A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants

TL;DR

This review evaluates the evidence for different transcatheter aortic valves used in Australia to help doctors and patients make informed decisions.

Contribution

The study provides a comprehensive evaluation of the evidence base for transcatheter aortic valves in the Australian context.

Findings

The Sapien series has the largest number of patients and publications compared to other valve series.

The CoreValve/Evolut series also has substantial evidence published in high-impact journals.

The review summarizes Australia's regulatory and funding processes for these medical devices.

Abstract

Currently, multiple transcatheter aortic valves exist in clinical use, with varying efficacy and safety rates. This review aims to evaluate the evidence base for current transcatheter valves used in the management of aortic stenosis in Australia to improve informed decision making for both clinicians and patients. The evidence base included published peer-reviewed human studies of aortic valves with approval for use in Australia through the Therapeutic Goods Administration (TGA). Embase was utilised on the 17 September 2024, and one hundred ninety-seven publications met the inclusion criteria, including six from citation searching. The Sapien series led with the largest number of patients reported in the literature (n = 91,614) and publications (n = 147), followed by the CoreValve/Evolut series with 65,459 patients and 125 publications. Evidence for both of these transcatheter aortic valve series were also published in high impact journals, with the greatest H-index journal being The New England Journal of Medicine. In conclusion, the evidence base for the safety and efficacy of the Sapien and CoreValve/Evolut series currently leads in both quantity and quality. This review also summarises the Australian medical device regulatory and funding process in the context of transcatheter aortic valves.

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