TAVR: stroke risk higher with bicuspid vs tricuspid aortic stenosis

  • Makkar RR & al.
  • JAMA
  • 11 jun. 2019

  • de Susan London
  • Clinical Essentials
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Takeaway

  • Patients undergoing transcatheter aortic valve replacement (TAVR) for bicuspid vs tricuspid aortic stenosis have similar mortality, but the former have higher stroke risk.

Why this matters

  • As TAVR indications expand, more patients with bicuspid aortic stenosis are undergoing the procedure.

Key results

  • Bicuspid and tricuspid groups similar on all-cause mortality:
    • At 30 days (2.6% vs 2.5%; HR, 1.04; 95% CI, 0.74-1.47).
    • At 1 year (10.5% vs 12.0%; HR, 0.90; 95% CI, 0.73-1.10).
  • Bicuspid group had higher:
    • 30-day stroke rate (2.5% vs 1.6%; HR, 1.57; 95% CI, 1.06-2.33).
    • Rate of procedural complications requiring open heart surgery (0.9% vs 0.4%; absolute risk difference [RD], 0.5%; 95% CI, 0%-0.9%).
  • Groups similar on valve hemodynamics, on moderate or severe paravalvular leak:
    • At 30 days (2.0% vs 2.4%; absolute RD, 0.3%; 95% CI, –1.3% to 0.7%).
    • At 1 year (3.2% vs 2.5%; absolute RD, 0.7%; 95% CI, –1.3% to 2.7%).
  • No significant difference in 1-year improvement in cardiac-related QoL.

Expert comment

  • In an editorial, Colin M. Barker, MD and Michael J. Reardon, MD write, “Despite … limitations, the findings reported … are the best data available for the use of the current-generation valve in patients with bicuspid aortic valve and are encouraging. This investigation provides the basis for further study of TAVR in patients with bicuspid aortic valve, although it is reasonable to question whether a randomized trial could be practically conducted.”

Study design

  • Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers.
  • 2691 propensity score-matched pairs of patients with bicuspid and tricuspid aortic stenosis.
  • Main outcomes: mortality, stroke.
  • Funding: Edwards Lifesciences.

Limitations

  • Groups not randomized.
  • Bicuspid aortic stenosis has heterogeneous anatomy.
  • Association between aortopathy and procedural complications not assessed.
  • All patients treated with contemporary balloon-expandable valves.