Longest clinical follow-up study Of Ablation results

The article is fascinating because it is the first long term scientific research study of ablation results. My EP e-mailed me this study which was just published in the American Journal Of Cardiology. As you know there is so few followup literature on the actual outcomes of ablations as a "cure" for affib that it seems to me deliberate since EP's have a money maker in doing ablations, fostering the notion that they have enormously high success, cure rates, without any motivation and/or documentation that supports their contention of such positive results. EP's can't even agree on what constitutes a "cure" or a "success" post ablation, let alone the enormous variations of a Dr. Natale who has been claiming a 90-95% ablation cure rate for years while other EPS are claiming 70-80%. I have always felt that the EP's are "lying" by simply not following up with their patients post ablation and that they use flawed definitions that pronounce people as cured or a success.

The article is an eye opener and reveals that their rate is a 23% cure rate after 1 ablation and only 39% after the last ablation. That is very far away from the cure rates being touted by most EP's. It is a 6 year study and may have flaws in some of its design, but no where close to account for the large gap in cure

If anyone wants the full study, email me at jerrynmn1@aol.com and I will send it to you in PDF format.Jerry

The American Journal of Cardiology

[www.ncbi.nlm.nih.gov]

Volume 109, Issue 8, 15 April 2012, Pages 1179–1186


Am J Cardiol. 2012 Apr 15;109(8):1179-86. Epub 2012 Jan 14.
Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure.
Sorgente A, Tung P, Wylie J, Josephson ME.
Source

Harvard-Thorndike Electrophysiology Institute, Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. sorgente.antonio@gmail.com
Abstract

This single-center study evaluating the outcomes of proximal PVI provides the longest clinical follow-up of a rigorously defined ablation protocol with strict clinical fol­ low-up. We found that despite an experienced operator, survival free of AF or AT in the entire cohort at 6 years of follow-up after a single PVI procedure was only 23%, and
39% after the last ablation.

Long-term outcomes after pulmonary vein isolation for atrial fibrillation (AF) remain uncertain. In particular, the influence of rigorous arrhythmia monitoring on outcomes is not yet clear. In this study, 103 patients with symptomatic AF who underwent catheter ablation at a single academic medical center from 2002 to 2006 were evaluated, with a median follow-up time of 6 years. The primary end point was the success rate of catheter ablation, defined as the absence of any atrial arrhythmia recurrence lasting >10 seconds at the clinical visit and electrocardiographic or long-term cardiac rhythm recording after a single procedure and after the last procedure. In all, 153 procedures were performed, with a median of 1 (interquartile range 1 to 2) per patient as follows: 61 had 1, 35 had 2, 6 had 3, and 1 had 4 catheter ablations. Freedom from all atrial arrhythmias was present in 23% of patients at 6 years after a single procedure and in 39% of patients after the last procedure. No clinical predictors of AF recurrence were recognized after a single procedure, whereas after the last procedure, in univariate and multivariate Cox regression analysis, only nonparoxysmal AF (hazard ratio 1.92, 95% confidence interval 1.07 to 3.47, p = 0.02) was a predictor of recurrence. In conclusion, AF recurrence at 6-year follow-up after catheter ablation in a selected group of patients with symptomatic drug-refractory AF was relatively high, with 2/3 of AF relapses occurring in the first year of follow-up. Strict clinical surveillance after catheter ablation should be considered to help guide clinical decisions.

Thanks, Jerry, for this post. I had no idea the results were so low. It seems that what we are doing on this website--exchanging info. on diet, supplements, WW, ect.--is even more important than what I thought because the doctors can't seem to do much to help. I am on Flecainide 100 mg twice a day, and that isn't preventing afib attacks, despite trying to use all the supplements on this website. I keep plugging away, reading all I can, to try to get at the root cause of my afib, insomnia, and other health issues. Now after reading these ablation results, it seems that ablation isn't really an option either, and I was considering it if nothing else worked. I do know someone who had an ablation and has been afib free for several years. Guess she is one of the lucky ones.

Windstar (Nancy)

The purpose of my distributing this study is because each affiber has to be proactive, educate them selves, and not simply rely on what an EP claims.

