1. CoreValve® System Procedural Best Practices for:
CoreValve® to Stentless Bioprostheses
Valve-in-Valve
May 2013
Transaortic  Direct Aortic
These best practices were created with detailed input, review and approval from practicing physicians.
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The information in this document is intended for educational purposes and is not meant as a substitute for the protocol, Instructions for Use or product training. Practice may vary based on clinical judgment.

2. CoreValve® Valve-in-Valve in Stentless SAV’s
The following presentation outlines best practices and procedural considerations for the implantation for the CoreValve® System in failed bioprostheses and homografts (surgical aortic valves).

3. CoreValve to Stentless SAV
Content:
Nomenclature & Indications
Pre-procedure
Procedure
Post-procedure

4. CoreValve Valve-in-Valve
Nomenclature:
Transcatheter Aortic Valve (TAV)
Surgical Aortic Valve (SAV)
Stented SAV (valve composed of xenograft material suspended on a man made stent or frame)
Stentless SAV (valve composed of xenograft material without a stent or frame, includes homografts)
Generally, references in this document to “annulus” or “annular contact” apply to the inner diameter of the surgical aortic bioprosthesis for TAV in SAV procedures.
Stented SAV
Stentless SAV

5. Valve-in-Valve Indications
The Indications for the Medtronic CoreValve System have been updated:
The Medtronic CoreValve system is indicated for patients with symptomatic native aortic valve stenosis or stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement and presenting with femoral or subclavian/axillary access vessels with diameters ≥6 mm, or ascending aortic (direct aortic) access site ≥60 mm from the basal plane, and anatomical dimensions as described in the instructions for use.1
Bold italics added for emphasis

6. Individualization of Treatment Failed SAV
Additional instructions specific for TAV in SAV procedure:1
Implanting a CoreValve bioprosthesis in a degenerated surgical bioprosthesis (TAV in SAV) should be avoided in patients with any of the following conditions:
The degenerated surgical bioprosthesis presents with a significant concomitant perivalvular leak (between prosthesis and native annulus), and is not securely fixed in the native annulus, or is not structurally intact (e.g., wireform frame fracture).
The degenerated surgical bioprosthesis presents with a partially detached leaflet that in the aortic position may obstruct a coronary ostium. 

7. CoreValve to Stentless SAV
Nomenclature & Indications
Pre-procedure
Procedure
Post-procedure

8. Pre-procedure
Pre-procedure Steps for CoreValve Sizing and Orientation Considerations:
Identify SAV.
Determine annulus (inside) diameter of SAV.
Use the CoreValve Valve-in-Valve Sizing Guide.
Use CT and other imaging to measure annulus diameter.
3. Use CoreValve Annulus Size Ranges chart to select CoreValve size.
4. Image to consider orientation of SAV to coronary ostia.
5. Determine and consider stentless SAV’s surgical technique.

9. Identify the Failed SAV
Obtain the operative report from the patient’s SAV surgery (including implant technique) and other relevant details regarding the patient’s medical history.
Secure manufacturer, model and size information for the patient’s SAV
Information may be in:
The operative notes and/or
Valve identification card supplied to patient by manufacturer
Lack of radiopaque structures likely indicate a stentless SAV.

10. Determine SAV Annulus Diameter
Best Practice:
Determine the annulus (internal diameter) of the SAV:
Cross reference valve model and size to the CoreValve Valve-in-Valve Sizing Guide
Image the failed SAV to measure its annulus diameter
Compare internal diameter specification to measured diameter to confirm the annulus diameter
Considerations:
For pre-procedural screening:
It is possible that the recorded size or even model of the failed prosthesis is incorrect so this must be verified.
Pannus, etc., may have restricted the inflow orifice of the failed valve.

11. Determine Annulus Diameter of SAV
Best Practice
Imaging techniques consistent with native valve transcatheter replacement implant methodology should be used including measurement of the STJ and Sinus of Valsalva.
Computed tomography (CT) is required. Instead of measuring the native annulus measure the:
Inside diameter of SAV inflow
Inside diameter of SAV outflow
Distance between left and right ostia and the valve
CT of the aortic root and bioprosthesis.
Echocardiographic measurement of the aortic root.

12. CoreValve Sizing: Stentless SAVs
Best Practice:
Compare and contrast the imaging measurements to:
To minimize risk of coronary occlusion, identify coronary ostia in relation to the failed prosthesis. (Note: The proximity of stentless SAVs to coronary ostia are not homogeneous due to different designs and implant techniques.)
Compare CT measured annulus to the manufacturer’s reported inner diameter. (Contact the SAV manufacture for additional details)
If make and model is not in the Surgical Valve Specifications Chart, valve diameter will have to be measured with CT as one does for a native valve.
The final size decision should be based on intra-operative TEE.

13. CoreValve Sizing: Stentless SAVs
Consideration:
The labeled size of a homograft is typically reflective of its inside diameter.
The labeled size of stentless bioprostheses are determined by their outside diameter.
25 mm
Stentless Valve
23 mm
Homograft
Outside Diameter
Inside Diameter

14. CoreValve Sizing: Stentless SAVs Refer to the CoreValve Valve-in-Valve Sizing Guide
Internal diameter values of other stentless valves are not publicly available.

