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Recent Developments in the Management of Atrial Fibrillation. Greg C. Flaker, MD Brent Parker Professor of Medicine University of Missouri - Columbia. Recent Developments in AF. Rate control AV junction ablation / modification Rhythm control Focal ablation Surgery (MAZE)

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Recent developments in the management of atrial fibrillation

Recent Developments in the Management of Atrial Fibrillation

Greg C. Flaker, MD

Brent Parker Professor of Medicine

University of Missouri - Columbia


Recent developments in af

Recent Developments in AF

Rate control

AV junction ablation/

modification

Rhythm control

Focal ablation

Surgery (MAZE)

Catheter based

Combined

Devices

Stroke Prevention


Affirm trial hazard ratios for survival

AFFIRM TrialHazard Ratios for Survival

Favorable Unfavorable

CHF

LV Dysfunction

NSR

Warfarin

Digoxin

Rhythm Control Drug

0.5

1.0

1.5

Circ 2004;109:1909



Long-term Survival after Pace/ablate

NEJM 2001; 344: 1043-51


Av node ablation for atrial fibrillation

AV Node Ablation forAtrial Fibrillation

Pro’s Con’s

Simple Pacemaker dependence

High success Permanent

Improved QOL Anticoagulation

regular rate

controlled rate

“When the rate cannot be controlled with pharmacologic agents or tachycardia-mediated cardiomyopathy is suspected, catheter directed ablation of the AV node may be considered.” Class IIb, Level of evidence C

“It is reasonable to use ablation of the AV node or accessory pathway to control heart rate when pharmacologic therapy is insufficient or associated with side effects.” Class IIa, Level of evidence C

Circulation 2006;114:700-752


Acute MI Pacemaker

LVEF

5-01 10-01 2-03 6-03 9-03

DATE


Wide qrs proportional mortality increase
Wide QRS – Proportional Mortality Increase

QRS Duration (msec)

  • Vesnarinone Study1(VEST study analysis)

  • NYHA Class II-IV patients

  • 3,654 ECGs digitally scanned

  • Age, creatinine, LVEF, heart rate, and QRS duration found to be independent predictors of mortality

  • Relative risk of widest QRS group 5x greater than narrowest

<90

90-120

120-170

170-220

>220

Adapted from Gottipaty et al.

1Gottipaty V, Krelis S, et al. ACC 1999 [Abstr];847-4.


Ventricular Desynchronization due to RV Apical Pacing (LBBB)

Sinus node

AV

node

  • ?Decreased LVEF/LVFS

  • ?Increased LVEDD

  • ?Increased ESV

  • ?LV remodeling

  • ?Increased LA diameter

Conduction block

Pacemaker




MORE PACING = MORE HEART FAILURE

Sweeney et al. Circulation 2003;107:2932)


pQRS Duration Predicts Heart Failure

% with CHF hospitalization

Shukla PACE 2004



  • PAVE Study

  • chronic AF patients

  • NYHA I, II,III

  • AV junction ablation

J Cardiovascular Electrophysiology 2005; 16(11): 1160-5




Recent developments in af1

Recent developments in AF

Rate control

AV junction ablation/

modification

Rhythm control

Focal ablation

Surgery (MAZE)

Catheter based

Combined

Devices

Stroke Prevention


N=7401

N=7401

N=4060

N=4060


Devices for AF: Living Better Electrically

N Engl J Med 2002;346(26):2066


AF is reduced with dual chamber pacing

N Engl J Med 2002;346(24):1857


Ep peripheral based therapy
EP Peripheral Based Therapy

Catheter Approach


Endocardial ablation for atrial fibrillation 2007
Endocardial ablation for atrial fibrillation: 2007

Focal ablation Linear ablation

paroxysmal AF chronic AF

no structural disease remodeled atria

success rate 60-80% success rates ?


Catheter Based Pulmonary Vein Isolation – The Goal

L superior

PV

R superior

PV

L inferior

PV

R inferior

PV

Complete Isolation of Each Pulmonary Vein Orifice


Catheter ablation challenges long term results
Catheter Ablation Challenges Long Term Results

Freedom from AF

Oral H., Pulmonary Vein Isolation for Paroxysmal… Circulation 2002;105(9):1077-81.


