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 ==
ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX


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.
=== **If the patient has an existing RBBB, prep the right chest and no rampart.*** ===


Per Rosalie:
===Equipment: ===
 
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).
 
==Daniels (Spies has his own draft) - Draft==
ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX
===Sheaths:===


*5Fr Micropunture  Kit  
*5Fr Micropunture  Kit  
*6Fr x 10cm sheath
*7Fr Glidesheath (2.5 Verapamil)
*8Fr x 10 cm sheath  
*8Fr x 10 cm sheath


*(2) Cordis 150J
*(2) Cordis 150J
*Cordis 260J
*Cordis 260J
*Safari Wire (DANIELS)
*1.5mm J Glidewire (BABY J glide ; ADVANCED WITH A CHEATER without catheter loaded)
*Amplatz Extra Stiff 1cm tip (SPIES & GROVES)  
*Terumo Stiff Straight Glidewire 0.035 x 150 cm
*Terumo Stiff Straight Glidewire 0.035 x 150 cm
*Safari
*.035 Standard Straight for Valve-in-Valve crossing, no need for glidewire.
*.035 Standard Straight for Valve-in-Valve crossing, no need for glidewire.
*Acist hand control
*Acist hand control
*(3) Perclose
*(2) Perclose
*TR Band
*A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
*A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
*5Fr AL1 diagnostic 
*5Fr AL1 diagnostic 
*5Fr Ang Pigtail x 2
*(1) 5Fr Ang Pigtail
*(1) 5Fr St. Pigtail for root angio from radial
**'''Valve-in-valve: Mosaic needs pigtail, all others do not.'''
*6Fr JL4/JR4 (when doing coronary angiography)
*6Fr JL4/JR4 (when doing coronary angiography)
*Exofin topical adhesive
*NuKnit for closure
*Alligator Clip Remington Pacing Cables
* TZ Medical Defibrillation Pads -  Large pad utilized as a grounding pad on the patients left ribs.


=== Unipolar Transvenous pacing supplies (Daniels preference) ===
===Standby Equipment:===
* 125cm 5Fr Pigtail
* 85cm RTP
* 200cm Glide Advantage
* 8mm x 40mm x 200mm RX MetaCross balloon


* Alligator Clip Remington Pacing Cables
{{Protip|For patients with AI you don't need the Glidewire or AL1. Use second pigtail to cross. }}
* 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|</BR>For cases where patient has an LVAD you'll need a Safari II instead of an ES</BR>
=== Medications on table: ===
For patients with AI you don't need the Glidewire.}}
*Lido/Bupivicaine 50/50


{{Protip|For AI cases you'll need a second pigtail and no AL1.}}
*Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
*10 ml Rotaglide yellow syringe


=== Bipolar Transvenous pacemaker supplies (GROVES and SPIES preference) ===
===Edwards:===
*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


===Medications on table:===
*Crimper
*Indeflator
*Appropriate delivery system and valve


*Lido/Bupivicaine 50/50
===Standby ECMO & Pericardial Effusion supplies===
 
*Epinephrine 10mcg/ml in red medallion syringe (From anesthesia)
*10 ml Rotaglide
 
=== Sentinel ===


=== Sentinel: ===
* Grandslam 300cm
* Grandslam 300cm
* 5/6 Slender
* 5/6 Slender
Line 76: Line 72:


*22G Grey Lido needle for Spies
*22G Grey Lido needle for Spies
===Edwards:===
*Crimper
*Indeflator
**23-26 - 2530 for up to 26+2
**29 - 38
*Appropriate delivery system and valve
===Standby ECMO & Pericardial Effusion supplies===


==Procedure==
==Procedure==
'''''SEE BELOW FOR STEPS SPECIFIC TO SPIES and AGRAWAL'''''
'''''SEE BELOW FOR STEPS SPECIFIC TO SPIES and AGRAWAL and GROVES'''''


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


* Leg strap secured above knees. Wrists restrained.
* Leg strap secured above knees. Left wrist.
* Patient prepped from naval to mid thigh using chlorahexidine soap followed by chloraprep with 3 minute dry time.  
* Patient prepped from naval to mid thigh using chlorahexidine soap followed by chloraprep with 3 minute dry time.  
* Right radial prepped.
* Towel off site. Extend Femoral drape all the way to chin.  
* 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 .
* 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'''
===FRONT TABLE===


* 50/50 Lido and Bupivacaine mix used for local anesthetic.  Have extra available on 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  
* 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 of Rotaglide on table (Attached to E sheath)
* 10ml syringe of Epi taped on table.
* 10ml syringe of Epi on table.
* Lido with EPI.  
* U/S guidance for groin access
* U/S guidance for groin access


'''BACK TABLE'''- valve prep
===BACK TABLE (Valve)===


* 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 Bowls: (1) Normal Saline (500ml in each bowl)  (1) Hep Saline (500ml) (1) 15ml contrast (85ml 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)
* 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.  
* 60ml Syringe with contrast mixture for balloon prep.  
Line 115: Line 101:
* Indeflator: volume dependent upon valve size
* Indeflator: volume dependent upon valve size
* Crimper
* Crimper
* Hemostats and scissors for valve opening
* High pressure stopcock
* High pressure stopcock


'''PROCEDURE STEPS'''
===PROCEDURE STEPS===


*Contralateral arterial access - 6fr. Sheath (normally LFA) using micropuncture. Verify wire position with fluoro and save an image.
*Right radial access for 6Fr slender. 2.5 of verapamil.  
*Primary access - with 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.
**Pre-close x 1, sutures secured with hemostat.
**8F sheath reconstituted and advanced after pre-closure.
**8F sheath reconstituted and advanced after pre-closure.
*1.5mm Baby J glidewire with cheater advanced from the radial. DO NOT preload pigtail.


*Pigtail -> LFA -> AO root injection
*Straight Pigtail -> AO root injection
**Standard Injector settings (adjusted based on pt and root size)
**Standard Injector settings '''10/10 20mm valve, 15/15 23mm and 26mm valve, 20/20 29mm valve'''
 
'''10/10 20mm valve, 15/15 23mm and 26mm valve, 20/20 29mm valve'''


*AL1 advanced through 8F sheath over standard J.
*AL1 advanced through 8F sheath over standard J.
*Standard J removed and crossing wire advanced. Cross valve. Wire removed.
*Standard J removed and crossing wire advanced. Cross valve. Wire removed.
*Measure gradient...maybe
*Measure EDP and gradient.
*8F sheath removed and E Sheath advanced.
*8F sheath removed and E Sheath advanced.
*Insert valve delivery system
*Insert valve delivery system
Line 139: Line 123:
*'''Pacing : Bipolar pacing - pace 160 with 220 burst , A max output 25ma, set RAP to 220.'''
*'''Pacing : Bipolar pacing - pace 160 with 220 burst , A max output 25ma, set RAP to 220.'''
*Multiple AO grams for positioning
*Multiple AO grams for positioning
*Pace -> AO gram ->  Pigtail pulled back -> Deploy valve
*Pace -> AO gram --> Deploy valve
**Cine length set at 40 seconds or more
**Cine length set at 40 seconds or more
*TTE
*TTE
Line 154: Line 138:
**Have second perclose, tools and dilator ready
**Have second perclose, tools and dilator ready
*Protamine given, Preclosures completed, manual pressure for 5ish minutes
*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 advanced to iliac bifurcation and subtracted iliac angio performed (6/18 on Acist)
*Pigtail removed
*Pigtail removed
*Secondary access Perclosed
*Secondary access Perclose with Nu-Knit pieces.
*Dermabond all access sites, no dressing needed.  
*Lido with EPI for fem access.
===''THE SPIES TAVR EXPERIENCE''===
*TR Band on radial.
====Product substitution====
*Exofin all access sites, no dressing needed.
*2 Pigtails
 
*Balloon-tipped PACEL pacer
== THE SPIES TAVR EXPERIENCE ==
*Straight steel .035 wire (NO straight stiff glide)
 
*Supracore for E Sheath advancement
===Equipment:===


====Procedural Differences====
* 5Fr Micropunture  Kit  
*E Sheath in right after pre-closure over Supracore OR Ampaltz ES 
* 6Fr Glidesheath (2.5 Verapamil)
*Amplatz ES removed after E sheath insertion. AL1 advanced with J wire backloaded.
* 8Fr x 10 cm sheath
*After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced. Amplatz ES advanced through pigtail and pigtail removed.
* (2) Cordis 150J
*Have IM available for iliac angiogram.
* Cordis 260J
* Straight steel .035 wire (NO straight stiff glide)
* 1.5mm J Glidewire (BABY J glide ; ADVANCED WITH A CHEATER without catheter loaded)
* Safari
* Amplatz ES for sheath advancement
* hand control
* (2) Perclose
* TR Band
* A-extension line from anesthesia
* 5Fr AL1 diagnostic 
* (1) 5Fr Ang Pigtail
* (1) 5Fr St. Pigtail for root angio from radial
* 6Fr JL4/JR4 (when doing coronary angiography)
* Exofin topical adhesive
* Alligator Clip Remington Pacing Cables
* TZ Medical Defibrillation Pads -  Large pad utilized as a grounding pad on the patients left ribs.
 
