With HeartMate II (HMII) implants increasing so has the frequency of device exchange. However, identifying inflow cannula obstruction, pump thrombosis, or outflow obstruction as the mechanism of pump dysfunction can be difficult. Echocardiography, CT angiogram, and cardiac catheterization are not definitive in determining the location of pump failure. Therefore, intraoperative examination is of...

AIMS Implantable cardioverter defibrillators (ICDs) are well accepted by most patients, but 25-33% of patients are anxious and report device-related concerns. Previous studies focused on prevalence rates and mean scores, whereas the course of anxiety over time is unknown in individual patients. We examined the trajectory of anxiety in ICD patients during a 1-year period and determinants of thes...

BACKGROUND A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. METHODS AND RESULTS Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219 Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: s...

Introduction The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a novel device that demonstrates high efficacy for treatment of ventricular tachycardia and ventricular fibrillation and is an alternative to the transvenous ICD device. The safety and efficacy of the S-ICD has been thoroughly evaluated, and pooled data from the IDE and Effortless studies show only a 0.8% incidence ...

The aim of this EP Wire was to assess the management, indications, and techniques for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) device replacement in Europe. A total of 24 centres in 14 European countries completed the questionnaire. All centres were members of the European Heart Rhythm Association Electrophysiology Research Network. Replacement pr...

BACKGROUND The approach to treat device infection in patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) is a challenging procedure. Optimal treatment is complete extraction of the infected device. To protect these patients from sudden cardiac arrest while waiting for reimplantation and to avoid recurrent infection, a wearable ca...

BACKGROUND The purpose of this study is to describe key elements, clinical outcomes, and potential uses of the Kaiser Permanente-Cardiac Device Registry. METHODS AND RESULTS This is a cohort study of implantable cardioverter defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy (CRT) devices implanted between January 1, 2007 and December 31, 2013 by ≈400 physicians in 6...

Background—A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. Methods and Results—Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219 Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: sev...

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 requ...

In the last five years, evidence has accumulated confirming the superiority of implantable cardioverter-defibrillator (ICD) therapy compared to antiarrhythmic drug therapy for prevention of sudden death (1,2). Clinical trials, with rare exception, have established mortality benefits of ICD therapy in a variety of patients at risk for sudden arrhythmic death. Just as clinicians have begun to inc...