Fundación Favaloro

Transcription

Fundación Favaloro

Reemplazo Valvular Aórtico por
Cateterismo (TAVR)
Prevención de Complicaciones
Oscar A. Mendiz.MD.FACC.FSCAI
Jefe Cardiología Intervencionista
Presidente SOLACI
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Tuesday, December 11, 12
Disclosure
Speacker: O Mendiz MD.
Proctor Medtronic
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§ Indicación Adecuada:
§
§
§
EAo severa sintomática
Alto riesgo Quirúrgico
Anatomía favorable
§ Elegir el momento correcto
§ Tener el Equipo (Team)
§ Realizar en Lugar correcto
§
§
§
§
§
THOMAS WALTHER & JÖRG KEMPFERT EJCTS 2011
Cortesía Dr Batellini
EAo sintomática severa
Paciente compensado
Interdisciplinario
Quirófano Híbrido o
Cath Lab Adecuado
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Pa#ent Selec#on
1. Iden'fy the high or prohibi've risk surgical pa'ent
2. Anatomical characteris'cs and boundaries of the cardiovascular system from “skin to heart”
a)
b)
Feasibility
Vascular access site
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High Risk AVR Patients
Radiation chest wall/heart disease
Octogenarians with multiple co-morbidities
STS Predicted Risk >10%, Logistic
EuroSCORE >30% (~10-15% operative risk)
Cirrhosis with portal hypertension
ESRD on dialysis
Porcelain aorta
Degenerative neurocognitive dysfunction
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High Risk AVR Patients
Radiation chest wall/heart disease
Octogenarians with multiple co-morbidities
STS Predicted Risk >10%, Logistic
EuroSCORE >30% (~10-15% operative risk)
Cirrhosis with portal hypertension
ESRD on dialysis
Porcelain aorta
Degenerative neurocognitive dysfunction
There is no perfect formula!
Requires some quantitative risk algorithm
+ a thoughtful surgeon/cardiologist!!!
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Percutaneous Aortic Valve Replacement
CoreValve
Edwards-SAPIEN
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Percutaneous Aortic Valve Replacement
CoreValve
Edwards-SAPIEN
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Algorithm for Patient Selection @ Favaloro Foundation
First:
l
Transthoracic Echo for Diagnosis
Second:
l
Catheterization
l
l
l
Coronary Angiography (CAD should be previously treated)
Thoracic Aortogram (marked pigtail)
Abdominal Aortogram (marked pigtail)
Third:
CT Multislice (thoracic and abdominal aorta)
• Finally:
TEE: Focus in all needed measurements (advised operator)
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Screening: Angiographic Evaluation
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TAVR @ Favaloro Foundation
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TAVI @ Favaloro Foundation
Pte Selection: Don’t forget CT axial slices
Good Candidate for Femoral Approach
Poor Candidate for Femoral Approach
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Screening Mistakes: Annulus Discrepancies
Improving with learning curve.
Use 3 methods.
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TAVR:
Better Pte. & Valve Selection
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A Limitation of Echo
?
It is possible a true diameter is not measured due
to the imaging plane acquired
1. Piazza N, et al. Circ Cardiovasc Intervent. 2008;1(1):74-81.
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A Limitation of Echo
?
