Evaluating cardiac lead safety using observational, real-world data: EP PASSION proof-of-concept study.

Background: Traditional post-approval study (PAS) designs have been accepted by regulatory authorities to fulfill postmarketing requirements for cardiac leads, but they have several limitations.

Objective: We conducted a proof-of-concept study of alternative methods that use real-world data (RWD) to evaluate lead safety in large populations of patients.

Methods: Abbott patient device databases were linked with Medicare Fee-For-Service (FFS) claims to identify lead complications in patients implanted with Abbott Optisure lead.

Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations.

Background: Inadequate inclusion in clinical trial enrollment may contribute to health inequities by evaluating interventions in cohorts that do not fully represent target populations.

Objectives: The aim of this study was to determine if characteristics of patients with heart failure (HF) enrolled in a pivotal trial are associated with who receives an intervention after approval.

Methods: Demographics from 2,017,107 Medicare patients hospitalized for HF were compared with those of the first 10,631 Medicare beneficiaries who received implantable pulmonary artery pressure sensors.

Racial disparities in access to DBS: results of a real-world U.S. claims data analysis.

Introduction: Deep brain stimulation (DBS) is an effective and standard-of-care therapy for Parkinson's Disease and other movement disorders when symptoms are inadequately controlled with conventional medications. It requires expert care for patient selection, surgical targeting, and therapy titration. Despite the known benefits, racial/ethnic disparities in access have been reported.

Clinical Longevity of 106,462 Rechargeable and Primary Cell Spinal Cord Stimulators: Real World Study in the Medicare Population.

Introduction: Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, there are few studies of longevity of SCS in the real world.

Materials And Methods: This was an observational, nonrandomized, retrospective study of Medicare beneficiaries who received neurostimulator implants in the outpatient hospital.

Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database.

There have been significant improvements in the design and manufacturing of deep brain stimulation (DBS) systems, but no study has considered the impact of modern systems on complications. We sought to compare the relative occurrence of reoperations after implantation of modern and traditional DBS systems in patients with Parkinson's disease (PD) or essential tremor (ET) in the United States. Retrospective, contemporaneous cohort study.

Real-world Adoption of Smartphone-based Remote Monitoring Using the Confirm Rx™ Insertable Cardiac Monitor.

While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for remote monitoring (RM), the Confirm Rx™ ICM (Abbott, Chicago, IL, USA) utilizes Bluetooth, Wi-Fi/cellular technology, and a smart device to connect to the RM system. We aimed to characterize compliance, connectivity, and event transmission timing with the Confirm Rx™ ICM RM system. The study cohort included American patients who received the Confirm Rx™ ICM with SharpSense™ technology within three months of release (May-July 2019).

The Cost of Lost Productivity in an Opioid Utilizing Pain Sample.

Background And Aims: Chronic pain affects more adults in the United States than any other condition. Opioid medications are widely used in the treatment of chronic pain, but there remains considerable risk and cost associated with their use. This study aims to characterize the effects of opioid prescribing for chronic pain and similar pain conditions on lost productivity in the United States.

The cost of non-response to cardiac resynchronization therapy: characterizing heart failure events following cardiac resynchronization therapy.

Aims: The aim of this study is to quantify healthcare resource utilization among non-responders to cardiac resynchronization therapy (CRT-NR) by heart failure (HF) events and influence of comorbidities.

Methods And Results: The ADVANCE CRT registry (2013-2015) prospectively identified responders/CRT-NRs 6 months post-implant using the clinical composite score. Heart failure event rates and associated cost, both overall and separated for inpatient hospitalizations, office visits, emergency room visits, and observational stays, were quantified.

Gain in real-world cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: Heart failure hospitalizations and costs.

Background: SyncAV, a device-based cardiac resynchronization therapy (CRT) algorithm, promotes electrical optimization by dynamically adjusting atrioventricular intervals.

Objective: The purpose of this study was to evaluate the impact of SyncAV on heart failure hospitalizations (HFHs) and related costs in a real-world CRT cohort.

Methods: Patients with SyncAV-capable CRT devices followed by remote monitoring and enrolled in Medicare fee-for-service for at least 1 year preimplant and up to 2 years postimplant were studied.

Cost-Effectiveness of Dorsal Root Ganglion Stimulation or Spinal Cord Stimulation for Complex Regional Pain Syndrome.

Objectives: ACCURATE, a randomized controlled trial, compared safety and effectiveness of stimulation of the dorsal root ganglion (DRG) vs. conventional spinal cord stimulation (SCS) in complex regional pain syndrome (CRPS-I and II) of the lower extremities. This analysis compares cost-effectiveness of three modalities of treatment for CRPS, namely DRG stimulation, SCS, and comprehensive medical management (CMM).

Effect of High Influenza Activity on Risk of Ventricular Arrhythmias Requiring Therapy in Patients With Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators.

Influenza is associated with an increased risk of cardiovascular events. Influenza's association with ventricular arrhythmias (VAs) has not been adequately studied. We investigated the relation of seasonal influenza activity with the incidence of VAs requiring therapy in patients with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator.

Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices.

Aims: Atrial fibrillation (AF) is associated with increased mortality, but the temporal relationship between AF burden (AFB) and death among patients with cardiac implanted electronic devices is unknown. We sought to characterize the timing and progression of AFB before death.

Methods And Results: Using Merlin.

A control-theoretic system identification framework and a real-time closed-loop clinical simulation testbed for electrical brain stimulation.

