Edwards Sapien. Medtronic CoreValve. Inoperable FDA approved High risk: in trials. FDA approved

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1 Transcatheter Aortic Valve Replacement Symptomatic Aortic Stenosis Asymptomatic Juan Crestanello, MD Interim Director, Division of Cardiac Surgery Associate Professor Division of Cardiac Surgery The Ohio State University Wexner Medical Center Leon ME et al. NEJM 2010, Otto CM et al. Circulation 1997 Transcatheter AVR Transcatheter AVR Edwards Sapien Medtronic CoreValve FDA approved Inoperable FDA approved High risk: in trials 1

2 Edwards Sapien TAVR Transcatheter AVR Transfemoral Baloon Expandable Transapical Transfemoral Medtronic CoreValve Direct Aortic Subclavian Direct Aortic CoreValve Deployment Self Expandable The Trials PARTNER TRIAL (EDWARDS SAPIEN) MEDTRONIC US TRIAL INOPERABLE HIGH RISK EXTREME RISK (INOPERABLE) HIGH RISK Medical Management vs TAVR SAVR vs TAVR TAVR SAVR vs TAVR 2

3 PARTNER TRIAL PARTNER TRIAL Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Inoperable Aortic Stenosis TAVR vs. Medical Management Inoperable Aortic Stenosis TAVR vs. Medical Management TAVR: 80% on NYHA class I or II Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. 3

4 Inoperable Aortic Stenosis TAVR vs. Medical Management Inoperable Aortic Stenosis TAVR vs. Medical Management Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Inoperable Aortic Stenosis TAVR vs. Medical Management PARTNER TRIAL Medical management did not change the natural history of aortic stenosis TAVR relieved aortic stenosis TAVR was superior to medical therapy: Decreased all cause mortality Decreased cardiovascular mortality Decreased rate of rehospitalization Improved NYHA functional class Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. 4

5 High Risk Aortic Stenosis TAVR vs. AVR High Risk Aortic Stenosis TAVR vs. AVR 80% on NYHA class I or II Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. High Risk Aortic Stenosis TAVR vs. AVR High Risk Aortic Stenosis TAVR vs. AVR TAVR increased risk of early stroke Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. 5

6 High Risk Aortic Stenosis Paravalvular Aortic Regurgitation Paravalvular Aortic Regurgitation p < p < p < p < N = 277 N = 226 N = 230 N = 172 N = 216 N = 155 N = 145 N = 112 High Risk Aortic Stenosis Paravalvular Aortic Regurgitation High Risk Aortic Stenosis TAVR vs. SAVR TAVR and SAVR effectively relieved AS Mortality was similar up to 2 years NYHA class was similar 30 day stroke rate was higher in TAVR TAVR was associated with PVL Mild moderate and severe PVL resulted in increased mortality Permission to use Partner Trial information and images provided courtesy of Edwards Lifesciences. 6

7 CoreValve Trial Pivotal Trial Design CoreValve US Pivotal Trials Aortic Stenosis Extreme Risk Primary Endpoint All Cause Mortality or Major Stroke CoreValve Iliofemoral Extreme Risk Iliofemoral Access > 18 Fr Sheath Yes No CoreValve Non- Iliofemoral N=487 N=147 High Risk Randomization 1:1 Versus CoreValve SAVR y or Major Stroke All Cause Mortality 9.3% [6.7,12.0] Months Post Procedure P < Performance Goal = 43% 25.5% [21.6,29.4] Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Aortic Stenosis Extreme Risk 1 Year Mortality Aortic Stenosis Extreme Risk Major Stroke Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October

8 Aortic Stenosis Extreme Risk Secondary Endpoints Events* 1 Month 1 Year Any Stroke, % Major, % Minor, % Myocardial Infarction, % Reintervention, % VARC Bleeding, % Life Threatening or Disabling, % Major, % Major Vascular Complications, % Permanent Pacemaker Implant, % Per ACC Guidelines, % * Percentages obtained from Kaplan Meier estimates Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Aortic Stenosis Extreme Risk NYHA Class Survivors 91% 8.8% Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Aortic Stenosis Extreme Risk Echocardiographic Findings Aortic Stenosis Extreme Risk Perivalvular Aortic Regurgitation Paravalvular Regurgitation Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October

9 Aortic Stenosis Extreme Risk Perivalvular Aortic Regurgitation Paravalvular Regurgitation N=46 Aortic Stenosis Extreme Risk Perivalvular Aortic Regurgitation Impact of PVL on Late Mortality Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October CoreValve Extreme Risk TAVR relieved aortic stenosis TAVR reduced mortality and stroke rate at one year Low rate of stroke Pivotal Trial Design CoreValve Mild and moderate PVL was not associated with increased mortality MARCH 2014 Jeffrey J. Popma, MD. CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study Results. Data presented at TCT. San Francisco, California. October

