For severe AS in low-risk patients, TAVR appears safe

  • Waksman R & al.
  • J Am Coll Cardiol
  • 9 Aug 2018

  • curated by Jenny Blair, MD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.


  • With transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis (AS) in low-risk patients, no deaths or disabling strokes had occurred by 30 days.

Why this matters

  • TAVR is standard of care for higher-risk severe AS patients.
  • Increasingly, it is offered to surgical aortic valve replacement (SAVR)-eligible patients.
  • Risk for subclinical leaflet thrombosis in low-risk TAVR patients was previously unknown.

Key results

  • Mean patient age, 74 years.
  • TAVR vs SAVR:
    • All-cause mortality: 0.0% vs 1.7% (P=.079).
  • In-hospital complications:
    • Stroke: 0% vs 0.6% (P=.582);
    • Major vascular complications, life-threatening/major bleeding: 2.5% vs 10.3% (P<.001>
    • New permanent pacemaker: 5.0% vs 4.5% (P=.742);
    • New-onset Afib: 3.0% vs 40.8% (P<.001>
    • Length of stay: 2.0±1.1 vs 6.4±3.9 days (P<.001>
  • Subclinical leaflet thrombosis in TAVR patients:
    • Hypoattenuated leaflet thickening: 14.0%;
    • Reduced leaflet motion: 11.2%;
    • Hypoattenuation affecting motion: 7.4%.

Study design

  • Randomized, multicenter, open-label trial (first Investigational Device Exemption trial enrolling low-risk US patients). 
  • Researchers compared outcomes in 200 prospective patients undergoing transfemoral TAVR with 719 historical SAVR control patients from Society of Thoracic Surgeons database.
  • All participants had low surgical risk.
  • Outcome: 30-day all-cause mortality.
  • Funding: MedStar Health Research Institute. 


  • Some risk factors not captured in database.
  • No data past 30 days.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.