Evidence map›Paper›PMID 36130748›Full record

ArticleBMJ open2022

Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study.

Mariusz Kowalewski, Wojciech Wańha, Radoslaw Litwinowicz, Michalina Kołodziejczak, Michal Pasierski, Rafal Januszek, Łukasz Kuźma, Marek Grygier, Maciej Lesiak, Agnieszka Kapłon-Cieślicka and 11 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05144958 (Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

NCT05144958 unknown statusnot on this map

Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)

Typeobservational_patient_registrySponsorNicolaus Copernicus UniversityRan2019 to 2025Enrolled400ConditionsAtrial Fibrillation, StrokeArmsTotally thoracoscopic LAAO - ATRICLIP, Percutaneous LAAO - WATCHMAN, Hybrid- minimally invasive LAAO - LARIAT
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Observational
  2. Article
  3. Article
  4. A decade later: long-term results of the first percutaneous epicardial closure of the left atrial appendage using the LARIAT device.Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery · 2023
    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

21 authors at 10 institutions in 2 countries.

Mariusz KowalewskiDepartment of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, Warsaw, Poland kowalewskimariusz@gazeta.pl.ORCID 0000-0002-5478-3245
Wojciech WańhaDepartment of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Radoslaw LitwinowiczDepartment of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland.ORCID 0000-0003-3736-8987
Michalina KołodziejczakDepartment of Anaesthesiology and Intensive Care, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Antoni Jurasz University Hospital No. 1, Bydgoszcz, Poland.
Michal PasierskiDepartment of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, Warsaw, Poland.
Rafal JanuszekDepartment of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Łukasz KuźmaDepartment of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland.
Marek GrygierDepartment of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.
Maciej LesiakDepartment of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.
Agnieszka Kapłon-Cieślicka1st Department of Cardiology, Medical University of Warsaw, 02-091 Warsaw, Poland.
Krzysztof ReczuchCentre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, Wrocław, Poland.
Robert GilDepartment of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
Tomasz PawłowskiDepartment of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
Krzysztof BartuśDepartment of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland.
Sławomir DobrzyckiDepartment of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland.
Roberto LorussoCardio-Thoracic Surgery Department, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands.
Stanislaw BartuśDepartment of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Marek Andrzej DejaDepartment of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.
Grzegorz SmolkaDepartment of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Wojciech WojakowskiDepartment of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Piotr SuwalskiDepartment of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, Warsaw, Poland.
Jagiellonian University · PLMedical University of Silesia · PLCentral Clinical Hospital · PLMaastricht University Medical Centre · NLMedical University of Białystok · PLMinistry of Interior and Administration · PLPoznan University of Medical Sciences · PLMedical University of Warsaw · PLNicolaus Copernicus University · PLWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA METHODS AND ANALYSIS: Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER) will be conducted in 10 heart surgery and cardiology centres across Poland to assess the outcomes of LAAO performed by fully thoracoscopic-epicardial, percutaneous-endocardial or hybrid endo-epicardial approach. The registry will include patients with nonvalvular AF at a high risk of thromboembolic and bleeding complications (CHA2DS2-VASc Score ≥2 for males, ≥3 for females, HASBLED score ≥2) referred for LAAO. The first primary outcome is composite procedure-related complications, all-cause death or major bleeding at 12 months. The second primary outcome is a composite of ischaemic stroke or systemic embolism at 12 months. The third primary outcome is the device-specific success assessed by an independent core laboratory at 3-6 weeks. The quality of life (QoL) will be assessed as well based on the QoL EQ-5D-5L questionnaire. Medication and drug adherence will be assessed as well. ETHICS AND DISSEMINATION: Before enrolment, a detailed explanation is provided by the investigator and patients are given time to make an informed decision. The patient's data will be protected according to the requirements of Polish law, General Data Protection Regulation (GDPR) and hospital Standard Operating Procedures. The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was granted by the local Bioethics Committee of the Upper-Silesian Medical Centre of the Silesian Medical University in Katowice (decision number KNW/0022/KB/284/19). The results will be published in peer-reviewed journals and presented during national and international conferences. TRIAL REGISTRATION NUMBER: NCT05144958.

Indexed as

Atrial AppendageAtrial FibrillationBrain IschemiaStrokeThromboembolismAnimalsAnticoagulantsCaudataFemaleHemorrhageHumansMaleObservational Studies as TopicQuality of LifeRegistriesTreatment OutcomeAnticoagulantsAdult cardiologyCardiothoracic surgeryThromboembolism

Identifiers

PMID36130748
PMCPMC9494590
OpenAlexW4296798585

What OpenQuestion holds

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LicenceCC BY-NC
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.