A new expert review not only summarizes what is known about percutaneous occlusion of the left atrial appendage (LAA) for stroke prevention in A-fib but also explores the critical issues involved in appropriately integrating the devices into clinical practice. The paper, published online June 29, 2015, ahead of print in the Journal of the American College of Cardiology, stems from a collaboration of the American College of Cardiology, the Heart Rhythm Society, and the Society for Cardiovascular Angiography and Interventions.

In the wake of the recent approval of the Watchman device (Boston Scientific), “[i]t is anticipated that the use of LAA occlusion technologies in clinical practice will expand,” the report notes. “The dissemination of this technology should proceed thoughtfully, guided by a coalition of stakeholders dedicated to delivering high-quality, patient-centered care while collecting the data necessary to determine optimal patient selection, effectiveness, and safety.”

Writing committee chair Frederick A. Masoudi, MD, of the University of Colorado Hospital (Denver, CO), and colleagues note that recent devices for LAA occlusion have been developed through multiple pathways, resulting in widely varying degrees of supporting evidence.

“Percutaneous LAA closure is technically challenging and may be achieved through different approaches (eg, internal occlusion [and] external ligation) that may vary in efficacy and safety,” they write. “As these technologies become available as potential alternatives to anticoagulation for stroke prevention in A-fib, it will be important for experienced centers and cohesive teams to guide deployment into clinical practice.

“Furthermore, mechanisms to rigorously evaluate the short- and long-term safety, comparative effectiveness, and cost-effectiveness of these approaches… must be developed,” the authors add.

To ensure that the technology is adopted in a way that optimizes patient outcomes, it will be necessary to develop and implement requirements for training, operator credentialing, and institutional policies, the statement says.

Timely, If Not Overdue

With the entire LAA occlusion field picking up momentum, this overview is timely, if not overdue, suggested Dhanunjaya Lakkireddy, MD, of the University of Kansas Medical Center (Kansas City, KS), in a telephone interview with TCTMD. However, he added, it is unlikely that major guidelines can be developed until more robust data are generated not just for Watchman but also for other devices.

Among the key questions raised by the statement is how to purposefully extend the therapies to patients not studied in the initial trials.

“The population that might best benefit from implantation of an LAA device is the high-CHA₂DS₂-VASc patients who are ineligible for oral anticoagulants due to prior bleeding or underlying disease state,” Robert J. Sommer, MD, of Columbia University Medical Center (New York, NY), told TCTMD in an email. He reported that he and his Columbia colleagues are also focusing on:

• Young patients at high stroke risk who are unlikely to take oral anticoagulants due to their active lifestyle
• Older high-risk patients who are prone to falling or other bleeding triggers
• Patients with DES who would be at increased bleeding risk if subjected to triple anticoagulant therapy

Dr. Lakkireddy agreed that “the biggest unanswered question” regarding LAA occlusion centers on warfarin-ineligible patients. “That’s where a quick registry or study should be done to show that these devices are in fact safe to use in this high-risk population, where the need seems to be greatest,” he said, also pointing to a potential role for LAA occlusion as an adjunct to ablation.

Following TAVR’s Lead

Taking a cue from the TAVR field, the authors underline the importance of hospitals assembling a multidisciplinary “heart team” and establishing structural heart disease and electrophysiology programs. Whether the LAA cases should be restricted to centers of excellence remains an open question.

In addition, they say, specific protocols should be put in place to assess patients’ stroke and bleeding risks, any contraindications to anticoagulation, adherence to and history of adequacy of anticoagulation, cardiac structural factors, and patient preferences. Specifically, standards should be established for pre- and postprocedural evaluation as well as for the timing and frequency of follow-up TEE.

Dr. Lakkireddy strongly endorsed the multidisciplinary concept.

“In the early days, the structural world was dominated by intervention,” he noted. “But now you also have electrophysiologists, who are the ones who see a lot of A-fib and are familiar with the LAA. The collaboration of an interventionalist, an electrophysiologist, and imaging specialists—all of whom bring different skill sets to the table—is very important to rigorous assessment of patients.” It is also helpful to have a surgeon onboard, he added, noting that together the team can evaluate the merits of each of the different LAA closure devices and choose the one best suited to an individual patient.

Ensuring appropriate operator training is also critical to safe expansion of LAA occlusion into the “real world,” the authors say. Though manufacturers often provide initial training, “it is incumbent on professional societies to set minimal performance standards for LAA procedures, develop the training curriculum, and establish the metrics for evaluation,” they add.

Performing septal punctures and maneuvering a sheath into the LAA are not trivial skills, Dr. Lakkireddy stressed. Manufacturers should set standards for operators by providing training, proctoring, and robust tracking of outcomes, he said.

In the case of Watchman, Boston Scientific is limiting initial use is to experienced, higher-volume centers, because the FDA is monitoring compliance with approval indications as well as complication rates, Dr. Sommer noted.

LAA Registry Key to Quality, Reimbursement

Also important, Dr. Masoudi and colleagues say, is careful tracking of real-world use.

“Addition of LAA occlusion to an existing registry or creation of a new registry similar to the TVT Registry [for transcatheter valve replacement and repair] would greatly benefit the still-nascent field of LAA occlusion technologies, in which the use of only one of multiple technologies is supported by randomized controlled trial data and significant learning curve effects exist,” they write. Ideally, the registry would include all devices, whether they are used on or off label, they note, adding that this would jibe with the FDA’s goal of enhanced postmarket surveillance of medical devices.

Importantly, this approach would also “provide payers with a mechanism to collect robust, consistent data in this patient population,” the authors observe.

Hopefully, such data would strengthen the case for reimbursement with third-party payers because “good outcomes drive coverage decisions,” Dr. Lakkireddy said. “It’s high time that we [undertook] standardized reporting of all devices. In fact, the American College of Cardiology has an LAA registry that is going to be kick-started anytime now.”

So far, the Centers for Medicare & Medicaid Services (CMS) has not issued a National Coverage Determination on LAA occlusion technology, Dr. Sommer observed, and in the meantime, “each regional CMS contractor is determining payment eligibility on their own, with remarkably disparate results.”

“I would anticipate that Watchman will start the process of getting coverage, and once the other devices do the necessary trials to show at least noninferiority to Watchman, then they should automatically be considered for approval as well,” Dr. Lakkireddy commented.

Now that Watchman is approved by the FDA, “it’s time that people started thinking about LAA occlusion more critically and not just as a research tool,” Dr. Lakkireddy concluded. “This statement suggests ways for individual physicians and institutions to be able to embrace the technology and do it more safely and effectively.”

Masoudi FA, Calkins H, Kavinsky CJ, et al. 2015 ACC/HRS/SCAI left atrial appendage occlusion device societal overview: a professional societal overview from the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2015;Epub ahead of print.

Disclosures:

• Dr. Masoudi reports no relevant conflicts of interest.
• Dr. Sommer reports serving as a principal investigator for the PREVAIL trial.
• Dr. Lakkireddy reports receiving an unrestricted research grant from SentreHEART and serving as principal investigator for the AMAZE trial and as a consultant to St. Jude Medical.

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