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New Advances in Atrial Fibrillation Ablation: Cryoballoon-Based Pulmonary Vein Isolation

New Advances in Atrial Fibrillation Ablation: Cryoballoon-Based Pulmonary Vein Isolation . Ahmed F. Osman, MD, FACC FESC, FHRS, FASE Florida Heart Rhythm Specialists, PLLC Director, Cardiac EP lab, Broward General Medical Center NOVA Southeastern University . 1.

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New Advances in Atrial Fibrillation Ablation: Cryoballoon-Based Pulmonary Vein Isolation

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  1. New Advances in Atrial Fibrillation Ablation: Cryoballoon-Based Pulmonary Vein Isolation Ahmed F. Osman, MD, FACC FESC, FHRS, FASE Florida Heart Rhythm Specialists, PLLC Director, Cardiac EP lab, Broward General Medical Center NOVA Southeastern University 1

  2. Atrial Fibrillation Health Risks and Costs Negative impact on quality of life1,2 Leading cause of stroke: 5x increased risk3 Increases risk of heart failure4 Increases US healthcare system costs: $12 billion estimated cost to treat AF5 1.Singh SN, et al. J Am Coll Cardiol. 2006;48:721-730. 2.Kang Y. Heart Lung. 2006;35:170-177. 3.Wolf PA, et al. Stroke. 1991;22:983-988. 4. White PD: Heart disease. New York, NY, The McMillan Co, 1937. 5.Kim M, et al. Adv.Ther. 2009;26:847-857. 2

  3. SVC SVC SVC RSPV RSPV LSPV LSPV RSPV LSPV LIPV LIPV RIPV RIPV LIPV RIPV IVC IVC IVC SVC RSPV LSPV LIPV RIPV IVC Thoracic vein and atrial pathogenesis of AF Large and small reentrant wavelets that play a role in initiating and sustaining AF Extension of muscular fibers into pulmonary vein (PV) Ganglia noted in yellow Composite of anatomic and arrhythmic mechanisms of AF Common locations of PV (purple) and common sites of origin of non-PV triggers (black) Calkins et al. Heart Rhythm. 2007;4:1-46.

  4. Indications for Catheter AF Ablation Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic medication In rare clinical situations, it may be appropriate as first-line therapy Selected symptomatic patients with heart failure and/or reduced ejection fraction Presence of a left atrial thrombus is contraindication to catheter ablation of AF “It's far more important to know what person the disease has than what disease the person has.” Hippocrates

  5. Patient Selection for Ablation Courtesy of Hugh Calkins, MD.

  6. Pulmonary Vein Isolation (PVI) is the Cornerstone of AF Ablation “Ablation strategies which target the PVs and/or PV antrum are the cornerstone for most AF ablation procedures.” 2007 HRS Consensus Statement Superior Vena Cava Complete electrical isolation should be the goal for targeted PVs and entrance and/or exit block should be demonstrated Left Superior Pulmonary Vein Right Superior Pulmonary Vein • Isolate each PV independently LeftInferior Pulmonary Vein Right Inferior Pulmonary Vein Inferior Vena Cava 6 Cappato et al., Circ Arrhythm Electrophysiol 2010;3;32-38 http://www.HRSonline.org/Policy/ClinicalGuidelines

  7. Controlled Trials of AF Ablation Patients Free of AF (% at 1 Year) Percent Courtesy of Jeremy N. Ruskin, MD, Massachusetts General Hospital.

  8. Challenges Using RF Focal Ablation Catheter to Isolate PV and Ablate Atrial Tissue Patient anatomy and atrial tissue depth is variable Cardiac contractions make maintaining position difficult Catheter force varies with position in heart Technically challenging Good lesions require transmurality Successful procedure requires contiguous lesions 8

  9. Clinical Issues with Conventional RF Focal Ablation Catheter • Risk of perforation • Uncontrolled energy delivery • Esophageal damage • Char/coagulum formation • Inconsistent results • Time consuming point-by-point ablation • 6% complication rate • 3- to 6-hour procedure times • Success rates: • – 14.5% - 76.5% w/o AAD • – 8.8% - 50.3% w/AAD Cappato R, et al. Circulation. 2005;111:1100-1105. 9

