4.4 The safety of LAAC with ICE imaging
No severe intra-procedural complications occurred in either group. There was no device-related thrombus, device embolism, major bleeding or death occurred in either group at 2 months follow-up. One patient in TEE group developed pericardial effusion which was inherent to the procedure. No complication was related to the manipulation of ICE catheter.
The presence of residual iatrogenic atrial septal defect (iASD) after transseptal catheterization is not uncommon. Sheldon et al13 reported that patients undergoing LAAC with WATCHMAN device as a part of PROTECT-AF study had a high incidence of 34% at 45 days TEE follow-up. However, the study also showed a high spontaneous closure rate (7% at 12 months) of iASDs that was not associated with an increased rate of stroke/systemic embolization during long-term follow-up. Chan et al14 documented an occurrence rate for persistent iASD of 30.6% at 9-month and 20% at 6-year TEE follow-up in AF patients with cryoballoon pulmonary vein isolation. Two patients with a defect size of over 10mm required percutaneous closure due to significant left-to-right shunting in that study. The long-term effect of persistent iASD on echocardiographic parameters and on clinical outcomes remain unclear. Korsholm et al5 compared ICE-guided LAAC under local anesthesia with TEE-guided LAAC under general anesthesia using Amplatzer Cardiac Plug or Amulet device. The mean 55-day follow-up of TEE after procedure showed no significant difference in incidence (35% vs 26%) and size of iASD between the two groups. Our study showed that the ICE group had numerically more iASD cases than the TEE group without increased size at 45-day follow-up. Whether ASD would close spontaneously remains to be assessed at long-term follow-up.