don’t hold up under close scrutiny. More important for patients is the high complication rate and safety of surgical ablation.

Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011. 
http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf

US Food and Drug Administration. “AtriCure Synergy Ablation System – P100046” December 15, 2011. http://tinyurl.com/npfacep

NOVEMBER 28, 2011

DABIGATRAN (PRADAXA)—RECENT SAFETY ADVISORIES—SHOULD WE WORRY?

The Japanese Ministry of Health, Labor, and Welfare recently issued a safety advisory warning of the potential for adverse effects following the deaths of five patients. Of the deceased patients, one had kidney failure and four were over 80 years old. In Japan there were 81 reported cases of serious side effects, including gastrointestinal bleeding, out of 64,000 people who have used dabigatran since it was first introduced in Japan in 2011.

Editor’s Comments:
81 out of 64,000 is a very low number of serious side effects, particularly compared to warfarin. In a recent study warfarin was implicated in 33% of “adverse drug events (ADEs)” for seniors requiring emergency hospitalizations.

Of the five patients who died, dabigatran is counter indicated (shouldn’t be used) in patients with renal failure. Caution is obviously needed in patients over 80 years old. They should be monitored more closely to determine if they have risk factors for bleeding. This should be reflected in the labeling of dabigatran.

The Australian regulatory authority, the Therapeutic Goods Administration, issued a “safety advisory” on dabigatran because of an increase in the number of bleeding-related adverse events reports. The most common site of serious bleeding for dabigatran was the gastrointestinal track, whereas for warfarin it is intracranial.

Editor’s Comments: The clinical trials of dabigatran revealed that nearly two out of five patients could not tolerate dabigatran. The Pradaxa Fact Sheet from Boehringer Ingelheim states under “Adverse Reaction from RE-LY” (the clinical trial of Pradaxa): Patients on Pradaxa 150mg had an increased incidence of gastrointestinal adverse reactions (35%/yr) compared to warfarin (24%/yr).
Dabigatran may not be the perfect substitute for warfarin. If you’re taking dabigatran (Pradaxa), watch out for indigestion, burning, stomach pain (and weight loss). But which would you rather have―a hemorrhagic (intracranial bleeding) stroke or indigestion? On the other hand, based on the clinical trial data, there is a danger that dabigatran over time may cause long-term damage to the gastrointestinal system. This is a decision you and your doctor have to make depending on how you react to dabigatran.
Overall, dabigatran, though not perfect and not tolerated by all A-Fib patients, could become a welcome addition to the tools doctors have to prevent A-Fib stroke.

Caveat
If you’re taking dabigatran and have a major traumatic accident, emergency doctors have no antidote to stop you from bleeding to death (with the exception of emergency dialysis which is not easily done on patients with serious trauma and bleeding). Whereas doctors can rapidly reverse the anticoagulant effect of warfarin using vitamin K (and possibly plasma factor Vlla and factor concentrates).

Also, the degree of warfarin anticoagulation can be easily assessed, whereas no such tests exist for dabigatran.

Wood, Shelley. “Deaths Prompt Dabigatran Safety Advisory in Japan.” HeartWire, TheHeart.org. 8/17/11

“Dabigatran: Australia issues bleeding warning” HeartWire, TheHeart.org October 7, 2011

Wood, Shelley “Trauma patients on dabigatran prompt call for “pragmatic” trials, trauma surveillance.” HeartWire, TheHeart.org. November 24, 2011

Lowes, Robert. “Warfarin tops list for emergency hospitalizations in seniors.” HeartWire. TheHeart.org. November 25, 2011.
http://www.theheart.org/article/1318469.do

(Added 3/18/13) Death From Pradaxa

We’ve been reading heart-wrenching stories of people on Pradaxa bleeding to death in Emergency Rooms because there’s no antidote to reverse its blood-thinning effects. Doctors and nurses in the ER feel helpless and powerless. They try everything they can think of, but then have to watch as their patient dies from uncontrolled bleeding. “And that’s a very bad feeling for us,” in the words of Dr. Bryan A. Cotton, a trauma surgeon at Memorial Hermann-Texas Medical Center in Houston. According to Dr. Cotton, Pradaxa has contributed to the bleeding deaths of at least eight patients at the hospital.

Can you imagine what it must be like to feel yourself bleeding to death in the ER? Terror, confusion, panic, frustration—“Why can’t all these doctors do something?!” What a horrible way to die.

How devastating for relatives and friends to watch someone you love die from uncontrolled bleeding, to be told by doctors that there’s nothing they can do.

