transcatheter aortic valve implantation; transcatheter aortic valve replacement (TAVI, TAVR, CoreValve system)

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Indications

* no difference between TAVR & open surgery in death, stroke, or MI at 1 year in patients >= 70 years of age (13% vs 16%)[16]

* selected low-risk surgical candidates can have good short-term outcomes with TAVR[35]

* TAVR provides durable function through at least 5 years & up to 8 year years in low-risk patients[37]

* similar outcomes vs surgical AVR* at 5 years in patients with severe aortic stenosis.

* in elderly >=70 years with severe, symptomatic aortic stenosis at moderately increased operative risk, TAVI is noninferior to surgery for all-cause mortality at 1 year

Contraindications

Procedure

* Meditronic's CoreValve system[13]

* 3rd generation transcatheter aortic valve FDA-approved June 2015[17]

* mechanically expanded (not yet FDA-approved) valve (MEV [Lotus]) non-inferior to self-expanding valve[34]

Complications

* compared with standard surgical AVR (SAVR)

Management

Notes

  • significantly reduces mortality, repeat hospitalization, & cardiac symptoms, despite higher incidence of stroke & vascular complications[1][4]
    • all cause mortality 43% vs 68% at 2 years[4]
  • similar rates of survival compared with standard AVR[2]
  • similar risk for stroke or mortality at 5 years compared with standard AVR[45]
  • improved health-related quality of life relative to standard AVR[3]
    • difference at 30 days, but no difference at 1 year[2] improves clinical outcomes but has modest effect on psychological & general health measures[9]
  • compared with balloon angioplasty, TAVI is associated with
    • a higher incidence of major strokes (5.0% vs 1.1%) & major vascular complications (16.2% vs 1.1%) at 30 days
    • higher incidence of major bleeding
    • better outcomes regarding symptoms
    • decreased need for re-intervention (balloon angioplasty, repeat TAVI, AVR)
    • lower mortality (30.7% vs 50.7%) at 1 year[1]
  • survival benefit of TAVR in high-risk patients after 1 year
  • TAVR noninferior to surgical aortic valve replacement at 2 & 5 years in patients with intermediate level of surgical risk[21][57]
  • Lotus valve with comparable outcomes to the CoreValve/EvolutR[58]
  • more adverse procedural events, but similar overall outcomes for TVAR vs surgery for bicuspid vs tricuspid aortic valves[31]
  • in-hospital complications higher in nonagenarians than in younger patients
    • death (6.5% vs. 4.5%)
    • stroke (2.7% vs. 2.1%)
    • major vascular site complications (1.0% vs. 0.7%)
    • major bleeding (8.1% vs. 6.8%)[20]
  • improvement in quality of life similar for nonagenarians compared with younger patients[20]
  • blacks & Hispanics may be underrepresented in TAVR[43]
  • repeat TAVR is safe & provides acceptable outcomes[46]

More general terms

Additional terms

References

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    video of the TAVI procedure http://dx.doi.org/10.1056/NEJMoa1008232 (subscription required)
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