Objective: Closed-loop electrical brain stimulation systems may enable a precisely-tailored treatment for neurological and neuropsychiatric disorders by controlling the stimulation based on neural activity feedback in real time. Developing model-based closed-loop systems requires a principled system identification framework to quantify the effect of input stimulation on output neural activity by learning an input-output (IO) dynamic model from data. Further, developing these systems needs a realistic clinical simulation testbed to design and validate the closed-loop controllers derived from the IO models before testing in human patients.

Increased Hospitalizations and Overall Healthcare Utilization in Patients Receiving Implantable Cardioverter-Defibrillator Shocks Compared With Antitachycardia Pacing.

Objectives: The purpose of this study was to evaluate the effect of these therapies on healthcare utilization in a large patient cohort.

Background: Antitachycardia pacing (ATP) terminates ventricular tachycardia and avoids delivery of high-voltage shocks. Few data exist on the impact of shocks on healthcare resource utilization compared with ATP.

High-resolution local field potentials measured with deep brain stimulation arrays.

Objective: Local field potential (LFP) recordings along a deep brain stimulation (DBS) lead can provide useful feedback for titrating DBS therapy. However, conventional DBS leads with four cylindrical macroelectrodes likely undersample the spatial distribution of sinks and sources in a given brain region. In this study, we investigated the spectral power and spatial feature sizes of LFP activity in non-human primate subthalamic nucleus and globus pallidus using chronically implanted 32-channel directional DBS arrays.

Association of Opioid Usage with Spinal Cord Stimulation Outcomes.

Study Design: Observational study using insurance claims.

Objective: To quantify opioid usage leading up to spinal cord stimulation (SCS) and the potential impact on outcomes of SCS.

Setting: SCS is an interventional therapy that often follows opioid usage in the care continuum for chronic pain.

Overcoming Operational Challenges to Ebola Case Investigation in Sierra Leone.

The Ebola virus disease (EVD) epidemic that hit West Africa in 2013 was the worst outbreak of EVD in recorded history. While much has been published regarding the international and national-level EVD responses, there is a dearth of literature on district-level coordination and operational structures, successes, and failures. This article seeks to understand how the EVD response unfolded at the district level, namely the challenges to operationalizing EVD surveillance over the course of the outbreak in Port Loko and Kambia districts of Sierra Leone.

Association of Antitachycardia Pacing or Shocks With Survival in 69,000 Patients With an Implantable Defibrillator.

Aims: Antitachycardia pacing (ATP) is an effective treatment for ventricular tachycardia (VT) and can reduce the frequency of shocks in patients with an implantable cardioverter defibrillator (ICD). The association between survival and ATP, as compared to a shock, has not been confirmed in a large patient population. This study aims to determine if patients with an ICD receiving ATP have lower mortality, as compared to those receiving shock.

A Novel Lead Design for Modulation and Sensing of Deep Brain Structures.

Goal: Develop and characterize the functionality of a novel thin-film probe technology with a higher density of electrode contacts than are currently available with commercial deep brain stimulation (DBS) lead technology. Such technology has potential to enhance the spatial precision of DBS and enable a more robust approach to sensing local field potential activity in the context of adaptive DBS strategies.

Methods: Thin-film planar arrays were microfabricated and then assembled on a cylindrical carrier to achieve a lead with 3-D conformation.

Local field potential recordings in a non-human primate model of Parkinsons disease using the Activa PC + S neurostimulator.

Objective: Using the Medtronic Activa® PC + S system, this study investigated how passive joint manipulation, reaching behavior, and deep brain stimulation (DBS) modulate local field potential (LFP) activity in the subthalamic nucleus (STN) and globus pallidus (GP).

Approach: Five non-human primates were implanted unilaterally with one or more DBS leads. LFPs were collected in montage recordings during resting state conditions and during motor tasks that facilitate the expression of parkinsonian motor signs.

Establishment of an Ebola Treatment Unit and Laboratory - Bombali District, Sierra Leone, July 2014-January 2015.

The first confirmed case of Ebola virus disease (Ebola) in Sierra Leone related to the ongoing epidemic in West Africa occurred in May 2014, and the outbreak quickly spread. To date, 8,704 Ebola cases and 3,955 Ebola deaths have been confirmed in Sierra Leone. The first Ebola treatment units (ETUs) in Sierra Leone were established in the eastern districts of Kenema and Kailahun, where the first Ebola cases were detected, and these districts were also the first to control the epidemic.

Modulations in oscillatory frequency and coupling in globus pallidus with increasing parkinsonian severity.

While beta oscillations often occur within the parkinsonian basal ganglia, how these oscillations emerge from a naive state and change with disease severity is not clear. To address this question, a progressive, nonhuman primate model of Parkinson's disease was developed using staged injections of MPTP. Within each parkinsonian state (naive, mild, moderate, and severe), spontaneous local field potentials were recorded throughout the sensorimotor globus pallidus.

Classification of pallidal oscillations with increasing parkinsonian severity.

The firing patterns of neurons in the basal ganglia are known to become more oscillatory and synchronized from healthy to parkinsonian conditions. Similar changes have been observed with local field potentials (LFPs). In this study, we used an unbiased machine learning approach to investigate the utility of pallidal LFPs for discriminating the stages of a progressive parkinsonian model.

Computational modeling of an endovascular approach to deep brain stimulation.

Objective: Deep brain stimulation (DBS) therapy currently relies on a transcranial neurosurgical technique to implant one or more electrode leads into the brain parenchyma. In this study, we used computational modeling to investigate the feasibility of using an endovascular approach to target DBS therapy.

Approach: Image-based anatomical reconstructions of the human brain and vasculature were used to identify 17 established and hypothesized anatomical targets of DBS, of which five were found adjacent to a vein or artery with intraluminal diameter ≥1 mm.