Transcript Conduction Disturbances after TAVR

Conduction Disturbances after
Percutaneous Aortic Valve Replacement
Reducing Post-TAVR Conduction Disturbances
UC201303178a EE
Conduction Disturbances after TAVR
• Anatomical Considerations
• Conduction Disturbances and Pacemaker Implantation
– Driving Factors
– Patient Impact
• Conclusions
Anatomical Considerations
• Conduction abnormalities are not atypical following TAVR
due to the anatomical proximity of the aortic valve to the
conduction system
– Distance from the non-coronary cusp to the HIS bundle has been
measured to be 6.3 ± 2.4 mm.
Modified from Tawara.
Igawa et. al, Jap Circ 2009
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Conduction Disturbances after TAVR
• Anatomical Considerations
• Conduction Disturbances and Pacemaker Implantation
– Driving Factors
– Patient Impact
• Conclusions
Mechanisms Driving Post-TAVR Conduction
Disturbances
More than 25 studies have been published on predictors of post-TAVR
conduction disturbances (CDs) and permanent pacemaker implant (PPI)
Patient-Related
Factors
• Male gender3
Anatomical Factors
Procedural Factors
(Device / Operator)
• Age > 75 years9
• Variations in location
of LBBB exit point1
• Radial force of the
prosthesis3
• Previous MI3
• Septum thickness1,6
• Implant Depth2,3,7
• Right Bundle Branch
Block (RBBB)2,3,4,5,7
• Thickness of the noncoronary cusp1
• Balloon Aortic
Valvuloplasty8
• Other pre-existing
conduction
disturbances3,4,8,9
• Application of PPI
guidelines10
• Learning Curve11
1Jilaihawi,
et al. Am Heart J 2009; 2Munoz-Garcıa, et. al. JACC CV 2012; 3Piazza et. al. EuroIntervention 2010; 4De Carlo , et. al. Am Heart J 2012; 5Calvi, et. al. JICE 2011;
et. al. Cath Card Intv 2012; 7Fraccarao, et. al. Am J Card 2011; 8Khawaja, et. al. Circ 2011; 9Schroeter et. al. EuroPACE 2011; 10Wenaweser, et. al. presented at
EuroPCR 2013; 11Meredith, et. al. presented at TCT 2012
6Saia,
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Patient-Related Drivers of Conduction Disturbances
and Pacemaker Implantation
 Pre-existing Conduction
Disturbances, including RBBB
Pre-existing Conduction Disturbances
• Degenerative Aortic Stenosis (AS) is associated with electrical
conduction abnormalities because calcification in and around
the aortic valve can progress and extend to involve the
electrical conduction system of the heart
• Rates of conduction disturbances at baseline are high in
patients with AS
•
•
•
•
Atrial Fibrillation 32%
Hemiblock 23%
LBBB 17%
RBBB 17%
Van Mieghem et. al., Ann Thorac Surg 2012
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Pre-existing Conduction Disturbances
• Pre-existing CDs may contribute to the development of post-TAVR
arrhythmias which necessitate PPI
• This chart demonstrates how pre-existing RBBB can contribute to the
formation of 3°AV block if the patient develops LBBB during TAVR
AV conduction at baseline:
AV conduction after TAVI:
AV conduction at follow-up:
•
Black boxes = pts w/o follow-up , ▪ # in parentheses = pts with PPI
Roten et. al., Am J Card 2010
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Procedural Drivers of Conduction Disturbances and
Pacemaker Implantation
 Pre-implant BAV
Contribution of TAVR Procedural Steps to
Conduction Disturbances
• ECG recording during individual
TAVR steps showed that BAV may
contribute half of the CDs that
develop during TAVR.
• Patients developing new CDs during
BAV had a significantly higher
balloon/annulus ratio (1.10 ± 0.10
vs. 1.03 ± 0.11, p=0.030)1
• 2%1 to 16%2 of PPI in TAVR may be
due to CDs caused during BAV
1Nuis
R. Eur Heart J. 2011;32(16):2067-2074. 2Grube E . JACC Cardiovasc Interv 2011;4(7):751-757.
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Procedural Drivers of Conduction
Disturbances and Pacemaker Implantation
 Pre-implant BAV
 Implant Depth
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Implant Depth Impacts Conduction Disturbances
• A lower (ventricular) position of the valve relative to the
hinge point of the anterior mitral leaflet was associated with
a higher incidence of new LBBB (35% vs. 0%, P = .029).
