Proponent: Roger A. Winkle Disclosures - UCSF CME Winkle Protagonist.pdf · ♥ Proponent: Roger A....

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11/2/11 1 Catheter Ablation of Atrial Fibrillation Has Become the Prime Therapy for Most Patients with Atrial Fibrillation Proponent: Roger A. Winkle Disclosures Investigator for Cardiorobotics Investigator for CABANA trial Investigator Medtronic MelScheinerone is not FDA approved I have no financial interest in MelScheinerone Questions 1. I believe in Afib ablation and it is my treatment of choice for symptomatic patients 2. I like the idea of Afib ablation but there are too many complications 3. I like the idea of Afib ablation but it does not cure enough patients to make it worthwhile 4. I like the idea of Afib ablation but there are too many complications and it does not cure enough patients 5. I don’t like the idea of Afib ablation

Transcript of Proponent: Roger A. Winkle Disclosures - UCSF CME Winkle Protagonist.pdf · ♥ Proponent: Roger A....

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Catheter Ablation of Atrial Fibrillation Has Become the Prime Therapy for Most Patients

with Atrial Fibrillation

♥ Proponent: Roger A. Winkle

♥ Disclosures •  Investigator for Cardiorobotics •  Investigator for CABANA trial •  Investigator Medtronic •  MelScheinerone is not FDA approved •  I have no financial interest in MelScheinerone

Questions

1.  I believe in Afib ablation and it is my treatment of choice for symptomatic patients

2.  I like the idea of Afib ablation but there are too many complications

3.  I like the idea of Afib ablation but it does not cure enough patients to make it worthwhile

4.  I like the idea of Afib ablation but there are too many complications and it does not cure enough patients

5.  I don’t like the idea of Afib ablation

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Future Afib Ablator

Atrial Fibrillation is Bad!

♥ Symptoms are present in almost all patients

♥ Worsens most patient’s QOL ♥ Increases stroke risk substantially ♥ Results in multiple hospitalizations and

medical encounters ♥ Increases mortality ♥ Makes “patients fatter and wears out their

hearts”

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Lévy et al. Circulation 1999;99:3028-3035.

Type of Symptoms

Palpitations Chest pain Dyspnea Syncope, dizzy spells

Fatigue Other None

54.1

44.4

10.1 10.4 14.3

0.9

11.4

60

50

40

30

20

10

0

Wolf et al: Arch Int Med: 1987: 147; 1561-64"

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Framingham Heart Study: Percent of Men and Women Dead with and without AF (ages 55-74)

(Benjamin et al Circ 1998;98:946-952)"

Adjusted for age, BP, smoking,"diabetes, LVH, MI, CHF, valve disease, "CVA and TIA"

Framingham Heart Study: Percent of Men and Women Dead with and without AF (ages 75-94)

(Benjamin et al Circ 1998;98:946-952)"

Adjusted for age, BP, smoking,"diabetes, LVH, MI, CHF, valve disease, "CVA and TIA"

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Early Termination of Persistent AF and Ablation Outcomes

(Winkle et. Al. AJC 1011;108:374-379)

Persistent AF (AF2)

♥ AF2a: 179 patients whose physicians always terminated persistent AF by drugs or CV in < 1 week

♥ AF2b: 244 patients left in persistent AF for > 1 week up to 1 year

Compared to

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Early Termination of Persistent Atrial Fibrillation is Associated with Smaller Left Atrial Size and Better Ablation Outcomes

(Winkle et. Al. AJC 1011;108:374-379)

Early Termination of Persistent Atrial Fibrillation is Associated with Smaller Left Atrial Size and Better Ablation Outcomes

(Winkle et. Al. AJC 1011;108:374-379)

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AF2a  

AF  always  terminated  

AF2b  

AF  >1  week  <  1year   P  Value

Number 179  (42.3%) 244  (57.7%)

