Progression of bicuspid-related aortopathy in patients undergoing transcatheter aortic valve implantation: Rationale and design of the international, multicenter PROSPERO-TAVI registry.

BACKGROUND

Transcatheter aortic valve implantation (TAVI) is now an established and effective alternative to surgery for elderly patients affected by severe aortic stenosis. With the expansion of the indications to younger patients, the proportion of patients with bicuspid aortic valve (BAV) undergoing TAVI is expected to increase. Nevertheless, the presence of BAV-associated aortopathy may complicate the transcatheter treatment or it may progress if left untreated.

METHODS

The progression of bicuspid-related aortopathy in patients undergoing Transcatheter Aortic Valve Implantation (PROSPERO) registry is an investigator-initiated, multicenter, observational, ambi-spective registry designed to evaluate the aortopathy progression in consecutive BAV patients undergoing TAVI.

RESULTS

All patients with native bicuspid aortic valve who underwent TAVI for severe aortic stenosis between January 2018 and December 2019 with available preprocedural computed tomography angiography (CTA) assessment are considered. The primary endpoint of the study is to assess the progression of BAV-associated aortopathy at follow-up. Secondary endpoints include long-term clinical outcomes and aortopathy-related events.

CONCLUSIONS

The PROSPERO registry will provide real-world evidence on the evolution of BAV-associated aortopathy after TAVI. Its results may help define follow-up strategies and improve patient selection and management in this increasingly relevant population.

TRIAL REGISTRATION: ClinicalTrials.govNCT06248294.