Why Approve Pradaxa?

Why in the world would the FDA put blood thinners on the market that have no antidote or reversal agent, where people die because their bleeding can’t be stopped? Warfarin may not be perfect, but ER doctors at least have a fighting chance to stop someone from bleeding to death if they are taking warfarin.

Pradaxa was identified as the primary suspect in 542 patient deaths reported to the FDA in 2011. (How many more were not reported to the FDA, how many disabling injuries?) Pradaxa “was linked to more reports of injury and death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices.”

Conclusions

We can’t expect the FDA to take Pradaxa off of the market or put any significant limits or safeguards on its use any time soon. The FDA tends to stand by any drug it approves. It’s embarrassing to them to admit they were wrong. (Some people go so far as to say the Drug Industry has a great deal of influence over the FDA.)

Some doctors who receive consulting fees, etc. from Boehringer Ingelheim are arguing that there was no evidence that the lack of an antidote contributed to the deaths of the Pradaxa takers who bled to death. (Try telling that to the ER doctors who had to watch their patients die from uncontrolled bleeding.) Another argument is that 542 deaths is a small number compared to the number of people using Pradaxa. But bleeding to death like this is an awful way to die. And many of these 542 deaths did not have to happen. Many probably could have been prevented if there was a reversal agent like there is with warfarin.

The solution is simple: Stop Prescribing or Taking Pradaxa. Go back to warfarin which isn’t as convenient as the new anticoagulants. But it does work reasonably well if you stay in the proper INR range. And it does have a reversal agent.

And there are two other new anticoagulants approved by the FDA:

  1. Rivaroxaban (Xarelto), Bayer & Johnson and Johnson
  2. Apixaban (Eliquis), Briston-Meyers Squibb & Pfizer

But these new anticoagulants also don’t have reversal agents. However, there is anecdotal evidence that Xarelto doesn’t have as many bleeding deaths associated with it. Eliquis was only recently approved by the FDA. We don’t have much real world data on it yet. But it tested better than the other new anticoagulants.

Thomas, Katie. “A Promising Drug with a Flaw” The New York Times, Business Day, November 2, 2012. http://tinyurl.com/asmfwp9

Warriner, Cal. “The Debate Over Pradaxa (Dabigatran) Safety – Follow the Money” The Legal Examiner, West Palm Beach, Florida, March 20, 2012. http://tinyurl.com/7bhdwcz

NOVEMBER 26, 2011

DRONEDARONE (MULTAQ)—TIME TO STOP TAKING IT?

This report is a compilation of several recent news reports about dronedarone (Multaq) and what they mean for A-Fib patients.
1. “Multaq should not be prescribed for patients with permanent A-Fib.” according to Sanofi-Aventis’ warning to doctors. In the PALLAS study, terminated early, patients on dronedarone were dying at more than twice the rate of those on a placebo. The ratio of stroke and hospitalization for heart failure was also more than twice as high.
2. French health authorities concluded that the efficacy of dronedarone was “insufficient.” This could lead to the drug being dropped from France’s drug reimbursement program.
3. The European Medicines Agency stated that, because of the increased risk of liver. lung and cardiovascular adverse events, dronedarone “should only be prescribed after alternative treatment options have been considered.”
4. Dr. Steven Nissen of the Cleveland Clinic told the Wall Street Journal that he thinks the drug is dangerous.
5. Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los Angeles added, “It doesn’t even appear safe in  intermediate-risk patients.
6. Dr. John Mandrola of Louisville stated, “I don’t know any of my colleagues who would start a patient out on Multaq. It just doesn’t work.”
7. The FDA publishes a list of drugs to monitor after having identified potential signs of serious risks or new safety information. Dronedarone appeared on this list for the fifth straight time.

But according to Dr. Stuart Connolly (McMasters Un., Hamilton Ontario), one of the co-primary investigators of the PALLAS trial, patients with non-permanent A-Fib benefit from dronedarone, and he doesn’t think this type of patient should be worried. 