LA  size  (cm) 4.14+0.61 4.51+0.66        <  0.0001*

Age  (years) 61.3+11.1 62.7+10.5 =0  .194

Females 29.1% 22.5% =  0.128

DuraNon  of  AF  (years) 7.5+7.5 6.0+7.2      =  0..035*

#  Drugs  Failed 1.55+1.02 1.27+0.98        =  0.0036*

Average  CHADS  score 0.80+0.98 0.92+0.96 =  0.212

Hypertension 44.1% 50.0% =  0.239

Diabetes 7.3% 9.0% =  0.593

BMI 28.5+5.5 30.3+5.5        =  0.0008*

Cardioversions 65.9% 69.7% =  0.460

%  Redo  ablaNons 34.1% 30.3% =  0.460

Coronary  artery  disease 12.8% 17.2% =  0.224

Dilated  cardiomyopathy 3.9% 11.1%      =  0.010*

Prior  Stroke/TIA 6.1% 6.1% =  1.000

*  StaNsNcally  significant

Early Termination of Persistent Atrial Fibrillation: Clinical Variables (Winkle et. Al. AJC 1011;108:374-379)

Early Termination of Persistent Atrial Fibrillation is Associated with Smaller Left Atrial Size and Better Ablation Outcomes

(Winkle et. Al. AJC 1011;108:374-379)

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Rate control is not the answer!

♥ Multiple studies compare rate control to rhythm control using AADs

♥ Rate control does nothing to reduce the stroke risk

♥ The drugs for rate control cause side effects and even death (digoxin)

♥ Due to poor AAD efficacy and crossovers the studies may not really show what they claim

♥ AADs may be so toxic that they “wipe out” any benefit of NSR

Atrial Fibrillation Follow-Up Investigation of Rhythm Management-The AFFIRM Study Design

(AFFIRM Investigators. NEJM 2002;347:1825-1833)

♥ Enrolled 4060 patients ♥ Patients with atrial fibrillation and high risk of

stroke ♥ All patients on anticoagulation with target INR =

2.5 (range 2.0-3.0) ♥ Randomized to initial strategy of rate control or

attempts to maintain NSR ♥  Primary endpoint: Total Mortality ♥ Intention to treat analysis

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Atrial Fibrillation Follow-Up Investigation of Rhythm Management-The AFFIRM Study Design

(AFFIRM Investigators. NEJM 2002;347:1825-1833)

♥ Hypothesis: Antiarrhythmic therapy to maintain NSR has no effect on total mortality compared with therapy that controls the heart rate

♥ Enrolled 4060 patients ♥ Primary endpoint: Total Mortality ♥ Secondary endpoints

•  mortality + CVA’s •  mortality + CVA’s + cardiac arrest •  cost •  quality of life

♥ Intention to treat analysis

Atrial Fibrillation Follow-Up Investigation of Rhythm Management-The AFFIRM Study Design

(AFFIRM Investigators. NEJM 2002;347:1825-1833)

♥ Patients with atrial fibrillation and high risk of stroke •  > 65 years old •  < 65 years old and > 1 other risk factor

•  (hypertension, diabetes, CHF, TIA, prior CVA, LA > 50mm, fractional shortening < 25%, LVEF< 40%)

♥ All patients on anticoagulation with target INR = 2.5 (range 2.0-3.0)

♥ All patients may have one initial successful cardioversion

♥ Randomized to initial strategy of rate control or attempts to maintain NSR

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The Unfortunate Saga of “MelScheinerone”

5000 patients at high risk of CV

death

2500 MelScheinerone

MelScheineron labeled as placebo

25% Mortality on Placebo

2500 Placebo

Placebo labeled as

MelScheinerone 50 % Mortality on MelScheinerone

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The Unfortunate Saga of “MelScheinerone”

5000 patients at high risk of CV

death

2500 MelScheinerone

MelScheineron labeled as placebo

25% Mortality on Placebo

2500 Placebo

Placebo labeled as

MelScheinerone 50 % Mortality on MelScheinerone

AFFIRM Trial: Percent of patients “Crossing-Over”

AFFIRM Investigators. NEJM 2002;347:1825-1833

Perc

ent o

f pat

ient

s cr

ossi

ng o

ver (

%)

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AFFIRM Trial: Percent of Patients in NSR

AFFIRM Investigators. NEJM 2002;347:1825-1833

Perc

ent o

f pat

ient

s in

NSR

(%)

Only 28% contributing meaningful data

Atrial Fibrillation Follow-Up Investigation of Rhythm Management

♥ A subsequent “on treatment” statistical analysis gives a very different interpretation of the AFFIRM Trial results

