2009 roma, policlinico umberto i. workshop interattivo. trattamento del ritmo vs trattamento della...
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” ” RATE control RATE control vs vs RHYTHM control ”RHYTHM control ”
Stefano Nardi, MD
AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNIDIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE
UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE
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RATE RATE vs vs RHYTHMRHYTHM control control
AFib
CURE Clinical control
AFib controlRestore SR
Clinical control
paroxistic permanentpersistent
STRATEGIES
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QUESTIONSRATE RATE vs vs RHYTHMRHYTHM control control
• 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
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ConsiderationsRATE RATE vs vs RHYTHMRHYTHM control control
• 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)
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Which objective and desiderable approach in AFib pts?
RATE RATE vs vs RHYTHMRHYTHM control control
REDUCE the SymptomsPREVENT thromboembolic events
ELIMINATE detrimental effetcs
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RATE RATE vs vs RHYTHMRHYTHM control control
Therapeutic OptionsRhythm management
Heart Rhythm CTR
ThromboEmbolismProphylaxis
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AFFIRM
STAFSTAF
PIAFPIAF
HOT CAFÉHOT CAFÉ
PAF-2PAF-2
RACERACE
RATE RATE vs vs RHYTHMRHYTHM control control
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
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• 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
RATE RATE vs vs RHYTHMRHYTHM control control
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• 252 pts • Chronic AF
(7 and 360 days) • Rate vs Rhythm CTR • Rate – diltiazem 1st • Rhythm – amiodarone 1st
(23% SR restoring)
Hohnloser SH, Lancet ‘00
PIAF PIAF (Pharmacological Intervention in Atrial Fibrillation)(Pharmacological Intervention in Atrial Fibrillation)
Primary end-point: Primary end-point: 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).
RATE RATE vs vs RHYTHMRHYTHM control control
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RATE RATE vs vs RHYTHMRHYTHM control control
STAF STAF (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
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• 200 pts • Persistent AF ≥ 4 weeks • Rate vs Rhythm CTR • Rate – β blocker 1st • Rhythm – ECV plus Class
I or Amiodarone (LVEF)
Primary end-point: Primary end-point: Composite of Clinical eventsComposite of Clinical events
RATE RATE vs vs RHYTHMRHYTHM control control
STAF STAF (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
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• 4060 pts (70 y old)• PeAF (≥69%) and PaAF • Rate vs Rhythm CTR • Rate – Digoxin (51%), β-
blocker (49%), Ca CB (41%) + ACT
• Rhythm – ECV plus Class I or Class III (Amiodarone 39%) + ACT
Primary end-point: Primary end-point: DeathDeath
RATE RATE vs vs RHYTHMRHYTHM control control
AFFIRM AFFIRM
AFFIRM NEJM ‘02
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• 522 pts (68 y old) • Pe AF (median 32 days
recurrent after ECV) • Rate vs Rhythm CTR • Rate – AV junction RFCA • Rhythm – Claa Ic, III, ECV
RACERACE
Primary end-point: Primary end-point: 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%
RATE RATE vs vs RHYTHMRHYTHM control control
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• 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
RATE RATE vs vs RHYTHMRHYTHM control control
Cost
EfficacyContinuative ACT administration (Inaltered Risk of CVA or Bleeding)
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does it meansAtrial Fibrillation
= Synus Rhythm?
RATE RATE vs vs RHYTHMRHYTHM control control
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Lack of effective Atrial Contraction
Chronically Elevated HR
IMPAIR LV function
Irregular Ventricular
Interval↓ LVEF
Lack of AV synchrony
RATE RATE vs vs RHYTHMRHYTHM control control
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“Age-associated Changes in LV Filling Pattern
Età (anni)
Riem
pim
ento
VS
(%)
20 40 60 800
20
40
60
80
100
riempimento rapido
contributo atriale
Swinne, et al. JACC ‘89
Cardiac Resynchronization TherapyCardiac Resynchronization Therapy
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Reduction of Atrial Refractoriness
Increase rate and stability AF
Increase inLA - EDP
Development of atrial
Enlargement Atrial Stretch
Reduction of Rate Adaption
RATE RATE vs vs RHYTHMRHYTHM control controlEffects on LA
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• 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
RATE RATE vs vs RHYTHMRHYTHM control 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
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• 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
RATE RATE vs vs RHYTHMRHYTHM control 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
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The original AFFIRM STUDY
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One year later…
AFFIRM revisited…AFFIRM revisited…
AFFIRM revisited…AFFIRM revisited…
AFFIRM revisited…AFFIRM revisited…
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The AFFIRM Study. NEJM 2002
RATE RATE vs vs RHYTHMRHYTHM control controlAFFIRM
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RATE RATE vs vs RHYTHMRHYTHM control controlPooled (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
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Quinidine 1 yr 3fold increase mortalityDrug Efficacy F.U. Drawbacks
50% SR
AuthorCoplen, ‘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
RATE RATE vs vs RHYTHMRHYTHM control control
Overall long term efficacy (meta-analysis)
Why therapeutic approach Why therapeutic approach AADs-based doesn’t work ? AADs-based doesn’t work ?
