Clinical Outcomes of the First 200 Cases of Single-Operator TEE-Guided Left Atrial Appendage Occlusion (SOLOCLOSE).

Abstract

SOLOCLOSE is a simplified methodology for left atrial appendage occlusion (LAAO) with the Watchman device consisting of single-operator TEE guidance, nurse-driven conscious sedation, same-day discharge, and deferment of any preprocedural imaging. We aim to investigate the efficacy and safety of LAAO with the SOLOCLOSE methodology. A single-center prospective analysis of 208 consecutive patients undergoing SOLOCLOSE between December 2020 and January 2024 was performed. The primary efficacy outcome was the rate of significant peri‑device (>5 mm) leak at 45-day TEE. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), comprised of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke at 45 days. Procedure times, 7-day all cause readmission, incidents of all-cause death, device-related thrombi, stroke, device embolization, pericardial effusion, and major postprocedure bleeding within 45 days of the index procedure were also collected. The technical success rate was 96.2% (n = 200). The mean age was 77 ± 8 years, mean CHA₂D₂SVASc score was 5.2 ± 1.4, mean HAS-BLED score was 3.4 ± 1.0, and mean procedural time was 28 ± 14 minutes. At 45 days, there were no significant peri‑device leak (>5 mm). Immediate procedural complications included 1 (0.5%) esophageal trauma, 1 (0.5%) pulmonary hemorrhage, 1 (0.5%) TIA, and 1 (0.5%) pericardial effusion. MACE occurred in 4 patients (2.0%). The incidences of all-cause mortality, major bleeding, and device related thrombus were 3 (1.5%), 5 (2.5%), and 2 (1.0%), respectively. The 7-day all-cause readmission rate was 3.5%. The SOLOCLOSE technique has potential to significantly enhance clinical efficiency and cost-effectiveness for LAAO while maintaining comparable procedure-related safety outcomes to that of other closure methodologies.