The likely source of registry data would be the database that will be created and maintained by the ACC according to an announcement from the ACC in August. This registry is seen by the ACC as addressing the need for a postapproval safety and efficacy assessment of 1,000 U.S. Watchman recipients that the FDA mandated as part of its device approval last March.
“The registry will function as the postapproval study mandated by the FDA,” said Dr. Varosy of Denver, who led the effort to develop and structure the ACC’s Watchman registry. One goal of the registry “will be to get a better understanding of how the device performs” in patients who can’t take an anticoagulant. “I think that’s where the strongest rationale is for having a device like this,” he said. “It would be great to do something for patients who can’t take warfarin, but until we have data for that group we’ll just have to wait.”
Recommendations detail appropriate Watchman rollout
A recent review of LAA occlusion-device options by the ACC, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions was an attempt by these three U.S. professional societies with a stake in AF management and LAA closure to “address issues critical to the appropriate integration of new technologies into the care of patients with AF” (J Am Coll Cardiol. 2015. doi:10.1016/j.jacc.2015.06.028]). One of the review’s most notable features is a section that makes specific recommendations about the composition of the physician team that assesses prospective AF patients for LAA closure and performs the procedure. The document suggests the process involve a team of physicians with expertise in electrophysiology, cardiac catheterization, stroke prevention, echocardiography, x-ray imaging, and possibly anesthesiology if general anesthesia is planned. The panel also recommended having a cardiac surgeon on hand for surgical backup if needed. The review also made recommendations on the facilities needed to safely and effectively perform LAA occlusion, the training that should be in place for the operator who performs the procedure, the protocols that should exist to guide patient management before, during, and after occlusion, the methods used to select AF patients for LAA occlusion, and the need for a U.S.-based LAA registry.
Despite these recommendations, “it is currently too early to tell how Watchman will be introduced into practice with respect to facilities, training, etc.,” Dr. Frederick A. Masoudi, a cardiologist at the University of Colorado in Denver and chair of the review committee, said in an interview. The three professional societies “are separately releasing a statement that focuses in greater detail on recommended operator characteristics and training.” This statement is still pending, he said.
A spokeswoman for Boston Scientific said that the company “supports the recommendations [from Dr. Masoudi’s committee], which are very much in line with our established criteria for new implanting centers. We are committed to the rational dispersion of the technology through a disciplined and highly selective approach to center identification. We will ensure that all implanters and implanting centers meet specific prerequisites including appropriate facilities and a dedicated and experienced team to perform the procedure. In addition, we will require implanters and echocardiographers to complete a rigorous clinical training program.”
As of late August, Boston Scientific identified on its website 32 U.S. centers performing LAA closure using Watchman. The company anticipates that about 100 U.S. centers will be performing the procedure by the end of 2015.
The PREVENT AF and PREVAIL pivotal trials for Watchman and their subsequent continued-access programs were sponsored by Boston Scientific. Dr. Kowey has been a speaker for Boston Scientific and has consulted for several drug companies that market anticoagulants. Dr. Weiss has been a speaker for Boston Scientific and also for St. Jude, Biosense Webster, and Stereotaxis. Dr. Kar has received research grants from Boston Scientific and served as principal investigator for the two continued-access programs that followed the two Watchman pivotal trials. He has also received research grants from Abbott Vascular and St. Jude, and has an equity interest in Coherex. Dr. Holmes and the Mayo Clinic have a financial interest in technology related to Watchman and this technology was licensed to Boston Scientific. Dr. Reddy has been an adviser to and received research grants from Atritech/Boston Scientific. Dr. Lakkireddy, Dr. Varosy, Dr. Masoudi, and Dr. Tomaselli had no disclosures.
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