Evidence map›Paper›PMID 33820423›Full record

ArticleCirculation2021

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

Saibal Kar, Shephal K Doshi, Ashish Sadhu, Rodney Horton, Jose Osorio, Christopher Ellis, James Stone, Manish Shah, Srinivas R Dukkipati, Stuart Adler and 11 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02702271 (Protection Against Embolism for Non-valvular AF Subjects), which is not on this map. Cited by 179 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
179citing papers in PubMed, 8 pooled it
46.3field-weighted citation impact, top 1% 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.

NCT02702271 nacompletednot on this map

Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

TypeinterventionalSponsorBoston Scientific CorporationRan2018 to 2021Enrolled458ConditionsAtrial FibrillationArmsWATCHMAN FLX
3 · Its place in the literature

Who cites it

179 citing papers in PubMed, 8 syntheses or guidelines pooled it, 385 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Risk factors, clinical implications, and management of peridevice leak following left atrial appendage closure: A systematic review.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  5. Guideline
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Article
  11. Review
  12. Article
  13. Article
  14. Left Atrial Appendage Closure: Past, Present, and Future.The Journal of innovations in cardiac rhythm management · 2026
    Review
  15. 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
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article

119 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 16 institutions in 2 countries.

Saibal KarLos Robles Regional Medical Center, Thousand Oaks, CA (S.K.).
Shephal K DoshiProvidence, Saint Johns Health Center, Pacific Heart Institute, Santa Monica, CA (S.K.D.).
Ashish SadhuPhoenix Cardiovascular Research Group, AZ (A.S.).
Rodney HortonTexas Cardiac Arrhythmia, Austin (R.H.).
Jose OsorioArrhythmia Institute at Grandview, Birmingham, AL (J.O.).
Christopher EllisVanderbilt University Medical Center, Nashville, TN (C.E.).
James StoneNorth Mississippi Medical Center, Tupelo (J.S.).
Manish ShahMedStar Health Medical Center, Washington, DC (M.S.).
Srinivas R DukkipatiHelmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York (S.R.D.).
Stuart AdlerHealth Fairview Heart Care, St Paul, MN (S.A.).
Devi G NairSt Bernard's Heart and Vascular Center, Jonesboro, AR (D.G.N.).
Jamie KimNew England Heart and Vascular Institute at Catholic Medical Center, Manchester, NH (J.K.).
Oussama WazniCleveland Clinic, OH (O.W.).
Mathew J PriceScripps Clinic, La Jolla, CA (M.J.P.).
Federico M AschMedStar Health Research Institute, Washington, DC (F.M.A.).
David R HolmesMayo Clinic, Rochester, MN (D.R.H.).
Robert D ShipleyBoston Scientific Corporation, Marlborough, MA (R.D.S., N.T.G., D.J.A.).
Nicole T GordonBoston Scientific Corporation, Marlborough, MA (R.D.S., N.T.G., D.J.A.).
Dominic J AlloccoBoston Scientific Corporation, Marlborough, MA (R.D.S., N.T.G., D.J.A.).
Vivek Y Reddy
PINNACLE FLX Investigators
Boston Scientific (United States) · USMedStar Health · USArizona Research Center · USBakersfield Heart Hospital · USCatholic Medical Center · USCleveland Clinic · USFairview Health Services · USGrandview Medical Center · USIcahn School of Medicine at Mount Sinai · USMayo Clinic in Arizona · USNorth Mississippi Medical Center · USSaint John's Health Center · USScripps Health · USSt Bernard's Hospital · GITexas Cardiac Arrhythmia · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeft atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.

methodsThis was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up.

resultsA total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA

conclusionsLAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.

Indexed as

AgedAtrial AppendageHumansProspective StudiesTreatment Outcomeatrial appendageatrial fibrillationprevention & controlstroke

Identifiers

PMID33820423
OpenAlexW3150320039

What OpenQuestion 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 OpenQuestion graph.