Reporting Clinical Outcomes In Tavi Registries

Abstract

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. 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. 20 TAVI registries were identified in our review with an overall sample size of 12,583 patients. 20 TAVI registries used either EuroScore or Society of Thoracic Surgery Risk Score (STS) or both to record patients’ baseline characteristics and case selection. The 30-day all-cause mortality ranged from 0 to 12.7%. 14 registries reported 30-day cardiovascular mortality, and only 11 registries reported 1-year mortality. Myocardial infarction (MI) should be differentiating into periprocedural MI and spontaneous MI, the author only can identify 11 registries who reported periprocedural MI. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation. Of all 20 TAVI registries, 30% reported 9 of 9 complications, and 55% missed 1-2 complications. 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.