This study clearly indicates that there ARE people who appear to be cured by ablations. So it doesn't mean people with affib should not have an ablation. However, it does also show a very disturbing amount of people who are not cured vs. the suspect success/cure claims of many EP'S. The ultimate choice should be one that you are comfortable with as an affiber'

[www.bidmc.org]


Dr. Josephson, (see below) who is a well respected EP pioneer and considered the "father of Clinical Cardiac Electrophysiology" is one of the main authors of this study so it's findings DO carry a lot of credibility in my mind.Jerry

Chief of Cardiovascular Medicine
Mark E. Josephson, MD
Read Dr. Mark E. Josephson's profile >>

Mark E. Josephson, MD, an internationally recognized investigator, clinician and educator, is chief of the Division of Cardiovascular Medicine within the CardioVascular Institute at Beth Israel Deaconess Medical Center. He is also Herman Dana Professor of Medicine at Harvard Medical School and director of the Harvard-Thorndike Electrophysiology Institute and Arrhythmia Service.

Dr. Josephson’s focus is cardiac electrophysiology, the study of the electrical activity that stimulates the heart to beat, and cardiac arrhythmias, a group of conditions in which abnormal electrical activity produces irregular beats. Millions of heart patients have benefited from his work.
Groundbreaking Researcher

Dr. Josephson is known as the “father of clinical cardiac electrophysiology” because of his work in the 1970s, when he authored a number of groundbreaking studies. His work transformed electrophysiology from a research curiosity to a powerful clinical tool to treat arrhythmias. Among the topics his research addresses are:

The electrophysiologic and anatomic factors that are responsible for lethal arrhythmias associated with coronary artery disease and heart attacks.
The mechanism that causes rapid heart beats arising in the upper chamber of the heart (supraventricular tachycardias).
Catheter mapping of arrhythmias, a technique allowing the doctor to locate abnormal electrical pathways in the heart. This technique became the basis for all ablation techniques – non-surgical procedures in which radio waves or other energy sources are applied to the heart to restore normal electrical flow and thus normal rhythm.
Stimulation techniques allowing doctors to characterize the size and critical components of electrical currents causing extra heart beats and the effect of drugs on the heart tissue.
Effectiveness of the early defibrillator, a battery-powered device that regulates fast heart beats by delivering electricity to the heart.
Development of surgery to prevent ventricular tachycardia and sudden cardiac arrest in patients with coronary artery disease.

Educator and Author

As an educator, Dr. Josephson has had a significant impact on the professional development of electrophysiologists as well development of the field itself. In 1979, he published “Clinical Cardiac Electrophysiology: Techniques and Interpretations,” a textbook that today, in its fourth edition, remains the definitive electrophysiology textbook. It is one of the extremely rare single-author texts in any field. In 2008, Dr. Josephson and his CVI colleague, Peter J. Zimetbaum, MD, published “Practical Clinical Physiology,” a text book guiding physicians in managing arrhythmia patients outside the electrophysiology lab.

Since 1982, Dr. Josephson and Hein J.J. Wellens, MD, of the Academic Hospital in Maastricht, Netherlands, another key figure in the field, have taught a seminar on interpretation of complex arrhythmias in Europe and the United States. This event has been attended by the vast majority of electrophysiology fellows in the United States. Dr. Josephson has mentored more than 150 electrophysiology fellows, many of whom are leaders in the field.

The author of more than 400 original scientific publications, Dr. Josephson has also written 200 chapters, reviews and editorials.
Distinguished Clinician

Throughout his career, Dr. Josephson has maintained an active clinical practice, first at the Hospital of the University of Pennsylvania in Philadephia and, since 1992, at Beth Israel Deaconess Medical Center in Boston. He became chief of cardiovascular medicine at Beth Israel Deaconess in 2001.

Dr. Josephson has received numerous awards:

The Career Achievement Award from the University of California at San Francisco Medical School.
The International Research in Cardiology (RESCAR) Award given by the University of Limburg in the Netherlands (becoming the first to receive it).
The University Medal for Excellence from Columbia University (becoming one of only two physicians to ever receive it), awarded with the citation, "In an age in which diseases of the heart claim so many lives, you have been responsible for the development of innovative diagnostic and therapeutic interventions which permit survival."
Both the Distinguished Teacher Award and the Pioneer Award in Cardiac Pacing and Electrophysiology from the Heart Rhythm Society (becoming the first American to receive both awards).

