9/7/2012 Should Balloon Technologies be Used Disclosures for All paroxysmal AF Ablation? • E Gerstenfeld MD Edward P Gerstenfeld MD Associate Professor of Medicine • Research grant, honoraria: St Jude Medical University of California, San Francisco • Research grant, honoraria: Medtronic • Research grant, honoraria: Biosense-webster • Research grant: Rhythmia medical • Research grant, SAB: Voyage medical Balloon Ablation Balloon Ablation How often is Cryoballoon used for AF I plan to use balloon ablation in AF patients ablation in your practice? in my practice in the next 1-2 years 70% A. None A. Yes B. 20% 56% B. No C. 50% 44% D. 70% 16% 12% E. 100% 2% 0% % % % % e n 0 0 0 0 o 2 5 7 0 N 1 s e o N Y 1
9/7/2012 Thermocool AF Current Approach to PV Isolation • Prospective, multicenter, randomized (2:1) study of paroxysmal AF ablation. • 167 patients randomized to ablation (106) vs. AAD (61) Freedom From AF Recurrence 1.0 Repeat RFA in 12.6% 0.8 66% Ablation 0.6 (n=103) P <.001 0.4 AAD 16% 0.2 (n=56) 0.0 0 30 60 90 120 150 180 210 240 270 300 330 360 � Irrigated 4mm tip catheter Days Into Effectiveness Follow-up Number of subjects at risk: � Steerable sheath Ablation 103 69 69 66 63 62 61 54 52 37 15 3 2 � General anesthesia AAD 56 39 29 19 16 13 11 10 7 2 0 0 0 � Endpoint: PV entrance/exit block. Pace&ablate. Wilber D et al. JAMA. 2010;303(4):333-340. Complications of AF Ablation What Do We Need? � Rapid PV isolation � Little need for fluoroscopy � Persistent PVI with 1 procedure � 20,825 procedures � 16,309 patients � No need for additional complex mapping � Safe � Inexpensive Are balloons the answer? Cappato et al. Circulation EP 2010;3:32-38. 2
9/7/2012 STOP-AF Trial Current Balloon Options… Inclusion: Patients >2 AF episodes in Cryoballoon Laser balloon 2 months w ECG doc. of 1 Follow- up Cryoballoon Rx Failure of > 1 AA Rx Blanking ablation period (90 day) 1,3,6,9, n=163 &12 mo AA Rx Randomized failure 2:1 to ablation vs. n=304 Drug Rx Holters Drug Drug Rx Weekly optimization n=82 90 days TTMs Cross-over n=65 Courtesy Dr Packer Primary Effectiveness Analysis Summary of All Adverse Events Treatment Success (Intention-to-Treat) CRYO DRUG 30 days Type of Adverse Event (n = 163) (n = 82) 100 Treatment success Stroke 4 2.5% 1 1.2% TIA 3 1.8% 1 1.2% 80 Tamponade 1 0.6% 1 1.2% Myocardial infarction 2 1.2% 0 0.0% CRYO 69.9% 114/163 (%) Hemorrhage requiring transfusion 3 1.8% 1 1.2% 60 New atrial flutter 6 3.7% 13 15.9% Atrial esophageal fistula 0 0.0% 0 0.0% 40 Death 1 0.6% 0 0.0% New or worsened AV fistula 2 1.2% 0 0.0% Blanked DRUG Rx 7.3% 6/82 20 19% redo Pseudoaneurysm 1 0.6% 1 1.2% Phrenic nerve palsy 22 13.5% 6 7.3% 0 Persistent phrenic nerve palsy 4 2.5% 0 0.0% 0 100 200 300 400 500 PV stenosis 5 3.1% 2 2.4% Days Courtesy Dr Packer P<0.001 3
9/7/2012 Conclusions Cryoballoon PV Isolation • Cryoballoon ablation is effective for treating recurrent drug-refractory paroxysmal AF in symptomatic patients • Balloon-only ablation is feasible in most patients • Phrenic nerve injury and PV stenosis may occur with cryoablation Cryoballoon PV Isolation - 27 pts with PAF underwent PVI with 28mm cryoballoon only � Temp<-51 ° ° ° ° C: 100% specific for PVI - PVI achieved in 97/99 PVs (98%) � Temp>36 ° ° C Su PV or >33 ° ° ° ° ° C In PV @ 120 sec: 97% sp for ineffective ° - Procedure/balloon time = 220/130 minutes - 3 transient phrenic palsy, 0 PV stenosis PVI � Time to PVI < 83 secs: 97% specific for PVI - 19/27 (70%) in SR at mean 371 days post ablation Furnkranz et al. Heart Rhythm 2011;8:821-825. Dorwarth et al. JICE 2011;32:205-211. 4
