TAVI - Sapien 3 (Edwards)

From Bay Area Structural Heart Wiki

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:

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).

MITRAL CLIP (Mitral/Tricuspid):

  1. Use the barcode on Mckesson screen in Lab 1 – Mitraclip (Abbott) bundle consists of (1) Steerable Guide Catheter, (2) NTR Clip Delivery System & (1) XTR Clip Delivery System.

Daniels/Spies - Draft

ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX


*** Procedural variance as of 2/20 for DD ONLY***

  • 8F dilator opened instead of sheath set.
  • 9F sheath opened
  • ONE preclose then 150 J wire
  • 9F sheath inserted for valve crossing.
  • Valve opened upon sheath insertion. Final crimp still performed after Amplatz ES across valve.
  • 9F exchanged for ESheath just prior to valve insertion.



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

Catheters:

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

Medications on table:

  • Lido/Bupivicaine 50/50
  • Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
  • 10 ml Rotaglide

Miscellaneous Supplies

  • 3-port manifold kit
  • Acist hand control
  • (4) Sterile Bowls
  • Back table cover
  • High Pressure stopcock
  • 60ml syringe
  • 20 ml syringe
  • (3) Perclose
  • Fluoro cover
  • A & V extension line from anesthesia
  • O- Ethibond
  • 2-0 Prolene
  • (3) hemostats
  • Needle drivers

Transvenous pacemaker supplies

  • 5Fr Josephson Pacing catheter
  • Dual Red/Black Pacing Remington cables
  • EP Quad Cable

Standby ECMO & Pericardial Effusion supplies

Procedure

SEE BELOW FOR STEPS SPECIFIC TO SPIES


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 (for E sheath just prior to valve insertion)

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
    • Double preclose. Each perclose suture secured with hemostat.
    • After second perclose Amplatz ES is inserted using micropuncture sheath as a cheater
  • Venous access- 8F 35cm brite tip over 150cm J wire. (Same side as TAVR sheath)
  • Esheath sutured with 0-Ethibond
  • 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 E sheath over Amplatz ES
  • Amplatz ES removed and crossing wire advanced. Cross valve. Wire removed.
  • Measure gradient
  • Amplatz ES shaped by MD and advanced to LV. AL1 removed.
    • 8fr. Dilator or micropuncture sheath on Amplatz ES as a cheater
  • Rotoglide in sheath.
  • 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 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
  • Pigtail removed
  • Secondary access Perclosed
  • Venous sheath exchanged for 9fr. Sheath 10cm sheath -> suture-locked


THE SPIES TAVR EXPERIENCE

  • All accesses obtained with micropuncture
  • 50/50 contrast for groin shot at both arterial access sites
  • 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.
  • NO ROTOGLIDE
  • Have IM available for iliac angiogram.
  • Iliac angio 6/18ml



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

EMERGENT PERICARDIOCENTESIS

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



Approved: MM/YY