conduction disturbances after percutaneous aortic valve replacement reducing post-tavr conduction...

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

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.

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




– Driving Factors

– Patient Impact

• Conclusions

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.

• Male gender3

• Age > 75 years9

• Previous MI3

• Right Bundle Branch Block (RBBB)2,3,4,5,7

• Other pre-existing conduction disturbances3,4,8,9

Patient-Related Patient-Related FactorsFactors

• Variations in location of LBBB exit point1

• Septum thickness1,6

• Thickness of the non-coronary cusp1

• Radial force of the prosthesis3

• Implant Depth2,3,7

• Balloon Aortic Valvuloplasty8

• Application of PPI guidelines10

• Learning Curve11

Anatomical FactorsAnatomical Factors Procedural Factors Procedural Factors (Device / Operator)(Device / Operator)

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)

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; 6Saia, 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

Pre-existing Conduction

Disturbances, including RBBB

Patient-Related Drivers of Conduction Disturbances and Pacemaker Implantation


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


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

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

Roten et. al., Am J Card 2010

Pre-implant BAV

Procedural Drivers of Conduction Disturbances and Pacemaker Implantation


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.



Pre-implant BAV

Implant Depth


Gutierrez et al. Am Heart J 2009, (N=33)

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 Below → 35% of patients developed LBBB

Hinge Point of the Anterior Mitral Valve

Implanted Above → 0% of patients developed LBBB


Implant Depth and PPI Rate

CoreValve Implant Depth (mm)

Pace

mak

er Im

plan

ts (%

pts

.)

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;

1

2

3

5

4

Data from independent studies plotted on the same graph show the strong relationship between PPI rate and implant depth


CoreValve Procedural Outcomes at Target Implant Depth

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)

• 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

*12 of 113 patients without baseline pacemaker.

Tchetche, et al; EuroIntervention 2012; e-publication.


Pre-implant BAV

Implant Depth

Variations in Application of Pacemaker

Indications



Application of PPI Guidelines

Gillis et al HRS/ACCF Pacemaker Mode Selection

• 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


CoreValve ADVANCE | Permanent Pacemaker Implant Rate by Geography

Countries with less than 15 implants not shown

Varying 30-day pacemaker rates across geographies in the ADVANCE study may reflect differences in the application of PPI

guidelines

1Wenaweser, et al. Presented at EuroPCR 2013


Absolute vs. Relative Pacemaker Indications

Thygesen et al, London Valves 2012.

• 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


Pre-implant BAV

Implant Depth

Variations in Application of Pacemaker Indications

Learning Curve



Overall PPM =31.1%Recent experience = 17.2%

PPM rates in 6-mo blocks of pt enrollment, except most recent is 8-mo.

Enrolling centers: 6 9 10 10 10 10 10 10

PPI

Effect of Learning Curve on PPI RateThe overall rate of PPI in the CoreValve Australia-New Zealand Study decreased over time as operators gained experience.

1Muller, et al. Presented at EuroPCR 2013




– Driving Factors

– Patient Impact

• Conclusions


Pacemaker Dependency

Some TAVR-induced AV conduction disturbances may be transient1-9

1Piazza, et al. JACC CV 2008; 2Gutierrez, et. al. Am Heart J 2009; 3Piazza et. al. EuroIntervention 2010; 4Guetta, et. al. Am J Cardiol 2011; 5Fraccarao, 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

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: • Presence of high degree AV block (HDAVB)• a slow (<30 bpm) or absent escape rhythm


• Tissue compression during BAV

• Hypotension during rapid pacing (BAV procedure)

• Other hypotensive episodes

Ischemic InjuryIschemic Injury

Pacemaker Dependency

Conduction abnormalities may resolve due to the transient nature of some TAVR-induced tissue injury

Mechanical InjuryMechanical Injury

• Wall tension due to radial force

• Procedural Inflammation

• Procedural Edema


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, 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 2013; 6Urena, et. al. JACC 2012; 7Houthuizen, et. al. Circ 2012;


CoreValve ADVANCE | Impact of LBBBThe ADVANCE study showed no significant difference in survival between those

patients with a new LBBB post-implant and those without.



Current Research is Inconclusive Regarding Mortality Impact of LBBB Post –TAVR

LBBB Post-TAVR NO Mortality Impact

Houthuizen, et. al. Circulation 2012, (N=679)

Urena, et. al. JACC 2012, (N=202)

De Carlo, et. al. AHJ 2012, (N=275)

LBBB Post-TAVR Mortality Impact

Patients not receiving permanent pacemaker before discharge.

Muller, et. al. EuroPCR 2013, (N=200)


1 Year: p = 0.138

For this analysis, no patient in either group had a pacemaker

Post-Implant LBBB N=145 N=115 N=119 N=102 No Post-Implant LBBB N=276 N=222 N=216 N=224

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


CoreValve ADVANCE | Survival by PacemakerThe ADVANCE study showed no significant difference in survival between those

patients with a post-implant pacemaker and those without.



Pacemaker Implantation Post-TAVRNot Associated With Increased Mortality

Three additional large studies demonstrate no association

between pacemaker implantation and mortality

Buellesfeld, et. al. JACC 2012, (N=353)

De Carlo, et. al. AHJ 2012, (N=275) CoreValve ANZ Study, Muller, et. al. EuroPCR 2013, (N=476)





– Driving Factors

– Patient Impact

• Conclusions


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 post-TAVI 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.

conduction disturbances after percutaneous aortic valve replacement reducing post-tavr conduction...

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