2009 roma, policlinico umberto i. workshop interattivo. trattamento del ritmo vs trattamento della frequenza nella fibrill. atriale

”” RATE controlRATE control vsvs RHYTHM control ”RHYTHM control ”
Stefano Nardi, MD
AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNI
DIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE
UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACAUNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA
LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONELABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE

RATERATE vsvs RHYTHMRHYTHM controlcontrol
AFib
CURE Clinical control
AFib controlRestore SR
Clinical control
paroxistic permanentpersistent
STRATEGIES

QUESTIONS
• The FIRST STEP in the treatment of AF
consists in the TERMINATION of AF and
MAINTENANCE of SR.
• Several factors contribute to create a
problematic management,including
UNDERLYING DISEASE, diversity of
CLINICAL CONDITIONS and uncertain
THERAPEUTIC GOALS goals for each pt

Considerations
• All AFib affected patients have an increased Morbidity
• The overall increased Mortality is between 1,6-2,6%
(Manitoba and Framingham Studies)
• 5% year ischemic stroke (non-rheumatic AF) 2-7
times without AF
• 1/6 Cerebro-Vascular Accident (CVA) occurs in AFib
• Framingham Study
- RHD 17 X rate of CVA (age-matched CTR)
- Attributable risk 5 X > non-RHD
- Risk of Stroke increased with age
(1,5% at 50-59 yrs vs 23,5% at 80-89 yrs)

Which objective and desiderable
approach in AFib pts?
REDUCE the Symptoms
PREVENT thromboembolic events
ELIMINATE detrimental effetcs

Therapeutic Options
Rhythm
management
Heart
Rhythm CTR
Thrombo
Embolism
Prophylaxis

AFFIRM
STAFSTAF
PIAFPIAF
HOT CAFÉHOT CAFÉ
PAF-2PAF-2
RACERACE
Randomized TRIALS
• Paroxysmal Atrial Fibirllation 2 (PAF2)
Eur Heart J ’02
• Pharmacological Intervention in AF
(PIAF) Lancet ’00.
• Comparison of rate control and rhythm
control in pts with AF
(AFFIRM) NEJM ‘02.
• Randomized trial of rate-control versus
rhythm CTR in PeAF: the Strategies of
Treatment of AF (STAF) study. JACC ‘03.
• Effect of rate or rhythm control on QoL
in PeAF: results from the Rate Control
Versus Electrical Cardioversion (RACE)
Study. JACC ‘ 04.
• How to treat C-AF (HOT-CAFÉ`) New DehliNew Dehli

• 141 pts
• Paroxysmal severely
symptomatic AF
• Rate vs Rhythm CTR
• Rate – AV junction RFCA
• Rhythm – amiodarone 1st
Brignole M, Eur Heart J ‘02
PAFPAF22 (Paroxysmal Atrial Fibrillation)(Paroxysmal Atrial Fibrillation)
Primary end-point:Primary end-point:
Development permanent
AF
• No differences in QoL
or Echo measurement
• Incidence of hospitalization
and CHF fewer in RATE
control arm
• The LACK of BENEFIT of
Rhythm CTR arm is not
surprising, given that the pts
enrolled had already AADs
rhythm CTR

• 252 pts
• Chronic AF
(7 and 360 days)
• Rate – diltiazem 1st
• Rhythm – amiodarone 1st
(23% SR restoring)
Hohnloser SH, Lancet ‘00
PIAFPIAF (Pharmacological Intervention in Atrial Fibrillation)(Pharmacological Intervention in Atrial Fibrillation)
symptoms improvementsymptoms improvement
• QoL showed no differences
between two groups.
• Incidence of hospit.
higher with RHYTHM [69%]
vs. RATE control [24%]
(p=0.001).
• AADs side-effects more
frequently with RHYTHM
[25%] vs RATE control
[14%] (p=0.036).