It is possible a true diameter is not measured due
to the imaging plane acquired
1. Piazza N, et al. Circ Cardiovasc Intervent. 2008;1(1):74-81.
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The Aortic Annulus
The aor'c annulus is typically non-‐circular
Double-oblique axial images at the aortic annular plane
Courtesy of Dr. Piazza and Prof. Lange, German Heart Center, Munich
Germany
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Clinician Publications: Imaging
Courtesy E Grube
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Clinician Publications: Imaging
1. Sizing is an important part of pre-case
planning for TAVI
2. Most current literature suggests a multimodality approach and many prefer 3D
method (MSCT)
Courtesy E Grube
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Hayashida K, et al. EuroInterven#on 2012;8:546-‐555
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Diameter Range (mm)
Perimeter Range (mm)
Area Range (mm2)
18 - 20
56.5 - 62.8
254.5 - 314.2
20 - 23
62.8 - 72.3
314.2 - 415.5
23 - 27
72.3 - 84.8
415.5 - 572.6
26 - 29
81.7 - 91.1
530.9 – 660.5
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Messika-Zeitoun D et al. J Am Coll Cardiol 2010;55(3)186-194
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Multimodal Assessment of Aortic Annulus
Correlation
TE & ETE
TTE & MSCT
ETE & MSCT
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Correlation
TE & ETE
TTE & MSCT
ETE & MSCT
TAVI Strategy
would have been
different in 17%
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Correlation
TE & ETE
TAVI Strategy
would have been
different in 17%
TTE & MSCT
TAVI Strategy would
have been different in
40% & 42%
ETE & MSCT
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Tamburini C. TCT 2012
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Tamburini C. TCT 2012
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CoreValve Sizing
Prosthesis
Annulus
Perimeter
%oversizing
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TAVR:
Avoiding Perforations
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Avoid Perforations
Pacemaker:
l
With distal balloon tip
Left Ventricule:
l
l
l
Crossing the Valve (“J” or soft wires)
Soft entrance of the catheter (push & pulling)
Curve shape of stiff wire (small loop)
Check by Echo before leaving the Cath Lab
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TAVRI: Avoid Perforations
Pacemaker with distal balloon
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TAVRI: Avoid Perforations
Pacemaker with distal balloon
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Perforation: Urgent Perdicardial Dranaige
CASO 3
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TAVR:
Correct Positioning
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Valve Positioning
Aortic Root perpendicular alignment:
l
Angio: RAO caudal (10/20) or LAO cranial (10/10)
l
Paeion system
Dyna CT system.
l
Delivery Alignment:
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Dyna CT System
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Correct positioning
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Buscar la adecuada alineación de los senos
Aortograma en oblicua derecha y luego en derecha caudal con
mejor alineación
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Buscar la adecuada alineación de los senos
Aortograma en oblicua derecha y luego en derecha caudal con
mejor alineación
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Starting Valve Delivery
CASO 3
Ring postioning
Try to see 3 cusped
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Design of the CoreValve Prosthesis
Photograph provided by Piazza, Serruys, and DeJaegere
Photograph provided by Piazza, Serruys, and
DeJaegere
Photograph provided by Piazza, Serruys, and
DeJaegere
Skirt height ~ 12 mm
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Starting Valve Delivery
4mm
7-8mm
Good Starting
Too Deep!!!
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Valve-in-Valve TAVR: Fundación Favaloro
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Strategies to Manage Device Malposi#on
Prosthesis too high
Retrieve while still attached
l Implantation of a second valve
l Valve in valve
l
Prosthesis too low
Pull while still attached
l Snare and pull
l Valve in valve
l
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Device Malposi#on: Prosthesis Too High
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Prosthesis Too High: Retrieval
Prosthesis Retrieval
Prosthesis Retrieved into
Abd Aorta
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Abd Aorta
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Abd Aorta
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Prosthesis Retrieval into Sheath
Prosthesis Removed via
Sheath
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Prosthesis Retrieval into Sheath
Prosthesis Removed via
Sheath
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Risk of stroke with prosthesis retrieval
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Desplazamiento a la aorta ascendente e
implante de 2° válvula
Aortograma con válvula desplazada a la Ao ascedente por lo que se la retiró
con lazo
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Desplazamiento a la aorta ascendente e
implante de 2° válvula
Mismo paciente con implante de una 2° válvula y aortograma final
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Valve Too Deep: Pulling Maneuver
CASO 3
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Valve Too Deep: Pulling Maneuver
CASO 3
Aortic Arch rectification
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CASE 6: Angulated aorta: Valve Too Deep
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CASE 6: Angulated aorta: Valve Too Deep
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Valve Hoocks Full Detachment !!!!
