Young female physician talking to a female patient

RESTORING LIFE'S RHYTHM The sooner. The better.

New evidence states early rhythm control results in better cardiovascular outcomes.1 In addition, catheter ablation as a rhythm control strategy is more effective than drug therapy at preventing AF progression2 and is highly effective at reducing the amount of time patients spend in AF.3
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Clinical Evidence

Arctic Front™ cryoballoon:  first and only ablation catheter FDA approved for first-line treatment

Three randomized studies recently showed that cryoballoon ablation is superior to AADs for preventing atrial arrhythmia recurrence4-6 and is a safe and effective first-line treatment. 

View the Evidence

Efficacy4-6

STOP AF First (n = 225)

United States

Graph from the STOP AF First clinical trial that shows the efficacy of first line cryoablation over AF drug treatment

Enlarge STOP AF 

Cryo-First (n = 220)

Europe, Australia, and Argentina

Graph from the Cryo-FIRST European clinical trial that shows the efficacy of first line cryoablation over AF drug treatment

Enlarge Cryo-First

Early-AF (n = 303)

Canada

Graph from the EARLY-AF clinical trial that shows the efficacy of first line cryoablation over AF drug treatment

Enlarge Early-AF

Safety4-6

Across all three trials there was no death, AE fistula, stroke, or PV stenosis.

Quality of life (QOL) improvement4-6

First-line ablation is associated with better symptom resolution and larger improvements in AF-specific QOL.

 AF is a Progressive Disease

AF impacts an estimated 59.7 million patients worldwide7 and is a progressive disease.

Multicolored infographic highlighting the progressive nature of paroxysmal, persistent, and permanent atrial fibrillation.
This is a purple color index that supports an AF progressive disease infographic

AF-related remodeling 

This is a light blue color index that supports an AF progressive disease infographic

Age/disease-related remodeling

This is a medium blue color index that supports an AF progressive disease infographic

Genetic predisposition

The figure above was adapted from: Heijman J, Voigt N, Nattel S, Dobrev D. Cellular and molecular electrophysiology of atrial fibrillation initiation, maintenance, and progression. Circ Res. 2014;114:1483-1499.

As AF progresses, the risks become greater.

Decreased health-related quality of life
(EuroQoL-5D) due to worsening AF symptoms and adverse events (progression versus no progression)8

20%
higher risk of stroke or systemic embolism in patients with persistent/permanent versus paroxysmal AF treated with oral anticoagulation9

31%
of patients with AF have ≥ one hospitalization per year10

28%
higher risk of death in patients with persistent/permanent versus paroxysmal AF treated with oral anticoagulation9

1.5x
increased hospitalizations for cardiovascular problems and 2x for electrical cardioversions (progression versus no progression)11

Why refer for catheter ablation?

  • Catheter ablation is highly successful at reducing the time patients spend in AF.3
    • AF burden was reduced by 99% after catheter ablation for patients in paroxysmal AF.
  • Shorter diagnosis-to-ablation time is associated with lower arrhythmia recurrence and reduced cardiovascular hospitalization.12
  • Catheter ablation reduces progression to persistent AF.2
    • In the ATTEST trial, patients who underwent ablation were about 10x less likely than patients on AADs to develop persistent AF.

The Leading Ablation Technology for First-line Treatment

PVI isolation 

PVI by catheter ablation is considered the cornerstone of AF ablation. The anatomical design of the Medtronic cryoballoon makes it an ideal choice for PVI.13

Preservation of cardiac tissue

Cryoballoon has demonstrated higher rates of durable lesions than radiofrequency, leading to fewer cardiovascular hospitalizations and repeat ablations.14,15

Radiofrequency lesion at one week.16 Arrow indicating thrombus and disrupted endocardium.

Radiofrequency canine lesion showing thrombus and a disrupted endocardium

Cryolesion at one week.16 Well-demarcated with minimal thrombus and endocardium intact.

