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18 Marzo a las 14:00h
Casa del Corazón, Madrid
La Sociedad Española de Cardiología
en colaboración con MSD,
presentan en directo
#PostACC15
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
Catheter ablation compared with Amiodarone among patients with persistent
atrial fibrillation and heart failure.
Group 1 and 2 did not
differ in their baseline
characteristics:
Left atrium size (48 mm)
Median AF duration 8.5 m
LVEF 30%
#PostACC15
Follow-up 26±8 month
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
Primary Endpoint: Long-term procedural-success. freedom from
AF, AFL, or AT of > 30 second duration off-AAD
#PostACC15
80
22
In the 102 patients
undergoing
catheter ablation
PVI plus posterior wall
and non PV trigger
ablation
PVI alone
78,8
36,4
0
10
20
30
40
50
60
70
80
90
PVI plus posterior
wall and non PV
trigger ablation
PVI alone
Higher success rate in patients
undergoing PVI plus ablation
compared to PVI alone (%)
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
31
57
0
10
20
30
40
50
60
Catheter ablation
(n=102)
Amiodarone
(n=101)
Follow-up 26±8 month
Hospitalization (%)
p<0,001
All cause Mortality (%)
p<0,037
8
18
0
5
10
15
20
Catheter ablation
(n=102)
Amiodarone
(n=101)
Follow-up 26±8 month
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
Cardiac related re-hospitalizations during post-
ablation follow- up (AF/CHF related).
#PostACC15
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
No Ablation Pulmonary vein isolation Biatrial Maze
LAA closure performed in all patients
Patients with mitral valve disease undergoing open heart surgery.
Persistent (>7 days) or long-standing persistent (>1 year) atrial fibrillation.
Compare mitral valve surgery plus ablation vs mitral valve surgery alone.
Mean patient age: 70 years
Percentage female: 43%
NYHA III-IV: 45% EF: 55%
Type of atrial fibrillation: persistent 47%, long-standing persistent 53%
Mitral valve surgery: replacement 41%, repair 59%
#PostACC15
29,4
63,2
0
20
40
60
80
MVS Alone MVS +
Ablation
FreedomFromAF(%)
Risk Difference of Success
0.34 (95% CI, 0.21 - 0.47), P<0.001
Randomization Group
Primary Endpoint
66
61
0
20
40
60
80
100
Biatrial
Lesions
PVI
Ablation Group
Biatrial Maze vs. PVI
FreedomFromAF(%)
Risk Difference of Success
0.05 (95% CI, -0.13 - 0.23), P=0.60
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
Freedom from AF at both 6 and 12
months by 3-day Holter monitor
Total number of enrollees: 260 Follow-up: 12 months
Mortality(%)
Mortality
Months
MACCE
CompositeCardiacEndPoint(%)
Months
8.7%
6.8%
23.3%
20.5%
Major adverse cardiac or cerebrovascular events
Quality of Life
MVS Alone
(N=127)
MVS & Ablation
(N=133)
P-Value
SF-12
Physical Function 45.3 ±7.9 44.3 ±9.0 0.38
Mental Function 48.5 ±6.5 48.0 ±6.3 0.56
AF Severity Scale
Daily AF –no. (%) 42 (45.2) 20 (19.8) <0.001
Life Rating (1-10, median) 8.0 (7,9) 8.0 (7,9) 0.45
NYHA Class III + IV –no. (%) 3 (2.9) 8 (7.0) 0.17
#PostACC15
120
143
0
50
100
150
200
MVS Alone MVS + Ablation
SAE(Rate/100Pt-Yrs)
Incidence Rate Ratio
1.20 (95% CI, 0.95 - 1.51), P=0.12
Randomization Group
Serious Adverse Events
8,1
21,5
0
10
20
30
MVS Alone MVS +
Ablation
Incidence Rate Ratio
2.64 (95% CI, 1.20 - 6.41), P<0.001
Pacemaker Implantation
Randomization Group
Pacemakerimplantation(%)
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
SAE: HF, Stroke, Conduction abnormality (Pacemaker),
nonperioperative myocardial infarction, renal failure,
Bleeding, Ventricular Arrhythmia, Pneumonia, Sepsis,
Respiratory failure.
#PostACC15
Patients with BMI ≥ 27
N=825
3-9%WL
N=103
Final Cohort
N=355
≥10%WL
N=135
<3%WL or WG
N=117
Patients >65 y + BMI>27 referred
for management of symptomatic
paroxysmal or persistent AFib,
without a history of myocardial
infarction or cardiac surgery in the
previous 12 m.
Similar Baseline
Characteristics.
BMI 33
Weight Management
LEGACY Study:
Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation
Cohort: A 5-Year Follow-Up Study
Impact on AF Symptoms
*Group-Time
P<0.001
*Group-Time
P<0.001
AF Symptom Burden
AFib Severity Scale questionnaire
Global Well Being Score
Total Arrhythmia-Free Survival
P<0.001
86%
66%
40%
With AAD +/- ablation
P<0.001
Without AAD or ablation
13%
22%
46%
AF freedom: 7 day Holter monitoring
Structural Remodeling
(ml/m2)
*Group-Time
P<0.001
*Group-Time
P<0.001
(mm)
LA Volume (indexed) Septal Dimension
Weight Fluctuation
P<0.001
85%
59%
44%
With AAD +/- ablationWith AAD +/- ablation
P<0.001
76%
59%
38%
Weight Loss Trend
Multivariate Predictors of AF Recurrence
Weight Loss Weight Fluctuation
≥10% weigh loss was associated
with AF free survival
HR 5.7 [95% CI: 3.3-10.1]
(P<0.001)
>5% weight fluctuation was
associated with AF recurrence
HR 2.2 [95% CI: 1.1-4.2](P<0.001)
#PostACC15
Age >18 y, stable symptomatic systolic HF (NYHA II – IV), LV ejection
fraction <45%. Current episode of major depression diagnosed by
Structured Clinical Interview (SCID)
MOOD-HF Trial
Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and
mood in Depressed Heart Failure patients
#PostACC15
Primary Outcome
Time to all-cause death or
hospitalization
Major Secondary Outcome
10- item Montgomery–Åsberg
Depression Rating Scale
MOOD-HF Trial
Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and
mood in Depressed Heart Failure patients
Total number of enrollees: 235 Follow-up: 24 months
#PostACC15
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
LVRestorationwithAlgisyl
Placement of Alginate Hydrogel via a Limited Thoracotomy
Algisyl (Algisyl-LVRTM) is a medical device
that consists of an alginate hydrogel that is
injected into the midwall of the LV, where it
remains as a permanent implant that is
intended to reduce LV wall stress and prevent
or reverse the progression of HF
#PostACC15
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
78 Patients with moderate to severe HF (highly symptomatic, LVEF ≤ 35%,
Peak VO2 of 9.0 - 14.5 mL/min/kg, LVEDDi 30 to 40 mm/m2 (LVEDD/BSA))
that had been treated with optimal medical and/or device therapy
• Primary Efficacy Endpoint: peak VO2 at 6 months assessed by blinded core lab
• Safety Assessments: clinical outcomes over 30 days, 6, 12 and 24 months
• Secondary Endpoints: symptoms, 6 min-WT & cardiac function during follow-up
4038
Algisyl implant procedure
+
optimal medical therapy
optimal medical
therapy alone
#PostACC15
AUGMENT-HF–ChangeinMeanPeakVO2
12.2! 12.3! 12.4!