(But is there that much of a difference between permanent and non-permanent A-Fib patients that we shouldn’t be worried or concerned? For example, by the time liver damage shows up in tests, liver cells have already been damaged, probably permanently.)
Editor’s Comments: So many red flags have been raised about dronedarone (Multaq) that anyone taking dronedarone should discuss with your doctor if you can take another antiarrhythmic med instead. If the worst fears about dronedarone are true, it may be both ineffective and dangerous. Why take a drug associated with increased strokes, hospitalizations, heart failure, liver damage, lung damage and death if it doesn’t work? Even if it did work, the side effects probably wouldn’t justify taking it.
No antiarrhythmic drug is 100% safe and effective for all A-Fib patients. But until we get more favorable research on dronedarone, all A-Fib patients should probably consider not taking it, not just those in permanent A-Fib. It’s not worth the risk of taking a drug that isn’t very effective any way.
For a spirited, lengthy discussion of dronedarone, read Mellanie True Hills’ article/editorial http://www.stopafib.org/newsitem.cfm/NEWSID/353/What we have learned about Multaq/dronedarone. But in her own words, “The maker of Multaq is one of many organizations that has contributed so that we can do research and writing to give you the best content.”

Wood, Shelley. “Deaths doubled with dronedarone in PALLAS: FDA and EMA updates” HeartWire, July 21, 2011 

Nainggolan, Lisa. “EMA Adds CV Events to Review of Dronedarone” HeartWire, July 12, 2011 

O’Riordan, Michael. “EMA recommends restricting use of dronedarone” HeartWire, September 20, 2011. http://www.theheart.org/article/1283205.do 

Miller, Reed. “Dronedarone “dear doctor” letter sums up recent alerts.” HeartWire, August 17, 2011. http://www.theheart.org/article/1264551.do  

 

NOVEMBER 25, 2011

SUCCESSFUL A-FIB CATHETER ABLATION IMPROVES HEALTH

It feels so great to be A-Fib free and in normal sinus rhythm after a successful Pulmonary Vein Isolation (PVI) procedure that one feels more healthy. But is one’s health actually improved after a successful PVI?

In an observational long-term study of the impact of A-Fib ablation, over 4,000 patients from the Murray, Utah Intermountain Medical Center were followed for over three years. Compared to matched controls who had A-Fib but did not have an ablation, ablated patients had a significantly lower risk of death, stroke, heart failure, cardiovascular hospitalization and dementia.

Editor’s comment: People with A-Fib have an increased risk of developing dementia, because blood is not being pumped properly to the brain and other organs when in A-Fib.

Catheter Ablation Superior to Drug Therapy
The article cited previous studies which showed that antiarrhythmic drugs, which attempt to return the heart to normal sinus rhythm, don’t improve morbidity and mortality compared to leaving patients in A-Fib with rate control drugs, perhaps because current antiarrhythmic meds aren’t highly effective, recurrence rates during therapy are high (44%-67% at 1 year), and adverse events and side effects are common.
Catheter ablation was found superior to drug therapy in suppressing A-Fib and improving symptoms, exercise capacity, and quality of life.

Successful Ablation Patients More Healthy Than People Without A-Fib!
The over 4,000 ablated patients were also matched with controls who did not have A-Fib. Ablated patients were more likely to have had hypertension, heart failure, and significant valvular disease—were more likely to be less healthy than the controls. But after three+ years of normal sinus rhythm, there was a trend towards lower long-term adverse events in the A-Fib ablation group compared to the “healthier” control group (with the exception of heart failure).

Editor’s Comments: We know that we feel better after a successful Pulmonary Vein Isolation (PVI) procedure. It makes intuitive sense that our heart and body would function better, that we would be more healthy after a successful PVI. But it’s good to have studies that document this in no uncertain terms.
But what’s even more interesting is that patients A-Fib free were to some extent healthier than matched controls who never had A-Fib, even though the patients with A-Fib probably had more health problems going in than the controls. The authors of this study didn’t speculate on why this occurred. Could it be that those of us made A-Fib free value normal sinus rhythm more and take more steps to stay healthy and A-Fib free?

T. Jared Bunchet al. “Patients Treated with Catheter Ablation for Atrial Fibrillation have Long-Term Rates of Death, Stroke, and Dementia Similar to Patients without Atrial Fibrillation.”  J Cardiovasc Electrophysiol. 2011 Aug;22(8):839-45. doi: 10.1111/j.1540-8167.2011.02035.x. Epub 2011 Mar 15.

http://www.ncbi.nlm.nih.gov/pubmed/21410581  

See also: Hunter RJ et al. “Maintenance of sinus rhythm with an ablation strategy in patients with atrial fibrillation is associated with a lower risk of stroke and death.” Heart doi:10.1136/heartjnl-2011-300720
http://heart.bmj.com/content/early/2011/09/19/heartjnl-2011-300720.abstract

SEPTEMBER 15, 2011
Dr. Marcos Daccarett, MD, MSc, FACC, FAHA, FHRS has moved from the University of Utah Hospital to St. Luke’s Idaho Cardiology Associates in Boise.

