Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Fear of Recurrence of Atrial Fibrillation: Translating a Cancer Fear Model to the Atrial Fibrillation Patient Experience.

Background: Atrial fibrillation occurs when rapid and disorganized electrical signals cause the atria in the heart to beat irregularly and is associated with an increased risk for stroke. Despite medical advancements, first and second line atrial fibrillation treatments exhibit significant recurrence rates. Because of this, atrial fibrillation patients often experience disease-specific fears that are not routinely assessed and targeted in clinical management. Fear of recurrence models in cancer research and other cardiac-specific fears have paved the way for a patient-centric approach to disease intervention. Purpose: Clinical assessment focused solely on the taxonomy of anxiety disorders may miss key components unique to the atrial fibrillation patient experience. An anxiety disorder diagnosis in the presence of an arrhythmia could be misleading and ultimately fail to address patient needs. Modeled from the cancer literature, providers may benefit from a broader disease specific conceptualization for AF patients that differs from a general DSM-5 diagnosis. Aims: The objectives of this paper are: (1) to review the medical aspects of atrial fibrillation, (2) to examine the comparability of fear of recurrence concept from cancer literature to the atrial fibrillation patient, and (3) to suggest considerations of these novel concepts in patient care. Future Directions: Increased understanding of fear of recurrence among atrial fibrillation patients aims to define and assess fear of recurrence components, determine treatment targets, and ultimately improve patient outcomes.

Managing atrial fibrillation: The intersection of cardiology, health psychology, and the patient experience.

Atrial fibrillation (AF) is the most common cardiac dysrhythmia and is an accelerating public health challenge. Challenges related to detection, management, and prevention of disability and dysfunction secondary to AF are increasingly apparent. The subspecialty of cardiology, cardiac electrophysiology, is primarily tasked with the treatment of AF. Patients with AF are often ambushed by the condition with approximately 28% to 38% of patients experiencing significant anxiety or depressive symptoms. Behavioral risk reduction can be targeted by achieving and maintaining a healthy BMI, abstaining from smoking, avoiding alcohol consumption, and sustaining regular physical activity. AF patients are also tasked with considering possible treatment options, adhering to medication regiments & lifestyle changes, utilizing wearable technologies, and managing emotional distress, to minimize health risks and optimize quality of life. Major medical organizations have called for integrated, multidisciplinary management as the treatment of choice for AF patients. Health psychologists bring valuable expertise but are not uniformly involved in the care of AF patients. The purposes of this article are to (a) review the existing research on the medical, psychological, and behavioral aspects of contemporary management of AF, (b) highlight the intersections between cardiac electrophysiology and clinical health psychology in managing AF, and (c) call for more health psychologists in this specialized area of cardiac electrophysiology. This opportunity for health psychologists may challenge the profession to further specialize as "cardiac psychologists" and mirror our medical colleagues. (PsycInfo Database Record (c) 2022 APA, all rights reserved).