STAFSTAF (Strategies of Treatment of Atrial Fibrillation)(Strategies of Treatment of Atrial Fibrillation)
Inclusion Criteria:
• Persistent AF (≥ 4 weeks)
• LA enlargement (> 45 mm)
• CHF ≥ NYHA Class II
• LVEF < 45%
• Prior ECV with AF recurrence
Exclusion criteria:
• Paroxismal AF
• Recent Successful ECV (<4m)
• Longstanding PeAF (≥ 2 yrs)
• LA dilatation (> 70 mm)
• LVEF < 20%)
• PRIMARY ENDPOINT was
composite of death,
cerebrovascular event,
cardiopulmonary resuscit.
and systemic embolism.
• SECONDARY ENDPOINTS
were Echo parameters,
hospital admissions,
syncope, QoL, bleeding and
deterioration of HF.
Carlsson J, JACC ‘01

• 200 pts
• Persistent AF ≥ 4 weeks
• Rate – β blocker 1st
• Rhythm – ECV plus Class
I or Amiodarone (LVEF)
Composite of Clinical eventsComposite of Clinical events
STAFSTAF (Strategies of Treatment of Atrial Fibrillation)(Strategies of Treatment of Atrial Fibrillation)
• No difference between
Rate and Rhythm CTR
with regard to the
composite endpoint,
secondary endpoints or
QoL assessments.
• Significantly more
hospitalizations in the
RHYTHM control arm
(repeat CV and initiation
of ACT)• 23% in SR at 3-year FU,
despite
≥ 4 ECV and multiple AADs Carlsson J, JACC ‘01

• 4060 pts (70 y old)
• PeAF (≥69%) and PaAF
• Rate – Digoxin (51%), β-
blocker (49%), Ca CB (41%)
+ ACT
• Rhythm – ECV plus Class I
or Class III (Amiodarone
39%) + ACT
DeathDeath
AFFIRMAFFIRM
AFFIRM NEJM ‘02

• 522 pts (68 y old)
• Pe AF (median 32 days
recurrent after ECV)
• Rate – AV junction RFCA
• Rhythm – Claa Ic, III, ECV
RACERACE
Cardiac Death, HF-H,
Thromboembolic, Severe
Bleeding, PM implantation
• Primary END POINT
Rate CTR: 17,2% vs
Rhythm CTR: 22,6%
• Cardiovascular death
Rate CTR: 7,0% vs
Rhythm CTR: 6,7%
• Heart Failure- Hospit.
Rate CTR: 3,5% vs
Rhythm CTR: 4,5%

• Fewer adverse SIDE-EFFECTS
• Avoid potential proarrhythmic
or side effects of AADs
• Fewer HOSPITALIZATION
• Decrease compliance problems
• LOWER COST of treatment
Heart Rate Control
Potential Advantages
Cost
Efficacy
Continuative ACT administration
(Inaltered Risk of CVA or Bleeding)

does it means
Atrial Fibrillation
=
Synus Rhythm?

Lack of effective
Atrial Contraction
Chronically
Elevated HR
IMPAIR
LV function
Irregular
Ventricular
Interval
↓ LVEF
Lack of
AV synchrony

“Age-associated Changes
in LV Filling Pattern
Età (anni)
RiempimentoVS(%)
20 40 60 80
0
20
40
60
80
100
riempimento rapido
contributo atriale
Swinne, et al. JACC ‘89
Cardiac Resynchronization TherapyCardiac Resynchronization Therapy

Reduction of Atrial
Refractoriness
Increase rate
and stability AF
Increase in
LA - EDP
Development
of atrial
Enlargement
Atrial Stretch
Reduction of
Rate Adaption
Effects on LA

• Which is the BEST ACTIVITY-RELATED INCREASED
HR we should obtained in AFib pts during exercise ?
• UNTREATED AFib often produce POOR EXERCISE
TOLERANCE that improves when Rx that lowers the
HR is initiated.
Heart Rate Control
• There are virtually NO DATA from which the most
appropriate TARGET for activity-related HR during AF
can be determined.
• All such TARGET HR are TOTALLY ARBITRARY
AFFIRM AmJC, ‘97

• The same pt over a SHORT-PERIOD can demonstrate
both Symptomatic Tachycardia and Bradicardia
during AFib, even W/O a change in ACTIVITY LEVEL
• No OBJECTIVE DATA suggest that routine treatment
to lower the Exericse-induced INCREASE in HR
provides any advantages over merely treating the
RESTING HR
Heart Rate Control
• Independently of resting and activity level of HR, there
is evidence that irregularity of the HR during AFib has
a negative physiological conseguence.
Daoud EG, AmJC, ‘96

