Download Trattamento elettrico nello scompenso cardiaco

Trattamento elettrico dello
scompenso cardiaco
Dr. Leonardo Calo’
Laboratorio di aritmologia clinica ed interventistica
Policlinico Casilino - Roma
Pazienti con insufficienza cardiaca
in Classe NYHA II: Punti chiave
§  Due recenti sperimentazioni prospettiche multicentriche randomizzate
sull'insufficienza cardiaca lieve (MADIT-CRT
e REVERSE) dimostrano una morbilità ridotta.
§  Il 18% dei pazienti in REVERSE e il 15% dei pazienti in MADIT-CRT
erano nella classe NYHA I alla baseline, sebbene la maggior parte di
questi pazienti fosse stata precedentemente sintomatica.
§  Il miglioramento si è osservato principalmente nei pazienti con
QRS ≥ 150 ms e/o LBBB tipico.
§  Nel MADIT-CRT, le donne con LBBB hanno mostrato una risposta
particolarmente favorevole.
§  Vantaggio in termini di sopravvivenza non stabilito.
§  In MADIT-CRT l'estensione del rimodellamento inverso era
concordante e predittiva del miglioramento nei risultati clinici.
2010 Focused Update of ESC guidelines on device therapy in Heart Failure, K.Dickstein et al., European Heart Journal doi:10.1093/eurheartj/ehq337
C. Linde: the REVERSE trial
2009
CRITERI D’INCLUSIONE E METODO
Classe NYHA I-II; LVEDD>55mm; FE: <40%; RS; QRS>120ms
CRT on (con o senza ICD) vs CRT off (con o senza ICD)
C. Linde
C. Linde
RISULTATI NEJM 20091
SOTTOANALISI LBBB* CON ULTERIORI
6 MESI DI FOLLOW-UP2
Risposta notevolmente precoce nel braccio
CRT-D – a partire dai primi 2 mesi
ENDPOINT PRIMARIO PER TUTTI I PAZIENTI
ENDPOINT PRIMARIO PER I PAZIENTI LBBB
Riduzione relativa del 34% della mortalità per
tutte le cause o del primo evento di
insufficienza cardiaca (p=0,001)
Riduzione del 57% della mortalità per tutte le
cause o del primo evento di insufficienza cardiaca
rispetto al solo ICD (p<0,001)
1. N Engl J Med. 2009 Oct 1;361(14):1329-38. Cardiac-resynchronization therapy for the prevention of heart-failure events. MADIT-CRT Trial Investigators.
2. Indicazione FDA 2010 per il sistema CRT-D COGNIS (solo USA).
*Il blocco di branca sinistro (LBBB) non era un parametro di inclusione per la sperimentazione MADIT-CRT. È stata tuttavia rilevata un'interazione significativa tra il
trattamento e la morfologia del blocco di branca sinistro. Ulteriori analisi hanno evidenziato che il blocco di branca sinistro (LBBB) è una discriminante oggettiva del
beneficio assicurato al paziente dalla CRT-D indipendentemente da altre caratteristiche alla baseline.
Inclusion Criteria
MADIT CRT
REVERSE
No pts
1820
610
EF
<30%
<40%
no
yes
≥130
≥120
LVEDD> 55 mm
QRS duration (ms)
Results
MADIT CRT
REVERSE
24%-24%
26.4%-26.8%
QRS duration (ms)
159-158
154-153
Mortality
3.3-2.5%
2.2-1.6%
QRS < 150 ms
QRS < 150 ms
EF
No Effects
Criterio Elettrocardiografico:
QRS > 120 msec
Reliability and Reproducibility of QRS Duration
•  Results: Significant interobserver differences (P < 0.001) were
found between each combination of paired observers, with an up to
50-ms absolute variability between cardiologists and low
concordance with computerized measurements. Intraobserver
absolute variability was also significant (P < 0.01) for the 3
observers. These significant differences persisted (P < 0.01) when
focusing our interest on the ECGs in the 100–140 ms range
(defined as at least one out of the 4 measures in this range).
Considering the 120 ms limit, 22 (27.5%) ECGs were differently
classified by at least one of the cardiologists. We observed similar
interobserver differences between each combination of paired
observers with a 50 mm/s sweep speed.
Guillebon et al. J Cardiovasc Electrophysiol, Vol. pp. 1-3, In press.
Evidences from randomized clinical trials
QRS duration (msec)
COMPANION
< 147 NO advantage
148-168 No advantage in primary end-point
> 168 CRT better
CARE-HF
< 160 NO advantage
> 160 CRT better
MUSTIC
Only > 150 enrolled
MADIT-CRT
> 150 CRT better
< 150 No advantage
REVERSE
> 152 CRT better
Effectiveness of Cardiac Resynchronization Therapy by QRS
Morphology in the Multicenter Automatic DefibrillatorImplantation
Trial–Cardiac Resynchronization Therapy (MADIT-CRT)
Circulation. 2011;123:1061-1072
CRT in Patients with HF and Narrow QRS
(RethinQ) trial
Primary end point
Proportion of patients with
an increase in peak oxygen
consumption of at least 1.0
ml per kilogram of body
weight per minute during
cardiopulmonary exercise
testing at 6 months.
• Ischemic or nonischemic cardiomyopathy
•  Ejection fraction ≤35%
•  NHYA class III heart failure
•  QRS interval <130 msec
•  Mechanical dyssynchrony as measured on
echocardiography.
