It was just a matter of time, wasn't it? Finally, on Friday the 13th no less, the FDA approved Boston Scientific's WATCHMAN left atrial appendage (LAA) closure device. The device has been on the brink for 5 years, ever since a panel voted tenuously in favor of approval in 2010. The FDA, however, felt that safety needed to be confirmed. The result was the PREVAIL trial, which despite the unique communication of its results passed the safety endpoint with flying colors, only to miss its primary efficacy endpoint.
Two more panel meetings and a whole bunch of follow-up data later, the device has finally been approved as a second-line therapy for patients with atrial fibrilliation and a high stroke risk. While the pathway has been tortuous, interventional cardiologists at this weekend's ACC conference in San Diego are excited and relieved to finally have commercial access to the device.
Specifically, a jam-packed session on stroke prevention Saturday afternoon featured Dr. Matthew Price and Dr. Brian Whisenant hinting at some of the trends we might see for this therapy going forward. Dr. Whisenant noted that the totality of clinical data favors LAA closure over medical management with oral anticoagulants (OACs) in many cases, but that for now it should remain a second-line therapy until more data is generated. He also noted that the data, and patient anecdotes, show a marked increase in quality of life after patients are able to cease warfarin therapy.
Dr. Price's talk was focused primarily on the balancing act between ischemic stroke prevention with OACs and the dangerous bleeding risks associated with them. Interestingly, Dr. Price noted that physician behavior is primarily driven by a fear of bleeding rather than ischemic stroke risk reduction. This was the most interesting observation made during the whole session, with regards to LAA closure device market potential. As one member of the audience stated, If you have a patient on warfarin, you should wake up in a sweat at least once per night, due to the risk of intracranial hemorrhage. Dr. Price also pointed out that during the terminal phase of device-based LAA closure i.e. 45 days post-procedure and onwards patients can be taken off dual anticoagulation or antiplatelet therapy, dramatically reducing their bleeding risk. With that in mind, the market for LAA closure devices looks to have a bright future.
Despite that bright future, rational dispersion is probably the smart way to go about rolling out this technology. Boston Scientific can learn from the success of TAVR; as Amy Simone pointed out in her TAVR discussion Saturday afternoon, the best way to sink a new technology is through poor patient selection. All signs point to LAA closure devices following the successful TAVR path: the company will roll out the technology only to experienced centers first, and has an extensive and effective training program to get new operators up to speed (as evidenced by excellent safety data for new operators in PREVAIL). Perhaps the vaunted heart team approach, a popular topic of conversation at ACC this year, will also lead to better patient outcomes as LAA closure devices finally become commercially available in the United States.
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