LAA Closure Device a Reality: Now What? (Video)

An expert’s take on FDA’s ‘appropriate rationale’ caveat

Oussama Wazni, MD

The FDA’s long-awaited approval earlier this year of the WATCHMAN™ left atrial appendage (LAA) closure device provides an alternative to oral anticoagulation therapy in high-risk patients with nonvalvular atrial fibrillation.

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The percutaneous LAA closure device is indicated to reduce the risk of thromboembolism in patients with nonvalvular afib who:

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
  • Are deemed by their physicians to be suitable for warfarin; and
  • Have an “appropriate rationale” to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device relative to warfarin.

“Since FDA left the indication open to ‘appropriate rationale’ when considering these types of patients, it’s important to define what that is in order to weigh the risks and benefits and select the best candidates,” says Oussama Wazni, MD, Director of the Outpatient Electrophysiology Department and Co-Director of the Ventricular Arrhythmia Center in Cleveland Clinic’s Section of Cardiac Electrophysiology and Pacing.

In this video, Dr. Wazni discusses his clinical criteria for “appropriate rationale”: Patients with a history of bleeding when taking oral anticoagulants, or those whose future risk of bleeding is deemed to be high. He adds: “Implanting the WATCHMAN device in these patients would prevent stroke, while at the same time avoiding the risk of bleeding.”

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