Evidence map›Paper›PMID 29336017›Full record

Observational studyEpilepsia2018

Long-term surveillance of SUDEP in drug-resistant epilepsy patients treated with VNS therapy.

Philippe Ryvlin, Elson L So, Charles M Gordon, Dale C Hesdorffer, Michael R Sperling, Orrin Devinsky, Mark T Bunker, Bryan Olin, Daniel Friedman

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Epilepsia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 4 pooled it
–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

58 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  5. Trial
  6. A guide to neuromodulation in drug-resistant epilepsy.Epileptic disorders : international epilepsy journal with videotape · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Philippe RyvlinDepartment of Clinical Neurosciences, Vaud University Hospital, Lausanne, Switzerland.
Elson L SoDepartment of Neurology, Mayo Clinic, Rochester, MN, USA.
Charles M GordonCyberonics, Inc. (LivaNova, PLC), Houston, TX, USA.
Dale C HesdorfferSergievsky Center, Columbia University Medical Center, New York, NY, USA.ORCID 0000-0003-1783-5381
Michael R SperlingDepartment of Neurology, Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, Philadelphia, PA, USA.
Orrin DevinskyDepartment of Neurology, Comprehensive Epilepsy Center, New York University Langone Medical Center, New York, NY, USA.
Mark T BunkerCyberonics, Inc. (LivaNova, PLC), Houston, TX, USA.
Bryan OlinCyberonics, Inc. (LivaNova, PLC), Houston, TX, USA.
Daniel FriedmanDepartment of Neurology, Comprehensive Epilepsy Center, New York University Langone Medical Center, New York, NY, USA.ORCID 0000-0003-1068-1797

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLimited data are available regarding the evolution over time of the rate of sudden unexpected death in epilepsy patients (SUDEP) in drug-resistant epilepsy. The objective is to analyze a database of 40 443 patients with epilepsy implanted with vagus nerve stimulation (VNS) therapy in the United States (from 1988 to 2012) and assess whether SUDEP rates decrease during the postimplantation follow-up period.

methodsPatient vital status was ascertained using the Centers for Disease Control and Prevention's National Death Index (NDI). An expert panel adjudicated classification of cause of deaths as SUDEP based on NDI data and available narrative descriptions of deaths. We tested the hypothesis that SUDEP rates decrease with time using the Mann-Kendall nonparametric trend test and by comparing SUDEP rates of the first 2 years of follow-up (years 1-2) to longer follow-up (years 3-10).

resultsOur cohort included 277 661 person-years of follow-up and 3689 deaths, including 632 SUDEP. Primary analysis demonstrated a significant decrease in age-adjusted SUDEP rate during follow-up (S = -27 P = .008), with rates of 2.47/1000 for years 1-2 and 1.68/1000 for years 3-10 (rate ratio 0.68; 95% confidence interval [CI] 0.53-0.87; P = .002). Sensitivity analyses confirm these findings. SIGNIFICANCE: Our data suggest that SUDEP risk significantly decreases during long-term follow-up of patients with refractory epilepsy receiving VNS Therapy. This finding might reflect several factors, including the natural long-term dynamic of SUDEP rate, attrition, and the impact of VNS Therapy. The role of each of these factors cannot be confirmed due to the limitations of the study.

Indexed as

Population SurveillanceAdolescentAdultAgedAged, 80 and overChildChild, PreschoolDeath, SuddenDrug Resistant EpilepsyFemaleFollow-Up StudiesHumansInfantInfant, NewbornMaleMiddle Agedepilepsymortalitysudden unexpected death in epilepsy patientsvagus nerve stimulation

Identifiers

PMID29336017

What OpenQuestion holds

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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.