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AFib Management and the Role of Catheter Ablation. Slide Kit Structure. Section I. AFib Overview Section II. Clinical Management of AFib Section III. Catheter Ablation for the Treatment of AFib. Section I: AFib Overview. Atrial fibrillation.

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slide kit structure
Slide Kit Structure

Section I. AFib Overview

Section II. Clinical Management of AFib

Section III. Catheter Ablation for the Treatment of AFib

atrial fibrillation
Atrial fibrillation
  • Atrial fibrillation (AFib) is a common disease that causes the upper chambers of the heart (atria) to beat rapidly and in an uncontrolled manner (fibrillation).
  • Uncoordinated, rapid beating of the atria affects the flow of blood through the heart, causing an irregular pulse and sometimes a sensation of fluttering in the chest.
classification of afib subtypes
Classification of AFib Subtypes

Levy S, et al. Europace (2003) 5: 119

prevalence of afib
Prevalence of AFib

General population-based prevalence

0.95%

ATRIA study

2.5%

Olmsted County study

Go AS, et al. JAMA (2001) 285: 2370

Miyasaka Y, et al. Circulation (2006) 114: 119

slide7

Prevalence of AFib in the General Population in USA and EU

ATRIA Olmsted

USA 2.8 million 7.4 million

( 300 million inhabitants)

EU 4.3 million 11.4 million

( 456 million inhabitants of 25 member states)

prevalence of afib1
Prevalence of AFib
  • Olmsted County study

15.9

15.2

16

14.3

14

13.1

11.7

12

10.2

12.1

11.7

10

8.9

11.1

Projected number of persons with AF (millions)

7.7

10.3

8

9.4

6.7

5.9

8.4

5.1

6

7.5

6.8

6.1

5.6

4

5.1

2

0

2000

2005

2010

2015

2020

2025

2030

2035

2040

2045

2050

Year

Miyasaka Y, et al. Circulation (2006) 114: 119

incidence of afib in the general population gender differences
Incidence of AFib in the General Population – Gender Differences

Olmsted County study

Observational period: 20 years

Men0.49 %

Women 0.28 %

Ratio men to women = 1.86

Miyasaka Y, et al. Circulation (2006) 114: 119

principal reasons for increasing incidence and prevalence of afib
Principal Reasons for Increasing Incidence and Prevalence of AFib
  • The population is aging rapidly, increasing the pool of people most at risk of developing AFib
  • Survival from underlying conditions closely associated with AFib, such as hypertension, coronary heart disease and heart failure, is also increasing
  • According to the Olmsted County study, the increase is also related to the increasing population
  • These figures may also be significantly under-estimated because they do not take into account asymptomatic AFib (25% of cases in Olmsted survey)

Miyasaka Y, et al. Circulation (2006) 114: 119

Steinberg JS, et al. Heart (2004) 90: 239

afib h as an impact on all aspects of qo l
AFib has an Impact on All Aspects of QoL

SF-36 quality of life scores in AFib patients and healthy subjects

Healthy controls(n=47)

AFib patients(n=152)

SF-36 scale

* p<0.001

Dorian P, et al. J Am Coll Cardiol (2000) 36: 1303

risk factors for afib
Risk Factors for AFib

ATRIA study

Characteristic

(n=17,974)

Baseline characteristics of 17,974 adults with diagnosed AFib,July 1, 1996-December 31, 1997

Go AS, et al. JAMA (2001) 285: 2370

afib is responsible for 15 20 of all strokes
AFib is Responsible for 15-20% of all Strokes
  • AFib is responsible for a 5-fold increase in the risk of ischaemic stroke

12

8

Cumulativestrokeincidence (%)

Men AFib+

Women AFib+

Men AFib-

Women AFib-

4

0

1

2

3

4

5

1

2

3

4

5

Years of follow-up

Wolf PA, et al. Stroke (1991) 22: 983

Go AS, et al. JAMA (2001) 285: 2370

Friberg J, et al. Am J Cardiol (2004) 94: 889

increased risk of cardiovascular events
Increased Risk of Cardiovascular Events
  • Death or hospitalization in individuals with CV event(s) after 20 years

Men

Women

100

89

80

66

60

At least one CV event (%)

45

40

27

20

0

AFib

No AFib

AFib

No AFib

Stewart S, et al. Am J Med (2002) 113: 359

mortality associated with afib
Mortality Associated with AFib
  • Framingham Heart Study, n=5209

80

60

Men AFib+

Women AFib+

Mortality during follow-up (%)

40

Men AFib-

Women AFib-

20

0

0

1

2

3

4

5

6

7

8

9

10

Follow-up (y)

