Authors' objectives: This health technology assessment looked at the effectiveness, safety, cost-effectiveness, budget impact, and patient experiences of transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic valve stenosis at intermediate surgical risk.

Authors' results and conclusions: Results: We identified two randomized controlled trials; they found that in patients with severe, symptomatic aortic valve stenosis, TAVI was noninferior to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke within 2 years of follow-up (GRADE: High). However, compared with SAVR, TAVI had a higher risk of some complications and a lower risk of others. Device-related costs for TAVI (approximately $23,000) are much higher than for SAVR (approximately $6,000). Based on two published cost-effectiveness analyses conducted from the perspective of the Ontario Ministry of Health, TAVI was more expensive and, on average, more effective (i.e., it produced more quality-adjusted life-years) than SAVR. The incremental cost-effectiveness ratios showed that TAVI may be cost-effective, but the probability of TAVI being cost-effective versus SAVR was less than 60% at a willingness-to-pay value of $100,000 per quality-adjusted life-year. The net budget impact of publicly funding TAVI in Ontario would be about $2 million to $3 million each year for the next 5 years. This cost may be reduced if people receiving TAVI have a shorter hospital stay (≤ 3 days). We interviewed 13 people who had lived experience with aortic valve stenosis. People who had undergone TAVI reported reduced physical and psychological effects and a shorter recovery time. Patients and caregivers living in remote or northern regions reported lower out-of-pocket costs with TAVI because the length of hospital stay was reduced. People said that TAVI increased their quality of life in the short-term immediately after the procedure. Conclusions: In people with severe, symptomatic aortic valve stenosis at intermediate surgical risk, TAVI was similar to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke. However, the two treatments had different patterns of complications. The study authors also noted that longer follow-up is needed to assess the durability of the TAVI valve. Compared with SAVR, TAVI may provide good value for money, but publicly funding TAVI in Ontario would result in additional costs over the next 5 years. People with aortic valve stenosis who had undergone TAVI appreciated its less invasive nature and reported a substantial reduction in physical and psychological effects after the procedure, improving their quality of life.

Authors' recommendations: The Quality business unit at Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic aortic valve stenosis who are at intermediate surgical risk

Authors' methods: We conducted a health technology assessment of TAVI versus SAVR in patients with severe, symptomatic aortic valve stenosis at intermediate surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, budget impact, and patient preferences and values. We performed a literature search to retrieve systematic reviews and selected one that was relevant to our research question. We complemented the systematic review with a literature search to identify randomized controlled trials published after the review. Applicable, previously published cost-effectiveness analyses were available, so we did not conduct a primary economic evaluation. We analyzed the net budget impact of publicly funding TAVI in people at intermediate surgical risk in Ontario. To contextualize the potential value of TAVI for people at intermediate surgical risk, we spoke with people who had aortic valve stenosis and their families.

Project Status: Completed

URL for project: https://www.hqontario.ca/Evidence-to-Improve-Care/Health-Technology-Assessment/Journal-Ontario-Health-Technology-Assessment-Series

Year Published: 2020

URL for published report: https://www.hqontario.ca/Evidence-to-Improve-Care/Health-Technology-Assessment/Journal-Ontario-Health-Technology-Assessment-Series

Requestor: Ontario Health Technology Advisory Committee (OHTAC); Ontario Ministry of Health

URL for additional information: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/transcatheter-aortic-valve-implantation-in-patients-with-severe-symptomatic-aortic-valve-stenosis-at-intermediate-surgical-risk

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 32194880

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: Nancy Sikich, Director Health Technology Assessment

Contact Email: oh-hqo_hta@ontariohealth.ca

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