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

Derk Frank, Simon Kennon, Nikolaos Bonaros, Mauro Romano, Thierry Lefèvre, Carlo Di Mario, Pierluigi Stefàno, Flavio Luciano Ribichini, Dominique Himbert, Marina Urena-Alcazar, Jorge Salgado-Fernandez, Jose Joaquin Cuenca Castillo, Bruno Garcia, Jana Kurucova, Martin Thoenes, Claudia Lüske, Peter Bramlage, Rima Styra, Derk Frank, Simon Kennon, Nikolaos Bonaros, Mauro Romano, Thierry Lefèvre, Carlo Di Mario, Pierluigi Stefàno, Flavio Luciano Ribichini, Dominique Himbert, Marina Urena-Alcazar, Jorge Salgado-Fernandez, Jose Joaquin Cuenca Castillo, Bruno Garcia, Jana Kurucova, Martin Thoenes, Claudia Lüske, Peter Bramlage, Rima Styra

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.

Keywords: aortic stenosis; aortic valve replacement; quality of life; questionnaire; transcatheter.

Conflict of interest statement

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.

References

    1. Baumgartner H, Falk V, Bax JJ, et al. . 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739–91. 10.1093/eurheartj/ehx391
    1. Leon MB, Smith CR, Mack M, et al. . Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med Overseas Ed 2010;363:1597–607. 10.1056/NEJMoa1008232
    1. Bonaros N, Petzina R, Cocchieri R, et al. . Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the route registry. Eur J Cardiothorac Surg 2017;51:919–26. 10.1093/ejcts/ezw406
    1. Arnold SV, Spertus JA, Lei Y, et al. . How to define a poor outcome after transcatheter aortic valve replacement: conceptual framework and empirical observations from the placement of aortic transcatheter valve (partner) trial. Circ Cardiovasc Qual Outcomes 2013;6:591–7. 10.1161/CIRCOUTCOMES.113.000354
    1. Kundi H, Strom JB, Valsdottir LR, et al. . Trends in Isolated Surgical Aortic Valve Replacement According to Hospital-Based Transcatheter Aortic Valve Replacement Volumes. JACC Cardiovasc Interv 2018;11:2148–56. 10.1016/j.jcin.2018.07.002
    1. Lancellotti P, Magne J, Dulgheru R, et al. . Outcomes of patients with asymptomatic aortic stenosis followed up in heart valve clinics. JAMA Cardiol 2018;3 10.1001/jamacardio.2018.3152
    1. Shi S, Afilalo J, Lipsitz LA, et al. . Frailty phenotype and deficit accumulation frailty index in predicting recovery after transcatheter and surgical aortic valve replacement. The Journals of Gerontology: Series A 2018;62 10.1093/gerona/gly196
    1. Devins GM. Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease. J Psychosom Res 2010;68:591–602. 10.1016/j.jpsychores.2009.05.006
    1. Green CP, Porter CB, Bresnahan DR, et al. . Development and evaluation of the Kansas City cardiomyopathy questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000;35:1245–55. 10.1016/S0735-1097(00)00531-3
    1. Spertus JA, Winder JA, Dewhurst TA, et al. . Development and evaluation of the Seattle angina questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995;25:333–41. 10.1016/0735-1097(94)00397-9
    1. Rector TS, Cohn JN. Assessment of patient outcome with The Minnesota living with heart failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. pimobendan multicenter Research Group. Am Heart J 1992;124:1017–25. 10.1016/0002-8703(92)90986-6
    1. Dixon T, Lim LLY, Oldridge NB. The MacNew heart disease health-related quality of life Instrument: reference data for users. Qual Life Res 2002;11:173–83. 10.1023/A:1015005109731
    1. Ware J, Kosinski M, Keller SD. A 12-Item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33.
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. Arnold SV, Reynolds MR, Wang K, et al. . Health status after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis at increased surgical risk: results from the CoreValve us pivotal trial. JACC Cardiovasc Interv 2015;8:1207–17. 10.1016/j.jcin.2015.04.018
    1. Arnold SV, Spertus JA, Lei Y, et al. . Use of the Kansas City cardiomyopathy questionnaire for monitoring health status in patients with aortic stenosis. Circ Heart Fail 2013;6:61–7. 10.1161/CIRCHEARTFAILURE.112.970053
    1. Arnold SV, Spertus JA, Vemulapalli S, et al. . Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: a report from the STS/ACC transcatheter valve therapy registry. JAMA Cardiol 2017;2:409–16. 10.1001/jamacardio.2016.5302
    1. Toronto Aortic Stenosis Quality of Life Scale (TASQ) Development and psychometric quality of life properties in TAVI patients. Toronto Aortic Stenosis Quality of Life Scale, 2017.
    1. Folkmann S, Gorlitzer M, Weiss G, et al. . Quality-of-life in octogenarians one year after aortic valve replacement with or without coronary artery bypass surgery. Interact Cardiovasc Thorac Surg 2010;11:750–3. 10.1510/icvts.2010.240085
    1. Oliveira SM, Correia AS, Paiva M, et al. . Long-term survival, autonomy, and quality of life of elderly patients undergoing aortic valve replacement. J Card Surg 2012;27:20–3. 10.1111/j.1540-8191.2011.01360.x
    1. Biermann J, Horack M, Kahlert P, et al. . The impact of transcatheter aortic valve implantation on quality of life: results from the German transcatheter aortic valve interventions registry. Clin Res Cardiol 2015;104:877–86. 10.1007/s00392-015-0857-9
    1. Bona V, Khawaja MZ, Bapat V, et al. . Early and late changes in quality of life following transcatheter aortic valve implantation using the transfemoral and transapical approaches. EuroIntervention 2015;11:221–9. 10.4244/EIJV11I2A41
    1. Fairbairn TA, Meads DM, Mather AN, et al. . Serial change in health-related quality of life over 1 year after transcatheter aortic valve implantation: predictors of health outcomes. J Am Coll Cardiol 2012;59:1672–80. 10.1016/j.jacc.2012.01.035
    1. Reynolds MR, Magnuson EA, Wang K, et al. . Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the partner (placement of aortic transcatheter valve) trial (cohort a). J Am Coll Cardiol 2012;60:548–58. 10.1016/j.jacc.2012.03.075
    1. Reynolds MR, Magnuson EA, Lei Y, et al. . Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011;124:1964–72. 10.1161/CIRCULATIONAHA.111.040022
    1. Díez-Villanueva P, Salamanca J, Rojas A, et al. . Importance of frailty and comorbidity in elderly patients with severe aortic stenosis. J Geriatr Cardiol 2017;14:379–82. 10.11909/j.issn.1671-5411.2017.06.005

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe