Key result
The Edwards SAPIEN 3 transcatheter heart valve showed very low rates of vascular complications and paravalvular regurgitation, with stroke and mortality lower than anticipated with SAVR.
Why the study?
Does the SAPIEN 3 transcatheter heart valve reduce vascular complications, paravalvular regurgitation, stroke, and mortality compared to SAVR in patients with severe aortic stenosis?
Does the SAPIEN 3 transcatheter heart valve reduce vascular complications, paravalvular regurgitation, stroke, and mortality compared to SAVR in patients with severe aortic stenosis?
The SAPIEN 3 transcatheter heart valve demonstrates favorable safety and efficacy profiles, with lower than anticipated stroke and mortality rates compared to SAVR in intermediate and high-risk patients.
Supports SAPIEN 3 consideration in intermediate- and high-risk aortic stenosis; leaves open randomized confirmation across risk strata.
Transcatheter aortic valve replacement is a viable alternative to surgical aortic valve replacement in patients with severe aortic stenosis. The SAPIEN 3 is the latest generation of balloon-expandable transcatheter heart valve, designed to address some of the shortcomings of earlier versions of transcatheter heart valves. It has a lower device profile to reduce access-related vascular injury, an improved delivery catheter to facilitate accurate implantation, and incorporates an additional outer sealing cuff to minimize paravalvular leakage. The latest European and North American trials using SAPIEN 3 have documented very low rates of vascular complications and paravalvular regurgitation with rates of stroke and mortality rates lower than anticipated with SAVR in both intermediate and high surgical risk patients.
No takes yet. Share an insight, caveat, or question.
Htun et al. (2016) conducted a review in severe aortic stenosis. Edwards SAPIEN 3 Transcatheter Valve vs. surgical aortic valve replacement (SAVR) was evaluated. The Edwards SAPIEN 3 transcatheter heart valve showed very low rates of vascular complications and paravalvular regurgitation, with stroke and mortality lower than anticipated with SAVR.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: