FAQ

FAQ iVAC 2L

  1. Is using iVAC 2L create hemolysis?
    1. Every pump creates blood destruction but iVAC 2L almost not damaging RBC due to low negative pressure during suction and smooth membrane pump that keep smooth circle blood flow, level of FHb is significantly lower than impeller pump <10mg/DL comparing 50-100mg/DL in continuance flow pumps.
  2. What is the ACT level?
    1. ACT level is 200 sec.
  3. I never used a pump during High-risk PCI why should I start now?
    1. Performing high-risk cases normally create heart deuteriation during blocking LM coronary with a balloon. This, in many cases, forced to stop procedure in order to let myocardial to recover. Therefore, the optimum treatment cannot be accomplished in one time (continue with opening other deeper vessels). In order to perform “all in one” and get to maximum outcome from one procedure, the iVAC 2L can prevent patient collapsing and give the “safety network” needed to continue for next steps.
    2. Not using safety network pump during these cases force you to perform the procedure at high speed for senior doctors and well experienced that option can work. but with less experienced doctors we believe it will be safer for patients to be on the safe side.
  4. Is 17fr. Catheter crossing AV creates valve insufficiency?
    1. From our experience almost not at all. Due to synchronizing between the heart and iVAC 2L ejection of blood starts after AV is closed therefore downstream flow and pressure increasing on to of closed AV leaflets force leaflets wrapped around the catheter and prevent blood backflow to LV.
  5. Is 17fr. not blocking blood flow to lower extremities?
    1. This is one of iVAC 2L limitation and contra indications, vessel smaller than 5.9mm is too small and may create full lower limb occlusion that may lead to future complication. Therefor patient selection is highly important and pre assessment of femoral artery is crucial. We recommend to use the same assessment procedure as TAVI.
  6. What is the benefit of pulsatile over continuance flow?
    1. In general, both can support failing heart almost the same, it appears in a study done by Tokyo university that due to synchronization with heart phases the afterload effect is lower in the aorta during diastolic. Therefore, LVP is lower and energy consumption of myocardial is lower, the outcome is a better myocardium relief.
  7. How many supported cases do I need in order to perform it by myself?
    1. The learning curve is very short 2-3 cases will give you enough confidence to perform case without support. The procedure is very simple and daily routine (place catheter tip in LV) also running IABP driver is very easy and similar to usual use with a balloon.
  8. How do I close the big wound?
    1. You may use the same technique you use with TAVI. Double proglide / prostar closer device or the new Manta can be also used post procedure.
  9.  What console shall I use with iVAC 2L?
    1. The iVAC 2L can be driven by any IABP drive you have in your clinic (Arrow or Maquet) the setting is similar to IAB settings.
  10. Is Maquet or Arrow approve to use IVAC 2L with their device?
    1. Our CE approval include a list of drivers tested with iVAC 2L.
    2. Till today we got no problem from their side both of them checked iVAC 2L with IABP internally.
    3. In worth case scenario PulseCath will give you a written obligation that if IABP damaged because of using iVAC 2L it will take the responsibility to cover fixing costs.
  11. How long can I leave iVAC 2L in a patient?
    1. At the moment it is approved for 24H.
    2. We applied to CE notified body to extend it to 48H supported with clinical results showed safety with using iVAC 2L up to 48H.
  12. Is iVAC 2L efficient with end stage CS patients
    1. At the moment we don’t have enough clinical data support iVAC 2L efficacy in end stage CS patients. Our experience showed high efficacy during high risk PCI with low EF patients.
  13. Is 2L/min enough to support failing LV patients?
    1. The 2L/min is additional volume added to LV CO, as these 2L ejected at the diastolic phase and systolic CO remain the same, the accumulated volume (Sys CO+ IVAC 2L ) is enough to support these indications.
  14. What are the main indications for using IVAC 2L?
    1. The main indication is protected high-risk PCI procedure.
    2. Early stage CS (second high dose of inotropic drugs).
    3. Unloading LV with ECMO combination.
    4. Postcardiotomy patients cannot wean from HLM.
  15. Can you show studies support these claims? 
    1. During the last 2 years more than 15 different publication about iVAC 2L performance and efficacy. Some studies compared iVAC 2L and Impella showed igh similarity with clinical outcome.
    2. PV loop study results showed a significant improve of hemodynamics and mechanical function of myocardial. For more clinical studies please check the clinical information section.
  16. Is there a risk of Thrombus in the gap between membrane and catheter valve?
    1. As long the pump is working there is no risk of thrombus, the Volume between membrane and valve is 12cc and the pump eject in every cycle 20-35cc, therefore, the amount of blood in the catheter exchange in every beat.
  17. What is iVAC 2L experience so far?
    1. iVAC 2L commercially launched in August 2018. Since then more than 200 cases performed in more than 30 countries worldwide. The device is used in leading centers arround Europe such as, Erasmus Rotterdam, St. Thomas London, Charite Berlin , Groningen NL, Minden University Germany, CHU Liege BL, Mediterane Naples and many more.