TAVI in TAVI: Clinical and Hemodynamic Outcomes According to the Type of Prosthesis Used in TAVI-in-TAVI

With the expansion of TAVI to younger and lower surgical risk patients, bioprosthetic valve degeneration and the need for repeat interventions are expected to become increasingly frequent. In this context, TAVI-in-TAVI has emerged as a feasible strategy for the treatment of degenerated transcatheter valves, although questions remain regarding hemodynamic and clinical performance according to the combination of supra-annular valves (SAV) or intra-annular valves (IAV). The international multicenter PANDORA Registry evaluated the safety, hemodynamic performance, and clinical outcomes of TAVI-in-TAVI according to different prosthetic configurations. CoreValve/Evolut and ACURATE prostheses were considered supra-annular, whereas Edwards SAPIEN and Lotus valves were classified as intra-annular.

Between 2011 and 2024, among approximately 30,000 TAVI procedures performed across 12 high-volume centers in Europe and the United States, 172 TAVI-in-TAVI cases (0.4%) were identified. Patients were divided into four groups according to valve combination: SAV-IAV (n=32), SAV-SAV (n=29), IAV-SAV (n=74), and IAV-IAV (n=37). The median time between the first and second procedures was 1,401 days. The most frequently implanted index prostheses were CoreValve/Evolut (49.4%) and Edwards SAPIEN (35.5%), while the second implanted valve was predominantly Edwards SAPIEN (60.5%), followed by Evolut (35.5%).

The median age was 80 years, 55.8% were male, and 83.7% were in NYHA functional class III-IV. The main cause of failure of the initial valve was structural valve deterioration in 77.9% of cases, predominantly associated with severe stenosis (51.7%). Non-structural valve deterioration occurred in 40.7%, mainly due to severe paravalvular leak. The indication for reintervention was defined by the Heart Team considering symptoms, hemodynamic deterioration, and mechanisms of prosthetic failure.

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VARC-3 technical success was achieved in 91.3% of cases, with numerically higher rates in the SAV-IAV (93.8%) and IAV-SAV (93.2%) groups. Transfemoral access was used in 97.7% of procedures, and no intraprocedural mortality was reported. Coronary obstruction occurred in only 2 patients (1.2%), while implantation of a third rescue valve was required in 3 cases (1.7%). BASILICA and chimney coronary protection techniques were used in 1.7% and 1.1% of patients, respectively.

Thirty-day device success was 68% overall, with better outcomes in the SAV-IAV group (75.9%) and worse outcomes in the IAV-IAV group (54.8%), although without statistically significant differences (p=0.301). Device failure was mainly driven by residual gradients ≥20 mmHg (12.7%), 30-day mortality (7.3%), and significant paravalvular leak (2.7%). The IAV-IAV group showed the highest proportion of elevated residual gradients (25.8%), whereas SAV-SAV demonstrated the lowest incidence (7.4%).

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During a median follow-up of 391 days, no significant differences were observed among groups regarding stroke, myocardial infarction, major bleeding, acute kidney injury, valve thrombosis, or endocarditis. However, the IAV-IAV group maintained the worst hemodynamic outcomes, with 29% of patients presenting residual gradients ≥20 mmHg during follow-up (p=0.030). At one year, freedom from all-cause mortality was numerically higher in the IAV-SAV group (91.1%) and lower in the IAV-IAV group (76.1%), although without statistical significance (p=0.734). Similarly, the composite endpoint of survival free from death and heart failure hospitalization was also worse in the IAV-IAV group (76.1%; p=0.902).

Conclusion: TAVI-in-TAVI With Intra-Annular Valves Showed Worse Residual Gradients and a Trend Toward Lower Survival

In summary, the PANDORA Registry demonstrates that TAVI-in-TAVI is a feasible and safe strategy, with high technical success rates and favorable overall clinical outcomes. However, prosthetic configuration significantly influences hemodynamic performance, particularly regarding residual gradients, with IAV-IAV combinations showing the worst hemodynamic profile and a trend toward poorer clinical outcomes.

Original Title: Supra-Annular Versus Intra-Annular Devices for Transcatheter Aortic Valve-in-Valve Replacement: The PANDORA International Registry.