A-Fib News
    A-Fib News items are listed by date, most recent first.
    To find an A-Fib News item by topic, go to the A-Fib News Index.

FEBRUARY 3, 2012
Stem Cells Reverse Heart Damage---(This May Work to Repair Fibrosis and Scarring in A-Fib)
    Dr. M (John Mandrola) in his excellent blog described fascinating research using stem cells to regenerate damaged heart tissue.
    Patients who had suffered a heart attack or who had advanced heart failure and heart muscle damage received infusions of stem cells grown from cells taken from a biopsy of their own heart. Dr. Robert Bolli of the University of Louisville and Dr. Piero Anversa at Brigham and Women's Hospital/Harvard Medical School took the heart stem cells harvested from patients during coronary artery bypass surgery and sent them to Boston where they were purified and allowed to grow. Once there were about 1 million of the stem cells per patient, Dr. Bolli's team in  Louisville reintroduce them into the region of the patient's heart that had been scarred by a heart attack. The purified batch  of cardiac stem cells was infused into the patient's hearts approximately 4 months after their bypass surgery, allowing time for the bypass surgery to heal.

JANUARY 31, 2012
Septum Opening Plugged? You Can Still Have a Catheter Ablation to Fix your A-Fib.
    According to conventional A-Fib practice, if someone had a closure device installed to plug a hole in the septum, then they couldn't have a catheter ablation. It would be difficult to get the catheter through the septum wall since the plug occupied part of the septum wall. The plugging device would block the trans-septal puncture needed to get to the left atrium.
    But a recent study at the Texas Cardiac Arrhythmia Center in Austin, Texas by doctors Pasquale Santangeli and Luigi Di Biase demonstrated that it is feasible and safe to do a catheter ablation on patients with a septal occlusion device (Amplatzer, CardioSEAL).
    in most cases( 35) the doctors were able to puncture the septum in an area not covered by the closure device. In four cases the doctors were able to puncture through the closure device itself using normal procedures and instruments, though this did take longer and involved more fluoroscopy time.

A-Fib Patients with a Septal Closure Device Often Need Aggressive Treatment
    The patients in this study all had A-Fib before the septum plug was installed. They all progressed to highly symptomatic A-Fib and were not helped by drugs. Over a period of at least four years 11 patients progressed to persistent A-Fib. Five with persistent A-Fib progressed  to permanent long-standing A-Fib. These patients obviously needed an aggressive treatment.  (A septum opening between the left and right atria can lead to clot formation and stroke {see Tedy Bruschi]. Closing off this septal defect helps prevent stroke and is considered to decrease the risk of developing A-Fib. But if one already has A-Fib, closing off the septal defect opening doesn't halt the progression of A-Fib.)

Catheter Ablation Successful through a Septal Closure Device
    After a mean follow-up of around 14 months, 77% were free of A-Fib and atrial tachycardia (this is a high success rate considering that 67% of the patients had persistent or long-standing persistent A-Fib which is more difficult to ablate). There were no significant differences in outcome between those who had transseptal puncture or puncture through the closure device. No patients at three and six months intervals had "interatrial shunt;" i.e., the puncture holes all closed up by themselves.
    The doctors concluded that catheter ablation in patients with the septal closure device was "feasible, safe and effective." They added, "Transseptal puncture can easily be performed in a portion of the native septum not covered by the device in the majority of patients. Direct access through the device is also feasible and safe but requires significantly longer time."

eDITOR'S COMMENTS:
    Closing a septal opening decreases the risk of stroke and possibly also of developing A-Fib. But if someone already has A-Fib, closing this septal defect doesn't halt the progression of A-Fib. These patients often need aggressive treatment such as surgery ( Cox-Maze or Mini Maze).
    If you have a closure or plug device installed in your septum, you now have another option besides surgery to fix your A-Fib. But be aware that most catheter ablation centers will still be reluctant to do a PVI in your case and will likely refer you to a surgeon. Even though PVIs in patients with  septal closure devices can be "easily performed," It may take a while for the techniques and experiences of the Texas Cardiac Arrhythmia Center to become common practice in other catheter ablation centers. Right now you may need to go to Texas or to another center with experience doing PVIs on patients with septal closure devices.
    If you have a septal closure device installed, be sure and ask the doctor(s) you are working with if they have experience in ablating patients with septal closure devices.

Santangeli, P, Di Biase, L, et al. "Transseptal access and atrial fibrillation ablation guided by intracardiac echocardiography in patients with atrial septal closure devices." Heart Rhythm. 2011 Nov;8(11):1669-75. Epub 2011 Jun 22.

http://www.ncbi.nlm.nih.gov/pubmed/21703215

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."³⁰¹ The 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 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.
    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."³⁰² "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."³⁰²

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."³⁰² (In a somewhat surprising observation, the authors concluded "efficacy tended to be a little lower in patients with such lines."³⁰²) The Left Atrial Appendage was also removed. And Ganglia areas on the outside of the heart were also ablated. (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."³⁰²
 
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."³⁰²
    "The events reported with CA seemed more transient and did not require intervention."³⁰²  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.)
    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."³⁰²

EDITOR'S COMMENTS
    Though not the fault of the study's designers and 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 relatively low 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 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."³⁰² 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. But it does raise red flags particularly about the safety, but also about the efficacy, of Mini-Maze operations. The efficacy results for catheter ablation should probably be discounted, because of the design bias of the study.

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://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm284063.htm
    

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 date 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, is nevertheless 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, plasma factor Vlla, and factor concentrates.
    Also, the degree of warfarin anticoagulation can be easily assessed, whereas no such tests exist for dabigatran.
    But the advantages of dabigatran may outweigh the chances of a traumatic accident like a car crash which may not be survivable any way. How likely are you to be in a traumatic accident? This is again a decision you need to consider with your doctor.

Wood, Shelley. "Deaths Prompt Dabigatran Safety Advisory in Japan." HeartWire, TheHeart.org. 8/17/11
http://www.theheart.org/article/1264365.do

"Dabigatran: Australia issues bleeding warning" HeartWire, TheHeart.org October 7, 2011
http://www.theheart.org/article/1291757.do

Wood, Shelley "Trauma patients on dabigatran prompt call for "pragmatic" trials, trauma surveillance." HeartWire, TheHeart.org. November 24, 2011
http://www.theheart.org/article/1317869.do

Lowes, Robert. "Warfarin tops list for emergency hospitalizations in seniors." HeartWire. TheHeart.org. November 25, 2011.
http://www.theheart.org/article/1318469.do
 
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 defense 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 http://www.theheart.org/article/1255799.do

Nainggolan, Lisa. "EMA Adds CV Events to Review of Dronedarone" HeartWire, July 12, 2011 http://www.theheart.org/article/1252319.do

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. (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 Bunch, et 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."
    (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.)

NSAID use associated with risk of atrial fibrillation or flutter

       
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

http://www.medwire-news.md/59/93424/Hypertension/NSAID_use_in_elderly_with_hypertension_linked_to_increased_cardiac_risk_.html

 
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://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm240110.htm

JUNE 25, 2011
    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!" See Michelle Straube's story.

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.²⁶⁴
    (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.⁵⁸ But there is some disagreement among researchers as to whether a successful PVA(I) over time improves Ejection Fraction.²⁵⁸
     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.²⁵⁹
    (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.)  
 ²⁵⁹ 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


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://www.drugwatch.com/pradaxa/side-effects.php

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.²⁵³ (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.²⁵³

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."²⁴⁷
    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.²⁴⁷ [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. See nebivolol.

DECEMBER 20, 2010
    FDA APPROVES CRYOBALLOON ABLATION CATHETER
    The FDA approved the first cryoablation balloon catheter for A-Fib---the Arctic Front system (Medtronic, Minneapolis, MN). This is a major medical breakthrough in treating A-Fib.  Cryoballoon ablation appears to be safer, faster and easier than RF. The cryoballoon can isolate a pulmonary vein opening in as little as one freeze (about 10 minutes per vein), while an RF ablation requires ablating one spot at a time. Also, the frozen balloon sticks to the PV opening, which keeps the catheter stable during the ablation. In one study of the clinical trial (STOP AF), there were no strokes, no pulmonary vein stenosis, no esophageal injury, and no coronary artery injury as sometimes occurs with RF ablation (RF ablations typically have a major complication rate of around 4%).
    (Added 3/7/11: Results from the North American Arctic Front STOP-AF trial did show a PV stenosis rate of 3.1% which did not show up in the European trials. This may have come from the use of a smaller 23 mm balloon which possibly penetrates too far into the Pulmonary Vein opening.²⁴² The STOP-AF trial also showed a Phrenic Nerve Palsy (paralysis, weakening) of 11.2 %. Some of these cases did not resolve within 12 months (18 %). This Phrenic Nerve damage may have come from the use of the smaller 23 mm balloon which gets closer to the Phrenic Nerve. Dr. Kuck has had good results (no PV stenosis) using only the larger 28 mm balloon.⁾²⁴²
    In the clinical trial 69.9% of patients treated with the Arctic Front Cryoballoon catheter were free from A-Fib at one year, compared to only 7.3% of patients on meds only.
    See Cryoballoon Safer than RF, CryoBalloon & RF Ablation---the future of A-Fib treatment, and Dr. Kerwin's explanation of Cryo Ablation.
    (The author predicts that Cryoballoon ablation, perhaps combined with RF, will become the treatment of choice for Pulmonary Vein Ablations.)

http://www.theheart.org/article/1166735.do?utm_campaign=newsletter&utm_medium=email&utm_source=20101222_EN_Heartwire

DECEMBER 14, 2010
    CLEVELAND CLINIC SECOND OPINION PROGRAM
    The Cleveland Clinic has developed an online consulting service that A-Fib patients can use. They will "review your individual situation (including medical records and test results), answer your questions and provide you with a comprehensive report - with treatment options or alternatives, as well as recommendations regarding your future care needs." The cost is less than $600. There is a caveat, "Availability of online medical second opinion varies by state of residence."
    (If anyone uses this service, could you please tell us what you think of it? Thanks.)
http://eclevelandclinic.org/myconsult
    (Thanks to Jerome Jacobi for calling our attention to this service.)

NOVEMBER 15, 2010
    Rivaroxaban Another Possible Replacement for Warfarin
    Rivaroxaban (brand name Xarelto by Bayer/Johnson & Johnson) tested well as a replacement for the blood thinner warfarin. Both rivaroxaban and warfarin block the action of vitamin-K dependent proteins called clotting factors, but rivaroxaban targets a specific clotting factor called Xa.
    Unlike dabigatran, rivaroxaban is reversible is cases of serious bleeds.²²³

http://www.newsroom.heart.org/index.php?s=43&item=1191

NOVEMBER 3, 2010
Dabibatran Now Available In Pharmacies
    Dabigatran (brand name Pradaxa by Boehringer Ingelheim) will be priced at a "wholesale-acquisition" cost of $6.75/day.
    According to Dr. Michael Ezekowitz, switching patients from Coumadin is relatively easy. If the INR (international normalized ratio) is 2 or less, you can switch the patient immediately to dabigatran. It only takes 30 minutes to two hours for it to become effective. Dabigatran produces a 34% reduction in stroke, a 60% reduction in intracranial bleeds, and fewer bleeds in general.
    The only patients who shouldn't take dabigatran are those with kidney problems (creatinine clearance of less than 15 which is close to needing dialysis), and patients with mechanical heart valves (not part of the original RE-LY trial).
http://www.theheart.org/article/1142899.do
    (Added November 29, 2010.) Dabigatran (brand name Pradaxa) is a direct thrombin inhibitor, a newer type of medication. Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound.
    Dabigatran is currently irreversible. In case of a serious bleed, there is no way to stop the bleed short of dialysis. It takes approximately one day for dabigatran to leave the body.²²³   
    INR tests, such as for warfarin, aren't good tests for monitoring the effectiveness of dabigatran. Doctors may use other tests such as Thrombin-Antithrombin Complex (TAT) (normal levels 0.85-3.2 microgram/l)²²¹ or Prothrombin Fragment 1+2 (normal levels 0.4-1.2 nmol/l)²²².


OCTOBER 31, 2010
Anticoagulants and Antiplatelets Don't Mix
    If someone is taking an anticoagulant like warfarin to prevent A-Fib stroke, wouldn't it be more effective to also take an antiplatelet like aspirin as well since they work differently? That doesn't seem to be the case.
    A Danish study, reported in Hans Larson's October The AFIB Report, indicates that combining anticoagulant and antiplatelet meds in the same patient is associated with a substantially higher risk of fatal or non-fatal internal bleeding. And there was no indication that combining warfarin with an antiplatelet (aspirin, clopidogrel, or both) reduced the risk of ischemic stroke.

http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Anticoagulation-Dangerous combinations" Number 103, October, 2010. p. 8.
Hansen, ML, et al. "Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation." Archives of Internal Medicine, Vol. 170, No. 16, September 13, 2010, pp. 1433-41.

