Evidence map›Paper›PMID 36789852›Full record

ArticleJournal of the American Heart Association2023

Two-Year Outcomes With a Next-Generation Left Atrial Appendage Device: Final Results of the PINNACLE FLX Trial.

Shephal K Doshi, Saibal Kar, Ashish Sadhu, Rodney Horton, Jose Osorio, Christopher Ellis, James Stone, Manish Shah, Srinivas R Dukkipati, Stuart Adler and 10 more

Open access · goldAbstract read
In one paragraph

Article in Journal of the American Heart Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
7.2field-weighted citation impact, top 2% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.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 · 2023
    Trial
  3. Outcomes of Different Device Sizing Strategies Using the Newer-Generation WATCHMAN Devices for Closure of Borderline-Sized Left Atrial Appendage.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Article
  4. Article
  5. Percutaneous left atrial appendage closure for stroke prevention: current challenges and future perspectives.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Left Atrial Appendage Occlusion: Expanding Indications and New Developments.Structural heart : the journal of the Heart Team · 2025
    Review
  11. Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.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 · 2024
    Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Watchman FLX's Sophomore Year Report Card.Journal of the American Heart Association · 2023
    Article
  17. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 18 institutions in 2 countries.

Shephal K DoshiProvidence, Saint Johns Health Center Pacific Heart Institute Santa Monica CA.ORCID 0000-0001-8567-0211
Saibal KarLos Robles Regional Medical Center Thousand Oaks CA.ORCID 0000-0003-1547-4869
Ashish SadhuPhoenix Cardiovascular Research Group Phoenix AZ.
Rodney HortonTexas Cardiac Arrhythmia Austin TX.ORCID 0000-0001-9958-2941
Jose OsorioArrhythmia Institute at Grandview Birmingham AL.ORCID 0000-0001-7466-123X
Christopher EllisVanderbilt University Medical Center Nashville TN.ORCID 0000-0002-7333-5720
James StoneNorth Mississippi Medical Center Tupelo MS.
Manish ShahMedStar Health Medical Center Washington DC.ORCID 0000-0001-6560-5914
Srinivas R DukkipatiHelmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai New York NY.ORCID 0000-0002-0931-7704
Stuart AdlerM Health Fairview East Region St Paul MN.
Devi G NairSt Bernard's Heart and Vascular Center Jonesboro AR.ORCID 0000-0001-8253-947X
Jamie KimNew England Heart and Vascular Institute at Catholic Medical Center Manchester NH.
Oussama WazniCleveland Clinic Cleveland OH.ORCID 0000-0001-7115-7716
Matthew J PriceScripps Clinic La Jolla CA.ORCID 0000-0002-7892-2430
David R HolmesMayo Clinic Rochester MN.ORCID 0000-0002-0037-0373
Robert ShipleyBoston Scientific Corporation Marlborough MA.
Thomas ChristenBoston Scientific Corporation Marlborough MA.
Dominic J AlloccoBoston Scientific Corporation Marlborough MA.
Vivek Y ReddyHelmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai New York NY.ORCID 0000-0002-5638-4993
PINNACLE FLX investigators [Link]
Boston Scientific (United States) · USCatholic Medical Center · USIcahn School of Medicine at Mount Sinai · USLos Robles Hospital & Medical Center · USMedStar Health · USNorth Mississippi Medical Center · USScripps Clinic · USTexas Cardiac Arrhythmia · USVanderbilt University Medical Center · USFairview Health Services · USMayo Clinic in Arizona · USSaint John's Health Center · USSt Bernard's Hospital · GIThe Arrhythmia Institute · USUniversity of Phoenix · USCleveland Clinic · USMayo Clinic in Florida · USPhoenix (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background The PINNACLE FLX (Protection Against Embolism for Non-valvular AF [Atrial Fibrillation] Patients: Investigational Device Evaluation of the Watchman FLX LAA [Left Atrial Appendage] Closure Technology) trial evaluated the safety and efficacy of a next-generation left atrial appendage closure device (WATCHMAN FLX; Boston Scientific, Marlborough, MA). At 1 year, the study met the primary end points of safety and anatomical efficacy/appendage closure. This final report of the PINNACLE FLX trial includes the prespecified secondary end point of ischemic stroke or systemic embolism at 2 years, also making it the first report of 2-year outcomes with this next-generation left atrial appendage closure device. Methods and Results Patients with nonvalvular atrial fibrillation with CHA

Indexed as

Atrial AppendageAtrial FibrillationEmbolismIschemic StrokeStrokeAgedCardiac CatheterizationFemaleHemorrhageHumansMaleTreatment Outcomeatrial fibrillationleft atrial appendage closureWATCHMAN FLX

Identifiers

PMID36789852
PMCPMC10111496
OpenAlexW4320856193

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.