Transcript slides

Managing TAVI Rhythm Disturbances
(New LBBB, Bradyarrhythmias, and
Temporary and Permanent Pacemakers)
Jeffrey J. Popma, MD
Director, Interventional Cardiology
Clinical Services
Beth Israel Deaconess Medical Center
Associate Professor of Medicine
Harvard Medical School
Boston, MA
Jeffrey J. Popma, MD
 Honoraria
– Boston Scientific Corporation
– Cordis Corporation
 Grants/Contracted Research
– Boston Scientific Corporation
– Cordis Corporation
– Medtronic, Inc.
– Abbott Laboratories
I intend to reference off label or unapproved uses
of drugs or devices in my presentation.
I intend to discuss Transcatheter aortic valves that
are not approved in the USA
Managing TAVI Rhythm Disturbances
WHY DO THEY OCCUR?
HOW OFTEN DO PROBLEMS DEVELOP?
HOW CAN WE PREDICT THEM?
HOW SHOULD WE MANAGED?
WHO SHOULD RECEIVE PPMS?
PERSPECTIVES FOR THE FUTURE
The Triangle of Koch (Right Atrium)
The tendon of
Todaro is the
continuation of the
Eustachian valve
Atrioventricular
node
The AVN is
contiguous to the
membranous
septum and
origin of the
LBBB .
The AVN is found
at the apex of the
triangle of Koch
Courtesy of Professor Damian Sanchez-Quintana
Conduction Abnormalities After CoreValve
Piazza et al JACC CV Interv 2008;1;310-316
Depth of implant and conduction system
Conduction system
15mm past annulus
Conduction system
5mm past annulus
Depth of Implant May Affect Need for Pacemaker
1.
Piazza N, Onuma Y, Jesserun E, et al. Early and persistent intraventricular conduction abnormalities and requirements for
pacemaking after percutaneous replacement of the aortic valve. J Am Coll Cardiol Intv. 2009;1:
Conduction Abnormalities After CoreValve
Piazza JACC Interventions 2008; 1: 310
Managing TAVI Rhythm Disturbances
WHY DO THEY OCCUR?
HOW OFTEN DO PROBLEMS DEVELOP?
HOW CAN
WE PREDICT THEM?
 Left Bundle Branch Block
HOW SHOULD
E MANAGEDDisturbances
?
 AV W
Conduction
WHO SHOULD
RECEIVEHeart
PPMSBlock
?
 Complete
PERSPECTIVES
FOR THE FPacemaker
UTURE
 Permanent
Use
New-Onset LBBB following CoreValve Implantation
30 day follow-up
80
% patients
65
60
46
40
38
39
40
30
20
0
Piazza N TVT2010 Seattle
New permanent pacemaking at 30-days
Single-center studies (except *)
47
50
33
% patients
40
27
19
19
34
35
27
20
30
20
10
0
Piazza N TVT2010 Seattle
EuroPCR: National Registries Outcomes
Registry
Pts
Device
Stroke
PPM
COR02-20061
72
Corevalve
7.1
25.4
Italian Registry2
772
CoreValve
1.7
18.5
Belgian Registry3
141
CoreValve
4
23.0
French Transfemoral4
66
CoreValve
3.6
26.9
UK CoreValve Registry5
417
CoreValve
NR
26.0
Edwards
4.0
8
Contemporary Registries
Total
1,396
Source Registry (Cohort 1) 6 463
Appropriate PPM will likely be < 20%
EuroPCR2010: 1 Gerckens et al; 2Petronio et al; 3 Bosmans et al; 4 Eltchaninoff
et al; 5 Ludman et al; 6 Thomas et al
Pacemaker Implantation Varies Widely by Center
50%
Average Pacemaker
Implantation Rate 18.5%
45%
40%
36.2%
32.3%
35%
30%
24.1%
25%
20%
15%
35.7% 35.0%
18.6%
14.7%
15.4%
21.4%
18.2%
14.9%
11.1%
10%
5%
3.7%
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Pacemaker Implantation Rate (%)
Italian Registry - Pacemaker Implantation Rate by Center
Petronio, AS. The Italian CoreValve Registry, EuroPCR 2010.
Managing TAVI Rhythm Disturbances
WHY DO THEY OCCUR?
HOW OFTEN DO PROBLEMS DEVELOP?
HOW CAN WE PREDICT THEM?
HOW SHOULD WE MANAGED?
WHO SHOULD RECEIVE PPMS?
PERSPECTIVES FOR THE FUTURE
The Roots of “Prophylactic” PPM after SAVR
J Thorac Cardiovasc Surg
1982;84:382-6
Am J Cardiol 2004;94:10081011
n=133 SAVR
n=389 SAVR
Mean follow-up: 2.5 yrs
Mean follow-up: 4.5 yrs
Post-op LBBB: 32%
Post-op BBB: 16%
Cumulative survival:
66% vs. 90% (p<0.001)
“There may be an indication to
insert prophylactic permanent
PM in this group”
Complete HB - syncope - SCD:
17% vs. 1.6% (p<0.001)
“Early prophylactic permanent PM
implantation should be considered
in these patients”
Piazza N TVT2010 Seattle
Clinical Factors Affecting Pacemaker Need After AVR
Age
Poor left ventricular function
Pre-operative aortic regurgitation imposing progressive
stretch on the nearby AV node and bundle of His1
Previous myocardial infarction
Preexisting conduction disorders2
BB and RBBB
Pulmonary hypertension3
Bicuspid native aortic valve3
Calcium profile3
1. Limongelli G, Ducceschi V, D’Andrea A, et al. Risk factors for pacemaker implantation following aortic valve replacement: A single
centre experience. Heart. 2003;89:901-904.
