WHY AND WHEN TO REFER PATIENTS FOR CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION

FIRST-LINE CRYOBALLOON ABLATION

CRYO-FIRST TRIAL

Atrial Arrhythmia study result graph

Catheter Cryoablation versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation (Cryo-FIRST) is a 1:1 randomised control trial designed to compare the safety and efficacy of antiarrhythmic drug (AAD) therapy against cryoballoon pulmonary vein isolation (PVI) as a first-line therapy in treatment naïve patients with paroxysmal AF (PAF).

Study Size: 220 patients enrolled by 18 hospitals.

Primary Endpoint: Freedom from any atrial arrhythmia >30 seconds after blanking

Principal Investigators: Gian Battista Chierchia (BE), Malte Kuniss (DE)

Conclusions:
  • The Cryo-FIRST trial demonstrated that PVI performed with the Arctic Front Advance ™ Cryoablation catheter can reduce atrial arrhythmia recurrence safely and more effectively than AAD therapy in first-line patients with symptomatic PAF1.
Key findings:
  • Cryoballoon catheter ablation was associated with a >50% reduction in the risk of atrial arrhythmia recurrence compared to AAD therapy at 12 months post-treatment2
  • A similar safety profile was observed in both arms when examining serious adverse events during the study2
  • AF-Specific quality of life was significantly higher in the catheter ablation group at 3, 6, 9 and 12 month follow-up3

Watch Prof. G.B. Chierchia present :

  • The primary and secondary end point results from Cryo-FIRST

Watch Dr. M. Kuniss present:

  • The primary endpoint results from the Cryo-FIRST trial, comparing the safety and efficacy of first-line cryoablation vs. AADs

Watch Dr. A. Metzner discuss:

  • The impact of AF progression and the value of early AF ablation
  • Benefits of first-line cryoablation vs. AADs
Graph cryoballoon ablation

STOP AF FIRST TRIAL

The STOP AF First Trial (NCT03118518) was an FDA-regulated, prospective, multicentre randomised study designed to evaluate the safety and effectiveness of the Medtronic cryoablation system as an initial first-line treatment in patients with symptomatic paroxysmal atrial fibrillation (PAF).  Patients were randomised (1:1) to antiarrhythmic drug therapy (class I or III) or pulmonary vein isolation with the Arctic Front Advance ™ Cryoablation catheter. 

Study Size: 225 patients enrolled by 24 hospitals (U.S.)

Primary Safety Endpoint:

  • Composite of pre-specified procedure and system-related serious adverse events
  • Prespecified performance goal: failure rate <12%

Primary Efficacy Endpoint

Treatment success at 12 months.

Treatment failure included:

  • Acute procedural failure
  • Any subsequent AF surgery or ablation in the left atrium (including those performed during the blanking period)
  • Any of the following after the 90-day blanking period:
    • Documented AF/AT/AFL; cardioversion; class I or III AAD use (ablation arm only)

Principal Investigator: Oussama Wazni

Conclusions:

  • Freedom from primary efficacy failure at 12 months was 74.6% for the cryoballoon arm and 45% for the AAD arm (p < 0.001)4
  • Two primary safety events were observed in the catheter ablation arm (estimated 12-month rate: 1.9%)4

Graph recurrence atrial tachyarrhythmia

EARLY-AF TRIAL

Early Aggressive Invasive Intervention for Atrial Fibrillation (EARLY AF, NCT02825979) is a multicentre, randomized, controlled trial comparing the safety and efficacy of Arctic Front AdvanceTM Cryoablation with antiarrhythmic drug (AAD) therapy as a first line therapy. Clinical efficacy was assessed by an insertable cardiac monitor (ICM).

Study Size: 303 patients enrolled by 18 hospitals in Canada

Primary Endpoint:
Time to first recurrence of any symptomatic or asymptomatic atrial tachyarrhythmia ≥30 sec between days 91 and 365 after treatment initiation.

Principal Investigator: Jason Andrade (CA)

Key findings:
  • Freedom from asymptomatic or symptomatic atrial tachyarrhythmia (AF/AFL/AT) was 57.1% in cryoablation group vs. 32.2% in the AAD group at 12 months5
  • Freedom from symptomatic arrhythmia recurrence was 89.0% in the ablation group and 73.8% in the AAD group at 12 months5
  • The percentage of patients with a serious adverse event related to the trial regimen was similar between groups5
Conclusions:
  • First-line ablation was associated with a significant reduction in time to first recurrence of symptomatic and asymptomatic atrial tachyarrhythmia (AF/AFL/AT)5
  • Ablation was associated with larger improvements in quality of life and a higher rate of symptom resolution5

Study Highlights

Watch Prof. J. Andrade present the key findings from EARLY-AF 

Watch Prof. J. Camm, Prof. J. Andrade, Dr. O. Wazni, and Dr. N. Pavlović discuss the Cryo-FIRST, STOP AF First, and EARLY-AF trial findings

CRYO-FIRST BROCHURE

Learn more about the Cryo-FIRST trial results.

