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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)

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