Incidence and economics of transvenous ICD lead complications: Implications for tricuspid valve function and interventions.

Background: Implantable cardioverter-defibrillators are used globally and are reliable, but complications related to transvenous leads remain a concern. Evidence related to the incidence and costs of those complications is heterogeneous with respect to scope and healthcare system. This analysis aims to create estimates of the incidence and costs of tricuspid valve (TV) complications, lead failures, and lead extractions from a single large real-world data set.

Antitachycardia pacing success in implantable cardioverter-defibrillators by patient, device, and programming characteristics.

Background: Antitachycardia pacing (ATP) is an established implantable cardioverter-defibrillator (ICD) therapy that terminates ventricular tachycardias (VTs) without painful ICD shocks. However, factors influencing ATP success are not well understood.

Objective: The purpose of this study was to examine ATP success rates by patient, device, and programming characteristics.

Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.

Background: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant.

Performance evaluation of implantable cardioverter-defibrillators with SmartShock technology in patients with inherited arrhythmogenic diseases.

Background: Patients with inherited arrhythmogenic diseases (IADs) are often prescribed preventative implantable cardioverter-defibrillators (ICDs) to manage their increased sudden cardiac arrest risk. However, it has been suggested that ICDs in IAD patients may come with additional risk. We aimed to leverage the PainFree SmartShock Technology dataset to compare inappropriate therapies, appropriate therapies, mortality, and complications in patients with and without IAD.

Small decreases in biventricular pacing percentages are associated with multiple metrics of worsening heart failure as measured from a cardiac resynchronization therapy defibrillator.

Background: Lower BiVentricular (BiV) pacing percentages have been associated with significantly worse survival in patients with chronic heart failure (HF). However, the pathophysiology behind this observation has not been further delineated. This analysis evaluated whether small incremental decreases in BiV pacing percentages were associated with worse measures, related to HF physiology using individual sensor trends and the HeartLogic composite index.

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system.

SVT discrimination algorithms significantly reduce the rate of inappropriate therapy in the setting of modern-day delayed high-rate detection programming.

Background: Contemporary implantable cardioverter-defibrillator (ICD) programming involving delayed high-rate detection and use of supraventricular tachycardia (SVT) discriminators has significantly reduced the rate of inappropriate shocks. The extent to which SVT algorithms alone reduce inappropriate therapies is poorly understood.

Methods And Results: PainFree SST enrolled 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization defibrillator.

Transcatheter aortic valve replacement and cardiac conduction.

Conduction abnormalities after transcatheter aortic valve replacement (TAVR) account for a high percentage of post-TAVR complications. Areas covered: The etiology of conduction abnormalities is closely tied to cardiac anatomy (length of membranous septum, degree of calcification, location of left bundle within the membranous septum), baseline conduction abnormalities (preprocedure right bundle branch block), and procedural variables (type of valve, depth of implant). Management of new high-grade AV block and new left bundle branch block varies by institution in the absence of consensus guidelines.

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection.

Background: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections.

Methods: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations.

Internal insulation breaches in an implantable cardioverter-defibrillator lead with redundant conductors.

Background: Internal insulation breaches (IBR) may result in implantable cardioverter-defibrillator lead failure and adverse clinical events. Concerns exist that the Durata lead may be prone to IBR.

Objective: The goals of this study were to assess Durata failures in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to failures in MAUDE for Endotak Reliance and Sprint Quattro Secure (QS) leads.

Estimating the incidence of atrial fibrillation in single-chamber implantable cardioverter defibrillator patients.

Background: Atrial arrhythmias are associated with major adverse cardiovascular events. Recent reports among implantable cardioverter defibrillator (ICD) patients have demonstrated a high prevalence of atrial fibrillation (AF), predominantly in dual-chamber recipients. AF incidence among patients with single-chamber systems (approximately 50% of all ICDs) is currently unknown.

Comparison of ICD shock rates in Japanese and non-Japanese patients in the PainFree SST study.

Background: The PainFree Smart Shock Technology (SST) study showed a low implantable cardioverter-defibrillator (ICD) inappropriate shock rate. However, the majority of patients were from Western countries with patient characteristics different from those in Japan. ICD shock rates using the novel SST algorithms in Japanese patients are still unknown.

Defibrillator shocks and their effect on objective and subjective patient outcomes: Results of the PainFree SST clinical trial.

