Materials & Methods:
This was a retrospective, observational cohort study based on a
single-center prospective LAAO registry at Piedmont hospital, Atlanta,
GA. The Study protocol was approved by the institutional IRB. The first
25 consecutive patients undergoing balloon dilation of IAS during LAAO
served as the experimental cohort. The 25 consecutive patients prior to
that in whom balloon dilation was not performed, served as controls.
Two separate venous accesses were obtained in the right femoral vein
with 8.5 F Versacross™ sheath and 9-F 45-cm sheaths to accommodate the
transeptal delivery system and the ICE catheter (AcuNav™, Siemens
healthcare), respectively. Full anticoagulation was administered before
trans-septal puncture (TSP). An ICE positioned in the mid right atrium
guided the TSP.
For the experimental group, post TSP, the 8.5 F Versacross™ sheath was
retracted to the right atrium with the guide wire still in the LA. An
8x40 mm Evercross™ over the wire balloon was placed across the IAS. The
balloon was inflated at nominal pressure for 1 min and retracted back
into the sheath (Figure 1). The ICE catheter was then crossed into the
LA using the fluoroscopic landmark of the guide wire and ICE imaging
(Video 1). ICE imaging was used to decide on appropriate LAAO device and
an LAAO sheath was chosen. The TSP sheath was then exchanged for the
LAAO sheath, which was advanced along the ICE catheter via the TSP and
the procedure continued. In the control group, the Versacross™ sheath
was exchanged for the LAAO delivery sheath and septum was “flossed”
with the LAAO sheath and the sheath was pulled to RA. ICE advancement
was then attempted via the same TSP. Once the ICE catheter was in LA,
the LAAO sheath was also advanced into the LA6. The
rest of the procedure was performed in standard fashion. After
completion of LAAO implant, the sheath and ICE catheter were brought to
RA and the size of the atrial septal defect (ASD) was measured on 2D and
color doppler echocardiography.
All patients underwent cardiac CT 4-8 weeks post procedure and the LAAO
device was assessed for position and seal. Assessment was also made of
any residual ASD and its size.
Descriptive statistics were used to analyze the data. Data are reported
as
mean± SD and median with interquartile range (IQR).