Benjamin EJ, et al. Circulation (1998) 98: 946

incremental afib healthcare costs

Other costs

Incremental AFib Healthcare Costs

UK costs for AFib in 1995 vs. 2000

  • 1995: Direct cost of AFib in the UK between £244 and £531 million (0.6–1.2% of overall health care expenditure)
  • 2000: £459 million direct cost – double that in 1995 (0.9–2.4% of NHS expenditure)

Cost of heart failureadmission

+50%

Cost of strokeadmission

+48%

+5.1%

­warfarin use

10%­admission

+7.4%

10%­community-based care

+5.6%

Base cost of AFin 2000

0

100

200

300

400

500

600

700

Total health care expenditure (£ million)

Base cost of associated conditions and procedures

Incremental cost of AFib

Base cost of AFib

Stewart S, et al. Heart (2004) 90: 286

major costs in treatment of afib
Major Costs in Treatment of AFib
  • COCAF Study

6%

2%

8%

52%

Hospitalizations

9%

Drugs

Consultations

Further investigations

Paramedical procedures

Loss of work

23%

Le Heuzey JY, et al. Am Heart J (2004) 147:121

cost of afib europe
Cost of AFib (Europe)
  • FIRE study
  • 4507 consecutive patients with AFib/flutter admitted to ER enrolled in FIRE study (1.5% of all ER admissions)
  • 61.9% of AFib/flutter patients were hospitalized (3.3% of all hospitalizations)
  • Mean hospital stay 7+6 days

Santini M, et al. Ital Heart J (2004) 5: 205

the burden of afib
The Burden of AFib
  • AFib is responsible for significant economic and healthcare costs
    • Hospitalization costs
    • Drug treatment
    • Treatment of AFib-associated co-morbidities and complications
  • The health and economic impact will increase with the increasing prevalence and incidence of AFib
  • AFib, owing to its epidemiology, morbidity, and mortality, represents a significant health problem with important social and economic implications that needs greater attentionand allocation of more resources
primary therapeutic aims in afib
Primary Therapeutic Aims in AFib
  • Restore and maintain sinus rhythm whenever possible
  • Prevent thromboembolic events

In order to:

      • Reduce symptoms and improve QoL
      • Minimize impact of AFib on cardiac performance
      • Reduce risk of stroke
      • Minimize cardiac remodelling

ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation

J Am Coll Cardiol (2006) 48: 854

treatment options for afib
Treatment Options for AFib

Cardioversion

  • Pharmacological
  • Electrical

Drugs to prevent AFib

  • Antiarrhythmic drugs
  • Non-antiarrhythmic drugs

Drugs to control ventricular rate

Drugs to reduce thromboembolic risk

Non-pharmacological options

  • Electrical devices (implantable pacemaker and defibrillator)
  • AV node ablation and pacemaker implantation (ablate & pace)
  • Catheter ablation
  • Surgery (Maze, mini-Maze)
recurrence following cardioversion affirm study

Treatment Arm

Rate control

Rhythm control

Recurrence Following Cardioversion: AFFIRM Study
  • AFFIRM: most recurrences occur within 2 monthsof cardioversion

100

80

60

Patients with AF Recurrence (%)

40

Log rank statistic = 58.62

p<0.0001

20

0

0

1

2

3

4

5

6

Time (years)

N, Events (%)

Raitt MN, et al. Am Heart J (2006) 151: 390

amiodarone to prevent recurrence of afib
Amiodarone to Prevent Recurrence of AFib

CTAF Study: mean follow-up 16 months

100

p<0.001

80

60

Patients without AFib (%)

40

Sotalol

Propafenone

20

Amiodarone

0

0

100

200

300

400

500

600

Follow-up (days)

Roy D, et al.N Engl J Med(2000) 342: 913

effectiveness of current aads
Effectiveness of Current AADs
  • Even with the most effective AAD, such as amiodarone, long-term efficacy is low

~50% or less at 1 year

non pharmacological treatment options for afib
Non-Pharmacological Treatment Options for AFib
  • Pacemakers not curative and must be worn for life
  • Surgical procedures may be effective but are not a practical solution for the millions of sufferers of AFib
  • Catheter ablation is potentially curative

Devices

Electrophysiological

Surgery

Pacemaker(single or dual chamber)

Internal atrialdefibrillators

Catheter ablation

AV node ablation

Maze procedure

Modified Maze

(mini-Maze)

ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation

J Am Coll Cardiol (2006) 48: 854

management of afib summary
Management of AFib - Summary
  • Current antiarrhythmic drug therapies are not highly effective in maintaining sinus rhythm and generally have poor outcomes
    • high recurrence rates
    • adverse effects and high discontinuation rate
  • A potentially curative therapy for AFib is desirable
catheter ablation
Catheter Ablation
  • Uses a series of long, thin wires (catheters) that are inserted through an artery or a vein and then guided through to the heart.
  • One of the catheters is then used to localise the source of the abnormal electrical signals and another then delivers high energy waves that neutralise (ablate) abnormal areas.
  • Using catheters to reach the heart is a common approach to treat a range of heart conditions and is much less invasive than surgical treatments.
1998 ablation of pv foci
1998: Ablation of PV Foci

Spontaneous Initiation of Atrial Fibrillation by Ectopic Beats Originating in the Pulmonary Veins

Haïssaguerre, M, Jaïs, P, Shah, DC, et al.

