The Heart Team 8/6/2013. Can Cardiologist and CV Surgeons really work together? Disclosures OWNERSHIP/EQUITY:

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8/6/2013 The Heart Team Michael J Mack MD David L Brown MD The Heart Hospital Baylor Plano Can Cardiologist and CV Surgeons really work together? David Brown Disclosures OWNERSHIP/EQUITY: The Heart Hospital Baylor Plano, The Oracles Medical Ventures, The Honors for Cardiovascular Training, Cardiaq Venture Technologies, TRG Healthcare Solutions Michael Mack No disclosures 1

8/6/2013 Blalock-Taussig-Shunt 1945 Blalock, Alfred, MD Physiologist, Surgeon Taussig, Helen B, MD Physiologist, Cardiologist 4 Surgeons Interventionalists Patient 2

8/6/2013 Obstacles Culture Workflow Logistics Financial No Proof of Benefit Not Necessary in a Majority of Patients 3

8/6/2013 All Politics Is Local And Other Rules of the Game I realized that I was facing the type of problem (with my oncology care) that I never permitted at Apple my treatment was fragmented rather than integrated. Nobody at Stanford seemed to be in charge of figuring out how nutrition was related to pain care and to oncology. I was being treated by oncologists, pain specialists, nutritionists, hepatologists, hematologists but not being coordinated in a cohesive way.. So he convened the team of the various Stanford specialists at his house to coordinate treatment 4

Deaths/1000 procedures 8/6/2013 Medical Team and Surgical Outcomes Average risk-adjusted mortality rate Baseline Quarters of training program Facilities (no.) 74 16 20 24 14 Neily et al: JAMA 2010; 304(15):1693 1999 What Really Catalyzed Integration of the Heart Team? SYNTAX Trial- Heart Team Requirement PARTNER Trial- Partner Clinic, Partner Service 5

8/6/2013 Heart Team Approach For SYNTAX 2005 Transcatheter Aortic Valve Implantation The Creation Of theses Partnerships has been essential to the development of the Transcatheter Valve Progam 6

8/6/2013 Interventional Cardiology & Surgery on The Same Page Each specialty brings something to the table Cardiologist Wire and Catheter skills Experience with fluoroscopy / angiography of aortic valve Ability to treat coronary complications without conversion Surgeon Experience with large sheaths and vascular access Intimate understanding of the 3 dimensional anatomy of the heart Ability to convert to open or salvage procedure Interventional Cardiology & Surgery on The Same Page Team choreography key to success Dedicated team for procedures Builds institutional knowledge and experience Optimizes coordination and team chemistry Reduces potential for mistakes due to inexperience Interventional Cardiology & Surgery on The Same Page Exact delineation of responsibilities Echocardiography Hemodynamic management Pacing control Angiography Control of inflation device Team leader Gives commands, coordinates procedure 7

8/6/2013 Learn from Each Other Cross pollination improves the skill set of both disciplines Improves response when disaster strikes Builds camaraderie Who Is On the Heart Team? Interventional Cardiologists Cardiac Surgeons General Cardiologists Heart Failure Specialists Echocardiographers Imaging Specialists Geriatric Specialists Intensivists/Hospitalists Nephrologists Nurse Practitioners Physician Assistants Service Line Managers Administrators Social Workers Physical Therapy Speech Therapy OR Techs/Nurses Cath Lab Techs/Nurses Echo/CT Techs TAVI Service Surgeons Surgical AVR Partner Clinic TAVI- TF /TA Inpatient Rounds Outpatient Clinic Bi-weekly conference Calls Weekly Clinical Service Meeting Cardiologists Diagnostic Caths PCI BAV 8

8/6/2013 Team Concept Disease Management Creating Combined Valve clinics shortens work-up times and expedites decision making Fosters collegiality Creates a cohesive approach to valvular heart disease Levels of Collaboration Hospital Department Clinical Research Trials Clinics Procedures Societies Databases Rationale for Collaboration Explosion of catheter based procedures that previously were only performed open Endovascular AAA Repair Thoracic Aortic Endografting Carotid Stenting Peripheral Arterial Interventions Percutaneous LVAD Insertion ASD closure Catheter Based Mitral Valve Repair Transcatheter Aortic Valve Implantation 9

