Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug

Apostolos Tzikas, Samera Shakir, Sameer Gafoor, Heyder Omran, Sergio Berti, Gennaro Santoro, Joelle Kefer, Ulf Landmesser, Jens Erik Nielsen-Kudsk, Ignacio Cruz-Gonzalez, Horst Sievert, Tobias Tichelbäcker, Prapa Kanagaratnam, Fabian Nietlispach, Adel Aminian, Friederike Kasch, Xavier Freixa, Paolo Danna, Marco Rezzaghi, Paul Vermeersch, Friederike Stock, Miroslava Stolcova, Marco Costa, Reda Ibrahim, Wolfgang Schillinger, Bernhard Meier, Jai-Wun Park, Apostolos Tzikas, Samera Shakir, Sameer Gafoor, Heyder Omran, Sergio Berti, Gennaro Santoro, Joelle Kefer, Ulf Landmesser, Jens Erik Nielsen-Kudsk, Ignacio Cruz-Gonzalez, Horst Sievert, Tobias Tichelbäcker, Prapa Kanagaratnam, Fabian Nietlispach, Adel Aminian, Friederike Kasch, Xavier Freixa, Paolo Danna, Marco Rezzaghi, Paul Vermeersch, Friederike Stock, Miroslava Stolcova, Marco Costa, Reda Ibrahim, Wolfgang Schillinger, Bernhard Meier, Jai-Wun Park

Abstract

Aims: To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF).

Methods and results: Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events.

Conclusions: In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

Source: PubMed

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