Cryoablation canine lesion showing minimal thrombus damage and intact endocardium

Efficient and predictable17

  • Opportunity for conscious sedation and same-day discharge18,19
  • Shorter and predictable procedure times (take control, block scheduling)

Predictable patient outcomes

  • Fewer repeat ablations15
  • Fewer rehospitalizations15
  • Fewer cardioversions15
  • More predictable outcomes regardless of experience or volume17

Additional efficiency protocols

  • Minimal intraprocedural discomfort; enables moderate sedation protocols20
  • Patient-specific dosing via time-to-isolation dosing21-23
  • Enables same-day discharge24

Early Treatment

The Medtronic cryoablation catheters have led AF ablation innovation in safety and efficacy for more than 16 years and have treated over 1 million patients worldwide.

  

Learn more about Cryo

References

1

 Kirchhof P, Camm AJ, Goette A, et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. October 2020;383(14):1305-1316.

2

Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. March 2021;23(3):362-369.

3

Andrade JG, Champagne J, Dubuc M, et al. Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial. Circulation. November 2019;140(22):1779-1788.

4

Kuniss M, Pavlovic N, Velagic V, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021;23(7):1033-1041.

5

Wazni OM, Dandamudi G, Sood N, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. January 2021;384(4):316-324.

6

Andrade JG, Wells GA, Deyell MW, et al. Cryoballoon or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. January 2021;384(4):305-315.

7

Roth GA, Mensah GA, Johnson CO, et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020;76:2982-3021.

8

Dudink EAMP, Erkuner O, Berg J, et al. The influence of progression of atrial fibrillation on quality of life: a report from the Euro Heart Survey. Europace. June 2018;20(6):929-934.

9

Zhang W, Xiong Y, Yu L, Xiong A, Bao H, Cheng X. Meta-analysis of Stroke and Bleeding Risk in Patients with Various Atrial Fibrillation Patterns Receiving Oral Anticoagulants. Am J Cardiol. March 2019;123(6):922-928.

10

Steinberg BA, Kim S, Fonarow GC, et al. Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. May 2014;167(5):735-42.e2.

11

de Vos CB, Pisters R, Nieuwalaat R, et al. Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J AM Coll Cardiol. February 2010;55(8):725-731.

12

Kawaji T, Shizuta S, Yamagami S, et al. Early choice for catheter ablation reduced readmission in management of atrial fibrillation: Impact of diagnosis-to-ablation time. Int J Cardiol. September 2019;291:69-76.

13

Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. October 2017;14(10):e275-e444.

14

Kuck KH, Albenque JP, Chun KJ, et al. Repeat Ablation for Atrial Fibrillation Recurrence Post Cryoballoon or Radiofrequency Ablation in the FIRE AND ICE Trial. Circ Arrhythm Electrophysiol. May 2019;12(6):e007247.

15

Kuck KH, Furnkranz A, Chun KR, et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. October 2016;37(38):2858-2865.

16

Khairy P, Chauvet P, Lehmann J, et al. Lower incidence of thrombus formation with cryoenergy versus radiofrequency catheter ablation. Circulation. April 2003;107(15):2045-2050.

17

Providencia R, Defaye P, Lambiase PD, et al. Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: is cryoablation more reproducible? Europace. January 2017;19(1):48-57.

18

Kowalski M, Parikh V, Salcido JR, et al. Same-day discharge after cryoballoon ablation of atrial fibrillation: A multicenter experience. J Cardiovasc Electrophysiol. February 2021;32(2):183-190.

19

Opel A, Mansell J, Butler A, et al. Comparison of a high throughput day case atrial fibrillation ablation service in a local hospital with standard regional tertiary cardiac centre care. Europace. March 2019;21(3):440-444.

20

Wasserlauf J, Kaplan RM, Walega DR, et al. Patient-reported outcomes after cryoballoon ablation are equivalent between moderate sedation and general anesthesia. J Cardiovasc Electrophysiol 2020;31:1579-1584.

21

Fürnkranz A, Bologna F, Bordignon S, et al. Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon. Europace. December 2016;18(12):1795-1800.

22

Aryana A, Mugnai G, Singh SM, et al. Procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation. Heart Rhythm. February 2016;13(2):424-432.

23

Chun KR, Stich M, Fürnkranz A, et al. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. Heart Rhythm. April 2017;14(4):495-500.

24

Reddy SA, Nethercott SL, Chattopadhyay R, Heck PM, Virdee MS. Safety, Feasibility and Economic Impact of Same-Day Discharge Following Atrial Fibrillation Ablation. Heart Lung Circ. December 2020;29(12):1766-1772.