  10. Clinical Issues with Conventional RF Focal Ablation Catheter 6% complication rate 3- to 6-hour procedure times Success rates: – 14.5% - 76.5% w/o AAD – 8.8% - 50.3% w/AAD Cappato R, et al. Circulation. 2005;111:1100-1105. 10

  11. Arctic Front® Catheter Design Arctic Front Catheter Balloon Segment • Pressurized N2O delivered through ultrafine injection tube • Straightforward positioning: over-the-wire, steerable, good visibility • Several safety mechanisms: double balloon, pressure and flow monitoring, blood detection Deflection Wires Outer Balloon Inner Balloon Guide Wire Lumen Thermocouple Injection Tube Marker Band Guide Wire

  12. Cryoablation Effects Include Multiple Mechanisms • Ice formation and thawing • Apoptosis • Necrosis Hypothermia 12 Baust, Institute of Biomedical Technology, SUNY 2002

  13. Histological Effect on the Connective Tissue Matrix • Cryoadhesion improves contact and stability, minimizing the amount of fluoro used • Preserves the extracellular matrix and endothelial integrity1 • Decreases risk of thrombus formation1 • Demonstrates well demarcated lesions1 1 Sarabanda AV, et al. J Am Coll Cardiol. 2005;46:1902-1912. 13

  14. Properties of Cryoablation • Hypothermic Zone • Ablation Zone (sub-zero) • Removes heat from the tissue • Leads with a wave of hypothermia • Ablates at the point of balloon contact 14

  15. Achieve™ Mapping Catheter Achieve is an intracardiac electrophysiology diagnostic catheter which can be deployed through the Arctic Front® guide wire lumen Available in 15 mm and 20 mm loop diameters Either diameter compatible with 23 mm and 28 mm Arctic Front 15

  16. How Arctic Front® Balloon Catheter and AchieveTM Work 2. Inflate and position 1. Accesstargeted vein 4. Assess PVI 3. Occlude and ablate 16

  17. Standardized ProcedureDoes Not Require Complex 3D Mapping • Arctic Front creates circumferential lesions,1 using 2-3 applications per vein to achieve PVI2 • Does not require 3D mapping • Achieve Mapping Catheter can be deployed through the Arctic Front guide wire lumen, minimizing catheter exchanges • Allows the procedure to be performed using a single transseptal puncture Arctic Front® Cryoballoon Achieve™ Mapping Catheter Fluoroscopy image during contrast dye injection shows full occlusion of the left superior pulmonary vein. Entire procedure can be done using fluoroscopy or intracardiac echocardiography Image: Courtesy of Dr. Vogt, Herz- und Diabeteszentrum NRW, Germany 1Sarabanda AV, et al. EffJ Am CollCardiol. 2005;46:1902-1912. 2 Medtronic, Inc. Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA premarket approval. 17

  18. Assessment of Real-Time PV Isolation • Achieve™ mapping catheter allows for real-time assessment of PV isolation during cryoablation with Arctic Front® Arctic Front is positioned against the LIPV ostium, with Achieve positioned to assess PV isolation Delay Increased Delay Isolation Images: Courtesy of Dr. Schwagten, ZNA Middelheim, Belgium (above) and Dr. Vogt, Herz- und Diabeteszentrum NRW, Germany (right) 18

  19. European Clinical Study ResultsSymptomatic Drug Refractory PAF Efficacy Results 20

  20. European Clinical Study ResultsArctic Front® Safety Results 21

  21. Shorter Procedures Demonstrated with Experienced European Users 300 250 200 150 100 50 0 Data from 9 German Centers: Arctic Front® is 33% faster than point-by-point catheter systems with a 24% reduction in fluoro time. -33% -33% Point-by-Pointwith 3D Mapping Arctic Front Minutes -24% Lab Occupancy Time Primary Physician Time Fluoroscopy Time 22 Medtronic data on file.

