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 (Dilator used only)
• 8Fr x 35 cm Brite Tip Sheath

Wires

• (2) Cordis 150J
• Cordis 260J
• Amplatz Extra Stiff 260cm
• Terumo Stiff Straight Glidewire 0.035 x 150 cm

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.

Catheters:

• 5Fr AL1 diagnostic 
• 5Fr Ang Pigtail (2 for Spies)
• 6Fr JL4/JR4 (when doing coronary angiography)

Warning: This has changed to 6 French!

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

Medications on table:

• Lido/Bupivicaine 50/50

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

Miscellaneous Supplies

• Acist hand control
• (3) Perclose
• A & V extension line from anesthesia
• 22G Grey Lido needle for Spies

Edwards:

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

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

For coronary protection:

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

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 Bupivicaine mix used for local anesthetic. Have extra available on front table.

100% contrast available on table. (May need for hand injection or for peripheral balloon prep)

10ml of Rotoglide 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 (1) Hep Saline (1) 30ml contrast, 170ml Hep Saline mix (15%)

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

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
  • Leave micropuncture wire in while venous access is obtained
  • Once venous sheath is in place, dilate tract with 8F dilator
  • Pre-close x 1, sutures secured with hemostat.
  • 8F sheath reconstituted and advanced after pre-closure.

• Venous access- 8F 35cm brite tip over 150cm J wire. (Same side as TAVR sheath)
• 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

• Insert and test pacemaker
  • Rapid pace 160, check for capture, 220 burst
• AL1 advanced through 8F sheath over standard J.
• Standard J removed and crossing wire advanced. Cross valve. Wire removed.
• Measure gradient...maybe
• Amplatz ES shaped by MD and advanced to LV. AL1 removed.
  • 8fr. Dilator or micropuncture sheath on Amplatz ES as a cheater
• 8F sheath removed and E Sheath advanced.
• Insert valve delivery system
• 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 Amplatz ES was pulled back, recross wire will be needed (260cm angled stiff glide)

• Pigtail readvanced to AO for AO gram (15/30 standard injection)
• Amplatz ES exchanged for 260 J
• Temp pacer removed
• 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...maybe
• Pigtail removed
• Secondary access Perclosed
• Venous sheath removed in lab and manual pressure held until hemostasis achieved.
• 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

Not DD or CS

Call Echo

• Micropuncture
• 75 Amplatz SS
• Pericardiocentesis tray
• Accordion drain bag

Spies

Call Echo

Supplies:

• Micro puncture
• 150cm J wire
• 4/5fr slender sheath
• 5fr straight pigtail diagnostic
• gravity drainage bag
• brown reservoir lab canister
• Two 50 or 60ml syringes

Daniels

Call Echo

Supplies

Open

Emergency Kit located in each lab containing the following items:

• Eye drape
• Skater introducer set
• Bard locking pigtail (6f or 8f)
• (3) 60ml luer lock syringe
• Amplatz super stiff .035 180cm wire
• Probe cover
• Stopcock
• Accordion drainage bag

Standby

• Chiba biopsy needle 10cm 18g
• Standard .035 150cm j wire

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Approved: MM/YY