TAVR Emerging As Next Big Application For Embolic Protection Devices

Article preview from Medtech Insight - July 2013

Studies suggest transcatheter aortic valve replacement is associated with a higher stroke risk than standard surgical valve replacement, presumably due to embolic debris released during the TAVR procedure. To address this concern, several companies are developing TAVR-specific embolic protection devices, and their success may prove to be a key driver of future growth in this $1+ billion market.

TAVR Emerging As Next Big Application For Embolic Protection Devices

Article preview from Medtech Insight - July 2013

Transcatheter aortic valve replacement (TAVR) has emerged as one of the most promising new cardiovascular device markets, and it is successfully penetrating a segment of the aortic stenosis population not well-served by current surgical therapies. Over the past 10 years, more than 50,000 TAVR procedures in over 40 countries have been performed in patients deemed too high risk for surgical aortic valve replacement (SAVR), according to an article in the March/April 2013 issue of Cardiology in Review (Tang et al). However, despite advances in TAVR technology and experience, periprocedural stroke remains a major concern.

In Edwards Lifesciences Corp.’s landmark PARTNER trial (investigating the company’s Sapien TAVR device), and in more recently released data, evidence has been documented on the release of embolic debris and potential cerebrovascular events during TAVR. Advanced patient age, atherosclerotic burden of the aorta, severity of aortic valve calcification, and implantation-related practices are cited as important contributing factors to these events.

Both Edwards’ PARTNER I and PARTNER II trials demonstrated stroke rates in the Sapien arms that were higher than those observed or expected with either medical therapy or standard surgical valve replacement, although TAVR stroke rates have improved over time with increasing experience. In the PARTNER trial (Cohort B), the rate of all stroke at one year was 10.6% in the Sapien arm versus 4.5% in the medical therapy arm, while Cohort B of the PARTNER II study demonstrated a one-year all-stroke rate of 5.7% in the Sapien arm and 5.9% in the Sapien XT arm, according to Edwards. Still, magnetic resonance imaging (MRI) studies have detected subclinical postprocedural ischemic brain lesions (suggesting silent embolic events) in up to 80% of TAVR patients, double the rate found following SAVR.

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