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.