Patients and Procedure Characteristics
Baseline demographics of the ten patients are shown in Table 1; patients
had an average age of 65.6 ± 10.3 years and 60% were female. Single
transseptal catheterization was performed in each patient guided by
fluoroscopy and ICE. A powered transseptal needle (NRG®, Baylis Medical,
Toronto, Canada) was used in nine patients and a powered 8.5 French
guidewire (VersaCross®, Baylis Medical, Toronto, Canada) was used in the
one patient with an atrial septal defect occluder in place. Pulmonary
vein isolation was performed in eight patients who underwent catheter
ablation for refractory atrial fibrillation. Cryoballoon ablation was
performed in seven patients using the second-generation cryoballoon
(Artic Front Pro™, Medtronic, Minneapolis, MN), and pulsed-field
ablation (PFA) was performed in one patient (PulseSelect ™ PFA System,
as part of the Pulsed AF pivotal clinical trial sponsored by Medtronic).
In one patient who underwent CBA, additional left atrial posterior wall
isolation was performed using radiofrequency ablation (RFA) with an
open-irrigation ablation electrode. Left atrial appendage closure was
performed in two patients using an FDA-approved plug-type device
(Watchman FLX™, Boston Scientific, Malborough, MA). The ICE catheter was
placed in the LA in two patients who underwent CBA and in two patients
who underwent LAAC.
Diagnostic-quality 2D and 4D images of various cardiac structures,
transseptal catheterization equipment, long guide sheaths, ablation
tools, and closure devices were acquired with the ICE catheter
positioned in the RA, LA, PV, coronary sinus, right ventricle, and
pulmonary artery. Operators noted that the 4D ICE catheter was easy to
advance into the RA and LA and easy to manipulate to acquire images.
Compared to other commonly used, commercially available 2D ICE
catheters, the 4D ICE catheter was notably more flexible at the segment
just proximal to the distal imaging portion. This flexibility enabled
the catheter to be placed in alternate positions including the coronary
sinus with little risk of cardiac perforation. Fluoroscopy could be used
to discern the imaging direction based on the appearance of the tip of
the ICE catheter. The standard 2D, X-plane, 3D, and 4D ICE images were
of high-quality and were able to guide the EP procedures. A combination
of 2D imaging, X-plane imaging, and 3D imaging was used for all cases.
There were no complications related to the use of the catheter.