Five-year outcome in 18 010 patients from the German Aortic Valve Registry

Friedhelm Beyersdorf; Timm Bauer; Nick Freemantle; Thomas Walther; Christian Frerker; Eva Herrmann; Sabine Bleiziffer; Helge Möllmann; Sandra Landwehr; Stephan Ensminger; Raffi Bekeredjian; Jochen Cremer; Karl Heinz Kuck; Buntaro Fujita; Jan Gummert; Lisa Müller; Andreas Beckmann; Christian W Hamm; GARY Executive Board

doi:10.1093/ejcts/ezab216

Five-year outcome in 18 010 patients from the German Aortic Valve Registry

Eur J Cardiothorac Surg. 2021 Nov 2;60(5):1139-1146. doi: 10.1093/ejcts/ezab216.

Authors

Friedhelm Beyersdorf^{1

2}, Timm Bauer³, Nick Freemantle⁴, Thomas Walther⁵, Christian Frerker⁶, Eva Herrmann^{7

8}, Sabine Bleiziffer⁹, Helge Möllmann¹⁰, Sandra Landwehr¹¹, Stephan Ensminger¹², Raffi Bekeredjian¹³, Jochen Cremer¹⁴, Karl Heinz Kuck¹⁵, Buntaro Fujita¹², Jan Gummert⁹, Lisa Müller¹¹, Andreas Beckmann¹⁶, Christian W Hamm¹⁷; GARY Executive Board

Affiliations

¹ Department of Cardiovascular Surgery, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
² Medical Faculty of the Albert-Ludwigs-University Freiburg, Freiburg, Germany.
³ Department of Cardiology, Sana Klinikum Offenbach, Offenbach, Germany.
⁴ Comprehensive Clinical Trial Unit, University College London, London, UK.
⁵ Department of Thoracic, Cardiac and Thoracic Vascular Surgery, University of Frankfurt, Frankfurt, Germany.
⁶ Department of Cardiology, University Hospital Cologne, University of Cologne, Faculty of Medicine, Cologne, Germany.
⁷ German Center for Cardiovascular Research (DZHK), Partner Site Rhein/Main, Germany.
⁸ Institute of Biostatistics and Mathematical Modelling, Goethe University Frankfurt, Frankfurt, Germany.
⁹ Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany.
¹⁰ Department of Internal Medicine I, St.-Johannes-Hospital, Dortmund, Germany.
¹¹ BQS Institute for Quality and Patient Safety, Düsseldorf, Germany.
¹² Department of Cardiac Surgery, University Hospital Lübeck, Lübeck, Germany.
¹³ Department of Cardiology, Robert-Bosch-Hospital, Stuttgart, Germany.
¹⁴ Department of Cardiac and Vascular Surgery, University Hospital Kiel, Kiel, Germany.
¹⁵ Department of Cardiology, Angiology, Intensive Care, University Hospital Lübeck, Lübeck, Germany.
¹⁶ Germany Society for Thoracic and Cardiovascular Surgery, Berlin, Germany.
¹⁷ Department of Cardiology, Campus Kerckhoff University of Giessen, Bad Nauheim, Germany.

PMID: 33942061
DOI: 10.1093/ejcts/ezab216

Abstract

Objectives: To determine the 5-year outcome in patients treated by isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR)-a prospective observational cohort study.

Methods: A total of 18 010 patients were included (n = 8942 TAVI and n = 9068 sAVR) in the German Aortic Valve Registry (GARY) who were treated in 2011 and 2012 at 92 sites in central Germany. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty) were excluded (n = 4785 for TAVI and n = 2 for sAVR). This led to 13 223 patients (4157 TAVI and 9066 sAVR) as an unmatched subcohort. The main outcome measure was the 5-year all-cause mortality.

Results: TAVI patients were significantly older (80.9 ± 6.1 vs 68.5 ± 11.1 years, P < 0.001), had a higher Society of Thoracic Surgeons (STS) score (6.3 ± 4.9 vs 2.6 ± 3.0, P < 0.001) and a higher 5-year all-cause mortality (49.8% vs 16.5%, P < 0.0001). There was no major difference in in-hospital stroke, in-hospital myocardial infarction, or temporary and chronic dialysis. In the propensity score-matched group (n = 3640), there were 763 deaths (41.9%) among 1820 TAVI patients compared with 552 (30.3%) among 1820 treated with sAVR during the 5-year follow-up (hazard ratio 1.51, 95% confidence interval 1.35-1.68; P < 0.0001). New pacemaker implantation was performed in 448 patients (24.6%) after TAVI and in 201 (11.0%) after sAVR (P < 0.0001).

Conclusions: The 5-year follow-up data show that TAVI patients were significantly older and had a higher STS score than sAVR patients. After propensity score matching, TAVI with early-generation prosthesis was associated with significantly higher 5-year all-cause mortality than sAVR.

Keywords: 5-Year follow-up; German Aortic Valve Registry; Surgical aortic valve replacement; Transcatheter aortic valve implantation.

Publication types

Observational Study

MeSH terms

Aortic Valve / surgery
Aortic Valve Stenosis* / surgery
Heart Valve Prosthesis Implantation*
Humans
Prospective Studies
Registries
Risk Factors
Transcatheter Aortic Valve Replacement* / adverse effects
Treatment Outcome