engager™ transapical system pre-implantation imaging, patient and size selection august 2013...
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Engager™ Transapical SystemPre-Implantation Imaging, Patient and Size Selection
August 2013
Innovating for life.
UC201301195c EE
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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
AcademiaMedical Education
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MSCT Criteria for Bioprosthesis Selection
Echocardiography for Patient EvaluationAortic annulus diameter > 19 mm and < 26 mm
AcademiaMedical Education
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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 27.0 19.0 27.0 23.0 25.5
26 mm 30.0 21.0 30.0 26.0 27.5
A
BBE
D
C C
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.
Different echo definitions of annulus in use
Annulus – inner edge-to-edge diameter at leaflet insertion
24 mm
Derek nDerek Chin, et
al.Arnold Ng, et al.
Annulus – diameter at the leaflet hinge, including all the calcium
Sizes and Sizing
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Echo (A and B) vs MSCT (C, D, E)
A B
C D E
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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
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INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.
Hamdan, Schwammenthal J Am Coll Cardiol 2012
Assessment of the Aortic Annulus
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.
Ellipticity 1 : 1.14 Ellipticity 1 : 1.38
Min diameter: 21 mmMax diameter: 24Perimeter-derived annulus diameter: 22.5Perimeter: 71 mm
Min diameter: 21 mmMax diameter: 29Perimeter-derived annulus diameter: 25Perimeter: 79 mm
Aortic Annulus Is Non-CircularThe degree of non-circular varies substantially
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.
Ellipticity 1 : 1.14 Ellipticity 1 : 1.38
Min diameter: 21 mmMax diameter: 24Perimeter-derived annulus diameter: 22.5Perimeter: 71 mm
Min diameter: 21 mmMax diameter: 29Perimeter-derived annulus diameter: 25Perimeter: 79 mm
Aortic Annulus Is Non-CircularThe degree of non-circular varies substantially
AcademiaMedical Education
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Perimeter AreaMin. diameter
Max. diameter
Hamdan, Schwammenthal J Am Coll Cardiol 2012
Assessment of the Aortic Annulus
AcademiaMedical Education
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Variation of annular dimensions throughout the cardiac cycle
Perimeter shows least variation
Hamdan, Schwammenthal J Am Coll Cardiol 2012
AcademiaMedical Education
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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 %
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Systole Diastole
Deformation Dynamics of the Aortic Annulus Systole Diastole
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
AcademiaMedical Education
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SystoleDiastole
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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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
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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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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 Annulus Sinus 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
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Aortic Annulus Measurement ExamplePerimeter 75 mm
Perimeter-derived annulus diameter24 mm22mm
26mm75mm
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Screening by EchoSizing (anatomical fit) by MSCT
Echocardiographic: Annulus Diameter
19 to 26 mm
MSCT:Perimeter: 66-74 mm Perimeter-derived annulus diameter: > 21 and < 23.6 mmSTJ > 23 mmSoV > 27 mm
MSCT:Perimeter: 72-84 mmPerimeter-derived annulus diameter: > 23 and < 26.7 mmSTJ > 26 mmSoV > 30 mm
Engager™ 26 mmEngager™ 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
AcademiaMedical Education
INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. 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.