Publications by authors named "Steven Mullane"
Article Synopsis
- This study investigates the effects of mRNA COVID-19 vaccines on the incidence of atrial arrhythmias (AAs) and ventricular arrhythmias in patients with cardiac implantable electronic devices (CIEDs), using data from BIOTRONIK and Medicare.
- It found a statistically significant but small increase in AAs in the three months after the first COVID-19 vaccination compared to the previous three months, which was similar to increases noted after receiving the influenza vaccine.
- The researchers concluded that the observed rise in AAs is likely related to the progression of atrial fibrillation rather than the vaccine itself, suggesting that monitoring for AAs is especially important for older males post-vaccination.
Background: Shock-reduction implantable cardioverter-defibrillator programming (SRP) was associated with fewer therapies and improved survival in randomized controlled trials, but real-world studies investigating SRP and associated outcomes are limited.
Methods And Results: The BIOTRONIK CERTITUDE registry was linked with the Medicare database. We included all patients with an implantable cardioverter-defibrillator implanted between August 22, 2012 and September 30, 2021 in the United States.
Background: Despite effectiveness of the implantable cardioverter-defibrillator (ICD) in saving patients with life-threatening ventricular arrhythmias (VAs), the temporal occurrence of VA after ICD implantation is unpredictable.
Objective: The study aimed to apply machine learning (ML) to intracardiac electrograms (IEGMs) recorded by ICDs as a unique biomarker for predicting impending VAs.
Methods: The study included 13,516 patients who received Biotronik ICDs and enrolled in the CERTITUDE registry between January 1, 2010, and December 31, 2020.
Post-market evaluation is important to ensure the ongoing safety and effectiveness of cardiovascular implantable electronic device (CIED) leads. The Twenty-First Century Cures Act and subsequent Food and Drug Administrative (FDA) Guidance provide an opportunity to leverage real-world data sources for this purpose. The past 4 years have seen the development of EP PASSION: a multi-stakeholder, collaborative effort between the FDA, CIED manufacturers, Heart Rhythm Society, and academics.
View Article and Find Full Text PDFBackground: Cardiac implantable electronic devices (CIED)-ie, pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices-have recently been designed to allow for patients to safely undergo magnetic resonance imaging (MRI) when specific programming is implemented. MRI AutoDetect is a feature that automatically switches CIED's programming into and out of an MR safe mode when exposed to an MRI environment.
Objective: The purpose was to analyze de-identified daily remote transmission data to characterize the utilization of the MRI AutoDetect feature.
The relation between epileptic spikes and seizures is an important but still unresolved question in epilepsy research. Preclinical and clinical studies have produced inconclusive results on the causality or even on the existence of such a relation. We set to investigate this relation taking in consideration seizure severity and spatial extent of spike rate.
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