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AADs

From My Mailbox: Catheter Ablation Complication Rate: Compared to What?

Frequently I get emails asking about the complication rate of catheter ablation.

I like the suggestion made by Dr. David Keane of St. Vincent’s University Hospital, Dublin Ireland. Complications from A-Fib ablation should be viewed in perspective, that is, compared to the alternative of a lifetime on antiarrhythmic drugs (AADs).

The following is based on his presentation from the 2014 Boston AF Symposium.

Meta-Analysis: RF Catheter Ablation vs. Antiarrhythmic Drugs

In what may be the first systematic literature review and meta-analysis of clinical studies of Radiofrequency Ablation (RFA) vs. Antiarrhythmic Drugs (AADs), the reviewers looked at studies from 1990 to 2007. [Note: RFA wasn’t in use until the mid-1990s.] Included were sixty-three RFA studies and 34 AAD studies.

RF Ablation: From 1990-2007, the single procedure success rate for Radiofrequency Ablation (RFA) without need of post-op Antiarrhythmic Drug (AAD) therapy was 57% [today’s success rates are in the 70%–85% range], multiple procedure success rates without post-op AADs were 71% [today’s success rates are closer to 90%], and the multiple procedure success rate with post-op AADs was 77%.

AAD Therapy: The success rate for AAD therapy alone was 52%.

Note: The meta-analysis included five AADs: amiodarone, dofetilide, sotalol, flecainide, and propafenone. Amiodarone was the most effective. [Amiodarone is the most toxic and dangerous of the five AADs and is usually prescribed only for short periods of time and under close supervision for bad side effects.]

Adverse Event: side effect or any undesirable experience associated with the use of a medical product in a patient. In the US, adverse events are reported to the FDA.

Side Effects Cause Patients to Stop Taking AADs: Because of adverse events (side effects), 10.4% of patients discontinued taking their AADs, 13.5% discontinued AADs because of treatment failure, and 4.2% just didn’t take the AADs.

The overall discontinuation rate of AADs was almost 30%.

Findings: Efficiency and Complications Rates

Based on the meta-analysis, reviewers found Radiofrequency Ablation (RFA) had a higher efficiency rate and a lower rate of complications than AAD Therapy.

Findings: Adverse Events Ablation vs AAD

As a point of reference, the complication rate of the common appendectomy is 18%.

This meta-analysis found adverse events for catheter ablation was 5% vs 30% for AAD studies.

More about AAD Therapy adverse events: The overall death rate for AAD therapy was 2.8% (i.e., sudden death 0.6%, treatment-related death 0.5%, non treatment-related death 1.3%). Other adverse events from AAD therapy were:

•  CV (cardiovascular) Events 3.7%
•  Bradycardia 1.9%
•  GI (Gastrointestinal problems) 6.5%
•  Neuropathy 5.0%
•  Thyroid Dysfunction 3.3%
•  Torsades 0.7%
•  Q-T prolongation 0.2%

Conclusions from Meta-Analysis

Most adverse events associated with antiarrhythmic drugs (AADs) are life altering and permanent. (For example, bradycardia requires a pacemaker.)

Whereas complications from catheter ablation are generally short term and not permanent. (For example, when tamponade is repaired, the heart usually returns to normal.)

While this meta-analysis covered 1990-2007, based on subsequent research the trends are continuing. In general, it appears it’s safer to have an ablation than to not have one while living a life-time on AAD therapy.

D. Keane MD

The Full Report: For the full summary of Dr. Keane’s 2014 Symposium presentation, see: Catheter Ablation Complications: In-depth Review and Comparison with Antiarrhythmic Drug Therapy.

What this Means to Patients

If you are age 70 or 80, antiarrhythmic drugs might be a realistic option.

But if you are younger, it’s inconceivable that you would spend the rest of your life taking AADs. In addition to not working well or losing their effectiveness over time, they can have bad, cumulative side effects as described above.

Today’s ‘Guidelines for the Management of Patients with Atrial Fibrillation’ reflect this fact and allow you to select a catheter ablation without having to spend time trying various antiarrhythmic drugs (while your A-Fib may be getting worse).

In general, research shows it’s safer to have an ablation than to not have one (and live a lifetime on AA drug therapy).

