Evidence map›Paper›PMID 38576630›Full record

ArticleCureus2024

Safety of Amulet Left Atrial Appendage Occluder and Watchman Device for Left Atrial Appendage Closure in Patients With Atrial Fibrillation.

Fadi Sawaya, Bernard Abi-Saleh, Abbas Hoteit, Jennifer Jdaidany, Mohamad B Moumneh, Bernard Harbieh, Maurice Khoury, Salim Aramouni, Farah Abdulhai, Marwan Refaat

Open access · diamondAbstract read
In one paragraph

Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Fadi SawayaCardiology, American University of Beirut Medical Center, Beirut, LBN.
Bernard Abi-SalehCardiology, American University of Beirut Medical Center, Beirut, LBN.
Abbas HoteitCardiology, American University of Beirut Medical Center, Beirut, LBN.
Jennifer JdaidanyCardiology, American University of Beirut Medical Center, Beirut, LBN.
Mohamad B MoumnehHeart and Vascular, Inova, Falls Church, USA.
Bernard HarbiehCardiology, American University of Beirut Medical Center, Beirut, LBN.
Maurice KhouryCardiology, American University of Beirut Medical Center, Beirut, LBN.
Salim AramouniCardiology, American University of Beirut Medical Center, Beirut, LBN.
Farah AbdulhaiCardiology, American University of Beirut Medical Center, Beirut, LBN.
Marwan RefaatCardiology, American University of Beirut Medical Center, Beirut, LBN.
American University of Beirut Medical Center · LBAlaska Heart and Vascular Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeft atrial appendage (LAA) closure is an alternative to chronic anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation. Multiple devices were used for LAA closure, with the Amplatzer Amulet LAA Occluder (Abbott, Chicago, IL, USA) and Watchman device (Boston Scientific, Marlborough, MA, USA) being the most commonly used in clinical practice. In August 2021, the FDA approved the use of the Amplatzer Amulet LAA Occluder. There is still a knowledge gap in the safety profile of the Amplatzer Amulet LAA Occluder device in comparison to the Watchman device.

objectiveThe aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA Occluder and Watchman devices.

methodsPatients who underwent LAA closure using Watchman or Amulet devices from July 2015 to August 2020 at the American University of Beirut Medical Center were included in the analysis. Primary endpoints included peri-operative and post-procedural complications (thromboembolic events, bleeding complications, vascular access complications, pericardial effusion/tamponade, device positional complications and in-hospital death).

resultsThe study included 37 patients (21 had Watchman devices, 16 had Amplatzer Amulet LAA Occluder devices, and 28 were men, mean age 76.57 ± 9.3 years). Seven patients developed post-procedural iatrogenic atrial septal defects (four in the Watchman group vs three in the Amulet group, p-value=0.982). Three patients developed pericardial effusion (one in the Watchman vs two in the Amulet group, p-value=0.394). Only one patient developed peri-device leak (one in the Watchman group vs none in the Amulet group, p-value=0.283). One device could not be deployed (one in the Amulet group vs none in the Watchman group, p-value=0.191). None of the patients developed in-hospital death, cardiac tamponade, device embolism, device thrombosis, stroke/transient ischemic attack (TIA), cranial bleeding, or arrhythmias after the procedure. The rate of peri-operative complications was similar between both groups. Both groups displayed low rates of adverse events in the peri-operative and post-operative periods.

conclusionThere was no significant difference in the safety profile of Amplatzer Amulet LAA Occluders and Watchman devices. There was a low incidence of peri-operative and post-operative adverse events with the implanted devices.

Indexed as

amuletatrial fibrillationcardiac arrhythmiasleft atrial appendage occlusionsafetywatchman

Identifiers

PMID38576630
PMCPMC10993002
OpenAlexW4392468787

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.