===Standby Equipment:===
 
* 125cm 5Fr Pigtail
* 85cm RTP
* 200cm Glide Advantage
* 8mm x 40mm x 200mm RX MetaCross balloon
 
===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
*Iliac angio 6/18ml
*Lido with EPI at end of case  
*Lido with EPI at end of case  


=== ''THE GROVES TAVI EXPERIENCE'' ===
== THE GROVES TAVI EXPERIENCE ==


===== Product Substitute =====
=== Product Substitute ===


* 2 pigtails
* 2 pigtails
* Amplatz ES 1CM tip
* Amplatz ES 1CM tip for sheath advancement
* Balloon-tipped Abbott Pacer  
* Balloon-tipped Abbott Pacer  


==='''''AGRAWAL SPECIAL'''''===
== AGRAWAL SPECIAL ==
 
*All accesses with mircopuncture
*All accesses with mircopuncture
*2 Percloses on primary access site
*2 Percloses on primary access site
Line 188: Line 199:
*After valve crossing, EXCHANGE J inserted, AL1 removed and SECOND PIGTAIL advanced. Amplatz ES advanced through pigtail and pigtail removed.
*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 />
*Amplatz ES to exchange 8F for E sheath<br />
===PERIPHERAL BAILOUT EQUIPMENT===
 
 
==PERIPHERAL BAILOUT EQUIPMENT==


* ''Have everything available in the room, but verify items prior to opening.''
* ''Have everything available in the room, but verify items prior to opening.''
Line 199: Line 212:
* Viabahn stents <br />
* Viabahn stents <br />


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

Latest revision as of 18:14, 20 February 2025

Transcatheter Aortic Valve Repair (Wikipedia)

Daniels

ACIST A1000V SYRINGE USED WITH 50/50 CONTRAST MIX

**If the patient has an existing RBBB, prep the right chest and no rampart.***

Equipment:

  • 5Fr Micropunture  Kit  
  • 7Fr Glidesheath (2.5 Verapamil)
  • 8Fr x 10 cm sheath
  • (2) Cordis 150J
  • Cordis 260J
  • 1.5mm J Glidewire (BABY J glide ; ADVANCED WITH A CHEATER without catheter loaded)
  • Terumo Stiff Straight Glidewire 0.035 x 150 cm
  • Safari
  • .035 Standard Straight for Valve-in-Valve crossing, no need for glidewire.
  • Acist hand control
  • (2) Perclose
  • TR Band
  • A extension line from anesthesia (Venous extension only if we are doing bipolar pacing)
  • 5Fr AL1 diagnostic 
  • (1) 5Fr Ang Pigtail
  • (1) 5Fr St. Pigtail for root angio from radial
    • Valve-in-valve: Mosaic needs pigtail, all others do not.
  • 6Fr JL4/JR4 (when doing coronary angiography)
  • Exofin topical adhesive
  • NuKnit for closure
  • Alligator Clip Remington Pacing Cables
  • TZ Medical Defibrillation Pads - Large pad utilized as a grounding pad on the patients left ribs.

Standby Equipment:

  • 125cm 5Fr Pigtail
  • 85cm RTP
  • 200cm Glide Advantage
  • 8mm x 40mm x 200mm RX MetaCross balloon

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 and GROVES

  • Patient on defib pads. IF PATIENT HAS ICD: DEVICE DISABLED FOR PROCEDURE, COMPANY REP PRESENT IF POSSIBLE.
  • Leg strap secured above knees. Left wrist.
  • Patient prepped from naval to mid thigh using chlorahexidine soap followed by chloraprep with 3 minute dry time.
  • Right radial prepped.
  • 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.
  • Lido with EPI.
  • U/S guidance for groin access

BACK TABLE (Valve)

  • 3 Bowls: (1) Normal Saline (500ml in each bowl) (1) Hep Saline (500ml) (1) 15ml contrast (85ml 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

  • Right radial access for 6Fr slender. 2.5 of verapamil.
  • 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.
  • 1.5mm Baby J glidewire with cheater advanced from the radial. DO NOT preload pigtail.
  • Straight Pigtail -> 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 --> 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 advanced to iliac bifurcation and subtracted iliac angio performed (6/18 on Acist)
  • Pigtail removed
  • Secondary access Perclose with Nu-Knit pieces.
  • Lido with EPI for fem access.
  • TR Band on radial.
  • Exofin all access sites, no dressing needed.

THE SPIES TAVR EXPERIENCE

Equipment:

  • 5Fr Micropunture  Kit  
  • 6Fr Glidesheath (2.5 Verapamil)
  • 8Fr x 10 cm sheath
  • (2) Cordis 150J
  • Cordis 260J
  • Straight steel .035 wire (NO straight stiff glide)
  • 1.5mm J Glidewire (BABY J glide ; ADVANCED WITH A CHEATER without catheter loaded)
  • Safari
  • Amplatz ES for sheath advancement
  • hand control
  • (2) Perclose
  • TR Band
  • A-extension line from anesthesia
  • 5Fr AL1 diagnostic 
  • (1) 5Fr Ang Pigtail
  • (1) 5Fr St. Pigtail for root angio from radial
  • 6Fr JL4/JR4 (when doing coronary angiography)
  • Exofin topical adhesive
  • Alligator Clip Remington Pacing Cables
  • TZ Medical Defibrillation Pads - Large pad utilized as a grounding pad on the patients left ribs.

Standby Equipment:

  • 125cm 5Fr Pigtail
  • 85cm RTP
  • 200cm Glide Advantage
  • 8mm x 40mm x 200mm RX MetaCross balloon

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 for sheath advancement
  • 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
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