2. Sinhal A, Altwegg L, Pasupati, et al. Atrioventricular block after transcatheter balloon expandable aortic valve implantation. J Am
Coll Cardiol Intv. 2008;1;305-309.
3. Jilaihawi H, Chin D, Vasa-Nicotera M, et al. Predictors for permanent pacemaker requirement after transcatheter aortic valve
implantation with the CoreValve prosthesis. American Heart J. 2009; 157:860-866.
Delivery System with AccuTrak™ Stability Layer
Medtronic data on file. Physician usability testing using the ZBAM flow model simulator. Six physicians participated in
controlled usability testing. TBD month 2010.
Predictors of Permanent Pacemaker after TAVI
Jilaihawi et al. Am
Heart J 2009
LBBB +left axis deviation
Thickness of non-coronary leaflet
Septal wall thickness
Bleiziffer et al. JACC
Interv 2010
Intra-operative AV block
Baan et al. Am
Heart J 2010
Small LVOT
Borderline small annulus size
Left axis deviation
Mitral annular calcification
Latsios et al. CCI
2010 (in press)
Aortic valve calcification (MSCT)
Female gender
Left ventricular dysfunction
Piazza N TVT2010 Seattle
Predictors for new-onset LBBB and PPM
Table 6. Univariable analysis for predictors of new-onset LBBB after valve
implantation and permanent pacemaker
OR (95% CI)
Baseline Patient Characteristics
Age (years)
1.00 (0.94 to 1.07)
Gender
1.46 (0.61 to 3.47)
Logistic EuroSCORE (%)
1.02 (0.97 to 1.07)
New York Heart Association (I-IV)
II
Reference
III
2.12 (0.53 to 8.44)
IV
2.57 (0.52 to 12.72)
Hypertension
1.73 (0.72 to 4.14)
Diabetes mellitus
1.22 (0.42 to 3.54)
Coronary artery disease
0.84 (0.36 to 2.00)
Myocardial infarction
1.31 (0.47 to 3.62)
Percutaneous coronary Intervention
0.74 (0.25 to 2.17)
Coronary artery bypass graft surgery
1.54 (0.60 to 3.92)
History of atrial fibrillation
1.36 (0.51 to 3.64)
Stroke
0.50 (0.16 to 1.52)
Peripheral vascular disease
2.95 (0.47 to 18.64)
Chronic renal failure
2.51 (0.70 to 8.98)
Dialysis
0.90 (0.58 to 1.40)
Chronic obstructive pulmonary disease
0.42 (0.14 to 1.27)
Pulmonary hypertension
2.47 (1.01 to 6.04)
Baseline Echocardiography
Left ventricular outflow tract (mm)
1.13 (0.95 to 1.35)
Aortic valve annulus (mm)
0.97 (0.80 to 1.18)
Septal wall thickness (mm)
1.19 (0.99 to 1.43)
Aortic valve area (cm 2)
1.64 (0.16 to 17.24)
Ejection fraction (%)
1.00 (0.97 to 1.03)
Mitral annular calcification
0.51 (0.19 to 1.40)
Baseline Electrocardiogram
Cardiac rhythm
Sinus
Reference
Atrial fibrillation
1.65 (0.64 to 4.28)
PR interval (msec)
1.00 (0.98 to 1.02)
QRS duration (msec)
1.01 (0.99 to 1.02)
QTc interval (msec)
1.01 (1.00 to 1.02)
Hemiblock
None
Reference
Left anterior hemiblock
1.23 (0.36 to 4.14)
Left posterior hemiblock
1.96 (0.12 to 32.67)
Bundle branch block
No bundle branch block
Reference
LBBB
0.89 (0.25 to 3.21)
RBBB
8.00 (0.84 to 75.92)
Procedural-Related Factors
Valve size
26 mm inflow
Reference
29 mm inflow
0.69 (0.30 to 1.64)
Measurement of inflow diameter (mm) - AP view
1.13 (0.96 to 1.33)
Measurement of inflow diameter (mm) - Lateral
1.14 (0.96 to 1.36)
Ratio of valve size (26- or 29-mm) to AV annulus (mm)
0.57 (0.02 to 14.81)
Depth of implantation from non-coronary leaflet (mm)
1.30 (1.06 to 1.59)
Depth of implantation from left coronary leaflet (mm)
1.14 (1.00 to 1.31)
Post-implant dilatation
1.39 (0.40 to 4.82)
P value
0.93
0.39
0.48
0.49
0.29
0.25
0.22
0.71
0.7
0.61
0.59
0.37
0.55
0.22
0.25
0.16
0.64
0.13
0.047*
0.16
0.76
0.064*
0.68
0.85
0.19
0.30
0.97
0.53
0.19
0.86
0.74
0.64
Pulmonary hypertension
Septal wall thickness
Right bundle branch block
Depth of implant from non-coronary leaflet
0.47
0.86
0.07*
0.40
0.15
0.14
0.73
0.011*
0.048*
0.60
Depth of implant from left coronary leaflet
Univariable Analysis
Piazza et al. EuroIntervention 2010 (in press)
Managing TAVI Rhythm Disturbances
 Baseline Conduction System
WHY DO THEY
OCCUR? Precautions
 Procedural
HOW OFTENDPost-Procedural
O PROBLEMS DEVELOP
Care?
