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Multicenter Study
. 2022 Jun 16;22(1):271.
doi: 10.1186/s12872-022-02708-4.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

Lucie Kretzler  1   2 , Christoph Mues  3   4 , Carsten Wunderlich  3   5 , Anke Langbein  3   6 , S G Spitzer  3   6 , Ulrich Gerk  3   7 , Sebastian Schellong  3   7 , Thomas Ketteler  3   8 , Hans Neuser  3   9 , Marcus Schwefer  3   10 , Ruth Strasser  3   11 , Karim Ibrahim  12 , Steffen Schoen #  3   5 , Marian Christoph #  12
Affiliations
Multicenter Study

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

Lucie Kretzler et al. BMC Cardiovasc Disord. .

Abstract

Background: Various randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.

Aims: The prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety.

Methods and results: The total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.

Conclusions: The ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers. Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803 .

Keywords: Atrial fibrillation; Left atrial appendage; Patient registry; Stroke prevention.

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Conflict of interest statement

The authors declare no competing interests.

None of the authors has any conflicts of interest or competing interests to declare for this specific project.

Figures

Fig. 1
Fig. 1
Periprocedural data during LAAC. A total procedure time in min; B implantation success in %; C number of discarded devices/LAAC procedure; D fluoroscopy time in minutes; E contrast agent consumption in ml. LAAC/year left atrial appendage closure procedure/year/study center
Fig. 2
Fig. 2
Anticoagulation drug regimens after interventional left atrial appendage closure. DAPT dual antiplatelet therapy, NOAC novel anticoagulant, VKA vitamin K antagonist
See this image and copyright information in PMC

References

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