Data presented at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October – 2 November, Denver, USA) suggest that transcatheter aortic valve implantation (TAVI) with either Sapien XT device or Sapien 3 (both Edwards Lifesciences) in intermediate-risk patients is highly cost-effective even though the TAVI devices were more expensive than the surgical valves used in the study.
The principal investigator for the study, David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, USA) commented that these findings, along with previous results, indicate that TAVI should be now be the “preferred approach” for intermediate-risk patients.
Previous data from the PARTNER 2A trial and the SAPIEN 3 registry indicate that, respectively, the Sapien XT device is non-inferior and that the Sapien 3 is superior to surgical aortic valve replacement in aortic stenosis patients at intermediate risk. However, while TAVI has been found to be cost-effective for patients at high surgical risk compared with surgery, no data are available for the cost-effectiveness of TAVI for intermediate-risk patients. Therefore, the aim of the present analysis was to explore the costs associated with TAVI in this patient subset as compared with surgery.
In PARTNER 2A, after being grouped into eligibility for the transfemoral approach, patients were randomised to undergo surgery or to undergo TAVI with Sapien XT. In SAPIEN 3, patients underwent TAVI with Sapien 3 and their outcomes were compared with those of patients from the surgical group of PARTNER 2A.
Speaking at TCT 2017, Cohen reported that data from these two studies were used to perform a formal, patient-level economic analysis. He said: “Index hospitalisation costs were calculated using a combination of resource-based accounting (for TAVI/surgical procedures) and claims data (charges converted to costs at department level). All other costs (follow-up hospitalisations, doctor services, outpatient testing, custodial care), were based directly on Medicare payments derived from claims.”
In the PARTNER 2A analysis, procedural costs were US$22,083 higher with Sapien XT. However, when costs related to hospital stay and in-hospital complications were considered (higher for surgery), procedural costs were only US$2,900 higher with the device. Furthermore, over the following 24 months, Sapien XT was associated with significantly lower costs: US$107,716 vs. US$114,132 for surgery (p=0.014). Overall, TAVI with Sapien XT resulted in both cost savings (US$7,949) and greater quality adjusted life expectancy (by 0.15 years).
When the Sapien 3 data were reviewed, the device was associated with lower index hospitalisation costs – US54, 256 vs. 58,410 for surgery (p=0.014) – even though devices costs were higher for Sapien 3. Similar to Sapien XT, when in-trial results were projected over a lifetime horizon, the TAVI device was associated with costs savings (US$9,692) and a significant gain quality adjusted life-years (0.27 years).
Cohen stated: “These results demonstrating substantial cost savings and improved quality-adjusted life expectancy indicate that TAVI should be considered the preferred strategy based on both clinical and economic considerations.”