1. CoreValve® Implantation Best Practices January 2013
These best practices were created with detailed input, review and approval from Medtronic proctors.
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2. Device and Patient Selection Measurements per MSCT
Valve Size
Aortic Annulus Measurements
Sinus of Valsalva Diameter
Native Leaflet to Sinutubular
Junction Length
Ascending Aorta Diameter*
Diameter
Perimeter
Area Range 23
18 mm – 20 mm
56.5 mm –
62.8 mm mm
≥ 25 mm
≥ 15mm
≤ 34 mm 26
20 mm – 23 mm
62.8 mm –
72.3 mm mm
≥ 27 mm
≤ 40 mm 29
23 mm – 27 mm
72.3 mm –
84.8 mm mm
≥ 29 mm
≤ 43 mm 31
26 mm – 29 mm
81.6 mm –
91.1 mm mm
Recommend 31mm valve for annulus ranges 26 and greater to ensure optimal radial interference (proper sizing of prosthesis to native annulus).
*Ascending Aorta measurements are taken at 30 mm from the aortic annulus for the 23 mm device
and at 40 mm from the aortic annulus for the 26, 29, and 31 mm devices. 2

3. TAVI Fundamentals Standard steps to deployment:
Ensure accurate annulus measurement
Align annulus / catheter marker band
Target coaxial alignment of catheter and annulus (┴)
Properly shape and maintain control of guidewire to ensure stable placement during deployment

4. TAVI Fundamentals: Valve Sizing
Ensure Accurate Annulus Measurement
Use a multi-modality approach to calculate anatomical measurements (CT, Echo, and Angio), particularly in borderline cases
CT is highly recommended and coronary angiography is required on all patients (see Recommended Sizing Methodology using MSCT presentation)
CT may not be used alone, it must be used in conjunction with angiography
Adhere to patient evaluation matrix when selecting valve size

5. TAVI Fundamentals: Imaging Projection
Proper imaging projection helps ensure a more accurate valve placement
Identify the ideal annular viewing plane using contrast injections at various angiographic angles considering the following:
Alignment of three annulus cusps in a common plane
Radiopaque catheter marker band appearing as a straight line

6. TAVI Fundamentals: Coaxial Alignment
Target coaxial alignment of catheter and annulus
Adjust catheter and guidewire tension to ensure valve is aligned within the annulus and perpendicular to the basal plane

7. TAVI Fundamentals: Guidewire Management
Properly shape and maintain control of guidewire to ensure stable placement during deployment
Pre-shape the guidewire to the contours of the patient’s left ventricle
Confirm proper placement within the ventricle with the transition point of the guidewire held above the apex and pointing away from the ventricle wall
Maintain strict fluoroscopic surveillance of the guidewire in the left ventricle
The position of the prosthesis can be regularly adjusted by a combination of pulling the catheter and pushing on the wire

8. Implantation Best Practices
Medtronic CoreValve Transfemoral Procedure
Implantation Best Practices
These best practices were created with detailed input, review and approval from Medtronic proctors.

9. Procedural Best Practices
Target implant depth is 4-6 mm
Start deployment at target implant depth
31mm: Anticipate slight movement towards the ventricle during 1st 1/3 deployment and adjust starting depth &/or reposition before annular engagement accordingly
Consider fast pacing during deployment in patients with aortic regurgitation, hypertension, and/or large anatomies
Slow release during first 1/3 deployment and reposition if necessary until annular engagement
31mm: Very slow release during first 1/3 deployment and pause frequently to release radial force
Check position (3 – 4 times) & reposition if necessary until annular engagement
Understand foreshortening as a potential contributor to tension in catheter during deployment
If present, release system tension just prior to final valve release from catheter by:
Releasing tension on guidewire
Slightly pushing on catheter to remove any tension placed on valve by catheter
Extrapolate on your experience implanting the 29mm valve in larger anatomies.

