Self-Expanding TAVR: Conduction Abnormalities Jeffrey J. Popma, MD Director, Interventional Cardiology Clinical Services Beth Israel Deaconess Medical Center Associate Professor of Medicine Harvard Medical School Boston, MA

Conflict of Interest Statement Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Company/Relationship Jeffrey J. Popma, MD Research Grants: Cordis, Boston Scientific, Medtronic, Abbott-Guidant, eV3, LabCoat Medical Advisory Board: Cordis, Boston Scientific, Abbot Vascular Disclaimer: “Caution – Percutaneous Aortic Valves are investigational devices, limited by United States to Investigation use only.”

Managing Post TAVR Rhythm Disturbances Why Do They Occur? How Often Do Problems Develop? How Can we Predict Them? Who Should Receive PPMs?

The Triangle of Koch (Right Atrium) The atrioventricular node is contiguous to the membranous septum The origin of the LBBB and is found at the apex of the triangle of Koch Atrioventricular node Courtesy of Professor Damian Sanchez-Quintana

Conduction Abnormalities Piazza et al JACC CV Interv 2008;1;310-316

Permanent Pacemaker Need Khawaja Circulation. 2011;123:951-960

Managing Post TAVR Rhythm Disturbances Why Do They Occur? How Often Do Problems Develop? How Can we Predict Them? Who Should Receive PPMs? Left Bundle Branch Block AV Conduction Disturbances Complete Heart Block Permanent Pacemaker Use

CoreValve Implantation Case Day 1 post-procedure New onset LBBB Day 3 Post-procedure LBBB Serruys et al. Tips & Tricks to Avoid Failure (Informa Healthcare 2010)

New LBBB After CoreValve 30 day follow-up 65 46 38 39 40 % patients 30 Piazza N TVT2010 Seattle

EuroPCR: National Registries Outcomes Registry Pts Device Stroke PPM COR02-20061 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 may 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

Other Contemporary Series Italian Registry: New PPM in 17.4% at 30 Days Tamburino Circulation. 2011;123:299-308 Hospital Universitario N=181 EuroPCR 2011 P=0.007 34.5 Hazard Ratio P Value Depth of Implant 1.15 0.001 RBBB 3.08 0.007 Standard 59 14 STD Accutrak

Managing Post TAVR Rhythm Disturbances Why Do They Occur? How Often Do Problems Develop? How Can we Predict Them? Who Should Receive PPMs?

Permanent Pacemaker Need 270 patients from 10 clinical center in UK 8% of patients with prior PPM LBBB 13% at baseline  61% after procedure 33.3% new permanent pacemaker requirement Baseline conduction abnormalities - Baseline RBBB  65.2% PPM - Base LBBB  43.75% PPM - Normal QRS complex  27.6% PPM Median time to PPM implant, 4 days Multivariable predictors: AV block, balloon predilation, use of 29 mm valve, IV septum diameter, prolonged QRS Khawaja Circulation. 2011;123:951-960

Predictors of Permanent Pacemaker Placement 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 Aortic valve calcification (MSCT) Female gender Left ventricular dysfunction

Conduction Abnormalities After CoreValve Depth of Implantation Relates to PPM Requirements Piazza JACC Interventions 2008; 1: 310

Predictors of New 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 Multivariable Analysis Piazza et al. EuroIntervention 2010 (in press)

What Are We Doing to Reduce This? Sizing of pre-dilation balloon based on minimal diameter of the CTA to lessen trauma to membranous septum Shorter pre-dilatation balloon length Rapid ventricular pacing CoreValve sizing based on CTA annular diameter Accutrek deployment system High implantation deph (< 6 mm) Follow ACC/AHA for PPM Judicious use EPS to determine HV intervals

Managing Post TAVR Rhythm Disturbances Why Do They Occur? How Often Do Problems Develop? How Can we Predict Them? Who Should Receive PPMs?

Managing Post TAVR Rhythm Disturbances

HV Interval and Complete Heart Block Three major prospective studies have shown prolonged HV intervals (> 70ms) predict patients at higher risk of AV block. Even in highest risk patients (HV > 80msec and symptomatic) rate of CHB approaches 6%/yr -- > low PPV Patients with HV interval great than 100msec (rare) are at extreme high risk by all accounts.

Baseline Chronic Fascicular Block Epstein et al JACC Vol. 51, No. 21, 2008; e1–62

Baseline Chronic Fascicular Block Epstein et al JACC Vol. 51, No. 21, 2008; e1–62

Atrial Fibrillation Post TAVR 138 patients without prior atrial fibrillation New onset atrial fibrillation in 31.9% with 72 hours Predictive factors of AF were left atrial size (odds ratio [OR]: 1.21 for each increase in 1 mm/m2) and transapical approach (OR: 4.08, 95% CI: 1.35 to 12.31, p = 0.019). Cumulative stroke and stroke/systemic embolism rates at FU in the NOAF group were 13.6% and 15.9% in the NOAF group vs. 3.2% in the no-NOAF group (p = 0.039, adjusted p = 0.037 for stroke; p = 0.020, adjusted p = 0.023 for stroke/systemic embolism). Amat-Santo J Am Coll Cardiol 2012;59:178–88

Preventative Measurement: PPM Pre-procedural PPM when indicated Undersized, shorter BAV balloon ? Avoid oversizing device High (< 6 mm implantation) Temporary pacemaker x 48 hours AHA/ACC Indications for PPM EP study may assist