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RATE RATE vs vs RHYTHMRHYTHM control controlPooled (meta-analysis) data from 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 givenUpper curve Outcome with repeated ECV in conjunction with AADs prophylaxis
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EFFICACY: in controlled studies, in symptoms and QoL
Limit: Palliative Rx Need of PM !
OBJECTIVE: HR control
RATE RATE vs vs RHYTHMRHYTHM control 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)
Pooled (meta-analysis) data from PAF2, PIAF, STAF, AFFIRM e RACE Ablate and Pace
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• 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)
RATE RATE vs vs RHYTHMRHYTHM control controlPooled (meta-analysis) data from PAF2, PIAF, STAF, AFFIRM e RACE Ablate and Pace
• Continue to have loss of LA contraction
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“[…] These results suggest that if an effective method for maintaining SR
with fewer adverse effects were available, it might improve survival”.
AFFIRM, Circulation 2004
RATE RATE vs vs RHYTHMRHYTHM control control
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What‘s news in Electrophysiology ?
RATE RATE vs vs RHYTHMRHYTHM control control
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RATE RATE vs vs RHYTHMRHYTHM control control
Ellenbogen KA, JACC ‘03
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RATE RATE vs vs RHYTHMRHYTHM control control
Hocini M, Card. Res ’02 Hocini M, Circulation ‘02
Firing from LUPV
RF
Haissaguerre, NEJM ‘96
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RATE RATE vs vs RHYTHMRHYTHM control control
Haissaguerre Circulation ’00 73% FAPHaissaguerre Circulation ’00 73% FAPChen SAChen SA Circulation ’01 81% FAP Circulation ’01 81% FAPErnstErnst PACE ‘03 PACE ‘03 69% FAP 69% FAPArentzArentz Circulation ’03 62% FAP Circulation ’03 62% FAPCappatoCappato Circulation ’03 88% FAP Circulation ’03 88% FAPMarrouche JACC ‘02Marrouche JACC ‘02 90% FAP 90% FAP
OralOral Circulation ’02 85% FAP Circulation ’02 85% FAP 22% FAC 22% 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
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The Antagonist positions
• Pulmonary vein ablation in AF: hype or hope? Wellens H; Circulation ‘00.
RATE RATE vs vs RHYTHMRHYTHM control control
• 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 ?
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Why Rhythm CTR is the way to prefer? Why Rhythm CTR is the way to prefer? RATE RATE vs vs RHYTHMRHYTHM control control
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
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MortalityMorbidityQoL
RATE RATE vs vs RHYTHMRHYTHM control control
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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
RATE RATE vs vs RHYTHMRHYTHM control control
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 “
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But ….. back in the real world• Data comes from 3 centres
with a huge experience
Mickelson S, JICE ‘05
Cappato R, Circulation ‘05
RATE RATE vs vs RHYTHMRHYTHM control control
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
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• 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
Cappato R, Circulation ‘04
RATE RATE vs vs RHYTHMRHYTHM control control
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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
ConclusionsRATE RATE vs vs RHYTHMRHYTHM control control
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.
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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
RATE RATE vs vs RHYTHMRHYTHM control controlConclusions
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Grazie per la Cortese Attenzione
RATE RATE vs vs RHYTHMRHYTHM control control
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RATE RATE vs vs RHYTHMRHYTHM control control
5.2 seconds 5.2 seconds pausepause
AFAF SRSR AFAF
MEAN HEART RATE MAXIMUM HEART RATE HRV
p=0.001 p<0.0001 p<0.0001
Hocini, Circulation ‘03
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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
RATE RATE vs vs RHYTHMRHYTHM control control
Hocini, Circulation ‘03
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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
1520253035404550556065
0 11±7
LV FunctionLV Function
MonthsMonths
LVEFLVEFP=<0.001P=<0.001
LVFSLVFS
%%
P=<0.001P=<0.001
Hsu, Bordeaux 2004
RATE RATE vs vs RHYTHMRHYTHM control control
Hocini, Circulation ‘03
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Miscellaneous
RATE RATE vs vs RHYTHMRHYTHM control control
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- Highly symptomatic AFib pts who refuse AADs.