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Atrial Fibrillation Follow-Up Investigation of Rhythm Management

♥ Due to the large number of cross-overs, the poor efficacy of AADs with many rhythm control patients in AF and the fact that many “rate control” patients were actually in NSR, Intention to treat analysis may be misleading

♥ A subsequent “on treatment” statistical analysis gives a very different interpretation of the AFFIRM Trial results

AFFIRM Trial: Importance of NSR (Circ 2004; 109:15009-1513)

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AFFIRM Trial: Importance of NSR (Circ 2004; 109:15009-1513)

AFFIRM Trial: Importance of NSR (Circ 2004; 109:15009-1513)

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AFFIRM Trial: Importance of NSR (Circ 2004; 109:15009-1513)

Danish Investigators of Arrhythmia and Mortality on Dofetitlde in CHF (DIAMOND-CHF)

(NEJM 1999;341:857-865)

♥ 1518 patients with symptomatic CHF and LV dysfunction

♥ Double-blind, placebo controlled at 34 Danish centers

♥ Inclusion criteria •  hospitalized patients with new or worsening CHF and •  at least one episode of SOB on minimal exertion or at rest or

PND •  ECHO with wall motion score of 1.2 or less (EF approx. 35%)

♥ Exclusion criteria acute MI within 7 days K+ < 3.6 or > 5.5 heart rate < 50 creatinine clearance < 20 cc/min SA or AV block without a pacer recent Class I or III antiarrhythmics history of proarrhythmia planned or recent PTCA/CABG QTc >460msec (>500 if bundle branch block) Aortic stenosis BP > 115 diastolic or < 80 systolic ICD

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Dofetilide in patients with CHF and LV dysfunction (DIAMOND-CHF) (NEJM 1999;341:857-865)

DIAMOND-CHF Sub study of patients in AF at time of enrollment

(Pedersen et. al. Circ 2001;104:292-296)

Probability of survival during treatment and follow-up periods in 506 patients with LV dysfunction and AF-AFl at baseline treated with dofetilide or placebo.

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DIAMOND-CHF Sub study of patients in AF at time of enrollment

(Pedersen et. al. Circ 2001;104:292-296)

Survival rates of patients treated with or placebo who converted or did not convert to SR.

Antiarrhythmic Drugs

♥ Cause a lot of side effects ♥ Most do not work very well for patients

with atrial fibrillation ♥ Many cannot be given to patients with

poor LV function, CAD, sick sinus etc. ♥ All have “black box” warnings from the

FDA which are scary to patients

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Rhythm Control for AF: Antiarrhythmic Drugs

Flecainide

Propafenone

Class 1A Class 1C Class 3

Treatment Choices (oral)

Atrial Fibrillation: Prevention of Recurrence after Cardioversion by Quinidine

Coplen SE. Circulation. 1990;82:1106-1116.

Perc

ent o

f pat

ient

s in

NSR

(%)

Time (months)

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Odds Ratio for Total Mortality for Patients Treated with Quinidine Compared to Control

Coplen SE. Circulation. 1990;82:1106-1116.

RCT

Boissel

Byrne-Quinn

Hartel

Hillestad

Lloyd

Sodermark

ALL STUDIES N = 808

0 1 2 3 4 5 6 7 8 9 10 11 12

Odds Ratio (Quinidine: Control) Quinidine Better Quinidine Worse

212

92

175

100

53

176

n

Maintenance of Sinus Rhythm with Oral Sotalol in Patients with Symptomatic Atrial Fib / Flutter

(Benditt et al AJC 1999;84:270-277)

♥ 253 patients with atrial fibrillation / flutter

♥ Multicenter, randomized, double-blind study

♥ Evaluated safety and efficacy of 3 fixed doses of d,l-sololol (80, 120 or 160 mg bid)

♥ Primary endpoint: time to recurrence of AF

♥ Treatment continued 1 year or until AF recurred

♥ Transtelephonic monitoring used

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Time to documented AF on Sotalol (80, 120, 160 mg bid) or placeb0 Intention to Treat

30%"40%"45%"

28%"

Sotalol Side Effects Compared to Placebo (Benditt et al AJC 1999;84:270-277)

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Dronedarone: Amiodarone Without Side Effects or Just a Different Poison?