SEPTEMBER 12, 2011

HAVING TROUBLE SLEEPING?—THE ASPIRIN (NASIDS) YOU’RE TAKING MAY BE THE PROBLEM

People with A-Fib are often prescribed the blood thinner aspirin to help prevent clots and A-Fib stroke. NSAIDs (aspirin, ibuprofen, etc.)  work by inhibiting prostaglandin synthesis which is involved in pain and inflammation. But they are also involved in melatonin synthesis and body temperature regulation.

A recent double blind study found that aspirin and ibuprofen suppressed melatonin synthesis and attenuated the normal circadian decrease in body temperature during nighttime hours. This alteration of normal sleep patters in healthy individuals by the NSAIDs aspirin and ibuprofen was not found, however, in all study subjects.

Editor’s Comments: if you’re taking aspirin, even at the lowest dosage 81 mg, and are having trouble getting to sleep, try taking the aspirin in the morning rather than in the evening before bedtime. However, you may find that even taking aspirin in the morning may still affect your sleep.
NSAIDs are the most frequently prescribed medications worldwide. But one wonders why when considering the documented side effects to the gastrointestinal tract, liver, kidneys, central nervous system, endocrine system, and articular cartilage this article briefly documents.
For example, “researchers estimate that 8-10% of the overall incidence of end-stage renal (kidney) disease is attributable to acetaminophen [Tylenol]. The risk is dose dependent with measurable increases of risk beginning at 105-365 pills per year or greater than 1000 pills per lifetime.” What this means in non-medical language is if you take more than 1000 acetaminophen during your lifetime, you stand a good chance of permanently destroying your kidneys. For a 50-year-old that’s only 20 pills a year. One wonders why so many doctors and hospitals in the US prescribe or recommend acetaminophen for pain relief, even for children. [Some researchers do not consider acetaminophen a NSAID, though it works by the same mechanism—inhibition of prostaglandin synthesis.] 

Thanks to one of our readers for calling our attention to this article and to its importance. He had trouble sleeping when taking 81 mg of aspirin (baby aspirin). ayatingl(at)gmail.com

NSAIDS—The Unintended Consequences Dynamic Chiropractic
October 20, 1997, Volume 15, Issue 22 By Alan Cook, Dc

http://www.chiroweb.com/archives/15/22/06.html

SEPTEMBER 11, 2011

NSAIDS ASSOCIATED WITH A-FIB

NSAIDs (nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen [Advil, Motrin], naproxen [Aleve, Naprosyn) and COX-2 inhibitors are associated with an increased risk of developing A-Fib and/or Flutter.

A Danish study of 32,602 patients with A-Fib or Flutter found that the use of NSAIDs was associated with an adjusted 17% increased risk of developing A-Fib or Flutter. There was a slightly higher risk associated with the use of COX-2 inhibitors.
New users had the highest risk. For those who filled a prescription for NSAIDs within the previous two months, they had a 46% chance of developing A-Fib/Flutter. For COX-2 inhibitors there was a 71% increased risk.

A previous study based on the United Kingdom General Practice Research Database also found an association between the use of NSAIDs and A-Fib. But this study found the highest risk among long term users (for more than one year) rather than first-time users.

But an “association” doesn’t necessarily mean that NSAIDs cause or trigger A-Fib/Flutter. Perhaps an inflammation condition increases the risk of A-Fib on the one hand or prompts the use of NSAIDs on the other. According to Dr. Jerry H. Gurwitz (Un. of Massachusetts Medical School, Worchester), “The risk is unproven. But NSAIDs should be used with caution in high risk patients anyway.”

NSAID use associated with risk of atrial fibrillation or flutter.

Editor’s Comments: though inflammation may produce fibrosis, loss of atrial muscle mass and thereby foster A-Fib, that doesn’t explain how nearly one out of two new users filling prescriptions for NSAIDs developed A-Fib/Flutter within two months.
Until further research clarifies these points, it’s prudent to consider NSAIDs not just associated with A-Fib but actual triggers or causes of A-Fib.
These Danish and British studies may be medical breakthrough research. Avoiding NSAIDs may help prevent the development and/or triggering of A-Fib/Flutter.

