Real World Performance Evaluation of Transcatheter Aortic Valve Implantation

Abstract

Background: The aim of this research is to describe the performance over time of transcatheter aortic valve implantations (TAVIs) in a high-volume center with a contemporary, real-world population. Methods: Patients referred for TAVIs at the University Hospital of Verona were prospectively enrolled. By cumulative sum failures analysis (CUSUM), procedural-control curves for standardized combined endpoints—as defined by the Valve Academic Research Consortium-2 (VARC-2)—were calculated and analyzed over time. Acceptable and unacceptable limits were derived from recent studies on TAVI in intermediate and low-risk patients to fit the higher required standards for current indications. Results: A total of 910 patients were included. Baseline risk scores significantly reduced over time. Complete procedural control was obtained after approximately 125 and 190 cases for device success and early safety standardized combined endpoints, respectively. High risk patients (STS ≥ 8) had poorer outcomes, especially in terms of VARC-2 clinical efficacy, and required a higher case load to maintain in-control and proficient procedures. Clinically relevant single endpoints were all influenced by operator’s experience as well. Conclusions: Quality-control analysis for contemporary TAVI interventions based on standardized endpoints suggests the need for relevant operator’s experience to achieve and maintain optimal clinical results, especially in higher-risk subjects.