Futility, benefit, and transcatheter aortic valve replacement

Abstract

Transcatheter aortic valve replacement (TAVR) is a transformative innovation that provides treatment for high or prohibitive surgical risk patients with symptomatic severe aortic stenosis who either were previously not referred for or were denied operative intervention. Trials have demonstrated improvements in survival and symptoms after TAVR versus medical therapy; however, there remains a sizable group of patients who die or lack improvement in quality of life soon after TAVR. This raises important questions about the need to identify and acknowledge the possibility of futility in some patients considered for TAVR. In this very elderly population, a number of factors in addition to traditional risk stratification need to be considered including multimorbidity, disability, frailty, and cognition in order to assess the anticipated benefit of TAVR. Consideration by a multidisciplinary heart valve team with broad areas of expertise is critical for assessing likely benefit from TAVR. Moreover, these complicated decisions should take place with clear communication around desired health outcomes on behalf of the patient and provider. The decision that treatment with TAVR is futile should include alternative plans to optimize the patient's health state or, in some cases, discussions related to end-of-life care. We review issues to be considered when making and communicating these difficult decisions.

Keywords: aortic valve stenosis; frailty; heart failure; outcomes; valve replacement.

Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1. Survival, heart failure symptoms, and quality of life at 1 year in patients treated with TAVR in the PARTNER trial

Data shown is from the PARTNER Trial (8-11). Abbreviations: NYHA, New York Heart Association; QoL, quality of life.

Figure 2. Decision making by the multidisciplinary heart valve team on patients referred for TAVR

The multidisciplinary heart valve team considers and weighs the various factors shown and makes a decision regarding whether TAVR will likely be beneficial or futile. Areas of uncertainty require clinical judgment. What factors are thought to most influence the patient's current health status affects assessment of the anticipated benefit of TAVR. Anticipated benefits or risks may clearly outweigh the other, but in some cases there is uncertainty when patient goals and preferences are especially important to incorporate into decision-making regarding whether to perform TAVR.

Figure 3. Outcome of patients at prohibitive surgical risk in the PARTNER Trial

From Makkar et al.(22) (PERMISSION NEEDED).

Figure 4. Obstacles to benefits of TAVR

The step-wise, progressive benefits and milestones anticipated to result from TAVR may not be realized due to several potential obstacles.