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Engager™ Transapical System Pre-Implantation Imaging, Patient and Size Selection August 2013 Innovating for life. UC201301195c EE.

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Presentation on theme: "Engager™ Transapical System Pre-Implantation Imaging, Patient and Size Selection August 2013 Innovating for life. UC201301195c EE."— Presentation transcript:

1 Engager™ Transapical System Pre-Implantation Imaging, Patient and Size Selection August 2013 Innovating for life. UC c EE

2 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Objectives Discuss patient selection including indications and contraindications for use Outline guidelines for echocardiography and MSCT for patient and bioprosthesis size selection

3 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Indications for Use Symptomatic severe aortic stenosis High or extreme risk for operative mortality –Logistic EuroSCORE I ≥20% or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement The system is intended for use in patients with life expectancy of at least one year following TAVI Transapical procedure

4 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Contraindications Known hypersensitivity to (that cannot be controlled with premeds): –Aspirin –Heparin –Ticlopidine –Clopidogrel –Contrast Media –Nitinol Intracardiac mass, thrombus or vegetation Aortic aneurysm Sepsis or acute endocarditis

5 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Contraindications Continued Bleeding diathesis or coagulopathy Cardiogenic shock or suspected cardiogenic shock The safety and performance of valve in valve procedures has not been evaluated The safety and performance of the Engager™ bioprosthesis placed within another bioprosthesis or placed within a unicuspid or bicuspid aortic valve has not been studied* * Reference source Engager™ Instructions for Use

6 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. MSCT Criteria for Bioprosthesis Selection Echocardiography for Patient Evaluation Aortic annulus diameter > 19 mm and < 26 mm

7 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Engager ™ Bioprosthesis Dimensions Device Size Inflow Outer Diameter A (mm) Throat Outer Diameter B (mm) Control Arm Outer Diameter C (mm) Outflow Outer Diameter D (mm) Length of Device E (mm) 23 mm mm A B B E D CC

8 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Different echo definitions of annulus in use Annulus – inner edge-to-edge diameter at leaflet insertion 24 mm Derek n Derek Chin, et al. Arnold Ng, et al. Annulus – diameter at the leaflet hinge, including all the calcium Sizes and Sizing

9 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Echo (A and B) vs MSCT (C, D, E) A B C D E

10 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Even in a round anatomy, the diameter (blue) is underestimated by 2D echo (red) as the measurement does not pass through the center In an elliptic anatomy the 2D echo diameter (red) is typically close to the minor diameter of the ellipse (blue). The major diameter (white) is not taken into account, this underestimates the effective annulus diameter Standard 2D Echo Limitations

11 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Hamdan, Schwammenthal J Am Coll Cardiol 2012 Assessment of the Aortic Annulus

12 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Ellipticity 1 : 1.14Ellipticity 1 : 1.38 Min diameter: 21 mm Max diameter: 24 Perimeter-derived annulus diameter: 22.5 Perimeter: 71 mm Min diameter: 21 mm Max diameter: 29 Perimeter-derived annulus diameter: 25 Perimeter: 79 mm Aortic Annulus Is Non-Circular The degree of non-circular varies substantially

13 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Ellipticity 1 : 1.14Ellipticity 1 : 1.38 Min diameter: 21 mm Max diameter: 24 Perimeter-derived annulus diameter: 22.5 Perimeter: 71 mm Min diameter: 21 mm Max diameter: 29 Perimeter-derived annulus diameter: 25 Perimeter: 79 mm Aortic Annulus Is Non-Circular The degree of non-circular varies substantially

14 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Perimeter Area Min. diameter Max. diameter Hamdan, Schwammenthal J Am Coll Cardiol 2012 Assessment of the Aortic Annulus

15 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Variation of annular dimensions throughout the cardiac cycle Perimeter shows least variation Hamdan, Schwammenthal J Am Coll Cardiol 2012

16 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Relative Percent Change of Aortic Annular Dimensions Normal subjects Aortic stenosis Hamdan, Schwammenthal J Am Coll Cardiol 2012 In Normal subjects strain averages 2.2 %, in Aortic Stenosis 0.6 %

17 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. SystoleDiastole Deformation Dynamics of the Aortic Annulus SystoleDiastole Aortic annulus Mitral annulus “Valvular interdependence” of the aorto-mitral orifice: Aorto-Mitral Coupling Aortic and mitral annulus are embedded within one common aorto- mitral orifice, so that reciprocal changes of size and shape of each element result from the pressure- sensitive motion of its common aorto-mitral septum. Hamdan, Schwammenthal J Am Coll Cardiol 2012

18 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Systole Diastole A larger area can be inscribed by the same perimeter (finger length) by assuming a rounder (less elliptic) shape The circle is the shape with the largest area for a given length of perimeter

19 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Lessons for Sizing in TAVI? Requirements for an ideal annular parameter for sizing: Integrates dimensions across the whole 2- dimensional annular plane Is most stable during the cardiac cycle Independent of annular shape

20 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Only Annular Perimeter Fulfills Requirements Circumferentially integrates annular dimension (effective, or mean circumferential diameter can be easily obtained by dividing perimeter into π) Shows minimal variation during the cardiac cycle Is not affected by shape (in contrast to area) and stretches only minimally at physiologic pressures

21 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Measurements for Assessment of Anatomic Fit by MSCT Aortic annulus perimeter-derived diameter Sino-tubular junction (STJ) Sinus of Valsalva (SoV) Aortic AnnulusSinus of Valsalva Measured from double-oblique axial slice showing nadirs of all 3 leaflets (basal plane) Perimeter-derived annulus diameter = perimeter / π Perimeter & area trace (reference) Measured from double oblique axial slice SoV diameter = 2 x (average of 3 radius measurements) Measured from double-oblique axial slice STJ diameter = (max + min) / 2 Sino-Tubular Junction

22 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Aortic Annulus Measurement Example Perimeter 75 mm Perimeter-derived annulus diameter 24 mm 22mm 26mm 75mm

23 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Screening by Echo Sizing (anatomical fit) by MSCT Echocardiographic: Annulus Diameter 19 to 26 mm MSCT: Perimeter: mm Perimeter-derived annulus diameter: > 21 and < 23.6 mm STJ > 23 mm SoV > 27 mm MSCT: Perimeter: mm Perimeter-derived annulus diameter: > 23 and < 26.7 mm STJ > 26 mm SoV > 30 mm Engager ™ 26 mm Engager ™ 23 mm Failure to align the bioprosthesis with the native valve through incorrect bioprosthesis selection could result in a cardiovascular injury including obstruction, perforation or dissection of vessels that may require intervention

24 Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc All Rights Reserved. Summary Appropriate patient selection will lead to safe and effective Engager™ system implantations Echocardiography assists with patient screening MSCT is the best modality for accurate bioprosthesis size selection Engager is a registered trademark of Medtronic, Inc. For more information and a complete list of adverse events, warning and contraindications reference Engager IFU.


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