10. 1. Target Implantation Depth
Target implant depth is mm (Marker Band 1 – 1.5)
Due to valve profile and native annulus interaction, higher implantation provides greater radial interference. This consideration is especially important for larger anatomies
Most implants should trend closer to 4 mm depth
6 mm
4 mm

11. 2. Starting Deployment Depth
Start deployment at intended final landing zone
Anticipate slight movement towards the ventricle during 1st 1/3 deployment and adjust starting depth &/or reposition before annular engagement accordingly
Appreciate the tendency for larger anatomies to experience greater movement during deployment
Target Implant Depth

12. 3. Controlled Pacing
Consider controlled pacing (90 – 130 bpm) during deployment in patients with aortic regurgitation, hypertension, and/or large anatomies
Pacing increases valve stability during deployment by controlling heart rhythm and blood pressure

13. 4. Slow Deployment for First 1/3
Release the valve slowly during first 1/3 deployment and reposition if necessary until annular engagement
Appreciate the tendency to experience greater valve movement in larger anatomies and adjust deployment pace and valve position accordingly
Deploy very slowly & use the wire to maintain a good coaxial position.
Deploy slowly and recognize the tension in the system
Deploys the first third of the valve by pausing four times to check positioning with contrast (baseline, before flowering, 50% open, immediately before annular contact)

14. 5. Understand Foreshortening
Understand foreshortening as a potential contributor to minor (~2 mm) valve antegrade movement during first 1/3 deployment, and tension in catheter during remainder of deployment
55.5 mm (26mm Frame)
53.4 mm (29mm Frame)
52.4 mm (31mm Frame)
Frame length decreases as it changes from crimped to expanded state (foreshortening effect).
Foreshortening may:
Cause frame inflow to move up (2-3 mm) during first 1/3 unsheathing step (deployment to point of annular engagement), and/or
Pull catheter down (4-5 mm) creating tension in system that is released when frame is detached from catheter
23 mm Valve
Crimped Length: 55mm
Expanded Length: 45 mm
Note: Measurements exclude loading tabs in calculation of length

15. 6. Release System Tension
System with Tension
The position of catheter along inner curvature of aortic arch may indicate presence of tension in system
Tension can create an antegrade (e.g. upward) force on valve during deployment
If present, release system tension just prior to final valve release from catheter by:
Releasing tension on guidewire*
Slightly pushing on catheter to remove any tension placed on valve by catheter
Tension may contribute to an antegrade force during deployment.
System without Tension:
* Always ensure guidewire is located in an atraumatic position
Catheter may be positioned along outer curvature (as shown) or in middle of arch

16. Procedural Implantation Best Practices
Medtronic CoreValve
Procedural Implantation Best Practices
These best practices were created with detailed input, review and approval from Medtronic proctors.

17. Other Procedural Considerations
Pre-Procedural Screening
Use TEE if TTE is technically difficult or adequate images can not be obtained
For low-gradient stenosis, stress TEE needed as well as LV angiogram for assessment of critically-low EF and definition of LV outflow track
If transfemoral implantation could be impracticable, perform aortic root and left subclavian angiography with graduated pigtail for potential alternative access route assessment.

18. Other Procedural Considerations
Sedation
During first five cases, general anesthesia is recommended, unless contra-indicated
If patient is under general anesthetic then TEE should be utilized
If conscious sedation is used then TTE should be on stand-by

19. Other Procedural Considerations
Temporary Pacemaker
First choice: implant temporary lead from femoral vein at beginning of procedure - move to jugular vein at end of procedure
Second choice: implant temporary lead from jugular vein at beginning of procedure - leave indwelling at end of procedure
Third choice: implant temporary lead from femoral vein at beginning of procedure – leave indwelling in femoral vein at end of procedure
An operator that has experience with manipulating guide wires and catheters inside the heart should position the PM in the RV
A balloon-tip temporary PM is highly recommended. The balloon should be kept fully-inflated during positioning and semi-inflated for the rest of the procedure and postoperatively
If an active-fixation PM lead is contemplated, it should be inserted by an experienced operator.
For operation of the pacing generator during the procedure, identify one person that will be responsible for the PM settings and limit instructions for its operator to a single, designated operator