Resources for this Article
•  Deshmukh, A. et al. In-Hospital Complications Associated with Catheter Ablation of AF in US: 2000-2010. Analysis of 93,801 Procedures. Circulation. 2013;128:2104-2112. http://circ.ahajournals.org/content/128/19/2104.abstract

•  Haïssaguerre M. “Electrophysiological End Point for Catheter Ablation of Atrial Fibrillation Initiated From Multiple Pulmonary Venous Foci,” Circulation. 2000;101:p. 1409

•  Jais, P. “Ablation Therapy for Atrial Fibrillation: Past, Present and Future,” Cardiovascular Research, Vol. 54, Issue 2, May 2002, P. 343

•  Cappato R et al. “Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.” Circulation: Arrhythmia and Electrophysiology. 2010: 3:32-38.

•  AHA/ACC/HRS. 2014 Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2014; 130: e199-e267 DOI: 10.1161/CIR.0000000000000041.

Catheter Ablation as Recommended First Choice – 2014 Boston AF Symposium

Dr. Hugh Calkins, Johns Hopkins Medical Center

Dr. Hugh Calkins

2014 Boston AF Symposium

Catheter Ablation as Recommended First Choice

Report by Dr. Steve S. Ryan, PhD, August 26, 2014

Dr. Hugh Calkins from Johns Hopkins gave a presentation entitled “Indications for AF Ablation: Guidelines vs. Clinical Reality.”

To begin his presentation, Dr. Calkins asked the Symposium attendees:

“Which statement correctly reflects your current approach to AF ablation as first line therapy in patients with symptomatic paroxysmal AF?”

•  I rarely recommend AF ablation as first line therapy in this patient group.

•  I routinely recommend AF ablation as first line therapy in this patient group.

Response: 79% of the attendees selected choice #1 {They used an electronic polling system placed at each seat.]

CURRENT GUIDELINES

According to the 2012 Guidelines (ESC Focused Update)1:

“Symptomatic AF refractory or intolerant to at least one Class 2 or 3 antiarrhythmic medication, catheter ablation is recommended.” With the following footnote: “Catheter ablation of symptomatic AF is considered a Class 1 indication only when performed by an electrophysiologist who has received appropriate training and is performing the procedure in an experienced center.”

“Symptomatic AF prior to initiation of antiarrhythmic drug therapy with a class 2 or 3 antiarrhythmic, Catheter ablation is reasonable.”

[If a paroxysmal patient has no or minimal structural heart disease, their first line choice can be catheter ablation or the antiarrhythmic meds dronedarone, flecainide, propafenone, or sotalol. Should these antiarrhythmics fail, the patient can choose catheter ablation or amiodarone.]

Dr. Calkins also asked “And What About Ablation in Patients with Asymptomatic AF?”

He notes that the indications listed in all guidelines refer only to patients with symptomatic atrial fibrillation. No mention is made of asymptomatic AF. In rare circumstances, it may be reasonable to perform AF ablation in a truly asymptomatic patient with the aim of reducing long term consequences of AF including increased risk of stroke, heart failure, and dementia.

But patients need to be aware of the immediate risks of AF ablation and also that AF ablation has not been shown to reduce the risks of stroke, heart failure, or dementia. [But see my article Live Longer—Have a Catheter Ablation’. In this research (published after Dr. Calkins’ presentation) they found that a successful PVI reduces by 60% the risk of death from stroke and other cardiovascular events. Though some consider this study flawed saying it does not correct for important differences in those who do and those who do not undergo A-Fib ablation.]

ABLATION VS ANTIARRHYTHMIC meds

Dr. Calkins cited a study comparing Radiofrequency Ablation vs. Antiarrhythmic Drugs as First-line Treatment of Symptomatic Atrial Fibrillation. The A-Fib free success rate was significantly higher for catheter ablation. The study concluded “Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF.”2

But what about possible complications from catheter ablation? [For a more extensive discussion of this topic, see Dr. Keane’s earlier Symposium presentation Risk of Complications from a Catheter Ablation.] Dr. Calkins discussed the RAAFT 2 randomized clinical trial. The CA study found a 7.7% complication rate compared to 19% for patients on antiarrhythmics (AADs). The success rate for CA was 45% [low compared to other studies], while the success rate for AADs was only 28%. In the AAQD study, 59% had to stop at least one drug and nearly half did choose to have a catheter ablation.