OCTOBER 30, 2010
Flutter Ablation should be Combined with Left Atrium A-Fib Ablation
    Hans Larson, in his October The AFIB Report, points out that trying to cure A-Fib with only a right atrium Flutter ablation "is usually fruitless with a success rate somewhere between 5 and 10%."
    But what if someone only has Atrial Flutter and not A-Fib? Since a Flutter ablation in the right atrium is relatively simple and doesn't take much time, should an A-Fib ablation in the left atrium be done at the same time? Some Flutter may originate in the left atrium, or the Flutter may mask A-Fib which may appear later after a successful Flutter ablation? "As many as half of all patients ablated for Flutter may later develop A-Fib."
    Researchers at Ball Memorial Hospital in a small study of patients with lone right atrium flutter gave some patients a right atrium Flutter ablation only, while others received both a Flutter and an A-Fib ablation at the same time.
    After a 16-month follow-up, 87% of the group that had received both a Flutter and an A-Fib ablation were free of any arrhythmia without the use of any medication. But only 44% of the Flutter-only group were so lucky. 36% developed paroxysmal A-Fib and 20% developed persistent A-Fib. The researchers concluded that adding Pulmonary Vein Isolation ablation to Flutter ablation for lone atrial flutter provides better long-term freedom from arrhythmias than just performing a Flutter ablation by itself.
    (Editor's Comments: If someone recommends you get a Flutter-only ablation, you should probably get a second opinion. If you have A-Fib and A-Flutter, you are probably wasting your time on a right atrium Flutter-only ablation.
    If you only have documented Atrial Flutter, you should still get a second opinion. Some Flutter does originate in the left atrium, or the Flutter may mask A-Fib which can often appear later. This Ball Memorial Hospital study suggests that anyone with only Flutter would be better served by both a Flutter and an A-Fib ablation at the same time.

http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Flutter ablation may unmask AF" Number 103, October, 2010. p. 6.
Navarrete, A. et al. "Ablation of atrial fibrillation at the time of cavotricuspid isthmus ablation in patients with atrial flutter without documented atrial fibrillation derives a better long-term benefit." Journal of Cardiovascular Electrophysiology, July 19, 2010 (Epub ahead of print)
  
OCTOBER 29, 2010
    Acupuncture Helps A-Fib---Specific Acupuncture Sites Identified
    Hans Larson, in his October The AFIB Report, states that Italian researchers found acupuncture effective in preventing A-Fib in persistent A-Fib patients who had just undergone successful cardioversion.
    The acupuncture points used in the Italian clinical trial were:
    1. Neiguan (PC-6)
    2. Shenmen (HT-7)
    3. Xinshu (BL-15)
    Acupuncture at the Neiguan and Xinshu points help modulate and stabilize the autonomic nervous system. Stimulation of the Shenmen point has a calming and sedative effect on cardiac excitability. Patients received 10 weekly acupuncture sessions.
    The article also includes two stories of patients whose A-Fib was eliminated primarily by acupuncture:
    http://www.afibbers.org/resources/journeys/Craig.pdf
    http://www.afibbers.org/resources/journeys/Girskis.pdf
    (Editor's Comment: As Hans Larson points out, now that we know the exact points to be stimulated, why not use acupuncture for Paroxysmal A-Fib as well?)

http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Acupuncture: An effective antiarrhythmic?" Number 103, October, 2010. p. 5.
Lomuscio, A et al. "Efficacy of acupuncture in preventing atrial fibrillation recurrences after electrical cardioversion." Journal of Cardiovascular Electrophysiology, August 30, 2010 (Epub ahead of print)

OCTOBER 28, 2010
Vigorous Exercise and A-Fib
    Some commentators have cited recent research on vigorous exercise to say it is associated with the development of A-Fib. "Vigorous exercise increases the risk of atrial fibrillation."²¹⁸ But a close examination of the observational study used to support this statement shows that A-Fib is associated only with men under 50 years of age who jogged/ran over four miles a day 5-7 times a week. This is a level of running usually associated only with elite athletes. Other types of vigorous exercise such as cycling, swimming or racquet sports were not associated with an increased risk of A-Fib.
    Why only elite male runners under 50? The authors of this study hypothesized that several factors might explain the increased risk of A-Fib in elite male runners under 50 years old.
    - left atrial enlargement
    - left ventricular hypertrophy
    - left ventricular dilation
    - an increase in parasympathetic tone (the most commonly cited factor)
"Jogging in particular results in greater enhancement of the parasympathetic nervous system compared to other exercise types." "Heightened parasympathetic tone has been associated with A-Fib onset in patients with structurally normal hearts; and in animal and human studies, parasympathetic stimulation frequently induces and maintains A-Fib, whereas vagal denervation prevents A-Fib."
    People over 50 years old have decreased parasympathetic activity and usually exercise less vigorously as they age.
    The authors of this study recognize the benefits of vigorous exercise for most people. "Exercise has multiple beneficial effects on cardiovascular health that may lower A-Fib risk." In particular, exercise lowers blood pressure, improves lipid profile and glucose control, and decreases risk of cardiovascular disease.
    (Editor's Comments: With the exception of elite male runners under 50 who run over four  miles a day 5-7 times a week, vigorous exercise does not increase the risk of A-Fib, according to this study. Rather, vigorous exercise may lower A-Fib risk.)
Aizer, A. et al. "Relation of Vigorous Exercise to Risk of Atrial Fibrillation." The American Journal of Cardiology, Volume 103, Issue 11, Pages 1572-1577, June 1, 2009
http://www.ajconline.org/article/S0002-9149(09)00549-9/fulltext
      
OCTOBER 27, 2010
Steroids Reduce A-Fib Recurrence after an Ablation
     For A-Fib patients (as well as for EPs and Mini-Maze surgeons), the biggest frustration after an ablation or surgery is the recurrence of A-Fib. Even the most experienced A-Fib centers have unacceptably high rates of recurrence. This recurrence is often due to regrowth/re-connection of previously ablated areas (see Marchlinski "Regrowth/Reconnection of Ablated Areas"). http://www.a-fib.com/BostonA-FibSymposium2007.htm#ThirdandFourthPVIsolation/AblationProcedures
    Japanese researchers administered intravenous hydrocortisone to Paroxysmal A-Fib patients the day of their ablation, followed by oral prednisolone for three days after the ablation. (The hydrocortisone dosage was 2mg/kg which translates to approximately 750 mg for a 170 lb. person. The oral prednisolone dosage was 0.5mg/kg which translates to approximately 190 mg for a 170 lb person.)
    Within the first three days, 31% of individuals treated with a placebo had a recurrence of A-Fib, compared with only 7% of those treated with corticosteroids. Corticosteroid treatment did not decrease A-Fib recurrences between 4 and 30 days after ablation (A-Fib patients were not given corticosteroid treatment during these days). The A-Fib-free rate at 14 months post-ablation was greater in the corticosteroid group---85% versus 71% for the placebo group (a statistically significant difference [p=0.032), but not nearly as large as the first days' results).
    (Editor's Note: One wonders what would have happened if the oral prednisolone was continued for more than three days.)
    The researchers found that inflammation, highest body temperature, largest change in body temperature, maximum C-reactive-protein (CRP) levels, and change in CRP were lowest among patients with steroid therapy.
    (Editor's Note: All of the above are markers or signs of inflammation which some research links to A-Fib^.84 Steroids may work to reduce recurrence of A-Fib by lowering inflammation after a procedure. Steroid therapy, by reducing inflammation, may be a safe and effective method of reducing recurrence of A-Fib after an ablation. Steroid therapy after ablation may be a medical breakthrough in the treatment of A-Fib..
    Even though this study is small (125 patients) and limited, A-Fib patients undergoing ablation and/or Mini-Maze surgery should receive steroid therapy, unless counter indicated. The steroid therapy should probably be continued for more than three days. Steroid therapy certainly seems to reduce the recurrence rate of A-Fib after ablation.)
(Thanks to David Holzman to calling our attention to this article.)

http://www.theheart.org/article/1139047.do
Koyama, T. et al. "Prevention of Atrial Fibrillation Recurrence With Corticosteroids After Radiofrequency Catheter Ablation."  Journal of the American College of Cardiology, 2010; 56:1463-1472.
    
OCTOBER 26, 2010

Increased PR Interval a Red Flag for developing A-Fib

        In the well-known Framingham Heart Study, people who had PR Intervals longer than 200 ms had twice the risk of developing A-Fib (as well as three times the risk of requiring a pacemaker and a 40% increased risk of death from all causes).

    ("PR Interval" is the time it takes for an electrical signal to spread from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). A PR Interval of less than 200 microseconds (ms) is considered normal. A prolonged or increased PR Interval is known as "first-degree atrioventricular block (AVB)" when the PR interval exceeds 200 ms.)

    (Editor's Note: A prolonged PR Interval may be a sign or marker for fibrosis, scarring, or other heart conduction problems that may lead to A-Fib. A routine EKG would show whether you have a prolonged PR Interval. If so, your doctor should  check you periodically to make sure you aren't developing any progressive conduction block.)

http://www.theheart.org/article/981659.do

Cheng S. et al. "Long-term outcomes in individuals with prolonged PR interval or first-degree atrioventricular block." JAMA 2009;301:2571-2577.

OCTOBER 26, 2010
Pot May Lead To or Trigger A-Fib

    This year voters in California will vote to legalize and tax cannabis (pot) which is already approved for medical use. Pot is widely used in the US and internationally.

    In this article from Israel where pot is the most widely used illegal drug, the author observed that a 20-year-old male admitted to the hospital for A-Fib had no other apparent pathological cause of his A-Fib except "cannabis abuse." He recommends that young people admitted to the hospital for A-Fib be tested for cannabis abuse, and be counseled to stop cannabis drug abuse.

    "Cannabis abuse is responsible for a wide range of pathologies, including atrial and ventricular arrhythmias, cognitive impairment, a rise in the prevalence of lung, head, and neck tumors, and an increase in the risk of ischemic cardiovascular events (strokes). Cannabis abuse can induce A-Fib in predisposed patients."

    (Editor's Note: Please be advised that this is an observational study based on the author's experience and observations, rather than a clinical study of cannabis. Also, the term "cannabis abuse" is not defined. How much cannabis use would be considered "abuse?" Would any use of cannabis be considered "abuse?"

    In spite of the above reservations, this article may be an important warning, particularly for young people. If you use pot and develop A-Fib [whatever your age], you may need to cut your use or stop using pot all together.

    Research Question: Are there types of pot less likely to trigger A-Fib?)

      HAREFUAH. 2005 Jan; 144(1):2-3,72.

    Cited in http://www.raysahelian.com/atrialfibrillation.html

OCTOBER 26, 2010
Watchman Device Encouraging Results

    The original clinical trial for the Watchman device (PROTECT AF) was completed in 2009. However, doctors in the trial continue to insert the Watchman device and follow up on patients who have received it.

    In new studies and updates, procedure time to insert the Watchman device was reduced, implant success was greater, and the proportion of patients who discontinued warfarin at 45 days was significantly increased. Device safety improved. Major bleeds, pericardial effusion, and device embolization dropped from a hazard ratio of 2.85 to 1.57. According to a study to be published by Dr. Vivek Reddy (Mount Sinai Medical Center), pericardial effusions for the most part occurred very early on, and rates tend to go down with more operator experience.

    Dr. Joseph Rodes-Cabau (Quebec Heart and Lung Institute) called the results "really encouraging." He was particularly impressed by the reduction in ischemic strokes. "Most of the ischemic strokes in the device group occurred in the first 7 days." The rate of ischemic stroke over follow-up was "pretty low...The concept seems to be right---that thrombus (clot) formation in the left atrium is mostly in the Left Atrial Appendage, and that closing it will significantly reduce ischemic stroke."

    An FDA advisory panel approved the Watchman device in a close 7-5 vote (PROTECT AF trial presented April, 2009). But the FDA has mandated a new trial of the Watchman device dubbed PREVAIL that will randomize 475 patients 2:1. In order to address several of the concerns raised during the advisory panel hearing, the trial will focus on enrolling patients with a CHADS2 score of 2 or higher or CHADS2 1 patients with existing heart disease. The last follow-up visit will be in September 2013, with the data to be submitted to the FDA one month later.

    One problem not addressed in current US trials is whether the Watchman device can be used in patients who can not tolerate warfarin at all. (In the original PROTECT AF study, patients who received the Watchman device also took warfarin for several weeks.) There is a higher risk of thrombus (clotting) in the first week after device implementation. A current study in Europe gives patients six months of Clopidogrel plus aspirin instead of warfarin. Though this study is ongoing, so far out of 64 patients there has been one serious pericardial effusion and no strokes or transient ischemic attacks.

    A surgical device for LAA occlusion, known as the AtriClip, has been FDA approved. It is usually used during a Mini-Maze or other heart operation rather than as a stand-alone operation. (Surgical devices tend to be more readily approved by the FDA than catheter devices.)

    (Editor's Note: The Watchman device is considered a low risk procedure with an even lower risk than a typical catheter ablation, since there is no ablation involved.
    "Pericardial effusion" refers to blood leaking from the heart into the pericardium, the sac surrounding the heart. This may occur when the Watchman device is inserted into the Left Atrial Appendage, and is less likely to happen with operator experience.
    "Device embolism" refers to clots that form on or are possibly stirred up by inserting the Watchman device. (There is a similar risk during catheter ablations.) However. after seven days this risk is eliminated. To prevent device embolisms, anticoagulants are administered during and after the Watchman is inserted. In the Editor's opinion, the payoff of a 90-95% reduction in A-Fib strokes certainly justifies the small risk of a device embolism.

    The Watchman device not only reduces the risk of an ischemic stroke, but also the risk of a hemorrhagic stroke by reducing or eliminating the need to take warfarin or other anticoagulants.

    Though the FDA won't approve the Watchman device till 2013, it is still available for most people in the US at selected sites.  See http://www.a-fib.com/Facilities.htm#DOCTORSINSTALLINGTHEWATCHMANDEVICE)

http://www.theheart.org/article/1124905.do

OCTOBER 19, 2010
    FDA Approves Dabigatran!  
 The FDA has approved dabigatran! A-Fib patients now have an alternative to warfarin (Coumadin)! See Dabigatran to Replace Warfarin. http://www.theheart.org/article/1138703.do

SEPTEMBER 20, 2010
    FDA Advisory Panel Unanimously Approves Dabigatran
    An FDA advisory panel unanimously recommended approval of the anticoagulant dabigatran---an oral thrombin inhibitor (brand name Pradaxa by Boehringer Ingelheim). The 18,000 patient RE-LY trial (Randomized Evaluation of Long-Term Anticoagulant Therapy) showed low dose dabigatran was as good as warfarin, while the high dose was better at preventing stroke and systemic embolism. It doesn't require anticoagulant monitoring or major diet changes.
    (Author's Note: Warfarin is one of the most widely used and effective anticoagulants. But it's also one of the most disliked. Dabigatran's recommended approval is a major medical breakthrough and most welcome news for A-Fib patients who will no longer have to cope with measuring INR levels, worrying about diet, vitamin K deficiency, side effects, etc. It's also welcome news for doctors who won't have to wrestle with keeping patients at the right INR levels. They will have an oral anticoagulant that is very effective, has fewer side effects, and can be administered to a broader range of patients.
    Upon FDA approval [almost assured] will dabigatran (and/or ticagrelor) replace warfarin? Probably not right away. A-Fib patients doing well on warfarin and maintaining their INR between 2-3, might be advised not to switch. Dabigatran (and ticagrelor) do not use INR to measure their anticoagulant effectiveness. This can be somewhat disconcerting to A-Fib patients who measure their INR and know they are being protected from an A-Fib stroke.
    Doctors would risk malpractice suites if they would switch someone from warfarin and that person had a stroke. [A small number of people on warfarin at the proper INR levels do still have strokes. Warfarin reduces but doesn't totally eliminate the threat of an A-Fib stroke.] These new anticoagulants are very effective, but they are not full proof and most likely will not totally eliminate the threat of an A-Fib stroke.)
http://www.theheart.org/article/1123797.do
   
SEPTEMBER 18, 2010
    FDA Advisory Panel Approves the Blood Thinner Ticagrelor
    An FDA advisory panel recommended the approval of the antiplatelet drug ticagrelor (brand name Brilinta by AstraZeneca). (Clinical trial PLATO---Platelet Inhibition and Patient Outcomes.) Ticagrelor reduced the rate of MI (heart attack), stroke, and cardiovascular death compared with Plavix (clopidogrel).  
http://www.theheart.org/article/1106859.do
       
September 15, 2010
    Calcium Supplements Danger
    Calcium supplements (at least 500mg/day) without vitamin D were associated with a 30% increase in heart attacks. (Vitamin D is necessary for calcium absorption.)
    This increase in heart attacks may occur because "calcium supplements speed vascular calcification and...increase cardiovascular events and MI (Myocardial Infarction---heart attacks) in women." Dr. Ian Reid in an article in Bottom Line Health adds, "Calcium from supplements, including antacids such as Tums and Rolaids, elevates blood calcium quickly, which may contribute to artery disease." Whereas "calcium in foods is absorbed slowly."²¹⁷
    However, an article in Bottom Line Health points out that the researchers in this study did not analyze what happens when calcium is taken with Vitamin D. The study excluded people who were taking vitamin D. But according to Dr. John Schindler "Vitamin D is protective from a cardiovascular standpoint."²¹⁵
    The Bottom Line Health article somewhat disputes the calcium danger findings. "The majority of existing studies have shown no link between calcium supplements and heart attack risk," and further suggests that eating calcium-rich foods is a safe way for most people to boost their intake of calcium.²¹⁶    
    (Author's Note: Calcium supplements may also trigger or make the heart more susceptible to A-Fib attacks. See WARNING: DANGER OF TOO MUCH CALCIUM !.)
    http://theheart.org/article/1108009.do

SEPTEMBER 3, 2010
    Anticoagulant (Coumadin) can be Stopped 3-6 Months after a Pulmonary Vein Ablation (Isolation)
    In a study of 3,355 patients who had a successful PVI, some stopped taking anticoagulants after 3-6 months, while the second group kept on taking anticoagulants. Only two of the 3-6 month group and three of the second group had an ischemic stroke. Whereas 13 (2%) of the second group had a major hemorrhagic stroke.
    (Author's Note: From this study there doesn't seem to be a need or benefit for anticoagulation for more than 3-6 months after a successful PVI.) "The risk/benefit ratio favored the suspension of oral anticoagulants after successful A-Fib ablation even in cases of patients at moderate-high risk of TE (thromboembolic events---strokes)."
    Themistoclakis S. et al. "The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation." J Am Coll Cardiol. 2010 Feb 23;55(8):735-43.
    http://www.ncbi.nlm.nih.gov/pubmed/20170810?dopt=Abstract
 
SEPTEMBER 2, 2010
    A-Fib Patients at Risk of Dementia
    In a study of 37,025 aging patients, 27% developed A-Fib, and 4.1% of these developed dementia during the five year follow-up. A-Fib was significantly associated with all types of dementia, particularly in the younger group (under 70 years of age). And dementia combined with A-Fib put patients at a high risk of death.
    (Author's Note: Treatment strategies to keep people in A-Fib while controlling the heart rate (rate control meds) may lead to dementia and early death.)
 
Bunch TJ, et al. "Atrial fibrillation is independently associated with senile, vascular, and Alzheimer's dementia." Heart Rhythm. 2010 Apr;7(4):433-7. Epub 2009 Dec 11.
http://www.ncbi.nlm.nih.gov/pubmed/20122875?dopt=Abstract

AUGUST 31, 2010
    Magnesium Importance for A-Fib

      In a letter to the editor of BMJ (British Medical Journal) Drs. Dietch, Wilson and Thomas point out that magnesium is important in regulating the electrical activity of the heart and can help cases of acute A-Fib. "Treatment with magnesium may correct rhythm disturbances in patients with both low and normal magnesium concentrations." Magnesium is "superior to amiodarone in treating atrial tachycardias in critically ill patients."

     "It is our impression that magnesium is underused; should we not use it more widely?"

     (Author's Note: Magnesium is a naturally occurring element that we should be getting from the food we eat. However, almost everyone today is magnesium deficient, due to the lack of magnesium and other trace elements in today's over-farmed soil (some magnesium can be obtained from fish). Because it is a naturally occurring element, magnesium is considered safe to take in normal doses. "Magnesium is a relatively safe drug." It is certainly safer than amiodarone or other antiarrhythmic meds.

     In addition to cases of acute A-Fib, all A-Fib patients may want to discuss with their doctor whether magnesium supplements might help their A-Fib.)

http://www.bmj.com/cgi/content/full/312/7038/1101/b

BMJ Letters "Magnesium is underused in acute atrial fibrillation." 1996;312:1101 (27 April)

AUGUST 29, 2010
    Effects of a Successful Catheter Ablation
    In an analysis of 17 different studies enrolling 869 patients, a successful catheter ablation significantly decreased (improved) left atrial diameter and volume, but had no significant difference in ejection fraction and actual emptying fraction.
    (Author's Note: It's certainly reason for hope for A-Fib patients, that a successful A-Fib ablation will not only stop but reverse some of the remodeling effects of A-Fib.
    If before an ablation one's ejection fraction is low, one would expect an improvement over time as the heart becomes stronger. But for someone with a normal ejection fraction before ablation, there may not be much of an improvement. "Ejection Fraction" just measures what the ventricle does with the blood it receives, not whether it receives more or less blood from the left atrium.)

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
 
AUGUST 29, 2010
    Carotid Sinus Stimulus or Massage by manual pressure for A-Flutter/A-Fib
    Carotid Sinus Stimulation or Massage is a technique used by doctors to partially block or slow down the flow of blood through the carotid sinus. It is used to tell the difference between different types of arrhythmias, and "rarely, may also terminate the arrhythmias and reestablish sinus rhythm." It is used in patients "in whom a rapid decrease in heart rate is desirable."
    Dr. Nayab Ali describes why carotid sinus massage may work. "Vagal Stimulation, by altering the atrial refractory period, may break the circus movement, atrial reentry, and atrial response to ectopic focus, thus allowing the sinus node to take over control."²¹²
Nayab Ali, "Conversion of Atrial Flutter to sinus rhythm by carotid sinus pressure." Journal of the National Medical Association, Vol. 74, NO. 8, 1982.
   
    WARNING: Carotid Sinus Stimulus or Massage should be done only by doctors and not by individual patients on themselves.
   
AUGUST 28, 2010
    "Radioactivity in Low Doses is Good for Us."
    In 1983 180 apartment building were built in Taiwan. But somehow highly radioactive Cobalt-60 was mixed into the concrete. The 10,000 people who lived in these apartments for 9-20 years received an average of 74 millisieverts (mSv) of radiation a year (a typical catheter ablation using fluoroscopy produces around 15 mSv¹⁷⁶---non-x-ray imaging systems much less).
    But cancer rates of people living in these highly radioactive buildings were 3.6% of prevailing Taiwanese rates. This is a reduction in cancer rates of 96.4%. This phenomena is perhaps explained by the theory of hormesis which holds that intermediate levels of radioactivity actually stimulate life and improve health.
http://www.jpands.org/vol9no1/chen.pdf
http://www.ecolo.org/documents/documents_in_english/taiwan-cobalt-60-apartmt-04.htm
New Scientist, "Radiation thresholds." October 30, 2004
    (Author's Note: The nuclear theory that any level of radiation is cumulatively damaging may not be valid [the "Linear No Threshold [LNT}" theory.] The levels of radiation received during a typical catheter ablation may not be dangerous, but may even be healthful.)

AUGUST 28, 2010
    CryoBalloon & RF Ablation---the future of A-Fib treatment
    CryoBalloon ablation is safe and effective in Pulmonary Vein Isolation, but is limited in treating persistent A-Fib (because it only isolates the pulmonary veins and not other parts of the heart). Doctors at Mass General used a combined CryoBalloon and RF ablation to treat patients with persistent A-Fib.
    (Added December 20, 2010: The FDA approves the CryoBalloon Catheter.)
    First a PVI was done using the CryoBalloon catheter. It took approximately 10 minutes to isolate each vein (a considerable savings in time compared to a typical RF ablation). 6% of patients required additional RF ablations to completely isolate the pulmonary veins.
    Then an RF catheter was used to ablate complex fractionated electrograms (CFAEs). Finally linear ablations were performed with the RF catheter to terminate the persistent A-Fib.
    After a single procedure 86.4% of patients were A-Fib free without antiarrhythmic drugs (a high success rate for persistent A-Fib after only one procedure).
    (Author's Note: The above study only dealt with cases of persistent A-Fib. But this combination of CryoBalloon {or possibly Laser Balloon] and RF will probably become the standard treatment for all cases of A-Fib.
    Because the CryoBalloon is safe, effective, and fast, it will probably become the normal method of isolating the pulmonary vein openings. If A-Fib remains after the CryoBalloon ablation, then RF can be used to ablate other areas of the heart that produce A-Fib signals. This combination of CryoBalloon and RF ablation is a major medical breakthrough in the treatment of A-Fib.) 
Heart Rhythm. 2010 Apr;7(4):452-8. Epub 2009 Dec 24
http://www.ncbi.nlm.nih.gov/pubmed/20188229?dopt=Abstract
    
AUGUST 27, 2010
    Bypass Surgery and A-Fib
    It is estimated that one out of three bypass surgery patients will suffer at least one episode of A-Fib after surgery. 40% of these will have more than one A-Fib attack.
     Beta-blockers and ACE inhibitors, as well as potassium and non-steroidal anti-inflammatory drugs (NSAIDS) appear to reduce the risk of developing A-Fib after bypass surgery.
    The risk factors most associated with developing A-Fib after bypass surgery are:
        - Advancing age,
        - Past history of A-Fib,
        - Chronic obstructive pulmonary disease,
        - The discontinuation of beta-blockers and ACE inhibitors after bypass surgery.
(It was assumed that patients were too sick after surgery to continue to take beta-blockers or ACE inhibitors. But according to this study, "the discontinuation of beta-blockers and ACE inhibitors would be unwise, and their use appears to be protective.")

