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Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

Suzanne V Arnold1,2, George Petrossian3, Michael J Reardon4

  • 1Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., K.W.).

Circulation. Cardiovascular Interventions
|June 7, 2021
PubMed

Insights

Transcatheter aortic valve replacement (TAVR) offers 5-year benefits in hemodynamics and quality of life for high-risk patients with severe aortic stenosis. Despite high mortality, TAVR remains a valuable option for these challenging cases.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Transcatheter aortic valve replacement (TAVR) is an option for older adults with comorbidities at extreme risk for surgical aortic valve replacement.
  • This study presents 5-year outcomes of patients treated with CoreValve self-expanding supra-annular TAVR.

Purpose of the Study:

  • To evaluate the 5-year clinical, echocardiographic, and health status outcomes of patients undergoing TAVR for severe aortic stenosis at extreme surgical risk.
  • To assess the long-term efficacy and safety of the CoreValve system in this high-risk population.

Main Methods:

  • Prospective, nonrandomized, single-arm clinical trial (CoreValve US Extreme Risk Pivotal Trial) involving 639 patients.
  • Primary outcome: all-cause mortality or major stroke. Secondary outcomes: echocardiographic parameters and health status (Kansas City Cardiomyopathy Questionnaire).

Main Results:

  • The 5-year rate of death or major stroke was 72.6%. Among survivors, valve hemodynamics remained favorable (mean gradient 7.5 mm Hg, 3.1% moderate/severe regurgitation).
  • Health status significantly improved by 1 month and remained improved at 5 years (mean KCCQ-OS score increase of 14.3 points from baseline).

Conclusions:

  • Self-expanding supra-annular TAVR in extreme-risk patients with severe aortic stenosis is associated with high 5-year mortality.
  • Despite mortality, TAVR provides sustained short-term benefits in valve hemodynamics and quality of life among survivors, supporting its use in this challenging group.
Abstract

Keywords:
aortic valvehealth statusquality of liferisktranscatheter aortic valve disease

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