Disclosures for All paroxysmal AF Ablation? E Gerstenfeld MD - - PowerPoint PPT Presentation

9/7/2012 1

Should Balloon Technologies be Used for All paroxysmal AF Ablation?

Edward P Gerstenfeld MD Associate Professor of Medicine University of California, San Francisco

Disclosures

• E Gerstenfeld MD
• Research grant, honoraria: St Jude Medical
• Research grant, honoraria: Medtronic
• Research grant, honoraria: Biosense-webster
• Research grant: Rhythmia medical
• Research grant, SAB: Voyage medical

Balloon Ablation

How often is Cryoballoon used for AF ablation in your practice?

N

• n

e 2 % 5 % 7 % 1 %

70% 16% 0% 2% 12%

• A. None
• B. 20%
• C. 50%
• D. 70%
• E. 100%

Balloon Ablation

I plan to use balloon ablation in AF patients in my practice in the next 1-2 years

Y e s N

• 44%

56%

• A. Yes
• B. No

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Current Approach to PV Isolation

Irrigated 4mm tip catheter Steerable sheath General anesthesia Endpoint: PV entrance/exit block. Pace&ablate.

Days Into Effectiveness Follow-up

Thermocool AF

Ablation 103 69 69 66 63 62 61 54 52 37 15 3 2 AAD 56 39 29 19 16 13 11 10 7 2 Number of subjects at risk:

Wilber D et al. JAMA. 2010;303(4):333-340.

16%

AAD (n=56)

66% Ablation (n=103) Freedom From AF Recurrence

0.0 0.2 0.4 0.6 0.8 1.0 30 60 90 120 150 180 210 240 270 300 330 360

P<.001

• Prospective, multicenter, randomized (2:1) study of paroxysmal AF ablation.
• 167 patients randomized to ablation (106) vs. AAD (61)

Repeat RFA in 12.6%

Complications of AF Ablation

Cappato et al. Circulation EP 2010;3:32-38.

20,825 procedures 16,309 patients

What Do We Need?

Rapid PV isolation Little need for fluoroscopy Persistent PVI with 1 procedure No need for additional complex mapping Safe Inexpensive Are balloons the answer?

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Current Balloon Options…

Cryoballoon Laser balloon

Blanking period (90 day) Drug

• ptimization

90 days

STOP-AF Trial

AA Rx failure n=304 Randomized 2:1 to ablation vs. Drug Rx Cryoballoon ablation n=163 Drug Rx n=82 Cross-over n=65

Follow- up 1,3,6,9, &12 mo Holters Weekly TTMs

Inclusion: Patients >2 AF episodes in 2 months w ECG doc. of 1 Rx Failure of > 1 AA Rx

Courtesy Dr Packer

20 40 60 80 100 100 200 300 400 500

Primary Effectiveness Analysis

Treatment Success

Treatment success (%) Days

P<0.001

Blanked 19% redo

DRUG Rx 7.3% 6/82

30 days

CRYO 69.9% 114/163

Courtesy Dr Packer

Summary of All Adverse Events (Intention-to-Treat)

Type of Adverse Event CRYO (n = 163) DRUG (n = 82) Stroke 4 2.5% 1 1.2% TIA 3 1.8% 1 1.2% Tamponade 1 0.6% 1 1.2% Myocardial infarction 2 1.2% 0 0.0% Hemorrhage requiring transfusion 3 1.8% 1 1.2% New atrial flutter 6 3.7% 13 15.9% Atrial esophageal fistula 0 0.0% 0 0.0% Death 1 0.6% 0 0.0% New or worsened AV fistula 2 1.2% 0 0.0% Pseudoaneurysm 1 0.6% 1 1.2% Phrenic nerve palsy 22 13.5% 6 7.3% Persistent phrenic nerve palsy 4 2.5% 0 0.0% PV stenosis 5 3.1% 2 2.4%

9/7/2012 4

Conclusions

• 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 Cryoballoon PV Isolation

Temp<-51° ° ° °C: 100% specific for PVI Temp>36° ° ° °C Su PV or >33° ° ° °C In PV @ 120 sec: 97% sp for ineffective PVI Time to PVI < 83 secs: 97% specific for PVI

Furnkranz et al. Heart Rhythm 2011;8:821-825. Dorwarth et al. JICE 2011;32:205-211.