  22. Meta Analysis of Clinical Experience Andrade JG, Khairy P, Guerra PG, et al. Efficacy and Safety of Cryoballoon Ablation for Atrial Fibrillation – A Systematic Review of Published Studies. Heart Rhythm. 2011. • 539 articles screened, 23 were retained for the final analysis • Efficacy results strong: • Acute success over 98% • 12-month freedom from AF: 72.83% with 3-month blanking • No difference in 6-month and 12-month freedom from recurrent AF between those who underwent Cryoballoon ablation for paroxysmal AF and who underwent RF ablation 23

  23. Complications – Meta Analysis Andrade JG, Khairy P, Guerra PG, et al. Efficacy and Safety of Cryoballoon Ablation for Atrial Fibrillation – A Systematic Review of Published Studies. Heart Rhythm. 2011. 24

  24. European Arctic Front® Study Conclusions for Symptomatic Drug Resistant PAF Patients Arctic Front System had a very high rate of acute PVI success Arctic Front System had high rate of success in reducing long-term AF events Arctic Front System had a low rate of complications; most resolved by 1 year Arctic Front System significantly reduced procedure time for complete PVI compared to other PVI approaches There was no occurrence of atrioesophageal fistula 25

  25. STOP AF Trial • Key Inclusion Criteria: • ≥ 2 documented AF Episodesin the prior 2 months • Efficacy failure of ≥ 1 AAD (flecainide, propafenone, sotalol) Redo ablationn = 31 (19%) Follow-up at 1, 3, 6, 9 & 12 Months Blankingperiod (90 day) Cryoballoonablation (CRYO)n = 163 N = 245Randomized2:1 to CRYO*or DRUG AAD Rx (DRUG)n = 82 AAD optimization 26 centers in US and Canada * CRYO: Arctic Front® System DRUG Crossovern = 65 (79%) 26

  26. Effectiveness ResultsFreedom from AF after 90 Days Blanked for Detectable AF CRYO 69.9% (114 / 163) Treatment Success OR = 29.5 (12.0 – 72.2) p < 0.001 Blanked for DetectableAF DRUG7.3% (6 / 82) 27

  27. CRYO Procedure Experience Impacts Treatment Success P < 0.001 by quartile (Wald) OR = 1.14 for each procedure 90% 100% 69% 66% 80% 56% 60% Treatment Success 40% 25 centers n=43 14 centers n=38 10 centers n=42 4 centers n=40 20% 0% 1st and 2nd procedures 6th – 11th procedures 3rd – 5th procedures 12th – 23rd procedures

  28. Device Related and Procedure Related Serious Adverse Events with Increasing Experience *p = 0.27 for SAE by first procedure sequence (initial procedure and reablation) **p = 0.13 for SAE by first procedure sequence (initial procedure only) ***p = 0.30 for SAE within 30 days by first procedure sequence (initial procedure only) Kowal, et al. in preparation.

  29. Additional STOP AF Results • CRYO Results: • 98.2% acute procedural success • 62.2% of patients were treatment successes without any AF drugs at 12 months • 60.1% single procedure success rate • 19% of patients had redo procedures within the first 90-day follow-up period • DRUG Results: • 79% of DRUG group demonstrated chronic treatment failure and crossed over to the cryoablation procedure 30

  30. Phrenic Nerve Palsy (PNP) * 29 PNP events out of 259 procedures in 28 subjects • 29/259 (11.2%) procedures:* • 15 subjects - asymptomatic • 13 subjects - symptomatic with DOE, SOB, and/or cough • 25/29 (86.2%) resolved by 1 year • Median time for CXR resolution 102 days • 4/259 subjects (1.5%) had an abnormal CXR at 1 year, 1 (0.4%) remained symptomatic 31

  31. STOP AF Trial Conclusions • STOP AF met pre-specified primary effectiveness end point: • 98.2% of CRYO group had acute procedure success • 69.9% of CRYO group compared to 7.3% of DRUG group were considered a treatment success at 12 months • STOP AF met the pre-specified primary safety end points: • Cryoablation procedure events were observed in 3.1% (6.3%, UCB) of CRYO group; below the pre-specified 95% upper confidence bound of 14.8% • The major AF event rate in the CRYO group was non-inferior to the DRUG group at 12 months, at 3.1% and 8.5% respectively 32

  32. Conclusions Cryoablation for early Atrial Fibrillation: Is effective in isolation of Pulmonary veins. Is a safe procedure. Has shorter procedure times, compared to conventional RF ablation procedures. Ideal procedure for PV / antral based atrial fibrillation. 33

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