[PDF] - Catheter Ablation of AF 35% Expected Outcomes with Cryoballoon vs. PDF Document

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Catheter Ablation of AF –

Expected Outcomes with Cryoballoon vs. RF

Jason G. Andrade

Cardiology and Cardiac Electrophysiology, Division of Cardiology, Vancouver General Hospital and Montreal Heart Institute Associate Professor, University of British Columbia; Adjunct Professor, Université de Montréal Medical Lead, Atrial Fibrillation Care, Cardiac Services British Columbia, Canada Email: jason.andrade@vch.ca twitter: @drJasonAndrade

Disclosures

Grants/Research Support:

Baylis Medical
Medtronic, Inc

Catheter Ablation of Atrial Fibrillation

APAF 93% 35% 89% 23%

1 3

70% 7% 66% 16% STOP‐AF

2 4

1. Pappone C et al. J Am Coll Cardiol 2006;48(11):2340‐7.
2. Packer DL et al. J Am Coll Cardiol 2013;61(16):1713‐23.
3. Jais P et al. Circulation 2008;118(24):2498‐505.
4. Wilber DJ et al. JAMA 2010;303(4):333‐40.

Contact‐Force RF Ablation

Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441.

Catheter Ablation of Atrial Fibrillation

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Contact‐Force RF Ablation

Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441.

Patient anatomy is variable
Atrial tissue depth differs
Complex / time‐consuming
Cardiac contractions make

maintaining position difficult

Catheter force varies with

position in heart

Rapid edema formation:
↓ lesion penetraon
↓ long‐term durability
Collateral damage

Catheter Ablation of Atrial Fibrillation

Contact‐Force RF Ablation

Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441.

Cryoballoon Ablation

Catheter Ablation of Atrial Fibrillation CRYO VS. RF – LESION SCIENCE

RADIOFREQUENCY

Disrupted endocardium Thrombus Persistent hemorrhage +70°C • 50 W • 60 seconds

Tissue temperature Warmer than 50oC

Cell membrane collapse
Protein denaturation
Halt in enzyme function
Impairs DNA replication
Mitochondrial dysfunction
Cytoskeletal denaturation
Coagulative necrosis

CRYO VS. RF – LESION SCIENCE

RADIOFREQUENCY CRYOABLATION

Disrupted endocardium Thrombus Persistent hemorrhage +70°C • 50 W • 60 seconds more homogeneous lesion well demarcated border

75°C • 1 x 4 minutes

Intact endocardium

Tissue temperature Warmer than 50oC Tissue temperature Colder than ‐20oC

Cell membrane collapse
Protein denaturation
Halt in enzyme function
Impairs DNA replication
Mitochondrial dysfunction
Cytoskeletal denaturation
Coagulative necrosis
Extracellular ice (‐15oC)
Dehydration (water out)
Imbalance of solutes (H+ in)
Intracellular ice (‐40oC)
Damage to cell machinery
Mechanical shear stress
Vascular Injury
Vasoconstriction
Microvascular thrombosis

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PACE 2008; 31:112–120

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source

PACE 2008; 31:112–120

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source

How lesions are created equal? How lesions are not created equal?

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source Cryoballoon vs. Radiofrequency: Lesion Size ‐ Biomarkers of Myocardial Injury

w

RF Cryo Cryo RF

Rev Esp Cardiol. 2011;64(2):127–132 Heart Rhythm 2012;9:189 –196

Schmidt et al. Wojcik et al. Herrera Siklódy et al.

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How lesions are created equal?

1. Lesion size
2. AF outcomes
3. Quality of Life
4. Health Care Utilisation

How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Thromboembolism b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source

No difference in the risk of recurrent AF in observational studies,

randomised studies, or new generation technologies Overall Randomised Trials CB2 vs. CF‐RF

Cryoballoon vs. Radiofrequency: AF Outcomes

No difference in the risk of recurrent AF in observational studies,

randomised studies, or new generation technologies Overall Randomised Trials CB2 vs. CF‐RF

Cryoballoon vs. Radiofrequency: AF Outcomes

No difference in the risk of recurrent AF in observational studies,

randomised studies, or new generation technologies Overall Randomised Trials CB2 vs. CF‐RF

