TAVI - Sapien 3 (Edwards): Difference between revisions

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


*[https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/cardiovascular/transcatheter-aortic-valve-replacement.html CoreValve by Medtronic] - [[TAVR - CoreValve (Medtronic)|CoreValve Procedure Page]]
*[https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/cardiovascular/transcatheter-aortic-valve-replacement.html CoreValve by Medtronic] - [[TAVR - CoreValve (Medtronic)|CoreValve Procedure Page]]
*[https://www.edwards.com/gb/devices/heart-valves/transcatheter-SAPIEN-3-Ultra Sapien 3 Ultra by Edwards] - This page
*[https://www.edwards.com/gb/devices/heart-valves/transcatheter-SAPIEN-3-Ultra Sapien 3 Ultra by Edwards]  


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.
==Daniels ==
 
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
 
#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).
#Medtronic Core Valve – all items are charge separately.  Scan all barcodes (delivery system, loading system and valve).
 
MITRAL CLIP (Mitral/Tricuspid):
 
#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
ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX
<br />
===Equipment :===
===Sheaths:===


*5Fr Micropunture  Kit  
*5Fr Micropunture  Kit  
*6Fr x 10cm sheath
*6Fr x 10cm sheath
*8Fr x 10 cm sheath (Dilator used only)
*8Fr x 10 cm sheath  
*8Fr x 35 cm Brite Tip Sheath
*9Fr x 10cm sheath
 
===Wires===


*(2) Cordis 150J
*(2) Cordis 150J
*Cordis 260J
*Cordis 260J
*Amplatz Extra Stiff 260cm
*Safari Wire (DANIELS & SPIES)
*Amplatz Extra Stiff 1cm tip (GROVES)
*Terumo Stiff Straight Glidewire 0.035 x 150 cm
*Terumo Stiff Straight Glidewire 0.035 x 150 cm
*.035 Standard Straight for Valve-in-Valve crossing, no need for glidewire.
*Acist hand control
*(3) Perclose
*A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
*5Fr AL1 diagnostic 
*(2) 5Fr Ang Pigtail
**'''Valve-in-valve: Mosaic needs pigtail, all others do not.'''
*6Fr JL4/JR4 (when doing coronary angiography)
*Exofin topical adhesive
*NuKnit for closure


===Catheters:===
=== Unipolar Transvenous pacing supplies (Daniels preference) ===
 
* 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)
 
{{Protip|For patients with AI you don't need the Glidewire or AL1. Use second pigtail to cross. }}


*5Fr AL1 diagnostic 
*5Fr Ang Pigtail
*5Fr JL4/JR4 (when doing coronary angiography)


===Medications on table:===
===Medications on table:===
Line 48: Line 41:


*Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
*Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
*10 ml Rotaglide
*10 ml Rotaglide yellow syringe
 
===Edwards:===
 
*Crimper
*Indeflator
*Appropriate delivery system and valve
 
===Standby ECMO & Pericardial Effusion supplies===
 
=== 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 advanced 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
 
==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.
* Extension tubing for anesthesia flushed and secured on respecitve sides of the groin .


===Miscellaneous Supplies===
'''FRONT TABLE'''


*Daniel’s TAVR 3-port manifold kit
* 50/50 Lido and Bupivacaine mix used for local anesthetic.  Have extra available on front table.
*Acist hand control
* 1-1.5 L of Hep Saline in large bowl
*25g  1 ½ “ Daniels Lido Needle"
* 10ml of Rotaglide on table (Attached to E sheath)
*Suture Lock
* 10ml syringe of Epi on table.
*(4) Sterile Bowls
* U/S guidance for groin access
*¾ sterile sheet or back table cover
 
*(2) High Pressure stopcocks
'''BACK TABLE'''- valve prep
*(2) 60ml syringe
 
*20 ml syringe
* 3 Bowls: (1) 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%)
*(3) Perclose
* 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
* 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 '''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 EDP and gradient.
*8F sheath removed and E Sheath advanced.
*Insert valve delivery system
*Test pacer, black alligator clip on back of wire.
*'''Pacing : Unipolar Pacing - pace 120 - 180 , V max output 20ma. "Dial up to 180, dial down to 120, per MD request"'''
*'''Pacing : Bipolar pacing - pace 160 with 220 burst , A max output 25ma, set RAP to 220.'''
*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 Perclose
*Exofin all access sites, no dressing needed.
 
