Presentation on theme: "CoreValve® Implantation Best Practices January 2013"— Presentation transcript:
1 CoreValve® Implantation Best Practices January 2013 These best practices were created with detailed input, review and approval from Medtronic proctors.Innovating for life.UC c EE
2 Device and Patient Selection Measurements per MSCT Valve SizeAortic Annulus MeasurementsSinus of Valsalva DiameterNative Leaflet to SinutubularJunction LengthAscending Aorta Diameter*DiameterPerimeterArea Range2318 mm – 20 mm56.5 mm –62.8 mmmm≥ 25 mm≥ 15mm≤ 34 mm2620 mm – 23 mm62.8 mm –72.3 mmmm≥ 27 mm≤ 40 mm2923 mm – 27 mm72.3 mm –84.8 mmmm≥ 29 mm≤ 43 mm3126 mm – 29 mm81.6 mm –91.1 mmmmRecommend 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 deviceand 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 measurementAlign annulus / catheter marker bandTarget 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 MeasurementUse a multi-modality approach to calculate anatomical measurements (CT, Echo, and Angio), particularly in borderline casesCT 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 angiographyAdhere to patient evaluation matrix when selecting valve size
5 TAVI Fundamentals: Imaging Projection Proper imaging projection helps ensure a more accurate valve placementIdentify the ideal annular viewing plane using contrast injections at various angiographic angles considering the following:Alignment of three annulus cusps in a common planeRadiopaque catheter marker band appearing as a straight line
6 TAVI Fundamentals: Coaxial Alignment Target coaxial alignment of catheter and annulusAdjust 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 deploymentPre-shape the guidewire to the contours of the patient’s left ventricleConfirm proper placement within the ventricle with the transition point of the guidewire held above the apex and pointing away from the ventricle wallMaintain strict fluoroscopic surveillance of the guidewire in the left ventricleThe 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 ProcedureImplantation Best PracticesThese best practices were created with detailed input, review and approval from Medtronic proctors.
9 Procedural Best Practices Target implant depth is 4-6 mmStart deployment at target implant depth31mm: Anticipate slight movement towards the ventricle during 1st 1/3 deployment and adjust starting depth &/or reposition before annular engagement accordinglyConsider fast pacing during deployment in patients with aortic regurgitation, hypertension, and/or large anatomiesSlow release during first 1/3 deployment and reposition if necessary until annular engagement31mm: Very slow release during first 1/3 deployment and pause frequently to release radial forceCheck position (3 – 4 times) & reposition if necessary until annular engagementUnderstand foreshortening as a potential contributor to tension in catheter during deploymentIf present, release system tension just prior to final valve release from catheter by:Releasing tension on guidewireSlightly pushing on catheter to remove any tension placed on valve by catheterExtrapolate 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 anatomiesMost implants should trend closer to 4 mm depth6 mm4 mm
11 2. Starting Deployment Depth Start deployment at intended final landing zoneAnticipate slight movement towards the ventricle during 1st 1/3 deployment and adjust starting depth &/or reposition before annular engagement accordinglyAppreciate the tendency for larger anatomies to experience greater movement during deploymentTarget Implant Depth
12 3. Controlled PacingConsider controlled pacing (90 – 130 bpm) during deployment in patients with aortic regurgitation, hypertension, and/or large anatomiesPacing 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 engagementAppreciate the tendency to experience greater valve movement in larger anatomies and adjust deployment pace and valve position accordinglyDeploy very slowly & use the wire to maintain a good coaxial position.Deploy slowly and recognize the tension in the systemDeploys 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 deployment55.5 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/orPull catheter down (4-5 mm) creating tension in system that is released when frame is detached from catheter23 mm ValveCrimped Length: 55mmExpanded Length: 45 mmNote: Measurements exclude loading tabs in calculation of length
15 6. Release System Tension System with TensionThe position of catheter along inner curvature of aortic arch may indicate presence of tension in systemTension can create an antegrade (e.g. upward) force on valve during deploymentIf 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 catheterTension may contribute to an antegrade force during deployment.System without Tension:* Always ensure guidewire is located in an atraumatic positionCatheter may be positioned along outer curvature (as shown) or in middle of arch
16 Procedural Implantation Best Practices Medtronic CoreValveProcedural Implantation Best PracticesThese best practices were created with detailed input, review and approval from Medtronic proctors.
