Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation (OAC) for thromboembolic risk reduction in patients with non-valvular atrial fibrillation (NVAF). Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with NVAF in whom OAC is indicated, but who have an appropriate rationale to seek a non-pharmaceutical alternative. Methods: This was a prospective, non-randomized, multi-center FDA study. The primary safety endpoint was the occurrence of one of the following events within 7 days post-procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness endpoint was the incidence of effective LAA closure (peri-device flow ≤5mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8{plus minus}8.6 years and the mean CHA2DS2-VASc score was 4.2{plus minus}1.5. The incidence of the primary safety endpoint was 0.5% with a one-sided 95% upper confidence interval (CI) of 1.6%, meeting the performance goal (PG) of 4.2% (P<0.0001). The incidence of the primary effectiveness endpoint was 100%, with a onesided 95% lower CI of 99.1%, again meeting the PG of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. Conclusions: LAA closure with this next generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02702271

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Aortic lesions pathognomonic for Spirocerca lupi were found in 123 of 150 (82%) coyotes, Canis latrans, 23 of 66 (35%) bobcats, Felis rufus, one of five gray foxes, Urocyon cinereoargenteus and one of two red foxes, Vulpes vulpes, examined in West Texas. Adult nematodes in the esophagus were recovered from 11 of 150 (7%) coyotes. In the aorta there was initially an acute inflammatory response followed by an eosinophilic granuloma surrounding larval nematodes. The principal lesions was scarring of the aorta with replacement of elastic tissue with collagen. There was blockage of the intervertebral arteries, pitting and formation of granulomatous nodules on the intimal surface and scarring with diverticula and anuerysms in affected animals. The response to adult nematodes in the esophagus was usually a small eosinophilic granuloma surrounding the worms. There was no evidence of esophageal sarcoma or spondylosis deformans of thoracic vertebrae as reported in the dog.

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