Edwards SAPIEN Transcatheter Heart Valve

Device preparation
  1. Unpack Edwards eSheath Introducer set and flush the sheath and dilator. Set loader to the side for later use.
  2. Flush delivery system through flush port. Remove the distal balloon cover over tapered tip and remove stylet and set aside. Flush guidewire lumen and insert stylet back into guidewire lumen.
  3. Place loader cap on delivery system. Place delivery system in default position (end of strain relief is aligned between the two white markers on the balloon shaft). Make sure the FlexTip is covered by the proximal balloon cover. Unscrew loader cap from loader tube and flush loader cap and seal. Gently place loader cap over proximal cover and onto the Flex Catheter with inside of cap facing towards the tapered tip. Place delivery system back to packaged position (fully advance the balloon catheter in the Flex catheter). Remove proximal balloon catheter.
  4. Attach high pressure 3-way stopcock to balloon inflation port and attach a 50 cc or larger luer lock syringe with 15-20 ml diluted contrast and inflation device (fill with excess volume relative to indicated balloon catheter inflation volume) to the remaining ports of the stopcock. Close stopcock to balloon catheter and de-air inflation device. Close stopcock to inflation device and de-air balloon catheter with luer lock syringe. Close stopcock to balloon catheter and rotate inflation device knob clockwise to remove any remaining air bubbles and diluted contrast from inflation device to luer lock syringe to achieve specified volume. Ensure inflation device is locked, open 3-way stopcock to inflation device and remove luer syringe.
  5. Place the transcatheter heart valve (THV) into Qualcrimp Crimping Accessory aligning the edge of the Qualcrimp Accessory with the outflow of the THV. Full Crimp is performed until it reaches final stop and hold for 5 seconds. Repeat this Crimp step two more times, for a total of 3 crimps each for 5 seconds.
  6. Advance THV into the loader until yellow portion of the tapered tip is exposed, but loader tip is still within the tapered tip section. THV is within the straight section of the loader. Screw loader cap to loader tube. Gently flush flex catheter through flushport until loader is completely filled and close stopcock to delivery system.
Transfemoral access site preparation
  1. Femoral arterial access is serially dilated to accommodate sheaths [20, 23 & 26 mm – 14 Fr (I.D); 29 mm – 16 Fr (I.D)]. Preclosure of the arteriotomy using two Perclose Proglide are performed. Administer weight based heparin (100 U/Kg) with a goal ACT of 250s prior to sheath insertion. Insert the sheath Edwards logo facing upward over a stiff wire (Supracore or Extra Stiff Amplatz wire) and advance past the aortic bifurcation.
  2. In the contralateral femoral artery, a diagnostic pigtail catheter is advanced into the aortic arch for aortic arch angiography to assess for cerebral embolic protection device. Then pigtail catheter was advanced to the right coronary cusp for root angiography to assess for implantation angle in the annular plane (fluoroscopic angle where bases of all three cusps are aligned in one line and preprocedural CT scan can help identify the best fluoroscopic view to get the appropriate annular plane) (Figure).
Crossing the valve and Wire positioning
  1. Refer to BAV section for crossing the valve. Choose an appropriate guide wire, either Confida or Safari wire depending on the LV size and risk factors for LV perforation (chemotherapy or chronic immunosuppression or radiation therapy)
Advancement of the Commander delivery system
  1. Delivery system should be inserted into the eSheath with the Edwards logo facing upwards, the flush port pointing away and holding the loader cap along with the THV. Then, wire position should be confirmed in the LV and sheath tip distal to aortic bifurcation.
Align the THV
  1. After the balloon mounted THV is advanced into descending aorta, Flex catheter should be retracted at the Y-connector until part of the warning marker is visible by fixing the delivery system with left hand and pulling back balloon catheter with right hand and the balloon lock secured. Use the Fine Adjustment Wheel to position the THV between the alignment markers.
Crossing the aortic valve with Edwards SAPIEN Delivery System
  1. Before crossing the aortic arch, the delivery catheter is flexed, and advanced in the LAO projection. When the nose cone is past the aortic valve, return to the prior fluoroscopic view for THV implantation. Once the THV crosses the native valve, the outer flex catheter is withdrawn to avoid interference with balloon inflation.
 Valve positioning and deployment
  1. THV is positioned in 80-20% across the aortic valve annulus (80% aortic side and 20% ventricular side) and the valve plane is confirmed with aortic root angiography with pigtail placed in the noncoronary cusp.
  2. Once the valve position is confirmed, rapid pacing is started and when the BP drops around 50 mmHg, the THV is then balloon expanded rapidly but steady inflation mode. After ensuring proper expansion of THV pacing can be stopped and balloon is deflated and pulled in the ascending aorta.