17 Other Procedural Considerations Pre-Procedural ScreeningUse TEE if TTE is technically difficult or adequate images can not be obtainedFor low-gradient stenosis, stress TEE needed as well as LV angiogram for assessment of critically-low EF and definition of LV outflow trackIf 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 SedationDuring first five cases, general anesthesia is recommended, unless contra-indicatedIf patient is under general anesthetic then TEE should be utilizedIf conscious sedation is used then TTE should be on stand-by
19 Other Procedural Considerations Temporary PacemakerFirst choice: implant temporary lead from femoral vein at beginning of procedure - move to jugular vein at end of procedureSecond choice: implant temporary lead from jugular vein at beginning of procedure - leave indwelling at end of procedureThird choice: implant temporary lead from femoral vein at beginning of procedure – leave indwelling in femoral vein at end of procedureAn operator that has experience with manipulating guide wires and catheters inside the heart should position the PM in the RVA 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 postoperativelyIf 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/SheathTransfemoral puncture should be a single-wall stick of the common femoral arteryWhen 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 arteryPercutaneous closure devices may be used. However, a surgical cut-down is not discouraged. Site should use what they are comfortable with and maintain consistencyTransfemoral introducer sheath priority is patient specific. Consider the resistance to kinking, the OD, and the hemostasis provided when selecting a sheathNon-iliofemoral introducer recommendation: Cook Check-Flo
21 Other Procedural Considerations Inter-Procedure ImagingIdeal implant projections will be recommended by Clinical Analyst contained in the Patient AssessmentBaseline aortography should be performed before insertion of 18 Fr introducerVarious angiographic projections are recommended to assure correct expansion of the frame. This is especially important if the leaflets are heavily calcifiedWhen 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 guidewireNon-iliofemoral: 18F introducer should be inserted AFTER crossing the valve with the super-stiff guidewireTransfemoral: Valve preparation may be initiated after insertion of the 18F introducerPre-implantation balloon catheter selection:Use the minor annular axis as determined by CT angiographyUndersize the balloon according to previous guideline – but select a balloon that is at least 18mm and no larger than 25mm in diameterPreferred balloon characteristics: Short, straight, non-compliantSuperstiff wire (1 cm tip) should be deployed in the left ventricle utilizing a pigtail catheterPre-implant dilatation of the native aortic valve should not performed until the CoreValve device is prepared and ready for implantationIdentify 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 sinusChanging 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 procedureValve orientation should be instructed during proctoring sessionsFollowing 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 systemAfter deployment of the CoreValve device, close the capsule after withdrawing the delivery catheter to the descending aorta
23 Other Procedural Considerations Evaluation of PVLInvolves 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 DevicesConsider 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.