EURIDIS AND ADONIS (Singh B et al. N Engl J Med 2007;357:987-999)

♥ Age >21 years ♥ One episode of Afib in prior 3 months ♥ In NSR for one hour before randomization ♥ Randomized 2:1 Dronedarone 400mg bid

or placebo ♥ Endpoint: Time to first documented AF

lasting 10 minutes ♥ Secondary endpoints

•  Symptoms related to AF •  Mean Ventricular Rate during first AF

recurrence

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EURIDIS and ADONIS Primary Endpoint: Median # Days to First AF Recurrence

(Singh et al NEJM 2007;357:987-99)

Kaplan-Meier Incidence of First Recurrence of A Fib or Flutter (Singh et al NEJM 2007;357:987-99)

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“ANDROMEDA” Antiarrhythmic Trial with Dronedarone in

Moderate-to-Severe CHF Evaluating Morbidity Decrease

Stopped by DSMB January,2003 after 627 patients enrolled due to increased mortality in Dronedarone group

PALLUS Trial

♥  Age > 65 years with at least one of the following major risk factors •  systemic arterial embolism •  myocardial infarction •  documented coronary artery disease •  prior stroke •  symptomatic heart failure

♥  Age > 75 years + hypertension and diabetes mellitus. ♥  Exclusions: NYHA Class IV or unstable Class III CHF ♥  Endpoints

•  Major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death)

•  Cardiovascular hospitalization or death from any cause

♥  10,800 patients enrolled in 43 countries at 700 sites ♥  Randomized to dronederone 400 mg bid or placebo

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PALLUS Trial Adverse event Placebo

n=1577 n (%) Dronedarone n=1572, n (%)

Hazard ratio

p

CV death, MI, stroke, systemic embolism

14 (0.9) 32 (2) 2.3 0.009

Death, unplanned CV hospitalization*

81 (5.1) 118 (7.5) 1.5 0.006

Death 7 (0.4) 16 (1) 2.3 0.065 MI 3 (0.2) 3 (0.2) 1.0 1 Stroke 7 (0.4) 17 (1.1) 2.4 0.047 HF hospitalization 15 (1) 34 (2.2) 2.3 0.008

Antiarrhythmic Drugs for Maintaining Sinus Rhythm After Cardioversion of Atrial Fibrillation: A Systematic Review of

Randomized Controlled Trials Arch Intern Med. 2006;166:719-728.

♥ 44 trials were included, with a total of 11,322 pts ♥ All drugs increased withdrawals due to adverse

effects (NNH, 9-27) ♥ All but amiodarone and propafenone increased

proarrhythmia (NNH, 17-119) ♥ Class IA drugs (disopyramide, quinidine), pooled,

were associated with increased mortality compared with controls P = .04; NNH, 109

♥ No other antiarrhythmic showed a significant effect on mortality compared with controls

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Withdrawals and Proarrhythmia

Lafuente-Lafuente, C. et al. Arch Intern Med 2006;166:719-728.

Overall Mortality

Lafuente-Lafuente, C. et al. Arch Intern Med 2006;166:719-728.

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Death by Treadmill!

♥ 59 year old recently retired lawyer ♥ No cardiac or non-cardiac diseases ♥ Spring 2007 first Afib while visiting NYC

•  Hospitalized 4 days, spontaneous conversion, echo normal and DC on warfarin and metoprolol

♥ California cardiologist changed to ASA ♥ Afib got worse, occurring anytime ♥ Treated with propafenone but had side effects ♥ Flecainide started 100 mg bid, increased to 150 mg

bid, still had Afib ♥ October, 2007 was at movie and felt lightheaded ♥ Went to urgent care where sinus rate in 30s and

metoprolol decrease to 25 mg a day ♥ Referred for a treadmill

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TM (November 2, 2007) Baseline

TM EKG #1

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TM EKG #2

TM EKG #3 Collapse and was unconscious for 15

seconds

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Saw Dr. Winkle on November 15, 2007

♥ Patient declined further antiarrhythmic drugs ♥ Metoprolol 25 mg a day (very fatigued on

higher doses changed to diltiazem with gradual dose escalation to 240 mg AM and 120 mg PM

♥ Still with several episodes of Afib a week lasting for hours at a time during which he could not do much

♥ Underwent successful Afib ablation March 21, 2008. AF free ever since.

