ArticleHeart rhythm2020
Complications involving the subcutaneous implantable cardioverter-defibrillator: Lessons learned from MAUDE.
Article in Heart rhythm, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Air entrapment as a potential cause of early subcutaneous implantable cardioverter defibrillator malfunction: a systematic review of the literature.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022Pooled it
- Efficacy and Complications of Subcutaneous versus Conventional Cardioverter Defibrillators: A Systematic Review and Meta-analysis.Current cardiology reviews · 2022Pooled it
- Surgical and Multidisciplinary Management of ICD Migration Into the Breast Implant Pocket.JACC. Case reports · 2026Article
- Crossed wires: a shocking case of an subcutaneous-ICD lead jailed by sternal wires.European heart journal. Case reports · 2026Article
- Extravascular implantable cardioverter-defibrillator implantation in a patient with nickel and cobalt allergies.HeartRhythm case reports · 2025Article
- Long-Term Complications Related to Cardiac Implantable Electronic Devices.Journal of clinical medicine · 2025Review
- Electrocardiographic imaging metrics to predict the risk of arrhythmia in patients with ischemic cardiomyopathy.Journal of arrhythmia · 2025Article
- Complete pneumothorax during subcutaneous cardiac defibrillator implantation by crocheting a rib: an uncommon complication.European heart journal. Case reports · 2024Article
- Subcutaneous versus transvenous implantable cardioverter defibrillator in hypertrophic cardiomyopathy: a systematic review and meta-analysis.Cardiovascular diagnosis and therapy · 2024Article
- Do Implantable Cardioverter-Defibrillators Prevent Sudden Cardiac Death in End-Stage Renal Disease Patients on Dialysis?Journal of clinical medicine · 2024Review
- Ultrasound-Guided Pectoserratus Plane Block and Superficial Serratus Anterior Plane Block for Subcutaneous Implantable Cardioverter-Defibrillator Implantation: A Comparative Study.Medical science monitor : international medical journal of experimental and clinical research · 2023Article
- Abdominal Emergency After Subcutaneous ICD Implantation.JACC. Case reports · 2022Article
- Subcutaneous Implantable Cardioverter-defibrillator Explantation-A Single Tertiary Center Experience.The Journal of innovations in cardiac rhythm management · 2022Article
- A real-world experience of subcutaneous and transvenous implantable cardiac defibrillators-comparison with the PRAETORIAN study.Journal of arrhythmia · 2022Article
- The potential impact of acute coronary syndromes on automatic sensing system in Subcutaneous-ICDs.International journal of cardiology. Heart & vasculature · 2021Article
- Eligibility for subcutaneous implantable cardioverter-defibrillator in patients with left ventricular assist device.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021Article
- Appropriate and inappropriate shocks in hypertrophic cardiomyopathy patients with subcutaneous implantable cardioverter-defibrillators: An international multicenter study.Heart rhythm · 2020Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundReports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices.
objectiveThe purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database.
methodsWe reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service.
resultsAfter removing duplicate entries and nonclinical events (n = 493), 1604 events remained. A total of 542 instances of infection were reported with system removal in 414/542 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow-up (n = 2), ventricular fibrillation induced by the device (n = 4), device-device interaction resulting in undersensing (n = 1), procedure-related complications (n = 4), and uncertain etiology (n = 4). There were 137 reports of system migration, and in 57 (42%) of these, there were associated inappropriate shocks. System migration events were managed with a combination of system revision (69 [51%]), reprogramming (25 [18%]), and system removal (44 [32%]).
conclusionSeveral S-ICD complications have been reported that appear to be related to the ICD's design and function over time. A better understanding of these complications may help inform patient selection, implant technique, and postimplantation management.
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Registered trials
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.