== ''THE SPIES TAVR EXPERIENCE'' ==


===Transvenous pacemaker supplies===
====Equipment: ====


*5Fr Josephson Pacing catheter
* 5Fr Micropunture  Kit  
* 6Fr x 10cm sheath
* 8Fr x 10 cm sheath
* 8Fr x 35 cm Brite Tip Sheath
* (2) Cordis 150J
* Cordis 260J
* 2 Perclose
* 2 Pigtails
* Straight steel .035 wire (NO straight stiff glide)
* Amplatz ES for sheath advancement
* Safari
* 5F Abbott Pacel Balloon Flow Directed Tip Pacing catheter for CS
*Dual Red/Black Pacing Remington cables
*Dual Red/Black Pacing Remington cables
*EP Quad Cable
*EP Quad Cable


===Standby ECMO & Pericardial Effusion supplies===
====Procedural Differences====
*E Sheath in right after pre-closure over Supracore
*AL1 advanced with J wire backloaded.
*After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced.
*Safari advanced through pigtail and pigtail removed.
*Iliac angio 6/18ml
*Lido with EPI at end of case
 
== ''THE GROVES TAVI EXPERIENCE'' ==
 
===== Product Substitute =====


==Procedure==
* 2 pigtails
* Amplatz ES 1CM tip
* Balloon-tipped Abbott Pacer


# Contralateral access artery -> 6fr. Sheath (normally LFA)
== '''''AGRAWAL SPECIAL''''' ==
# RFV access -> 8.5 Brite -tip
*All accesses with mircopuncture
# Primary access -> 8fr dilator -> Perclose -> e-sheath (normally RFA)
*2 Percloses on primary access site
# Pigtail -> LFA -> AO root
*.035 Standard Straight wire for valve crossing
# <br />
*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<br />
===PERIPHERAL BAILOUT EQUIPMENT===


===EMERGENT PERICARDIOCENTESIS===
* ''Have everything available in the room, but verify items prior to opening.''
{{Pericardiocentesis}}
* 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 <br />


<br/>
<hr />
<hr/>
Approved: MM/YY
Approved: MM/YY
[[Category:Procedures]]
[[Category:Procedures]]

Latest revision as of 16:49, 1 November 2024

Transcatheter Aortic Valve Repair (Wikipedia)

Daniels

ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX

Equipment :

  • 5Fr Micropunture  Kit  
  • 6Fr x 10cm sheath
  • 8Fr x 10 cm sheath
  • (2) Cordis 150J
  • Cordis 260J
  • Safari Wire (DANIELS & SPIES)
  • Amplatz Extra Stiff 1cm tip (GROVES)
  • Terumo Stiff Straight Glidewire 0.035 x 150 cm
  • .035 Standard Straight for Valve-in-Valve crossing, no need for glidewire.
  • Acist hand control
  • (3) Perclose
  • A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
  • 5Fr AL1 diagnostic 
  • (2) 5Fr Ang Pigtail
    • Valve-in-valve: Mosaic needs pigtail, all others do not.
  • 6Fr JL4/JR4 (when doing coronary angiography)
  • Exofin topical adhesive
  • NuKnit for closure

Unipolar Transvenous pacing supplies (Daniels preference)

  • 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 Protip: For patients with AI you don't need the Glidewire or AL1. Use second pigtail to cross.


Medications on table:

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

Edwards:

  • Crimper
  • Indeflator
  • Appropriate delivery system and valve

Standby ECMO & Pericardial Effusion supplies

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 advanced 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

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.
  • Extension tubing for anesthesia flushed and secured on respecitve sides of the groin .

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)
  • 10ml syringe of Epi on table.
  • U/S guidance for groin access

BACK TABLE- valve prep

  • 3 Bowls: (1) 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
  • 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 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 EDP and gradient.
  • 8F sheath removed and E Sheath advanced.
  • Insert valve delivery system
  • Test pacer, black alligator clip on back of wire.
  • Pacing : Unipolar Pacing - pace 120 - 180 , V max output 20ma. "Dial up to 180, dial down to 120, per MD request"
  • Pacing : Bipolar pacing - pace 160 with 220 burst , A max output 25ma, set RAP to 220.
  • 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 Perclose
  • Exofin all access sites, no dressing needed.

THE SPIES TAVR EXPERIENCE

Equipment:

  • 5Fr Micropunture  Kit  
  • 6Fr x 10cm sheath
  • 8Fr x 10 cm sheath
  • 8Fr x 35 cm Brite Tip Sheath
  • (2) Cordis 150J
  • Cordis 260J
  • 2 Perclose
  • 2 Pigtails
  • Straight steel .035 wire (NO straight stiff glide)
  • Amplatz ES for sheath advancement
  • Safari
  • 5F Abbott Pacel Balloon Flow Directed Tip Pacing catheter for CS
  • Dual Red/Black Pacing Remington cables
  • EP Quad Cable

Procedural Differences

  • E Sheath in right after pre-closure over Supracore
  • AL1 advanced with J wire backloaded.
  • After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced.
  • Safari advanced through pigtail and pigtail removed.
  • Iliac angio 6/18ml
  • Lido with EPI at end of case

THE GROVES TAVI EXPERIENCE

Product Substitute
  • 2 pigtails
  • Amplatz ES 1CM tip
  • Balloon-tipped Abbott Pacer

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

Approved: MM/YY