TAVI - Sapien 3 (Edwards)

Transcatheter Aortic Valve Repair (Wikipedia) procedures utilize a femoral approach to deliver a stent-based aortic valve to the patients heart. There are two valve types available:

• CoreValve by Medtronic - CoreValve Procedure Page
• Sapien 3 Ultra by Edwards - This page

This procedure is usually done in Room 1, and requires a 5 person team: Front table scrub, Back table scrub (device prep), Circulator, Pacer/Circulator, and Recorder. The rep for the respective company will be present to assist with device prep except in the case of an emergency valve placement.

In rare cases, the BASILICA procedure will be necessary to split the existing valve leaflets to prevent blockage of the coronary arteries. In that situation, the equipment on the BASILICA page will be needed in addition to the equipment listed below.

Per Rosalie:

TAVR/TMVI

1. Edwards Sapien 3 Ultra (20, 23 & 26mm) and Sapien 3 (29mm) – scan the valve barcode (box) in McKesson for documentation and charges.  Bundle includes valve, delivery system, crimper, e sheath intro set, balloon cath & locking syringe.  With the new inventory system (POU) space is limited in entering item full description.   If pre dilatation Edwards balloon is necessary free text the balloon used in procedure notes (McKesson).
2. Medtronic Core Valve – all items are charge separately.  Scan all barcodes (delivery system, loading system and valve).

Daniels (Spies has his own draft) - Draft

ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX

Sheaths:

• 5Fr Micropunture  Kit  
• 6Fr x 10cm sheath
• 8Fr x 10 cm sheath

• (2) Cordis 150J
• Cordis 260J
• Safari Wire
• Terumo Stiff Straight Glidewire 0.035 x 150 cm
• Acist hand control
• (3) Perclose
• A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
• 5Fr AL1 diagnostic 
• 5Fr Ang Pigtail (2 for Spies)
• 6Fr JL4/JR4 (when doing coronary angiography)

Unipolar Transvenous pacing supplies

• Alligator Clip Remington Pacing Cables
• TZ Medical Defibrillation Pads - Found in EP pyxis in labs. Large pad utilized as a grounding pad on the patients chest (subxyphoid)
• NOTE : If patient is in second degree HB please prep and drape RIJ

Protip:
For cases where patient has an LVAD you'll need a Safari II instead of an ES
For patients with AI you don't need the Glidewire.

Protip: For AI cases you'll need a second pigtail and no AL1.

Bipolar Transvenous pacemaker supplies

• 5Fr Josephson Pacing catheter for DD ; 5F Abbott Pacel Balloon Flow Directed Tip Pacing catheter for CS
• Dual Red/Black Pacing Remington cables
• EP Quad Cable
• 8Fr x 35 cm Brite Tip Sheath
• Amplatz Extra Stiff 260cm on standby

Medications on table:

• Lido/Bupivicaine 50/50

• Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
• 10 ml Rotaglide

Sentinel

• Grandslam 300cm
• 5/6 Slender
• 2.5 Verapamil
• DSA at 6fps of aortic arch with contralateral pigtail
• Don't open sentinel until we see the Grandslam advance thru the arm to the arch
• Prep instructions in lab 1 on the wall next to the light switches

For coronary protection:

• Radial access OR 12F dryseal in LFA if using sentinel
• 6F JL4
• Runthrough
• coronary balloon on md request

• 22G Grey Lido needle for Spies

Edwards:

• Crimper
• Indeflator
  • 23-26 - 2530 for up to 26+2
  • 29 - 38
• Appropriate delivery system and valve

Procedure

SEE BELOW FOR STEPS SPECIFIC TO SPIES and AGRAWAL

• Patient on defib pads. IF PATIENT HAS ICD: DEVICE DISABLED FOR PROCEDURE, COMPANY REP PRESENT IF POSSIBLE.

• Leg strap secured above knees. Wrists restrained.
• Patient prepped from naval to mid thigh using chlorahexidine soap followed by chloraprep with 3 minute dry time.
• Towel off site. Extend Femoral drape all the way to chin.
• Fluoro cover used to drape anesthesia's IV pole/x-ray shield.
• Extension tubing for anesthesia flushed and secured on respecitve sides of the groin .
• Dual pressure lines primed and zeroed prior to case start.

