Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
University Hospitals Cleveland Medical Center
Summary
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.
Description
Project Overview/Summary Transcatheter aortic valve replacement (TAVR) is an alternative to open heart surgery for the treatment of severe aortic stenosis, and has recently been approved for low surgical risk patients. This has resulted in a shifting of TAVR patient demographics to younger and more active individuals. It is, therefore, imperative to deliver excellent hemodynamics after valve replacement to enable patients to recover an active lifestyle with enhanced exercise capacity. Several studies, mostly conducted with resting echocardiogram have suggested self-expanding valves (SEV) Evolu…
Eligibility
- Age range
- 18–105 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team; * Planned transfemoral TAVR; 18 years of age or older; * Able to give informed consent. Exclusion Criteria: * Patients with permanent pacemakers or implantable defibrillators; * Patients with non-MRI safe implants; * Severe claustrophobia; * Inability or contraindication to perform exercise bike stress test; * Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation; * Reduced left ventricular systolic function (\<40%); * History of surgi…
Interventions
- DeviceSelf-expanding valve (Medtronic Evolut FX)
Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve
- DeviceBalloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
Bioprosthesis Edwards Sapien 3 Ultra valve
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio