What Are the Expectations for Cardiac Resynchronization Therapy? A Validation of Two Response Definitions
Toshiko Nakai, Yukitoshi Ikeya, Rikitake Kogawa, Naoto Otsuka, Yuji Wakamatsu, Sayaka Kurokawa, Kimie Ohkubo, Koichi Nagashima, Yasuo Okumura
Abstract
Background: The definition of response to cardiac resynchronization therapy (CRT) varies across clinical trials. There are two main definitions, i.e., echocardiographic response and functional response. We assessed which definition was more reasonable. Methods: In this study of 260 patients who had undergone CRT, an echocardiographic response was defined as a reduction in a left ventricular end-systolic volume of greater than or equal to 15% or an improvement in left ventricular ejection fraction of greater than or equal to 5%. A functional response was defined as an improvement of at least one class category in the New York Heart Association functional classification. We assessed the response to CRT at 6 months after device implantation, based on each definition, and investigated the relationship between response and clinical outcomes. Results: The echocardiographic response rate was 74.2%. The functional response rate was 86.9%. Non-responder status, based on both definitions, was associated with higher all-cause mortality. Cardiac death was only associated with functional non-responder status (hazard ratio (HR) 2.65, 95% confidence interval (CI) 1.19–5.46, p = 0.0186) and heart failure hospitalization (HR 2.78, 95% CI, 1.29–5.26, p = 0.0111). Conclusion: After CRT implantation, the functional response definition of CRT response is associated with a higher response rate and better clinical outcomes than that of the echocardiographic response definition, and therefore it is reasonable to use the functional definition to assess CRT response.