Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study.

Aims: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices.

Methods And Results: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation.

Characterization of postoperative "fibrin web" formation after canine cataract surgery.

Purpose: To describe the occurrence and associated factors for "fibrin web" (FW) formation following phacoemulsification in dogs.

Methods: A retrospective review of medical records of all dogs undergoing phacoemulsification (MU-Veterinary Health Center, 2014-2018) was conducted to associate FW formation with signalment, systemic co-morbidities, cataract stage, surgeon (resident vs faculty), phacoemulsification time, IOL, and intracameral injections including viscoelastic type. Both univariate and multivariate statistical analyses were performed to evaluate associations among variables with FW formation.

Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up.

Objectives: The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate.

Evaluation of subcutaneous ICD early performance in hypertrophic cardiomyopathy from the pooled EFFORTLESS and IDE cohorts.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a potential alternative to transvenous systems in hypertrophic cardiomyopathy (HCM) where lead complications are a significant issue.

Objectives: To compare the S-ICD efficacy of defibrillation threshold (DFT) testing, arrhythmia therapy, and complications in HCM versus non-HCM patients.

Methods: Outcomes of patients with HCM implanted with S-ICD were compared to non-HCM S-ICD recipients using pooled data from a total of 872 subjects enrolled in the EFFORTLESS Registry and US IDE study.

The learning curve associated with the introduction of the subcutaneous implantable defibrillator.

Aims: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs).

Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort.

Background: The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system.

Pediatric medical complexity algorithm: a new method to stratify children by medical complexity.

Objectives: The goal of this study was to develop an algorithm based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), codes for classifying children with chronic disease (CD) according to level of medical complexity and to assess the algorithm's sensitivity and specificity.

Methods: A retrospective observational study was conducted among 700 children insured by Washington State Medicaid with ≥1 Seattle Children's Hospital emergency department and/or inpatient encounter in 2010. The gold standard population included 350 children with complex chronic disease (C-CD), 100 with noncomplex chronic disease (NC-CD), and 250 without CD.

Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry.

Aims: The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry.

Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator.

Background: The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation).

Community detection of long QT syndrome with a clinical registry: an alternative to ECG screening programs?

Background: Long QT syndrome (LQTS) prevalence is estimated at 4 of 10,000 based on community electrocardiogram (ECG) screening, about which there is disagreement regarding efficacy, accuracy, cost-effectiveness, and practicality. Family studies of autosomal dominant conditions such as LQTS have revealed 8-9 gene-positive family members per proband.

Objective: To evaluate a cardiac/genetic registry and family screening program as a tool to identify LQTS in the community.

Subcutaneous chronic implantable defibrillation systems in humans.

The recent introduction of subcutaneous implantable cardioverter defibrillator (S-ICD) has raised attention about the potential of this technology for clinical use in daily clinical practice. We review the methods and results of the four studies conducted in humans for approval of this innovative technology for daily practice. Two studies using a temporary S-ICD system (acute human studies) were conducted to search for an appropriate lead configuration and energy requirements.

An entirely subcutaneous implantable cardioverter-defibrillator.

Background: Implantable cardioverter-defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system.

Methods: First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements.

First human demonstration of cardiac stimulation with transcutaneous ultrasound energy delivery: implications for wireless pacing with implantable devices.

Objectives: The purpose of this study was to evaluate the feasibility and safety of a novel technology that uses energy transfer from an ultrasound transmitter to achieve cardiac stimulation without the use of a pacing lead in humans.

Background: To overcome the limitations of pacemaker leads, a new technology enabling stimulation without the use of a lead is desirable.

Methods: A steerable bipolar electrophysiology catheter incorporating a receiver electrode into the tip and circuitry to convert ultrasound energy to electrical energy was inserted transvenously into the heart.

Atrial pacing should be used more frequently in sinus node disease.

Background: Single lead atrial (AAI(R)) pacing for sick sinus syndrome provides physiological pacing and is less expensive than a dual chamber system. Compared with ventricular-based pacing, it maintains the normal cardiac depolarization sequence, is associated with less atrial fibrillation and heart failure, and avoids pacemaker syndrome. We sought whether it is possible to select patients for AAI(R) pacing with a low likelihood of subsequent ventricular pacing, and whether this approach was cost-effective.

Cerebral embolism from atrial myxoma in pediatric patients.

We describe 2 children with cerebrovascular events caused by emboli from left atrial myxomas and review 7 other pediatric cases from the literature. Transient cutaneous eruptions involving the extremities preceded the cerebrovascular events and were most likely attributable to fragmentation of the atrial tumor with peripheral embolization. Our first case demonstrates the more common presentation with acute hemiplegia caused by cerebral infarction and the second case a transient ischemic attack manifested by more subtle features as a result of involvement of the vertebrobasilar circulation.

Trimethoprim-induced aseptic meningitis in an adolescent male.

Drug-induced aseptic meningitis attributable to trimethoprim alone has only rarely been documented in the literature. A previously healthy adolescent male presented to our hospital with recurrent headaches, photophobia, and meningismus after serially starting and stopping trimethoprim. Cerebrospinal fluid studies revealed elevated white blood cell counts with a polymorphonuclear predominance.