Safety and Device Success of Transcatheter Aortic Valve Replacement: A 12-Year Single-Center VARC-3 Report.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established therapy for severe aortic stenosis (AS) across all surgical risk categories. However, data from Latin America remain scarce, particularly using standardized outcome definitions such as those from the Valve Academic Research Consortium-3 (VARC-3).

AIMS: To describe baseline characteristics, technical and device success, and early clinical outcomes over a 12-year period at a single established TAVR program in Colombia.

METHODS: We conducted a retrospective observational case series of consecutive patients with severe symptomatic AS who underwent TAVR between January 2012 and December 2023. Data were collected from institutional databases and electronic health records. Outcomes were defined according to VARC-3 criteria and assessed at 30 days. Procedural success and secondary endpoints were analyzed using the Wilson score method for 95% confidence intervals to account for the sample size. Exploratory temporal trend and multivariable logistic regression analyses were performed.

RESULTS: A total of 134 patients were included (median age 80 years; 52.2% female). Technical success was achieved in 95.5%, and device success at 30 days in 81.3%. Thirty-day mortality was 7.4%; acute kidney injury (19.4%), permanent pacemaker implantation (18.7%), and vascular complications (12.7%) were the most common adverse events. In an exploratory multivariable model, diabetes mellitus was associated with increased 30-day mortality (AOR 1.25, 95% CI 1.07-2.41; p = 0.021), although this finding is limited by the low absolute number of events and should be interpreted with caution.

CONCLUSIONS: In this 12-year single-center experience, TAVR demonstrated high technical and device success with complication rates comparable to international benchmarks. These findings support the feasibility and safety of TAVR in a Latin American setting.