8/6/2013 Hybrid OR Procedures Hybrid Aortic Arch Procedures Percutaneous LVAD- TandemHeart Transcatheter Aortic Valves Transcatheter Mitral Valve Procedures Hybrid CABG/PCI Hybrid Aortic Valve /PCI Completion Angiography post CABG Peripheral Vascular Procedures Thoracic and Abdominal Aortic Endografting Hybrid catheter/thoracoscopic Maze for AF Other Heart Team Activities Heart Transplant/VAD Program Hybrid Coronary Revascularization Program Atrial Fibrillation Hybrid Procedures Mitral Valve Program Instead of Traditional Specialities Non-Interventional Cardiology Interventional Cardiology Pediatric Cardiology Cardiac Surgery Pediatric Cardiac Surgery Radiology Electrophysiology 10

8/6/2013 Reorganizing as Coronary Team (Primary cardiologist, PCI, Surgery, Emergency Service) Mitral Valve Team (Primary cardiologist, Surgery, Interventional, EP) Aortic Valve Team (Primary cardiologist, Surgery, Interventioanl) Congenital Team (Pediatric cardiologist, Surgery, Interventional) Aortic Team (Surgery, Interventional, Emergency Service) Heart Failure Team (Heart failure cardiologist, EP, Surgery, Emergency Service) Arrhythmia Team (Primary cardiologist, EP, Surgery) Rational Dispersion Multidisciplinary Heart Team Valve Centers of Excellence National Valve Registry First Patient Enrolled in PARTNER US Pivotal Trial 11

8/6/2013 A Successful TAVI Program It s a Team Sport, Not an Individual One 12

8/6/2013 Subclavian Access Michael J. Reardon, M.D. Professor of Cardiothoracic Surgery Methodist DeBakey Heart & Vascular Center Disclosures Advisory Board Medtronic Consultant Medtronic Corevalve trial Surgical local PI National steering committee National screening committee Publication committee SurTAVI trial National PI Steering committee Corevalve is not currently approved in the US Access Routes Safe remote access to the aortic valve is imperative to success Transfemoral access is generally considered first if feasible If transfemoral is not feasible then options include; Subclavian Trans-apical Direct aortic 1

8/6/2013 Considerations for Subclavian Access For 18 F sheath Corevalve Minimum 6 mm uncalcified or 7 mm calcified subclavian diameter Patent IMA bypass? Aortic angle Graft/ no graft? Subclavian Access Supraclavicular Subclavian Access 7 2

8/6/2013 Subclavian Access First cased reports 2008 and 2009 BY 2010, 514 cases at 13 Italian hospitals using subclavian approach in 54 cases. 8 2 year subclavian data Same survival as TF 3

8/6/2013 Patent LIMA? Feasible and safe Thank You 4

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 Gregory P. Fontana MD, FACS, FACC Professor and Chairman Department of Cardiothoracic Surgery Lenox Hill North Shore Long Island Jewish Health System St Jude Medical: National PI (Portico), Consultant, SAB Edwards Lifesciences: Site Co-PI (Transform), Consultant Medtronic: Site PI (CoreValve), Consultant Sorin: Site PI (Perceval), Consultant Entourage: Consultant, Equity Transfemoral Transapical Transaortic Subclavian Transaxillary Rodes-Cabau et al. Nature Rev. Cardiol. 2012 1

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 Vast majority of cases performed over past 24 months Well selected at experienced centers (avoidance of cohort C ) Mortality and morbidity at or below contemporary TF and TA rates Significant experience with both approaches and with self and balloon expandable valves 2

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 85 y.o. female STS 17.7% NYHA III Creatinine= 1.4 Hgb = 8.6 Plt = 170 Clinical History Hypertension Hyperlipidemia Atrial fibrillation Chronic renal insufficiency Coronary Artery Disease s/p PCI with DES mid LAD/RCA 2006 PAH (PASP 75-80mmHg) Severe aortic stenosis Frail woman, wheelchair required for outside of home Albumin <3.3, does not live independently Unable to perform 6MWT (could not stand long enough) Grip test (rt 6.3kg, lt 4.0kg) Severe pulmonary hypertension with PASP 75-80mmHg Chronic Atrial Fibrillation Coronary Angiography Coronary Artery Disease? Prior revascularization (CABG or PCI)? Additional Revascularization Indicated? Yes PCI DES 2006 mid LAD, patent PCI DES 2006 mid RCA, patent Right heart: RA 19mmHg, RV 63/19mmHg PASP 63mmHg No 3