JULY 5, 2011 
Michael O’Riordan http://www.theheart.org/article/1249265.do

NSAIDs and atrial fibrillation
BMJ 2011; 343:d2495 doi: 10.1136/bmj.d2495 (Published 4 July 2011) Cite this as: BMJ 2011; 343:d2495

Jerry H Gurwitzhttp://www.bmj.com/content/343/bmj.d2495.short


SEPTEMBER 11, 2011

ELDERLY SHOULDN’T USE NSAIDS

NSAID (nonsteroidal anti-inflammatory drugs—such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn) use among elderly patients with high blood pressure and coronary artery disease leads to increased mortality, heart attacks and stroke. Chronic NSAID users had a 60% increased risk of death, heart attack and stroke. And according to Dr. Anthony Bavry (Un. of Florida, Gainesville), “This association doesn’t appear to be due to elevated blood pressure, because chronic NSAID users actually had slightly lower…blood pressure.”

Editor’s Note: Many A-Fib patients are elderly. It’s all too tempting to turn to NSAIDs to handle pains big and small. But what can we elderly do? Acetaminophen (Tylenol) is associated with kidney failure. COX-2 inhibitors have their own set of problems. Are there any pharmaceutical pain killers that are safe to take?
We need to investigate “natural” pain killers. Are there natural pain relievers that would help us without causing bad side effects? Has anyone studied natural pain relievers which A-Fib patients might use? Here is a starting list of natural pain relievers:
  • Olive Oil
  • Fish Oil
  • Tart Cherries
  • White Willow Bark (like aspirin)
  • Boswella
  • Tumeric (circumin)
  • MSM (Methyl Sulphonyl Methane
  • Feverfew (tanecetum parthenum)
  • Essential Oils (jasmine, peppermint, juniper, rose, rosemary)
  • Ginger
  • Skullcap Tincture
  • Yucca
  • Cat’s Claw
  • Eucalyptus
  • Aloe Vera Gels
  • Kava Kava
  • Valerian Root

“NSAID use in elderly with hypertension linked to increased cardiac risk” By Piriya Mahendra, 18 July 2011. Am J Med 2011; 124: 614–620. http://tinyurl.com/ooxwu3b

Thanks to Ira David Levin for calling our attention to this article and for pointing out its importance for A-Fibbers.

SEPTEMBER 3, 2011

SILENT CLOTS FROM MULTIELECTRODE PHASED-RF ABLATION CATHETERS

In two small studies of catheter ablation, Magnetic Resonant Imaging (MRI) revealed “subliminal (silent) intracranial embolic events” (clots, lesions) that normally would not have been detected if MRI weren’t used. These non-randomized studies raise concerns that catheter ablation may cause small, unnoticeable clots or lesions in the brain. The studies compared Multielectrode Phased-RF Ablation Catheters (Medtronic Ablation Frontiers), conventional Irrigated-Tip Catheters (Navistar Thermocool, Biosense Webster), and CryoBalloon Catheters Arctic Front, Medtronic).

In one study using the Multielectrode Phased-RF Ablation Catheter 38.9% of patients (9 out of 27) experienced silent cerebral lesions. This was significantly more than a conventional Irrigated-Tip RF catheter (2 out of 27, 7.4%) or the CryoBalloon catheter (1 out of 23, 4.3%). (Some reports cite only the percentages which can be misleading, since the actual numbers of patients were so small.)

Why Lesions from Multielectrode Phased-RF Catheters?
Why would a Multielectrode Phased-RF Catheter produce so many small clots or lesions? Possibly because, unlike conventional Irrigated-Tip catheters, it is not irrigated. What may happen is, when heart tissue is heated, energy is transferred back to the electrode, which as it heats up can cause char. This char can break off and cause clots and strokes. Conventional Irrigated-Tip catheters are cooled by saline solution to reduce or eliminate this heat effect.

MRI-Detected Lesions may be Insignificant or may Reverse Themselves
A Medtronic spokesperson pointed out that the lesions detected by MRI have not been clearly linked to neurologic defect or cognitive decline, and that some studies have shown that the lesions detected have been shown to reverse on follow-up. (These MRI-detected lesions may not have any lasting effect or may resolve themselves much as a more serious TIA (Transient Ischemic Attack) often resolves itself and doesn’t seem to have a lasting effect.)

But A-Fib Patients Should Still be Concerned
Any kind of lesions in the brain are cause for concern. In the words of Dr. Vivek Reddy (Mount Sinai School of Medicine, New York), “It can’t be a good thing to have all this stuff in your brain.” What do these silent ischemic lesions mean, how do they affect us? Dr. Jonathan Steinberg (Columbia College of Physicians & Surgeons, New York) sums up, “We don’t know if some of this is reversible, or if it’s such a small volume of damage that it ultimately is negligible or has no functional impact.”

Need for Further Study 
What needs to be done is to follow patients who have had these MRI-detected lesions to see if they are affected neurologically over time, to see if these lesions do indeed resolve themselves and disappear.

