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RF ablation

Clinical Study Findings: CryoBalloon Better Than RF Ablation?

We can now say that CryoBalloon ablation is better than RF, at least according to a secondary analysis of a recent clinical study.

In the FIRE AND ICE clinical trial by Dr. Karl-Heinz Kuck and his colleagues, 762 patients with symptomatic paroxysmal A-Fib were randomized into two groups, either RF catheter ablation or CryoBalloon ablation.

Results: Many findings were comparable. Both groups had similar results in terms of primary efficacy and safety endpoints. Furthermore, both groups had improvement in quality of life over 30 months of follow-up.

Where Results Diverged: Re-Hospitalization and Recurrence

While many of the outcomes were similar between the two groups, there were some significant differences. The CryoBalloon group had lower rates of re-hospitalization (32% with CryoBalloon versus 41.5% with RF catheter ablation). In addition, the CryoBalloon patients had fewer:

• Cardiovascular re-hospitalizations (23.8% vs 35.9%)
• Repeat ablations (11.8% vs 17.6%)
• Direct current cardioversions (3.2% vs 6.4%)

Karl-Heinz Kuck, MD portrait at A-Fib.com

KH Kuck, MD

According to lead researcher, Dr. Kuck:

“The secondary analysis (of the FIRE AND ICE study) favors CryoBalloon over (RF ablation), with important implications [for EPs] on daily clinical practice.”

Dr. Wilber Su of Banner-University Medical Center in Phoenix, who was not part of this FIRE AND ICE study, concluded:

Dr Wilber Su at A-Fib.com

Dr Wilber Su

“…for most operators, CryoBalloon may be a safer and more efficient approach… . In my practice, CryoBalloon has already become the preferred approach both from personal experience as well as patient demand.”

What Patients Need to Know

Which ablation procedure is better—RF or CryoBalloon? According to the FIRE AND ICE clinical trial, we can now say that CryoBalloon is better in terms of less re-hospitalizations, repeat ablations and recurrences within a 30 month period.

More important than the energy source used to perform the ablation, is the skill and experience of the operator (EP).

Don’t Avoid RF: In practical terms, the differences weren’t so great that you should avoid EPs who prefer to use RF.

Dr. Su points out that many electrophysiologists (EPs) may continue with RF ablation because being comfortable with their choice of technology is a critical factor.

Look for Skill and Experience: More important than the energy source used to perform the ablation, is the skill and experience of the operator (EP).

The Bottom Line: When researching an EP to do your ablation, look for the best, most experienced high volume operator you can find and afford, even if you have to travel.

Caveat About CryoBalloon Ablation

CryoBalloon catheter

CryoBalloon catheter

CryoBalloon ablation is much easier and faster to do than RF point-by-point ablation. Consequently, some operators are entering the field with little RF ablation experience on which to build or complement their Cryo skills.

Others are doing only “anatomical ablation”—only ablating the pulmonary vein openings and not looking for and ablating non-PV triggers. (Happily in many cases, this is often all that is needed, particularly in cases of recent onset or Paroxysmal A-Fib.)

For more critical information about choosing your EP for a Cryoballoon Ablation, read my posts:

• Huge Growth in Number of EPs Doing Catheter Ablations
• CryoBalloon Ablation: Alarming O.R. Reports (Part I)
• CryoBalloon Ablation: All EPS Are Not Equal (Part II)

Resources for this article

 

Is Cryoballoon as Effective and Safe as RF Ablation? A Clinical Study

There have been few randomization trials directly comparing CryoBalloon ablation to RF ablation.

That’s why Dr. Armin Luik and his colleagues developed the FreezeAF clinical trial―to directly compare CryoBalloon ablation to RF ablation for treating patients with paroxysmal atrial fibrillation. Dr. Luik (U. of Freiburg, Karlsruhe, Germany) presented the study results at the May 2015 meeting of the Heart Rhythm Society.

CryoBalloon catheter

CryoBalloon catheter

FREEZEAF Trial: Patients and Method

In the FREEZEAF study, 315 paroxysmal A-Fib patients with a mean age of 60 years were randomized to either a CryoBalloon ablation (n=156) or a RF ablation (n=159) of the pulmonary veins. Clinical follow up was at three, six, nine and 12 months.

