Original Title: Dispositivos implantables para el cierre de la orejuela auricular izquierda. Estudio de monitorización

Authors' objectives: The objective is to assess the effectiveness and safety under routine conditions of use of interventions for percutaneous left atrial appendage closure through implantable devices.

Authors' results and conclusions: RESULTS A total of 670 patients were treated on between the beginning of the study (07-19-2017) and the end of the case inclusion period (07-18-2019). The 86.4% of the cases accomplished the first follow-up, 77.0% the second follow-up, 65.1% the third follow-up and 50.3% the fourth follow-up. A total of 294 patients accomplished the four scheduled follow-ups without any loss during the study and without having died. Patients had a mean age of 76.15 years, 64% were men, with a mean HAS-BLED score of 3.85 and CHA2DS2-VASc of 4.47. Device implanted were Watchman, 249 (37.16%), Amplatzer Amulet Occluder, 392 (58.51%), LAmbre, 24 (3.58%) and Ultaseal, 4 (0.60%). Intervention phase. Percutaneous endovascular implantation of the device was performed by septal puncture (97.3%) and required hospital admission for an average of 3.4 days. Device implantation was successful in 98.96% of cases; on the first attempt in 84.5% of cases, and after several attempts in 14.48% of cases. The intervention was unsuccessful in 1.04% of cases. In 93% of cases, no perioperative complications were registered during the intervention phase. There were five deaths, five cardiac tamponade cases, three ischemic strokes, seven hemorrhages, one cardiac embolism, four pericardial effusions, two pulmonary edemas and two device embolizations, one of which caused implantation failure and was associated with death. Thrombus and device leaks. During follow-up, 26 device-related thrombus were registered, representing 2.1% in the first follow-up, 3.7% in the second, and 5.6% in the third. No device thrombus were observed during the fourth follow-up. In the first follow-up, 49 measurable leaks were registered in the device (11.8%) and they decreased throughout the follow-ups to 4.35% in the last follow-up. Evolution of the administered treatment. The antithrombotic treatment that patients received before the intervention was modified throughout the study. Before the intervention patients received DOACs (25.97%), heparin (19.55%), acenocoumarol (12.84%), warfarin (1.49%), acetylsalicylic acid (23.43%), clopidogrel (7.46%), without treatment (20.75%). At 12 months after the intervention, they received DOACs (8.84%), heparin (0.70%), acenocoumarol (2.56%), acetylsalicylic acid (53.95%), clopidogrel (13.72%), without treatment (24.65%). At 24 months after the intervention, they received DOACs (7.58%), heparin (0.30%), acenocoumarol (1.82%), acetylsalicylic acid (51.21%), clopidogrel (11.21%), without treatment (31.21%). Mortality. During the study, 106 deaths (15.8%) were registered, age mean 78.5 years, of which 29.2% were due to cardiovascular causes. The mortality rate at 2 years was 13 per 100 person-years. Three cases of death associated with the intervention were reported: an embolization of the device 72 hours after implantation with aortic dissection, an esophageal perforation with sepsis and deep vein thrombosis, and an aortic endarteritis 43 days after the intervention with probable endocarditis and multi-organic failure. Global effectiveness analysis. Prevention of cardiovascular events. At two years of follow-up, the incidence rate of ischemic stroke was 1.58 per 100 person-years and the rate of hemorrhagic stroke was 0.73 per 100 person-years. Incidence rates of relevant bleeding and severe bleeding were 5.36 and 3.66 per 100 person-years, respectively. The synthetic incidence rate of ischemic events (ischemic stroke, systemic embolism plus pulmonary embolism) was 1.94 per 100 person-years. The synthetic incidence rate of bleeding events (hemorrhagic stroke plus severe/severe bleeding) was 4.39 per 100 person-years. The rate of expected ischemic stroke events in the study population, with a mean CHA2DS2-VASC score of 4.47, was 5.93 per 100 person-years. The ischemic stroke rate of 1.58 per 100 person-years observed in the study represents a 73.3% of risk reduction compared with that expected. The expected synthetic rate of bleeding events in the MS population with a mean HAS-BLED score of 3.85 is 8.43 per 100 person-years. The observed synthetic rate of bleeding events was 4.39 per 100 person-years, which represents a 48% reduction of risk reduction compared with that expected. CONCLUSIONS The results allow us to conclude that the percutaneous left atrial appendage closure in patients with non-valvular atrial fibrillation, CHA2DS2-VASc equal to or greater than 2 and contraindication, intolerance or ineffectiveness of anticoag ulation therapy, can be performed in the Spanish Health System successfully and in safe conditions, allowing a relevant reduction in the expected risk of ischemic and hemorrhagic events

Authors' methods: The methodology was agreed upon in a consensus protocol. The included patients were those with non-valvular atrial fibrillation, CHA2DS2-VASc equal to or greater than 2, and contraindication or intolerance to anticoagulation therapy. The designated centers were 27 from 14 Autonomous Communities, of which 23 centers registered interventions in SIEM. The evaluated outcomes were about safety (implantation success, events related to the device or intervention, and perioperative complications) and effectiveness (mortality, comparison of observed and expected cardiovascular events according to risk profile and other specific events), in follow-ups at 45 days, and at 6, 12 and 24 months after the intervention.

Project Status: Completed

Year Published: 2024

URL for published report: https://repisalud.isciii.es/handle/20.500.12105/18530

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: <p>Agencia de Evaluacion</p>