Edwards’ TAVR Economic Data Presented at TVT Structural Heart Summit

July 22, 2021—Edwards Lifesciences announced that clinical and economic results from the 3M-TAVR Economic Study and the PARTNER 3 Bicuspid Registry for Sapien 3 TAVR study were presented at the Cardiovascular Research Foundation’s TVT 2021: The Structural Heart Summit.

According to the company, the 3M-TAVR study demonstrated positive findings supporting similar clinical outcomes and substantial cost savings associated with minimalist transcatheter aortic valve replacement (TAVR) when compared with conventional TAVR in patients at intermediate risk for surgery.

The study compared health care costs for patients in the 3M (multidisciplinary, multimodality, but minimalist) trial to health care costs for patients enrolled in the Sapien 3 Intermediate Risk registry who underwent conventional transfemoral TAVR, and whose outcomes were linked to Medicare claims.

In the PARTNER 3 Bicuspid Registry for Sapien 3 TAVR in low-risk patients with bicuspid aortic valves, Edwards reported that clinical results demonstrated similar outcomes and benefits, such as symptom relief and quality of life, when compared to matched tricuspid anatomy patients. The study compared the 1-year safety and efficacy of the Sapien 3 TAVR system in selected low surgical risk patients with severe symptomatic aortic stenosis and bicuspid anatomy to a clinically similar cohort of patients with tricuspid anatomy treated with Sapien 3 TAVR in the PARTNER 3 trial.

As summarized by Edwards, the presentation of clinical data from the economics of 3M-TAVR included the following:

• Index hospitalization costs for patients in the 3M cohort were $10,843 lower per patient, driven by reductions in procedure duration, anesthesia costs and length of stay.
• Cumulative cost differences out to 30 days post procedure were $11,305 lower in the 3M cohort compared to traditional TAVR.
• Use of the 3M pathway was associated with significant reductions in hospital length of stay (reduction of 0.5 intensive care unit (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).
• There were no differences in death, stroke, or rehospitalization through 30 days of follow-up utilizing this new approach.
• Based on previous comparisons with surgical aortic valve replacement (SAVR), the investigators determined that these findings suggest that minimalist TAVR for intermediate-risk patients may reduce 30-day costs by greater than $20,000 per patient compared with SAVR.

David Cohen, MD, commented in the company’s announcement, “The 3M pathway, which builds on innovations in both TAVR design and technique, was designed to improve procedural efficiency and facilitate next-day discharge of TAVR patients. 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 TAVR is a unique technology that extends life, improves quality of life, and is more efficient for the health care system.” Dr. Cohen is Director of Clinical and Outcomes Research at the Cardiovascular Research Foundation in New York, New York.

The clinical data presentation of the PARTNER 3 Bicuspid Registry for Sapien 3 TAVR in Low-Risk Patients included the following findings:

• The composite primary endpoint of death, stroke, or cardiovascular rehospitalization related to valve or procedure and heart failure at 1 year were similar for both the bicuspid and tricuspid cohorts (10.9% vs 10.2%; P = .9).
• The individual components of the primary endpoint were also similar at 1 year (bicuspid vs tricuspid: 0.7% vs 1.4% mortality; 2.1% vs 2.0% stroke; 9.6% vs 9.5% rehospitalization related to valve or procedure and heart failure).
• The new pacemaker implantation rate was similar between the two groups (6.8% vs 7.4%).
• Both cohorts experienced similar symptomatic relief and quality of life gains at 30 days and 1 year when measured by both the New York Heart Association Classification and the Kansas City Cardiomyopathy Questionnaire.