Cryoballoon vs. Radiofrequency: AF Outcomes

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CIRCA‐DOSE Outline

353 patients enrolled 6 did not undergo ablation 1 withdrawn 346 patients randomized 115 randomized to CF‐RF 115 randomized to CRYO‐4 116 randomized to CRYO‐2 353 patients implanted with Reveal LINQ 115 completed study 0 Death 1 Protocol violation 0 Withdrew 0 Lost to follow‐up 114 completed study 0 Death 1 Protocol violation 1 Withdrew 0 Lost to follow‐up 114 completed study 1 Death 0 Protocol violation 1 Withdrew 0 Lost to follow‐up 116 included in primary analysis 115 included in primary analysis 115 included in primary analysis 30‐90 days prior to ablation 7‐14 days prior to ablation

CIRCA DOSE

CvRF – Efficacy

Freedom From ANY Atrial Tachyarrhythmia 53.9% CF‐RF 52.2% CRYO‐4 51.7% CRYO‐2

CIRCA DOSE

CvRF – Efficacy

Freedom From ANY Atrial Tachyarrhythmia 53.9% CF‐RF 52.2% CRYO‐4 51.7% CRYO‐2 79.1% CF‐RF 79.1% CRYO‐4 73.3% CRYO‐2 Freedom From Symptomatic Tachyarrhythmia

CIRCA DOSE CIRCA DOSE

CvRF – Efficacy

Freedom From ANY Atrial Tachyarrhythmia 53.9% CF‐RF 52.2% CRYO‐4 51.7% CRYO‐2 79.1% CF‐RF 79.1% CRYO‐4 73.3% CRYO‐2 Freedom From Symptomatic Tachyarrhythmia

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How lesions are created equal?

1. Lesion size
2. AF outcomes
3. Quality of Life
4. Health Care Utilisation

How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Thromboembolism b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source Cryoballoon vs. Radiofrequency: Quality of Life Outcomes

European Heart Journal (2016) 37, 2858–2865

Cryoballoon vs. Radiofrequency: Quality of Life Outcomes

CF‐RF CF‐RF Cryoballoon Cryoballoon

European Heart Journal (2016) 37, 2858–2865

How lesions are created equal?

1. Lesion size
2. AF outcomes
3. Quality of Life
4. Health Care Utilisation

How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Thromboembolism b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source

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Cryoballoon vs. Radiofrequency: Health Care Utilisation Cryoballoon vs. Radiofrequency: Health Care Utilisation

Rehospitalisation

Reablation

European Heart Journal 2016; 37, 2858–2865

Cryoballoon vs. Radiofrequency: Health Care Utilisation

Rehospitalisation

Reablation

European Heart Journal 2016; 37, 2858–2865

How lesions are created equal?

1. Lesion size
2. AF outcomes
3. Quality of Life
4. Health Care Utilisation

How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Thromboembolism b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source

SLIDE 8

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1. Non‐AF AT
2. Complications
3. Esophagus
4. Procedure
5. Learning Curve
6. Consistency
7. Health Care Utilisation

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

Significantly lower incidence of non‐AF Atrial Tachycardia

OR 0.46

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

Jin ES, et al. Korean Circ J 2018;48(2):114-123.

1. Non‐AF AT
2. Complications
3. Esophagus
4. Procedure
5. Learning Curve
6. Consistency
7. Health Care Utilisation

Serious Complication Risk – OR 0.39 with Cryo2

Tamponade, GI bleeding, esophageal ulceration, and thromboembolic events

Significant differences:
Pericardial Effusion
Tamponade
Phrenic Nerve Palsy
No significant difference in:
Vascular complications
1.7% CB vs. 2.0% RF
OR 0.75; 95%CI 0.51‐1.11
P=0.15 (14 studies; 6,463 pts)
Major vascular complications
1.1% CB vs. 1.3% RF
OR 0.79; 95% CI 0.38‐1.62
P=0.52 (7 studies; 3,264 pts)
Stroke
CB (3/1, 422; 0.2%)
RF (8/2, 636; 0.3%) (P= 0.63)

CvRF – Complications

J Cardiovasc Electrophysiol, Vol. 27, pp. 1151‐1159, October 2016

OR 0.44 OR 0.31 OR 7.40

Significant differences:
Pericardial Effusion
Tamponade
Phrenic Nerve Palsy
No significant difference in:
Vascular complications
1.7% CB vs. 2.0% RF
OR 0.75; 95%CI 0.51‐1.11
P=0.15 (14 studies; 6,463 pts)
Major vascular complications
1.1% CB vs. 1.3% RF
OR 0.79; 95% CI 0.38‐1.62
P=0.52 (7 studies; 3,264 pts)
Stroke
CB (3/1, 422; 0.2%)
RF (8/2, 636; 0.3%) (P= 0.63)

