Safety and feasibility of peri-device leakage closure after LAAO: an international, multicentre collaborative study.

BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure. AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO. METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure. RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding). CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.

In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients.

AIMS: The aim of this study was to assess clinical and prognosis differences in patients with COVID-19 and STEMI. METHODS AND RESULTS: Using a nationwide registry of consecutive patients managed within 42 specific STEMI care networks, we compared patient and procedure characteristics and in-hospital outcomes in two different cohorts, according to whether or not they had COVID-19. Among 1,010 consecutive STEMI patients, 91 were identified as having COVID-19 (9.0%). With the exception of smoking status (more frequent in non-COVID-19 patients) and previous coronary artery disease (more frequent in COVID-19 patients), clinical characteristics were similar between the groups, but COVID-19 patients had more heart failure on arrival (31.9% vs 18.4%, p=0.002). Mechanical thrombectomy (44% vs 33.5%, p=0.046) and GP IIb/IIIa inhibitor administration (20.9% vs 11.2%, p=0.007) were more frequent in COVID-19 patients, who had an increased in-hospital mortality (23.1% vs 5.7%, p<0.0001), that remained consistent after adjustment for age, sex, Killip class and ischaemic time (OR 4.85, 95% CI: 2.04-11.51; p<0.001). COVID-19 patients had an increase of stent thrombosis (3.3% vs 0.8%, p=0.020) and cardiogenic shock development after PCI (9.9% vs 3.8%, p=0.007). CONCLUSIONS: Our study revealed a significant increase in in-hospital mortality, stent thrombosis and cardiogenic shock development after PCI in patients with STEMI and COVID-19 in comparison with contemporaneous non-COVID-19 STEMI patients.

Percutaneous left atrial appendage occlusion in patients with atrial fibrillation and left appendage thrombus: feasibility, safety and clinical efficacy.

AIMS: The aim of this study was to investigate the feasibility, safety and efficacy of percutaneous closure for prevention of thromboembolic events in patients with atrial fibrillation (AF) and left atrial appendage (LAA) thrombus. METHODS AND RESULTS: The study included consecutive patients with AF and LAA thrombus who underwent transcatheter occlusion in eight high-volume centres. Clinical and transoesophageal echocardiography (TEE) follow-up was carried out as per each centre's protocol. Twenty-eight patients were included. The location of the LAA thrombus was distal in 100% of cases. Technical and procedural success was achieved in all patients. A cerebral protection device was used in six cases. There were no periprocedural adverse events. Follow-up was complete in all patients (total 32 patient-years). No death or thromboembolic events were reported. There was one major bleeding during follow-up. Among the 23 patients undergoing TEE, device thrombosis was present in one patient. No significant peri-device leaks were observed. CONCLUSIONS: In this multicentre study, percutaneous closure in selected patients with distal LAA thrombus appears to be feasible and safe, and is associated with high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Special implant techniques avoiding mechanical mobilisation of the thrombotic mass and the liberal use of cerebral embolic protection devices are recommended.