Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

There is limited available information on long term TAVR valve function. In this
observational study, the investigators will enroll subjects who underwent TAVR or SAVR more
than 3 years ago. Clinical and procedural data from the implant/surgery will be collected,
alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date
echocardiography will be performed and analyzed in a Core Lab to assess valve function
yearly.

Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

1. Subjects unable to consent to participate, unless the subject has a legally authorized
representative

2. Subjects unwilling to participate

3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure
(e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)

4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years
post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic
regurgitation)

Inclusion criteria for SAVR subjects

1. SAVR performed more than 3 years ago

2. Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless
the subject has a legally authorized representative f) Subjects unwilling to participate g)
Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g.
balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic
evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic
gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)