linee guida acc/aha/hrs 2008 - tigullio cardiotigulliocardio.com/slide/lunati.pdf · 2015-07-28 ·...
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I risultati dei recenti trial suggeriscono un’estensione delle indicazioni della CRT dalla terapia dello scompenso conclamato alla sua prevenzione; suggerimenti per un approccio appropriato
Maurizio Lunati MDS.C. Elettrofisiologia‐Dipartimento Cardiologico “De Gasperis”
AO Niguarda Cà GrandaMilano
Key points:• 1‐L’evidenza che la “CRT profilattica” migliori outcome clinico e struttura ventricolare e’ convincente e solida• 2‐Le evidenze che la CRT nella FA e in funzione “anti pacemaker‐cardiomiopatia” migliori outcome clinico e struttura ventricolare sono convincenti • 3‐Sulla base dell’EBM e del “real world” è opportuno aggiornare la LG
Linee guida ACC/AHA/HRS 2008
Linee guida AIAC 2006
Cardiac Resynchronisation Therapy
Class I Indication Synus Rhythm, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
NYHA III-IV despite Optimal Medical Therapy
Class II IndicationsSynus Rhythm, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
Symptomatic (NYHA II) and with pacing indication or Primary Prevention ICD indication
Chronic Right Ventricular Stimulation, Reduced EF (≤ 35%)Severe Ventricular DyssynchronyNYHA III-IV despite Optimal Medical Therapy
Pts In Atrial Fibrillation, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
NYHA III-IV despite Optimal Medical Therapy
Reduced EF (≤ 35%), QRS ≤ 120 msVentricular Dyssynchrony (Echo assessment)
NYHA III-IV despite Optimal Medical Therapy
CRT nei pts in Classe NYHA I/II
Pazienti con indicazione convenzionale al pacing
Pazienti in fibrillazione atriale
CRT nei pts con dissincronia meccanica con o
senza dissincronia elettrica
Questioni aperte
CRT nei pts in Classe NYHA I/II
Pazienti con indicazione convenzionale al pacing
Pazienti in fibrillazione atriale
CRT nei pts con dissincronia meccanica con o
senza dissincronia elettrica
Questioni aperte
CRT in NYHA II
Abraham et al., MIRACLE ICD II, Circulation 2004
36% 34% 31%
58%
22% 20%
0%
20%
40%
60%
Improved No Change Worsened
Prop
ortio
n
CRT OFF (n=101) CRT ON (n=85)
Clinical Composite Score
186 pts in NYHA II, FE < 35% and QRS > 130ms randomized CRT ON vs CRT OFF
End Point CRT OFF CRT ON P
Change in peak VO2 0.2±3.2 0.5±3.2 0.87
Change in exercise duration, s
37±186 42±167 0.56
Change in NYHA 0.01±0.63) 0.18±0.61 0.05
Change in QOL 10.7±21.7 13.3±25.1 0.49
Change in 6MHWT, m 33±98 38±109 0.59
Left Ventricular End Diastolic Volume
200
250
300
350
400cm3
Base 6 Mo
P=0.04
Left Ventricular Ejection Fraction
20
22
24
26
28
30%
Base 6 Mo
P=0.02
Left Ventricular Ejection Fraction
20
22
24
26
28
30%
Base 6 Mo
P=0.02
Left Ventricular End Systolic Volume
200
250
300
350
400cm3
Base 6 Mo
P=0.01
Left Ventricular End Systolic Volume
200
250
300
350
400cm3
Base 6 Mo
P=0.01
•CRT (n=69)
Landolina et al.; AJC 2007
CRT in NYHA II952 pts analyzed: NYHA II (188 pts) vs NYHA III-IV (764)
Un minor numero di eventi CV maggiori Classe NYHA che migliora, ma in
una percentuale minore di soggetti
Simile grado di rimodellamento inverso
CRT in NYHA II: REVERSE & MADIT CRT
CRT in NYHA II: REVERSE & MADIT CRT
presentedat ESC 09
presentedat ACC09
Age (mean) yrs 61.3 ± 10.4
Ischemic 44%
NYHA II 83%
EF 27.1 ± 6.8
LVEDD (mm) 68.8 ± 9.2
QRS (ms)ICD therapy optional
156 ± 2368%
REVERSE262 patients (Europe) followed for 24 months
CRT OFF 82 Patients CRT ON 180 Patients
MADIT-CRT1820 patients (US&Europe) >30 months
Age (mean) yrs N.A.
Ischemic N.A.
