Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies.

Objectives: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant.

Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections.

Burden of Psychosocial and Cognitive Impairment in Patients With Atrial Fibrillation.

Background: Impairments in psychosocial status and cognition relate to poor clinical outcomes in patients with atrial fibrillation (AF). However, how often these conditions co-occur and associations between burden of psychosocial and cognitive impairment and quality of life (QoL) have not been systematically examined in patients with AF.

Methods: A total of 218 patients with symptomatic AF were enrolled in a prospective study of AF and psychosocial factors between May 2013 and October 2014 at the University of Massachusetts Medical Center.

Association of Left Atrial Function Index With Late Atrial Fibrillation Recurrence after Catheter Ablation.

Introduction: Although catheter ablation (CA) for atrial fibrillation (AF) is commonly used to improve symptoms, AF recurrence is common and new tools are needed to better inform patient selection for CA. Left atrial function index (LAFI), an echocardiographic measure of atrial mechanical function, has shown promise as a noninvasive predictor of AF. We hypothesized that LAFI would relate to AF recurrence after CA.

Addition of B-Type Natriuretic Peptide to Existing Clinical Risk Scores Enhances Identification of Patients at Risk for Atrial Fibrillation Recurrence After Pulmonary Vein Isolation.

Introduction: Predicting which patients will be free from atrial fibrillation (AF) after pulmonary vein isolation (PVI) remains challenging. Clinical risk prediction scores show modest ability to identify patients at risk for AF recurrence after PVI. B-type natriuretic peptide (BNP) is associated with risk for incident and recurrent AF but is not currently included in existing AF risk scores.

Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions.

Background: Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI).

Objective: The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI.

Methods: The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s).

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions.

Background: Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI).

Objective: The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions.

Methods: The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead.

Phone-delivered mindfulness training for patients with implantable cardioverter defibrillators: results of a pilot randomized controlled trial.

Background: The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators.

Purpose: This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety.

Methods: Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call.

Spiritual well-being may buffer psychological distress in patients with implantable cardioverter defibrillators (ICD).

Psychological distress is common in patients with implantable cardioverter defibrillators (ICDs) and has been associated with a worse prognosis. The authors examined whether spiritual wellbeing is associated with reduced psychological distress in patients with ICDs. The Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SWB) questionnare and the Hospital Anxiety and Depression Scale (HADS) were used to measure spiritual wellbeing and overall psychological distress.

Design and methods for a pilot study of a phone-delivered, mindfulness-based intervention in patients with implantable cardioverter defibrillators.

Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs).

Genome-wide association of implantable cardioverter-defibrillator activation with life-threatening arrhythmias.

Objectives: To identify genetic factors that would be predictive of individuals who require an implantable cardioverter-defibrillator (ICD), we conducted a genome-wide association study among individuals with an ICD who experienced a life-threatening arrhythmia (LTA; cases) vs. those who did not over at least a 3-year period (controls).

Background: Most individuals that receive implantable cardioverter-defibrillators never experience a life-threatening arrhythmia.

Characteristics of Dispositional Mindfulness in Patients with Severe Cardiac Disease.

The characteristics of dispositional mindfulness have rarely been explored in unhealthy populations. We sought to evaluate its association(s) with psychological morbidity and disease severity in 30 outpatients with implantable cardioverter defibrillators naïve to mindfulness training. We used the Five Facets of Mindfulness and the Hospital Anxiety and Depression Scale to measure dispositional mindfulness and anxiety/depression, respectively.

Patient preferences after endoscopic ultrasound with fine needle aspiration (EUS-FNA) diagnosis of pancreas cancer: rapid communication valued over long-term relationships.

Background: Endoscopic ultrasound with fine needle aspiration (EUS-FNA) is used for the diagnosis of pancreatic malignancy. However, there are limited data as to patient preferences regarding the delivery of cancer diagnoses.

Objective: This study aimed to assess if patients had met the endosonographer before their EUS, their suspicion of having cancer, and whether they would like the cytology results given to them by their referring physician (with whom they had a previous relationship) or the endosonographer.

Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial.

Objectives: The CAPTURE study evaluated the accuracy of automated atrial and right ventricular (RV) threshold algorithms.

Background: Modern pacemakers include many added features designed to improve the ease of patient follow-up, as well as algorithms to reduce pacing outputs and/or reduce the atrial or ventricular pacing percentages, thus improving longevity.

Methods: Automated atrial and RV threshold measurements were assessed versus manual measurements at 6 months.

Reduced heart rate variability correlates with insulin resistance but not with measures of obesity in population undergoing laparoscopic Roux-en-Y gastric bypass.

Background: Obesity is associated with a pathologic predominance of sympathetic over parasympathetic tone. With respect to the heart, this autonomic dysfunction presents as a decreased heart rate variability (HRV), which has been associated with increased cardiovascular morbidity. Gastric bypass (GB) reduces cardiovascular mortality, and, thus, could beneficially affect the HRV.

Device diagnostics and long-term clinical outcome in patients receiving cardiac resynchronization therapy.

Aims: This retrospective analysis sought to develop and validate a model using the measured diagnostic variables in cardiac resynchronization therapy (CRT) devices to predict mortality.

Methods And Results: Data used in this analysis came from two CRT studies: Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices (CRT RENEWAL) (n = 436) and Heart Failure-Heart Rate Variability (HF-HRV) (n = 838). Patients from CRT RENEWAL were used to create a model for risk of death using logistic regression and to create a scoring system that could be used to predict mortality.

Inadvertent lead placement in the left ventricle: a case report and brief review.

Inadvertent lead placement in the left ventricle (LV) is an uncommon and often under-diagnosed complication of cardiac device implantation. Thromboembolic (TE) events are common and usually secondary to fibrosis or thrombus formation on or around the lead. Anticoagulation can prevent TE events.

EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles.

Background: There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses.

Objectives: Our primary aim was to compare the diagnostic yield of 22-gauge and 25-gauge needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications.

Driving and implantable cardioverter-defibrillator shocks for ventricular arrhythmias: results from the TOVA study.

Objectives: This study examined the risk of implantable cardioverter-defibrillator (ICD) shocks for ventricular tachycardia (VT) or ventricular fibrillation (VF) associated with driving.

Background: Concerns regarding VT/VF occurring during driving are the basis for driving restrictions in ICD patients; however, limited data are available to inform recommendations.

Methods: This study used a prospective nested case-crossover design to compare the risk of ICD shock for VT/VF both during and up to 60 min after an episode of driving as compared with that during other activities among 1,188 ICD patients enrolled in the TOVA (Triggers of Ventricular Arrhythmia) study.

Impact of rate-modulated pacing on quality of life and exercise capacity--evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT).

Background: Ninety-nine percent of pacemakers implanted in the United States include an option for rate modulation.

Objective: The purpose of this study was to determine whether dual-chamber rate-modulated pacing, when compared with dual-chamber pacing alone, improved quality of life.

Methods: This was a single-blind randomized controlled trial comparing dual-chamber with rate-modulated dual-chamber pacing.