Overview
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.
Description
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.
Eligibility
Inclusion criteria for TAVR subjects
- TAVR performed more than 3 years ago
Exclusion criteria
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate
- Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- 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
- SAVR performed more than 3 years ago
- 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)