Editor’s Comments: These studies, though small, seem to indicate that A-Fib patients should probably avoid ablations by Multielectrode Phased-RF catheters until these silent cerebral lesions are proven to be benign.
But what about conventional Irrigated-Tip and CryoBalloon catheters? The number of silent lesions was so small in both studies that it’s hard to make decisions based on such limited sample sizes. (One would expect the CryoBalloon catheter to produce less silent lesions. In the clinical trials, it was safer than conventional Irrigated-Tip catheters and produced less clots. See CryoBalloon Ablation Safer Than RF)
However, there is a small but real risk of stroke during a RF catheter ablation procedure even with using an irrigated tip catheter (less than 0.5%34). Stroke is less of a risk when using CryoBalloon ablation.

“Silent-embolization concerns mount for RF ablation catheter.” http://www.theheart.org/article/1260023.do

Siklódy CH, Deneke T, Hocini M, et al. Incidence of asymptomatic intracranial embolic events after pulmonary vein isolation. J Am Coll Cardiol 2011; 58: 681-688. http://www.theheart.org/article/1237547.do

Gaita F, Leclercq JF, Schumacher B, et al. Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: Comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon. J Cardiovasc Electrophysiol 2011; DOI:10.1111/j.1540-8167.2011.02050.x.

JULY 20, 2011
Dr. Edward Gerstenfeld has moved from the Un. of Pennsylvania to the Un. of California San Francisco where he will be directing the EP program and performing A-Fib ablations.

JULY 19, 2011

DRONEDARONE (BRAND NAME MULTAQ) “RISK OF SEVERE LIVER INJURY.”

The FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

If you start feeling nausea, vomiting, fever, anorexia, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching, it’s recommended you stop taking Multaq and get in touch with your doctor ASAP.
Your doctor should be testing you for “hepatic (liver) serum enzymes” especially during the first 6 months of treatment.

Editor’s Note: It’s disappointing that the FDA had to issue this risk notification about Multaq. The FDA found cases of cellular liver damage “hepatocellular liver injury.”280  We can’t help but ask if Multaq may cause long-term damage to the liver, even though it’s tolerated in the short term. How many people taking Multaq have had their liver serum enzymes tested, know what their benchmark liver serum enzymes numbers are, and keep track of any rise (not just whether they are in an acceptable range)?
Is Multaq destined to be yet another antiarrhythmic med that causes more problems/side effects than it solves? http://tinyurl.com/not6d5o

JUNE 25, 2011

WALKING THE ALPS TO PROMOTE A-FIB AWARENESS!

Michelle Straube is walking the Alps to promote A-Fib Awareness! After being in A-Fib for 30 years she was made A-Fib free in 2009. Check out her blog Into the Heart of the Alps for Atrial Fibrillation Awareness:  http://bit.ly/hHPG2f.

“We’re leaving for the first 22 days of our trek this Sunday — still so much to do, but so excited.  Just walking uphill fast is a miracle, but now I can do that and talk at the same time, or carry a 20-lb backpack and make it up without wheezing or dizziness.  Life is so good!” 

APRIL 24, 2011

FIBROSIS PREDICTS STROKE RISK

In a study from Dr. Nassir Marrouche at the Comprehensive Arrhythmia Research and management Center in Utah, Stage IV (over 35% fibrosis) patients were four times more likely to have a stroke than patients with a low level of atrial fibrosis. And the level of fibrosis didn’t always correlate with standard CHADS2 risk scores of stroke. 16.5% of patients with a CHADS2 score of 0 (low risk) and 18.5% with a score of 1 (intermediate risk) had Stage IV atrial fibrosis.
Whether you were in paroxysmal or persistent A-Fib didn’t seem to have an impact on the likelihood of stroke rate.
Women were three times more likely to have a stroke than men. The researchers hypothesized that, because men tend to get treatment for A-Fib sooner, women had more extensive remodeling and fibrosis than men, which led to a higher stroke risk.8

Editor’s Observations: MRIs to measure fibrosis in the heart should become a routine diagnostic tool for anyone in A-Fib. According to this study, the CHADS2 method of evaluating risk of stroke doesn’t work in many cases. Should we retire the CHADS2 and replace it with a more empirical, scientific method such as fibrosis measurement?
Some people have argued that there is less risk of stroke if one is in continuous A-Fib rather than paroxysmal (occasional), because one might be more at risk of a clot when the heart stops and starts beating normally. But this study indicates that whether one is paroxysmal or persistent doesn’t seem to influence the risk of stroke.
The finding that women are three times more likely to have a stroke than men should be a wake-up call for doctors (and of course for women)! If women hear from their doctor “It’s all in your mind,” or Take a valium,” it’s time to get a second opinion ASAP. An  A-Fib stroke is a fate worse than death, if you live through it. Doctors should become more aware of the increased danger A-Fib presents to women.