12.1!
12.9!
13.2!
11(
12(
13(
14(
15(
Usual(Care(
AlgisylSLVR(
Baseline! 3!months! 6!months!
*P<0.014(
RER(Mean(( (1.02(±(0.09( ((((((((((((((((((((((((((((1.03(±(0.12(((((((((((((((((((((((((((((((((((1.02(±(0.11((
mL/kg/min!
AUGMENT-HF–ExerciseTime(CPX), changefrombaseline
*P=0.001(
31.0(
49.0(
S26.0(
S10.0(
S40.0(
S20.0(
0.0(
20.0(
40.0(
60.0(
80.0(
seconds!
3!months!(n=48)!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!6!months!(n=45)!
AlgisylSLVR(
Usual(Care(
AUGMENT-HF6min-WT- changefrombaseline
N9.6! N15.4!
60.8!
84.7!
S50(
0(
50(
100(
150(
3m!(n=63)! 6m!(n=63)!
meters(
Usual(Care(
AlgisylSLVR(
*P<0.001+
NYHAFunctional Class–continuousrepresentation
P*<0.001(
2.9(
2.2(
2.0(
2.8( 2.8( 2.8(
1.0(
2.0(
3.0(
4.0(
Baseline!(n=73)! 3!mo!(n=62)! 6!mo!(n=63)!
NYHA(Class(
AlgisylSLVR(
Usual(Care(
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
#PostACC15
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
#PostACC15
BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of
Heart Failure with a Reduced Ejection Fraction
Integrated Autonomic Nervous
System Response
Inhibits Sympathetic Activity
Enhances Parasympathetic Activity
Carotid Baroreceptor Stimulation
↓ HR
↓ Remodeling
↑ Vasodilation
↓ Elevated BP
↑ Diuresis
↓ Renin secretion
The Baroreflex as a Therapeutic Target
#PostACC15
Variable
BAT
(n=71)
Med Mgmt
(n=69)
Race: Caucasian 82% 90%
Gender: Female 13% 16%
NYHA: Class III 99% 100%
Age (years) 64 ± 11 66 ± 12
SBP (mmHg) 115 ± 18 119 ± 17
DBP (mmHg) 72 ± 11 73 ± 11
HR (bpm) 73 ± 11 75 ± 12
LVEF (%) 24 ± 7 25 ± 7
eGFR (mL/min) 58 ± 21 59 ± 19
NT-pro BNP (pg/mL)* 1422 [455, 4559] 1172 [548, 2558]
6 Minute Hall Walk (m) 297 ± 79 308 ± 85
MN Living with HF QOL† 51 ± 21 43 ± 22
Number of Meds 4.8 ± 1.6 4.4 ± 1.9
Coronary Artery Disease 66% 68%
History of Atrial Fibrillation 45% 44%
Chronic Kidney Disease 34% 25%
HF hospitalizations prior 6 Mo
(days/pt/year)
7.0 ± 21 2.4 ± 9
*Median [IQR]
†p≤0.05 between groups
Baseline Demographics
BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of
Heart Failure with a Reduced Ejection Fraction
N=140
Reduces NT-proBNP LevelsImproves 6-MWT Distance
Improves Quality of Life ScoreImproves NYHA Class
#PostACC15
Variable
BAT
(n=57)
Med Mgmt
(n=50)
Difference
Mean ± SE
HF Hospitalization Days per Year
6 Months Pre-Enrollment 6.95 ± 20.7 2.40 ± 8.6 4.55 ± 34
6 Months Post Enrollment 0.67 ± 2.5 2.48 ± 7.4 -1.82* ± 1
Change from Pre to Post -6.28** ± 2.7 0.08 ± 1.7 -6.36** ± 3
Negative Binomial 6M Post 0.38 2.10 82% RR†*
*p≤0.10; **p≤0.05
†RR – Relative Reduction adjusted for 6 months Pre-Enrollment Heart Failure Hospitalizations (Negative Binomial Model)
Number of Hospitalization Days for Heart Failure
BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of
Heart Failure with a Reduced Ejection Fraction
#PostACC15
conclusiones
AATAC: En pacientes con IC sistólica y FA persistente, la ablación con
catéter es más eficaz que el tratamiento con Amiodarona para
mantener el ritmo sinusal a largo plazo. Además se asocia con una
reducción de la mortalidad y las hospitalizaciones
Surgical Ablation of Afib: En pacientes con valvulopatía mitral y FA
persistente, la cirugía valvular mitral y la ablación quirúrgica de la FA
permite un mejor control del ritmo cardíaco, aumentando la proporción
de pacientes libres de FA en el seguimiento
LEGACY: En pacientes obesos con FA paroxística o persistente, la
estrategia de perder peso de forma sostenida evitando fluctuaciones
se relaciona con una reducción dosis dependiente de la carga de FA,
el mantenimiento del Ritmo sinusal y se asocia a un beneficioso
remodelado estructural cardíaco
#PostACC15
Mood HF: En pacientes con IC sistólica sintomática y depresión mayor,
el tratamiento con Escitalopram no mejoró los síntomas depresivos y fue
similar al placebo en términos de mortalidad y hospitalización en el
seguimiento
conclusiones
BAT for HFrEF: La Terapia de Activación de los Baroreceptores
carotideos es segura y mejora los síntomas de los pacientes con ICFER.
Se asocia a una mejoría de la CF, calidad de vida, capacidad de
esfuerzo, NT-proBNP y reducción de las hospitalizaciones por IC.
AUGMENT–HF: La administración de Algisyl intramiocárdico en
pacientes con IC avanzada tiene una morbimortalidad aceptable. Se
relaciona con una mejoría sintomática y aumenta la capacidad
funcional del corazón. Podría tener un potencial impacto favorable en
la reducción de hospitalizaciones por IC
#PostACC15
#PostACC15
5. Arritmias / Insuficiencia cardiaca
• AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment
of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an
Implanted device
• Effectiveness of Surgical Ablation of Atrial Fibrillation during Mitral Valve
Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials
Network
• LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an
Atrial Fibrillation Cohort: A 5-Year Follow-Up Study.