CRT in Patients with HF and Narrow QRS
(RethinQ) trial
CRT did not improve peak
oxygen consumption in patients
with moderate-to-severe HF,
providing evidence that patients
with HF and narrow QRS
intervals may not benefit from
CRT.
Peak oxygen consumption and the
NYHA class improved in patients in
the CRT group with a QRS ≥120 msec.
However, no difference was observed in
the quality-of-life score and the 6minute walking test
in either stratum.
Criterio Clinico:
Classe NYHA
The limitations of the NYHA functional
classification system
Raphael et al. Heart 2007;93:476-482
The limitations of the NYHA functional
classification system
Raphael et al. Heart 2007;93:476-482
Terapia Medica Ottimale
Euro Heart Failure Survey 2003
Only 17% of the population
received the Recommended
Triple Association: Diuretic,
ACE- Inhibitor, Beta-blocker.
M. Komajda et al. European Heart Journal (2003)
Euro Heart Failure Survey II 2009
M. Komajda et al. European Heart Journal (2009)
Pennsylvania, USA…
Voigt A. et al. Clin Cardiol 2010
Criterio Ecocardiografico:
FE < 35%
Sugeng L et al Circulation 2006;114:654
RENAL FUNCTION AND CRT
Overall survival among CRT-D recipients stratified according to
baseline GFR category
ADELSTEIN ET AL. PACE 2010; 1–10.
Heart Failure Monitor for the early detection of decompensation in HF pts
Atrial and ventricular arrhythmias SDANN Mean heart rate / 24 h Mean heart rate at rest % CRT Ac=vity / 24h Thoracic Fluid (intrathoracic impedance) Hemodynamics (intracardiac impedance) BP/WEIGHT
Trend: which information ?
AT/AF BURDEN
V rate during AT/AF
OptiVol Fluid Index
Patient Activity
Avg. V rate
Thoracic Impedance
Heart rate variability
% Pacing/day
®  We retrospectively reviewed HM report database and hospital files of 92
consecutive patients routinely implanted with a CRT-D device in our
centre from February 2006 to May 2009.
®  HM Group. 26 patients (28%) were remotely followed with HM in addition
to in-office visits scheduled every 4 months;
®  SF Group. 66 patients (72%) were followed with a standard program of
quarterly in-office visits.
PACE 2011
Clinical AE Survival Rates Kaplan-Meier curves
Clinical AE survival rates
Complete observations Censored
1,0
0,9
0,8
0,7
0,6
SF Group
0,5
0,4
p=0.00004
0,3
0,2
0,1
HM Group
0
100
200 300 400 500 600
Time (days from implant)
De Ruvo, …, Calo’ PACE 2011
700
Effect of Evaluation Frequency
•  More frequent evaluations enhance risk stratification.
•  Monthly evaluations provide reasonable balance of
risk stratification benefit and clinician effort.
Majority of pts retired (81%) and accompanied by a relative or a carer (72%) who, in 43% of the pts,
had to ask for a special permission at work.
Private car was the most commonly used means of transportation, with a median home-to-hospital distance of about 20 Km.
Median waiting time for a visit 20 minutes. Overall time spent by a pt for a single visit (home-to-hospital trip, waiting time, visit time
and return trip) was about 2 hours. No significant differences were observed between the two groups for any of these data.
Calo’ Heart Rhythm 2012
HF admission in our Hospital (2009)
- Internal Medicine: 123 pts
- Emergency Department 56 pts
- Cardiology Division 17 pts
- Intensive Unit Care: 2 pts
NUMBER OF ADMISSIONS IN EAD FOR ACUTE HF (2009)
N acces.
N paz
%
1
449
65,2
2
145
21,0
3
54
7,83
4
23
3,33
5
8
1,16
6
4
0,58
7
3
0,44
8
1
0,15
10
1
0,15
30
1
0,15
totale
689
100
HF MANAGEMENT
Filling
Pressures
Filling
pressures
Increase,
increase
Sympathetic
Sympathetic
Activation Stable
activation;
NYHA Class
Impedence
reduction
Change
in
Impedance
Euvolemia Stable NYHA
Class
Stable NYHA
Class
Worsening
Symptoms or
Weight Change
Optivolemia;
Symptoms or
Stable NYHA Class
Increase of weight
Days
Days
> 30
> 30
New “active” phase
-21 a -7
-21 to -7
“Pre-active”
“Pre-active”
phase
phase
-6 a -2
-6 to -2
E.R.
Hospitalization
Hospitalization,
ER visit, Urgent
Care
0a5
0 to 5
“Reactive” phase
“Reactive” phase
HF-Management
HF-Clinical Decision and Outcome
Partners Criteria
•  Il Risk Score normalizzato dovrà –  essere nell’intervallo [0, 10] •  La fascia di rischio proposta è la seguente: Basso
Medio
Alto
Livello
Di Rischio
0
2
4
10
•  Il risk score viene confrontato con due ulteriori soglie che permeSono di assegnare il livello di rischio (basso, medio, alto) •  Per ogni criterio, visione del n° di pazien= per cui è soddisfaSo ciascun criterio, isolatamente o accompagnato da almeno un altro Grazie !!
Alessio Borrelli
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Emanuele Guerra
Renzo Iulianella
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Anna Maria Martino
Marta Marziali
Monia Minati
Giovanna Navone
Francesca Nuccio
Lorena Pisciella
Marco Rebecchi
Antonio Scara’
Luigi Sciarra
Roberto Scioli
Francesco Sebastiani
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