Implanted Above → 0% of patients developed LBBB
Hinge Point of the Anterior Mitral Valve
Implanted Below → 35% of patients developed LBBB
Gutierrez et al. Am Heart J 2009, (N=33)
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Implant Depth and PPI Rate
Pacemaker Implants (% pts.)
Data from independent studies plotted on the same graph show
the strong relationship between PPI rate and implant depth
5
4
3
2
1
CoreValve Implant Depth (mm)
1Tchetche,
et al. EuroIntervention 2012; 2Munoz-Garcıa, et. al. JACC CV 2012; 3Piazza et. al. EuroIntervention 2010; 4De Carlo , et. al. Am Heart J
2012; 5Calvi, et. al. JICE 2011; 6Saia, et. al. Cath Card Intv 2012; 7Fraccarao, et. al. Am J Card 2011; 8van der Boon, et. al. Int J Card 2013;
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
CoreValve Procedural Outcomes
at Target Implant Depth
• 134 CoreValve patients treated
at 2 experienced centers
• All implants performed using
the AccuTrak delivery system
and a 4-6 mm target implant
depth
• Appropriately sized balloon
used for pre-implant BAV
N=134
Patients (%)
Procedural Success
133 (99.2)
BAV
129 (98.5)
Balloon-Annulus Ratio
0.95  0.09
Depth of Implant
4.9  2
PVL > 2/4
0 (0)
Central leak
0 (0)
New LBBB
18 (13.4)
New Transient or
Sustained AVB
17 (12.7)
New Pacemaker
Implantation
12* (10.6)
*12 of 113 patients without baseline pacemaker.
Tchetche, et al; EuroIntervention 2012; e-publication.
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Procedural Drivers of Conduction Disturbances and
Pacemaker Implantation
 Pre-implant BAV
 Implant Depth
 Variations in Application of
Pacemaker Indications
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Application of PPI Guidelines
• PPI for relative indications by some centers and not others, driven by the
desire to mobilize patients quickly after TAVR, may be a reason for the
variability in reported pacemaker rates
Gillis et al HRS/ACCF Pacemaker Mode Selection
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
CoreValve ADVANCE |
Permanent Pacemaker Implant
Rate by Geography
Varying 30-day pacemaker rates across geographies in the
ADVANCE study may reflect differences in the application of PPI
guidelines
Countries with less than 15 implants not shown
1Wenaweser,
et al. Presented at EuroPCR 2013
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Absolute vs. Relative Pacemaker Indications
• 258 CoreValve patients from Nov
2007 to Feb 2012 (Copenhagen,
Denmark)
• 9% with preexisting pacemaker
• 19.7% of patients had an absolute
pacemaker indication (3°and 2°AVB)
• After periprocedural period only 9.8%
of TAVR patients had an absolute
pacemaker indication
–
9.9% of conduction disturbances
resolved
Thygesen et al, London Valves 2012.
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Procedural Drivers of Conduction Disturbances and
Pacemaker Implantation
 Pre-implant BAV
 Implant Depth
 Variations in Application of
Pacemaker Indications
 Learning Curve
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Effect of Learning Curve on PPI Rate
100%
The overall rate of PPI in the CoreValve Australia-New Zealand
Study decreased over time as operators gained experience.
80%
PPI
Overall PPM =31.1%
Recent experience = 17.2%
60%
40%
42.9%
39.7%
33.3%
20%
32.2%
24.6%
28.6%
26.1%
17.2%
0%
Enrolling centers:
Aug 08 Feb 09
Feb 09 Aug 09
Aug 09 Feb 10
Feb 10 Aug 10
Aug 10Feb 11
Feb 11 Aug 11
Aug 11 Feb 12
Feb 12 Oct 12
6
9
10
10
10
10
10
10
PPM rates in 6-mo blocks of pt enrollment, except most recent is 8-mo.
1Muller, et
al. Presented at EuroPCR 2013
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Conduction Disturbances after TAVR
• Anatomical Considerations
• Conduction Disturbances and Pacemaker Implantation
– Driving Factors
– Patient Impact
• Conclusions
Pacemaker Dependency
Some TAVR-induced AV conduction disturbances may be transient1-9
van der Boon, et. al, 20136:
• More than half of patients who had
received a new pacemaker after
CoreValve were pacemaker
independent at follow-up (median time:
12 months).