• Mood HF Trial. Effects of Selective Serotonin Re-Uptake Inhibition on Mortality,
Morbidity and Mood in Depressed Heart Failure Patients
• AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
• BAT for HFrEF : Baroreflex Activation therapy for the Treatment of Heart Failure
with a Reduced Ejection Fraction
#PostACC15
MVS
Alone
(N=127)
MVS &
Ablation
(N=133)
Female –no. (%) 63 (49.6) 57 (42.9)
Age (yr) 69.4 ± 10.0 69.7 ± 10.4
NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1)
Atrial fibrillation duration –med
(IQR)
29 (3, 96) 18.5 (3, 65)
Atrial fibrillation type 28 (18.7) 24 (16.0)
Longstanding Persistent 71 (55.9) 70 (52.6)
Persistent 56 (44.1) 63 (47.4)
Anticoagulants –no. (%) 97 (76.4) 105 (79.0)
Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5)
Mitral disease etiology
Organic 73 (57.5) 75 (56.4)
Functional non-ischemic 48 (37.8) 43 (32.3)
Ischemic 6 (4.7) 15 (11.3)
Baseline Characteristics
Total number of enrollees: 260
MVS Alone
(N=127)
MVS &
Ablation
(N=133)
Mitral Valve Surgery
Replacement 61 (48.4) 54 (40.6)
Repair 65 (51.6) 79 (59.4)
Concomitant Procedures
Tricuspid Valve Surgery 48 (38.1) 50 (37.6)
Aortic Valve Replacement 20 (15.9) 14 (10.5)
CABG 25 (19.8) 27 (20.3)
Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3
Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5
#PostACC15
28,8 30,2
38,4 34,6
0
20
40
60
Success Recurrence
Baseline Follow-up
347 352374 360
0
100
200
300
400
Success Recurrence
Baseline Follow-up
LVEF (%) 6MWT (meters)
53 4947 46,6
0
20
40
60
Success Recurrence
Baseline Follow-up
MLHFQ score
p<0,038p<0,001 p<0,013
Change in LVEF, 6MWD, and MLHFQ score by recurrence status
At the end of follow-up, recurrence free patients (n=105) experienced
significantly better improvement in all parameters compared to those who
experienced recurrence (n=98).
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
LEGACY Study:
Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation
Cohort: A 5-Year Follow-Up Study
Hypothesis
Weight loss, if sustained, will be of incremental benefit in
rhythm control
Weight fluctuation has detrimental effect
Primary Outcomes
 AF symptom burden: AFib Severity Scale questionnaire
 AF freedom: 7 day Holter monitoring
Secondary Outcomes
 Structural parameters: LAV and LV thickness
 Metabolic and Inflammatory profile
#PostACC15
Yearly Weight Trend
(N=344)
>5%WF
N=57
2-5%WF
N=68
<2%WF
N=54
Linear
Weight Loss
N=141
(41%)
Weight
Fluctuation
N=179
(52%)
Linear Gain
N=24 (7%)
Effect of
Weight Loss Trend
Effect of Degree of
Weight fluctuation
#PostACC15
Implications of Dedicated Weight Loss Clinic
 52 patients lost >10% weight
in first year
 34/52 (66%) maintained WL
 30/34 (85%) attended WL
clinic
 18 regained weight, only 2
(11%) attended clinic
WL Clinic
35 (30%)
0
20
40
60
80
100
≥10% WL 3-9 % WL <3% WL
85%
57%
30%
WLClinic
WLClinic
WLClinic
TotalPatientsN=135
TotalPatientsN=103
TotalPatientsN=117
#PostACC15
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
Operative Procedure Metrics for Algisyl-LVR Implant
#PostACC15
5. Arritmias / Insuficiencia cardiaca
• AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent
Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device
• Effectiveness of Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A
Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
• LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial
Fibrillation Cohort: A 5-Year Follow-Up Study.
• PADN-2. Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension:
Results From A Controlled Before And After Study
• Mood HF Trial. Effects of Selective Serotonin Re-Uptake Inhibition on Mortality, Morbidity
and Mood in Depressed Heart Failure Patients
• AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical
Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients
with Advanced Heart Failure.
• Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection
Fraction
#PostACC15
Target drugs:
5’-PDE
Prostacyclin
ET-receptor antagonists
PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary
Arterial Hypertension: Results From A Controlled Before And After Study
#PostACC15
PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary
Arterial Hypertension: Results From A Controlled Before And After Study
#PostACC15
PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary
Arterial Hypertension: Results From A Controlled Before And After Study
#PostACC15
PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary
Arterial Hypertension: Results From A Controlled Before And After Study
Clinical events at 6-month follow-up
#PostACC15
PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary
Arterial Hypertension: Results From A Controlled Before And After Study
Conclusion: Pulmonary Artery Denervation treatment was
associated with significant improvement of 6 MWT and less
PAH-related event
En pacientes con Hipertensión arterial Pulmonar, el tratamiento de
denervación de la arteria pulmonar se asocia con una mejoría
significativa de la capacidad funcional medida con el test de 6 MWT
y menos eventos adversos relacionado con la propia HAP
#PostACC15
CTSN Surgical AF Ablation Trial Design
Excluded (n=3242)
Enrollment
Allocated to MVS + Ablation (n=133)
• Pulmonary Vein Isolation (PVI) (n=67)
• Biatrial Maze (n=66)
Allocated to MVS Alone (n=127)
Allocation
• Withdrawal or lost to follow-up (n=8)
• Death before month 12 (n=9)
• Withdrawal or lost to follow-up (n=10)
• Death before month 12 (n=11)
Follow-Up
Primary Endpoint Analysis (n=133)
• Primary Endpoint Data (n=106)
• 6 & 12 Month Holter (n=96)
• Died (n=9)
• Underwent Ablation (n=1)
• Imputed (n=27)
Primary Endpoint Analysis (n=127)
• Primary Endpoint Data (n=102)
• 6 & 12 Month Holter (n=88)
• Died (n=11)
• Underwent Ablation (n=3)
• Imputed (n=25)
Analysis
Randomized (n=260)
Assessed for Eligibility
(n=3502)
#PostACC15
Freedom from AF at both 6 and 12
months by 3-day Holter monitor
Pts who died before 12 month
assessment or had subsequent
ablation were considered
treatment failures
Primary endpoint
• Mortality
• MACCE
• Quality of life
• Serious adverse events
Secondary endpoint
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
#PostACC15
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
AF Freedom: Drug & Ablation-Free
P<0.001
13%
22%
Without AAD
or ablation
46%46%
#PostACC15
Impact on Risk Factors
#PostACC15
 NYHA Functional Class III
 Left ventricular ejection fraction ≤ 35%
 Six-minute hall walk distance 150 - 400 m
 On stable optimal medical therapy for at least 4 weeks prior
to baseline assessment
 No restriction on QRS, concomitant devices*, or AF
* ≥ 6 months of CRT therapy in patients with CRT
Key Enrollment Criteria
BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of
Heart Failure with a Reduced Ejection Fraction
#PostACC15
Twitter
La pérdida de peso y evitar la fluctuación del peso constituyen
estrategias importantes para reducir los episodios de Fibrilación
auricular. La pérdida de peso también se asoció con una beneficiosa
remodelación estructural incluyendo reducciones significativas del
volumen de la aurícula izquierda y de la hipertrofia ventricular izquierda
En pacientes con Insuficiencia cardiaca sistólica y Fibrilación auricular
persistente, la ablación con catéter ha mostrado ser más eficaz que el
tratamiento farmacológico con amiodarona para el mantenimiento a
largo plazo del ritmo sinusal, así como se asocia a una reducción de la
mortalidad y de las hospitalizaciones
La ablación quirúrgica mediante aislamiento de las venas pulmonares
durante la cirugía de válvula mitral se relaciona con un mejor control
del ritmo cardíaco en el seguimiento a los 6 y 12 meses, en pacientes
con enfermedad valvular mitral y Fibrilación auricular persistente o de
larga duración
#PostACC15
En pacientes obesos con fibrilación auricular paroxística o persistente, la
pérdida de peso mantenida en el tiempo se asocia con una reducción
dosis dependiente de la carga de Fibrilación auricular y el
mantenimiento del ritmo sinusal. La pérdida de peso también se asocia
con una beneficiosa remodelación cardíaca estructural, incluyendo
reducciones significativas del volumen de la aurícula izquierda y de la
hipertrofia ventricular izquierda
Una fluctuación del peso >5% amortigua el beneficio conferido por la
pérdida de peso
Una unidad específica de obesidad favorece la implicación del
paciente y la adherencia, previniendo la ganancia y la fluctuación de
peso
#PostACC15
En pacientes con Insuficiencia cardiaca sistólica sintomática y
depresión mayor, el tratamiento con Escitalopram no mejoró los
síntomas depresivos y fue similar al placebo en términos de
mortalidad y hospitalización en el seguimiento
Among patients with mitral valve disease and persistent atrial fibrillation, mitral
valve surgery plus atrial fibrillation ablation was effective at improving freedom
from atrial fibrillation at 6 and 12 months. There was no difference between
ablation techniques on freedom from atrial fibrillation. Major adverse cardiac
and cerebrovascular events were similar between the groups.
