PARTNER II SAPIEN 3 Trial – TAVR Outperforms SAVR – Again!

Charles Franc

PARTNER II SAPIEN 3 Trial – TAVR Outperforms SAVR – Again!

The one year results of the PARTNER II, SAPIEN 3 clinical trial for intermediate-risk patients with severe aortic stenosis were recently announced at the American College of Cardiology’s 65th Annual Scientific Session in Chicago. The results are good news for

patients with severe aortic stenosis who potentially require valve replacement surgery and are classified as “moderate risk” – approximately 20% of candidates. Previous trials have concentrated on “high-risk” patients undergoing TAVR (transcatheter aortic valve replacement) in comparison to SAVR (surgical aortic valve replacement).

According to the study, intermediate-risk patients who received TAVR with the latest generation SAPIEN 3 device (Edwards Lifesciences) fared better after one year than patients receiving traditional SAVR. TAVR produced superior outcomes for the study’s endpoints: a combination of death, stroke and moderate or severe aortic insufficiency (i.e., leakage of blood across the replaced valve).

Study findings were announced by the Emory University School of Medicine and Vinod H. Thourani, MD, professor of surgery and medicine,[1] and published simultaneously in The Lancet.[2] Dr. Thourani said, “This study shows the lowest mortality rate ever of any transcatheter valve platform after one year, which is very exciting for the management of aortic stenosis. Taken together, these results demonstrate substantial improvements in outcomes among intermediate-risk patients receiving the SAPIEN 3 valve as compared in a propensity score analysis in intermediate-risk patients receiving surgery.” Changes in both implantation techniques and improvements in the design of the valve itself have made the procedure both safer and easier to perform.

The study found that TAVR was superior to SAVR mortality, occurring in only 7.4% of TAVR patients versus 13.0% of patients receiving surgery. The stroke rate was also lower with TAVR: 4.6% compared to 8.2% for surgical patients.

Because these results were in intermediate-risk, as opposed to high-risk patients, the previous FDA-approved target population for TAVR, a significant potential number of surgical candidates will eventually have a new procedural option for their care. SAPIEN 3 was approved by the FDA in June 2015 for high-risk patients with severe, symptomatic aortic stenosis who are not candidates for open-heart valve replacement surgery; the valve is not yet fully approved for intermediate risk patients in the U.S.

Note that reimbursement is still an issue, especially with the average cost of TAVR devices being several thousand dollars more than surgical artificial aortic valves. However, it is anticipated that the cost of the devices and of the procedures should go down over time as TAVR’s usage expands, as is typical of many new technologies. The current value-conscious healthcare environment should also embrace TAVR as the cost drops, especially if this less invasive technique has the potential to become a short-stay or same-day outpatient procedure for select patients.

These findings, and the pending FDA approval of the device, should establish TAVR as the standard of care over the next few years and increase the number of patients with severe aortic stenosis who can successfully be treated with TAVR as opposed to traditional SAVR procedures. If studies prove that less invasive procedures have as good or superior outcomes to open surgical procedures, the less invasive procedure will typically win out in the marketplace every time. Also, it seems that this change may come much sooner than many predicted. Good news for patients and hospital TAVR programs alike.

As always, CFA welcomes your comments, questions and suggestions.

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