What is the clinical evidence from this study?

Study design: RCT. Population: drug-refractory paroxysmal atrial fibrillation (n=346). Intervention: Contact force-guided radiofrequency ablation (CF-RF) vs. 4-minute (Cryo-4) or 2-minute (Cryo-2) cryoballoon ablation. Primary outcome: Time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia between days 91 and 365 after ablation or a repeat ablation procedure (p=0.87).

What question did this study set out to answer?

To compare the 1-year efficacy and safety of contact force–guided radiofrequency ablation against two different application durations of cryoballoon ablation using continuous rhythm monitoring.

October 21, 2019CirculationOpen Access

Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring

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Why the study?

Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation and minimize arrhythmia recurrence after AF ablation.

Does cryoballoon ablation improve time to first recurrence of atrial tachyarrhythmia compared to contact force-guided radiofrequency ablation in patients with drug-refractory paroxysmal atrial fibrillation?

Population

346 patients with drug-refractory paroxysmal AF receiving an implantable loop recorder

Comparison

Contact force-guided RF ablation vs 4-minute cryoballoon ablation vs 2-minute cryoballoon ablation

Design

Multicenter, randomized, single-blinded trial

Follow-up

12 months

Key result

Contact force-guided radiofrequency and two cryoballoon ablation regimens showed no difference in 1-year freedom from atrial tachyarrhythmia (53.9% vs 52.2% vs 51.7%; P=0.87).

Authors

JAJason G. Andrade JCJean Champagne MDMarc Dubuc

Discussion

Member takes

Overview

No efficacy difference supports either approach in paroxysmal AF; confirms equivalence of contact force RF and cryoballoon ablation.

Key Points

To compare the 1-year efficacy and safety of contact force–guided radiofrequency ablation against two different application durations of cryoballoon ablation using continuous rhythm monitoring.
Multicenter, single-blinded randomized trial assigning 346 patients with drug-refractory paroxysmal AF to contact force–guided radiofrequency (CF-RF; n=115), 4-minute cryoballoon (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116) (NCT01913522).
All patients received an implantable loop recorder to continuously monitor atrial tachyarrhythmia recurrence and AF burden over a 12-month follow-up period.
One-year freedom from continuous monitor-detected atrial tachyarrhythmia was 53.9% with CF-RF, 52.2% with Cryo-4, and 51.7% with Cryo-2 (P=0.87), while freedom from symptomatic arrhythmia was 79.1%, 78.2%, and 73.3%, respectively (P=0.26).
Median AF burden decreased by 99.3% (IQR 67.8%–100.0%) with CF-RF, 99.9% (IQR 65.3%–100.0%) with Cryo-4, and 98.4% (IQR 56.2%–100.0%) with Cryo-2 (P=0.36), with serious adverse events in 2.6%, 5.3%, and 6.0% of patients, respectively (P=0.24).
CF-RF procedures took significantly longer total operating time but required significantly less fluoroscopy exposure compared to both cryoballoon protocols (P<0.001).

Study Design

Type

RCT (n=346)

Blinding

Single-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Population

346 patients with drug-refractory paroxysmal atrial fibrillation followed for 12 months.

Intervention

4-minute cryoballoon ablation (Cryo-4) or 2-minute cryoballoon ablation (Cryo-2)

Comparator

Contact force-guided radiofrequency ablation (CF-RF)

Outcome

Time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) between days 91 and 365 after ablation or a repeat ablation procedure at any timecomposite

Main Result

Absolute Event Rate: 53.9% vs 52.2%

p-value: p=0.87

Contact force-guided radiofrequency ablation and two different regimens of cryoballoon ablation showed no significant difference in 1-year efficacy for preventing atrial tachyarrhythmia recurrence in patients with paroxysmal AF.

Cite This Study

Andrade et al. (2019) conducted an RCT in drug-refractory paroxysmal atrial fibrillation (n=346). Contact force-guided radiofrequency ablation (CF-RF) vs. 4-minute (Cryo-4) or 2-minute (Cryo-2) cryoballoon ablation was evaluated on Time to first documented recurrence of symptomatic or asymptomatic atrial tachyarrhythmia between days 91 and 365 after ablation or a repeat ablation procedure (p=0.87). Contact force-guided radiofrequency and two cryoballoon ablation regimens showed no difference in 1-year freedom from atrial tachyarrhythmia (53.9% vs 52.2% vs 51.7%; P=0.87).

synapsesocial.com/papers/6a7d99fa286d888403cda37e https://doi.org/10.1161/circulationaha.119.042622

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October 21, 2019CirculationOpen Access

Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring

View Full Paper

Ask AI

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Why the study?

Advanced generation ablation technologies have been developed to achieve more effective pulmonary vein isolation and minimize arrhythmia recurrence after AF ablation.

Population

346 patients with drug-refractory paroxysmal AF receiving an implantable loop recorder

Comparison

Contact force-guided RF ablation vs 4-minute cryoballoon ablation vs 2-minute cryoballoon ablation

Design

Multicenter, randomized, single-blinded trial

Follow-up

12 months

Key result

Contact force-guided radiofrequency and two cryoballoon ablation regimens showed no difference in 1-year freedom from atrial tachyarrhythmia (53.9% vs 52.2% vs 51.7%; P=0.87).

Authors

JAJason G. Andrade JCJean Champagne MDMarc Dubuc

Discussion

Member takes

Overview

No efficacy difference supports either approach in paroxysmal AF; confirms equivalence of contact force RF and cryoballoon ablation.

Key Points

To compare the 1-year efficacy and safety of contact force–guided radiofrequency ablation against two different application durations of cryoballoon ablation using continuous rhythm monitoring.
Multicenter, single-blinded randomized trial assigning 346 patients with drug-refractory paroxysmal AF to contact force–guided radiofrequency (CF-RF; n=115), 4-minute cryoballoon (Cryo-4; n=115), or 2-minute cryoballoon ablation (Cryo-2; n=116) (NCT01913522).
All patients received an implantable loop recorder to continuously monitor atrial tachyarrhythmia recurrence and AF burden over a 12-month follow-up period.
One-year freedom from continuous monitor-detected atrial tachyarrhythmia was 53.9% with CF-RF, 52.2% with Cryo-4, and 51.7% with Cryo-2 (P=0.87), while freedom from symptomatic arrhythmia was 79.1%, 78.2%, and 73.3%, respectively (P=0.26).
Median AF burden decreased by 99.3% (IQR 67.8%–100.0%) with CF-RF, 99.9% (IQR 65.3%–100.0%) with Cryo-4, and 98.4% (IQR 56.2%–100.0%) with Cryo-2 (P=0.36), with serious adverse events in 2.6%, 5.3%, and 6.0% of patients, respectively (P=0.24).
CF-RF procedures took significantly longer total operating time but required significantly less fluoroscopy exposure compared to both cryoballoon protocols (P<0.001).

Study Design

Type

RCT (n=346)

Blinding

Single-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Population

346 patients with drug-refractory paroxysmal atrial fibrillation followed for 12 months.

Intervention

4-minute cryoballoon ablation (Cryo-4) or 2-minute cryoballoon ablation (Cryo-2)

Comparator

Contact force-guided radiofrequency ablation (CF-RF)

Outcome

Main Result

Absolute Event Rate: 53.9% vs 52.2%

p-value: p=0.87

Cite This Study

synapsesocial.com/papers/6a7d99fa286d888403cda37e https://doi.org/10.1161/circulationaha.119.042622

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