La cirugía de la válvula mitral asociada a la ablación quirúrgica de la
fibrilación auricular es eficaz para conseguir un mejor control del ritmo
cardíaco, aumentando la proporción de pacientes sin fibrilación
auricular los 6 y 12 meses de seguimiento.
Los pacientes con enfermedad valvular mitral y Fibrilación auricular
persistente sometidos a cirugía valvular p
#PostACC15
La Terapia de Activación de los Baroreceptores carotídeos es segura
en pacientes ICFER y mejora significativamente la clase funcional de la
NYHA, la calidad de vida, la capacidad de esfuerzo, el NT-proBNP, y
posiblemente reduzca las hospitalizaciones por insuficiencia cardiaca
La administración de Algisyl intramiocárdico en pacientes con
insuficiencia cardiaca avanzada es segura, con una morbimortalidad
aceptable. El tratamiento con Algisyl proporcionó una mejoría
sintomática y de la capacidad en la funcional del corazón en
comparación con los pacientes en el grupo de control.
La evaluación inicial de los eventos adversos cardiovasculares mayores
a los 6 meses sugieren un potencial impacto favorable en la reducción
de la hospitalización por IC en los pacientes tratados con Algisyl
#PostACC15
Conclusions: This multicenter randomized study shows that
catheter ablation of Persistent AF is superior to Amiodarone
in achieving freedom from AF at long term follow up and
reducing hospitalization and mortality in patients with heart
failure.
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
Conclusions: Surgical ablation improves rhythm control in
mitral valve patients with persistent and long-standing
persistent AF
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
Among patients with mitral valve disease
and persistent atrial fibrillation, mitral valve
surgery plus atrial fibrillation ablation was
effective at improving freedom from atrial
fibrillation at 6 and 12 months. There was no
difference between ablation techniques
on freedom from atrial fibrillation. Major
adverse cardiac and cerebrovascular
events were similar between the groups.
#PostACC15
CONCLUSIONS
Sustained weight loss is associated with dose dependent
reduction in AF burden and maintenance of sinus rhythm
>5% Weight fluctuation dampens the benefit conferred by
weight loss
A dedicated clinic improves patient engagement, promoting
treatment adherence, preventing weight regain and
fluctuation
Simultaneous online publication on 16 March 2015
LEGACY Study:
Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation
Cohort: A 5-Year Follow-Up Study
#PostACC15
MOOD-HF Trial
Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and
mood in Depressed Heart Failure patients
Conclusions: MOOD-HF is the first larger-scale RCT on long-term
efficacy and safety of an SSRI in systolic heart failure patients
with co-morbid depression.
Escitalopram neither improved the composite primary outcome
(all-cause death or hospitalization), nor depression in this
population.
#PostACC15
AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard
Medical Therapy to Determine Impact on Functional Capacity and Clinical
Outcomes in Patients with Advanced Heart Failure.
#PostACC15
BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of
Heart Failure with a Reduced Ejection Fraction
Conclusions:
• Baroreflex Activation Therapy is safe in HFrEF patients
 No system- or procedure-related deaths
 Few and short-lived complications; complication rate comparable to
established HF device therapies
 No hypotension
• BAT significantly improves NYHA Class, quality of life
score, exercise capacity, NT-proBNP, and possibly the
burden of heart failure hospitalizations
Manuscript online today at JACC Heart Failure
http://heartfailure.onlinejacc.org
#PostACC15
AATAC Multicenter Randomized Trial:
Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients
With Congestive Heart Failure and an Implanted device (ICD/CRTD)
#PostACC15
MVS Alone
(N=127)
MVS & Ablation
(N=133)
Female –no. (%) 63 (49.6) 57 (42.9)
Age (yr) 69.4 ± 10.0 69.7 ± 10.4
NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1)
Atrial fibrillation duration –med
(IQR)
29 (3, 96) 18.5 (3, 65)
Atrial fibrillation type 28 (18.7) 24 (16.0)
Longstanding Persistent 71 (55.9) 70 (52.6)
Persistent 56 (44.1) 63 (47.4)
Anticoagulants –no. (%) 97 (76.4) 105 (79.0)
Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5)
Mitral disease etiology
Organic 73 (57.5) 75 (56.4)
Functional non-ischemic 48 (37.8) 43 (32.3)
Ischemic 6 (4.7) 15 (11.3)
Baseline Characteristics
Total number of enrollees: 260
#PostACC15
MVS Alone
(N=127)
MVS & Ablation
(N=133)
Mitral Valve Surgery
Replacement 61 (48.4) 54 (40.6)
Repair 65 (51.6) 79 (59.4)
Concomitant Procedures
Tricuspid Valve Surgery 48 (38.1) 50 (37.6)
Aortic Valve Replacement 20 (15.9) 14 (10.5)
CABG 25 (19.8) 27 (20.3)
Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3
Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5
Operative Characteristics
*P-Value for Cardiopulmonary Bypass Time = 0.03
Total number of enrollees: 260
#PostACC15
Mortality(%)
Mortality
Months
MACCE
CompositeCardiacEndPoint(%)
Months
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
8.7%
6.8%
23.3%
20.5%
Major adverse cardiac or cerebrovascular events
#PostACC15
Quality of Life
MVS Alone
(N=127)
MVS & Ablation
(N=133)
P-Value
SF-12
Physical Function 45.3 ±7.9 44.3 ±9.0 0.38
Mental Function 48.5 ±6.5 48.0 ±6.3 0.56
AF Severity Scale
Daily AF –no. (%) 42 (45.2) 20 (19.8) <0.001
Life Rating (1-10, median) 8.0 (7,9) 8.0 (7,9) 0.45
NYHA Class III + IV –no. (%) 3 (2.9) 8 (7.0) 0.17
Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery:
A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
#PostACC15
1° Outcome
Time to all-cause death or hospitalization
#PostACC15
Major 2° Outcome
10- item Montgomery–Åsberg Depression Rating Scale
#PostACC15
<3% Wt Loss
N= 117
3-9% Wt Loss
N = 103
≥10% Wt Loss
N = 135 P Value
Age (years) 6111 6311 6511 0.06
Male gender, n (%) 83 (71) 65 (63) 86 (64) 0.4
Non-Paroxysmal AF, n (%) 45 (56) 46 (45) 64 (47) 0.9
BMI 32.94.8 32.74.4 33.64.7 0.2
Hypertension 90 (78) 75 (73) 109 (81) 0.3
DM/IGT, n (%) 34 (29) 28 (27) 41 (30) 0.5
Hyperlipidemia, n (%) 56 (48) 45 (44) 66 (49) 0.7
CAD, n (%) 14 (12) 12 (12) 21 (16) 0.3
AHI>30, n (%) 61 (52) 52 (50) 69 (51) 0.1
Smoker, n (%) 47 (40) 41 (40) 50 (37) 0.9
ETOH (>30g/week), n (%) 34 (29) 35 (34) 42 (31) 0.7
Baseline Characteristics

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Arritmias/Insuficiencia cardiaca

  • 1. 18 Marzo a las 14:00h Casa del Corazón, Madrid La Sociedad Española de Cardiología en colaboración con MSD, presentan en directo
  • 2. #PostACC15 AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD) Catheter ablation compared with Amiodarone among patients with persistent atrial fibrillation and heart failure. Group 1 and 2 did not differ in their baseline characteristics: Left atrium size (48 mm) Median AF duration 8.5 m LVEF 30%