APRIL 14, 2011

PVA(I) IMPROVES EJECTION FRACTION

A successful Pulmonary Vein Ablation (Isolation) (PVA(I) reverses many of the remodeling effects of A-Fib. For example, enlargement of the left atrium and the ability of the atria to contract can be reversed after a successful catheter ablation.9But there is some disagreement among researchers as to whether a successful PVA(I) over time improves Ejection Fraction.10

In a study from the Bordeaux group, A-Fib patients with Congestive Heart Failure and an ejection fraction of less than 45% (normal ejection fraction range is 56%-78%), had a PVA(I). After approximately 12 months, 78% were A-Fib free without meds. They had significant improvement in left ventricular function including increases in ejection fraction of approximately 21% (as well as exercise capacity, symptoms, and quality of life). The ejection fraction also improved significantly (24%) in the control group of A-Fib patients without Congestive Heart Failure.11

Editor’s Note: It’s not all that surprising that A-Fib patients with a low ejection fraction would improve after a successful PVA(I). But the control group without Congestive Heart Failure also improved their ejection fractions. In this study a successful PVA(I) improves ejection fraction even if one has a relatively normal ejection fraction to begin with.12

APRIL 10, 2011

DABIGATRAN (PRADAXA) INDIGESTION, BURNING, STOMACH PAIN, (WEIGHT LOSS) SIDE EFFECTS

If you’ve started taking Pradaxa, watch out for indigestion, burning, stomach pain (and weight loss). These are listed as common side effects of Pradaxa. As many as 35% of people taking Pradaxa may experiences these symptoms. There is a fine line between allowing one’s body to get used to a new drug, and deciding this drug isn’t for me because of its bad side effects.
The Pradaxa Fact Sheet from Boehringer Ingelheim states under “Adverse Reaction from RE-LY” (the clinical trial of Pradaxa):

• Patients on Pradaxa 150mg had an increased incidence of gastrointestinal adverse reactions (35%/yr) compared to warfarin (24%/yr).
• The discontinuation rate due to drug-related adverse events was 21% for Pradaxa 150mg and 16% for warfarin.
“In addition to bleeding, Pradaxa can cause stomach upset or burning, and stomach pain.” (Pradaxa Fact Sheet 101910.pdf)

Editor’s Note: In the RE-LY clinical trial nearly 2 out of 5 people had gastrointestinal adverse reactions. 35% is a very high rate of adverse reactions. Pradaxa may not be the wonder drug we’ve all been hoping would replace warfarin. If it has such bad side effects, it may be damaging many more people’s stomachs over a longer period of time.

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=60264

APRIL 9, 2011

LARIAT II SUTURE DELIVERY DEVICE

Most A-Fib strokes (90-95%) come from clots which form in the Left Atrial Appendage. One strategy to prevent A-Fib stroke is to close off the Left Atrial Appendage. In most cases this is as effective as taking blood thinner medications. Though, as with blood thinners, it isn’t an absolute guarantee you will never have an A-Fib stroke.

A novel noose device to close off the Left Atrial Appendage is inserted from outside the heart (Lariat II, SentreHeart, Inc., Palo Alto, CA) (unlike for example the Watchman device which is inserted into the LAA from inside the heart).  It is used in cases where the patient can not tolerate anticoagulants like Coumadin. (The Watchman device requires a patient be on anticoagulants for a couple of months.)

From the inside of the heart a balloon is placed inside the Left Atrial Appendage to expand it and make it accessible to the noose device which is inserted from the outside of the heart. The positioning balloon is withdrawn before the Lariat noose is closed around the base of the Left Atrial Appendage. The noose completely closes off the Left Atrial Appendage which dies and is no longer electrically active. The Lariat II snare device has been approved by the FDA.

The Lariat device was invented by Dr. William E. “Billy” Cohn, Director of Minimally Invasive Surgical Technology at the Texas Heart Institute at St. Luke’s Episcopal Hospital. (Thanks to Beverly Stansfield for calling our attention to the importance of this device.)

APRIL 8, 2011
Dr. Edward Gerstenfeld from the Un. of Pennsylvania will be moving to the Un. of California San Francisco in July, 2011.