Download

STOP AF FIRST
FLYER

225 patients enrolled from 24 centres in the Unites States.

Download

CLINICAL PRESENTATION

Complete the form to access the Cryo-FIRST peer-to-peer presentation.

Download

ATRIAL FIBRILLATION PROGRESSION

AF is progressive is nature, with longer diagnosis-to-ablation times associated with markers of atrial remodelling2.

For patients with symptomatic paroxysmal AF, antiarrhythmic drugs (AAD) are often prescribed as the first-line therapy. However, these drugs fail to prevent AF recurrence in up to 50% of patients3. Some of these patients go on to receive catheter ablation.

Importantly, prior studies suggest that a shorter diagnosis to ablation time is associated with lower rates of atrial arrythmia recurrence, repeat procedures, and cardiovascular hospitalisation4-7. These observations paired with evidence that catheter ablation can halt AF progression more effectively than AAD therapy7 has sparked debate around the optimal first line therapy for symptomatic AF patients.

The positive results from the Cryo-FIRST study demonstrate Cryoballoon ablation is safe and superior to AAD therapy in reducing AF recurrence in this first line patient population1.

AF DETECTION AND TREATMENT

  • AF detection tools that are best suited for different patients and how they can impact clinical practice
  • AF detection and treatment guidelines
  • Who should be referred for an AF ablation and what outcomes can be expected
  • An overview of AF progression and the benefits of early treatment
  • AF patient expectations for treatment
  • Risks and benefits associated with AF ablation compared to AAD therapy
  • The role of AF management guidelines in improving the standard of care delivered to patients

2020 ESC Guidelines for atrial fibrillation Management

The 2020 ESC Guidelines for the Diagnosis and Management of Atrial Fibrillation recommend catheter ablation for AF symptom improvement (class I, level A), targeting pulmonary vein isolation (class I, level A)6.

AF Catheter Ablation as a First-line Therapy:

  • Should be considered as first-line rhythm control therapy to improve symptoms in selected patients with symptomatic paroxysmal AF episodes (class IIa, level B)
  • May be considered for persistent AF without major risk factors for AF recurrence (level IIb, level C)
  • Is recommended to reverse LV dysfunction in AF patients when tachycardia-induced cardiomyopathy is highly probable, independent of their symptom status (class I, level A)
  • Should be considered in selected AF patients with HF with reduced LVEF to improve survival and reduce HF hospitalization (class IIa, level B)6

2020 ESC Guidelines Highlights
Watch Prof. G. Hindricks explain key updates made to the ESC Guidelines for AF Management.
Please refer to the following link for additional guidance on which patients to refer for catheter ablation: 2020 ESC Guidelines on AF Management

TREATING PERSISTENT ATRIAL FIBRILLATION

Find out more
Atric Front Advance Pro Cryoballoon

PATIENT VIDEOS FOR YOUR WAITING ROOM​

Part 1 - What is Atrial Fibrillation - (04:00)

Atrial Fibrillation Disease And Symptoms
More information (see more) Less information (see less)

Part 2 - What is Atrial Fibrillation - (03:14)

patient resources

 

 

 

VIEW PATIENT BROCHURE

EDUCATIONAL
RESOURCES
ON MEDTRONIC 
ACADEMY

Find additional feature information along with a variety of educational resources and tools.

Visit Medtronic Academy

request more information

 

 

 

Contact us

References

1

Hermida et al., Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study. Am Heart J. 2020 Apr;222:64-72    

2

Kuniss et al. Presented at the German Cardiac Society conference DGK 2020.

3

Chierchia, GB., et al. Quality of Life Measured in First-Line Therapy During the Cryo-FIRST Study: A Comparison Between Cryoballoon Catheter Ablation Versus Antiarrhythmic Drug Therapy. Poster presented at the 2020 ESC Congress – The Digital Experience.

4

Wazni et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. New England Journal of Medecine. 2020. 

5

Andrade, J. et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. New England Journal of Medecine. 2020.    

6

Hindricks, G., et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2020. 00, 1-126.