  • 3. #PostACC15 Follow-up 26±8 month AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD) Primary Endpoint: Long-term procedural-success. freedom from AF, AFL, or AT of > 30 second duration off-AAD
  • 4. #PostACC15 80 22 In the 102 patients undergoing catheter ablation PVI plus posterior wall and non PV trigger ablation PVI alone 78,8 36,4 0 10 20 30 40 50 60 70 80 90 PVI plus posterior wall and non PV trigger ablation PVI alone Higher success rate in patients undergoing PVI plus ablation compared to PVI alone (%) AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 5. #PostACC15 31 57 0 10 20 30 40 50 60 Catheter ablation (n=102) Amiodarone (n=101) Follow-up 26±8 month Hospitalization (%) p<0,001 All cause Mortality (%) p<0,037 8 18 0 5 10 15 20 Catheter ablation (n=102) Amiodarone (n=101) Follow-up 26±8 month AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD) Cardiac related re-hospitalizations during post- ablation follow- up (AF/CHF related).
  • 6. #PostACC15 Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network No Ablation Pulmonary vein isolation Biatrial Maze LAA closure performed in all patients Patients with mitral valve disease undergoing open heart surgery. Persistent (>7 days) or long-standing persistent (>1 year) atrial fibrillation. Compare mitral valve surgery plus ablation vs mitral valve surgery alone. Mean patient age: 70 years Percentage female: 43% NYHA III-IV: 45% EF: 55% Type of atrial fibrillation: persistent 47%, long-standing persistent 53% Mitral valve surgery: replacement 41%, repair 59%
  • 7. #PostACC15 29,4 63,2 0 20 40 60 80 MVS Alone MVS + Ablation FreedomFromAF(%) Risk Difference of Success 0.34 (95% CI, 0.21 - 0.47), P<0.001 Randomization Group Primary Endpoint 66 61 0 20 40 60 80 100 Biatrial Lesions PVI Ablation Group Biatrial Maze vs. PVI FreedomFromAF(%) Risk Difference of Success 0.05 (95% CI, -0.13 - 0.23), P=0.60 Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network Freedom from AF at both 6 and 12 months by 3-day Holter monitor Total number of enrollees: 260 Follow-up: 12 months
  • 8. Mortality(%) Mortality Months MACCE CompositeCardiacEndPoint(%) Months 8.7% 6.8% 23.3% 20.5% Major adverse cardiac or cerebrovascular events Quality of Life MVS Alone (N=127) MVS & Ablation (N=133) P-Value SF-12 Physical Function 45.3 ±7.9 44.3 ±9.0 0.38 Mental Function 48.5 ±6.5 48.0 ±6.3 0.56 AF Severity Scale Daily AF –no. (%) 42 (45.2) 20 (19.8) <0.001 Life Rating (1-10, median) 8.0 (7,9) 8.0 (7,9) 0.45 NYHA Class III + IV –no. (%) 3 (2.9) 8 (7.0) 0.17
  • 9. #PostACC15 120 143 0 50 100 150 200 MVS Alone MVS + Ablation SAE(Rate/100Pt-Yrs) Incidence Rate Ratio 1.20 (95% CI, 0.95 - 1.51), P=0.12 Randomization Group Serious Adverse Events 8,1 21,5 0 10 20 30 MVS Alone MVS + Ablation Incidence Rate Ratio 2.64 (95% CI, 1.20 - 6.41), P<0.001 Pacemaker Implantation Randomization Group Pacemakerimplantation(%) Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network SAE: HF, Stroke, Conduction abnormality (Pacemaker), nonperioperative myocardial infarction, renal failure, Bleeding, Ventricular Arrhythmia, Pneumonia, Sepsis, Respiratory failure.
  • 10. #PostACC15 Patients with BMI ≥ 27 N=825 3-9%WL N=103 Final Cohort N=355 ≥10%WL N=135 <3%WL or WG N=117 Patients >65 y + BMI>27 referred for management of symptomatic paroxysmal or persistent AFib, without a history of myocardial infarction or cardiac surgery in the previous 12 m. Similar Baseline Characteristics. BMI 33 Weight Management LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study
  • 11. Impact on AF Symptoms *Group-Time P<0.001 *Group-Time P<0.001 AF Symptom Burden AFib Severity Scale questionnaire Global Well Being Score
  • 12. Total Arrhythmia-Free Survival P<0.001 86% 66% 40% With AAD +/- ablation P<0.001 Without AAD or ablation 13% 22% 46% AF freedom: 7 day Holter monitoring
  • 14. Weight Fluctuation P<0.001 85% 59% 44% With AAD +/- ablationWith AAD +/- ablation P<0.001 76% 59% 38% Weight Loss Trend
  • 15. Multivariate Predictors of AF Recurrence Weight Loss Weight Fluctuation ≥10% weigh loss was associated with AF free survival HR 5.7 [95% CI: 3.3-10.1] (P<0.001) >5% weight fluctuation was associated with AF recurrence HR 2.2 [95% CI: 1.1-4.2](P<0.001)
  • 16. #PostACC15 Age >18 y, stable symptomatic systolic HF (NYHA II – IV), LV ejection fraction <45%. Current episode of major depression diagnosed by Structured Clinical Interview (SCID) MOOD-HF Trial Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and mood in Depressed Heart Failure patients
  • 17. #PostACC15 Primary Outcome Time to all-cause death or hospitalization Major Secondary Outcome 10- item Montgomery–Åsberg Depression Rating Scale MOOD-HF Trial Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and mood in Depressed Heart Failure patients Total number of enrollees: 235 Follow-up: 24 months
  • 18. #PostACC15 AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure. LVRestorationwithAlgisyl Placement of Alginate Hydrogel via a Limited Thoracotomy Algisyl (Algisyl-LVRTM) is a medical device that consists of an alginate hydrogel that is injected into the midwall of the LV, where it remains as a permanent implant that is intended to reduce LV wall stress and prevent or reverse the progression of HF
  • 19. #PostACC15 AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure. 78 Patients with moderate to severe HF (highly symptomatic, LVEF ≤ 35%, Peak VO2 of 9.0 - 14.5 mL/min/kg, LVEDDi 30 to 40 mm/m2 (LVEDD/BSA)) that had been treated with optimal medical and/or device therapy • Primary Efficacy Endpoint: peak VO2 at 6 months assessed by blinded core lab • Safety Assessments: clinical outcomes over 30 days, 6, 12 and 24 months • Secondary Endpoints: symptoms, 6 min-WT & cardiac function during follow-up 4038 Algisyl implant procedure + optimal medical therapy optimal medical therapy alone
  • 20. #PostACC15 AUGMENT-HF–ChangeinMeanPeakVO2 12.2! 12.3! 12.4! 12.1! 12.9! 13.2! 11( 12( 13( 14( 15( Usual(Care( AlgisylSLVR( Baseline! 3!months! 6!months! *P<0.014( RER(Mean(( (1.02(±(0.09( ((((((((((((((((((((((((((((1.03(±(0.12(((((((((((((((((((((((((((((((((((1.02(±(0.11(( mL/kg/min! AUGMENT-HF–ExerciseTime(CPX), changefrombaseline *P=0.001( 31.0( 49.0( S26.0( S10.0( S40.0( S20.0( 0.0( 20.0( 40.0( 60.0( 80.0( seconds! 3!months!(n=48)!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!6!months!(n=45)! AlgisylSLVR( Usual(Care( AUGMENT-HF6min-WT- changefrombaseline N9.6! N15.4! 60.8! 84.7! S50( 0( 50( 100( 150( 3m!(n=63)! 6m!(n=63)! meters( Usual(Care( AlgisylSLVR( *P<0.001+ NYHAFunctional Class–continuousrepresentation P*<0.001( 2.9( 2.2( 2.0( 2.8( 2.8( 2.8( 1.0( 2.0( 3.0( 4.0( Baseline!(n=73)! 3!mo!(n=62)! 6!mo!(n=63)! NYHA(Class( AlgisylSLVR( Usual(Care( AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure.
