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May 10, 2019Heart RhythmOpen Access

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

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Why the study?

Prior S-ICD cohorts had less heart disease and fewer comorbidities than standard ICD populations, leaving acute performance uncharacterized in primary prevention patients with LVEF ≤35%.

Does subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation have high acute success and low perioperative complication rates in primary prevention patients with LVEF ≤35%?

Population

1116 primary prevention patients with LVEF ≤35%

Comparison

S-ICD implantation

Design

Prospective cohort study

Follow-up

30-day

Authors

LBLucas V.A. BoersmaMEMikhael F. El‐ChamiMBMaria Grazia Bongiorni

Discussion

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Member takes

Overview

S-ICD acute performance in higher-comorbidity primary-prevention LVEF ≤35% patients needs confirmation; this cohort study leaves open generalizability to broader populations.

Structured PICO

Does subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation have high acute success and low perioperative complication rates in primary prevention patients with LVEF ≤35%?

P
Population
1,116 primary prevention patients with left ventricular ejection fraction (LVEF) ≤35% and no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure.
I
Intervention
Subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation
O
Outcome
Acute performance including successful implantation rate, defibrillation testing (DFT) conversion efficacy, and 30-day freedom from complicationssafety

S-ICD implantation demonstrates high procedural success and low perioperative complication rates in a higher-risk primary prevention cohort with LVEF ≤35%, though higher BMI warrants careful implant technique.

Cite This Study

Boersma et al. (2019) studied this question.

synapsesocial.com/papers/6a6f8903a528af2d65c3099fhttps://doi.org/10.1016/j.hrthm.2019.04.048
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The Design of the Understanding Outcomes with the S‐ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)2016 · 24 citations
  2. 2Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry2014 · 463 citations
  3. 3The learning curve associated with the introduction of the subcutaneous implantable defibrillator2015 · 115 citations
  4. 4Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial2015 · 118 citations
  5. 5Implantation of the Subcutaneous Implantable Cardioverter-Defibrillator2017 · 70 citations