Article Text
Abstract
Background A logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) ≥20% is frequently recognised as a finite criteria for transcatheter aortic valve implantation (TAVI) reimbursement, despite guideline modifications to reflect the appropriacy of TAVI in selected lower-risk patients. The aim was to evaluate the clinical value of this threshold cut-off in TAVI patients and to identify factors associated with mortality in those below this threshold.
Methods We analysed data from a single-centre, German, observational, TAVI-patient registry, gathered between 2008 and 2016. Patients were stratified by logEuroSCORE (≥ or <20%) for comparisons. Logistic regression was performed to identify predictors of mortality at 1 year, with this analysis used to generate a calculated (‘real’) risk value for each patient.
Results 1679 patients (logEuroSCORE <20%: n=789; logEuroSCORE ≥20%: n=890) were included. LogEuroSCORE <20% patients were significantly younger (80.1 vs 81.6 years; p<0.001) and less comorbid than logEuroSCORE ≥20% patients, with a higher rate of transfemoral TAVI (35.6% vs 26.1%; p<0.001) and predilation (70.0% vs 63.3%; p=0.004). Patients with a logEuroSCORE <20% experienced more vascular complications (3.4% vs 1.5%; p=0.010). One-year survival was 88.3% in the logEuroSCORE <20% and 81.8% in the logEuroSCORE ≥20% group (p=0.005), with the calculated mortality risk falling within 2% of the logEuroSCORE in just 12.9% of patients. In the logEuroSCORE <20% group, only coronary artery disease was significantly predictive of 1-year mortality (OR 2.408; 95% CI 1.361 to 4.262; p=0.003).
Conclusions At our institution, patients with a logEuroSCORE <20% selected for TAVI have excellent outcomes. The decision not to reimburse TAVI in such patients may be viewed as inappropriate.
- minimally invasive
- valvular disease
- aortic valve disease
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Footnotes
Contributors All authors except PB and KB established and conducted the registry. PB and KB designed the statistical approach, analysis and interpretation. GI and PB outlined the first version of the manuscript, which all other authors revised for important intellectual content. KB performed the statistical analyses. All authors approved the final version of the manuscript to be submitted.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests PB is a consultant for Edwards Lifesciences.
Patient consent for publication Not required.
Ethics approval The study was approved by the responsible ethics committee in Hannover (Landesärztekammer) and was carried out in accordance with the declaration of Helsinki and its amendments.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request from the corresponding author.