Safety and Feasibility of 3D Intracardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With WATCHMAN...

Intracardiac echocardiography (ICE) is an alternative to transesophageal echocardiography to guide left atrial appendage occlusion (LAAO). However, 2-dimensional ICE has important limitations that hinder its adoption in routine practice.

This prospective multicenter study (NCT04569734) investigated the feasibility and safety of ICE-guided LAAO with Watchman FLX using a novel 3-dimensional ICE catheter (VeriSight Pro, Philips).

A total of 100 patients undergoing LAAO with the Watchman FLX device were recruited. All cases were performed under moderate sedation. A simplified 2 orthogonal view ICE imaging protocol was adopted to assess PASS (position, anchoring, sizing, and sealing) criteria. The feasibility endpoint was successful implantation of the FLX device and adequate seal (peri-device leak <5 mm) at 45 days. The safety endpoint was the incidence of major complications at 7 and 45 days. Physician experience and imaging quality scores were collected (1 = lowest, 5 = highest).

The mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA₂DS₂-VASc score was 4.8 ± 1.5 and HAS-BLED score was 3.2 ± 1.1. Total procedural time was 54 ± 25 minutes. Mean contrast volume was 41 ± 46 ml, with no contrast used in 16 patients. The feasibility endpoint was achieved in 95 patients (95%); 4 patients were not implanted due to unsuitable anatomy, and 1 patient had a leak >5 mm at 45 days. There was 1 periprocedural stroke and 2 gastrointestinal bleeds requiring transfusion at 7 days with no other major complications. Physicians' rating of overall ICE imaging quality was 4.6 ± 0.6.

The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.