CASO 3
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CASO 3
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CASO 3
Be carefull
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CASO 3
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CASO 3
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CASO 3
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Delivery trabado en el Ca
Posicionamiento de la válvula e imposibilidad de retirar el delivery por el Ca
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Delivery trabado en el Ca
Post dilatación con delivery y aortograma final
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Valve Positioning & Delivery:
Hemodynamic Stability
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Evitar la hipotensión durante la liberación
especialmente en pacientes con baja FEVI
VI diátole
VI sístole
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TAVR:
Vascular Access Complications
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Vascular Complications
Bleeding
Vessel obstruction
(Vessel rupture)
Grube ISET Miami 2012
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Early Vascular Access Complications
Relationship to 1 Year Mortality (NB 22/24F Device)
59
Approach
% Survival in Pts who did not
have vascular access
complications
% Survival in Pts who did
complications
P-Value
TF
83.9%
72.2%
0.0121
TA
73.2%
47.4%
0.0188
Ganesh Manoharan
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Early Vascular Access Complications
Relationship to 1 Year Mortality (NB 22/24F Device)
59
Approach
% Survival in Pts who did not
complications
% Survival in Pts who did
complications
P-Value
TF
83.9%
72.2%
0.0121
TA
73.2%
47.4%
0.0188
Ganesh Manoharan
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Percutaneous TAVI
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Correct puncture site
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Correct puncture site
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Vascular Access Mistakes
Prostar 10XL
after 9 F predilatation
Site access predilatation
(smaller sheath)
Prostar delivery under
fluoro.
Contralateral access for
bleeding control.
Stent graft back-up.
Surgcial back up
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Vascular Access Mistakes
Prostar 10XL
after 9 F predilatation
Site access predilatation
(smaller sheath)
Prostar delivery under
fluoro.
Contralateral access for
bleeding control.
Stent graft back-up.
Surgcial back up
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Prevención complicaciones vasculares, infección herida
quirúrgica y linfocele
Cierre percutáneo con Prostar XL y angiografía de control
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Estenosis por cierre percutáneo
Estenosis por cierre
percutáneo
Angioplastia
con balón
Angiografía final
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InSeal Intravascular Closure Device
Acute
Tether (biodegradable)
Sealing membrane
(biodegradable)
Grube ISET Miami 2012
After biodegradation
Nitinol frame
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TAVR: Stroke
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Cerebral Embolism after TAVI
73% of TAVI patients had new cerebral lesions after TAVI
A DW-MRI in a 73-year-old man demonstrates multiple, bilateral embolism of the cerebrum
and cerebellum (white arrows). Selected emboli demonstrate signal intensity in the fluidattenuated inversion recovery sequence as sign of neuronal repair (yellow arrows). The patient
had no clinically apparent focal neurological deficits after TAVI (NIHSS: 0).