N Engl J Med (1998) 339: 659

  • Pivotal study identifying the pulmonary veins as a major source of ectopic electrical activity
  • Radiofrequency ablation of ectopic foci was associated witha 62% success rate (absence of recurrence at 8  6m follow-up)
slide32

A Combination of Techniques may now be used Depending on the Type of AFib

AFib

Substrate -

Atrial tissue

Trigger -

Ectopic Foci

Autonomic Nervous System

CFAEs Ablation

Linear Lesions

(e.g. mitral isthmus, roof)

PV & non-PV Foci Ablation,

PV Isolation

Vagal Denervation (parasympathetic ganglia ablation)

cardiac imaging techniques
Cardiac Imaging Techniques
  • Electroanatomical mapping
    • CARTO™ / CARTOMERGE™
  • Fluoroscopy
  • Angiography
  • Intracardiac echography
  • Cardiac spiral CT
  • Cardiac MRI
slide34

CARTO™ System

  • Localization of catheter to within 1 mm
  • Increase safety margin during ablation
  • 3D-electroanatomic maps (CARTO™) showing ablation points encircling PVs
slide35

RUPV

RMPV

LUPV

LA

AC

RLPV

LLPV

PV Antrum Isolation Guided by CARTOMERGE™ Image Integration Software Module

Courtesy of Professor Antonio Raviele, Mestre, Italy

meta analysis of catheter ablation
Meta-analysis of Catheter Ablation

Paroxysmal AF

Patients

SHD

6-month cure

Ablation method

6-months OK

Cure (by each author’s criteria) means no further AFib 6 months after the procedure in the absence of AAD.

OK means improvement (fewer episodes, no episodes with previously ineffective AAD).

SHD indicates structural heart disease.

Fisher JD, et al. PACE (2006) 29: 523

worldwide survey on efficacy and safety of catheter ablation for afib
Worldwide Survey on Efficacy and Safety of Catheter Ablation for AFib
  • Total success rate: 76%
  • Of 8745 patients:
    • 27.3% required 1 procedure
    • 52.0% asymptomatic without drugs
    • 23.9% asymptomatic with an AAD within <1 yr
  • Outcome may vary between centres

Cappato R, et al. Circulation (2005) 111: 1100

improved survival with ablation vs drug treatment

Medical Group

Ablation Group

100

90

Expected

80

Observed

Survival probability (%)

70

60

One-sample log-rank testObs=36, Exp=31, Z=0.597, p=0.55

One-sample log-rank testObs=79, Exp=341, Z=7.07, p<0.001

0

0

180

360

540

720

900

1080

0

180

360

540

720

900

1080

Days of follow-up

Days of follow-up

Improved Survival with Ablation vs Drug Treatment
  • 589 ablated patients compared with 582 on AADs

Pappone C, et al. J Am Coll Cardiol (2003) 42: 185

more afib free patients with catheter ablation vs drug treatment
More AFib-free Patients with Catheter Ablation vs Drug Treatment

100

80

60

AFib-freesurvival probability (%)

Ablation Group

40

Medical Group

20

0

0

100

200

300

Follow-up (days)

No. at risk

589

507

479

379

282

217

135

Ablation

Medical

582

456

354

277

207

141

97

Pappone C, et al. J Am Coll Cardiol (2003) 42: 185

randomised clinical trials of catheter ablation
Randomised Clinical Trials of Catheter Ablation

RF ablation vs AAD as first-line treatment for AFib

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

Catheter ablation in drug-refractory AFib

  • Stabile G et al. Eur Heart J (2006) 27: 216-221

Circumferential PV ablation for chronic AFib

  • Oral H et al. N Engl J Med (2006) 354: 934-941
slide43

RF Ablation vs Antiarrhythmic Drugs as First-line Therapy

  • Patients randomised to receive ablation (n=33) or AADs (n=37): AFib-free Survival

1.0

0.8

0.6

AFib.free survival

PVI Group

0.4

Antiarrhythmic DrugGroup

0.2

0

0

100

200

300

Follow-up (days)

