Introduction. Intracardiac echocardiography (ICE-Abbot ViewFlex) is used increasingly as an alternative to transoesophageal echocardiography (TEE) to guide left atrial appendage closure (LAAC). ICE allows LAAC to be carried out under local anesthesia and can be performed by the interventional cardiologist, as sole operator. Previous works on ICE-guided LAAC are registry studies with self-reported data.
We aimed to investigate the efficacy and safety of ICE-guided LAAC with the novel Watchman FLX device (Boston Scientific, Marlborough, Massachusetts) in a single-center study.
Methods. This is a rigorous study of patients undergoing LAAC with the Watchmann FLX device. Procedures were guided by ICE from left atrium with local anesthesia.
Atrial fibrillation (AF) patients with CHA2DS2VASc score ≥2 and a clinical indication for LAAC were eligible for the study. Procedural preplanning with either cardiac CT or TEE within 7 days prior to LAAC was mandatory, to exclude the presence of LAA thrombus. ICE was used to guide the transseptal puncture and intraprocedurally was carried out with a single transseptal access directly from the left atrium to guide the procedure and device implantation. The primary outcome was the rate of significant peri-device leaks (>5 mm) at 45-days TEE. Safety outcome was a composite of periprocedural complications.
Results. Twenty-four patients were enrolled over 2 years. Mean age was 75±8 years, CHA2DS2VASc score 4.0±1.3 and HASBLED score 3.4±0.9. The incidence of the primary outcome of significant peri-device leak (>5 mm) was 0,04%; all patients had effective LAAC at 45-days. All patients had a Watchman FLX implanted and technical success was 100%. The number of devices per case was 1.0±0.2. ICE successfully guided assessment of device release criteria, including mean device compression of 21%, which was within the recommended 10-30% range.
No subject required conversion to TEE. The only procedural complications were 3 access site bleeds. There were no episodes of stroke, transient ischemic attack, systemic embolization, pericardial effusion, device embolization or device-related thrombus during the procedure or 45-days follow-up.
Conclusions. ICE can be used to successfully guide LAAC with Watchman LFX with excellent procedural success, a high rate of effective LAAC and minimal peri-procedural complications. The efficacy and safety results are comparable to those reported for TEE-guided Watchmann FLX implantation.