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

• Type of Material: Article
• Authors: Suzanne V. Arnold, St Lukes Mid America Heart Institute; John A. Spertus, St Lukes Mid America Heart Institute; Yang Lei, St Lukes Mid America Heart Institute; Philip Green, Columbia Presbyterian Medical Center; Ajay J. Kirtane, Columbia Presbyterian Medical Center; Samir Kapadia, Cleveland Clinic Foundation; Vinod Thourani, Emory University; Howard C. Herrmann, University of Pennsylvania; Nirat Beohar, Columbia Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL; Alan Zajarias, Washington University; Michael J. Mack, Medical City Dallas; Martin B. Leon, Columbia Presbyterian Medical Center; David Cohen, Emory University
• Language: English
• Date: 2013-09-01
• Publisher: AHA Journals
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2013 American Heart Association, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1161/CIRCOUTCOMES.113.000354
• Title of Journal or Parent Work: Circulation: Cardiovascular Quality and Outcomes
• Volume: 6
• Issue: 5
• Start Page: 591
• End Page: 597
• Grant/Funding Information: The PARTNER trial was sponsored by Edwards Lifesciences. This current study was self-funded, and the funding organization for the trial did not play a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.
• Keywords: Clinical outcomes; aortic valve stenosis; Implantation; valve; transcatheter aortic valve; Quality of life; Health status; High-risk patients; Heart failure; Ventricular assist device; Stenosis; Cardiovascular System & Cardiology; quality of life; Science & Technology; Long-term outcomes; City cardiomyopathy questionnaire; Cardiac & Cardiovascular Systems; Life Sciences & Biomedicine
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Health Care Management; Health Sciences, Rehabilitation and Therapy

Abstract

Background: Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components. Methods and Results: Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR. Conclusions: Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR. © 2013 American Heart Association, Inc.