Wazni OM, et al. JAMA (2005) 293: 2634

catheter ablation v s aads alone in drug refractory afib
Catheter Ablation vs. AADs Alone in Drug-refractory AFib

AADs plus ablation (n=68) or AADs alone (n=69):

1 year follow-up

Ablation Group

100

Medical Group

80

60

AFib-freesurvival (%)

40

20

0

0

1

2

3

4

5

6

7

8

9

10

11

12

Months

Stabile G, et al. Eur Heart J (2006) 27: 216

randomized controlled trial of amiodarone cardioversion catheter ablation
Randomized Controlled Trial of Amiodarone + Cardioversion + Catheter Ablation

Amiodarone & cardioversion (n=69) vs. amiodarone & cardioversion plus PV ablation (n=77)

100

Circumferentialpulmonary-vein ablation

Control

80

60

Sinus rhythm(%)

40

20

0

1

2

3

4

5

6

7

8

9

10

11

12

Months

Oral H, et al. N Engl J Med (2006) 354: 9

catheter ablation is successful in the long term
Catheter Ablation is Successful in the Long Term

No ERAF

1.0

ERAF

0.8

0.6

Freedom from Recurrent AFib

0.4

0.2

0

0

2

4

6

8

10

12

Months after PV isolation

Oral H, et al. J Am Coll Cardiol (2002) 40: 100

complications reported by leading centres
Complications Reported by Leading Centres
  • Major complications with pulmonary vein ablationin 1039 patients (6 series)

Events(n)

Rate(%)

Range in studies(%)

Complication

Verma A & NataleA Circulation (2005) 112: 1214

catheter ablation may be more cost effective t han pharmacological therapy
Catheter Ablation May Be More Cost-effective than Pharmacological Therapy
  • After 5 years, the cost of RF ablation was below that of medical management and further diverged thereafter

118 patientswithsymptomatic,drug-refractory AFib

1.52 ± 0.71 ablationprocedures

32 weeks

Pharmacological treatment

Catheter ablation

€1590/year

€4715 followed by €445/year

Weerasooriya R, et al. Pacing Clin Electrophysiol (2003) 26: 292

differences in hospital visits and costs with and without catheter ablation
Differences in Hospital Visits and Costs with and without Catheter Ablation
  • Although the initial cost of ablation is high, after ablation, utilization of healthcare resources is significantly reduced

No ablation

Catheter ablation

Goldberg A, et al. J Interv Card Electrophysiol (2003) 8: 59

catheter ablation cost effective in patie nts at high risk of stroke
Catheter Ablation Cost-Effective in Patients at High Risk of Stroke

Model to compare the cost-effectiveness of left atrial catheter ablation (LACA), amiodarone, and rate control therapy in the management of AFib

The use of LACA may be cost-effective in patients with AFib at moderate risk for stroke

This model did not find it to be cost-effective in low-risk patients.

Conclusions

Cost-effective in patients at moderate or high risk of stroke

Chan DP, et al. J Am Coll Cardiol (2006) 47: 2513

current acc aha esc guidelines
Current ACC/AHA/ESC Guidelines

RecurrentParoxysmal AF

Minimal orno symptoms

Disabling symptomsin AF

Anticoagulation and rate control as needed

Anticoagulation and rate control as needed

No drug for preventionof AF

AAD therapy

AF ablation if AADtreatment fails

ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation

J Am Coll Cardiol (2006) 48: 854

recent commentary
Recent Commentary

Why Ablation for AFib might be Considered First-Line Therapy for Some Patients

“Current therapies, especially AAM, not onlyare ineffective but also pose a threat to patientQoL and even longevity.

In the hands of experienced operators, AF ablation is an effective, safe, and established treatment for AF that offers an excellent chance for a lasting cure … unlike other therapies, ablation tackles AF at its electrophysiological origin.”

Verma A & NataleA Circulation (2005) 112: 1214

summary of catheter ablation i
Summary of catheter ablation (I)
  • Catheter ablation for AFib has undergone significant methodological and technical revolution since its initial appearance two decades ago
  • Discovery that PVs are a major source of ectopic triggers was pivotal in determining efficacy of procedure
  • Significant technological advances in catheters and imaging are further improving the efficiency of catheter ablation
  • 3D reconstructions of actual left atrial PV anatomy using CT, MRI, or intracardiac echography enables ever more accurate placement of lesions
summary of catheter ablation
Summary of catheter ablation
  • High success rate
  • Improves survival, cardiac function and freedom from recurrence
  • New data from RCTs confirm benefits
  • Safe, with a risk comparable to other low-risk, routine interventions
  • Cost effective compared to standard pharmacological therapy, at least in patients at moderate thromboembolic risk