    (Author's Note: It wasn't clear whether this study included antiarrhythmic drugs. The author questions whether administering antiarrhythmic meds after bypass surgery [similar to what is often done after an A-Fib ablation] might prevent the development of A-Fib after bypass surgery.)
http://www.scienceblog.com/community/older/2004/3/20042692.shtml   
       
AUGUST 26, 2010
    Fibrosis in A-Fib: Chicken or the Egg?
    In a study indirectly related to A-Fib, it was found that fibrosis leads to or is the cause of the development of cardiomyopathy, rather than being caused by or a result of the disease. (People with cardiomyopathy often have A-Fib as well.) According to Dr. Carolyn Y Ho of Brigham and Women's Hospital in Boston, MA, "...the development of fibrosis might play a role in actually driving the development of the disease, rather than being a reaction to the development of overt disease."
http://www.theheart.org/article/1109291.do
    (Author's Note: Since fibrosis also occurs in A-Fib, strategies to prevent fibrosis or to identify factors such as genetics, diet, life style, chemical/biological markers, etc. which influence the development of fibrosis may help prevent the future development of A-Fib. "...targeting fibrosis...may help to forestall the development of clinical disease."²⁰⁹)

AUGUST 18, 2010
    Five-Box Thorascopic (Mini-)Maze Surgery 
    Dr. John Sirak of the Ohio State University has developed a type of Mini-Maze surgery for A-Fib---the "Five-Box Thorascopic Maze Surgery" or Total Thorascopic Maze (TTM) which, according to his web site, has a "cure rate in excess of 95%." (Author's Note: This Mini-Maze surgery may be an alternative to the full Cox (Radial) Maze surgery for A-Fib.)
http://www.ohioafib.com/maze-surgery/
    (Added 9/25/10: See Sirak et al. "The Five-Box Thoracoscopic Maze Procedure" Ann Thorac Surg 2010;90:986-989. http://ats.ctsnetjournals.org/cgi/content/full/90/3/986. It is not explained in the study what happened to the missing patients. 48 started, 36 made the 3-month interval, while only 4 completed the 13-month interval.)

AUGUST 9, 2010
    Chicago Cubs Pitcher Carlos Silva has Catheter Ablation  
    Chicago Cubs pitcher Carlos Silva had a catheter ablation procedure to correct a problem with his heart rate (paroxysmal supraventricular tachycardia). Dr. Bradley Knight performed the two-hour procedure at Northwestern Memorial Hospital. He is expected to begin light physical activity in a week, and start a throwing program early the next week.
    Silva had the same procedure as former Cubs player Mark DeRosa, now with the Giants. DeRosa had the heart work done during spring training 2008 and was able to play in 149 games that season. http://www.washingtonexaminer.com/breaking/cubs-silva-undergoes-heart-procedure-100310124.html

August 8, 2010
    40% Recurrence/Reconnection in Mini-Maze Surgery  
    In a study of 50 patients who underwent Mini-Maze surgery, 40% had recurrences of arrhythmias during the healing process, in a follow-up study of 12 months. PV reconnection accounted for most recurrences. Most patients' A-Fib was terminated by catheter ablation, often combined with antiarrhythmic and rate control meds.²⁰⁸ (Catheter Ablation procedures also have significant recurrence rates.)
    (Author's Note: This article may be very important to A-Fib doctors and researchers, because it identifies specific areas of the heart where re-growth/recurrence is likely to occur. "The relative thickness of human myocardium, particularly in areas with endocardial ridges, as well as the presence of blood flow, may explain the discrepant results between patient outcomes..."
    Catheter ablation does follow the contours and ridges of the heart. Can the catheter be programmed to produce deeper burns in areas of greater heart thickness like endocardial ridges? This might be a solution to a very troublesome problem for both A-Fib doctors and patients.)
    The author questions whether other energy sources like Cryo or Laser might help both surgery and catheter ablation overcome this problem of re-growth/re-connection after surgery and ablation for A-Fib.)

JUNE 18, 2010
    FDA Approves AtriClip to Close Off Left Atrial Appendage
    The AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip is made by AtriCure, Inc. (West Chester, OH). The surgeon positions the rectangular-shaped device around the LAA. The frame assembly of the device consists of two springs connecting two opposing tubes which are covered with pressure pads. The springs close the device like a clamp, leaving behind a Woven Dacon Fabric which eventually becomes part of the heart.  Blood no longer flows into and out of the Left Atrial Appendage.
    The FDA approved the AtriClip on the basis of one trial with 70 patients. It was determined to be "substantially equivalent" to other devices such as staplers and sutures already FDA approved.^291,292   

MAY 22, 2010
Vernakalant Successful in Stopping A-Fib
    For A-Fib patients with underlying heart disease, the intravenous med Vernakalant converted 51.7% of A-Fib patients to sinus rhythm after only around 11 minutes. It was shown to be safe, well tolerated, and associated with greater improvements in quality of life (the AVRO trial). An FDA advisory panel voted in favor of vernakalant, but the FDA still has not approved it in the US.¹⁸³ http://www.theheart.org/article/1079027.do 
    (Vernakalant is a medical breakthrough for A-Fib patients with structural heart disease who cannot use other antiarrhythmic drugs, if the FDA approves it.)
   
MAY 21, 2010
Ablation of A-Fib Reduces Risk of Alzheimer's and Dementia
    In a large population study (37,908) at the Intermountain Medical Center in Utah, some patients with A-Fib received catheter ablation treatment, while others received drug therapy. After three years of follow-up, the rate of Alzheimer's disease and all forms of dementia was significantly lower among patients who underwent catheter ablation. According to Dr. John Day, "In fact, the rates we saw were similar to those that you'd see in patients who never had A-Fib to begin with." Catheter ablation also reduced the risk of mortality and stroke at three years.^182*
    (Catheter ablation may reduce Alzheimer's and dementia:
    1. By improving and/or normalizing blood flow to the brain.
    2. By reducing inflammation. There may also be an inflammatory connection, "with both A-Fib and Alzheimer's disease associated with high levels of C-reactive protein."
    3. By reducing and eliminating TIAs and subclinical strokes caused by A-Fib. These mini-strokes produce amyloid plaque found in Alzheimer's disease patients.)
    Catheter ablation reduces the risk of mortality and stroke, and reduces the risk of Alzheimer's and dementia. Then why leave A-Fib patients on medications? As Dr. Day suggested, "...if you have A-Fib and medication isn't working, maybe we should move toward a potentially curative procedure earlier, rather than spinning our wheels for years with medication."¹⁸¹ http://www.theheart.org/article/1079365.do
     *The title of reference ¹⁸² is confusing. I have written the author for a clarification.  
   
MAY 17, 2010
High Dose Steroids May Cause A-Fib
    In a case-control study in the Netherlands involving 7,983 men and women, high-dose corticosteroid use significantly increased the risk of developing A-Fib. (Corticosteroids include meds such as prednisone, cortisone, hydrocortisone, budesonide, betamethasone, dexamethasone, Advair. High-dose refers to a daily dose greater than 7.5 mg of prednisone equivalents.)
    But it's dangerous to suddenly stop taking steroids. Sudden withdrawal can lead to serious side effects and, in some cases, be life threatening.¹⁸⁰ http://www.theheart.org/article/696423.do
 
May 15, 2010
Dr. Andrea Natale Joins Scripps
    Dr. Andrea Natale has been named the Director of Interventional Electrophysiology at Scripps Clinic in La Jolla, CA (April 5, 2010). Here is his address info:
Scripps Clinic
10666 N. Torrey Pines Rd SW 206
La Jolla, CA 92037
(858) 554-5049
    Dr. Andrea Natale, Director of Interventional Electrophysiology
    Dr. Douglas N. Gibson (858) 554-8730
Dr. Natale is also available to help A-Fib patients in other areas of the US: see
    ---Austin, Texas Dr. Natale is the Executive Director of the Texas Cardiac Arrhythmia Institute
    ---Akron, Ohio Akron General Medical Center
    ---Cleveland, Ohio MetroHealth Medical Center
    ---San Francisco, CA Northern California Heart Center
 
APRIL 15, 2010
Women with A-Fib Have Higher Risk of Stroke
    Women with A-Fib had a higher stroke risk, more stroke-related disability, and were less often prescribed blood thinners, according to researchers analyzing past A-Fib studies comparing how A-Fib affects men and women. Doctors may be more reluctant to prescribe warfarin (Coumadin) to women, because some evidence shows that women have a significantly higher risk of bleeding from blood-thinning medication.¹⁷⁷
    (If you are a women with A-Fib, make sure you consult with your doctor about the risk-benefit of taking blood thinners. An A-Fib stroke is often a fate worse than death. See Anticoagulants.)

december 22, 2009
Catheter Ablation Survey Good Results 
    The latest worldwide survey of A-Fib ablations includes data on 20,825 catheter ablation procedures performed on 16,309 patients over a four-year period from 2003 to 2006 (some patients had more than one ablation). This is almost twice the number of patients treated compared to the first survey from 1995 to 2002.
    The success rate was 70% (A-Fib symptom-free without having to take antiarrhythmic drugs), which was a major improvement over the 52% reported in the first survey. The "overall success rate"---defined as freedom from A-Fib with or without the use of antiarrhythmic drugs---was similar in both surveys, at 80%.
    More patients with persistent and long-lasting A-Fib were treated than in the previous survey. Of the 1,108 patients with long-standing A-Fib, the success rate was 63.1%, while the overall success rate was 72.3%.
    The overall complication rate was 4.5%, down slightly from the previous survey. But Transient Ischemic Attacks were cut in half, and Pulmonary Vein Stenosis was reduced by two thirds. (Pulmonary Vein Ablation is a relatively new procedure. More experience, improved techniques and equipment, and the sharing of knowledge have definitely improved the outlook for A-Fib patients.)
    There were 25 procedure-related deaths and 37 strokes, similar to the previous survey. Atypical Atrial Flutter doubled. Atrioesophageal Fistula, not reported previously, occurred in 0.04% of patients, of whom 71% died. (The author is not sure about these figures. 0.04% of 16,309 is only around 7 patients.) (Atrioesophageal Fistula is less of a problem today. Most centers now take precautions to prevent Atrioesophageal Fistula.)
http://www.theheart.org/article/1035905.do

Author's Conclusions
    Limitations of the survey
        85 electrophysiology centers in North America, Europe, Asia, and Australia provided data for this survey. But in the US alone there are currently around 200 centers performing A-Fib ablations. The 85 centers providing data may be the most experienced, larger centers. Are the newer, smaller centers achieving similar success and complication rates? We simply don't know. (From the author's limited experience, the newer, smaller practices seem to be achieving similar success and complication rates, at least in the US.)
    Insufficient doctors and medical centers for A-Fib
       Though 16,000+ patients seems like a huge number, it's very small compared to the number of people developing A-Fib. Though there has been a tremendous growth in medical centers and doctors doing A-Fib ablations, they can not possibly handle all the cases of A-Fib which some are calling an epidemic.¹¹⁴ Nearly three million people in the U.S. have A-Fib. By the year 2050, the number will be 5.6 million.⁷¹ In the US people over 40 have a one in four chance of developing A-Fib.⁸² A-Fib needs to become a national and worldwide health issue.
    Remarkable progress in a short time
        A-Fib patients should be encouraged by the remarkable progress doctors have made in A-Fib catheter ablation within a relatively short period of time. The first Pulmonary Vein Ablation was done a little more than a decade ago. A worldwide improvement from 52% to 70% success rate is a notable achievement and a testament to the hard work of A-Fib doctors everywhere.)
   
december 19, 2009
Warfarin to be Taken for Two Months after a PVA(I), but Aspirin Option for Low Risk
    Following a Pulmonary Vein Ablation procedure, patients should be given warfarin for at least 2 months regardless of their stroke risk factors (HRS/EHRA/ECAS AF Ablation Consensus Statement).¹²⁵ But a recent study found that "low-risk patients with a low CHADS2 (0-1) score... can safely be discharged on aspirin alone."¹⁷¹ (Thanks to William Pfeifer for calling our attention to this research.)
    (Author's Note: For safety's sake [and to avoid legal liability problems], your doctor will probably still want you to be on warfarin after an ablation.) 

december 7, 2009
Fibrosis Measured by MRI
Recent research indicates that A-Fib Fibrosis can be measured by an MRI.^{169, 170}

november 23, 2009
Medifocus Free Abstracts of Latest A-Fib Journal Articles
Medifocus provides a listing of the latest medical journal articles published in MEDLINE, with direct links to the specific article summaries (abstracts). To subscribe to the free Medifocus Digest Alert on Atrial Fibrillation, click on this link: http://www.medifocus.com/zcr004.php?assoc=afib

NOVEMBER 19, 2009
Dabigatran to Replace Warfarin (Coumadin)
    The above title is presumptuous, because the FDA hasn't yet approved the oral anticoagulant dabigatran. But the recent RE-LY trial comparing dabigatran etexilate (by Boehringer Ingelheim) to warfarin at 951 centers in 44 countries with 18,113 A-Fib patients produced results that are hard to ignore. Low dose dabigatran was as good as warfarin, while the high dose was better at preventing stroke and systemic embolism.
    To paraphrase the lead investigator Dr. Wallentin, dabigatran does not need frequent blood-test monitoring for INR levels, isn't affected by possible food-drug or drug-drug interactions, can be used in many more patients than warfarin, has few side effects, and is more effective and safer than warfarin.
    (The author predicts that dabigatran will be approved by the FDA and will quickly replace warfarin as a treatment to prevent A-Fib stroke. [It is already approved in the European Union and Canada.]} This is a major medical breakthrough and most welcome news for A-Fib patients who will no longer have to cope with measuring INR levels, worrying about diet, vitamin K deficiency, side effects, etc. It's also welcome news for doctors who won't have to wrestle with keeping patients at the right INR levels. They will have an oral anticoagulant that is very effective, has fewer side effects, and can be administered to a broader range of patients.
http://www.theheart.org/article/1024935.do (Thanks to Ira David Levin for calling our attention to this article.)
   