• Definition of pacemaker dependent:
1Piazza,
•
Presence of high degree AV block (HDAVB)
•
a slow (<30 bpm) or absent escape rhythm
et al. JACC CV 2008; 2Gutierrez, et. al. Am Heart J 2009; 3Piazza et. al. EuroIntervention 2010; 4Guetta, et. al. Am J Cardiol 2011;
et. al. Am J Card 2011; 6van der Boon, et. al. Int J Card 2013; 7Pereira, et. al. PACE 2013; 8Simms, et. al. ICVTS 2013; 9Franzoni, et al. Am J Card 2013
5Fraccarao,
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Pacemaker Dependency
Conduction abnormalities may resolve due to the transient nature of
some TAVR-induced tissue injury
Mechanical Injury
Ischemic Injury
• Wall tension due to radial force
• Tissue compression during BAV
• Procedural Inflammation
• Hypotension during rapid
pacing (BAV procedure)
• Procedural Edema
• Other hypotensive episodes
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Clinical Impact of LBBB Post-TAVR
• LBBB is typically associated with left ventricular dyssynchrony,
ventricular remodeling, and impaired function7.
• Several studies have looked at the impact of LBBB on cardiac
function1,2 and mortality post-TAVR2-7.
• There is no consensus in the field on impact of post-TAVR LBBB
on mortality or cardiac function.
• The frequency, degree, timing, and durability of CD recovery
after TAVR is currently unknown. This variability may be driving
inconsistent conclusions about the clinical impact of LBBB.
1Hoffmann,
2013;
et. al. JACC CV Int 2012; 2Wenaweser, et al. Presented at EuroPCR 2013; 3Franzoni et. al. Am J Card 2013; 4De Carlo , et. al. Am Heart J 2012; 5Testa, et. al. Circ
et. al. JACC 2012; 7Houthuizen, et. al. Circ 2012;
6Urena,
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
CoreValve ADVANCE
| Impact of LBBB
The ADVANCE study showed no significant difference in survival between those
patients with a new LBBB post-implant and those without.
1Wenaweser,
et al. Presented at EuroPCR 2013
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
Current Research is Inconclusive Regarding
Mortality Impact of LBBB Post –TAVR
LBBB Post-TAVR
Mortality Impact
Patients not receiving permanent
pacemaker before discharge.
LBBB Post-TAVR
NO Mortality Impact
De Carlo, et. al. AHJ 2012, (N=275)
Houthuizen, et. al. Circulation 2012, (N=679)
Urena, et. al. JACC 2012, (N=202)
Muller, et. al. EuroPCR 2013, (N=200)
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
CoreValve ADVANCE
| Impact of LBBB
The ADVANCE study showed no significant adverse effect of a new
LBBB at discharge on the mean LV ejection fraction post-TAVR
1 Year:
p = 0.138
Post-Implant LBBB
No Post-Implant LBBB
1Wenaweser,
N=145
N=276
et al. Presented at EuroPCR 2013
N=115
N=222
N=119
N=216
N=102
N=224
For this analysis, no patient in either group had a pacemaker
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.
CoreValve ADVANCE
| Survival by Pacemaker
The ADVANCE study showed no significant difference in survival between those
patients with a post-implant pacemaker and those without.
1Wenaweser,
et al. Presented at EuroPCR 2013
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Pacemaker Implantation Post-TAVR
Not Associated With Increased Mortality
Three additional large studies
demonstrate no association
between pacemaker implantation
and mortality
Buellesfeld, et. al. JACC 2012, (N=353)
CoreValve ANZ Study, Muller, et. al. EuroPCR 2013, (N=476)
De Carlo, et. al. AHJ 2012, (N=275)
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Conduction Disturbances after TAVR
• Anatomical Considerations
• Conduction Disturbances and Pacemaker Implantation
– Driving Factors
– Patient Impact
• Conclusions
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan.
©Medtronic, Inc. 2013. All Rights Reserved.
Conclusions
• Conduction abnormalities are not atypical following AVR and
TAVR due to the anatomical proximity of the aortic valve to the
conduction system
• Rates of conduction abnormalities are high in patients with AS.
These pre-existing conduction disturbances predict post-TAVR
pacemaker implantation
• Post-TAVR pacemaker implantation is not associated with an
increase in mortality
– The field has not reached consensus on the mortality effect of postTAVI LBBB.
• Best practice in BAV sizing, depth of implant, and application
of pacemaker implant guidelines can result in low rates of
post-TAVR conduction disturbances
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
For more information and a complete list of adverse events, warning and contraindications reference CoreValve IFU.
INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.