REPORTING CLINICAL OUTCOMES IN TAVI REGISTRIES

Author(s)

Kolominsky-Rabas PL, Zhang S
Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for high surgical risk patients with severe aortic stenosis. However, the fast growth of TAVI has created difficulties in cross-study result comparison. In 2011 and 2013, Valve Academic Research Consortium (VARC) published standardized definitions on reporting endpoints in TAVI studies. The objective of this study is to provide an overview of TAVI registries and the reporting of clinical outcomes based on VARC-2 definitions.

METHODS: A systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients’ characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications. No publication time restriction was used.

RESULTS: CONCLUSIONS: VARC and VARC-2 definitions are more and more widely used by TAVI registries. Reporting VARC-2 definitions makes cross-registry comparisons more feasible. Since the introduction of VARC, the number of systematic-review and meta-analysis is dramatically increasing. This transparence will provide better evidence to patients and decision makers such as regulatory bodies, payers and HTA agencies.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PMD126

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care

Topic Subcategory

Health Disparities & Equity, Pricing Policy & Schemes, Quality of Care Measurement, Treatment Patterns and Guidelines

Disease

Cardiovascular Disorders

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