• 27 pts with PAF underwent PVI with 28mm

cryoballoon only

• PVI achieved in 97/99 PVs (98%)
• Procedure/balloon time = 220/130 minutes
• 3 transient phrenic palsy, 0 PV stenosis
• 19/27 (70%) in SR at mean 371 days post ablation

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28mm cryoballoon Two 5 min freezes/PV Touch up focal cryo Characteristics Cryoablation(n=90) RFA(n=53) Age (years) 57.3± ± ± ±9.4 59.3± ± ± ±9.7 Men (%) 75% 77% LA diameter (mm) 39.6± ± ± ±7.1 41.6± ± ± ±6.5 AF duration (yrs) 5.6± ± ± ±4.1 6.0± ± ± ±4.8 # failed AAD 2.1± ± ± ±0.6 1.9± ± ± ±0.6

Kojodjojo et al. Heart 2010;96:1379-84.

Cryoballoon vs. RFA

Paroxysmal AF

Procedure Cryoablation(n=90) RFA(n=53) Follow-up(months) 14.9± ± ± ±7.7 15.6± ± ± ±7.4 CTI RFA 17 (19%) 6 (11%) Procedure time(min) 108± ± ± ±28* 208± ± ± ±58 Fluoro time(min) 27± ± ± ±9* 62± ± ± ±36 Complications

• ne effusion,

2 effusions 2 transient phrenic nerve palsy

Kojodjojo et al. Heart 2010;96:1379-84.

Cryoballoon PVI

Paroxysmal vs. Persistent AF

77% 48%

Kojodjojo et al. Heart 2010;96:1379-84.

Cryoballoon vs. RFA

77% 72%

Kojodjojo et al. Heart 2010;96:1379-84.

9/7/2012 6

Cryoballoon

Non-coaxial Alignment Improved Balloon Cooling Uniformity

Arctic Front Arctic Front Advance

Stockigt F et al. JCE online 2012 pp1-4.

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

9/7/2012 7

Cryoballoon Summary

Relatively quick Relatively expensive ≈ 5% need to touch up PVs with focal catheter Single procedure success ≈ 60-70% Small risk of phrenic injury, PV stenosis

Endoscopic Laser Balloon Ablation System

Compliant balloon Variable inflation pressure from 1 (low) to 5 (high) PSI Variable diameter 25-32mm

5 PSI 1 PSI

Why Use Light Energy?

Efficient energy transfer - energy is almost completely transferred through balloon into tissue Energy is directed in vivo under direct endoscopic visualization Energy delivered can vary depending on target tissue (ant vs. post wall)

Endoscopic PV Anatomy

LSPV LIPV LAA

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Endoscopic PV Anatomy

RSPV

Laser PVI in Swine Model

Acute LSPV Chronic RSPV

Laser PVI Worldwide Experience

200 patients (age 57 ± 9.9 y) with PAF 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

78.3% of PV’ ’ ’ ’s isolated on initial attempt 98.8% of PVs isolated after an average of 1.3 attempts/PV

Dukkipati et al. Heart Rhythm, Vol. 8, No. 5, AB36-1, May Supplement 2011

Laser PVI Worldwide Experience

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Laser PVI Worldwide Experience

65% AF free off AAD single procedure at 6-months Complication Incidence Phrenic nerve injury 5 (2.5%) TIA 0 (0%) 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

Laser Balloon Summary

Allows PVI under direct visualization 99% PVs isolated with balloon alone (compliant) 65% single procedure AF freedom off AAD at 6-mos Cost ??? Safe (No PV stenosis, no A-E fistula). No randomized multicenter trial (HeartLight enrolling UCSF)

What is the Level of Balloon PV Isolation?

23mm cryoballoon

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28mm cryoballoon

Van Belle et al. JICE 2009 25:59-65.

Laser Balloon PVI

AP PA

Results

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Yes, in experienced hands (if suitable anatomy and cost effective)

Should Balloon Technologies be Used for all PAF cases?

Balloon Ablation

I plan to use balloon ablation in AF patients in my practice in the next 1-2 years

Y e s N

• 44%

56%

• A. Yes
• B. No

Thank You