The FREEZEAF Study Results

The FreezeAF trial researchers noted that a number of CryoBalloon ablation studies have demonstrated its efficacy and safety for treatment of A-Fib, but few studies have compared the two techniques head-to-head.

How did Cryoballoon compare to RF Ablation? … Continue reading this report…->

Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

Ross-J Hunter

Ross J Hunter

Pulmonary Vein ablation (PVA), using RF point-by-point isolation, or using CryoBalloon technology? It is really a choice of one or the other?

What happens when you combine the two techniques? Do ablation success rates increase?

To answer these questions, UK researcher, Dr. Ross J. Hunter devised a single-center study to compare three different ablation strategies. He divided 237 Paroxysmal A-Fib patients undergoing their first ablation into three treatment groups.

Group 1 Strategy: standard RF point-by-point ablation of the Pulmonary Vein openings (PVs) using an irrigated tip catheter guided by a 3D mapping system.

Group 2 Strategy: CryoBalloon ablation using the Arctic Front CryoBalloon catheter, and if PV isolation wasn’t achieved using the CryoBalloon alone, RF focal lesions were added.

Group 3 Strategy: RF point-by-point ablation followed by two applications of the CryoBalloon.

Success Rates After One Year

Group 1:  At one year 47% were A-Fib free and off of all antiarrhythmic drugs; (This is a relatively low success rate compared to some centers using RF ablation.) Average procedure time was 211 minutes;

Group 2:  The one year success rate was 67% (significantly better than the RF group); Important Note: In addition to the CryoBalloon, 31% needed RF focal lesions to achieve PV isolation. Average procedure time was 167 minutes;

Group 3: After one year the success rate was 76% which was better than the CryoBalloon alone, but the difference wasn’t ‘statistically significant’ (meaning it could have occurred by chance). Average procedure time was 278 minutes.

The Study Results: How the Three Strategies Compare

Best result: Group 2 Strategy:CryoBalloon plus RF lesions as needed strategy’. It was faster, easier to use and was more effective after one year than the Group 1 strategy ‘RF point-by-point ablation’.

Disappointing result: Using the novel Group 3 strategy of combining ‘RF ablation followed by CryoBalloon ablation’ did not significantly improve results and took longer to do.

Most surprising result: When the authors designed this study, they thought the combined approach of ‘RF ablation followed by CryoBalloon’ (Group 3) would turn out to be superior to the other two strategies. Their prediction was wrong. It turned out it was only superior to ‘RF alone’  strategy (Group 1).

The Bottom Line

The take-away: About 30% of CryoBalloon ablations required RF focal lesions to achieve isolation of all A-Fib signals and to restore the patient to normal sinus rhythm.

What This Means for A-Fib Patients

For the best results with a CyroBalloon ablaltion, you want an electrophysiologist (EP) who is not only experienced with CryoBalloon, but who can also use RF technology when needed to map and isolate A-Fib signals originating beyond the pulmonary veins.

Finding the right EP: Be cautious. With the advent of CryoBalloon ablation, some EPs with little or no expertise with RF ablations are now doing CryoBalloon ablations. Why? Because they’re easier to perform. As a patient, you want to stay away from EPs who only do CryoBalloon ablation.

Here’s an example why:

Recently a patient, still in A-Fib, sent me the O.R. (Operating Room) report of their CryoBalloon ablation. From reviewing the report, it appears the EP didn’t make any attempt to map and isolate non-Pulmonary Vein (PV) triggers, and simply shocked the patient to return him to normal sinus rhythm. This may work in some cases. But for this patient the ablation was a failure.

Most experienced EPs who have switched from performing RF ablations to CryoBalloon ablations have the ability, skill and experience when needed to use RF technology to isolate non-PV triggers when needed.

Questions to Ask Prospective EPs: to find the right EP for your CryoBalloon ablation ask:

What do you do if I’m still in A-Fib after you do the CryoBalloon ablation?
Will you use RF techniques to get me back into normal sinus rhythm?

(You want an EP who answers ‘yes’ to the second question.)

