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What MitraClip's indication expansion means for your CV program

March 15, 2019

    On March 14, 2019, FDA made the much-anticipated announcement that it has expanded indications for the MitraClip device to heart failure patients who also have moderate to severe mitral regurgitation (MR).

    TAVR program requirements are changing, are you ready?

    Transcatheter mitral valve repair using the MitraClip device allows physicians to treat MR through a catheter-based procedure instead of open heart surgery. When first approved in 2013, MitraClip was indicated only for patients with degenerative MR. FDA's latest move opens the door for MitraClip to treat what is often referred to as "secondary" or "functional" MR, a much broader patient group.

    Many in the medical community have been eagerly awaiting this announcement since the overwhelmingly positive COAPT trial results, revealed at TCT 2018, showcased the opportunity for MitraClip in this new patient population. However, indication expansion wasn't a sure bet, given another recent study in this patient population found no advantages of MitraClip compared with medical therapy.

    Welcome news for many CV service lines

    FDA's announcement will be welcome news for cardiovascular programs that have invested in MitraClip only to see modest program growth in recent years. Although on the market since 2013, transcatheter mitral valve repair has not seen the explosive growth that its sister procedure, transcatheter aortic valve replacement (TAVR), has. This disparity stems largely from the limited indications for TAVR to only a small subset of the overall MR market.

    In fact, our analysis found that 22 of 249 programs stopped offering MitraClip between fiscal year (FY) 2015 and FY2016. While the data can't specify the reasons, anecdotal evidence shows this drop off is likely due to challenges maintaining volume as well as finances for this procedure. However, this indication expansion to secondary MR opens up the procedure to a patient group estimated by trial leads to be 300,000 to 500,000 in the United States—a population even larger than the population TAVR could reach.

    Capacity may become an issue for structural heart programs

    With this indication expansion and the likely future approval of TAVR to low-risk candidates, hospitals with structural heart programs will need to evaluate if their infrastructure is poised to take on the increasing number of patients. The growth in both mitral and TAVR patients will put pressure on already capacity-constrained screening clinics, hybrid cath labs, care coordinators, operating physicians, and inpatient beds.

    For example, when we surveyed our membership in 2016, 60% of structural heart programs performed transcatheter procedures only one day a week. Looking forward, programs offering MitraClip will likely need to increase the number of procedure days, as well as focus on efficient post-procedure management of patients.

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