When considered RFCA as When considered RFCA as 11stst line therapy in AFib ? line therapy in AFib ?
RATE RATE vs vs RHYTHMRHYTHM control control
- 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.
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• 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 RATE RATE vs vs RHYTHMRHYTHM control control
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Terapia Ibrida della Terapia 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 AFANTITACHYCARDICAL PACING
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- 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)
RATE RATE vs vs RHYTHMRHYTHM control controlHeart Rate Control
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Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
• 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 ATRIALEOPZIONI Terapeutiche
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Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
• Alta efficacia in ACUTO (96%)
• Fonte prevalente di STRESS ed importante fattore limitante l’impiego del sistema in automatico.
DEFIBRILLATORE ATRIALECONSIDERAZIONI
• In un elevato numero di pz (52%):- necessità di SHOCKS multipli - Aggiunta di farmaci AA in cronico - Successivo intervento addizionale (ECV + AA).
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Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
OBIETTIVO: Ripristino RS
• Tecnicamente: EFFICACE nelle aritmie regolari• Presupposto: DEBOLE
(estrapolazione di osservazioni su studi animali)• Disegno clinico: NON SOLIDO
(studi non controllati, scarsa attenzione alla QOL)
CONSIDERAZIONIDEFIBRILLATORE ATRIALE
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Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
• 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 AFATRIAL DEFIBRILLATOR
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• 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 PaceRATE RATE vs vs RHYTHMRHYTHM control control
• 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.
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RATE RATE vs vs RHYTHMRHYTHM control control
ABLATION
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• 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 del Valutazione del contatto del contatto del catetere catetere
-Miglioramento Miglioramento dell’efficienza dell’efficienza dell’erogazione dell’erogazione di energia di energia
MAPPAGGIO MAPPAGGIO TRACKINGTRACKING ABLAZIONE ABLAZIONE
Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
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ACT: Trials Principali• SPAF1 Stroke Prevention in Atrial Fibrillation
• BAATAF2 Boston Area Anticoagulation Trial for Atrial Fibrillation
• CAFA3 Canadian Atrial Fibrillation Anticoagulation
• AFASAK4Copenhagen Investigators
• SPINAF5 Stroke Prevention in NonrheumaticAtrial Fibrillation
1 Circulation ’91; 2 NEJM ’90; 3 JACC ’91; 4 The Lancet ’89; 5 NEJM ’92
RATE RATE vs vs RHYTHMRHYTHM control control
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• 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
RATE RATE vs vs RHYTHMRHYTHM control control
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5.2 seconds 5.2 seconds pausepause
AFAF SRSR AFAF
• In patients with sinus node disease
• Sinus node remodeling
RATE RATE vs vs RHYTHMRHYTHM control control
Considerations
(Hocini,Circulation ‘03)
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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
RATE RATE vs vs RHYTHMRHYTHM control control
Considerations
(Hocini,Circulation ‘03)
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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
RATE RATE vs vs RHYTHMRHYTHM control control
(Hocini,Circulation ‘03)
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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
1520253035404550556065
0 11±7
LV FunctionLV Function
MonthsMonths
LVEFLVEFP=<0.001P=<0.001
LVFSLVFS
%%
P=<0.001P=<0.001
Hsu, Bordeaux 2004
RATE RATE vs vs RHYTHMRHYTHM control control
(Hocini,Circulation ‘03)
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•Drugs - RHYTHM CTR - RATE CTR - Steroid, ACE-I, ARBs, Statin• Ablate and pace”
• Ablation
• Multisite Pacing/ATP
RATE RATE vs vs RHYTHMRHYTHM control control
Therapeutic Options
• ECV
• LAA occlusion
- Primary Ablation - Modulation/Ablation AVN
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Objective: Restore SR
• Tecnicamente: EFFICACY in regular Arrhythmias • Presupposto: Weak
(estrapolazione di osservazioni su studi animali)• Disegno clinico: NON SOLIDO
(Non Controled Studies, no attention to QoL)
Anti-tachycardia PACINGRATE RATE vs vs RHYTHMRHYTHM control control
• 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 treatment of AF
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Terapia Ibrida della Terapia Ibrida della FIBRILLAZIONE ATRIALEFIBRILLAZIONE ATRIALE
• It’s UNCLEAR which pts are appropriate candidates for such a device.
The HYBRID Tx in AFATRIAL 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.
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Science Advisory From the AHA Council on Clinical Cardiology. Circulation ‘05
Pacing, Multisite pacing, Overdive pacingRATE RATE vs vs RHYTHMRHYTHM control control
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AV node modulation
RATE RATE vs vs RHYTHMRHYTHM control control
• 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 !
