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
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Takeaway

  • 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. 

Limitations

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

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