Hafez Golzarian, Mallory Knous, Anna Kleman, Jamie Saum, Jennifer Koenig, Emily Miller, Maile Miller, Sarah Stechschulte, Andria Utendorf, Jordan Trombley, Denise M Walker, Amy Carder, William Carder, Janelle Fields, Cynthia Hoersten, Sarah Kallay, Andrew Macke, Jennifer Music, Gerri Hempfling, Amanda Laird, Sandeep M Patel
{"title":"单操作者tee引导左心耳闭塞术(SOLO-CLOSE) 200例临床疗效分析。","authors":"Hafez Golzarian, Mallory Knous, Anna Kleman, Jamie Saum, Jennifer Koenig, Emily Miller, Maile Miller, Sarah Stechschulte, Andria Utendorf, Jordan Trombley, Denise M Walker, Amy Carder, William Carder, Janelle Fields, Cynthia Hoersten, Sarah Kallay, Andrew Macke, Jennifer Music, Gerri Hempfling, Amanda Laird, Sandeep M Patel","doi":"10.1016/j.amjcard.2025.06.033","DOIUrl":null,"url":null,"abstract":"<p><p>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 CHA<sub>2</sub>D<sub>2</sub>SVASc 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.</p>","PeriodicalId":7705,"journal":{"name":"American Journal of Cardiology","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Outcomes of the First 200 Cases of Single-Operator TEE-Guided Left Atrial Appendage Occlusion (SOLOCLOSE).\",\"authors\":\"Hafez Golzarian, Mallory Knous, Anna Kleman, Jamie Saum, Jennifer Koenig, Emily Miller, Maile Miller, Sarah Stechschulte, Andria Utendorf, Jordan Trombley, Denise M Walker, Amy Carder, William Carder, Janelle Fields, Cynthia Hoersten, Sarah Kallay, Andrew Macke, Jennifer Music, Gerri Hempfling, Amanda Laird, Sandeep M Patel\",\"doi\":\"10.1016/j.amjcard.2025.06.033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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 CHA<sub>2</sub>D<sub>2</sub>SVASc 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.</p>\",\"PeriodicalId\":7705,\"journal\":{\"name\":\"American Journal of Cardiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-07-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.amjcard.2025.06.033\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.amjcard.2025.06.033","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Clinical Outcomes of the First 200 Cases of Single-Operator TEE-Guided Left Atrial Appendage Occlusion (SOLOCLOSE).
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.
期刊介绍:
Published 24 times a year, The American Journal of Cardiology® is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty in cardiology throughout the world. AJC is an independent, scientific, peer-reviewed journal of original articles that focus on the practical, clinical approach to the diagnosis and treatment of cardiovascular disease. AJC has one of the fastest acceptance to publication times in Cardiology. Features report on systemic hypertension, methodology, drugs, pacing, arrhythmia, preventive cardiology, congestive heart failure, valvular heart disease, congenital heart disease, and cardiomyopathy. Also included are editorials, readers'' comments, and symposia.