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JACC 2010
Addressing Stroke Risk
Poten&al Issues
Embolic material released during the procedure
Post-‐implant events
Solu&ons
• Alterna've access routes
• Embolic protec'on devices
• An'-‐coagula'on management—
guidelines and training
• Diﬀeren'a'ng late-‐diagnosis
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Cerebral Embolic Protection Device
Embrella Embolic Deflector
Device
Claret Dual Filter Device
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Improving Technique: TAVI Direct (n=63)
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Timing, Predictive factors and Prognostic value of cerebrovascular
events in a large cohort of patients undergoing TAVI
Prospective Registry, 5 hotspital, 1081 Ptes (Edwards & CoreValve)
Incidence:
-Acute: 5.1% (0.8 transient)
-1-year
3.1%
Predictors:
-Acute Phase: Post dilatation; Valve Deformation/detachment
-Follow-Up: atrial fibrialtion
CVE
2.7
2.7
3.0
2.6
2.5
CVE
2.3
2.4
1.5
2.3
0.8
2.2
0
Acute (<24hs) Sub-acute (1-30 days)
Nombela-Franco L, et al. TCT 12 abstract Nro 89. Quebec Heart & Lung Institute
www.solaci.org
2.8
1.4
Major
Minor
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TAVR:
Paravalvular Leak & AI
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Mechanisms of peri-prosthetic AR
Shallow implantation
Deep implantation
Prosthesis-annulus size mismatch
Sinning JM et al., JACC 2012
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Paravalvular AR and Mortality
TAVR Patients (AT)
None - Trace
Mortality
Mild - Moderate - Severe
Months Post Procedure
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild-Mod-Sev
160
134
112
101
64
26
12
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TAVR Patients (AT)
None - Trace
Mortality
24.8%
14.5%
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild-Mod-Sev
160
134
112
101
64
26
12
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TAVR Patients (AT)
HR [95% CI] =
2.01 [1.38, 2.92]
p (log rank) = 0.0002
None - Trace
Mortality
39.5%
29.5%
24.8%
14.5%
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild-Mod-Sev
160
134
112
101
64
26
12
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Mild Paravalvular AR and Mortality
TAVR Patients (AT)
None - Trace
Mild
Mortality
Moderate - Severe
24.8%
14.5%
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild
136
115
95
86
51
21
10
24
19
17
15
13
5
2
Mod-Sev
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TAVR Patients (AT)
None - Trace
Mild
Mortality
Moderate - Severe
39.2%
29.5%
24.8%
14.5%
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild
136
115
95
86
51
21
10
24
19
17
15
13
5
2
Mod-Sev
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TAVR Patients (AT)
p (log rank) < 0.001
None - Trace
Mild
Moderate - Severe
Mortality
41.7%
39.2%
29.5%
29.2%
24.8%
14.5%
Numbers at Risk
None-Tr
167
149
140
126
87
41
16
Mild
136
115
95
86
51
21
10
24
19
17
15
13
5
2
Mod-Sev
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METHODS:
• Dimensionless AR index [(DBP-LVEDP)/SBP] X 100 used to
determine the significance of PVL in 146 TAVR pts
RESULTS:
• AR index <25 predicts ↑ 1-yr mortality (46.0% vs. 16.7%, p<0.001);
ind pred of 1-yr mortality beyond TEE measures of PVL severity
Sinning et al. J Am Coll Cardiol 2012; 59: 1134-41
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Aortic Regurgitation Index: Mild AR
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RRsys 150 mmHg
RRdia 60 mmHg
LVEDP 15 mmHg
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RRsys 150 mmHg
RRdia 60 mmHg
LVEDP 15 mmHg
Aor'c regurgita'on Index = [(RRdia – LVEDP) / RRsys] x 100 Tuesday, December 11, 12
= [(60 -‐ 15) / 150] x 100 = 30.0 Fundación Favaloro
Aortic Regurgitation Index: Moderate AR
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RRsys 120 mmHg
RRdia 40 mmHg
LVEDP 20 mmHg
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RRsys 120 mmHg
RRdia 40 mmHg
LVEDP 20 mmHg