Atricure instrument
AtriCure Instrument

Tip Bias Insures Uniform Tissue Contact

Sliding Jaw

Fixed Jaw

Self Adjusting Internal Spring Provides Uniform Pressure on Tissue


Mis approach wolf mini maze the next step in evolution in surgical ablation
MIS Approach – Wolf Mini-MazeThe Next Step in Evolution in Surgical Ablation

  • Sole paroxysmal and persistent AF patients

  • Bi-lateral pulmonary vein isolation – 90+% success

  • Close left atrial appendage to manage stroke

  • Collaborate with EP partners with dual approach


Pulmonary vein isolation ganglionic plexis ablation left atrial appendage exclusion procedure steps

Pulmonary Vein IsolationGanglionic Plexis AblationLeft Atrial Appendage Exclusion Procedure Steps

This material is intended to provide general information, including opinions and recommendations, contained herein for educational purposes only. Such information is not intended to be a substitute for professional medical advice, diagnosis or treatment. The material is not intended to direct clinical care in any specific circumstance. The judgment regarding a particular clinical procedure or treatment plan must be made by a qualified physician in light of the clinical data presented by the patient and the diagnostic and treatment options available.

This material may contain uses of AtriCure devices for the surgical treatment of atrial fibrillation which are investigational and have not been approved by the U.S. Food and Drug Administration.

Please review the Instructions for Use for a complete listing of indications, contraindications, warning, precautions, potential adverse events and Directions for Use prior to using these devices. Federal Law (USA) restricts these devices to sale, distribution, or use by or on the order of a physician.


SVC

R1

RSPV

R3

R2

RA

LA

R4

R5

Waterston’s

Groove

RIPV

R6

R7

R8

R9

R10

IVC

Ganglionic Plexi - Right


Pulmonary Artery

L2

L1

LSPV

LA

Appendage

L4

L3

Marshall

Tract

L6

L5

LIPV

L8

LA

L7

LV

L10

L9

AV Groove

Ganglionic Plexi - Left


Silent atrial fibrillation special populations
Silent Atrial Fibrillation:Special Populations

Catheter ablation 19%

Pacemaker population 18%

Circulation 2002;106:II-52

Circulation 2003;107:1614



Recent developments in af2

Recent developments in AF

Rate control

AV junction ablation/

modification

Rhythm control

Focal ablation

Surgery (MAZE)

Catheter based

Combined

Devices

Stroke Prevention


Stroke prevention in atrial fibrillation chads 2

Congestive heart failure

Hypertension

Age > 75 years

Diabetes mellitus

Stroke or TIA

PointsRisk of stroke/100pt-years

0 1.9

1 2.8

2 4.0

3 5.9

4 8.5

5 12.5

6 18.2

Stroke Prevention in Atrial Fibrillation: CHADS2

JAMA 2001;285:2864


Oral Anticoagulant and Aspirin Use in Atrial Fibrillation from 1980 to 2000

Minidose Warfarin Study

AFASAK II

LASAF

EAFT

Oral Anticoagulant

PATAF

SPAF II

Aspirin

SPINAF

SPAF III

Japanese NVAF study

SPAF I

CAFA

BAATAF

AFASAK I


Patients With Nonvalvular AF from 1980 to 2000

And Risk Factors for Stroke n=7,329

Adjusted-dose

Warfarin

(INR 2-3)

Fixed-dose

Ximelagatran

(36 mg bid)

Stroke Prevention Using anORal Thrombin Inhibitor in Atrial FibrillationThe SPORTIF III and V Trials

SPORTIF III 23 nations Open-label (n=3,407)

SPORTIF V US, Canada Double-blind (n=3,922)


Sportif program stroke and systemic embolism intention to treat analysis

Warfarin from 1980 to 2000

Ximelagatran

2.3%/year

1.6%/year

1.2%/year

1.6%/year

SPORTIF ProgramStroke and Systemic EmbolismIntention-to-treat Analysis

SPORTIF

7

V

III

6

5

4

Cumulative Event Rate (%year)

3

2

1

0

0

3

6

9

12

15

18

21

24

Months


Sportif program primary analyses intention to treat analysis

-0.66 from 1980 to 2000

SPORTIF III

p=0.10

+0.45

p=0.13

SPORTIF V

-0.03

Pooled

p=0.94

SPORTIF ProgramPrimary AnalysesIntention-to-treat Analysis

Ximelagatran Better

Warfarin Better

-4

-3

-2

-1

0

1

2

3

4

Difference in Absolute Event Rates(Ximelagatran – Warfarin)


Sportif program major bleeding on treatment analysis
SPORTIF Program from 1980 to 2000Major BleedingOn-treatment Analysis

p=0.054

Event Rate (%/year)

