Devices & Diagnostics

Are transcatheter aortic valve implantations overused? Edwards Lifesciences disagrees

Many believe that transcatheter aortic valve implantation is one of the most exciting and lucrative new technologies to hit the market providing an option for patients to sick to undergo open heart surgery. Edwards Lifesciences, the Irvine, California, firm has the lead in the U.S. market with its Sapien transcatheter aortic valve replacement system. Medtronic, […]

Many believe that transcatheter aortic valve implantation is one of the most exciting and lucrative new technologies to hit the market providing an option for patients to sick to undergo open heart surgery.

Edwards Lifesciences, the Irvine, California, firm has the lead in the U.S. market with its Sapien transcatheter aortic valve replacement system. Medtronic, based in Fridley, Minnesota, is actively enrolling patients in its CoreValve pivotal clinical trial for U.S. approval and has been doing so for quite some time now. Boston Scientific, the Natick, Massachusetts firm, is conducting  a feasibility trial for its Lotus system.

But now a Belgian study flatly declares that the product is being overused in Europe and there is scant clinical evidence for it. Authors argue that the very costly procedure should only be used for the small section of the population that cannot undergo open heart surgery. Edwards Lifesciences, which is waiting to receive regulatory approval of its Sapien system for use on a wider set of patients in the U.S., naturally and forcefully disagrees. Medtronic had a slightly more measured repose, perhaps because the BMJ editorial did not mention the company.

Theheart.org reported the news like this:

“Given the enthusiasm with which the procedure has been adopted, we might expect the evidence for its efficacy to be solid,” Dr Hans Van Brabandt (Belgian Health Care Knowledge Center, Brussels) and colleagues write. But, they conclude, “Based on current evidence, and considering efficient use of limited resources, it is difficult to see how healthcare payers can justify reimbursing TAVI for patients suitable for surgery.”

Van Brabandt et al conducted a health-technology assessment for the Belgian government that concluded that the country’s health system should pay for TAVI only for patients who are ineligible for surgery—only about 10% of those currently considered for the therapy. Their analysis of observational data found that TAVI costs about €20 000 more per patient in Belgium than traditional surgical valve replacement [2]. The average initial costs, including the €18 000 for an Edwards Lifescience’s Sapien valve, are €43 600 for TAVI vs €23 700 for surgical valve replacement.

The analysis also found that transapical TAVI procedures cost more than transfemoral procedures (€49 800 vs €40 900). The authors also note that the transapical approach was linked to a 25.5% one-year mortality rate in the UK TAVI registry and a 20.2% six-month mortality rate in the FRANCE-2 registry.

The authors cite a guidance from the UK’s National Institute for Health and Clinical Excellence (NICE) that concluded that the evidence supporting TAVI for patients for whom surgery was possible is not strong and that it should be used for these patients only as part of an appropriately governed clinical trial. However, NICE’s guidance did not explicitly consider the cost-effectiveness of TAVI, but “these costs should be taken into account by local [UK National Health Service] commissioners in decisions about whether to fund the procedure,” Van Brabandt et al argue. “If policy makers are willing to pay for TAVI, they should give priority to anatomically inoperable patients.”

Theheart.org article also mentioned that the Belgian authors felt that the control and treatment groups in the Edwards’ PARTNER trial were “unbalanced in a way that would favor TAVI for inoperable patients.” It also suggested that the Belgian authors had tried in vain to access unpublished data about 90 patients on a follow up trial conducted by Edwards Lifesciences that would forward their belief that standard care is more clinically effective than TAVI especially using the transfemoral approach.

An Edwards Lifesciences spokeswoman pushed back against the Belgian study by this lengthy statement:

The BMJ editorial contains no new data, but is simply a repackaging of old, non-peer-reviewed arguments against TAVR that have been fully and publicly answered.  Globally, there exists a remarkable body of clinical, quality-of-life, and economic evidence on SAPIEN, collected over 10 years. This data has been published in more than 350 peer-reviewed publications and extensively presented at public meetings and reviewed by regulators and payors worldwide.

Multiple studies have shown TAVR to be cost-effective. In Cohort B patients, published data in NEJM demonstrated TAVR was very cost-effective given the life years added and the quality of life improvements. For Cohort A, transfemoral access was shown to be more cost-effective than traditional surgery in this high risk patient population. While this was not demonstrated for transapical access this is likely due to the small size of that cohort and the very early experience associated with the procedure. It is expected to improve in the larger continued access cohort. 

A Medtronic spokeswoman also issued a statement regarding the Belgian study about TAVI but it was less of a push back against the study’s conclusions:

Medtronic supports the diligent consideration of how to make new therapies available to patients so that their well-being is at the forefront of each decision. We call this “safe growth,” and this has been our mantra outside the U.S. where the CoreValve System has been available since 2007, and in the US where we are actively enrolling patients in our CoreValve U.S. Pivotal Trial.

We believe more data are needed to more accurately demonstrate the clinical benefit of TAVI for patients who are at lower risk, and that is why we have initiated the Medtronic SURTAVI Clinical Trial, which is the largest global, randomized controlled trial on TAVI patients. It is enrolling patients deemed to be at intermediate risk for open-heart surgery, and will compare the Medtronic CoreValve System with surgical aortic valve replacement (SAVR).