Evidence map›Paper›PMID 34183276›Full record

SynthesisCardiovascular revascularization medicine : including molecular interventions2022

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis.

Joseph N Heaton, Alexis K Okoh, Seungmo Suh, Ebru Ozturk, Arash Salemi, Sergio Waxman, Rajiv Tayal

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Cardiovascular revascularization medicine : including molecular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Observational
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

7 authors.

Joseph N HeatonDepartment of Medicine, The Brooklyn Hospital Center, Brooklyn, NY, United States of America; Cardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America. Electronic address: JosephNHeaton@gmail.com.
Alexis K OkohCardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Seungmo SuhDepartment of Medicine, The Brooklyn Hospital Center, Brooklyn, NY, United States of America.
Ebru OzturkCardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Arash SalemiCardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Sergio WaxmanCardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.
Rajiv TayalCardiovascular Research Unit, RWJ Barnabas Health. NBIMC, Newark, NJ, United States of America.

Funding

Multidisciplinary Research Training to Reduce Inequities in Cardiovascular HealthT32HL130025 · NHLBI · EMORY UNIVERSITY · PI Tené T Lewis, Viola Vaccarino · 2016 to 2026
$6.4M
NHLBI NIH HHS T32 HL130025
6 · The paper itself

Abstract

objectivesTo assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.

backgroundThe Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile.

methodsWe conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events.

resultsWe included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity.

conclusionA high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure. CONDENSED ABSTRACT: The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.

Indexed as

Heart Septal Defects, AtrialSeptal Occluder DeviceCardiac CatheterizationCohort StudiesFemaleHumansMaleTreatment OutcomeAmplatzerCongenital heart defectSecundum type atrial septal defectSeptal occluder

Identifiers

PMID34183276
PMCPMC10909392

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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.