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

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.

Transcatheter versus Isolated Surgical Aortic Valve Replacement in Young High-Risk Patients: A Propensity Score-Matched Analysis

“…On the other hand, the most recent real-world analysis of the GARY registry, published by Beyersdorf et al, in 2021, showed a difference in the 5-year outcomes. The study, conducted on a propensity score-matched collective chosen from a total of 18010 patients (1820 TAVR vs. 1820 iSAVR), showed a significantly reduced long-term survival (hazard ratio 1.51, 95% confidence interval 1.35–1.68; p < 0.0001) after an implantation of early generation TAVI valves compared with SAVR [ 24 ].…”

Cardiac Surgery 2021 Reviewed

“…While durability is no explanation for the mortality differences 37 most prominently observed in propensity-matched registry analyses, 38 the combination of other adverse events may be plausible. Several registries illustrated that mild paravalvular leaks (more frequent in TAVI) may already be prognostically relevant.…”

“…Fig.5(A) Survival after TAVI or SAVR in propensity-matched patients from the Germany Aortic valve Registry (GARY) (Reproduced with permission of Beyersdorf et al 202138 ). (B) Landmark analysis from a reconstructed individual patient-data meta-analysis having included all randomized trials with 5-year follow-up comparing SAVR and TAVI (Reproduced with permission of Doenst et al 202134 ).…”

Economic Evaluation of Transcatheter Aortic Valve Replacement Compared to Surgical Aortic Valve Replacement in Chinese Intermediate-Risk Patients

“…Surgical aortic valve replacement (SAVR) has always been the optimal treatment for patients with AS across different risk stratifications (5,6). However, several important clinical studies regarding transcatheter aortic valve replacement (TAVR) (7)(8)(9)(10) have demonstrated the efficacy and safety of TAVR all over the world (11,12). It is estimated that more than 306,000 patients with AS have undergone TAVR in the United States (13).…”