NYHA I+II
EF <30%
LVEDD (mm) >55
QRS (ms)ICD therapy mandatory
>130100%
CRT ON ~1092 PatientsCRT OFF ~728 Patients
Daubert et al.; JACC 2009 Moss et al 2009. NEJM 361; epub Sept 1
CRT in NYHA II: REVERSE
Daubert et al.; JACC 2009
Primary End Point:Clinical Composite Response at 24-month
% worsened
Entire distribution analysis of worsened, unchanged and improved: P=0.0006
CRT in NYHA II: REVERSE
Daubert et al.; JACC 2009
Powered Secondary End Point: LVESVi
91.688.8
94.5
76.873.6
69.2 69.7
92.5
93.9
96.6
60
70
80
90
100
110
0 6 12 18 24
Months Since Randomization
LVES
Vi (m
l/m2 )
CRT OFF
CRT ON P<0.0001
P-value compares 24-month changes.
CRT in NYHA II: REVERSE
Daubert et al.; JACC 2009
Other Remodeling ParametersLVEDVi (ml/m2) LVEF (%)
129 128124
132
112108
103 103
129
133
90
100
110
120
130
140
150
0 6 12 18 24
Months
LVE
DV
i (m
l/m2 )
CRT OFF
CRT ON
P<0.0001
29.0 29.1 29.5 29.9
32.733.4
34.9 34.8
27.8
28.1
25
30
35
40
0 6 12 18 24
Months
LVE
F (%
)CRT OFF
CRT ON
P<0.0001
P-value compares 24-month changes.
129 128124
132
112108
103 103
129
133
90
100
110
120
130
140
150
0 6 12 18 24
Months
LVE
DV
i (m
l/m2 )
CRT OFF
CRT ON
P<0.0001
29.0 29.1 29.5 29.9
32.733.4
34.9 34.8
27.8
28.1
25
30
35
40
0 6 12 18 24
Months
LVE
F (%
)CRT OFF
CRT ON
P<0.0001
CRT in NYHA II: MADIT CRT confirms REVERSE
Moss et al 2009. NEJM 361; epub Sept 1
Improvements in LV function with CRT-DChanges from baseline to 1-year follow-up
Time to First HF Hospitalization or Death
0%
5%
10%
15%
20%
25%
30%
0 6 12 18 24Months Since Randomization
Perc
enta
ge H
ospi
taliz
ed fo
r HF
or
Die
d
CRT ON
CRT OFF
24.0%
11.7%
HR (95%CI): 0.38 (0.20-0.73)P=0.003
Number at RiskCRT OFF 82 79 76 70 39CRT ON 180 176 173 168 77
CRT in NYHA II: REVERSE
Daubert et al.; JACC 2009
CRT in NYHA II: MADIT CRT confirms REVERSE
Moss et al 2009. NEJM 361; epub Sept 1
Primary endpoint:Heart Failure or Death
Predictive value of QRS: MADIT CRT-REVERSEMADIT CRT
REVERSE 24-months
P for interaction: 0.001
REVERSEPresented at ACC09
Presented results show that CRT
Significanty reduces time to first HF hospitalization or
death1 by 62 percent(HR 0.38 (0.20-0.73) p=0.003
within 24 months
When compared to OMT, ICD optional
CRT in NYHA II: REVERSE & MADIT CRT
Daubert et al.; JACC 2009 Moss et al 2009. NEJM 361; epub Sept 1
CRT reduces Morbidity and Mortality in asymptomatic HF Patients with LVD and wide QRS
MADIT-CRTPresented at ESC
Presented results show that CRT is associated with a
Significant 34 percent reduction (p<0.001) in death or heart failure interventions within 33 months
When compared to OMT, ICD mandatory1 Note:ime to First HF hospitalization or death“ was not the primary endpoint
L’evidenza che la “CRT profilattica”
migliori outcome clinico e struttura ventricolare e’ convincente e solida
CRT nei pts in Classe NYHA I/II
Pazienti con indicazione convenzionale al pacing
Pazienti in fibrillazione atriale
CRT nei pts con dissincronia meccanica con o
senza dissincronia elettrica
Questioni aperte
CRT in pts con indicazioni convenzionali al pacing
•50 pts with complete A-V block and normal pump function
•randomized single site RV pacing or BIV pacing
Conclusions:
BIV pacing preserved LV pump function and minimized LV dyssynchrony as compared to conventional RV pacing;
LV pump function decreased significantly and LV dyssynchrony was more pronounced in the RV pacing group
Albertsen AE et al, Europace 2008
BioPace studyRandomized, multicentric, prospective, single-blind, parallel-group-
designInternational (EMEAC + Australia)
– 1st large scaled randomized study looking at the prevention of mechanical desynchronization
– Extend the benefit of BiV pacing to a broader patient population
Enrollment Goal– 1800 patients @ 94 centers– Follow-up phase
Evaluate whether patients with standard pacing indication (pacemaker or ICD)
– any standard-indication for permanent ventricular pacing– LVEF without any limitation– any QRS-width– benefit from the prevention of ventricular remodeling (induced by RV
pacing) with the implantation of a BiV pacing systemA landmark study which results will impact the future of pacemaker therapy
CRT in pts con indicazioni convenzionali al pacing
Yu et al., NEJM Nov 2009
177 pts with bradycardia and normal EF implanted with a CRT deviceRandomization 1:1 Biventricular pacing versus Right Ventricular Apical pacing
Primary end-point: LVEF and LVESV at 12 mos FU
CRT in pts con indicazioni convenzionali al pacing
Yu et al., NEJM Nov 2009
177 pts with bradycardia and normal EF implanted with a CRT deviceRandomization 1:1 Biventricular pacing versus Right Ventricular Apical pacing
Subgroup analysis of LVEF and LVESV
Pazienti con funzione sistolica preservata e indicazione convenzionale al pacing
beneficiano della terapia di resincronizzazione cardiaca in termini di
rimodellamento venrticolare inverso e miglioramento della frazione di eiezione.
