Sergio Berti1, Gennaro Santoro2, Elvis Brscic3, Matteo Montorfano4, Luigi Vignali5, Paolo Danna6, Claudio Tondo7, Gianpiero D'Amico8, Amerigo Stabile9, Salvatore Saccà10, Giuseppe Patti11, Antonio Rapacciuolo12, Arnaldo Poli13, Paolo Golino14, Paolo Magnavacchi15, Alberto De Caterina16, Francesco Meucci2, Bruno Pezzulich3, Marco Rezzaghi16, Miroslava Stolcova2, Giuseppe Tarantini8. 1. UO Cardiologia Diagnostica ed Interventistica, Fondazione Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy. Electronic address: berti@ftgm.it. 2. UO Cardiologia Generale, Azienda Ospedaliero-Universitaria di Careggi, Firenze FI, Italy. 3. UO Cardiologia, Maria Pia Hospital, Turin, Italy. 4. UO Cardiologia Interventistica ed Emodinamica, Ospedale San Raffaele, Milan, Italy. 5. UO Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 6. UO Cardiologia, Ospedale Luigi Sacco, Milan, Italy. 7. Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, IRCCS, Università di Milano, Milan, Italy. 8. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy. 9. UO Cardiologia, Maria Eleonora Hospital, Palermo, Italy. 10. UOC Cardiologia, ULSS13 Mirano, Mirano, Italy. 11. UOS di Servizi Cardiologici, Campus Bio-medico, Rome, Italy. 12. Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. 13. UO Cardiologia - Emodinamica, Ospedale Civile di Legnano, Legnano, Italy. 14. UOC Cardiologia Clinica, Azienda Ospedaliera "Sant'Anna e San Sebastiano" di Caserta, Caserta, Italy. 15. UO Cardiologia, Policlinico di Modena - Ospedale di Baggiovara, Modena, Italy. 16. UO Cardiologia Diagnostica ed Interventistica, Fondazione Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy.
Abstract
BACKGROUND: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding. METHODS: From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset. RESULTS: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively. CONCLUSIONS: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.
BACKGROUND:Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAFpatients at high-risk of stroke and bleeding. METHODS: From December 2008 to April 2015 613 NVAFpatients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset. RESULTS: AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively. CONCLUSIONS: In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.
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