One year later…
AFFIRM revisited…AFFIRM revisited…

The AFFIRM Study. NEJM 2002
AFFIRM

Pooled (meta-analysis) data from
PAF2, PIAF, STAF, AFFIRM e
RACE
- Theese studies does not conclude that RATE CTR is ≥
RHYTHM CTR, but that strategies-based using AADs
does’t work
Hohnloser SH, Lancet ’00; Carlsson J, JACC ’01;
Brignole M, Eur Heart J ’02, AFFIRM, Circulation ‘04
Therapeutic STRATEGIES AADs-based are
frequently INEFFICACY or should be stopped
(ADVERSE or SIDE- effects)
Considerations

Quinidine 1 yr 3fold increase mortality
Drug Efficacy F.U. Drawbacks
50% SR
Author
Coplen, ‘90
Dysopiramide 1 yr Many side effects,
11% drop out
As quinidine Karlson ‘88
Flecainide 1 yr Not indicated in CAD49% SR Van Gelder, ‘89
Propafenone 6 mo Not indicated in CAD60% SR Stroobandt, ‘97
Amiodarone 1 yr Side effects61% SR Gosselink, ‘92
Overall long term efficacy (meta-analysis)
Why therapeutic approachWhy therapeutic approach
AADs-based doesn’t work ?AADs-based doesn’t work ?

PIAF, STAF, AFFIRM e RACE
• Arrhythmia-free survival
after ECV in pts with PeAF
Lower Curve
Outcome after a
single shock when no
prophylactic AADs was
given
Upper curve
Outcome with repeated
ECV in conjunction with
AADs prophylaxis

EFFICACY: in controlled studies,
in symptoms and QoL
Limit: Palliative Rx
Need of PM !
OBJECTIVE: HR control
Reduction of symptoms w/o eliminating AF
Still have CVA risk and necessity of ACT.
(Wood MA, Circulation ’00; Brignole M, EHJ ’02,
Europace ‘01)
RACE
Ablate and Pace

• The survival rate is similar to the CTR group with
AADs therapy.
• In absence of CAD, the Mortality Rate in the
A&P group is similar to the general population.
Ozcan C, NEJM ’01 and ‘04
• Controversial issue in the long-term FU
(detrimental effects of RVA pacing)
RACE
Ablate and Pace
• Continue to have loss of LA contraction

“[…] These results suggest that if an
effective method for maintaining SR
with fewer adverse effects were
available, it might improve survival”.
AFFIRM, Circulation 2004

What‘s news in
Electrophysiology ?

Ellenbogen KA, JACC ‘03

Hocini M, Card. Res ’02
Hocini M, Circulation ‘02
Firing from
LUPV
RF
Haissaguerre, NEJM ‘96

Haissaguerre Circulation ’00 73% FAPHaissaguerre Circulation ’00 73% FAP
Chen SAChen SA Circulation ’01 81% FAPCirculation ’01 81% FAP
ErnstErnst PACE ‘03PACE ‘03 69% FAP69% FAP
ArentzArentz Circulation ’03 62% FAPCirculation ’03 62% FAP
CappatoCappato Circulation ’03 88% FAPCirculation ’03 88% FAP
Marrouche JACC ‘02Marrouche JACC ‘02 90% FAP90% FAP
OralOral Circulation ’02 85% FAPCirculation ’02 85% FAP
22% FAC22% FAC
PAPPONEPAPPONE JACC ‘03JACC ‘03 83% FAP/75%FAC83% FAP/75%FAC
Circulation ‘03Circulation ‘03STABILESTABILE 38% FAP/FAC38% FAP/FAC
HOCINIHOCINI 60% FAP*60% FAP*AbstractAbstract
ORALORAL 88% FAP (+ line)*88% FAP (+ line)*Circulation ‘03Circulation ‘03

The Antagonist positions
• Pulmonary vein ablation in AF:
hype or hope? Wellens
H; Circulation ‘00.
• Potential benefits, risks, and
complications of CA of AF: more
questions than answers. Hindricks G
and Kottkamp H; J CV Electr ‘02
• Ablation for AF: are cures
really achieved? Pacifico A; Jacc ‘04.
• Should ablation be first line therapy and for
whom? The antagonist position. Padanilam BJ;
Circulation ‘05
• Carenza di studi clinici
randomizzati su larga scala
• Ampio range di % successo e di
complicanze
• “Publication bias”
• Complessità ed evolutività del
substrato
• Qual e` FU a lungo termine ?
• E nell’ FA asintomatica ?

Why Rhythm CTR is the way to prefer?Why Rhythm CTR is the way to prefer?
Reant P, Circulation ‘05
Reverse
Remodelling
• 48 pts with isolated AF
• AADs ineffective
• RFCA with PVI +
CT isthmus
• Echo evaluation
• 1 yr Follow up
78% PaAF 54% C-AF
PROSPECTIVE
DOUBLE BLINDED

Mortality
Morbidity
QoL

Randomized Trials
Catheter ablation treatment in pts with AADs-
refractory AFib: a prospective, multi-centre, randomized,
controlled study (Catheter Ablation For The Cure Of
Atrial Fibrillation Study). Stabile Eur H J ‘06
RFCA vs AADs as first-line treatment of symptomatic AFib: a
randomized trial. Wazni OM, JAMA ‘05
Stabile G, Eu H J ‘06
“ Ablation therapy combined with
AADs therapy is superior tu AADs
alone in preventing arrhythmia
recurrences in pts with PaAF or PeAF
in whom AADs therapy has already
failed “

But ….. back
in the real world
• Data comes from 3 centres
with a huge experience
Mickelson S, JICE ‘05
Cappato R, Circulation ‘05
In US EP believe 29% of pts with AF
are candidates for RFCA
• Within these 3 centres there
was a definite learning curve
• Lower volume centres have
lower success rates and
higher complication rate

• In a broad spectrum of EP laboratories using
different techniques over a wide time frame (7 yrs)
- free of AADs 48.0%
- under AADs 24.1%
SUCCESS RATES
CLINICAL SUCCESS
- Free of AADs: 3,866 (47,0%)
- With AADss: 7,408 (79,0%)
LATE RECURRENCE

The EP community has to face to the warning trend toward a
higher risk of death in the rhythm-control groups in Several
RANDOMIZED studies.
Ellenbogen KA, JACC ‘03Ellenbogen KA, JACC ‘03
Conclusions
As it is intrinsically unlikely that SR is per se harmful to the
patient’s life, we believe that the quest for safer and more
effective techniques (RFCA) for curing AF will, and should,
continue.

Only large and prospective or randomized clinical
studies in comparison between RFCA of PV and
alternative approach (rate CTR, AADs Rx for
prevent AFib , Ablate and Pace etc) for Rhythm
CTR and for Ventricular rate based strategies
will give us the ANSEWERs our question on
best treatment for AFib
Conclusions

Grazie per la
Cortese Attenzione

5.2 seconds5.2 seconds
pausepause
AFAF SRSR AFAF
MEAN HEART RATE MAXIMUM HEART RATE HRV
p=0.001 p<0.0001 p<0.0001
Hocini, Circulation ‘03

120
170
220
270
320
370
420
470
520
570
Baseline 24.0±11.3months
CL600ms; p=0.016
CL400ms; p=0.019
ms
42% CSNRT > 500ms 0% CSNRT > 500ms
TRNSC

30
35
40
45
50
55
60
65
0 11±7
LV DimensionsLV Dimensions
MonthsMonths
LVEDDLVEDD
P=0.003P=0.003
P=0.001P=0.001
LVESDLVESD
mmmm
15
20
25
30
35
40
45
50
55
60
65
0 11±7
LV FunctionLV Function
MonthsMonths
LVEFLVEF
P=<0.001P=<0.001
LVFSLVFS
%%
P=<0.001P=<0.001
Hsu, Bordeaux 2004

Miscellaneous

- Highly symptomatic AFib pts who refuse AADs.
When considered RFCA asWhen considered RFCA as
11stst
line therapy in AFib ?line therapy in AFib ?
- When Amiodarone represent the only AAD of choice
- In high risk pts for stroke who refuse or cannot take
long term warfarin therapy (???)
- Young pts with FAP and SND who may not tolerate
AADs w/o a permanent pacemaker.