In another study, the overall complication rate was 6.9% in patients undergoing AF ablation. But more importantly, the study concluded “there was a significant association between operator and hospital volume and adverse outcomes.”3

DR. CALKINS’ CONCLUSIONS

•  The guidelines have gotten it right.

•  It is difficult to advise that all patients undergo AF ablation as first line therapy given that AF ablation is associated with a significant risk of major complications including death.

•  Clearly a patient’s values and preferences play a big role.

•  But of equal importance is the operator’s own data on success and complications.

•  There is increasing evidence that experience matters when it comes to the outcomes of AF ablation. Most experienced operators have waiting lists.

•  While waiting for an experienced operator, you might as well try an AA drug.

•  It is my impression that the Guidelines are being adhered to. Most patients undergoing ablation today have failed at least one antiarrhythmic medication and have symptomatic AF.

•  Consistent with the guidelines, in rare situations select patients are undergoing ablation as first line therapy.

•  Some asymptomatic or minimally symptomatic patients are undergoing ablation for “theoretical reasons”. “In my mind, this is acceptable provided adequate informed consent has been obtained and patients are aware that the only proven benefit of AF ablation is to improve quality of life.”

Editor’s Comments:
Problems With Today’s Antiarrhythmic Meds
Doctors know all too well that today’s antiarrhythmic meds don’t work very well, or they have bad side effects, or they lose their effectiveness over time. They also tend to cause more and more lasting adverse events than catheter ablation. It’s often safer to have an ablation than to not have one. And the complications from a catheter ablation are most often temporary as compared to living a life in A-Fib or on A-Fib meds.
Also, one of the main reasons people have a catheter ablation is so that they don’t have to take antiarrhythmic meds and anticoagulants for the rest of their lives.
Catheter Ablation First-Line Choice
Today’s guidelines happily take into account these realities. According to current guidelines, you don’t have to spend months or a year trying various antiarrhythmic meds while your A-Fib gets worse, your heart develops more fibrosis, “remodels” itself, and your quality of life is in the toilet.
Then why did 79% of the attendees not recommend A-Fib ablation as first-line therapy? Because, even though catheter ablation is a low risk procedure, it isn’t risk free. The risk is similar to having your tubes tied, i.e. 1-2%. (By comparison, the risks of an appendectomy are around 18%.)
Know Your Rights—Be Assertive
As an A-Fib patient, you should know your rights and be assertive—that according to the guidelines, you have a right to choose catheter ablation as your first choice. Your doctor may try to talk you into first trying antiarrhythmic meds before offering you the option of a catheter ablation.
(The author frequently hears of Cardiologists who refuse to refer patients for a catheter ablation, who tell patients a catheter ablation is unproven and dangerous. When you hear something like that, it’s time to get a second opinion and/or change doctors.)
Current guidelines “recommend” catheter ablation or say it is a “reasonable” option.
Catheter Ablation for Patients Without Symptoms
Dr. Calkins, who headed the committee which drafted the guidelines, goes even further. Patients without symptoms or with minimum symptoms can get a catheter ablation.
”In my mind this is acceptable provided adequate informed consent has been obtained and patients are aware that the only proven benefit of AF ablation is to improve quality of life.”
Side note: It’s questionable whether anyone with A-Fib is really symptom-free. If you have A-Fib, the upper parts of your heart (the atria) aren’t pumping properly. Your body and brain are losing 15% or more of their normal blood flow. People get used to it or they write off the increased fatigue, tiredness, mental slowness, etc. as old age. But anyone with A-Fib is affected by it to some extent.
If you have A-Fib and are symptom-free, you have the option of simply living out the rest of your life in A-Fib. But some people may not be able to do this without worrying about it, e.g., “How is A-Fib affecting my heart, how much fibrosis am I developing, how is my heart remodeling over time?” Realize that you can choose to have a catheter ablation for what Dr. Calkins terms “theoretical reasons”.

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Last updated: Wednesday, September 2, 2015 

 

Footnote Citations    (↵ returns to text)

  1. Epstein AE, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2013; 127: e283-e352 doi: 10.1161/CIR.0b013e318276ce9b
  2. Wazni OM, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi:10.1001/jama.293.21.2634.
  3. Abhishek, D. et al. In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the US between 2000 and 2010: Analysis of 937,810 Procedures. Circulation. 2013;128:2104-2112. http://circ.ahajournals.org/content/128/19/2104.abstract doi: 10.1161/CIRCULATIONAHA.113.003862

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