Clinical and economic results from the 3M TAVR economic study have been presented at TVT 2021 (The Structural Heart Summit, 20–22 July, Miami Beach, USA & virtual), Edwards Lifesciences has announced, with findings suggesting that a minimalist transcatheter aortic valve implantation (TAVI) approach was not only safe and effective, but also led to substantial cost savings compared with more traditional care patterns.
The 3M (multidisciplinary, multimodality, but minimalist) TAVR study compared healthcare costs for patients in the 3M trial to healthcare costs for patients enrolled in the SAPIEN 3 Intermediate Risk (S3i) registry who underwent conventional transfemoral transcatheter aortic valve implantation (TAVI), and whose outcomes were linked to Medicare claims.
The trial demonstrated positive findings supporting similar clinical outcomes and substantial cost savings associated with minimalist TAVI when compared with conventional TAVI in patients at intermediate risk for surgery.
Presentation of the 3M study findings indicated that index hospitalisation costs for patients in the 3M cohort were US$10,843 lower per patient, driven by reductions in procedure duration, anaesthesia costs and length of stay. Cumulative cost differences out to 30 days post procedure were US$11,305 lower in the 3M cohort compared to traditional TAVI.
Use of the 3M pathway was associated with significant reductions in hospital length of stay (reduction of 0.5 ICU days and 1.7 non-ICU days), new pacemaker implantation (3.4% vs. 8.3%), and rehabilitation days during follow-up (0.4 days vs. 1.4 days). Additionally, there were no differences in death, stroke or rehospitalisation through 30 days of follow-up utilising this new approach.
Based on previous comparisons with surgical aortic valve replacement (SAVR), researchers determined that these findings suggest that minimalist TAVI for intermediate-risk patients may reduce 30-day costs by greater than US$20,000 per patient compared with SAVR.
“The 3M pathway, which builds on innovations in both TAVI design and technique, was designed to improve procedural efficiency and facilitate next-day discharge of TAVI patients,” said David Cohen, director of clinical and outcomes research at the Cardiovascular Research Foundation, New York, USA. “In our study, we found that this approach was not only safe and effective, but also led to substantial cost savings compared with more traditional care patterns. These findings add to a substantial body of evidence demonstrating that TAVI is a unique technology that extends life, improves quality of life and is more efficient for the healthcare system.”