CvRF – Complications

J Cardiovasc Electrophysiol, Vol. 27, pp. 1151‐1159, October 2016

OR 0.44 OR 0.31 OR 7.40

SLIDE 9

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Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

500 1000 1500 2000 2500 3000 3500 4000 4500 CRF iRF CB 500 1000 1500 2000 2500 3000 3500 4000 4500 PVAC PVAC‐ACT CB J Cardiovasc Electrophysiol 2009; 20; 1102‐1107 Circ Arrhythm Electrophysiol. 2013;6:473‐480

P=0.19 P=0.001 P=0.02 P=0.14 P<0.001 P<0.001

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility
Cryoablation
Normal elastic fibers and tensile strength
Radiofrequency
Disruption of elastic fiber architecture
Acute degradation of tensile strength

Masson’s Trichrome Elastica‐Van Gieson’s RF Cryo

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility
Cryoablation
Normal elastic fibers and tensile strength
Radiofrequency
Disruption of elastic fiber architecture
Acute degradation of tensile strength

Masson’s Trichrome Elastica‐Van Gieson’s RF Cryo

Esophageal ulceration (22% RF, 0% Cryo)

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

Jin ES, et al. Korean Circ J. 2018 Feb;48(2):114-123

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Procedure Time – mean difference ‐37.6 minutes with cryo Fluoroscopy Time – mean difference ‐3.1 minutes with cryo

SLIDE 10

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Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Dormant Conduction b. ERAF

5. Learning Curve
6. Reproducibility

Procedure Time – mean difference ‐37.6 minutes with cryo Fluoroscopy Time – mean difference ‐3.1 minutes with cryo

P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 P=NS P<0.001

20 40 60 80 100 120 140 160 180 Procedure Duration Left Atrial Time Fluoroscopy Time CF‐RF CRYO‐4 CRYO‐2

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Adenosine b. ERAF

5. Learning Curve
6. Reproducibilit

56 41 56 43 60.4 35.8 27.6 53 39 15 16 13 21 6 10 42 11 8 4.5 15 10 20 30 40 50 60 70

Radiofrequency Cryoballoon CF‐RF

1st generation 2nd generation

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Adenosine b. ERAF

5. Learning Curve
6. Reproducibilit

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Adenosine b. ERAF

5. Learning Curve
6. Reproducibilit

SLIDE 11

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Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Adenosine b. ERAF

5. Learning Curve
6. Reproducibility

Hagerstown, et al. J Cardiovasc Med 2017;18(7):518‐527. First 30 pt/OP (120 patients) Second 30 pt/OP (120 patients) Senior Operator (60 patients)

Cryoballoon vs. Radiofrequency: How lesions are not created equal?

1. Non‐AF AT
2. Complications

a. Brain b. Esophagus

3. Procedure
4. Prognostication

a. Adenosine b. ERAF

5. Learning Curve
6. Reproducibility

Providencia R, et al. Europace 2017;19(1):48‐57.

Radiofrequency Cryoballoon

860 consecutive patients undergoing a first ablation procedure for paroxysmal AF

Summary – Cryo and RF

Cryoballoon given similar efficacy outcomes to RF
Similar benefit on quality of life and HCU
Less serious complications with cryoballoon ablation
Shorter, more reproducible ablation procedure with cryoballoon

CIRCA DOSE

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Cryoballoon vs. Radiofrequency: Anatomic Variants – Common Ostia Cryoballoon vs. Radiofrequency: Anatomic Variants – Common Ostia

Kubala et al. PACE 2011; 34:837
Normal PV pattern associated

with fewer recurrences at 13m

[33% vs. 50%; P=0.02]

Cryoballoon vs. Radiofrequency: Anatomic Variants – Common Ostia Cryoballoon vs. Radiofrequency: Anatomic Variants – Common Ostia

Kubala et al. PACE 2011; 34:837
Normal PV pattern associated

with fewer recurrences at 13m

[33% vs. 50%; P=0.02]