Ablation to treat AF: Frequent Negative Comments

♥ It takes all day to do ♥ It does not work ♥ Repeat ablations do not work ♥ There are too many complications ♥ It works, but almost all patients eventually

have a recurrence ♥ Most patients still have to stay on

anticoagulation even if they are not having AF

None of these are true in 2011

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Sequoia Hospital AF Ablation Results

♥ 1504 AF ablations in 1125 patients as of Dec, 31, 2010

♥ All patients symptomatic and most have failed rate control and rhythm control

♥ Includes both paroxysmal and persistent AF with and without heart disease

  270 (30.9%) AF1 (paroxysmal)

  423 (52.8%) AF2 (persistent)   150 (16.3%) AF3 (long-standing persistent)

Sequoia Hospital AF Ablation Results

♥ Success = no AF off of all drugs

♥ Partial success = no AF on AAD •  Most partial successes and failures offered redo

ablation

♥ Failure = AF on AAD 3 months after final procedure

Both Single Procedure Success rates and final status reported

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AF Ablation Outcome by AF Type (No AF off of drugs)

(Winkle et. al. Am Heart J 2011;162:193-200)

Sequoia Hospital: Reasons Why Patients do not have a Redo Ablation

Reason  for  no  Redo Total

N  =  138

Females

N  =  49

Males

N  -­‐  89

Redo  done  or  to  be  done  a`er  Dec.  31  

2009  (Last  date  of  paNent  enrollment) 55  (39.9%) 12  (24.5%) 43  (48.3%)

Physician  or  Medical  Decision

                   Extensive  LA  scar 12 8 4

                   AV  node  ablaNon 2 1 1

                   Medical  condiNons 2 0 2

                   Death/Terminal  cancer 3 1 2

                   Prior  MAZE  or  AF  ablaNon  elsewhere 12 0 12

                   Total    Physician  or  Medical  Decision 31(22.5%) 9  (18.4%) 22  (24.7%)

PaNent  Decision

                   Much  improved  a`er  ablaNon 7    5  (10.2%) 2  (2.3%)

                   No  AF  on  drugs  a`er  iniNal  ablaNon 23 11  (22.4%) 12  (13.5%)

                   PaNent  preference 22 12  (24.5%) 10    (11.2%)

                   Total    PaNent  Decision 52  (37.7%) 29  (57.1%)* 25  (27.0%)*

*P  =  0.028  Females  vs.  Males

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Freedom from AF at 1,3 and 5 years for those patients “Going all the Way”

1 year AF free rate 3 year AF free rate 5 year AF free rate

Paroxysmal AF1 94.5% 94.5% 94.5%

Persistent AF2 87.9% 82.9% 77.3%

Long-standing AF3 83% 79.4% 74.4%

Long term outcome to almost 7 years for patients cured by the first ablation or who come back for a

redo if the first ablation fails

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How to do a faster and safer AF ablation

♥ Use only one groin ♥ Do only one transseptal puncture (you can put 2

catheters thru the single stick) ♥ Use an RF needle for the transseptal ♥ No Foley catheter ♥ Have dedicated echo machine in EP lab ♥ Use general anesthesia ♥ Use the open irrigated tip catheter at 50W ♥ Mark the location of the esophagus ♥ Keep the ACT at 225 and infuse heparin thru the

transseptal sheath ♥ Reverse heparin and pull sheaths in the EP lab ♥ Avoid “gadgets”: Stereotaxis, Cyroballoons, Robots

Zero Gravity: A cheaper way to reduce operator radiation than $2M magnets!