Aor'c regurgita'on Index = [(RRdia – LVEDP) / RRsys] x 100 Tuesday, December 11, 12
= [(40 – 20) / 120] x 100 = 16.7 Fundación Favaloro
Mecanismos Involucrados en la Aparición de Leak
PROTESIS
Tamaños
-Medición Anillo
-Relación Ani/Val
Posición
-Técnica
-Alineación
-Profundida
Adaptada de Tamburino C. TCT2012
Expanción
-Circularidad
-Calcio
-Stent frame
-Fuerza Radial
Aposición
-Calcio
-Bi/Tricúspide
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Strategies to Manage Paravalvular Leak
Hemodynamic assessment
Under-deployed valve
l Post-dilate
Problem of valve positioning
l Snare and pull
l Valve in valve
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TAVR:
Clinical Outcomes
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Outcomes after TAVR using VARC criteria:
Review of the literature and a study-level
meta-analysis of 3,519 patients from 17 studies
Philippe Généreux, MD
Stuart Head
Columbia University Med Center Cardiovascular
Research Center New York City
Erasmus University Med Center Rotterdam, the
Netherlands
VARC – 2 Meeting
Washington DC; September 26, 2011
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TAVR Outcomes - VARC Meta-Analysis
(17 studies; 3,519 patients)
J Am Coll Cardiol 2012;59:2297-306
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TAVR Outcomes - VARC Meta-Analysis
(17 studies; 3,519 patients)
P Généreux and S.J.Head
Unpublished data/Submitted JACC
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Predictive Factors of 30-day Mortality
Pulmonary Hypertension
OR: 2.09, 95% CI: 1.02-4.43, P=0.048
Severe Mitral Regurgitation
OR: 3.01, 95% CI: 1.09-8.24, P=0.033
Need for peri-procedural
hemodynamic support
Josep Rodés-Cabau, Canadian Registry, ACC 12,
OR: 6.84, 95% CI: 2.04-22.93, P=0.002
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Procedural Predictors of Mortality
Stroke
HR
[95% CI]
p-value
TAVR
2.76
[1.58-4.82]
<0.001
AVR
4.99
[2.85-8.75]
<0.001
TAVR
2.14
[1.42-3.20]
<0.001
AVR
2.88
[1.99-4.14]
<0.001
TAVR
1.67
[1.04-2.70]
0.03
AVR
1.40
[0.57-3.44]
0.46
Major Bleeding
Major Vascular
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Transcatheter Aortic Valve Replacement: Outcomes of Pts with Moderate or
Severe Mitral Regurgitation
451 pts stratified by MR status (71% mild, 29% moderate/severe).
Moderate/Severe vs.
Mild MR
Adjusted HR for
Mortality
95% CI
P Value
≤ 30 Days
2.10
1.12-3.94
0.02
> 30 Days
0.82
0.50-1.34
0.42
At 1 year, MR was improved in 55% of patients with
moderate or severe MR at baseline.
Conclusion: Moderate/severe MR in pts undergoing TAVR is associated with higher early—
but not late—mortality, with improvements in MR in over half of survivors at 1 year.
Toggweiler S, et al. J Am Coll Cardiol.
2012;Epub ahead of print.
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Left Bundle Branch Block (LBBB) Induced by
TAVI Increases Risk of Death
Registry study of 679 pts receiving either CoreValve or Sapien
at 8 Dutch centers.
About one-third (n = 233) of pts experienced new LBBB within 7 days of
implantation
At 450-day follow-up, all-cause mortality higher in patients with LBBB vs. without
(37.8% vs. 24.0%; P = 0.002)
New LBBB more common in CoreValve- vs. Sapien-treated patients (51.1% vs.
12.0%; P < 0.001)
Implications: LBBB is a serious complication of TAVR that may strongly attenuate the survival
benefit of this procedure.
Houthuizen P, et al. Circulation.
2012;Epub ahead of print.
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TAVR in Pts with Severe Left Ventricular Dysfunction
Retrospective analysis of 2-center experience that stratified patients according to
baseline LVEF.
LVEF ≤ 35%
LVEF > 35%
(n = 50)
(n = 334)
Periprosthetic Leak > 2+/4
10%
3%
0.027
30-Day Mortality
10%
3%
0.010
Outcomes After TAVR
P Value
In pts with severe LV dysfunction, LVEF increased from 27.7 ± 6.0% at baseline to 35.4 ± 11.1%
at discharge (P < 0.0001).
Conclusion: TAVR offers immediate and lasting benefit to patients with severe left
ventricular dysfunction at an acceptable mortality risk.