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 Required Measurements AVA 0.5cm 2 Peak Velocity 4.4 m/s AVA index 0.3 Annulus Diameter 21 mm Mean Gradient 46mmHg Ejection Fraction 65% Findings Moderate MR Moderate TR PAH: PASP 75-80mmHg Mild LVH 4

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 5

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 6

Lenox Hill Lenox Hill Lenox Hill 8/6/2013 Uncomplicated hospital course Discharged on POD 4 Currently NYHA Class I Mobility significantly improved Safe alternative access for TAVR Either Second ICS or Mini- Sternotomy Preoperative planning critical to confirm best approach 7

VuMedi The Heart Team Approach to TAVR Aug. 6, 2013 Case of Self-Expanding TAVR James Hermiller, MD, FACC, FSCAI St Vincent Medical Group St Vincent Heart Center Indianapolis, IN Disclosures Affiliation/Financial Relationship Consulting Fees/Honoraria Speaker Bureau Research Support CoreValve Steering Committee US Pivotal Trial Company Abbott, BSC, Medtronic and St Jude Medicines Company Medtronic, Abbott, BSC, St Jude Medtronic 78 year old man with Hx of Coarct repair in 1960, prior CABG x 4, Cr 1.8 mg/dl, moderate COPD (FEV1 58% predicted), myasthenia gravis (immunosuppressive therapy), DM, atrial fibrillation, prior right CEA, DM, HTN, Pulm HTN (60/26), PPM and CHF (FC II-III) STS 11.9% with morbidity/mortality of 41% LVEF 40% Case History Coronary Anatomy 4 Grafts All patent 1

Baseline Echocardiography Peak AV Velocity - 4.3 M/sec Peak AV Gradient - 73 mmhg Mean Gradient - 43 mmhg EF 40% Estimated PAP - 60/26 mmhg MR 2+ TR 1+ CTA Data Max ascending aorta diameter of 30 mm Sinus of valsalva width 29 mm Sinus height 18 mm ST width 27 mm Annulus/Root Assessment Heavily Calcified Tri-leaflet Valve 2

Annulus/Root Assessment Area 550 mm2 Ascending Aorta (Outfow Size) Measurement Sinus Width Annulus Measurement (Perimeter) Sinus Height > 15 mm (From the Native Leaflet to the STJ) 3

CoreValve Sizing Table Valve Size Aortic Annulus Diameter (mm) Ascending Aortic Diameter (mm) Sinus of Valsalva Width (mm) Sinus Valvsalva Height (mm) Perimeter (mm) 23 18-20 <34 >25 >15 56.5-63 -62 26 20-23 <40 >27 >15 62.8-72.3 62-72 29 23-27 <43 >29 >15 72.3-84.8 72-84 31 26-29 <43 >29 >15 81.6-91.1 82-91 Valve Size Aortic Annulus Diameter (mm) Ascending Aortic Diameter (mm) Sinus of Valsalva Width (mm) Sinus Valsalva Height (mm) Perimeter (mm) 29 23-27 <43 >29 >15 72.3-84.8 31 26-29 <43 >29 >15 82-91.1 4

Case Plan General anesthesia/tee Access - Cutdown RFA (18 Fr sheath) Left femoral arterial access (5F) Use PPM for RV pacing Screw-in RV TPM lead via IJ if no PPM Valvuloplasty with 20 mm x 4 cm balloon pre-deployment 31 mm CoreValve 5

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Optimal Starting Position Pigtail in noncoronary cusp Oval Radiopaque catheter marker band appearing as a straight line Straight Line Target Implantation Depth Target implant depth is 4-6 mm (Marker Band 1 1.5) Due to valve profile and native annulus interaction, higher implantation provides greater radial interference. This consideration is especially important for larger anatomies Most implants should trend closer to 4 mm depth or less 4 mm 7

Optimal Starting Position Coaxial Alignment Target coaxial alignment of catheter and annulus Adjust catheter and guidewire tension to ensure valve is aligned within the annulus and perpendicular to the basal plane 8

9

1 mm Depth 10

Hemodynamics Post 11

Post Procedure Procedure time 35 minutes TEE No AI with appropriate valve positioning Extubated on table Ambulating that evening Creatinine peaked to 2.0 mg/dl and at discharge 1.6 mg/dl Home day 3 12

Thanks for Your Attention!!! Team Sport Dave Heimansohn MD Sina Moainie MD Gregg Elsner MD 13