CRT nei pts in Classe NYHA I/II
Pazienti con indicazione convenzionale al pacing
Pazienti in fibrillazione atriale
CRT nei pts con dissincronia meccanica con o
senza dissincronia elettrica
Questioni aperte
CRT e FA
Evaluation of CRT in 263 consecutive pts, 96 with chronic AF and 167 in sinus rhythm
Delnoy et al., Am J Cardiol 2007
NYHA QOL
LVEF
CRT e FA
Gasparini et al., JACC 2006
In 162 pts with permanent AF vs 511 pts in SR162 pts with permanent AF where: 48 pts with rhythm control by drugs; 114 pts with AVJ ablation
CRT e FA
Khadjooi et al., Heart 2008
In 86 pts with AF vs 209 pts in SR86 pts with AF where: 66 permanent AF, 20 paroxismal AF
I dati delle casistiche pubblicate mostrano come i pazienti in FA
beneficino della CRT almeno quanto i pazienti in ritmo sinusale
CRT nei pts in Classe NYHA I/II
Pazienti con indicazione convenzionale al pacing
Pazienti in fibrillazione atriale
CRT nei pts con dissincronia meccanica con o
senza dissincronia elettrica
Questioni aperte
68%
32%
≥ 40IVMD < 40≥ 40IVMD < 40
74%
26%
≥ 40IVMD < 40
77%
23%
QRS < 110 ms(46%)
110 ms ≤ QRS < 150 ms(22%)
QRS ≥ 150 ms(32%)
QRS Duration and IVMD
Ghio et al;European Heart Journal(2004) 25,571-578
Ampiezza del QRS e IVMD
CRT e QRS stretto
Beshai et al., RETHIN Q; NEJM 2007
172 pts with narrow QRS (<130ms), EF<35% and NYHA IIIRandomization 1:1 CRT ON vs CRT OFF
I dati disponibili non consentono di affermare che i pazienti con sola
dissincronia meccanica beneficiano della CRT quanto i pazienti con QRS
largo.
EHJ; 31 Aug 2009
EHJ; 31 Aug 2009
...e noi....
Clinical Service data
560 pazienti
Età media: 63,7 + 10,9 anni
21%
79%femmine maschi
Conclusioni
Cardiac Resynchronisation Therapy
Class I Indication Synus Rhythm, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
NYHA III-IV despite Optimal Medical Therapy
Class II IndicationsSynus Rhythm, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
Symptomatic (NYHA II) and with pacing indication or Primary Prevention ICD indication
Chronic Right Ventricular Stimulation, Reduced EF (≤ 35%)Severe Ventricular DyssynchronyNYHA III-IV despite Optimal Medical Therapy
Pts In Atrial Fibrillation, Reduced EF (≤ 35%)Ventricular Dyssynchrony (QRS > 120ms)
NYHA III-IV despite Optimal Medical Therapy
Reduced EF (≤ 35%), QRS ≤ 120 msVentricular Dyssynchrony (Echo assessment)
NYHA III-IV despite Optimal Medical TherapyNecessità di altri studi
Come negare l’evidenza?
Come negare l’evidenza?
Evidenze molto forti
Il futuro...Babec's Story
“On September 25th, 2004, the Birmingham Zoo successfully implanted the first cardiac resynchronization therapy device, or CRT, in a gorilla. One year later Babec is still alive, an unlikely scenario without the device, and his quality of life is significantly improved from that prior to surgery.”
Babec died in 2009...5 years after CRT!!!
http://www.birminghamzoo.com/babec%20story.asp
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