Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial
Why the study?
Older adults with comorbidities at extreme risk for surgical aortic valve replacement may be appropriate candidates for TAVR, warranting long-term evaluation of clinical, echocardiographic, and health status outcomes.
Does CoreValve self-expanding supra-annular TAVR improve long-term outcomes in patients with severe aortic stenosis at extreme surgical risk?
Population
639 patients with severe aortic stenosis at extreme surgical risk
Comparison
CoreValve self-expanding supra-annular TAVR (single-arm)
Design
Prospective nonrandomized single-arm multicenter trial at 41 US sites
Follow-up
5 years
Authors
Discussion
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Member takes
Implication
High 5-year mortality in extreme-risk TAVR patients warrants cautious selection; leaves comparative long-term benefit versus alternatives open.
Structured PICO
Does CoreValve self-expanding supra-annular TAVR improve long-term outcomes in patients with severe aortic stenosis at extreme surgical risk?
P
Population
639 patients with severe aortic stenosis at extreme surgical risk, mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, United States (41 sites).
I
Intervention
CoreValve self-expanding supra-annular transcatheter aortic valve replacement (TAVR)
O
Outcome
All-cause mortality or major strokecomposite
In extreme-risk patients with severe aortic stenosis, TAVR is associated with high 5-year mortality but provides sustained improvements in valve hemodynamics and quality of life among survivors.
Cite This Study
Arnold et al. (2021) studied this question.