• Promising tool to interact with the ongoing
arrhythmia, and may prove effective in REDUCING
symptoms in SELECTED pts
• Its use in clinical practice reflects the NON-
OPTIMAL applicability of AADs strategy to the
VARIOUS SUBSTRATES and MECHANISMS.
Antitachycardia Pacing

Terapia Ibrida dellaTerapia Ibrida della
FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
OBIETTIVO: Ripristino RS
• Tecnicamente: EFFICACE
• Presupposto: DEBOLE
(estrapolazione di osservazioni su studi animali)
• Disegno clinico: NON SOLIDO
(studi non controllati, scarsa
attenzione alla QOL)
The HYBRID Tx in AF
ANTITACHYCARDICAL PACING

- A Retrospective of US Carvedilol HF Trials, show
the efficacy of this strategies in CHF/AFib pts.
- However, β-blocker may reduce LV function acutely
and may not be tolerated at doses required to fully
CTR ventricular rate.
- The same consideration are available from non-
dihydropiridine calcium channel blocker, whereas
digoxin does’t work as monotherapy.
(US Carvedilol HF Trials, AHJ ‘01)
Heart Rate Control

• Atrial Defibrillator (AD) could restore SR
rapidly by use of LOW-ENERGY SHOCK
• In a highly selected group of pts with
paroxysmal AF, the AD was able to achieve SR
for at least a brief period of time in 96% of
patients with AF.
Wellens HJJ, Circulation ‘98
DEFIBRILLATORE ATRIALE
OPZIONI Terapeutiche

• Alta efficacia in ACUTO (96%)
• Fonte prevalente di STRESS ed importante
fattore limitante l’impiego del sistema in automatico.
CONSIDERAZIONI
• In un elevato numero di pz (52%):
- necessità di SHOCKS multipli
- Aggiunta di farmaci AA in cronico
- Successivo intervento addizionale (ECV + AA).

OBIETTIVO: Ripristino RS
• Tecnicamente: EFFICACE nelle aritmie regolari
• Presupposto: DEBOLE
(studi non controllati, scarsa
CONSIDERAZIONI

• Although the device can in ACUTE convert parox.
AF (96%), a large number of pts (52%) needed
multiple shocks or drugs or required subsequently
an additional intervention (ECV with AA drugs).
• These findings STRESS an important limitation
of the use of the system as an automatic device.
The HYBRID Tx in AF
ATRIAL DEFIBRILLATOR

• First routinely used of RFCA for symptomatic AF in
whom a RATE CONTROL with AADs is not obtainable.
• Accepted form of HR control associated with
HAEMODYNAMIC BENEFITS, and does not
require AADs, with their correlated side effects.
Ablate and Pace
• In SSS who require PM and have AF with rapid
responses, in whom AADs may be detrimental on
hemodinamic Function
DATA SOURCE:
Fitzpatrick AP, Am Heart J ’96; Wood MA, Circulation ’00;
Brignole M, Eu Heart J ’02; Brignole M, Europace ’01.

ABLATION

• singole appl.RFsingole appl.RF
• LassoLasso
• SpiralSpiral
• BasketBasket
• XrayXray
• CARTOCARTO
• LocaLisaLocaLisa
• NavXNavX
• RPMRPM
• ICEICE
• ConvenzionaleConvenzionale
• 8 mm tip8 mm tip
• Irrigated tipIrrigated tip
• InvestigationalInvestigational
(balloon,(balloon,
cryo...)cryo...)
- Framework per l’ablazioneFramework per l’ablazione
- Guidare il mappaggioGuidare il mappaggio
- Localizzazione AnatomicaLocalizzazione Anatomica
- Tag sui siti di ablazione- Tag sui siti di ablazione
- Valutazione delValutazione del
contatto delcontatto del
cateterecatetere
-MiglioramentoMiglioramento
dell’efficienzadell’efficienza
dell’erogazionedell’erogazione
di energiadi energia
MAPPAGGIOMAPPAGGIO TRACKINGTRACKING ABLAZIONEABLAZIONE

ACT: Trials Principali
• SPAF1
Stroke Prevention in Atrial Fibrillation
• BAATAF2
Boston Area Anticoagulation Trial for
Atrial Fibrillation
• CAFA3
Canadian Atrial Fibrillation Anticoagulation
• AFASAK4
Copenhagen Investigators
• SPINAF5
Stroke Prevention in Nonrheumatic
Atrial Fibrillation
1
Circulation ’91; 2
NEJM ’90; 3
JACC ’91; 4
The Lancet ’89; 5
NEJM ’92

• Carenza di studi clinici randomizzati su larga scala
• Ampio range di percentuali di successo e di
complicanze
• “Publication bias”
• Complessità ed evolutività del substrato
• Follow up a lungo termine?
• FA asintomatica
The Antagonist positions
AFib ablation

5.2 seconds5.2 seconds
pausepause
AFAF SRSR AFAF
• In patients with sinus node disease
• Sinus node remodeling
Considerations
(Hocini,Circulation ‘03)

20 consecutive pts with prolonged synusal pauses
(3-10’’) and AF, underwent RFCA of PV
MEAN HEART RATE MAXIMUM HEART RATE HRV
p=0.001 p<0.0001 p<0.0001
Considerations

At 26.0±17.6 mo FU: 17 pz were asymptomatic, 2 improve
with AADs and only 1 required pacing (AFA & pause)
120
170
220
270
320
370
420
470
520
570
Baseline 24.0±11.3months
CL600ms; p=0.016
CL400ms; p=0.019
ms
42% CSNRT > 500ms 0% CSNRT > 500ms
TRNSC

Improvement of LV Size & Function In CHF
30
35
40
45
50
55
60
65
0 11±7
LV DimensionsLV Dimensions
MonthsMonths
LVEDDLVEDD
P=0.003P=0.003
P=0.001P=0.001
LVESDLVESD
mmmm
15
20
25
30
35
40
45
50
55
60
65
0 11±7
LV FunctionLV Function
MonthsMonths
LVEFLVEF
P=<0.001P=<0.001
LVFSLVFS
%%
P=<0.001P=<0.001
Hsu, Bordeaux 2004

•Drugs - RHYTHM
CTR
- RATE CTR
- Steroid, ACE-I,
ARBs, Statin
• Ablate and pace”
• Ablation
• Multisite Pacing/ATP
Therapeutic Options
• ECV
• LAA occlusion
- Primary Ablation
-

Objective: Restore SR
• Tecnicamente: EFFICACY in regular Arrhythmias
• Presupposto: Weak
(Non Controled Studies, no
attention to QoL)
Anti-tachycardia PACING
• According to an evidence-based approach, No ATP
Strategies has been validated.
• The ABSENCE of CTR GROUPS assigned to conventional
Rx accounts for the non validation of curative ATP in the

• It’s UNCLEAR which pts are appropriate candidates
for such a device.
The HYBRID Tx in AF
ATRIAL DEFIBRILLATOR
• People with paroxysmal AFib are probably POOR
candidates, because of their very frequent
episodes which would require too many shocks.
• People with chronic AFib (>1 yr) are probably
also NOT IDEAL CANDIDATES.

Science Advisory From the AHA Council on Clinical Cardiology. Circulation ‘05
Pacing, Multisite pacing, Overdive pacing

AV node modulation
• Objective: HR CTR
• Success Rate 60-80%
• Recurrence Rate 20-30%
• Efficacy in sub-group of pts (30%-50%).
• Relatively Short “FU”
• Effect NOT EVALUABLE before procedure
• Unaltered Morbidity
Limit: palliative therapy !
RACE

FARMACO SUCCESS %
propafenone (e.v.)
propafenone (os)
flecainide (e.v.)
flecainide (os)
amiodarone (e.v.)
ibutilide (ev)
dofetilide (e.v.)
dofetilide (os)
29-91
72
57-59
78
34-92
34-47
31
32
Acute efficacy
Rhythm Control
• Physiologic rate CTR
• Atrial contribution to
CO maintained
• Better exercise
tolerance
• Possibility of reduced
thromboembolic risk
Potential
Advantages

- Strategies based to maintaining SR at 1 yrs FU
without AADs is <30% (recurrence between 50-70%) ....
RACE
- … however in most cases AADs based strategies are
not able to prevent RECURRENCE of A Fib.
• Global efficacy 40 - 50% (Reduce in long term FU)
25% dei casi interruzione del trattamento !
• SIDE EFFECTS
– Until 20% of cases (3-5% TdP)

RATERATE vsvs RHYTHMRHYTHM controlcontrolNumerodipazienticonrecidivadiFANumerodipazienticonrecidivadiFA
0 5 10 15 20 25 30
Giorni Post Conversione
PIAF, STAF, AFFIRM e RACE
• AADs (Class IA, IC, III) has been demonstrated to
be effective in IMPROVING the EFFICACY of ECV
- Lower THRESHOLD of AF
- Prolong the CL of vagally-mediated acute AF
- Higher SUCCESS RATE (> 90%)

AFib and Stroke
• Incidenza: 5-8% annuo in
pazienti ad alto rischio
• La valutazione del rischio
embolico per una adeguata
ACT è prioritaria nei
pazienti con FA
• Numerosi trials randomizzati
hanno fornito linee guida per
l’identificazione ed il
trattamento dei pazienti con
FA a rischio embolico
• SPAF1 Stroke Prevention in
AF
• BAATAF2 Boston Area
Anticoagulation Trial for AF
• CAFA3 Canadian AF Anticoagulation
• AFASAK4
Copenhagen Investigators
• SPINAF5 Stroke Prevention in
Nonrheumatic AF
Principal
Trials

Which is the way
to prefer ?
ACC/AHA/ESC Guidelines; Circulation ‘01ACC/AHA/ESC Guidelines; Circulation ‘01

PATIENT
FEATURES
ANTITHROMBOTIC Rx
ACC/AHA/ESC ACCP
Age < 60 yrs (65 in ACCP)
No HD (lone AF)
ASA (325 mg daily) or no Rx ASA (325 mg daily) or noRx
Age < 60 yrs (65 in ACCP)
HD but no risk factors
ASA (325 mg daily) ASA (325 mg daily)
Age ≥ 60 yrs (65 in ACCP) and no
risk factors
ASA (325 mg daily) ASA (325 mg daily) or ACT
Age ≥ 60 yrs (65 in ACCP) with
diabetes mellitus or CAD
ACT (INR 2.0 – 3.0); Addition
ASA (81-162mg) daily optional
ACT (INR 2.0 – 3.0)
Addition ASA (81-162 mg)
daily is optional
Age ≥ 75 years, especially women Oral ACT INR ~ 2.0 (1.6-2.5) Oral ACT ~ 2.5 (2.0 – 3.0)
HF, LVEF ≤ 0.35,
Thyrotoxicosis, Hypertension
Oral ACT (INR 2.0 – 3.0) Oral ACT (INR 2.0 – 3.0)
Rheumatic HD, Prosthetic valves
Prior embolism, Persistent TR (TEE)
Oral ACT (INR ≥ 2.5-3.5) Oral ACT (INR ≥ 2.5-3.5)
GuidelinesGuidelines

Adjusted OR for ischemic stroke and
intracranial bleeding in relation to ACT
ACC/AHA/ESC Guidelines; Circulation ‘01ACC/AHA/ESC Guidelines; Circulation ‘01
• SPAF1 Stroke Prevention in AF
• BAATAF2 Boston Area
Anticoagulation Trial for AF
• CAFA3 Canadian AF
Anticoagulation
• AFASAK4 Copenhagen
Investigators
• SPINAF5
Stroke Prevention in
Nonrheumatic AF
Randomized Trials

SuedaSueda
Ann Thorac Surg 1997Ann Thorac Surg 1997
Circuiti diCircuiti di
microrientromicrorientro
HaissaguerreHaissaguerre
NEJM 1998NEJM 1998FociFoci
delledelle
VPVP
L di ML di M
HwangHwang
Circulation 2000Circulation 2000

RF

Who to refer ….
• Symptomatic AFib
• PaAF or PeAF
• Failed AADs therapy
• No major cardiac structural disease
• Age <70
• LA size <5.0 cm

Hsu, NEJM ‘04
And .... in patients with
Congestive Heart Failure ?

