{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["4(2)"],"submitter":["Sularz A"],"pubmed_abstract":["<h4>Background</h4>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.<h4>Objectives</h4>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).<h4>Methods</h4>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).<h4>Results</h4>The mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA<sub>2</sub>DS<sub>2</sub>-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.<h4>Conclusions</h4>The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol."],"journal":["JACC. Advances"],"pagination":["101570"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11782859"],"repository":["biostudies-literature"],"pubmed_title":["Safety and Feasibility of 3D Intracardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With WATCHMAN FLX."],"pmcid":["PMC11782859"],"pubmed_authors":["Sularz A","Chavez Ponce A","Doshi SK","Al-Abcha A","Simard T","Killu AM","Alkhouli M"],"additional_accession":[]},"is_claimable":false,"name":"Safety and Feasibility of 3D Intracardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With WATCHMAN FLX.","description":"<h4>Background</h4>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.<h4>Objectives</h4>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).<h4>Methods</h4>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).<h4>Results</h4>The mean age was 77.0 ± 8.1 years, and 39 (39%) were women. CHA<sub>2</sub>DS<sub>2</sub>-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.<h4>Conclusions</h4>The novel 3-dimensional ICE VeriSight Pro Probe can safely and effectively guide LAAO with Watchman FLX using a simplified imaging protocol.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Feb","modification":"2026-05-26T03:08:32.12Z","creation":"2025-04-03T23:26:39.21Z"},"accession":"S-EPMC11782859","cross_references":{"pubmed":["39898347"],"doi":["10.1016/j.jacadv.2024.101570"]}}