Procedural safety and mid-term outcomes after valve-in-valve transcatheter aortic valve implantation: a prospective single-center study

Abstract Background/Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is the preferred therapy for degenerated surgical bioprostheses, yet residual gradients, patient–prosthesis mismatch (PPM), and coronary obstruction remain major concerns. Purpose This study aims to assess procedural safety and mid-to-long term outcomes in a prospective ViV TAVI cohort. Methods This is a prospective single-center cohort of consecutive patients with symptomatic structural valve degeneration (NYHA III–IV) undergoing transfemoral ViV TAVI between July 2022 and June 2025. Outcomes followed VARC-3 definitions with echocardiography at discharge, 30 days, and 1 year. Exploratory modeling examined predictors of elevated 1-year gradients and PPM. Results Sixty-eight patients (51% female; mean age 77 ± 7 years; EuroSCORE II 7.3 ± 1.8%) were treated. Failure mechanism was stenosis in 50%, regurgitation 22%, mixed 28%; mean true ID 22 ± 3 mm, with 35% ≤21 mm. Valve fracture was performed in 24% (n=16). Commissural alignment was successful in 98.5%. Coronary protection was used in 11.8% (n=8); chimney stenting in 5.9% (n=4), all preserving flow. Technical success was 100%. Thirty-day outcomes: mortality 0%, stroke 0%, MI 0%, new pacemaker 2.9%, major vascular complication 1.5%. Mean transvalvular gradient decreased from 38.0 ± 9.5 mmHg to 6.6 ± 2.0 mmHg post-procedure (p<0.001), was 7.4 ± 2.3 mmHg at 30 days, and 8.2 ± 2.4 mmHg at 1 year (Figure 1). Aortic valve area increased from 0.80 ± 0.23 cm² to 2.00 ± 0.18 cm² (p<0.001), measuring 1.92 ± 0.20 cm² at 30 days and 1.88 ± 0.22 cm² at 1 year (Figure 1). At 1 year, 23.5% (16/68) had gradients ≥10 mmHg. Each 1 mm decrease in true ID increased odds of a 1-year gradient ≥10 mmHg (adjusted OR 1.31; 95% CI 1.04–1.76; p=0.03). In small valves (≤21 mm), gradients were higher (9.0 ± 2.5 vs 7.6 ± 2.2 mmHg; p=0.01) and ≥10 mmHg more frequent (38% vs 14%; p=0.01); valve fracture reduced this risk (21% vs 50%; p=0.04). Moderate/severe PPM at 1 year occurred in 7.4% overall. At median follow-up of 12.8 months, survival was 95.6%, HF hospitalization 4.4%, and no endocarditis, valve thrombosis, or reintervention. NYHA I–II was achieved in 94.1% (0% at baseline) (Figure 2). Post-ViV coronary angiography/PCI was feasible in all attempted cases (20/20). Conclusions In this prospective single-center study, a standardized ViV TAVI strategy achieved high technical success, favorable safety, and durable hemodynamics. Smaller true ID was the main predictor of elevated 1-year gradients, while surgical valve fracture mitigated this risk in small valves. Universal coronary access preservation and marked functional improvement reinforce the value of anatomy-driven planning and contemporary device selection in the modern ViV TAVI era.Figure 1For image description, please refer to the figure legend and surrounding text. Figure 2For image description, please refer to the figure legend and surrounding text.