FRONT TABLE

• 50/50 Lido and Bupivacaine mix used for local anesthetic. Have extra available on front table.
• 1-1.5 L of Hep Saline in large bowl
• 10ml of Rotaglide on table (Attached to E sheath with a 20ml flush of hep saline)
• 10ml syringe of Epi taped on table.
• U/S guidance for groin access

BACK TABLE- valve prep

• 4 Bowls: (2) Normal Saline (500ml in each bowl) (1) Hep Saline (500ml) (1) 30ml contrast (170ml Hep Saline added to by scrub person to make it 15%)
• 20 ml of contrast in cup (100% contrast available on table. May need for hand injection or for peripheral balloon prep)
• 60ml Syringe with contrast mixture for balloon prep.
• 20ml Syringe for flushing delivery system
• Indeflator: volume dependent upon valve size
• Crimper
• Hemostats and scissors for valve opening
• High pressure stopcock

PROCEDURE STEPS

• Contralateral arterial access - 6fr. Sheath (normally LFA) using micropuncture. Verify wire position with fluoro and save an image.
• Primary access - with micropuncture. Verify wire position with fluoro and save an image
  • Pre-close x 1, sutures secured with hemostat.
  • 8F sheath reconstituted and advanced after pre-closure.

• Pigtail -> LFA -> AO root injection
  • Standard Injector settings (adjusted based on pt and root size)

10/10 20mm valve, 15/15 23mm and 26mm valve, 20/20 29mm valve

• AL1 advanced through 8F sheath over standard J.
• Standard J removed and crossing wire advanced. Cross valve. Wire removed.
• Measure gradient...maybe
• 8F sheath removed and E Sheath advanced.
• Insert valve delivery system
• Test pacer, black alligator clip on back of wire. Rapid pace 160, check for capture, 220 burst
• Multiple AO grams for positioning
• Pace -> AO gram -> Pigtail pulled back -> Deploy valve
  • Cine length set at 40 seconds or more
• TTE

if post dilation is needed...

Rep will come up and re-prep valve, adding desired amount of additional volume

If Safari was pulled back, recross wire will be needed (260cm angled stiff glide)

• Pigtail readvanced to AO for AO gram (15/30 standard injection)
• Safari exchanged for 260 J
• Delivery system removed
  • Have second perclose, tools and dilator ready
• Protamine given, Preclosures completed, manual pressure for 5ish minutes
• Pigtail pulled back to iliac bifurcation and subtracted iliac angio performed (6/18 on Acist)
• Pigtail removed
• Secondary access Perclosed
• Dermabond all access sites, no dressing needed.

THE SPIES TAVR EXPERIENCE

Product substitution

• 2 Pigtails
• Balloon-tipped PACEL pacer
• Straight steel .035 wire (NO straight stiff glide)
• Supracore

Procedural Differences

• E Sheath in right after pre-closure over Supracore
• Amplatz ES removed after E sheath insertion. AL1 advanced with J wire backloaded.
• After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced. Amplatz ES advanced through pigtail and pigtail removed.
• Have IM available for iliac angiogram.
• Iliac angio 6/18ml
• Lido with EPI at end of case

AGRAWAL SPECIAL

• All accesses with mircopuncture
• 2 Percloses on primary access site
• .035 Standard Straight wire for valve crossing
• After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced. Amplatz ES advanced through pigtail and pigtail removed.
• Amplatz ES to exchange 8F for E sheath
  

PERIPHERAL BAILOUT EQUIPMENT

• Have everything available in the room, but verify items prior to opening.
• 5F Rim Catheter
• 6F or 7F Destination RDC
• Exchange length Glidewire advantage
• Exchange length angled glidewire
• Supracore wire
• Mustang balloons on 75cm shaft (6mm to 10mm x 40mm)
• Viabahn stents
  

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Approved: MM/YY