How to improve implantable cardioverter defibrillator therapy: Focus on patient-reported outcomes and enhanced programming

Abstract

Cardiovascular implantable electronic devices (CIEDs), such as pacemakers, implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy (CRT) devices, have become the treatment of choice for cardiac rhythm disorders in subgroups of patients with heart disease. Due to the expanding indications for CIEDs and the availability of data supporting the clinical effectiveness of these devices, the number of CIED implants has increased significantly over the past decades. While in the past mortality reduction was the primary goal of CIED therapy, in recent years increasing attention has been paid towards assessing the impact of these life-saving devices on patients’ lives. Despite increased focus on the patient perspective, there are still several knowledge gaps that need to be filled in order to optimize the management and care for patients with a CIED. In the first two parts of the current dissertation, the course and determinants of patient-reported health status following CIED implantation and the impact of patient-reported outcomes (PROs) on prognosis in ICD and heart failure patients was explored. Findings indicate that levels of (disease-specific) health status vary considerably across subgroups of patients receiving an ICD or CRT-defibrillator device. Depending on the health status component that was measured, 4-7 different outcome trajectories were identified in the first 12-14 months after implantation. The different health status trajectories generally showed an initial small to large improvement between device implantation and short-term follow-up, followed by stabilization between short- and long-term follow-up. Overall, poorer health status was particularly associated with patients’ psychological profile (i.e., negative affectivity, anxiety, depression, use of psychotropic medication and Type D personality) and less with their clinical status (except for NYHA classification), which is consistent with earlier research. Furthermore, this dissertationcorroborates that PROs not only compromise the well-being of patients but also increase their risk of adverse clinical outcomes including premature death. In the third part of this dissertation, current and previous research on the effects of optimization of ICD programming on (unnecessary) ICD therapy and PROs was reviewed. In recent years, a series of important clinical trials have led to a shift in ICD programming towards less early and aggressive arrhythmia termination using in-device detection algorithms, prolonged detection duration, and no therapy delivery for slower and stable ventricular tachyarrhythmias, allowing them to terminate spontaneously. These efforts have significantly reduced the incidence of inappropriate ICD shocks (i.e., approximately 2% at 1-year). However, with respect to reducing appropriate but unnecessary antitachycardia pacing and shocks, there are still gains to be made. The ENHANCED Implantable Cardioverter Defibrillator programming to reduce therapies and improve quality of life study (ENHANCED-ICD study), a prospective, single-arm safety monitoring study which was designed together with Tilburg University and implemented in the University Medical Center Utrecht, showed that programming a number of intervals to detectof 60/80 instead of 30/40 for ventricular tachyarrhythmia/ventricular fibrillation detection was safe for patients (N = 60) receiving a first-time ICD or CRT-defibrillator due to a primary or secondary prevention indication.