15. CoreValve Sizing: Stentless SAVs
Refer to Annulus Size Ranges for the CoreValve device (below) and:
If the measured internal diameter dimension is smaller than the manufacturer’s then use the measured size to determine the CoreValve device size.
If measurements are “in between” choose the smaller CoreValve device.
CoreValve Size
Aortic Annulus Diameter
Ascending Aorta Diameter
Perimeter Ranges
Evolut 23
18 mm – 20 mm
< 34 mm
56.5 mm mm 26
20 mm – 23 mm
≤ 40 mm
62.8 mm mm 29
23 mm – 27 mm
≤ 43 mm
72.3 mm mm 31
26 mm – 29 mm
81.6 mm – 91.1
Annulus Size Ranges for CoreValve &
CoreValve Evolut

16. Pre-procedural Planning for Stentless SAVs
Consideration:
Surgical implant technique varies for stentless SAVs and may impact the relationship of the prosthetic annulus to the coronary ostia.
Implant Techniques for Stentless Bioprostheses and Homografts
Stentless Valve Model
Manufacturer
Specific Implant Technique(s)*
Homograft NA
Full root, root inclusion, subcoronary (complete or modified)
Freestyle®
Medtronic
3f®
Subcoronary
Toronto SPV®
St. Jude Medical
SJM Toronto Root†
Full root, root inclusion, subcoronary (modified)
Edwards Prima Plus®
Edwards Lifesciences
Full root†, root inclusion†, subcoronary
* Per manufactures labeling † Not approved in U.S.

17. Pre-procedural Planning for Stentless SAVs
Typical Implant Techniques for Homografts and Stentless Bioprostheses

18. Pre-procedural Planning for Stentless SAVs
Consideration:
Stentless bioprostheses and homografts lack radiopaque structures and calcification is typically less than with native valves. This challenges visualization of the level of the annulus.

19. CoreValve to Stentless SAV
Nomenclature & Indications
Pre-procedure
Procedure
Post-procedure

20. Procedural Considerations
Sedation:
Normal institutional TAV sedation protocols should be followed. Consideration should be given to imaging as TEE is recommended for Stentless SAV’s.
Imaging:
Simultaneous Angiography and Fluoroscopy is recommended.
TEE is recommended.
Access Routes:
Most appropriate access route selected by clinician based on patient anatomical characteristics.

21. Procedural Considerations
Predilatation of Implant Site
In most cases predilatation is not necessary.
Balloon predilatation of a stenotic surgical aortic bioprostheses has not been evaluated. In cases where there is severe stenosis, pre-dilatation of the surgical aortic bioprosthesis may be done and the steps used are identical to native valve predilatation.1
Insert the valvuloplasty balloon through the 18-Fr introducer sheath and advance it to the ascending aorta.1
Reposition the angiographic equipment to the ideal viewing plane. Position the valvuloplasty balloon across the native or surgical valve, while maintaining strict fluoroscopic surveillance of the distal tip of the guidewire in the LV.1
Perform balloon valvuloplasty per hospital protocol and remove the valvuloplasty balloon while maintaining guidewire position across the native or surgical aortic valve.1

22. Deployment Best Practice:
Advance the device through the native or surgical valve. Perform an angiogram to confirm that the pigtail catheter is in position within the noncoronary cusp of the aortic root. Fluoroscopically identify the
appropriate landmarks.1
To maintain maximum stability and mitigate forward movement of the CoreValve bioprosthesis the guidewire should be shaped and well positioned in the apex of the left ventricle.
Align the CoreValve coaxially.
Control pace during deployment to reduce cardiac output and provide stabilization of the CoreValve during deployment.

23. Deployment Considerations:
Stentless SAV’s have challenges to viewing the angiographic floor of the aortic root. To identify the angiographic floor consider the following steps. If the stentless SAV presents with open regurgitation, insertion of a guidewire in the left main ostium may provide a distal landmark as it is difficult to determine the level of the aortic annulus.
If the regurgitation is less severe or the valve is stenotic, a pigtail catheter can be placed in the base of a sinus and contrast utilized during deployment. The operator should withdraw the pigtail catheter before complete deployment.
Alternatively:
Place a pigtail catheter in the non-coronary sinus and an Amplatz or Judkins left catheter in the left coronary sinus; or
Place a pigtail catheter in both the non- and left-coronary sinuses

24. Deployment Best Practice: Deployment Depth
Within the aortic annulus (approximately 4 mm to 6 mm below the annulus)
The annulus is defined as the angiographic floor of the aortic root in native anatomy, certain stented bioprosthetic valves without radiopaque markers at the inflow, and stentless bioprosthetic valves. In certain stented bioprosthetic valves, the radiopaque marker of the stent or sewing ring at the inflow of the valve can be used as the annulus for optimal placement.1

25. Deployment Consideration:
With an SAV there is less consistent retrograde friction on the CoreValve System components compared to native calcification.
Anticipate movement of the CoreValve bioprosthesis toward the ventricle during deployment and adjust starting depth &/or reposition before annular engagement accordingly.
Target a 4 mm implant depth.
Avoid oversizing the CoreValve bioprosthesis
Avoid placing bioprosthesis too deeply in the annulus.
Conversely, once the CoreValve begins to deploy and contacts the SAV, antegrade friction is higher than with native valves making pull back difficult.

26. Deployment
Consideration: If the CoreValve is positioned too deeply into the left ventricular outflow tract do not attempt to reposition. Refer to Complications Management materials for the CoreValve bioprosthesis for considerations to mitigate this issue.

27. CoreValve to Stentless SAV
Nomenclature & Indications
Pre-procedure
Procedure
Post-procedure

28. Post-procedure Best Practice:
Confirm gradient across the valve with invasive measurement.

29. References CoreValve System Instructions for Use.
The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment.
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
All other marks are registered by their respective owners.
For more information and a complete list of adverse events, warning and contraindications reference CoreValve IFU.
Medtronic, Inc All Rights Reserved.