Rationale and design of the FELICITAR registry (Frailty Evaluation After List Inclusion, Characteristics and Influence on Transplantation and Results)

• Published in: Clinical cardiology (Mahwah, N.J.) N.J.), 2018-03, Vol.41 (3), p.293-299
• Main Authors: Ayesta, Ana, Astiz, María Teresa Vidán, Masa, María Jesús Valero, Segovia, Javier, Cosío, María Dolores García, Martínez‐Sellés, Manuel
• Format: Article
• Language: English
• Subjects: Aged; Female; Follow-Up Studies; Frailty; Frailty - epidemiology; Heart failure; Heart Failure - epidemiology; Heart Failure - surgery; Heart Transplantation; Heart Transplantation - mortality; Humans; Male; Middle Aged; Prevalence; Prognosis; Prospective Studies; Quality of Life; Registries; Spain - epidemiology; Survival Rate - trends; Trial Designs; Waiting Lists - mortality
• ISSN: 0160-9289; 1932-8737
• DOI: 10.1002/clc.22871

Frailty reflects a state of decreased physiological reserve and vulnerability to stressors. Its prevalence among patients with cardiovascular disease is as high as 60%. Frailty is associated with a poor prognosis for patients with heart failure, increasingly frequent hospitalization, and death. The recent published listing criteria for heart transplantation of the International Society for Heart and Lung Transplantation recommend assessing frailty (class IIb recommendation, level of evidence C). However, this recommendation is not based on prospective studies, and frailty scores have only been validated in patients age > 65 years. The aim of the FELICITAR registry (Frailty Evaluation After List Inclusion, Characteristics and Influence on Transplantation and Results) is to assess the impact of frailty on prognosis before and after heart transplantation. A series of 100 patients from 3 Spanish centers will be included as soon as they are added to the national heart transplantation waiting list. Frailty will be evaluated again every 3 months until heart transplantation and at 3, 6, and 12 months thereafter. Depression, cognitive assessment, and quality of life also will be analyzed. The 2 primary endpoints are all‐cause mortality and prevalence of frailty assessed using the Fried frailty index. Results from this study may show that frailty is frequent in patients with advanced heart failure listed for heart transplantation and is associated with a poor prognosis both before and after surgery. The findings may contribute to a better understanding of the characteristics of the optimal candidate for heart transplantation.