  • 21. #PostACC15 AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure.
  • 22. #PostACC15 BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction Integrated Autonomic Nervous System Response Inhibits Sympathetic Activity Enhances Parasympathetic Activity Carotid Baroreceptor Stimulation ↓ HR ↓ Remodeling ↑ Vasodilation ↓ Elevated BP ↑ Diuresis ↓ Renin secretion The Baroreflex as a Therapeutic Target
  • 23. #PostACC15 Variable BAT (n=71) Med Mgmt (n=69) Race: Caucasian 82% 90% Gender: Female 13% 16% NYHA: Class III 99% 100% Age (years) 64 ± 11 66 ± 12 SBP (mmHg) 115 ± 18 119 ± 17 DBP (mmHg) 72 ± 11 73 ± 11 HR (bpm) 73 ± 11 75 ± 12 LVEF (%) 24 ± 7 25 ± 7 eGFR (mL/min) 58 ± 21 59 ± 19 NT-pro BNP (pg/mL)* 1422 [455, 4559] 1172 [548, 2558] 6 Minute Hall Walk (m) 297 ± 79 308 ± 85 MN Living with HF QOL† 51 ± 21 43 ± 22 Number of Meds 4.8 ± 1.6 4.4 ± 1.9 Coronary Artery Disease 66% 68% History of Atrial Fibrillation 45% 44% Chronic Kidney Disease 34% 25% HF hospitalizations prior 6 Mo (days/pt/year) 7.0 ± 21 2.4 ± 9 *Median [IQR] †p≤0.05 between groups Baseline Demographics BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction N=140
  • 24. Reduces NT-proBNP LevelsImproves 6-MWT Distance Improves Quality of Life ScoreImproves NYHA Class
  • 25. #PostACC15 Variable BAT (n=57) Med Mgmt (n=50) Difference Mean ± SE HF Hospitalization Days per Year 6 Months Pre-Enrollment 6.95 ± 20.7 2.40 ± 8.6 4.55 ± 34 6 Months Post Enrollment 0.67 ± 2.5 2.48 ± 7.4 -1.82* ± 1 Change from Pre to Post -6.28** ± 2.7 0.08 ± 1.7 -6.36** ± 3 Negative Binomial 6M Post 0.38 2.10 82% RR†* *p≤0.10; **p≤0.05 †RR – Relative Reduction adjusted for 6 months Pre-Enrollment Heart Failure Hospitalizations (Negative Binomial Model) Number of Hospitalization Days for Heart Failure BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction
  • 26. #PostACC15 conclusiones AATAC: En pacientes con IC sistólica y FA persistente, la ablación con catéter es más eficaz que el tratamiento con Amiodarona para mantener el ritmo sinusal a largo plazo. Además se asocia con una reducción de la mortalidad y las hospitalizaciones Surgical Ablation of Afib: En pacientes con valvulopatía mitral y FA persistente, la cirugía valvular mitral y la ablación quirúrgica de la FA permite un mejor control del ritmo cardíaco, aumentando la proporción de pacientes libres de FA en el seguimiento LEGACY: En pacientes obesos con FA paroxística o persistente, la estrategia de perder peso de forma sostenida evitando fluctuaciones se relaciona con una reducción dosis dependiente de la carga de FA, el mantenimiento del Ritmo sinusal y se asocia a un beneficioso remodelado estructural cardíaco
  • 27. #PostACC15 Mood HF: En pacientes con IC sistólica sintomática y depresión mayor, el tratamiento con Escitalopram no mejoró los síntomas depresivos y fue similar al placebo en términos de mortalidad y hospitalización en el seguimiento conclusiones BAT for HFrEF: La Terapia de Activación de los Baroreceptores carotideos es segura y mejora los síntomas de los pacientes con ICFER. Se asocia a una mejoría de la CF, calidad de vida, capacidad de esfuerzo, NT-proBNP y reducción de las hospitalizaciones por IC. AUGMENT–HF: La administración de Algisyl intramiocárdico en pacientes con IC avanzada tiene una morbimortalidad aceptable. Se relaciona con una mejoría sintomática y aumenta la capacidad funcional del corazón. Podría tener un potencial impacto favorable en la reducción de hospitalizaciones por IC
  • 29. #PostACC15 5. Arritmias / Insuficiencia cardiaca • AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device • Effectiveness of Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network • LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study. • Mood HF Trial. Effects of Selective Serotonin Re-Uptake Inhibition on Mortality, Morbidity and Mood in Depressed Heart Failure Patients • AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure. • BAT for HFrEF : Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction
  • 30. #PostACC15 MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3) Baseline Characteristics Total number of enrollees: 260 MVS Alone (N=127) MVS & Ablation (N=133) Mitral Valve Surgery Replacement 61 (48.4) 54 (40.6) Repair 65 (51.6) 79 (59.4) Concomitant Procedures Tricuspid Valve Surgery 48 (38.1) 50 (37.6) Aortic Valve Replacement 20 (15.9) 14 (10.5) CABG 25 (19.8) 27 (20.3) Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3 Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5
  • 31. #PostACC15 28,8 30,2 38,4 34,6 0 20 40 60 Success Recurrence Baseline Follow-up 347 352374 360 0 100 200 300 400 Success Recurrence Baseline Follow-up LVEF (%) 6MWT (meters) 53 4947 46,6 0 20 40 60 Success Recurrence Baseline Follow-up MLHFQ score p<0,038p<0,001 p<0,013 Change in LVEF, 6MWD, and MLHFQ score by recurrence status At the end of follow-up, recurrence free patients (n=105) experienced significantly better improvement in all parameters compared to those who experienced recurrence (n=98). AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 32. #PostACC15 LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study Hypothesis Weight loss, if sustained, will be of incremental benefit in rhythm control Weight fluctuation has detrimental effect Primary Outcomes  AF symptom burden: AFib Severity Scale questionnaire  AF freedom: 7 day Holter monitoring Secondary Outcomes  Structural parameters: LAV and LV thickness  Metabolic and Inflammatory profile
  • 33. #PostACC15 Yearly Weight Trend (N=344) >5%WF N=57 2-5%WF N=68 <2%WF N=54 Linear Weight Loss N=141 (41%) Weight Fluctuation N=179 (52%) Linear Gain N=24 (7%) Effect of Weight Loss Trend Effect of Degree of Weight fluctuation
  • 34. #PostACC15 Implications of Dedicated Weight Loss Clinic  52 patients lost >10% weight in first year  34/52 (66%) maintained WL  30/34 (85%) attended WL clinic  18 regained weight, only 2 (11%) attended clinic WL Clinic 35 (30%) 0 20 40 60 80 100 ≥10% WL 3-9 % WL <3% WL 85% 57% 30% WLClinic WLClinic WLClinic TotalPatientsN=135 TotalPatientsN=103 TotalPatientsN=117
  • 35. #PostACC15 AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure. Operative Procedure Metrics for Algisyl-LVR Implant
  • 36. #PostACC15 5. Arritmias / Insuficiencia cardiaca • AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device • Effectiveness of Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network • LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study. • PADN-2. Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study • Mood HF Trial. Effects of Selective Serotonin Re-Uptake Inhibition on Mortality, Morbidity and Mood in Depressed Heart Failure Patients • AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure. • Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction
  • 37. #PostACC15 Target drugs: 5’-PDE Prostacyclin ET-receptor antagonists PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study