NOVEMBER 17, 2009
Rhythm (Antiarrhythmic) Meds Better Than Rate Control
     In a study of 5604 patients with A-Fib who were treated with either antiarrhythmic or rate control meds, "81% of patients treated with rhythm control, compared with 33% of patients in the rate-control arm were in sinus rhythm, after one year... 13% progressed to permanent A-Fib in the rhythm-control arm, whereas 54% in the rate-control arm had permanent A-Fib after one year." This finding disagrees with the AFFIRM trial which indicated there was no advantage of rhythm control vs. rate control for the prevention of cardiovascular events.
    Author's Note: Though the study found no significant difference in clinical outcomes, from this patient's perspective it's certainly better to have a normally beating heart than to be in A-Fib---from a clinical as well as from a quality of life aspect. If the study were longer than one year, one would expect to see more heart problems develop in those still in A-Fib. And why isn't progressing to permanent A-Fib not considered a clinical outcome? Anyone who suffers from A-Fib dreads and fears going into permanent A-Fib.
    A disturbing point mentioned in passing in this study is the high percentage of patients (54%) in the rate-control arm who progressed to permanent A-Fib within one year! This should be a wake-up call to all A-Fib patients. If you don't aggressively try to stop your A-Fib (as with antiarrhythmic meds or a Pulmonary Vein Ablation. etc.), you can expect your A-Fib to become permanent within one year (54% chance).
    This RECORD AF Registry data was presented at the American Heart Association 2009 Scientific Sessions by Dr. John Camm. http://www.theheart.org/article/1023939.do (Thanks to Ira David Levin for calling our attention to this article.)

OCTOBER 1, 2009
    Dr. Wharton Audio Presentation on A-Fib Ablation
Dr. j. Marcus Wharton of the Medical Un. of South Carolina has a very informative 18 minute audio presentation on A-Fib Ablation http://www.muschealth.com/multimedia/Podcasts/displayPod.aspx?podid=252&autostart=true

August 14, 2009
A-Fib Support Volunteers Started
  We are very excited about starting a new way of helping people with A-Fib. Many people who've had A-Fib have generously committed to serve as A-Fib Support Volunteers, to help people cope with and be cured of A-Fib. They've listed their Email addresses and are there for anyone who needs advice, emotional support, and hope in getting through the A-Fib ordeal.

JULY 30, 2009
Dronedarone (brand name Multaq) Now Available in Pharmacies 
Dronedarone (brand name Multaq) is now available in pharmacies in the U.S. http://www.reuters.com/article/rbssHealthcareNews/idUSLS59493520090728

JULY 2, 2009
Dronedarone (Multaq) Approved by FDA
Dronedarone (brand name Multaq by Sanofi-Aventis) was approved by the FDA. This is a major medical breakthrough for many A-Fib patients. See Dronedarone. http://www.theheart.org/article/983519.do.
      But there is a caveat. "Dronedarone is not indicated in patients with severe heart failure or those with NYHA (New York Heart Association) class 2 or 3 heart failure with a recent decompensation requiring hospitalization." (Class 2 refers to patients with slight, mild limitation of activity, class 3 refers to patients with marked limitation of activity. "Decompensation" refers to rapid accumulation of fluid in the lungs due to heart problems.) "The ANDROMEDA trial showed that dronedarone increased the risk of mortality twofold among those treated by the drug." This is a major difference from amiodarone which dronedarone is similar to but with less toxic effects. Amiodarone is considered safer for patients with structural heart disease, while dronedarone is not indicated for patients with severe heart failure.

June 20, 2009
RF & CryoBalloon Produce Parallel Double Vein Lesions to Reduce Recurrence 
Dr. Richard Schilling of the London AF Center is doing preliminary research to help eliminate regrowth/reconnection of ablated areas in a Pulmonary Vein Ablation and the recurrence of A-Fib after ablation.
    He uses both RF (Radio Frequency burns) and Cryo (Freezing) ablation. He first performs a wide encirclement RF ablation of the left atrium pulmonary vein ostia. Then he supplements this with Cryo balloon ablation, which tends to freeze the veins a little bit closer to the origins of the veins. In effect he produces two parallel lines of electrical block, which reduces the chances of recovery of electrical connection between the pulmonary veins and the left atrium. This reduces the recurrence of A-Fib after ablation.
    Though this procedure has only been performed in 15 patients with reasonable follow-up, he has seen a dramatic improvement in the first time success rate for ablation of paroxysmal A-Fib. This technique is now being tested in a randomized control trial to see if the additional cost of using two technologies (RF and Cryo) is justified by a significant improvement in first time success rates.
    (Editor's Note: Dr. Shilling's innovative technique of using both RF and Cryo balloon may be a major medical breakthrough for A-Fib patients. Eliminating regrowth/reconnection and the recurrence of A-Fib after ablation may significantly reduce the need for a second ablation and improve the success rate of Pulmonary Vein Ablations.)

JUNE 9, 2009
A-Fib Patients at Greater Risk of Developing Alzheimer's 
Researchers have made a medical breakthrough connection showing a strong relationship between A-Fib and the development of Alzheimer's. This finding was presented at the May 15, 2009 Heart Rhythm Society Scientific Sessions.
    In the Intermountain Heart Collaborative Study in Murray, UT 37,025 people were followed for five years:
        1. Patients with A-Fib were 44 percent more likely to develop dementia than others.
        2. Younger patients with A-Fib were at a higher risk of developing all types of dementia, particularly Alzheimer's. A-Fib patients under age 70 were 130% more likely to develop Alzheimer's.
        3. Patients who had both A-Fib and dementia were 61 percent more likely to die during the study than dementia patients without A-Fib.
        4. Younger A-Fib patients with dementia may be at higher risk of death than older A-Fib patients with dementia.
    Alzheimer's is the most common form of dementia (a general term for life-altering loss of memory and other cognitive abilities), and accounts for 60-80 percent of all dementia cases today. Today Alzheimer's is the sixth leading cause of death in the US.
    "Previous studies have shown that patients with A-Fib are at higher risk for some types of dementia, including vascular dementia. But to our knowledge, this is the first large-population study to clearly show that having A-Fib puts patients at greater risk for developing Alzheimer's," according to Dr. T. Jared Bunch, the study's lead researcher.¹⁵⁴
    (Editor's Note: The study only states there is a strong connection or relationship between A-Fib and Alzheimer's, because there may be other factors influencing both the development of A-Fib and Alzheimer's. But as A-Fib patients we have to assume until proven otherwise, that A-Fib causes or leads to Alzheimer's and dementia. This conclusion makes intuitive sense. In A-Fib, blood is not being pumped properly to the brain and other organs.
    Another conclusion to be drawn from this study is: therapies which leave patients in A-Fib while controlling the ventricular rate should be avoided (rate control meds like Metoprolol or Digoxin), because they may lead to Alzheimer's and dementia.)
   
   
May 22, 2009
Dr. Reddy to Mount Sinai
Dr. Vivek Y. Reddy will join the Mount Sinai Medical Center July 1, 2009. He previously was affiliated with the Un. of Miami, Miller School of Medicine.¹⁵¹  Dr. Andre d'Avila and Dr. Srinivas R. Dukkipati will also transfer to Mount Sinai in December. (Thanks to contributor Ray for this info.)
    Their address will be:
Cardiac Electrophysiology Laboratories
1468 Madison Av. @ 100th. St.
New York, NY 10029
(212) 241-7911

MAY 11, 2009
Coffee and Caffeine May Not Trigger A-Fib and May Be Antiarrhythmic 
Some research suggests that coffee and caffeine in moderate to heavy doses may be antiarrhythmic and may reduce propensity and inducibility of A-Fib both in normal hearts and in those with focal forms of A-Fib.¹⁴³

MAY 8, 2009
Predicting A-Fib Using ECGs(EKGs) 
    (For people with occasional or silent A-Fib, it is sometimes difficult to get an ECG or documentation of the A-Fib. By the time one gets to the Doctor's office or the ER, the A-Fib attack has stopped. It may now be possible to predict A-Fib simply by examining an ECG of the heart in sinus rhythm. Doctors can predict A-Fib by looking at the P wave which is formed when the atria contract. See EKG Signal.)
    The measures used to predict A-Fib are: "P-wave terminal force, P-wave duration, P-wave area, and PR duration."¹³⁹ For example, a P-wave duration of greater than 140 milliseconds is predictive of A-Fib.¹³⁸
     The study found that African Americans "seem to have more of these ECG predictors than whites, which might explain why they are at higher risk of ischemic stroke than whites, despite apparently having a lower prevalence of A-Fib." They may have intermittent or silent A-Fib which is not always detected.¹³⁹
    (Editor's Notes: The authors of the above study did not draw the following conclusions.
    Why not use the above A-Fib predictors to develop a nation-wide program to screen for A-Fib? For example, anyone over 50 could be screened by a Cardiologist looking at the patient's ECG. Anyone with A-Fib predictors, even though in sinus rhythm, could be given a Holter or other monitoring system to document if the patient has A-Fib. The A-Fib, even though it may be asymptomatic ("silent"), could then be treated. This would save many people from an A-Fib stroke or deteriorating heart health due to progressive A-Fib.)
   
    
MAY 5, 2009
FDA Advisory Panel Approves Watchman Device
An FDA advisory panel on April 24, 2009 approved the Watchman device (Atritech, Plymouth, MN) with conditions: centers implanting the device must have surgical backup, and a physician certification program must be created. The panel also recommended the creation of a registry, and extended follow-up of current trials. The FDA usually follows its advisory panel's recommendations.
     Though the vote was split 7-5, "most panel members felt the sponsor showed the device to be effective." Some panel members were uncomfortable with the size of the 800-patient study, the duration of follow-up (two or three years) and the long-term safety of the device. Some felt a decision on effectiveness was difficult when there were so few strokes in either arm. (Six patients in the control Warfarin arm had a hemorrhagic stroke, four of whom died. No one died who received the Watchman device.)
    The PROTECT-AF study on which the FDA advisory panel based its approval was a prospective randomized trial comparing closure of the Left Atrial Appendage by the Watchman occluder with long-term warfarin therapy (90% of strokes come from the Left Atrial Appendage). This was a "noninferiority" study---"the Watchman device was associated with a reduction in hemorrhagic stroke risk vs. warfarin, and all-cause stroke and all-cause mortality outcomes were noninferior to warfarin."
    Of the patients receiving the Watchman device, 87% were able to stop taking warfarin after day 45. By 12 months, 93% were off warfarin permanently.
    There were problems such as pericardial effusion in the first implantings of the Watchman device. But these decreased with experience and improved devices, training, and procedural modifications. According to Dr. David R. Holmes, Jr., current effusion rates are now around 1% and "are going to be much more what we will see as the device rolls out." Dr. Gary Abrams added, "I think that once the early morbidity from this gets worked out as people get experience with it, I think it offers an option for people who need to stay on warfarin for many, many years." http://www.theheart.org/article/962955/print.do and http://www.theheart.org/article/951777.do
    Editors Comments: This advisory panel's approval of the Watchman device is a major medical breakthrough for A-Fib patients.
     It is estimated that only 50% of patients who need anticoagulation protection are receiving warfarin, because it's so hard to get the right dosage or because people can't tolerate it. But most A-Fib patients can receive the Watchman device. Dr. Holmes speculated that the Watchman device might be an option for up to 70% of patients with nonvalvular A-Fib.  
    Most of the panel were of the opinion that warfarin can have "devastating" effects over time. Dr. Jeffrey Brinker said, "the risk of Coumadin is high, especially in an older population who fall or who are more fragile," and who are more at risk of a hemorrhagic stroke. The Watchman device is a most welcome alternative to warfarin/Coumadin and other blood thinners.
    Practical Consequences of the FDA Advisory Panel's Approval:
    Coumadin reduces but does not totally eliminate the risk of stroke. Even with the proper INR levels of Coumadin, a small number of people with A-Fib have had strokes. The Watchman device also reduces but does not totally eliminate the risk of stroke. Like Coumadin, the Watchman is not an absolute guarantee one will never have a stroke. It basically reduces the risk of stroke similar to that of a person with a normal heart.
     Those of us who hate having to take Coumadin or other blood thinners will be able to go in for a low risk procedure that takes as little as 20 minutes, and never have to take Coumadin again! This is incredibly good news for many of us. 
    Even while we are waiting for or trying to decide on having a Pulmonary Vein Ablation, we can have the Watchman inserted and then not have to worry about an A-Fib stroke.
    The Watchman device may become part of most catheter ablation procedures. If the catheter ablation procedure were unsuccessful or in case of silent A-Fib attacks after ablation, we patients would still be protected from an A-Fib stroke by the closing off of the Left Atrial Appendage.

