Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project.
Testa L., Agnifili M., Van Mieghem NM., Tchétché D., Asgar AW., De Backer O., Latib A., Reimers B., Stefanini G., Trani C., Colombo A., Giannini F., Bartorelli A., Wojakowski W., Dabrowski M., Jagielak D., Banning AP., Kharbanda R., Moreno R., Schofer J., van Royen N., Pinto D., Serra A., Segev A., Giordano A., Brambilla N., Popolo Rubbio A., Casenghi M., Oreglia J., De Marco F., Tanja R., McCabe JM., Abizaid A., Voskuil M., Teles R., Biondi Zoccai G., Bianchi G., Sondergaard L., Bedogni F.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. METHODS: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. RESULTS: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. CONCLUSIONS: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500964.