Evidence map›Paper›PMID 42644716›Full record

ArticleEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2026

Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety.

Dhanunjaya Lakkireddy, Jacqueline Saw, Akash Makkar, Dipak Shah, Ruby Satpathy, Muhamed Saric, Rahul Sharma, Frank Cuoco, Robert Percell, George Manoukian and 3 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05997446 (A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05997446 active not recruitingnot on this map

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

TypeobservationalSponsorAbbott Medical DevicesRan2023 to 2027Enrolled610ConditionsAtrial Fibrillation, Stroke, BleedingArmsLeft atrial appendage occlusion (LAAO)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Dhanunjaya LakkireddyKansas City Heart Rhythm Institute and Research Foundation, @ HCA Midwest, 5100 W 100th St, Suite-200, Overland Park, KS 66211, USA.ORCID 0000-0002-1492-2693
Jacqueline SawVancouver General Hospital, Vancouver, BC, USA.ORCID 0000-0002-7027-984X
Akash MakkarArizona Heart Arrhythmia Associates, Phoenix AZ, USA.
Dipak ShahHeart Cardiology Consultants, Southfield, MI, USA.
Ruby SatpathyBaptist Heart Specialists, Jacksonville, FL, USA.
Muhamed SaricNYU Langone Health, New York, NY, USA.
Rahul SharmaCardiovascular Medicine, Stanford, CA, USA.
Frank CuocoTrident Medical Center, Charleston, SC, USA.
Robert PercellNorthwestern Medicine, Mchenry, IL, USA.ORCID 0000-0002-7356-2421
George ManoukianHeart Rhythm Associates, Shenandoah, TX, USA.
Ryan GageAbbott Electrophysiology, Plymouth, MN, USA.ORCID 0009-0006-4247-2163
Jordan A AndersonAbbott Electrophysiology, Plymouth, MN, USA.ORCID 0000-0002-6983-1019
Himanshu AgarwalCHI Creighton University School of Medicine - Bergan Mercy Hospital, Omaha, NE, USA.

Funding

ADVANCELAA
6 · The paper itself

Abstract

aimsThe Watchman device is widely used for left atrial appendage occlusion but may be unsuitable in patients with complex anatomies, resulting in screening failures. The Amulet occluder, with its dual-seal design, may overcome these limitations. The aim of this analysis is to evaluate procedural success, closure, and clinical outcomes of Amulet occluder implantation in patients who failed Watchman screening. METHODS AND

resultsThis analysis from the ADVANCE LAA study included patients ineligible for Watchman (Screen Fail) compared to patients eligible for Amulet and Watchman (Device Eligible). Baseline characteristics, procedural details, cardiac imaging, and clinical events were assessed through 1 year. The safety endpoint composite was a composite of all-cause death, ischaemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention within hospital discharge or 7 days post-implant. Independent core laboratory and clinical events committee adjudicated imaging and adverse events, respectively. A total of 609 patients underwent Amulet implantation (Screen Fail: n = 97; Device Eligible: n = 512). Screen Fail patients had more complex anatomy and higher CHA2DS2-VASc and HAS-BLED scores. Despite these differences, implant success was high (96.9% vs. 98.0%; P = 0.446). Clinically relevant closure on transoesophageal echocardiography (≤3 mm peri-device leak) was achieved in ≥97% of patients in both groups at implant and 1-3 months. The peri-procedural safety endpoint composite rate was similar in both groups [3.1% vs. 2.7%; OR: 1.14 (0.32, 4.03); P = 0.742]. One-year rates of stroke (1.1% vs. 1.0%), major bleeding (9.6% vs. 6.2%), cardiovascular/unknown death (2.1% vs. 5.2%), and all-cause death (6.3% vs. 6.6%) were similar between groups (P > 0.05).

conclusionAmulet occluder implantation was feasible, safe, and effective in patients with or without failed Watchman screening, providing a viable option for both anatomically simple and complex anatomies. CLINICAL

trial registrationURL https://clinicaltrials.gov Unique Identifier NCT05997446.

Indexed as

Atrial FibrillationCardiac CatheterizationLeft Atrial Appendage ClosureSeptal Occluder DeviceAgedAged, 80 and overEchocardiography, TransesophagealEmbolismFemaleHumansIschemic StrokeMaleProsthesis DesignRisk FactorsStrokeTime FactorsAmuletAtrial fibrillationLeft atrial appendageStrokeWatchman

Identifiers

PMID42644716
PMCPMC13554794

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.