Key result
Transvascular transcatheter aortic valve implantation (TAVI) was reported to have an in-hospital mortality rate of 2.6% versus 2.9% for isolated surgical aortic valve replacement (P=0.19).
This commentary highlights methodological flaws in a recent study comparing TAVI and iSAVR, cautioning against premature expansion of TAVI indications based on unsuitable data.
This commentary refers to ‘Outcome after transvascular transcatheter aortic valve implantation in 2016’, by L. Gaede et al., 2018;39:667–675. The authors analysed the number of procedures, complications, and in-hospital mortality rates of patients undergoing transvascular transcatheter aortic valve implantation (TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) in Germany from 2014 to 2016.1 They used the data pool of the Institute for Quality Assurance and Transparency in Healthcare (IQTIG), which is part of the mandatory external quality control programme with published data.2 The IQTIG report as well as the authors themselves stress that these data are unsuitable for comparisons of different aetiologies and risk profiles. The paper, however, does just that, resulting in shortcomings in methodology and conclusions drawn. The key result emphasized is that the overall in-hospital mortality rate after TAVI fell ‘numerically below’ that of iSAVR (2.6% vs. 2.9%, P = 0.19) in 2016. ... Interestingly, a paper with similar shortcomings was published in EuroIntervention in 20163 and severely criticized.4 In the current paper, the conclusion suggesting ‘further widening of the TV–TAVI indication spectrum’ cannot be drawn or substantiated. However, it has already led to an unfortunate premature spreading of the suggested news by secondary publications.5
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Welz et al. (2018) conducted an editorial in Aortic valve disease. Transvascular transcatheter aortic valve implantation (TAVI) vs. Isolated surgical aortic valve replacement (iSAVR) was evaluated on In-hospital mortality rate (p=0.19). Transvascular transcatheter aortic valve implantation (TAVI) was reported to have an in-hospital mortality rate of 2.6% versus 2.9% for isolated surgical aortic valve replacement (P=0.19).
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