Background: The WATCHMAN left atrial appendage occluder device (Atritech, Inc, Minneapolis, MN) is currently being tested in a Food and Drug Administration-approved clinical trial, the PROTECT AF trial, for patients who are diagnosed with paroxysmal, persistent, or permanent nonvalvular atrial fibrillation. However, rigorous screening and the study design have resulted in the exclusion of a large number of patients. Hence, the purpose of this study was to assess the potential utility of this device among those who were eligible but excluded for trial criteria and the reasons for exclusion.
Methods: Screening logs from the respective sites participating in the PROTECT AF trial were collected and analyzed for potential utilization outside of a research trial. Only 31 patients were enrolled into the research trail from the screening of 1798 total patients.
Results: Information from the excluded patients was examined and it was determined that 79% of these patients would be eligible for the device outside the research trial. Twenty-one percent of patients were not able to receive the device because of long-term warfarin need, contraindications to warfarin, unsuitable anatomy as determined by echocardiography, or the inability to take short-term aspirin and clopidogrel for protocol requirements.
Conclusions: Should a device like the WATCHMAN left atrial appendage occluder be approved, approximately 79% of all patients with atrial fibrillation would be eligible for device placement.