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 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 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

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

Depth of implant and conduction system 15mm past annulus 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? 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

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

New permanent pacemaking at 30-days Single-center studies (except *) 47 33 34 35 27 27 19 19 20 % patients 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 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 Average Pacemaker Implantation Rate 18.5% 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;94:1008-1011 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: 66% vs. 90% (p<0.001) Complete HB - syncope - SCD: 17% 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

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;89:901-904. 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. 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 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

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)

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

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 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

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

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

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

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