Temporal Trends and Outcomes in Low-Risk Patients Undergoing TAVI: Insights From the LAPLACE-TAVI Registry.

BACKGROUND: Transcatheter aortic valve implantation is now indicated in low-risk patients following favorable outcomes in clinical trials and real-world registries. OBJECTIVES: The authors aimed to investigate temporal trends and long-term outcomes in this population. METHODS: Using a multicenter registry database (2010-2025), we stratified 5,691 patients by their Society of Thoracic Surgeons scores: low risk (<4%, n = 1,580 of 5,691 [27.8%]), intermediate risk (4% to 8%, n = 2,388 of 5,691 [42.0%]), and high risk (>8%, n = 1,723 of 5,691 [30.3%]). Low-risk patients were further classified according to clinical trial eligibility. The primary outcomes were crude 30-day and Kaplan-Meier-estimated 4-year all-cause mortalities. RESULTS: The annual procedure volume among low-risk patients did not show a sustained increase and declined after peaking in 2022. Low-risk patients were younger, predominantly male, had a higher body mass index (BMI), fewer comorbidities, and fewer procedural complications. They also demonstrated higher rates of elective procedure and transfemoral access. Thirty-day mortality and procedural complication rates remained consistently low among the low-risk cohort; furthermore, 4-year mortality was the lowest among trial-eligible low-risk patients (overall follow-up: 2.2 years). Clinical trial eligibility criteria (frailty [HR: 2.43; 95% CI: 1.43-4.14; P = 0.003] and renal dysfunction [HR: 3.00; 95% CI: 1.46-6.20; P = 0.010]), female sex (HR: 0.62; 95% CI: 0.44-0.89; P = 0.009), BMI (HR: 0.94 per kg/m2; 95% CI: 0.90-0.98; P = 0.008), and albumin levels (HR: 0.52 per g/dL; 95% CI: 0.36-0.77; P = 0.001) were associated with all-cause mortality in low-risk patients. CONCLUSIONS: Despite the overall expansion of transcatheter aortic valve implantation, procedure volume among low-risk patients has not consistently increased. Clinical trial eligibility, female sex, BMI, and albumin levels may refine risk stratification in Society of Thoracic Surgeons-defined low-risk patients. (Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry; UMIN000031133).