20. Other Procedural Considerations
Puncture/Sheath
Transfemoral puncture should be a single-wall stick of the common femoral artery
When percutaneous access is planned, arterial puncture should be performed under fluoroscopic visualization using either a contra-lateral injection into the target vessel, or positioning of a catheter or guidewire into the target vessel from the contra-lateral artery
Percutaneous closure devices may be used. However, a surgical cut-down is not discouraged. Site should use what they are comfortable with and maintain consistency
Transfemoral introducer sheath priority is patient specific. Consider the resistance to kinking, the OD, and the hemostasis provided when selecting a sheath
Non-iliofemoral introducer recommendation: Cook Check-Flo

21. Other Procedural Considerations
Inter-Procedure Imaging
Ideal implant projections will be recommended by Clinical Analyst contained in the Patient Assessment
Baseline aortography should be performed before insertion of 18 Fr introducer
Various angiographic projections are recommended to assure correct expansion of the frame. This is especially important if the leaflets are heavily calcified
When deploying the valve, proper image projections helps assure a more accurate valve placement. The preferred viewing plan for deployment is LAO

22. Other Procedural Considerations
Transfemoral: 18F introducer should be inserted before crossing the valve with a guidewire
Non-iliofemoral: 18F introducer should be inserted AFTER crossing the valve with the super-stiff guidewire
Transfemoral: Valve preparation may be initiated after insertion of the 18F introducer
Pre-implantation balloon catheter selection:
Use the minor annular axis as determined by CT angiography
Undersize the balloon according to previous guideline – but select a balloon that is at least 18mm and no larger than 25mm in diameter
Preferred balloon characteristics: Short, straight, non-compliant
Superstiff wire (1 cm tip) should be deployed in the left ventricle utilizing a pigtail catheter
Pre-implant dilatation of the native aortic valve should not performed until the CoreValve device is prepared and ready for implantation
Identify you are in the perfect projection before implant by aligning radiopaque marker band on the delivery catheter.
Maintain the pigtail position deep in the non-coronary sinus
Changing projection during the implant is not recommended (Might have to in 31mm)
Unless utilizing cine acquisition, fluoroscopy should be used throughout the entire deployment portion of the procedure
Valve orientation should be instructed during proctoring sessions
Following deployment of the valve, use a 90 degree angiographic angle to assure that the loops are properly detached from the catheter prior to withdrawing the delivery system
After deployment of the CoreValve device, close the capsule after withdrawing the delivery catheter to the descending aorta

23. Other Procedural Considerations
Evaluation of PVL
Involves a joint assessment of echo, angio and hemodynamics. Proper echo and pressure tracing equipment and skills present in the cath lab. The actions to take if significant PVL should be based on an integrated analysis of the implanted valve including depth, expansion or both (see complication management presentation for details)
AR Index: Implementation of AR index should be encouraged

24. Other Procedural Considerations
Perc Closing Devices
Consider using contra-lateral crossing prior to access vessel closure in case a vascular intervention is needed

25. Best Practices Medtronic CoreValve Non-Iliofemoral Procedure
These best practices were created with detailed input, review and approval from Medtronic proctors.

26. Subclavian

27. Access Routes Indicated for use access routes:
Iliofemoral: Right or Left
Subclavian/Axillary: Right or Left
Left preferred (versus right) due to delivery pathway’s typically better alignment with native aortic valve anatomy and less obstructive interaction with cranial perfusion
Most appropriate access route selected by clinician based on patient anatomical characteristics

28. Access
ACT
Ensure appropriate ACT level is maintained throughout procedure
Pigtail
Iliofemoral or contralateral radial access
Temporary internal pacemaker catheter and lead
Internal jugular vein
CoreValve delivery catheter system
Axillary artery example below:
Pre-op CT to assess access
It is recommended that only Aspirin be given prior to the procedure, other antiplatelet therapy may be administered post procedure
Surgical cut down located approximately 2 cm below and parallel to left clavicle, and 4-5 cm lateral to midclavicular line
Identify and place two (2) vessel loops around axillary artery. Do not apply significant force to vessel to prevent damage.
Place two (2) standard double purse-string sutures* and create an oval-shaped axillary artery access incision starting at downstream edge of purse-string sutures.
Consider adding incision in the anterior axillary line to create shallower delivery catheter entry angle to minimize risk of access site complications
Use scalpel to control vessel opening while advancing sheath
Use direct cannulation (recommend Cook introducer for kink resistance)
Axillary Artery Double Purse-string Access
* Caution: Use appropriate access/closure technique to avoid clinically unacceptable arterial stenosis at the access site.

