{"id":"d27b8a1b9f81","type":"article","url":"https://hartvaat.nl/2026/05/06/vereenvoudigde-linkervoorhoofdaanhangsel-occlusie-onder-fluoroscopie-met-watchma/","title":"Vereenvoudigde linkervoorhoofdaanhangsel-occlusie onder fluoroscopie met WATCHMAN FLX is veilig en haalbaar","title_en":"Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":[],"journal":"Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology","doi":"10.1093/europace/euag045","source_url":"https://doi.org/10.1093/europace/euag045","authors":["Wei Zhou","Qian Tang","Anning Zeng","Jiulin Chen","Fang Wang","Jing Wang","Jingjing Chen","LinYan Shi","Ji Li","Yirong Zhang","Dawei Tian","Dandan Chen","Fuliang Luo","Zheyi Wu","Na Deng","Fei Yan","Qianjiang Pan","Zhongrong Liao","Yongxian Tian","Yifan Mao","Huimin Lu","Xing Zhou","Ya Yang","ZhenFa Zhang","Runze Huang","Wei Li"],"significance":5,"published":"2026-07-29","source_date":"2026-05-06","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/transesofageale-echo-bij-af/","https://hartvaat.nl/kennis/atriumfibrilleren/hasbled-score/"],"congress":"","summary_en":"The prospective multicentre ROSE-FLX registry evaluated simplified left atrial appendage occlusion (LAAO) using the WATCHMAN FLX device under exclusive fluoroscopic guidance and local anaesthesia in 400 patients with non-valvular atrial fibrillation at high thromboembolic and bleeding risk. Procedural success was 100%, with low rates of pericardial effusion (0.5%), access-site complications (1.3%), and major bleeding (0.8%). Over a median follow-up of 194.5 days, all-cause mortality was 0.8%, TIA 3.3%, and device-related thrombosis 0.3%, with COPD and higher CHA2DS2-VASc scores independently predicting adverse events. These findings suggest that fluoroscopy-only LAAO is a safe, feasible, and resource-efficient alternative for centres lacking advanced echocardiographic or anaesthetic support, pending confirmation from head-to-head trials.","created":"2026-07-22T00:57:17Z","updated":"2026-08-10T10:38:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De prospectieve multicentre ROSE-FLX studie onderzocht de veiligheid en effectiviteit van een vereenvoudigde linkervoorhoofdaanhangsel-occlusie (LAAO) met het WATCHMAN FLX-apparaat, uitsluitend geleid door fluoroscopie en onder lokale verdoving, bij 400 patiënten met niet-valvulair atriumfibrilleren en een hoog trombo-embolisch en bloedingsrisico. De procedure was in 100% van de gevallen succesvol, met lage incidenties van pericardvocht (0,5%), toegang-complicaties (1,3%) en ernstige bloedingen (0,8%). Gedurende een mediane follow-up van ongeveer zes maanden traden weinig ernstige gebeurtenissen op (sterfte 0,8%, TIA 3,3%, apparaatgerelateerde trombose 0,3%), waarbij COPD en een hoge CHA2DS2-VASc-score de belangrijkste voorspellers van complicaties waren. Deze bevindingen suggereren dat deze vereenvoudigde aanpak een veilige en resource-efficiënte optie kan zijn voor centra zonder uitgebreide TEE- of alledaagse anesthesiecapaciteit, mits bevestigd in vergelijkende studies.","abstract_original":"AIMS: Conventional left atrial appendage occlusion (LAAO) procedures typically require transoesophageal echocardiography and general anaesthesia, which may limit feasibility in resource-limited settings. Simplified LAAO (sLAAO) guided exclusively by fluoroscopy offers a practical and efficient alternative. This study evaluated procedural safety, efficacy, and short-term outcomes of sLAAO using the WATCHMAN FLX device under exclusive fluoroscopic guidance in a real-world, multicentre setting. METHODS AND RESULTS: The ROSE-FLX study was a prospective, multicentre, single-arm registry including 400 patients with non-valvular atrial fibrillation at high thromboembolic and bleeding risk. All underwent sLAAO under local anaesthesia and exclusive fluoroscopic guidance. Procedural data, peri-procedural complications, and follow-up outcomes were analysed. Predictors of adverse events were determined using Cox regression. Procedural success was 100%, with low major complication rates: pericardial effusion (0.5%), access-site complications (1.3%), and major bleeding (0.8%). Over median follow-up of 194.5 days [interquartile range (IQR) 129.0-265.0], all-cause mortality occurred in three patients (0.8%), transient ischaemic attacks in 13 patients (3.3%), and device-related thrombosis in one patient (0.3%). In multivariable Cox regression, chronic obstructive pulmonary disease (HR 2.86, 95% CI 1.98-4.11, P < 0.001) and higher CHA2DS2-VASc scores (HR 4.69, 95% CI 1.90-11.57, P < 0.001) independently predicted adverse events. CONCLUSION: Exclusive fluoroscopy-guided sLAAO with the WATCHMAN FLX device is feasible, safe, and resource efficient, achieving high procedural success and low complication rates, suggesting that this approach may be considered in selected centres lacking advanced echocardiographic or anaesthetic support, pending confirmation from comparative studies."}