A native New Yorker, Dr. Josephson received his medical degree from Columbia University College of Physicians and Surgeons. He completed an internship and a residency in medicine at Mount Sinai Hospital, and a fellowship in cardiology at the University of Pennsylvania School of Medicine. Dr. Josephson and his wife have two grown children and two grandchildren.

I have been reading research papers on AF ablation for the last 10 years, and this is the first time I have come across the name of Dr Josephson. I thought Professor Haissaguerre in Bordeaux, whose landmark study in 1998 is quoted in many texts, was the 'father'!

Gill

I have always believed that you have to supplemrnt and watch the Sodium or your ablation would be shortlived, and if more ablated patients were told what we know here and followed through with this advice, the results would be much improved. I also believe that the inability to reduce alcohol consumption after an ablation is a major contributor to the failed ablation rate.

Studies from the University of Cal, San Diego; Asklepios Klinik, Hamburg; affibers.org, and the Cleveland Clinic give five-year success rates of 84, 80, 70 and 84 percents respectively for multiple procedures. (This is from Han's resources). Why the rather large difference in those success rates vs the subject study? I remember reading that for at least one of those studies a five-minute or longer arrhythmia run was the cut-off point for failure vs success - so maybe the most recent study has more conservative parameters for defining success?

I am sure glad I did not have my ablation with Dr. Josephson or any of his colleagues at Harvard Medical School; but really, what can you expect from an institution that would appear to have done only 50 procedures a year? Unless of course they selected their worst cases for this article. Quite frankly I don't remember ever coming across a published study demonstrating incompetence on such a massive scale.

Actually, there are at least five previous long-term studies and none report a 5-year final success rate below 63%. For the Cleveland Clinic it is 84% after an average of 1.2 procedures per patient (63% for initial procedure). For details of this see the June 2011 issue of The AFIB Report [www.afibbers.org].

To accuse some of the top electrophysiologists in the world of lying is pretty strong stuff. Based on my independent surveys including hundreds of procedures I can assure you that Drs. Natale, Jais, Haissaguerre and several others really are that good; but then again they have all done 3000-4000 procedures each. It would be interesting to know who sponsored this study and get details of the financial ties between the authors and the pharmaceutical industry.

Hans

PS. See my 2009 Ablation/Maze survey at [www.afibbers.org].



Edited 1 time(s). Last edit at 05/11/2012 03:33AM by Hans Larsen.

Tom,

The vast majority of studies regarding ablation success rates do not count afib episodes lasting less than 30 seconds. I think most afibbers can live quite happily with that. I have no idea why the Harvard EPs went against the norm and made the cut-off 10 seconds.

Hans

Well I guess Harvard is just not very good. Bordeaux presented their 5 yr at this week's HRS meeting and it is way way better than Harvard. I will add the results here in an edit later on when I get the word version of the abstract. Right now, I have the PDF version which for some reason doesn't let me do cut and paste without turning it into jibberish. The Bordeaux results are very impressive and they use a very strict definition for recurrence. Other groups are also presenting 5 yr followup results.

