9/11/2019 Catheter Ablation of Atrial Fibrillation 1 APAF 2 STOP‐AF 70% 93% 7% Catheter Ablation of AF – 35% Expected Outcomes with Cryoballoon vs. RF 3 4 Jason G. Andrade 89% 66% 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 23% 1. Pappone C et al. J Am Coll Cardiol 2006;48(11):2340‐7. 16% 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. Catheter Ablation of Atrial Fibrillation Disclosures Contact‐Force RF Ablation Grants/Research Support: • Baylis Medical • Medtronic, Inc Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441. 1
9/11/2019 CRYO VS. RF – LESION SCIENCE Catheter Ablation of Atrial Fibrillation • Cell membrane collapse RADIOFREQUENCY Thrombus • Protein denaturation Contact‐Force RF Ablation • Halt in enzyme function Disrupted Tissue temperature • Impairs DNA replication endocardium • Patient anatomy is variable • Mitochondrial dysfunction Persistent hemorrhage Warmer than 50 o C • Atrial tissue depth differs • Cytoskeletal denaturation • Coagulative necrosis • Complex / time‐consuming +70°C • 50 W • 60 seconds • Cardiac contractions make maintaining position difficult • Catheter force varies with position in heart • Rapid edema formation: • ↓ lesion penetra�on • ↓ long‐term durability • Collateral damage Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441. CRYO VS. RF – LESION SCIENCE Catheter Ablation of Atrial Fibrillation • Cell membrane collapse Thrombus RADIOFREQUENCY • Protein denaturation Contact‐Force RF Ablation Cryoballoon Ablation • Halt in enzyme function Disrupted Tissue temperature • Impairs DNA replication endocardium • Mitochondrial dysfunction Persistent hemorrhage Warmer than 50 o C • Cytoskeletal denaturation • Coagulative necrosis +70°C • 50 W • 60 seconds • Extracellular ice (‐15 o C) CRYOABLATION • Dehydration (water out) Intact endocardium • Imbalance of solutes (H + in) • Intracellular ice (‐40 o C) well demarcated border Tissue temperature • Damage to cell machinery • Mechanical shear stress Colder than ‐20 o C • Vascular Injury more homogeneous lesion • Vasoconstriction • Microvascular thrombosis -75°C • 1 x 4 minutes Andrade JG, et al. Canadian Journal of Cardiology 2014; 30(12):s431‐s441. 2
9/11/2019 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source The Clinical Effect of the Energy Source How lesions are created equal? How lesions are not created equal? PACE 2008; 31:112–120 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source Lesion Size ‐ Biomarkers of Myocardial Injury Schmidt et al. Wojcik et al. Herrera Siklódy et al. RF • w Cryo RF Cryo PACE 2008; 31:112–120 Rev Esp Cardiol. 2011;64(2):127–132 Heart Rhythm 2012;9:189 –196 3
9/11/2019 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source AF Outcomes Overall Randomised Trials How lesions are created equal? How lesions are not created equal? 1. Non‐AF AT 1. Lesion size 2. Complications 2. AF outcomes a. Thromboembolism 3. Quality of Life b. Esophagus CB2 vs. CF‐RF 4. Health Care Utilisation 3. Procedure 4. Prognostication a. Dormant Conduction b. ERAF 5. Learning Curve • No difference in the risk of recurrent AF in observational studies, 6. Reproducibility randomised studies, or new generation technologies Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: AF Outcomes AF Outcomes Overall Randomised Trials Overall Randomised Trials CB2 vs. CF‐RF CB2 vs. CF‐RF • No difference in the risk of recurrent AF in observational studies, • No difference in the risk of recurrent AF in observational studies, randomised studies, or new generation technologies randomised studies, or new generation technologies 4