References for this article

Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

Research Findings

Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

by Steve S. Ryan, PhD

Ross-J Hunter

Ross-J Hunter

Pulmonary Vein ablation (PVA), using RF point-by-point isolation, or using CryoBalloon technology? It is really a choice of one or the other?

What happens when you combine the two techniques? Do ablation success rates increase?

To answer these questions, UK researcher, Dr. Ross J. Hunter devised a single-center study to compare three different ablation strategies. He divided 237 Paroxysmal A-Fib patients undergoing their first ablation into three treatment groups.

Group 1 Strategy: standard RF point-by-point ablation of the Pulmonary Vein openings (PVs) using an irrigated tip catheter guided by a 3D mapping system.

Group 2 Strategy: CryoBalloon ablation using the Arctic Front CryoBalloon catheter, and if PV isolation wasn’t achieved using the CryoBalloon alone, RF focal lesions were added.

Group 3 Strategy: RF point-by-point ablation followed by two applications of the CryoBalloon.

Success Rates After One Year

Group 1:  At one year 47% were A-Fib free and off of all antiarrhythmic drugs; (This is a relatively low success rate compared to some centers using RF ablation.) Average procedure time was 211 minutes;

Group 2:  The one year success rate was 67% (significantly better than the RF group); Important Note: In addition to the CryoBalloon, 31% needed RF focal lesions to achieve PV isolation. Average procedure time was 167 minutes;

Group 3: After one year the success rate was 76% which was better than the CryoBalloon alone, but the difference wasn’t ‘statistically significant’ (meaning it could have occurred by chance). Average procedure time was 278 minutes.

The Study Results: How the Three Strategies Compare

Best result: Group 2 Strategy:CryoBalloon plus RF lesions as needed strategy’. It was faster, easier to use and was more effective after one year than the Group 1 strategy ‘RF point-by-point ablation’.

Disappointing result: Using the novel Group 3 strategy of combining ‘RF ablation followed by CryoBalloon ablation’ did not significantly improve results and took longer to do.

Most surprising result: When the authors designed this study, they thought the combined approach of ‘RF ablation followed by CryoBalloon’ (Group 3) would turn out to be superior to the other two strategies. Their prediction was wrong. It turned out it was only superior to ‘RF alone’  strategy (Group 1).

The Bottom Line

The take-away: About 30% of CryoBalloon ablations required RF focal lesions to achieve isolation of all A-Fib signals and to restore the patient to normal sinus rhythm.

What This Means for A-Fib Patients

For the best results with a CyroBalloon ablaltion, you want an electrophysiologist (EP) who is not only experiened with CryoBalloon, but who can also use RF technology when needed to map and isolate A-Fib signals originating beyond the pulmonary veins.

Finding the right EP: Be cautious. With the advent of CryoBalloon ablation, some EPs with little or no expertise with RF ablations are now doing CryoBalloon ablations. Why? Because they’re easier to perform. As a patient, you want to stay away from EPs who only do CryoBalloon ablation.

Here’s an example why:

Recently a patient, still in A-Fib, sent me the O.R. (Operating Room) report of their CryoBalloon ablation. From reviewing the report, after ablating the Pulmonary Veins (PV), it appears the EP didn’t make any attempt to map and isolate non-PV triggers. When the patient didn’t return to normal sinus rhythm on his own, the EP simply cardioverted the patient back into normal sinus rhythm. This may work in some cases. But for this patient the ablation was a failure.

Most experienced EPs who have switched from performing RF ablations to CryoBalloon ablations have the ability, skill and experience when needed to use RF technology to isolate non-PV triggers when needed.

Questions to Ask Prospective EPs: to find the right EP for your CryoBalloon ablation ask:

What do you do if I’m still in A-Fib after you do the CryoBalloon ablation?
Will you use RF techniques to get me back into normal sinus rhythm?

(You want an EP who answers ‘yes’ to the second question.)

References for this article

A Must Read, if You Are Considering a CryoBalloon Ablation…

CryoBalloon catheter

CryoBalloon catheter

Question: What happens when you combine CryoBalloon and RF ablation techniques? Do success rates increase?

