Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry

Sergio Berti, Gennaro Santoro, Elvis Brscic, Matteo Montorfano, Luigi Vignali, Paolo Danna, Claudio Tondo, Gianpiero D'Amico, Amerigo Stabile, Salvatore Saccà, Giuseppe Patti, Antonio Rapacciuolo, Arnaldo Poli, Paolo Golino, Paolo Magnavacchi, Alberto De Caterina, Francesco Meucci, Bruno Pezzulich, Marco Rezzaghi, Miroslava StolcovaGiuseppe Tarantini

Research output: Contribution to journalArticle

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 ± 8.0 years, 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 20 months, 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 6 months 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.

Original languageEnglish
Pages (from-to)103-107
Number of pages5
JournalInternational Journal of Cardiology
Volume248
DOIs
Publication statusPublished - Dec 1 2017

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Keywords

  • Atrial fibrillation
  • Ischemic stroke
  • Left atrial appendage occlusion

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Berti, S., Santoro, G., Brscic, E., Montorfano, M., Vignali, L., Danna, P., Tondo, C., D'Amico, G., Stabile, A., Saccà, S., Patti, G., Rapacciuolo, A., Poli, A., Golino, P., Magnavacchi, P., De Caterina, A., Meucci, F., Pezzulich, B., Rezzaghi, M., ... Tarantini, G. (2017). Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry. International Journal of Cardiology, 248, 103-107. https://doi.org/10.1016/j.ijcard.2017.07.052