9/7/2012 Cryoballoon vs. RFA Paroxysmal AF 14.9 ± ± 7.7 ± ± Procedure Cryoablation(n=90) RFA(n=53) 15.6 ± ± 7.4 ± ± 57.3 ± ± ± 9.4 ± 59.3 ± ± ± ± 9.7 Follow-up (months) Characteristics Cryoablation(n=90) RFA(n=53) Age (years) 39.6 ± ± 7.1 ± ± 41.6 ± ± 6.5 ± ± Procedure time (min) 108 ± ± ± 28* ± 208 ± ± 58 ± ± Men (%) 75% 77% CTI RFA 17 (19%) 6 (11%) 5.6 ± ± 4.1 ± ± 6.0 ± ± 4.8 ± ± LA diameter ( mm) 27 ± ± ± ± 9* 62 ± ± ± ± 36 2.1 ± ± 0.6 ± ± 1.9 ± ± 0.6 ± ± AF duration (yrs) Fluoro time (min) # failed AAD Complications one effusion, 2 effusions � 28mm cryoballoon � Two 5 min freezes/PV 2 transient phrenic nerve palsy � Touch up focal cryo Kojodjojo et al. Heart 2010;96:1379-84. Kojodjojo et al. Heart 2010;96:1379-84. Cryoballoon PVI Cryoballoon vs. RFA Paroxysmal vs. Persistent AF 77% 77% 72% 48% Kojodjojo et al. Heart 2010;96:1379-84. Kojodjojo et al. Heart 2010;96:1379-84. 5
9/7/2012 Cryoballoon Improved Balloon Cooling Uniformity Non-coaxial Alignment Arctic Front Arctic Front Advance Cryoablation - Cost Arctic front $4,800 Sheath 12F $1,200 Achieve circular $950 CS catheter $250 Acunav $800 Subtotal $8,000 EAM ref patch $380 Sheath SL1 $300 Circular map $1200 Irrigated RF $2,200 Total $12,080 2011 CA MediCal reimbursement AF RFA: $10,787 Stockigt F et al. JCE online 2012 pp1-4. 6
9/7/2012 Endoscopic Laser Balloon Ablation Cryoballoon Summary System � Relatively quick Compliant balloon � Relatively expensive � Variable inflation pressure from 1 (low) to 5 (high) PSI � ≈ 5% need to touch up PVs with focal catheter � Variable diameter 25-32mm � Single procedure success ≈ 60-70% � Small risk of phrenic injury, PV stenosis 5 PSI 1 PSI Why Use Light Energy? Endoscopic PV Anatomy � Efficient energy transfer - energy is almost completely transferred through balloon into tissue � Energy is directed in vivo under direct endoscopic visualization LSPV � Energy delivered can vary depending on target LAA tissue (ant vs. post wall) LIPV 7
9/7/2012 Endoscopic PV Anatomy Laser PVI in Swine Model RSPV Chronic RSPV Acute LSPV Laser PVI Laser PVI Worldwide Experience Worldwide Experience � 78.3% of PV ’ ’ s isolated on initial attempt ’ ’ � 200 patients (age 57 ± 9.9 y) with PAF � 98.8% of PVs isolated after an average of 1.3 attempts/PV � 94% failed ≥ 1 AAD � 33 operators, 15 centers � No patients met exclusion PV > 32mm � Weekly TTM, 3 mo CTA Srinivas R. Dukkipati, MD, Karl-Heinz Kuck, MD, Petr Neuzil, MD PhD, Ian Woollett, MD, Josef Kautzner, MD, H.Thomas McElderry, MD, Boris Schmidt, MD, Edward P Gerstenfeld MD, Shephal Doshi, MD, Andre d’Avila, MD PhD, Jeremy N. Ruskin MD, Andrea Natale MD, Vivek Y . Reddy, MD Dukkipati et al. Heart Rhythm, Vol. 8, No. 5, AB36-1, May Supplement 2011 8
9/7/2012 Laser PVI Laser Balloon Summary Worldwide Experience � Allows PVI under direct visualization � 65% AF free off AAD single procedure at 6-months � 99% PVs isolated with balloon alone (compliant) � 65% single procedure AF freedom off AAD at 6-mos Complication Incidence � Cost ??? Phrenic nerve injury 5 (2.5%) � Safe (No PV stenosis, no A-E fistula). TIA 0 (0%) � No randomized multicenter trial (HeartLight enrolling UCSF) Stroke 0 (0%) Cardiac tamponade 4 (2%) A-E fistula 0 (0%) N=200 Dukkipati et al. Heart Rhythm, Vol. 8, No. 5, AB36-1, May Supplement 2011 What is the Level of Balloon PV Isolation? 23mm cryoballoon 9
9/7/2012 Laser Balloon PVI 28mm PA AP cryoballoon Van Belle et al. JICE 2009 25:59-65. Results 10
9/7/2012 Balloon Ablation Should Balloon Technologies be Used for all PAF cases? I plan to use balloon ablation in AF patients in my practice in the next 1-2 years Yes, in experienced hands (if suitable anatomy and A. Yes 56% B. No cost effective) 44% s e o Y N Thank You 11
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