Fraccaro C, et al. Circ Cardiovasc Interv. 2012;Epub
ahead of print.
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TAVR:
Permanent Pacemaker
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Meta-Analysis – PPM
50.0
42.5
40
95% CI: 20.6-36.8%
35.2
37.5
28.7
23
25.0
28.7%
25.7
26
16.6
12.5
Italian
Belgian
French
Spanish
UK
German
Auz-NZ
Meta-Analysis3
0
PPM
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Depth of Implantation
May Play a Role in Onset of Rhythm Disturbances1
New-onset LBBB acquired
during or after valve
implantation
10.3 mm
No new-onset LBBB or
new-onset LBBB acquired
during procedure but
before valve implantation
7.3 mm
6.0 mm below
coronary sinus
1Grube,
et al. TCT Asia 2010
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Primary TAVI: Clinical Outcome at 30days
Study Group
Control Group
n=60
n=126
6.7% (4)
14.3% (18)
0
5.6% (7)
5.0% (3)
11.9% (15)
11.7% (7)
27.8% (35)
10.0% (6)
9.5% (12)
All-cause Mortality
Myocardial infarction
Stroke/TIA
Need for pacemaker
implantation
Vascular Access Complication
*Buellesfeld L et al. J Am Coll Cardiol. 2011; 57:1650-1657
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TCT12 Abstract 90: Predictive Factors and long-term clinical consequences of persistent
LBBB following aortic valve implantation with balloon expandable valve
Nuevo BCRI
30%
Predictores
lProfundidad
37%
lDuración
24%
QRS previo
Consecuencias:
lNO
AUMENTO MORTALIDAD
lPredijo
pero capacidad funcional y función ventricular.
Urena L, TCT12, abstract 90
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Experiencia en Fund Favaloro: Resultados a 30 días
Variable
n° 72 pacientes
Edad (años)
Masculino (%)
80±8
42 (58)
Antecedente de IAM (%)
Antecedente CRM (%)
Antecedente ATC (%)
14 (19)
13 (18)
27 (38)
Antecedente IRC (%)
Antecedente EPOC Severo (%)
8 (11)
12 (17)
Fracción de eyección menor a 40%
Euroscore logístico
Insuficiencia mitral 3-4 (%)
8 (11)
21.4±0.15
13 (18)
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Experiencia en Fund Favaloro: Resultados a 30 días
Eventos adversos a 30 días
Éxito procedimiento
n° patients (%)
70 (97)
Muerte (%)
2 (3)
Perforación cardíaca con pericardiocentesis (%)
3 (4)
Insuficiencia cardíaca (%)
A.C.V. Menor (%)
Marcapaso definitivo (%)
Insuficiencia renal aguda (%)
B.C.R.I. Definitivo (%)
20 (28)
1 (2)
20 (28)
2 (3)
17 (24)
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Experiencia en Fund Favaloro: Follow-Up
Evolución alejada
n° 70
patients
(86%)
12±11
Período de seguimiento (2-35 meses)
Muerte de cualquier causa (%)
6 (8.6)
IAM (%)
1 (1.4)
ACV Menor + TIA (%)
2 (2.8)
Marcapaso definitivo (%)
2 (2.8)
Asintomáticos (%)
Mediciones
Aortic valve area (cm²)
Gradiente pico Hemodinamia / Eco-Doppler (mmHg)
Insuficiencia aórtica leve final (%)
Insuficiencia aórtica moderada final (%)
62 (85.7)
Pre Implante
Valvular
0.6±0.2
89±10 / 91±12
Post implante
Valvular
1.7±0.2
3±1 / 13±10
36 (50)
32 (44)
Fundación Favaloro
Fundación Favaloro
Fundación Favaloro
Gracias por su Atención
Fundación Favaloro
Fundación Favaloro
Fundación Favaloro
Subclavian Access
Fundación Favaloro
Fundación Favaloro
Fundación Favaloro

Fundación Favaloro

Transcription

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