9/11/2019 CIRCA CIRCA CIRCA‐DOSE Outline DOSE DOSE CvRF – Efficacy 353 patients enrolled 6 did not undergo ablation 30‐90 days prior to ablation 353 patients implanted with Reveal LINQ 1 withdrawn 79.1% CF‐RF 79.1% CRYO‐4 Freedom From Symptomatic Tachyarrhythmia 7‐14 days prior to ablation 346 patients randomized 73.3% CRYO‐2 53.9% CF‐RF 52.2% CRYO‐4 Freedom From ANY Atrial Tachyarrhythmia 115 randomized to CF‐RF 115 randomized to CRYO‐4 116 randomized to CRYO‐2 51.7% CRYO‐2 0 Death 0 Death 1 Death 115 114 114 1 Protocol violation 1 Protocol violation 0 Protocol violation completed study completed study completed study 0 Withdrew 1 Withdrew 1 Withdrew 0 Lost to follow‐up 0 Lost to follow‐up 0 Lost to follow‐up 115 included in primary analysis 115 included in primary analysis 116 included in primary analysis CIRCA CIRCA DOSE DOSE CvRF – Efficacy CvRF – Efficacy 79.1% CF‐RF 79.1% CRYO‐4 Freedom From Symptomatic Tachyarrhythmia 73.3% CRYO‐2 53.9% CF‐RF 53.9% CF‐RF 52.2% CRYO‐4 Freedom From ANY Atrial Tachyarrhythmia 52.2% CRYO‐4 Freedom From ANY Atrial Tachyarrhythmia 51.7% CRYO‐2 51.7% CRYO‐2 5
9/11/2019 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: The Clinical Effect of the Energy Source Quality of Life Outcomes European Heart Journal (2016) 37, 2858–2865 How lesions are created equal? How lesions are not created equal? 1. Non‐AF AT 1. Lesion size 2. Complications 2. AF outcomes a. Thromboembolism 3. Quality of Life b. Esophagus 4. Health Care Utilisation 3. Procedure 4. Prognostication a. Dormant Conduction b. ERAF 5. Learning Curve 6. Reproducibility CF‐RF Cryoballoon CF‐RF Cryoballoon Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: Quality of Life Outcomes The Clinical Effect of the Energy Source European Heart Journal (2016) 37, 2858–2865 How lesions are created equal? How lesions are not created equal? 1. Non‐AF AT 1. Lesion size 2. Complications 2. AF outcomes a. Thromboembolism 3. Quality of Life b. Esophagus 4. Health Care Utilisation 3. Procedure 4. Prognostication a. Dormant Conduction b. ERAF 5. Learning Curve 6. Reproducibility 6
9/11/2019 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: Health Care Utilisation Health Care Utilisation Rehospitalisation Reablation European Heart Journal 2016; 37, 2858–2865 Cryoballoon vs. Radiofrequency: Cryoballoon vs. Radiofrequency: Health Care Utilisation The Clinical Effect of the Energy Source How lesions are created equal? How lesions are not created equal? 1. Non‐AF AT 1. Lesion size 2. Complications 2. AF outcomes a. Thromboembolism 3. Quality of Life b. Esophagus Rehospitalisation Reablation 4. Health Care Utilisation 3. Procedure 4. Prognostication a. Dormant Conduction b. ERAF 5. Learning Curve 6. Reproducibility European Heart Journal 2016; 37, 2858–2865 7
9/11/2019 Cryoballoon vs. Radiofrequency: CvRF – Complications How lesions are not created equal? • Significant differences: 1. Non‐AF AT OR 0.44 • Pericardial Effusion 2. Complications • Tamponade • Phrenic Nerve Palsy 3. Esophagus • No significant difference in : 4. Procedure • Vascular complications • 1.7% CB vs. 2.0% RF 5. Learning Curve OR 0.31 • OR 0.75; 95%CI 0.51‐1.11 OR 0.46 • P=0.15 (14 studies; 6,463 pts) 6. Consistency • Major vascular complications • 1.1% CB vs. 1.3% RF 7. Health Care Utilisation • OR 0.79; 95% CI 0.38‐1.62 Significantly lower incidence of non‐AF Atrial Tachycardia • P=0.52 (7 studies; 3,264 pts) • Stroke • CB (3/1, 422; 0.2%) • RF (8/2, 636; 0.3%) (P= 0.63) OR 7.40 J Cardiovasc Electrophysiol, Vol. 27, pp. 1151‐1159, October 2016 Cryoballoon vs. Radiofrequency: CvRF – Complications How lesions are not created equal? • Significant differences: 1. Non‐AF AT OR 0.44 • Pericardial Effusion Serious Complication Risk – OR 0.39 with Cryo 2 2. Complications • Tamponade • Phrenic Nerve Palsy 3. Esophagus • No significant difference in : 4. Procedure • Vascular complications • 1.7% CB vs. 2.0% RF 5. Learning Curve OR 0.31 • OR 0.75; 95%CI 0.51‐1.11 • P=0.15 (14 studies; 6,463 pts) 6. Consistency • Major vascular complications • 1.1% CB vs. 1.3% RF 7. Health Care Utilisation • OR 0.79; 95% CI 0.38‐1.62 • P=0.52 (7 studies; 3,264 pts) • Stroke Tamponade, GI bleeding, esophageal ulceration, and thromboembolic events • CB (3/1, 422; 0.2%) • RF (8/2, 636; 0.3%) (P= 0.63) OR 7.40 Jin ES, et al. Korean Circ J 2018;48(2):114-123. J Cardiovasc Electrophysiol, Vol. 27, pp. 1151‐1159, October 2016 8
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