Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial.

Background: There is conflicting evidence on the efficacy of primary prevention implantable cardioverter-defibrillator (ICD) implantation in the elderly.

Objective: The purpose of this study was to determine the efficacy and safety of ICD implantation in patients 70 years and older.

Methods: Patients (n = 167) aged 70 years or older and eligible for ICD implantation were randomly assigned (1:1) to receive either optimal medical therapy (OMT) (n = 85) or OMT plus ICD (n = 82).

Informational letters or postcards to initiate remote monitoring among veterans with pacemakers and implantable cardioverter-defibrillators: A randomized, controlled trial.

Background: Remote monitoring (RM) of pacemakers and implantable cardioverter-defibrillators (ICDs) is a Class 1, Level of Evidence A recommendation because of its multitude of clinical benefits. However, RM adherence rates are suboptimal, precluding patients from achieving these benefits. There is a need for direct-to-patient efforts to improve adherence.

Monitoring of Remotely Reprogrammable Implantable Loop Recorders With Algorithms to Reduce False-Positive Alerts.

Background: Implantable loop recorders (ILRs) are increasingly placed for arrhythmia detection. However, historically, ≈75% of ILR alerts are false positives, requiring significant time and effort for adjudication. The LINQII and LUX-Dx are remotely reprogrammable ILRs with dual-stage algorithms using artificial intelligence to reduce false positives, but their utility in routine clinical practice has not been studied.

Informational Postcards Increase Engagement with Remote Monitoring Among Veterans with Pacemakers and Implantable Cardioverter-Defibrillators: a Stepped-Wedge Randomized Controlled Trial.

Background: Remote monitoring (RM) of pacemakers and implantable cardioverter-defibrillators (ICDs) reduces morbidity and mortality. However, many patients are not adherent to RM.

Objective: To test the effect of informational postcards on RM adherence.

Barriers and Facilitators Associated With Remote Monitoring Adherence Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators: Qualitative Cross-Sectional Study.

Background: The Heart Rhythm Society strongly recommends remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) because of the clinical outcome benefits to patients. However, many patients do not adhere to RM and, thus, do not achieve these benefits. There has been limited study of patient-level barriers and facilitators to RM adherence; understanding patient perspectives is essential to developing solutions to improve adherence.

An Unexpected Pacemaker Response to Catheter Ablation: Failure of Pacing Pulse Delivery During Asynchronous Pacing Mode.

Radiofrequency (RF) ablation can be a source of electromagnetic interference (EMI) for cardiovascular implantable electronic devices (CIEDs). The response of CIEDs to this type of EMI can be variable and unpredictable. We report a case with an uncommon response where there was a failure to deliver pacing pulses to both atrial and ventricular pacing leads during RF ablation close to the atrial lead even when the pacemaker was set to pace asynchronously.

Ventricular arrhythmia detection for contemporary Biotronik and Abbott implantable cardioverter defibrillators with markedly prolonged detection in Biotronik devices.

Background: Implantable cardioverter defibrillators (ICDs) are typically programed with both ventricular tachycardia (VT) and ventricular fibrillation (VF) treatment zones. Biotronik and Abbott ICDs do not increment the VT counter when the tachycardia accelerates to the VF zone, which could result in a prolonged delay in tachycardia detection.

Methods: Patients with Biotronik and Abbott ICDs receiving care at Veterans Affairs facilities in Northern California were identified.

Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation.

Background: Current methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead.

Objective: The purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation.

Methods: Among 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021.

Implantable cardioverter-defibrillator placement among patients with left ventricular ejection fraction ≤35 % at least 40 days after acute myocardial infarction.

Background: Implantable cardioverter-defibrillators (ICDs) reduce the risk of sudden cardiac death among patients with persistently reduced (≤35 %) left ventricular ejection fraction (LVEF) at least 40 days following acute myocardial infarction (AMI). Few prior studies have used LVEF measured after the 40-day waiting period to examine primary prevention ICD placement.

Methods: We sought to determine factors associated with ICD placement among patients who met LVEF criteria post-MI within a large integrated health care system in the U.

Reduction in Ventricular Tachyarrhythmia Burden in Patients Enrolled in the RAID Trial.

Background: The RAID (Ranolazine Implantable Cardioverter-Defibrillator) randomized placebo-controlled trial showed that ranolazine treatment was associated with reduction in recurrent ventricular tachycardia (VT) requiring appropriate implantable cardioverter-defibrillator (ICD) therapy.

Objectives: This study aimed to identify groups of patients in whom ranolazine treatment would result in the highest reduction of ventricular tachyarrhythmia (VTA) burden.

Methods: Andersen-Gill analyses were performed to identify variables associated with risk for VTA burden among 1,012 patients enrolled in RAID.

Factors associated with remote monitoring adherence for cardiovascular implantable electronic devices.

Background: Professional societies strongly recommend remote monitoring (RM) of all cardiac implantable electronic devices, and higher RM adherence is associated with improved patient outcomes. However, adherence with RM is suboptimal.

Objective: The purpose of this study was to better understand factors associated with RM adherence.

Adaptive Cardiac Resynchronization Therapy Effect on Electrical Dyssynchrony (aCRT-ELSYNC): A randomized controlled trial.

Background: Adaptive cardiac resynchronization therapy (aCRT) is known to have clinical benefits over conventional CRT, but the mechanisms are unclear.

Objective: Compare effects of aCRT and conventional CRT on electrical dyssynchrony.

Methods: A prospective, double-blind, 1:1 parallel-group assignment randomized controlled trial in patients receiving CRT for routine clinical indications.

Health-Related Quality of Life in the ronolactone to educe CD herapy (SPIRIT) Trial.

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg ( = 44) or placebo ( = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ).

Development and implementation of standardized study performance metrics for a VA healthcare system clinical research consortium.

The cost of conducting clinical trials is continuously increasing and is driven in large part by the time and resources required to activate trials and reach accrual targets. The impact of low enrollment in a clinical trial can negatively affect the validity of study results and delay its generalizability to the broader population. Quality is a multidimensional concept which could relate to the design, conduct, and analysis of a trial, its clinical relevance, protection/safety of study participants, or quality of reporting.

Practice Gap in Atrial Fibrillation Oral Anticoagulation Prescribing at Emergency Department Home Discharge.

Introduction: Current U.S. cardiology guidelines recommend oral anticoagulation (OAC) to reduce stroke risk in selected patients with atrial fibrillation (AF), but no formal AF OAC recommendations exist to guide emergency medicine clinicians in the acute care setting.