HOW CAN WE
PREDICT THEM
? Interrogation
 Long-Term
PPM
HOW SHOULD WE MANAGED PATIENTS?
WHO SHOULD RECEIVE PPMS?
PERSPECTIVES FOR THE FUTURE
Peri-Procedural Recommendations
•
•


RIJ or LIJ access
4-5 Fr. balloon-tip pacing
wire in the right ventricular.
A screw-tip wire may used
for more secure placement,
if necessary.
Sterile techinique with
sterile sleeve as temporary
pacemaker wire will be left
in place for 48 hours or
longer
Replace air with saline at
one-half inflation to avoid
RV perforation
CoreValve Procedural Recommendations
• Cautious advancement of Amplatz catheter
and 35 mm Amplatz Superstiff Guidewire to
avoid injury to the membranous septum
• Pre-dilation balloon selection:
- Undersized balloon (to annular size)
- Shorter balloon length (4 cm)
• Avoid oversizing of CoreValve Device
• Optimal placement CoreValve placement < 6
mm below sinus of Valsalva
Managing TAVI Rhythm Disturbances
HOW OFTEN DO PROBLEMS DEVELOP?
WHY DO THEY OCCUR?
HOW CAN WE PREDICT THEM?
HOW SHOULD WE MANAGED?
WHO SHOULD RECEIVE PPMS?
PERSPECTIVES FOR THE FUTURE
Assessing Baseline Conduction Abnormalities
Critical review
of baseline
ECG during
preprocedural
assessment
Alternating LBBB and RBBB
Incomplete trifascular block
? PPM prior to TAVI
in patients with
conduction system
disorders with
appropriate
programming
Indications for PPM After TAVI
New Third Degree or Advanced 2nd Degree AV Block
Class
LOE
Associated with symptoms (e.g, CHF) or VEA felt to be due
to AV block
I
C
Associated with arrhythmias and other medical conditions
that require drug therapy that results in symptomatic
bradycardia
I
C
In awake, symptom-free patients in sinus rhythm, with
documented periods of ≥to 3.0 seconds or any escape rate
< 40 bpm, or with an escape rhythm below the AV node.
I
C
In awake, symptom-free patients with AF and bradycardia
with 1 or more pauses of at least 5 seconds or longer
I
C
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62
Indications for PPM After TAVI
New Third Degree or Advanced 2nd Degree AV Block
Class LOE
At any anatomic level associated with postoperative AV
block that is not expected to resolve after cardiac surgery.
I
C
Persistent third-degree AV block at any anatomic site with
average awake ventricular rates of 40 bpm or faster if
cardiomegaly or LV dysfunction is present or if the site of
block is below the AV node.
I
B
During exercise in the absence of myocardial ischemia.
I
C
IIa
C
Persistent third-degree AV block with an escape rate
greater than 40 bpm in asymptomatic adult patients
without cardiomegaly
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62
Indications for Post-TAVI PPM
New Second Degree AV Block
Class
LOE
Associated symptomatic bradycardia regardless of type or site
I
C
Type II 2nd degree AV block occurs with a wide QRS, including
isolated right bundle-branch block
I
B
Asymptomatic second-degree AV block at intra- or infra-His levels
found at electrophysiological study.
IIa
B
Second-degree AV block with symptoms similar to those of
pacemaker syndrome or hemodynamic compromise
IIa
B
Asymptomatic type II 2nd degree AV block with a narrow QRS.
IIa
C
Permanent pacemaker implantation is not indicated for
asymptomatic type I second-degree AV block at the supra-His (AV
node) level or that which is not known to be intra- or infra-Hisian.
III
C
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62
Managing TAVI Rhythm Disturbances
HOW OFTEN DO PROBLEMS DEVELOP?
WHY DO THEY OCCUR?
HOW CAN WE PREDICT THEM?
HOW SHOULD WE MANAGED?
WHO SHOULD RECEIVE PPMS?
PERSPECTIVES FOR THE FUTURE
Managing TAVI Rhythm Disturbances
•
US Pivotal Trial will provide answers:
- Pre-procedural PPM indications
- Undersized BAV
- Meticulous attention to device placement
- PPM for ACC/AHA indications
•
ADVANCE-2 Registry
•
Interrogation of pacemakers to assess
the duration of pacemaker
requirements