Found the abstract online - copy and paste below

Session: New Indications and Treatment Strategies for Patients with Non-Paroxysmal Atrial Fibrillation
Thursday, May 10, 2012, 1:30 PM - 3:00 PM
Presentation: AB16-05 - Five Years Follow Up Of Patients Undergoing Catheter Ablation Of Persistent Atrial Fibrillation Using The Stepwise Approach: BLOC-AF Study
Pres. Time: Thursday, May 10, 2012, 2:30 PM - 2:45 PM
Location: 156C
Author(s): Daniel Scherr, MD, Shinsuke Miyazaki, MD, Valerie Aurillac-Lavignolle, RN, Patrizio Pascale, MD, Laurent Roten, MD, Yuki Komatsu, MD, Khaled Ramoul, MD, Ashok Shah, MD, Amir Jadidi, MD, Stephen Wilton, MD, Michala Pedersen, MD, Nick Linton, MD, Rukshen Weerasooriya, MD, Paul Khairy, MD, Sebastien Knecht, MD, Hubert Cochet, MD, Arnaud Denis, MD, Frederic Sacher, MD, Nicolas Derval, MD, Meleze Hocini, MD, Pierre Jais, MD and Michel Haissaguerre, MD. CHU Bordeaux, Hôpital du Haut-Lévêque, Pessac, France
Abstract: Introduction: Data on long-term rhythm outcome after persistent AF (PsAF) ablation are limited. The BLOC-AF study (Bordeaux Long term Outcome after Catheter ablation of persistent AF) evaluates long-term success rates and predictors of success after stepwise ablation of PsAF.
Methods: 160 consecutive pts with persistent AF undergoing de novo catheter ablation (stepwise approach: PVI, ablation of fractionated electrograms, and linear ablation) were included, with the desired procedural endpoint being AF termination. Repeat ablation was performed for pts with recurrent AF/AT after a 1 month blanking period. A minimum follow up (FU) of 48 months with repeated Holter monitoring was performed. Arrhythmia recurrence was defined as AF or AT ≥30 sec. Interim analysis of the first 75 pts (5f, 55±9 years, LVEF 57±14%, 56% long-standing PsAF) having completed FU is presented.
Results: AF was terminated during the index procedure in 60 of 75 pts (80%). LA diameter, AF cycle length, and duration of continuous AF were predictors of AF termination (All p<0.05). Arrhythmia-free survival rates were 46%, 31%, and 20% after a single procedure, and were 84%, 79%, and 67% after multiple procedures (2.2±1.1 procedures; median=2 (1-3)) at 1, 2, and 5 years FU, respectively. At 5.3±1.9 years of FU, 57 pts (76%) were either free of arrhythmia recurrence (n=50; 67%) or showed clinical improvement (>90% AF burden reduction) under previously ineffective antiarrhythmic drugs (n=7; 9%). Most recurrences occurred over the first 6 months. Duration of continuous AF (13±13 months vs. 23±25 months; p<0.05) and termination of AF during index procedure (75% vs. 29%; p<0.01) were associated with freedom from arrhythmia recurrence. In multivariate analysis, only termination of AF was an independent predictor of freedom from AF/AT during FU (OR 7.5; 95% CI 1.7-34.5; p<0.01). Major complications (cardiac tamponade, phrenic nerve injury) occurred in 2 pts (2.6%).
Conclusions: In pts with persistent AF, stepwise ablation with repeat intervention as necessary provides good long-term rhythm outcome even with strict definition for failure (AF/AT ≥30sec). A slow decline of arrhythmia-free survival is noted over 5 years FU. Procedural termination of AF predicts long-term arrhythmia-free survival.
Disclosures: D. Scherr: None. S. Miyazaki: None. V. Aurillac-Lavignolle: None. P. Pascale: None. L. Roten: None. Y. Komatsu: None. K. Ramoul: None. A. Shah: None. A. Jadidi: None. S. Wilton: None. M. Pedersen: None. N. Linton: None. R. Weerasooriya: None. P. Khairy: None. S. Knecht: None. H. Cochet: None. A. Denis: None. F. Sacher: None. N. Derval: None. M. Hocini: None. P. Jais: None. M. Haissaguerre: None.



Edited 1 time(s). Last edit at 05/11/2012 02:57PM by researcher.

I'm not gonna assert that ablation has no place. But I do think that this study adds to the general attitude of extreme caution, if not scepticism re these operations, that is the best approach for an afibber, combined with fanatically ferretting in every conceivable nook and cranny of their diet and lifestyle, before succumbing to the procedure.

In the last study discussed here, I recall that those 70%-type, 5-yr success rates included patients with up to 7(!) ablations, and an average of 2 if I recall. There was also about 1% severe outcome and 1 death if I recall.

