ArticleJournal of cardiovascular electrophysiology2022
Leadless pacemaker perforations: Clinical consequences and related device and user problems.
Article in Journal of cardiovascular electrophysiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of Postoperative Outcomes between Leadless and Conventional Transvenous Pacemakers Implantation: An Up-to-Date Meta-analysis.Reviews in cardiovascular medicine · 2024Pooled it
- Safety and performance of a novel subxiphoidal pacemaker system.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- Impact of Leadless Pacemaker Implantation Position on Subclinical Right Ventricular Perforation.Pacing and clinical electrophysiology : PACE · 2026Article
- Safety and efficacy of leadless pacemakers: A systematic review and meta-analysis.Heart rhythm O2 · 2026Review
- Safety and efficacy of completely transthoracic echocardiography guided leadless pacemaker implantation assisted by Panna guide wire: initial clinical experience.Frontiers in cardiovascular medicine · 2026Article
- Leadless Pacemaker Implantation in an Adolescent with Durable LVAD Support.Pediatric cardiology · 2026Article
- Temporary Pacing for Electric Cardiac Stimulation and Neuromodulatory Cardiovascular Therapy.Cardiovascular engineering and technology · 2025Review
- A case of successful salvage despite right ventricular perforation during AVEIR VR leadless pacemaker implantation.Journal of arrhythmia · 2025Article
- Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2024Article
- A case of endocardial dissection caused by Micra implantation.BMC cardiovascular disorders · 2024Article
- A PARYLENE-BASED MEMS INTRAVASCULAR IMPLANT FOR WIRELESS CARDIAC PACING.Proceedings. IEEE International Conference on Micro Electro Mechanical Systems · 2024Article
- Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers.Journal of clinical medicine · 2023Review
- Leadless pacemaker perforations: Clinical consequences and related device and user problems.Journal of cardiovascular electrophysiology · 2022Article
- The knowns and unknowns of leadless pacing in 2022.Indian pacing and electrophysiology journalArticle
Corrections and comments
- Commented on by
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).
methodsFDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems.
resultsBetween 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non-septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries.
conclusionThe Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.
Indexed as
Identifiers
What OpenQuestion holds
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.