Health Problem: Aortic stenosis (AS) is the most common cause of aortic valve disease in older patients; approximately 7% of the population > 65 years of age is affected. The prevalence of AS is approximately 0.4% among adults aged ≥ 18 to 75 years in the United States. At younger ages, AS is most often related to bicuspid aortic valve but in older patients, AS is related to degenerative disease. Moderate or severe AS occurs in patients aged ≥ 75 years with a prevalence of 2.8%. The overall incidence and prevalence of AS has increased with the aging population.

Technology Description: Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR), is an alternative to open surgical aortic valve replacement (SAVR) for AS that uses percutaneous access through a peripheral artery to place a bioprosthetic valve within the stenotic aortic valve. Through percutaneous access, a catheter is guided to the implantation site through 1 of 3 approaches: (1) the femoral artery (transfemoral); (2) the apex of the heart (transapical, delivered through the intercostal space); or (3) through the ascending aorta (transaortic) to the stenotic valve. Transfemoral delivery is the most common and generally preferred method. A bioprosthetic valve is then deployed and implanted to support the stenotic valve.

Controversy: TAVI has demonstrated success in treating patients with AS who are at high surgical risk or ineligible for surgical intervention. Interest has grown in using TAVI as an alternative to surgical intervention in patients with low and intermediate surgical risk and an evaluation of evidence is warranted to better characterize the comparative efficacy and safety of TAVI and SAVR in these patient populations. Specifically, it must be determined whether the potential benefits of TAVI outweigh its risks in patients at lower surgical risk who are otherwise eligible for SAVR.

Key Questions: For patients with severe calcific AS and low or intermediate surgical risk, this report addresses the following questions:

  • What is the comparative effectiveness of TAVI and SAVR?
  • What is the comparative safety of TAVI and SAVR?
  • Do efficacy or safety outcomes vary by TAVI device used?
  • Have definitive patient selection criteria been established for use of TAVI or SAVR?

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