SPORTIF III

SPORTIF V

Pooled


Sportif program liver enzyme elevation alt 3 x uln

Ximelagatran from 1980 to 2000

Elevated bilirubin

SPORTIF ProgramLiver Enzyme ElevationALT >3 x ULN

Warfarin

p<0.001

p<0.001

p<0.001

Incidence (%)

SPORTIF III

SPORTIF V

Pooled


Active design
ACTIVE from 1980 to 2000 – Design

Evidence of AF

Evidence of High Risk of Vascular Events

No exclusion criteria for ACTIVE

Contra-indications to OAC or Unwilling

Eligible for ACTIVE W

(C+A* vs OAC - INR 2.0-3.0)

Eligible for ACTIVE A

(C+A* vs placebo+A)

No Exclusion criteria for ACTIVE I

Partial Factorial Design

Eligible for ACTIVE I

(Irbesartan vs placebo-I)

*C=clopidogrel 75 mg QD

A=aspirin 75-100 mg QD recommended

Mean Follow-up 3 years


Stroke non cns systemic embolism mi vascular death
Stroke, Non-CNS Systemic Embolism, MI & Vascular Death from 1980 to 2000

5.64 %/year

RR = 1.45

P = 0.0002

3.93 %/year

Cumulative Hazard Rates

# at Risk

C+A 3335 3149 2387 916

OAC 3371 3220 2453 911

Years


Major bleeding
Major Bleeding from 1980 to 2000

2.4 %/year

RR = 1.06

P = 0.67

2.2 %/year

Cumulative Hazard Rates

# at Risk

C+A 3335 3172 2403 914

OAC 3371 3212 2423 901

Years


Challenges of oral anticoagulation therapy
Challenges of Oral Anticoagulation Therapy from 1980 to 2000

Narrow efficacy window + complex kinetics + multiple interactions = hard to use/take

15.0

STROKE

INTRACRANIAL BLEED

10.0

Odds Ratio

5.0

1.0

0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

INR

Hylek EM et al. N Eng J Med. 1996; 335(8): 540-6

Hylek EM et al. Ann Intern Med. 1994; 120(11): 897-902


Measuring INR Values from 1980 to 2000

INRs 15

2-3 11

% 73%

Avg INR 2.5

I

N

R

4

15

1

2

3

5

6

7

8

9

10

12

13

14

11

Months

INRs 11

2-3 4

% 36%

Avg INR 2.5

I

N

R

4

15

1

11

2

3

5

6

7

8

9

10

12

13

14

Months

INRs 1

2-3 1

% 100%

Avg INR 2.5

I

N

R

9

14

15

6

7

8

13

1

11

12

2

3

5

10

4

Months


Inr ranges us centres with 10 w pts
% INR Ranges - US Centres from 1980 to 2000 with > 10 W Pts

% in range

Centre No.

As of October 31, 2004


Primary outcome by center inr control
Primary Outcome by Center INR Control from 1980 to 2000

InteractionP = 0.013

 65% INR in Range

<65% INR in Range

RR = 1.83

P < 0.0001

RR = 1.11

P = 0.47

Cumulative Hazard Rates

Years


Major bleeding by center inr control
Major Bleeding by Center INR Control from 1980 to 2000

 65% INR in Range

<65% INR in Range

Interaction P = 0.0006

RR = 1.55

P = 0.027

RR = 0.68

P = 0.08

Cumulative Hazard Rates

Years


Predicting an out of range inr

Clinical from 1980 to 2000

age

gender

BMI

diabetes

renal function

heart failure

drugs

warfarin naive

mini-mental score

country/center

Predicting an Out of Range INR


Adding aspirin to warfarin sportif iii and v
Adding Aspirin to Warfarin from 1980 to 2000SPORTIF III and V

p = 0.01

p = NS

p = NS

p = NS

American Heart J 2006: 152:967-73


Targets for a nticoagulant d rugs

VII from 1980 to 2000

IX

X

II

Direct thrombin inhibitors

Ximelagatran, Dabagatran

IIa

Targets for anticoagulant drugs

Intrinsic pathway

(surface contact)

Extrinsic pathway

(tissue damage)

XII

XIIa

Tissue factor

XI

XIa

IXa

VIIa

VIII

VIIIa

Heparin(s)

Vitamin K antagonists

Xa

V

Va

(Thrombin)

IIa

Fibrinogen

Fibrin


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