10 Valve in Valve Ongoing and Upcoming Trials Intermediate Risk High Risk Extreme Risk SURTAVI Trial CoreValve Pivotal Trial Expanded Use CoreValve Pivotal Trial Expanded Use PARTNER II PARTNER A PARTNER B The Structural Heart Disease Team TAVR with Medtronic CoreValve: Femoral Approach Barry George, MD Director Advanced Catheter-Based Therapeutics and Structural Heart Disease Associate Professor Clinical Department of Cardiovascular Medicine The Ohio State University Wexner Medical Center 10

11 CoreValve Delivery Options CoreValve Delivery Options Transfemoral Direct Aortic Transfemoral Direct Aortic Subclavian Subclavian Transfemoral Step by Step Transfemoral Step by Step Vascular Access Valvuloplasty Crossing Aortic Valve Hemodynamic Assessment Vl Valve Vl Valve Vl Valve Positioning Deployment Release Angiographic Assessment Hemodynamic Assessment ECHO Assessment Vascular Access Repair 11

12 Vascular Access Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Contralateral femoral artery placement of 6F sheath. Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Vascular Access Femoral artery cut down (percutaneous) for delivery sheath 5-0 Prolene purse string Needle and guidewire Administer Heparin to achieve ACT>300 s 12

13 Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Angi o 6 French Sheath placement Pigtail placement into descending thoracic aorta Insertion Amplatz Super Stiff guidewire over pigtail catheter Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Vascular Access Femoral artery cut down (percutaneous) for delivery sheath Angi o Arterial dilatation with 12,14 and 18 F dilators over Amplatz Super Stiff guidewire Placement of 18 F sheath 13

14 Vascular Access Contralateral femoral artery placement of 6F sheath. Implant projection Percutaneous arterial access 6F Sheath and pigtail Determination of implantation projection Alignment of all 3 cusps of aortic valve in a single plane. Crossing Aortic Valve angi o NCC Initial Hemodynamic Assessment Pigtail advance to noncoronary sinus 14

15 Crossing the Aortic Valve AL 2 catheter with straight guidewire AP projection Crossing the Aortic Valve Exchange guidewire ROA projection Pigtail placement in LV apex Vide o Initial Hemodynamic Assessment LV and Aortic pressure Placement of stiff guidewire in the LV apex RAO projection Amplatz Super Stiff ST1 (pigtail configuration) vide o 15

16 Aortic balloon valvuloplasty Aortic Valvuloplasty Balloons: Z MED (NuMED Inc) NuCLEUS Ballon (NuMED Inc) True Balloon (Loma Vista Medical) Balloon size: smaller diameter of aortic annulus Pacing rate: bpm Screw-in temporary pacing lead If patient has a PPM,transvenous pacer in the OR. No valvuloplasty in: Low EF patients <30-35% Large plaque-calcifications in the aorta or sinus of Valsalva Valve in valve Aortic balloon valvuloplasty Pacer on Balloon up Ballon down Pacer off CoreValve Implantation angi o 16

17 CoreValve Implantation CoreValve is loaded into the delivery system before the valvuloplasty CoreValve in the delivery capsule Optimal implantation depth 2 to 6 mm Depth of implantation CoreValve insertion and advancement into the aortic root Ao Ao Ao Ao Ao LV c v LV c v c v LV c v c v LV c v LV c v Correct No AI Too deep AI AV block Too shallow AI Pop out Irregular annulus AI Large annulus AI 17

18 CoreValve insertion and advancement into the aortic root CoreValve Deployment Video 0 to 1 CoreValve Deployment Pushing guidewire: CoreValve moves out (toward the aorta) Position adjustments Operator #1: Pulling or pushing delivery catheter Operator #2: Pulling or pushing guidewire 18

19 CoreValve Deployment Node 0 Pulling guidewire: CoreValve moves in (toward ventricle) CoreValve Deployment CoreValve Deployment Node 2 to 3/4 Node 1 Video Final release Video Final release Rapid ventricular pacing 19

20 CoreValve Deployment Final release Nosecone Recapture of the nosecone in the descending aorta and removal of the delivery catheter Video Final release Valve Function Assessment Angiography Valve Function Assessment 20

21 Hemodynamics Valve Function Assessment Valve Function Assessment Hemodynamics Aortic Systolic Pressure Aortic Regurgitation Index Ao Diastolic - LVEDP >0.25 Ao Systolic Aortic Diastolic Pressure Left Ventricular End-diastolic Pressure Aortic Diastolic Pressure >40 mmhg Valve Function Assessment Hemodynamics Valve Function Assessment Echocardiography Aortic Regurgitation Index Ao Diastolic - LVEDP Ao Systolic >0.25 (62-22) 135 =

22 Sheath removal Sheath Removal Access Repair Over stiff guidewire Inject contrast through sheath Contralateral t l pigtail il in the aortic bifurcation Sheath removal Arteriotomy repair If iliac artery rupture: Advance sheath and dilator over stiff guidewire Place Coda aortic occlusion balloon through contralateral pigtail (arterial sheath may need to be exchange) Place coverstent through ipsilateral sheath 22