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Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation

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Abstract

Background

Transcatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications.

Aim

To investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion.

Methods

Retrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success.

Results

There were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78 % with ACP vs. 70 % with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94 %, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8 %, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14 %, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2 %, 0 vs. 0 %, or 6 vs. 6 %, p = ns).

Conclusion

Transcatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure.

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Abbreviations

ACP:

Amplatzer cardiac plug

AF:

Atrial fibrillation

ASA:

Acetylsalicylic acid

ASD:

Atrial septal defect

DAPT:

Dual antiplatelet therapy

GI:

Gastrointestinal

INR:

International normalized ratio

LAA:

Left atrial appendage

LAAO:

Left atrial appendage occlusion

MI:

Myocardial infarction

NOAC:

New anticoagulant drug

OAC:

Oral anticoagulation

PAD:

Peripheral artery disease

PCI:

Percutaneous coronary intervention

PFO:

Patent foramen ovale

TAVI:

Transcatheter aortic valve implantation

TIA:

Transient ischemic attack

VARC:

Valve Academic Research Consortium

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Conflict of interest

Ahmed A. Khattab and Fabian Nietlispach are consultants to St. Jude Medical, Stefan Windecker has received grants to the institution from St. Jude Medical, and Bernhard Meier is a consultant to and has received grants to the institution from St. Jude Medical.

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Author notes

    Authors and Affiliations

    1. Cardiology, Cardiovascular Department, Bern University Hospital, Bern, Switzerland

      Steffen Gloekler, Samera Shakir, Janosch Doblies, Ahmed A. Khattab, Fabien Praz, Dezsoe Koermendy, Stefan Stortecky, Thomas Pilgrim, Lutz Buellesfeld, Peter Wenaweser, Stephan Windecker & Aris Moschovitis

    2. Department of Cardiology, Zurich University Hospital, Zurich, Switzerland

      Milosz Jaguszewski & Fabian Nietlispach

    3. Centro de Cardiopatias Congênitas et Estruturais do Paranà, Curitiba, Brazil

      Ênio Guerios

    4. Department of Cardiology, Charité Universitätsmedizin Berlin, Berlin, Germany

      Ulf Landmesser

    5. Department of Cardiology, Bern University Hospital, 3010, Bern, Switzerland

      Bernhard Meier

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    1. Steffen Gloekler
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    Correspondence to Samera Shakir.

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    S. Gloekler and S. Shakir contributed equally to this work.

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    Gloekler, S., Shakir, S., Doblies, J. et al. Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol 104, 656–665 (2015). https://doi.org/10.1007/s00392-015-0828-1

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