One of the things of interest is the standard outcome of raised heart-rate for months afterwards. In my case, and I think other "vagal" afibbers would report the same, any increase in rate above their absolute resting minimum is essentially certain to keep them out of afib - it pretty-much only onsets at the minimum. If one allows for the number of ablation patients being kept out of afib simply by the raised heart-rate resulting from the trauma, in some cases "refreshed" by 2nd and 3rd ablations, what does this say about the 5-yr "efficiency" of the procedure, once combined with the other aspects of the statistics? Isn't there also a raised B.P. effect? (Could be wrong). Again, in this vagal afibber, that would be enough to keep me out of it. But there are easier ways to achieve raised heart rate and/or B.P.

Researcher,

Would you mind telling me where I might be able to get my hands on that data? I am going to Bordeaux at the end of June for an ablation, and I am trying to get the insurance company to pick-up the cost. As you can imagine, it is a battle, and the more data I have the better chance of a favorable outcome. So if you can tell me where I can find all the five year data (on al centers), it would be of a great help. Though I live in Boston, where lots of opportunities exist to have the procedure (and probably get it wrong), I have decided to go with the best of the best.

Thanks,
Steve

I'm one who has had a single, successful ablation (Natale 2003).

However, I did learn that after the 4th year and in order to avoid an occasional AF breakthrough, I needed to supplement diligently with the core, essential nutrients as mentioned in the observational report, The Strategy, and to alkalize with regular consumption of WW. Had I not done that, undoubtedly, I'd have been lined up for a second ablation.

Jackie

Steve, it is presentation number AB16-05 at HRS meeting. Check PM for my message. I will be traveling starting in a few hours and won't be able to post or send email until Sunday. I will send the files then.

Steve, found the abstract available online so I pasted it in my post above. Enjoy. You are in good hands.



Edited 1 time(s). Last edit at 05/11/2012 02:58PM by researcher.

Clearly there are many different opinions among the medical profession and even those of us here about the "right" way to treat our affib. Medicine is a business, not a simple " help the patient Hippocratic oath event" for many Drs. and EP's. Yes, I feel that there are numerous questions that are raised by the the inordinately high success/cure rates spouted by certain EP's vs. others that cannot be simply completely explained away by having better skills , better equipment.

Yes, there are legions of "cured/successful" ablation patients who have been freed of the affib monster by ablations, that is wonderful and has changed many, many lives from despair to being almost reborn. At the same time there are also many affibers who have had multiple failed ablations, or have been able to find success through homeopathic, diet, other methods, including medications.

I am not posting to create dissent but as I said to share, educate, and provide an opportunity for those here to think for themselves with as much a variety of information as is available.

To suggest that because the Harvard study is flawed due to the researchers bias, alleged financial interests, or bias, because some people don't like it's "poor" results is ludicrous. This is a professional study that used stringent clinical research protocols to reach it's results.

To suggest that if I voice my personal opinion that there is hype, lying going on among Ep's as to their inflated results begs the question as to why there is such a dearth of truly scientific research for a medical disorder as important as affib, despite the studies cited by others in some of the above posts. Money makes the world go round, and it is naive to believe that in such a competitive, lucrative arena of ablations, surgery, that Drs. will use statistics that are gathered/defined in ways that make their success/cure rates much higher than others. Look at the different ways that Ep's define cure/success. I know for a fact that there are many EP's who count an ablation as a a success if the person leaves surgery no longer in affib but if the affib returns after surgery the EP never changes the person's ablation as a failure. There are EP"s who never do followups, say you are cured of affib even though you are kept on meds after the ablation, or arbitrarily pick 6 months as the point of declaring one cured.

We all are aware of the fact that ablations for affib are a relatively new procedure that does not fit nor is designed to be used on all the different subgroups of affib sufferers. One size does not fit all yet there are EP's performing ablations on patients 4,5,6,7 times who are just not good candidates for ablation.

I think ablations are right for some affibers and not others. The medical understanding of what causes idiopathic affib is non-existent and those with affib are understandably desperate to be cured. There are those in every profession that will abuse and use their positions in self serving, money profit
ways in dealing with us. Buyer beware also extends to medicine, sadly there is nothing sacred about Drs. and it behooves each and every one of us to be proactive, ask questions, self educate, make our own decisions, and not be so automatically trusting of what is being "fed" to us. Just my 2 cents.

