Implementation of transcatheter aortic valve insertion (TAVI) in clinical practice: An ethical analysis

Abstract

Objective

The objective of this article is to provide an ethical analysis of a high-risk, advanced treatment case where the patient received transcatheter aortic valve insertion (TAVI), for aortic valve stenosis. Particular emphasis will be placed upon the significance of evidence and the implications for priority setting.

Method

One paradigmatic case involving a TAVI patient from a large university hospital in Norway is described and analysed. The method used was ethical case analysis modified after Kymlicka by Miljeteig et al. Perioperative mortality risk was estimated using the Euroscore risk-logarithm and the Society of Thoracic Surgeons’ risk model, STS. These predict the risk of operative mortality and morbidity associated with adult cardiac surgery. GRADE, the Grading of Recommendations Assessment, Development and Evaluation, was used to evaluate the evidence.

Results

In the case analysis, we found that it would be ethically justifiable not to recommend TAVI treatment for this patient. Although the patient had a severe condition in need of treatment, the expected improvement was marginal, the quality of evidence was low and the opportunity costs for other patients and society were higher than usually deemed appropriate.

Conclusions

Decision-making in the absence of high quality evidence from randomized trials is a complex process involving difficult ethical judgments. Novel high-risk devices often enter the European market with limited clinical evidence. Transparency and improved clinical evaluation are required so patient safety is not jeopardized. We argue that implementation of high risk, high cost interventions should be better regulated at a national level.

Background

All clinical decisions imply priority setting and therefore indirectly affect other patients and other patient groups. The use of expensive, innovative health technologies has an affect on individual patients as well as on other patient groups competing for the same resources.

Keywords

Clinical ethics resource allocation biomedical research bioethics and medical ethics

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