Pooled (meta-analysis) data from PAF2, PIAF, STAF, AFFIRM e RACE
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FARMACO SUCCESS %propafenone (e.v.)propafenone (os)flecainide (e.v.)flecainide (os)amiodarone (e.v.)ibutilide (ev)dofetilide (e.v.)dofetilide (os)
29-9172
57-5978
34-9234-47
3132
Acute efficacy
RATE RATE vs vs RHYTHMRHYTHM control control
Rhythm Control
• Physiologic rate CTR• Atrial contribution to
CO maintained• Better exercise
tolerance• Possibility of reduced
thromboembolic risk
Potential Advantages
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- Strategies based to maintaining SR at 1 yrs FU without AADs is <30% (recurrence between 50-70%) ....
RATE RATE vs vs RHYTHMRHYTHM control controlPooled (meta-analysis) data from PAF2, PIAF, STAF, AFFIRM e 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)
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RATE RATE vs vs RHYTHMRHYTHM control controlN
umer
o di
paz
ient
i con
rec
idiv
a di
FA
Num
ero
di p
azie
nti c
on r
ecid
iva
di F
A
0 5 10 15 20 25 30 Giorni Post Conversione
Pooled (meta-analysis) data from 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%)
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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
RATE RATE vs vs RHYTHMRHYTHM control control
• 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
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Which is the way to prefer ?
ACC/AHA/ESC Guidelines; Circulation ‘01ACC/AHA/ESC Guidelines; Circulation ‘01
RATE RATE vs vs RHYTHMRHYTHM control control
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RATE RATE vs vs RHYTHMRHYTHM control control
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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 valvesPrior embolism, Persistent TR (TEE)
Oral ACT (INR ≥ 2.5-3.5) Oral ACT (INR ≥ 2.5-3.5)
GuidelinesGuidelinesRATE RATE vs vs RHYTHMRHYTHM control control
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Adjusted OR for ischemic stroke and intracranial bleeding in relation to ACT
ACC/AHA/ESC Guidelines; Circulation ‘01ACC/AHA/ESC Guidelines; Circulation ‘01
RATE RATE vs vs RHYTHMRHYTHM control control
• 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
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Sueda Sueda Ann Thorac Surg 1997Ann Thorac Surg 1997
Circuiti di Circuiti di microrientromicrorientro
HaissaguerreHaissaguerreNEJM 1998NEJM 1998 Foci Foci
delle delle VPVP
L di ML di M
HwangHwangCirculation 2000Circulation 2000
RATE RATE vs vs RHYTHMRHYTHM control control
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RATE RATE vs vs RHYTHMRHYTHM control controlRF
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RATE RATE vs vs RHYTHMRHYTHM control control
Who to refer ….• Symptomatic AFib• PaAF or PeAF • Failed AADs therapy • No major cardiac structural disease • Age <70• LA size <5.0 cm
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Hsu, NEJM ‘04
RATE RATE vs vs RHYTHMRHYTHM control controlAnd .... in patients with Congestive Heart Failure ?
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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
RATE RATE vs vs RHYTHMRHYTHM control control
Cappato R, Circulation ‘04
World Wide Survey
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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
RATE RATE vs vs RHYTHMRHYTHM control control
Cappato R, Circulation ‘04
World Wide Survey
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Pts with symptomatic AADs refractory AF, should be judged on an individual basis according to the Ablation Centre’s experience
RATE RATE vs vs RHYTHMRHYTHM control control
Who to refer ….• Should we try to run before we can walk,
especially if there are other therapeutic options
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RATE RATE vs vs RHYTHMRHYTHM control control
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
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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)
RATE RATE vs vs RHYTHMRHYTHM control control
Strategies
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RATE RATE vs vs RHYTHMRHYTHM control control
REDUCTION LA refrac. and rate adaption INCREASED in rate, inducibility and stability of AFibDEVELOPMENT of LA/RA enlargement (atrial stretch)INCREASE in mitochondrial size and nr ACCUMULATION of glycogenFRAGMENTATION/DISRUPTION of REG MORPHOLOGIC and CELLULAR remodel. ALTERATION in Ca++ regulatory proteins
A VICIOUS CYCLE
Cellular Remodelling
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Verma, Circulation ‘05
RATE RATE vs vs RHYTHMRHYTHM control controlMeta-analysis
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RATE RATE vs vs RHYTHMRHYTHM control control
THESYS
ANTI-THESYS
CONCLUSIONS
Does it means AFib = Synus Rhythm?
Why therapeutic approach AADs-based Why 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”.
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ConclusionsRATE RATE vs vs RHYTHMRHYTHM control control
• 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