Transcatheter Aortic Valve-in-Valve Implantation Using Lotus Valve for Failed Surgical Bioprostheses.

BACKGROUND: Patients with failed bioprostheses are an increasing population at high risk for redo surgery. Valve-in-valve transcatheter aortic valve implantation is a promising alternative but a limited number of first-generation devices have proven efficacy in all cases.

METHODS: Patients with degenerated bioprostheses at high risk for redo surgery were included in the registry after being assigned to valve-in-valve intervention by a local heart team. Main basal and follow-up data (at 1 month and 6 months) of patients undergoing valve-in-valve transcatheter aortic valve implantation with the Lotus valve system (Boston Scientific, Natick, MA) in three high-volume Italian centers were entered in the registry.

RESULTS: Twelve patients (aged 71.1 ± 14.1 years, 66% male, logistic European System for Cardiac Operative Risk Evaluation score 28.8 ± 22.9) were included in the registry. Implantation success rate was 92%; in 1 patient, the valve was completely retrieved because of unsatisfactory gradients after valve positioning. All procedures were done through femoral access, and all but one required only local anesthesia. In patients with stenosis as pure or mixed mechanism for degeneration (n = 7), mean ventriculoaortic gradient decreased from 46.7 ± 7.0 mm Hg to 16.6 ± 5.7 mm Hg (p < 0.001). No patients had more than mild aortic regurgitation at hospital discharge. Results where confirmed at 1-month and 6-month follow-up, with improvement of New York Heart Association functional status in all patients (functional class I to II in 100% of patients).

CONCLUSIONS: The valve-in-valve procedure using the Lotus valve is a feasible alternative to repeat surgery in high-risk patients with degenerated bioprostheses. Using the Lotus valve in this challenging and increasingly frequent scenario could offer a safe and effective strategy that should be explored in larger clinical trials.