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  • 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

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Valvular heart disease
Protocol
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
  1. Derk Frank1,
  2. Simon Kennon2,
  3. Nikolaos Bonaros3,
  4. Mauro Romano4,
  5. Thierry Lefèvre4,
  6. Carlo Di Mario5,
  7. Pierluigi Stefàno5,
  8. Flavio Luciano Ribichini6,
  9. Dominique Himbert7,
  10. Marina Urena-Alcazar7,
  11. Jorge Salgado-Fernandez8,
  12. Jose Joaquin Cuenca Castillo8,
  13. Bruno Garcia9,
  14. Jana Kurucova10,
  15. Martin Thoenes11,
  16. Claudia Lüske12,
  17. Peter Bramlage12 and
  18. Rima Styra13
  1. 1 Departmentof Internal Medicine III (Cardiology, Angiology and Intensive Care Medicine), UKSH University Clinical Center Schleswig-Holstein, Kiel, Germany and DZHK (German Centre for Cardiovascular Research), partner site Hamburg/Kiel/Lübeck, Kiel, Germany
  2. 2 Department of Cardiology, Barts Heart Centre, St. Bartholomew’s Hospital London, London, UK
  3. 3 Departmentof Cardiac Surgery, Innsbruck Medical University, Innsbruck, Austria
  4. 4 Departmentof Thoracic and Cardiovascular Surgery, Department of Interventional Cardiology, Hopital Privé Jacques Cartier, Massy, France
  5. 5 Department of Structural Interventional Cardiology, Department of Cardiac Surgery, Careggi University Hospital, Florence, Italy
  6. 6 Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy
  7. 7 Department of Cardiology, Bichat-Claude Bernard Hospital, Paris, France
  8. 8 Department of Cardiology, Department of Cardiovascular Surgery, Hospital Juan Canalejo, Coruña, Spain
  9. 9 Department of Cardiology, Hospital Vall d’Hebron, Barcelona, Spain
  10. 10 Edwards Lifesciences, Prague, Czech Republic
  11. 11 Edwards Lifesciences, Nyon, Switzerland
  12. 12 Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
  13. 13 Department of Psychiatry, University Health Network, Toronto, Ontario, Canada
  1. Correspondence to Dr Derk Frank; derk.frank{at}uksh.de

Abstract

Background Patients 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.

Methods The 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.

Discussion Validation 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 number NCT03186339

  • aortic stenosis
  • aortic valve replacement
  • transcatheter
  • quality of life
  • questionnaire

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/openhrt-2019-001008

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    Footnotes

    • Contributors DF, SK, TL, CL, PB and RS were involved in the conception and design of the registry. The remaining authors gave feedback on the final protocol and are currently including patients. DF, CL and PB drafted the manuscript and all other authors have been revising the article for important intellectual content. All authors have given final approval of the version to be published. All authors are fully accountable for the content of the manuscript.

    • Funding A research grant provided by Edwards Lifesciences (Nyon, Switzerland) to the Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany).

    • Competing interests PB is the representative of the Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. All centres were paid by IPPMed for the enrolment and documentation of patients.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol will be submitted to the relevant Independent Ethics Committee or Institutional Review Board at each centre for approval. The registry for this validation protocol will be in accordance with the Declaration of Helsinki and its amendments, as well as country-specific laws and regulations.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement There are no data in this work.