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Implantable loop recorder versus conventional diagnostic workup for unexplained recurrent syncope.

Monica Solbiati1, Giorgio Costantino, Giovanni Casazza

  • 1Dipartimento di Medicina Interna e Specializzazioni Mediche, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Via Francesco Sforza 35, Milan, Italy, 20122.

The Cochrane Database of Systematic Reviews
|April 20, 2016
PubMed
Summary
This summary is machine-generated.

Implantable loop recorders (ILRs) increase diagnostic rates for unexplained syncope but do not reduce mortality. Further trials are needed to assess ILRs' impact on quality of life, syncope relapse, and costs.

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Area of Science:

  • Cardiology
  • Medical Devices
  • Diagnostic Strategies

Background:

  • Current syncope guidelines recommend implantable loop recorders (ILRs) for recurrent unexplained syncope, especially in high-risk patients or after negative evaluations.
  • Observational studies suggest ILRs improve diagnosis and reduce unexplained syncope rates, but randomized controlled trials (RCTs) are needed to confirm clinical practice impact.
  • Focus on ILR-guided therapy, not just ECG diagnosis, is crucial for changing clinical practice.

Purpose of the Study:

  • To evaluate mortality incidence, quality of life, adverse events, and costs associated with ILRs versus conventional diagnostic workup for unexplained syncope.
  • To synthesize evidence from RCTs comparing ILR implantation with standard diagnostic procedures in adult patients with unexplained syncope.

Main Methods:

  • Systematic literature search of multiple databases (Cochrane CENTRAL, MEDLINE, EMBASE, ClinicalTrials.gov, WHO ICTRP) up to April 2015.
  • Inclusion of all RCTs involving adult participants (≥18 years) with unexplained syncope comparing ILR with standard diagnostic workup.
  • Data extraction and risk of bias assessment by two independent reviewers; dichotomous data analyzed using risk ratios (RR) with 95% confidence intervals (CI); heterogeneity assessed using Chi² and I² statistics; GRADE framework used for evidence quality assessment.

Main Results:

  • Four RCTs with 579 participants were included. No significant difference in long-term mortality risk was observed between ILR and conventional groups (RR 0.97, 95% CI 0.41-2.30; very low quality evidence).
  • ILR-based strategies significantly increased the rate of aetiologic diagnosis compared to standard assessment (RR 0.61, 95% CI 0.54-0.68; moderate quality evidence).
  • Data on quality of life, adverse events, and short-term mortality were limited or inconclusive. Some evidence suggested a trend towards reduced syncope relapses with ILRs, but costs were higher initially, though cost per diagnosis was lower.

Conclusions:

  • This systematic review found no evidence that ILR-based strategies reduce long-term mortality for unexplained syncope compared to standard care.
  • Moderate quality evidence indicates ILRs improve the rate of aetiologic diagnosis in patients with unexplained syncope.
  • Further RCTs are warranted to investigate the impact of ILRs on clinically relevant outcomes like quality of life, syncope recurrence, and cost-effectiveness.