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Comparison of Cryoballoon to RF ablation Cryoballoon

Medronic FDA data

(n = 163 patients)

Radiofrequency at

Sequoia Hospital

(n = >1800 ablations)

Superior

outcome Cryo

or RF

Death 0.6% 0.0% RF Superior

Stroke/TIA 4.3% 0.26% RF Superior

Heart Attack 1.2% 0.0% RF Superior

Pulmonary Vein Stenosis 3.1% 0.07% RF Superior

Bleeding Needing

Transfusion 1.8% 0.13% RF Superior

AV fistula/

Pseudoaneurysms 1.8% 0.93% RF Superior

Phrenic Nerve Paralysis 16% 0.0% RF Superior

Procedure Time 6 hours 11 minutes 2 hours RF Superior

Flouroscopy Time 62.8 minutes 60.2 minutes RF Superior

1Year Cure Rate 69.9% 86.2% RF Superior

With OITC Ablate at 50W and Keep the Catheter Moving (Winkle et. al. PACE 2011;34 :531-539)

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ATRIAL FIBRILLATION ABLATION: “PERPETUAL MOTION” OF OPEN IRRIGATED TIP CATHETERS AT 50 WATTS

IS SAFE AND IMPROVES OUTCOMES (Winkle et. al. PACE 2011;34 :531-539)

Kaplan-Meier Freedom from Afib after initial ablation (n = 843)

AF1 = 32% AF2 = 50.2% AF3 = 17.8%

Sequoia Hospital Afib Ablations Procedure Times by Catheter and Power (N = 1122)

*P<0.041 *P<0.001

*P<0.001

* Compared to CTC

P<0.0005

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The use of the RF needle for transseptal punctures (Winkle et. al. Heart Rhythm 2011;8:1411-1415)

Baylis NRG™ RF Transseptal Needle

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Fewer Complications and better Septal Crossing with the RF Needle

(Sequoia Hospital: 1495 AF Ablations)

With OITC: Lower Target ACT to 225 Seconds and Reduce Complications

(Winkle et. al. AJC 2011;107:704-708)

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Safety of Lower Activated Clotting Times During Afib Ablation using Open Irrigated Tip Catheters and a Single Transseptal Puncture

(Winkle et. al. AJC 2011;107:704-708) )

Sequoia Hospital AF Ablation Trends over Time (1504 AF ablations in 1125 patients)

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Sequoia Hospital AF Ablation: all Major Complications from 2003-2010 in 1504 Ablations

Sequoia Hospital AF Ablation Trends over Time (1504 AF ablations in 1125 patients)

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Why Patients Should Skip AADs and Go Directly to Ablation

♥ The risk of permanent side effect from ablation is about 1:400 which is the risk of stroke every 2-3 months for the lowest risk AF groups

♥ Every drug a patient fails lowers their chance of a successful ablation

♥ Every randomized trial of Ablation vs. AAD strongly favors Ablation

Sequoia Hospital AF Ablation: Impact of number of AADs failed pre-ablation

(Europace in press)

♥ 942 patients with paroxysmal AF (n = 348) and persistent AF (n = 594) •  We examined the impact of number of AADs

failed on clinical characteristics and ablation outcomes

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Sequoia Hospital AF Ablation: Change in clinical parameters as patients fail more AADs

Number  of  Drugs  Failed No  Drugs

(n  =  195)

One  Drug

(n  =  400)

Two  Drugs

(n  =  232)

3  or  MoreDrugs

(n  =  115) P  Value

Le`  atrial  size  (cm) 4.20+0.72 4.26+0.69 4.21+0.66 4.26+0.60 0.675

Age  (years) 61.1+10.2 61.8+10.6 62.7+10.9 65.7+9.6 0.001*

DuraNon  of  AF  (years) 5.2+7.5 5.5+6.4 7.4+6.3 9.5+8.9 0.0001*

Repeat  ablaNons   26.  2% 26.8% 31.9% 35.7% 0.045*

%  Female   27.7% 30.0% 30.1% 40.9% 0.037*

Average  CHADS2  score 0.76+0.95 0.82+0.89 0.90+1.05 1.03+1.06 0.083

Hypertension 45.6% 47.2% 46.6% 47.8% 0.778

Diabetes 7.7% 8.5% 10.3% 6.1% 0.967

Coronary  artery  disease 11.3% 13.0% 15.5% 16.5% 0.115

Dilated  cardiomyopathy 7.7% 8.5% 10.3% 6.1% 0.967

Body  Mass  Index 29.3+5.1 29.2+5.2 29.1+5.5 29.7+6.5 0.797

AF1  (paroxysmal  AF) 43.1% 64.2% 35.0% 34.7% 0.003*

Prior  Stroke/TIA 7.2% 5.3% 7.3% 9.6% 0.414

*StaNsitcally  significant,  AbbreviaNons:  AF  =  atrial  fibrillaNon,  TIA  =  transient  ischemic  agack