Background: The effect of implantable cardioverter-defibrillator (ICD) shock on device-measured activity and patient-reported outcomes is unknown.

Objective: The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data (ie, device-based physical activity) and subjective patient-reported outcomes (eg, quality of life and shock anxiety).

Methods: The PainFree Smart Shock Technology (SST) clinical trial included 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization therapy - defibrillator device who were followed for 22 ± 9 months.

Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis.

Aims: Single-chamber (VR-ICD) and subcutaneous (S-ICD) implantable cardioverter-defibrillators are effective to protect patients against sudden death but expose them to higher risk of inappropriate shock (IS). We sought to quantify the annual rate and influencing factors of ISs in VR- and S-ICDs from the literature.

Methods And Results: PubMed, Embase, and Cochrane Library were searched for full text articles with IS rates.

Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST.

Background: Prolonged ventricular fibrillation (VF) detection has been shown to reduce implantable cardioverter-defibrillator (ICD) therapies and improve prognosis in primary prevention ICD patients. Data in secondary prevention patients are limited.

Objective: The PainFree SST secondary prevention study is the largest trial of secondary prevention patients randomized between standard and prolonged detection to assess the safety of this strategy in these patients.

Medical specialty certification in the United States-a false idol?

Purpose: Recent changes to medical specialty certification in the USA have prompted the process to come under intense scrutiny.

Methods: We review the history of board certification and the changes made to the process. As part of this review, we examine both literature and public record to examine the motives behind the changes made.

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.

Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results.

Background: The benefits of implantable cardioverter-defibrillators (ICDs) have been well demonstrated in many clinical trials, and ICD shocks for ventricular tachyarrhythmias save lives. However, inappropriate and unnecessary shock delivery remains a significant clinical issue with considerable consequences for patients and the healthcare system.

Objective: The purpose of the PainFree SmartShock Technology (SST) study was to investigate new-generation ICDs to reduce inappropriate and unnecessary shocks through novel discrimination algorithms with modern programming strategies.

Indications for cardiac resynchronization therapy.

Initial studies established patient selection criteria for cardiac resynchronization therapy (CRT) as left ventricular ejection fraction less than or equal to 35%, QRS greater than or equal to 120 ms, and New York Heart Association 3-4. Based on newer data, post hoc analyses, and meta-analyses, these criteria have been refined and guidelines updated, highlighting left bundle branch morphology and QRS greater than 150 ms in selecting patients with a likelihood of favorable outcomes. Guidelines will change as more data become available; the decision to apply CRT should be based on patient clinical profile and the balance of risk tolerance and likelihood of benefit.

Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla.

Background: Magnetic resonance imaging (MRI) of pacemakers is a relative contraindication because of the risks to the patient from potentially hazardous interactions between the MRI and the pacemaker system. Chest scans (ie, cardiac magnetic resonance scans) are of particular importance and higher risk. The previously Food and Drug Administration-approved magnetic resonance conditional system includes positioning restrictions, limiting the powerful utility of MRI.

Safety, efficacy, and performance of new discrimination algorithms to reduce inappropriate and unnecessary shocks: the PainFree SST clinical study design.

Introduction: Implantable cardioverter defibrillator (ICD) shock therapy improves survival of patients at risk for sudden cardiac death. The high sensitivity of ICDs to detect tachycardia events is accompanied by reduced specificity resulting in inappropriate and unnecessary shocks. Up to 30% of ICD patients may experience inappropriate shocks, which are most commonly caused by lead noise, oversensing of T-waves, and supraventricular tachycardias.

Peri-infarct pacing with CRT in the early postinfarct phase to attenuate long-term remodeling.

Deleterious left ventricular remodeling routinely occurs after myocardial infarction (MI) and novel strategies to attenuate this phenomenon may prove valuable. Here, we describe the potential role of left ventricular (LV) peri-infarct pacing (delivered via biventricular pacemakers) to reduce post-MI remodeling. Regional wall stress in the infarcted area is predictive of remodeling and therefore represents a potential therapeutic target.

Feasibility of biventricular pacing in patients with recent myocardial infarction: impact on ventricular remodeling.

To test the hypothesis that biventricular pacing after a myocardial infarction with reduced ejection fraction can attenuate left ventricular (LV) remodeling, the authors studied 18 patients (myocardial infarction within 30-45 days, ejection fraction View Article and Find Full Text PDF