CoreValve ® System Procedural Best Practices for: May 2013 CoreValve ® to Stented Bioprostheses Valve-in-Valve These best practices were created with detailed

CoreValve® System Procedural Best Practices for:

May 2013

CoreValve® to Stented Bioprostheses Valve-in-Valve

These best practices were created with detailed input, review and approval from practicing physicians.

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.

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CoreValve® Valve-in-Valve

The following presentation outlines best practices and procedural considerations for the implantation for the CoreValve® System in failed stented aortic bioprostheses.



CoreValve to Stented SAV

Content:•Nomenclature & Indications•Pre-procedure•Procedure•Post-procedure



CoreValve Valve-in-Valve Stented Bioprostheses

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



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



Individualization of TreatmentFailed SAVAdditional instructions specific for TAV in SAV procedure:1

•Implanting a CoreValve or CoreValve Evolut™ percutaneous aortic valve in a degenerated surgical aortic bioprosthesis (valve in valve) should generally 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), 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.



CoreValve to Stentless SAV

• Nomenclature & Indications• Pre-procedure• Procedure• Post-procedure



Pre-procedure

Pre-procedure Steps for CoreValve Sizing and Orientation Considerations:1.Identify SAV.2.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.



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• Failed stented SAVs may also be identified by radiopaque

structures unique to a given device (see sections on Radiographic/Fluoroscopic Identification).

• Lack of radiopaque structures likely indicate a stentless SAV



Identification of Failed SAVsRadiographic/Fluoroscopic Identification of SAVs

Refer to the CoreValve Valve-in-Valve Sizing Guide



Determine Annulus Diameter of SAV

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 diameterConsiderations:For pre-procedural screening:•It is possible that the recorded size or even model of the failed prosthesis is incorrect so this should be verified. •Pannus, etc., may have restricted the inflow orifice of the failed valve.



Determine Annulus Diameter of SAVBest PracticeImaging techniques consistent with native valve transcatheter replacement implant methodology should be used.Computed tomography (CT) is required. Instead of measuring the native annulus measure the:

• Inside diameter of SAV inflow (at the annulus)• Distance between coronary ostia take off and the SAV

valve annulusEchocardiographic measurement of the aortic root. CT of the aortic root and

bioprosthesis.



Determine Annulus Diameter of SAVConsideration:When using the bioprosthesis manufacturer’s stated inside

diameter it is important to know that “inside diameter” is only the space within the valve’s stent or frame.* Thus, “inside diameter” does not consider the space taken by the bioprosthetic tissue. See figure below.

= valve inside diameter

*Exceptions are the Sorin Mitroflow and St. Jude Medical Trifecta valves as these have the bioprosthetic tissue mounted outside of the frame.



Determine Annulus Diameter of SAV

.

Surgical Stented SAV SpecificationsRefer to the CoreValve Valve-in-Valve Sizing Guide



CoreValve Sizing:

Best PracticeRefer to Annulus Size Ranges for the CoreValve device (below) and:

– If the measured internal diameter dimension of the SAV is smaller than the manufacturer’s stated internal diameter 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 2318 mm – 20 mm ≤ 34 mm 56.5 mm - 62.8 mm

26 20 mm – 23 mm ≤ 40 mm 62.8 mm - 72.3mm

29 23 mm – 27 mm ≤ 43 mm 72.3 mm - 84.8 mm

31 26 mm – 29 mm ≤ 43 mm 81.6 mm – 91.1

Annulus Size Ranges for CoreValve & CoreValve

Evolut



Pre-procedure Planning for Stented SAVsConsiderations: •Compare and contrast imaging measurements to:

– Identify coronary ostia in relation to the failed prosthesis, especially stent posts.

– Measure distance from basal plane to right and left coronary ostia takeoffs.

•It is common and recommended surgical practice to implant surgical valve commissure posts in alignment with the native aortic commissures. •In consideration of the failed prosthesis stent posts observe that some models have 120°apposition (Fig. 1) while some may not (Fig. 2).

Fig. 1 Examples include Carpentier-Edwards Perimount Valves. Stent posts are 120° apart. Sinus sizes are equal.

Fig. 2 Examples include Hancock ® M.O., Hancock ® II and Mosaic ® valves. Stent posts are, clockwise from the largest sinus: 120°, 135° and 105°







Procedural Considerations

Sedation:Normal institutional TAV sedation protocols should be followed.–If patient is under general anesthetic then TEE should be utilized. –If conscious sedation is used then TTE should be on stand-by.

Imaging:Simultaneous TEE, Angiography and Fluoroscopy is recommended.

Access Routes:Most appropriate access route selected by clinician based on patient anatomical characteristics.



Procedural Considerations (cont.)

Predilatation of Implant SiteIn 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



Deployment

Considerations:Stented SAVs versus native valves:•Present a stiffer non-expandable landing zone.•Have less ellipticity than native anatomy.•Have less consistent friction on the CoreValve System components compared to native calcification — anticipate movement toward the ventricle.



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 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.



DeploymentBest 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



Deployment

Considerations: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.



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.

Deployment

Deployment







Post-Deployment

Best Practice:

Confirm gradient across the valve with invasive measurement.



References

1. 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.

Documents

CoreValve ® System Procedural Best Practices for: May 2013 CoreValve ® to Stented Bioprostheses Valve-in-Valve These best practices were created with detailed