27 Access Routes Indicated for use access routes: Iliofemoral: Right or LeftSubclavian/Axillary: Right or LeftLeft preferred (versus right) due to delivery pathway’s typically better alignment with native aortic valve anatomy and less obstructive interaction with cranial perfusionMost appropriate access route selected by clinician based on patient anatomical characteristics
28 AccessACTEnsure appropriate ACT level is maintained throughout procedurePigtailIliofemoral or contralateral radial accessTemporary internal pacemaker catheter and leadInternal jugular veinCoreValve delivery catheter systemAxillary artery example below:Pre-op CT to assess accessIt is recommended that only Aspirin be given prior to the procedure, other antiplatelet therapy may be administered post procedureSurgical cut down located approximately 2 cm below and parallel to left clavicle, and 4-5 cm lateral to midclavicular lineIdentify 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 complicationsUse scalpel to control vessel opening while advancing sheathUse 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 catheterOperator 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 interferenceInvest time upfront to optimize room setup to meet unique aspects of subclavian/axillary approachORO2Key:O1 = Operator 1O2 = Operator 2Option BO1O2
30 Introducer Positioning Abduction of arm may help facilitate sheath passageAdvance 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 apexUse caution when advancing introducer, especially:Near stenotic and/or calcified regionsAt thoracic inlet and subclavian artery originPosition distal end of 18 Fr introducer immediately distal (upstream) to innominate/brachiocephalic artery for catheter advancement, valve deployment, and catheter withdrawalO1 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) accessMonitor cardiac function and patent ipsilateral IMA graft to ensure acceptable perfusion is maintained during intervention with 18 F introducerIf signs of compromised perfusion become present, adjust position of 18 F introducer to maintain acceptable perfusionSubclavian artery straightening due to introducer advancement could potentially cause patent ipsilateral IMA graft occlusionRecommended that vessel diameter be ≥ 7.5mm to reduce the occurrence of ischemic complications
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 onClinical preference (e.g. familiarization with approach)AnatomyDistance between vascular access site and basal planeAortic root angulation / coaxial alignmentIntended access site with respect to surrounding anatomical structuresComorbidities (e.g. avoiding pleural space with COPD)Clinician to discuss risks pertaining to the intended access route with the patientIt is recommended that only Aspirin be given prior to the procedure, other antiplatelet therapy may be administered post procedureMini-SternotomyMini-ThoracotomyTransaortic 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 consideredReasons to consider sternotomyNon-operated chestShort, or a relatively vertical and long, ascending aortaAortic root and LVOT well alignedInexperience with re-op thoracotomy or CoreValve direct aortic proceduresPatients with elevated risk due to pulmonary injury (e.g., severe pulmonary hypertension, COPD)Reasons to consider thoracotomyRIMA present by sternumOperated chest (i.e., redo)Challenging angulation (e.g. horizontal aorta) that may present coaxial alignment challengesAbility 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 procedureOperator 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 complicationsOperator 1 (O1) and Operator 2 (O2) must be in comfortable working positions with clear and close view of imaging screensConsider location of any additional equipment (e.g., additional table) to avoid/minimize C-arm interferenceConsider use of third operator on patient’s left side to maintain dedicated control of introducer sheath throughout procedureRecommend extension table for catheter and/or wireRoom Setup Example
36 Aortic AccessPlace graduated pigtail into noncoronary native aortic valve cusp and along greater curvature of ascending aortaPerform 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 metManually 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 insertionBruschi 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 recommendedPre-shaping introducer may help optimize delivery trajectory to achieve coaxial alignment with native aortic valveAdvance 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 positionPosition distal end of introducer approximately 2 cm into the aortic lumenUse 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 procedureIntroducer 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), orA 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 WithdrawalWith delivery catheter system tip distal to introducer, advance capsule to tip and withdraw delivery catheter system from introducerUse caution to avoid catching delivery catheter system tip on introducer during catheter withdrawalIntroducer WithdrawalPerformed together by both operators in a controlled mannerCarefully manage purse-string sutures to maintain effective hemostasisConsider rapid pacing for de-cannulationSuper Stiff Guidewire WithdrawalUse angiographic catheter to remove guidewireClosureClose per hospital protocol using appropriate closure technique to avoid dissection, tearing, and/or bleeding at access siteConsider placing additional suture across double purse- string sutures and access site to ensure effective closureConsider rapid pacing or pharmacologic agent to reduce systolic blood pressure below 100 mm Hg during closurePerform post-procedure angiography to ensure acceptable closurePost-Procedure CareNormal post-procedure care for any vascular access and minimally invasive thoracotomy/sternotomy procedureConsider 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.