Five-Year Outcome in 18,010 Patients from the German Aortic Valve Registry

Abstract

Background: The 5-year outcome in patients undergoing isolated transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (sAVR) was evaluated from the German Aortic Valve Registry (GARY). Methods: Allocation to TAVI or sAVR was performed after a heart team decision. Eligible patients with TAVI and sAVR were matched using propensity scores in a nearest-neighbour approach. Findings: A total of 18,010 patients treated in 2011 and 2012 were included (n=8,942 TAVI and n=9,068 sAVR). Patients with repeat procedures or unequivocal indication for one treatment option (e.g. frailty, etc.) were excluded (n=4,785 for TAVI and n=2 for sAVR). This led to 13,223 patients (4,157 TAVI and 9,066 sAVR) as an unmatched subcohort. TAVI patients were significantly older (80·9±6·1 versus 68·5±11·1 years, p<0·001), had a higher Society of Thoracic Surgeons (STS) score (6·3±4·9 versus 2·6±3·0, p<0·001) and a higher 5-year all-cause mortality (49·8% versus 16·5%, p<0·0001). There was no major difference in-hospital stroke, in-hospital myocardial infarction, or temporary and chronic dialysis.In the propensity score-matched group (n=3,640), there were 763 deaths (41·9%) among 1,820 TAVI patients compared with 552 (30·3%) among 1,820 treated with sAVR during the 5-year follow-up (HR 1·51 (95% CI 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<·0001). Interpretation: 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 prothesis was associated with significantly higher 5-year all-cause mortality than sAVR. Funding Statement: The registry receives funding of unrestricted grants from medical device companies (Edwards Lifesciences, Medtronic, Abbott, Boston Scientific), from the German Center for Cardiovascular Research (DZHK), the German Heart Foundation, the German Ministry of Health and donations from the Dr. Rolf M. Schwiete Foundation. Funding Statement: The registry receives funding of unrestricted grants from medical device companies (Edwards Lifesciences, Medtronic, Abbott, Boston Scientific), from the German Center for Cardiovascular Research (DZHK), the German Heart Foundation, the German Ministry of Health and donations from the Dr. Rolf M. Schwiete Foundation. Declaration of Interests: Sabine Bleiziffer received proctor and speaker fees from Medtronic. All other authors have no competing interests to declare. Ethics Approval Statement: The study complies with the Declaration of Helsinki. Subjects included in the registry gave informed consent and an ethics body at participating institutions approved the use of patient data for research purposes.