march 28, 2009
Digoxin May Harm A-Fib Patients
The AFIB REPORT by Hans Larson has the following caution about digoxin. "Recent research has clearly shown that digoxin should not be used on a continuous basis in patients with paroxysmal lone A-Fib, since it is likely to worsen their condition and result in it eventually becoming permanent.^{" No References Cited)} And, "Digoxin poisoning is a leading cause of hospital admissions with anywhere between 10 and 30% of patients on the drug being hospitalized for digoxin intoxication."^{(No References Cited)131}

March 21, 2009
Dronedarone Approved by FDA Advisory Committee 
Dronedarone (brand name Multaq) was recommended for approval by an FDA advisory committee (March 18, 2009). It isn't guaranteed that the FDA will approve dronedarone, but it usually doesn't disagree with its committee's recommendations.
    (This is a major medical breakthrough for A-Fib-ers, especially for older patients, for those who can't have a Pulmonary Vein Ablation or a Mini-Maze surgery, or for those who have failed these procedures/surgeries. Dronedarone may allow many of these A-Fib-ers to lead a relatively A-Fib free life.
    Dronedarone is similar to amiodarone which is considered the most effective anti-arrhythmic drug, but without its toxic side effects. In the ATHENA clinical trial, Multaq (by Sanofi-aventis) was the only anti-arrhythmic drug "to have shown a significant reduction in morbidity and mortality in patients with A-Fib/A-Flutter..." ) http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/03-18-2009/0004991096&EDATE
     
March 4, 2009 WorldOne research is an independent market research organization based in London. We would like to invite patients with ATRIAL FIBRILLATION for a 15-20minutes research study. This can be completed via telephone or online.
    The Study aims at gaining an understanding of the following areas:

• Satisfaction with the treatment for Atrial Fibrillation.
•  Sources patients utilise in finding information on Atrial Fibrillation related topics.
• Their experiences with their condition.
      In appreciation of a patient’s time and contribution we would like to offer  a honorarium of $25 on completion of the study.
      We would like to remind you that the results of the study are for analytical purposes only and patients confidentiality will be strictly maintained. Our research is treated in accordance with Esomar and MRS Code of Conduct.
      Should you require further clarification,  please contact me or my colleague Dino Lista at World One Research on: +44 (0) 207 252 1118 (ext: 1140), or drop me an email to: anthony.menkiti@w1-research.com.

February 16, 2009
A-Fib.com Receives HONcode Certification
A-Fib.com complies with the HONcode standard of trustworthy health information on the internet. (The Health on the Net Foundation in Switzerland tries to guide lay users and medical professionals to reliable sources of health-care information online. This HONcode accreditation indicates that A-Fib.com has been deemed a reliable source of health information and meets standards, including those related to the qualification of the authorities cited, privacy of personal data submitted by a visitor to A-Fib.com, and financial disclosure of funding sources. It does not guarantee that all the health information on A-Fib.com is infallible.)

February 15, 2009
Ablation Frontiers' Multi Electrode Catheters Positive Preliminary Tests
Preliminary tests results of Ablation Frontiers' multi electrode catheters is very positive, with an 83% success rate for Paroxysmal A-Fib patients. See http://download.journals.elsevierhealth.com/pdfs/journals/1547-5271/PIIS1547527108008679.pdf

February 14, 2009
Insertable Cardiac Monitor by Medtronic Detects A-Fib Signals
Medtronic has developed an insertable cardiac monitor to detect A-Fib signals. The Reveal XT is placed just under the skin of the chest in a short outpatient procedure. It captures an electrogram (ECG) during an actual A-Fib episode. To store the ECG the patient places a hand-held, pager-sized assistant over the Reveal XT and presses a button. Later, a physician analyzes the stored information, transmitted via the Medtronic CareLink Network or during an in-office patient visit. For further info, go to http://www.medtronic.com.

February 10, 2009
FDA Approves First Ablation Catheter for A-Fib
The FDA approved the first ablation catheters for the treatment of A-Fib. The two radiofrequency catheters, the NaviStar ThermoCool and EZ Steer ThermoCool Nav (BioSense Webster), were approved February 6, 2009. http://www.theheart.org/article/939929.dohttp://www.theheart.org/
article/939929.do See also: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01953.html

November 25, 2008
FDA Advisory Panel Unanimously Approves First A-Fib Ablation Catheter 
An FDA panel unanimously recommended approval of an A-Fib Ablation Catheter, the first to be so recommended. (Up to this point doctors had been using ablation catheters off-label.) http://www.theheart.org/viewArticle.do?primary Key=923617
     (As a consequence of this FDA panel decision, Pulmonary Vein Ablation (Isolation) procedures have officially entered mainstream medicine and can no longer be considered "experimental.")

August 11, 2008
Death of Dr. Carolyn Kimme-Smith
A-Fib-ers in Southern California were sadden to learn of the death of Dr. Carolyn Kimme-Smith who hosted and supported the local A-Fib support Group in her Newport Beach home.
    Dr. Kimme-Smith was a breast cancer survivor who tirelessly devoted her time and energy to many issues, primarily focused on early detection of breast cancer. She had a distinguished career as a full Professor at UCLA's School of Medicine, Dept. of Radiological Sciences.
    Her husband Hal and her three children hosted a memorial celebration of her life August 9 which filled their home. We all learned a great deal about this wonderful woman who touched so many lives.

August 4, 2008
Osteoporosis Drug Alendronate (Fosamax) Linked to A-Fib
The osteoporosis drug alendronate (brand name Fosamax) is linked to A-Fib. Women who have used alendronate at any time in their lives have an 86% greater risk of developing A-Fib than women who have not used the drug.¹²⁸

July 17, 2008
Nebivolol (Bystolic) New Beta Blocker Approved by FDA
The FDA recently approved the new beta blocker drug nebivolol (brand name Bystolic by Forest/Mylan, a selective beta-1-blocker).¹²⁶This is a minor medical breakthrough for A-Fib-ers taking traditional beta blockers like atenolol or metoprolol who may feel tired or fatigued due to slower blood flow. (Traditional beta blockers reduce the effect of excitement and physical exercise on heart rate and force of heart contraction.) Nebivolol is an effective beta blocker that also produces vasodilation (an expansion of the blood vessels) and reduces peripheral resistance by increasing nitric-oxide release. Instead of slowing blood flow, nebivolol maintains blood flow and lowers vascular resistance.
    Nebivolol is similar to the newer beta blocker carvedilol (Coreg), though they act differently. (Carvedilol is a non-cardioselective beta 1, beta 2 and alpha-receptor blocker, whereas nebivolol is highly cardioselective [blocking beta 1 receptors only] and produces vasodilation by nitric-oxide release.) 

June 30, 2008
Procanbid No Longer Available
The anitarrhythmic drug Procanbid will no longer be available for A-Fib patients. There doesn't seem to be any generic substitute. King Pharmaceuticals, Inc. which makes Procanbid issued this statement about its decision. It was "based upon many factors, including our understanding of current medical therapy and the general availability of alternative antiarrhythmics."

June 28, 2008
CryoBalloon Ablation Safer Than RF
"Cryoablation (with the CryoCath Arctic Front cryoballoon): Safer than RF..." Dr. Burghard Schumacher of Germany described a study involving 346 patients with Paroxysmal (293) or Persistent (53) A-Fib. Following one Cryoballoon ablation, 74% of Paroxysmal patients were free of A-Fib and in permanent sinus rhythm. But this figure was much lower for those with persistent A-Fib---just 38%. There were no strokes, no pulmonary vein stenosis, no esophageal injury, and no coronary artery injury as sometimes occurs with RF ablation (RF ablations typically have a major complication rate of around 4%). The main complication reported was a temporary palsy of the phrenic nerve.
    According to Dr. Philippe Ritter, president of Cardiostim, "Cryoablation (with the Cryoballoon catheter) appears to have a lower complication rate than RF ablation and is easier to perform...but we need some more years to look at it and compare it with RF ablation." (See: http://www.theheart.org/article/877315.do)
    (Editor's Comments: A 74% cure rate for the CryoCath balloon catheter is similar to current cure rates for RF ablations for Paroxysmal A-Fib. The low 38% cure rate for Persistent A-Fib might be due to only having one ablation. Most RF ablation procedures for Persistent A-Fib now require two or more ablations. [See: 95% Success Rate in Curing Persistent A-Fib.] Also, in this study only the Pulmonary Vein openings were treated with the CryoCath balloon catheter. They did not attempt any other lines or lesions as is commonly done with current RF ablations for Persistent A-Fib. Persistent A-Fib is more complex and difficult to cure. As doctors get more experienced with Cryo, they may well be able to achieve similar success rates as RF for Persistent A-Fib.
    In the future we may see centers first use Cryoballoon catheters to isolate the Pulmonary Veins because it is safer, easier, and uses less fluoroscopic exposure; and secondly use RF or non-balloon Cryo catheters for linear lesions and to target other areas of the heart in more complex cases of Persistent A-Fib. Cryo will probably also be used to ablate near the esophagus to prevent Atrial-Esophageal Fistula [see Morady: Boston A-Fib Symposium 2008].
    Cryoballoon catheter ablation may also be the answer to the problem of re-do's. [See Dr. Marchlinski's presentation on Ablation re-do's.] All too often RF ablation patients have to return for a second ablation, because of re-growth and reconduction of the RF ablated areas, and because PV isolation with RF is difficult to achieve in a uniform fashion, even with experienced operators. Circumferential ablation with small-tipped catheters often results in gaps in the lesions lines and uneven scar formation. The Cryo balloon catheter ablation may solve the problem of  re-do's, because of its ability to easily and quickly produce uniform pulmonary vein isolation. [See: Dr. Kerwin's explanation of Cryo Ablation.])

June 27, 2008
Dronedarone Safe in ATHENA Clinical Trials
"Dronedarone safety, efficacy standings bolstered in huge A-Fib trial." Dronedarone (brand name Multaq by Sanofi-Aventis) is a drug in clinical trials to replace amiodarone which often has serious toxic side effects. Both drugs have similar molecular structures and seem to work in a similar way. But dronedarone (a benzofuran analog of amiodarone) doesn't have the iodine component that is largely responsible for amiodarone' s toxic effects on the lungs, thyroid, eyes and other organs.
    In the randomized ATHENA trial over 4,500 A-Fib patients in 37 countries took either dronedarone or a placebo in "the largest antiarrhythmic drug trial ever conducted." Patients who took dronedarone experienced a 24% drop in risk of Cardiovascular (CV) hospitalizations or death over almost two years. Unlike other antiarrhythmic drugs, dronedarone seems to carry a low risk of adverse events. Secondary clinical end points also improved, such as less hospital admissions for A-Fib and acute coronary syndromes. According to Dr. Bramah N. Singh of UCLA, "...in terms of safety, it (dronedarone) is the best drug we have for atrial fibrillation." See http://www.theheart.org/article/867591.do.
    The trial did not compare the efficacy of dronedarone to amiodarone, which is the subject of another ongoing randomized clinical trial called DIONYSUS.
     

June 16, 2008 A new advancement in mapping techniques may significantly improve ablation treatments. A specialized multielectrode mapping catheter with a 20-pole penta-array produces rapid, high-density atrial mapping.  The whole atrium can be mapped in less than 8 minutes. It is used with an Ensite NavX mapping system.  See: http://circep.ahajournals.org/cgi/content/abstract/1/1/14 (Thanks to Dick Inglis for calling our attention to this article.)

June 8, 2008 Preliminary results very positive for Chronic A-Fib Clinical Trials. See: http://ablationfrontiers.com/webdocuments/
poster-heart-rhythm-society-2008.pdf

April 9, 2008 (Good news for A-Fib patients with Chronic [constant] A-Fib.)  
Multi Electrode Catheter for Chronic A-Fib Clinical Trials Begin
    The first clinical trials focusing on ablation of Chronic A-Fib have begun in the US. The study, known as the Tailored Treatment of Permanent Atrial Fibrillation (TTOP AF) is sponsored by Ablation Frontiers (http://www.AblationFrontiers.com). It uses three innovative catheters with multiple electrodes to produce a variety of different ablations depending on the needs of the patient. Preliminary data show an 80% success rate after two ablations with relatively short ablation times. The purpose of this study is to make effective ablation for Chronic A-Fib available and feasible to all EPs in all clinics. 25 centers will be participating in these Chronic A-Fib trials. For a more detailed, technical description of this study, go to http://www.ablationfrontiers.com/webdocuments/acc-poster-march-20-2008.pdf.
    Patients will be randomly selected into two treatment groups: for every three patients who apply, two will receive ablation therapy, the third drug treatments. The trial allows patients in the control (drug treatment) arm to receive an ablation if they do not respond to drug therapy (a likely occurrence).
    (This may be a major medical breakthrough for patients with Chronic A-Fib. In the past, medical centers were often reluctant to ablate patients with Chronic A-Fib, because they were more difficult to cure. Some centers, for example, had rules excluding patients who had Chronic A-Fib for more than one year. But with the progress of these Chronic A-Fib clinical trials, most centers will be able to ablate Chronic A-Fib patients with a success rate similar to Paroxysmal (occasional) A-Fib patients.)
    If you wish to participate in this Chronic A-Fib clinical trial, a full listing of Medical Centers, Locations, Doctors, and Contact Information is available at TTOPAFTrialsContacts.