APRIL 1, 2011

HALF OF ALL A-FIB DUE TO AVOIDABLE RISK FACTORS

There are factors somewhat under our control which my influence or trigger A-Fib, such as hypertension, diabetes, obesity and smoking. One study says that half of all cases of A-Fib are due to the above cardiovascular risk factors, with hypertension the strongest predictor of A-Fib.13
(Editor’s Comment: One wonders why the study didn’t also mention binge drinking as a cause or trigger of A-Fib. That’s certainly something we have control over.)

Maintaining a healthy diet and life style may help prevent A-Fib. But don’t count on them to make you A-Fib free once you develop A-Fib. However, anything that makes you more healthy overall might influence the amount and severity of A-Fib attacks.
The study also found that African Americans have a lower risk of developing A-Fib, even though they have more risk factors for A-Fib, such as high blood pressure and obesity.14

MARCH 30, 2011

MOST BETA-BLOCKERS CAN HAVE A HARMFUL EFFECT, EXCEPT CARVEDILOL (COREG)

A new study casts doubt on the effectiveness of most beta-blockers which “undermine the structure and function of the heart…Blocking the beta-receptor alone promotes cardiac remodeling via growth of cardiac fibroblasts induced by alpha-adrenergic receptor signaling. The growth of fibroblasts in the heart further damages the integrity and function of the heart.”15

Carvedilol, however, targets both the beta- and alpha-adrenergic receptors on the heart muscle. Beta-blockers (like carvedilol) which target both receptors “offer the most benefit to cardiac patients.” A study in 2003 showed that carvedilol produced a greater survival rate than metoprolol.16(Thanks to Janet Brown for calling our attention to this research.)

Nebivolol seems to eliminate most of the common bad side effects of beta blockers by dilating blood vessels through the release of nitric oxide. But it also only blocks Beta 1 receptors. 

###

Footnote Citations    (↵ returns to text)

  1. US Food and Drug Administration. “AtriCure Synergy Ablation System – P100046” December 15, 2011.
  2. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
    ; Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  3. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  4. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  5. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  6. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  7. Borsama, L.V.A. et al. “Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST).” CIRCULATION. 111.074047 Published online before print November 14, 2011.
    http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
  8. http://www.stopafib.org/newsitem.cfm/NEWSID/317/fibrosis from atrial remodeling/atrial fibrillation stroke risk
  9. Pappone, Carlo et al. “Circumferential Pulmonary Vein Ablation for Atrial Fibrillation: the Milan Experience,” Cardiac Electrophysiology and Pacing Unit of the Department of Cardiology, San Raffaele University Hospital, Milan, Italy. 2003. p. 7. “…the term “electroanatomical remodeling” coined by us derives from the fact that circumferential PV ablation, when effective, determines a significant reduction in LA size and improvement in its transport function during follow-up.”
  10. Jeevanantham, V et al. “Meta-analysis of the effect of radiofrequency catheter ablation on left atrial size, volumes and function in patients with atrial fibrillation.” Am J Cardiol. 2010 May 1;105(9):1317-26.
    http://www.ncbi.nlm.nih.gov/pubmed/20403486?dopt+Abstract
  11. Hsu, Li-Fern et al. “Catheter Ablation for Atrial Fibrillation in Congestive Heart Failure.” N Eng J Med 2004; 351:2373-2383 December 2, 2004.
    http://www.nejm.org/doi/full/10.1056/NEJMoa041018
  12. Hsu, Li-Fern et al. “Catheter Ablation for Atrial Fibrillation in Congestive Heart Failure.” N Eng J Med 2004; 351:2373-2383 December 2, 2004.http://www.nejm.org/doi/full/10.1056/NEJMoa041018
  13. Huxley, RR et al. “Absolute and attributable risks of AF in relation to optimal and borderline risk factors. The Atherosclerosis Risk in Communities (ARIC) study.” Circulation. 2011;DOI:10.1161.
  14. Huxley, RR et al. “Absolute and attributable risks of AF in relation to optimal and borderline risk factors. The Atherosclerosis Risk in Communities (ARIC) study.” Circulation. 2011;DOI:10.1161.
  15. Gillespie, W. “Carvedilol Shown To Have Unique Characteristics Among Beta Blockers.” Circulation Research. November 23, 2009.  http://www.medicalnewstoday.com/articles/171826.php
  16. Gillespie, W. “Carvedilol Shown To Have Unique Characteristics Among Beta Blockers.” Circulation Research. November 23, 2009.  http://www.medicalnewstoday.com/articles/171826.php
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