Year RAC LAC PV-TR PV-Dis Other Total
1995 13 2 0 0 3 18
1996 38 4 1 0 5 48
1997 67 32 23 0 0 122
1998 109 57 158 49 22 395
1999 142 89 332 88 28 679
2000 135 110 383 569 42 1,239
2001 179 230 274 1,534 31 2,248
2002 169 556 355 4,360 10 5,450
Total 852 1,080 1,526 6,600 141 10,199
World Wide Survey

No. of No. of No. of Success without AADs Success with AADs Overall Success
Procedures Centers Pts. No. Rate [Range] No. Rate [Range] No. Rate
per Center (%) (%) (%) (%) (%)
[Range]
1- 30 35 547 163 29.8 [14.5-43.6] 165 30.1 [18.7-46.5] 328 59.9
31- 60 15 639 214 33.5 [20.8-46.6] 217 34.0 [20.4-48.1] 431 67.5
61- 90 12 923 341 36.9 [18.3-51.2] 311 33.7 [16.7-50.3] 652 70.6
91- 120 7 728 258 35.4 [24.1-48.7] 221 30.4 [22.8-39.0] 594 81.6
121- 150 4 556 187 33.6 [22.6-46.5] 160 28.8 [20.9-37.1] 347 62.4
151-180 4 671 297 44.3 [32.8-51.9] 199 29.7 [23.1-37.8] 496 74.0
181- 230 3 607 320 52.7 [42.1-63.0] 138 22.7 [18.3-25.9] 458 75.4
231- 300 3 830 519 62.5 [55.7-70.4] 236 28.4 [22.3-35.6] 755 91.0
> 300 7 3,244 2,069 63.8 [50.3-76.5] 514 15.8 [8.8-24.5] 2,583 87.9
Total 90 8,745 4,550 52.0 [14.5 -76.5] 2,094 23.9 [8.8 -50.3] 6,644 75.9
World Wide Survey

Pts with symptomatic AADs
refractory AF, should be judged
on an individual basis according to
the Ablation Centre’s experience
Who to refer ….
• Should we try to run before we can walk,
especially if there are other therapeutic options

Who to refer ….
• Symptomatic AFib
• PaAF or PeAF
• Failed AADs therapy
• No major cardiac structural disease
• Age <70
• LA size <5.0 cm
• Accept 1-2% risk of STROKE
• Accept to 4-5 hour of procedure
• Accept 20-30% 2nd
procedure
• Accept 75-85% improvement rate,
40-50% cure rate off AADs

1. Pharmacological Approach
3.Radiofrequency Catheter ABLATION
– AV node Modulation
– AV node Ablation and PM implant (ABLATE & PACE)
– Primary Ablation (CURATIVE)
2.Anti-tachycardia PACING (ATP)
Strategies

REDUCTION LA refrac. and rate adaption
INCREASED in rate, inducibility and
stability of AFib
DEVELOPMENT of LA/RA enlargement
(atrial stretch)
INCREASE in mitochondrial size and nr
ACCUMULATION of glycogen
FRAGMENTATION/DISRUPTION of REG
MORPHOLOGIC and CELLULAR remodel.
ALTERATION in Ca++ regulatory proteins
A VICIOUS CYCLE
Cellular Remodelling

Verma, Circulation ‘05
Meta-analysis

THESYS
ANTI-THESYS
CONCLUSIONS
Does it means AFib = Synus Rhythm?
Why therapeutic approach AADs-basedWhy therapeutic approach AADs-based
doesen’t work ?doesen’t work ?
“The meta-analyses suggest that if an effective
non-pharmacological approach for maintaining SR
is available, it might improve survival”.

Conclusions
• RFCA should be considered in symptomatic PaAF or PeAF pts due to not reversible causes,
AADs refractory and w/o severe LA enlargement
• If AMIODARONE the only long-term option.
• In patients who REFUSE AADs.
• In HIGH RISK EMBOLIC patients with CI to ACT
• Nei giovani con FA parossistica e SSS che non possono
essere sottoposti a AADs senza PM

2009 roma, policlinico umberto i. workshop interattivo. trattamento del ritmo vs trattamento della frequenza nella fibrill. atriale

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