  • 38. #PostACC15 PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study
  • 39. #PostACC15 PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study
  • 40. #PostACC15 PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study Clinical events at 6-month follow-up
  • 41. #PostACC15 PADN-2 Study: Pulmonary Artery Denervation For Treatment Of Pulmonary Arterial Hypertension: Results From A Controlled Before And After Study Conclusion: Pulmonary Artery Denervation treatment was associated with significant improvement of 6 MWT and less PAH-related event En pacientes con Hipertensión arterial Pulmonar, el tratamiento de denervación de la arteria pulmonar se asocia con una mejoría significativa de la capacidad funcional medida con el test de 6 MWT y menos eventos adversos relacionado con la propia HAP
  • 42. #PostACC15 CTSN Surgical AF Ablation Trial Design Excluded (n=3242) Enrollment Allocated to MVS + Ablation (n=133) • Pulmonary Vein Isolation (PVI) (n=67) • Biatrial Maze (n=66) Allocated to MVS Alone (n=127) Allocation • Withdrawal or lost to follow-up (n=8) • Death before month 12 (n=9) • Withdrawal or lost to follow-up (n=10) • Death before month 12 (n=11) Follow-Up Primary Endpoint Analysis (n=133) • Primary Endpoint Data (n=106) • 6 & 12 Month Holter (n=96) • Died (n=9) • Underwent Ablation (n=1) • Imputed (n=27) Primary Endpoint Analysis (n=127) • Primary Endpoint Data (n=102) • 6 & 12 Month Holter (n=88) • Died (n=11) • Underwent Ablation (n=3) • Imputed (n=25) Analysis Randomized (n=260) Assessed for Eligibility (n=3502)
  • 43. #PostACC15 Freedom from AF at both 6 and 12 months by 3-day Holter monitor Pts who died before 12 month assessment or had subsequent ablation were considered treatment failures Primary endpoint • Mortality • MACCE • Quality of life • Serious adverse events Secondary endpoint Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
  • 44. #PostACC15 AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 45. #PostACC15 AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 46. #PostACC15 AF Freedom: Drug & Ablation-Free P<0.001 13% 22% Without AAD or ablation 46%46%
  • 48. #PostACC15  NYHA Functional Class III  Left ventricular ejection fraction ≤ 35%  Six-minute hall walk distance 150 - 400 m  On stable optimal medical therapy for at least 4 weeks prior to baseline assessment  No restriction on QRS, concomitant devices*, or AF * ≥ 6 months of CRT therapy in patients with CRT Key Enrollment Criteria BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction
  • 49. #PostACC15 Twitter La pérdida de peso y evitar la fluctuación del peso constituyen estrategias importantes para reducir los episodios de Fibrilación auricular. La pérdida de peso también se asoció con una beneficiosa remodelación estructural incluyendo reducciones significativas del volumen de la aurícula izquierda y de la hipertrofia ventricular izquierda En pacientes con Insuficiencia cardiaca sistólica y Fibrilación auricular persistente, la ablación con catéter ha mostrado ser más eficaz que el tratamiento farmacológico con amiodarona para el mantenimiento a largo plazo del ritmo sinusal, así como se asocia a una reducción de la mortalidad y de las hospitalizaciones La ablación quirúrgica mediante aislamiento de las venas pulmonares durante la cirugía de válvula mitral se relaciona con un mejor control del ritmo cardíaco en el seguimiento a los 6 y 12 meses, en pacientes con enfermedad valvular mitral y Fibrilación auricular persistente o de larga duración
  • 50. #PostACC15 En pacientes obesos con fibrilación auricular paroxística o persistente, la pérdida de peso mantenida en el tiempo se asocia con una reducción dosis dependiente de la carga de Fibrilación auricular y el mantenimiento del ritmo sinusal. La pérdida de peso también se asocia con una beneficiosa remodelación cardíaca estructural, incluyendo reducciones significativas del volumen de la aurícula izquierda y de la hipertrofia ventricular izquierda Una fluctuación del peso >5% amortigua el beneficio conferido por la pérdida de peso Una unidad específica de obesidad favorece la implicación del paciente y la adherencia, previniendo la ganancia y la fluctuación de peso
  • 51. #PostACC15 En pacientes con Insuficiencia cardiaca sistólica sintomática y depresión mayor, el tratamiento con Escitalopram no mejoró los síntomas depresivos y fue similar al placebo en términos de mortalidad y hospitalización en el seguimiento Among patients with mitral valve disease and persistent atrial fibrillation, mitral valve surgery plus atrial fibrillation ablation was effective at improving freedom from atrial fibrillation at 6 and 12 months. There was no difference between ablation techniques on freedom from atrial fibrillation. Major adverse cardiac and cerebrovascular events were similar between the groups. La cirugía de la válvula mitral asociada a la ablación quirúrgica de la fibrilación auricular es eficaz para conseguir un mejor control del ritmo cardíaco, aumentando la proporción de pacientes sin fibrilación auricular los 6 y 12 meses de seguimiento. Los pacientes con enfermedad valvular mitral y Fibrilación auricular persistente sometidos a cirugía valvular p
  • 52. #PostACC15 La Terapia de Activación de los Baroreceptores carotídeos es segura en pacientes ICFER y mejora significativamente la clase funcional de la NYHA, la calidad de vida, la capacidad de esfuerzo, el NT-proBNP, y posiblemente reduzca las hospitalizaciones por insuficiencia cardiaca La administración de Algisyl intramiocárdico en pacientes con insuficiencia cardiaca avanzada es segura, con una morbimortalidad aceptable. El tratamiento con Algisyl proporcionó una mejoría sintomática y de la capacidad en la funcional del corazón en comparación con los pacientes en el grupo de control. La evaluación inicial de los eventos adversos cardiovasculares mayores a los 6 meses sugieren un potencial impacto favorable en la reducción de la hospitalización por IC en los pacientes tratados con Algisyl
  • 53. #PostACC15 Conclusions: This multicenter randomized study shows that catheter ablation of Persistent AF is superior to Amiodarone in achieving freedom from AF at long term follow up and reducing hospitalization and mortality in patients with heart failure. AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 54. #PostACC15 Conclusions: Surgical ablation improves rhythm control in mitral valve patients with persistent and long-standing persistent AF Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network Among patients with mitral valve disease and persistent atrial fibrillation, mitral valve surgery plus atrial fibrillation ablation was effective at improving freedom from atrial fibrillation at 6 and 12 months. There was no difference between ablation techniques on freedom from atrial fibrillation. Major adverse cardiac and cerebrovascular events were similar between the groups.
  • 55. #PostACC15 CONCLUSIONS Sustained weight loss is associated with dose dependent reduction in AF burden and maintenance of sinus rhythm >5% Weight fluctuation dampens the benefit conferred by weight loss A dedicated clinic improves patient engagement, promoting treatment adherence, preventing weight regain and fluctuation Simultaneous online publication on 16 March 2015 LEGACY Study: Long-Term Effect of Goal Directed Weight Management on an Atrial Fibrillation Cohort: A 5-Year Follow-Up Study
  • 56. #PostACC15 MOOD-HF Trial Effects of selective serotonin re-uptake inhibition on MOrtality, mOrbidity and mood in Depressed Heart Failure patients Conclusions: MOOD-HF is the first larger-scale RCT on long-term efficacy and safety of an SSRI in systolic heart failure patients with co-morbid depression. Escitalopram neither improved the composite primary outcome (all-cause death or hospitalization), nor depression in this population.
  • 57. #PostACC15 AUGMENT–HF trial: A Prospective Comparison of Algisyl-LVR with Standard Medical Therapy to Determine Impact on Functional Capacity and Clinical Outcomes in Patients with Advanced Heart Failure.
  • 58. #PostACC15 BAT for HFrEF Study Group: Baroreflex Activation therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction Conclusions: • Baroreflex Activation Therapy is safe in HFrEF patients  No system- or procedure-related deaths  Few and short-lived complications; complication rate comparable to established HF device therapies  No hypotension • BAT significantly improves NYHA Class, quality of life score, exercise capacity, NT-proBNP, and possibly the burden of heart failure hospitalizations Manuscript online today at JACC Heart Failure http://heartfailure.onlinejacc.org
  • 59. #PostACC15 AATAC Multicenter Randomized Trial: Ablation vs Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted device (ICD/CRTD)
  • 60. #PostACC15 MVS Alone (N=127) MVS & Ablation (N=133) Female –no. (%) 63 (49.6) 57 (42.9) Age (yr) 69.4 ± 10.0 69.7 ± 10.4 NYHA Class III & IV –no. (%) 62 (49.2) 56 (42.1) Atrial fibrillation duration –med (IQR) 29 (3, 96) 18.5 (3, 65) Atrial fibrillation type 28 (18.7) 24 (16.0) Longstanding Persistent 71 (55.9) 70 (52.6) Persistent 56 (44.1) 63 (47.4) Anticoagulants –no. (%) 97 (76.4) 105 (79.0) Anti-arrhythmic Drugs (Class III) 15 (11.8) 14 (10.5) Mitral disease etiology Organic 73 (57.5) 75 (56.4) Functional non-ischemic 48 (37.8) 43 (32.3) Ischemic 6 (4.7) 15 (11.3) Baseline Characteristics Total number of enrollees: 260
  • 61. #PostACC15 MVS Alone (N=127) MVS & Ablation (N=133) Mitral Valve Surgery Replacement 61 (48.4) 54 (40.6) Repair 65 (51.6) 79 (59.4) Concomitant Procedures Tricuspid Valve Surgery 48 (38.1) 50 (37.6) Aortic Valve Replacement 20 (15.9) 14 (10.5) CABG 25 (19.8) 27 (20.3) Cardiopulmonary Bypass Time (min)* 132.5 +51 147.8 +63.3 Cross-Clamp Time (min) 95.9 +36.3 102.9 +41.5 Operative Characteristics *P-Value for Cardiopulmonary Bypass Time = 0.03 Total number of enrollees: 260
  • 62. #PostACC15 Mortality(%) Mortality Months MACCE CompositeCardiacEndPoint(%) Months Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network 8.7% 6.8% 23.3% 20.5% Major adverse cardiac or cerebrovascular events
  • 63. #PostACC15 Quality of Life MVS Alone (N=127) MVS & Ablation (N=133) P-Value SF-12 Physical Function 45.3 ±7.9 44.3 ±9.0 0.38 Mental Function 48.5 ±6.5 48.0 ±6.3 0.56 AF Severity Scale Daily AF –no. (%) 42 (45.2) 20 (19.8) <0.001 Life Rating (1-10, median) 8.0 (7,9) 8.0 (7,9) 0.45 NYHA Class III + IV –no. (%) 3 (2.9) 8 (7.0) 0.17 Surgical Ablation of Atrial Fibrillation during Mitral Valve Surgery: A Randomized Clinical Trial from the Cardiothoracic Surgical Trials Network
  • 64. #PostACC15 1° Outcome Time to all-cause death or hospitalization
  • 65. #PostACC15 Major 2° Outcome 10- item Montgomery–Åsberg Depression Rating Scale
  • 66. #PostACC15 <3% Wt Loss N= 117 3-9% Wt Loss N = 103 ≥10% Wt Loss N = 135 P Value Age (years) 6111 6311 6511 0.06 Male gender, n (%) 83 (71) 65 (63) 86 (64) 0.4 Non-Paroxysmal AF, n (%) 45 (56) 46 (45) 64 (47) 0.9 BMI 32.94.8 32.74.4 33.64.7 0.2 Hypertension 90 (78) 75 (73) 109 (81) 0.3 DM/IGT, n (%) 34 (29) 28 (27) 41 (30) 0.5 Hyperlipidemia, n (%) 56 (48) 45 (44) 66 (49) 0.7 CAD, n (%) 14 (12) 12 (12) 21 (16) 0.3 AHI>30, n (%) 61 (52) 52 (50) 69 (51) 0.1 Smoker, n (%) 47 (40) 41 (40) 50 (37) 0.9 ETOH (>30g/week), n (%) 34 (29) 35 (34) 42 (31) 0.7 Baseline Characteristics