Sequoia Hospital AF Ablation: Reasons why some patients did not fail AAD before ablation

Reason  for  no  prior  anNarrhythmic  drug Total

(N  =  195)

Physician  or  Medical  Decision

           Sinus  node  disease/bradycardia 25

           ConducNon  system  disease 1

           Coronary  artery  disease 6

           Cardiomyopathy 6

         Unexpained  syncope 1

         Liver  or  kidney  disease 3

         Total    Physician  or  Medical  Decision 42(21.5%)

PaNent  Decision

           PaNent  preference 153

         Total    PaNent  Decision 153  (78.5%)

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Sequoia Hospital: AF Ablation Outcome after Initial and Final Ablation by Number of AADs failed Pre-Ablation

(Europace in press)

Sequoia Hospital AF Ablation: Multivariate analysis of factors predicting failure of initial and final ablations

AF recurrence after Initial Ablation AF recurrence after Final Ablation

Variable Hazard

ratio

Hazard ratio

95% CI P Value

Hazard

ratio

Hazard ratio

95% CI P Value

Age 0.998 0.988-1.008 0.704 1.022 1.007-1.038 0.004*

Left Atrial size 1.354 1.154-1.306 0.0001* 1.381 1.121-1.701 0.002*

BMI (Body Mass Index) 0.989 0.989-1.008 0.250 1.001 0.977-1.026 0.940

Atrial Fibrillation Duration 1.010 0.997-1.023 0.137 1.003 0.985-1.021 0.769

Gender (female vs. male) 1.579 1.274-1.956 0.0001* 2.043 1.541-2.707 0.0001*

AF type (paroxysmal vs. persistent) 0.668 0.537-0.830 0.0001* 0.457 0.333-0.629 0.0001*

CAD (absent vs. present) 0.801 0.606-1.058 0.118 0.747 0.529-1.054 0.097

Hypertension (absent vs.present) 0.894 0.723-1.105 0.299 0.891 0.673-1.179 0.420

Diabetes (absent vs. present) 0.732 0.526-1.018 0.064 0.798 0.521-1.221 0.298

Total # of antiarrhythmics failed 1.193 1.089-1.306 0.0001* 1.317 1.167-1.486 0.0001*

* Statistically Significant, abbreviations: AF = atrial fibrillation, CAD = coronary artery disease, CI = confidence interval

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Summary of Randomized AF Ablation Trials vs. Drugs

* Excluding RAAFT

ThermoCool AF Trial (Wilber et. Al. JAMA 2010;303(4):333-340)

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ThermoCool AF Trial (Wilber et. Al. JAMA 2010;303(4):333-340)

Kaplan-Meier Curves of Time to Protocol-Defined Treatment Failure, Recurrence of Symptomatic Atrial Arrhythmia, and Recurrence of Any Atrial Arrhythmia by Treatment

Group

RF Ablation vs. Antiarrhythmic Drugs as “First-Line” Treatment of Sx Atrial Fibrillation: A Randomized Trial

(Wazni et al. JAMA 2005; 293:2634-2640)

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RF Ablation vs. Antiarrhythmic Drugs as “First-Line” Treatment of Sx Atrial Fibrillation: A Randomized Trial

(Wazni et al. JAMA 2005; 293:2634-2640)

RF Ablation vs. Antiarrhythmic Drugs as “First-Line” Treatment of Sx Atrial Fibrillation: A Randomized Trial

(Wazni et al. JAMA 2005; 293:2634-2640)

Quality of Life Assessment*.

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2010 European Guidelines:Treatment Recomendations

Conclusions

♥ Rate control is a poor solution for AF as it only “sweeps the dirt under the carpet”

♥ AADs do not work in a majority of patients and cause a lot of side effects and possibly deaths

♥ Ablation can be done safely, in a reasonable amount of time and can restore NSR in a high percentage of patients

♥  In randomized trials ablation is vastly superior to AADs ♥ The earlier in the AF course ablation is done the greater

the chance of eliminating AF ♥ The time has come for ablation to be considered as first

line treatment for most patients with AF

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Dr. Moss Thank you for all you have done over

so many years to help our patients live longer and better quality lives!