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. 2019 Mar;157(3):874-882.e8.
doi: 10.1016/j.jtcvs.2018.06.097. Epub 2018 Jul 27.

Observed to expected 30-day mortality as a benchmark for transcatheter aortic valve replacement

Matthew C Henn  1 , Alan Zajarias  2 , Nishath Quader  2 , Marc Sintek  2 , John M Lasala  2 , Kelly Koogler  1 , Marci S Damiano  2 , Puja Kachroo  1 , D Craig Miller  3 , C Ryan King  4 , Spencer J Melby  1 , Marc R Moon  1 , Ralph J Damiano Jr  1 , Hersh S Maniar  5
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Free article

Observed to expected 30-day mortality as a benchmark for transcatheter aortic valve replacement

Matthew C Henn et al. J Thorac Cardiovasc Surg. 2019 Mar.
Free article

Abstract

Objective: The observed-to-expected 30-day mortality ratio (O:E ratio) is a standard metric by which transcatheter aortic valve replacement (TAVR) trials have been evaluated. Early TAVR trials consistently demonstrated O:E ratio less than 0.6 after TAVR when based on the Society for Thoracic Surgery Predicted Risk of Mortality (STS-PROM) for surgical aortic valve replacement. Recent published results from the Transcatheter Valve Therapy (TVT) Registry have demonstrated O:E ratios of 1.0. We evaluated our own O:E ratios for TAVR to investigate this discordance.

Methods: Data were collected prospectively for TAVR patients from 2008 through 2015 (N = 546) and were reviewed retrospectively. The observed mortality and STS-PROM were calculated to formulate O:E ratios and were compared over a variety of subgroups.

Results: Overall, the O:E ratio for 30-day mortality was 0.4 and significantly less than 1 (P < .001; 95% confidence interval, 0.25-0.63). The O:E ratio relationship remained less than 0.5 for patients with low (STS-PROM < 4), moderate (STS-PROM = 4-8) and high risk (STS-PROM > 8). The O:E ratio was significantly higher for transapical patients (O:E ratio = 0.8) when compared with transfemoral patients (O:E ratio = 0.2). Lastly, O:E ratios for both commercial (O:E ratio = 0.5) and research (O:E ratio = 0.3) patients were similar (P = .337), and both were significantly less than 1 (P = .007 and P < .001, respectively).

Conclusions: The STS-PROM consistently overestimated 30-day mortality after TAVR. Achieving an O:E ratio less than 0.6 may be a realistic goal for all TAVR programs. While an accurate and specific risk calculator for 30-day mortality after TAVR remains to be established, our data suggest that current TVT results are not acceptable for commercial TAVR and that programs with an O:E ratio greater than 0.6, based on the STS-PROM, should reevaluate internal processes to improve their results.

Keywords: TAVR; aortic stenosis; aortic valve replacement; survival.

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