Evidence map›Paper›PMID 30460588›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2019

Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies.

Hassan Awada, J Christoph Geller, Michele Brunelli, Marc-Alexander Ohlow

Abstract read
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In one paragraph

Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

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

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Wide-awake local anesthesia during insertion of cardiac implantable electronic devices: a randomized study.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2024
    Article
  8. Real-world survey of post-operative cardiac implantable electronic device (CIED) complications reported by the electrophysiology team in 2022.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Very early discharge after cardiac implantable electronic device implantations: is this the future?Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    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

4 authors.

Hassan AwadaDepartment of Cardiology, Zentralklinik, Robert-Koch-Allee 9, 99437, Bad Berka, Germany.
J Christoph GellerDepartment of invasive and interventional Electrophysiology, Zentralklinik, Robert-Koch-Allee 9, 99437, Bad Berka, Germany.
Michele BrunelliDepartment of Cardiology and Endocrinology, Staedtisches Klinikum, 39130, Magdeburg, Germany.
Marc-Alexander OhlowDepartment of Cardiology, Zentralklinik, Robert-Koch-Allee 9, 99437, Bad Berka, Germany. marc.ohlow@zentralklinik.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT).

methodsWe enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection.

resultsWe included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16-0.94) and Premofix® (HR: 0.37 (95% CI 0.15-0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma.

conclusionsIn patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

Indexed as

BandagesAgedAnticoagulantsBlood Loss, SurgicalDefibrillators, ImplantableDrainageFemaleHematomaHemostaticsHumansMalePacemaker, ArtificialPlatelet Aggregation InhibitorsProspective StudiesVacuumAnticoagulantsHemostaticsPlatelet Aggregation InhibitorsAnticoagulationCIEDPocket hematomaPremofixStyproVacuum drainage

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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.