29. Room Setup O1 Recommend either option A or B
Operator 1 (O1) needs to be at subclavian/axillary access site to have control of access site and delivery catheter
Operator 1 (O1) and Operator 2 (O2) must be in comfortable working positions with clear and close view of imaging screens. Note: Option B operators may be on opposite side of catheter facing patient’s head (versus patient’s feet) depending on monitor position and preferences.
Consider location of any additional equipment (e.g., additional table) to avoid/minimize C-arm interference
Invest time upfront to optimize room setup to meet unique aspects of subclavian/axillary approach OR O2
Key:
O1 = Operator 1
O2 = Operator 2
Option B O1 O2

30. Introducer Positioning
Abduction of arm may help facilitate sheath passage
Advance 18 Fr introducer under direct fluoroscopy over super stiff guidewire (to prevent dilator from injuring ascending aorta) which has been positioned in the left ventricle apex
Use caution when advancing introducer, especially:
Near stenotic and/or calcified regions
At thoracic inlet and subclavian artery origin
Position distal end of 18 Fr introducer immediately distal (upstream) to innominate/brachiocephalic artery for catheter advancement, valve deployment, and catheter withdrawal
O1 should always be aware of introducer position throughout procedure. Consider holding positioned introducer with one hand throughout procedure to stabilize placement.
Consider placing a suture to secure introducer to skin

31. Introducer Positioning with IMA Graft
Strongly recommend using contralateral subclavian/axillary artery or ascending aorta (direct aortic) access
Monitor cardiac function and patent ipsilateral IMA graft to ensure acceptable perfusion is maintained during intervention with 18 F introducer
If signs of compromised perfusion become present, adjust position of 18 F introducer to maintain acceptable perfusion
Subclavian artery straightening due to introducer advancement could potentially cause patent ipsilateral IMA graft occlusion
Recommended that vessel diameter be ≥ 7.5mm to reduce the occurrence of ischemic complications

32. Direct Aortic

33. Direct Aortic Access Route
Surgical access performed via minimally invasive thoracotomy (e.g. right anterior mini-thoracotomy) or sternotomy (e.g. upper partial mini-sternotomy)
Mini-sternotomy versus mini-thoracotomy decision may be based on
Clinical preference (e.g. familiarization with approach)
Anatomy
Distance between vascular access site and basal plane
Aortic root angulation / coaxial alignment
Intended access site with respect to surrounding anatomical structures
Comorbidities (e.g. avoiding pleural space with COPD)
Clinician to discuss risks pertaining to the intended access route with the patient
It is recommended that only Aspirin be given prior to the procedure, other antiplatelet therapy may be administered post procedure
Mini-Sternotomy
Mini-Thoracotomy
Transaortic  Direct Aortic, adds comorbities to account for things such as COPD (may encourage use of sterno vs thora)

34. Access Route Considerations
Sternotomy vs. Thoracotomy: Preferred approach is surgeon specific (driven by surgeon’s experience and comfort level) but here are some options to be considered
Reasons to consider sternotomy
Non-operated chest
Short, or a relatively vertical and long, ascending aorta
Aortic root and LVOT well aligned
Inexperience with re-op thoracotomy or CoreValve direct aortic procedures
Patients with elevated risk due to pulmonary injury (e.g., severe pulmonary hypertension, COPD)
Reasons to consider thoracotomy
RIMA present by sternum
Operated chest (i.e., redo)
Challenging angulation (e.g. horizontal aorta) that may present coaxial alignment challenges
Ability to perform tunnel cannulation, which can facilitate introducer stabilization and coaxial alignment

