The Convergent Approach for the

Treatment of Persistent Atrial Fibrillation

Bryan Piedad, MD, FACC

Wellstar Medical Group

Atrial Fibrillation

• Most common arrhythmia worldwide

• Prevalence of atrial fibrillation

– 1-2 % estimated prevalence

– Increasing incidence with age

– Only 12 to 15% of all patients with afib are paroxysmal

– Overwhelming majority of patients are persistent

• Significant morbidity and mortality

• Significant health care costs

Percutaneous Ablation For Atrial Fibrillation

Percutaneous Ablation for Atrial Fibrillation

• Primary strategy in paroxysmal afib is

electrical isolation of the pulmonary veins

• Good success rate for paroxysmal atrial

fibrillation (70 to 80%)

• Low complication rate (2-4%)

• Minimally invasive

Wellstar Electrophysiology

• Calendar year 2012

– 130 percutaneous ablations

• Calendar year 2013

– 200 percutaneous ablations

– Highest volume cryo-ablation center in the Southeast

– Top 10 in the country for cryo-ablation volume

– Training center for cryo-ablation

– Research site for cryo-ablation

Limitations of Percutaneous Ablation

• Lower success rates for persistent atrial fibrillation (50%

to 60%), especially with enlarged and fibrotic atria

• Need for repeat ablation in up to 50% of patients

– Average number of procedures is 2.3 per patient

• Difficulty in delivering and confirming contiguous lesions

• Extensive endocardial lesions and the risk for embolus

• Potential esophageal damage and risk for esophageal-

atrial fistula formation

Convergent Approach• Multi-disciplinary approach

– Cardiac Anesthesiology

– Cardiothoracic Surgery

• Linear lesions via an epicardial approach

• Closed chest, trans-diaphragmatic endoscopic approach

– Cardiac Electrophysiology

• Percutaneous EP testing and ablation (PVI and CTI

ablation)

n-Contact Technology

n-Contact Technology

Percutaneous Endocardial Ablation After Epicardial Ablation

Percutaneous AccessBreakthrough Locations @

Pericardial Reflections

Study% Persistent /

Longstanding AFMonitoring Level Procedure Efficacy Redos

Serious Adverse Event Rate4

Allegheny CV StudyB

AER 2013N=43

86%Med

2wk Monitors 89% @ 6 mo1 NR 0%

2-Site US CV StudyAHeart Rhythm

N=101

83%(Avg CHADS = 2.1)

MedReveal & Holter

79.7% @ 12 mo170.5% @ 12 mo1(Survival Analysis)

6% 6%

4-Site US CV StudyB

Boston AF 2012N=115

83.5%Med

72h Holter

84% @ 11.4 mo1

77% @ 11.4 mo2

64% @ 11.4 mo3

4% 6.1%

Slovenia CV StudyA,B

Boston AF 2012, JCEN=50

94%High

All Reveals91% @ 1 yr1

78% @ 1 yr3 2% 10.0%

OLOL CV StudyB

HRS 2012N=104

73%Med

72h Holter92% @ 8 mo1

68% @ 8 mo3 4%0%

(5.8% > 30d)

CPW CV StudyB

HRS 2012N=39

79%Med

72h Holter94% @ 12.6 mo1

68% @ 12.6 mo3 6% 2.6%

STV CV StudyB

HRS 2012N=61

88%Med

72h Holter79% @ 11 mo1

66% @ 11 mo3 8% 3.3%

4-Site EU CV StudyD

EU JournalN=73

100%High

Reveals or 7d Holters79% @ 1 yr1 4% 11.0%

2-Site CV StudyA

Innovations 2011N=65

92%Med/High

Reveal or 24h Holter88% @ 1 yr1

83% @ 1 yr3 NR 7.7%

1Efficacy = Sinus Rhythm; 2Efficacy = Sinus Rhythm & No AAD Tx; 3Efficacy = Sinus Rhythm & Off AADs, 4Safety = 30-Day Adverse EventsAPublished Article; BPublished/Presented Abstract; CAccepted Abstract; DSubmitted Article; EAccepted Article

Published/Presented Outcomes

Summary

• 1. Highly effective therapy for patients with persistent

atrial fibrillation that still maintains a minimally

invasive approach

• 2. Reduction in repeat procedures

• 3. Providing a new treatment option for a significant

proportion of the afib population which has been

somewhat “forgotten”

• 4. Marketing opportunity for the health care system,

cardiology, cardiac electrophysiology and CT surgery