December 20, 2007
Vice-President Dick Cheney Successfully Electrical Cardioverted from A-Fib
Vice-President Dick Cheney was diagnosed with A-Fib and successfully Electrical Cardioverted back to normal sinus rhythm at George Washington University Hospital November 27, 2007.¹¹³

October 19, 2007 The A-Fib community is shocked to learn that the Cleveland Clinic did not renew Dr. Andrea Natale's contract. There is no word yet where Dr. Natale will work, or where A-Fib patients can be treated by him. For more information see http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/119131405528890.xml&coll=2 . You can leave messages for Dr. Natale at his E-mail address andreanatalemd(at)gmail(dot) com.

September 1, 2007 Dr. Peng-Sheng Chen is moving from Cedars-Sinai in Los Angeles to become the new director of the Krannert Institute of Cardiology at Indiana University.

August 19, 2007
FDA Approves Genetic Testing Labeling for Warfarin (Coumadin)
    The FDA's new labeling for Coumadin will explain that people's genetic makeup may influence how they respond to the drug. In the Precautions section, "Periodic determination of PT/INR is essential. (See DOSAGE AND ADMINISTRATION: Laboratory control.) Numerous factors, alone or in combination including changes in diet, medications, botanicals, and genetic variations in the CYP2C9 and VKORC1 enzymes (see CLINICAL PHARMACOLOGY, Pharmacogenomics) may influence the response of the patient to warfarin."¹⁰⁵
    Genetic variants of the CYP2C9 and VKORC1 genes are individually responsible for anywhere from 35% to 50% of the variable dose response to warfarin, FDA officials say. But the agency stopped short of requiring physicians to use the test: there are no adequate clinical trials proving that genetic testing improves warfarin's safety profile; testing is also not universally available. The CYP2C9 gene is involved in drug metabolism such that certain variations permit the drug to remain active in the blood for longer. The VKORC1 gene represents the site of action of warfarin such that gene variants could affect patient sensitivity to the drug.
    The FDA estimates that 2 million persons start taking warfarin (the generic of Coumadin) in the U.S. every year to prevent blood clots, heart attacks and stroke. Warfarin is the second most common drug--after insulin--implicated in emergency room visits for adverse drug events.
    The FDA's "personalized medicine" initiative may further the study and application of pharmacogenomics---the science that predicts a response to drugs based upon a person's genetic makeup. Healthcare providers may use genetic tests to improve their estimate of what is a reasonable warfarin dose for individual patients. Warfarin is only the second drug in which specific pharmacogenetic details have been used in the label relating to drug dosing. However, this is the first time a widely used agent like warfarin has included these types of genetic details.
    (Author's Note: If your doctor puts you on warfarin (Coumadin) and does not test you for the above gene variations, you should probably get a second opinion. The tests cost between $125 and $500 and are fairly widely available. These tests could save you heart problems related to under- or over-dosing of warfarin.)
(See http://www.sciencedaily.com/releases/2007/
08/070817113120.htm) (Thanks to Larry Kushman for calling our attention to this article.)

July 18, 2007
Bordeaux Five-Step Ablation Protocol for Chronic A-Fib
The French Bordeaux group now uses a five-step process to treat Chronic A-Fib.
    1. They start by isolating the Pulmonary Vein openings. They also eliminate potentials at the base of the Left Atrial Appendage, but do not isolate or electrically disconnect the whole of the LAA which could possibly lead to clots forming in the LAA and A-Fib stroke. (Ablating at the base of the LAA as part of the first step in treating A-Fib is a new approach and may become a very important first step in the ablation treatment of A-Fib.)

    2. Next they make a roof line linear ablation linking the Right Superior Pulmonary Vein with the Left Superior Pulmonary vein opening to create complete electrical block

3. They then work in the Inferior Left Atrium and the Coronary Sinus. They make an incomplete blocking line between the Right Inferior and Left Inferior PVs in order to slow down the rapid atrial electrical activity.

They treat the Coronary Sinus as though it were another heart structure or Left Atrium, rather than just another vein opening. They disconnect the CS from the Left Atrium and ablate potentials along the Mitral Annulus. They also slow down Coronary Sinus electrical activity by ablating both inside and outside the CS with a lower wattage power, usually 25 Watts. (Treating the Coronary Sinus as another Left Atrium is a new approach. Most current A-Fib ablation procedures tend to stay away from the Coronary Sinus because of the risk of Stenosis (swelling). The French Bordeaux group, by using a low wattage, irrigated tip catheter, ablates within the Coronary Sinus without damaging it.)

4. The fourth step is eliminating organized atrial activity in areas such as:

Anterior Left Atrium & Left Atrial Appendage

Septum

Posterior Left Atrium

Superior Vena Cava

Right Atrial Septum

5. The fifth step is to create a Mitral Isthmus blocking linear ablation line from the Mitral Annulus to the Left Inferior PV. The goal is to eliminate all potentials along this line.

In practice, even after these five steps, rapid atrial activity often remains. It has to be mapped, traced to its source and ablated. Often the top of the Left Atrial Appendage has to be ablated.

This whole procedure requires a great deal more time, effort, persistence, skill and experience than normal left ablation procedures. (Author’s note: Please be advised that this five-step process for treating Chronic A-Fib is relatively new and isn’t available today at most A-Fib medical centers.)

June 20, 2007
President George Bush may have Chronic A-Fib
An interesting article from the Houston Independent Media Center suggests that President George Bush may have Chronic A-Fib http://houston.indymedia.org/news/2004/
12/35839_comment.php#45166.
 

June 1, 2007
Warfarin Bests Aspirin for Stroke Prevention in Elderly A-Fib Patients
    Results of the Birmingham Atrial Fibrillation Treatment of the Aged trial show that even among A-Fib patients older than 75 years, warfarin was superior to aspirin for primary stroke prevention without a significant increase in hemorrhage risk. (16th European Stroke Conference.) [31 May]
 

May 25, 2007
LOCAL A-FIB SUPPORT GROUPS FORMING.
    Are you interested in forming or participating in a local A-Fib support group? Our goals would be to share our experiences with A-Fib, get advice, learn about new developments, and form friendships with others who understand what A-Fib is like. Those who have been cured of A-Fib are also encouraged to join (and perhaps volunteer to mentor a new A-Fib-er). We'd meet for informal lunch or dinner, or an evening mixer with a speaker.
    We are trying to set up the first local A-Fib support group in the greater Los Angeles/ Southern California area. If you are interested in participating in this local A-Fib support group or in forming an A-Fib support group where you live, contact Joyce at jarintime(at)yahoo.com (the @ is written as "at" to prevent access by spam mailing lists).

May 25, 2007
A-Fib Decreases Mental Abilities
    Men with A-Fib had lower levels of cognitive performance compared to men in normal sinus rhythm in the Framingham Offspring Study. This may be due to the reduced cardiac output and decreased blood flow to the brain in persons with A-Fib. Multiple cognitive abilities were tested over a wide age range (37-89 years).
     "...A-Fib may be one of a number of risk factors for conversion from mild cognitive deficit to dementia."⁹⁸ In a previous study persons with chronic A-Fib had a 3-fold risk of cognitive deficit compared with persons in normal sinus rhythm.⁹⁹
    There were too few women with A-Fib for analysis in this study. However, in a previous study women with A-Fib had a higher prevalence of dementia and cognitive impairment.¹⁰⁰ (Thanks to Darrel Seife for calling our attention to this study.)
    (Author's Note: This is an important study, especially for those in Chronic A-Fib. The option of simply staying in A-Fib while controlling the rate and taking blood thinners to prevent stroke may no longer be acceptable, because of the risk of mental impairment and dementia from A-Fib.)

May 13, 2007
Cox Maze Operation for Patients with Chronic A-Fib
    People with Chronic long-standing A-Fib and large left atria were generally thought not to benefit from a Maze operation. This Cox maze operation, which also utilizes supplemental RF ablation, cuts out sections of the atria to reduce atrial size and improve ejection fraction.⁹⁷

May 6, 2007
First Ablation Using Visually Guided Endoscopic Catheter by Dr. Shephal Doshi
Dr. Shephal Doshi of St. John's Health Center in Santa Monica, CA performed what may be the first visually guided catheter ablation for A-Fib, using  the investigational "Visually Guided Endoscopic Ablation System." A steerable catheter with fiber optics and a transparent dome at the end works as a video camera using infrared signals to see through the blood in the heart  The system was developed by CardioFocus, Inc. of Marlborough, MA. For more info call (508) 658-7200 or visit http://www.cardiofocus.com.⁹⁶ For a list of the 20 medical centers participating in the clinical trials of this system, go to: http://www.cardiofocus.com/afib_trial_enable.htm

April 26, 2007 Additional centers participating in the CryoCath balloon catheter trials are: Bay Heart Group, Iowa Heart Center, Massachusetts General Hospital, Mayo Clinic, Virginia Commonwealth Medical Center Baylor Heart and Vascular Hospital, Arrhythmia Associates/Inova Research Center, Stanford Hospital, Quebec Heart Institute/Laval Hospital. See Cryo Cath balloon catheter trials.

April 16, 2007 The University of Chicago Hospitals announces new developments in their treatment of A-Fib. Joining their staff are: Drs. John F. Beshai, Martin Burke, Bradley P. Knight, and Al Lin.

March 21, 2007 A gentleman from India with A-Fib needs financial help in getting a Pulmonary Vein Ablation (Isolation) procedure. If you have the financial means to help him (or if you have any contacts in India), his E-mail address is: alexander_john123@yahoo.com. 

February 8, 2007 The A-Fib ablation doctors formerly associated with Riverside Methodist Hospital/MidOhio Cardiology have moved to the Ohio State University. Their new address is:
The Ohio State University
DHLRI, Suite 200
473 W. 12^th Avenue
Columbus, OH 43210-1252
(877) 478-2478
    Dr. Emile G. Daoud, Dr. Ralph S. Augostini, Dr. John D. Hummel, Dr. Steven J. Kalbfleisch, Dr. Raul Weiss

January 19, 2007
Cryo Balloon Catheter Ablation Trials to Begin
     Dr. Walter Kerwin of Cedars-Sinai Medical Center in Los Angeles and Dr. Christopher Cole of Colorado Springs Cardiologists will begin clinical randomized FDA trials of the Arctic Front-TM balloon CryoAblation catheter made by CryoCath Technologies Inc. Patients receiving Cryo (freezing) balloon ablation will be compared to patients taking antiarrhythmic drug therapy (Sotalol, Rhythmol or Flecainide).
    For every three patients, two will be randomly assigned to receive a CryoCath balloon ablation, while the third will take drug therapy (a 2:1 randomized ratio). After 90 days, patients in the drug therapy group who are still in A-Fib (a likely occurrence) can cross over and receive a CryoCath balloon ablation. Patients will be followed carefully during a one year follow-up.
    (To this author, Cryo ablation seems to be significantly safer for patients than standard RF ablation. However, Cryo ablations currently take more time to perform than RF ablations. The Cryo balloon catheter will likely allow a doctor to perform a Cryo ablation and isolation of the Pulmonary Vein openings more easily and much faster than current methods. The Cryo balloon catheter may become a major improvement in the treatment of A-Fib. It has already been approved in Europe, with close to 100% success rate in isolating the PVs, and 75-80% success in keeping patients free of A-Fib without anti-arrhythmic drugs.)
    The trial will be covered by most good insurance policies that provide for clinical research participation. Patients will not be paid or separately charged by the clinical trial for participation. If you're interested in participating in this Cryo balloon catheter ablation trial for A-Fib, here is the contact info:
Cedars-Sinai Medical Center
8631 W. 3rd. St., Suite 1017-E
Los Angeles, CA 90048
(310)-289-5901
    Dr. Walter Kerwin
Colorado Springs Cardiologists
2222 N. Nevada Ave., Ste 4007
Colorado Springs, CO 80907
(719) 634-6671
    Dr. Christopher Cole
   
The Ohio State University
DHLRI, Suite 200
473 W. 12^th Avenue
Columbus, OH 43210-1252
(877) 478-2478
    Dr. Emile G. Daoud, Dr. Ralph S. Augostini, Dr. John D. Hummel, Dr. Steven J. Kalbfleisch, Dr. Raul Weiss
    (There will be twenty different centers in the US participating in these cryo balloon ablation randomized trials. That info will be published here as it becomes available.)
    (Added April 26, 2007: Other centers participating in the CryoCath balloon trials are: Bay Heart Group, Iowa Heart Center, Massachusetts General Hospital, Mayo Clinic, Virginia Commonwealth Medical Center, Baylor Heart and Vascular Hospital, Arrhythmia Associates/Inova Research Center, Stanford Hospital, Quebec Heart Institute/Laval Hospital.)