I'd like to see the success rates of LAF'rs compared other types of afibers. The comparative success of afib types within a study should not be affected by any overall outcome bias, if such does exist.



Edited 1 time(s). Last edit at 05/11/2012 09:16PM by Tom B.

To me it is the EP who performs the ablation. I would like to see the results of a Dr. Natale or a Dr. Pinski (who performed 2 ablations for me) over the years and then we have some real large numbers. In conclusion, I do not put much faith in this study and as for the use of the word "cure" I would rather see the numbers of those who have been afib free and for how long and forget the word 'cure.'

I met with an EP at Mt Sinai here in New York last month for a consultation and he told me any doctor/EP who tells you a ablation is a cure is full of it.........

See; [www.afibbers.org]

Hans

[www.theheart.org]

Success rates ranged from 33% at one center to 100% at three centers, according to Dr Ralph J Damiano Jr (Washington University School of Medicine, St Louis, MO), who presented CURE-AF here at the American Association of Thoracic Surgery 2012 Annual Meeting. The differences probably weren't due to varying patient or institutional characteristics, as the case mix was similar at each place, and most were highly experienced tertiary centers, Damiano told heartwire.

"That variability was almost certainly due to [the surgeons] not performing the procedure correctly—which is shown in the ablation times," he said. Ablation times tracked with success and ranged from less than three minutes, associated with a success rate of 50%, to more than 12 minutes, with a success rate of 81%.

McHale

I agree with you that catheter ablation for atrial fibrillation is unlikely to permanently cure afib - primarily because it, like other medical procedures does not address the underlying cause. However, being afib-free for 8-10 years before perhaps needing a repeat sure is nice.

Actually, it is difficult to think of any disease/condition that is actually cured by western medicine.

Cancer may go into long-term remission after treatment, but it is rarely cured.
A bypass or angioplasty does not cure heart disease.
A hip replacement does not cure arthritis
Antiarhythmic drugs do not cure atrial fibrillation
Beta-blockers do not cure hypertension.
Metformin does not cure diabetes.
etc, etc,

About the only conditions that I can think of that can actually be cured by medical intervention is bacterial infections (antibiotics) and broken bones.

Hans



Edited 1 time(s). Last edit at 05/13/2012 11:26PM by Hans Larsen.

Liked your comments Jerry.

Consider myself lucky that I'm so asymptomatic with my AF, and can afford to hold-off a bit to hopefully see greater success in procedures before taking the "Nestea Plunge."

Special thanks to Hans, and to all here for sharing your knowledge, experience and guidance.

Hans,
I never said that there is no cure for afib just parroting what the EP told me.
8-10 years is sweet and like a cure but I'm sure they find the underlying cause of afib soon and bring better treatments to the table!
Dr Narayan is on to something!

Hans,

Up to 30 years ago I read an artical that said the only western pharmiceutical 'medicine' that actually cured things were the anti-biotics for bacterial infections and it appears absolutly nothing as changed in all those years. That statement has always stuck with me as it was so suprising but apparently true.

We have to admire Big Pharm's advertising stratagies that can still provide billions in profit whilst delivering virtual total failure with regards to any real cures. That said Big Pharm seems to be able to find 'relief' to virtually all sickness's, as long as you keep taking the tablets and therein possibly lies the plot.

Barry G.

I have afib, currently in NSR and have been since my third ablation by Dr. Natale. Reading all of the topics above and as much of the test as I can handle, I believe the success of this procedure is more due to the experience of the operator than almost anything pointed to. To protect the teaching aspect of medicine I believe all practioners of the art of ablation are treated the same and that the success rate is not related to proficiency is absurd. But that aint the way it works for those of us haveing the procedure done. Dr. Natale told me that he had done over 2000 ablations. Doing just 300 over two or three years or watching an ablation being done hardly qualifies as experienced. I am ed at the people I know who do not ask the question----how many have you done, how long have you been dong these, what is you mortality and morbidity rate, what is you definition of success, and who taught you how to do this. Not the best qualifier but a darn site better than not trying to qualify your sugeon at all. I have one heart, the doctor has other patients.