1. 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

2. Jeffrey J. Popma, MD Honoraria Boston Scientific Corporation
Cordis Corporation
Grants/Contracted Research
Medtronic, Inc.
Abbott Laboratories

3. 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

4. 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

5. The Triangle of Koch (Right Atrium)
The tendon of Todaro is the continuation of the Eustachian valve
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
Atrioventricular node
Courtesy of Professor Damian Sanchez-Quintana

6. Conduction Abnormalities After CoreValve
Piazza et al JACC CV Interv 2008;1;

7. Depth of implant and conduction system
15mm past annulus
5mm past annulus

8. 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:

9. Conduction Abnormalities After CoreValve
Piazza JACC Interventions 2008; 1: 310

10. 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
Left Bundle Branch Block
AV Conduction Disturbances
Complete Heart Block
Permanent Pacemaker Use

11. New-Onset LBBB following CoreValve Implantation
30 day follow-up 65 46
% patients 38 39 40 30
Piazza N TVT2010 Seattle

12. New permanent pacemaking at 30-days
Single-center studies (except *) 47 33 34 35 27 27 19 19 20
% patients
Piazza N TVT2010 Seattle

13. EuroPCR: National Registries Outcomes
Registry
Pts
Device
Stroke
PPM
COR 72
Corevalve
7.1
25.4
Contemporary Registries
Italian Registry2
772
CoreValve
1.7
18.5
Belgian Registry3
141 4
23.0
French Transfemoral4 66
3.6
26.9
UK CoreValve Registry5
417 NR
26.0
Total
1,396
Source Registry (Cohort 1) 6
463
Edwards
4.0 8
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

14. Pacemaker Implantation Varies Widely by Center
Average Pacemaker Implantation Rate 18.5%
Petronio, AS. The Italian CoreValve Registry, EuroPCR 2010.

15. 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

16. The Roots of “Prophylactic” PPM after SAVR
J Thorac Cardiovasc Surg 1982;84:382-6
Am J Cardiol 2004;94:
n=133 SAVR
Mean follow-up: 2.5 yrs
n=389 SAVR
Mean follow-up: 4.5 yrs
Post-op LBBB: 32%
Post-op BBB: 16%
Cumulative survival: % vs. 90% (p<0.001)
Complete HB - syncope - SCD: % vs. 1.6% (p<0.001)
“There may be an indication to insert prophylactic permanent PM in this group”
“Early prophylactic permanent PM implantation should be considered in these patients”
Piazza N TVT2010 Seattle

17. 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
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:
Sinhal A, Altwegg L, Pasupati, et al. Atrioventricular block after transcatheter balloon expandable aortic valve implantation. J Am Coll Cardiol Intv. 2008;1;
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:

18. 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

19. 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
Borderline small annulus size
Baan et al. Am Heart J 2010
Small LVOT
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

20. Predictors for new-onset LBBB and PPM
Pulmonary hypertension
Septal wall thickness
Right bundle branch block
Depth of implant from non-coronary leaflet
Depth of implant from left coronary leaflet
Univariable Analysis
Piazza et al. EuroIntervention 2010 (in press)

21. Managing TAVI Rhythm Disturbances
Baseline Conduction System
Procedural Precautions
Post-Procedural Care
Long-Term PPM Interrogation
Why Do They Occur?
How Often Do Problems Develop?
How Can we Predict Them?
How Should We Managed Patients?
Who Should Receive PPMs?
Perspectives for the Future

22. 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

23. 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

24. 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

25. Assessing Baseline Conduction Abnormalities
Alternating LBBB and RBBB
Critical review of baseline ECG during pre-procedural assessment
Incomplete trifascular block
? PPM prior to TAVI in patients with conduction system disorders with appropriate programming

26. 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
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.
In awake, symptom-free patients with AF and bradycardia with 1 or more pauses of at least 5 seconds or longer
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62

27. 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. B
During exercise in the absence of myocardial ischemia.
Persistent third-degree AV block with an escape rate greater than 40 bpm in asymptomatic adult patients without cardiomegaly
IIa
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62

28. 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 B
Asymptomatic second-degree AV block at intra- or infra-His levels found at electrophysiological study.
IIa
Second-degree AV block with symptoms similar to those of
pacemaker syndrome or hemodynamic compromise
Asymptomatic type II 2nd degree AV block with a narrow QRS.
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
Epstein et al JACC Vol. 51, No. 21, 2008; e1–62

29. 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

30. 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