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For the experimental group, post TSP, the 8.5 F Versacross™ sheath was retracted to the right atrium with the guide wire still in the LA.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).