Trial protocol for the validation of the‘Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire’ in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry

Abstract

BackgroundPatients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency.MethodsThe present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS.DiscussionValidation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients.Trial registration numberNCT03186339

Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire

“…[2][3][4] However, the KCCQ focuses on HF-specific symptoms and does not capture parameters that are specific to AS. 5 In addition, the treatment of severe AS, and the likely outcome of such treatment, differs from that for other types of HF. Patients with severe AS develop symptoms of HF in the presence of a preserved ejection fraction (HFpEF).…”

“…The TASQ has been designed to address that need, by taking into account the physical, emotional, and social factors associated with severe AS. 5 It also includes a health expectations domain, which reflects how hopeful the patient is that their health will improve, a factor that is not assessed by the KCCQ. Some research identifies that patient expectations and perceptions may impact post-procedural outcomes including QoL.…”

“…The TASQ registry was a prospective observational registry with a follow-up period of 3 months. 5,6 Patients with severe symptomatic AS were recruited from 10 centres in nine countries in Europe (Austria/Germany, 2 France, 2 Italy, 2 Spain, 2 and the UK 1 ) and one centre in Canada with the intention to have at least two sites for each language. Patients either underwent transfemoral (TF) TAVI using the balloon expandable SAPIEN 3 valve (Edwards Lifesciences) or SAVR using any commercially available surgical valve.…”

“…The TASQ registry was a prospective observational registry with a follow‐up period of 3 months 5,6 . Patients with severe symptomatic AS were recruited from 10 centres in nine countries in Europe (Austria/Germany, 2 France, 2 Italy, 2 Spain, 2 and the UK 1 ) and one centre in Canada with the intention to have at least two sites for each language.…”

“…It is short, convenient to use and dedicated for patients with AS. It has been shown to provide an accurate picture of QoL in patients with severe AS before and after treatment 5,6 . Here, we present the results of the validation of the TASQ in patients undergoing treatment for severe AS, based on a prospective, multinational registry.…”