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

Int J Cardiol. 2017 Dec 1:248:103-107. doi: 10.1016/j.ijcard.2017.07.052. Epub 2017 Jul 16.

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.

Keywords: Atrial fibrillation; Ischemic stroke; Left atrial appendage occlusion.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Appendage / diagnostic imaging*
  • Atrial Appendage / surgery*
  • Atrial Fibrillation / diagnostic imaging*
  • Atrial Fibrillation / epidemiology
  • Atrial Fibrillation / surgery*
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Italy / epidemiology
  • Male
  • Registries*
  • Retrospective Studies
  • Septal Occluder Device / statistics & numerical data*
  • Treatment Outcome