To find out, UK researcher, Dr. Ross J. Hunter devised a single-center study to compare three different ablation strategies. He divided 237 Paroxysmal A-Fib patients undergoing their first ablation into three treatment groups.

Group 1 Strategy: standard RF point-by-point wide of the Pulmonary Vein openings (PVs) using an irrigated tip catheter guided by a 3D mapping system.

Group 2 Strategy: CryoBalloon ablation using the Arctic Front CryoBalloon catheter, and if PV isolation wasn’t achieved using the CryoBalloon alone, RF focal lesions were added.

Group 3 Strategy: RF point-by-point ablation followed by two applications of the CryoBalloon.

Read my new research report and learn what the findings mean if you are considering a CryoBalloon ablation. See Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

By Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

Research: Combining RF and CryoBalloon Ablation Techniques

Combining RF and CryoBalloon Ablation Techniques

Research Findings

By Combining RF and CryoBalloon Ablation Techniques, Do Success Rates Increase?

RF point-by-point ablation for Pulmonary Vein (PV) isolation is technically challenging, time consuming, and the first-time success rate is variable. CryoBalloon ablation is easier and faster.

Question: What happens when you combine the two techniques? Do success rates increase?

To find out, UK researcher, Dr. Ross J. Hunter devised a single-center study to compare three different ablation strategies. He divided 237 Paroxysmal A-Fib patients undergoing their first ablation into three treatment groups.

Group 1 Strategy: standard RF point-by-point wide of the Pulmonary Vein openings (PVs) using an irrigated tip catheter guided by a 3D mapping system.

Group 2 Strategy: CryoBalloon ablation using the Arctic Front CryoBalloon catheter, and if PV isolation wasn’t achieved using the CryoBalloon alone, RF focal lesions were added.

Group 3 Strategy: RF point-by-point ablation followed by two applications of the CryoBalloon.

Success Rates After One Year

Group 1:  At one year 47% were A-Fib free and off of all antiarrhythmic drugs; (This is a relatively low success rate compared to some centers using RF ablation.) Average procedure time was 211 minutes;

Group 2:  The one year success rate was 67% (significantly better than the RF group); Important Note: In addition to the CryoBalloon, 31% needed RF focal lesions to achieve PV isolation; Average procedure time was 167 minutes;

Group 3: After one year the success rate was 76% which was better than the CryoBalloon alone, but the difference wasn’t ‘statistically significant’ (meaning it could have occurred by chance); Average procedure time was 278 minutes.

How the Strategies Compare

In this single center study, the CryoBalloon plus RF lesions as needed strategy (Group 2) was faster, easier to use and was more effective after one year than RF point-by-point ablation approach (Group 1). Using the novel strategy of combining RF followed by CryoBalloon ablation (Group 3) did not significantly improve results and took longer to do.

Editor’s Comments:
When the authors designed this study, they thought the combined approach of RF followed by CryoBalloon (Group 3) would turn out to be superior to either RF alone or CryoBalloon with RF as needed. But the combined RF followed by CryoBalloon strategy was only superior to RF alone (Group 1).
Key Result for Patients: The most important finding of this study is that about 30% of CryoBalloon ablations required RF focal lesions to achieve isolation (and restore normal sinus rhythm).
CryoBalloon ablation is very effective. But for the best results, you want an EP who is not only experienced with CryoBalloon, but also, when needed, can use RF to map and isolate non-PV triggers.
Be cautious. With the advent of CryoBalloon ablation, some EPs with little or no expertise with RF ablations are now doing CryoBalloon ablations because they’re easier. Stay away from EPs who only do CryoBalloon ablation.
For example, recently a patient, still in A-Fib, sent me the O.R. (Operating Room) report of their CryoBalloon ablation. From reviewing the report, it appears the EP didn’t to make any attempt to map and isolate non-PV triggers, and simply shocked the patient to return him to normal sinus rhythm. This may work in some cases. But for this patient the ablation was a failure.
Most experienced EPs who have switched from RF to CryoBalloon ablation have the ability, skill and experience to use focal point RF as needed to make you A-Fib free.
Seek out these experienced EPs by asking “What do you do if I’m still in A-Fib after you do the CryoBalloon ablation? Will you use RF focal lesions to achieve isolation?”
References for this article

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