November 1, 2006
Stereotaxis Starts Computerized Magnetic Ablation Niobe R System
Stereotaxis announces Initial U.S. Clinical Usages of Cardiac Ablation Catheter with Company's Niobe R) System. The Niobe system utilizes a computer-controlled magnetic field to remotely steer a magnetic ablation catheter that applies a consistent, "soft-touch" contact with the heart which may reduce the risk of perforation during ablation procedures.⁹⁴

October 21, 2006 A study comparing the Pappone Circumferential Anatomical PV Isolation procedure with an integrated approach using both the Pappone method followed by a Segmental ablation (with electrophysiological confirmation of PV disconnection) was found to be more effective than the Pappone method alone. "Electrophysiological confirmation of PV disconnection could be a useful marker of successful RF treatment of A-Fib."⁹³

October 14, 2006
Bordeaux Group Reports 95% Success Rate in Curing Persistent/Chronic A-Fib after Two Ablations
In a major medical breakthrough the French Bordeaux group reported a 95% success rate in curing Persistent/Chronic A-Fib.⁹² See Jaïs Chronic A-Fib.

August 5, 2006
Four Patients Die after AtriCure (Wolf) Mini-Maze Surgery
According to a Wall Street Journal article by David Armstrong, four patients are known to have died after having the AtriCure (Wolf) Mini-Maze surgical operation to cure A-Fib.⁹¹

August 5, 2006
Cleveland Clinic Surgeons' Financial Ties to Equipment Manufacturers
According to a Wall Street Journal article by David Armstrong, surgeons at the Cleveland Clinic may have or may have had extensive financial ties to manufacturers of medical equipment these surgeons use to treat A-Fib patients.⁹¹

June 11, 2006 Dr. Andrea Natale and the Cleveland Clinic now call their catheter ablation procedure to cure A-Fib "Pulmonary Vein Antrum Isolation (PVAI)." This procedure still involves making circumferential lesions around the outside of the PV openings.

June 11, 2006 
Low-Dose Steroids Prevent Recurrence of A-Fib after Ablation
Low-dose steroids have been reported to prevent recurrence of A-Fib, possibly because they suppress systemic inflammation.⁸⁵

June 10, 2006
Dr. Wolf Admonished for Not Revealing Financial Ties to AtriCure
"The Journal of Thoracic and Cardiovascular Surgery has admonished a Un. of Cincinnati surgeon (Dr. Randall K. Wolf who developed the Wolf Mini Maze operation for A-Fib) for failing to disclose financial ties to AtriCure, the West Chester, (Ohio) maker of heart-surgery equipment he and other researchers evaluated in a published study." Cincinnati Business Courier and The Wall Street Journal December 28, 2005. ⁸¹ "An AtriCure filing with the SEC in August, (2005) reports Dr. Wolf owns 18,402 shares of company stock (approximate current value $140,000) and has warrants or options to purchase 13,913 additional shares of stock. (ArtiCure's recent stock price was $7.60.) In November, AtriCure reported a four-year royalty agreement with Dr. Wolf that will pay him a minimum of $200,000 a year up to a total of $2 million over the entire length of the agreement."⁸¹

June 6, 2006
"Pill-In-The-Pocket" Strategy using Flecainide or Propafenone is Effective 
Flecainide or propafenone can be safely self-administered by outpatients for control of recurrent atrial fibrillation. This "pill-in-the-pocket" approach resulted in fewer emergency room visits. http://www.medscape.com/viewarticle/495111?rss, New England Journal of Medicine 2004;351:2384-2391.
    (There is some disagreement about this strategy. Some say it might be better to keep patients out of A-Fib by taking antiarrhythmic meds daily [keeping a fire from starting], rather than waiting for an A-Fib attack to start [having to put the fire out once it starts].)

May 27, 2006
Obesity, Smoking, but not Age Affect Recurrence Rates after A-Fib Ablation
Obesity (BMI over 30) and Smoking, but not Age, affect reoccurrence rates of A-Fib after ablation. Dr. Dimpi Patel of the Cleveland Clinic hypothesized that obese patients have larger left ventricles, often due to hypertension or diabetes, and left atrial dilation, resulting in an increased substrate (structure of the heart). These conditions may lead to reoccurrence of A-Fib after ablation.
    In a Mayo Clinic study by Dr. Jared Bunch reoccurrence rates were basically the same for patients under 50, between 50 and 65 years old, and over 65. (Studies presented at the Heart Rhythm Society 2006 Scientific Sessions in Boston, MA. http://www.theheart.org/article/706883.do

May 24, 2006
Long-term Warfarin Use Increases Risk of Bone Fracture in Men   
The long-term use of warfarin appears to increase the risk of bone fractures in men (not women). Warfarin prevents coagulation by blocking the vitamin K-dependent activation of certain clotting factors. Because vitamin K is also used to activate osteocalcin and other bone matrix proteins, "vitamin K antagonists might increase the risk of osteoporotic fractures." The study also found that taking beta-blockers decreased the risk of fractures, perhaps because they increase bone mass. (Archives of Internal Medicine, Jan. 23, 2006.) http://www.medscape.com/viewarticle/522264

April 23, 2006
    "Bottom Line Health," Vol. 20, number 5, May, 2006. "Aspirin vs. stroke. Because aspirin can cause bleeding, it is typically avoided by people who have had a hemorrhagic stroke, which occurs when a blood vessel bursts in the brain. New Finding: In a study of 207 hemorrhagic stroke survivors, those who took an antiplatelet drug, such as aspirin, were not at increased risk for another hemorrhage. Implication: Aspirin therapy may be appropriate for hemorrhagic stroke survivors who are at high risk for heart attack or ischemic stroke, in which a blood clot blocks blood flow to the brain.

April 15, 2006 The Cleveland Clinic has an E-Clinic Consult program that allows patients to receive a second opinion and start the registration process at the Cleveland Clinic. In cooperation with your cardiologist, all records pertaining to your A-Fib are sent to the C.C. for evaluation. An extensive medical questioner is also completed. Then all the data are evaluated by the C.C. cardiology staff. If deemed a candidate for ablation, the pre-registration process is then completed, and a procedure date is given for the ablation. The current fee is $565.

    November, 2005
Veterinary Antibiotic Lasalocid Found in Eggs and Poultry Meat May Trigger A-Fib
A recent report from England suggests that the veterinary antibiotic "Lasalocid" found in eggs and poultry meat may cause or trigger A-Fib.
    Lasalocid is given as a feed supplement to certain farm animals particularly poultry as a preventative treatment against "coccidiosis"---an infectious disease caused by a parasite which damages the birds' intestines and causes illness and sometimes death. Outbreaks of coccidiosis are likely to occur when large numbers of animals are crowded together in warm and moist conditions. Lasalocid is considered a "highly toxic heart poison. ...It belongs to a group known as the ionophores, all of which are potent heart poisons many of which are in regular use in animal feed."⁶⁵ (Thanks to Richard Gee of the UK for providing this info.)

    June, 2005 Dr. Moussa Mansour of Massachusetts General Hospital reports that MGH now uses a mapping system called Carto-Merge to do PVIs. This  system incorporates an MRI (or a CT) of the pulmonary veins with real-time electroanatomical mapping. This image integration provides the operator with significantly better navigation of the left atrium and thus a safer and more effective procedure.

    January, 2004 Australia and New Zealand now have a doctor from the French Bordeaux group practicing in Australia. Here is his address:
AUSTRALIA
Royal Perth Hospital
Wellington St., Perth 6000
Perth, Australia
(+618) 9224 2388
Fax: (+618) 9389 5261
E-mail: ruk(at)ziplip.com (the @ is  written out as "at" to prevent it from being accessed by spam mailing lists)
    Dr. Rukshen Weerasooriya

April 25, 2003
Massachusetts General Hospital Tribute to Dr. Brian McGovern

Brian McGovern, MD: Remembering a physician, colleague and friend
 

Every seat in the O'Keeffe Auditorium was taken April 19. Two overflow rooms were filled beyond capacity. The aisles of the auditorium were crowded with people craning to see the podium and hear the words of remembrance for a beloved and world-renowned cardiologist, Brian McGovern, MD (right), who was killed April 8 in a senseless tragedy that stunned and saddened the hospital community. The memorial service, which was designed for McGovern's patients, also included colleagues, family, friends and MGH employees who came to hear eloquent words and heartfelt messages about the man who touched so many lives in his extraordinary 23-year career at the MGH.

"We can't put a good face on this terrible tragedy, but every time I think of Brian – which will be often – I will aspire in that moment to be a little more patient, a little nicer, a little more like the ideal that he personified," said David Torchiana, MD, chairman and CEO of the Massachusetts General Physicians Organization. "If that can happen a thousand times to all of us, maybe a million times over the years, I believe this world might be a better place."

With McGovern's widow, Anne Jennings, MD, and one of their daughters, Caitriona, in the audience, Torchiana introduced the service, which also included tributes from physicians, colleagues, patients, friends and family members of McGovern. While each shared personal anecdotes, tearful remembrances and even a few light-hearted memories, a common theme surfaced: McGovern was a brilliant physician who possessed the precious gift of genuine compassion and empathy for all he came into contact with – patients, friends and colleagues alike.

"When you met him, he made you feel like you were so important to him and that he was so happy to see you," said Guillermo Sosa-Suarez, MD, a colleague of McGovern's at St. Peter's Hospital in Albany, NY. "He drew people to him. They liked him because of his skills as a physician and because of his personal warmth."

During his tenure at the MGH, McGovern grew into a master clinician and was well known as a doctor's doctor – a physician who many colleagues confided in, consulted with and looked to for advice and wisdom. He built one of the largest referral practices in New England and was widely known as an expert in cardiac arrhythmia.

He was a sought-after lecturer, a highly respected teacher and, in addition to his commitment to patient care, he devoted much time to important clinical research. For many years, he served as medical director for the Ellison 10 Cardiac Step-Down Unit. Every Wednesday, McGovern traveled to Albany, NY, to see patients at the highly successful outreach arrhythmia program that he had founded and built. But beyond the impressive credentials and the lauded achievements, McGovern was what Torchiana described as a "good man" who was highly accomplished yet humble and self-effacing.

"Despite his incredible accomplishments, Brian never took himself too seriously, which is what we loved most deeply about him," said Jeremy Ruskin, MD, a colleague of McGovern's in MGH Cardiology and a close friend. "Everyone knew him for his sense of humor, which was kind-hearted and borne of intelligence and generosity. He was always funny, but his humor was never at anyone's expense. He was able to defuse countless difficult situations with his humor."
 

For Ruskin, this memorial tribute was a deeply personal one. Ruskin first met McGovern in 1981 when the young medical school graduate came to the MGH from Ireland to interview for a fellowship. During McGovern's training at the MGH and his subsequent career, Ruskin grew to rely on him for his insightful medical expertise and thoughtful advice. "Brian was my student, but he became my teacher," said Ruskin. "I'll always be grateful for his friendship, his loyalty and everything that he taught me. A piece of each of us is lost with Brian, but a part of him is alive in all of us. As we try to take care of each other – as he did so often for us – we must continue the extraordinary work he did with such grace, skill and generosity."

It is that extraordinary work of providing the highest quality patient care that was honored by McGovern's patients, who also spoke of his compassion, caring and commitment to the many people who walked into his exam room.

Bud Mueller, MD, was one of those patients. Mueller credited McGovern for saving his life and saving the lives of thousands of other cardiac patients. "His expertise and kindness gave and continue to give individuals and families the ultimate gift – the gift of time," he said. "His work improved beyond measure the quality of time for patients by decreasing the anxiety that is part of the condition that patients and their families must endure. Brian delved into his life's work in a way that showed compassion, caring, respect, empathy and love. We should try to do the same. If we can try to make the world a better place, we can honor Brian, his wife, his children, his MGH team, and then Brian can live on in an important way through each of us whose lives he enriched."

While McGovern touched the lives of many of his patients and his physician colleagues, the staff of the Arrhythmia Service, Electrophysiology Laboratory, the Ellison 10 Cardiac Step-Down Unit and the entire Cardiology Division also are particularly feeling the void left by the loss of a cherished colleague and friend.
Katie Lynch, RN, a nurse from Ellison 10, spoke of the profound impact McGovern had made on the step-down unit staff, both professionally and personally. "He cared for his patients with the utmost respect and compassion," she said. "He elevated our practice to do our very best work. Personally, he made us better because his happiness and love of life were evident and contagious. His presence in our lives was a gift from God, and we will try to honor his memory by caring for patients as he had taught us."
 

"The good physician knows his patients through and through, and his knowledge is bought dearly. Time, sympathy and understanding must be lavishly dispensed, but the reward is to be found in that personal bond, which forms the greatest satisfaction of the practice of medicine. One of the essential qualities of the clinician is interest in humanity, for the secret of the caring of the patient is in the caring for the patient."
- Francis Weld Peabody, MD, (1881-1927) renowned physician and teacher at Harvard Medical School

"No one I've met in my professional
life embodied these words more than Brian did."
- Jeremy Ruskin, MD 

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