Self-expanding, anatomically correct transapical aortic valve implantation Ehud Schwammenthal, MD, PhD Associate Professor of Cardiology Sheba Medical Center, Tel Hashomer, Israel

Ehud Schwammenthal, MD, PhD DISCLOSURES Ehud Schwammenthal, MD, PhD Consulting Fees Medtronic CardioVascular, Inc. Honoraria The Engager device is not commercially available in any geography and only available for Clinical Study in the EU

Medtronic Engager Design Concept Self-expandable transcatheter valve Minimizes pressure loss at the inlet Maximizes pressure recovery at the outlet Optimized fluid dynamic shape (Venturi tube) allows to avoid oversizing of the diameter at annular-leaflet level Resulting shape – inlet, waist, outlet – creates an optimal anatomic fit facilitating intuitive deployment and axial fixation

Venturi Tube Principle Outlet geometry allowing gradual expansion of streamlines eliminates flow separation and prevents turbulence (pressure recovery) Abrupt outflow (nozzle): turbulence, head loss Gradually expanding outflow: eliminates flow separation and recovers the pressure drop Prandtl L, Tietjens O: Applied Hydro- and Aeromechanics, New York, Dover 1957

Valve Hemodynamics EOA: 1.62 cm2 (5L/min) Producing the hemodynamics of a 23 valve without oversizing at the native aortic orifice (CE Magna 21: 1.48 cm2 , Mitroflow 23: 1.57 cm2)* *Gerosa et al, The Journal of Thoracic and CV Surgery, May 2006

Medtronic Engager Transcatheter Valve Scalloped bovine pericardial leaflets Dedicated commissural posts Nitinol main frame Nitinol support frame The valve’s outlet section is designed as a regular surgical bioprosthesis dedicated commissural posts scalloped bovine pericardial lealfets not encompassed by a metal stent frame, so that they are folded rather than compressed during valve loading Polyester skirt 6

Medtronic Engager Implantation

Shape creates anatomical fit: positioning and fixation Medtronic Engager Shape creates anatomical fit: positioning and fixation Shape facilitates implementation of a periannular anchoring system for intuitive and accurate deployment, anatomical positioning and axial fixation The native leaflets are embraced between an inlet and a 3D support frame tracking the shape of the aortic root Arms at the floor of the sinuses, prosthetic commissural posts riding astride the native commissures Periannular fixation – anatomically correct supraannular position

Shape creates anatomical fit: positioning and fixation Medtronic Engager Shape creates anatomical fit: positioning and fixation Native leaflets are prevented from being pushed against coronary ostia. Native leaflets held against the mainframe and thus recruited to seal off potential perivalvular regurgitation. Native leaflets are kept below the prosthetic leaflets, allowing the prosthetic leaflets to interact with the natural vortex flow in the sinuses for optimal closing. α Design (shape) causes support arms to maintain a predesigned angle upon deployment

Medtronic Engager Leaflet Kinematics Leonardo da Vinci B C D A Gharib M, et al. Exp in Fluids 2003

Medtronic Engager Rotational Positioning RAO R N L 11 11

Medtronic Engager Rotational Positioning LAO R N L 12

CRL 1. Establish delivery axis as the commissure between 2 sinuses 2. Align window of prosthetic commissural post with native one LCS RCS CRL Delivery Axis Commissure is the tip of the intercusp triangle spared by contrast medium

Taped Case 3:20

Post-Implantation rotational angiography (Dyna CT)

FIM: Baseline Characteristics 30 patients, 25 female (83%) and 5 male Age: 83 ± 4 years Logistic EuroSCORE: 23±12.0 % Functional Class: 90% NYHA III and IV Pressure Gradient: Peak 86±22 mmHg (56.0-143.0) Mean 52±14 mmHg Concomitant AR: None - 17% I - 57%, II - 23%, III - 3%

FIM: Placement and Hemodynamics Accurate placement in 29/30 (97%) No device embolization Pressure gradient: Peak-to-peak 13 ± 9 mmHg Peak 24 ± 10 mmHg Mean 12 ± 6 mmHg Aortic regurgitation : None or trace 30% I 47% I-II 13% II 3%

FIM: Procedural Details Skin-to-skin time 74 ±16 minutes Implantation time: 5.9±2.4 minutes Contrast medium volume: 130±58 ml Fluoroscopy time: 7.5±2.6 minutes Mention only means Contrast medium 330ml first case PG invasively measured… and the corresponded mean pressure… AR – up to 1 - 60%, no grade 3 or 4

FIM: Procedure Outcome No coronary obstruction No stroke or myocardial infarction PM implantation for AV conduction blocks 3/30 Mortality at 30 days 20%, all non-device related (No perioperative mortality in the last 12 cases) Conversion to surgery for aortic dissection: 3/30

General Misconception “[Access to] the aortic valve from the left ventricular apex is straight and relatively short”, Dewey TM, Walther T, Mack MJ, et al Ann Thorac Surg 2006 and 2009 LAO

LAO view creates impression of relatively straight access. BUT, the ventriculo-aortic angle can be appropriately appreciated only in the RAO view. RAO equiv LAO equiv

Learned to use RAO to guide adjustment of delivery angle (correct misplacement of support arm below NCS if needed) Before After

Learned to use of RAO to monitor advancement of delivery catheter to avoid injury to aortic wall

Learnings from Feasibility Study: Need for Delivery System Improvements Flexible over-the-wire design (forgiving) Full coverage of commissural posts to protect aorta until device is positioned Mechanism for release of support arms that does not require advancing the delivery catheter further into aorta Converted delivery into one-piece system (no need for exchange of dilator) to streamline procedure

Summary – Medtronic Engager Self-guided, reproducible and intuitive deployment into an anatomically correct position Relies on axial in addition to radial forces for fixation Leaves the coronary ostia unobstructed and accessible Reduces the risk of perivalvular regurgitation Applies proven surgical design standards for long-term durability Enhancements of the delivery system are under way in preparation of EU Pivotal Trial (2010)

Thank You !