35. Room Setup Plan room setup upfront
Recommend pre-procedure planning (and training, if necessary) to ensure both operators understand and are proficient at their roles (e.g. access site management, wire management, catheter operations, fluoroscopy) throughout procedure
Operator 1 (O1) needs to be at access site to have control of access site and delivery catheter system. Meticulous access site management is critical to avoiding access site complications
Operator 1 (O1) and Operator 2 (O2) must be in comfortable working positions with clear and close view of imaging screens
Consider location of any additional equipment (e.g., additional table) to avoid/minimize C-arm interference
Consider use of third operator on patient’s left side to maintain dedicated control of introducer sheath throughout procedure
Recommend extension table for catheter and/or wire
Room Setup Example

36. Aortic Access
Place graduated pigtail into noncoronary native aortic valve cusp and along greater curvature of ascending aorta
Perform minimally invasive surgical cut down (right internal mammary artery sparing if necessary). Use caution to avoid damage to any lung tissue present.
Perform aortography with radiographic instrument (e.g. forceps) pointing to aortic access site to confirm ≥6 cm basal plane to aortic access site distance is met
Manually palpate access site to confirm absence of calcification and suitability. Echocardiography may also be helpful tool for this assessment.
Place two (2) standard double purse-string sutures around access site using caution to avoid vessel dissection/tearing*. Consider suture type (e.g. pledgeted prolene) selection to minimize vessel trauma.
Gain arterial access via seldinger technique (or direct cannulation via scalpel puncture)
Follow standard CoreValve guidewire-catheter exchange sequence to place super stiff guidewire, prior to 18 Fr introducer insertion
Bruschi G, et al. Direct Aortic Access Through Right Minithoracotomy for Implantation of Self-Expanding Aortic Bioprosthesis Valves . The Journal of Thoracic and Cardiovascular Surgery. 140 (3): (2010).
* Ensure double purse-string sutures are managed appropriately in the event they are needed to regain hemostasis during the procedure.

37. Introducer Access & Positioning
Use of an 18 Fr kink-resistant introducer is recommended
Pre-shaping introducer may help optimize delivery trajectory to achieve coaxial alignment with native aortic valve
Advance 18 Fr introducer under direct fluoroscopy over super stiff guidewire using extreme caution to avoid aortic or left ventricular perforation, coronary or septum injury, or other trauma that could lead to bleeding, dissection, or thromboembolism by monitoring introducer dilator tip position
Position distal end of introducer approximately 2 cm into the aortic lumen
Use extreme caution to maintain this recommended introducer position throughout procedure to avoid introducer popout from the aortic vessel (proximal movement) or interaction with the aortic root complex anatomy (distal movement)
Operator 1 should always be aware of introducer position throughout procedure
Introducer position management needs to control both axial and lateral displacement, and may be accomplished by:
Securing introducer in place with one suture looped around the introducer length via the flush port (axial securement) and a second suture wrapped around the distal introducer end (lateral securement), or
A dedicated hand or operator to manually hold introducer in place*
Introducer movement will move delivery catheter system (once it is placed through introducer)
Image courtesy of Dr. Neil Moat.
Axial Securement Suture
* Caution: Due to close proximity of operators to fluoroscope, use caution to avoid unnecessary radiation exposure.
Lateral Securement Suture

38. Withdrawal, Closure, and Patient Care
Catheter Tip Retrieval and Withdrawal
With delivery catheter system tip distal to introducer, advance capsule to tip and withdraw delivery catheter system from introducer
Use caution to avoid catching delivery catheter system tip on introducer during catheter withdrawal
Introducer Withdrawal
Performed together by both operators in a controlled manner
Carefully manage purse-string sutures to maintain effective hemostasis
Consider rapid pacing for de-cannulation
Super Stiff Guidewire Withdrawal
Use angiographic catheter to remove guidewire
Closure
Close per hospital protocol using appropriate closure technique to avoid dissection, tearing, and/or bleeding at access site
Consider placing additional suture across double purse- string sutures and access site to ensure effective closure
Consider rapid pacing or pharmacologic agent to reduce systolic blood pressure below 100 mm Hg during closure
Perform post-procedure angiography to ensure acceptable closure
Post-Procedure Care
Normal post-procedure care for any vascular access and minimally invasive thoracotomy/sternotomy procedure
Consider epidural infusion into wound for assistance with pain management

39. 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.
For more information and a complete list of adverse events, warning and contraindications reference CoreValve IFU.
Medtronic, Inc All Rights Reserved.