Biomaterial Database

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy. 2015

Hemal Gada, and Ajay J Kirtane, and Kaijun Wang, and Yang Lei, and Elizabeth Magnuson, and Matthew R Reynolds, and Mathew R Williams, and Susheel Kodali, and Torsten P Vahl, and Suzanne V Arnold, and Martin B Leon, and Vinod Thourani, and Wilson Y Szeto, and David J Cohen, and

From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).

BACKGROUND In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. RESULTS We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. CONCLUSIONS Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. BACKGROUND URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D011474	Prosthesis Design	The plan and delineation of prostheses in general or a specific prosthesis.	Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D011788	Quality of Life	A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.	HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D011795	Surveys and Questionnaires	Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions.	Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D012042	Registries	The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers.	Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D005260	Female		Females
D005500	Follow-Up Studies	Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.	Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006350	Heart Valve Prosthesis	A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material.	Prosthesis, Heart Valve,Cardiac Valve Prosthesis,Cardiac Valve Prostheses,Heart Valve Prostheses,Prostheses, Cardiac Valve,Prostheses, Heart Valve,Prosthesis, Cardiac Valve,Valve Prostheses, Cardiac,Valve Prostheses, Heart,Valve Prosthesis, Cardiac,Valve Prosthesis, Heart
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000369	Aged, 80 and over	Persons 80 years of age and older.	Oldest Old