Transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has greater cost savings compared with surgical aortic valve replacement (SAVR) at 2 years, according to study findings published in the journal Circulation.
Compared with SAVR, TAVR with SAPIEN 3 has demonstrated superior efficacy at 2 years among patients with low surgical risk who have severe symptomatic aortic stenosis. However, the comparative cost effectiveness has not been evaluated.
The researchers conducted a prespecified analysis from the Placement of Aortic Transcatheter Valves PARTNER 3 (ClinicalTrials.gov Identifier: NCT02675114) trial. Patients (N=929) with severe symptomatic aortic stenosis who were at low surgical risk were randomly assigned in a 1:1 ratio to receive TAVR with the SAPIEN 3 system (n=485) or SAVR (n=444). Costs were estimated using Medicare claims data and the SAVR and TAVR costs included the average device costs ($5900 and $32,500, respectively). Quality-adjusted life years (QALYs) were defined using the EuroQOL 5-item questionnaire. Economic value was defined as an incremental cost-effectiveness ratio (ICER) of less than $50,000 per QALY gained.
The TAVR and SAVR groups were mean age, 73.6 (SD, 5.8) and 74.0 (SD, 6.1) years; 67.4% and 71.6% were men; they had a Society of Thoracic Surgery risk score of 1.9 (SD, 0.7) and 1.9 (SD, 0.6); and 31.5% and 23.9% had a New York Heart Association class III or IV, respectively.
Compared with SAVR, the TAVR procedure was associated with a significantly shorter procedure time (P <.001), lower stroke incidence (P =.016), lower major bleeding rate (P <.001), shorter total hospital stay (P <.001), and a greater rate of discharge to home with self-care (P <.001).
The TAVR and SAVR index procedures cost an average of $37,370 and $18,327 (P <.001) and an associated hospitalization cost of $7174 and $23,578 (P <.001), physician fees of $2652 and $4702 (P <.001), and total index admission cost of $47,196 and $46,606 (P =.586), respectively.
During the 2-year follow-up, the TAVR and SAVR groups had similar rehospitalization and hospital stay usage, however, the TAVR group spent fewer days in a skilled nursing facility (SNF) or in rehabilitation than the SAVR group (difference, -210 days; P <.001).
During the follow-up, the TAVR procedure was associated with a lower SNF and rehabilitation cost (P =.004). Overall, the total follow-up costs of the TAVR and SAVR procedures was $19,638 and $22,258 (P =.132) and cumulative 2-year costs of $66,834 and $68,864 (P =.306), respectively.
For the base case, the TAVR procedure had a 95% probability of being within the $50,000 cost effective cutoff per QALY gained.
Stratified by subgroup, the groups with the greatest probability of being within the margin for cost-effectiveness were patients with left-ventricular ejection fraction (LVEF) of 65% or less (99%), Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 70 or less (98%), NYHA class III/IV (98%), and men (98%). The lowest probability of cost-effectiveness was observed for patients with LVEF greater than 65% (51%).
The researchers noted that “TAVR remained an economically dominant strategy unless the long-term relative risk of death for patients undergoing TAVR versus SAVR was >1.04.”
“[F]or patients with severe AS [aortic stenosis] and low surgical risk, transfemoral TAVR with the SAPIEN 3 valve is economically dominant compared with SAVR at 2-year follow-up and is projected to be highly cost-effective over a lifetime horizon, as long as there are no differences in late mortality between the 2 strategies,” the researchers concluded.
Disclosures: This research was supported by Edwards Lifesciences Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Galper BZ, Chinnakondepalli KM, Wang K, et al. Economic outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis and low surgical risk: results from the PARTNER 3 trial. Circulation. Published online May 8, 2023. doi:10.1161/CIRCULATIONAHA.122.062481