The Registry Evaluating Functional Outcomes of Resynchronization Management (REFORM): Quality of Life and Psychological Functioning in Patients Receiving Cardiac Resynchronization Therapy


  • Medtronic funded this project.

  • S. Sears serves as a consultant to Medtronic and has research grants from Medtronic in past 2 years. These funds are directed to East Carolina University. Dr. Sears also has received speaker honoraria from Medtronic, Boston Scientific, St. Jude Medical, and Biotronik. D. Reynolds serves as a consultant/advisor to Medtronic and has several research grants from Medtronic. P. Nguyen has received research funding from Medtronic. Dr. Nguyen has also received speaker honoraria from Medtronic, Boston Scientific, and Biotronik. C. Murray has received research funding from Medtronic and Biotronic. R. Thompson has research honoraria from Medtronic. M. Fedewa was an employee of Medtronic, Inc. during her engagement in this study. Other authors: No disclosures.


QoL and Psychosocial Outcomes of CRT. Background

Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) that improves cardiac, functional, and quality of life (QoL) outcomes. This study was designed to examine the effect of the addition of CRT (CRTD) to the implantable cardioverter defibrillator (ICD) on psychological functioning.

Methods and Results

Overall, 99 participants completed batteries before and 9 months after ICD or CRTD implantation in a registry of HF patients receiving device treatment in 3 US centers. Measures included validated indices of mental health (State Trait Anxiety Inventory, Patient Health Questionnaire: Depression) and generic and disease/device-specific QoL (Medical Outcomes Study-Short Form-12, Kansas City Cardiomyopathy Questionnaire, Florida Patient Acceptance Survey, Florida Shock Anxiety Scale). Mixed between-within analyses of covariance were employed to compare device groups on each outcome controlling for cardiac and demographic covariates. Clinically significant anxiety was elevated in both groups at both time points (57% CRTD at baseline, 29% CRTD 9 months, 44% ICD at baseline, 45% ICD 9 months). Clinically significant depressive symptoms were high at baseline (38% CRTD, 31% ICD), but dropped at follow-up (16% CRTD, 7% ICD; P = 0.01). Participants with CRTD had improved mental component and disease-specific QoL following CRT; however, CRTD patients had worse QoL, worse mental component QoL at baseline, and worse device acceptance at 9-month follow-up than patients with ICDs (all P < 0.05).


Evidence of low QoL, psychological functioning, and device acceptance provides the impetus to increase research on well-being of HF patients being implanted with CRTD in research and clinical work.