Clinic Time Required for Remote and In-Person Management of Patients With Cardiac Devices: Time and Motion Workflow Evaluation.

BACKGROUND: The number of patients with cardiac implantable electronic device (CIED) is increasing, creating a substantial workload for device clinics. OBJECTIVE: This study aims to characterize the workflow and quantify clinic staff time requirements for managing patients with CIEDs. METHODS: A time and motion workflow evaluation was performed in 11 US and European CIEDs clinics. Workflow tasks were repeatedly timed during 1 business week of observation at each clinic; these observations included all device models and manufacturers. The mean cumulative staff time required to review a remote device transmission and an in-person clinic visit were calculated, including all necessary clinical and administrative tasks. The annual staff time to manage a patient with a CIED was modeled using CIED transmission volumes, clinical guidelines, and the published literature. RESULTS: A total of 276 in-person clinic visits and 2173 remote monitoring activities were observed. Mean staff time required per remote transmission ranged from 9.4 to 13.5 minutes for therapeutic devices (pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) and from 11.3 to 12.9 minutes for diagnostic devices such as insertable cardiac monitors (ICMs). Mean staff time per in-person visit ranged from 37.8 to 51.0 and from 39.9 to 45.8 minutes for therapeutic devices and ICMs, respectively. Including all remote and in-person follow-ups, the estimated annual time to manage a patient with a CIED ranged from 1.6 to 2.4 hours for therapeutic devices and from 7.7 to 9.3 hours for ICMs. CONCLUSIONS: The CIED patient management workflow is complex and requires significant staff time. Understanding process steps and time requirements informs the implementation of efficiency improvements, including remote solutions. Future research should examine heterogeneity in patient management processes to identify the most efficient workflow.

Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: Results from the Reveal LINQ Usability Study.

BACKGROUND: For clinicians, confidence in atrial fibrillation (AF) episode classification is an important consideration when electing to use insertable cardiac monitors (ICMs). OBJECTIVE: The purpose of this study was to report on the improved AF detection algorithm in the Reveal LINQ ICM. METHODS: The Reveal LINQ Usability Study is a nonrandomized, prospective, multicenter trial. The ICM has been miniaturized, uses wireless telemetry for remote patient monitoring, and its AF algorithm includes a new p-wave filter. At 1 month post-device insertion, Holter monitor data were collected and annotated for true AF episodes ≥2 minutes, and performance metrics were evaluated by comparing Holter annotations with ICM detections. RESULTS: The study enrolled 151 patients (age 56.6 ± 12.1, male 67%). Reasons for monitoring included AF ablation or AF management in 81.5% (n = 123), syncope in 12.6% (n = 19), and other indications in 5.9% (n = 9) of patients. Of the 138 patients with an analyzable Holter recording, a total of 112 true AF episodes were identified in 38 patients (27.5%). The overall accuracy of the ICM to detect durations of AF or non-AF episodes was 99.4%, and the AF burden measured by the ICM was highly correlated with the Holter (Pearson coefficient 0.995). CONCLUSION: The new AF detection algorithm in the Reveal LINQ ICM accurately detects the presence or absence of AF. Additionally, it showed high sensitivity in detecting AF duration in patients with a history of intermittent and symptomatic AF.

Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials.

BACKGROUND: Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion. METHODS: To evaluate the safety profile of the ICM procedure, we analyzed procedure-related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ(TM) Usability study) and a multicenter registry (Reveal LINQ(TM) Registry) evaluating real-world experience. For the Registry we reported all procedure-related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow-up. RESULTS: The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow-up, an infection was observed in 1.3% patients and a procedure-related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow-up, an infection was observed in 1.6% patients and a procedure-related SAE in 1.6% patients. CONCLUSIONS: The cumulative experience from a controlled clinical trial and a "real-world" registry demonstrate that the new ICM can be inserted with very low incidence of AEs.

Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience.

BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias. OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission. METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions. RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period. CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.

An exploratory double-blind, randomized clinical trial with selisistat, a SirT1 inhibitor, in patients with Huntington's disease.

AIMS: Selisistat, a selective SirT1 inhibitor is being developed as a potentially disease-modifying therapeutic for Huntington's disease (HD). This was the first study of selisistat in HD patients and was primarily aimed at development of pharmacodynamic biomarkers. METHODS: This was a randomized, double-blind, placebo-controlled, multicentre exploratory study. Fifty-five male and female patients in early stage HD were randomized to receive 10 mg or 100 mg of selisistat or placebo once daily for 14 days. Blood sampling, clinical and safety assessments were conducted throughout the study. Candidate pharmacodynamic markers included circulating soluble huntingtin and innate immune markers. RESULTS: Selisistat was found to be safe and well tolerated, and systemic exposure parameters showed that the average steady-state plasma concentration achieved at the 10 mg dose level (125 nm) was comparable with the IC50 for SirT1 inhibition. No adverse effects on motor, cognitive or functional readouts were recorded. While circulating levels of soluble huntingtin were not affected by selisistat in this study, the biological samples collected have allowed development of assay technology for use in future studies. No effects on innate immune markers were seen. CONCLUSIONS: Selisistat was found to be safe and well tolerated in early stage HD patients at plasma concentrations within the anticipated therapeutic concentration range.